Patient interface

Abstract

A patient interface comprising: a plenum chamber; a seal-forming structure; a vent; a positioning and stabilising structure; wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient's head and comprising: a superior portion, a pair of lateral portions, and an anterior portion; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient's head to the plenum chamber in use; wherein the conduit strap portion is flexible in the anterior portion of the conduit strap portion; wherein the patient interface comprises a membrane portion connected to the anterior portion of the conduit strap portion, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion.

Description

PATIENT INTERFACE1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to Australian Patent Application No. 2024902530, filed 14 August 2024, the content of which is hereby incorporated by reference in its entirety.2 BACKGROUND OF THE TECHNOLOGY2.1 FIELD OF THE TECHNOLOGY

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

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

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

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

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

[0007] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upperA2578192 12.0 1airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem, e.g. see US Patent No. 4,944,310 (Sullivan).2.2.2 Therapies

[0008] 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.2.2.2.1 Respiratory pressure therapies

[0009] 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).

[0010] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.2.2.3 Respiratory Therapy Systems

[0011] 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.

[0012] 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.A2578192 12.0 22.2.3.1 Patient Interface

[0013] 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.

[0014] Certain mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.

[0015] Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.

[0016] Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.

[0017] Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.

[0018] Certain masks may cause some patients a feeling of claustrophobia, unease and / or may feel overly obtrusive.

[0019] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.A2578192 12.0 3

[0020] Consequently, some masks suffer from being obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and / or uncomfortable especially when worn for long or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy, especially if the mask is to be worn during sleep.

[0021] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0022] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0023] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.2.2.3.1.1 Seal-forming structure

[0024] 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.

[0025] 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 to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element thatA2578192 12.0 4surrounds 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.

[0026] A seal -forming structure that may be effective in one region of a patient’s face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead may not be appropriate to use on a patient’s nose.

[0027] Certain seal-forming structures may be designed for mass manufacture such that one design is able to fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass- manufactured patient interface, one or both must adapt in order for a seal to form.

[0028] One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0029] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.A2578192 12.0 5

[0030] Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.

[0031] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.

[0032] 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.

[0033] 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 Puri tan -Bennett Corporation.

[0034] 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).2.2.3.1.2 Positioning and Stabilising Structure

[0035] A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and / or claustrophobia when wearing the patient interface; and aesthetic appeal.A2578192 12.0 6

[0036] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some.

[0037] 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.2.2.3.1.3 Pressurised Air Conduit

[0038] 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.2.2.3.1.4 Pressurised Air Conduit used for Positioning / Stabilising the Seal- Forming Structure

[0039] 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.

[0040] 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.2.2.3.1 Respiratory Pressure Therapy (RPT) Device

[0041] 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 pressureA2578192 12.0 7therapies) 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.2.2.3.3 Air circuit

[0042] 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.2.1.3.4 Humidifier

[0043] 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.2.2.3.5 Data Management

[0044] 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.

[0045] 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.

[0046] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.2.2.3.6 Vent technologies

[0047] 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 ofA2578192 12.0 8a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.3 BRIEF SUMMARY OF THE TECHNOLOGY

[0048] 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.

[0049] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0050] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0051] 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.

[0052] 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.

[0053] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0054] 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 chamberA2578192 12.0 9throughout 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.

[0055] 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.

[0056] 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.

[0057] Another aspect of one form of the present technology is a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmfhO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the sealforming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head;A2578192 12.0 10wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use; wherein the conduit strap portion is flexible in the anterior portion of the conduit strap portion; wherein the patient interface comprises a cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber, and wherein the cushion structure comprises a membrane portion at least partially forming the plenum chamber, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion.

[0058] In examples:• the anterior portion of the conduit strap portion comprises a plenum chamber portion partially forming the plenum chamber; wherein the membrane portion is connected to the plenum chamber portion of the conduit strap portion along a path formed: along a superior side of the plenum chamber portion; along an inferior side of the plenum chamber portion; and on each lateral side of the conduit strap portion, along a patientfacing side of the plenum chamber portion between the superior side of the plenum chamber portion and the inferior side of the plenum chamber portion;• the membrane portion and the plenum chamber portion define an internal volume of the plenum chamber substantially in the shape of a triangular prism;• the plenum chamber portion of the conduit strap portion comprises at least one hole forming a plenum chamber inlet port, the at least one hole configured to provide the flow of air at the therapeutic pressure from inside the conduit strap portion into the plenum chamber;• the at least one hole comprises a pair of holes forming plenum chamber inlet ports;A2578192 12.0 11• the at least one hole comprises a slot aligned along a length of the conduit strap portion in the plenum chamber portion;• the patient interface comprises a cushion module removably attachable to the anterior portion of the conduit strap portion, the cushion module forming the cushion structure and the plenum chamber, the cushion module being fluidly connected to the anterior portion of the conduit strap portion, the cushion module comprising the membrane portion and comprising a chassis portion constructed and arranged to support the membrane portion;• the chassis portion is stiffer than the membrane portion;• the chassis portion is formed from an elastomeric material;• the chassis portion is attached to the anterior portion of the conduit strap portion;• the chassis portion comprises a connection portion and the anterior portion of the conduit strap portion comprises a connection portion, the connection portions of the chassis portion and the conduit strap portion being structured to allow removable attachment of the cushion module to the conduit strap portion;• the connection portions of the chassis portion and the conduit strap portion form a plenum chamber inlet port when the cushion module is attached to the conduit strap portion;• the connection portion of the chassis portion is a hole and the connection portion of the conduit strap portion is a protrusion structured to be received in the hole;• the connection portion of the chassis portion is a protrusion and the connection portion of the conduit strap portion is a hole structured to receive the protrusion;• the hole and protrusion are circular;• the hole and protrusion are non-circular to prevent relative rotation between the hole and protrusion when the protrusion is received in the hole;• the hole and protrusion are elliptical or oval;• one of the hole and protrusion comprises a keying portion and the other one of the hole and protrusion comprises a recess shaped to receive the keying portion;A2578192 12.0 12• the chassis portion comprises a pair of connection portions and the anterior portion of the conduit strap portion comprises a corresponding pair of connection portions;• the cushion module comprises the vent;• the vent is provided to the chassis portion of the cushion module;• the chassis portion comprises at least one vent hole forming the vent;• the vent is provided to an anterior wall of the chassis portion, the conduit strap portion passes over the anterior wall of the chassis portion inferiorly to the vent;• the vent is positioned in the mid-sagittal plane of the user’s head in use, and the conduit strap portion is shaped to intersect the mid-sagittal plane at a position inferior to the vent;• the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the chassis portion comprising one or more vent protrusions structured and positioned to prevent occlusion of the vent;• the one or more vent protrusions comprise a plurality of vent protrusions proximate the vent;• the one or more vent protrusions comprise one or more ribs proximate the vent;• the vent comprises a pair of vent holes each provided to the anterior wall of the chassis portion on a respective lateral side of the mid-sagittal plane, the conduit strap portion being shaped and positioned to overlie each vent hole of the pair of vent holes, the one or more vent protrusions comprising one or more vent protrusions proximate each vent hole and being structured and positioned to prevent occlusion of each vent;• the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the conduit strap portion comprising a non-inflatable portion overlying the vent, the non- inflatable portion comprising a vent passage through the conduit strap portion allowing the flow of gases exhaled by the patient to pass therethrough; and / or• the vent passage is formed by a diffusing material to diffuse the flow of gases exhaled by the patient passing therethrough.A2578192 12.0 13

[0059] In further examples:• the seal-forming structure is attached to the membrane portion;• the seal-forming structure comprises a pair of nasal pillows;• the nasal pillows are stalkless;• the seal-forming structure is at least partially formed by the membrane portion;• the membrane portion is constructed and arranged to form a seal in use against an at least partially inferior-facing portion of the patient’s pronasale, against the nasal alae and against the lip superior of the patient’s face in use;• the cushion structure comprises a support portion to which the membrane portion is attached, the support portion connecting the membrane portion to the conduit strap portion;• the support portion is formed from an elastomeric material;• the support portion is stiffer than the membrane portion;• the membrane portion is formed at least partially from a textile material;• the membrane portion has a patient-facing surface formed from a textile material;• the membrane portion comprises an air-impermeable layer; and / or• the membrane portion is formed from an elastomeric material.

[0060] In further examples:• the conduit strap portion is hollow in the anterior portion of the conduit strap portion and filled with air at the therapeutic pressure in use;• the conduit strap portion is formed at least partially from a textile material;• the conduit strap portion is formed at least partially from foam;• the lateral portions of the conduit strap portion are stiffer than the anterior portion of the conduit strap portion;• each of the lateral portions of the conduit strap portion has a cross section that is at least partially thermoformed to shape;• the cross section is substantially trapezoidal in shape;A2578192 12.0 14• the conduit strap portion has a thickness defined between a patient-facing side of the conduit strap portion and a non-patient facing side of the conduit strap portion, the thickness being greater in the lateral strap portions than in the anterior portion of the conduit strap portion;• the conduit strap portion is able to bend at the location at which it intersects the mid-sagittal plane of the patient’s head in use;• the superior portion of the conduit strap portion comprises a connector connected in use to each of the lateral portions of the conduit strap portion and comprising a connection port constructed to receive the flow of air at the therapeutic pressure into the conduit strap portion;• the connector comprises an elbow comprising the connection port; and / or• the connector comprises a transverse portion connected in use to each of the lateral portions of the conduit strap portion, the connector further comprising a short tube extending from the transverse portion and comprising the connection port.

[0061] Another aspect of one form of the present technology is a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmPbO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the sealforming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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,A2578192 12.0 15wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use; wherein the patient interface comprises a cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber; wherein the cushion structure comprises a membrane portion at least partially forming the plenum chamber, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion; and wherein the positioning and stabilising structure comprises a backstrap connecting between each of the lateral portions of the conduit strap portion and configured to overlie a posterior surface of the patient’s head in use, the positioning and stabilising structure further comprising a pair of tabs each provided to a respective one of the lateral portions of the conduit strap portion, the backstrap being configured to connect to each of the tabs, and wherein each tab is able to be connected to the respective lateral portion of the conduit strap portion at a range of positions along the lateral portion.

[0062] In further examples:• each tab is formed at least partially from a textile material;• each tab comprises an eyelet, the backstrap being configured to connect to the eyelets;• each eyelet is formed from a material stiffer than the textile material;A2578192 12.0 16• each eyelet is substantially rigid;• each tab is adjustably connected to the respective lateral portion of the conduit strap portion by a hook-and-loop connection;• each tab comprises a hook portion configured to be releasably connected to an unbroken loop material on a surface of the respective lateral portion of the conduit strap portion; and / or• each tab connects to a patient-facing surface of the respective lateral portion of the conduit strap portion.

[0063] Another aspect of one form of the present technology is a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmBLO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the sealforming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; andA2578192 12.0 17an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use; wherein the conduit strap portion is flexible in the anterior portion of the conduit strap portion; wherein the conduit strap portion is hollow in the anterior portion of the conduit strap portion and filled with air at the therapeutic pressure in use; wherein the lateral portions of the conduit strap portion are stiffer than the anterior portion of the conduit strap portion.

[0064] In examples:• each of the lateral portions of the conduit strap portion has a cross section that is at least partially thermoformed to shape;• the cross section is substantially trapezoidal in shape;• the conduit strap portion has a thickness defined between a patient-facing side of the conduit strap portion and a non-patient facing side of the conduit strap portion, the thickness being greater in the lateral strap portions than in the anterior portion of the conduit strap portion;• the conduit strap portion is able to bend at the location at which it intersects the mid-sagittal plane of the patient’s head in use;• the conduit strap portion is formed at least partially from a textile material;• the conduit strap portion is formed at least partially from foam;• the patient interface comprises a cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber, and wherein the cushion structure comprises a membrane portion at least partially forming the plenum chamber, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion;• the anterior portion of the conduit strap portion comprises a plenum chamber portion partially forming the plenum chamber;A2578192 12.0 18wherein the cushion structure is connected to the plenum chamber portion of the conduit strap portion along a path formed: along a superior side of the plenum chamber portion; along an inferior side of the plenum chamber portion; and along a patient-facing side of the plenum chamber portion between the superior side of the plenum chamber portion and the inferior side of the plenum chamber portion, on each lateral side of the conduit strap portion;• the membrane portion and the plenum chamber portion define an internal volume of the plenum chamber substantially in the shape of a triangular prism;• the plenum chamber portion of the conduit strap portion comprises at least one hole forming a plenum chamber inlet port, the at least one hole configured to provide the flow of air at the therapeutic pressure from inside the conduit strap portion into the plenum chamber;• the at least one hole comprises a pair of holes forming plenum chamber inlet ports;• the at least one hole comprises a slot aligned along a length of the conduit strap portion in the plenum chamber portion;• the patient interface comprises a cushion module removably attachable to the anterior portion of the conduit strap portion, the cushion module forming the cushion structure and the plenum chamber and being fluidly connected to the anterior portion of the conduit strap portion, the cushion module comprising the membrane portion and comprising a chassis portion constructed and arranged to support the membrane portion;• the chassis portion is stiffer than the membrane portion;• the chassis portion is formed from an elastomeric material;• the chassis portion is attached to the anterior portion of the conduit strap portion;• the chassis portion comprises a connection portion and the anterior portion of the conduit strap portion comprises a connection portion, the connection portions of the chassis portion and the conduit strap portion being structured to allow removable attachment of the cushion module to the conduit strap portion;A2578192 12.0 19• the connection portions of the chassis portion and the conduit strap portion form a plenum chamber inlet port when the cushion module is attached to the conduit strap portion;• the connection portion of the chassis portion is a hole and the connection portion of the conduit strap portion is a protrusion structured to be received in the hole;• the connection portion of the chassis portion is a protrusion and the connection portion of the conduit strap portion is a hole structured to receive the protrusion;• the hole and protrusion are circular;• the hole and protrusion are non-circular to prevent relative rotation between the hole and protrusion when the protrusion is received in the hole;• the hole and protrusion are elliptical or oval;• one of the hole and protrusion comprises a keying portion and the other one of the hole and protrusion comprises a recess shaped to receive the keying portion; and / or• the chassis portion comprises a pair of connection portions and the anterior portion of the conduit strap portion comprises a corresponding pair of connection portions;• the cushion module comprises the vent;• the vent is provided to the chassis portion of the cushion module;• the chassis portion comprises at least one vent hole forming the vent;• the vent is provided to an anterior wall of the chassis portion, the conduit strap portion passes over the anterior wall of the chassis portion inferiorly to the vent;• the vent is positioned in the mid-sagittal plane of the user’s head in use, and the conduit strap portion is shaped to intersect the mid-sagittal plane at a position inferior to the vent;• the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the chassis portion comprising one or more vent protrusions structured and positioned to prevent occlusion of the vent;A2578192 12.0 20• the one or more vent protrusions comprise a plurality of vent protrusions proximate the vent;• the one or more vent protrusions comprise one or more ribs proximate the vent;• the vent comprises a pair of vent holes each provided to the anterior wall of the chassis portion on a respective lateral side of the mid-sagittal plane, the conduit strap portion being shaped and positioned to overlie each vent hole of the pair of vent holes, the one or more vent protrusions comprising one or more vent protrusions proximate each vent hole and being structured and positioned to prevent occlusion of each vent;• the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the conduit strap portion a non-inflatable portion overlying the vent, the non-inflatable portion comprising a vent passage through the conduit strap portion allowing the flow of gases exhaled by the patient to pass therethrough; and / or• the vent passage is formed by a diffusing material to diffuse the flow of gases exhaled by the patient passing therethrough.

[0065] In further examples:• the seal-forming structure is attached to the membrane portion;• the seal-forming structure comprises a pair of nasal pillows;• the nasal pillows are stalkless;• the seal-forming structure is at least partially formed by the membrane portion;• the membrane portion is constructed and arranged to form a seal in use against an at least partially inferior-facing portion of the patient’s pronasale, against the nasal alae and against the lip superior of the patient’s face in use;• the cushion structure comprises a support portion to which the membrane portion is attached, the support portion connecting the membrane portion to the conduit strap portion;• the support portion is formed from an elastomeric material;• the support portion is stiffer than the membrane portion;A2578192 12.0 21• the membrane portion is formed at least partially from a textile material;• the membrane portion has a patient-facing surface formed from a textile material;• the membrane portion comprises an air-impermeable layer; and / or• the membrane portion is formed from an elastomeric material.

[0066] Another aspect of one form of the present technology is a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmBLO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the sealforming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head;A2578192 12.0 22wherein the patient interface comprises a cushion structure comprising the seal-forming structure, the cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber; wherein the conduit strap portion comprises an outer portion formed at least partially from a textile material and further comprises at least one air-impermeable bladder internal to the outer portion, the at least one bladder being structured to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use.

[0067] In examples:• the bladder is inflatable by the flow of air at the therapeutic pressure and, upon inflation, the bladder stiffens the conduit strap portion;• the bladder is formed by injection moulding;• the bladder comprises a wall having a thickness within a range of 0.2-lmm;• the thickness is in a range of 0.3-0.8mm, such as between 0.4-0.6mm;• the superior portion of the conduit strap portion comprises a connector connected in use to each of the lateral portions of the conduit strap portion and comprising a connection port constructed to receive the flow of air at the therapeutic pressure into the conduit strap portion;• the bladder comprises a superior end having a bladder inlet connector connected to the connector of the superior portion of the conduit strap portion;• the bladder is overmoulded to the bladder inlet connector;• the bladder inlet connector is fixedly attached to the outer portion of the conduit strap portion;• the bladder comprises an inferior end having a bladder outlet connector to supply the flow of air in use to the plenum chamber;• the bladder outlet connector passes through the outer portion of the conduit strap portion;• the bladder outlet connector is fixedly attached to the outer portion of the conduit strap portion;• the bladder is overmoulded to the bladder outlet connector;A2578192 12.0 23• the outer portion of the conduit strap portion comprises a textile patientcontacting layer and a textile non-patient contacting layer;• the patient-contacting layer and non-patient contacting layer are attached to each other along respective edges;• the patient-contacting layer and non-patient contacting layer are welded to each other along respective edges;• the non-patient contacting layer is thermoformed into a curved cross sectional shape;• the patient-contacting layer is substantially flat in cross section;• the patient interface comprises a cushion module removably attachable to the anterior portion of the conduit strap portion, the cushion module forming the cushion structure and the plenum chamber, the cushion module being fluidly connected to the bladder;• the cushion module comprises a membrane portion at least partially forming the plenum chamber, wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion, and wherein the cushion module comprises a chassis portion constructed and arranged to support the membrane portion;• the chassis portion comprises a connection portion structured to removably attach to the bladder outlet connector;• the connection portion of the chassis portion is a hole and the bladder outlet connector is a protrusion structured to be received in the hole;• the hole and protrusion are circular;• the hole and protrusion are non-circular to prevent relative rotation between the hole and protrusion when the protrusion is received in the hole;• the hole and protrusion are elliptical or oval;• one of the hole and protrusion comprises a keying portion and the other one of the hole and protrusion comprises a recess shaped to receive the keying portion; and / or• the at least one bladder comprises a pair of bladders provided to respective lateral sides of the conduit strap portion, and the chassis portion comprises a pair of connection portions respectively structured to removably attach to a pair of bladder outlet connectors of the pair of bladders.A2578192 12.0 24

[0068] 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.

[0069] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.A2578192 12.0 25

[0076] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.4 BRIEF DESCRIPTION OF THE DRAWINGS

[0077] 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:4.1 RESPIRATORY THERAPY SYSTEMS

[0078] Fig. 1 A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0079] 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.

[0080] 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.4.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0081] Fig. 2 A 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.

[0082] Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0083] Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior,A2578192 12.0 26mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.

[0084] Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.

[0085] Fig. 2E is a further side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. The coronal plane is also indicated.

[0086] Fig. 2F shows a base view of a nose with several features identified including naso-labial sulcus, lip inferior, upper Vermilion, naris, subnasale, columella, pronasale, the major axis of a naris and the midsagittal plane.

[0087] Fig. 2G shows a side view of the superficial features of a nose.

[0088] Fig. 2H shows subcutaneal structures of the nose, including lateral cartilage, septum cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.

[0089] Fig. 21 shows a medial dissection of a nose, approximately several millimeters from the midsagittal plane, amongst other things showing the septum cartilage and medial crus of greater alar cartilage.

[0090] Fig. 2J shows a front view of the bones of a skull including the frontal, nasal and zygomatic bones. Nasal concha are indicated, as are the maxilla, and mandible.

[0091] Fig. 2K shows a lateral view of a skull with the outline of the surface of a head, as well as several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is indicated. The following muscles are shown: digastricus, masseter, sternocleidomastoid and trapezius.

[0092] Fig. 2L shows an anterolateral view of a nose.4.3 PATIENT INTERFACE

[0093] Fig. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0094] Fig. 3A-1 shows forces acting on the patient interface of Fig. 3 A, while in use.A2578192 12.0 27

[0095] Fig. 3B shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3C.

[0096] Fig. 3C shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3B.

[0097] Fig. 3D shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a value of zero.

[0098] Fig. 3E shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3F.

[0099] Fig. 3F shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3E.

[0100] Fig. 3G shows a cushion for a mask that includes two pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.

[0101] Fig. 3H shows a cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0102] Fig. 31 shows the surface of a structure, with a one dimensional hole in the surface. The illustrated plane curve forms the boundary of a one dimensional hole.

[0103] Fig. 3J shows a cross-section through the structure of Fig.31. The illustrated surface bounds a two dimensional hole in the structure of Fig. 31.

[0104] Fig. 3K shows a perspective view of the structure of Fig. 31, including the two dimensional hole and the one dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 31.

[0105] Fig. 3L shows a mask having an inflatable bladder as a cushion.A2578192 12.0 28

[0106] Fig. 3M shows a cross-section through the mask of Fig. 3L, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask.

[0107] Fig. 3N shows a further cross-section through the mask of Fig. 3L. The interior surface is also indicated.

[0108] Fig. 30 illustrates a left-hand rule.

[0109] Fig. 3P illustrates a right-hand rule.

[0110] Fig. 3Q shows a left ear, including the left ear helix.

[0111] Fig. 3R shows a right ear, including the right ear helix.

[0112] Fig. 3S shows a right-hand helix.

[0113] Fig. 3T shows a view of a mask, including the sign of the torsion of the space curve defined by the edge of the sealing membrane in different regions of the mask.

[0114] Fig. 3U shows a view of a plenum chamber 3200 showing a sagittal plane and a mid-contact plane.

[0115] Fig. 3 V shows a view of a posterior of the plenum chamber of Fig. 3U. The direction of the view is normal to the mid-contact plane. The sagittal plane in Fig. 3 V bisects the plenum chamber into left-hand and right-hand sides.

[0116] Fig. 3W shows a cross-section through the plenum chamber of Fig. 3 V, the cross-section being taken at the sagittal plane shown in Fig. 3 V. A ‘mid-contact’ plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of a chord 3210 which lies on the sagittal plane and just touches the cushion of the plenum chamber at two points on the sagittal plane: a superior point 3220 and an inferior point 3230. Depending on the geometry of the cushion in this region, the mid-contact plane may be a tangent at both the superior and inferior points.

[0117] Fig. 3X shows the plenum chamber 3200 of Fig. 3U in position for use on a face. The sagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in position for use. The mid-contact plane corresponds generally to the ‘plane of the face’ when the plenum chamber is in position for use. In Fig. 3X the plenum chamber 3200 is that of a nasal mask, and the superior point 3220 sits approximately on the sellion, while the inferior point 3230 sits on the lip superior.A2578192 12.0 29

[0118] Fig. 3Z shows a patient interface having conduit headgear, in accordance with one form of the present technology.

[0119] Fig. 3Z-1 shows forces acting on the patient interface of Fig. 3Z, while in use.4.4 RPT DEVICE

[0120] Fig. 4 A shows an RPT device in accordance with one form of the present technology.

[0121] Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. The blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.4.5 HUMIDIFIER

[0122] Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0123] 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 5130.4.6 BREATHING WAVEFORMS

[0124] Fig. 6 shows a model typical breath waveform of a person while sleeping.4.7 MODULARITY

[0125] 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.

[0126] 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.

[0127] Fig. 7C shows a perspective view of tubes usable with either the cushion of Fig. 7 A or the cushion of Fig. 7B.

[0128] Fig. 7D shows a perspective view of rigidiser arms usable with either the cushion of Fig. 7 A of the cushion of Fig. 7B.A2578192 12.0 30

[0129] Fig. 7E shows a perspective view of headgear straps usable with the cushion of Fig. 7 A.

[0130] Fig. 7F shows a perspective view of headgear straps usable with the cushion of Fig. 7B.

[0131] Fig. 7G shows a front view of a pair of sleeves that is removably fitted to either the tubes of Fig. 7C or the rigi diser arms of Fig. 7D.

[0132] Fig. 7H shows a front view of a full sleeve that is removably fitted to the rigi diser arms of Fig. 7D.

[0133] Fig. 71 shows a front perspective view of yet another alternate form of a full sleeve that is removably fitted to the rigi diser arms of Fig. 7D.

[0134] 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.

[0135] Fig. 7K is a front view of a patient wearing the cushion of Fig. 7A connected to the rigi diser arms of Fig. 7D, the headgear straps of Fig. 7E, and the sleeve of Fig. 7H.

[0136] 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.

[0137] 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.

[0138] Fig. 7N is an isolated perspective view of the vent of Fig. 7L.

[0139] Fig. 70 is an isolated perspective view of a portion of the air circuit ofFig. 7M.

[0140] Fig. 7P is a schematic view illustrating the possible combinations of the patient interfaces.

[0141] Fig. 8A is an anterior perspective view illustration of a patient interface according to one example of the present technology.

[0142] Fig. 8B is a detail view of illustration of a portion of the patient interface shown in Fig. 8A.

[0143] Fig. 8C is an illustration of a triangular prism to illustrate the general shape of a plenum chamber of the patient interface shown in Fig. 8A.

[0144] Fig. 8D is an illustration of nasal pillows of the patient interface shown in Fig. 8A.A2578192 12.0 31

[0145] Fig. 8E is an illustration of the patient interface shown in Fig. 8A while worn by a patient.

[0146] Figs. 9A-9D are schematic illustrations of anterior portions of patient interfaces according to further examples of the present technology.

[0147] Fig. 10A is an anterior perspective view illustration of a patient interface according to another example of the present technology.

[0148] Fig. 10B is a detail view of illustration of a portion of the patient interface shown in Fig. 10A.

[0149] Fig. 10C is an anterior view illustration of a portion of the patient interface shown in Fig. 10A when worn by a patient.

[0150] Fig. 11 A is an exploded view of a cushion module and a portion of a conduit strap portion of a patient interface according to another example of the present technology.

[0151] Fig. 1 IB is a cross-section view of connection portions of a cushion module and conduit strap portion of the patient interface shown in Fig. 11 A.

[0152] Fig. 11C is an exploded view of a cushion module and a portion of a conduit strap portion of a patient interface according to another example of the present technology.

[0153] Fig. 12A is a perspective view of a patient-facing side of an anterior portion of a conduit strap portion of a patient interface according to another example of the present technology.

[0154] Fig. 12B is a lateral view of a cushion module configured to connect to the conduit strap portion shown in Fig. 12A.

[0155] Fig. 12C is a view of a connection portion of the conduit strap portion shown in Fig. 12A.

[0156] Fig. 12D is a view of a connection portion of the cushion module shown in Fig. 12B.

[0157] Figs. 13 A and 13B are perspective views of a patient interface according to another example of the present technology.

[0158] Fig. 14 is a perspective view of an anterior portion of a patient interface according to another example of the present technology.

[0159] Fig. 15A is a perspective view of a patient interface according to another example of the present technology.A2578192 12.0 32

[0160] Fig. 15B is a side view of the patient interface of Fig. 15A worn by a patient.

[0161] Figs. 16A and 16B are perspective views of a patient interface according to another example of the present technology.

[0162] Figs. 17A-17C are side views of cushion modules according to further examples of the present technology.

[0163] Figs. 18A-18C are side views of cushion modules according to further examples of the present technology.

[0164] Fig. 19 is a perspective view of a cushion module according to another example of the present technology.

[0165] Fig. 20A is a view of an outer portion of a conduit strap portion and a bladder of a conduit strap portion, in another example of the present technology.

[0166] Fig. 20B is a view of a conduit strap portion constructed from the outer portion and bladder shown in Fig. 20A.

[0167] Fig. 21 is a schematic illustration of the construction of a conduit strap portion according to another example of the present technology.

[0168] Fig. 22 is a side view of a cushion module according to another example of the present technology.

[0169] Fig. 23 is a schematic side view of a conduit strap portion according to another example of the present technology.5 DETAILED DESCRIPTION OF EXAMPLES OF THETECHNOLOGY

[0170] 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.

[0171] 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 singleA2578192 12.0 33feature or combination of features in any of the examples may constitute a further example.5.1 THERAPY

[0172] 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.

[0173] 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.

[0174] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.5.2 RESPIRATORY THERAPY SYSTEMS

[0175] 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 3800.5.3 PATIENT INTERFACE

[0176] 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 some forms, one physical component may provide one or more functional aspects. In use the seal -forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.

[0177] As shown in Fig. 3Z, 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 thatA2578192 12.0 34it or they can be replaced with different components, for example components of a different size.

[0178] 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.

[0179] 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.5.3.1 Seal-forming structure

[0180] 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.

[0181] In one form the target seal -forming region is located on an outside surface of the seal-forming structure 3100.

[0182] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.

[0183] A seal -forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0184] 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.5.3.1.1 Sealing mechanisms

[0185] In one form, the seal -forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respondA2578192 12.0 35to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.

[0186] In one form, the seal -forming structure 3100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter. The support flange is or includes a springlike element and functions to support the sealing flange from buckling in use.

[0187] In one form, the seal -forming structure may comprise a compression sealing portion or a gasket sealing portion. In use the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.

[0188] In one form, the seal -forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.

[0189] In one form, the seal -forming structure comprises a region having a tacky or adhesive surface.

[0190] In certain forms of the present technology, a seal -forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.5.3.1.2 Nose bridge or nose ridge region

[0191] In one form, the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.

[0192] In one form, the seal -forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.A2578192 12.0 365.3.1.3 Upper lip region

[0193] In one form, the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.

[0194] In one form, the seal -forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face.5.3.1.4 Chin-region

[0195] In one form the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on a chin-region of the patient's face.

[0196] In one form, the seal -forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face.5.3.1.5 Forehead region

[0197] In one form, the seal -forming structure that forms a seal in use on a forehead region of the patient's face. In such a form, the plenum chamber may cover the eyes in use.5.3.1.6 Nasal pillows

[0198] 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.

[0199] Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected.5.3.1.7 Nose-only Masks

[0200] 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 toA2578192 12.0 37seal 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.

[0201] 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.

[0202] 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. 3Z, 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 surface of 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.A2578192 12.0 38

[0203] In some forms, a nose-only mask may comprise nasal pillows, described above.5.3.1.8 Nose and Mouth Masks

[0204] 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.

[0205] 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”.

[0206] 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 include the 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 anA2578192 12.0 39oral portion, the nasal portion sealing to the patient’s face at similar locations to a nasal cradle mask.

[0207] 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.

[0208] 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.

[0209] 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.5.3.2 Plenum chamber

[0210] 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.

[0211] 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.

[0212] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.A2578192 12.0 40

[0213] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0214] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the sealforming structure.

[0215] In some forms, the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 3200 may be made from a material having Young's modulus of 0.1 GPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and 0.3MPa. An example of such a material is silicone.5.3.2.1 Multiple Openings

[0216] 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.

[0217] 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.

[0218] 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.

[0219] 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).5.3.2.1.1 Nose and Mouth Mask

[0220] 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 outA2578192 12.0 41of 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.

[0221] 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.

[0222] 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.5.3.2.1.2 Nose-only Mask

[0223] 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.

[0224] 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.

[0225] 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.

[0226] 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.5.3.3 Positioning and stabilising structure

[0227] 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 toA2578192 12.0 42hold 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.

[0228] 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).

[0229] 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.

[0230] 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 force Fpss 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).

[0231] 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).A2578192 12.0 43In 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.

[0232] 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 Fpienum tend 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 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 equilibrium.

[0233] 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.

[0234] 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 actualA2578192 12.0 44bulk 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.

[0235] 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.

[0236] 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.

[0237] 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.

[0238] 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.

[0239] 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.

[0240] 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 otobasionA2578192 12.0 45superior of the patient’s head and overlays a portion of a parietal bone without overlaying the occipital bone.

[0241] 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.

[0242] 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.

[0243] 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.

[0244] 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,

[0245] 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.5.3.3.1 Conduit headgear5.3.3.1.1 Conduit headgear tubes

[0246] 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. 3Z, 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 patientA2578192 12.0 46interface 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.

[0247] In the form of the present technology illustrated in Fig. 3Z, 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 with their 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.

[0248] 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.

[0249] 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.

[0250] In the form of the technology shown in Fig. 3Z, 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-shapedA2578192 12.0 47connector. 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.

[0251] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0252] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0253] 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 the third 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.

[0254] 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.

[0255] 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.

[0256] 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.

[0257] 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.A2578192 12.0 48

[0258] 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. 3Z, 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 parietal bone, over the frontal bone and / or over the junction therebetween (e.g. the coronal suture).

[0259] 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.

[0260] 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 ofA2578192 12.0 49the patient’s face, for example on either side of the patient’s nose and the patient’s lip superior.

[0261] 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. 3Z-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 FCOnduit directed may also be directed at least partially in the superior direction in order to overcome the gravitational force Fg.

[0262] 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.

[0263] 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.

[0264] 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 -formingA2578192 12.0 50structure 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).

[0265] 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 Fpienum tend 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 and stabilising 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 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 equilibrium.5.3.3.1.2 Extendable and non-extendable tube portions

[0266] 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 tubeA2578192 12.0 51comprising a tube wall having an extendable concertina structure. The patient interface 3000 shown in Fig. 3Z comprises tubes 3350, the superior portions of which comprise extendable tube sections each in the form of an extendable concertina structure 3362.

[0267] 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 may allow 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.

[0268] 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.

[0269] 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.

[0270] 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 chamberA2578192 12.0 523200. 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.5.3.3.1.3 Conduit headgear connection port

[0271] 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 3Z, 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 the patient interface 3000 comprises an elbow 3610 forming the connection port 3600. The elbow 3610 may be configured to fluidly connect with a conduit of an air circuit 4170. The elbow 3610 may be configured to swivel with respect to the positioning and stabilising structure 3300 to at least partially decouple the conduit from the positioning and stabilising structure 3300. In some examples the elbow 3610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 3350 by a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient’s head in use.

[0272] 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 duringA2578192 12.0 53movement 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).5.3.3.1.4 Headgear Tube Fluid Connections

[0273] 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. The tubes 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.

[0274] 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 orA2578192 12.0 54connector of the plenum chamber 3200 to form or enhance a seal between the tube 3350 and plenum chamber 3200.5.3.3.2 Headgear straps

[0275] 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).

[0276] 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. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and / or stretching of the headgear 3302.

[0277] 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.

[0278] 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.5.3.3.2.1 Four-point connection

[0279] 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.

[0280] 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 straps 3304-1 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 theA2578192 12.0 55posterior of the patient’s head, and may overlay the occipital bone and / or the trapezius muscle.

[0281] 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 straps 3305-1 may also connect to the tubes 3350 (e.g., by interfacing with the tabs 3320).

[0282] 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. The 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.

[0283] 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.

[0284] 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.

[0285] 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.

[0286] 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.A2578192 12.0 565.3.3.2.2 Two-point connection

[0287] 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.

[0288] 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.).

[0289] 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. 3Z, 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.

[0290] In the example shown in Fig. 3Z, 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. 3Z, 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.

[0291] 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.,A2578192 12.0 57configured 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).

[0292] 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 3340.5.3.3.3 Rigidiser Arm

[0293] 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.

[0294] 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).

[0295] 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).

[0296] 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.A2578192 12.0 58

[0297] In certain forms, the rigi diser arm 3340 may remain in the new position after being bent. This may allow a patient adjust the shape of the rigi diser arm 3340 for their specific head and then the rigi diser arm 3340 will keep the desired shape while in use in order to promote patient comfort.

[0298] 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.

[0299] In some forms, the arm connection structure 3504 may be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and 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.).

[0300] 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 3200.5.3.4 Vent

[0301] 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.A2578192 12.0 59

[0302] 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.

[0303] 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.

[0304] 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.

[0305] 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).

[0306] 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).

[0307] 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).

[0308] 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.A2578192 12.0 60

[0309] 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.

[0310] 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.).

[0311] 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.5.3.5 Decoupling structure(s)

[0312] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.5.3.6 Connection port

[0313] Connection port 3600 allows for connection to the air circuit 4170.5.3.7 Forehead support

[0314] In one form, the patient interface 3000 includes a forehead support 3700.5.3.8 Anti-asphyxia valve

[0315] In one form, the patient interface 3000 includes an anti-asphyxia valve.5.3.9 Ports

[0316] 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.5.3.10 Modularity

[0317] As described above, the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e.g., mouth breathing, nasalA2578192 12.0 61breathing, 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.

[0318] 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.

[0319] 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. 3Z). 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.

[0320] 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.5.3.10.1 Sleeve

[0321] 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 theA2578192 12.0 62sleeve 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.

[0322] 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.

[0323] 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.

[0324] 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.

[0325] 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.).5.3.10.1.1 Conduit Sleeve

[0326] 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.

[0327] 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).

[0328] 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.A2578192 12.0 63

[0329] 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.

[0330] 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).

[0331] 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.

[0332] 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.5.3.10.1.2 Four-point arm sleeve

[0333] 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.

[0334] 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).A2578192 12.0 64

[0335] 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.

[0336] 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).

[0337] 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 at an end of the inferior extension 3384, although the connection member 3386 could alternatively be positioned anywhere along the inferior extension 3384.

[0338] 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.

[0339] 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 3350.5.3.10.1.3 Two-point arm sleeve

[0340] 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.

[0341] 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.

[0342] 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 theA2578192 12.0 65two-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.

[0343] 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 3350.5.3.10.2 Assembled Patient Interfaces

[0344] 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 of patient interfaces) may simplify manufacturing and / or may allow a patient to more easily switch between styles of patient interfaces.5.3.10.2.1 Nose and Mouth Mask Tube Up Configuration

[0345] 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.

[0346] 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.

[0347] 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.

[0348] 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.

[0349] 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, eachA2578192 12.0 66inferior 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.5.3.10.2.2 Nose and Mouth Mask Tube Down Configuration

[0350] 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.

[0351] 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. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0352] 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.

[0353] 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.

[0354] 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.5.3.10.2.3 Nose Mask Tube Up Configuration

[0355] 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

[0356] 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 theA2578192 12.0 67illustrated example, the tubes 3350 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.

[0357] 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.5.3.10.2.4 Nose Mask Tube Down Configuration

[0358] 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.

[0359] 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 the cushion 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.

[0360] 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.5.3.10.2.5 Modularity of Elements

[0361] 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.5.3.11 Patient interface with conduit strap portion

[0362] Figs. 8A-11C show examples of patient interfaces 3000 according to further examples of the present technology, or components thereof.A2578192 12.0 68

[0363] The patient interfaces 3000 described with reference to Figs. 8A-11C may comprise one or more of a plenum chamber 3200, a seal-forming structure 3100, a vent 3400 and a positioning and stabilising structure 3300.

[0364] A plenum chamber 3200 may be as described elsewhere herein and may be pressurisable to a therapeutic pressure of at least 6 cmFFO above ambient air pressure and may comprise at least one plenum chamber inlet port 3212 being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. A seal -forming structure 3100 may be as described elsewhere herein and may be constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways. A seal-forming structure 3100 may have at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares. The seal -forming structure 3100 may be constructed and arranged to maintain said therapeutic pressure in the plenum chamber 3200 throughout the patient’s respiratory cycle in use.

[0365] A vent 3400 may be as described elsewhere and may be structured to allow a flow of gases exhaled by the patient from an interior of the plenum chamber 3200 to ambient and may be sized and shaped to maintain the therapeutic pressure in the plenum chamber 3200 in use. The vent 3400 may be a single hole, or may be a plurality of holes, and may or may not comprise a diffuser. In some examples the vent 3400 may comprise a slot and may comprise any suitable shape.

[0366] A positioning and stabilising structure 3300 may be as described elsewhere and may be configured to provide a force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient’s head. The positioning and stabilising structure 3300 may comprise a conduit strap portion 3330 and a backstrap 3310. The conduit strap portion 3330 and backstrap 3310 may form conduit headgear, some principles and behaviour of which are described elsewhere herein. Specific features and behaviour of the conduit strap portion 3330 according to examples of the present technology are described below.5.3.11.1 Conduit strap portion

[0367] In the patient interfaces 3000 shown in Figs. 8A-11C, the positioning and stabilising structure 3300 comprises a conduit strap portion 3330. The conduit strapA2578192 12.0 69portion 3330 may at least partially encircle a portion of the patient’s head. The conduit strap portion 3330 may comprise a superior portion 3331 positioned in use at a superior region of the patient’s head, as shown in Fig. 8E for example. The conduit strap portion 3330 may comprise a pair of lateral portions 3332 positioned in use at respective lateral sides of the patient’s head, one of which is visible in Fig. 8E. The lateral portions 3332 may each pass between a respective eye and ear of the patient. Also as shown in Fig. 8E, the conduit strap portion 3330 comprises an anterior portion 3333 positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head. For example, the anterior portion 3333 may pass through the mid-sagittal plane of the patient’s head from one side of the mid-sagittal plane to the other.

[0368] The conduit strap portion 3330 may be hollow at least in the superior portion 3331 and the lateral portions 3332 to convey the flow of air from the superior region of the patient’s head to the plenum chamber 3200 in use.

[0369] In the examples shown in Figs. 8A-11C, the conduit strap portion 3330 is flexible in the anterior portion 3333 of the conduit strap portion 3330. Flexibility in the anterior portion 3333 may advantageously prevent, limit or reduce disruptive forces received by the conduit strap portion 3330 from being transferred from one side of the conduit strap portion 3330 to the other lateral side and / or the seal-forming structure 3100 or plenum chamber 3200. A rigid anterior portion 3333 may instead transfer disruptive forces laterally from one lateral side of the conduit strap portion 3330 to the other, and to the seal-forming structure 3100, which may occur when the patient’s lies on their side and one lateral side of the conduit strap portion 3330 is pushed into the patient’s pillow. The anterior portion 3333 being flexible may in particular reduce, prevent or limit lateral shunting of the plenum chamber 3200. The flexibility may allow the material forming the anterior portion 3333 to deform to absorb disruptive forces instead of transferring them to the plenum chamber 3200 or seal-forming structure 3100.

[0370] In some examples of the present technology, such as the examples shown in Figs. 8A-11C, the conduit strap portion 3330 is hollow in the anterior portion 3333 of the conduit strap portion 3330 and filled with air at the therapeutic pressure in use. This advantageously stiffens the anterior portion 3333 of the conduit strap portionA2578192 12.0 703330 due to the pneumatic splint effect. Advantageously, this may help the conduit strap portion 3330 hold the plenum chamber 3200 and seal-forming structure 3100 in a stable position in use, while the flexibility in the material forming the anterior portion 3333 of the conduit strap portion 3330 remains able to deform to absorb disruptive forces that would otherwise tend to move the plenum chamber 3200 and / or disrupt the seal between the seal -forming structure 3100 and the patient’s face.

[0371] The conduit strap portion 3330 may be formed at least partially from a textile material and / or a foam material. In the examples shown in Figs. 8A-11C, the conduit strap portion 3330 is formed from foam with textile outer layers. The interior of the conduit strap portion 3330 may be lined with an air-impermeable layer, such as a film formed from silicone or another suitable polymer material.

[0372] In some examples of the present technology, the lateral portions 3332 of the conduit strap portion 3330 are stiffer than the anterior portion 3333 of the conduit strap portion 3330. Alternatively stated, the anterior portion 3333 is more flexible than the lateral portions 3332. The greater flexibility in the anterior portion 3333 may help prevent disruptive forces from being transferred from the lateral portions 3332 to the seal-forming structure 3100 in use. The lateral portions 3332 may be stiffer which may advantageously help them apply a force to hold the seal -forming structure 3100 in the sealing position in use and may advantageously allow the lateral portions 3332 to maintain a curved shape lying below the cheek bones. The lateral portions 3332 may nevertheless still be flexible (but less so than the anterior portion 3333) to provide for patient comfort, especially during side sleeping.

[0373] Each of the lateral portions 3332 of the conduit strap portion 3330 may have a cross section that is at least partially thermoformed to shape. The cross section is substantially trapezoidal in shape, as shown in Fig. 1 IB, which shows a cross section of the conduit strap portion 3330. The conduit strap portion 3330 has a thickness T defined between a patient-facing side of the conduit strap portion 3330 and a non-patient facing side of the conduit strap portion 3330. In the examples shown in Figs. 8A-11C, the thickness T is greater in the lateral strap portions 3332 than in the anterior portion 3333 of the conduit strap portion 3330. This may advantageously facilitate the conduit strap portion 3330 being more bendable or, more generally, more flexible, in the anterior portion 3333 than in the lateral portions 3332.A2578192 12.0 71The conduit strap portion 3330 may be able to bend at the location at which it intersects the mid-sagittal plane of the patient’s head in use. Other patient interfaces 3000 with conduit headgear may have a rigid portion intersecting the mid-sagittal plane, which may be more likely than the present technology to transfer disruptive forces from the positioning and stabilising structure 3300 to the seal-forming structure 3100. Additionally, in the examples shown in Figs. 8A-11C, the lateral portions 3332 of the conduit strap portion 3330 are integrally formed with the anterior portion 3333 of the conduit strap portion 3330. Advantageously, this means that the anterior portion 3333 and the lateral portions 3332 are not connected to each other by rigid connectors. This may advantageously further allow high bendability in the conduit strap portion 3330 and reduce the risk of transferring disruptive forces to the sealforming structure 3100 in comparison to other patient interfaces 3000 having conduit headgear with rigid connectors connecting an anterior portion 3333 of the conduit headgear to lateral portions 3332 thereof.

[0374] With reference to Fig. 8A, the superior portion 3331 of the conduit strap portion 3330 may comprise a connector 3335 connected in use to each of the lateral portions 3332 of the of the conduit strap portion 3330. The connector 3335 may comprise a connection portion 3600, which may be constructed to receive the flow of gas at the therapeutic pressure into the conduit strap portion 3330. The connector 3335 in this example comprises an elbow comprising the connection port 3600. The elbow may be rotatably connected to the body of the connector 3335 forming the superior portion 3331 and may be able to swivel / rotate about one, two or three axes. The elbow in this example is a decoupling structure which may advantageously help reduce tube drag. The elbow in this example is connected to a transverse portion 3336 connected in use to each of the lateral portions 3332 of the conduit strap portion 3330. In an alternative example, the connector 3335 forming the superior portion 3331 of the conduit strap portion 3330 comprises a transverse portion 3336 connected in use to each of the lateral portions 3332 of the conduit strap portion 3330, and the connector further comprises a short tube extending from the transverse portion and comprising the connection port 3600. The short tube may function as a decoupling structure to help reduce tube drag in use.A2578192 12.0 72

[0375] The conduit strap portion 3330, while flexible, may be substantially inextensible in length. Advantageously, this may facilitate the conduit strap portion 3330 to hold the seal-forming structure 3100 in sealing position against the user’s face in use. When therapeutic pressure is applied in use, the membrane portion 3220 (described below) expands until an equilibrium is reached between the expanding membrane portion 3220 and the hoop resistance provided by the substantially inextensible conduit strap portion 3330.

[0376] In some examples, the connector 3335 may be provided in multiple sizes. For example, the positioning and stabilising structure 3300 may comprise multiple connectors 3335, each having a transverse portion 3336 with a different length to the other(s). The different connectors 3335 would therefore provide conduit strap portions 3330 having different overall lengths / circumferences. The patient may select the connector 3335 which provides for a conduit strap portion 3330 that fits them best. Figs. 13A and 13B show one such patient interface 3000. As shown in Fig. 13A, the patient interface 3000 comprise a small connector 3335 fitted to the conduit strap portion 3330. A larger connector 3335 (with a longer transverse portion 3336) is shown separately in Fig. 13A. Fig. 13B shows the same patient interface 3000 assembled with the larger connector 3335 while the smaller connector 3335 is shown separately.5.3.11.2 Membrane portion and seal-forming structure

[0377] The patient interface 3000 may comprise a cushion structure 3250 connected to the anterior portion 3333 of the conduit strap portion 3330 and at least partially forming the plenum chamber 3200. The cushion structure 3250 may comprise a membrane portion 3220 at least partially forming the plenum chamber 3200. In some examples, such as the examples shown in 10A-10C and 11C, the membrane portion 3220 at least partially forms the seal-forming structure 3100. In other examples the seal-forming structure 3100 may be attached to the membrane portion 3220 as shown by way of example in Figs. 8A-9D and 11 A-l IB.

[0378] Referring to Figs. 8A-9D and 11 A-l IB, the seal-forming structure 3100 is attached to the membrane portion 3220, for example by adhesion, overmoulding or another suitable manner of attachment. In some examples the seal-forming structure 3100 may be permanently attached to the membrane portion 3220 and in otherA2578192 12.0 73examples the seal-forming structure 3100 may be removably attached, such as by a press fit, snap fit or any other suitable manner of removable attachment. The cushion structure 3250 may comprise the membrane portion 3220 and a seal-forming structure 3100 attached to the membrane portion 3220. In these examples the seal-forming structure 3100 comprises a pair of nasal pillows. As illustrated, the nasal pillows are stalkless, but in other examples the nasal pillows may each comprise a stalk. The stalk may be connected to the membrane portion 3220. In this example, the membrane portion 3220 is formed at least partially from a textile material. For example, membrane portion 3220 may have a patient-facing surface formed from the textile material. The plenum chamber 3200 may further comprise an air-impermeable layer, which may advantageously make the membrane portion 3220 airtight to maintain pressure in the plenum chamber 3200. The air-impermeable layer may be silicone, a thermoplastic elastomer (TPE) or other suitable polymer material. Such a membrane portion 3220 may have a thickness within the range of 0.3mm-lmm, for example. In other examples, the membrane portion 3220 may be formed from an elastomeric material such as silicone or a TPE. Such a membrane portion 3220 may have a thickness within the range of 0. Imm-lmm, for example.

[0379] The seal-forming structure 3100 may be at least partially formed by the membrane portion 3220. Referring to Figs. 10A-10C and 11C, the seal-forming structure 3100 is substantially entirely formed by the membrane portion 3220. In these examples the membrane portion 3220 is constructed and arranged to form a seal in use against an at least partially inferior-facing portion of the patient’s pronasale, against the nasal alae and against the lip superior of the patient’s face in use. The sealforming structure 3100 is in the form a nasal cradle cushion, which is also described elsewhere herein. In this example, the cushion structure 3250 comprises a membrane portion 3220 and a support portion 3222 connecting the membrane portion 3220 to the conduit strap portion 3330. The support portion 3222 in these examples is formed from an elastomeric material, such as silicone or TPE. The support portion 3222 may be stiffer than the membrane portion 3220. In this example the membrane portion 3220 is formed at least partially from a textile material, as described above. The membrane portion 3220 with a textile patient-facing surface may provide for a comfortable feel on the patient’s face while the stiffer elastomeric support portion 3222 may advantageously provide flexible support to the patient-facing surface. InA2578192 12.0 74other examples, the membrane portion 3220 may be formed from an elastomeric material (e.g. silicone or TPE), as described above.5.3.11.3 Plenum chamber

[0380] In the examples shown in Figs. 8A-9D, the anterior portion 3333 of the conduit strap portion 3330 comprises a plenum chamber portion 3334 partially forming the plenum chamber 3200. The membrane portion 3220 is connected to the plenum chamber portion 3334 of the conduit strap portion 3330 along a path P. Said path P may be formed along a superior side of the plenum chamber portion 3334 and along an inferior side of the plenum chamber portion 3334. The path P may be further formed along a patient-facing side of the plenum chamber portion 3334 between the superior side of the plenum chamber portion 3334 and the inferior side of the plenum chamber portion 3334, on each lateral side of the conduit strap portion 3330. Figs. 8A and 8B show the path P along which the membrane portion 3220 is connected to the plenum chamber portion 3334 of the conduit strap portion 3330 on the superior side of the plenum chamber portion 3334. The portion of the path P along the inferior side of the plenum chamber portion 3334 may be substantially the same as the portion of the path P along the superior side. The portions of the path P along the patient-facing side of the plenum chamber portion 3334 between the superior side of the plenum chamber portion 3334 and the inferior side of the plenum chamber portion 3334 are labelled in Fig. 8D. Additionally, Figs. 9A-9D show schematic views of four exemplary paths along the patient-facing sides of the plenum chamber portion 3334. As shown in Figs. 10A-10C, the cushion structure 3250 (specifically the support portion 3222 in this example) is attached to the conduit strap portion 3330 along a path P which may be similar to the path P along which the membrane portion 3220 is attached in the examples shown in Figs. 8A-9D.

[0381] The membrane portion 3220 and the plenum chamber portion 3334 may define an internal volume of the plenum chamber 3200 substantially in the shape of a triangular prism. This shape is depicted in isolation in Fig. 8C. The flexible membrane portion 3220 defines the superior, inferior and patient-facing sides of the plenum chamber 3200. The conduit strap portion 3330 defines the two anterolateral sides of the plenum chamber 3200. The conduit strap portion 3330 is stiffer than the membrane portion 3220 and provides support that holds the shape of the plenumA2578192 12.0 75chamber 3200 while the more flexible membrane portion 3220 is able to inflate and / or conform to assist the seal -forming structure 3100 to form a comfortable, stable seal during use.

[0382] The stiffness of the lateral and anterior sides of the plenum chamber 3200 are provided partially by the material forming the conduit strap portion 3330 and partially by the flow of air through the anterior portion 3333 of the conduit strap portion 3330 at the therapeutic pressure. The air inside the conduit strap portion 3330 and / or plenum chamber 3200 is sufficiently pressurised in use to stiffen the conduit strap portion 3330. The pressurised air provides a pneumatic splint effect. The material forming the conduit strap portion 3330, while providing some stiffness to the shape of the plenum chamber 3200, is advantageously somewhat loose and floppy in the absence of air pressure within its hollow interior. The internal pressure produces, within the conduit strap portion 3330 and / or plenum chamber 3200, an inflating and stiffening effect without requiring the anterior portion 3333 of the conduit strap portion 3330 to be formed from a rigid material or otherwise rigidised (which could result in an actual or perceived lack of comfort and / or may have a tendency to pass disruptive forces from the conduit strap portion 3330 to the seal-forming structure 3100 which may disrupt the seal resulting in leaks).

[0383] In the examples shown in Figs. 8A-10C, the plenum chamber portion 3334 of the conduit strap portion 3330 comprises at least one hole (not visible) forming a plenum chamber inlet port 3212 (not shown in Figs. 8A-10C but shown in Fig. 1 IB). The at least one hole may be configured to provide the flow of air at the therapeutic pressure from inside the conduit strap portion 3330 into the plenum chamber 3200. In some examples, the at least one hole comprises a pair of holes forming plenum chamber inlet ports 3212. That is, there are two holes, for example one on each lateral side of the plenum chamber 3200. In other examples, the at least one hole may comprise a slot aligned along a length of the conduit strap portion 3330 in the plenum chamber portion 3334. In further examples, the conduit strap portion 3330 may be tubular on each lateral side of the plenum chamber 3200 and plenum chamber portion 3334, but the plenum chamber portion 3334 of the conduit strap portion 3330 may be substantially entirely open inside of the path P along which the membrane portion 3220 is connected to the conduit strap portion 3330. For example,A2578192 12.0 76the plenum chamber portion 3334 of the conduit strap portion 3330 may comprise only an anterior wall defining the anterior side of the plenum chamber 3200.

[0384] In the example shown in Figs. 8A-9D, the seal-forming structure 3100 comprises a pair of nasal pillows. The nasal pillows are attached to the membrane portion 3220. In use, the membrane portion 3220 inflates to urge the nasal pillows towards the patient’s nares. This may advantageously provide for a stable seal in use. Some of the membrane portion 3220 may also engage the user’s face. For example, the membrane portion 3220 may engage the user’s lip superior in use, while the nasal pillows forming the seal-forming structure 3100 engage and seal to the nares.

[0385] It is described above that the membrane portion 3220 may be connected to the plenum chamber portion 3334 of the conduit strap portion 3330 along a path P, and that portions of the path P may be formed along a patient-facing side of the plenum chamber portion 3334 between the superior side of the plenum chamber portion 3334 and the inferior side of the plenum chamber portion 3334, on each lateral side of the conduit strap portion 3330. The profiles of the path P on each lateral side of the plenum chamber 3200 may vary between examples of the present technology. That is, the membrane portion 3220 may be connected to the conduit strap portion 3330 along paths having different shapes / profiles, in different examples. Figs. 9A-9D show schematic views of anterior portions 3333 in four different examples of the present technology to illustrate four possible profiles of the path P where the membrane portion 3220 is joined to the conduit strap portion 3330 at the lateral sides of the plenum chamber 3200. In the example shown in Fig. 9A, the lateral portions of the path P may form a convex profile which may provide the portion of the membrane portion 3220 that engages the lip superior with a convex shape having a generous radius of curvature. This may advantageously provide for high comfort levels. In Fig. 9B the path P is less convex and close to straight. In Fig. 9C the lateral portion of the path P travels as far as possible anteriorly at the inferior end of the path P. This creates a short inferior edge of the path P which spans from one lateral side of the plenum chamber 3200 to the other and may advantageously reduce contact of the membrane portion 3220 on the user’s lip superior. In Fig. 9D the lateral portion of the path P travels as far as possible anteriorly at both superior and inferior ends thereof.A2578192 12.0 77This may advantageously provide for a plenum chamber 3200 having a low profile / minimal appearance.5.3.11.4 Cushion module

[0386] In the examples shown in Figs. 11 A-l 1C, the patient interface 3000 comprises a cushion module 3150 removably attachable to the anterior portion 3333 of the conduit strap portion 3330. The cushion module 3150 may form the cushion structure 3250 and the plenum chamber 3200 and may be fluidly connected to the anterior portion 3333 of the conduit strap portion 3330. The cushion module 3150 in these examples comprises the membrane portion 3220 and may comprise a chassis portion 3225 constructed and arranged to support the membrane portion 3220. The chassis portion 3225 may be stiffer than the membrane portion 3220. The chassis portion 3225 may be constructed to support the perimeter of the membrane portion 3220 allowing a central portion of the membrane portion 3220 to be loose to inflate under the therapeutic pressure and deform as required for a good seal between the seal-forming structure 3100 and the user’s face. In some examples, the chassis portion 3225 is formed from an elastomeric material such as silicone or TPE. The chassis portion 3225 may provide similar functions to the support portion 3222 described above.

[0387] The chassis portion 3225 may be attached to the anterior portion 3333 of the conduit strap portion 3330. As shown in Figs. 11 A-l 1C, the chassis portion 3225 in these examples comprises a connection portion 3223 and the anterior portion 3333 of the conduit strap portion 3330 comprises a connection portion 3224. The connection portions 3223, 3224 of the chassis portion 3225 and the conduit strap portion 3330 are structured to allow removable attachment of the cushion module 3150 to the conduit strap portion 3330. Additionally, in these examples, each pair of the connection portions 3223, 3224 of the chassis portion 3225 and the conduit strap portion 3330 forms a plenum chamber inlet port 3212 when the cushion module 3150 is attached to the conduit strap portion 3330. As shown in Figs. 11 A-l IB, the connection portion 3223 of the chassis portion 3225 is a hole and the connection portion 3224 of the conduit strap portion 3330 is a protrusion structured to be received in the hole. As shown in Fig. 11C, the connection portion 3223 of the chassis portion 3225 is a protrusion and the connection portion 3224 of the conduit strap portion 3330A2578192 12.0 78is a hole structured to receive the protrusion. The holes and protrusions are interchangeable. Either or both of the hole and protrusion may comprise a lip, flange or like to help achieve a good fit. The connection portions 3223, 3224 may connect together with an interference fit, radial snap fit or other suitable manner of connection. In the examples shown in Figs. 11 A-l 1C, the chassis portion 3225 comprises a pair of connection portions 3223 and the anterior portion 3333 of the conduit strap portion 3330 comprises a corresponding pair of connection portions 3224. Examples of the present technology which include a cushion module 3150 may advantageously allow for the cushion module 3150 (and therefore seal-forming structure 3100) to be provided in different sizes and / or different seal types (e.g. cradle or pillows), to be selected by a patient or clinician based on anatomy and / or personal preference.

[0388] Figs. 12A-12D illustrate a similar manner of connection between a cushion module 3150 and an anterior portion 3333 of a conduit strap portion 3330. Only certain differences will be described in detail. In this example the connection portion 3223 of the chassis portion 3225 is a hole and the connection portion 3225 of the conduit strap portion 3330 is a protrusion. The hole and the protrusion are noncircular in this example, which may advantageously prevent relative rotation between the hole and protrusion when the protrusion is received in the hole. Additionally, the non-circular shape may ensure that when the chassis portion 3225 is connected to the conduit strap portion 3330, the seal-forming structure 3100 is presented to the patient’s face at the correct orientation. The connection portions 3223 and 3224 may have any complementary non-circular shape, and in this example the hole and protrusion are elliptical. In other examples they may be oval, square, rectangular, triangular or any other shape that will not allow relative rotation between the two connection portions 3223 and 3224.

[0389] In some examples, the connection portions 3223, 3224 may additionally, or alternatively, comprise complementary features to ensure correct alignment during assembly and / or prevent relative rotation between the conduit strap portion 3330 and cushion module 3150. In particular, one of the hole and protrusion may comprise a keying portion 3226 and the other one of the hole and protrusion may comprise a recess 3227 shaped to receive the keying portion 3226. The keying portion mayA2578192 12.0 79comprise a protrusion sized and positioned to fit within the recess 3227. With reference to Figs. 12C and 12D in particular, in this example the chassis portion comprises the keying portion 3226 extending inwardly with respect to the hole which forms the connection portion 3223 and the conduit strap portion 3330 comprises the recess 3227 provided to the protrusion. In this example the protrusion forming the connection portion 3223 of the conduit strap portion 3330 comprises a lip over which the chassis portion 3225 must be stretched during assembly. The recess 3227 is in this example formed in the lip. The keying portion 3226 is positioned internally such that once the material of the chassis portion 3225 is stretched over the lip, the keying portion 3226 aligns and fits into the recess 3227. The chassis portion 3225 may be formed from silicone, TPE or another elastomeric material able to be stretched to fit to each of the protrusions on the conduit strap portion 3330. Likewise, the elastomeric material forming the chassis portion 3225 allows the user to peel the cushion module 3150 and conduit strap portion 3330 apart. The membrane portion 3220 may be bonded around a perimeter edge of the chassis portion 3225.

[0390] Figs. 17A-17C, 18A-18C and 19 show further examples of cushion modules 3150. As illustrated, the cushion module 3150 may be provided in different sizes, such as a small size shown in Fig. 17 A, a medium size shown in Fig. 17B and a large size shown in Fig. 17C. Fig. 18A-18C show cushion modules 3150 having chassis portions 3225 which vary in shape and size. A chassis portion 3150 which angles upwards towards the middle from the sides, such as is shown in Fig. 18A and, to a lesser extent, in Fig. 18B may be preferred by some patients due to less ballooning of the membrane portion 3220 on the patient’s upper lip in use. The cushion module 3150 shown in Fig. 18C may be suitable for, and may be preferred by, other patients. Fig. 19 shows an example of a cushion module 3150 of the nasal cradle / under-the-nose type. In this example the seal-forming structure 3100 may seal to at least at portion of the pronasal e, nasal alae and lip superior of the patient’s face. Under-the-nose cushion modules 3150 may comprise a support portion 3222 supporting the membrane portion 3220. The support portion 3222 may be part of the chassis portion 3225 or may be an intermediate portion / component, for example a portion overmoulded to the chassis portion. Under-the-nose cushion modules 3150 (e.g. the type shown in Fig. 19) may be provided with support portions 3222 having aA2578192 12.0 80range of sizes, to provide a range of under-the-nose cushion modules 3150 with different presentation angles and different fits for different patients.

[0391] Each cushion module 3150 may comprise a connection portion 3223 structured to connect to a corresponding connection portion 3224 of the type shown in Fig. 12A. It is to be understood that the cushion modules 3150 disclosed herein may be adapted to be used with any suitable conduit strap portion 3330. Likewise, the conduit strap portions 3330 and positioning and stabilising structures 3300 disclosed herein may be adapted to connect to and be used with any suitable cushion module 3150.5.3.11.5 Exemplary vents

[0392] As described above, the patient interface 3000 may comprise a cushion module 3150. In some examples the cushion module 3150 may comprise the vent 3400. Fig. 14 shows one such example. As illustrated, in this example the vent 3400 is provided to the chassis portion 3225 of the cushion module 3150. The chassis portion 3225 may comprise at least one vent hole forming the vent 3400. As shown in Fig. 14, the vent 3400 may be provided to an anterior wall of the chassis portion 3225 and the conduit strap portion 3330 may pass over the anterior wall of the chassis portion 3225 inferiorly to the vent 3400. The conduit strap portion 3330 may be shaped so as to not cover, overlie or occlude the vent 3400. As shown in Fig. 14, the vent 3400 is positioned in the mid-sagittal plane of the user’s head in use, and the conduit strap portion 3330 is shaped to intersect the mid-sagittal plane at a position inferior to the vent 3400. The vent 3400 is positioned superiorly with respect to the conduit strap portion 3330 in the mid-sagittal plane in front of the patient’s face. This arrangement ensures the vent flow remains unhindered. The vent 3400 in this example may be a rectangular slot. In other examples the vent 3400 may comprise a plurality of vent holes. In some examples the vent 3400 may be provided at the location shown in Fig. 14 and described above, and may be comprise a plurality of vent holes formed in a rigid insert.

[0393] Fig. 22 shows another example of the present technology in which a vent 3400 is provided to an anterior wall of the chassis portion 3225 of a cushion module 3150. In this example the conduit strap portion 3330 is shaped and positioned to overlie the vent 3400 in use and the chassis portion 3225 comprises one or more ventA2578192 12.0 81protrusions 3401 structured and positioned to prevent occlusion of the vent 3400. The vent protrusions 3401 may advantageously hold the conduit strap portion 3330 off of the vent 3400 to prevent the conduit strap portion 3330 preventing vent flow. As shown in Fig. 22, the chassis portion 3225 comprises a plurality of vent protrusions 3401 proximate the vent, four in this particular example. In other examples there may be any number of vent protrusions 3401. In this example the vent protrusions 3401 are studs / bumps / knobs, and in other examples the vent protrusions 3401 may comprise one or more ribs proximate the vent 3400. In this particular example, the vent 3400 comprises a pair of vent holes each provided to the anterior wall of the chassis portion 3225 on a respective lateral side of the mid-sagittal plane (only one vent hole of which is visible in the side view of Fig. 22). The conduit strap portion 3330 is shaped and positioned to overlie each vent hole of the pair of vent holes. In this example there are one or more vent protrusions 3401 proximate each vent hole, which are structured and positioned to prevent occlusion of each vent 3400. In this example there is a vent 3400 on each lateral side of the cushion module 3150. In other examples the cushion module 3150 may comprise multiple vents 3400 on each lateral side, one vent 3400 in the middle of the cushion module 3150 (e.g. in the mid-sagittal plane), multiple vents in the middle of the cushion module 3150, or a combination thereof.

[0394] Fig. 23 shows schematically another arrangement of a conduit strap portion 3330 in which a vent 3400 may be provided to an anterior wall of the chassis portion 3225 (not shown) and the conduit strap portion 3330 is shaped and positioned to overlie the vent 3400 in use. However, instead of, or in addition to, the vent protrusions 3401, in this example the conduit strap portion 3330 comprises a non- inflatable portion 3337 overlying the vent, the non-inflatable portion 3337 comprising a vent passage 3402 through the conduit strap portion 3330 allowing the flow of gases exhaled by the patient to pass therethrough. The vent passage 3402 may be open or may be formed by a diffusing material to diffuse the flow of gases exhaled by the patient passing therethrough, which may advantageously provide for a quiet vent 3400. As shown in Fig. 23, a seam S separates the non-inflatable portion 3337 from the hollow inflatable part of the conduit strap portion 3330. The location of the connection portion 3224 of the conduit strap portion 3330 is indicated in broken lines. In other examples the conduit strap portion 3330 may not comprise a seam S and theA2578192 12.0 82conduit strap portion 3330 may otherwise transition from a hollow portion to a nonhollow portion at the location of seam S in Fig. 23. The diffuser material may comprise an open weave textile material which allows air to pass through, or another material that allows air to pass through while diffusing the vent flow.5.3.11.6 Backstrap and associated exemplary connections

[0395] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a backstrap 3365 connecting between each of the lateral portions 3332 of the conduit strap portion 3330 and configured to overlie a posterior surface of the patient’s head in use. Fig. 15B shows an example of a patient interface 3000 comprising a backstrap 3365 while worn by a patient. Figs. 15A and 16A-16B show portions of the patient interface 3000. In some examples, the positioning and stabilising structure 3300 comprises a pair of tabs 3360 each provided to a respective one of the lateral portions 3332 of the conduit strap portion 3330. The backstrap may be configured to connect to each of the tabs 3360. Each tab 3360 may be at least partially formed from a textile material, which may be a textile material also used for other portions of the conduit strap portion 3330 or may be a different textile material. Additionally or alternatively, each tab 3360 may be formed at least partially from foam, such as a foam-textile laminate.

[0396] As shown in Fig. 15A in particular, each tab 3360 comprises an eyelet 3361, the backstrap 3365 being configured to connect to the eyelets 3361. The eyelets 3361 may comprise slots sized to receive the backstrap 3365. In some examples, each eyelet 3361 may be formed from a material stiffer than the textile material. For example, each eyelet 3361 may be substantially rigid (e.g. the material defining the slot may be substantially rigid 3361). In some examples, the eyelets 3361 may be formed from a substantially rigid thermoplastic material. In other examples the eyelets 3361 may be stiffer than the textile forming the tabs 3360 but may be formed from an elastomeric material such as silicone or TPE. The backstrap 3365 may pass through each of the eyelets 3361, loop back and may be secured to itself, on each lateral side of the patient’s head, for example with a hook-and-loop connection or ladderlock connection, which advantageously provide for adjustment of an effective length of the backstrap 3365.A2578192 12.0 83

[0397] Each tab 3360 may be adjustably connected to a respective one of the lateral portions 3332 of the conduit strap portion 3330. As shown in Figs. 16A-16B, each tab 3360 is connected to a respective lateral portion 3332 by a hook-and-loop connection. Each tab may be able to be connected to the respective lateral portion 3332 of the conduit strap portion 3330 at a range of positions along the lateral portion 3332. Advantageously, this may allow the patient to adjust the fit of the positioning and stabilising structure 3300 to achieve an optimal balance between comfort, stability and seal performance (e.g. no or minimal leaks). In this particular example each tab 3360 comprises a hook portion 3366 configured to be releasably connected to an unbroken loop material 3367 on a surface of the lateral portion 3332 of the conduit strap portion 3330. The hook portion 3366 may comprise a broken loop material configured to releasably attach to the unbroken loop material 3367. In some examples the unbroken loop material 3367 may be formed separately and may be applied to the material forming the conduit strap portion 3330, as shown in the example of Figs. 16A and 16B. In other examples, the unbroken loop material 3367 may be the same material forming the conduit strap portion 3330. In further other examples, the tab 3360 may comprise an unbroken loop material structured to releasably connect to a broken loop material provided to the conduit strap portion 3330. In the example shown in Figs. 16A and 16B, each tab 3360 connects to a patient-facing surface of the respective lateral portion 3332 of the conduit strap portion 3330. This may allow for a more robust connection of the tab 3360 to the conduit strap portion 3330 when the conduit strap portion 3330 comprises a flat patient-facing surface (in comparison to if the tab 3360 is connected to a rounded nonpatient facing surface). In other examples, the tabs 3360 may be connected to nonpatient facing surfaces on the conduit strap portion 3330.

[0398] As shown in Fig. 15B, the tabs 3360 are shaped to angle the backstrap 3365 inferiorly away from the horizontal plane. The tabs 3360 may comprise a superior edge and an inferior edge, the superior edge being longer than the inferior edge. The tabs 3360 may each curve posteriorly and inferiorly from the conduit strap portion 3330. Each eyelet 3361 may be angled to have a posterosuperior- anteroinferior orientation in use. Advantageously, these features (or any one thereof) may encourage the backstrap 3365 to lie low on the posterior of the patient’s head in use and / or resist riding up.A2578192 12.0 845.3.11.7 Conduit strap portion exemplary constructions

[0399] In some forms of the present technology, the conduit strap portion 3330 comprises an outer portion 3371 formed at least partially from a textile material and may further comprise at least one air-impermeable bladder 3372 internal to the outer portion 3371. The at least one bladder 3372 may be structured to convey the flow of air from the superior region of the patient’s head to the plenum chamber 3200 in use. Figs. 20A and 20B show such a conduit strap portion 3330 in a separated state and an assembled state, respectively. In examples, the textile material forming the outer portion 3371 may have a thickness within the range of 0.1-lmm, which may include a backing layer. In some examples a single textile layer may have a thickness within the range of 0.2-0.5mm, such as 0.3mm. In other examples a silicone backed textile material having an overall thickness within the range of 0.5-0.8mm, such as 0.7mm, may be used to form the outer portion 3371.

[0400] In some examples, the bladder 3372 may be inflatable by the flow of air at the therapeutic pressure and, upon inflation, the bladder 3372 may stiffen the conduit strap portion 3330. Advantageously, this may allow the conduit strap portion 3330 to transfer greater force than if not stiffened by the inflation. Additionally, this may advantageously enable the conduit strap portion 3330 to hold a desired curved shape in use avoiding the patient’s eyes and top of cheek bones.

[0401] In some examples, the bladder 3372 is formed by injection moulding. The bladder 3372 may comprise a wall having a thickness within a range of 0.2-lmm, such as within the range of 0.3-0.8mm, or between 0.4-0.6mm. The use of a thin, inflatable bladder may, advantageously, allow for the outer portion 3371 to be formed from air permeable textile, which may provide for more material selection options than if the textile forming the outer portion is required to be air-impermeable. Furthermore, the inflatable nature of the bladder 3372 described above provides sufficient rigidity that the combination of the outer portion 3371 and the bladder 3372 can be made to be lightweight because additional structure such as a foam layer, or rigidisers, may not be required.

[0402] The superior portion 3331 of the conduit strap portion 3330 may comprise a connector 3335 connected in use to each of the lateral portions 3332 of the conduit strap portion 3330 and comprising a connection port 3600 constructed to receive theA2578192 12.0 85flow of air at the therapeutic pressure into the conduit strap portion 3330. The connector 3335 is not shown in Fig. 20A or Fig. 20B but may be as shown in Figs 13A, 13B, 15A or 15B, for example, or may be a different connector 3335.

[0403] With reference to Figs. 20A-20B, the bladder 3372 in this example comprises a superior end having a bladder inlet connector 3373 connected to the connector 3335 of the superior portion 3331 of the conduit strap portion 3330. The bladder may be overmoulded to the bladder inlet connector 3373. In the assembled conduit strap portion 3330 as shown in Fig. 20B, the bladder inlet connector 3373 may be fixedly attached to the outer portion 3371 of the conduit strap portion 3330.

[0404] The bladder 3372 in this example may comprise an inferior end having a bladder outlet connector 3374 to supply the flow of air in use to the plenum chamber 3200. In the assembled state, the bladder outlet connector 3374 may pass through the outer portion 3371 of the conduit strap portion 3330. As shown in Fig. 20A, the outer portion 3371 may comprise a bladder outlet opening 3375, through which the bladder outlet connector 3374 passes, as shown in Fig. 20B. In this assembled state, the bladder outlet connector 3374 is fixedly attached to the outer portion 3371 of the conduit strap portion 3330. The bladder outlet connector 3374 may be overmoulded to the bladder 3372.

[0405] The bladder inlet connector 3373 may be substantially rigid or may be formed from an elastomeric material formed sufficiently stiff to provide a robust connection. Likewise the bladder outlet connector 3374 may be substantially rigid or may be formed from an elastomeric material formed sufficiently stiff to provide a robust connection.

[0406] The outer portion 3371 of the conduit strap portion 3330 may comprise a textile patient-contacting layer and a textile non-patient contacting layer. The patientcontacting layer may face and lie against the patient’s face in use, while the nonpatient contacting layer may face away from the patient’s face in use. The patientcontacting layer and non-patient contacting layer may be attached to each other along respective edges, such as by being welded to each other along respective edges. The bladder 3372 may be between the patient-contacting layer and non-patient contacting layer during their attachment but may remain loose in the finished conduit strapA2578192 12.0 86portion 3330. In some examples the non-patient contacting layer is thermoformed into a curved cross-sectional shape, optionally with flat longitudinal edges (such as the shape of one of the layers 3378 of the non-patient contacting portion 3377 shown in Fig. 21, described below), which may advantageously define a space for the bladder 3372 to inflate. The patient-contacting layer may be substantially flat in cross section, which may advantageously provide for a comfortable feel against the user’s face and head. The patient-contacting layer and the non-patient contacting layer may each be formed from a plurality of sub layers, e.g. they may each be a laminate. While not essential, in some examples each of the patient-contacting layer and non-patient contacting layer may comprise a textile layer and an air-impermeable layer, such as a silicone, TPE, TPU film layer or the like.

[0407] A conduit strap portion 3330 of the type shown in Figs. 20A-20B may be configured for use with any cushion module 3150 described herein. A patient interface 3000 comprising the conduit strap portion 3330 may comprise a cushion module 3150 removably attachable to the anterior portion 3333 of the conduit strap portion 3330, the cushion module 3150 forming the cushion structure 3250 and the plenum chamber 3200, the cushion module 3150 being fluidly connected to the bladder 3372.

[0408] In some examples, the cushion module 3150 may comprise a membrane portion 3220 at least partially forming the plenum chamber 3200, the membrane portion 3220 at least partially forming the seal-forming structure 3100 (e.g. as shown in Figs. 11C or 19) or the seal-forming structure 3100 being attached to the membrane portion 3220 (e.g. as shown in Figs. 17A-18C). As described elsewhere, the cushion module 3150 may comprise a chassis portion 3225 constructed and arranged to support the membrane portion 3220. The chassis portion 3225 may comprise a connection portion 3223 structured to removably attach to the bladder outlet connector 3374. The connection portion 3223 may take the form of any connection portion 3223 of a chassis portion 3225 described herein. Likewise, the bladder outlet connector 3374 in some examples may take the form of any connection portion 3224 of a conduit strap portion 3330 described herein. For example, the connection portion 3223 of the chassis portion 3225 may be a hole and the bladder outlet connector 3374 may be a protrusion structured to be received in the hole. The hole and protrusion mayA2578192 12.0 87be circular, as described with reference to Figs. 11 A and 1 IB or non-circular, as described with reference to Figs. 12A-12D, for example.

[0409] A patient interface 3000 having a conduit strap portion 3330 of the type described with reference to Figs. 20A-20B may comprise a pair of bladders 3372 provided to respective lateral sides of the conduit strap portion 3330, and may comprise a cushion module 3150 having a chassis portion 3225 which comprises a pair of connection portions 3223 respectively structured to removably attach to a pair of bladder outlet connectors 3374 of the pair of bladders 3372.

[0410] Fig. 21 shows schematically an alternative construction of a conduit strap portion 3330. In this example, the conduit strap portion 3330 may comprise a patientfacing portion 3376 and a non-patient facing portion 3377. The patient-facing portion 3376 may comprise at least one layer 3378, which may be formed by a textile layer backed with a silicone layer. In this example the patient-facing portion 3376 comprises two layers 3378, each formed from silicone-backed textile. Likewise, the non-patient facing portion 3377 may comprise at least one layer 3378, which may be formed by a textile layer backed with a silicone layer. In this example the non-patient facing portion 3377 comprises two layers 3378, each formed from silicone-backed textile. The layers 3378 of the patient-facing portion 3376 may be joined to each other by any suitable method, such as adhesion with a suitable glue or RTV silicone, or welding. Likewise, the layers 3378 of the non-patient facing portion 3377 may be joined to each other by any suitable method, such as adhesion with a suitable glue or RTV silicone, or welding. The patient-facing portion 3376 and non-patient facing portion 3377 may be joined to each other along their edges by any suitable method, such as adhesion with a suitable glue or RTV silicone, or welding.5.4 RPT DEVICE

[0411] 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 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.A2578192 12.0 88

[0412] 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.

[0413] 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.

[0414] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.

[0415] 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.

[0416] As shown in Fig. 4C, the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. Electrical components 4200 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 4202.5.5 AIR CIRCUIT

[0417] 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 3000.5.6 HUMIDIFIER5.6.1 Humidifier overview

[0418] 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 toA2578192 12.0 89a 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.

[0419] 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 5240.5.7 BREATHING WAVEFORMS

[0420] 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 of about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.5.8 GLOSSARY

[0421] 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.5.8.1 General

[0422] 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.

[0423] 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.

[0424] For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the roomA2578192 12.0 90where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

[0425] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0426] In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0427] Automatic Positive Airway Pressure (APAP) therapy. CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[0428] Continuous Positive Airway Pressure (CPAP) therapy. Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0429] Flow rate. The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

[0430] In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. Device flow rate, Qd, is the flow rate of air leaving the RPT device. Total flow rate, Qt, is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit. Vent flow rate, Qv, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, QI, is the flow rate of leak from a patient interface system orA2578192 12.0 91elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient's respiratory system.

[0431] Flow therapy. Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient’s breathing cycle.

[0432] Humidifier'. The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.

[0433] Leak'. The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.

[0434] Noise, conducted (acoustic) '. Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

[0435] Noise, radiated (acoustic) '. Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power / pressure levels of the object in question according to ISO 3744.

[0436] Noise, vent (acoustic) '. Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.

[0437] Oxygen enriched air '. Air with a concentration of oxygen greater than that of atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.

[0438] Medical Oxygen'. Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater.

[0439] Patient'. A person, whether or not they are suffering from a respiratory condition.

[0440] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmFFO, g-f / cm2and hectopascal. 1 cmFFO is equal to 1 g-f / cm2andA2578192 12.0 92is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m2= 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmlLO.

[0441] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.

[0442] Respiratory Pressure Therapy. The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0443] Ventilator'. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.5.8.1.1 Materials & their properties

[0444] 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.

[0445] 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.

[0446] Polycarbonate', a thermoplastic polymer of Bisphenol-A Carbonate.5.8.1.2 Mechanics

[0447] Axes: a. Neutral axis'. An axis in the cross-section of a beam or plate along which there are no longitudinal stresses or strains.A2578192 12.0 93b. 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.

[0448] 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.

[0449] Elasticity '. The ability of a material to return to its original geometry after deformation.

[0450] 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.

[0451] Resilience'. Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0452] Resilient'. Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0453] 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.

[0454] 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.

[0455] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions. The inverse of stiffness is flexibility.

[0456] Viscous'. The ability of a material to resist flow.A2578192 12.0 94

[0457] Visco-elasticity : The ability of a material to display both elastic and viscous behaviour in deformation.

[0458] Yield: The situation when a material can no longer return back to its original geometry after deformation.5.8.1.3 Structural Elements

[0459] Compression member: A structural element that resists compression forces.

[0460] 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.

[0461] 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.

[0462] 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.

[0463] Tie (noun): A structure designed to resist tension.

[0464] 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, i. 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 & ShellsA2578192 12.0 95i. These may be relatively long in two directions, with one thin dimension. They may have bending, tensile, and / or compressive stiffness.

[0465] Thick structures: Solids

[0466] 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.

[0467] 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.

[0468] 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.

[0469] 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.

[0470] 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.5.8.2 Anatomy5.8.2.1 Anatomy of the face

[0471] Ala: the external outer wall or "wing" of each nostril (plural: alar)

[0472] Alar angle: An angle formed between the ala of each nostril.

[0473] Alare: The most lateral point on the nasal ala.

[0474] Alar curvature (or alar crest) point: The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.

[0475] Auricle: The whole external visible part of the ear.A2578192 12.0 96

[0476] (nose) Bony framework: The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.

[0477] (nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.

[0478] Columella: the strip of skin that separates the nares and which runs from the pronasale to the upper lip.

[0479] Columella angle: The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal while intersecting subnasale.

[0480] Frankfort horizontal plane: A line extending from the most inferior point of the orbital margin to the left tragion. The tragi on is the deepest point in the notch superior to the tragus of the auricle.

[0481] Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0482] Lateral nasal cartilage: A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.

[0483] Lip, lower (labrale inferius): The lip extending between the subnasale and the mouth.

[0484] Lip, upper (labrale superius): The lip extending between the mouth and the supramenton.

[0485] Greater alar cartilage: A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.

[0486] Nares (Nostrils): Approximately ellipsoidal apertures forming the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nares are separated by the nasal septum.

[0487] Naso-labial sulcus or Naso-labial fold: The skin fold or groove that runs from each side of the nose to the comers of the mouth, separating the cheeks from the upper lip.

[0488] Naso-labial angle: The angle between the columella and the upper lip, while intersecting subnasale.A2578192 12.0 97

[0489] Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.

[0490] Otobasion superior: The highest point of attachment of the auricle to the skin of the face.

[0491] Pronasale: the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.

[0492] Philtrum: the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.

[0493] Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.

[0494] Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.

[0495] Sagittal plane: A vertical plane that passes from anterior (front) to posterior (rear). The midsagittal plane is a sagittal plane that divides the body into right and left halves.

[0496] Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.

[0497] Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.

[0498] Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.

[0499] Subnasal point: Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.

[0500] Supramenton: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion

[0501] Anatomy of the skull

[0502] Frontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.

[0503] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0504] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.A2578192 12.0 98

[0505] Nasal bones: The nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the "bridge" of the nose.

[0506] Nasion: The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.

[0507] Occipital bone: The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0508] Orbit: The bony cavity in the skull to contain the eyeball.

[0509] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.

[0510] Temporal bones: The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.

[0511] Zygomatic bones: The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.5.8.3 Patient interface

[0512] 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.

[0513] 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.

[0514] 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.

[0515] 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.

[0516] 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 perA2578192 12.0 99minute to about 100 litres per minute, depending on the mask design and treatment pressure.5.8.4 Shape of structures

[0517] Products in accordance with the present technology may comprise one or more three-dimensional mechanical structures, for example a mask cushion or an impeller. The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using a label to describe an associated surface orientation, location, function, or some other characteristic. For example a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface. In another example, a seal-forming structure may comprise a face-contacting (e.g. outer) surface, and a separate non-facecontacting (e.g. underside or inner) surface. In another example, a structure may comprise a first surface and a second surface.

[0518] To facilitate describing the shape of the three-dimensional structures and the surfaces, we first consider a cross-section through a surface of the structure at a point, / ?. See Fig. 3B to Fig. 3F, which illustrate examples of cross-sections at point p on a surface, and the resulting plane curves. Figs. 3B to 3F also illustrate an outward normal vector at p. The outward normal vector at p points away from the surface. In some examples we describe the surface from the point of view of an imaginary small person standing upright on the surface.5.8.4.1 Curvature in one dimension

[0519] The curvature of a plane curve at p may be described as having a sign (e.g. positive, negative) and a magnitude (e.g. 1 / radius of a circle that just touches the curve at p).

[0520] Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken to be positive (if the imaginary small person leaves the point p they must walk uphill). See Fig. 3B (relatively large positive curvature compared to Fig. 3C) and Fig. 3C (relatively small positive curvature compared to Fig. 3B). Such curves are often referred to as concave.

[0521] Zero curvature: If the curve at p is a straight line, the curvature will be taken to be zero (if the imaginary small person leaves the point p, they can walk on a level, neither up nor down). See Fig. 3D.A2578192 12.0 100

[0522] Negative curvature: If the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken to be negative (if the imaginary small person leaves the point p they must walk downhill). See Fig. 3E (relatively small negative curvature compared to Fig. 3F) and Fig. 3F (relatively large negative curvature compared to Fig. 3E). Such curves are often referred to as convex.5.8.4.1 Curvature of two dimensional surfaces

[0523] A description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include multiple normal crosssections. The multiple cross-sections may cut the surface in a plane that includes the outward normal (a “normal plane”), and each cross-section may be taken in a different direction. Each cross-section results in a plane curve with a corresponding curvature. The different curvatures at that point may have the same sign, or a different sign. Each of the curvatures at that point has a magnitude, e.g. relatively small. The plane curves in Figs. 3B to 3F could be examples of such multiple cross-sections at a particular point.

[0524] Principal curvatures and directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values are called the principal directions. In the examples of Fig. 3B to Fig. 3F, the maximum curvature occurs in Fig. 3B, and the minimum occurs in Fig. 3F, hence Fig. 3B and Fig. 3F are cross sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0525] Region of a surface: A connected set of points on a surface. The set of points in a region may have similar characteristics, e.g. curvatures or signs.

[0526] Saddle region: A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary person turns, they may walk uphill or downhill).

[0527] Dome region: A region where at each point the principal curvatures have the same sign, e.g. both positive (a “concave dome”) or both negative (a “convex dome”).

[0528] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0529] Planar region: A region of a surface where both of the principal curvatures are zero (or, for example, zero within manufacturing tolerances).A2578192 12.0 101

[0530] Edge of a surface: A boundary or limit of a surface or region.

[0531] Path: In certain forms of the present technology, ‘path’ will be taken to mean a path in the mathematical - topological sense, e.g. a continuous space curve from f(0) to f(l) on a surface. In certain forms of the present technology, a ‘path’ may be described as a route or course, including e.g. a set of points on a surface. (The path for the imaginary person is where they walk on the surface, and is analogous to a garden path).

[0532] Path length: In certain forms of the present technology, ‘path length’ will be taken to mean the distance along the surface from f(0) to f(l), that is, the distance along the path on the surface. There may be more than one path between two points on a surface and such paths may have different path lengths. (The path length for the imaginary person would be the distance they have to walk on the surface along the path).

[0533] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points. (For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’.)5.8.4.3 Space curves

[0534] Space curves: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, that is, having no endpoints. A space curve may be considered to be a one-dimensional piece of three-dimensional space. An imaginary person walking on a strand of the DNA helix walks along a space curve. A typical human left ear comprises a helix, which is a left-hand helix, see Fig. 3Q. A typical human right ear comprises a helix, which is a right-hand helix, see Fig. 3R. Fig. 3S shows a right-hand helix. The edge of a structure, e.g. the edge of a membrane or impeller, may follow a space curve. In general, a space curve may be described by a curvature and a torsion at each point on the space curve. Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve may be characterised with reference to the tangent, normal and binormal vectors at that point.A2578192 12.0 102

[0535] Tangent unit vector (or unit tangent vector): For each point on a curve, a vector at the point specifies a direction from that point, as well as a magnitude. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell off her vehicle at a particular point, the direction of the tangent vector is the direction she would be travelling.

[0536] Unit normal vector: As the imaginary person moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0537] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction may be determined by a right-hand rule (see e.g. Fig. 3P), or alternatively by a left-hand rule (Fig. 30).

[0538] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 30 and 3P.

[0539] Torsion of a space curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve which lies in a plane has zero torsion. A space curve which deviates a relatively small amount from the osculating plane will have a relatively small magnitude of torsion (e.g. a gently sloping helical path). A space curve which deviates a relatively large amount from the osculating plane will have a relatively large magnitude of torsion (e.g. a steeply sloping helical path). With reference to Fig. 3S, since T2>T1, the magnitude of the torsion near the top coils of the helix of Fig. 3S is greater than the magnitude of the torsion of the bottom coils of the helix of Fig. 3S

[0540] With reference to the right-hand rule of Fig. 3P, a space curve turning towards the direction of the right-hand binormal may be considered as having a righthand positive torsion (e.g. a right-hand helix as shown in Fig. 3S). A space curve turning away from the direction of the right-hand binormal may be considered as having a right-hand negative torsion (e.g. a left-hand helix).

[0541] Equivalently, and with reference to a left-hand rule (see Fig. 30), a space curve turning towards the direction of the left-hand binormal may be considered as having a left-hand positive torsion (e.g. a left-hand helix). Hence left-hand positive is equivalent to right-hand negative. See Fig. 3T.A2578192 12.0 1035.8.4.4 Holes

[0542] A surface may have a one-dimensional hole, e.g. a hole bounded by a plane curve or by a space curve. Thin structures (e.g. a membrane) with a hole, may be described as having a one-dimensional hole. See for example the one dimensional hole in the surface of structure shown in Fig. 31, bounded by a plane curve.

[0543] A structure may have a two-dimensional hole, e.g. a hole bounded by a surface. For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre. In another example, a bladder with a cavity for air or gel could have a two-dimensional hole. See for example the cushion of Fig. 3L and the example cross-sections therethrough in Fig. 3M and Fig. 3N, with the interior surface bounding a two dimensional hole indicated. In a yet another example, a conduit may comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimension hole bounded by the inside surface of the conduit. See also the two dimensional hole through the structure shown in Fig. 3K, bounded by a surface as shown.5.9 OTHER REMARKS

[0544] 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.

[0545] 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.

[0546] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.A2578192 12.0 104

[0547] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0548] 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.

[0549] 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.

[0550] 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.

[0551] 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.

[0552] 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.

[0553] 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.

[0554] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrativeA2578192 12.0 105of 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.

[0555] 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.A2578192 12.0 106

Claims

6 CLAIMS1. A patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cml-bO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the seal -forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use;A2578192 12.0 107wherein the conduit strap portion is flexible in the anterior portion of the conduit strap portion; wherein the patient interface comprises a cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber, and wherein the cushion structure comprises a membrane portion at least partially forming the plenum chamber, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion.

2. The patient interface of claim 1, wherein the anterior portion of the conduit strap portion comprises a plenum chamber portion partially forming the plenum chamber; wherein the membrane portion is connected to the plenum chamber portion of the conduit strap portion along a path formed: along a superior side of the plenum chamber portion; along an inferior side of the plenum chamber portion; and on each lateral side of the conduit strap portion, along a patientfacing side of the plenum chamber portion between the superior side of the plenum chamber portion and the inferior side of the plenum chamber portion.

3. The patient interface of claim 2, wherein the membrane portion and the plenum chamber portion define an internal volume of the plenum chamber substantially in the shape of a triangular prism.

4. The patient interface of claim 2 or claim 3, wherein the plenum chamber portion of the conduit strap portion comprises at least one hole forming a plenum chamber inlet port, the at least one hole configured to provide the flow of air at the therapeutic pressure from inside the conduit strap portion into the plenum chamber.

5. The patient interface of claim 1, wherein the patient interface comprises a cushion module removably attachable to the anterior portion of the conduitA2578192 12.0 108strap portion, the cushion module forming the cushion structure and the plenum chamber, the cushion module being fluidly connected to the anterior portion of the conduit strap portion, the cushion module comprising the membrane portion and comprising a chassis portion constructed and arranged to support the membrane portion.

6. The patient interface of claim 5, wherein the chassis portion is attached to the anterior portion of the conduit strap portion.

7. The patient interface of claim 6, wherein the chassis portion comprises a connection portion and the anterior portion of the conduit strap portion comprises a connection portion, the connection portions of the chassis portion and the conduit strap portion being structured to allow removable attachment of the cushion module to the conduit strap portion.

8. The patient interface of claim 7, wherein the connection portions of the chassis portion and the conduit strap portion form a plenum chamber inlet port when the cushion module is attached to the conduit strap portion.

9. The patient interface of claim 7 or claim 8, wherein the connection portion of the chassis portion is a hole and the connection portion of the conduit strap portion is a protrusion structured to be received in the hole.

10. The patient interface of claim 7 or claim 8, wherein the connection portion of the chassis portion is a protrusion and the connection portion of the conduit strap portion is a hole structured to receive the protrusion.

11. The patient interface of claim 9 or claim 10, wherein the hole and protrusion are circular.

12. The patient interface of claim 9 or claim 10, wherein the hole and protrusion are non-circular to prevent relative rotation between the hole and protrusion when the protrusion is received in the hole.A2578192 12.0 10913. The patient interface of claim 12, wherein the hole and protrusion are elliptical or oval.

14. The patient interface of any one of claims 9-13, wherein one of the hole and protrusion comprises a keying portion and the other one of the hole and protrusion comprises a recess shaped to receive the keying portion.

15. The patient interface of any one of claims 7-14, wherein the chassis portion comprises a pair of connection portions and the anterior portion of the conduit strap portion comprises a corresponding pair of connection portions.

16. The patient interface of any one of claims 5-15, wherein the cushion module comprises the vent.

17. The patient interface of claim 16, wherein the vent is provided to the chassis portion of the cushion module.

18. The patient interface of claim 17, wherein the vent is provided to an anterior wall of the chassis portion, the conduit strap portion passes over the anterior wall of the chassis portion inferiorly to the vent.

19. The patient interface of claim 17 or claim 18, wherein the vent is positioned in the mid-sagittal plane of the user’s head in use, and the conduit strap portion is shaped to intersect the mid-sagittal plane at a position inferior to the vent.

20. The patient interface of claim 17, wherein the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the chassis portion comprising one or more vent protrusions structured and positioned to prevent occlusion of the vent.

21. The patient interface of claim 20, wherein the one or more vent protrusions comprise a plurality of vent protrusions proximate the vent.A2578192 12.0 11022. The patient interface of claim 21, wherein the one or more vent protrusions comprise one or more ribs proximate the vent.

23. The patient interface of any one of claims 20-22, wherein the vent comprises a pair of vent holes each provided to the anterior wall of the chassis portion on a respective lateral side of the mid-sagittal plane, the conduit strap portion being shaped and positioned to overlie each vent hole of the pair of vent holes, the one or more vent protrusions comprising one or more vent protrusions proximate each vent hole and being structured and positioned to prevent occlusion of each vent.

24. The patient interface of claim 17, wherein the vent is provided to an anterior wall of the chassis portion and the conduit strap portion is shaped and positioned to overlie the vent in use, the conduit strap portion comprising a non-inflatable portion overlying the vent, the non-inflatable portion comprising a vent passage through the conduit strap portion allowing the flow of gases exhaled by the patient to pass therethrough.

25. The patient interface of claim 24, wherein the vent passage is formed by a diffusing material to diffuse the flow of gases exhaled by the patient passing therethrough.

26. The patient interface of any one of claims 1-25, wherein the seal -forming structure comprises a pair of nasal pillows.

27. The patient interface of any one of claims 1-25, wherein the membrane portion is constructed and arranged to form a seal in use against an at least partially inferior-facing portion of the patient’s pronasale, against the nasal alae and against the lip superior of the patient’s face in use.

28. The patient interface of any one of claims 1-27, wherein the membrane portion is formed at least partially from a textile material.A2578192 12.0 11129. The patient interface of any one of claims 1-28, wherein the conduit strap portion is hollow in the anterior portion of the conduit strap portion and filled with air at the therapeutic pressure in use.

30. The patient interface of any one of claims 1-29, wherein the conduit strap portion is formed at least partially from a textile material.

31. The patient interface of any one of claims 1 -30, wherein the lateral portions of the conduit strap portion are stiffer than the anterior portion of the conduit strap portion.

32. The patient interface of claim 30, wherein each of the lateral portions of the conduit strap portion has a cross section that is at least partially thermoformed to shape.

33. The patient interface of claim 31 or 32, wherein the conduit strap portion has a thickness defined between a patient-facing side of the conduit strap portion and a non-patient facing side of the conduit strap portion, the thickness being greater in the lateral strap portions than in the anterior portion of the conduit strap portion.

34. The patient interface of any one of claims 31-33, wherein the conduit strap portion is able to bend at the location at which it intersects the mid-sagittal plane of the patient’s head in use.

35. The patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to theA2578192 12.0 112patient’s nares, the seal -forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use; wherein the patient interface comprises a cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber; wherein the cushion structure comprises a membrane portion at least partially forming the plenum chamber, and wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion; and wherein the positioning and stabilising structure comprises a backstrap connecting between each of the lateral portions of the conduit strap portion and configured to overlie a posterior surface of the patient’s head in use, a pair of tabs each provided to a respective one of the lateral portions of the conduit strap portion, the backstrap being configured toA2578192 12.0 113connect to each of the tabs, and wherein each tab is able to be connected to the respective lateral portion of the conduit strap portion at a range of positions along the lateral portion.

36. The patient interface of claim 35, wherein each tab is formed at least partially from a textile material.

37. The patient interface of claim 35 or 36, wherein each tab comprises an eyelet, the backstrap being configured to connect to the eyelets.

38. The patient interface of claim 37, wherein each eyelet is formed from a material stiffer than the textile material.

39. The patient interface of claim 38, wherein each eyelet is substantially rigid.

40. The patient interface of any one of claims 35-39, wherein each tab is adjustably connected to the respective lateral portion of the conduit strap portion by a hook-and-loop connection.

41. The patient interface of claim 40, wherein each tab comprises a hook portion configured to be releasably connected to an unbroken loop material on a surface of the respective lateral portion of the conduit strap portion.

42. The patient interface of claim 40 or 41, wherein each tab connects to a patientfacing surface of the respective lateral portion of the conduit strap portion.

43. A patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmkhO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that theA2578192 12.0 114flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the conduit strap portion is hollow at least in the superior portion and the lateral portions to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use; wherein the conduit strap portion is flexible in the anterior portion of the conduit strap portion; wherein the conduit strap portion is hollow in the anterior portion of the conduit strap portion and filled with air at the therapeutic pressure in use; wherein the lateral portions of the conduit strap portion are stiffer than the anterior portion of the conduit strap portion.

44. The patient interface of claim 43, wherein each of the lateral portions of the conduit strap portion has a cross section that is at least partially thermoformed to shape.A2578192 12.0 11545. The patient interface of claim 44, wherein the cross section is substantially trapezoidal in shape.

46. The patient interface of any one of claims 43-45, wherein the conduit strap portion has a thickness defined between a patient-facing side of the conduit strap portion and a non-patient facing side of the conduit strap portion, the thickness being greater in the lateral strap portions than in the anterior portion of the conduit strap portion.

47. The patient interface of any one of claims 44-46, wherein the conduit strap portion is able to bend at the location at which it intersects the mid-sagittal plane of the patient’s head in use.

48. The patient interface of any one of claims 44-47, wherein the conduit strap portion is formed at least partially from a textile material.

49. The patient interface of any one of claims 44-48, wherein the conduit strap portion is formed at least partially from foam.

50. A patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmfbO above ambient air pressure, the plenum chamber comprising at least one plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure 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 having at least one opening therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;A2578192 12.0 116a 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, wherein the positioning and stabilising structure comprises a conduit strap portion at least partially encircling a portion of the patient’s head and comprising: a superior portion positioned in use at a superior region of the patient’s head; a pair of lateral portions positioned in use at respective lateral sides of the patient’s head; and an anterior portion positioned in use anterior to the patient’s face and intersecting the mid-sagittal plane of the patient’s head; wherein the patient interface comprises a cushion structure comprising the seal-forming structure, the cushion structure connected to the anterior portion of the conduit strap portion and at least partially forming the plenum chamber; wherein the conduit strap portion comprises an outer portion formed at least partially from a textile material and further comprises at least one air- impermeable bladder internal to the outer portion, the at least one bladder being structured to convey the flow of air from the superior region of the patient’s head to the plenum chamber in use.

51. The patient interface of claim 50, wherein the bladder is inflatable by the flow of air at the therapeutic pressure and, upon inflation, the bladder stiffens the conduit strap portion.

52. The patient interface of claim 50 or 51, wherein the bladder is formed by injection moulding.

53. The patient interface of any one of claims 50-52, wherein the bladder comprises a wall having a thickness within a range of 0.4-0.6mm.

54. The patient interface of any one of claims 50-53, wherein the superior portion of the conduit strap portion comprises a connector connected in use to each ofA2578192 12.0 117the lateral portions of the conduit strap portion and comprising a connection port constructed to receive the flow of air at the therapeutic pressure into the conduit strap portion.

55. The patient interface of claim 54, wherein the bladder comprises a superior end having a bladder inlet connector connected to the connector of the superior portion of the conduit strap portion.

56. The patient interface of claim 55, wherein the bladder is overmoulded to the bladder inlet connector.

57. The patient interface of claim 55 or 56, wherein the bladder inlet connector is fixedly attached to the outer portion of the conduit strap portion.

58. The patient interface of any one of claims 54-57, wherein the bladder comprises an inferior end having a bladder outlet connector to supply the flow of air in use to the plenum chamber.

59. The patient interface of claim 58, wherein the bladder outlet connector passes through the outer portion of the conduit strap portion.

60. The patient interface of claim 58 or 59, wherein the bladder outlet connector is fixedly attached to the outer portion of the conduit strap portion.

61. The patient interface of any one of claims 58-60, wherein the bladder is overmoulded to the bladder outlet connector.

62. The patient interface of any one of claims 58-61, wherein the outer portion of the conduit strap portion comprises a textile patient-contacting layer and a textile non-patient contacting layer.

63. The patient interface of claim 62, wherein the patient-contacting layer and non-patient contacting layer are attached to each other along respective edges.A2578192 12.0 11864. The patient interface of claim 62 or 63, wherein the non-patient contacting layer is thermoformed into a curved cross sectional shape.

65. The patient interface of any one of claims 62-64, wherein the patientcontacting layer is substantially flat in cross section.

66. The patient interface of any one of claims 58-65, wherein the patient interface comprises a cushion module removably attachable to the anterior portion of the conduit strap portion, the cushion module forming the cushion structure and the plenum chamber, the cushion module being fluidly connected to the bladder.

67. The patient interface of clam 66, wherein the cushion module comprises a membrane portion at least partially forming the plenum chamber, wherein the membrane portion at least partially forms the seal-forming structure or the seal-forming structure is attached to the membrane portion, and wherein the cushion module comprises a chassis portion constructed and arranged to support the membrane portion.

68. The patient interface of claim 67, wherein the chassis portion comprises a connection portion structured to removably attach to the bladder outlet connector.

69. The patient interface of claim 68, wherein the connection portion of the chassis portion is a hole and the bladder outlet connector is a protrusion structured to be received in the hole.

70. The patient interface of claim 69, wherein the hole and protrusion are circular.

71. The patient interface of claim 69, wherein the hole and protrusion are noncircular to prevent relative rotation between the hole and protrusion when the protrusion is received in the hole.A2578192 12.0 11972. The patient interface of any one of claims 58-71, wherein the at least one bladder comprises a pair of bladders provided to respective lateral sides of the conduit strap portion, and the chassis portion comprises a pair of connection portions respectively structured to removably attach to a pair of bladder outlet connectors of the pair of bladders.A2578192 12.0 120

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