Catheter sleeve, four-point arm sleeve and two-point arm sleeve

Abstract

The utility model relates to a catheter sleeve, a four-point arm sleeve and a two-point arm sleeve. A catheter sleeve configured to connect to a positioning and stabilizing structure of a patient interface, the catheter sleeve comprising: a longitudinal extension forming a passageway extending between an upper opening and a lower opening, the passageway configured to receive a fluid conduit; the catheter sleeve is characterized in that the catheter sleeve comprises a lower extension part which is positioned outside the passage and is adjacent to the lower opening; and the connecting component is connected with the lower extension part.

Description

[0001] This application is a divisional application of application No. 202323392753.5, with a filing date of October 28, 2022, the title of which is “Patient interface”, which is a divisional application of application No. 202222870695.1, with a filing date of October 28, 2022, the title of which is “Patient interface”.

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of Singapore Provisional Application No. 10202112048R filed October 29, 2021, the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of a respiratory-related disorder. The present technology also relates to medical devices or apparatus, and their use. BACKGROUND

[0005] 2.2 DESCRIPTION OF RELATED ART

[0006] 2.2.1 The human respiratory system and its disorders

[0007] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of the patient.

[0008] The airways include a sequence of branching tubes when the branching airways penetrate deeper into the lung, they become narrower, shorter, and more numerous. The main function of the lung is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to exit from arterial blood in the opposite direction. The trachea divides into the left and right main bronchus, which ultimately subdivide into end- terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually the pulmonary alveoli. The pulmonary alveoli region of the lung is where gas exchange occurs and is known as the respiratory zone. See West, John B. Respiratory Physiology, 9thedition, Lippincott Williams & Wilkins, 2012.

[0009] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0010] 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.

[0011] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) that involves partial or complete obstruction of the upper airway. Posterior- lingual collapse is the most common site of obstruction. Obstruction can occur over the entire cross-sectional area of the airway or can be localized to one side. Snoring results from obstruction of the pharynx, which causes vibration of the soft palate and uvula. When apnea occurs, the patient may experience 100% oxyhemoglobin desaturation and arousal. The apnea-hypopnea index (AHI) is the number of apneic and hypopneic episodes per hour. An AHI of 5 is considered abnormal. OSA is the most common form of SDB and is a common disorder in middle aged males, although it is also found in women and in all age groups. It is more prevalent in obese patients and in those with a large neck circumference. OSA is associated with hypertension, cardiac arrhythmias, and heart attacks. It is also associated with brain damage, including stroke, dementia, and death. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes Respiration (CSR) is another form of Sleep Disordered Breathing. CSR is a disorder of the central nervous system that manifests itself in a characteristic pattern of breathing during sleep. In CSR, there is a regularly repeating cycle of increasing and decreasing ventilatory effort. This cycling of hyperpnea and hypopnea is associated with repetitive oxyhemoglobin desaturation and reoxygenation. The cycling is typically of 1 minute period, although this can vary between 40 and 2 minutes. CSR is a form of SDB, but it is not currently considered to be a form of obstructive sleep apnea. It is associated with heart failure and is a marker of poor cardiovascular prognosis. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is a term used to describe diseases of the respiratory system in which the lungs cannot take in sufficient oxygen or remove sufficient CO2 to meet the needs of the patient. Respiratory failure can encompass some or all of the following disorders.

[0014] A patient with respiratory insufficiency, a form of respiratory failure, can experience abnormally short breaths when exercising.

[0015] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnea in the presence of a normal ventilatory drive. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0016] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the single most important risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly through intrinsic muscle pathology, or indirectly as a result of nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, dysphagia, respiratory muscle weakness, and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular sclerosis (DMD) in teenagers). (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly shortens life expectancy (e.g. Limb girdle, Facioscapulohumeral, and Myotonic muscular disorders). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling of the respiratory muscles to the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion and at rest, peripheral oedema, orthopnea, repeated chest infections, morning headache, fatigue, poor sleep quality, and poor concentration.

[0019] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals can take advantage of such therapies to prevent respiratory disorders from arising. However, these therapies have a number of drawbacks.

[0020] 2.2.2 Treatment

[0021] 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.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the supply of air to the entrance of the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as with a tank ventilator or a conduit ventilator).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnoea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can 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 can be voluntary, and thus a patient can elect not to comply with the therapy if the patient finds the device used to provide such therapy to be any one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0025] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient's breathing and / or to maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which presents in forms such as OHS, COPD, NMD and Chest Wall Disorder. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] Invasive ventilation (IV) provides ventilatory support to a patient who is unable to breathe effectively on their own and can be provided using an tracheostomy or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] 2.2.2.2 Flow therapy

[0028] Not all respiratory therapies aim to deliver a prescribed treatment pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow curve over a target duration (possibly superimposed on a positive baseline pressure). In other cases, the interface to the patient's airways is "open" (unsealed) and the respiratory therapy can supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow Therapy (HFT) is the provision of a continuous, heated, humidified flow of air through an unsealed or "open" patient interface to the entrance of the airways at a "treatment flow rate" that can remain approximately constant throughout the respiratory cycle. This treatment flow rate is nominally set to exceed the peak inspiratory flow rate of the patient. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow of air at the entrance of the airways improves ventilation efficiency by flushing or washing out exhaled C02 from the patient's anatomic dead space. HFT is therefore sometimes referred to as deadspace therapy (DST). Other benefits can include elevated warmth and humidity (possibly beneficial in secretion management) and the potential to elevate airway pressures appropriately. As an alternative to a constant flow, the treatment flow rate can follow a curve that varies over the respiratory cycle.

[0029] Another form of flow therapy is Long Term Oxygen Therapy (LTOT) or supplemental oxygen therapy. A physician can prescribe a continuous flow of oxygen enriched air to be delivered to the patient's airways at a specified oxygen concentration (from 21%, the fraction of oxygen in ambient air, to 100%) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0030] 2.2.3 Respiratory therapy system

[0031] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used to screen for, diagnose, or monitor a disorder without treating it.

[0032] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0033] 2.2.3.1 Patient interface

[0034] A patient interface can be used to interface a respiratory device to its wearer, e.g., by providing a flow of air to the entrance of the airways. The flow of air can be provided via a mask to the nose and / or mouth of a patient, via a tube to the mouth, or via a tracheal tube to the tracheal of a patient. Depending on the treatment to be applied, the patient interface can form a seal with a region of the patient's face, e.g., the nose and mouth of the patient, to facilitate the delivery of gas pressure to the airways that is sufficiently different from ambient pressure to effect therapy, e.g., positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, e.g., oxygen delivery, a patient interface can not include a seal sufficient to deliver gas pressure about 10 cmH20 above ambient to the airways. For flow therapies such as nasal HFT, the patient interface is configured to blow gas into the nares, but specifically avoids a full seal. One example of such a patient interface is a nasal cannula.

[0035] Certain other mask systems can not be functionally suitable for use in the art. For example, purely decorative masks can not be able to maintain an appropriate pressure. Mask systems for use in underwater swimming or diving can be configured to prevent water from the higher pressure outside from entering, but do not maintain the internal air at a pressure higher than ambient.

[0036] Certain masks can be clinically disadvantageous for the present technology, e.g., where they block airflow through the nose and only allow it through the mouth.

[0037] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal through their lips, this can be uncomfortable or impractical for the present technology.

[0038] Certain masks can not be achievable for use while sleeping, e.g., when lying on one's side in bed with one's head on a pillow.

[0039] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head varies greatly among different individuals. As the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible, or lower jaw, can move relative to other bones of the skull. The entire head can move during the course of a period of respiratory therapy.

[0040] Due to these challenges, some masks suffer from one or more of the following problems: obtrusiveness, unattractiveness, expense, disproportionality, difficulty of use, and, in particular, discomfort when worn for a long period of time or when the patient is not familiar with the system. Masks of the wrong size can result in reduced compliance, reduced comfort, and poorer patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g. filtering masks), SCUBA masks, or masks designed for the administration of anaesthetics can be acceptable for their original application, but are not ideally comfortable for long periods of wear (e.g. several hours). This discomfort can result in reduced patient compliance with therapy. This is even more so if the mask is worn during sleep.

[0041] Nasal CPAP therapy is very effective for treating certain respiratory disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient can not comply with the therapy. Since it is generally recommended that patients clean their masks on a regular basis, if the mask is difficult to clean (e.g. difficult to assemble or disassemble), the patient can not clean their mask, which can impact patient compliance.

[0042] While masks for other applications (e.g. pilots) can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0043] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0044] 2.2.3.1.1 Seal-forming structure

[0045] The patient interface can include a seal-forming structure. Because of its direct contact with the patient’s face, the shape and construction of the seal-forming structure can directly impact the effectiveness and comfort of the patient interface.

[0046] Patient interfaces can be characterised in part according to the design intent of the seal-forming structure in use to interface with the face. In one form of patient interface, the seal-forming structure can include a first sub-portion to form a seal around the left nare and a second sub-portion to form a seal around the right nare. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nare in use. Such a single element can be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region in use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nare and the mouth region in use. These different types of patient interfaces can be variously named by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nose masks.

[0047] A seal-forming structure that can be effective in one region of a patient's face can not be suitable in another region, for example because of differences in the shape, structure, variability and sensitive areas of a patient's face. For example, a seal on swimming goggles that covers a patient's forehead can not be suitable for use on a patient's nose.

[0048] Certain seal-forming structures can be designed for mass production, such that one design is suitable, comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface, one or both must accommodate to form a seal.

[0049] One type of seal-forming structure extends around the periphery of a patient interface and is intended to seal against a patient's face when a force is applied to the patient interface while the seal-forming portion is in confronting engagement with the patient's face. The seal-forming structure can comprise an air or fluid-filled cushion, or a molded or shaped surface of an elastomeric (e.g. rubber) sealing element. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0050] Another type of seal-forming structure incorporates a sheet-like seal of thin material around the periphery of the mask to provide a self-sealing action against a patient's face when positive pressure is applied within the mask. Like the previous type of seal-forming portion, if the fit between the face and the mask is not good, additional force can be required to achieve a seal, or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can wrinkle or buckle in use, causing a leak.

[0051] Another type of seal-forming structure can include a friction-fit element, such as for insertion into a nostril, however some patients find these uncomfortable.

[0052] Another form of seal-forming structure can use adhesive to achieve a seal. Some patients can find it inconvenient to apply and remove adhesive from their face on a regular basis.

[0053] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0054] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal prong was the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to Puritan Bennett Corporation.

[0055] ResMed manufactures the following products incorporating nasal pillows: SWIFT™ nasal pillow mask, SWIFT™ II nasal pillow mask, SWIFT™ LT nasal pillow mask, SWIFT™ FX nasal pillow mask, and MIRAGE LIBERTY™ full-face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: the following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO 2004 / 073778 (which describes further aspects of the ResMed SWIFT™ nasal pillow), U.S. Patent Application 2009 / 0044808 (which describes further aspects of the ResMed SWIFT™ LT nasal pillow); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which describe aspects of the ResMed MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052560 (which describes further aspects of the ResMed SWIFT™ FX nasal pillow).

[0056] 2.2.3.1.2 Positioning and stabilisation

[0057] Seal-forming structures for patient interfaces for positive air pressure therapy are subject to corresponding forces of the air pressure that seeks to break the seal. Accordingly, various techniques have been used to position the seal-forming structure, and to maintain it in sealing relationship with the appropriate portion of the face.

[0058] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesive can be uncomfortable for some people.

[0059] Another technique is to use one or more straps and / or stabilising ligatures. Many such ligatures suffer from one or more of being unsuitable, bulky, uncomfortable, and inconvenient to use.

[0060] 2.2.3.2 Respiratory pressure therapy (RPT) device

[0061] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of a number of therapies described above, for example by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0062] The designer of the device can be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, comfort and efficacy in certain respects can be highly sensitive to small, subtle changes in one or more parameters.

[0063] 2.2.3.3 Air circuit

[0064] An air circuit is a conduit or tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as an RPT device and a patient interface. In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for inhalation and exhalation.

[0065] 2.2.3.4 Humidifier

[0066] Delivering a flow of air without humidification can cause drying of the airways. Using a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in cooler climates, warm air applied generally to the face area surrounding and in the patient interface is more comfortable than cold air.

[0067] 2.2.3.5 Data management

[0068] There can be many clinical reasons to obtain data that determines whether a patient prescribed with respiratory therapy is "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 is required to use the RPT device for at least four hours a night for at least 21 or 30 consecutive days in order to be considered compliant. To determine the compliance of a patient, a provider of the RPT device, such as a health care provider, can manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period and compare to the compliance rules. Once the health care provider has determined that the patient has used their RPT device according to the compliance rules, the health care provider can inform a third party that the patient is compliant.

[0069] There can be other aspects of patient therapy that would benefit from communication of therapy data to a third party or external system.

[0070] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming and error prone.

[0071] 2.2.3.6 Vent Technologies

[0072] Some forms of therapy systems can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow gas to flow from an interior space of the patient interface, such as a plenum chamber, to an exterior space of the patient interface, such as to ambient.

[0073] The vent can include an orifice and in use of the mask gas can flow through the orifice. Many such vents are noisy. Others can become obstructed with moisture, thereby providing inadequate flushing. Some vents can disturb a bed partner 1100 of the patient 1000, e.g., by noise or concentrated gas flow.

[0074] Riethmiiid Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034665; and International Patent Application Publication No. WO 2000 / 078381 ; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0075] Noise table for existing masks (ISO 17510-2:2007, 10 cm H20 pressure at 1 m)

[0076]

[0077] (* Only one sample, measured at 10 cm H20 in CPAP mode using test method specified in ISO 3744).

[0078] The sound pressure values for various objects are listed below

[0079]

[0080] 2.2.4 Screening, Diagnosis and Monitoring Systems

[0081] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardio-respiratory disorders, and typically involves a professional clinical staff applying the system. PSG typically involves placing 15 to 20 contact sensors on a patient to record various body signals, such as electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing involves observing a patient for two nights in a clinic, one night purely for diagnosis and a second night for the clinician to titrate treatment parameters. PSG is therefore expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0082] Screening and diagnosis generally describe the identification of a disorder from signs and symptoms of the disorder. Screening typically gives a true / false result indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis can produce clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progression of the condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some can also be used for monitoring.

[0083] A clinical specialist can be able to adequately screen, diagnose or monitor a patient from visual observation of PSG signals. However, there are situations where a clinical specialist can not be available or can not be affordable. Different clinical specialists can disagree on the patient's condition. Furthermore, a given clinical specialist can apply different criteria at different times. Invention Content

[0084] The present technology is directed towards providing a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0085] A first aspect of the present technology concerns apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0086] Another aspect of the present technology concerns methods for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0087] One aspect of certain forms of the present technology is a method and / or apparatus for providing improved patient compliance with respiratory therapy.

[0088] One form of the present technology includes a sleeve for facilitating connection between a headgear and a cushion of a positioning and stabilising structure.

[0089] Another aspect of one form of the present technology is a series of modular elements that can be interconnected so as to form different types of patient interface.

[0090] One aspect of one form of the present technology is a patient interface comprising

[0091] a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure, said plenum chamber including at least one plenum chamber inlet port sized and structured to receive a flow of air at said therapeutic pressure for breathing by the patient,

[0092] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and

[0093] characterized in that the patient interface further comprises:

[0094] a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising:

[0095] a non-extensible element configured to cover the patient's cheeks,

[0096] a sleeve configured to cover at least a portion of the non-extensible element, the sleeve being removably positioned about at least a portion of the non-extensible element, the sleeve comprising:

[0097] a longitudinal extension forming a passageway having a lower opening, the passageway being configured for receiving the at least a portion of the non-extensible element,

[0098] a lower extension positioned outside of the passageway and adjacent to the lower opening, and

[0099] a connection member connected to the lower extension, and

[0100] a headgear strap configured to be detachably connected to the connection member of the lower extension of the sleeve and configured to provide at least a portion of the force to hold the seal-forming structure in a sealing position;

[0101] wherein

[0102] the patient interface is configured to allow the patient to breath from ambient through their mouth without a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured such that the patient's mouth is not covered.

[0103] In one form, a) at least one sleeve is included in the modular element; b) the sleeve is constructed of a comfort material; and / or c) the at least one sleeve is selectively used for use in a tube up or tube down arrangement with a cushion.

[0104] In one form, a) the cushion is included in the modular element; b) the cushion includes at least one first opening and at least one second opening; and / or c) the plenum chamber of the cushion is configured for receiving pressurized air through either the at least one first opening or the at least one second opening, depending on the style selected.

[0105] In one form, each modular element has at least two versions or types. These versions or types can be used interchangeably with one another to form different modular assemblies.

[0106] Another aspect of one form of the present technology is a sleeve configured to be selectively used in a modular patient interface, the sleeve being configured to at least partially contain a portion of a positioning and stabilising structure, and the sleeve having at least two connection points for removably connecting to a strap of the headgear.

[0107] In one form, a) the sleeve is configured to substantially or completely cover the rigidiser arm; b) the sleeve includes a pair of tabs configured to receive a strap; c) the sleeve includes a lower extension having a connector configured to be detachably connected to a strap; and / or d) the connector is a magnet.

[0108] In one form, a) the sleeve is configured to partially cover a conduit for delivering pressurized air to a patient; b) the sleeve includes a pair of tabs configured to receive a strap; c) the sleeve includes a lower extension having a connector configured to be detachably connected to a strap; and / or d) the connector is a magnet.

[0109] In one form, the sleeve is configured to connect to a cushion for a tube down configuration in which a pressurized air flow is delivered to a patient from in front of the patient's head.

[0110] In one form, the sleeve is configured to connect to a cushion for a tube up configuration in which a pressurized air flow is delivered to a patient through a conduit headgear.

[0111] Another aspect of one form of the present technology is a conduit sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve including:

[0112] a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway being configured to receive a fluid conduit;

[0113] a lower extension positioned outside the passageway and adjacent the lower opening; and

[0114] a connecting member connected to the lower extension.

[0115] In some forms, a) the lower extension is more rigid than the passageway; b) the lower extension is formed from a rigid material (e.g., plastic); c) the lower extension is made rigid using a stitching method (e.g., flat knitting); and / or d) the lower extension is substantially inextensible.

[0116] In some forms, a) the connecting member is a magnet; and / or b) the connecting member and the connecting member are oriented in opposite directions.

[0117] In some forms, a) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; and / or b) the material between the upper opening and the lower opening is substantially inextensible.

[0118] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of a patient interface; b) the upper opening is configured to be positioned in a location under an ear of a patient in use; and / or c) the conduit sleeve is one of a pair of conduit sleeves, each conduit sleeve of the pair of conduit sleeves being configured to be removably connected to a fluid conduit of a conduit headgear.

[0119] Another aspect of one form of the present technology is a four-point arm sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve comprising:

[0120] an upper section; and

[0121] a pair of lower sections, each lower section of the pair of lower sections comprising,

[0122] a passageway having a lower opening, the passageway being configured for receiving a rigidiser arm,

[0123] a lower extension connected proximate to the lower opening, the lower extension being positioned out of the passageway, a connecting member connected to the lower extension, and

[0124] a tab arranged proximate to the upper section and configured for receiving one headgear strap.

[0125] In some forms, a) the lower extension is more rigid than the passageway; b) the lower extension is formed from a rigid material (e.g., plastic); c) the lower extension is made rigid using a stitching method (e.g., flat knitting); and / or d) the lower extension is substantially inextensible.

[0126] In some forms, a) the connecting member is a magnet; and / or b) the connecting member and the connecting member are oriented in opposite directions.

[0127] In some forms: a) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening; b) the remaining lower sections are substantially inextensible; and / or c) the upper portion is substantially inextensible.

[0128] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of the patient interface; b) the tab is configured to be positioned at a location over an ear of the patient in use; and / or c) the upper section.

[0129] Another aspect of one form of the present technology is a two-point arm sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve comprising:

[0130] an upper section; and

[0131] a pair of lower sections, each of the pair of lower sections comprising,

[0132] a passage having a lower opening, the passage being configured for receiving a rigidiser arm,

[0133] a connection member connected to the lower extension, and

[0134] a tab arranged proximate the upper section and configured for receiving one headgear strap.

[0135] In some forms: a) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening; b) the remaining lower sections are substantially inextensible; and / or c) the upper portion is substantially inextensible.

[0136] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of the patient interface; b) the tab is configured to be positioned at a location over an ear of the patient in use; and / or c) the upper section.

[0137] Another aspect of one form of the present technology is a cushion configured to seal a portion of a patient's face about an entrance to a patient's airways. The cushion includes at least one first opening and at least one second opening. One of the at least one first opening and the at least one second opening is configured to receive a flow of pressurised air, and the other of the at least one first opening and the at least one second opening is configured to receive a plug to restrict ingress and / or egress of pressurised air from a plenum chamber of the cushion.

[0138] In some forms, a) the first plug is removably received in the at least one first opening and the second plug is removably received in the at least one second opening; b) the first plug is different to the second plug; c) the at least one first opening comprises a pair of first openings and a pair of first plugs are removably received within the pair of first openings when the at least one second opening is configured to receive a flow of pressurized air; and / or d) the first plug is connected to the elongate member.

[0139] Another aspect of one form of the present technology is a method of assembling a modular system, comprising providing a positioning and stabilising structure, and connecting the positioning and stabilising structure to a first cushion or a second cushion.

[0140] Another aspect of one form of the present technology is a method of assembling a modular system, comprising:

[0141] providing an interface structure, the interface structure comprising a first cushion and a second cushion, the first cushion configured to seal against a patient's nares and mouth, the second cushion configured to seal against a patient's nares and to leave a patient's mouth exposed, wherein the first cushion and the second cushion each comprise an inlet port;

[0142] providing a positioning and stabilising structure, the positioning and stabilising structure comprising a conduit head strap configured to deliver a flow of pressurised air and a rigidiser arm, wherein the conduit head strap and the rigidiser arm are configured to be removably connected to the inlet port of the first cushion or the second cushion;

[0143] providing a sleeve, the sleeve comprising a conduit sleeve removably connected to the conduit head strap and an arm sleeve removably connected to the rigidiser arm, wherein the conduit sleeve and the arm sleeve each comprise at least two connection points;

[0144] providing a headgear comprising a two-point headgear and a four-point headgear, wherein each of the two-point headgear and the four-point headgear is configured to connect to the at least two connection points on the conduit sleeve or the arm sleeve;

[0145] selecting one interface structure, one positioning and stabilising structure, one sleeve, one headgear; and

[0146] assembling the selected interface structure, positioning and stabilising structure, sleeve and headgear.

[0147] In some forms, at least one of the selected interface structure, positioning and stabilising structure, sleeve and headgear can be replaced with a different version or type and assembled into a different structure.

[0148] In some forms, different types or versions of the interface structure, positioning and stabilising structure, sleeve and headgear can be interchangeable.

[0149] Another aspect of one form of the present technology comprises a patient interface, the patient interface comprising:

[0150] a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure, said plenum chamber including at least one plenum chamber inlet port sized and structured to receive a flow of air at said therapeutic pressure for breathing by the patient,

[0151] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use,

[0152] 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, the positioning and stabilising structure comprising:

[0153] a non-extensible element configured to cover the patient's cheeks,

[0154] a sleeve configured to cover at least a portion of the non-extensible element, and

[0155] a headgear strap configured to provide at least a portion of the force;

[0156] wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured to not cover the patient's mouth,

[0157] In one form, the non-extensible element is a conduit headgear comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber; and the sleeve is a first conduit sleeve, the positioning and stabilising structure further comprising a second conduit sleeve, the second conduit sleeve having the same structure as the first conduit sleeve, the second conduit sleeve being removably connected to one of the pair of conduits, wherein the first and second conduit sleeves each comprise: a longitudinal extension forming a passageway extending between an upper opening and a lower opening, the passageway configured to receive one of the pair of conduits; a lower extension positioned out of the passageway and adjacent the lower opening; and a connection member connected to the lower extension.

[0158] In one form, the non-extensible element is a pair of rigid piece arms configured to extend along the contours of the patient's face; and the sleeve is a single sleeve configured to receive both of the pair of rigid piece arms, the sleeve comprising: an upper section, and a pair of lower sections, wherein each of the pair of lower sections is connected to the upper section, wherein each of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one of the pair of rigid piece arms, wherein each of the pair of lower sections further comprises: a lower extension connected proximate to the lower opening, the lower extension positioned outside of the passageway; and a connecting member connected to the lower extension.

[0159] In one form, the non-extensible element is a pair of rigid piece arms configured to extend along the contours of the patient's face; and the sleeve is a single sleeve configured to receive both of the pair of rigid piece arms, the sleeve comprising: an upper section that is substantially non-extensible; and a pair of lower sections that are at least partially extensible, wherein each of the pair of lower sections is connected to the upper section, wherein each of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive a rigid piece arm of the pair of rigid piece arms, wherein each passageway is isolated from the other passageway.

[0160] In some forms: a) the non-extensible element is a conduit headband comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to an inflation chamber; b) each conduit of the pair of conduits comprises a tab; c) an upper strap of the headband harness, the upper strap configured to be removably connected to the tabs; and / or d) each tab is configured to be positioned over a patient's ear in use.

[0161] In some forms: a) the at least one inflation chamber inlet is a pair of inflation chamber inlet ports, the pair of conduits removably connected to the pair of inflation chamber inlet ports; b) each conduit of the pair of conduits comprises a clip, the clip configured to engage one of the pair of inflation chamber inlet ports; c) the sleeve comprises a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway configured to receive a fluid conduit of the pair of fluid conduits; d) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; e) the material between the upper opening and the lower opening is substantially non-extensible; f) the lower opening is configured to be positioned proximate to the inflation chamber in use; and / or g) the upper opening is configured to be positioned at a location below a patient's ear in use.

[0162] In some forms, a) the sleeve includes a lower extension that is positioned outside the passageway and adjacent the lower opening; b) the lower extension is more rigid than the passageway; c) the lower extension is formed from a rigid material; d) the lower extension is rigidized using a stitching method; e) the lower extension is substantially non-extensible; f) a connecting member is connected to the lower extension; g) the connecting member is a magnet; and / or h) the lower opening and the connecting member are oriented in opposite directions.

[0163] In some forms, a) the sleeve is a first conduit sleeve, the positioning and stabilizing structure further includes a second conduit sleeve having the same structure as the first conduit sleeve, the second conduit sleeve being removably connected to one of the pair of conduits; and / or b) the seal-forming structure is configured to form a seal around a patient's mouth and a patient's nares.

[0164] In some forms, a) the non-extensible element is a pair of rigidizer arms configured to extend along the contours of a patient's face; b) the plenum chamber inlet port is configured to align with a patient's mouth; c) the plenum chamber further includes a pair of arm openings; d) the pair of rigidizer arms are removably connected to the pair of arm openings; e) the pair of rigidizer arms are flexible in one direction and rigid in another direction, the pair of rigidizer arms being configured to bend so as to conform to the shape of a patient's cheeks; f) each rigidizer arm of the pair of rigidizer arms includes a free end and a clip opposite the free end, the clip being configured to engage one of the pair of arm openings; g) each clip is configured to restrict airflow through the respective arm opening; and / or h) the sleeve is a single sleeve configured to receive both rigidizer arms of the pair of rigidizer arms.

[0165] In some forms, a) the sleeve includes an upper section; b) the sleeve includes a pair of lower sections; c) each lower section of the pair of lower sections is connected to the upper section; d) each lower section of the pair of lower sections includes a longitudinal extension forming a passageway having a lower opening; and / or e) the passageway is configured to receive one of the pair of rigidizer arms.

[0166] In some forms, a) each passageway is separate from another passageway; b) the upper section is constructed from a different material than the pair of lower sections; c) the upper section is substantially non-extensible and the pair of lower sections are at least partially extensible; and / or d) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening.

[0167] In some forms, a) the upper section includes a length-adjustable section and is configured to be adjusted based on the size of the patient's head; b) each of the pair of lower sections further includes a tab disposed proximate the upper section and configured to receive a headgear strap; c) each of the pair of lower sections includes a lower extension connected proximate the lower opening, the lower extension positioned outside the passageway; d) the lower extension is more rigid than the passageway; e) the lower extension is formed of a rigid material; f) the lower extension is rigidized using a stitching method; g) the lower extension is substantially inextensible; h) a connecting member is connected to the lower extension; i) the connecting member is a magnet; and / or j) the connecting member and the connecting member are oriented in opposite directions.

[0168] In some forms, a) the seal-forming structure is configured to form a seal around the patient's mouth and nares; and / or b) the seal-forming structure is configured to form a seal around the patient's nares and is configured to leave the patient's mouth exposed to ambient.

[0169] Another aspect of one form of the present technology includes a patient interface comprising:

[0170] a plenum chamber pressurisable to a therapeutic pressure above ambient pressure at least 4 cmH20, said plenum chamber including a pair of first and second openings, said plenum chamber being structured and arranged to receive a flow of air at said therapeutic pressure for breathing by a patient,

[0171] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance of the patient's nares, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance of the patient's nares, said seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle,

[0172] 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, said positioning and stabilising structure comprising:

[0173] at least one inextensible element configured to cover the patient's cheeks, said at least one inextensible element connected to said pair of first openings,

[0174] a sleeve configured to cover at least a portion of the inextensible element, and

[0175] a headgear connected to said at least one inextensible element and / or said sleeve, said headgear configured to provide at least a portion of the force;

[0176] wherein

[0177] The patient interface can be configured to allow the patient to breathe from ambient through their mouth in the absence of a pressurized flow of air through the inlet port of the plenum chamber, or the patient interface is configured so that the patient's mouth is not covered,

[0178] In one form, the non-extensible element is a conduit head strap comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber; and the sleeve comprises a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway configured to receive a fluid conduit of the pair of fluid conduits, wherein the sleeve further comprises a lower extension positioned outside of the passageway and proximate to the lower opening, and a connection member connected to the lower extension; the head strap band is directly connected to the connection member and the conduit head strap.

[0179] In one form, the non-extensible element is a pair of rigid arms configured to extend along the contours of the patient's face, each rigid arm of the pair of rigid arms connected to a first opening of the pair of first openings; and the sleeve is a single sleeve configured to receive both rigid arms of the pair of rigid arms, the sleeve comprising: an upper section, and a pair of lower sections, wherein each lower section of the pair of lower sections is connected to the upper section, wherein each lower section of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one rigid arm of the pair of rigid arms, wherein each lower section of the pair of lower sections comprises a lower extension connected proximate to the lower opening, the lower extension positioned outside of the passageway.

[0180] In some forms, the non-extensible element is a pair of rigid arms configured to extend along the contours of the patient's face, each rigid arm of the pair of rigid arms connected to a first opening of the pair of first openings; and the sleeve is a single sleeve configured to receive both rigid arms of the pair of rigid arms, the sleeve comprising: an upper section, and a pair of lower sections constructed from a different material than the upper section, wherein each lower section of the pair of lower sections is connected to the upper section, wherein each lower section of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one rigid arm of the pair of rigid arms, each lower section of the pair of lower sections further comprising a tab disposed proximate to the upper section and configured to receive a head strap band.

[0181] In some forms: a) the non-extensible element is a conduit head strap comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber; b) the head strap band is directly connected to the conduit head strap; and / or c) the conduit head strap is connected to the pair of first openings by a snap-fit connection.

[0182] In some forms: a) the sleeve includes a longitudinal extension forming a passageway extending between the upper opening and the lower opening; b) the passageway is configured to receive one of the pair of fluid conduits; c) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; d) the sleeve includes a lower extension positioned outside of the passageway and adjacent to the lower opening; e) the lower extension is more rigid than the passageway; f) the lower extension is formed from a rigid material; g) the lower extension is rigidized using a stitching method; and / or h) the lower extension is substantially non-extensible.

[0183] In some forms: a) the connection member is connected to the lower extension; b) the headgear strap is directly connected to the connection member; c) the lower opening and the connection member are oriented in opposite directions from one another; and / or d) a vent connected to the second opening and configured to allow fluid to exit the plenum.

[0184] In some forms: a) the non-extensible element is a pair of rigidizer arms configured to extend along the contours of the patient's face; b) each of the pair of rigidizer arms is connected to a first opening of the pair of first openings; c) each of the pair of rigidizer arms includes a free end and a clip opposite the free end; d) the clip is configured to be connected to a first opening of the pair of first openings using a snap fit; and / or e) the sleeve is a single sleeve configured to receive both of the pair of rigidizer arms.

[0185] In some forms: a) the sleeve includes an upper section; b) the sleeve includes a pair of lower sections; c) each of the pair of lower sections is connected to the upper section; d) each of the pair of lower sections includes a longitudinal extension forming a passageway having a lower opening; and / or: f) the passageway is configured to receive one of the pair of rigidizer arms.

[0186] In some forms: a) each passageway is isolated from the other passageway; b) the upper section is constructed from a different material than the pair of lower sections; c) each of the pair of lower sections further includes a tab disposed proximate the upper section and configured to receive a headgear strap; d) each of the pair of lower sections includes a lower extension connected proximate the lower opening, the lower extension positioned outside of the passageway; e) the lower extension is more rigid than the passageway; f) a connection member connected to the lower extension; and / or g) the headgear strap is directly connected to the connection member.

[0187] Another aspect of one form of the present technology includes a method comprising:

[0188] providing a plenum pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the plenum including a pair of first openings and a second opening;

[0189] a first non-extensible member is a conduit head strap and the second non-extensible member is a pair of rigidizer arms;

[0190] a first sleeve that is usable with the first non-extensible member and a second sleeve that is usable with the second non-extensible member are provided;

[0191] one of the first non-extensible member and the second non-extensible member is selected;

[0192] a corresponding one of the first sleeve and the second sleeve is selected;

[0193] the selected one of the first non-extensible member and the second non-extensible member is connected to the corresponding one of the first sleeve and the second sleeve; and

[0194] the selected one of the first non-extensible member and the second non-extensible member is connected to the pair of first openings of the plenum chamber.

[0195] In some forms, the selected one of the first non-extensible member and the second non-extensible member is connected to the pair of first openings of the plenum chamber using a snap fit.

[0196] Additional steps can include: a) providing a first headgear strap band that is usable with the first non-extensible member and a second headgear strap band that is usable with the second non-extensible member; and / or b) connecting a selected one of the first headgear strap band and the second headgear strap band directly to the selected one of the first non-extensible member and the second non-extensible member and / or the selected one of the first non-extensible member and the second non-extensible member.

[0197] Additional steps can include: a) providing a vent that is usable with the first non-extensible member and a conduit that is usable with the second non-extensible member and connecting one of the conduit and the vent to the second opening; and / or b) the plenum chamber is a first plenum chamber, the method further comprising providing a second plenum chamber and selecting one of the first plenum chamber and the second plenum chamber.

[0198] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that is complementary to a peripheral shape of an intended wearer.

[0199] An aspect of one form of the present technology is a method of manufacturing a device.

[0200] One aspect of certain forms of the technology is a medical device that is easy to use, for example by a person without medical training, by a person with limited dexterity, vision or by a person with limited experience in using this type of medical device.

[0201] One aspect of one form of the technology is a portable RPT device that can be carried by a person, for example in the person’s home.

[0202] One aspect of one form of the technology is a patient interface that can be washed in soapy water at the patient’s home, for example, without the need for specialised cleaning equipment. One aspect of one form of the technology is a humidifier tank that can be washed in soapy water at the patient’s home, for example, without the need for specialised cleaning equipment.

[0203] The described methods, systems, devices and apparatus can be implemented to improve the functioning of processors, for example, processors of special purpose computers, respiratory monitors and / or respiratory treatment devices. Furthermore, the described methods, systems, devices and apparatus can provide improvements in the technical field of automatic management, monitoring and / or treatment of respiratory conditions including, for example, sleep disordered breathing.

[0204] Of course, parts of these aspects can form sub-aspects of the technology. The sub-aspects and / or individual aspects of the aspects can be combined in various ways and also form further aspects or sub-aspects of the technology.

[0205] Other features of the technology will be apparent from consideration of the following detailed description, abstract, drawings and claims. BRIEF DESCRIPTION OF DRAWINGS

[0206] The technology is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which like references indicate similar elements, including:

[0207] 4.1 Respiratory treatment system

[0208] FIG. 1A A system is shown including a patient 1000 wearing a patient interface 3000 in the manner of a nasal pillow 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.

[0209] FIG. 1BA system is shown comprising a patient 1000 wearing a patient interface 3000 as 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.

[0210] FIG. 1C A system is shown comprising a patient 1000 wearing a patient interface 3000 as 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 sleeps in a side sleeping position.

[0211] 4.2 Respiratory system and facial anatomy

[0212] FIG. 2A A diagrammatic view of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, oesophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

[0213] FIG. 2B A view of the upper airways of a human is shown, including the nasal cavity, nasal bone, nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0214] FIG. 2C is a front view of a face with several surface anatomical features identified, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alar base, nasolabial sulcus and the corners of the mouth. Also indicated are superior, inferior, radially inward and radially outward directions.

[0215] FIG. 2D is a side view of a head with several surface anatomical features identified, including the glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasal ridge, alar crest, otobasion superior and otobasion inferior. Also indicated are superior-inferior and anterior-posterior directions.

[0216] FIG. 2E is another side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. Also indicated is the coronal plane.

[0217] FIG. 2F is a bottom view of a nose with several features identified, including the nasolabial sulcus, lower lip, upper vermilion, nostril, subnasale, columella, pronasale, long axis of the nostril and the central sagittal plane.

[0218] FIG. 2G is a side view of the surface features of the nose.

[0219] FIG. 2HSubcutaneous structures of the nose are shown, including lateral cartilage, septal cartilage, alar major cartilage, alar minor cartilage, concha, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrofatty tissue.

[0220] FIG. 2I Medial dissection of the nose is shown, about a few millimetres medial to the central sagittal plane, showing, among other things, the septal cartilage and the medial crura of the alar major cartilages.

[0221] FIG. 2J An anterior view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. Also indicated are the turbinate bones, as well as the maxilla and mandible.

[0222] FIG. 2K A lateral view of the skull is shown, with the surface contours of the head, as well as several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0223] FIG. 2L An anterolateral view of the nose is shown.

[0224] 4.3 Patient interface

[0225] FIG. 3A A patient interface in the form of a nasal mask according to one form of the present technology is shown.

[0226] FIG. 3B A schematic diagram of a cross-section through a structure at a point is shown. An outward normal at the point is indicated. The curvature at the point has a positive sign, and has a relatively large magnitude when compared to the curvature magnitude shown. FIG. 3C

[0227] A schematic diagram of a cross-section through a structure at a point is shown. An outward normal at the point is indicated. The curvature at the point has a positive sign, and has a relatively small magnitude when compared to the curvature magnitude shown. FIG. 3C FIG. 3B A schematic diagram of a cross-section through a structure at a point is shown. An outward normal at the point is indicated. The curvature at the point has a zero value.

[0228] FIG. 3D A schematic diagram of a cross-section through a structure at a point is shown. An outward normal at the point is indicated. The curvature at the point has a negative sign, and has a relatively small magnitude when compared to the curvature magnitude shown.

[0229] FIG. 3E FIG. 3F

[0230] FIG. 3F ​​​A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... FIG. 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0231] FIG. 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The vaulted and saddle-shaped areas are shown.

[0232] FIG. 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0233] FIG. 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0234] FIG. 3J It shows crossing FIG. 3I The cross-section of the structure. The surface shown is in FIG. 3I The structure defines a two-dimensional hole.

[0235] FIG. 3K It shows FIG. 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... FIG. 3I The surface of the two-dimensional hole is defined in the structure.

[0236] FIG. 3L A face mask with an inflatable airbag as padding is shown.

[0237] FIG. 3M It shows crossing FIG. 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0238] FIG. 3N Showing through FIG. 3L Another cross-section of the mask. The inner surface is also indicated.

[0239] FIG. 3O The left-hand rule is shown.

[0240] FIG. 3P The right-hand rule is shown.

[0241] FIG. 3Q The left ear is shown, including the left ear spiral.

[0242] FIG. 3R The right ear is shown, including the right ear spiral.

[0243] FIG. 3S A right hand helix is shown.

[0244] FIG. 3T A view of the mask is shown, including the notation of the twist of the space curve defined by the edge of the sealing membrane in different regions of the mask.

[0245] FIG. 3U A view of the plenum 3200 is shown, showing the sagittal plane and the mid-contact plane.

[0246] FIG. 3V A view of the back of the plenum of FIG. 3U is shown. The orientation of this view is perpendicular to the mid-contact plane. FIG. 3V The sagittal plane in

[0247] FIG. 3W A cross-section through the plenum of FIG. 3V is shown, taken at the sagittal plane shown in FIG. 3V The "mid-contact" plane is shown. This mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and just touches the cushion of the plenum at two points on the sagittal plane: an upper point 3220 and a lower point 3230. Depending on the geometry of the cushion in this region, the mid-contact plane can be a tangent at the upper and lower points.

[0248] FIG. 3X A view of the plenum 3200 of FIG. 3U in use on a face. When the plenum is in the use position, the sagittal plane of the plenum 3200 coincides approximately with the median sagittal plane of the face. When the plenum is in the use position, the mid-contact plane corresponds generally to the 'face plane'. In FIG. 3X the plenum 3200 is the plenum of a nasal mask, and the upper point 3220 is located approximately at the nasion, while the lower point 3230 is located on the upper lip.

[0249] 4.4 RPT device

[0250] FIG. 4A An RPT device according to one form of the technology is shown.

[0251] FIG. 4B is a schematic view of the pneumatic path of an RPT device according to one form of the technology. The directions upstream and downstream are indicated with reference to the air mover and the patient interface. The air mover is defined as upstream of the patient interface and the patient interface is defined as downstream of the air mover, regardless of the actual flow direction at any particular instant. Items located within the pneumatic path between the air mover and the patient interface are downstream of the air mover and upstream of the patient interface.

[0252] 4.5 Humidifier

[0253] FIG. 5A An isometric view of a humidifier is shown in accordance with one form of the present technology.

[0254] FIG. 5B An isometric view of a humidifier is shown in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from a humidifier reservoir base 5130.

[0255] 4.6 Respiratory Waveform

[0256] FIG. 6 A model typical respiratory waveform of a person sleeping is shown.

[0257] 4.7 Module Aspects

[0258] FIG. 7 A perspective view of a cushion of a patient interface is shown, the patient interface being configured to be worn by a patient and to deliver pressurized air to the patient’s nose and to the patient’s mouth.

[0259] FIG. 8 A front view of a cushion of FIG. 7 is shown.

[0260] FIG. 9 A rear view of a cushion of FIG. 7 is shown.

[0261] FIG. 10 A perspective view of a cushion of a patient interface is shown, the patient interface being configured to be worn by a patient and to deliver pressurized air to the patient’s nose.

[0262] FIG. 11 A front view of a cushion of FIG. 10 is shown.

[0263] FIG. 12 A rear view of a cushion of FIG. 10 is shown.

[0264] FIG. 13 A perspective view of a conduit head strap is shown that can be used with a cushion of FIG. 7 or a cushion of FIG. 10 .

[0265] FIG. 14 A perspective view of a rigidiser arm is shown that can be used with a cushion of FIG. 7 or a cushion of FIG. 10 .

[0266] FIG. 15 is a perspective view of a headgear strap that can be used with a cushion of FIG. 7 .

[0267] FIG. 16 is a perspective view of a headgear strap that can be used with the cushion of FIG. 10

[0268] FIG. 17 shows a pair of sleeves removably fitted to the conduit headgear of FIG. 13 or the rigidizer arm of FIG. 14

[0269] FIG. 18 shows a front view of an alternative pair of sleeves removably fitted to the conduit headgear of FIG. 13 or the rigidizer arm of FIG. 14

[0270] FIG. 19 shows a rear view of the pair of sleeves of FIG. 17

[0271] FIG. 20 shows a front view of a complete sleeve removably mounted to the rigidizer arm of FIG. 14

[0272] FIG. 21 shows a front view of an alternative complete sleeve removably mounted to the rigidizer arm of FIG. 14

[0273] FIG. 22 shows a rear view of the complete sleeve of FIG. 20

[0274] FIG. 23 shows a front perspective view of yet another alternative form of a complete sleeve removably fitted to the rigidizer arm of FIG. 14

[0275] FIG. 24 shows a front perspective view of another alternative form of a complete sleeve of FIG. 23

[0276] FIG. 25 shows a first step of connecting the sleeve of FIG. 17 to the conduit headgear of FIG. 13 where the sleeve and conduit headgear are not in contact

[0277] FIG. 26 shows a second step of connecting the sleeve of FIG. 17 to the conduit headgear of FIG. 13 where the conduit headgear is initially slid into the sleeve

[0278] FIG. 27 shows a third step of connecting the sleeve of FIG. 17 to the conduit headgear of FIG. 13 where the end of the conduit headgear is positioned through the opening in the sleeve​​​​​​​​​

[0279] FIG. 28 A fourth step of connecting the sleeve of FIG. 17 to the conduit head band of FIG. 13 is shown, wherein the sleeve is fully connected to the conduit head band.

[0280] FIG. 28-1 A front perspective view of the sleeve of FIG. 13 connected to the conduit head band of FIG. 17 is shown.

[0281] FIG. 28-2 A rear perspective view of the sleeve of FIG. 13 connected to the conduit head band of FIG. 17 is shown.

[0282] FIG. 29 A first step of connecting the sleeve of FIG. 20 to the rigid piece arm of FIG. 14 is shown, wherein the sleeve and the arm are not in contact.

[0283] FIG. 30 A second step of connecting the sleeve of FIG. 20 to the rigid piece arm of FIG. 14 is shown, wherein the arm is initially slid into the sleeve.

[0284] FIG. 31 A third step of connecting the sleeve of FIG. 20 to the rigid piece arm of FIG. 14 is shown, wherein the arm is further slid into the sleeve.

[0285] FIG. 32 A fourth step of connecting the sleeve of FIG. 20 to the rigid piece arm of FIG. 14 is shown, wherein the end of the rigid piece arm is positioned through the opening in the sleeve.

[0286] FIG. 33 A fifth step of connecting the sleeve of FIG. 20 to the rigid piece arm of FIG. 14 is shown, wherein the sleeve is fully connected to the conduit head band.

[0287] FIG. 33-1 A front perspective view of the sleeve of FIG. 20 relative to the rigid piece arm of FIG. 14 is shown.

[0288] FIG. 33-2 A rear perspective view of the sleeve of FIG. 20 relative to the rigid piece arm of FIG. 14 is shown.

[0289] FIG. 34 A first step of connecting the sleeve of FIG. 23 to the rigid piece arm ofFIG. 14 first step of connecting the sleeve of to the rigid arm of

[0290] . FIG. 35 FIG. 23 second step of connecting the sleeve of FIG. 14 to the rigid arm of .

[0291] FIG. 36 third step of connecting the sleeve of FIG. 23 to the rigid arm of FIG. 14 .

[0292] FIG. 37 fourth step of connecting the sleeve of FIG. 23 to the rigid arm of FIG. 14 .

[0293] FIG. 38 fifth step of connecting the sleeve of FIG. 23 to the rigid arm of FIG. 14 .

[0294] FIG. 38-1 front perspective view of the sleeve of FIG. 23 relative to the rigid arm of FIG. 14 .

[0295] FIG. 38-2 front perspective view of the sleeve of FIG. 23 relative to the rigid arm of FIG. 14 .

[0296] FIG. 39 rear perspective view of the rigid arm of FIG. 14 , FIG. 20 sleeve connected to the cushion of FIG. 7 .

[0297] FIG. 40 front perspective view of the rigid arm of FIG. 14 , FIG. 20 sleeve connected to the cushion of FIG. 7 .

[0298] FIG. 41 perspective view of a vent removably connected to the cushion of FIG. 7 .

[0299] FIG. 42 perspective view of an airflow conduit removably connected to the cushion of FIG. 7 .

[0300] FIG. 43 wearing the cushion ofFIG. 13 catheter head strap, FIG. 15 headgear strap and FIG. 17 sleeve of FIG. 7 patient's front view of cushion.

[0301] FIG. 44 is a side view of a patient wearing FIG. 43 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in an upright position.

[0302] FIG. 44-1 is a side view of a patient wearing FIG. 43 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in a supine sleeping position.

[0303] FIG. 44-2 is a side view of a patient wearing FIG. 43 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in a side sleeping position.

[0304] FIG. 45 is a front view of FIG. 13 catheter head strap, FIG. 15 headgear strap and FIG. 17 sleeve of FIG. 7 cushion.

[0305] FIG. 46 is an exploded view of FIG. 45 cushion, catheter head strap, headgear strap and sleeve.

[0306] FIG. 47 is a front view of a patient wearing FIG. 14 rigidizer arm, FIG. 15 headgear and FIG. 20 sleeve of FIG. 7 cushion.

[0307] FIG. 48 is a side view of a patient wearing FIG. 47 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in an upright position.

[0308] FIG. 48-1 is a side view of a patient wearing FIG. 47 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in a supine sleeping position.

[0309] FIG. 48-2 is a side view of a patient wearing FIG. 47 cushion, catheter head strap, headgear strap and sleeve. The patient is oriented in a side sleeping position.

[0310] FIG. 49 is a front view of FIG. 14 rigidizer arm, FIG. 15headgear and FIG. 20 sleeve of FIG. 7 front view of the cushion of

[0311] FIG. 50 is FIG. 49 exploded view of the cushion, conduit headgear, headgear strap, and sleeve of

[0312] FIG. 51 is a front view of a patient wearing the conduit headgear connected to FIG. 13 the headgear strap of FIG. 16 FIG. 10 the cushion of

[0313] FIG. 52 is a side view of a patient wearing the cushion, conduit headgear, and headgear strap of FIG. 51 The patient is oriented in an upright position.

[0314] FIG. 52-1 is a side view of a patient wearing the cushion, conduit headgear, headgear strap, and sleeve of FIG. 51 The patient is oriented in a supine sleeping position.

[0315] FIG. 52-2 is a side view of a patient wearing the cushion, conduit headgear, headgear strap, and sleeve of FIG. 51 The patient is oriented in a side-lying sleeping position.

[0316] FIG. 53 is a front view of the cushion of FIG. 13 the conduit headgear connected to FIG. 16 the headgear strap of FIG. 10

[0317] FIG. 54 is an exploded view of the cushion, conduit headgear, and headgear strap of FIG. 53

[0318] is a front view of a patient wearing the rigidizer arm connected to FIG. 55 the headgear of FIG. 14 the sleeve of FIG. 16 the cushion of FIG. 23 FIG. 10

[0319] FIG. 56 is a side view of a patient wearing the cushion, rigidizer arm, headgear strap, and sleeve of FIG. 55 The patient is oriented in an upright position.

[0320] FIG. 56-1 is a side view of a patient wearing the cushion, conduit headgear, headgear strap, and sleeve of FIG. 55 The patient is oriented in a supine sleeping position.

[0321] FIG. 56-2 is a side view of a patient wearing​​​​FIG. 55 side view of the patient's cushion, conduit headgear, headgear strap and sleeve. The patient is oriented in a side-lying sleeping position.

[0322] FIG. 57 is a rigidiser arm connected to FIG. 14 is a headgear of FIG. 16 is a sleeve of FIG. 23 is a front view of the cushion of FIG. 10

[0323] FIG. 58 is an exploded view of the cushion, rigidiser arm, headgear and sleeve of FIG. 57

[0324] FIG. 59 is a schematic diagram showing possible combinations of patient interfaces. DETAILED DESCRIPTION

[0325] Before describing the present technology in further detail, it is to be understood that the technology is not limited to the particular examples described herein, as variations of these specific examples can be made and still fall within the scope of the present technology. Also, it is to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting.

[0326] There is provided the following description relating to various examples which can share one or more common characteristics and / or features. It will be appreciated that one or more features of any one example can be combined with the one or more features of another or other examples. In addition, any single feature or combination of features in any of the examples can constitute additional examples.

[0327] 5.1 Treatment

[0328] In one form, the present technology includes a method for treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0329] In certain examples of the present technology, air supply at positive pressure is provided to the patient's nares via one or both nares.

[0330] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0331] 5.2 Respiratory treatment system

[0332] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory treatment system can include an RPT device 4000 for supplying a flow of air to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0333] 5.3 Patient interface

[0334] ​​The non-invasive patient interface 3000 according to an aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, a functional aspect can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the airways of the patient so as to maintain positive pressure at the entrance to the airways of the patient 1000. The sealed patient interface 3000 is thus suitable for the delivery of positive pressure therapy.

[0335] A patient interface can not be suitable for respiratory pressure therapy if it is not able to comfortably deliver a minimum level of positive pressure to the airways.

[0336] A patient interface 3000 according to one form of the present technology is constructed and arranged to be capable of supplying air at a positive pressure of at least 6 cm H20 relative to ambient.

[0337] A patient interface 3000 according to one form of the present technology is constructed and arranged to be capable of supplying air at a positive pressure of at least 10 cm H20 relative to ambient.

[0338] A patient interface 3000 according to one form of the present technology is constructed and arranged to be capable of supplying air at a positive pressure of at least 20 cm H20 relative to ambient.

[0339] The patient interfaces 6000-1, 6000-2, 7000-1 and 7000-2 can be similar to the patient interfaces shown in FIG. 3A and FIG. 3A the features and descriptions of the can be applicable to any of the patient interfaces 6000-1, 6000-2, 7000-1 and 7000-2.

[0340] Only some similarities and differences between the different patient interfaces are described below. Although a certain feature can be described with particularity for one example, the description can be applicable to other examples.

[0341] 5.3.1 Seal-forming structure

[0342] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming region and can additionally provide a cushioning function. The target seal-forming region is the region of the seal-forming structure 3100 where a seal is intended to occur. The region where a seal actually occurs - the actual sealing surface - can vary from day to day and from patient to patient, depending on a range of factors including, for example, the position of the patient interface on the face, the tension in the positioning and stabilising structure, and the shape of the patient's face.

[0343] In one form, the target seal-forming area is on an outer surface of the seal-forming structure 3100.

[0344] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material such as silicone rubber.

[0345] The seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible, resilient material such as silicone.

[0346] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure 3100 that is suitable for large-sized heads but not small-sized heads, and another that is suitable for small-sized heads but not large-sized heads.

[0347] As described in more detail below, in certain forms of the present technology, the seal-forming structure 6100 includes a first seal-forming structure 6101 connected to the mouth portion 6201 of the plenum chamber 6200 and constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's mouth, and a second seal-forming structure 6102 connected to the nose portion 6202 of the plenum chamber 6200 and constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's nose (see, for example FIG. 9 ). The phrase "connected to" is used herein to refer to portions or components that are formed as a single piece as well as portions or components that are separately formed and subsequently joined together. In some cases, components can be connected by way of intervening components.

[0348] In certain forms, the first seal-forming structure 6101 independently seals the patient's face relative to the second seal-forming structure 6102.

[0349] In certain forms, the first seal-forming structure 6101 and the second seal-forming structure 6102 cooperate to form a single, common seal against the patient's face.

[0350] In one form, the target seal-forming area is on an outer surface of the seal-forming structure 6100.

[0351] In certain forms of the present technology, the seal-forming structure 6100 is constructed from a biocompatible material (such as silicone rubber, fabric, foam, etc.).

[0352] The seal-forming structure 6100 according to the present technology can be made from a soft, flexible, resilient material (e.g. silicone, fabric, foam, etc.). The seal-forming structure 6100 can also be constructed from a variety of soft, flexible, resilient materials. For example, one portion of the seal-forming structure 6100 can be silicone, while another portion can be fabric.

[0353] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 6100, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure 6100 that is suitable for a large size head, but not a small size head, and another that is suitable for a small size head, but not a large size head.

[0354] In other forms of the present technology, the seal-forming structure 7100 can be connected to an air chamber 7200 that is constructed and arranged to form a seal with the region of the patient's face surrounding the entrance of the patient's nose (see, for example FIG. 12 ).

[0355] In one form, the target seal-forming region is located on an outer surface of the seal-forming structure 7100.

[0356] In certain forms of the present technology, the seal-forming structure 7100 is constructed from a biocompatible material (e.g. silicone rubber, fabric, foam, etc.).

[0357] The seal-forming structure 7100 according to the present technology can be made from a soft, flexible, resilient material (e.g. silicone, fabric, foam, etc.). The seal-forming structure 7100 can also be constructed from a variety of soft, flexible, resilient materials. For example, one portion of the seal-forming structure 7100 can be silicone, while another portion can be fabric.

[0358] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 7100, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure 7100 that is suitable for a large size head, but not a small size head, and another that is suitable for a small size head, but not a large size head.

[0359] 5.3.1.1 Seal mechanism

[0360] In one form, the seal-forming structure includes a seal flange that utilizes a pressure-assisted sealing mechanism. In use, the seal flange is able to readily respond to the system positive pressure acting on its underside from within the plenum chamber 3200, thereby causing it to form a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the resilient tension in the positioning and stabilising structure.

[0361] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness of less than about 1 mm, such as from about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum chamber 3200. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the edge of the plenum chamber 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the seal flange against buckling in use.

[0362] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is configured and disposed to be in compression, such as as a result of the resilient tension in the positioning and stabilising structure.

[0363] In one form, the seal-forming structure includes a tensioned portion. In use, the tensioned portion is held in tension, such as by adjacent regions of the seal flange.

[0364] In one form, the seal-forming structure includes a region having a tacky or adhesive surface.

[0365] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioned portion, and a portion having a tacky or adhesive surface.

[0366] 5.3.1.2 Nasal region

[0367] Next referring to FIG. 9 In certain forms of the present technology, the second seal-forming structure 6102 includes a central portion 6110 configured to seal to a surface of the patient's nose in use. The central portion can seal to the lower periphery of the patient's nose (e.g. around the patient's nostrils) as well as to the patient's upper lip. In examples, a portion of the seal-forming structure 6100 can engage the patient's septum. The second seal-forming structure 6102 can further include lateral portions 6111 on lateral sides of the central portion 6110. In examples, the seal-forming structure 6102 can be configured to contact the patient's face below the nasal bridge or below the sellion.

[0368] In some forms, the central portion 6110 can include nasal openings 6112 that deliver pressurized breathable gas to the patient’s nares. There can be one nasal opening 6112 per naris (although there can be a single nasal opening). The periphery of the nasal openings 6112 can seal against the patient’s nose (e.g., against the patient’s ala).

[0369] With continued reference to FIG. 9 , some forms of the central portion 6110 can include a bridge portion 6114 formed between the narial openings 6112. In use, the bridge portion 6114 can contact the patient’s columella and / or subnasal region. The bridge portion 6114 can also contact the patient’s nose proximate the pronasale, but can not contact the patient’s nose proximate the ridge of the patient’s nose. In other examples, the bridge portion 6114 can not contact the patient’s nose beyond or substantially beyond the pronasale of the patient’s nose to avoid contact with the ridge of the patient’s nose. The bridge portion 6114 can seal against the patient’s nose such that the entire periphery of each nasal opening 6112 seals against the patient’s nose (e.g., so as to limit leakage). The bridge portion 6114 can also limit the patient’s nose from extending into the plenum chamber 6200.

[0370] In some forms, the bridge portion 6114 can be substantially flat between the nasal openings 6112. This can be a result of the molding process that imparts the shape of the bridge portion 6114. In some examples, the bridge portion 6114 can be in a taut position prior to use by the patient. In other examples, the bridge portion 6114 can be at least partially relaxed prior to use and can be under tension as a result of contact with the patient’s nose.

[0371] With continued reference to FIG. 9 , some examples of the bridge portion 6114 can be crimped so as to impart local tension in the bridge portion 6114 prior to use. For example, the second seal-forming structure 6102 can initially be constructed with a relaxed bridge portion 6114 and a crimp can be applied during the manufacturing process to increase the tension in the bridge portion 6114. In some forms, the bridge portion 6114 can be crimped so as to allow the second seal-forming structure 6102 (or the entire seal-forming structure 6100) to be constructed from a fabric material having complex curvature (e.g., curvature along multiple non-parallel axes). The crimped bridge portion 6114 can limit the interaction between the various complex curvatures so as to limit the occurrence of leak-forming creases across the surface of the second seal-forming structure 6102. Crimping methods are described in International Application No. PCT / AU2021 / 050344 and U.S. Published Patent Application No. 2020 / 0246572, which are incorporated by reference herein in their entireties.

[0372] In some forms, an adhesive (e.g., glue) can be used to apply the crimp to the bridge portion 6114. In some forms, stitching can be used to apply the crimp to the bridge portion 6114. In some forms, ultrasonic welding can be used to apply the crimp to the bridge portion 6114. In some forms, radio frequency (RF) welding can be used to apply the crimp to the bridge portion 6114. In some forms, multiple techniques can be used to form the crimp on the bridge portion 6114.

[0373] In some forms, the central portion 6110 can include a positive curvature between the lateral portions 6111. The central portion 6110 can have a substantially small radius of curvature so as to have a tight fit around the patient's nose.

[0374] As FIG. 12 shown, the seal-forming structure 7100 can have a similar shape and / or have a similar structure as the seal-forming structure 6100 described above. Accordingly, only some similarities and differences between the seal-forming structures 6100, 7100 will be described below.

[0375] The seal-forming structure 7100 can include a central portion 7110 configured to seal to a surface of a patient's nose in use. The central portion can seal to a lower perimeter of the patient's nose (e.g., around the patient's nostrils) and to the patient's upper lip. In examples, a portion of the seal-forming structure 7100 can engage the patient's septum. The second seal-forming structure 7102 can further include lateral portions 7111 on lateral sides of the central portion 7110. In examples, the seal-forming structure 7102 can be configured to contact the patient's face below the nasal bridge or below the sellion.

[0376] In some forms, the central portion 7110 can include nasal openings 7112 that deliver pressurized breathable gas to the patient's nostrils. There can be one nasal opening 7112 for each nostril (although there can be a single nasal opening). The perimeters of the nasal openings 7112 can seal against the patient's nose (e.g., against the patient's ala).

[0377] With continued reference to FIG. 12 , some forms of the central portion 7110 can include a bridge portion 7114 formed between the nasal openings 7112. In use, the bridge portion 7114 can contact the patient's columella and / or the subnasal region. Additionally, the bridge portion 7114 can also contact the patient's nose near the sellion (e.g., down so as to avoid extending past the sellion), but can not contact the ridge of the patient's nose.

[0378] As described above, the bridging portion 7114 can be crimped in accordance with the crimping process described in International Application No. PCT / AU2021 / 050344 and U.S. Published Patent Application No. 2020 / 0246572.

[0379] 5.3.1.3 Mouth region

[0380] As described above, FIG. 9 One form of a non-invasive patient interface 6000 is shown that includes a first seal-forming structure 6101 that forms a seal about at least a patient’s mouth in use. The first seal-forming structure 6101 can form a seal on a lower region of the patient’s face (e.g. below the patient’s lip and / or above the chin).

[0381] The seal-forming structure 6100 includes a sub-lip portion 6130 that forms a seal against a lower lip and / or upper chin of the patient. The sub-lip portion 6130 can be connected to (e.g. abut) a lip superior portion 6131 that forms a seal against an upper lip of the patient. The connection between the sub-lip portion 6130 and the lip superior portion 6131 can form a mouth opening 6133.

[0382] The seal-forming structure 6100 includes a relatively low wall thickness (compared to other portions of the interface) at the periphery of the mouth opening 6133, for example less than 0.7mm, against the lower region by the sub-lip portion 6130 and at least against a centre of the sub-lip portion 6130. The low wall thickness in these locations helps to achieve an effective, comfortable seal. The seal-forming structure 6100 in these regions is able to readily conform to any complex geometry.

[0383] In some forms of the technology, the mouth opening 6133 is substantially trapezoidal rather than oval or elliptical in shape so as to more accurately correspond to the shape of the patient’s face (e.g. wider under the patient’s mouth and narrower proximate the patient’s nose). This shape of the mouth opening can make the interface 6000 particularly compact and substantially no wider than the width of the patient’s nostrils. In other examples, the mouth opening 6133 can be rectangular, circular, elliptical or any other shape.

[0384] In some forms, the sub-lip portion 6130 can be continuous with the lip superior portion 6131 which can limit seams or other discontinuities that can otherwise cause discomfort.

[0385] As FIG. 10 to 12 As shown, the seal-forming structure 7100 includes only a mouth portion and is not intended to seal against the patient’s mouth. Thus, the patient’s mouth can be exposed to the ambient environment when using the patient interfaces 7000-1, 7000-2 that include the seal-forming structure 7100.

[0386] 5.3.1.4 Boundary between the nose and mouth regions

[0387] like FIG. 9 As shown, in one form of this technology, the boundary between the first sealing forming structure 6101 and the second sealing forming structure 6102 forms or includes a corner or ridge 6120. The corner or ridge 6120 may provide at least a partially sharp boundary between the first and second sealing forming structures 6101, 6102. The corner or ridge 6120 may be rounded, but may include a small radius of curvature.

[0388] A corner or ridge 6120 can form a separator between the upper lip portion 6131 of the first sealing structure 6101 and the central portion 6110 of the second sealing structure 6102. In use, the corner or ridge 6120 can engage the patient's face above the lip and directly below the nose. The sharp boundary allows the corner or ridge 6120 to contact the subnasal point, but the slight radius of curvature does not significantly reduce patient comfort (e.g., because the corner or ridge 6120 penetrates deep into the patient's face).

[0389] In some forms, the ridge 6120 forms a relatively sharp angle between the first and second sealing structures 6101, 6102. This sharp angle reduces the likelihood of creases forming on or near the corner or ridge 6120 in the first and / or second sealing structures 6101, 6102 when the mask is worn and treatment is applied. Some oronasal patient interfaces that do not use this structure may require a very thin, rounded structure in this area, which is less resistant to wrinkling. In contrast, the corner or ridge 6120 can be stiffer than such interfaces and can better maintain its shape, and therefore can better seal indentations and creases present around the patient's nose. This effect can be enhanced in embodiments provided with support portions that resist or abut against compression in this area.

[0390] In some forms of this technology, the radius of the corner or ridge 6120 can be less than 2 mm, for example, about 1.75 mm. In one form of this technology, the radius can vary from about 1.75 mm at the center of the ridge to about 0.75 mm at the lateral portion.

[0391] The angle formed by the first and second sealing structures can be from about 20 degrees to about 90 degrees, for example, about 36 degrees.

[0392] In some forms of this technology, the corner or ridge 6120 may extend across substantially the entire boundary 6103 between the first sealing formation 6101 and the second sealing formation 6102. In embodiments, the corner or ridge 6120 may engage the patient's face at least close to the entrance of the nostril, for example, where the flap meets the face above the lips.

[0393] In other forms, the boundary between the first and second sealing structures 6101, 6102 may include a smooth or substantially smooth transition. Smooth surfaces along the smooth boundary can improve patient comfort because sharp surfaces are reduced.

[0394] As described above, the sealing structure 7100 may not include a boundary region because the sealing structure 7100 only seals the patient's nose and not the patient's mouth.

[0395] 5.3.1.5 Nasal bridge or nasal ridge area

[0396] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0397] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face.

[0398] like FIG. 43 and FIG. 47 As shown, the sealing structure 6100 can contact the patient's face to minimize contact with the bridge or ridge of the nose. In some examples, the sealing structure 6100 can be positioned such that the patient's nasal protuberance is exposed during use. This can increase patient comfort because sensitive areas along the bridge or ridge of the nose are not under pressure.

[0399] like FIG. 51 and FIG. 55 As shown, the sealing structure 7100 can similarly minimize contact with the nasal bridge or nasal ridge area of ​​the patient's face.

[0400] In other examples (not shown), the sealing structure 6100 and / or the sealing structure 7100 may be configured to contact and seal against the patient's nasal ridge.

[0401] 5.3.1.6 Upper lip area

[0402] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that, in use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0403] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of the patient's face during use.

[0404] As mentioned above, the upper lip region can assist in forming a seal at least partially around the patient's nares and at least partially around the patient's mouth (e.g. in a full-face patient interface). The upper lip region can also assist in forming a seal only around the patient's nares (e.g. in a nasal-only patient interface).

[0405] 5.3.1.7 Chin region

[0406] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which forms a seal on the chin region of the face of the patient, in use.

[0407] In one form, the seal-forming structure includes a chin region configured to form a seal on the chin region of the face of the patient, in use.

[0408] 5.3.1.8 Forehead region

[0409] In one form, the seal-forming structure forms a seal on the forehead region of the face of the patient, in use. In this form, the plenum chamber can cover the eyes, in use.

[0410] 5.3.1.9 Nasal pillows

[0411] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal pillows, each nasal pillow being constructed and arranged to form a seal with a respective naris of the patient.

[0412] A nasal pillow according to one aspect of the present technology includes a frusto-cone which forms a seal on an underside of the patient's nose, a stem, and a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stem. Further, the nasal pillow of the present technology includes a flexible region proximate the underside of the stem. The flexible regions can act in concert to facilitate a universal joint structure which is able to accommodate relative movement of both displacement and angular movement between the frusto-cone and the stem-connected structure. For example, the position of the frusto-cone can be moved axially towards the stem-connected structure.

[0413] 5.3.2 Plenum chamber

[0414] As FIG. 3AAs shown, in the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 (or at least a portion of the air chamber 3200) and the sealing structure 3100 (or at least a portion of the sealing structure 3100) are formed from a single homogeneous sheet of material (e.g., molded silicone, woven fabric, etc.). The combination of the sealing structure 3100 and the air chamber 3200 can be considered as a pad.

[0415] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0416] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0417] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0418] 5.3.2.1 Flexible Shell

[0419] In some forms of this technology, the inflation chamber 6200 may include a housing 6250, which may be made of a rigid material (e.g., polycarbonate). The rigid material may provide support for the hermetically molded structure 6100.

[0420] like FIG. 7 to 12 As shown, some forms of housing 6250, or parts thereof, or other forms of the technology, may be slightly flexible (e.g., made of soft, flexible, elastic materials such as silicone, fabric, foam, etc.). For example, in this example, housing 6250 may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of the technology, housing 6250 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of the technology, housing 6250 may be made of a material with a Young's modulus of 0.7 MPa or less, for example, between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0421] In certain forms, the shell 6250, and one or both of the first and second seal-forming structures 6101, 6102 can be formed from the same material (e.g., silicone, fabric, etc.). The shell 6250 and seal-forming structures 6101, 6102 can be removable from one another, or can be a single piece of homogenous material.

[0422] In some forms of the technology, the shell 6250 can be substantially entirely constructed from a flexible material, which can provide the greatest degree of freedom of movement to the shell 6250 (i.e., substantially no rigid and / or thickened portions to limit bending). The shell 6250 can require addition of one or more components to provide a desired degree of stiffness in one or more areas of the shell 6250 (e.g., to limit creasing of the seal-forming structure 6100 proximate to the nasal wing area). For example, one or more vent modules; connection ports; headgear connectors; headgear connectors connected to rigidiser arms and rigidiser members can be connected to the shell 6250 in a manner that increases the stiffness of the plenum chamber 6200 in the area proximate to the component, as described further below. In some forms of the technology, these components can be releasably connected to the flexible shell 6250.

[0423] Additionally or alternatively, one or more components can be permanently connected to the shell 6250, such as by bonding and / or overmolding. Rigidising members can also be used to increase stiffness and / or support the shape of the seal-forming structure 6100. In certain forms of the technology, permanently connected rigidising members can be dedicated stiffening members or rigidising members (e.g., without other functionality).

[0424] In some forms of the technology, the shell 6250 can be generally flexible, but can include stiffened portions having a greater thickness than the immediately adjacent portions of the shell 6250. Such stiffened portions can be configured as ribs or bands, such as extending transversely across the shell and / or in the superior-inferior direction, although many other configurations are possible. In some forms, the shell can include substantially rigid portions, such as made of polycarbonate, and slightly flexible portions.

[0425] In some forms of this technology, the central portion 6251 on the front side of the mouth portion 6201 of the inflation chamber may preferably have greater rigidity than the rest of the inflation chamber 6200. In some forms of this technology, the region of increased rigidity may be directly below the nose portion 6202 and / or directly above the mouth portion 6201. In one form of this technology, part or all of the first front wall portion 6240 may be a region of increased rigidity rather than a region of increased flexibility. Providing increased rigidity in one or more of these regions can provide shape stability and can limit the degree to which the housing 6250 deforms due to head-carrying forces. Excessive deformation can cause the second sealing structure 6102 to obstruct the nostrils. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important for patients with narrow noses, or in some cases undesirable. Furthermore, the described region of increased rigidity can help reduce torsional deformation of the interface, which could otherwise cause one side of the second sealing structure 6102 to lose contact with the patient's nose, thereby creating a leakage path.

[0426] 5.3.2.1.1 Multiple openings

[0427] like FIG. 7 to 12 As shown, the air chambers 6200 and 7200 can be formed as part of the multi-opening gaskets 6050 and 7050. In the example shown, each of the gaskets 6050 and 7050 includes three openings, but alternative gaskets can be formed with more or fewer openings.

[0428] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0429] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, one opening can serve as both an inlet and an outlet.

[0430] Multiple openings allow for various configurations of air delivery to the inflation chambers 6200 and 7200. For example, depending on the patient's needs and / or comfort, the patient may use a given pad 6050 or 7050 in a "tube-up" configuration (e.g., using a catheter headband as described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0431] 5.3.2.1.1.1 Full-face padding

[0432] like FIG. 7 to 9 As shown, the air chamber 6200 may be included in the full-face patient interface 6000 (e.g., a full-face mask, an ultra-compact full-face mask, etc.), and the full-face patient interface includes the first and second sealing structures 6101 and 6102 described above.

[0433] As shown in Figs. 6A and 6B, the plenum chamber 6200 includes a pair of plenum chamber inlet ports 6254 that can be used to pass gas into and / or out of the plenum chamber 6200. The plenum chamber inlet ports 6254 can be provided on opposite sides (e.g., left and right sides) of the plenum chamber 6200. FIG. 8 9 As shown in Figs. 6A and 6B, the plenum chamber 6200 includes a pair of plenum chamber inlet ports 6254 that can be used to pass gas into and / or out of the plenum chamber 6200. The plenum chamber inlet ports 6254 can be provided on opposite sides (e.g., left and right sides) of the plenum chamber 6200.

[0434] In some forms, each plenum chamber inlet port 6254 includes a partially rectangular shape. For example, the plenum chamber inlet ports 6254 can include at least one substantially straight side. The corners between different sides can also be rounded. In the illustrated example, each plenum chamber inlet port 6254 can include one curved side 6255. The curved side 6255 can be arranged proximate to the center of the plenum chamber 6200 and can generally extend in the up-down direction. The remaining portions of the illustrated sides of the plenum chamber inlet ports 6254 can be substantially straight sides, although any number of sides can be curved.

[0435] In other examples, the plenum chamber inlet ports 6254 can include an elliptical, circular, or any similar shape. For example, the plenum chamber inlet ports 6254 can include a circular shape. In other forms, the plenum chamber inlet ports 6254 can be symmetric only about a single axis.

[0436] As shown in Figs. 6A and 6B, the plenum chamber 6200 includes a pair of plenum chamber inlet ports 6254 that can be used to pass gas into and / or out of the plenum chamber 6200. The plenum chamber inlet ports 6254 can be provided on opposite sides (e.g., left and right sides) of the plenum chamber 6200. FIG. 8 As shown in Figs. 6A and 6B, the plenum chamber 6200 includes a pair of plenum chamber inlet ports 6254 that can be used to pass gas into and / or out of the plenum chamber 6200. The plenum chamber inlet ports 6254 can be provided on opposite sides (e.g., left and right sides) of the plenum chamber 6200.

[0437] In some forms, the plenum chamber inlet ports 6254 can be arranged on the mouth portion 6201 of the plenum chamber 6200. In the illustrated example, each plenum chamber inlet port 6254 can extend proximate to the transition between the mouth portion 6201 and the nose portion 6202 of the plenum chamber 6200. The plenum chamber inlet ports 6254 can be positioned at least partially above the patient's mouth (e.g., as determined when the patient is in an upright position, an axis through the plenum chamber inlet ports 6254 (e.g., perpendicular to the plenum chamber inlet ports 6254) can be aligned with the patient's mouth when the patient interface 6000 is in use.

[0438] ​In some forms, the opening portion 6201 of the inflation chamber 6200 may have a substantially negative dome curvature (e.g., when facing the anterior surface). The inflation chamber inlet port 6254 may be positioned on a curved surface of the central portion 6251 of the inflation chamber 6200, and may be on either side of the apex of curvature. The inflation chamber inlet ports 6254 may be aligned such that a single axis can pass through both inflation chamber inlet ports 6254. The axis may be substantially perpendicular to the patient's sagittal plane.

[0439] In some forms, the air chamber 6200 may also include at least one vent opening 6402 (see example...) FIG. 7 The vent opening 6402 can be located at the center of the inflation chamber 6200. For example, the vent opening 6402 can be arranged between the inflation chamber inlet ports 6254.

[0440] In some configurations, the vent opening 6402 may be arranged below at least a portion of each inflation chamber inlet port 6254. For example, the vent opening may be arranged adjacent to the lowest portion of the inflation chamber 6200.

[0441] In some forms, the vent opening 6402 may have a rounded perimeter. For example, the vent opening 6402 may have a circular perimeter. In other examples, the vent opening 6402 may have an elliptical perimeter, or it may have a perimeter formed by different polygonal shapes (e.g., triangles, rectangles, etc.). These polygonal shapes may have angled corners, or they may have rounded corners.

[0442] In some configurations, when using the patient interface, the ventilation opening 6402 can be aligned with the patient's mouth. In other words, when the patient wears the patient interface 6000, the ventilation opening 6402 can be positioned directly in front of the patient's mouth. Air exhaled by the patient (e.g., through his mouth) can travel directly toward the ventilation opening 6402.

[0443] In some forms, the material surrounding the ventilation opening 6402 may be substantially flush with the central portion 6251 of the inflation chamber 6200. This helps to maintain a substantially small device footprint. For example, when using the patient interface 6000, the material surrounding the central portion 6251 may not extend substantially away from the patient's face and may not obstruct the patient's view. In other examples, the material surrounding the ventilation opening 6402 may protrude from the central portion 6251.

[0444] like FIG. 7 and 8 As shown, some forms of the inflation chamber 6200 may include a groove 6266 that can be arranged along the side of the inflation chamber 6200.

[0445] In some forms, the inflation chamber 6200 may include a pair of recesses 6266. Each recess 6266 may be arranged near one of the inflation chamber inlet ports 6254. Each recess 6266 may form a partially recessed surface.

[0446] In some forms, the area of ​​each recess 6266 may be larger than the area of ​​each inflation chamber inlet port 6254. Additionally, the shape of each recess 6266 may not correspond to the shape of each inflation chamber inlet port 6254 (although they may). For example, each inflation chamber inlet port 6254 may be close to the upper end of the corresponding recess 6266. The recess 6266 may extend towards the lower portion of the inflation chamber 6200 beyond the periphery of the corresponding inflation chamber inlet port 6254. Each recess 6266 may have substantially the same depth (although the depth may vary).

[0447] 5.3.2.1.1.2 Nasal Liner

[0448] like FIG. 10 and 12 As shown, an inflation chamber 7200 may be included in a nasal patient interface 7000, which is sealed only in or around the patient's nostrils and exposes the patient's mouth to the surrounding environment. As described above, the nasal patient interface 7000 includes only a single sealing structure 7100 (e.g., similar to a second sealing structure 6102) and does not include separate first and second sealing structures as in the full-face patient interface 6000.

[0449] The air chamber 7200 of the nasal patient interface 7000 can be similar to the air chamber 6200 of the full-face patient interface 6000. The following describes only some similarities and differences between air chambers 6200 and 7200.

[0450] like FIG. 11 and 12 As shown, the inflation chamber 7200 includes a pair of inflation chamber inlet ports 7254, which can be used to deliver gas into and / or out of the inflation chamber 7200. The inflation chamber inlet ports 7254 may be located on opposite sides of the inflation chamber 7200 (e.g., left and right sides).

[0451] In the example shown, the shape of the inflation chamber inlet port 7254 can be substantially the same as that of the inflation chamber inlet port 6254 described above. As described below, this allows a single connector to be interchangeably connected to the inflation chamber inlet ports 6254 and 7254 on either of the inflation chambers 6200 and 7200.

[0452] In some forms, the inflation chamber 7200 may also include at least one ventilation opening 7402 (see example...) FIG. 10The vent opening 7402 can be located at the center of the inflation chamber 7200. For example, the vent opening 7402 can be arranged between the inflation chamber inlet ports 7254.

[0453] In the example shown, the inlet port 7254 and the ventilation opening 7402 can be aligned along a single axis on the inlet chamber 7200. For example, the inlet port 7254 can be located in a similar position to the inlet port 6254 relative to the patient's face. However, because the overall inlet chamber 7200 is smaller than the inlet chamber 6200 (i.e., because the inlet chamber 7200 does not receive the patient's mouth), the ventilation opening 7402 cannot be positioned in a straight line with the patient's mouth as it is in the inlet chamber 6200. The ventilation opening 7402 of the inlet chamber 7200 must therefore be positioned higher on the patient's face since the inlet chamber 7200 only includes the nasal portion.

[0454] In some configurations, when the patient is wearing padding 7050, the ventilation opening 7402 of the air chamber 7200 can be aligned with the patient's upper lip.

[0455] In some forms, the material surrounding the ventilation opening 7402 may be substantially flush with the central portion 7251 of the inflation chamber 7200. This helps to maintain a substantially small device footprint. For example, when using the patient interface 7000, the material surrounding the central portion 7251 may not extend substantially away from the patient's face and may not obstruct the patient's view. In other examples, the material surrounding the ventilation opening 7402 may protrude from the central portion 7251.

[0456] like FIG. 10 and 11 As shown, some forms of the inflation chamber 7200 may include a groove 7266 that can be arranged along the side of the inflation chamber 7200.

[0457] In some forms, the inflation chamber 7200 may include a pair of recesses 7266. Each recess 7266 may be arranged near one of the inflation chamber inlet ports 7254. Each recess 7266 may form a partially recessed surface.

[0458] Unlike the aforementioned groove 6266, the dimensions of groove 7266 can be substantially the same as those of the inflation chamber inlet port 7254. In other words, groove 7266 does not need to extend further in a direction lower than the lateral direction.

[0459] 5.3.3 Positioning and Stabilizing Structure

[0460] like FIG. 3A As shown, the sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0461] The positioning and stabilising structure 3300 provides a positioning and stabilising structure force F PSS at least sufficient to overcome the effects of the positive pressure in the plenum chamber 3200, thereby causing the surface to disengage (i.e. F 充气 the chamber).

[0462] In one form, the positioning and stabilising structure 3300 provides a retention force to overcome the effects of gravity on the patient interface 3000.

[0463] With continued reference to FIG. 3A , the positioning and stabilising structure 3300 provides a positioning and stabilising structure force F PSS (or a positioning and stabilising force F PSS ) that assists in maintaining the plenum chamber 3200 in a sealing position on the patient’s face. The positioning and stabilising force F PSS may be the resultant of various force vectors from different elements of the positioning and stabilising structure 3300. For example, the headgear straps can individually provide a strap force F 绑带 to hold the seal-forming structure 3100 against the patient’s face. F 绑带 may also be directed at least partially in an upward direction, so as to overcome the effects of gravity F g . The force of gravity F g may be specifically illustrated in relation to the seal-forming structure 3100 and the plenum chamber 3200, but the force of gravity will act on the entire patient interface 3000 (i.e. in the same direction as the force of gravity F g illustrated).

[0464] The force of gravity F g may be opposed by a frictional force F f that acts in a direction directly opposite to the force of gravity F g . When the force of gravity is pulling the seal-forming structure 3100 and the plenum chamber 3200 in a downward direction (as illustrated in FIG. 3A , the frictional force F f will act in an upward direction (e.g. against the patient’s face). For example, the patient can experience a frictional force F f over their lips (and / or other surfaces of the patient’s face that are in contact with the seal-forming structure 3100) to resist movement in a downward direction (which can help to stabilise the cushion 6050 in place). Although the frictional force F f is specifically illustrated as being opposite to the force of gravity F g of the seal-forming structure 3100 and the plenum chamber 3200, a component of the total frictional force (not illustrated) will also be associated with the force of gravity F gIn contrast, frictional forces can act along any location where the patient interface 3000 contacts the patient's skin (or hair). The frictional forces F f along the direction of gravity F g and extending along the patient's skin (or hair).

[0465] In some forms, the sum of the various forces can equal zero, such that the patient interface 3000 is in equilibrium (e.g. does not move along the patient's face when in use). In particular, the gravitational force F g and the blowout force F 充气室 tend to move the seal-forming structure 3100 away from the desired sealing location. The positioning and stabilising force F PSS is applied so as to counteract the gravitational force F g and the blowout force F 充气室 (and any frictional forces F f ) and maintain the seal-forming structure 3100 in the appropriate sealing position. Although the positioning and stabilising force F PSS may exceed the sum of the other forces, and still maintain the seal-forming structure 3100 in the appropriate sealing position, patient comfort can be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force F PSS is just strong enough to achieve this. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilising force F PSS required to achieve equilibrium.

[0466] In one form, the positioning and stabilising structure 3300 provides a holding force as a safety margin to overcome potential effects of disruptive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0467] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner that is consistent with being worn by a patient while sleeping. In one example, the positioning and stabilising structure 3300 has a small side or cross-sectional thickness to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap that is rectangular in cross-section. In one example, the positioning and stabilising structure 3300 comprises at least one flat strap.

[0468] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured to be not too large and bulky to prevent the patient from lying in a supine sleeping position with the back region of the patient's head on a pillow.

[0469] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured to be not too large and bulky to prevent the patient from lying in a side sleeping position with the side region of the patient's head on a pillow.

[0470] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion between the front of the positioning and stabilising structure 3300 and the rear of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible strap or a soft strap. The decoupling portion is constructed and arranged so that when the patient lies on the pillow with their head, the presence of the decoupling portion prevents forces acting on the rear portion being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0471] In one form of the present technology, the positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to enable moisture (e.g. sweat) to pass through the strap. In one form, the fabric outer layer comprises loop material for partial engagement with hook material.

[0472] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is extendable, for example elastically extendable. For example, the strap can be constructed to be in tension in use and to direct forces to cause the seal forming structure to be in sealing contact with a portion of the patient's face. In examples, the strap can be configured as a tie.

[0473] In one form of the present technology, the positioning and stabilising structure comprises a first tie configured and arranged so that in use at least a portion of a lower edge of the first tie passes over a lower ear base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0474] In one form of the present technology suitable for use with a nasal only mask or a full face mask, the positioning and stabilising structure comprises a second tie configured and arranged so that in use at least a portion of an upper edge of the second tie passes under a lower ear base of the patient's head and covers or is located under the occipital bone of the patient's head.

[0475] In one form of the present technology suitable for use with a nasal only mask or a full face mask, the positioning and stabilising structure comprises a third tie configured and arranged to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to separate from each other.

[0476] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable for the patient to lie on while sleeping.

[0477] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is constructed to be breathable to allow moisture to be transported through the strap,

[0478] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0479] In some forms, a positioning and stabilizing structure of one type can be interchanged with multiple types or varieties of pads having sealing formation structures and inflation chambers. For example, two different pads have been described in the preceding section; the full-face pad 6050 and the nose pad 7050. A single positioning and stabilizing structure can be used interchangeably with two types of pads 6050, 7050 (or other forms not explicitly described herein).

[0480] Interchangeability of positioning and stabilization structures between different types or styles of liners can simplify manufacturing and / or allow patients to easily switch between different liners without needing to obtain entirely new components.

[0481] 5.3.3.1 Catheter headband

[0482] Catheters, such as headbands, can provide force F that helps with positioning and stability. PSS The force. For example, each conduit can provide a force F in the backward direction and the corresponding lateral direction. 导管 This is to hold the sealing structure 3100 on the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the air chamber 3200 to lift it away from the face (i.e., F 充气室 The guiding force F 导管 It can also be guided at least partially in the upward direction to overcome gravity F. g .

[0483] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. For example, the catheter can expand as pressurized air is delivered through it. This force can help grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0484] The position of the patient's head can also change the clamping force of the catheters. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface such as a pillow) can expand additionally to maintain substantially the same pressurized airflow rate.

[0485] As shown in FIG. 13 Some forms of the patient interface 6000 can include a tube or conduit 6320 that can be coupled (e.g., removably coupled or permeably coupled) to each conduit connection structure 6500. Each conduit 6320 can deliver a pressurized flow of breathable gas to the airways of a patient (e.g., from the RPT device 4000). The pressurized flow of breathable gas can enter the plenum chamber 6200 through the conduit connection structure 6500 and the plenum chamber inlet port 6254. A sealed engagement between each conduit connection structure 6500 and the plenum chamber inlet port 6254 can limit the flow of pressurized breathable gas from leaking through the interface to the ambient environment.

[0486] In use (see, for example, FIG. 43 , 44 , 51 and 52), the conduit 6320 can form a conduit head strap 6319 and can extend along the head of the patient (e.g., along the cheeks of the patient and towards the upper region of the head of the patient). The conduit 6320 can replace the upper headgear strap band of the patient interface 6000. As such, the conduit 6320 can be constructed from a flexible or semi-rigid material (e.g., silicone, fabric, etc.) and can be able to flex when the patient interface 6000 is donned by the patient. The length of the conduit 6320 can be non-adjustable and all adjustment can come from the lower strap band.

[0487] In some forms, the conduit 6320 can be removably connected to the cushion 6050 using the conduit connection structure 6500. The conduit 6320 can be integrally connected to the conduit connection structure 6500, which in turn is connected to the plenum chamber inlet port 6254. The conduit connection structure 6500 can be removably connected to the cushion 6050 via the plenum chamber inlet port 6254 by a mechanical connection (e.g., a snap fit, a press fit, a friction fit, etc.). In other examples, the conduit connection structure 6500 can be permanently connected in the plenum chamber inlet port 6254 and the conduit 6320 can be removable from the conduit connection structure 6500. In other examples, the conduit connection structure 6500 can be removably connected from the conduit 6320 and the plenum chamber inlet port 6254.

[0488] As described above, the recess 6266 can be larger than the plenum chamber inlet port 6254. For example, the recess 6266 can extend past the plenum chamber inlet port 6254 in either lateral direction. The conduit connection structure 6500 can also be larger than the plenum chamber inlet port 6254 and can contact the surface of the recess 6266 when connected to the plenum chamber inlet port 6254. This can allow the conduit connection structure 6500 to at least partially recess when connected to the plenum chamber inlet port 6254 in order to maintain a low profile patient interface 6000.

[0489] In certain forms, the area formed by the lateral extension of the recess 6266 and the plenum inlet port 6254 can be approximately the same size as the conduit connection structure 6500. The conduit connection structure 6500 can thus be secured within the recess and within the plenum inlet port 6254. For example, the conduit connection structure 6500 can be connected to the recess 6266 using a press fit, a friction fit, a snap fit, or similar mechanical connection.

[0490] Returning to FIG. 13 , some forms of the conduit 6320 can include tabs 6324 through which headband straps (described below) can be threaded. The tabs 6324 can be integrally formed with the rest of the conduit 6320.

[0491] Continuing to refer to FIG. 13 , some forms of the conduit 6320 can include an accordion section 6328 that is formed as a series of ridges and grooves on the surface of the conduit 6320. The accordion section 6328 can be biased toward a retracted position (e.g., as shown) and can be moved to an expanded position when the patient puts on the conduit headband 6319. Because the conduit 6320 can be substantially inextensible, the accordion section 6328 allows the conduit headband 6319 to stretch in order to fit different sized heads. In other words, the material of the conduit 6320 can be substantially inextensible, but the geometry of the accordion section 6328 can allow for a predetermined extension. Extending the accordion section 6328 can allow a single size of conduit 6320 to be used with multiple sizes of heads. For example, as a result of the accordion section 6328, the conduit 6320 can be "one-size-fits-all." Alternatively or additionally, the conduit 6320 and / or the accordion section 6328 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can select the length of the conduit that most closely fits their head, and the accordion section 6328 can make small adjustments in order to accommodate the individual patient. FIG. 13

[0492] When the patient puts on the conduit 6320, the accordion section 6328 can expand to fit around the patient's head. When the patient takes off the conduit 6320, the accordion section 6328 can return to its initial position (i.e., as shown). The total length of expansion of the accordion section 6328 can depend on the size of the patient's head and the initial length of the conduit 6320. FIG. 13

[0493] In some forms, the accordion section 6328 can be higher than the tabs 6324. In other words, these tabs 6324 can be disposed between the conduit connection structure 6500 and the accordion section 6328.

[0494] ​​In the illustrated form, the accordion section 6328 can not extend completely to the tab 6324. In other words, the accordion section 6328 is spaced apart from the tab 6324 such that the tab 6324 is not directly connected to the accordion section 6328.

[0495] In some forms, the conduit 6320 can include an inlet 6332 for receiving a pressurized flow of air. In the illustrated example, the inlet 6332 can be disposed between the accordion sections 6328. As FIG. 43 and 51 illustrated, the inlet 6332 can be located in the upper portion of the patient's head in use. For example, the inlet 6332 can cover the frontal bone and / or parietal bone of the patient in use.

[0496] In certain forms, the inlet 6332 can be disposed in the middle of the conduit 6320. For example, the conduit 6320 can be symmetrical about the inlet 6332 through at least one axis.

[0497] In some forms, the conduit 6320 can be a standard component that is interchangeably used with both the full-face mask 6050 and the nasal mask 7050. The conduit 6320 can be connected to each type of mask 6050, 7050 in a similar manner such that the conduit 6320 can be easily exchanged between the masks 6050, 7050 as needed.

[0498] 5.3.3.2 Rigid Arm

[0499] As FIG. 14 illustrated, the rigid arm 6340 can be an elongated rigid member that helps hold the mask 6050 in an operating position. The rigid arm 6340 can contact one side of the patient's head and provide a force to limit the seal-forming structure 6100 from sliding off the patient's nose and / or mouth.

[0500] In certain forms, the rigid arm 6340 is made of a rigid material, such as plastic. The rigid material does not allow the rigid arm 6340 to stretch. Additionally, the rigid arm 6340 can be substantially inflexible and can be unable to bend. The rigid arm 6340 can be pre-molded into a desired shape in order to fit the patient's head. For example, the rigid arm 6340 can be molded into a curved shape to substantially correspond to the shape of the side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0501] In certain forms, the rigid arm 6340 can be molded to conform to a particular patient's head (e.g., custom rigid arm 6340).

[0502] In some forms, the rigidizer arm 6340 can be flexible in at least one direction. For example, the rigidizer arm 6340 can be flexible with respect to its width and can be inflexible along its length. In other words, the rigidizer arm 6340 can bend about an axis along the width of the rigidizer arm 6340, but cannot bend about an axis perpendicular to the rigidizer arm 6340. This can allow an individual patient to adjust the rigidizer arm 6340 to better fit their individual head.

[0503] In certain forms, the rigidizer arm 6340 can remain in the new position after being bent. This can allow a patient to adjust the shape of the rigidizer arm 6340 for their particular head, and then the arm 6340 will maintain the desired shape for improved patient comfort when in use.

[0504] In some forms, the first or free end 6342 of the rigidizer arm 6340 can be free, and the second end 6344 of the rigidizer arm 6340 (e.g., opposite the first end 6342) can be fixed. The first end 6342 can be curved to minimize sharp edges that can cause discomfort to a patient. In use, the first end 6342 can also cover the patient’s head near the temporal bone. The second end 6344 can be fixed to the arm connection structure 6504. The rigidizer arm 6340 can be connected at an angle that is inclined relative to the arm connection structure 6504.

[0505] In some forms, the arm connection structure 6504 can be similar to the conduit connection structure 6500. For example, the arm connection structure 6504 and the conduit connection structure 6500 can have substantially the same shape. This can allow the conduit connection structure 6500 or the arm connection structure 6504 to fit into the groove 6266 and connect to the plenum inlet port 6254. The arm connection structure 6504 can connect to the cushion 6050 in substantially the same manner as the conduit connection structure 6500 (e.g., via a snap fit, a press fit, a friction fit, etc.).

[0506] In some forms, the arm connection structure 6504 can act as a plug for the plenum inlet port 6254. Unlike the conduit 6320, the rigidizer arm 6340 does not deliver pressurized air to the plenum 6200. The rigidizer arm 6340 can be used with a ‘tube down’ configuration, where a hose is connected to the vent opening 6402 and air is delivered into the plenum 6200 through the vent opening 6402. In this example, air does not need to travel into or out of the plenum inlet port 6254. Thus, the arm connection structure 6504 can form a seal with the plenum inlet port 6254 to limit airflow into or out of the plenum 6200.

[0507] As FIG. 13As shown, a pair of rigidizer arms 6340 are used with the plenum chamber 6200. The rigidizer arms 6340 can be separable from one another so that they can be independently connected in the recess 6266. Additionally, the individual arms 6340 can be individually shaped (e.g., manually shaped by bending or during a molding process) so as to fit different contours on different sides of the patient's head.

[0508] In some forms, the rigidizer arms 6340 can be standard components that are interchangeably used with both the full-face cushion 6050 and the nasal cushion 7050. The rigidizer arms 6340 can be connected to each type of cushion 6050, 7050 in a similar manner so that the rigidizer arms 6340 can be easily exchanged between the cushions 6050, 7050 as needed.

[0509] 5.3.3.3 Headgear straps

[0510] As shown in FIGS. 6A and 6B, the positioning and stabilizing structure 6300 can include a headgear 6302 that can be worn by the patient in order to help orient the seal-forming structure 6100 correctly with respect to the patient's face (e.g., in order to limit or prevent leaks). FIG. 15 16 In some forms, the headgear 6302 can be constructed of a fabric material that can comfortably rest against the patient's skin. The fabric can be flexible so as to conform to various facial contours. Although the fabric can include a rigidizer along a selected length, this can limit the bending, flexing, and / or stretching of the headgear 6302.

[0511] Under certain forms, the headgear 6302 can be at least partially extendable. For example, the headgear 6302 can include an elastic or similar extendable material. This can allow the headgear 6302 to extend under tension, which can help provide a sealing force for the seal-forming structure 6100.

[0512] The extendable headgear 6302 can also work similar to the accordion section 6328. The extendable headgear 6302 can start in an unextended position and can extend to an extended position when worn by the patient. In some examples, the headgear 6302 can be "one-size" while in other examples, there can be multiple sizes of headgear 6302 (e.g., small, medium, large) in order to control the overall length expansion of the headgear 6302. The headgear 6302 can return to its initial position when the headgear 6302 is removed by the patient.

[0513] The extendable headgear 6302 can also work similar to the accordion section 6328. The extendable headgear 6302 can start in an unextended position and can extend to an extended position when worn by the patient. In some examples, the headgear 6302 can be "one-size" while in other examples, there can be multiple sizes of headgear 6302 (e.g., small, medium, large) in order to control the overall length expansion of the headgear 6302. The headgear 6302 can return to its initial position when the headgear 6302 is removed by the patient.

[0514] ​In certain forms, only selected portions of the headgear 6302 are extendable. Other portions of the headgear 6302 can be non-extendable. For example, portions of the headgear can not be elastic and / or can include rigidizing members (e.g., rigidizing wires) to limit or prevent stretching of the portions of the headgear 6302. In other examples, the entire headgear 6302 can be non-extendable. The use of rigidizing members can help selectively determine where the headgear can stretch, which can result in a better fit for the patient and / or increased comfort.

[0515] 5.3.3.3.1 Four Point Connection

[0516] As shown in FIG. 63, some forms of the headgear 6302 can be a four point connection headgear. This means that the headgear 6302 can connect to four separate locations and, thus, can include four different straps that provide tension to help maintain the seal-forming structure 6100 in a sealing position. FIG. 15

[0517] In some forms, the headgear 6302 can include a lower strap 6304 that can connect to a lower portion of the cushion 6050. The lower strap 6304 can extend along the patient’s cheeks toward the back region of the patient’s head. For example, the lower strap 6304 can cover the masseter muscle on either side of the patient’s face. Thus, the lower strap 6304 can contact the patient’s head below the patient’s ear. The lower strap 6304 can meet at the back of the patient’s head and can cover the occipital bone and / or trapezius muscle.

[0518] The headgear 6302 can also include an upper strap 6305 that can cover the temporal bone, parietal bone, and / or occipital bone. The upper strap 6305 can also connect to the conduit 6320 (e.g., by interfacing with the tab 6324).

[0519] A posterior strap 6307 can extend between the upper strap 6305 and the lower strap 6304. The lower strap and the upper strap 6304, 6305 on a given side (e.g., left or right) can also connect to the posterior strap 6307 adjacent to each other. Thus, the height of the posterior strap 6307 can be approximately the combined height of the lower strap 6304 and the upper strap 6305. The posterior strap 6307 can cover the occipital bone and / or parietal bone in use. This can allow the posterior strap 6307 to help anchor the headgear 6302 to the patient’s head.

[0520] In the illustrated example, the headgear 6302 can be formed in a generally X-shape. The lower strap 6304 and the upper strap 6305 can be connected to the posterior strap 6307 using stitching, ultrasonic welding, or any similar process.

[0521] ​In some forms, the lower strap 6304 is connected to the magnetic member 6306. For example, each lower strap 6304 may pass through the magnetic member 6306, allowing the length of each lower strap 6304 to be adjusted. The magnetic member 6306 may be removably connected to the magnet 6370 (described below), allowing the lower strap 6304 to be disconnected from the inflation chamber 6200, but without affecting the length of the lower strap 6304.

[0522] In some configurations, the upper strap 6305 can be directly attached to the tab 6324 of the conduit 6320. The upper strap 6305 can pass through the tab 6324 to adjust the length and control the tension of each upper strap 6305.

[0523] In some configurations, headband 6302 may be used only with full-face pad 6050 (e.g., because nose pad 7050 does not have four connection points). However, headband 6302 may be used interchangeably with catheter headband 6319 and rigid arm 6340.

[0524] 5.3.3.3.2 Two-point connection

[0525] like FIG. 16 As shown, some forms of the headband 7302 can be a two-point connected headband. This means that the headband 7302 can be connected to two separate locations, and therefore can include two different straps that provide tension to help maintain the sealing structure 7100 in the sealed position.

[0526] The headband 7302 may also include an upper bandage 7305 that may cover the temporal, parietal, and / or occipital bones. The upper bandage 7305 may also be connected to the conduit 6320 (e.g., by abutting against a tab 6324). The upper bandage 7305 may contact the patient's head at substantially the same location as the upper bandage 6305.

[0527] In some forms, the headband 7302 may not include a separate posterior bandage. Instead, the upper bandage 7305 may be used as a posterior bandage. For example, the upper bandage 7305 may also contact the back of the patient's head and may cover the occipital bone and / or the trapezius muscle.

[0528] In some forms, the upper bandage 7305 may be formed from a continuous sheet of material. In other words, the headband 7302 may not be formed from multiple bandages joined together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different bandages. In other forms, the headband 7302 may be formed from multiple bandages joined together (e.g., two upper bandages, a back bandage, etc.).

[0529] like FIG. 16As shown, headgear 7302 can at least partially bifurcate. For example, a posterior portion 7307 of headgear 7302 (e.g., configured to contact a posterior portion of a patient's head) can be wider than a surrounding portion of headgear 7302. An intermediate portion 7308 of posterior portion 7307 can include a slit 7309. Thus, due to slit 7309, an upper segment of posterior portion 7307 can move relative to a lower segment. This can allow a patient to have greater strap coverage over a posterior region of their head, which can help better anchor headgear 7302 to a patient's head because there is no lower strap (e.g., 6304).

[0530] In some forms, headgear 7302 can be used only with nasal cushion 7050 (e.g., because full-face cushion 6050 does not have four connection points). However, headgear 6302 can be used interchangeably with conduit headgear 6319 and rigidizer arms 6340.

[0531] 5.3.3.4 Sleeve

[0532] A sleeve can be used with conduit headgear 6319 and / or rigidizer arms 6340. The sleeve can at least partially surround conduit headgear 6319 and / or rigidizer arms 6340. As FIG. 17 to 24 As shown, different shapes of sleeves can be used, which can correspond to different types of positioning and stabilizing structures 6300. In some forms, the configuration of the sleeve can be customized to fit a particular user's face. For example, the sleeve can be configured in a relatively more posterior region of a patient's head.

[0533] In certain forms, the sleeve can be made of a comfortable material. For example, the sleeve can be constructed of a textile material, a foam material, or a combination of both. The comfortable material can contact the patient in use and can feel soft against the patient's skin in order to improve the patient's compliance.

[0534] The material can also be flexible in order to help the sleeve be put on or taken off of conduit headgear 6319 or rigidizer arms 6340. For example, the material can allow the sleeve to bend to conform to the shape of conduit headgear 6319 or rigidizer arms 6340, which can vary depending on the shape of an individual patient's head.

[0535] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve stretch in order to fit around conduit headgear 6319 or rigidizer arms 6340. The elastic material can then return to an initial position that conforms to conduit headgear 6319 or rigidizer arms 6340 in order to limit the sleeve from sliding in use.

[0536] As described in more detail below, some forms of sleeves can be specifically designed for rigid elements (e.g., catheter headband 6319 and / or rigid arm 6340). However, sleeves can facilitate interchangeable connection of rigid elements with pads (e.g., full-face pad 6050, nasal pad 7050, etc.) of different types or forms.

[0537] 5.3.3.4.1 Catheter sleeve

[0538] like FIG. 17 to 19 As shown, one example of a sleeve is a catheter sleeve 6350, which can be used with the catheter headband 6319 described above.

[0539] like FIG. 17 As shown, the catheter sleeve 6350 may include similar components. FIG. 13 The catheter headband 6319 shown is in a curved shape. The flexible material used to construct the catheter sleeve 6350 allows the catheter sleeve 6350 to be further bent to correspond to the shape of the catheter 6320 (e.g., when worn by a patient).

[0540] In some forms, the catheter sleeve 6350 may include a first or upper opening 6352. The upper opening 6352 may be located at one end of the catheter sleeve 6350. The upper opening 6352 may be an opening in a passage extending along at least a portion of the catheter sleeve 6350.

[0541] In some forms, the catheter sleeve 6350 may be at least partially elastic near the upper opening 6352. As described above, elasticity allows the catheter sleeve 6350 to extend around the opening 6352 in order to increase the diameter of the opening 6352.

[0542] like FIG. 17 to 19 Some forms of the catheter sleeve 6350 may also include a lower extension 6354. The lower extension 6354 may be positioned on the end of the catheter sleeve 6350 opposite to the upper opening 6352. The catheter sleeve 6350 may be customized to fit the face of a particular user. For example, the lower extension 6354 of the catheter sleeve 6350 may be configured in a relatively posterior or anterior region of the patient's head.

[0543] Some forms of the lower extension 6354 may include a rigid or semi-rigid element (e.g., within the sleeve 6350). The rigid or semi-rigid element may be made of a plastic material or a similar material. Alternatively, the lower extension 6354 may be rigidified using manufacturing processes (e.g., stitching rigid threads, plain knitting, using a thicker material).

[0544] In some configurations, the lower extension 6354 may be separate from the passage through the catheter sleeve 6350. In other words, the catheter 6320 inserted into the catheter sleeve 6350 may not extend into the lower extension 6354.

[0545] like FIG. 17 and 18 As shown, some forms of the lower extension 6354 may include a connecting member 6356. In the example shown, the connecting member 6356 may be a magnet, although in other examples, the connecting member 6356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). The connecting member 6356 may also be positioned at the end of the lower extension 6354, although the connecting member 6356 may also be positioned anywhere along the lower extension 6354.

[0546] In some forms, the connecting member 6356 (e.g., a magnet) may be removably connected to the magnet 6370 of the headband 6302. For example, when the catheter sleeve 6350 is connected to the catheter 6320 (described below), the magnet 6370 connected to the lower strap 6304 may be removably connected to the connecting member 6356 to provide tension.

[0547] like FIG. 17 and 18 As shown, the lower extension 6354 can be disposed at different positions along the catheter sleeve 6350. For example, as described above, the lower extension 6354 can be positioned near the end of the catheter sleeve 6350 (see, for example, [reference needed]). FIG. 17 Alternatively, the lower extension 6354 may be located at an intermediate position between the upper opening 6352 and the opposite ends of the catheter sleeve 6350.

[0548] In some configurations, changing the position of the lower extension 6354 can alter the position of the connecting member 6356. Changing the position of the connecting member 6356 can also alter the force vector when the lower strap 6304 (via magnet 6370) is connected to the catheter sleeve 6350. This repositioning can facilitate a sliding fit for patients with various head shapes and sizes.

[0549] In some forms, the lower extension 6354 is formed together with the rest of the catheter sleeve 6350. For example, the catheter sleeve 6350 may be formed from a single piece of material. Alternatively, the lower extension 6354 may be sewn onto the rest of the catheter sleeve 6350. In either case, the lower extension 6354 cannot be moved from its position. Instead, the catheter sleeve 6350 may be manufactured with the lower extension 6354 in various positions to better accommodate a wider range of head sizes.

[0550] Alternatively, the lower extension 6354 can be removably connected to the rest of the conduit sleeve 6350 (e.g., using hook and loop material, using mechanical fasteners, using magnets, etc.). In other forms, the lower extension 6354 can be slidable relative to the rest of the conduit sleeve 6350. In either case, the patient can move the lower extension 6354 to a desired position relative to the rest of the conduit sleeve 6350. Depending on the type of adjustment, the adjustment can be between discrete positions, or between an infinite number of positions.

[0551] As FIG. 19 shown, the conduit sleeve 6350 can also include a lower opening 6358 at an end of the conduit sleeve 6350 opposite the upper opening 6352. A passageway can extend between the upper opening 6352 and the lower opening 6358.

[0552] In the illustrated example, the lower opening 6358 can open to a surface of the conduit sleeve 6350. In other words, the lower opening 6358 can open perpendicularly relative to the upper opening 6352.

[0553] In some forms, the lower opening 6358 can include a resilient material similar to the upper opening 6352. The resilience can allow the lower opening 6358 to stretch so that the conduit 6320 can fit through the opening.

[0554] FIG. 19 The illustrated example shows the lower opening 6358 aligned with the lower extension 6354 (e.g., the lower extension 6354 is in the FIG. 17 position shown). Moving the lower extension 6354 to another position (e.g., as FIG. 18 shown) can not change the position of the lower opening 6358. In other words, the lower opening 6358 can always be at an end of the conduit sleeve 6350 even if the lower extension 6354 is in a new position.

[0555] 5.3.3.4.2 Four-Point Arm Sleeve

[0556] As FIG. 20 to 22 shown, another example of a sleeve is a four-point arm sleeve 6380, which can be used with the rigidizer arm 6340 described above.

[0557] As FIG. 20 shown, the four-point arm sleeve 6380 can include a curved shape similar to the shape of the rigidizer arm 6340 shown. FIG. 14 The flexible material used to construct the four-point arm sleeve 6380 can allow the four-point arm sleeve 6380 to further curve so as to correspond to the shape of the rigidizer arm 6340 (e.g., when worn by the patient and / or when bent by the patient).

[0558] As FIG. 17 to 19As shown, some forms of the four-point arm sleeve 6380 may include a lower extension 6384. The lower extension 6384 may be positioned at an end of the four-point arm sleeve 6380.

[0559] In the illustrated example, the shape and / or structure of the lower extension 6384 is substantially the same as that of the lower extension 6354. For example, the lower extension 6384 may be more rigid than the rest of the four-point arm sleeve 6380 (e.g., due to rigidification of the thread or rigid material).

[0560] like FIG. 17 and 18 As shown, some forms of the lower extension 6384 may include a connecting member 6386. In the example shown, the connecting member 6386 may be a magnet, although in other examples, the connecting member 6386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). The connecting member 6386 may also be positioned at the end of the lower extension 6384, although the connecting member 6386 may also be positioned anywhere along the lower extension 6384.

[0561] In some forms, the connecting member 6386 (e.g., a magnet) may be removably connected to the magnet 6370 of the headband 6302. For example, when the four-point arm sleeve 6380 is connected to the rigid arm 6340 (described below), the magnet 6370 connected to the lower strap 6304 may be removably connected to the connecting member 6386 to provide tension.

[0562] like FIG. 20 and 21 As shown, the lower extension 6384 can be arranged at different locations along the four-point arm sleeve 6380. For example, as described above, the lower extension 6384 can be positioned near the end of the four-point arm sleeve 6380 (see, for example, [reference needed]). FIG. 20 Alternatively, the lower extension 6384 can be positioned toward the center of the four-point arm sleeve 6380 and away from that end (see, for example...). FIG. 21 ).

[0563] As described above regarding the catheter sleeve 6350, changing the position of the lower extension 6384 can alter the position of the connecting member 6386. Changing the position of the connecting member 6386 also alters the force vector when the lower strap 6304 (via magnet 6370) is connected to the four-point arm sleeve 6380. This repositioning can facilitate a sliding fit for patients with various head shapes and sizes.

[0564] The lower extension 6384 can be connected to the four-point arm sleeve 6380 in a similar manner as the lower extension 6354 is connected to the conduit sleeve 6350, as described above. For example, the lower extension 6384 can be permanently connected to the four-point arm sleeve 6380 at a fixed location, or the lower extension 6384 can be movably or removably connected to the four-point arm sleeve 6380.

[0565] As shown, the four-point arm sleeve 6380 can include a lower opening 6388 at an end of the four-point arm sleeve 6380. The lower opening 6388 can form an opening through a passageway of the four-point arm sleeve 6380. In the illustrated example, the lower opening 6388 can open to a surface of the conduit sleeve 6380. FIG. 22

[0566] In some forms, the lower opening 6388 can include a resilient material similar to the upper opening 6352 of the conduit sleeve 6350. The resilience can allow the lower opening 6388 to stretch so that the rigid member arms 6340 can fit through the opening.

[0567] FIG. 22 The illustrated example shows the lower opening 6388 aligned with the lower extension 6384 (e.g., the lower extension 6384 is in the FIG. 20 position shown). Moving the lower extension 6384 to another position (e.g., as shown in FIG. 21 ) can not change the position of the lower opening 6388. In other words, the lower opening 6388 can always be at an end of the four-point arm sleeve 6380 even if the lower extension 6384 is in a new position.

[0568] As shown, the four-point arm sleeve 6380 can be formed as a single sleeve (e.g., unlike the conduit sleeve 6350, which can be part of a pair of sleeves). The four-point arm sleeve 6380 can be shaped similarly to the conduit head strap 6319 described above, and can sit on a patient’s head in a similar position. FIG. 20 to 22

[0569] The four-point arm sleeve 6380 can include a lower opening 6388 on either end. The four-point arm sleeve 6380 can also include a lower extension 6384 on either end. Thus, the four-point arm sleeve 6380 can be symmetrical similar to the conduit head strap 6319.

[0570] In the illustrated example, the lower opening 6388 can be the only opening of the four-point arm sleeve 6380. In other words, the four-point arm sleeve 6380 can not include an upper opening (e.g., similar to the upper opening 6352). Additionally, the four-point arm sleeve 6380 can include multiple passageways, rather than a single connected passageway.

[0571] ​​For example, each lower opening 6388 can be an opening to a single passageway. Each passageway can include only one opening (i.e., the respective lower opening 6388), and the passageways can not be connected to one another. The length of each passageway can be approximately the length of the rigidizer arm 6340.

[0572] As shown in FIGS. 63 and 64, the four-point arm sleeve 6380 can include a pair of lower sections 6390 and an upper section 6392. The pair of lower sections 6390 includes a first lower section 6390 and a second lower section 6390. The lower sections 6390 can be positioned on the right and left sides of the four-point arm sleeve 6380 and can include the respective lower openings 6388 described above. The lower sections 6390 can also include tabs 6394, which can be similar to the tabs 6324 on the catheter head strap 6319. When the patient wears the four-point arm sleeve 6380, the tabs 6394 can be positioned on the patient’s head in substantially the same locations as the tabs 6324 when the patient wears the catheter head strap 6319. The lower sections 6390 can also include passageways. FIG. 22

[0573] In some forms, the upper end of each lower section 6390 (e.g., distal from the lower opening 6388 and proximal to the upper section 6392) can include a closed end. For example, the end of the lower section 6390 opposite the lower opening 6388 can be stitched closed so as to form the end of the respective passageway.

[0574] The upper section 6392 can be connected between the lower sections 6390. For example, the upper section 6392 can be stitched to both lower sections 6390 (although another manner of connection can be used). In use, the upper section 6392 can contact an upper region of the patient’s head (e.g., covering the frontal bone and / or parietal bone).

[0575] The upper section 6392 can be substantially flat and have no internal passageways. However, some forms of the upper section 6392 can include an outer fabric layer with an internal foam layer to provide additional cushioning to the patient’s head.

[0576] 5.3.3.4.3 Two-point arm sleeve

[0577] As shown in FIGS. 63 and 64, the four-point arm sleeve 6380 can include a pair of lower sections 6390 and an upper section 6392. The pair of lower sections 6390 includes a first lower section 6390 and a second lower section 6390. The lower sections 6390 can be positioned on the right and left sides of the four-point arm sleeve 6380 and can include the respective lower openings 6388 described above. The lower sections 6390 can also include tabs 6394, which can be similar to the tabs 6324 on the catheter head strap 6319. When the patient wears the four-point arm sleeve 6380, the tabs 6394 can be positioned on the patient’s head in substantially the same locations as the tabs 6324 when the patient wears the catheter head strap 6319. The lower sections 6390 can also include passageways. FIG. 23 24 As shown in FIGS. 63 and 64, the four-point arm sleeve 6380 can include a pair of lower sections 6390 and an upper section 6392. The pair of lower sections 6390 includes a first lower section 6390 and a second lower section 6390. The lower sections 6390 can be positioned on the right and left sides of the four-point arm sleeve 6380 and can include the respective lower openings 6388 described above. The lower sections 6390 can also include tabs 6394, which can be similar to the tabs 6324 on the catheter head strap 6319. When the patient wears the four-point arm sleeve 6380, the tabs 6394 can be positioned on the patient’s head in substantially the same locations as the tabs 6324 when the patient wears the catheter head strap 6319. The lower sections 6390 can also include passageways.

[0578] In some forms, the two-point arm sleeve 6380-1 can be similar to the four-point arm sleeve 6380 described above. Only some similarities and differences are described below.

[0579] As shown in FIGS. 63 and 64, the four-point arm sleeve 6380 can include a pair of lower sections 6390 and an upper section 6392. The pair of lower sections 6390 includes a first lower section 6390 and a second lower section 6390. The lower sections 6390 can be positioned on the right and left sides of the four-point arm sleeve 6380 and can include the respective lower openings 6388 described above. The lower sections 6390 can also include tabs 6394, which can be similar to the tabs 6324 on the catheter head strap 6319. When the patient wears the four-point arm sleeve 6380, the tabs 6394 can be positioned on the patient’s head in substantially the same locations as the tabs 6324 when the patient wears the catheter head strap 6319. The lower sections 6390 can also include passageways. FIG. 23 ​​As shown, the two-point arm sleeve 6380-1 can include a lower opening 6388-1 at an end of the two-point arm sleeve 6380-1. The lower opening 6388-1 can form an opening through a passageway of the two-point arm sleeve 6380-1. In the illustrated example, the lower opening 6388-1 can open to a surface of the conduit sleeve 6380-1.

[0580] In some forms, the lower opening 6388-1 can include a resilient material similar to the upper opening 6352 of the conduit sleeve 6350. The resilience can allow the lower opening 6388-1 to stretch such that the rigidizer arm 6340 can fit through the opening.

[0581] As shown, the two-point arm sleeve 6380-1 can be formed as a single sleeve (e.g., similar to the four-point arm sleeve 6380). The shape of the two-point arm sleeve 6380-1 can be similar to the conduit headband 6319 described above, and can sit on the head of the patient in a similar position. FIG. 23 As shown, another form of the two-point arm sleeve 6380-1 can be formed as multiple components. For example, the upper section 6392-1 can be formed in two parts that can be selectively connected to one another (e.g., with hook and loop material, snaps, etc.). This can allow the patient to adjust the size of the sleeve to better fit their head. Although not shown, a similar multi-piece adjustable sleeve can be used with the four-point arm sleeve 6380 described above.

[0582] FIG. 24 The two-point arm sleeve 6380-1 can include a lower opening 6388-1 on either end. Thus, the two-point arm sleeve 6380-1 can be symmetrical similar to the conduit headband 6319.

[0583] In the illustrated example, the lower opening 6388-1 can be the only opening of the two-point arm sleeve 6380-1. In other words, the two-point arm sleeve 6380-1 can not include an upper opening (e.g., similar to the upper opening 6352). Additionally, the two-point arm sleeve 6380-1 can include multiple passageways, rather than a single connected passageway.

[0584] For example, each lower opening 6388-1 can be an opening to a single passageway. Each passageway can include only one opening (i.e., the respective lower opening 6388-1), and the passageways can not be connected to one another. The length of each passageway can be approximately the length of the rigidizer arm 6340.

[0585] As shown, the two-point arm sleeve 6380-1 can be formed as a single sleeve (e.g., similar to the four-point arm sleeve 6380). The shape of the two-point arm sleeve 6380-1 can be similar to the conduit headband 6319 described above, and can sit on the head of the patient in a similar position.

[0586] As shown, another form of the two-point arm sleeve 6380-1 can be formed as multiple components. For example, the upper section 6392-1 can be formed in two parts that can be selectively connected to one another (e.g., with hook and loop material, snaps, etc.). This can allow the patient to adjust the size of the sleeve to better fit their head. Although not shown, a similar multi-piece adjustable sleeve can be used with the four-point arm sleeve 6380 described above. FIG. 23 ​As shown, the two-point arm sleeve 6380-1 can include a pair of lower sections 6390-1 and an upper section 6392-1. The pair of lower sections 6390-1 includes a first lower section 6390-1 and a second lower section 6390-1. The lower sections 6390-1 can be positioned on the right and left sides of the two-point arm sleeve 6380-1 and can include the respective lower openings 6388-1 described above. The lower sections 6390-1 can also include tabs 6394-1, which can be similar to the tabs 6324 on the catheter head strap 6319. When the patient wears the two-point arm sleeve 6380-1, the tabs 6394-1 can be positioned on the patient’s head in substantially the same locations as the tabs 6324 when the patient wears the catheter head strap 6319. The lower sections 6390-1 can also include passageways.

[0587] In some forms, the upper end of each lower section 6390-1 (e.g., distal from the lower opening 6388-1 and proximal to the upper section 6392-1) can include a closed end. For example, the end of the lower section 6390-1 opposite the lower opening 6388-1 can be stitched closed so as to form the end of the respective passageway.

[0588] The upper section 6392-1 can be connected between the lower sections 6390-1. For example, the upper section 6392-1 can be stitched to both lower sections 6390-1 (although another manner of connection can be used). In use, the upper section 6392-1 can contact an upper region of the patient’s head (e.g., covering the frontal bone and / or parietal bone).

[0589] The upper section 6392-1 can be substantially flat and have no internal passageway. However, some forms of the upper section 6392-1 can include an outer fabric layer with an internal foam layer to provide additional cushioning to the patient’s head.

[0590] Accordingly, the two-point arm sleeve 6380-1 can be substantially similar to the four-point arm sleeve 6380. However, the two-point arm sleeve 6380-1 can not include a lower extension or connecting member. Accordingly, the straps from the headgear 6302 can be connected to the two-point arm sleeve 6380-1 only by the tabs 6394.

[0591] 5.3.4 Vent

[0592] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow washout of exhaled gases, such as carbon dioxide.

[0593] In certain forms, the vent 3400 is configured to allow a continuous vent flow from the interior of the plenum chamber 3200 to ambient while the pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured such that the vent flow has a magnitude sufficient to reduce rebreathing of exhaled C02 by the patient while, in use, maintaining a therapeutic pressure in the plenum chamber.

[0594] 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.

[0595] The vent 3400 can be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure such as a swivel.

[0596] As shown in FIG. 41 , the vent 6400 can be used with the patient interface 6000. The vent 6400 can have a substantially similar shape to the vent 6402 (e.g., a substantially circular shape).

[0597] The vent 6400 can be used with a full-face patient interface 6000 (e.g., as shown in FIG. 7 to 9 ) or a nasal patient interface 7000 (e.g., as shown in FIG. 10 to 12 ).

[0598] With continued reference to FIG. 41 , the vent 6400 can comprise a vent housing or vent body 6404, which can be configured to interface with the vent opening 6402. The vent housing 6404 can be made of a rigid material or a semi-rigid material. For example, the vent housing 6404 can be constructed of plastic, metal, or any similar material. The vent housing 6404 can increase the rigidity of the patient interface 6000 (e.g., so as to limit unwanted bending that can affect the positioning of the seal-forming structure 6100 on the patient’s face).

[0599] The vent housing 6404 can comprise a front surface 6408, a rear surface 6412, and a recess 6416. The front surface 6408 faces away from the patient’s face in use, and can be positioned at the pressurized exterior of the plenum chamber 6200. The rear surface 6412 is disposed opposite the front surface 6408. In use, the rear surface 6412 can face the patient and can be disposed within the pressurized volume of the plenum chamber 6200. The recess 6416 can be formed between the front and rear surfaces 6408, 6412. A portion of the plenum chamber 6200 can be received within the recess 6416 so as to retain the vent 6400 in place.

[0600] In some forms, diffuser 6448 can be used with vent housing 6404. Diffuser 6448 helps limit decibel output from any patient interface 6000 (or any other patient interface). Specifically, diffuser 6448 helps limit the decibel level associated with air output (e.g., exhaled air) from patient interface 6000, although diffuser 6448 can limit the decibel level at any point within the patient interface.

[0601] The diffuser 6448 may include a damping member (not shown) and a cover 6456. The damping member and the cover 6456 may be coupled to the vent body 6404. The diffuser may be made of a sound-damping material, and the cover 6456 may hold the damping member in place.

[0602] like FIG. 41 As shown, some forms of the cover 6456 may not extend to the edge of the vent housing 6404. A gap 6464 may be formed between the edge of the cover 6456 and the surface of the vent body 6404. Airflow may exit from the vent 6400 through the gap 6464 to be discharged into the environment.

[0603] 5.3.5 Decoupling Structure

[0604] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or ball head and ball socket.

[0605] 5.3.6 Connection Port

[0606] Connection port 3600 allows connection to air circuit 4170.

[0607] 5.3.7 Forehead Stent

[0608] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0609] 5.3.8 Anti-asphyxiation valve

[0610] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0611] Port 5.3.9

[0612] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0613] 5.3.10 Modularity

[0614] As noted above, the cushion, headgear, and sleeve can have different styles, which can correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). The patient or clinician can select certain combinations of the cushion, headgear, and sleeve in order to optimize the effectiveness of the therapy and / or the comfort of the individual patient.

[0615] In some forms, different types of cushions, headgear, and sleeves can be used interchangeably with one another in order to form different combinations of the patient interface. This can be beneficial from a manufacturing perspective, as fewer components can be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations can allow the patient to change the type of patient interface without changing each component.

[0616] For example, air can be delivered to the patient in one of two main ways. First, the patient can receive a flow of pressurized air through a conduit headgear 6319. This can be referred to as a “tube up” configuration, and can position the connection port at the top of the patient’s head. Second, the patient can receive a flow of pressurized air through a hose that is connected directly to the cushion and positioned in front of the patient’s face. This can be referred to as a “tube down” configuration, and can separate the air flow conduit from the positioning and stabilizing arrangement. Even when wearing the same type of patient interface (e.g., full-face patient interface 6000, nasal patient interface 7000, etc.), some patients can prefer one type of air delivery over the other, and / or one type of air delivery can be more beneficial to their individual sleep type. Thus, it can be beneficial to allow a single type of patient interface (e.g., full-face patient interface 6000, nasal patient interface 7000) to be used with either a “tube up” or “tube down” configuration.

[0617] The patient or clinician can select different components (e.g., cushions, headgear, and sleeves, etc.) in order to manufacture modular assemblies for a particular patient. These different components are interchangeable, such that the patient can swap out one or more components for different types of the same component (e.g., a nasal mask for a full-face mask), and form different modular assemblies. Alternatively or additionally, the clinician can recommend that different patients swap at least some of the components in order to create different patient interfaces.

[0618] The following recitations describe various combinations that can be created by assembling different components together.

[0619] 5.3.10.1 Assemblies

[0620] The various elements of the above-described patient interfaces (e.g., the cushion, headgear, sleeve) can generally be universal. In other words, they can not be made in specific configurations (although they can have different sizes to fit different sized patients). This can allow the person assembling the patient interface (e.g., the manufacturer, clinician, patient, etc.) to select standard components in order to assemble an available patient interface.

[0621] 5.3.10.1.1 Full Face Tube Up Configuration

[0622] As shown in FIG. 63, the conduit sleeve 6350 can be connected to the conduit headgear 6319. This combination will enable the patient to experience the "tube up" type of air delivery with the full face patient interface 6000. Figures 25 to 28-2

[0623] As described above, a pair of conduit sleeves 6350 can be used with the conduit headgear 6319. The following description and related figures specifically relate to the connection between one conduit sleeve 6350 and one conduit 6320 of the conduit headgear 6319. The other conduit sleeve 6350 will be connected to the other conduit 6320 of the conduit headgear 6319 in substantially the same manner.

[0624] As shown in FIG. 63, the conduit sleeve 6350 can be connected to the conduit headgear 6319. This combination will enable the patient to experience the "tube up" type of air delivery with the full face patient interface 6000. Figure 25

[0625] In some forms, the conduit sleeve 6350 can be substantially flat when not in use. As described above, at least some portions of the conduit sleeve 6350 can comprise a resilient material (e.g., around the upper opening 6352). The patient can stretch the area around the upper opening 6352 in order to create enough space to accommodate the conduit connection structure 6500.

[0626] Figure 25 The configuration shown in FIG. 64 shows the inner surface of the conduit 6320 and the back surface of the conduit sleeve 6350. In other words, Figure 25 The surfaces of the conduit 6320 and the conduit sleeve 6350 shown in FIG. 64 will face and / or contact the patient during use. During assembly, the connection of the conduit 6320 and the conduit sleeve 6350 is oriented in the same direction so that the conduit connection structure 6500 can be ultimately connected to the plenum chamber 6200.

[0627] As shown in FIG. 65, the conduit sleeve 6350 can be connected to the conduit headgear 6319. This combination will enable the patient to experience the "tube up" type of air delivery with the full face patient interface 6000. Figure 26 ​​As shown, the upper opening 6352 of the catheter sleeve 6350 can receive the catheter clip structure 6500 and can be positioned at least partially along the length of the catheter 6320. The previously resilient portion of the catheter sleeve 6350 that allows the upper opening 6352 to extend and receive the catheter clip structure 6500 can return to its original position. This can create a sliding engagement between the catheter sleeve 6350 and the catheter 6320 (which limits relative movement between the catheter sleeve 6350 and the catheter 6320 to limit slippage during patient wear). The patient may need to continue stretching the upper opening 6352 to allow the catheter sleeve 6350 to continue moving along the catheter 6320.

[0628] See also Figure 26 The catheter clamp structure 6500 can be completely contained within the catheter sleeve 6350. In other words, the catheter clamp structure 6500 may not be aligned with the lower opening 6358 (and may not be exposed to the patient). Therefore, the patient may not be able to attach the catheter clamp structure 6500 to the inflation chamber 6200 in this position.

[0629] like Figure 27 As shown, the catheter sleeve 6350 can continue to slide along the surface of the catheter 6320. Specifically, the upper opening 6352 can be positioned further away from the catheter clamp structure 6500 (e.g., closer to the accordion-shaped segment 6328). As described above, the patient can continue to extend the upper opening 6352 to facilitate movement along the catheter 6320.

[0630] Figure 27 A catheter clip structure 6500 exposed to the patient is also shown. Specifically, the catheter clip structure 6500 can be aligned with a lower opening 6358. This can occur when the catheter 6320 has fully slid through the catheter sleeve 6350. Similar to the upper opening 6352, the lower opening 6358 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6358 to allow the catheter clip structure 6500 to be positioned through the lower opening 6358.

[0631] When the catheter clamp structure 6500 is positioned at Figure 27 When the orientation is correct, the catheter 6320 may not be positioned in the lower extension 6354. As described above, the lower extension 6354 can be cut from the passage of the catheter sleeve 6350 (e.g., by suturing, ultrasonic welding, etc.).

[0632] like Figure 28 As shown, the catheter sleeve 6350 can be fully connected to the catheter 6320. Specifically, the catheter clamp structure 6500 can be positioned through the lower opening 6358 (e.g., in...). Figure 27The lower opening 6358 can be elastic (e.g., to allow it to stretch to accommodate the conduit clamp structure 6500 and then return to its original shape after the stretch is removed). In some forms, the elasticity of the lower opening 6358 can allow the shape of the lower opening to relax and return toward its original position (e.g., so that it conforms to the conduit clamp structure 6500 and restricts sliding). In this position, the conduit clamp structure 6500 can be able to connect to the plenum chamber 6200 without substantial interference from the conduit sleeve 6350.

[0633] As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050). Figure 28-1 and 28-2 As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050).

[0634] 5.3.10.1.2 Full Face Tube Down Configuration

[0635] As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050). Figures 29 to 33-2 As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050).

[0636] As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050).

[0637] Figure 29 As shown in FIGS. 63A and 63B, the conduit sleeve 6350 can be connected to the conduit clamp structure 6500. The conduit sleeve 6350 can be connected to the conduit clamp structure 6500 in a manner that allows the conduit clamp structure 6500 to be removed from the conduit sleeve 6350 (e.g., to allow the conduit clamp structure 6500 to be connected to the cushion 6050, 7050).

[0638] In some forms, the four-point arm sleeve 6380 can be substantially flat when not in use. As described above, at least some portions of the four-point arm sleeve 6380 can comprise an elastic material (e.g., around the lower opening 6388). The patient can stretch the area around the lower opening 6388 in order to create enough space to accommodate the first end 6342 of the rigidizer arm 6340.

[0639] In some forms, the rigidizer arm 6340 (e.g., particularly the first end 6342) can be substantially flat. This can allow the patient to insert the rigidizer arm 6340 into the four-point arm sleeve 6380 without substantially stretching the lower opening 6388 (e.g., the first end 6342 can be smaller than the lower opening 6388 and can be able to slide in without stretching the opening 6388). ​

[0640] Figure 29 The configuration in FIG. 63 shows the inner surface of the four-point arm sleeve 6380 and the back surface of the rigidizer arm 6340. In other words, Figure 29 The surfaces of the rigidizer arm 6340 and the four-point arm sleeve 6380 shown are both facing and / or contacting the patient during use. During assembly, the connection of the four-point arm sleeve 6380 and the rigidizer arm 6340 are oriented in the same direction so that the arm connection structure 6504 can be ultimately connected to the plenum chamber 6200.

[0641] As shown in FIGS. 64 and 65, Figure 30 and 31 the lower opening 6388 of the four-point arm sleeve 6380 can receive the first end 6342 of the rigidizer arm 6340 and can be positioned at least partially along the length of the rigidizer arm 6340. The elastic portion of the four-point arm sleeve 6380 that can allow the lower opening 6388 to stretch and receive the free end 6342 can return to its original position (if initially stretched).

[0642] In some forms, the rigidizer arm 6340 can have a width that is substantially no greater than the four-point arm sleeve 6380. The patient can not need to continuously stretch the four-point arm sleeve 6380 to move the rigidizer arm 6340 through the four-point arm sleeve 6380. Instead, the rigidizer arm 6340 can slide through the four-point arm sleeve 6380 without significant resistance. The flexible material of the four-point arm sleeve 6380 can bend along the shape of the rigidizer arm 6340 (if the rigidizer arm 6340 is bent to better conform to the patient’s face). For example, between Figure 30 and Figure 31 the patient can slide the rigidizer arm 6340 through the four-point arm sleeve 6380 without substantially needing to stretch the lower opening 6388.

[0643] With continued reference to Figure 30 and 31 the conduit clip structure 6504 can be entirely located outside of the four-point arm sleeve 6380. In other words, the arm clip structure 6504 can not pass through the lower opening 6388 (and be exposed to the patient).

[0644] As shown in FIG. 66, Figure 32As shown, the four-point arm sleeve 6380 can continue to slide along the surface of the rigid arm 6340. The lower opening 6388 can be positioned closer to the arm clamp structure 6504. Specifically, the arm clamp structure 6504 can be positioned at least partially through the lower opening 6388 while remaining exposed to the patient. The arm clamp structure 6504 can be aligned with the lower opening 6388. This may occur when the rigid arm 6340 has fully slid through the four-point arm sleeve 6380. As previously described, the lower opening 6388 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6388 to allow the arm clamp structure 6504 to be positioned through the lower opening 6388.

[0645] When the arm clamp structure 6504 is positioned Figure 32 In the orientation, the rigid arm 6340 (e.g., arm clamp structure 6504) may not be positioned in the lower extension 6384. As described above, the lower extension 6384 can be cut from the passage of the four-point arm sleeve 6380 (e.g., by stitching, ultrasonic welding, etc.).

[0646] like Figure 33 As shown, the four-point arm sleeve 6380 can be fully connected to the rigid arm 6340. Specifically, the arm clamp structure 6504 can be partially positioned through and surrounded by the lower opening 6388 (e.g., in...). Figure 32 (After the lower opening 6388 is stretched). In some forms, the elasticity of the lower opening 6388 allows the shape of the lower opening to relax and return to its initial position (e.g., causing it to fit snugly against the arm clamp structure 6504 and restricting slippage). In this position, the arm clamp structure 6504 can connect to the inflation chamber 6200 without substantial interference from the four-point arm sleeve 6380.

[0647] See also Figure 33 The first end 6342 of the rigid arm 6340 (see example) Figure 29 The lower segment 6390 can be positioned at one end adjacent to the upper segment 6392. As described above, the upper segment 6392 may not include a passage for receiving the rigid member arm 6340. The length of the lower segment 6390 may be substantially similar to or equal to the length of the rigid member arm 6340, such that the rigid member arm 6340 is adjacent to or substantially close to the end of the lower segment 6390.

[0648] like Figure 33-1 and 33-2 As shown, after the four-point arm sleeve 6380 is fully engaged, the arm clamp structure 6504 remains exposed, allowing it to be connected to the gaskets 6050 and 7050. The arm clamp structure 6504 can extend from the four-point arm sleeve 6380 to limit interference when connecting the rigid arm 6340 to the gaskets 6050 and 7050 (see...). Figure 39 and 40 ).

[0649] 5.3.10.1.3 Downward Nasal Tube Configuration

[0650] like Figures 34 to 38-2 As shown, the two-point arm sleeve 6380-1 can be connected to the rigid arm 6340. This combination will allow patients to experience a "tube-down" air delivery type with a nasal patient interface 7000.

[0651] As described above, a single two-point arm sleeve 6380-1 can be used with a pair of rigid arms 6340. The following description and related drawings specifically relate to the connection between one rigid arm 6340 and the two-point arm sleeve 6380-1. The other rigid arm 6340 will be connected to the two-point arm sleeve 6380-1 in substantially the same manner.

[0652] like Figure 34 As shown, the rigid arm 6340 and the two-point arm sleeve 6380-1 can begin to separate from each other. The patient can position the lower opening 6388-1 of the two-point arm sleeve 6380-1 close to the first end 6342 of the rigid arm 6340.

[0653] In some forms, the two-point arm sleeve 6380-1 may be substantially flat when not in use. As described above, at least some portions of the two-point arm sleeve 6380-1 may include an elastic material (e.g., around the lower opening 6388-1). The patient can stretch the area around the lower opening 6388-1 to create a sufficiently wide space to accommodate the first end 6342 of the rigid arm 6340.

[0654] In some forms, the rigid arm 6340 (e.g., particularly the first end 6342) can be substantially flat. This allows the patient to insert the rigid arm 6340 into the two-point arm sleeve 6380-1 without substantially stretching the lower opening 6388-1 (e.g., the first end 6342 may be smaller than the lower opening 6388-1 and can slide in without stretching the opening 6388-1).

[0655] Figure 34 The configuration shown illustrates the inner surface of the two-point arm sleeve 6380-1 and the rear surface of the rigid arm 6340. In other words, Figure 34 The surfaces of the rigid arm 6340 and the two-point arm sleeve 6380-1 shown will face and / or contact the patient during use. During assembly, the connection between the two-point arm sleeve 6380-1 and the rigid arm 6340 is oriented in the same direction, such that the arm connection structure 6504 can be ultimately connected to the inflation chamber 6200.

[0656] like Figure 35 and 36As shown, the lower opening 6388-1 of the two-point arm sleeve 6380-1 can receive the first end 6342 of the rigid arm 6340 and can be positioned at least partially along the length of the rigid arm 6340. The elastic portion of the two-point arm sleeve 6380-1, which allows the lower opening 6388-1 to be stretched and receives the free end 6342, can return to its original position (if initially stretched).

[0657] In some forms, the rigid arm 6340 may have a width substantially no greater than that of the two-point arm sleeve 6380-1. The patient may not need to continuously stretch the two-point arm sleeve 6380-1 to move the rigid arm 6340 through it. Instead, the rigid arm 6340 can slide through the two-point arm sleeve 6380-1 without significant resistance. The flexible material of the two-point arm sleeve 6380-1 can be bent along the shape of the rigid arm 6340 (if the rigid arm 6340 is bent to better conform to the patient's face). For example, in... Figure 35 and Figure 36 Between these, the patient is able to slide the rigid arm 6340 through the two-point arm sleeve 6380-1 without substantially needing to stretch the lower opening 6388-1.

[0658] Reference Figure 36 The arm clamp structure 6504 can be located entirely outside the two-point arm sleeve 6380-1. In other words, the arm clamp structure 6504 can be without passing through the lower opening 6388-1 (and exposed to the patient).

[0659] like Figure 37 As shown, the two-point arm sleeve 6380-1 can continue to slide along the surface of the rigid arm 6340. The lower opening 6388-1 can be positioned closer to the arm clamp structure 6504. Specifically, the arm clamp structure 6504 can be positioned at least partially through the lower opening 6388-1 while remaining exposed to the patient. The arm clamp structure 6504 can be aligned with the lower opening 6388-1. This may occur when the rigid arm 6340 has fully slid through the two-point arm sleeve 6380-1. As previously described, the lower opening 6388-1 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6388-1 to allow the arm clamp structure 6504 to be positioned through the lower opening 6388-1.

[0660] like Figure 38 As shown, the two-point arm sleeve 6380-1 can be fully connected to the rigid arm 6340. Specifically, the arm clamp structure 6504 can partially pass through and be surrounded by the lower opening 6388-1 (e.g., at the lower opening 6388-1 in...). Figure 37The elasticity of the lower opening 6388-1 can cause the shape of the lower opening to relax and return toward its initial position (e.g., such that it snuggly fits against the arm clip structure 6504 and restricts sliding) after being stretched. In this position, the arm clip structure 6504 can be able to connect to the plenum chamber 6200 without substantial interference from the two-point arm sleeve 6380-1.

[0661] The first end 6342 of the rigidizer arm 6340 can be positioned at an end of the lower section 6390-1 adjacent the upper section 6392-1 (see, e.g., FIG. 63). As described above, the upper section 6392-1 can not include a passageway for receiving the rigidizer arm 6340. The length of the lower section 6390-1 can be substantially similar to or equal to the length of the rigidizer arm 6340, such that the rigidizer arm 6340 abuts or is substantially close to abutting the end of the lower section 6390-1. Figure 23 ). As described above, the upper section 6392-1 can not include a passageway for receiving the rigidizer arm 6340. The length of the lower section 6390-1 can be substantially similar to or equal to the length of the rigidizer arm 6340, such that the rigidizer arm 6340 abuts or is substantially close to abutting the end of the lower section 6390-1.

[0662] As shown in FIGS. 64 and 65, the arm clip structure 6504 can remain exposed after the two-point arm sleeve 6380-1 is fully connected, such that it can be connected to the cushion 6050, 7050. The arm clip structure 6504 can extend from the two-point arm sleeve 6380-1 to limit interference when the rigidizer arm 6340 is connected to the cushion 6050, 7050. Figure 38-1 38-2 As shown in FIGS. 64 and 65, the arm clip structure 6504 can remain exposed after the two-point arm sleeve 6380-1 is fully connected, such that it can be connected to the cushion 6050, 7050. The arm clip structure 6504 can extend from the two-point arm sleeve 6380-1 to limit interference when the rigidizer arm 6340 is connected to the cushion 6050, 7050.

[0663] 5.3.10.1.4 Tubing-up configuration

[0664] Patients who wish to use the "tubing-up" configuration as part of the nasal patient interface 7000 do not need to use a sleeve to accomplish assembly. The patient can connect the conduit head strap 6319 (e.g., via the arm clip structure 6504) directly to the plenum chamber 7200.

[0665] In some forms, the patient can connect a sleeve (not shown) to the conduit 6320 of the conduit head strap 6319. The sleeve can be similar to the conduit sleeve 6350 and can be formed of a textile material. Some forms of the sleeve can also be at least partially elastic. Additionally, each conduit 6320 can include a separate sleeve. The sleeve can be used for patient comfort (e.g., because the textile material can be comfortable against the patient's skin).

[0666] 5.3.10.1.5 Connection

[0667] Figure 39 40 ​​The process of connecting the rigidizer arm 6340 with the four-point arm sleeve 6380 to the full-face inflatable chamber 6200 is shown. The following description will specifically refer to this configuration. However, the same description will apply to other configurations (e.g., as the conduit clamp structure 6500 and the arm clamp structure 6504 are the same shape and connect to the inflatable chamber 6200, 7200 in the same manner).

[0668] As shown in Figure 39 , the air circuit 4170 is connected to the vent opening 6402 to indicate that the cushion 6050 is being assembled into the tube down configuration. Thus, the patient can select the rigidizer arm 6340 (e.g., as a result of the tube down configuration) and the four-point arm sleeve 6380 (e.g., as a result of the full-face cushion 6050).

[0669] The four-point arm sleeve 6380 and the rigidizer arm 6340 can be connected as described above. Once connected, the assembly can be connected to the inflatable chamber inlet port 6254.

[0670] Continuing to refer to Figure 39 , the lower opening 6388-1 of the four-point arm sleeve 6380 (e.g., see Figures 34 to 37 ) can be positioned around the arm clamp structure 6504 to avoid obstructing the arm clamp structure 6504.

[0671] In the illustrated example, the arm clamp structure 6504 can include at least one protrusion 6508 extending from a surface of the rigidizer arm 6340. The at least one protrusion 6508 can have a similar shape to the inflatable chamber inlet port 6254 and can be shaped to fit within the inflatable chamber inlet port 6254.

[0672] In some forms, the at least one protrusion 6508 can be fitted into the inflatable chamber inlet port 6254 with a snap fit, a press fit, and / or a friction fit. This connection can create a substantially airtight joint while also allowing the connection to be removable.

[0673] In some forms, the arm clamp structure 6504 also includes at least one protrusion 6512 Figure 39 and 40 one of which is shown in ) that can be connected to the at least one protrusion 6508. For example, the protrusion 6512 can be positioned at one end of the at least one protrusion 6508 and can extend in a direction that is substantially perpendicular to the at least one protrusion 6508 (although other positions and angles can be used). The protrusion 6512 can fit into the groove 6286 adjacent to the inflatable chamber inlet port 6254.

[0674] In some forms, the engagement between the protrusion 6512 and the recess 6286 can help to properly orient at least one protrusion 6508 in the inflation chamber inlet port 6254. For example, the arm clip structure 6504 can engage in only one direction, allowing the headband to be properly connected and making the interface substantially airtight.

[0675] In some forms, the engagement between the protrusion 6512 and the recess 6286 can facilitate further connection of the arm clamp structure 6504 to the inflation chamber 6200. For example, the protrusion 6512 may be fitted into the recess 6286 by press-fit, snap-fit, and / or friction fit.

[0676] like Figure 39 and 40 As shown, the patient can align the arm clamp structure 6504 with the inlet port 6254 of the inflation chamber, such that the protrusion 6512 aligns with the groove 6286. The patient can then move the arm clamp structure 6504 so that at least one protrusion 6508 fits into the inlet port 6254 of the inflation chamber, and the arm clamp structure 6504 is connected to the inflation chamber 6200.

[0677] 5.3.10.2 Patient Interface for Assembly

[0678] like Figures 43 to 58 As shown, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between different types of patient interfaces.

[0679] 5.3.10.2.1 Full-face tube upward interface

[0680] exist Figures 43 to 46 As shown, the patient can wear the pad 6050 in the tube-up configuration with the catheter headband 6319, the four-point headband 6302 and the catheter sleeve 6350.

[0681] These components can be assembled as described above. For example, the catheter sleeve 6350 can be connected to the catheter 6320 of the catheter headband 6319. The catheter 6320 (via the catheter connection structure 6500) can be used to connect the catheter headband 6319 to the pad 6050. The catheter sleeve 6350 provides a magnet 6356 for connection to the magnet 6370 of the four-point headband 6302 (see, for example). Figure 15 ).

[0682] like Figure 43 and 44 As shown, the four-point headband 6302 can be connected at four separate locations to provide tension for holding the pad 6050 in a sealed position on the patient's head.

[0683] For example, the lower straps 6304 can be removably connected to the magnets 6370 of the conduit sleeve 6350 (e.g., via the magnetic members 6306). In use, each of the lower straps 6304 can contact a patient’s cheek (e.g., covering the masseter muscle). The lower straps 6304 can also extend under the patient’s ear.

[0684] Tension can be provided along the lower straps 6304 toward the back region of the patient’s head (e.g., toward the occiput). The tensile force can pull the cushion 6050 into the patient’s head. In particular, the tension can be applied at the magnets 6370 on the conduit sleeve 6350. Because the lower extensions 6354 are composed of a rigid or semi-rigid material, the lower extensions 6354 can remain substantially fixed when tension is applied (e.g., due to the four-point headgear 6302 that is worn connected to the cushion 6050).

[0685] In some forms, the magnets 6370 can be positioned close to the lower portion of the cushion 6050 when the conduit headgear 6319 is connected. This can cause the tensile force to act particularly on the lower region of the cushion 6050. In other words, the tension provided by the lower straps 6304 causes the first seal-forming structure 6101 to remain in the sealed position. Of course, the tension from the lower straps 6304 can also help to keep the second seal-forming structure 6102 in the sealed position.

[0686] With continued reference to the drawings Figure 43 and 44 The conduits 6320 can be positioned along the patient’s cheeks and can extend to a position above the patient’s ears. For example, each of the conduits 6320 can extend along one side of the patient’s head toward the crown of the patient’s head. This can cause each of the conduits 6320 to cover the sphenoid and / or temporal bones, and extend toward the frontal and / or parietal bones.

[0687] The conduit sleeve 6350 can cover a portion of the conduit headgear 6319. In other words, the conduit sleeve 6350 and not the conduit headgear 6319 can contact the patient along at least a portion of the length of the conduit headgear 6319. As Figure 43 and 44 shown, the upper portion of each of the conduits 6320 can contact the patient’s head, while the inner portion can be covered by the conduit sleeve 6350 (such that the conduit sleeve 6350 contacts the patient along the patient’s cheeks).

[0688] The second seal-forming structure 6102 can contact the underside of the patient’s nose. For example, the second seal-forming structure 6102 can avoid contact with the patient’s nasal ridge, and can contact the patient’s nose at or below the pronasale and rest against the columella. The conduits 6320 can provide additional tensile force in an upward direction and a posterior direction (e.g., as Figure 44In this way, the second seal-forming structure 6102 can be pulled up onto the underside of the patient's nose at the sealing position (e.g., due to the higher orienting force). The conduits 6320 can also pull the cushion 6050 into the patient's head in order to maintain the cushion 6050 in the sealing position (and to help seal the first seal-forming structure 6101).

[0689] In some forms, the conduits 6320 can be generally inextensible and can be configured to provide tension when worn by the patient. As described above, the length of the conduits 6320 can be less than the patient's head such that they provide tension when worn. The conduits 6320 can fit closely against the patient's head even when the accordion section 6328 is inflated, and the passageways through the conduits 6320 can remain wide enough to allow a continuous flow of air.

[0690] The conduit headgear 6319 can include a tab 6324 on either conduit 6320. As Figure 44 shown, the upper straps 6305 can be connected to the respective tabs 6324. When the conduit headgear 6319 is worn by the patient, the tabs 6324 can be above the patient's ears. This can allow the upper straps 6305 connected to the tabs 6324 to also be positioned above the patient's ears. For example, each tab 6324 can be positioned proximate to the temporal bone, and each upper strap 6305 can cover the temporal bone and extend toward the occipital bone.

[0691] The upper straps 6305 can provide tension directed toward the back of the patient's head. In the example shown, the upper straps 6305 can extend in an angled direction toward a lower region of the patient's head (e.g., toward the occipital bone). The tensile force can maintain the conduits 6320 in a desired position (e.g., such that they do not slip over the patient's eyes) and / or provide additional force to maintain the seal-forming structure 6100 in the sealing position.

[0692] In some forms, the positioning and stabilizing structure 6300 provides a positioning and stabilizing force F PSS that helps to maintain the cushion 6050 in the sealing position on the patient's face. The positioning and stabilizing force F PSS may be the resultant of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0693] In Figure 44 the example shown, the patient is oriented in an upright position, so the force F PSS acts to counteract external forces acting in that direction. In other orientations of the patient, the magnitude of the force F PSS (and any other forces) can change.

[0694] For example, the conduit headgear 6319 can provide a tube force F管 so as to hold the seal-forming structure 6100 on the patient's face. As mentioned above, the conduit headgear 6319 can be sized so that it fits snugly over the patient's head. The accordion section 6328 can extend to provide the necessary F 管 . tube force F 管 may be directed upwards and / or rearwards.

[0695] F 管 may also be directed at least partially upwards so as to overcome the gravitational force F g . The gravitational force F g may be illustrated specifically for the seal-forming structure 6100 and the plenum chamber 6200, but the gravitational force will act on the entire patient interface 6000 (i.e. in the same direction as the illustrated gravitational force F g .

[0696] The gravitational force F g may be opposed by a frictional force F f . In contrast, the frictional force can act in a direction directly opposite to the gravitational force F g . When the gravitational force pulls the cushion 6050 in a downward direction (as shown in Figure 44 ), the frictional force F f will act in an upward direction (e.g. against the patient's face). For example, the patient can experience a frictional force F f over their lips (and / or other surfaces of the patient's face that are in contact with the seal-forming structure 6100) so as to resist movement in a downward direction (which can help to stabilise the cushion 6050 in place). Although the frictional force F f is specifically illustrated as being opposite to the gravitational force F g of the cushion 6050, a component of the total frictional force (not shown) will also be opposite to the gravitational force F g associated with the positioning and stabilising structure 6300 and any other parts of the patient interface 6000. The frictional force can act along any location of the patient interface 6000 that contacts the patient's skin (or hair). The frictional force F f extends in a direction opposite to the gravitational force F g and along the patient's skin (or hair).

[0697] Additionally, the headgear straps can individually provide a strap force F 绑带 so as to hold the seal-forming structure 6100 on the patient's face. Each strap can provide a different strap force F 绑带 based on how much the individual strap is pulled tight.

[0698] In some forms, the sum of the various forces can equal zero, such that the patient interface 6000 is in equilibrium (e.g. does not move along the patient's face when in use). In particular, the gravitational force F gand blow-out force F 充气室 tends to move the seal-forming structure 6100 away from the desired seal location. The positioning and stabilising force F PSS is applied so as to counteract the gravitational force F g and the blow-out force F 充气室 (and any frictional forces F f ) and keep the seal-forming structure 6100 appropriately positioned. Although the positioning and stabilising force F PSS may exceed the sum of the other forces, and still keep the seal-forming structure 6100 in the appropriate seal location, patient comfort can be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 6000 is zero and the positioning and stabilising force F PSS is generally strong enough to achieve this. As described below, various positions of the patient's head while using the patient interface 6000 can determine the positioning and stabilising force F PSS required to achieve balance.

[0699] The magnitude of the forces can change due to differences in the position of use (e.g. when the patient is sleeping in different positions). For example, Figure 44-1 shows the forces acting when the patient is sleeping on their back. In this position, the gravitational force F g points towards the patient's face, the frictional force F f points away from the patient's face. Thus, the gravitational force F g may point in a similar direction to the force F PSS . Thus, the gravitational force F g may not oppose the positioning and stabilising force F PSS . This can allow the positioning and stabilising structure 6300 to be less constricting and maintain the same sealing force (e.g. improve patient comfort).

[0700] Similarly, Figure 44-2 shows the forces acting when the patient is sleeping on their side. In the example shown, the gravitational force F g is represented as an "x" within a circle so as to show a force pointing towards the page. The gravitational force F g may be substantially perpendicular to the chamber force F 充气室 and / or the positioning and stabilising force F PSS . As described above, the positioning and stabilising force F PSS must counteract the gravitational force F g and the chamber force F 充气室 . Furthermore, the chamber 6200 and / or the conduit head strap 6319 can tend to compress on the lower side and be in tension on the upper side. The frictional force F f may still point in a direction opposite to the gravitational force F g (e.g. away from the page).

[0701] In some forms, tube drag forces can provide additional forces on the system. InFigures 44 to 44-2 In the tube-up configuration shown, tube drag forces can act on the superior region of the patient's head. Depending on the orientation of the tube (e.g., the angular position of the swivel), the tube drag forces can assist in positioning and stabilizing force F PSS and / or counteracting positioning and stabilizing force F PSS This can change throughout use as the position of the tube changes.

[0702] 5.3.10.2.2 Full-Face Tube-Up Interface

[0703] As shown, the patient can wear cushion 6050 in a tube-down configuration with rigidizer arms 6340, four-point headgear 6302, and four-point arm sleeve 6380. The same cushion 6050 and four-point headgear 6302 can be used for both full-face configurations (e.g., 40-43 and 47-50). In other words, rigidizer arms 6340 can be interchanged with conduits 6320 in order to form a tube-down configuration (i.e., as opposed to the tube-up configuration described above). Four-point arm sleeve 6380 can be used in place of conduit sleeve 6350 to facilitate this interchange. Figures 47 to 50 Figures 43-46

[0704] These elements can be assembled as described above. For example, four-point arm sleeve 6380 can be connected to rigidizer arms 6340. Rigidizer arms 6340 (via arm connection structure 6504) can be used to connect rigidizer arms 6340 to cushion 6050. Four-point arm sleeve 6380 provides magnets 6386 in order to connect to four-point headgear 6302.

[0705] As shown, four-point headgear 6302 can be connected at four separate locations in order to provide tension that holds cushion 6050 in a sealing position on the patient's head. Figure 47 48 For example, lower straps 6304 (e.g., via magnetic members 6306) can be removably connected to magnets 6386 of four-point arm sleeve 6380. In use, each lower strap 6304 can contact the patient's cheek (e.g., covering the masseter muscle). Lower straps 6304 can also extend under the patient's ear.

[0706] Tension can be provided along lower straps 6304 toward the posterior region of the patient's head (e.g., toward the occiput). The tensile force can pull cushion 6050 into the patient's head. In particular, tension can be applied at magnets 6386 on four-point arm sleeve 6380. Because lower extensions 6384 are composed of rigid or semi-rigid material, lower extensions 6384 can remain substantially fixed when tension is applied (e.g., due to wearing four-point headgear 6302 connected to cushion 6050).

[0707] Tension can be provided along lower straps 6304 toward the posterior region of the patient's head (e.g., toward the occiput). The tensile force can pull cushion 6050 into the patient's head. In particular, tension can be applied at magnets 6386 on four-point arm sleeve 6380. Because lower extensions 6384 are composed of rigid or semi-rigid material, lower extensions 6384 can remain substantially fixed when tension is applied (e.g., due to wearing four-point headgear 6302 connected to cushion 6050).

[0708] ​​​In some forms, the magnets 6386 can be positioned close to the lower portion of the cushion 6050 when the rigidizer arms 6340 are connected. This can cause tension to act particularly on the lower region of the cushion 6050. In other words, the tension provided by the lower strap 6304 causes the first seal-forming structure 6101 to be held in the sealing position. Of course, the tension from the lower strap 6304 can also help to hold the second seal-forming structure 6102 in the sealing position.

[0709] With continued reference to Figure 47 and 48 , the rigidizer arms 6340 (e.g., within the lower segments 6390) can be positioned along the patient’s cheeks and can extend to a position above the patient’s ears. For example, each rigidizer arm 6340 can extend along one side of the patient’s head toward the crown of the patient’s head. This can cause each rigidizer arm 6340 to cover the sphenoid and / or temporal bones, and extend toward the frontal and / or parietal bones. In some forms, the rigidizer arms 6340 can extend along a similar patient facial path as the conduit 6320.

[0710] In these figures, the rigidizer arms 6340 can be covered by the four-point arm sleeve 6380 such that each rigidizer arm 6340 is positioned within the interior of the four-point arm sleeve 6380. Thus, the rigidizer arms 6340 are not visible and do not directly contact the patient.

[0711] The second seal-forming structure 6102 can contact the underside of the patient’s nose. For example, the second seal-forming structure 6102 can avoid contact with the patient’s nasal ridge, and can contact the patient’s nose at or below the pronasale and rest against the columella. The four-point arm sleeve 6380 and the rigidizer arms 6340 (e.g., disposed within the four-point arm sleeve 6380 as shown in the steps of Figures 29 to 33 , can provide additional tension in the upward and posterior directions (e.g., as shown in Figure 48 ). In this way, the second seal-forming structure 6102 can be pulled up onto the underside of the patient’s nose in the sealing position (e.g., due to the higher orientation forces). The four-point arm sleeve 6380 and / or the rigidizer arms 6340 can also pull the cushion 6050 into the patient’s head in order to hold the cushion 6050 in the sealing position (and help seal the first seal-forming structure 6101).

[0712] In some forms, the rigidizer arms 6340 can be generally non-extensible and can be configured to provide tension when worn by the patient. The four-point arm sleeve 6380 can also be at least partially non-extensible along its length (although it can be able to stretch). The upper segments 6392 of the four-point arm sleeve 6380 can be adjustable (e.g., by hook and loop material) in order to fasten the four-point arm sleeve 6380 on the patient’s head and create tension.

[0713] The four-point arm sleeve 6380 may include a tab 6394 on the lower section 6390. For example... Figure 48 As shown, the upper bandage 6305 can be connected to the corresponding tab 6394. When the patient wears the four-point arm sleeve 6380, the tab 6394 can be positioned above the patient's ear (e.g., at approximately the same location as the tab 6324 of the catheter headband 6319). This allows the upper bandage 6305 connected to the tab 6394 to also be positioned above the patient's ear. For example, each tab 6394 can be positioned close to the temporal bone, and each upper bandage 6305 can cover the temporal bone and extend toward the occipital bone.

[0714] The upper bandage 6305 provides tension directed toward the back of the patient's head. In the example shown, the upper bandage 6305 may extend in an oblique direction toward the lower region of the patient's head (e.g., toward the occipital bone). This tension force may hold the four-point arm sleeves 6380 in the desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to hold the sealing formation 6100 in a sealed position.

[0715] In some forms, the positioning and stabilizing structure 6300 provides force F. PSS The F PSS This helps to hold the pad 6050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0716] exist Figure 48 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0717] For example, the four-point connecting sleeve 6380 can provide sleeve force F. 套筒 This is to hold the sealing structure 6100 on the patient's face. As described above, the size of the four-point connecting sleeve 6380 can be (and / or adjusted) to ensure a tight fit against the patient's head. Sleeve force F 套筒 It can point upwards and / or backwards.

[0718] Force F 套筒 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 6100 and the inflation chamber 6200, but gravity will act on the entire patient interface 6000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0719] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 6050 downwards (as shown in the image). Figure 48 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 6100). f This is to resist movement in the downward direction (which helps stabilize the 6050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 6050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 6300 and the patient interface 6000. g Conversely, friction can act at any point along the patient interface 6000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0720] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 6100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0721] In some forms, the sum of all forces can equal zero, so that the patient interface 6000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气室 The seal-forming structure 6100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 6100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 6100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 6000 is zero and the positioning and stabilizing force F... PSSGenerally strong enough to achieve this, maximum patient comfort can be achieved. As described below, various positions of the patient's head while using the patient interface 6000 can determine the positioning and stabilising forces F PSS .

[0722] The magnitude of the forces can change due to differences in the position of use (e.g. when the patient is sleeping in different positions). For example, Figure 48-1 The forces are shown for a patient sleeping on their back. In this position, the gravitational force F g is directed towards the patient's face, the frictional force F f is directed away from the patient's face. Thus, the gravitational force F g may be directed in a similar direction to the force F PSS . Thus, the gravitational force Fgmay not oppose the positioning and stabilising force FPSS, which can allow the positioning and stabilising structure 6300 to be less constricting and maintain the same sealing force (e.g. improve patient comfort).

[0723] Similarly, Figure 48-2 The forces are shown for a patient sleeping on their side. In the example shown, the gravitational force F g is represented as an "x" within a circle in order to show the force directed towards the page. The gravitational force F g may be substantially perpendicular to the chamber force F 充气室 and / or the positioning and stabilising force F PSS . As described above, the positioning and stabilising force F PSS must counteract the gravitational force F g and the chamber force F 充气室 . Furthermore, the chamber 6200 and / or the four-point connection sleeve 6380 can tend to compress on the lower side and be in tension on the upper side. The frictional force F f may still be directed in a direction opposite to the gravitational force F g (e.g. away from the page).

[0724] In some forms, the tube drag force can provide additional forces on the system. In Figures 48 to 48-2 the tube down configuration shown, the tube drag force can act on a location close to the patient's nose and / or mouth. Depending on the orientation of the tube (e.g. the angular position of the swivel), the tube drag force can act with the gravitational force F g and / or with the frictional force F f . This can change throughout use as the position of the tube changes.

[0725] 5.3.10.2.3 Nasal tube up interface

[0726] In Figures 51 to 54The patient can wear the cushion 7050 in a tube-up configuration with the conduit headgear 6319, and the two-point headgear 7302. The same conduit headgear 6319 can be used with the optional tube-up configuration. In other words, the conduit headgear 6319 can be interchangeable between the tube-up configurations (i.e., the conduit headgear 6319 can be connected to either of the cushions 6050, 7050). As noted above, this configuration can also not require a sleeve.

[0727] These elements can be assembled as described above. For example, the conduits 6320 (via the conduit connection structure 6500) can be used to connect the conduit headgear 6319 to the cushion 7050. The nasal cushion 7050 does not require a conduit sleeve 6350 because the two-point headgear 7302 is used. However, a sleeve 7350 can be used to cover the conduits 6320 and provide a comfortable material against the patient's head.

[0728] In other words, the interior of the sleeve 7350 can receive at least a portion of the conduits 6320. The patient cannot directly contact the portion of the conduits 6320 that is covered by the conduit sleeve 7350. As Figures 51 to 52-2 As shown, a portion of the conduit headgear 6319 is exposed and contacts the patient, while another portion is covered by the sleeve 7350, such that the sleeve 7350, rather than the conduit headgear 6319, contacts the patient in that location.

[0729] In some forms, because the connection between the conduit headgear 6319 and either cushion is substantially the same, one cushion (e.g., the full-face cushion 6050) can be interchangeable with another cushion (e.g., the nasal cushion 7050). This can be particularly useful in a setting where components are shared between multiple patients. For example, a first patient can use the full-face cushion 6050, and a second patient can use the nasal cushion 7050. The same conduit headgear 6319 can be interchangeable between the two cushions 6050, 7050, thereby reducing the total number of styles.

[0730] As Figure 51 and 52 shown, the two-point headgear 7302 can be connected at two separate locations in order to provide tension that holds the cushion 7050 in a sealing position on the patient's head.

[0731] With continuing reference to the drawings Figure 51 and 52 , the conduits 6320 can be positioned along the patient's cheeks and can extend to a position above the patient's ears. For example, each conduit 6320 can extend along one side of the patient's head toward the crown of the patient's head. This can cause each conduit 6320 to cover the sphenoid and / or temporal bones, and extend toward the frontal and / or parietal bones.

[0732] The second seal-forming structure 6102 can contact the underside of the patient's nose. For example, the seal-forming structure 7100 can avoid contact with the patient's nasal ridge and can contact the patient's nose at or below the sellion and rest against the columella. The conduits 6320 can provide additional tensile force in the superior and posterior directions (e.g., as shown). In this way, the seal-forming structure 7100 can be pulled superiorly onto the underside of the patient's nose at the seal location (e.g., due to the higher orientation force). The conduits 6320 can also pull the cushion 7050 into the patient's head in order to maintain the cushion 6050 in the seal location (and to assist in sealing the first seal-forming structure 6101). Figure 52

[0733] In some forms, the conduits 6320 can be generally inextensible and can be configured to provide tension when worn by the patient. As described above, the length of the conduits 6320 can be less than the patient's head such that they provide tension when worn. The conduits 6320 can fit closely against the patient's head even when the accordion section 6328 is expanded, and the passageway through the conduit 6320 can remain wide enough to allow continuous flow of air.

[0734] The conduit headgear 6319 can include tabs 6324 on either conduit 6320. As Figure 52 shown, the upper straps 7305 can be connected to the respective tabs 6324. When the conduit headgear 6319 is worn by the patient, the tabs 6324 can be superior to the patient's ears. This can allow the upper straps 7305 connected to the tabs 6324 to also be positioned superior to the patient's ears. For example, each tab 6324 can be positioned proximate the temporal bone, and each upper strap 7305 can cover the temporal bone and extend toward the occipital bone.

[0735] The upper straps 7305 can provide tension directed posteriorly of the patient's head. In the example shown, the upper straps 7305 can extend in an oblique direction toward the inferior region of the patient's head (e.g., toward the occipital bone). The tensile force can maintain the conduits 6320 in a desired position (e.g., such that they do not slip over the patient's eyes) and / or provide additional force to maintain the seal-forming structure 7100 in the seal location.

[0736] In some forms, the presence of the tabs 6324 on the conduits 6320 can allow different headgear straps to be interchangeable with the same conduit headgear 6319. As described above, the upper straps 7305 of the two-point connection headgear 7302 are connected to the tabs 6324. When used, the upper straps 6305 of the four-point connection headgear 6302 are also connected to the tabs 6324. This common connection point allows interchangeability between the two types of headgear 6302, 7302.

[0737] ​In some configurations, the positioning and stabilizing structure 6300 provides a force FPSS that helps hold the pad 7050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0738] exist Figure 52 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0739] For example, catheter headband 6319 can provide catheter force F. 管 This is to ensure that the sealing structure 7100 is held on the patient's face. As described above, the catheter headband 6319 can be sized so that it fits snugly against the patient's head. The accordion-style section 6328 can be extended to provide the necessary F 管 Pipe force F 管 It can point upwards and / or backwards.

[0740] F 管 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 7100 and the inflation chamber 7200, but gravity will act on the entire patient interface 7000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0741] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 7050 in the downward direction (e.g.) Figure 52 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 7100). f This is to resist movement in the downward direction (which helps stabilize the 7050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 7050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 7300 and the patient interface 7000. gConversely, friction can act at any point along the patient interface 7000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0742] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 7100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0743] In some forms, the sum of all forces can equal zero, so that the patient interface 6000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气室 The seal-forming structure 6100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 6100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 6100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 6000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. As described below, when using the patient interface 7000, various positions of the patient's head can determine the positioning and stabilizing force F required to achieve balance. PSS .

[0744] The magnitude of the force can vary depending on the position of use (e.g., when the patient sleeps in different positions). Figure 52-1 This shows the forces acting on the patient while they are lying on their back. In this position, gravity F... g Pointing towards the patient's face, friction force F f Pointing away from the patient's face. Therefore, gravity F g It can point to force F PSS In a similar direction. Therefore, gravity Fg may not be opposite to the positioning and stabilizing force FPSS, which allows the positioning and stabilizing structure 7300 to be less tight and maintain the same sealing force (e.g., improving patient comfort).

[0745] Similarly, Figure 52-2 The forces acting on the patient when lying on their side are shown. In the example shown, gravity F... gRepresented by an "x" inside a circle to indicate the force pointing towards the page. Gravity F g It can be basically perpendicular to the inflation chamber force F 充气室 and / or positioning and stabilizing force F PSS As mentioned above, the positioning and stabilizing force F PSS The gravitational force F must be counteracted g and inflation chamber force F 充气室 Furthermore, the inflation chamber 7200 and / or the catheter headband 6319 may tend to compress on the lower side and remain taut on the upper side. Friction force F f It can still point to gravity F g The opposite direction (e.g., leaving the page).

[0746] In some forms, pipe traction can provide additional force on the system. Figures 52 to 52-2 In the tube-up configuration shown, tube drag may act on the upper region of the patient's head. Depending on the tube's orientation (e.g., the angular position of the rotating component), tube drag can assist in positioning and stabilizing the force F. PSS and / or counter-positioning and stabilizing force F PSS This can change as the position of the tube changes throughout the entire usage process.

[0747] 5.3.10.2.4 Nasal tube downward interface

[0748] like Figures 55 to 59 As shown, the patient can wear the pad 7050 in a tube-down configuration with a rigid arm 6340, a two-point headband 7302, and a two-point arm sleeve 6380-1. The same pad 7050 and two-point headband 7302 can be used in two nasal configurations (e.g., Figures 51 to 54 (and 55-58).

[0749] These components can be assembled as described above. For example, the two-point arm sleeve 6380-1 can be connected to the rigid arm 6340. The rigid arm 6340 (via arm connection structure 6504) can be used to connect the rigid arm 6340 to the gasket 7050.

[0750] like Figure 55 and 56 As shown, the two-point headband 7302 can be connected in two separate positions to provide tension to hold the pad 7050 in a sealed position on the patient's head.

[0751] Continue to refer to the appendix Figure 55 and 56The rigidizer arms 6340 (covered by the two-point arm sleeve 6380-1) can be positioned along the patient's cheeks and can extend to a position above the patient's ears. For example, each rigidizer arm 6340 can extend along one side of the patient's head toward the crown of the patient's head. This can cause each rigidizer arm 6340 to cover the sphenoid and / or temporal bones, and extend toward the frontal and / or parietal bones. In some forms, the rigidizer arms 6340 can extend along a similar patient facial path as the conduit 6320.

[0752] In these figures, the rigidizer arms 6340 can be covered by the two-point arm sleeve 6380-1 such that each rigidizer arm 6340 is positioned inside the two-point arm sleeve 6380-1. Thus, the rigidizer arms 6340 are not visible and do not directly contact the patient.

[0753] The seal-forming structure 7100 can contact the underside of the patient's nose. For example, the seal-forming structure 7100 can avoid contact with the patient's nasal ridge, and can contact the patient's nose at or below the pronasale and rest against the columella. The two-point arm sleeve 6380-1 and the rigidizer arms 6340 can provide additional pulling force in the superior and posterior directions (e.g., as shown). In this way, the seal-forming structure 7100 can be pulled superiorly onto the underside of the patient's nose at the sealed position (e.g., due to the higher orientation force). The two-point arm sleeve 6380-1 and / or the rigidizer arms 6340 can also pull the cushion 7050 into the patient's head in order to maintain the cushion 7050 in the sealed position. Figure 56

[0754] In some forms, the rigidizer arms 6340 can be generally non-extensible and can be configured to provide tension when worn by the patient. The two-point arm sleeve 6380-1 can also be at least partially non-extensible along its length (although it can be able to stretch). The superior segment 6392-1 of the two-point arm sleeve 6380-1 can be adjustable (e.g., by hook and loop material) in order to secure the two-point arm sleeve 6380-1 on the patient's head and create tension.

[0755] The two-point arm sleeve 6380-1 can include tabs 6394-1 located on the inferior segment 6390-1. As shown, the superior straps 7305 can be connected to the respective tabs 6394-1. When the patient is wearing the two-point arm sleeve 6380-1, the tabs 6394-1 can be superior to the patient's ears (e.g., at approximately the same location as the tabs 6324 of the conduit headgear 6319). This can allow the superior straps 6305 connected to the tabs 6394-1 to also be positioned superior to the patient's ears. For example, each tab 6394-1 can be positioned proximate the temporal bone, and each superior strap 6305 can cover the temporal bone and extend toward the occipital bone. Figure 56 ​​

[0756] The upper strap 6305 can provide a tension force directed posteriorly of the patient's head. In the illustrated example, the upper strap 6305 can extend in an oblique direction toward a lower region of the patient's head (e.g., toward the occiput). This tensile force can maintain the four-point arm sleeves 6380 in a desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to maintain the seal-forming structure 7100 in a sealing position.

[0757] In some forms, tabs 6394, 6394-1 on the corresponding sleeves 6380, 6380-1 can be positioned in approximately the same location on the patient's head. As noted above, the upper strap 7305 of the two-point connection headgear 7302 is connected to the tab 6394-1. When used, the upper strap 6305 of the four-point connection headgear 6302 is also connected to the tab 6394. Having similarly positioned tabs 6394, 6394-1 of the two types of sleeves 6380, 6380-1 facilitates interchangeability of the four-point and two-point connection headgears 6302, 7302 with the same rigidizer arms 6340.

[0758] In some forms, the positioning and stabilizing structure 6300 provides a force Fpss that helps to hold the cushion 6050 in a sealing position on the patient's face. The positioning and stabilizing force Fpss PSS may be the resultant of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0759] In Figure 56 the illustrated example, the patient is oriented in an upright position, so the force Fpss PSS acts to counteract external forces acting in that direction. In other orientations of the patient, the force Fpss PSS (and any other forces) can vary in magnitude.

[0760] For example, the two-point connection sleeve 6380-1 can provide a sleeve force Fs 套筒 to hold the seal-forming structure 7100 on the patient's face. As noted above, the two-point connection sleeve 6380-1 can be sized (and / or adjusted) to fit snugly on the patient's head. The sleeve force Fs 套筒 may be directed upwardly and / or posteriorly.

[0761] The force Fpss 套筒 may also be directed at least partially superiorly, so as to overcome the force of gravity Fg g . The force of gravity Fg g may be illustrated specifically with respect to the seal-forming structure 7100 and the plenum chamber 7200, but the force of gravity will act on the entire patient interface 7000 (i.e., in the same direction as the illustrated force of gravity Fg g ).

[0762] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 7050 in the downward direction (e.g.) Figure 56 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 7100). f This is to resist movement in the downward direction (which helps stabilize the 7050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 7050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 7300 and the patient interface 7000. g Conversely, friction can act at any point along the patient interface 7000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0763] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 7100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0764] In some forms, the sum of all forces can equal zero, so that the patient interface 7000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气室 The seal-forming structure 7100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 7100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 7100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 7000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. As described below, when using the patient interface 7000, various positions of the patient's head can determine the positioning and stabilizing force F required to achieve balance.PSS .

[0765] The magnitude of the forces can change due to the different positions of use (e.g., when the patient is sleeping in different positions). For example, Figure 56-1 The forces are shown for a patient sleeping on their back. In this position, the gravitational force F g points towards the patient’s face, the frictional force F f points away from the patient’s face. Thus, the gravitational force F g may point in a similar direction as the force F PSS . Thus, the gravitational force F g may not oppose the positioning and stabilizing force F PSS . Instead, this can allow the positioning and stabilizing structure 7300 to be less constricting and maintain the same sealing force (e.g., improve patient comfort).

[0766] Similarly, Figure 56-2 The forces are shown for a patient sleeping on their side. In the example shown, the gravitational force F g is represented as an “x” within a circle in order to show a force pointing out of the page. The gravitational force F g may be substantially perpendicular to the chamber force F 充气室 and / or the positioning and stabilizing force F PSS . As described above, the positioning and stabilizing force F PSS must counteract the gravitational force F g and the chamber force F 充气室 . Moreover, the chamber 7200 and / or the two-point connection sleeve 6380-1 can tend to compress on the lower side and be in tension on the upper side. The frictional force F f may still point in a direction opposite (e.g., away from the page) the gravitational force F g .

[0767] In some forms, the tube drag force can provide additional forces on the system. In Figures 48 to 48-2 the tube down configuration shown, the tube drag force can act on a location close to the patient’s nose and / or mouth. Depending on the orientation of the tube (e.g., the angular position of the swivel), the tube drag force can act with the gravitational force F g and / or against the frictional force F f . This can change throughout use as the position of the tube changes.

[0768] 5.3.10.2.5 Modulus of the elements

[0769] Figure 59It is shown how different elements can be combined to form the four different patient interfaces described above. As shown, different components can be reused for different types of patient interface. This can allow easier manufacturing and assembly, as a larger number of identical components can be produced and used in multiple styles. The only components that can not be used in multiple styles can be the cuff. However, the cuff can be easier to manufacture.

[0770] 5.4 RPT device

[0771] An RPT device 4000 according to an aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, for example any of the whole or part of the methods described herein. The RPT device 4000 can be configured to generate a flow of air for delivery to the airways of a patient, for example for treating one or more respiratory conditions described elsewhere in this document.

[0772] In one form, the RPT device 4000 is constructed and arranged to be able to deliver a flow of air in the range -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH20, at least 6 cmH20, or at least 10 cmH20, or at least 20 cmH20.

[0773] The RPT device can have an outer housing 4010 which is constructed in two parts: an upper part 4012 and a lower part 4014. In addition, the outer housing 4010 can comprise one or more panels 4015. The RPT device 4000 comprises a chassis 4016 which supports one or more of the internal components of the RPT device 4000. The RPT device 4000 can comprise a handle 4018.

[0774] The pneumatic path of the RPT device 4000 can comprise one or more air path items, for example an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (for example a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 such as pressure and flow sensors.

[0775] One or more of the air path items can be provided within a detachable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 can be provided within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0776] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 can include more than one PCBA 4202.

[0777] 5.4.1 RPT device mechanical and pneumatic components

[0778] The RPT device can include one or more of the following components in an overall unit. In an alternative form, one or more of the following components can be provided as separate units.

[0779] 5.4.1.1 Air filter

[0780] An RPT device according to one form of the present technology can include one air filter 4110, or a plurality of air filters 4110.

[0781] In one form, an inlet air filter 4112 is positioned at the start of the pneumatic path upstream of the pressure generator 4140.

[0782] In one form, an outlet air filter 4114, for example an anti-bacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0783] 5.4.1.2 Silencer

[0784] An RPT device according to one form of the present technology can include one silencer 4120, or a plurality of silencers 4120.

[0785] In one form of the present technology, an inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0786] In one form of the present technology, an outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0787] 5.4.1.3 Pressure generator

[0788] In one form of the present technology, the pressure generator 4140 for generating a flow or supply of air at positive pressure is a controllable blower 4142. For example, the blower 4142 can include a brushless DC electric motor 4144 with one or more impellers. The impellers can be located in a volute. The blower can deliver a supply of air, for example, in the delivery of respiratory pressure therapy, for example, at a rate of up to about 120 litres per minute, and at positive pressures in a range of about 4 cm H20 to about 20 cm H20 or other forms up to about 30 cm H20. The blower can be as described in any one of the following patents or patent applications, which are incorporated herein in their entirety by this reference: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,14; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0789] The pressure generator 4140 can be under the control of the therapy device controller 4240.

[0790] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0791] 5.4.1.4 Transducer

[0792] The transducer can be internal to the RPT device, or external to the RPT device. An external transducer can be located on or form part of, for example, an air circuit, e.g., a patient interface. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or communicates data to the RPT device.

[0793] In one form of the present technology, one or more transducers 4270 can be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 can be constructed and arranged to generate a signal representative of a property of the flow of air, such as flow rate, pressure, or temperature, at that point in the pneumatic path.

[0794] In one form of the present technology, one or more transducers 4270 can be positioned proximally of the patient interface 3000.

[0795] In one form, the signal from the transducer 4270 can be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0796] 5.4.1.5 Anti-overflow check valve

[0797] In one form of the present technology, an anti-overflow check valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-overflow check valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0798] 5.4.2 RPT device algorithms

[0799] As mentioned above, in some forms of the technology the central controller can be configured to implement one or more algorithms represented as computer programs stored in a non-transitory computer readable storage medium such as a memory. The algorithms are generally grouped into sets called modules.

[0800] 5.5 Air circuit

[0801] An air circuit 4170 according to an aspect of the technology is a conduit or tube which, in use, is constructed and arranged to allow a flow of air to travel between two components such as the RPT device 4000 and the patient interface 3000.

[0802] As Figure 42 shown, the air circuit 4170 can be a hose capable of delivering a flow of pressurized air. The air circuit 4170 can be connected directly to the plenum chamber 6200, 7200 (e.g. in the corresponding vent opening 6402, 7402). In this configuration (i.e. "tube down"), the patient interface 6000, 7000 can not include a vent 6400. Instead, the hose of the air circuit 4170 can include the vent.

[0803] The air circuit 4170 can also be used in a tube up configuration and can be connected to the inlet 6332.

[0804] 5.6 Humidifier

[0805] 5.6.1 Humidifier overview

[0806] In one form of the technology, a humidifier 5000 (e.g. as Figure 5A shown) is provided to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the flow of air prior to delivery to the airways of a patient and to increase the temperature of the flow of air (relative to ambient air).

[0807] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving a flow of air, and a humidifier outlet 5004 for delivering a humidified flow of air. In some forms, as Figure 5A and Figure 5B shown, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 can also include a humidifier base 5006 which can be adapted to receive the humidifier reservoir 5110 and which includes a heating element 5240.

[0808] 5.6.2 Humidifier components

[0809] 5.6.2.1 Water reservoir

[0810] According to one arrangement, the humidifier 5000 can include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g. water) to be vaporised for humidifying the flow of air. The water reservoir 5110 can be configured to hold a predetermined maximum volume of water so as to provide sufficient humidification for a duration of at least a respiratory session, such as a night of sleep. Typically, the reservoir 5110 is configured to hold a few hundred millilitres of water, for example 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In other forms, the humidifier 5000 can be configured to receive a supply of water from an external water source, such as a water supply system of a building.

[0811] According to one aspect, the water reservoir 5110 is configured to add humidity to the flow of air from the RPT device 4000 as the flow of air travels through it. In one form, the water reservoir 5110 can be configured to facilitate the flow of air to travel in a tortuous path through the reservoir 5110 while in contact with a volume of water therein.

[0812] According to one form, the reservoir 5110 can be removable from the humidifier 5000, for example in a lateral direction as shown in Figs. 5A and 5B. Figure 5A and Figure 5B

[0813] The reservoir 5110 can also be configured to prevent the flow of liquid therefrom, such as through any aperture and / or between sub-components thereof, such as when the reservoir 5110 is displaced and / or turned from its normal orientation of operation. As the flow of air to be humidified by the humidifier 5000 is typically pressurised, the reservoir 5110 can also be configured to avoid loss of pneumatic pressure through leakage and / or flow impedance.

[0814] 5.6.2.2 Conduction portion

[0815] According to one arrangement, the reservoir 5110 includes a conduction portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conduction portion 5120 can be arranged as a plate, although other shapes can be equally suitable. All or a portion of the conduction portion 5120 can be made of a thermally conductive material, such as aluminium (e.g. approximately 2 mm in thickness, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another thermally conductive metal or some plastics. In some cases, a material of lower thermal conductivity can be used with an appropriate geometry to achieve suitable thermal conduction.

[0816] 5.6.2.3 Humidifier reservoir dock

[0817] ​In one form, humidifier 5000 can include a humidifier reservoir dock 5130 (as shown in Figure 5B some arrangements, humidifier reservoir dock 5130 can include a locking structure, such as a locking bar 5135 configured to retain reservoir 5110 in humidifier reservoir dock 5130.

[0818] 5.6.2.4 Water level indicator

[0819] Humidifier reservoir 5110 can include a water level indicator 5150 as shown in Figures 5A to 5B some forms, water level indicator 5150 can provide one or more indications to a user (such as patient 1000 or a caregiver) regarding the amount of water volume in humidifier reservoir 5110. The one or more indications provided by water level indicator 5150 can include an indication of a maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0820] 5.6.2.5 Heating element

[0821] In some cases, a heating element 5240 can be provided to humidifier 5000 to provide heat input to one or more of the water volume in humidifier reservoir 5110 and / or to the flow of air. Heating element 5240 can include a heat-generating component, such as a resistive electrical heating track. One suitable example of heating element 5240 is a laminar heating element, such as the laminar heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0822] In some forms, heating element 5240 can be provided in humidifier base 5006, where heat can be provided to humidifier reservoir 5110 primarily by conduction as shown in Figure 5B

[0823] 5.7 Breathing waveform

[0824] Figure 6 A model typical breathing waveform of a human at rest is shown. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5 L, inspiration time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiration time Te 2.4 s, peak expiratory flow rate Qpeak-0.5 L / s. The total duration of the breath Ttot is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), with a ventilation of Vent approximately 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.​

[0825] 5.8 Terminology

[0826] To achieve the objects of the present technology, one or more of the following definitions can apply in certain forms of the present technology. In other forms of the present technology, alternative definitions can apply.

[0827] 5.8.1 General

[0828] Air: In certain forms of the present technology, air can be taken to mean atmospheric air, and in other forms of the present technology, air can be taken to mean some other combination of breathable gases, such as oxygen enriched air.

[0829] Environment: In certain forms of the present technology, the term environment can have the following meanings (i) the exterior of the therapy system or patient, and (ii) the immediate surroundings of the therapy system or patient.

[0830] For example, the ambient humidity with respect to a humidifier can be the humidity of the air immediately surrounding the humidifier, such as the humidity in the room in which the patient is sleeping. This ambient humidity can be different to the humidity outside the room in which the patient is sleeping.

[0831] In another example, the ambient pressure can be the pressure immediately surrounding or outside the body.

[0832] In certain forms, ambient (e.g. acoustic) noise can be taken to be the background noise level in the room in which the patient is located, other than noise generated by, for example, the RPT device or out of the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0833] Automatic positive airway pressure (APAP) therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum, for example different for each breath, depending on whether or not there is an indication of an SBD event.

[0834] Continuous positive airway pressure (CPAP) therapy: Breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient’s respiratory cycle. 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, increasing in response to detecting an indication of partial airway obstruction, and decreasing in the absence of an indication of partial airway obstruction.

[0835] Flow: The volume (or mass) of air delivered per unit of time. Flow can refer to an instantaneous quantity. In some cases, reference to flow will be reference to a scalar quantity, i.e. a quantity with only a magnitude. In other cases, reference to flow will be reference to a vector quantity, i.e. a quantity with both a magnitude and a direction. Flow can be given the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0836] In the example of a patient breathing, flow can be nominally positive for the inspiration portion of the patient's breathing cycle and thus negative for the expiration portion of the patient's breathing cycle. Device flow Qd is the flow of air leaving the RPT device. Total flow Qt is the flow of air and any supplementary gases to the patient interface via the air circuit. Ventilation flow Qv is the flow of air leaving a vent to allow flushing of exhaled gases. Leak flow Ql is the flow of leaks from the patient interface system or elsewhere. Respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0837] Flow therapy: Respiratory therapy comprising delivery of a flow of air to the entrance of the airways at a controlled flow rate known as the treatment flow rate, which is generally positive throughout the patient's breathing cycle.

[0838] Humidifier: The term humidifier will be taken to mean a humidification apparatus constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H20) vapour to a flow of air to improve a patient's medical respiratory condition.

[0839] Leak: The word leak will be taken to mean an unwanted flow of air. In one example, a leak can occur due to an imperfect seal between a mask and a patient's face. In another example, a leak can occur in a swivel elbow to ambient.

[0840] Noise, conducted (acoustic): Conducted noise in this document refers to noise brought to the patient through the pneumatic path, such as the air circuit and patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0841] Noise, radiated (acoustic): Radiated noise in this document refers to noise brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0842] Noise, vented (acoustic): Vented noise in this document refers to noise produced by the flow of air through any vent, such as a vent of a patient interface.

[0843] Patient: A human, whether or not they suffer from a respiratory disorder.

[0844] Pressure: Force per unit area. Pressure can be expressed in units ranging from cm H2O, g-f / cm 2 , to hundreds of pascals. 1 cm H2O is equivalent to 1 g-f / cm 2 and is approximately 0.98 hundred pascals (1 hundred pascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). In this specification, pressure is given in units of cm H2O unless otherwise specified.

[0845] Pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value achieved by the interface pressure Pm at the current time instant.

[0846] Respiratory pressure therapy: Application of a supply of air at a typically positive pressure relative to atmosphere to the entrance of the airways.

[0847] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0848] 5.8.1.1 Materials and their properties

[0849] Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of LSR that is commercially available is SILASTIC (including 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.

[0850] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0851] 5.8.1.2 Mechanics

[0852] Deformation: The process by which the original geometry of a structure changes when subjected to a force, for example, a force in the direction relative to an axis. The process can include stretching or compression, bending, and twisting.

[0853] Stiffness: The ability of a structure or component to resist deformation in response to an applied load. A structure or component can have axial stiffness, bending stiffness, and torsional stiffness. A structure or component is said to be stiff when it does not easily deform when subjected to mechanical forces. The stiffness of a structure or component is related to its material properties and its shape. The inverse of stiffness is compliance.

[0854] Elasticity: The ability of a material to recover its original geometry after being deformed.

[0855] Viscosity: the ability of a material to resist flow.

[0856] Viscoelasticity: the ability of a material to exhibit both elastic and viscous behavior in deformation.

[0857] Yield: the condition when a material does not return to its original geometry after deformation.

[0858] 5.8.1.3 Structural Elements

[0859] Beam: a beam will be considered to mean an element that is relatively long in one direction.

[0860] Shell: a shell will be considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face shield can be a shell. In some forms, the shell can be polyhedral. In some forms, the shell can be air-tight. In some forms, the shell can not be air-tight.

[0861] Membrane: a membrane will be considered to mean an element that is typically thin, that preferably has substantially no resistance to bending, but has resistance to stretching. It can also have resistance to compression. A membrane can be relatively long in two dimensions and thin in one dimension.

[0862] Panel: a panel will be considered to mean an element that is relatively long in two dimensions and thin in one dimension. A panel has bending, stretching, and compressive stiffness.

[0863] Load transfer member: a structural member that transfers load from one location to another member.

[0864] Load support member: a structural member that transfers load from one location to a non-structural item, such as a face.

[0865] Tension member: a structural element that resists tension.

[0866] Lacing (noun): a structure designed to resist tension.

[0867] Compression member: a structural element that resists compression.

[0868] Support: a support will be considered to be a structural component designed to increase the resistance to compression of another component in at least one direction.

[0869] Stiffener: a stiffener will be considered to mean a structural component designed to increase the resistance to bending of another component in at least one direction.

[0870] Elbow: An elbow is an example of a structure that directs the axis of an air flow travelling therethrough through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater or less than 90 degrees. An elbow can have a cross-section that is approximately circular. In another form, an elbow can have an elliptical or rectangular cross-section. In certain forms, an elbow can be rotatable relative to a mating component, for example, about 360 degrees. In certain forms, an elbow can be removable from a mating component, for example, via a snap connection. In certain forms, an elbow can be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.

[0871] Frame: A frame will be taken to mean a mask structure that carries the tensile load between two or more connection points to a headgear. A mask frame can be a non-airtight load carrying structure in a mask. However, some forms of mask frame can also be airtight.

[0872] Seal: Can refer to the noun form of the structure (seal), and also to the verb form of the effect (sealing). Two elements can be constructed and / or arranged to'seal' or achieve'sealing' therebetween, without the need for a separate'seal' element per se.

[0873] Swivel: (Noun) A sub-assembly of components configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, a swivel can be configured to rotate through an angle of at least 360 degrees. In another form, a swivel can be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a pair of mating cylindrical conduits. There can be little or no air leakage from the swivel when in use.

[0874] 5.8.2 Respiratory cycle

[0875] Apnea: According to some definitions, an apnea is considered to occur when the flow drops below a predetermined threshold for a duration of time, for example 10 seconds. An obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow, even with the patient's efforts. A central apnea is considered to occur when a reduction or absence of respiratory effort is detected, despite the airway being open. A mixed apnea is considered to occur when a reduction or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0876] Respiratory rate: The rate of a patient's spontaneous breathing, which is typically measured in breaths per minute.

[0877] Hypopnoea: According to some definitions, a hypopnoea will be considered to be a reduction in flow, rather than a cessation of flow. In one form, a hypopnoea can be considered to occur when the flow reduces below a threshold rate for a period of time. A central hypopnoea is considered to occur when a hypopnoea is detected due to a reduction in respiratory effort. In one form for adults, either of the following can be considered to be a hypopnoea:

[0878] (i) a 30% reduction in patient breathing for at least 10 seconds plus an associated 4% desaturation; or

[0879] (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds with an associated at least 3% desaturation or arousal.

[0880] Hyperpnoea: An increase in flow to above normal levels.

[0881] Inspiratory portion of a breath: The period of time from the start of inspiratory flow to the start of expiratory flow is considered to be the inspiratory portion of a breath.

[0882] Open (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway openness can be quantified, for example, with a value of (1) for open, and a value of zero (0) for closed (obstructed).

[0883] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of a breath flow waveform.

[0884] Breath flow, patient air flow, respiratory air flow (Qr): These terms can be understood to refer to the RPT device's estimate of breath flow, as opposed to "true breath flow" or "true respiratory flow", which is the actual breath flow experienced by the patient, typically expressed in litres per minute.

[0885] Tidal volume (Vt): The volume of air inhaled or exhaled during a normal breath when no extra effort is applied. In principle, the inspiratory volume Vi (volume of air inhaled) is equal to the expiratory volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, for example, the average.

[0886] (Inhalation) time (Ti): The duration of the inspiratory portion of a breath flow waveform.

[0887] (Exhalation) time (Te): The duration of the expiratory portion of a breath flow waveform.

[0888] (Overall) time (Ttot): The total duration between the start of one breath flow waveform's inspiratory portion and the start of the subsequent breath flow waveform's inspiratory portion.

[0889] Typical recent ventilation: Ventilation recent value around which ventilation values tend to cluster, i.e. a measure of the central tendency of ventilation recent values.

[0890] Upper airway obstruction (UAO): includes partial and total obstruction of the upper airway. This can be associated with a state of flow limitation in which flow increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling resistance behavior).

[0891] Ventilation (Vent): A measure of the flow of gas exchanged by the patient's respiratory system. Measures of ventilation can include one or both of the inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes simply given as a volume and understood to be volume per minute.

[0892] 5.8.3 Anatomy

[0893] 5.8.3.1 Anatomy of the face

[0894] Ala: The outer, external wall or "wing" of each nostril (plural: alae)

[0895] Alar rim: The most lateral point on the ala.

[0896] Alar crease (or alar crest) point: The point at the last part of the curved base of each ala, found in the fold created by the junction of the ala with the cheek.

[0897] Auricle: The entire externally visible part of the ear.

[0898] (Nasal) skeletal framework: The nasal skeletal framework includes the nasal bones, frontal process of the maxilla, and nasal part of the frontal bone.

[0899] (Nasal) cartilaginous framework: The nasal cartilaginous framework includes the septum, lateral, greater, and lesser cartilages.

[0900] Columella: The skin strip separating the nostrils and extending from the tip of the nose to the upper lip.

[0901] Columellar angle: The included angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal (both lines intersect at the subnasal point).

[0902] Frankfort horizontal: A line extending from the lowest point of the orbital margin to the left ear canal. The ear canal is the deepest point in the notch on the upper part of the tragus of the auricle.

[0903] Glabella: The most prominent point in the soft tissue, in the median sagittal plane of the forehead.

[0904] Lateral nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its superior border is attached to the nasal and frontal process of the maxilla, and its inferior border is connected to the alar cartilages.

[0905] Alar cartilages: Cartilaginous plates located below the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages that comprise the alar base.

[0906] Nares (nose holes): The approximately elliptical openings that form the entrance to the nasal cavity chambers. The singular form of nare is naris (nose hole). The naris is separated by the nasal septum.

[0907] Nasolabial groove or fold: The skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheeks from the upper lip.

[0908] Nasolabial angle: The angle between the columella and the upper lip (which meets at the subnasale).

[0909] Subauricular base point: The lowest point at which the auricle is attached to the facial skin.

[0910] Supraauricular base point: The highest point at which the auricle is attached to the facial skin.

[0911] Nasal tip point: The most protruding point or tip of the nose that can be identified in a side view of the rest of the head.

[0912] Philtrum: The midline groove that extends from the lower border of the nasal septum to the lip superior in the region of the upper lip.

[0913] Prementon point: The midpoint of the most forward part of the chin, located on the soft tissue.

[0914] Ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the sellion to the tip of the nose.

[0915] Sagittal plane: A vertical plane that goes from front (anterior) to back (posterior). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0916] Sellion: The most concave point, located on the soft tissue, that covers the region of the frontonasal suture.

[0917] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity chambers.

[0918] Superior lateral crura: The points at the inferior border of the alar base where the alar base meets the skin of the superior (upper) lip.

[0919] Subnasale: The point, located on the soft tissue, where the columella meets the upper lip in the median sagittal plane.

[0920] Supramenton: Point on the midline of the lower lip between the lower lip midpoint and the soft tissue menton of the maximum concavity

[0921] 5.8.3.2 Anatomy of the Skull

[0922] Frontal bone: The frontal bone includes a large vertical part (frontal squama) that corresponds to the area called the forehead.

[0923] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0924] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The maxillary frontal process projects upward from the sides of the nose and forms part of the lateral boundary.

[0925] Nasal bone: The nasal bone is a small, oval-shaped bone that varies in size and form from individual to individual; it lies side by side in the middle and upper part of the face and forms the "bridge" of the nose with its junction.

[0926] Nasion: The junction of the frontal bone and the two nasal bones, directly between the eyes and in the depressed area of the upper part of the bridge of the nose.

[0927] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped hole (foramen magnum) through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0928] Orbit: The bony cavity in the skull that houses the eyeball.

[0929] Parietal bone: The parietal bone is the bone that, when joined together, forms the roof and the sides of the skull.

[0930] Temporal bone: The temporal bone is located at the bottom and on the sides of the skull and supports the part of the face known as the temple.

[0931] Zygomatic bone: The face includes two zygomatic bones that are located in the upper and lateral parts of the face and form the prominence of the cheeks.

[0932] 5.8.3.3 Anatomy of the Respiratory System

[0933] Diaphragm: A muscle sheet that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0934] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0935] Lungs: The respiratory organs of humans. The conducting region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes respiratory bronchioles, alveolar ducts, and alveoli.

[0936] Nasal cavity: The nasal cavity (or nasal fossa) is the large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal branches, which are called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nares.

[0937] Pharynx: The part of the throat that lies immediately below (inferior to) the lower part of the nasal cavity and above the larynx. The pharynx is conventionally divided into three sections: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (lower pharynx).

[0938] 5.8.4 Patient interface

[0939] Anti-asphyxia valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by venting to atmosphere in a fail-safe manner.

[0940] Headgear: Headgear will be understood as a form of positioning and stabilising structure designed to hold a device, such as a mask, on the head.

[0941] Plenum chamber: A mask plenum chamber will be taken to mean the part of the patient interface that has walls that at least partially enclose a volume of space that in use has air pressurised within it to above atmospheric pressure. A shell can form part of the walls of the mask plenum chamber.

[0942] Vent: (Noun): A structure that allows air flow from inside a mask or conduit to ambient air, for example for effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow of about 10 litres per minute to about 100 litres per minute, depending on mask design and therapy pressure.

[0943] 5.8.5 Shape of structure

[0944] A product according to the present technology can comprise one or more three-dimensional mechanical structures, such as a mask cushion or a plenum chamber. Three-dimensional structures can be joined by two-dimensional surfaces. These surfaces can be distinguished using labels to describe the relevant surface orientation, location, function, or some other characteristic. For example, a structure can comprise one or more of an anterior surface, a posterior surface, an inner surface, and an outer surface. In another example, a seal-forming structure can comprise a (e.g. external) surface that contacts the face and a separate (e.g. underside or internal) surface that does not contact the face. In another example, a structure can comprise a first surface and a second surface.

[0945] To assist in describing the shape of three-dimensional structures and surfaces, first consider a cross-section through a point p of a surface of the structure. SeeFigures 3B to 3F They show an example of a cross-section at a point p on a surface and the resulting planar curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of an imaginary little person standing upright on the surface.

[0946] 5.8.5.1 Curvature in one dimension

[0947] The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., the reciprocal of the radius of a circle that just touches the curve at p).

[0948] Positive curvature: If the curve at p turns away from the outward normal, then the curvature at that point will take on a positive value (if the imaginary little person leaves point p, then they must walk uphill). See Figure 3B (Compared to Figure 3C a relatively large positive curvature) and Figure 3C (Compared to Figure 3B a relatively small positive curvature). Such curves are often referred to as concave.

[0949] Zero curvature: If the curve at p is a straight line, then the curvature will take on a value of zero (if the imaginary little person leaves point p, then they can walk horizontally, without going uphill or downhill). See Figure 3D .

[0950] Negative curvature: If the curve at p turns away from the outward normal, then the curvature at that point will take on a negative value in that direction (if the imaginary little person leaves that point p, then they must walk downhill). See Figure 3E (Compared to Figure 3F a relatively small negative curvature) and Figure 3F (Compared to Figure 3E a relatively large negative curvature). Such curves are often referred to as convex.

[0951] 5.8.5.2 Curvature of two-dimensional surfaces

[0952] The description of the shape at a given point on a two-dimensional surface according to the present technology can include multiple normal cross-sections. The multiple cross-sections can cut the surface in planes that include the outward normal (“normal planes”), and each cross-section can be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. The different curvatures at that point can have the same sign or different signs. Each curvature at that point has a magnitude, e.g., a relatively small magnitude. Figures 3B to 3F The planar curves in FIG. 5.8.5.2 are examples of such multiple sections a...

Claims

1. A conduit sleeve configured to connect to a positioning and stabilizing structure of a patient interface, the conduit sleeve comprising: a longitudinal extension forming a passageway extending between an upper opening and a lower opening, the passageway configured to receive a fluid conduit; characterized in that the conduit sleeve comprises: a lower extension located outside the passageway and adjacent to the lower opening; and a connection member connected to the lower extension.

2. The catheter jacket of claim 1, wherein, The lower extension is more rigid than the passageway.

3. The catheter jacket of claim 1, wherein, The lower extension is formed of a rigid material.

4. The catheter jacket of claim 1, wherein, The lower extension is rigidified using a stitching method.

5. The catheter jacket of claim 1, wherein, The lower extension is substantially non-extensible.

6. The catheter jacket of claim 1, wherein, The connection member is a magnet.

7. The catheter jacket of claim 1, wherein, Material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand.

8. The catheter jacket of claim 1, wherein, Material between the upper opening and the lower opening is substantially non-extensible.

9. The catheter jacket of claim 1, wherein, In use, the lower opening is configured to be positioned proximate to a cushion of the patient interface.

10. The catheter jacket of claim 1, wherein, The upper opening is configured to be positioned, in use, at a location below a patient's ear.

11. The catheter jacket of claim 1, wherein, The conduit sleeve is one of a pair of conduit sleeves, each conduit sleeve of the pair of conduit sleeves configured to be removably connected to a fluid conduit of a conduit headgear.

12. A four-point arm sleeve for connecting a positioning and stabilising structure of a patient interface, characterised in that The four-point arm sleeve comprises: an upper section; and a pair of lower sections, each lower section of the pair of lower sections comprising a passageway having a lower opening, the passageway configured for receiving a rigidizer arm, a lower extension connected adjacent to the lower opening, the lower extension positioned outside the passageway, a connection member connected to the lower extension, and a tab disposed adjacent to the upper section and configured for receiving a headgear strap.

13. The four-point arm sleeve of claim 12, wherein, The lower extension is more rigid than the passageway.

14. The four-point arm sleeve of claim 12, wherein, The lower extension is formed of a rigid material.

15. The four-point arm sleeve of claim 12, wherein, The lower extension is rigidified using a stitching method.

16. The four-point arm sleeve of claim 12, wherein, The lower extension is substantially non-extensible.

17. The four-point arm sleeve of claim 12, wherein, The connection member is a magnet.

18. The four-point arm sleeve of claim 12, wherein, Material surrounding the lower opening is elastic and configured to allow the lower opening to stretch and expand a width of the respective opening.

19. The four-point arm sleeve of claim 12, wherein, The upper section is substantially non-extensible.

20. The four-point arm sleeve of claim 12, wherein, The lower opening is configured to be proximate, in use, to a cushion of the patient interface.

21. The four-point arm sleeve of claim 12, wherein, The tab is configured to be positioned, in use, at a location above a patient's ear.

22. A two-point arm sleeve configured to connect to a positioning and stabilising structure of a patient interface, characterised in that, The two-point arm sleeve comprises: an upper section; and a pair of lower sections, each lower section of the pair of lower sections comprising: a passageway having a lower opening, the passageway configured for receiving a rigidizer arm, a connection member connected to the lower extension, and a tab disposed adjacent to the upper section and configured for receiving a headgear strap.

23. The two-point arm sleeve of claim 22, wherein, Material surrounding the lower opening is elastic and configured to allow the lower opening to stretch and expand a width of the respective opening.

24. The two-point arm sleeve of claim 22, wherein, The remaining lower sections are substantially non-extensible.

25. The two-point arm sleeve of claim 22, wherein, The upper section is substantially non-extensible.

26. The two-point arm sleeve of claim 22, wherein, The lower opening is configured to be proximate, in use, to a cushion of the patient interface.

27. The two-point arm sleeve of claim 22, wherein, In use, the tab is configured to be positioned at a location above a patient's ear.

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