Headgear for patient interfaces

Abstract

To provide a headgear for a patient interface relating to one or more of screening diagnosis, monitoring, treatment, prevention and improvement of respiratory-related diseases.SOLUTION: A positioning and stabilizing structure comprising at least one gas delivery tube to receive the flow of air from a connection port on top of a patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the at least one gas delivery tube comprising a tube wall having an extendable concertina structure comprising a plurality of folds in the tube wall alternatingly forming a plurality of ridges and a plurality of grooves, the at least one gas delivery tube, where the folds able to be at least partially unfolded to increase a separation of the ridges to elongate the extendable concertina structure; and one or more ridge connecting portions provided to the tube wall, each of the one or more ridge connecting portions connecting two or more adjacent ridges of the plurality of ridges and the one or more ridge connecting portions being configured to resist the separation of the ridges.SELECTED DRAWING: Figure 8A

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Australian Provisional Application No. 62 / 764,995, filed August 20, 2018, the contents of which are incorporated herein by reference.

[0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes. [Background technology]

[0003] 2. Technology Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.

[0005] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD) and chest wall diseases.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes such as closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged overweight men, but patients are asymptomatic. See US Pat. No. 5,399,363 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep arousals, which cause severe insomnia, increased sympathetic activity, and increased afterload. See US Patent No. 5,399,313 (Berthon-Jones).

[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or breathe out enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience abnormal shortness of breath during exercise.

[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in the normal elasticity of the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0016] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).

[0018] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist in breathing by performing some or all of the respiratory functions and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided through a non-invasive patient interface. NIV is used to treat forms of CSR and respiratory failure such as OHS, COPD, NMD, and chest wall disorders. In some forms, it may improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheotomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0021] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0022] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another form of treatment system is a mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example by providing airflow to an airway entrance. The airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may be in close contact with, for example, an area of ​​the patient's face. A closure may be formed to facilitate gas delivery at a pressure with sufficient dispersion with ambient pressure for therapy to occur (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a sufficient seal to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.

[0025] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0026] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0027] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0029] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0030] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0031] CPAP therapy is highly effective in treating certain respiratory disorders if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0032] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0033] For these reasons, patient interfaces for CPAP delivery during sleep should be clearly defined. Form a field.

[0034] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0035] The patient interface may be characterized in part according to the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the mouth region in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0036] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0037] A particular seal-forming structure may be designed for mass production so that one design will fit, be comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both may need to be adapted in order to form a seal.

[0038] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or formed surface of a resilient sealing element comprised of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will develop between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion may fold or buckle during use, causing leakage.

[0040] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0041] Another form of seal-forming structure may use adhesives to achieve a seal. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0042] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: US Pat. No. 5,393,621; US ​​Pat. No. 5,493,621; and US Pat. No. 5,593,621).

[0043] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of US Pat. No. 5,399,323 (Trimble et al.), assigned to the Puritan-Bennett Corporation.

[0044] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® nasal pillows mask, SWIFT® II nasal pillows mask, SWIFT® LT nasal pillows mask, SWIFT® FX nasal pillows mask, and MIRAGE LIBERTY® full face mask. Examples of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: US Pat. No. 5,399,433 (which describes, among other things, aspects of ResMed Limited's SWIFT® nasal pillows), US Pat. No. 5,399,433 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows), US Pat. No. 5,499,433 (which describes, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask), and US Pat. No. 5,499,433 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX nasal pillows).

[0045] 2.2.3.1.2 Positioning and stabilization Seal-forming structures in patient interfaces used in positive air therapy experience corresponding forces from the air pressure that disrupt a seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0046] In one technique, adhesives are used, see, for example, US Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

[0047] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulkiness, discomfort and awkwardness.

[0048] 2.2.3.1.3 Compressed air conduits In one type of treatment system, a flow of pressurized air is provided to the patient interface through a conduit in the air circuit that is fluidly connected to the patient interface such that when the patient interface is positioned on the patient's face in use, the conduit extends forward from the patient interface and away from the patient's face. This may sometimes be referred to as an "elephant trunk" type interface.

[0049] Some patients find such interfaces unsightly, which can result in poor patient compliance if they stop wearing them. Furthermore, if the conduit is connected to the interface in front of the patient's face, it can easily become entangled with bedding.

[0050] 2.2.3.1.4 Pressurized air conduits used to position / stabilize seal-forming structures Another type of therapeutic system that attempts to address these problems includes a patient interface in which the tube responsible for delivering pressurized air to the patient airway is sealed to the patient interface. The patient interface also functions as part of the headgear for positioning and stabilizing the tubing-forming portion on the appropriate portion of the patient's face. This type of patient interface may also be referred to as using "headgear tubing" or "conduit headgear". Such a patient interface allows a conduit in the air circuit providing pressurized airflow from a respiratory pressure treatment device to be provided to a patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent No. 5,399,991, the contents of which are incorporated herein by reference. In this document, the conduit connects to a tube in the patient interface through a port located on the top of the patient's head in use.

[0051] Philips' DreamWear® mask includes such headgear tubing. The length of the DreamWear® headgear tube is not adjustable. Therefore, DreamWear® headgear is supplied in three different sizes to accommodate patients with different face sizes. A large number of different sizes can lead to increased complexity and cost in manufacturing the headgear and can lead to large packaging. Furthermore, supplying masks in separate sizes can limit the range of patients with different head sizes. If a certain number of patients are forced to select separate sizes that cannot be adjusted in length, it may be more likely that the patient will not be able to achieve the fit that they consider to be "perfect."

[0052] Using a patient interface with headgear tubing may provide some advantages (e.g., avoiding conduits connecting to the patient interface in front of the patient's face, which can be unsightly and uncomfortable), but it is desirable for a patient interface with headgear tubing to be comfortable while forming an effective seal with the patient's face when worn by the patient for extended periods of time while the patient is asleep.

[0053] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0054] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., medical equipment reliability requirements, size requirements, and weight requirements). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0055] One example of a special requirement of a particular RPT device is acoustic noise.

[0056] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.

[0057] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides a more comfortable experience than cool air. Increased comfort.

[0058] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0059] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of the air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0060] Although a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others are difficult or inconvenient for the patient to use.

[0061] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0062] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0063] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0064] 2.2.3.5 Mandibular repositioning Mandibular repositioning devices (MRDs) or mandibular advancement devices (MADs) are a treatment option for sleep apnea and snoring. They are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the oral cavity before the patient sleeps and removed afterwards. As such, MRDs are not designed for full-time wear. MRDs may be custom made or manufactured in standard forms and include bite impression sites designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls to reduce airway collapse and reduce palate vibration.

[0065] In certain examples, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0066] In such a design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion required for the mandible, which in turn determines the length of the connecting rod.

[0067] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. As such, the device is configured to minimize or avoid any movement of one or more of the teeth.

[0068] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0069] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.

[0070] ResMed Limited has developed several improved mask ventilation technologies, see: US Patent Nos. 5,991, 6,133, 5,143, 5,156, 5,162, 5,171, 5,181, 5,192, 6,196, 6,182, 6,197, 7,198, 8,199, 9,103, 9,104, 9, Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m)

[0071] [Table 1]

[0072] (*Measured one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744) The sound pressure values ​​of various objects are listed below.

[0073] [Table 2]

[0074] 2.2.4 Screening, diagnostic and monitoring systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, which typically requires expert clinical staff for system application. In PSG, typically 15-20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG)). For PSG of sleep-disordered breathing, patients need to be observed for two nights in a specialized hospital; the first night is purely for diagnosis, and the second night is required for titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable at home.

[0075] In general, screening and diagnosis are the identification of disease by signs and symptoms of the disease. Screening usually produces a true / false result indicating whether or not a patient's SDB warrants further investigation, whereas diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of the disease can continue indefinitely. Some screening / diagnostic systems are adapted for screening / diagnosis only, while some can be used for monitoring as well.

[0076] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid. Different clinical experts may have different opinions about a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. [Prior art documents] [Patent documents]

[0077] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Pat. No. 4,782,832 [Patent Document 7] International Publication No. 2004 / 073778 [Patent Document 8] US Patent Application Publication No. 2009 / 0044808 [Patent Document 9] International Publication No. 2005 / 063328 [Patent Document 10] International Publication No. 2006 / 130903 [Patent Document 11] International Publication No. 2009 / 052560 [Patent Document 12] US Patent Application Publication No. 2007 / 0246043 [Patent Document 13] International Publication No. 1998 / 034,665 [Patent Document 14] International Publication No. 2000 / 078, No. 381 [Patent Document 15] U.S. Patent No. 6,581,594 [Patent Document 16] US Patent Application Publication No. 2009 / 0050156 [Patent Document 17] US Patent Application Publication No. 2009 / 0044808 Summary of the Invention [Means for solving the problem]

[0078] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0079] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0080] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0081] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0082] One aspect of the present technology includes a patient interface for delivering a supply of pressurized breathable gas to an entrance of a patient airway.

[0083] Another aspect of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure. The patient interface may further include a venting structure. The patient may be further configured to expose the patient's oral cavity, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port.

[0084] Another aspect of the present technology relates to a patient interface including a plenum chamber, a seal-forming structure, a venting structure, and a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including at least one gas delivery tube for receiving an air flow from a connection port and delivering the air flow through the seal-forming structure to an entrance of the patient's airway, the gas delivery tube constructed and arranged to contact at least an area of ​​the patient's head above the superior ear-base point of the patient's head in use.

[0085] In accordance with one aspect of the present technology, a positioning and stabilizing structure is provided that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being adapted for use with and a positioning and stabilizing structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway to sealably deliver airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a respiratory cycle of said patient, said positioning and stabilizing structure comprising: at least one gas delivery conduit for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said gas delivery conduit constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, said gas delivery conduit comprising: a tube wall defining a hollow interior through which air can flow from the interior to the seal-forming structure, the tube wall having an extendable portion configured to stretch to vary a length of the gas delivery tube; The extension stiffness of the extendable portion, including the gas delivery tube, including the tube wall, is in the range of 0.2 to 0.35 N / mm.

[0086] In any embodiment of any of the aspects of the preceding paragraphs: (a) the tensile stiffness of the extensible portion (b) the pair of gas delivery tubes includes a combined unstretched length, measured along a centerline of a side of the pair of tubes configured to face a patient during use, that is in the range of 500 to 535 mm; (c) the combined unstretched length is in the range of 510 to 525 mm; (d) the combined unstretched length is in the range of 512 to 522 mm; (e) the pair of gas delivery tubes includes a combined unstretched length, measured along a centerline of a side of the pair of tubes configured to face a patient during use, that is in the range of 460 to 500 mm; (f) the combined unstretched length is in the range of 470 to 490 mm; (g) the combined unstretched length is in the range of 475 to 485 mm; (h) the gas delivery tubes form a loop around a patient's head with the cushion module, the loop having an unstretched length measured along a centerline of the side of the gas delivery tube. (i) the unstretched length of the loop is within the range of 528-548 mm; (j) the unstretched length of the loop is within the range of 535-541 mm; (k) the unstretched length of the loop is within the range of 534-554 mm; (l) the unstretched length of the loop is within the range of 539-549 mm; (m) the unstretched length of the loop is within the range of 539-549 mm; (n) the unstretched length of the loop is in the range of 546 to 556 mm; (o) the unstretched length of the loop is in the range of 564 to 584 mm; (p) the unstretched length of the loop is in the range of 571 to 581 mm; (q) the unstretched length of the loop is in the range of 577 to 597 mm; and / or (r) the unstretched length of the loop is in the range of 582 to 592 mm.

[0087] In accordance with one aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, in use, for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's respiratory cycle, the positioning and stabilizing structure comprising: at least one gas delivery conduit for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways; the at least one gas delivery tube comprises at least one gas delivery tube constructed and arranged to contact, in use, at least a region of the patient's head above an upper ear base point of the patient's head, the at least one gas delivery tube comprising: an upper tube portion configured to be placed on an upper region of the patient's head in use, the upper tube portion having: a first end configured to be placed on an upper portion of the patient's head at or near a sagittal plane of the patient's head in use; a second end configured to be placed on a side of the patient's head in use; and a rigid portion between the first end and the second end, the rigid portion adapted to accommodate relative movement between the first end and the second end in use. and a rigid portion configured to provide higher resistance in a forward and / or rearward direction than in an upward and / or downward direction relative to the gas delivery tube, and a lower tube portion connected between a second end of the upper tube portion and the seal-forming structure.

[0088] In any embodiment of any of the aspects of the preceding paragraph: (a) each upper tube section includes two rigid portions; (b) the rigid portions are provided on one or both of a side of the upper tube section configured to be forward in use and a side of the upper tube section configured to be rearward in use; (c) the upper tube section includes an extendable portion; (d) the extendable portion includes an extendable bellows structure formed in a tube wall of the gas delivery tube; (e) the extendable bellows structure includes a plurality of folds in the tube wall forming a plurality of alternating ridges and a plurality of grooves; (f) the rigid portion includes a plurality of connectors in the tube wall, each of the plurality of connectors connecting a pair of adjacent ridges; and / or (g) the rigid portion is integrally formed with the upper tube section.

[0089] In accordance with one aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a respiratory cycle of said patient, the positioning and stabilizing structure including: at least one gas delivery tube for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube being connected to a portion of the patient's head above an upper ear base point of the patient's head in use; and a gas delivery tube constructed and arranged to contact at least one region, the at least one gas delivery tube including a tube wall having an extendable bellows structure including: a plurality of folds in the tube wall formed with alternating ridges and grooves, the folds being at least partially expandable to increase ridge separation to allow the extendable bellows structure to have an elongated shape; and one or more ridge connections provided to the tube wall, each of the one or more ridge connections connecting two or more adjacent ridges of the plurality of ridges and configured to withstand ridge separation.

[0090] In any embodiment of any of the aspects of the preceding paragraph: (a) each pair of adjacent ridges is connected by at least one ridge connection of one or more ridge connections; (b) one or more pairs of adjacent ridges are connected by two ridge connections; (c) each pair of adjacent ridges is connected by two ridge connections; (d) one or more of the ridge connections are disposed on a side of the gas delivery tube configured to face forward in use; (e) one or more of the ridge connections are disposed on a side of the gas delivery tube configured to face rearward in use; (f) each ridge connection is centrally spaced between a side of the gas delivery tube configured to face downward in use and a side of the gas delivery tube configured to face upward in use; (g) each pair of adjacent ridges is connected by one of the ridge connections disposed on a side of the gas delivery tube configured to face forward in use. (h) each pair of adjacent ridges are connected by one of the ridge connectors disposed on a side of the gas delivery tube configured to face rearward; (i) the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of grooves is formed as a recess relative to the outer surface of the non-extendable portion; (j) the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of ridges is raised relative to the outer surface of the non-extendable portion; (k) each of the plurality of grooves is disposed between each pair of ridge connectors, and each ridge connector of a pair of ridge connectors is disposed at each end of each groove; (l) each of the plurality of grooves includes a groove depth, and each of the plurality of ridge connectors includes a ridge connector height, and the groove depth of each respective groove is equal to the height of the ridge connector of each respective pair of ridge connectors disposed at the end of each groove; (m) each ridge connector is an integrally formed portion of the tube wall; (n) the plurality of ridges, the plurality of grooves and the plurality of grooves are formed as recesses relative to the outer surface of the non-extendable portion; (o) each of the plurality of ridges includes a curved ridge section at a center of each of the plurality of grooves; (p) each of the plurality of grooves includes a curved groove section at a center of each of the plurality of grooves; (q) each of the plurality of ridges includes a pair of linear ridge sections provided at opposite ends of each of the ridges; (r) each of the plurality of ridge connections connects to each adjacent pair of ridges at the linear ridge sections of the ridges; (s) a cross-section of the gas delivery tube in the extendable bellows structure has a width and a height, the width being substantially aligned in the anterior-posterior direction in use and the width being greater than the height; (t) the width is at least twice the height; and / or (u) the positioning and stabilizing structure includes two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each gas delivery tube extending in one of the patient's cheek regions in use, the two gas delivery tubes being provided on different sides of the patient's head.

[0091] In accordance with one aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a respiratory cycle of said patient, the positioning and stabilizing structure including: at least one gas delivery tube for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube being connected to an upper ear of the patient's head in use; The gas delivery tube is constructed and arranged to contact at least a region of a patient's head above a nadir, the at least one gas delivery tube including a tube wall having a hollow interior and an extendable bellows structure disposed along a length of the gas delivery tube, the extendable bellows structure including: a first alternating series of ridges and grooves along a non-patient contacting side of the gas delivery tube and a second alternating series of ridges and grooves along a patient contacting side of the gas delivery tube, the extendable bellows structure including a plurality of folds in the tube wall formed with a first alternating series of ridges and grooves along a non-patient contacting side of the gas delivery tube and a second alternating series of ridges and grooves along a patient contacting side of the gas delivery tube, the first alternating series of ridges and grooves having a lower tensile stiffness than the second alternating series of ridges and grooves.

[0092] In an embodiment, (a) a plurality of folds are provided to form internal ridges and internal grooves within the gas delivery tube to form a first alternating series of ridges and grooves and a second alternating series of ridges and grooves; (b) each of the internal grooves of the first alternating series is provided across the interior of the gas delivery tube opposite a respective one of the internal grooves of the second alternating series to form a plurality of opposing groove pairs, each opposing groove pair including: a first internal groove, which is one of the first alternating series; and a second internal groove, which is one of the second alternating series. (c) the material thickness of the tube wall at the base of the second internal groove of each opposing groove pair is greater than the material thickness of the first internal groove of each opposing groove pair; (d) the material thickness of the tube wall at the base of each internal groove of the second alternating series decreases along the length of the gas delivery tube from the first end adjacent the connection port to the second end; (e) the material thickness of the tube wall at the base of each internal groove of the first alternating series is substantially constant along the length of the gas delivery tube; (f) the groove depth of the internal grooves of the first and second alternating series of internal ridges and internal grooves decreases along the length of the gas delivery tube from the first end adjacent the connection port to the second end; and / or (g) the first internal groove of each opposing groove pair is joined to the second internal groove of each opposing groove pair at a side of the gas delivery tube between the non-patient-contacting side and the patient-contacting side.

[0093] According to one aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure surrounding an entrance to a patient's airway for, in use, sealingly delivering airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. a positioning and stabilizing structure constructed and arranged to form a seal with an area of ​​a patient's face that is in contact with the patient's head, the positioning and stabilizing structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an entrance of the patient's airway, each of the pair of gas delivery tubes constructed and arranged to contact, in use, at least an area of ​​the patient's head above an upper ear-base point of the patient's head, each gas delivery tube comprising: a tube wall defining a hollow interior along a length of the gas delivery tube; a tab configured to be positioned above the tube wall; and a slit formed in the tab, the slit being positioned rearwardly from the tube wall in use, the slit including an upper end and a lower end, the upper end of the slit being positioned further away from the tube wall than the lower end of the slit; and a strap constructed and positioned to contact an area of ​​the patient's head that is positioned below or at the occipital bone of the patient's head in use, the strap configured to be connected to and between the slit.

[0094] In any embodiment of any of the aspects of any of the preceding paragraphs: (a) each tab is integrally formed with a respective tube wall; (b) each tab has an upper edge and a lower edge, the upper edge being longer than the lower edge; (c) the lower end of the slit is spaced from the tube wall by at least 5 mm; (d) the lower end of the slit is spaced from the tube wall by at least 7 mm; (e) the lower end of the slit is spaced from the tube wall by 8 mm or more; (f) the upper end of the slit is spaced from the tube wall by at least 8 mm; (g) the upper end of the slit is spaced from the tube wall by at least 10 mm; (h) the upper end of the slit is spaced from the tube wall by 12 mm or more; and (i) a midpoint along the slit is in the range of 5 mm to 30 mm from the tube wall. (j) the spacing is within the range of 7 mm to 20 mm; (k) the spacing is within the range of 8 mm to 15 mm; (l) the spacing is within the range of 9 to 11 mm; (m) each gas delivery tube includes an extendable tube section that is positioned above the tab of each gas delivery tube in use and a non-extendable tube section that is positioned below the tab of each gas delivery tube in use; (n) each tab is joined to a tube wall of each gas delivery tube at the non-extendable tube section; (o) each slit is arcuate between its upper and lower ends; (p) each slit is linear between its upper and lower ends; and / or (q) each slit is oriented perpendicular to a direction from the slit in the strap anchor region where the strap is anchored around the patient's head.

[0095] In accordance with one aspect of the present technology, there is provided a positioning and stabilising structure which provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to, in use, form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's respiratory cycle, the positioning and stabilising structure including: a pair of gas delivery tubes for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, each of said pair of gas delivery tubes constructed and arranged to, in use, contact at least an area of ​​the patient's head above an upper ear base point of the patient's head, each gas delivery tube comprising: a gas delivery tube including: a tube wall configured to be positioned on the patient's head along a path extending from a top of the patient's head to a seal-forming structure between the patient's eyes and ears; a tab connected to the tube wall, the tab configured to be positioned above an upper ear base point of the patient's head in use; and a slit formed in the tab and spaced posteriorly from a slit adjacent the path of the tube wall in use, the slit having a posterior-superior-anterior-inferior orientation in use and forming an oblique angle with a tangent to the path of the tube wall at the slit adjacent; and a strap constructed and arranged to contact an area of ​​the patient's head that is positioned below or at the occipital bone of the patient's head in use, the strap configured to be connected to and between the slit.

[0096] In any embodiment of any of the aspects of the preceding paragraph: (a) each tab is integrally formed with a respective one of the tube walls; (b) each tab has an upper edge and a lower edge, the upper edge being longer than the lower edge in use; (c) each gas delivery tube includes an extendable tube section that is above the tab of each gas delivery tube in use and a non-extendable tube section that is below the tab of each gas delivery tube in use; (d) each tab is connected to the tube wall of each gas delivery tube at the non-extendable tube section; (e) each slit is arcuate between its upper and lower ends; (f) each slit is linear between its upper and lower ends; and (g) the lower ends of the slits are spaced from the tube wall by at least 5 mm. (h) the lower end of the slit is spaced at least 7 mm from the vessel wall, (i) the lower end of the slit is spaced 8 mm or more from the vessel wall; (j) the upper end of the slit is spaced at least 8 mm from the vessel wall; (k) the upper end of the slit is spaced at least 10 mm from the vessel wall; (l) the upper end of the slit is spaced at least 12 mm from the vessel wall; (m) the bevel angle is in the range of 10 to 20 degrees; (n) the bevel angle is in the range of 12 to 18 degrees; and / or (o) each slit is oriented perpendicular to a direction from the slits in the strap anchor region where the straps are anchored around the patient's head.

[0097] In accordance with one aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to, in use, form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a respiratory cycle of said patient, the positioning and stabilizing structure including: a pair of gas delivery tubes for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, each of said pair of gas delivery tubes constructed and arranged to, in use, contact at least an area of ​​the patient's head above an upper ear base point of the patient's head, each gas delivery tube having a respective gas delivery tube and a respective gas delivery tube. The gas delivery tube includes: a tube wall configured to extend from the top of the patient's head through a seal-forming structure between the patient's eyes and ears and to be placed on the patient's head; a tab connected to the tube wall, the tab being positioned above the upper ear base point of the patient's head in use; an eyelet formed in the tab and positioned rearward of the tube wall in use; a trough formed in the tab and positioned rearward of the eyelet; and a strap constructed and arranged to contact an area of ​​the patient's head that is positioned below or at the occipital bone of the patient's head in use, the strap configured to connect to and between the eyelets of the pair of gas delivery tubes and to be positioned within the trough formed in the tab in use.

[0098] In any embodiment of any of the aspects of the preceding paragraphs: (a) a trough is formed in the tab between the eyelet and a rear side of the tab; (b) the tab includes an outwardly facing surface, the trough including a substantially planar surface formed as a recess relative to the outwardly facing surface; (c) the trough is formed by a portion of the tab having a reduced material thickness compared to other portions of the tab; (d) the trough includes a length approximately equal to a width of the strap; and / or (e) the eyelet takes the form of a slit.

[0099] In accordance with one aspect of the present technology, there is provided a patient interface that includes: A plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive air flow at the therapeutic pressure for breathing by a patient. a plenum chamber and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to an entrance to at least the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure according to any one of the aspects above; and a venting structure to allow a continuous flow of patient exhaled gases from within the plenum chamber to the surroundings, said venting structure sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; the patient interface configured to allow the patient to breathe from atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively the patient interface is configured to leave the patient's oral cavity exposed.

[0100] Another aspect of certain forms of the present technology is a system for treating a respiratory disorder, the system including a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of air at positive pressure.

[0101] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0102] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to expose the patient's oral cavity in use.

[0103] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that, in use, no part of the seal-forming structure enters the oral cavity.

[0104] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that the seal-forming structure does not extend into the patient's airway.

[0105] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that, in use, the seal-forming structure does not extend under the chin protuberance area.

[0106] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to expose the patient's eye during use.

[0107] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to allow the patient to breathe ambient air in the event of a power outage.

[0108] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to form a seal on the underside of the patient's nose without contacting the nose bridge region of the patient's nose.

[0109] Another aspect of certain forms of the present technology is a patient interface that includes a vent and a plenum chamber, the patient interface constructed and arranged such that gases from within the plenum chamber can travel through the vent to the surroundings.

[0110] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a side or lateral sleep position when using the patient interface.

[0111] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a supine sleep position when using the patient interface.

[0112] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a prone sleep position when using the patient interface.

[0113] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0114] One aspect of one form of the present technology is a patient interface that is washable in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0115] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0116] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief description of the drawings]

[0117] 4. Brief Description of the Drawings The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: 4.1 Treatment system [Figure 1A] The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 1 is a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also given. [Figure 2D]FIG. 1 is a lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points. The directions of superior and inferior, and anterior and posterior are also given. [Figure 2E] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The coronal plane is also noted. [Figure 2F] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 2G] FIG. 2 is a side view of the superficial features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull with the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygoma, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] Shown is the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C. [Figure 3C]3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 3E] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 3F] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The straight line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] FIGURE 3D is a cross-sectional view through the structure of Figure 3I.The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shown is a right-handed spiral. [Figure 3T] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left hand side and a right hand side. [Figure 3W] FIG. 3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is illustrated. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon. The tendon rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior and inferior). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of FIG. 3U is shown in a use position on the face. The mid-sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face of the face" when the plenum chamber is in the use position. In FIG. 3X, the plenum chamber 3200 is of a nasal mask, with the upper point resting approximately on the cerion and the lower point resting on the upper lip. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 4 is a schematic diagram of an air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items disposed in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] 5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Breath Waveforms [Figure 6A] A model of a typical human respiratory waveform during sleep is shown. 4.7 Screening, Diagnostic and Monitoring Systems [Figure 7A] A patient undergoing a polysomnogram (PSG) is shown sleeping in a supine sleep position. [Figure 7B] 4 shows a monitoring device for monitoring the condition of a patient, the patient being asleep in a supine sleeping position. 4.8 Specific Examples of the Present Technology [Figure 8A] 1 is a perspective view of a patient interface 3000 according to an embodiment of the present technology when worn by a patient 1000. [Figure 8B] FIG. 8B is a front view of the patient interface 3000 shown in FIG. 8A. [Figure 8C] FIG. 8B is a side view of the patient interface 3000 shown in FIG. 8A. [Figure 8D] FIG. 8B is another side view of the patient interface 3000 shown in FIG. 8A. [Figure 9A] FIG. 8B is a perspective view of the patient interface 3000 shown in FIG. 8A in an isolated state. [Figure 9B] FIG. 8B is a rear perspective view of the patient interface 3000 shown in FIG. 8A in an isolated state. [Figure 9C] FIG. 8B is a top view of the patient interface 3000 shown in FIG. 8A in an isolated state. [Figure 10A] 33 shows a top view of components of a positioning and stabilizing structure 3300 according to an example of the present technology. [Figure 10B] 10B shows cross section BB of a portion of the positioning and stabilizing structure 3300 of FIG. 10A. [Figure 10C] 10B shows cross section CC of the non-extendable portion of the positioning and stabilizing structure 3300 of FIG. 10A. [Figure 10D] 10B shows a plan view of a portion of the extendable portion of the positioning and stabilizing structure 3300 of FIG. 10A. [Figure 10E] 10D shows cross section EE of the extendable portion of the positioning and stabilizing structure 3300. [Figure 10F] 10B shows a front view of a portion of the extendable portion of the positioning and stabilizing structure 3300 of FIG. 10A. [Figure 10G] FIG. 10B is a front view of the positioning and stabilizing structure 3300 of FIG. 10A with the extendable portion in a straight configuration. [Figure 10H] FIG. 10F is a front view of the extendable portion shown in FIG. 10G in a curved configuration. [Figure 10I] FIG. 10H is a perspective view of the extendable portion shown in FIG. 10G in a curved configuration. [Figure 10J] FIG. 10F is a top view of the extendable portion shown in FIG. 10G in a curved configuration. [Figure 11A] FIG. 10B is a side view of the tab of the positioning and stabilizing structure 3300 of FIG. [Figure 11B] FIG. 10B is another side view of the tab of the positioning and stabilizing structure 3300 of FIG. [Figure 11C] FIG. 11B is a perspective view of the tab of FIG. [Figure 12A] FIG. 11 is a perspective view of a patient interface 3000 according to another embodiment of the present technology when worn by a patient 1000. [Figure 12B] FIG. 12B is a perspective view of the patient interface 3000 of FIG. 12A in an isolated state. [Figure 12C]FIG. 12B is a front view of the patient interface 3000 of FIG. 12A. [Figure 12D] FIG. 12B is a rear view of the patient interface 3000 of FIG. 12A. [Figure 12E] FIG. 12B is a plan view of the patient interface 3000 of FIG. 12A. [Figure 12F] FIG. 12B is a side view of the patient interface 3000 of FIG. 12A. [Figure 13] FIG. 3 is a perspective view of a portion of a positioning and stabilizing structure 3300 of a patient interface 3000 in accordance with another embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0118] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0119] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0120] 5.1 Treatment In one form, as shown in Figure IA, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to the entrance of the airways of a patient 1000.

[0121] In a particular embodiment of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0122] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0123] 5.2 Treatment system In one form, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000. Figures 1A, 1B and 1C show a treatment system that uses a patient interface 3000 with an RPT device 4000 and a humidifier 5000. 5.3 Patient Interface

[0124] 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing 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, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.

[0125] 8A-9C, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit (e.g., air circuit 4170 shown in FIGS. 1A-1C). In this example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by a cushion module 3150.

[0126] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0127] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0128] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0129] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0130] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0131] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0132] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0133] A seal-forming structure 3100 in accordance with the present technology may be constructed from a material that is soft, flexible and resilient (eg, silicone).

[0134] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0135] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 to act on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0136] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0137] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0138] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of a sealing flange.

[0139] In one form, the seal-forming structure includes an area having a sticky or adhesive surface and / or a high coefficient of friction relative to other surfaces.

[0140] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0141] 5.3.1.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0142] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0143] 5.3.1.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip area (ie, upper lip) of the patient's face.

[0144] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0145] 5.3.1.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin area of ​​the patient's face.

[0146] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the chin region of the patient's face in use.

[0147] 5.3.1.5 Frontal Area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, hi such a form, the plenum chamber may cover the eye when in use.

[0148] 5.3.1.6 Nasal pillow In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with a respective nostril of the patient's nose. Figures 12A-12F show a patient interface 3000 having a seal-forming structure 3100 provided by a pillow cushion module 3160. The pillow cushion module 3160 includes a pair of nasal pillows 3165. In this example, the same positioning structure 3300 as shown in Figures 8A-9C is used to maintain sealing contact between the pillow cushion module 3160 and the patient's nose. The same concepts and features of the positioning and stabilizing structure 3300 described for the cradle cushion module 3150 may be applied to a positioning and stabilizing structure 3300 configured for use with the pillow cushion module 3160 (or another type of cushion module (e.g., full face cushion module, oral-nasal cushion module, ultra-compact full face cushion module, nasal cushion module)).

[0149] The nasal pillows 3165 according to one aspect of the present technology include a frustum of a cone. At least a portion of the frustum forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the frustum, connecting the frustum to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stem. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum may be displaced axially towards the structure to which the stem is connected.

[0150] 5.3.1.7 Nasal Cradle In one form, as shown, for example, in Figures 8A-9C, the seal-forming structure 3100 is configured to form a seal with the underside of the nose around the nares and optionally the upper lip of the patient 1000 in use. This type of seal-forming structure may also be referred to as a "cradle cushion" or a "sub-nasal mask." The shape of the seal-forming structure may be configured to conform to or closely follow the underside of the patient's nose (i.e., the profile and angle of the seal-forming structure may be substantially parallel to the patient's nasal labial angle). In one form of a nasal cradle cushion, the seal-forming structure includes a bridge region that defines two orifices. Each of the two orifices delivers air or breathable gas to a different one of the patient's nares in use. The bridge region may be configured to contact or seal against the bridge of the patient's nose in use. In some forms of the present technology, the seal-forming structure 3100 is configured to form a seal with the underside of the patient's nose without contacting the nose bridge region of the patient's nose. In some examples, the patient interface may be configured to provide a seal with the underside of the patient's nose without contacting the nose bridge region of the patient's nose. The interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in PCT Application No. PCT / AU2018 / 050289, filed March 29, 2018, the entirety of which is incorporated herein by reference.

[0151] 5.3.1.8 Nasal mask cushion In one form, the non-invasive patient interface 3000 includes a seal-forming portion that, in use, forms a seal over the upper lip area (i.e., upper lip), nose bridge area, and cheek area of ​​the patient's face, such as the patient interface 3000 shown in FIG. IB. The seal-forming portion delivers an air supply or breathable gas to both nares of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "nasal cushion" or "nasal mask." In some embodiments of the present technology, a positioning and stabilizing structure 3300 shown in FIGS. 8A-9C may be utilized to hold the nasal cushion in a sealing position on the patient's face.

[0152] 5.3.1.9 Full face mask cushion In one form, the patient interface 3000 includes a seal-forming portion that forms a seal over the chin, nose bridge, and cheek regions of the patient's face, such as the patient interface 3000 shown in FIG. 1C. The seal-forming portion delivers an air supply or breathable gas to both nares and the oral cavity of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "full face mask." In some embodiments of the present technology, a positioning and stabilizing structure 3300 shown in FIGS. 8A-9C may be utilized to hold the full face cushion in a sealing position on the patient's face.

[0153] 5.3.1.10 Oronasal mask cushion In another form, the patient interface 3000 includes a nasal seal-forming structure and an oral seal-forming structure. The nasal seal-forming structure takes the form of a nasal cushion or nasal cradle cushion, and the oral seal-forming structure is configured to form a seal around the patient's oral cavity in use (which may also be referred to as an "oral cushion" or "oral mask"). In such a mask, air or breathable gas is delivered to the patient's nares and the patient's oral cavity through separate orifices in use. This type of seal-forming structure 3100 may be referred to as an "oral-nasal cushion" or an "ultra-compact full-face cushion." In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in U.S. Patent Application No. 62 / 649,376, which is incorporated herein by reference in its entirety.

[0154] The plenum chamber 3200 has a perimeter with a shape that is complementary to the surface contour of an average human face in the area where a seal is formed in use. In use, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogenous piece of material.

[0155] In some forms of the present technology, such as the patient interface 3000 shown in Figures 8A-9C, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve compliance with treatment, as they are often less intrusive and / or more comfortable for the wearer.

[0156] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and aid in improved compliance with treatment. The use of a transparent material may aid the clinician in seeing the placement and function of the patient interface.

[0157] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0158] 5.3.2 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position in use by the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may also be referred to as "headgear" as it engages the patient's head to hold the patient interface 3000 in the sealed position.

[0159] In one form, the positioning and stabilizing structure 3300 provides at least enough retention force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0160] In one form, the positioning and stabilising structure 3300 provides a retaining force sufficient to overcome the attractive force on the patient interface 3000.

[0161] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0162] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0163] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0164] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0165] In one form of the present technology, the positioning and stabilizing structure 3300 includes a separation section disposed between a front section of the positioning and stabilizing structure 3300 and a rear section of the positioning and stabilizing structure 3300. The separation section does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling section is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling section prevents a rearward force from being transferred along the positioning and stabilizing structure 3300 and disrupting the seal.

[0166] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a fabric patient-contacting layer, The strap 3310 includes a laminate of a foam material inner layer and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap 3310. The strap 3310 may be breathable, allowing water vapor to be transmitted through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0167] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured, and in some embodiments may be configured in combination with other straps or other structures, such that in use it is held taut to direct a force that seals the seal-forming structure against a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0168] A tie may be understood as a structure designed to resist tension. In use, the tie is the portion of the positioning and stabilizing structure 3300 that is under tension. Some ties add elasticity resulting from this tension, as described above. The tie may function to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0169] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that in use at least a portion of its lower edge passes over and moves to a superior aural point of the patient's head to cover a portion of the parietal and / or frontal bones without covering the occipital bone. The first tie may be provided as part of a patient interface including, for example, a cradle cushion, nasal pillows, nasal cushion, full face cushion, or oral-nasal cushion. For example, as shown in FIGS. 8A-9C, the positioning and stabilizing structure 3300 includes a first tie in the form of a tube 3350 that rests over the patient's head.

[0170] In one form of the present technology suitable for a nasal only or full face mask, the positioning and stabilizing structure 3300 includes a second tie. The second tie is constructed and arranged such that in use at least a portion of its upper edge passes under the lower ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head. The second tie may be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a full face cushion, a nasal cushion or an oral nasal cushion. As shown in FIGS. 8A-9C, the positioning and stabilizing structure 3300 includes a second tie in the form of a strap 3310 arranged against the rear of the patient's head.

[0171] In one form of the present technology suitable for a nasal only or full face mask or an oronasal mask, the positioning and stabilizing structure 3300 includes a third tie configured to be anchored against the posterior surface of the patient's neck. Additionally, in some forms the positioning and stabilizing structure includes a fourth tie constructed and arranged to interconnect the second and third ties to reduce the tendency of the second and third ties to move apart relative to one another.

[0172] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes a strap that is bendable, e.g., non-rigid. An advantage of this embodiment is that the strap is more comfortable when the patient lies down to sleep. As shown in Figs. 8A-9C, the positioning and stabilizing structure 3300 includes a bendable strap 3310. The strap 3310 can be considered a backstrap. The strap 3310 is flexible enough to pass around the rear of the patient's head and be comfortably positioned against the patient's head (even when under tension in use).

[0173] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 3300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0174] 5.3.2.1 Headgear tubing In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170, for example through the plenum chamber 3200 and the seal-forming structure 3100, from the RPT device to the patient's airway. In the form of the present technology shown in Figures 8A-9C, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the seal-forming structure 3100. These tubes 3350 are an integral part of the positioning and stabilizing structure 3300 of the patient interface 3000 for positioning and stabilizing the seal-forming structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). As a result, it is possible to connect the conduit of the air circuit 4170 that provides the pressurized air flow to the connection port 3600 of the patient interface at a location other than in front of the patient's face, which may be obtrusive to some people. While a pair of tubes 3350 has several advantages (discussed below), in some examples the positioning and stabilizing structure 3300 includes only a single tube 3350 configured to rest on only one side of the patient's head. Providing a strap or other stabilizing component on the other side of the patient's head between the top end of the single tube 3350 and the seal-forming structure 3100 allows for balancing of forces on the seal-forming structure 3100.

[0175] The positioning and stabilizing structure 3300 may be described as inflatable because air may be contained and moved through the headgear tubing 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway. It is understood that an inflatable positioning and stabilizing structure 3300 does not require all components of the positioning and stabilizing structure 3300 to be inflatable. For example, in the example shown in Figures 8A-9C and 12A-12F, the positioning and stabilizing structure 3300 includes headgear tubing 3350, which is inflatable, and straps 3310, which are non-inflatable.

[0176] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the form of the present technology shown in Figs. 8A-9C, the connection port 3600 is located on the patient's head. In this example, the patient interface 3000 includes an elbow 3610 with the connection port 3600 provided. The elbow 3610 may be rotatable relative to the positioning and stabilizing structure 3300 to allow movement of a conduit connected to the connection port 3600 to decouple it from the positioning and stabilizing structure 3300. Additionally or alternatively, the conduit connected to the connection port 3600 may rotate relative to the elbow 3610. In the illustrated example, the elbow 3610 includes a swivel-type conduit connector to which a conduit of the air circuit 4170 can be connected, thereby allowing the conduit to be rotated about a longitudinal axis relative to the elbow 3610. The connection port 3600 can include a fluid connection opening 3390, for example as shown in Figures 10A and 10B. In some examples, the air circuit 4170 can connect to the fluid connection opening 3390. The elbow 3610 can rotatably connect to the fluid connection opening or to a ring received in the fluid connection opening.

[0177] For patient interfaces where the connection port is not located in front of the patient's face, some patients find it unsightly and uncomfortable when the conduit is connected to a patient interface in front of the face. For example, conduits connecting to a front-of-the-face patient interface may be prone to entanglement with bedding or bed linens, especially if the conduit extends downward from the patient interface in use. Forms of the technology using a patient interface with a connection port located near and above the patient's head in use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: lateral or sideways position, supine position (i.e., face up on the back), and prone position (i.e., face down on the stomach). Furthermore, connecting the conduit to the front of the patient interface may exacerbate a problem known as tube drag. In tube drag, an undesirable pulling force may be generated from the conduit to the patient interface, causing it to be pulled down from the face.

[0178] In the form of the technology shown in Figures 8A-9C and 12A-12F, the positioning and stabilizing structure 3300 includes two tubes 3350. Each tube 3350 is positioned on a different side of the patient's head in use and extends from above each ear (above the upper ear base point on the patient's head) through each cheek area to the elbow 3610 at the top of the patient's 1000 head. This form of technology may be advantageous because if the patient is lying on their side and one of the tubes is compressed causing gas flow along that tube to be blocked or partially blocked, the other tube remains open and can provide pressurized gas to the patient. In other embodiments of the technology, the patient interface 3000 may include a different number of tubes (e.g., one tube or three or more tubes). In one example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., on one cheek area) during use and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head (e.g., on the other area) during use to assist in securing the patient interface 3000 on the patient's head.

[0179] In the form of the technology shown in Figures 8A-9C and 12A-12F, the two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In one embodiment, the two tubes are integrally formed, while in other embodiments, the tubes are separate components that may be interconnected during use and disconnected, for example, during cleaning or storage. If separate tubes are used, the tubes may be indirectly connected to each other, for example, to a T-shaped conduit having two conduit arms each fluidly connectable to the tube 3350, and a third conduit arm or opening that functions as the connection port 3600 and is connectable to the air circuit 4170 during use. The connection port 3600 may include an elbow 3610 in the center of the two integrally formed tubes 3350 that is received in a fluid connection opening 3390. The elbow 3610 can be configured to rotate within a ring received in the fluid connection opening 3390, the entirety of which is incorporated herein by reference. The fluid connection opening 3390 may be considered the connection port 3600 itself.

[0180] The tubes 3350 may be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). For example, as shown in FIG. 10A, the tubes 3350 from the left non-extendable tube section 3363 to the right non-extendable tube section 3363 may be formed (e.g., by molding) from a single homogenous piece of material (e.g., silicone). The tubes may have a natural preformed shape and may bend or move to assume another shape when a force is applied to the tube. For example, the tubes may generally assume an arc or curved shape that resembles the contour of the patient's head between the top of the head and the nose or mouth area.

[0181] In some examples, the positioning and stabilizing structure 3300 may include a sleeve 3364 around the tube 3350. For example, as shown in FIGS. 8A-8D, the sleeve 3364 is provided on a non-extendable tube section 3363. In some examples, the patient interface 3000 may not include a sleeve 3364, and in other examples, the patient interface 3000 may include a sleeve 3364. The face 3000 may include a sleeve 3364 that covers more of or the entire tube 3350. The sleeve 3364 may be formed to fit the curved shape of the tube 3350. In some examples, the sleeve 3364 is formed from a smooth woven fabric. Compared to a tube 3350 with no covering at all, the sleeve 3364 may be more comfortable against the patient's face.

[0182] As described in U.S. Patent No. 6,044,844, the entire contents of which are incorporated herein, the tube 3350 may also be crush resistant to prevent the flow of breathable gas through the tube if it is crushed during use (e.g., when crushed between the patient's face and a pillow). A crush resistant tube is not necessary in all cases, as the pressurized gas in the tube may act as a splint to prevent or at least limit the collapse of the tube 3350 during use. Using a crush resistant tube may be advantageous when there is only a single tube 3350, since if the single tube is blocked during use, gas flow will be restricted and treatment will cease or be less effective.

[0183] In certain forms of the present technology, one or more portions of the tube 3350 may be stiffened by one or more stiffening or stiffening elements. Examples of stiffening elements include: a relatively thicker walled portion of the tube 3350, a portion of the tube 3350 made of a relatively stiffer material than the material forming the other portions of the tube, and a stiff member attached or embedded inside or outside a portion of the tube. Such stiffening elements may be used to help control how the positioning and stabilizing structure 3300 functions when in use (e.g., when the tube 3350 is more likely to deform when a force is applied to the tube 3350, when the tube 3350 is more likely to maintain its shape when a force is applied to the tube 3350). Selecting where such stiffening elements are placed within the tube 3350 may help promote comfort when wearing the patient interface 3000 and may help maintain a good seal in the seal-forming structure 3100 when in use. Stiffening or stiffening elements may be placed within the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 is configured to support a relatively heavy seal-forming structure (eg, a full face or oral-nose cushion assembly).

[0184] The length of the tubes 3350 in the form of the present technology shown in Figures 8A-9C and 12A-12F is 15-30 cm, respectively (e.g., 20-27 cm, respectively). In one example, the length of each tube is about 26 cm. In another example, the length of each tube is about 23 cm. The length of the tubes is selected to suit the dimensions of a typical patient's head (e.g., the distance between the adjacent area on the top of the head where the upper end of the tube 3350 is located to the area adjacent the opening to the patient's airway where the lower end of the tube 3350 connects to the cradle cushion module 3150 (or pillow cushion module 3160) as it follows a generally arcuate path (e.g., as shown in Figures 8A-9C or 12A-12F) that extends down the side of the head and over the cheek region of the patient). As will be described in more detail below, the patient interface 3000 is configured such that the length of the tube 3350 can be varied in some forms of the present technology and can be applied to the tube in a contracted, extended or neutral state. It will be understood that the length of the tube 3350 will depend on the length of other components in the patient interface 3000 (e.g., the arm length of the T-shaped conduit to which the upper end of the tube 3350 is connected and / or the size of the plenum chamber 3200).

[0185] 5.3.2.1.1 Positioning of Headgear Components Each tube 3350 may be configured to receive airflow from a connection port 3600 on the patient's head and deliver the airflow to a seal-forming structure at the entrance to the patient's airway. In the examples of Figures 8A-9C and 12A-12F, at least one tube 3350 extends from a connection port 3600 on the patient's cheek region and on the patient's ear between the seal-forming structure 3100 (all i.e., between a portion of the tube 3350 that connects to the cushion module that covers the maxillary region of the patient's head in use and a portion of the tube 3350 that covers the region of the patient's head above the superior ear base point on the patient's head. Each of the one or more tubes 3350 may also rest on the patient's sphenoid and / or temporal bones and one or both of the patient's frontal and parietal bones. The connection port 3600 and elbow 3610 may be located on the patient's parietal bone, frontal bone or the junction therebetween in use.

[0186] The exemplary form of the present technology shown in Figures 8A-9C and 12A-12F has tubes 3350 that curve around the top of the patient's head from the top of the tube 3350 where it connects to an elbow 3610 on the top of the head to where the strap 3310 connects to the tube 3350 with relatively little curvature in the sagittal plane. Between where the rear headgear strap 3310 connects to the tube 3350 and the bottom end of the tube 3350 where it connects to a cradle cushion module 3150 in front of the patient's airway below the nose, the tube 3350 curves forward over the cheek area between the patient's ears and eyes. The radius of curvature of this portion of the tube 3350 can be in the range of 60-100mm (e.g., 70-90mm (e.g., 80mm)). The bottom end of the tube 3350 and the portion of the tube 3350 where the rear headgear straps 3310 connect to the tube 3350 may be at an angle ranging from 65 to 90 degrees (e.g., 75 to 80 degrees). The actual curvature present in the section of the tube 3350 above the straps 3310 and the section of the tube 3350 below the straps 3310 depends on the patient set-up and will in fact vary depending on the shape and size of the patient's head and the patient's preferences.

[0187] The degree to which the patient interface 3000 fits an individual patient can be altered by changing the length of the tube 3350, or alternatively or additionally, by changing the position of the patient interface 3000 on the patient's head, or the position of portions thereof on the patient's head. For example, by moving portions of the positioning and stabilizing structure 3300 in a posterior or anterior direction on the patient's head, a patient interface 3000 having a particular length of tube 3350 can be adjusted to better fit the patient. For example, moving the junction of the tube 3350 further forward (i.e., in the anterior direction) on the patient's head allows the patient interface 3000 having a particular length of tube 3350 to fit a larger head than if the junction of the tube 3350 was located further back (i.e., in the posterior direction). For most patients, when the junction of the tube 3350 is located forward, the top of the tube 3350 will be located on a smaller portion of the patient's head than if the junction of the tube 3350 is located posteriorly.

[0188] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned at a range of locations across the top of the patient's head, allowing the patient interface 3000 to be positioned for individual patient comfort or fit. One way this can be accomplished such that the seal-forming structure 3100 forms an effective seal with the patient's face regardless of the location of the connection port 3600 on the patient's head is by decoupling the movement of the upper portion of the patient interface 3000 from the lower portion of the patient interface 3000. Such decoupling can be achieved, for example, using mechanisms that allow parts of the headgear tubes 3350 to easily move or flex relative to other parts of the patient interface 3000. Such mechanisms are described below.

[0189] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally located at the top point of the patient's head. The connection port 3600 may be located in the sagittal plane and aligned with the superior auricular point in a plane parallel to the coronal plane. The superior auricular point is shown in FIG. 2D. As described below, in some forms of the present technology, positioning and The stabilizing structure 3300 is configured to be worn in different positions, i.e., the connection port 3600 can be placed near the top of the patient's head in the sagittal plane up to around 20 mm anterior or 20 mm posterior from the superior ear base point.

[0190] In some examples of the present technology, the connection port 3600 may be positioned in the sagittal plane and aligned with the junction between the frontal and parietal bones. The connection port 3600 may be positioned approximately on the junction of the coronal and sagittal sutures. In this configuration, the top of the tube 3350 may be positioned on and / or along a portion of the coronal suture. However, as noted above, the patient may move the connection port 3600 forward or backward to adjust the fit of the patient interface 3000.

[0191] An advantage of placing the tube 3350 on the patient's head slightly anterior to its highest point (e.g., at or near the coronal suture) is that it reduces the risk of the tube 3350 riding posteriorly during use. In many patients, there may be a depression or "divot" where the coronal suture meets the sagittal suture. If the tube 3350 is placed within this divot, the positioning and stabilizing structure 3300 may be particularly stable. Thus, in some instances, the tube 3350 is configured with the appropriate curvature and / or ability to curve and be placed over the coronal suture.

[0192] As noted above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion. The seal-forming structure 3100 is positioned generally under the nose to seal around the lower nose. The positioning and stabilizing structure 3300 may be constructed and arranged to pull the seal-forming structure 3100 into the patient's face under the nose (with a sealing force vector having a posterior and superior direction (e.g., a posterior-superior direction)). A sealing force vector in the posterior-superior direction may encourage the seal-forming structure 3100 to form a good seal on either side of the patient's nose and upper lip against both the lower nose circumference and the anterior surface of the patient's face.

[0193] In some examples, when in use, the positioning and stabilizing structure 3300 may apply a sealing force vector having a posterior-superior direction relative to the patient's Frankfurt horizontal at an angle of approximately 35°. The top of the tube 3350 (e.g., the portion of the tube 3350 above the strap 3310) may be oriented vertically and the rear headgear straps 3310 may extend in a posterior-inferior direction from the tube 3350 at an angle of approximately 35° relative to the patient's Frankfurt horizontal. In this particular setup, a 125° angle is formed between the strap 3310 and the top of the tube 3350 (where the strap 3310 is connected to the tube 3350).

[0194] FIG. 8D is a side view of the patient interface 3000 being worn by a patient. A particular force is shown in FIG. 8D acting on a point 3308 above each patient's ear near where the strap 3310 connects to the tube 3350. From the top of the tube 3350, a force 3301 due to headgear tension may be applied to the point 3308. The force 3301 may have a substantially vertical direction. From the bottom of the tube 3350 (e.g., between the seal-forming structure 3100 and the connection to the rear headgear strap 3310), a force 3303 may be applied onto this point 3308 (at an angle of approximately 125° in a front-down direction relative to the vertical force 3301 applied from the top of the tube 3350). The force 3303 may be equal in magnitude and opposite in direction to the sealing force that pulls the seal-forming structure 3100 down the nose into the patient's face. To balance the forces, the force 3302 from the straps 3310 is applied at an angle of approximately 125° in a rear-inferior direction to the normal force 3301 applied from the top of the tubes 3350. Therefore, the angle between the front-inferior force 3303 applied to a point 3308 along each tube 3350 above the patient's ear and the rear-inferior force 3302 applied from the straps 3310 is approximately The angle becomes 110°.

[0195] When using the positioning and stabilizing structure 3300 with a cradle cushion, a sealing force vector of 35° may be considered optimal for many patients. Furthermore, the directions of the forces applied from each part of the positioning and stabilizing structure 3300 described above may be considered ideal. However, it is understood that in practice, the actual directions of the forces applied from each part of the headgear will vary to accommodate the particular anatomy and preferences of each patient.

[0196] For example, in many instances, the positioning and stabilizing structure 3300 may be configured such that the top of the tube 3350 is positioned on the patient's head slightly anterior to the top point. As a result, for some patients, the tube 3350 may be angled slightly anteriorly rather than aligned vertically (e.g., in the coronal plane) such that it is positioned within a slight recess at or near the coronal suture of the skull. In such instances, the tension in the straps 3310 may be adjusted by the patient to balance the forces and achieve an optimal sealing force vector.

[0197] In some examples, the positioning and stabilizing structure 3300 can be configured to apply a force on the seal-forming structure 3100 in a posterior-superior direction at an angle that bisects the angle formed between the upper lip and the columella (e.g., the surfaces that form the nasolabial angle).

[0198] In a particular example of the present technology, the tubes 3350 are configured to receive the straps 3310 at a location above and adjacent to the patient's ears. If the straps 3310 are connected to the tubes 3350 too high on the patient's head, the straps 3310 may tend to ride up on the back of the patient's head. Additionally, the straps 3310 may form too large an angle with the top of the headgear tubes 3350, which may result in the patient having to over tighten the straps 3310, which may result in excessive tension in the positioning and stabilizing structure 3300 and an increased likelihood of the straps 3310 riding up on the back of the patient's head. Therefore, it is advantageous to have the connection between the straps 3310 and the tubes 3350 as low as possible, but spaced far enough from the top of the patient's ears, so that the tubes 3350 are not pulled into contact with the patient's ears when the straps 3310 are tightened.

[0199] 5.3.2.1.2 Headgear tubing fluid connections The two tubes 3350 are fluidly connected at their lower ends to the plenum chamber 3200. In the examples of Figures 8A-9C and 12A-12F, the tubes 3350 form a fluid connection with the cradle cushion module 3150 and the seal-forming structure 3100. In certain forms of the present technology, the connection between the tubes 3350 and the cradle cushion module 3150 is achieved by connecting two rigid components such that the patient can easily connect the two rigid components in a reliable manner. A "confirmable click" or similar audible tactile feedback may be used by the patient and may also let the patient know when the tubes are properly connected to the cradle cushion module 3150. In one form, the tubes 3350 are formed from silicone and the lower ends of each of the silicone tubes 3350 are overmolded into a rigid connector formed from, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connectors may include male mating features configured to connect to female mating features on the cradle cushion module 3150. Alternatively, the rigid connector may include a female mating feature configured to connect to a male mating feature on the cradle cushion module 3150. The manner in which the tube 3350 is connected to the cradle cushion module 3150 may also be applicable to a connection between the tube 3350 and the nasal cushion module 3150 or another plenum chamber 3200 or seal-forming structure 3100.

[0200] In another embodiment, a compression seal is used to connect each tube 3350 to the cradle cushion module 3150. For example, if a resilient flexible (e.g., silicone) tube 3350 is used without a rigid connector, the tube 3350 may need to be compressed slightly to reduce its diameter so that it can be forced into the port in the plenum chamber 3200, and the inherent elasticity of the silicone will push the tube 3350 outward to hermetically seal the tube 3350 into the port. If the engagement between the tube 3350 and the port is a rigid-to-rigid type engagement, a pressure activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is urged against the joint between the tube and the inner periphery of the port of the plenum chamber 3200 to promote a seal between the two. If the port is flexible and a rigid connector is provided to the tube 3350, a pressure activated seal as described above may also be used to ensure that the connection is airtight. In another example, each tube 3350 is formed from an elastically flexible (e.g., silicone) material and overmolded onto a rigid connector so that the elastically flexible material fits over the rigid connector and the elastically flexible material itself acts as a gasket to seal the connection between the tube 3350 and the cradle cushion module 3150 around the airflow passage from the tube 3350 into the plenum chamber 3200 of the cradle cushion module 3150.

[0201] In some forms of the present technology, a similar connection mechanism may be used to fluidly connect to the tube 3350 with a T-shaped upper member that defines or is connectable to the connection port 3600. In one embodiment, a swivel elbow connected at the connection port 3600 is rotatable such that this rotation drives a port size adjustment mechanism that increases or decreases the size of the port into which the tube 3350 is inserted, improving the fit of the tube through increased or decreased compression force and reducing unintended leakage.

[0202] 5.3.2.1.3 Extendible bellows structure The patient interface 3000 may include one or more extendable tube sections. In some examples, the extendable tube section includes an extendable bellows structure 3362. The patient interface 3000 may include a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 includes at least one gas delivery tube including a tube wall 3352 having an extendable bellows structure 3362. For example, the patient interface 3000 shown in Figures 8A-9C and 12A-12F includes a tube 3350 provided with extendable tube sections, each in the form of an extendable bellows structure 3362, on the upper portion of the tube 3350.

[0203] Each extendable bellows structure 3362 may include a portion of the tube 3350 having one or more folds, pleats, corrugations, or bellows to form an extendable portion of the tube 3350. In the example shown in FIGS. 8A-9C, each of the extendable bellows structures 3362 takes the form of an extendable bellows structure. The extendable bellows structures 3362 are separated by elbows 3610 and connection ports 3600. The extendable bellows structures 3362 are variable in length. In particular, each extendable bellows structure 3362 is capable of expanding or contracting to change the length of each tube 3350.

[0204] In some examples, each gas delivery tube 3350 may include a cross section at the extendable bellows structure 3362 having a width and a height. The width is greater than the height and is substantially aligned with the anterior-posterior direction in use. For example, the patient interface 3000 shown in Figures 8A-8C includes extendable bellows structures 3362 each having a cross-sectional width greater than the cross-sectional height. The width is a dimension aligned with the anterior and posterior directions of the illustrated patient 1000. In this example, the width is approximately twice as great as the height. That is, in this example, the width decreases along the height of the extendable bellows structure 3362. At the upper or intermediate end of each extendable bellows structure 3362, the width of the tube wall forming the extendable bellows structure 3362 is relatively large, and the width is substantially aligned with the anterior-posterior direction in use, where a swivel elbow 3610 is received in the tube 3350. At the lower or side edge of each extendable bellows structure 3362, the width of the tube wall is relatively small and sized similarly to the width of the non-extendable tube section 3363. The extendable bellows structure 3362 having a varying width between the larger tube size at the connection to the elbow 3610 and the smaller tube size of the non-extendable tube section 3363 provides a smooth and continuous tube 3350 which may increase comfort and / or aesthetics (which may result in improved patient compliance with treatment).

[0205] 5.3.2.1.3.1 Flexibility In some examples of the present technology, a portion of the positioning and stabilizing structure 3300 is configured to be more resistant to bending in or about several directions or on several axes.

[0206] For example, the upper portion of each tube 3350 of the positioning and stabilizing structure 3300 shown in FIGS. 8A-9C may be more bendable in a particular direction than in an orthogonal direction. Each gas delivery tube 3350 of the positioning and stabilizing structure 3300 may include an upper tube section 3304 configured to rest on an upper region of the patient's head in use (as shown in FIGS. 8A-8C). In the illustrated example, the upper tube section 3304 includes an extendable bellows structure 3362. In other examples of the present technology, the upper tube section 3304 may include another extendable tube structure (e.g., one of the options disclosed in PCT Patent Publication No. WO2017 / 124155, the contents of each of which are incorporated herein by reference in their entirety) or may be non-extendable.

[0207] The upper tube section 3304 may include a first end 3305 and a second end 3306. In this example, the first end 3305 is configured to rest or be positioned on the top of the patient's head, approximately in the sagittal plane of the patient's head (e.g., approximately the top and center of the patient's head). The second end 3306 is configured to rest laterally on the patient's head from the first end 3305 (e.g., closer to the side of the patient's head). In some examples, if the upper tube section 3304 is not very long, the second end 3306 may be positioned laterally relative to the first end 3305, but may not be specifically positioned below the first end 3305. In other examples, if the upper tube section 3304 is longer, the second end 3306 may be positioned both laterally and below the first end 3305. FIG. 13 illustrates a portion of another example of a positioning and stabilizing structure 3300. The positioning and stabilizing structures of Figures 8A-9C and 13 can bend about multiple axes. For example, the positioning and stabilizing structure 3300 in Figure 13 can drape downward over the patient's head and can also be curved in the anterior and posterior directions. As shown in Figure 13, the upper tube section 3304 is bent about two axes.

[0208] The upper tube section 3304 may also include one or more rigid sections between the first end 3305 and the second end 3306. These rigid section(s) may be configured such that there is more resistance to relative movement between the first end 3305 and the second end 3306 in the forward and / or rearward directions than in the upward and / or downward directions.

[0209] When the positioning and stabilizing structure 3300 is worn by a patient, the upper tube section 3304 may have relatively low resistance to bending in the vertical direction, allowing the second end 3306 to move downward relative to the first end 3305. This advantageously allows the upper tube section 3304 to "drape" over the top of the patient's head and down to the side of the patient's head. The relatively high degree of bendability and upward / downward direction may be advantageous in allowing the upper tube section 3304 to conform to the curvature of the patient's head.

[0210] Additionally, the upper tube section 3304 may have a relatively high resistance to bending in the horizontal direction, thereby preventing the first end 3305 from inadvertently moving forward and / or backward relative to the second end 3306. As a result, the upper tube section 3304 may be advantageously maintained in a desired position above the patient's head. The upper tube section 3304, and particularly the connection port 3600, may have a lower resistance to bending in the forward and / or backward directions, and therefore may be less likely to ride forward or backward along the top of the patient's head during use. Such resistance to forward or backward movement of the upper tube section 3304 is particularly advantageous for the patient interface 3000 when there is a connection from the air circuit 4170 to the top of the patient's head (i.e., tube drag may act directly on the upper tube section 3304).

[0211] In some instances, the upper tube section 3304 may include a shape that inherently provides advantageous resistance to bending. For example, the upper tube section 3304 may include a rectangular cross section with one of its parallel long sides configured to rest against the patient's head surface. The long side of the rectangular cross section provides a relatively high resistance to bending of the upper tube section in a direction parallel to the long side (e.g., in a forward and / or backward direction in use). However, the short side of the rectangular / trapezoidal cross section does not provide such high resistance to bending of the upper tube section 3304 and in a direction parallel to the short side (e.g., in a downward and / or upward direction in use). It is understood that the cross section of the upper tube section 3304 may not be a perfect rectangle. For example, the corners and / or short sides may be curved.

[0212] The stiffening portion may be formed by one or more stiffening structures provided to the tube wall of the tube 3350 or formed by a tube wall of the tube 3350. In the example shown in Figures 8A-10J, the stiffening portion is formed by a plurality of ridge connectors 3370 configured to resist separation of adjacent ridges formed by folds in the tube wall. In particular, the stiffening portion is formed by a series of ridge connectors 3370 along both the sides of the upper tube section 3304 and the rear side of the upper tube section 3304. A tube 3350 including stiffening portions on both the front and rear sides of the tube 3350 is advantageous because it may have a higher resistance to bending in both the front and rear of the tube 3350. However, in some examples, the stiffening portion is provided only on the front or rear of the tube 3350, since it may be possible to provide sufficient resistance to bending in both directions by providing stiffening portions only on one side depending on the stiffness.

[0213] In some examples, the rigid portion of the tube 3350 may be provided to the extendable portion of the upper tube section 3304. In the example shown in Figures 8A-10J, the extendable portion includes an extendable bellows structure 3362 formed in the tube wall of the tube 3350, the extendable bellows structure 3362 including a plurality of ridges 3372 and a plurality of grooves 3373, as described in further detail below. In this example, the rigid portion includes a plurality of ridge connectors 3370 formed in the tube wall, each of the plurality of ridge connectors 3370 connecting to a pair of adjacent ridges 3372. The stiffening effect of the ridge connectors 3370 is described in further detail below.

[0214] In other examples of the present technology, the patient interface 3000 may include a tube 3350 with a rigid portion formed by a structure other than a ridge connection. In some examples, a portion of the tube 3350 (e.g., anterior and / or posterior) may include a rigid portion that is rigidified by one or more stiffening elements. The tube 3350 may be rigidified by one or more stiffening components embedded within the tube wall that are more rigid than the tube 3350. For example, the tube wall may be overmolded into an elongated bar or rod formed from a material that is more rigid than the tube wall. In other examples, the rigid portion of the tube wall may be obtained by additional features of the tube wall geometry. In one example, the tube wall may include a greater material thickness at the anterior and / or posterior sides of the tube 3350. In another example, the tube wall may include a smaller groove depth (or ridge height) at the rigid portion of the tube 3350.

[0215] 5.3.2.1.3.2 Ridges and Grooves The extendable bellows structure 3362 forming each extendable tube is shown in FIGS. 10D-10J. As shown, the tube 3350 includes a plurality of ridges 3372 and a plurality of grooves 3373. The ridges 3372 and grooves 3373 are formed alternately in the wall of each tube 3350 to form a bellows structure. An alternating series of ridges and grooves is understood to refer to a series in which a groove is provided between each pair of ridges and a ridge is provided between each pair of grooves (e.g., ridge, groove, ridge, groove).

[0216] The alternating ridges 3372 and grooves 3373 function such that they can individually fold or unfold or cooperate to shorten or lengthen the extendable bellows structure 3362 and thus each tube 3350. A larger groove depth (or ridge height) may result in a more extendable tube 3350. When tension is applied to the tube 3350, the ridges 3372 and grooves 3373 of the extendable bellows structure 3362 are pulled away from each other, resulting in a straightening of the tube walls and an extension of the tube 3350. In this example, the extendable bellows structure 3362 is biased to its original (e.g., unstretched) length. When tension on the headgear is released, the ridges 3372 and grooves 3373 are biased to return each extendable bellows structure 3362 and tube 3350 to their original configuration with their original lengths.

[0217] The ridges 3372 and grooves 3373 may facilitate not only changes in length but also changes in shape of the extendable bellows structure 3362 of each tube 3350. In some examples of the present technology, a first series of alternating ridges 3372 and grooves 3373 may be formed on a first side (e.g., Non-patient contact side ) and a second series of alternating ridges 3372 and grooves 3373 are provided on a second opposite side of the tube 3350 (e.g., Patient Contact Side) into the tube 3350. The ridges 3372 and grooves 3373 may move relative to one another by different degrees on different sides of the tube 3350, so that the extendable bellows structure 3362 may facilitate bending of the tube 3350. For example, on a first side of the tube 3350, the ridges 3372 and grooves 3373 may contact, while on a second side of the tube 3350, the ridges 3372 and grooves 3373 may expand, causing the tube 3350 to bend within the extendable bellows structure 3362. Alternatively, the ridges 3372 and grooves 3373 on both the first side and the second side may expand during use, while the ridges 3372 and grooves 3373 on the first side may expand only slightly so that the tube 3350 can bend (e.g., curve) in the direction of the first side, for example to conform to or surround (e.g., drape over) the patient's head while extending in length.

[0218] In some examples, the first alternating series of ridges 3372 and grooves 3373 may have a lower tensile stiffness (e.g., less force may be required to achieve a unit length change) than the second alternating series of ridges 3372 and grooves 3373. The lower tensile stiffness on the non-patient contacting side of the extendable bellows structure 3362 may advantageously facilitate bending / curvature in the tube 3350 during use by stretching the outboard side of the tube 3350 to cover a greater arc length in the extendable bellows structure 3362 than the inboard side of the tube 3350. Although the tensile stiffness of both the first and second alternating series of ridges 3372 and grooves 3373 may differ from one another, the respective tensile stiffnesses may be selected to achieve a desired overall tensile stiffness of the extendable bellows structure 3362.

[0219] The ridges 3372 and grooves 3373 may each be formed along a portion of the tube wall around a majority of the longitudinal axis of the tube 3350 (e.g., the entire or nearly entire side of the tube 3350). As a result, the extendable bellows structure 3362 may be able to bend around multiple axes. As shown in FIGS. 10H-10J and 13, an extendable bellows structure 3362 according to examples of the present technology may allow the tube 3350 to bend around multiple axes. In FIGS. 10H and 10I, the extendable bellows structure 3362 may be (e.g., 10J shows the extendable bellows structure 3362 bending in a forward-backward direction (e.g., so that the tube 3350 can be positioned in different positions on the top of the patient's head), and in FIG. 13 shows the extendable bellows structure 10J bending in both the forward-backward and forward-backward directions simultaneously.

[0220] In some examples, the ridges 3372 and grooves 3373 are each substantially linear. In other examples, the ridges 3372 and / or grooves 3373 may include one or more arcuate portions.

[0221] 10D, each ridge 3372 includes a central curved ridge portion 3374. That is, each ridge 3372 includes a precision portion at its center. However, at the ends of each ridge 3372, linear ridge portions 3375 are provided. Thus, each ridge 3372 includes a pair of linear ridge portions 3375 provided at opposite ends of the ridge 3372.

[0222] Similarly, each groove 3373 includes a curved groove section 3376 in the center of each groove. Therefore, each groove 3373 is centered with high precision. Additionally, at the ends of each groove 3373, straight groove sections 3377 are provided. Each groove 3373 includes a pair of straight groove sections 3377 provided at opposite ends of the groove 3373. Each curved groove section 3376 may include a curvature that matches or is defined by the curvature of the pair of adjacent ridges 3372 (specifically, the curvature of the curved ridge section 3374).

[0223] Each ridge connector 3370 connects to each adjacent pair of ridges 3372 at a linear ridge section 3375 of the pair of ridges 3372. Each linear groove section 3377 may be defined along the length of the tube 3350 above or below the linear groove section 3377 and the ridge connector 3370 between adjacent linear ridge sections 3375 on either side (depending on whether it is on the above or below the tube 3350, as with each linear groove section 3377).

[0224] While the extendable bellows structure 3362 includes ridges 3372 and grooves 3373 on the exterior of the gas delivery tube 3350, the folds forming the extendable bellows structure 3362 may also form ridges and grooves on the interior of the gas delivery tube 3350 (e.g., by folds that form a wavy shape (e.g., a sinusoidal shape, square wave, or other waveform) in the tube wall). FIG. 10B illustrates a particular wavy shape formed in the tube wall. As shown in FIG. 10B, the extendable bellows structure 3362 includes folds that form internal ridges 3382 and internal grooves 3383. Specifically, the folds in the tube wall form a first alternating series of internal ridges 3382a and internal grooves 3383a on the interior of the tube 3350 along the non-patient contacting side of the tube 3350. Additionally, these folds form a second series of alternating internal ridges 3382b and internal grooves 3383b along the patient-contacting side of tube 3350.

[0225] Each internal groove 3383a of the first alternating series may be disposed across the interior of the tube 3350 opposite each internal groove 3383b of the second alternating series to form a plurality of opposing groove pairs. That is, each internal groove 3383a on the non-patient-contacting side of the tube 3350 may be paired with an internal groove 3383b on the opposite side of the patient-contacting side. As shown in FIG. 10B, each opposing groove pair includes a first internal groove 3383a and a second internal groove 3383b. In this example, the groove depth of the first internal groove 3383a is greater than the second internal groove 3383b. By providing a greater groove depth of the first internal groove 3383a in each opposing groove pair, the tensile stiffness of the first alternating series of ridges and grooves is lower than that of the second alternating series. In another example of the present technology, the first alternating series The relatively low stiffness of the ridges and grooves forming the second alternating series may be made possible by hardening the second alternating series of ridges and grooves. In one example, ridge connectors 3370 (described separately below) are provided to the tube wall to connect to adjacent pairs of ridges. In another example, the second alternating series of ridges and grooves are formed by a harder material than the first alternating series (e.g., a different, more stiff material or a region of higher durometer silicone (in the case of a tube formed from silicone)). In a further example, the second alternating series of ridges and grooves may be hardened by a stiffening component.

[0226] In the illustrated example, the wall of the tube 3350 is flush with the base of the second interior groove 3383b of each opposing groove pair. (bottom) The thickness of material at the base of the first internal groove 3383a of each groove pair is greater than the thickness of material at the base of the first internal groove 3383a of each groove pair. The greater the material thickness forming the base of the second internal groove 3383b of each groove pair, the smaller the groove depth of the second internal groove 3383b. The smaller the groove depth, the less extensible the extendable bellows structure 3362 (of the side having the second series of alternating ridges and grooves).

[0227] As shown in FIG. 10B, the material thickness of the tube wall at the base of each internal groove 3383b of the second alternating series decreases from the first end adjacent the connection port 3600 to the second end along the length of the tube 3350. Furthermore, the material thickness of the tube wall at the base of each internal groove 3383a of the first alternating series is substantially constant along the length of the tube 3350. The groove depth of the internal grooves 3383a and 3383b of the first and second alternating series of internal ridges 3382 and internal grooves 3383 decreases from the first end adjacent the connection port 3600 to the second end along the length of the gas delivery tube 3350. The decrease in groove depth along the length of the extendable bellows structure 3362 on both sides of the tube 3350 facilitates sizing of the tube 3350 between the larger connection port 3600 and the smaller non-extendable tube section 3363. Although the groove depth is generally less at the second end than at the first end, for each opposing groove pair, the groove depth of the second internal groove 3383b on the second patient-contacting side of the extendable bellows structure 3362 is less than the groove depth of the first internal groove 3383a on the opposite side of the first non-patient-contacting side.

[0228] In this example, the first internal groove 3383a of each opposing groove pair is joined to the second internal groove 3383b of each opposing groove pair at the side of the tube 3350 between the non-patient contacting side and the patient contacting side. That is, the tube 3350 is grooved all the way to the interior periphery of the tube wall. Thus, the first internal groove 3383a and the second internal groove 3383b of each opposing groove pair are continuous. Similarly, the first alternating series of internal ridges 3382a and each internal ridge 3382a of the internal groove 3383a are continuous with the second alternating series of internal ridges 3382b and internal ridges 3382b on the opposite side of the internal groove 3383b.

[0229] 5.3.2.1.3.3 Ridge connections 10D-10J, the extendable bellows structure 3362 also includes a plurality of ridge connections 3370 disposed to the tube wall of the gas delivery tube 3350. Each of the ridge connections 3370 connects to a pair of adjacent ridges 3372. Each of the ridge connections 3370 may comprise an integrally formed portion of the tube wall. Each of the ridge connections 3370 may be formed into the tube wall. Each of the ridge connections 3370 connects to two or more adjacent ridges 3372 and is configured to withstand separation of the ridges 3372. The ridge connections 3370 may increase the stiffness of the extendable bellows structure 3362, although separation of the ridges 3372 may not be avoided.

[0230] One function of the ridge connector 3370 is to reduce the stretchability of the extendable bellows structure 3362. Although the extendable bellows structure 3362 is intended to be extendable, and there are advantages associated with the length extendable tube 3350, excessive extendibility of the extendable tube 3350 can make it difficult for a patient to use comfortably and reliably. The rise connection 3370 restricts, but does not prevent, the length extension capability of the extendible bellows structure 3362. In the illustrated example, the rise connection 3370, along with the ridges 3372 and grooves 3373, form the extendible bellows structure 3362. The extendible bellows structure 3362 facilitates full extension of the length of the tube 3350, improving the ability of the positioning and stabilizing structure 3300 to accommodate a range of patient head sizes (without becoming too flexible to achieve sufficient tension and sealing force).

[0231] Each pair of adjacent ridges 3372 of the extendable bellows structure 3362 may be connected by at least one ridge connector 3370. Alternatively or additionally, one or more pairs of adjacent ridges 3372 may be connected by two ridge connectors 3370. As shown in Figures 10D-10J, each pair of adjacent ridges 3372 of the extendable bellows structure 3362 is connected by two ridge connectors 3370. The ridge connectors 3370 may each be centrally spaced between a lower side (e.g., a patient-contacting side) of the gas delivery tube 3350 and an upper side (e.g., an upwardly and / or outwardly facing side) of the gas delivery tube 3350.

[0232] Another function of the ridge connectors 3370 is to allow for localized stiffening of the extendable bellows structure 3362. Localized stiffening of the extendable bellows structure 3362 may be advantageous for headgear tubes 3350 that are intended to be easily bendable about one axis and have a particular resistance to bending about a different axis.

[0233] In some examples, a ridge connection 3370 is provided between a ridge 3372 and a groove 3373 on one side of the tube 3350 that is configured to bend less than the other side of the tube 3350. One or more ridge connections 3370 may be disposed on a forward facing side of the gas delivery tube 3350. Alternatively or additionally, one or more ridge connections 3370 may be disposed on a rear facing side of the gas delivery tube 3350.

[0234] In the illustrated example, as shown in Figures 10D-10J, ridge connectors 3370 are provided to the positioning and stabilizing structure 3300 between the front and rear ridges 3372 of the extendable bellows structure 3362. That is, each pair of adjacent ridges 3372 are connected by a ridge connector 3370 located on a forward facing side of the gas delivery tube 3350. Further, each pair of adjacent ridges 3372 are connected by a ridge connector 3370 located on a rear facing side of the gas delivery tube 3350.

[0235] In this example, the ridge connections 3370 are provided on the front and back sides, so that the ridge connections 3370 provide more resistance to the extendable bellows structure 3362 bending in the forward and rearward directions (rather than bending in the upward and downward directions). This is advantageous because it maintains the ability of the extendable bellows structure 3362 to bend and conform to the top and sides of the patient's head. This ability to bend allows the tube 3350 to drape downward over the patient's head for a comfortable fit. On the other hand, reducing the ability of the extendable bellows structure 3362 to bend in the forward and rearward directions may reduce the tendency of the top of the positioning and stabilizing structure 3300 to move or ride up or down in use, which may compromise the stability of the patient interface 3000.

[0236] An advantage of providing the ridge connection 3370 is that it limits the extensibility of the extendable bellows structure 3362 (without unduly compromising the ability of the extendable bellows structure 3362 to bend around a particular axis around which it is advantageous for the extendable tube to bend).

[0237] In some examples of the present technology, another function provided by the ridge connection 3370 is As a result, the extendable bellows structure 3362 is more resistant to twisting. Because the connection ports 3600 are provided between the extendable bellows structures 3362, tube drag in some circumstances may act on the tube 3350 in a manner that induces twisting of the extendable bellows structure 3362. Although the tube 3350 may be resistant to twisting due to its low profile (e.g., generally rectangular cross section), additional twisting resistance is advantageously provided by the ridge connections 3370. The ridge connections 3370 may stiffen the front and back sides of the extendable bellows structure 3362, acting as stiffeners that reduce the likelihood of kinking of the tube 3350.

[0238] In some examples of the present technology, the grooves 3373 of the extendable bellows structure 3362 may be formed as indentations relative to the outer surface of the gas delivery tube 3350. In other examples, the ridges 3372 of the extendable bellows structure 3362 may be raised relative to the outwardly facing surface of the tube wall, and the grooves 3373 may be formed by spaces between the raised ridges 3372. As shown in Figures 10D-10J, the grooves 3373 are formed as indentations relative to the outer surface of the tube 3350. The outer surface of the tube 3350 from which the recessed shape of the grooves 3373 originates may be continuous with the outer surface of the non-extendable tube section 3363. An advantage of forming the grooves 3373 as indentations relative to the outer surface of the tube 3350 is that the ridges 3372 do not protrude outward beyond the outer surface of the non-extendable tube section 3363. If the ridges protrude outward, this may be uncomfortable for the patient.

[0239] 10D-10J, the outwardly facing surfaces of the ridge connectors 3370 do not protrude further outwardly relative to the longitudinal axis of the tube than the ridges 3372. Furthermore, each of the ridge connectors 3370 includes an outwardly facing surface that is contiguous with the outwardly facing surfaces of the adjacent ridges 3372. Having the ridge connectors 3370 protrude further outwardly relative to the longitudinal axis of the tube 3350 than the ridges 3372, for example to increase bending and / or twisting resistance, may result in some aesthetic loss, as is done in some examples of the present technology.

[0240] Further, as shown in FIG. 10D to FIG. 10J, each of the plurality of grooves 3373 is disposed between each pair of ridge connection portions 3370. Each of the plurality of grooves 3373 is disposed at each end of each of the grooves 3373. Further, each of the plurality of grooves 3373 includes a groove depth, and each of the plurality of ridge connection portions 3370 includes a ridge connection height. In each pair of the ridge connection portions 3370 and the grooves 3373, the groove depth is equal to the ridge connection height. That is, the groove depth of each groove 3373 is equal to the ridge connection height of each ridge connection portion 3370 of each pair of the ridge connection portions 3370 disposed at the end of each of the grooves 3373. Therefore, the grooves 3373 are formed as depressions with respect to the outer surface of the ridge connection portion 3370, the ridges 3372, and the tube wall of the tube 3350.

[0241] The ridge connection portion 3370 can be relatively narrow and ribbed, as shown in the illustrated example, or the ridge connection portion 3370 can be thicker (e.g., so as to occupy a larger portion of the front and rear sides of the extendable portion of the tube 3350).

[0242] In the illustrated example, the ridge connection 3370 is provided on the outside of the tube 3350. That is, the ridge connection 3370 connects to the ridge 3372 on the outside of the tube wall (rather than on the inside defining the hollow interior within the tube 3350). In other examples, the ridge connection 3370 may be provided on the inside of the tube wall of the tube 3350. The folds in the tube wall forming the extendable bellows structure 3362 may form a series of alternating ridges and grooves on the inside of the tube wall that are inverse to the series of ridges 3372 and grooves 3373 formed on the outside of the tube wall. That is, the folds forming the ridges 3372 on the outside of the tube wall may form grooves around the interior perimeter of the tube wall. Similarly, the folds forming the grooves 3373 on the outside of the tube wall may form ridges on the inside of the tube wall.

[0243] The ridge connectors 3370 may connect between adjacent ridges on the outside or inside of the tube 3350 to resist separation of the ridges. In an example of the positioning and stabilizing structure 3300 with the ridge connectors 3370 on the outside of the tube 3350, ridges 3372 on the exterior of the tube are connected. These ridges 3372 require more tension to separate, while ridges on the interior of the tube are more easily separated. Similarly, in another example of the positioning and stabilizing structure 3300 with the ridge connectors 3370 connecting ridges on the interior of the tube 3350, ridges on the interior of the tube wall require more force to separate, while ridges on the exterior of the tube are more easily separated. In some examples, the ridge connectors 3370 connect a combination of interior and exterior ridges.

[0244] In some examples of the present technology, a single ridge connection 3370 connects multiple ridges 3372. In other examples, each ridge connection 3370 connects only a single pair of adjacent ridges 3372. In some examples, one or more ridge connections 3370 may connect to non-adjacent ridges 3372 (e.g., the first and last ridges, every second ridge).

[0245] 5.3.2.1.4 Non-extendable headgear tubing The patient interface 3000 may include one or more non-extensible tubes 3363. For example, the patient interface 3000 shown in Figures 8A-9C includes a tube 3350. A non-extensible tube 3363 is provided at a lower portion of the tube 3350. The non-extensible tube 3363 may be configured to rest on the patient's cheek and to contact the patient's face below the patient's cheekbone. Each non-extensible tube 3363 may extend downward from a connection between each headgear tube 3350 in a curve and then extend partially forward and partially medially into the seal-forming structure 3100 to avoid the patient's cheekbone.

[0246] Advantageously, the positioning and stabilizing structure 3300 of the patient interface 3000 does not rest on the patient's cheekbones. Areas of the patient's face below the cheekbones are typically more fleshy, and therefore the patient is better able to tolerate the headgear tubes 3350 resting on these facial areas. Additionally, the cheekbone areas of the patient's face are less able to move or deform, and therefore the non-extendable tubes 3363 rest firmly against the fleshy cheek areas. Additionally, the patient's cheekbones can help prevent the lower portion of the headgear tubes 3350 from riding up the cheekbones onto the patient's eyes. When the non-extendable tubes 3363 fit snugly against the patient's cheeks below the cheekbones, the rigidity and prominence of the patient's cheekbones provides a barrier to the headgear tubes 3350 riding up the patient's eyes (which could affect stability and / or block the patient's view).

[0247] The cross-sectional shape of the non-extendable tube section 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rectangular with rounded corners, for example as described in U.S. Patent No. 6,044,844. Cross-sectional shapes that present a flat surface of the tube on the side that faces and contacts other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross section.

[0248] The cross-sectional width and / or height of the tube 3350 may be 8-25 mm (e.g., 10-20 mm). In some configurations where the tube has a D-shaped cross-section, such as the longitudinal cross-section of the headgear tubing 3350 shown in FIG. 10C, the width of the tube is 15-25 mm (e.g., 20 mm) and the height is 8-15 mm (e.g., 10 mm). The height may be considered as the dimension of the tube that extends away from the patient's face in use (i.e., the distance between the patient-contacting side 3348 and the outermost non-patient-contacting side 3349), and the width may be considered as the dimension across the surface of the patient's head. The cross-sectional thickness of the material forming the tube 3350 may be 0.8-1.6 mm (e.g., 1.0-1.5 mm (e.g., 1.3 mm)).

[0249] The D-shaped cross-section tube 3350 has a curved edge 3347 located on the side 3348 that contacts the patient. The curved edge that contacts or is adjacent to the patient's skin helps to increase comfort when wearing the patient interface 3000 and to avoid marking or irritation on the patient's skin. The D-shaped cross-sectional profile of the tube also makes it more resistant to buckling than other shaped profiles.

[0250] A further advantage of the D-shaped cross section of the non-extendable tube section 3363 of the tube 3350 is that the non-extendable tube section 3363, which in use rests in front of the patient's face, is more resistant to bending in the vertical direction than in the horizontal direction. The D-shaped cross section of the non-extendable tube section 3363 allows the tube section to better withstand bending parallel to the long axis of the D shape than bending perpendicular to the long axis of the D shape. This is advantageous as it allows the non-extendable tube section 3363 to bend more easily inwardly in a curved manner from around the front of the patient's face into the seal-forming structure 3100 while still retaining stiffness in the vertical direction to transfer vertical forces applied from the extendable bellows structure 3362 onto the non-extendable tube section 3363 to the seal-forming structure 3100 to provide the necessary sealing force to the seal-forming structure 3100.

[0251] The ability to bend inwardly around the front of the patient's face allows the non-extendable tube section 3363 to fit snugly against the patient's cheek below the patient's cheekbone. As described in more detail above, the non-extendable tube section 3363 resting snugly against the patient's cheek below the patient's cheekbone allows a more stable seal to be obtained than if the non-extendable tube section 3363 were to rest loosely on the patient's cheek or above the patient's cheekbone.

[0252] In another example, the non-extendable tube 3363 can include a rectangular cross-section, which can provide similar benefits as a D-shaped cross-section. In particular, the rectangular cross-section can provide the non-extendable tube 3363 with a higher resistance to bending in a direction parallel to the short side of the rectangular cross-section. In another example, the non-extendable tube 3363 can include an elliptical or oval shaped cross-section, which can provide similar benefits.

[0253] In some examples of the present technology, the non-extendable tube 3363 connects to the cradle cushion module 3150 at a low angle. As described above, the headgear 3350 may extend downward on the sides of the patient's head, then curve forward and medially to connect to the cradle cushion module 3150 in front of the patient's face. Before connecting to the cradle cushion module 3150, the tube 3350 may extend to the same vertical position as the connection with the cradle cushion module 3150 or to a position below the connection with the cradle cushion module 3150 in some examples. That is, the tube 3350 may protrude at least partially upward before connecting to the cradle cushion module 3150. A portion of the tube 3350 may be positioned below the cradle cushion module 3150 and / or the seal forming structure 3100. The tube 3350 is positioned downward and in front of the patient's face to promote contact with the patient's face below the patient's cheekbones.

[0254] 5.3.2.2 Headgear sizing and rigidity The size of the positioning and stabilizing structure 3300 may vary between different examples of the technology. Providing different size options for the patient interface 3000 may allow for a greater range of patient accommodating. A loop around the patient's head may be formed by a pair of headgear tubes 3350 and a cradle cushion module 3150 (or pillow cushion module 3160 or other seal forming structure 3100) connected between the lower ends of the tubes 3350. The size of this loop may vary to accommodate different size patient interfaces 3000.

[0255] In one example, the unstretched length of the loop formed by the tube 3350 and the cradle cushion module 3150, measured along the centerline of the patient-facing side of the loop, may be in the range of 510-610 mm. In some examples, the unstretched length of the loop may be in the range of 525-600 mm. In some examples, the length of the loop may be in the range of 535-590 mm.

[0256] In some specific examples, the unstretched length of the loop may be within the range of 528-548 mm (e.g., within the range of 535-541 mm (e.g., about 538 mm)). In further specific examples, the length of the loop may be within the range of 534-554 mm (e.g., within the range of 539-549 mm (e.g., about 544 mm or about 547 mm in the examples). In further specific examples, the unstretched length of the loop may be within the range of 541-561 mm (e.g., within the range of 546-556 mm (e.g., about 551 mm)).

[0257] In other specific examples, the unstretched length of the loop can be within the range of 564-584 mm (e.g., within the range of 571-581 mm (e.g., about 574 or about 579 mm)). In further examples, the unstretched length of the loop can be within the range of 577-597 mm (e.g., 582-592 mm (e.g., about 583 mm or about 587 mm)).

[0258] In particular, the length of the gas delivery tube 3350 may be variable to allow for different sizes of the positioning and stabilizing structure 3300. In some examples, the unextended length of the tube 3350 measured along the centerline of the patient-facing side of the tube 3350 may be in the range of 500-535 mm (e.g., 510-525 mm (e.g., 512-522 mm (e.g., about 517 mm))). In further examples, the unextended length of the tube 3350 may be in the range of 460-500 mm (e.g., in the range of 470-490 mm (e.g., in the range of 475-485 mm (e.g., about 481 mm)).

[0259] As further detailed above, in some examples of the present technology, the headgear tube 3350 includes an extendable portion (e.g., an extendable bellows structure 3362). In some examples of the present technology, the extendable portion of the gas delivery tube 3350 (e.g., a single bellows portion on one side of the positioning and stabilizing structure 3300) may have a stiffness (of the extension portion) in the range of 2-3.5 N / 10 mm (e.g., 0.2-0.35 N / mm). In a detailed example, the stiffness of the extendable portion may be in the range of 2.5-3 N / 10 mm (e.g., 0.25-0.3 N / mm). In one example, the stiffness of the extendable portion may be approximately 2.75 N / 10 mm (e.g., 0.275 N / mm). In further examples of the present technology, the tension required to extend the extendable portion of the tube 3350 by 10 mm in length may be between 2.5N and 3N, and the tension required to extend the length by 20 mm may be between 5N and 5.5N. It is understood that in various examples of patient interfaces 3000 in accordance with the present technology, any of these disclosed stiffnesses may be provided to tubes 3350 having any of the sizes (e.g., lengths) described above.

[0260] 5.3.2.3 Headgear straps In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap. These headgear straps function to position and stabilize the seal-forming structure 3100 in a sealed position relative to an entrance to the patient's airway, in addition to the tube 3350. As shown in Figures 8A-9C, the patient interface 3000 includes a strap 3310 that forms part of the positioning and stabilizing structure 3300. The strap 3310 may be known, for example, as a rear strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface according to an embodiment of the present technology having a full face or oral-nasal cushion module may be provided. The patient interface 3000 may have a second, lower strap configured to rest on the back of the patient's neck.

[0261] 5.3.2.3.1 Straps In the example shown in Figures 8A-9C, the straps 3310 of the positioning and stabilizing structure 3300 are connected between two tubes 3350 that are positioned on each side of the patient's head and pass behind the patient's head (e.g., over or cover the back of the occipital bone of the patient's head in use). The straps 3310 connect to each tube above the patient's ear. In other embodiments, for example as part of an oronasal patient interface, the positioning and stabilizing structure 3300 includes upper straps similar to the straps 3310 and at least one additional lower headgear strap. These lower headgear straps connect between the tubes and / or between the cushion modules and pass below the patient's ears and behind the patient's head. Such lower headgear straps may also be connected to upper straps (e.g., similar to the straps 3310).

[0262] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a mechanism for connecting headgear straps to the headgear tubes 3350. The headgear straps may be directly or indirectly connected to the headgear tubes 3350. In the case of the patient interface 3000 shown in FIGS. 8A-9C, for example, tabs 3320 configured to connect to the straps 3310 project outwardly from each headgear tube 3350 in a generally rearward direction. These tabs 3320 have holes therein for receiving ends of the straps 3310.

[0263] In some forms of the present technology, the straps 3310 are adjustable. For example, in the case of the patient interface shown in Figs. 8A-9C, the straps 3310 are threaded through holes in the form of eyelets in each tab 3320 in use. The length of the straps 3310 between the tabs 3320 can be adjusted by pulling more or fewer straps 3310 through one or both of the tabs 3320. The straps 3310 can be fastened to themselves by passing the straps 3310 through the eyelets in the tabs 3320, for example using a hook and loop fastening means. Thus, the straps 3310 can be adjusted to fit different head sizes. In some forms of the present technology, the angle of the straps 3310 relative to the headgear tube 3350 or the patient's head can be adjusted to fit around the patient's head in different positions. Such adjustability helps the positioning and stabilizing structure 3300 to accommodate different head shapes and sizes.

[0264] In some forms of the present technology, the straps 3310 apply a force to the headgear tube 3350 to pull the headgear tube 3350 at least partially in a posterior (e.g., rearward) direction at the location of the tabs 3320. The straps 3310 may also apply a force to the headgear tube 3350 to pull the headgear tube 3350 at least partially in an inward (e.g., rearward) direction. The magnitude of this force can be adjusted by changing the length of the straps 3310 between the tabs 3320.

[0265] In some implementations of the present technology, such as the configurations shown in Figures 8A-9C, the direction of force applied from the strap 3310 to the headgear tube 3350 may be changed. This direction may be changed by adjusting the angle of the strap 3310 relative to the headgear tube 3350 or the patient's head. In some implementations of the present technology, the location at which force is applied from the strap 3310 to the headgear tube 3350 may be changed by adjusting the location at which the strap 3310 is secured to the headgear tube 3350.

[0266] Being able to adjust the magnitude and direction of force applied from the straps 3310 to the headgear tubes 3350 can be advantageous because it allows the positioning and stabilizing structure 3300 to accommodate a range of head sizes and head shapes. The straps 3310 can balance the forces in the headgear tubes 3350, which can help the headgear maintain its shape and obtain an effective seal against the patient's face while remaining comfortable.

[0267] In some forms of the present technology, when worn by a patient, a point on the headgear tube 3350 proximate the tab 3320 receives a generally upward (e.g., upward) force from the top of the headgear tube 3350 due to tension in the headgear tube 3350 and, in some embodiments, due to a biasing mechanism (described in further detail below) that functions to keep the headgear secured to the patient's head. Additionally, a point on the headgear tube 3350 proximate the tab 3320 may receive a generally forward (e.g., forward) and downward (e.g., downward) force resulting from a biasing mechanism that functions to urge the seal-forming structure 3100 upward and into the patient's nose. The direction and magnitude of the force required for a secure fit and effective seal may vary between patients based on the location of the positioning and stabilizing structure 3300 on the head, which may vary due to differences in head shape and size, for example. In some forms of the present technology, the rear headgear straps 3310 are adjustable, allowing for a balance of forces to be achieved for a range of head shapes and sizes to hold the positioning and stabilizing structure 3300 in a comfortable position while maintaining an effective sole.

[0268] For example, to increase the force on the headgear tube 3350 adjacent the tab 3320 in a posterior (e.g., rear) direction, the straps 3310 can be adjusted by pulling more of the straps 3310 through the slots in the tabs 3320. This can shorten the length of the straps 3310, which applies more force in a posterior (e.g., rear) direction against the headgear tube 3350, especially if the straps 3310 are elastic. Similarly, the angle of the straps 3310 can be adjusted as needed to balance both the vertical and horizontal components of force acting on the headgear tube 3350 adjacent the tab 3320 for a range of head shapes and sizes.

[0269] The strap 3310 may include a rectangular cross-section along part or all of its length. Additionally, the strap 3310 may have a profile that includes one or more curved edges that provide increased comfort and reduced risk of patient marks or irritation from the headgear straps. In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap 3310 that is bendable, e.g., non-rigid. An advantage of this embodiment is that the strap 3310 is more comfortable when the patient lies down to sleep.

[0270] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap 3310 that includes two or more strap bands separated by a split. For example, as shown in Figures 8A-9C and 12A-12F, the strap 3310 includes a split 3313 configured to be positioned against the rear of the patient's head in use. Depending on the patient interface design, the split strap 3310 may allow the patient interface 3000 to be anchored on the patient's head in a particularly stable manner. The rear of the patient's head may have a complex geometry and providing a split 3313 in the strap 3310 may help the strap to better conform to the rear of the patient's head.

[0271] 5.3.2.3.2 Eyelets As mentioned above, each of the gas delivery tubes includes an eyelet for connection to a strap. In some examples, the eyelet may be circular. In other examples, the eyelet may be elongated. Alternatively, the eyelet may have a curved side and a straight side. The eyelet may be D-shaped, for example. The eyelet in the exemplary patient interface 3000 shown in FIGS. 8A-9C takes the form of a slit 3322. In this example, a pair of gas delivery tubes 3350 provide a pair of slits 3322 to which the strap 3310 may be connected. That is, the strap 3310 may be connected between the eyelets. The strap 3310 may be constructed and arranged to contact an area of ​​the patient's head that, in use, is located below or at the occipital bone of the patient's head. In this example, the slit 3322 is formed in a tab 3320 that is connected to a tube wall of the tube 3350.

[0272] In some examples of the present technology, eyelets may be positioned along each tube 3350, each between 70 mm and 150 mm from the center of the pair of tubes 3350 (e.g., the connection port 3600). In further examples, each eyelet may be positioned along each tube 3350 between about 110 mm and 130 mm from the center of the pair of tubes 3350. In certain examples, eyelets may be positioned along each tube 3350 between about 120 mm and 125 mm from the connection port 3600. In the case of the illustrated positioning and stabilization structure 3300 having slits 3322, the midpoints of these slits are positioned between about 120 mm and 125 mm from the center of the pair of gas delivery tubes 3350.

[0273] The exemplary patient interface 3000 shown in Figures 8A-9C includes a single rear headgear strap 3310 which passes between the slits 3322 and is often required to apply a force partially downward and partially backward on the tube 3350. To apply a force on the tube 3350 in the required direction, the strap 3310 needs to wrap around the rear of the patient's head downward. Typically, the rear of the patient's head generally curves downward to cover the occipital bone of the skull in the anterior direction (up to where the head joins the patient's neck).

[0274] If the straps 3310 are not placed sufficiently below the rear circumference of the patient's head (e.g., if they are not under the rearmost point of the patient's head (where the rear surface of the patient's head curves forward and faces partially downwards) there is a risk that the straps 3310 will ride up on the rear of the patient's head during use. If the straps 3310 ride up above the rearmost point of the patient's head it may rest on an area of ​​the patient's head that faces partially upwards. If this occurs, tension in the straps 3310 may pull the straps further upwards which may lead to a failure to provide the required sealing force vector from the positioning and stabilising structure 3300 to the seal forming structure 3100 (which may then compromise the seal against the patient's face and require the patient to re-don the patient interface 3000).

[0275] 11A-11C, the gas delivery tubes 3350 may each include a tube wall 3352 that defines a hollow interior (e.g., forming a conduit) along the length of the tube 3350. A pressurized airflow may be directed from the connection port 3600 through the hollow interior within the tube wall 3352 for delivery to the seal-forming structure 3100.

[0276] 11A-11C, the tube 3350 includes tabs 3320. In this example, each of the tabs 3320 of the positioning and stabilizing structure 3300 is integrally formed with a respective tube wall 3352 of the tube 3350. Alternatively, the tabs 3320 may be separate pieces and assembled with the tube 3350. For example, a separate component may be included with the tab 3320 that movably connects to the tube 3350 to allow for adjustment of the position and / or angle of the tab 3320. By forming the tabs 3320 integrally with the tube wall 3352, the necessary assembly is eliminated. Reduced erection efforts may result in improved ease of use of the positioning and stabilizing structure 3300. Additionally, the integrally formed tabs 3320 may allow for a seamless connection between the tabs 3320 and the tube wall 3352, reducing the likelihood of connections that may cause patient discomfort.

[0277] In the illustrated example, the tubes 3350 each include an extendable tube section in the form of an extendable bellows structure 3362. Each tab 3320 is joined to a tube wall 3352 of the gas delivery tube 3350 below the extendable tube section. Specifically, each tab 3320 is joined to the tube wall 3352 of the gas delivery tube 3350 at a non-extendable tube section 3363 below the extendable tube section. In some examples, the tabs 3320 each can have an upper edge 3331 spaced from the end of the extendable tube section along the length of the tube 3350. In other examples, the tabs 3320 can have an upper edge 3331 that meets the tube wall 3352 at or near the lower end of the extendable tube section.

[0278] 11A-11C, the slits 3322 of the tube 3350 are formed in the tab 3320. In other examples, the slits 3322 may be formed directly in the tube wall 3352 or may be formed in another portion of the positioning and stabilizing structure 3300 or in a separate component configured to be connected to the positioning and stabilizing structure 3300.

[0279] Each of the slits 3322 may be spaced rearward from the tube wall of each tube 3350 in use. In particular, each of the slits 3322 may be spaced rearward from and adjacent to a slit abutment 3355 of the tube wall 3352. The slit abutment 3355 of the tube wall 3352 may be the portion of the tube wall 3352 to which the tab 3320 is connected. More particularly, the slit abutment 3355 of the tube wall 3352 may be the portion of the tube wall 3352 most adjacent to the slit 3322. In some examples, the slits 3322 may be spaced rearward over the entire length of the tube wall 3352. The slits 3322 may be located above the superior ear base point of the patient's head in use.

[0280] As shown in Figures 8A-8C, each of the tube walls 3352 is configured to rest on the patient's head along a path 3353 that passes between the patient's eyes and ears. A portion of the path 3353 is illustrated in Figures 11A and 11B. In some examples, the path 3353 is a path generally on the surface of the patient's head on which the tube walls 3350 rest. Furthermore, the path 3353 may be a path that guides gas flowing through the tube 3350 to move from the top of the patient's head to the seal-forming structure 3100. In fact, the path 3353 may include a curve in three-dimensional space (e.g., a space curve) since in some examples the path 3353 may not be limited to a surface. In the illustrated example, the tube 3350 extends laterally and inferiorly on the side of the patient's head and then extends inferiorly, forward and medially to connect with the cradle cushion module 3150.

[0281] As shown in FIGS. 11A-11C, each of the slits 3322 includes an upper end 3326 and a lower end 3327. The upper end 3326 and the lower end 3327 may be considered as a first end and a second end, respectively. In this example, the upper end 3326 is spaced further from the slit adjacent portion 3355 of the tube wall 3352 than the lower end 3327. As shown in FIG. 11A, the upper end 3326 of the slit 3322 is spaced from the tube wall 3352 by a distance indicated by SE in the figure. The lower end 3327 of the slit 3322 is spaced from the tube wall 3352 by a distance indicated by IE. As shown, the distance SE is greater than the distance IE, so the upper end 3326 is spaced further from the tube wall 3352 than the lower end 3327. When the patient interface 3000 including the positioning and stabilizing structure 3300 is worn by a patient, the upper end 3326 is spaced posteriorly relative to the lower end 3327. Unless the context clearly indicates, when an end of a slit or eyelet is described as being spaced further from the tube wall than another end of the slit or eyelet, this spacing should be understood to refer to the portion of the tube wall generally adjacent or closest to the slit or eyelet (e.g., adjacent the slit or adjacent the eyelet).

[0282] 11B, the slits 3322 are oriented with an angle at the slit adjacent portion 3355 of the tube wall 3352 relative to the orientation of the tube 3350. The slits 3322 are also oriented with an angle at the slit adjacent portion 3355 of the tube wall 3352 relative to the path 3353. In this example, the slits 3322 are arcuate between the upper end 3326 and the lower end 3327. The slits 3322 each have a curved elongated shape. In other examples, each slit 3322 can be straight between the upper end 3326 and the lower end 3327. The curved, arcuate shape of the slit 3322 may advantageously allow the strap 3310 to extend through the slit and center within the slit 3322, and may also allow the slit 3322 to tolerate some variation in the angle of the strap 3310 extending through the slit 3322 (without causing the strap 3310 to bunch as it approaches one end of the slit 3322).

[0283] Shown in FIG. 11B is the length axis 3323 of the slit 3322. In this example, the slit is elongated, so the length axis 3323 is defined along the general length of the slit 3322. An arcuate slit 3322 (e.g., the slit 3322 shown in FIGS. 11A-11C) may also include a length axis, since it is elongated. It will be appreciated that in the case of an arcuate slit 3322, the length axis 3323 may be defined by a general direction from one end of the slit 3322 to the other, but not parallel to each of the sides of the slit 3322. Alternatively, the length axis 3323 of the arcuate slit 3322 may be defined by a tangent to the curvature of the slit 3322 at the center of the slit 3322.

[0284] The slit 3322 may have a rear-superior-front-inferior orientation in use. That is, the length (e.g., length axis 3323) of the slit 3322 may be aligned parallel to a line extending between the rear-superior direction and the front-inferior direction. With this orientation, the upper end 3326 of the slit 3322 is spaced rearwardly relative to the lower end 3327 of the slit 3322. Shown in FIG. 11B is a tangent 3354 to the path 3353 at the slit adjacent portion 3355 of the tube 3350. As shown, the length axis 3323 of the slit 3322 forms a slit angle 3321 with the tangent 3354 to the path 3353. In this example, the slit angle 3321 is an oblique angle. The oblique angle may be in the range of 5 to 30 degrees. In some examples, the oblique angle may be in the range of 10 to 20 degrees. For example, the oblique angle may be in the range of 12 to 18 degrees. In certain examples, the oblique angle can be about 13 degrees, 15 degrees, or 17 degrees. In some examples, the slits 3322 can be angled along the length of the extendable bellows structure 3362 relative to the longitudinal axis. In particular, the slits 3322 can be oriented at an angle of 15 to 45 degrees relative to the longitudinal axis of the extendable bellows structure 3362 when straightened. For example, the angle can be in the range of 20 to 40 degrees (e.g., in the range of 22 to 35 degrees). In certain examples, the angle can be about 25 to 31 degrees relative to the longitudinal axis of the extendable bellows structure 3362 when straightened.

[0285] Advantageously, angling the slit 3322 rearward relative to the vessel wall 3352 or passage 3353 (e.g., spacing the upper end 3326 further from the vessel wall 3352 or passage 3353 than the lower end 3327) may allow for a better fit for receiving the strap 3310 from a lower position around the rear of the patient's head. In an ideal setup, the strap 3310 extends from the slit 3322 in a direction perpendicular to the length axis 3323 of the slit 3322. Thus, angling the slit 3322 further rearward may allow for a better fit for receiving the strap 3310 from a lower position around the rear of the patient's head. When angled, the slits 3322 are angled to receive the straps 3310 from a smaller angle, which may better accommodate the straps 3310 resting lower around the rear of the patient's head. In contrast, when the slits 3322 are oriented closer to a vertical orientation, the slits 3322 are angled to receive the straps 3310 from a higher position on the patient's head. Thus, orienting the slits 3322 at a greater angle relative to the adjacent portions of the tube wall 3352 and / or passageway 3353 may allow for some resistance to the straps 3310 riding up (e.g., sliding upward) on the rear of the patient's head.

[0286] Other methods are available for reducing the tendency of the straps 3310 to ride up on the back of the patient's head (e.g., by providing splits in the straps 3310 to allow the patient to fasten the straps 3310 and / or by providing the slits 3322 in a lower position), while angling the slits 3322 rotated backwards into the tube 3350 may provide additional resistance to the straps 3310 riding up. In some examples, each slit 3322 may be angled to receive the strap 3310 (from an orientation where the strap 3310 rests over an area of ​​the patient's head that rests on the bottom of the occipital bone). In further examples, the slits 3322 may be angled to receive the strap 3310 from an orientation where the strap 3310 rests on the middle or top of the patient's occipital bone.

[0287] Each slit 3322 may be oriented perpendicularly from the slit of the strap anchor region where the strap is anchored around the patient's head. The strap anchor region may be a region that rests on the patient's occipital bone (e.g., below the occipital bone). In some examples, the strap anchor region may be a region of the patient's neck that rests below the patient's occipital bone. In some examples, the strap 3310 may rest on the patient's upper trapezius muscle or a portion of the patient's neck or head below the occipital bone, and the slit 3322 may be angled to receive the strap 3310 from a corresponding direction.

[0288] For example, as shown in FIG. 8C, the slit 3322 may be angled far enough back to receive the strap 3310 from a direction in which the strap 3310 rests across the rear region of the patient's head below the bottom of the patient's head. The strap 3310 may rest on the rear of the patient's head facing at least partially downward, and the slit 3322 may be angled far enough back to receive the strap 3310 from this location. Resting the strap 3310 on the rear of the patient's head facing at least partially downward is advantageous because the eyelet is located above the rearmost portion of the strap 3310. After tension is applied to the strap 3310, the tube 3350 exerts a partial upward force on the strap 3310. That is, the strap 3310 may be less likely to ride up (when anchored to the rear of the patient's head facing downward).

[0289] 11A-11C, the tab 3320 includes an upper edge 3331 and a lower edge 3332. In this example, the upper edge 3331 is longer than the lower edge 3332. Making the upper edge 3331 longer results in an asymmetric shape such that the tab 3320 faces further downward than the tab 3320 would (if the length of the upper edge 3331 were equal to the length of the lower edge 3332). The slit 3322 is substantially centered between the upper edge 3331 and the lower edge 3332. Thus, with such an asymmetric shape of the tab 3320, the slit 3322 faces further downward. Having the tab 3320 facing downward may advantageously reduce the tendency of the strap 3310 to ride up on the back of the patient's head.

[0290] In addition to providing the slit 3322 with an oblique slit angle 3321, the slit 3 322 may be spaced from the tube wall 3352 by a sufficient distance to further reduce the tendency of the strap 3310 to ride up on the rear of the patient's head. Generous spacing between the slits or other eyelets and the tube wall 3352 may advantageously reduce the distance between the eyelets and the rear of the patient's head. A relatively short distance between the eyelets and the rear of the patient's head may allow the length of the strap 3310 to be short. The strap 3310 rests laterally on the side of the patient's head and extends between the slits 3322 to face rearward against the force of the patient's head. This short distance and strap length may advantageously reduce rotation of the strap 3310 relative to the eyelets, thereby reducing the tendency of the strap 3310 to ride up or down during use.

[0291] In some examples, the lower end 3327 of the slit 3322 can be spaced at least 5 mm from the tube wall 3352. In further examples, the lower end 3327 of the slit 3322 can be spaced at least 7 mm from the tube wall 3352. For example, the lower end 3327 of the slit 3322 can be spaced from the tube wall 3352 by about 8 mm or more.

[0292] The upper end 3326 of the slit 3322 can be spaced at least 8 mm from the tube wall 3352. In some examples, the upper end 3326 of the slit 3322 can be spaced at least 10 mm from the tube wall 3352. For example, the upper end 3326 of the slit 3322 can be spaced 12 mm or more from the tube wall 3352.

[0293] In some examples, the midpoint 3322 along the slit may be spaced from the tube wall 3352 by a distance in the range of approximately 5 mm to 30 mm. A very large distance between the eyelet and the tube wall 3352 may be advantageous in terms of increasing the stability of the strap 3310, but may increase the size of the tab 3320, which may create challenges / issues in manufacturability, weight, comfort, and aesthetics. A distance in the range of 5 to 30 mm (e.g., in the range of 7 mm to 20 mm) may provide stability benefits to avoid ride-up of the rear headgear strap 3310, while avoiding or minimizing issues due to the increased size of the tab 3320. In further examples, the distance may be in the range of 8 mm to 15 mm (e.g., in the range of 9 mm to 13 mm). In some particular examples, the distance may be about 9 mm to 11 mm (e.g., about 9.5 mm or 9.75 mm).

[0294] 5.3.2.3.3 Trough 11C is an enlarged perspective view of one of the tabs 3320 of the positioning and stabilizing structure 3300. As shown, in some examples, the tab 3320 of the positioning and stabilizing structure 3300 may include a trough 3324 formed in the tab and located rearward of the slit 3322. The trough 3324 may be formed in the body of the tab 3320 at a location below the strap 3310. In this example, the trough 3324 is provided between the slit 3322 and the rear side 3329 of the tab 3320. The tab 3320 may include an outwardly facing tab surface 3328 on the side of the tab 3320 facing away from the patient (e.g., laterally). The tab surface 3328 may be substantially planar adjacent the slit 3322. The trough 3324 may be formed by a portion of the tab 3320 at the trough 3324 (which has a thinner material thickness than other portions of the tab 3320). Thus, in this example, the trough 3324 is recessed relative to the tab surface 3328.

[0295] The trough 3324 may have a width substantially the same as the length of the slit 3322. That is, the trough 3324 may have an upper end adjacent the upper end 3326 of the slit and a lower end adjacent the lower end 3327 of the slit 3322. In this example, the trough 3324 has a width substantially the same as the strap 3310. The trough 3324 may be configured to receive the strap 3310. The trough 3324 reduces the combined thickness of the strap 3310 and the tab 3320. At the location of the trough 3324, the tab 3320 is sandwiched between two layers of the strap 3310 (as the strap passes through the slit and loops back on itself). Due to the bulk and / or thickness of the strap 3310 and the tab 3320 at this location, a pressure or discomfort point may occur when the patient sleeps on their side. The trough 3324 may advantageously reduce the stack thickness of the components at this location, which may result in less pressure being applied to the patient's head at this location when sleeping on their side.

[0296] Further, in this example, the trough 3324 has a side adjacent to a side of the strap 3310. As such, the width of the trough 3324 matches the width of the strap 3310. This may advantageously help align and keep the strap 3310 centered within the trough 3324. It may also provide a visual guide to the user as to the alignment of the strap 3310.

[0297] 5.3.3 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0298] In certain configurations, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to atmosphere when the pressure in the plenum chamber is positive with respect to atmosphere. The vent 3400 is configured such that the magnitude of the ventilation flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber in use. The vent 3400 may provide continuous ventilation flow from the interior of the plenum chamber 3200 to atmosphere throughout the patient's breathing cycle.

[0299] The ventilation section 3400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0300] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure (e.g., a swivel like elbow 3610). In the example shown in Figures 8A-9C, the patient interface 3000 includes multiple vents 3400. In particular, the patient interface 3000 includes at least one vent 3400 in the plenum chamber 3200 and at least one vent in the elbow 3610. More particularly, the plenum chamber 3200 includes two vents 3400. Each vent 3400 on the plenum chamber 3200 includes an array of holes. The vent 3400 on the elbow 3610 also includes an array of holes. The vents 3400 of the patient interface 3000 are sized and configured to provide sufficient gas flushing throughout the entire therapeutic pressure range.

[0301] The patient interface 3000 may include a diffuser configured to diffuse the airflow through the vent to reduce ventilation noise and reduce air blowing out of the vent. The diffuser may be provided on a cover over the vent. In some examples, the vent 3400 may include a ventilation module configured to be removed from the plenum chamber 3200. The ventilation module may include a diffuser.

[0302] 5.3.4 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or a ball socket). For example, the patient interface 3000 shown in FIGS. The base 3000 includes an elbow 3610 configured to rotate relative to the positioning and stabilizing structure 3300. In this example, the elbow 3610 is configured to rotate about an axis concentric with a circular opening in the positioning and stabilizing structure 3300. In some examples of the present technology, the elbow 3610 may form part of a ball and socket joint with the positioning and stabilizing structure 3300. For example, a ring having a partially spherical inner surface may be provided to the positioning and stabilizing structure 3300 and configured to receive the elbow 3610. The elbow 3610 may have a partially spherical outer surface that is complementary to the partially spherical inner surface of the ring, thereby allowing the elbow 3610 to rotate relative to the ring in multiple axes.

[0303] 5.3.5 Connection Ports The connection port 3600 allows for connection to the air circuit 4170. In the exemplary patient interface 3000 shown in Figures 8A-9C, an elbow 3610 forms part of the connection port 3600. As a decoupling structure, the elbow 3610 decouples movement of the air circuit 4170 from the positioning and stabilizing structure 3300 to reduce tubing drag on the positioning and stabilizing structure 3300.

[0304] 5.3.6 Forehead support In one form, the patient interface 3000 includes a forehead support 3700. In other forms, the patient interface 3000 does not include a forehead support. Advantageously, the exemplary patient interface 3000 shown in Figures 8A-9C includes a positioning and stabilizing structure 3300 capable of holding the seal-forming structure 3100 in a sealing position (without connection to a forehead support or any frame or strap member positioned in front of the patient's face at eye level).

[0305] 5.3.7 Anti-asphyxiation valves In one form, the patient interface 3000 includes an anti-asphyxiation valve. In some examples, the patient interface 3000 includes multiple anti-asphyxiation valves. For example, if airflow is provided to the seal-forming structure 3100 via two fluid connections, then two anti-asphyxiation valves may be provided to the patient interface 3000, one for each fluid connection to the seal-forming structure 3100.

[0306] 5.3.8 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a characteristic of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0307] 5.4 RPT Devices An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein, for example.

[0308] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0309] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0310] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., pressure and flow sensors).

[0311] One or more of the pneumatic path items may be disposed within a removable unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0312] 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, the RPT device 4000 can include more than one PCBA 4202.

[0313] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit, including the pneumatic component 4100. In one alternative, one or more of the following components may be disposed as their own separate units.

[0314] 5.4.1.1 Air filter(s) An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0315] In one form, the inlet air filter 4112 is positioned at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0316] In one form, an outlet air filter 4114 (eg, antibacterial factor) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0317] 5.4.1.2 Muffler(s) An RPT device according to one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0318] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0319] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0320] 5.4.1.3 Pressure generator In one form of the present technology, a pressure generator 4 is provided to generate an air flow or supply at positive pressure. 140 is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver an air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or otherwise up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Pat. No. 7,866,944; U.S. Pat. No. 8,638,014; U.S. Pat. No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.

[0321] The pressure generator 4140 is under the control of the treatment device controller 4240 .

[0322] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0323] 5.4.1.4 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0324] 5.4.2 RPT Device Algorithm As noted above, in some forms of the technology, the central controller may be configured to implement one or more algorithms expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory), the algorithms typically being grouped into groups called modules.

[0325] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

[0326] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0327] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference in its entirety.

[0328] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (eg, upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.

[0329] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airway.

[0330] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0331] 5.6.1.1 Conductive Sites According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm) thick), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0332] 5.6.1.2 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0333] 5.6.1.3 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200ml, 300ml or 400ml)).

[0334] 5.7 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0335] 5.7.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0336] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean: (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0337] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0338] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0339] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0340] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0341] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0342] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.

[0343] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilator flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0344] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0345] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, a leak may occur due to an imperfect seal between the mask and the patient's face. In another embodiment, a leak may occur at the elbow to the perimeter.

[0346] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., the air circuit and the 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.

[0347] Noise Radiation (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise is the acoustic power / pressure level of interest. It can be quantified by measuring the viscosity according to ISO 3744.

[0348] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vent holes in the patient interface).

[0349] Patient: A person with or without respiratory disease.

[0350] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressure is given in units of cmH2O unless otherwise specified.

[0351] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0352] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0353] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0354] 5.7.1.1 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.

[0355] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0356] 5.7.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0357] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0358] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size). "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.

[0359] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0360] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0361] Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application may be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0362] As one example, an I-beam may include a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction, hi another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0363] 5.7.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0364] 5.7.3 Anatomy 5.7.3.1 Facial anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0365] Alare: The outermost point on the ala of the nose.

[0366] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each ala, found in the crease formed by the union of the ala and cheek.

[0367] Pinna: the entire visible part of the ear.

[0368] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0369] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0370] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0371] Columella angle: the angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal intersecting the subnasal point.

[0372] Frankfort horizontal plane: A line extending from the inferiormost point of the orbital rim to the left auricular point, which is the deepest point above the notch to the tragus of the pinna.

[0373] Glabellar: Located in the soft tissue, the most prominent point on the midsagittal portion of the forehead.

[0374] Lateral nasal cartilage: A generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla and whose lower margin is connected to the greater alar cartilage.

[0375] Alar cartilage: a plate of cartilage located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0376] Nostrils (nose holes): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nares is naris (nose hole). The nostrils are separated by the nasal septum.

[0377] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth and separates the cheeks from the upper lip.

[0378] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0379] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0380] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0381] Nasal tip: the most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head section.

[0382] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0383] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0384] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0385] Sagittal Plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0386] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0387] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0388] Nasal Alar Lowest Point: The point on the lower margin of the alar base where it joins with the skin of the upper (top) lip.

[0389] Subnasal point: located on the soft tissue where the columella joins the upper lip in the midsagittal direction.

[0390] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0391] 5.7.3.2 Skull anatomy Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0392] Mandible: The mandible forms the lower jaw. The mental eminence is a bony protuberance in the jaw, forming the chin.

[0393] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upwards by the side of the nose and forms part of its lateral border.

[0394] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from one individual to another. They lie side by side in the middle and upper parts of the face and their junction forms the "bridge" of the nose.

[0395] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0396] Occipital bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole, the foramen magnum, through which the intracranial cavity communicates with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0397] Orbit: bony cavity in the skull that contains the eyeball.

[0398] Parietal bones: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0399] Temporal Bone: The temporal bone is located at the base and on the side of the skull and supports parts of the face known as the temples.

[0400] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0401] 5.7.3.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0402] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0403] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchiole, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0404] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the turbinates or nasal bones. At the front of the nasal cavity is the nose, and at the back it opens into the nasopharynx via the choanae.

[0405] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0406] 5.7.4 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive rebreathing of CO2 by the patient by venting to atmosphere in a fail-safe manner.

[0407] Elbow: An elbow is an example of a structure that directs the axis of airflow moving through it to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater or less than 90 degrees. An elbow is a generally circular structure. In another embodiment, the elbow may have an oval or rectangular cross section. In certain embodiments, the elbow may be rotatable, for example, about 360 degrees, relative to the mating component. In certain embodiments, the elbow may be removable, for example, via a snap connection, from the mating component. In certain embodiments, the elbow may be assembled to the mating component via a one-time snap at the time of manufacture, but cannot be removed by the patient.

[0408] Frame: Frame is taken to mean a mask structure that supports a tensile load between two or more points that connect the headgear. A mask frame may be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0409] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed to be used on the head. For example, the headgear may include a collection of one or more posts, ties and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0410] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0411] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0412] Seal: When used as a noun ("seal") it can refer to a structure, and when used as a verb ("seal") it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0413] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0414] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

[0415] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0416] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0417] Tie (noun): A structure designed to resist tension.

[0418] Vent: (noun): A structure that allows airflow to the ambient air inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, flow rates of about 10 L / min to about 100 L / min may be used for clinically effective flushing, depending on mask design and treatment pressure.

[0419] 5.7.5 Shape of structure A product of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be differentiated with labels to describe the orientation, location, function or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0420] To facilitate the description of the shape and surface of a three-dimensional structure, a cross section at a point p through the surface of the structure is first considered. See Figures 3B-3F. Figures 3B-3F show an example cross section at a point p on the surface, and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictional little person standing upright on the surface.

[0421] 5.7.5.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0422] Positive curvature: If the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, he or she would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0423] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, he can walk on a horizontal plane that is neither pointing up nor down). See Figure 3D.

[0424] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person were to walk away from point p, they would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0425] 5.7.5.2 Two-dimensional surface curvature The description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane that includes the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each of the curvatures at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0426] Principal curvature and direction: The directions of the normal plane in which the curvature of the curve has a maximum and a minimum value are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0427] Surface region: A collection of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0428] Saddle region: a region where the principal curvatures at each point have opposite signs (i.e., one side has a positive sign and the other a negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0429] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

[0430] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, within a manufacturing tolerance) and the other principal curvature is non-zero.

[0431] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0432] Surface Edge: the boundary or limit of a surface or area.

[0433] Path: In certain forms of the technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A fictional person's path is a place to walk on a surface, similar to a path in a garden.)

[0434] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along a surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on a surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along a path on the surface.)

[0435] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.")

[0436] 5.7.5.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, i.e., it has no end point. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear includes a left-handed helix (see FIG. 3Q). A typical human right ear includes a right-handed helix (see FIG. 3R). FIG. 3S shows a right-handed helix. The edges of structures (e.g., the edges of a membrane or an impeller) may trace space curves. In general, a space curve may be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve is determined by the tangent, normal, and binormal vectors at that point. can be characterized relative to the

[0437] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character was flying along a curve and fell off his vehicle at a particular point, the direction of the tangent vector is the direction he would be traveling.

[0438] Unit normal vector: If a fictional character is moving along a curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0439] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0440] Tangent plane: the plane containing the unit tangent vector and the unit principal normal vector, see Figures 3O and 3P.

[0441] Torsion of a Space Curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. The torsion of a space curve that lies within the plane is zero. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). With reference to FIG. 3S, the magnitude of torsion of the neighbors of the top coil of the spiral in FIG. 3S is greater than the magnitude of torsion of the bottom coil of the spiral in FIG. 3S because T2>T1.

[0442] Referring to the right-hand rule in Figure 3P, a space curve that bends towards the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative twist in the right-hand direction (e.g., a left-hand spiral).

[0443] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve with a left-handed binormal direction can be considered as having a left-handed positive twist (e.g., a left-handed spiral), where a left-handed positive direction thus corresponds to a right-handed negative direction, see Figure 3T.

[0444] 5.7.5.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a plane or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a plane curve.

[0445] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-section of FIG. 3L in FIG. 3M and FIG. 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. Through the structure shown in FIG. 3K and bounded by a surface as shown. See also bounded 2D hole.

[0446] 5.8 Other Notes Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0447] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0448] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0449] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0450] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0451] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology has not antedated such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0452] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.

[0453] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

[0454] Although the technology herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (etc.) may be used interchangeably. Although the terms are used herein, unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish between separate elements. Additionally, although the process steps in the methods may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order may be changed and / or aspects may be performed simultaneously or even synchronously.

[0455] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0456] [Additional note 1] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: at least one gas delivery conduit for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said at least one gas delivery conduit constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, said at least one gas delivery conduit comprising: 1. An upper tube configured to rest on an upper region of a patient's head in use, said upper tube comprising: a first end configured, in use, to rest on top of the patient's head at or near the sagittal plane of the patient's head; a second end configured to rest on a side of the patient's head in use; an upper tube portion including a rigid portion between the first end and the second end, the rigid portion being configured to provide a higher resistance to relative movement between the first end and the second end in a forward and / or rearward direction than in an upward and / or downward direction in use; and a lower tube portion connected between the second end of the upper tube portion and the seal-forming structure;

[0023] Including a gas delivery tube; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 2] 2. The patient interface of claim 1, wherein each upper tube portion includes two rigid portions. [Additional note 3] 3. The patient interface of claim 1 or 2, wherein the rigid portion is provided on one or both of a side of the upper tube portion that is configured to be in a forward position in use and a side of the upper tube portion that is configured to be in a rearward position in use. [Additional note 4] The patient interface device according to any one of claims 1 to 3, wherein the upper tube portion includes an extendable portion. -face. [Additional note 5] 5. The patient interface of claim 4, wherein the extendable portion includes an extendable bellows structure formed within a wall of the gas delivery tube. [Additional note 6] 6. The patient interface of claim 5, wherein the extendable bellows structure includes a plurality of folds in the tubular wall forming alternating ridges and grooves. [Additional note 7] 7. A patient interface as described in claim 6, wherein the rigid portion includes a plurality of connection portions within the tubular wall, each of the plurality of connection portions connecting a pair of adjacent ridges. [Additional note 8] 8. The patient interface of claim 1, wherein the rigid portion is integrally formed with the upper tube portion. [Additional note 9] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: at least one gas delivery conduit for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said gas delivery conduit constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, said gas delivery conduit comprising: a tube wall defining a hollow interior through which air can flow from the interior to the seal-forming structure, the tube wall having an extendable portion configured to stretch to vary a length of the gas delivery tube; The tensile stiffness of the extendable portion is in the range of 0.2 to 0.35 N / mm, including the pipe wall;

[0023] Including a gas delivery tube; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional Note 10] 10. The patient interface of claim 9, wherein the tensile stiffness of the extendable portion is in the range of 0.25 to 0.3 N / mm. [Additional Note 11] 11. The patient interface of claim 9 or 10, wherein the pair of gas delivery tubes include a combined unextended length, measured along a centerline of the side of the pair of tubes that is configured to face the patient in use, that is in the range of 500 to 535 mm. [Additional Note 12] 12. The patient interface of claim 11, wherein the combined unstretched length is in the range of 510 to 525 mm. [Additional Note 13] 13. The patient interface of claim 11 or 12, wherein the combined unstretched length is in the range of 512 to 522 mm. [Additional Note 14] 11. The patient interface of claim 9 or 10, wherein the pair of gas delivery tubes include a combined unextended length, measured along a centerline of the side of the pair of tubes that is configured to face the patient in use, that is in the range of 460 to 500 mm. [Additional Note 15] 15. The patient interface of claim 14, wherein the combined unstretched length is in the range of 470 to 490 mm. [Additional Note 16] 16. The patient interface of claim 15, wherein the combined unstretched length is in the range of 475 to 485 mm. [Additional Note 17] 10. A patient interface as described in claim 9, wherein the gas delivery tube forms a loop with a cushion module around the patient's head, the loop having an unextended length measured along a centerline of a side of the gas delivery tube and a cushion module configured to face the patient in use, the unextended length of the loop being within a range of 510-610 mm. [Additional Note 18] 18. The patient interface of claim 17, wherein the unstretched length of the loop is in the range of 528 to 548 mm. [Additional Note 19] 19. The patient interface of claim 18, wherein the unstretched length of the loop is in the range of 535 to 541 mm. [Additional Note 20] 20. The patient interface of claim 19, wherein the unstretched length of the loop is in the range of 534 to 554 mm. [Additional Note 21] 21. The patient interface of claim 20, wherein the unstretched length of the loop is in the range of 539 to 549 mm. [Additional Note 22] 18. The patient interface of claim 17, wherein the unstretched length of the loop is in the range of 541 to 561 mm. [Additional Note 23] 23. The patient interface of claim 22, wherein the unstretched length of the loop is in the range of 546 to 556 mm. [Additional note 24] 18. The patient interface of claim 17, wherein the unstretched length of the loop is in the range of 564 to 584 mm. [Additional note 25] 25. The patient interface of claim 24, wherein the unstretched length of the loop is in the range of 571 to 581 mm. [Additional note 26] 18. The patient interface of claim 17, wherein the unstretched length of the loop is in the range of 577 to 597 mm. [Additional note 27] 27. The patient interface of claim 26, wherein the unstretched length of the loop is in the range of 582 to 592 mm. [Additional note 28] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said gas delivery tube constructed and arranged to contact, in use, at least an area of ​​the patient's head above an upper ear base point of the patient's head, said at least one gas delivery tube including a tube wall having an extendable bellows structure, said extendable bellows structure comprising: a plurality of folds in the tube wall formed with alternating ridges and grooves, said folds being at least partially expandable to increase separation of the ridges and allow the extendable bellows structure to assume an elongated shape; and and one or more ridge connections disposed on the pipe wall, each of the one or more ridge connections connecting two or more adjacent ridges of the plurality of ridges and configured to resist separation of the ridges.

[0023] Including a gas delivery tube; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 29] 29. The patient interface of claim 28, wherein each pair of adjacent ridges is connected by at least one ridge connection of one or more ridge connections. [Additional note 30] 30. The patient interface of claim 28 or 29, wherein one or more pairs of adjacent ridges are connected by two ridge connections. [Additional note 31] Each pair of adjacent ridges is connected by two ridge connectors. On-board patient interface. [Additional note 32] 32. A patient interface as described in any one of clauses 28 to 31, wherein one or more of the ridge connections are located on a side of the gas delivery tube that is configured to face forward in use. [Additional note 33] 33. A patient interface as described in any one of clauses 28 to 32, wherein one or more of the ridge connections are located on a side of the gas delivery tube that is configured to face rearward in use. [Additional note 34] 34. A patient interface as described in any one of claims 28 to 33, wherein each of the ridge connections is centrally spaced between a side of the gas delivery tube configured to face downward in use and a side of the gas delivery tube configured to face upward in use. [Additional note 35] 35. A patient interface as described in any one of claims 28 to 34, wherein each pair of adjacent ridges is connected by one of the ridge connections located on a side of the gas delivery tube configured to face forward in use. [Additional note 36] 36. A patient interface as described in any one of claims 28 to 35, wherein each pair of adjacent ridges is connected by one of the ridge connections located on a side of the gas delivery tube configured to face rearward. [Additional note 37] 37. A patient interface as described in any one of claims 28 to 36, wherein the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of groove portions is formed as a recess in the outer surface of the non-extendable portion. [Additional note 38] A patient interface as described in any one of appended claims 28 to 37, wherein each of the plurality of groove portions is disposed between a respective pair of ridge connection portions, and each ridge connection portion of the pair of ridge connection portions is disposed at each end of each groove portion. [Additional note 39] 39. A patient interface as described in claim 38, wherein each of the plurality of grooves includes a groove depth and each of the plurality of ridge connections includes a ridge connection height, the groove depth of each respective groove being equal to the ridge connection height of each respective pair of ridge connections located at the ends of each respective groove. [Additional note 40] 40. The patient interface of any one of clauses 28 to 39, wherein each ridge connection is an integrally formed part of the vessel wall. [Additional note 41] 41. A patient interface as described in claim 40, wherein the plurality of ridges, the plurality of grooves and the plurality of ridge connections are integrally formed. [Additional note 42] 42. The patient interface of any one of claims 28 to 41, wherein each of the plurality of raised portions includes a curved raised portion at the center of each of the raised portions. [Additional note 43] 43. The patient interface of claim 42, wherein each of the plurality of grooves includes a curved groove portion in the center of each groove. [Additional note 44] 44. A patient interface as described in any one of claims 42 to 43, wherein each of the plurality of raised portions includes a pair of linear raised portions at opposite ends of each raised portion. [Additional note 45] 45. A patient interface as described in claim 44, wherein each of the plurality of ridge connections connects to each adjacent pair of ridges at a linear ridge portion of the ridges. [Additional note 46] 46. ​​A patient interface as described in any one of clauses 28 to 45, wherein a cross-section of the gas delivery tube in the extendable bellows structure has a width and a height, the width being substantially aligned in the anterior-posterior direction in use, and the width being greater than the height. [Additional note 47] 47. A patient interface as described in any one of clauses 28 to 46, wherein the positioning and stabilising structure includes two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each gas delivery tube extending in use in one of the patient's cheek regions, and the two gas delivery tubes being provided on different sides of the patient's head. [Additional note 48] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said gas delivery tube constructed and arranged to contact, in use, at least an area of ​​the patient's head above an upper ear base point of the patient's head, said at least one gas delivery tube including a tube wall having a hollow interior and having an extendable bellows structure disposed along a length of the gas delivery tube, said extendable bellows structure comprising: a plurality of folds in the tube wall defining a first series of alternating ridges and grooves along a non-patient contacting side of the gas delivery tube and a second series of alternating ridges and grooves along a patient contacting side of the gas delivery tube; the first series of alternating ridges and grooves having a lower tensile stiffness than the second series of alternating ridges and grooves;

[0023] Including a gas delivery tube; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 49] 49. A patient interface as described in claim 48, wherein the plurality of folds form internal ridges and internal grooves within the gas delivery tube to form a first series of alternating ridges and grooves and a second series of alternating ridges and grooves. [Additional Note 50] Each of the first alternating series of internal grooves is disposed across the interior of the gas delivery tube opposite a respective one of the second alternating series of internal grooves to form a plurality of opposing groove pairs, each opposing groove pair comprising: a first internal groove, the first internal groove being one internal groove of a first alternating series; a second internal groove, the second internal groove being one internal groove of a second alternating series; Including, 49. A patient interface as described in clause 48, wherein the groove depth of the first internal groove is greater than the second internal groove. [Additional note 51] A patient interface as described in claim 50, wherein the material thickness at the base of the second internal groove of each opposing groove pair in the tube wall is greater than the material thickness at the base of the first internal groove of each opposing groove pair. [Additional note 52] 52. A patient interface as described in claim 51, wherein the material thickness of the tube wall at the base of each internal groove of the second alternating series decreases along the length of the gas delivery tube from the first end proximate the connection port to the second end. [Additional note 53] 53. A patient interface as described in any one of clauses 51 to 52, wherein the material thickness of the tube wall at the base of each internal groove of the first alternating series is substantially constant along the length of the gas delivery tube. [Additional note 54] 54. A patient interface as described in any one of clauses 51 to 53, wherein a groove depth of the first and second alternating series of internal ridges and internal grooves decreases along the length of the gas delivery tube from a first end adjacent a connection port to a second end. [Additional note 55] 55. A patient interface as described in any one of clauses 50 to 54, wherein the first internal groove of each opposing groove pair is joined to the second internal groove of each opposing groove pair on a side of the gas delivery tube between the non-patient contacting side and the patient contacting side. [Additional note 56] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: The airflow is received from a connection port on the patient's head and directed through a seal-forming structure. A pair of gas delivery tubes for delivery to an entrance of a patient's airway, each of the pair of gas delivery tubes constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head, each gas delivery tube comprising: a tube wall defining a hollow interior along the length of the gas delivery tube; a tab connected to the tube wall, the tab configured to be positioned above an upper ear base point of a patient's head in use; and a slit formed in the tab, the slit being spaced rearwardly from the tube wall in use, the slit including an upper end and a lower end; an upper end of the slit is spaced further from the tube wall than a lower end of the slit; A gas delivery tube; a strap constructed and arranged to contact an area of ​​the patient's head that, in use, is disposed under or at the occipital bone of the patient's head, the strap configured to be connected to and between the slits; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 57] 57. The patient interface of claim 56, wherein each tab is integrally formed with a respective tube wall. [Additional note 58] 58. A patient interface according to claim 56 or 57, wherein each tab has an upper edge and a lower edge, the upper edge being longer than the lower edge. [Additional note 59] 59. A patient interface according to any one of clauses 56 to 58, wherein a lower end of the slit is spaced from the vessel wall by at least 5 mm. [Additional note 60] 60. The patient interface of claim 59, wherein a lower end of the slit is spaced from the vessel wall by at least 7 mm. [Additional note 61] 61. The patient interface of claim 60, wherein a lower end of the slit is spaced from the vessel wall by at least 8 mm. [Additional note 62] 62. A patient interface according to any one of clauses 56 to 61, wherein an upper end of the slit is spaced from the vessel wall by at least 8 mm. [Additional note 63] 63. The patient interface of claim 62, wherein an upper end of the slit is spaced from the vessel wall by at least 10 mm. [Additional note 64] 64. The patient interface of claim 63, wherein an upper end of the slit is spaced from the vessel wall by at least 12 mm. [Additional note 65] 65. A patient interface according to any one of clauses 56 to 64, wherein a midpoint along the slit is spaced from the vessel wall by a distance in the range of 5 mm to 30 mm. [Additional note 66] 66. The patient interface of claim 65, wherein the spacing is in the range of 7 to 20 mm. [Additional note 67] 67. The patient interface of claim 66, wherein the spacing is in the range of 8 to 15 mm. [Additional note 68] 68. The patient interface of claim 67, wherein the spacing is in the range of 9 to 11 mm. [Additional note 69] A patient interface as described in any one of appended claims 56 to 68, wherein each of the gas delivery tubes includes an extendable tube portion that is positioned above the tab of each of the gas delivery tubes when in use, and a non-extendable tube portion that is positioned below the tab of each of the gas delivery tubes when in use. [Additional note 70] 70. A patient interface as described in claim 69, wherein each tab is joined to a wall of each gas delivery tube at the non-extensible tube section. [Additional note 71] 71. The patient interface of any one of clauses 56 to 70, wherein each slit is arcuate between its upper and lower ends. [Additional note 72] 72. A patient interface as claimed in any one of clauses 56 to 71, wherein each slit is oriented perpendicular to a direction from the slit in a strap anchor region where the strap is anchored around the patient's head. [Additional note 73] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, each of the pair of gas delivery tubes constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, each gas delivery tube comprising: a tube wall configured to be positioned, in use, on the patient's head along a path extending from a top of the patient's head to a seal-forming structure between the patient's eye and ear; a tab connected to the tube wall, the tab configured to be positioned above an upper ear base point of a patient's head in use; and a slit formed in the tab and spaced rearwardly from an adjacent portion of the passageway in the tube wall in use, the slit includes a slit having a rear-superior-front-inferior orientation in use and forming an oblique angle with a tangent to a path of the tube wall adjacent the slit. A gas delivery tube; a strap constructed and arranged to contact an area of ​​the patient's head that, in use, is disposed under or at the occipital bone of the patient's head, the strap configured to be connected to and between the slits; a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 74] 74. The patient interface of claim 73, wherein each tab is integrally formed with a respective tube wall. [Additional note 75] 75. A patient interface according to claim 73 or 74, wherein each tab has an upper edge and a lower edge, in use, the upper edge being longer than the lower edge. [Additional note 76] 76. A patient interface as described in any one of appended claims 73 to 75, wherein each of the gas delivery tubes includes an extendable tube section that is above the tab of each of the gas delivery tubes when in use, and a non-extendable tube section that is below the tab of each of the gas delivery tubes when in use. [Additional note 77] 77. A patient interface as claimed in any one of clauses 73 to 76, wherein the tabs are connected to a wall of the respective gas delivery tube at a non-extendable tube section. [Additional note 78] 78. A patient interface according to any one of clauses 73 to 77, wherein each slit is arcuate between an upper and lower end of the slit. [Additional note 79] 79. A patient interface according to any one of clauses 73 to 78, wherein a lower end of the slit is spaced from the vessel wall by at least 5 mm. [Additional note 80] 80. The patient interface of claim 79, wherein a lower end of the slit is spaced from the vessel wall by at least 7 mm. [Additional note 81] 81. The patient interface of claim 80, wherein a lower end of the slit is spaced from the vessel wall by at least 8 mm. [Additional note 82] 82. A patient interface according to any one of clauses 73 to 81, wherein an upper end of the slit is spaced from the vessel wall by at least 8 mm. [Additional note 83] 83. The patient interface of claim 82, wherein an upper end of the slit is spaced from the vessel wall by at least 10 mm. [Additional note 84] 90. The patient interface of claim 88, wherein an upper end of the slit is spaced from the vessel wall by at least 12 mm. [Additional note 85] 85. The patient interface of any one of clauses 73 to 84, wherein the oblique angle is in the range of 10 to 20 degrees. [Additional note 86] 86. The patient interface of claim 85, wherein the oblique angle is in the range of 12 to 18 degrees. [Additional note 87] 87. A patient interface as claimed in any one of clauses 73 to 86, wherein each slit is oriented perpendicular to a direction from the slit in a strap anchor region where the strap is anchored around the patient's head. [Additional note 88] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways to sealably deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein whereby an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, each of the pair of gas delivery tubes constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, each gas delivery tube comprising: a tube wall configured to extend from a top of the patient's head to the seal-forming structure between the patient's eyes and ears and to be placed on the patient's head; a tab connected to the tube wall, the tab being positioned above the superior-basal point of the patient's head in use; an eyelet formed in the tab and positioned rearwardly of the tube wall in use; and a trough formed in the tab and positioned rearwardly of the eyelet; A gas delivery tube; a strap constructed and arranged to contact an area of ​​the patient's head that, in use, is positioned under or at the occipital bone of the patient's head, the strap configured to connect to and between the eyelets of the pair of gas delivery tubes and to be positioned within the trough formed in the tab in use; Including, a positioning and stabilizing structure; a venting structure that allows a continuous flow of gases exhaled by the patient from within a plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed. [Additional note 89] The trough is formed in the tab between the eyelet and a rear side of the tab. 89. A patient interface as described in claim 88. [Additional Note 90] 90. A patient interface as described in any one of clauses 88-89, wherein the tab includes an outwardly facing surface and the trough includes a substantially planar surface formed as a recess relative to the outwardly facing surface. [Additional Note 91] 91. A patient interface as claimed in any one of clauses 88 to 90, wherein the trough is formed by a portion of the tab having a reduced material thickness compared to other portions of the tab. [Additional Note 92] 92. The patient interface of any one of clauses 88 to 91, wherein the trough includes a length approximately equal to a width of the strap. [Additional Note 93] 93. The patient interface of any one of clauses 88 to 92, wherein the eyelet is in the form of a slit. [Explanation of symbols]

[0457] 5.9 List of References 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Sealing or seal-forming structures 3150 Cradle Cushion Module 3160 Pillow Cushion Module 3165 Nasal Pillow 3200 Plenum Chamber 3300 Positioning and stabilizing structures / headgear 3301 Force from the upper side of the pipe 3302 Strap Force 3303 Sealing force tension 3304 Upper pipe section 3305 First end of upper tube 3306 Second end of upper tube 3308 Tab side point 3310 Strap 3313 Split 3320 Tab 3321 Slit angle 3322 Slit 3323 Slit length axis 3324 Trough 3325 Point along the tube adjacent to the strap 3326 Slit top 3327 Slit bottom 3328 Tab surface 3329 rear side 3331 Tab top edge 3332 Tab bottom edge 3347 Curved Edge 3348 Patient Contact 3349 Non-patient contact side 3350 Air Delivery Tube 3353 Route 3354 Tangent to a path 3355 Slit adjacent part 3362 Extendable bellows structure 3363 Non-extendable pipe section 3364 Sleeve 3370 Raised joint 3372 Ridge 3373 Groove 3374 Curved raised area 3375 Linear raised area 3376 Curved groove area 3377 Straight groove part 3382 Internal ridge 3383 Internal Groove 3390 Fluid connection opening 3400 Ventilation section 3600 Connection Port 3610 Elbow 4000 RPT Devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4100 Pneumatic Components 4110 Air Filter 4112 Inlet Air Filter 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Controllable Blower 4144 Brushless DC Motor 4170 Air Circuit 4200 Electrical Components 4202 Printed Circuit Board Assembly (PCBA) 4210 Electrical power supply 4220 Input Device 4270 Converter 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5130 Humidifier Reservoir Dock 5240 heating element

Claims

1. At least 6cmH above ambient air pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; In use, the airflow is at least 6 cmH above ambient air pressure throughout the patient's breathing cycle ２ a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery at an elevated therapeutic pressure, the seal-forming structure having holes therein whereby airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilising structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, at least one gas delivery tube for receiving an air flow from a connection port on the top of a patient's head and delivering the air flow through said seal-forming structure to an entrance of said patient's airway, each of said at least one gas delivery tube being constructed and arranged to contact, in use, at least one area of ​​said patient's head above the upper ear base point of said patient's head, said at least one gas delivery tube having a tube wall with a hollow interior and an expandable bellows structure provided along a length of said gas delivery tube, said expandable bellows structure comprising: a plurality of folds in the tube wall forming a first series of alternating ridges and grooves along a non-patient-contacting side of the gas delivery tube and a second series of alternating ridges and grooves along a patient-contacting side of the gas delivery tube, the patient-contacting side being opposite the non-patient-contacting side of the gas delivery tube; Equipped with the grooves of the first series of alternating ridges and grooves are non-contiguous with the grooves of the second series of alternating ridges and grooves; a positioning and stabilizing structure comprising a gas delivery tube having a bellows structure, the first series of alternating ridges and grooves having a lower extension stiffness than the second series of alternating ridges and grooves; a venting structure that allows a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; 1. A patient interface comprising: the patient interface is configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed. Patient interface.

2. 2. The patient interface of claim 1, wherein the plurality of folds form internal ridges and grooves that form the first series of alternating ridges and grooves and the second series of alternating ridges and grooves on an interior side of the gas delivery tube.

3. the internal grooves in the first alternating series of ridges and grooves are disposed across the interior of the gas delivery tube opposite corresponding ones of the internal grooves in the second alternating series of ridges and grooves to form a plurality of opposing groove pairs; Each of the opposing groove pairs is a first internal groove, which is an internal groove in said first alternating series of ridges and grooves; a second internal groove, which is an internal groove in said second alternating series of ridges and grooves; Equipped with The patient interface of claim 2 , wherein the first internal groove comprises a greater groove depth than the second internal groove.

4. 4. A patient interface according to claim 3, wherein the tube wall comprises a greater thickness of material at a bottom of the second internal groove of each opposing pair of grooves than at a bottom of the first internal groove of the corresponding opposing pair of grooves.

5. 5. A patient interface as described in claim 4, wherein the material thickness at the bottom of each of the internal grooves in the second alternating series of ridges and grooves decreases along the length of the gas delivery tube from a first end proximate the connection port to a second end.

6. 6. A patient interface according to claim 4 or 5, wherein the material thickness of the gas delivery tube at the bottom of each of the internal grooves in the first alternating series of ridges and grooves is approximately constant along a length of the gas delivery tube.

7. A patient interface as described in any one of claims 4 to 6, wherein the groove depth of the internal groove in the first and second series of alternating ridges and internal grooves decreases along the length of the gas delivery tube from a first end adjacent the connection port to a second end.

8. 8. A patient interface according to any one of claims 3 to 7, wherein each internal ridge in the first alternating series of ridges and grooves is continuous with a corresponding opposing internal ridge in the second alternating series of ridges and grooves.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the positioning and stabilising structure comprises a ridge connector on the tube wall connecting adjacent pairs of the second alternating series of ridges and grooves and stiffening the second alternating series of ridges and grooves relative to the first alternating series of ridges and grooves.

10. 10. A patient interface according to any one of the preceding claims, wherein the second series of alternating ridges and grooves are formed from a more rigid material than the first series of alternating ridges and grooves.

11. 11. A patient interface according to any one of the preceding claims, wherein the second series of alternating ridges and grooves are stiffened relative to the first series of alternating ridges and grooves with a stiffening component.

12. the positioning and stabilizing structure comprises two of the gas delivery tubes fluidly connecting between the connection port and the seal-forming structure; each of the gas delivery tubes extends, in use, across one of the patient's cheek regions; A patient interface according to claim 1 , wherein the two gas delivery conduits are on different sides of the patient's head.

13. Each of the gas delivery tubes comprises: an upper tube part which, in use, rests on the upper region of the patient's head, a first end configured to be placed on an upper portion of the patient's head in use at or adjacent to the sagittal plane of the patient's head; a second end configured to rest on a side of the patient's head in use; and An upper tube portion comprising: a lower tube part connected between said second end of said upper tube part and said seal-forming structure; Equipped with The patient interface of claim 12 , wherein the expandable bellows structure is provided in the upper tube portion.

14. each of the gas delivery tubes includes a tab connected to the tube wall and configured, in use, to be positioned above the superior-basal point of the patient's head; the positioning and stabilising structure further comprising a strap configured to be positioned, in use, under or on an occipital bone of the patient's head; 14. A patient interface according to any one of claims 1-13, wherein the straps are configured to connect to and between the tabs.

15. A patient interface according to any one of claims 1 to 14, wherein the seal-forming structure is configured to, in use, form a seal with the patient's nares and with the patient's upper lip.

16. The seal-forming structure comprises a pair of nasal pillows; 15. A patient interface according to any one of the preceding claims, wherein each of the nasal pillows is constructed and arranged to form a seal with the nostril of the patient's nose.

17. A patient interface according to any one of claims 1 to 14, wherein the seal-forming structure comprises a nasal seal-forming structure and an oral seal-forming structure.

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