Headgear for patient interface

Abstract

A positioning and stabilizing structure includes at least one gas delivery tube that receives a flow of air from a connection port on the top of a patient's head and delivers the flow of air to an inlet of a patient's airway via a seal-forming structure, the at least one gas delivery tube including a tube wall having an extendable telescopic structure, the at least one gas delivery tube being configured to receive a flow of air from a connection port on the top of the patient's head and to deliver the flow of air to the inlet of the patient's airway via the seal-forming structure. A telescopic structure comprising a plurality of folds alternately forming a plurality of ridges and a plurality of grooves in the tube wall, the folds being at least partially deployable to increase separation of the ridges, thereby extending the extensible telescopic structure; and one or more ridge connections provided to the tube wall, each of the one or more ridge connections connecting two or more contiguous ridges of the plurality of ridges and configured to resist separation of the ridges.

Description

[0001] 1 Cross-reference to related applications

[0002] This application is a divisional application of the patent application with application number 201980065903.9, application date August 20, 2019, and invention name “Headband for patient interface”, and the original patent application with application number 201980065903.9 is the Chinese national phase application of the international application PCT / AU2019 / 050874 filed on August 20, 2019, which claims the benefit of U.S. Provisional Application No. 62 / 764,995 filed on August 20, 2018, the entire contents of which are incorporated herein by reference.

[0003] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever. 2 Background technology 2.1 Technical Field

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0005] 2.2 Description of Related Technology

[0006] 2.2.1 Human respiratory system and its disorders

[0007] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airway.

[0008] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchi and the right main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further airway division leads to respiratory bronchioles and eventually to alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th edition, published by John B.West, Lippincott Williams & Wilkins in 2012.

[0009] There are a range of respiratory disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0010] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. This is caused by an abnormally small upper airway in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep, coupled with a normal loss of muscle tone. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. It often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle-aged overweight men, although those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of rise and fall ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated arousals from sleep, which lead to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

[0014] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0015] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term that covers many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive types: (i) rapidly progressive disorders: characterized by muscle damage that worsens within a few months and leads to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapulohumeral and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of treatments have been used to treat or alleviate such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0020] 2.2.2 Treatment

[0021] Various therapies have been used to treat one or more of the above-mentioned breathing disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0023] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0024] Invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] 2.2.3 Treatment system

[0026] These treatments can be provided by a treatment system or device.Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0027] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0028] Another form of treatment system is a mandibular repositioning device.

[0029] 2.2.3.1 Patient interface

[0030] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway.

[0031] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving can be constructed to prevent water from flowing in from external high pressure, rather than maintaining air at a higher pressure than the environment inside.

[0032] Certain masks may be clinically disadvantageous to the present technology, for example where they block air flow through the nose and only allow it through the mouth.

[0033] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0034] Some masks may not be feasible for use while sleeping (eg, while sleeping on one's side in bed with the head resting on a pillow).

[0035] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0036] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0037] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0038] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0039] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0040] 2.2.3.1.1 Sealing structure

[0041] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0042] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0043] A seal-forming structure that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because of differences in shape, structure, variability, and sensitivity of the patient's facial areas. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0044] Certain seal-forming structures may be designed for mass manufacturing so that one design is conformable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0045] One type of seal-forming structure extends around the periphery of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal-forming structure is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0046] Another type of seal-forming structure includes a sheet-like seal of thin material positioned 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. Similar to the previous forms of seal-forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0047] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0048] Another form of seal-forming structure may use an adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove adhesive from their face.

[0049] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0050] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Company.

[0051] ResMed Inc. manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGELIBERTY TM Full face mask. The following patent application assigned to ResMed Ltd. describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073778 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which describe the MIRAGE LIBERTY TMOther aspects of full face masks); International patent application WO 2009 / 052560 (which describes the SWIFT TM Other aspects of the FX Nasal Pillows).

[0052] 2.2.3.1.2 Positioning and stabilization

[0053] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will break the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0054] One technique is to use adhesives. See, for example, US Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may make some people uncomfortable.

[0055] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and awkward to use.

[0056] 2.2.3.1.3 Pressurized air duct

[0057] In one type of therapy system, a pressurized air flow is provided to the patient interface through a conduit in an air circuit fluidly connected to the patient interface so that when the patient interface is positioned on the patient's face during use, the conduit extends forwardly out of the patient interface away from the patient's face. This may sometimes be referred to as an "elephant's trunk" type interface.

[0058] Some patients find such interfaces unsightly and refuse to wear them, thereby reducing patient compliance. In addition, the tubing connected to the interface in front of the patient's face can sometimes tend to get tangled in bedding.

[0059] 2.2.3.1.4 Pressurized air ducts for positioning / stabilizing seal-forming structures

[0060] An alternative type of treatment system that seeks to address these problems includes a patient interface in which the tube that delivers pressurized air to the patient's airway also serves as part of a headband to position and stabilize the seal-forming portion of the patient interface to the appropriate portion of the patient's face. This type of patient interface may be referred to as a combined "headband tube" or "conduit headband." Such a patient interface allows the conduit in the air circuit that provides the pressurized air flow from the respiratory pressure therapy device to be connected to the 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 Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to the tube in the patient interface via a port that is positioned on the top of the patient's head during use.

[0061] Philips DreamWear TM The mask includes this headband tube. DreamWear TM The length of the headband tube cannot be adjusted. Therefore, DreamWear is available in three different sizes to accommodate different patient face sizes. TM Headgear. Providing a greater number of different sizes may increase the complexity and cost of manufacturing the headgear and may result in a larger footprint. Additionally, providing masks in discrete sizes may limit the extent to which different sized patient heads can be accommodated. Some patients may be more likely to fail to achieve what they consider a "perfect" fit if forced to choose between discrete sizes that are not adjustable in length.

[0062] A patient interface incorporating headgear tubes may provide some advantages, such as avoiding tubing connected to the patient interface in front of the patient's face, which may be unsightly and obtrusive. However, it is desirable that a patient interface incorporating headgear tubes be comfortable for the patient to wear for extended durations while the patient is asleep, while forming an effective seal with the patient's face.

[0063] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0064] A respiratory pressure therapy (RPT) device may be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow may be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0065] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0066] An example of a special requirement for certain RPT devices is noise.

[0067] The designer of a device may have an infinite number of choices to make. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0068] 2.2.3.3 Humidifier

[0069] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0070] A range of artificial humidification devices and systems are known, but they may not meet the special requirements of medical humidifiers.

[0071] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, usually where the patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. Medical humidifiers can be constructed to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, but these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0072] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0073] 2.2.3.4 Data Management

[0074] Data may be obtained for clinical reasons to determine whether a patient prescribed a respiratory therapy is "compliant," such as that the patient has used their RPT device in accordance with one or more "compliance rules." An example of a compliance rule for CPAP therapy is that, in order to be considered compliant, a patient is required to use the RPT device for at least four hours per night for at least 21 out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing a patient's use of the RPT device for therapy, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform third parties that the patient is compliant.

[0075] There are other parties to patient treatments that could benefit from sending treatment data to third parties or external systems.

[0076] Existing methods of sending and managing this type of data can be one or more of the following: expensive, time consuming, and error prone.

[0077] 2.2.3.5 Mandibular reduction

[0078] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standardized form and includes a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and attenuates vibrations of the palate.

[0079] In some examples, the mandibular advancement device may include an upper splint for engaging or fitting with teeth on the maxilla or maxilla and a lower splint for engaging or fitting with teeth on the maxilla or mandible. The upper splint and the lower splint are connected together in the transverse direction by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0080] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible is held in an anterior position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0081] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as the ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and the temporomandibular joint (TMJ). Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.6 Ventilation technology

[0083] Some forms of therapy systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space outside the patient interface, such as to the environment.

[0084] The vent may include an orifice through which gas may flow when the mask is used. Many such vents are noisy. Others may become blocked when in use, thereby providing insufficient flushing. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example by making noise or by gathering airflow.

[0085] ResMed Inc. has developed many improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0086] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0087]

[0088] (*One sample only, measured at 10cmH2O using the test method specified in ISO 3744 in CPAP mode) The sound pressure values ​​for various objects are listed below

[0089]

[0090] 2.2.4 Screening, diagnosis and monitoring systems

[0091] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves professional clinical staff who apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea involves two nights of observation of the patient in the clinic, one night of pure diagnosis, and the second night of titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep apnea.

[0092] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening often gives true / false results indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis produces clinically actionable information. Screening and diagnosis tend to be one-time processes, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0093] A clinical expert may be able to appropriately screen, diagnose or monitor a patient based on visual observation of PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. 3. Summary of the invention

[0094] The present technology is intended to provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0095] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0096] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0097] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0098] One aspect of the present technology includes a patient interface for delivering a pressurized supply of breathable gas to an entrance to an airway of a patient.

[0099] Another aspect of the present technology relates to a patient interface, which may include: a plenum chamber; a seal-forming structure; a positioning and stabilizing structure. The patient interface may further include a vent structure. The patient may further be configured so that the patient's mouth is not covered, or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may further be configured to allow the patient to breathe from the surrounding environment in the absence of a pressurized air flow through the plenum inlet port.

[0100] Another aspect of the present technology relates to a patient interface, comprising: a plenum chamber; a seal-forming structure; a vent structure; and a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one gas delivery tube to receive an air flow from a connection port and deliver the air flow to an entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact an area of ​​the patient's head at least above a supra-auricular base point of the patient's head during use.

[0101] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0102] at least one gas delivery tube that receives a flow of air from a connection port on the top of the patient's head and delivers the flow of air to an entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least one area of ​​the patient's head above a supra-auricular base of the patient's head, the gas delivery tube comprising:

[0103] a tube wall defining a hollow interior through which air can flow to the seal-forming structure, the tube wall having an extendable portion configured to extend to change the length of the gas delivery tube;

[0104] Wherein the extendable portion comprises an extension stiffness in the range of 0.2 to 0.35 N / mm.

[0105] In an example of any aspect of any of the preceding paragraphs: (a) the extension stiffness of the extendable portion is in the range of 0.25 to 0.3 N / mm; (b) the pair of gas delivery tubes include a combined unextended length in the range of 500 to 535 mm, the combined unextended length measured along the centerline of the side of the pair of tubes that is configured to face the patient in use; (c) the combined unextended length is in the range of 510 to 525 mm; (d) the combined unextended length is in the range of 512 to 522 mm; (e) the pair of gas delivery tubes include a combined unextended length in the range of 460 to 500 mm, the combined unextended length measured along the centerline of the side of the pair of tubes that is configured to face the patient in use; (f) the combined unextended length is in the range of 470 to 490 mm; (g) the combined unextended length is in the range of 475 to 485 mm; (h) the gas delivery tubes together with the cushion module form a ring around the patient's head, the ring having a length of 5 The invention relates to an annular ring having an unextended length in the range of 10 to 610 mm, the unextended length being measured along the centerline of the side of the gas delivery tube and the cushion module, the cushion module being configured to face the patient during use; (i) the unextended length of the ring is in the range of 528 to 548 mm; (j) the unextended length of the ring is in the range of 535 to 541 mm; (k) the unextended length of the ring is in the range of 534 to 554 mm; (l) the unextended length of the ring is in the range of 539 to 549 mm (m) the unextended length of the ring is in the range of 541 to 561 mm; (n) the unextended length of the ring is in the range of 546 to 556 mm; (o) the unextended length of the ring is in the range of 564 to 584 mm; (p) the unextended length of the ring is in the range of 571 to 581 mm; (q) the unextended length of the ring is in the range of 577 to 597 mm; and / or (r) the unextended length of the ring is in the range of 582 to 592 mm.

[0106] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0107] at least one gas delivery tube for receiving a flow of air from a connection port on the top of a patient's head and delivering the flow of air to an entrance to the patient's airway via a seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base of the patient's head in use, the at least one gas delivery tube comprising:

[0108] An upper tube portion, which is configured to cover an upper region of a patient's head in use, the upper tube portion comprising:

[0109] a first end configured to cover an upper portion of the patient's head at or near a sagittal plane of the patient's head;

[0110] a second end configured to cover a side of a patient's head in use;

[0111] a rigidified portion between the first end and the second end, the rigidified portion being configured to provide, in use, a higher resistance to relative movement between the first end and the second end in an anterior and / or posterior direction than in an superior and / or inferior direction;

[0112] A lower tube portion is connected between the second end of the upper tube portion and the seal-forming structure.

[0113] In an example of any aspect of any of the preceding paragraphs: (a) each upper tube portion includes two rigidizing portions; (b) the rigidizing portion is disposed to one or both of a side of the upper tube portion that is configured to be forward in use and a side of the upper tube portion that is configured to be rearward in use; (c) the upper tube portion includes an extendable portion; (d) the extendable portion includes an extendable telescopic structure formed in a tube wall of the gas delivery tube; (e) the extendable telescopic structure includes a plurality of folds in the tube wall, the folds alternately forming a plurality of ridges and a plurality of grooves; (f) the rigidizing portion includes a plurality of connecting portions formed in the tube wall, each of the plurality of connecting portions connecting a pair of adjacent ridges; and / or (g) the rigidizing portion is formed integrally with the upper tube portion.

[0114] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0115] at least one gas delivery tube that receives a flow of air from a connection port on the top of the patient's head and delivers the flow of air to an entrance of the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head in use, the at least one gas delivery tube comprising a tube wall having an extendable telescoping structure, the telescoping structure comprising:

[0116] a plurality of folds in the tube wall that alternately form a plurality of ridges and a plurality of grooves, the folds being capable of at least partially unfolding to increase the spacing of the ridges to elongate the extendable telescoping structure; and

[0117] One or more ridge connections are 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 resist separation of the ridges.

[0118] In an example of any aspect of any of the preceding paragraphs: (a) each pair of adjacent ridges is connected by at least one of the 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 located on a side of the gas delivery tube that is configured to face forward in use; (e) 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; (f) each of the ridge connections is located on a side of the gas delivery tube that is configured to face downward in use and on a side of the gas delivery tube that is configured to face upward in use (g) each pair of adjacent ridges is connected by one of the ridge connections located on the side of the gas delivery tube that is configured to face forward in use; (h) each pair of adjacent ridges is connected by one of the ridge connections located on the side of the gas delivery tube that is configured to face rearward; (i) the gas delivery tube includes a non-extensible portion having an outer surface, and each of the plurality of grooves is formed as a depression relative to the outer surface of the non-extensible portion; (j) the gas delivery tube includes a non-extensible portion having an outer surface, and each of the plurality of ridges is elevated relative to the outer surface of the non-extensible portion; (k) each of the plurality of grooves is located between a corresponding pair of ridge connections, Each ridge connection of the pair of ridge connections is located at a respective end of a respective groove; (1) each groove of the plurality of grooves includes a groove depth, and each ridge connection 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 ridge connection of the respective pair of ridge connections located at the end of the respective groove; (m) each ridge connection is an integrally formed portion of the tube wall; (n) the plurality of ridges, the plurality of grooves and the plurality of ridge connections are integrally formed; (o) each of the plurality of ridges includes a curved ridge portion located at a center of the respective ridge; (p) each of the plurality of grooves includes a curved groove portion located at a center of the respective groove; (q) each of the plurality of ridges is (r) each of a plurality of ridge connections connects a respective pair of adjacent ridges at the straight ridges of the ridges; (s) the gas delivery tube comprises a cross-section having a width and a height at the extendable telescopic structure, the width being substantially aligned with the anterior-posterior direction in use, the width being greater than the height; (t) the width being at least twice as great as the height; and / or (u) the positioning and stabilizing structure comprises two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each gas delivery tube extending across one of the cheek regions of the patient in use, the two gas delivery tubes being located on different sides of the patient's head.

[0119] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0120] at least one gas delivery tube for receiving the air flow from a connection port on the top of the patient's head and delivering the air flow to an entrance of the patient's airway via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base of the patient's head in use, the at least one gas delivery tube comprising a tube wall having a hollow interior and having an extendable telescoping structure disposed along the length of the gas delivery tube, the extendable telescoping structure comprising:

[0121] a plurality of folds in the tube wall, the plurality of folds forming 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;

[0122] Wherein the first alternating series of ridges and grooves have a lesser extensional stiffness than the second alternating series of ridges and grooves.

[0123] In examples: (a) a plurality of folds form internal ridges and internal grooves on the interior of the gas delivery tube forming 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 arranged opposite a respective one of the internal grooves of the second alternating series across the interior of the gas delivery tube to form a plurality of opposing groove pairs, each opposing groove pair comprising: a first internal groove, which is an internal groove of the first alternating series; and a second internal groove, which is an internal groove of the second alternating series; wherein the first internal groove comprises a greater groove depth than the second internal groove; (c) the material thickness of the tube wall at the base of the second internal groove of each opposing groove pair is greater than that at the base of the second internal groove of the corresponding 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 to 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 first and second internal grooves of the alternating series of internal ridges and internal grooves decreases along the length of the gas delivery tube from the first end adjacent to 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 the corresponding opposing groove pair at the side of the gas delivery tube between the non-patient contacting side and the patient contacting side.

[0124] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0125] a pair of gas delivery tubes that receive a flow of air from a connection port on the top of the patient's head and deliver the flow of air to an entrance to the patient's airway via the seal-forming structure, each of the pair of gas delivery tubes being constructed and arranged to contact, in use, at least one area of ​​the patient's head above a supra-auricular base of the patient's head, and each gas delivery tube comprising:

[0126] a tube wall defining a hollow interior along a length of the gas delivery tube;

[0127] a tab connected to the tube wall and configured, in use, to be located above a supraauricular base point on the patient's head; and

[0128] a slit formed in the tab, the slit being spaced from the tube wall from the rear in use, the slit comprising an upper end and a lower end,

[0129] wherein an upper end of the slit is further away from the tube wall than a lower end of the slit; and

[0130] A strap constructed and arranged to contact, in use, an area of ​​the patient's head below or overlying the occipital bone of the patient's head, the strap being configured for connection to and between the slits.

[0131] In an example of any aspect of any of the preceding paragraphs: (a) each tab is integrally formed with the corresponding 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 at least 5 mm from the tube wall; (d) the lower end of the slit is spaced at least 7 mm from the tube wall; (e) the lower end of the slit is spaced 8 mm or more from the tube wall; (f) the upper end of the slit is spaced at least 8 mm from the tube wall; (g) the upper end of the slit is spaced at least 10 mm from the tube wall; (h) the upper end of the slit is spaced 12 mm or more from the tube wall; (i) the spacing from the tube wall along the midpoint of the slit is in the range of 5 mm to 30 mm; (j) the spacing is in the range of 7 mm to 20 mm; (k) The spacing is in the range of 8mm to 15mm; (l) the spacing is in the range of 9 to 11mm; (m) each gas delivery tube includes an extendable tube section and a non-extensible tube section, the extendable tube section is located above the joint of the corresponding gas delivery tube when in use, and the non-extensible tube section is located below the joint of the corresponding gas delivery tube when in use; (n) each tab is joined to the tube wall of the corresponding gas delivery tube at the non-extensible tube section; (o) each slit is arcuate between the upper end and the lower end; (p) each slit is straight between the upper end and the lower end; and / or (q) each slit is oriented perpendicular to the direction of the slit from the strap anchoring area, and the strap is anchored around the patient's head against the strap anchoring area.

[0132] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0133] a pair of gas delivery tubes that receive a flow of air from a connection port on the top of the patient's head and deliver the flow of air to an entrance to the patient's airway via the seal-forming structure, each of the pair of gas delivery tubes being constructed and arranged to contact, in use, at least one area of ​​the patient's head above a supra-auricular base of the patient's head, and each gas delivery tube comprising:

[0134] a tube wall configured to, in use, cover the patient's head along a path from an upper portion of the patient's head to a seal-forming structure passing between the patient's eyes and ears;

[0135] a tab connected to the tube wall and configured, in use, to be located above a supraauricular base point on the patient's head; and

[0136] a slit formed in the tab and spaced rearwardly from an abutment of the path of the tube wall by the slit in use;

[0137] wherein the slit has a rear-upward-front-downward orientation in use and forms an oblique angle with a tangent to the path of the tube wall at the slit adjoining portion; and

[0138] A strap constructed and arranged to contact, in use, an area of ​​the patient's head below or overlying the occipital bone of the patient's head, the strap being configured for connection to and between the slits.

[0139] In an example of any aspect of any of the preceding paragraphs: (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 in use, the upper edge being longer than the lower edge; (c) each gas delivery tube includes an extendable tube section located above the tab of the respective gas delivery tube in use and an inextensible tube section located below the tab of the respective gas delivery tube in use; (d) each tab is connected to the tube wall of the respective gas delivery tube at the inextensible tube section; (e) each slit is arcuate between the upper and lower ends of the slit; (f) each slit is straight between the upper and lower ends of the slit; g) the lower end of the slit is at least 5 mm from the tube wall; (h) the lower end of the slit is at least 7 mm from the tube wall; (i) the lower end of the slit is at least 8 mm from the tube wall; (j) the upper end of the slit is at least 10 mm from the tube wall; (k) the upper end of the slit is at least 10 mm from the tube wall; (l) the upper end of the slit is more than 12 mm from the tube 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 the direction starting from the slit in the strap anchoring area, and the strap is anchored around the patient's head against the strap anchoring area.

[0140] According to one aspect of the present technology, there is provided a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle when in use, the positioning and stabilizing structure comprising:

[0141] a pair of gas delivery tubes that receive a flow of air from a connection port on the top of the patient's head and deliver the flow of air to an entrance to the patient's airway via the seal-forming structure, each of the pair of gas delivery tubes being constructed and arranged to contact, in use, at least one area of ​​the patient's head above a supra-auricular base of the patient's head, and each gas delivery tube comprising:

[0142] a tube wall configured to cover the patient's head from an upper portion of the patient's head through a seal-forming structure between the patient's eyes and ears; and

[0143] a tab connected to the tube wall and located, in use, above the supraauricular base of the patient's head;

[0144] an eyelet formed in the tab and located, in use, behind the tube wall;

[0145] a slot formed in the tab and located rearwardly of the eyelet; and

[0146] A strap constructed and arranged to contact an area of ​​the patient's head below or covering the occipital bone of the patient's head in use, the strap being constructed to connect to and between the eyelets of the pair of gas delivery tubes and, in use, to reside within the grooves formed in the tabs.

[0147] In an example of any aspect of any of the preceding paragraphs: (a) the slot is formed in the tab between the eyelet and a rear side of the tab; (b) the tab includes an outwardly facing surface and the slot includes a substantially flat surface that is recessed relative to the outwardly facing surface; (c) the slot is formed by a portion of the tab having a reduced material thickness compared to other portions of the tab; (d) the slot includes a length that is substantially equal to the width of the strap; and / or (e) the eyelet is in the form of a slit.

[0148] According to one aspect of the present technology, there is provided a patient interface comprising:

[0149] 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 a flow of air at the therapeutic pressure for breathing by a patient;

[0150] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle;

[0151] The positioning and stabilizing structure according to any one of the above aspects; and

[0152] a vent structure configured to allow gas exhaled by the patient to flow continuously from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain said therapeutic pressure in the plenum chamber during use;

[0153] Wherein the patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured such that the patient's mouth is uncovered.

[0154] Another aspect of some forms of the present technology is a system for treating a respiratory disorder, the system comprising a patient interface, an air circuit, and a positive pressure air source according to any one or more of the other aspects of the present technology.

[0155]

[0013] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0156] Another aspect of some forms of the present technology is a patient interface comprising a seal-forming structure configured such that a patient's mouth is not covered during use.

[0157] Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured such that no portion of the seal-forming structure enters the mouth during use.

[0158] Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured such that the seal-forming structure does not extend inside an airway of a patient.

[0159] Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured such that, in use, the seal-forming structure does not extend beneath a metal ridge area.

[0160] Another aspect of some forms of the present technology is a patient interface constructed and arranged such that the patient's eyes are not covered during use.

[0161] Another aspect of some forms of the present technology is a patient interface constructed and arranged to allow a patient to breathe ambient air in the event of a power failure.

[0162] 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 an underside of a patient's nose without contacting a nasal bridge area of ​​the patient's nose.

[0163] Another aspect of certain forms of the present technology is a patient interface comprising a vent and a plenum chamber, wherein the patient interface is constructed and arranged such that gas from the interior of the plenum chamber can pass to the surrounding environment via the vent.

[0164] Another aspect of certain forms of the present technology is a patient interface constructed and arranged such that a patient may comfortably lie in a lateral or transverse sleeping position when using the patient interface.

[0165] Another aspect of some forms of the present technology is a patient interface constructed and arranged such that a patient may comfortably lie in a supine sleeping position while using the patient interface.

[0166] Another aspect of some forms of the present technology is a patient interface constructed and arranged such that a patient may comfortably lie in a prone sleeping position when using the patient interface.

[0167] One aspect of some forms of the present technology is a medical device that is easily used, for example, by a person without medical training, a person with limited dexterity, vision, or a person with limited experience in using such medical devices.

[0168] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, such as in soapy water, without the need for specialized cleaning equipment.

[0169] Of course, parts of these aspects may form sub-aspects of the present technology. Sub-aspects and / or various aspects in an aspect may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0170] Other features of the present technology will be apparent by considering the following detailed description, abstract, drawings, and information contained in the claims. 4. Description of the drawings

[0171] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements, including:

[0172] 4.1 Treatment system

[0173] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a positive pressure supply of air from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0174] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a positive pressure supply of air from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0175] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a positive pressure supply of air from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0176] 4.2 Respiratory system and facial anatomy

[0177] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0178] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0179] Figure 2C is a front view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0180] Figure 2Dis a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal bridge, nasal wing apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0181] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0182] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0183] Figure 2G A side view of the nasal surface features is shown.

[0184] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilages, septal cartilages, greater alar cartilages, lesser alar cartilages, sesamoid cartilages, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0185] Fig.2I The medial anatomy of the nose is shown approximately several millimeters from the midsagittal plane, showing the medial crus of the septal cartilage and the greater alar cartilage.

[0186] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0187] Figure 2K A lateral view of the skull with the outline of the head surface and several muscles is shown. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0188] Figure 2L An anterolateral view of the nose is shown.

[0189] 4.3 Patient Interface

[0190] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0191] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0192] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0193] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0194] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0195] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0196] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0197] Figure 3H A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and one dome region are indicated.

[0198] Fig. 3I A surface of a structure is shown, wherein the surface has a one-dimensional hole in it. The plane curves shown form the boundaries of the one-dimensional hole.

[0199] Figure 3J Shown through Fig. 3I The surface shown is in the cross section of the structure. Fig. 3I A two-dimensional hole is defined in the structure.

[0200] Figure 3K Shows Fig. 3I A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig. 3I The surface of the two-dimensional holes is defined in the structure.

[0201] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0202] Figure 3M Shown through Figure 3L A cross-section of a mask of FIG. 1 and showing the inner surface of the bladder. The inner surface defines a two-dimensional hole in the mask.

[0203] Figure 3N Shown through Figure 3L Another cross section of a mask of FIG. The inner surface is also shown.

[0204] Fig.3O The left-hand rule is shown.

[0205] Figure 3P The right-hand rule is shown.

[0206] Figure 3Q The left ear is shown, including the left ear helix.

[0207] Figure 3R The right ear is shown, including the right ear helix.

[0208] Figure 3S A right-hand helix is ​​shown.

[0209] Figure 3T A view of a mask is shown including the sign of the twist of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0210] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0211] Figure 3V Shows Figure 3U A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the air chamber into left and right sides.

[0212] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V The "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord that lies on the sagittal plane and contacts the cushion of the plenum at just two points on the sagittal plane (upper and lower points). Depending on the geometry of the cushion in this area, the mid-contact plane may be a tangent at the upper and lower points.

[0213] Figure 3X Shows Figure 3UThe inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 is roughly coincident with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'plane of the face'. Figure 3X In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point is approximately located on the bridge of the nose, while the lower point is located on the upper lip.

[0214] 4.4RPT device

[0215] Figure 4A One form of RPT device according to the present technology is shown.

[0216] Figure 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0217] 4.5 Humidifier

[0218] Figure 5A Shown is an isometric view of a humidifier in accordance with one form of the present technology.

[0219] Figure 5B An isometric view of a humidifier in accordance with one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0220] 4.6 Respiratory waveform

[0221] Fig. 6A A model typical breathing waveform of a sleeping person is shown.

[0222] 4.7 Screening, diagnosis and monitoring systems

[0223] Fig. 7A A patient undergoing a polysomnogram (PSG) is shown. The patient sleeps in a supine sleeping position.

[0224] Figure 7B A monitoring device for monitoring a patient's condition is shown. The patient is sleeping in a supine sleeping position.

[0225] 4.8 Specific Examples of This Technology

[0226] Fig. 8A is a perspective view of a patient interface 3000 as worn by a patient 1000 according to an example of the present technology.

[0227] Figure 8B yes Fig. 8A A front view of the patient interface 3000 is shown.

[0228] Figure 8C yes Fig. 8A A side view of patient interface 3000 is shown.

[0229] Fig.8D yes Fig. 8A Another side view of the patient interface 3000 is shown.

[0230] Fig. 9A is shown separately Fig. 8A 3000 is a perspective illustration of a patient interface 3000.

[0231] Fig. 9B is shown separately Fig. 8A 3000 is a rear perspective illustration of a patient interface 3000.

[0232] Fig. 9C is shown separately Fig. 8A A top view of the patient interface 3000 is shown.

[0233] Fig. 10A A plan view of components of a positioning and stabilizing structure 3300 is shown in accordance with an example of the present technology.

[0234] Fig. 10B Shows Fig. 10A Cross-sectional view BB of a portion of the positioning and stabilizing structure 3300.

[0235] Fig. 10C Shows Fig. 10A Cross-sectional view CC of the non-extensible portion of the positioning and stabilizing structure 3300.

[0236] Fig. 10D Shows Fig. 10A A plan view of a portion of the extendable portion of the positioning and stabilizing structure 3300.

[0237] Fig. 10E Shows Fig. 10D Cross-sectional view EE of the extendable portion of the positioning and stabilising structure 3300.

[0238] Fig.10F Shows Fig. 10A A front view of a portion of the extendable portion of the positioning and stabilizing structure 3300.

[0239] Figure 10G Shows Fig. 10A Front view of the extendable portion of the positioning and stabilizing structure 3300 in the straightened configuration.

[0240] Fig. 10HShown in a bent configuration Figure 10G A front view of the extendable portion shown in FIG.

[0241] Fig.10I Shown in a bent configuration Figure 10G A perspective view of the extendable portion shown in FIG.

[0242] Fig.10J Shown in a bent configuration Figure 10G A top view of the extendable portion shown in FIG.

[0243] Fig.11A Shows Fig. 10A Side view of the tab of the positioning and stabilizing structure 3300.

[0244] Fig. 11B Shows Fig. 10A Another side view of the tab of the positioning and stabilizing structure 3300.

[0245] Fig. 11C yes Fig.11A A perspective view of the tab.

[0246] Fig. 12A is a perspective view of a patient interface 3000 according to another example of the present technology as worn by a patient 1000 .

[0247] Fig. 12B is shown separately Fig. 12A A perspective view of a patient interface 3000 is shown.

[0248] Fig. 12C yes Fig. 12A Front view of patient interface 3000.

[0249] Fig.12D yes Fig. 12A Rear view of patient interface 3000.

[0250] Fig.12E yes Fig. 12A A top view of the patient interface 3000 is provided.

[0251] Fig.12F yes Fig. 12A Side view of patient interface 3000.

[0252] Fig.13 is a perspective view of a portion of a positioning and stabilising structure 3300 of a patient interface according to another example of the present technology. 5. Specific implementation methods

[0253] Before further describing the technology of the present invention in detail, it should be understood that the technology of the present invention is not limited to the specific examples described herein, and the specific examples described herein may be changed. It should also be understood that the terms used in this disclosure are only for the purpose of describing the specific examples described herein and are not intended to be limiting.

[0254] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute another example.

[0255] 5.1 Treatment

[0256] In such Figure 1A In one form shown, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an entrance to the airway of a patient 1000.

[0257] In certain examples of the present technology, a positive pressure supply of air is provided to the patient's nasal passages via one or both nostrils.

[0258] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0259] 5.2 Treatment system

[0260] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 . Figure 1A , Figure 1B and Figure 1C A processing system utilizing the patented interface 3000 having an RPT device 4000 and a humidifier 5000 is shown.

[0261] 5.3 Patient Interface

[0262] refer to Figure 3A , a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0263] like Figures 8A-9C As shown in FIG. 1 , a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connecting to an air circuit (e.g., Figures 1A-1C In this example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by the cushion module 3150.

[0264] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0265] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to ambient.

[0266] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to ambient.

[0267] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 20 cmH20 relative to ambient.

[0268] 5.3.1 Sealing structure

[0269] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs - the actual sealing surface - may vary from day to day during a given treatment period and from patient to patient, depending on a number of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0270] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0271] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material such as silicone rubber.

[0272] The seal-forming structure 3100 according to the present technology can be constructed of a soft, flexible and elastic material such as silicone.

[0273] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another form that is suitable for small-sized heads but not for large-sized heads.

[0274] 5.3.1.1 Sealing mechanism

[0275] In one form, the seal-forming structure 3100 includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on the interior of the plenum chamber 3200 on its underside, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0276] 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, such as about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum 3200 and extends around at least a portion of the path of the periphery. The support flange is or includes a spring-like element and acts to support the sealing flange in use to prevent it from buckling.

[0277] In one form, the seal forming structure may comprise a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example due to elastic tension in the positioning and stabilising structure.

[0278] In one form, the seal-forming structure comprises a tensioning portion. In use, the tensioning portion is held in tension, for example by an abutment region of the sealing flange.

[0279] In one form, the seal-forming structure includes a region having a tacky or adhesive surface and / or having a higher coefficient of friction compared to other surfaces.

[0280] 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 portion, a gasket seal portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0281] 5.3.1.2 Nose bridge or nasal ridge area

[0282] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over a nasal bridge region or nasal ridge region of a patient's face.

[0283] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of a patient's face in use.

[0284] 5.3.1.3 Upper lip area

[0285] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0286] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0287] 5.3.1.4 Chin area

[0288] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin region of the patient's face.

[0289] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0290] 5.3.1.5 Forehead area

[0291] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0292] 5.3.1.6 Nasal pillows

[0293] In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose. Fig. 12A -F shows 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, as shown in FIG. Figures 8A-9CThe same positioning structure 3300 is shown for maintaining the pillow cushion module 3160 in sealing contact with the patient's nose. The same concepts and features of the positioning and stabilizing structure 3300 described with reference to the support cushion module 3150 can be applied to the positioning and stabilizing structure 3300 configured for use with the pillow cushion module 3160 (or other types of cushion modules, such as a full face cushion module, an oronasal cushion module, an ultra-compact full face cushion module, a nasal cushion module, etc.).

[0294] A nasal pillow 3165 according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom side of the patient's nose; a stem; and a flexible region located on the bottom side of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0295] 5.3.1.7 Nasal support

[0296] In one form, for example Figures 8A-9C As shown, the seal-forming structure 3100 is constructed to be used with the underside of the nose around the nostrils and optionally with the upper lip of the patient 1000 to form a seal. Such a seal-forming structure may be referred to as a "stent cushion" or "under-the-nose mask". The shape of the seal-forming structure may be constructed to match or closely follow the underside of the patient's nose, i.e., the contour and angle of the seal-forming structure may be substantially parallel to the nasolabial angle of the patient. In one form of a nasal stent cushion, the seal-forming structure includes a bridge portion defining two orifices, each of which supplies air or breathable gas to a different one of the patient's nostrils in use. The bridge portion may be constructed to contact or seal the patient's columella in use. In some forms of the technology, the seal-forming structure 3100 is constructed to form a seal on the underside of the patient's nose without contacting the nasal bridge area of ​​the patient's nose. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a support cushion as disclosed in PCT Application No. PCT / AU 2018 / 050289 filed on March 29, 2018, the entire contents of which are incorporated herein by reference.

[0297] 5.3.1.8 Nasal mask cushion

[0298] In one form, the non-invasive patient interface 3000 includes a seal forming portion that forms a seal over the upper lip region (ie, upper lip), the bridge of the nose region, and the cheek region of the patient's face during use. Figure 1BThe seal-forming portion delivers a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice. This seal-forming structure may be referred to as a "nasal cushion" or "nasal mask". In some examples of the present technology, Figures 8A-9C The positioning and stabilizing structure 3300 shown in FIG. 3 can be used to maintain the nasal cushion in a sealing position on the patient's face.

[0299] 5.3.1.9 Full face mask cushion

[0300] In one form, the patient interface 3000 includes a seal forming portion which, in use, forms a seal over the chin, nose and cheek regions of the patient's face. Figure 1C The seal-forming portion delivers a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This seal-forming structure may be referred to as a "full face mask". In some examples of the present technology, Figures 8A-9C The positioning and stabilizing structure 3300 shown may be used to maintain a full face cushion in a sealing position on the patient's face.

[0301] 5.3.1.10 Oronasal mask cushion

[0302] In another form, the patient interface 3000 includes a nasal seal forming structure and an oral seal forming structure in the form of a nasal cushion or nasal support cushion, which is constructed to form a seal around the patient's mouth (which may be referred to as a "mouth cushion" or "oral mask") during use. In such a mask, air or breathable gas is supplied to the patient's nostrils and the patient's mouth through separate orifices during use. Such a seal forming structure 3100 may be referred to as an "oronasal cushion" or "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 support cushion as described in U.S. Patent Application No. 62 / 649,376, the entire contents of which are incorporated herein by reference.

[0303] In the area where the seal is formed in use, the plenum 3200 has a periphery shaped to complement the surface contour of an average human face. In use, the marginal edge of the plenum 3200 is positioned in close proximity 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 along the entire periphery of the plenum 3200 in use. In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0304] In some forms of the present technology, for example in Figures 8A-9CIn the patient interface 3000, the inflatable chamber 3200 does not cover the patient's eyes during use.

[0305] In other words, the eye is outside the pressurized volume defined by the gas-filled chamber.Such a form is less obtrusive and / or more comfortable for the wearer, which may improve compliance with treatment.

[0306] In some forms of the present technology, the plenum 3200 is constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functions.

[0307] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0308] 5.3.2 Positioning and stabilizing the structure

[0309] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be held in a sealed position in use by a positioning and stabilising structure 3300. The positioning and stabilising structure 3300 may be referred to as a "headgear" because it engages the patient's head to hold the patient interface 3000 in a sealed position.

[0310] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the lifting effect of the positive pressure in the plenum 3200 off the face.

[0311] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0312] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of disturbance forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0313] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0314] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be so large and bulky that a patient cannot lie flat in a supine position with the back region of the patient's head resting on a pillow.

[0315] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be so large and bulky that a patient cannot lie flat in a side-lying position with the side area of ​​the patient's head resting on a pillow.

[0316] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion located between the front of the positioning and stabilising structure 3300 and the back of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible strap or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on a pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilising structure 3300 and breaking the seal.

[0317] In one form of the present technology, a positioning and stabilizing structure 3300 includes a strap 3310 constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap 3310. The strap 3310 may be breathable to allow moisture to be transmitted through the strap. In one form, the fabric outer layer includes a loop material for engaging with a hook material portion.

[0318] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable, such as an elastically extendable strap. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to seal the seal-forming structure to a portion of the patient's face, in some instances in combination with other straps or other structures. In one example, the strap can be configured as a tie.

[0319] The ties will be understood as structures designed to resist tension. In use, the ties are part of the positioning and stabilizing structure 3300 that is under tension. As will be described, some ties will exert elastic forces due to this tension. The ties can be used to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0320] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes over a supra-auricular base of the patient's head and covers a portion of the parietal and / or frontal bones without covering the occipital bone. The first strap may be provided, for example, as part of a patient interface including a cradle cushion, nasal pillows, nasal cushions, full-face cushions, or oronasal cushions. For example, Figures 8A-9CAs shown, the positioning and stabilising structure 3300 includes a first strap in the form of a tube 3350 that is positioned over the patient's head.

[0321] In one form of the present technology adapted for use with a nasal mask only or with a full face mask, the positioning and stabilizing structure 3300 includes a second strap constructed and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and overlies or is located below the occipital bone of the patient's head. The second strap may be provided, for example, as part of a patient interface including a cradle cushion, nasal pillows, full face cushion, nasal cushion, or oronasal cushion. Figures 8A-9C As shown, the positioning and stabilising structure 3300 includes a second strap in the form of a strap 3310 that rests against the rear surface of the patient's head.

[0322] In one form of the present technology adapted for use with a nasal-only mask or a full-face mask or an oronasal mask, the positioning and stabilizing structure 3300 includes a third strap configured to anchor against the posterior surface of the patient's neck. Additionally, in some forms, the positioning and stabilizing structure includes a fourth strap configured and arranged to interconnect the second strap and the third strap to reduce the tendency of the second strap and the third strap to move away from each other.

[0323] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a flexible and, for example, non-rigid strap. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping. Figures 8A-9C As shown in FIG. 3 , the positioning and stabilizing structure 3300 includes a flexible strap 3310. The strap 3310 can be considered a shoulder strap. The strap 3310 is flexible enough to pass around the back of the patient's head and rest comfortably on the patient's head, even when under tension during use.

[0324] In some 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 being configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that fits a large sized head but not a small sized head, and another that fits a small sized head but not a large sized head.

[0325] 5.3.2.1 Headband tube

[0326] 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 from the RPT device to the patient's airway, for example, through the plenum chamber 3200 and the seal-forming structure 3100. Figures 8A-9CIn the form of the present technology illustrated in FIG, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilizing structure 3300 of the patient interface 3000 to position and stabilize the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (e.g., nose and / or mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface at a position other than the front of the patient's face, which may be unsightly for some people. Although a pair of tubes 3350 has some advantages (described below), in some examples, the positioning and stabilizing structure 3300 includes only a single tube 3350 that is configured to cover the patient's head on one side. A strap or other stabilizing member may be provided between the top end of the single tube 3350 and the seal-forming structure 3100 on the other side of the patient's head to provide a balanced force on the seal-forming structure 3100.

[0327] The positioning and stabilizing structure 3300 may be described as being inflatable because air may be contained and passed through the headband tubes 3350 in order to deliver pressurized air from the air circuit 4170 to the patient's airway. It should be understood that an inflatable positioning and stabilizing structure 3300 does not require that all components of the positioning and stabilizing structure 3300 be inflatable. For example, in Figures 8A-9C as well as Fig. 12A In the example shown in FIG. 33A , the positioning and stabilizing structure 3300 includes an inflatable headband tube 3350 and a non-inflatable strap 3310 .

[0328] In some 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. Figures 8A-9C In the form of the present technology illustrated in , the connection port 3600 is located above the patient's head. In this example, the patient interface 3000 includes an elbow 3610 to which the connection port 3600 is arranged. The elbow 3610 can be swiveled relative to the positioning and stabilizing structure 3300 so as to decouple the movement of the tubing connected to the connection port 3600 from the positioning and stabilizing structure 3300. In addition, or alternatively, the conduit connected to the connection port 3600 can be swiveled relative to the elbow 3610. In the example shown, the elbow 3610 includes a swivel conduit connector to which a conduit of the air circuit 4170 can be connected so that the conduit can be rotated relative to the elbow 3610 about its longitudinal axis. The connection port 3600 may include a fluid connection opening 3390, such as Fig. 10A and 10BIn some examples, the air circuit 4170 can be connected to the fluid connection opening 3390. The elbow 3610 can be rotatably connected to the fluid connection opening or to a ring received in the fluid connection opening.

[0329] A patient interface in which the connection port is not positioned in front of the patient's face may be advantageous because some patients find conduits connected to the patient interface in front of the face to be unsightly and obtrusive. For example, conduits connected to the patient interface in front of the face may tend to become tangled in bedding or sheets, particularly if the conduits extend downward from the patient interface during use. Forms of the technology using a patient interface with a connection port may make it easier or more comfortable for the patient to be in one or more of the following positions: in a lateral or transverse position; in a supine position (i.e., on their back, generally facing upward); and in a prone position (i.e., on their front, generally facing downward). In addition, connecting the conduits to the front of the patient interface can exacerbate a problem known as tube drag, in which the conduits can provide an undesirable drag on the patient interface, resulting in displacement from the face.

[0330] In Figures 8A-9C and Fig. 12A -F, 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 through a respective cheek region, above a respective ear (above the supra-auricular base point above the patient's head) to a bend 3610 on the top of the patient's head 1000. This form of technology may be advantageous because if the patient sleeps with his head on his side and one of the tubes is compressed to block or partially block the flow of gas along the tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, such as 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 in use (e.g., across one cheek region) and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another region) to help secure the patient interface 3000 to the patient's head.

[0331] by Figures 8A-9C and Fig. 12A-F shows the form of technology, two tubes 3350 are fluidly connected to each other at their upper ends and are fluidly connected to the connection port 3600. In one embodiment, the two tubes are integrally formed, while in other embodiments, the tubes are separate components that are connected together in use and can be disconnected, such as for cleaning or storage. In the case of using separate tubes, they can be indirectly connected together, such as each can be connected to a T-shaped conduit with two conduit arms and a third conduit arm or opening, and the two conduit arms can each be fluidly connected to these tubes 3350, and the third conduit arm or opening acts as a connection port 3600 and can be connected to the air circuit 4170 in use. The connection port 3600 may include an elbow 3610 received in the fluid connection opening 3390 at the center of the two integrally formed tubes 3350. The elbow 3610 can be received in a ring in the fluid connection opening 3390 and can be constructed to turn around in the ring. The fluid connection opening 3390 itself can also be considered as a connection port 3600.

[0332] The tube 3350 can be formed from a semi-rigid material, such as an elastomeric material, such as silicone. For example, the tube 3350 from the left non-extensible tube segment 3363 to the right non-extensible tube segment 3363 can be formed from a single homogeneous piece of material (e.g., by molding), such as silicone, such as Fig. 10A These tubes can have a natural, pre-formed shape and can be bent or moved into another shape if force is applied to the tubes. For example, the tubes can be generally arcuate or curved, with a shape that approximates the contour of the patient's head between the top of the head and the nasal or oral regions.

[0333] In some examples, the positioning and stabilizing structure 3300 may include a sleeve 3364 surrounding the tube 3350. For example, Figures 8A-8D As shown, sleeve 3364 is disposed on non-extensible tube section 3363. In some examples, patient interface 3000 may not include sleeve 3364, and in other examples, patient interface 3000 may include sleeve 3364 covering more or all of tube 3350. Sleeve 3364 may be formed to fit the curved shape of tube 3350. In some examples, sleeve 3364 is formed of smooth fabric. Sleeve 3364 may be more comfortable against the patient's face than tube 3350 without any covering.

[0334] As described in U.S. Pat. No. 6,044,844 (the contents of which are incorporated herein), if tube 3350 is squeezed during use (e.g., if it is squeezed between the patient's face and a pillow), tube 3350 may be crush-resistant to prevent breathable gas from flowing through the tube. A compression-resistant tube may not be necessary in all cases, as the pressurized gas in the tube may act as a splint to prevent or at least limit squeezing of tube 3350 during use. A compression-resistant tube may be advantageous in situations where only a single tube 3350 is present, as if the single tube becomes blocked during use, the flow of gas will be restricted and treatment will cease or efficacy will be reduced.

[0335] In some forms of the technology, one or more portions of the tube 3350 may be reinforced by one or more stiffening or reinforcing elements. Examples of stiffening elements include: portions of the tube 3350 that are relatively thicker than other portions; portions of the tube 3350 that are formed of a relatively more rigid material than the material forming other portions; and rigid members that are attached to the interior, exterior, or embedded in a section of the tube. The use of such stiffening elements helps control how the positioning and stabilizing structure 3300 functions in use, for example, if a force is applied to the tube 3350, the tube 3350 is more likely to deform, if a force is applied, the shape of the tube 3350 is more likely to be maintained. Therefore, selecting a position where such a stiffening element is positioned in the tube 3350 can help improve comfort when wearing the patient interface 3000, and can help maintain a good seal at the seal-forming structure 3100 during use. The stiffening or reinforcing element can be located in a positioning and stabilizing structure 3300 that is constructed to support a relatively heavy seal-forming structure, such as a full-face or oral-nasal cushion assembly.

[0336] Figures 8A-9C and Fig. 12A -F The length of the tubes 3350 in the technical form shown in FIG. 33 is 15 to 30 cm, for example 20 to 27 cm. In one example, each tube is about 26 cm long. In another example, each tube is about 23 cm long. The length of the tubes is selected to fit the head size of a typical patient, for example, the distance between the area near the top of the head where the upper end of the tube 3350 is located and the area near the opening of the patient's airway where the lower end of the tube 3350 is connected to the support cushion module 3150 (or pillow cushion module 3160) when following a generally arcuate path down the side of the head and across the cheek area of ​​the patient, as shown in FIG. Figures 8A-9C12A-F. As described in more detail below, the patient interface 3000 is configured so that the length of the tube 3350 can vary in some form of technology, and the above lengths can apply to the tube in a retracted, stretched, or neutral state. It should be understood that the length of the tube 3350 will depend on the length of other components in the patient interface 3000, such as the length of the arm of the T-shaped catheter to which the upper end of the tube 3350 is connected and / or the size of the inflation chamber 3200.

[0337] 5.3.2.1.1 Positioning of headband components

[0338] Each tube 3350 can be configured to receive air flow from a connection port 3600 on the top of the patient's head and deliver the air flow to a seal-forming structure at the entrance to the patient's airway. Figures 8A-9C and Fig. 12A -F example, at least one tube 3350 extends between the seal-forming structure 3100 and the connection port 3600 through the cheek area of ​​the patient and above the ear of the patient, that is, a portion of the tube 3350 connected to the cushion module covers the maxillary area of ​​the patient's head in use, and a portion of the tube 3350 covers an area of ​​the patient's head above the supra-auricular base point on the patient's head. Each of the one or more tubes 3350 can also be located on the patient's sphenoid bone and / or temporal bone and one or both of the patient's frontal bone and parietal bone. The connection port 3600 and the curved tube 3610 can be located above the patient's parietal bone, frontal bone, or the junction between them in use.

[0339] Figures 8A-9C and Fig. 12A -F has a tube 3350 that curves around the upper portion of the patient's head from the upper end of the tube 3350 connected to the elbow 3610 on the top of the head to the point where the strap 3310 connects to the tube 3350 with a relatively small curvature in the sagittal plane. Between the point where the rear headband strap 3310 connects to the tube 3350 and the lower end of the tube 3350, the tube 3350 curves forward between the patient's ears and eyes and passes through the cheek area at the point where the tube 3350 connects to the support cushion module 3150 in front of the patient's airway below the nose. The radius of curvature of this section of the tube 3350 can be in the range of 60-100 mm, such as 70-90 mm, such as 80 mm. The lower end of the tube 3350 and the section of the tube 3350 where the rear headband strap 3310 connects to the tube 3350 can subtend an angle in the range of 65-90°, such as 75-80°. The actual curvature present in the portion of the tube 3350 above the strap 3310, and the actual curvature in the portion of the tube 3350 below the strap 3310, depends on the patient setting and will actually vary depending on the shape and size of the patient's head and the patient's preference.

[0340] The degree to which the patient interface 3000 fits an individual patient can be changed by changing the length of the tube 3350 and alternatively or additionally by changing the position of the patient interface 3000 or a portion thereof on the patient's head. For example, a patient interface 3000 having a certain length of tube 3350 can be adjusted to better fit the patient by moving a portion of the positioning and stabilizing structure 3300 in a posterior or anterior direction of the patient's head. For example, positioning the junction of the tube 3350 further forward (i.e., in an anterior direction) above the patient's head can enable a patient interface 3000 having a certain length of tube 3350 to fit a larger head than if the junction of the tube 3350 was positioned further rearward (i.e., in a posterior direction) above the patient's head. In most patients, if the junction of the tube 3350 is positioned forward, the upper portion of the tube 3350 is located on a smaller portion of the patient's head than if the junction of the tube 3350 is positioned rearward.

[0341] In some forms of the present technology, the patient interface 3000 is constructed so that the connection port 3600 can be positioned within a range of positions across the top of the patient's head so that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. One way in which 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, can be achieved is by disengaging the upper portion of the patient interface 3000 from the lower portion of the patient interface 3000. Such separation can be achieved using, for example, a mechanism that allows portions of the headband tube 3350 to easily move or flex relative to other portions of the patient interface 3000. Such a mechanism is described below.

[0342] In certain forms of the present technology, the patient interface 3000 is configured so that the connection port 3600 is positioned approximately at the vertex of the patient's head. The connection port 3600 may be positioned in the sagittal plane and aligned with the supra-auricular base point in a plane parallel to the coronal plane. The supra-auricular base point is at Figure 2D As will be described below, in some forms of the technology, the positioning and stabilizing structure 3300 is constructed to be worn in different positions, with the effect that the connection port 3600 can be positioned near the top of the patient's head in the sagittal plane, up to about 20 mm anterior or 20 mm posterior to the supra-auricular base.

[0343] In some examples of the present technology, the connection port 3600 can be positioned in the sagittal plane and aligned with the junction between the frontal bone and the parietal bone. The connection port 3600 can be positioned approximately above the junction of the coronal suture and the sagittal suture. In this configuration, the upper portion of the tube 3350 can be located above and / or along a portion of the coronal suture. However, as described above, the patient has the ability to move the connection port 3600 forward or backward to adjust the fit of the patient interface 3000.

[0344] The advantage provided by having the tube 3350 covering the patient's head slightly in front of the uppermost point (e.g., at or near the coronal suture) is that the risk of the tube 3350 being retracted in a posterior direction during use can be reduced. In many patients, there may be a depression or "divot" where the coronal suture meets the sagittal suture. The positioning and stabilizing structure 3300 can be particularly stable when the tube 3350 is located within this divot. Therefore, in some examples, the tube 3350 is constructed with appropriate curvature and / or bending ability to be placed over the coronal suture.

[0345] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a support cushion that is generally located below the nose and seals to the lower periphery of the nose. The positioning and stabilizing structure 3300 can be constructed and arranged to pull the seal-forming structure 3100 into the patient's face below the nose with a sealing force vector having a posterior-superior direction (e.g., a posterior-superior direction). The sealing force vector having a posterior-superior direction can help the seal-forming structure 3100 form a good seal on the lower periphery of the patient's nose and the front-facing surface of the patient's face on either side of the patient's nose and upper lip.

[0346] In some examples, the positioning and stabilizing structure 3300 can apply a sealing force vector in use that has a posterior-inferior direction of approximately 35 degrees relative to the patient's Frankfort horizontal plane. The upper portion of the tube 3350 (e.g., the portion of the tube 3350 that is above the strap 3310) can be oriented vertically, and the rear headgear strap 3310 can extend from the tube 3350 in a posterior-inferior direction at an angle of approximately 35 degrees relative to the patient's Frankfort horizontal direction. In this particular arrangement, an angle of 125 degrees is formed between the strap 3310 and the upper portion of the tube 3350, where the strap 3310 is connected to the tube 3350.

[0347] Fig.8D A side view of a patient wearing the patient interface 3000 is shown. Fig.8D3308 above the patient's ear near where the strap 3310 connects to the tube 3350. The upper portion of the tube 3350 can apply a force 3301 generated by the headband tension on the point 3308. The force 3301 can have a substantially vertical direction. The lower portion of the tube 3350 (e.g., between the seal-forming structure 3100 and the connection to the rear headband strap 3310) can apply a force 3303 on the point 3308 in an anterior-inferior direction at an angle of approximately 125° to the vertical force 3301 applied by the upper portion of the tube 3350. The force 3303 can be equal in magnitude and opposite in direction to the sealing force of the seal-forming structure 3100 being pulled into the patient's face under the nose. To balance the forces, the strap 3310 applies a force 3302 in a posterior-inferior direction at an angle of approximately 125° to the vertical force 3301 applied by the upper portion of the tube 3350. Thus, there is an angle of approximately 110° between the downward anterior force 3303 applied to point 3308 along each tube 3350 above the patient's ear and the downward posterior force 3302 applied by the strap 3310.

[0348] When the positioning and stabilizing structure 3300 is used with a support cushion, a sealing force vector of 35° may be considered optimal for many patients. Additionally, the directions of the above forces applied by each portion of the positioning and stabilizing structure 3300 may be considered ideal. However, it should be understood that in practice, the actual directions of the forces applied by each portion of the headgear will vary to accommodate each patient's specific anatomy and preferences.

[0349] For example, in many embodiments, the positioning and stabilizing structure 3300 can be configured so that the upper portion of the tube 3350 is positioned across the patient's head, slightly forward of the uppermost point. For some patients, this may result in the tube 3350 being tilted slightly forward rather than vertically aligned (e.g., in the coronal plane) so as to be positioned within a slight depression at or near the coronal suture of the skull. In such an example, the patient can adjust the tension in the strap 3310 to balance the forces and achieve the optimal sealing force vector.

[0350] 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 forming the nasolabial angle).

[0351] In certain examples of the present technology, these tubes 3350 are configured to receive the straps 3310 at a position above and close to the patient's ears. If the straps 3310 are connected to the tubes 3350 so as to be higher relative to the patient's head, the straps 3310 may have a tendency to arch up the back of the patient's head. In addition, the straps 3310 may form too large an angle relative to the upper portion of the headband tubes 3350, causing the patient to over-tighten the straps 3310, which may cause excessive tension in the positioning and stabilizing structure 3300 and make the straps 3310 more likely to arch up the back of the patient's head. Therefore, it is advantageous to set the connection between the straps 3310 and the tubes 3350 as low as possible, but at a sufficient distance from the top of the patient's ears so that when the straps 3310 are tightened, the tubes 3350 are not pulled into contact with the patient's ears.

[0352] 5.3.2.1.2 Headband tube fluid connection

[0353] The two tubes 3350 are fluidically connected to the plenum chamber 3200 at their lower ends. Figures 8A-9C and Fig. 12A -F example, the tube 3350 is fluidly connected to the support cushion module 3150 and the seal forming structure 3100. In some forms of technology, the connection between the tube 3350 and the support cushion module 3150 is achieved by the connection of two rigid components, so that the patient can easily connect the two components together in a reliable manner. The tactile feedback of "re-ensure click" or similar sound can be easy for the patient to use or for the patient to know that the tube has been correctly connected to the support cushion module 3150. In one form, the tube 3350 is formed by silicone, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector may include a convex fitting feature, which is configured to be connected to a concave fitting feature of the support cushion module 3150. Alternatively, the rigid connector may include a concave fitting feature, which is configured to be connected to a convex fitting feature on the support cushion module 3150. The same connection method in which the tube 3350 is connected to the support cushion module 3150 can also be applied to the connection between the tube 3350 and the nose cushion module 3150, or another inflatable chamber 3200 or a seal forming structure 3100.

[0354] In another embodiment, compression seals are used to connect each tube 3350 to the support cushion module 3150. For example, an elastically flexible (e.g., silicone) tube 3350 without a rigid connector may need to be slightly squeezed to reduce its diameter so that it can be inserted into the port in the plenum 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. In the hard-to-hard type joint between the tube 3350 and the port, a pressure-actuated seal, such as a peripheral sealing flange, can be used. When pressurized gas is supplied by the tube 3350, the sealing flange is pushed against the joint between the inner circumferential surface of the port of the tube and the plenum 3200 to enhance the seal between them. If the port is soft and a rigid connector is set to the tube 3350, a pressure-actuated seal as described above can also be used to ensure that the connection is airtight. In another example, each tube 3350 is formed of a resilient, flexible (e.g., silicone) material that is overmolded onto a rigid connector such that the resilient, flexible material fits over the rigid connector and itself acts as a gasket to seal the connection between the tube 3350 and the bracket cushion module 3150 around the perimeter of the airflow channel in the plenum 3200 from the tube 3350 to the bracket cushion module 3150.

[0355] A similar connection mechanism may be used to fluidly connect the tube 3350 to the T-top member defining the connection port 3600, or in some technical form, connectable to the connection port 3600. In one embodiment, the swivel elbow connected at the connection port 3600 is rotatable to actuate a port size adjustment mechanism that reduces or increases the size of the port into which the tube 3350 is inserted to improve the fit of the tube by increasing or decreasing the compressive force and reduce unexpected leaks.

[0356] 5.3.2.1.3 Extendable telescopic structure

[0357] The patient interface 3000 may include one or more extendable tube segments. In some examples, the extendable tube segments include extendable telescoping structures 3362. The patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall 3352 having an extendable telescoping structure 3362. For example, Figures 8A-9C and Fig. 12A The patient interface 3000 shown in FIG. 300A comprises a tube 3350 , the upper portion of which comprises extendable tube segments, each of which is in the form of an extendable telescopic structure 3362 .

[0358] Each extendable telescoping structure 3362 may include a portion of a tube 3350 having one or more folds, pleats, corrugations, or bellows to form an extendable portion of the tube 3350. Figures 8A-9C In the example shown, the extendable telescopic structures 3362 each take the form of an extendable telescopic structure. The extendable telescopic structures 3362 are separated by a curved tube 3610 and a connection port 3600. The extendable telescopic structures 3362 can change length. In particular, each extendable telescopic structure 3362 can extend or contract to change the length of the corresponding tube 3350.

[0359] In some examples, each gas delivery tube 3350 at the extendable telescoping structure 3362 may include a cross-section having a width and a height, wherein the width is greater than the height and is substantially aligned with the front-to-back direction in use. Figures 8A-8C The illustrated patient interface 3000 includes extendable telescoping structures 3362, each of which has a cross-sectional width of a dimension aligned in the anterior-posterior direction of the illustrated patient 1000 that is greater than the cross-sectional height. In this example, the width is approximately twice the height. That is, in this example, the width decreases along the length of the extendable telescoping structures 3362. At the upper or middle end of each extendable telescoping structure 3362, the width of the tube wall forming the extendable telescoping structure 3362 is relatively large and is similar in size to the loop of the return bend 3610 housed in the tube 3350. At the lower or lateral end of each extendable telescoping structure 3362, the width of the tube wall is relatively small and is of a similar size to the width of the non-extendable tube segment 3363. An extendable telescoping structure 3362 that changes width between a larger tube size connected to the elbow 3610 and a smaller tube size of the non-extendable tube section 3363 can provide a smooth and contiguous tube 3350 that can be more comfortable and / or aesthetically pleasing (which can improve patient compliance with treatment).

[0360] 5.3.2.1.3.1 Bendability

[0361] In some examples of the present technology, portions of the positioning and stabilizing structure 3300 are constructed to be more resistant to bending in or about some directions or axes, but less resistant to bending in or about other directions or axes.

[0362] For example, Figures 8A-9C The upper portion of each tube 3350 of the positioning and stabilizing structure 3300 shown may be more flexible 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 portion 3304 configured to cover an upper region of a patient's head (e.g., Fig. 8A-C). In the example shown, the upper tube portion 3304 includes an extendable telescopic structure 3362. In other examples of the present technology, the upper tube portion 3304 may include an alternative extendable tube structure (for example, in PCT Patent Publication No. WO 2017 / 124155, the entire contents of which are incorporated herein by reference) or may be non-extensible.

[0363] The upper tube portion 3304 includes a first end 3305 and a second end 3306. In this example, the first end 3305 is configured to cover the upper portion of the patient's head or be placed against the upper portion of the patient's head at a substantially sagittal plane of the patient's head (e.g., substantially the top and center of the patient's head). The second end 3306 is configured to cover the patient's head laterally from the first end 3305 (e.g., closer to the side of the patient's head). In some examples, if the upper tube portion 3304 is not particularly long, the second end 3306 can be placed laterally relative to the first end 3305, but may not be placed particularly below the first end 3305. In other examples, if the upper tube portion 3304 is longer, the second end 3306 can be located laterally and below the first end 3305. Fig.13 A portion of another example of a positioning and stabilizing structure 3300 is shown. Positioning and stabilizing structure of the accompanying drawings Fig.13 It can also bend around multiple axes. For example, Fig.13 The positioning and stabilizing structure 3300 in FIG. 3 can be suspended downwardly over the patient's head and also bend in the anterior-posterior direction. Fig.13 As shown, the upper tube portion 3304 is bent about two axes.

[0364] The upper tube portion 3304 may also include one or more rigidified portions between the first end 3305 and the second end 3306. The one or more rigidified portions may be configured to provide a higher resistance to relative movement between the first end 3305 and the second end 3306 in a forward and / or rearward direction than in an upward and / or downward direction.

[0365] When the patient wears the positioning and stabilizing structure 3300, the upper tube portion 3304 can have a 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 enables the upper tube portion 3304 to "hang" downward over the top of the patient's head to the side of the patient's head. The relatively high degree of bendability and up / down orientation can be advantageous for allowing the upper tube portion 3304 to conform to the curvature of the patient's head.

[0366] In addition, the upper tube portion 3304 can have a relatively high resistance to bending in the horizontal direction so that the first end 3305 does not inadvertently move forward and / or backward relative to the second end 3306. This advantageously enables the upper tube portion 3304 to remain in a desired position across the top of the patient's head. Due to the lower resistance to bending in the anterior and / or posterior directions, the upper tube portion 3304, and in particular the connection port 3600, may be less likely to retract forward or backward along the top of the patient's head during use. Given that the connection to the air circuit 4170 is provided on top of the patient's head, this resistance to forward or backward movement of the upper tube portion 3304 is particularly advantageous for the patient interface 3000, meaning that tube drag forces can act directly on the upper tube portion 3304.

[0367] In some examples, the upper tube portion 3304 may include a shape that inherently provides favorable resistance to bending. For example, the upper tube portion 3304 may include a rectangular cross-section with one of the parallel long sides configured to be placed against the surface of the patient's head. The long sides of the rectangular cross-section provide relatively large resistance to the bending of the upper tube portion in a direction parallel to the long sides (e.g., the front and / or rear directions in use). However, the short sides of the rectangular cross-section may not provide such large resistance to the bending of the upper tube portion 3304 and the direction parallel to the short sides (e.g., the lower and / or upper directions in use). It should be understood that the cross-section of the upper tube portion 3304 may not be completely rectangular. For example, the corners and / or short sides may be rounded.

[0368] The rigidizing portion may be formed by or provided to one or more stiffening structures of the tube wall of the tube 3350. The rigidizing portion is formed by a plurality of ridge connections 3370 that are configured to resist separation of adjacent ridges formed by folds in the tube wall. In particular, the rigidizing portion is formed by a series of ridge connections 3370 along the front side of the upper tube portion 3304 and the rear side of the upper tube portion 3304. A tube 3350 that includes a rigidizing portion on both the front side and the rear side of the tube 3350 may advantageously have a higher resistance to bending toward the front side and the rear side of the tube 3350. However, in some examples, a rigidizing portion is provided on only one of the front side or the rear side of the tube 3350 because, depending on the stiffness, a rigidizing portion on only one side may provide sufficient resistance to bending in both directions.

[0369] In some examples, the rigidified portion of tube 3350 may be provided to the extendable portion of upper tube portion 3304. Figures 8A-10JIn the example shown, as will be described in more detail below, the extendable portion includes an extendable telescopic structure 3362 formed in the tube wall of the tube 3350, and the extendable telescopic structure 3362 includes a plurality of ridges 3372 and a plurality of grooves 3373. In this example, the rigidifying portion includes a plurality of ridge connectors 3370 formed in the tube wall, each of the plurality of ridge connectors 3370 connecting a pair of adjacent ridges 3372. The reinforcing effect of the ridge connectors 3370 will be described in more detail below.

[0370] In other examples of the present technology, the patient interface 3000 may include tubes 3350 having a rigidized portion formed by a structure other than a ridge connection portion. In some examples, portions of the tubes 3350 (e.g., the front and / or rear) may include a rigidized portion rigidified with one or more rigidizing elements. The tubes 3350 may be hardened with one or more hardening components embedded in the tube wall having a higher stiffness than the tubes 3350. For example, the tube wall may be overmolded into an elongated strip or rod formed of a material harder than the tube wall. In other examples, the rigidized portion of the tube wall may be provided by other features of the geometry of the tube wall. In one example, the tube wall may include a greater material thickness on the front side and / or rear side of the tube 3350. In another example, the tube wall may include a reduced groove depth (or ridge height) at the rigidized portion of the tube 3350.

[0371] 5.3.2.1.3.2 Ridges and grooves

[0372] The extendable telescopic structure 3362 forming each extendable tube segment includes a plurality of ridges 3372 and a plurality of grooves 3373, such as Figures 10D-10J These ridges 3372 and grooves 3373 are alternately formed in the wall of each tube 3350 so as to form a telescoping structure. An alternating series of ridges and grooves will be 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., ridges, grooves, ridges, grooves, etc.).

[0373] The alternating ridges 3372 and grooves 3373 can act like folds or bellows that can be folded and unfolded independently or in unison to shorten or lengthen the extendable telescopic structure 3362 and the corresponding tube 3350. A large groove depth (or ridge height) can provide a more extendable tube 3350. When tension is applied to the tube 3350, the ridges 3372 and grooves 3373 of the extendable telescopic structure 3362 can be pulled apart from each other, thereby straightening the tube wall and lengthening the tube 3350. In this example, the extendable telescopic structure 3362 is biased to the original (e.g., unextended) length. When the headband tension is released, the ridges 3372 and grooves 3373 are biased back to the initial configuration, in which each extendable telescopic structure 3362 and tube 3350 has an initial length.

[0374] In addition to facilitating changes in length, the ridges 3372 and grooves 3373 can also facilitate changing the shape of the extendable telescoping structure 3362 of each tube 3350. In some examples of the present technology, a first series of alternating ridges 3372 and grooves 3373 are provided to a first side (e.g., a patient contacting side) of the tube 3350 in the extendable telescoping structure 3362, while a second series of alternating ridges 3372 and grooves 3373 are provided to an opposite second side (e.g., a non-patient contacting side) of the tube 3350. When the ridges 3372 and grooves 3373 are able to move to different degrees relative to each other on different sides of the tube 3350, the extendable telescoping structure 3362 can facilitate bending of the tube 3350. For example, on a first side of the tube 3350, the ridges 3372 and grooves 3373 can contract, while on a second side of the tube 3350, the ridges 3372 and grooves 3373 can expand, resulting in bending of the tube 3350 in the extendable telescoping structure 3362. Alternatively, the ridges 3372 and grooves 3373 on the first side and the second side may expand during use, but the ridges 3372 and grooves 3373 on the first side may expand less to enable the tube 3350 to bend (e.g., into a curve) in the direction of the first side, such as to conform to or wrap (e.g., cover) the patient's head while extending in length.

[0375] In some examples, the first alternating series of ridges 3372 and grooves 3373 may have a lower extension stiffness (e.g., less force required to achieve a unit length change) than the second alternating series of ridges 3372 and grooves 3373. The reduced extension stiffness of the non-patient contacting side of the extendable telescoping structure 3362 may advantageously facilitate bending / curving of the tube 3350 in use by enabling the outside of the tube 3350 to extend to cover a greater arc length than the inside of the tube 3350 in the extendable telescoping structure 3362. While the extension stiffness of the first alternating series of ridges 3372 and grooves 3373 and the second alternating series of ridges 3372 and grooves 3373 may be different from each other, the extension stiffness of each may be selected to achieve a desired overall extension stiffness of the extendable telescoping structure 3362.

[0376] The ridges 3372 and grooves 3373 can each be formed along a portion of the tube wall around a majority of the longitudinal axis of the tube 3350, such as on all or nearly all sides of the tube 3350. This can enable the extendable telescoping structure 3362 to bend about multiple axes. Figures 10H-10J and Fig.13 As shown in , a telescoping structure 3362 according to an example of the present technology can enable the tube 3350 to be in multiple axes. Fig. 10H and 10I An extendable telescopic structure 3362 is shown that is bent in the up-down direction (e.g., covered on the patient's head). Fig.10J An extendable telescoping structure 3362 is shown that bends in an anterior-posterior direction (e.g., to enable the tube 3350 to be positioned on top of the patient's head at different locations), Fig.13 An extendable telescopic structure 10J is shown that bends simultaneously in the up-down and front-to-back directions.

[0377] In some examples, each of the ridges 3372 and grooves 3373 is substantially straight. In other examples, the ridges 3372 and / or grooves 3373 can include one or more arcuate portions.

[0378] like Fig. 10D As shown, each ridge 3372 includes a central curved ridge 3374. That is, each ridge 3372 includes a precise portion at its center. However, at the end of each ridge 3372 is a straight ridge 3375. Therefore, each ridge 3372 includes a pair of straight ridges 3375 disposed at opposite ends of the ridge 3372.

[0379] Similarly, each groove 3373 includes a curved groove portion 3376 located at the center of the corresponding groove. Therefore, the center of each groove 3373 is accurate. In addition, at the end of each groove 3373 is a straight groove portion 3377. Each groove 3373 includes a pair of straight groove portions 3377 disposed at opposite ends of the groove 3373. Each curved groove portion 3376 can include a curvature that matches or is defined by the curvature of the pair of adjacent ridges 3372, particularly the curvature of the curved ridge 3374.

[0380] Each ridge connection portion 3370 connects a corresponding pair of adjacent ridges 3372 at the straight ridge portions 3375 of the pair of ridges 3372. The straight groove portions 3377 may each be defined between adjacent straight ridge portions 3375 on either side along the length of the tube 3350 and the ridge connection portion 3370 above or below the straight groove portion 3377 (depending on whether it is on the upper or lower side of the tube 3350, as the case may be, for each straight groove portion 3377).

[0381] Although the extendable telescoping structure 3362 includes ridges 3372 and grooves 3373 on the exterior of the gas delivery tube 3350, the folds forming the extendable telescoping structure 3362 may also form ridges and grooves on the interior of the gas delivery tube 3350 (e.g., as a result of the folds forming a wavy shape in the tube wall, such as a sinusoidal shape, a square wave, or other waveform). Fig. 10B The specific wave shape formed in the tube wall is shown in FIG. Fig. 10BAs shown, the extendable telescoping structure 3362 includes folds that form internal ridges 3382 and internal grooves 3383. In particular, the folds in the tube wall form a first alternating series of internal ridges 3382a and internal grooves 3383a inside the tube 3350 along the non-patient contacting side of the tube 3350. Additionally, the folds form a second alternating series of internal ridges 3382b and internal grooves 3383b along the patient contacting side of the tube 3350.

[0382] Each of the first alternating series of interior grooves 3383a can be arranged across the interior of the tube 3350 to oppose a corresponding interior groove 3383b of the second alternating series to form a plurality of opposing groove pairs. That is, each interior groove 3383a on the non-patient contacting side of the tube 3350 can be paired with an opposing interior groove 3383b on the patient contacting side. Fig. 10B As shown, each relative groove pair includes a first inner groove 3383a and a second inner groove 3383b. In this example, the first inner groove 3383a includes a groove depth greater than the second inner groove 3383b. The greater groove depth of the first inner groove 3383a in each relative groove pair causes the first alternating series of ridges and grooves to have a lower extension stiffness than the second alternating series. In other examples of the present technology, a relatively low stiffness of the ridges and grooves forming the first alternating series can be provided by strengthening the ridges and grooves of the second alternating series. In one example, a ridge connector 3370 (described separately below) is provided to the tube wall to connect paired adjacent ridges. In another example, the ridges and grooves of the second alternating series are formed by a harder material than the first alternating series (e.g., a different material with higher stiffness, or in the case where the tube is formed by silicone, a silicone area with a higher Shore hardness, etc.). In another example, the ridges and grooves of the second alternating series can be strengthened with a hardened component.

[0383] In the example shown, the tube wall of the tube 3350 includes a greater material thickness at the base of the second inner groove 3383b of each opposing groove pair than at the base of the first inner groove 3383a of the corresponding groove pair. The greater material thickness forming the base of the second inner groove 3383b of each of the groove pairs reduces the groove depth of the second inner groove 3383b. The reduced groove depth reduces the extensibility of the extendable telescoping structure 3362 on the side having the second alternating series of ridges and grooves.

[0384] like Fig. 10BAs shown, the material thickness of the tube wall at the base of each internal groove 3383b of the second alternating series decreases along the length of the tube 3350 from the first end proximate the connection port 3600 to the second end. In addition, 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 along the length of the gas delivery tube 3350 from the first end proximate the connection port 3600 to the second end. The reduction in groove depth on both sides of the tube 3350 along the length of the extendable telescoping structure 3362 helps to change the size of the tube 3350 between the larger connection port 3600 and the smaller, non-extendable tube section 3363. Although the groove depth is generally smaller at the second end compared to the first end, for each opposing groove pair, the second internal groove 3383b on the second patient contacting side of the extendable telescoping structure 3362 has a smaller groove depth than the opposing first internal groove 3383a on the first non-patient contacting side.

[0385] In this example, the first internal groove 3383a of each opposing groove pair is joined to the second internal groove 3383b of the corresponding opposing groove pair at the side of the tube 3350 between the non-patient contact side and the patient contact side. That is, the tube 3350 is grooved all the way around the interior of the tube wall. Therefore, the first internal groove 3383a and the second internal groove 3383b of each opposing groove pair are adjacent. Similarly, each internal ridge 3382a of the first alternating series of internal ridges 3382a and internal grooves 3383a is adjacent to the opposing internal ridge 3382b of the second alternating series of internal ridges 3382b and internal grooves 3383b.

[0386] 5.3.2.1.3.3 Ridge connection

[0387] As shown in the figure. In some embodiments, the extendable telescopic structure 3362 also includes a plurality of ridge connections 3370 disposed on the tube wall of the gas delivery tube 3350. Each ridge connection 3370 connects a pair of adjacent ridges 3372. These ridge connections 3370 can each include an integrally formed portion of the tube wall. Each ridge connection 3370 can be formed into the tube wall. Each ridge connection 3370 connects two or more adjacent ridges 3372 and is configured to resist separation of these ridges 3372. These ridge connections 3370 may not prevent the separation of these ridges 3372, but may increase the rigidity of the extendable telescopic structure 3362.

[0388] One function of the ridge connection 3370 is to reduce the ability of the extendable telescoping structure 3362 to extend. While the extendable telescoping structure 3362 is intended to extend, and there are advantages associated with a tube 3350 that is extendable in length, an over-extendable tube 3350 may be difficult for a patient to use comfortably and safely. Thus, the ridge connection 3370 reduces the ability of the extendable telescoping structure 3362 to increase in length, but does not prevent it from extending at all. In the example shown, the ridge connection 3370, in combination with the ridge 3372 and the groove 3373, forms an extendable telescoping structure 3362 that facilitates full extension to the length of the tube 3350 to improve the ability of the positioning and stabilizing structure 3300 to adapt to a range of patient head sizes, without being too flexible to achieve sufficient tension and sealing force.

[0389] Each pair of adjacent ridges 3372 of the extendable telescopic structure 3362 may be connected by at least one ridge connection 3370. Alternatively, or in addition, one or more pairs of adjacent ridges 3372 may be connected by two ridge connections 3370. Figures 10D-10J , each pair of adjacent ridges 3372 of the telescoping structure 3362 is connected by two ridge connections 3370. Each ridge connection 3370 can be centrally spaced between a lower side of the gas delivery tube 3350 (e.g., a patient contacting side) and an upper side of the gas delivery tube 3350 (e.g., an upwardly and / or outwardly facing side).

[0390] Another function of the spine connectors 3370 is that they provide local reinforcement to the extendable telescoping structure 3362. The local reinforcement provided to the extendable telescoping structure 3362 is advantageous for the headband tube 3350, which is designed to bend easily about one axis while having certain resistance to bending about a different axis.

[0391] In some examples, a ridge connection 3370 is provided between the ridges 3372 and the grooves 3373 on the side of the tube 3350, and is configured to be less curved than the other sides of the tube 3350. One or more ridge connections 3370 can be located on the forward-facing side of the gas delivery tube 3350. Alternatively or additionally, one or more ridge connections 3370 can be located on the rearward-facing side of the gas delivery tube 3350.

[0392] In the example shown, if Figures 10D-10JAs shown in FIG, ridge connections 3370 are provided to the positioning and stabilizing structure 3300 between the ridges 3372 on the front and rear sides of the extendable telescoping structure 3362. That is, each pair of adjacent ridges 3372 is connected by a ridge connection 3370 located on the front-facing side of the gas delivery tube 3350. Additionally, each pair of adjacent ridges 3372 is connected by a ridge connection 3370 located on the rear-facing side of the gas delivery tube 3350.

[0393] Since the spine connection 3370 is located on the front and rear sides in this example, the spine connection 3370 provides greater resistance to the extendable telescopic structure 3362 bending toward the front and rear sides than the extendable telescopic structure 3362 bending toward the upper and lower directions. This is advantageous because the extendable telescopic structure 3362 maintains the ability to bend to fit the upper and side surfaces of the patient's head. This ability to bend results in the tube 3350 being able to hang down over the patient's head and fit comfortably. At the same time, the reduced ability of the extendable telescopic structure 3362 to bend in the front and rear directions can reduce the tendency of the uppermost portion of the positioning and stabilizing structure 3300 to move forward or backward or shrink during use, which may compromise the stability of the patient interface 3000.

[0394] The provision of the spine connection 3370 is advantageous in limiting the extendability of the extendable telescoping structure 3362 without unduly compromising the ability of the extendable telescoping structure 3362 to bend about a particular axis in which it is advantageous for the extendable tube segment to do so.

[0395] In some examples of the present technology, another function provided by the spine connection 3370 is to increase the torsional resistance of the extendable telescoping structure 3362. Because the connection ports 3600 are provided between the extendable telescoping structures 3362, in some cases, tube drag forces can act on the tubes 3350 to cause torsions in the extendable telescoping structures 3362. The low profile shape (e.g., a generally rectangular cross-section) of the tubes 3350 can provide twist resistance, however the spine connection 3370 advantageously provides further twist resistance. The spine connection 3370 can reinforce the front and rear sides of the extendable telescoping structure 3362, acting as a rigidifier to reduce the likelihood of the tubes 3350 twisting.

[0396] In some examples of the present technology, the grooves 3373 of the extendable telescopic structure 3362 can be formed as depressions relative to the outer surface of the gas delivery tube 3350. In other examples, the ridges 3372 of the extendable telescopic structure 3362 can be raised relative to the outward-facing surface of the tube wall, and the grooves 3373 can be formed by the spaces between the raised ridges 3372. Figures 10D-10J, the grooves 3373 are formed as depressions relative to the outer surface of the tube 3350. The outer surface of the tube 3350 from which these grooves 3373 are depressed can abut against the outer surface of the non-extensible tube segment 3363. An advantage of forming the grooves 3373 as depressions relative to the outer surface of the tube 3350 is that the ridges 3372 do not protrude outwardly from the outer surface of the non-extensible tube segment 3363. Ridges that protrude outwardly may be uncomfortable for the patient.

[0397] like Figures 10D-10J , the outwardly facing surface of the ridge connector 3370 does not protrude further outwardly relative to the longitudinal axis of the tube than the ridge 3372. In addition, each ridge connector 3370 includes an outwardly facing surface that is adjacent to the outwardly facing surface of the adjacent ridge 3372. The ridge connectors 3370 may be less aesthetically pleasing to protrude outwardly relative to the longitudinal axis of the tube 3350 than the ridges 3372, although they may do so in some examples of the present technology, for example to provide increased bending and / or torsional strength.

[0398] In addition, if Figures 10D-10J As shown, each of the plurality of grooves 3373 is located between a corresponding pair of ridge connections 3370. Each corresponding ridge connection 3370 is located at a corresponding end of the corresponding groove 3373. In addition, each of the plurality of grooves 3373 includes a groove depth, and each of the plurality of ridge connections 3370 includes a ridge connection height. For each set of ridge connections 3370 and 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 3370 of the corresponding pair of ridge connections 3370 located at the end of the corresponding groove 3373. Therefore, the grooves 3373 are formed as depressions relative to the ridge connections 3370, the ridges 3372, and the outer surface of the tube wall of the tube 3350.

[0399] These spine connections 3370 can be relatively narrow and rib-shaped, as shown in the example shown. Alternatively, the spine connections 3370 can be thicker (e.g., so that they occupy a larger portion of the front and rear sides of the extendable portion of the tube 3350).

[0400] In the example shown, the ridge connection 3370 is disposed on the outside of the tube 3350. That is, the ridge connection 3370 connects the ridge 3372 on the outside of the tube wall, rather than connecting the ridge 3372 on the inside of the hollow interior defined within the tube 3350. In other examples, the ridge connection 3370 can be disposed to the inside of the tube wall of the tube 3350. The fold in the tube wall forming the extendable telescoping structure 3362 can form a series of alternating ridges and grooves on the inside of the tube wall that is opposite to the series of ridges 3372 and grooves 3373 formed on the outside of the tube wall. That is, the fold that forms the ridge 3372 on the outside of the tube wall can form a groove around the interior of the tube wall. Similarly, the fold that forms the groove 3373 on the outside of the tube wall can form a ridge on the inside of the tube wall.

[0401] The ridge connections 3370 can connect between adjacent ridges on the outside or inside of the tube 3350 to resist separation of the ridges. In one example of a positioning and stabilizing structure 3300 having ridge connections 3370 on the outside of the tube 3350, the ridges 3372 on the outside of the tube are connected and require more tension to separate, while the ridges on the inside of the tube will separate more freely. Similarly, in an alternative example of a positioning and stabilizing structure 3300 having ridge connections 3370 connecting ridges on the inside of the tube 3350, the ridges on the inside of the tube wall require more force to separate, while the ridges on the outside of the tube may separate more freely. In some examples, the ridge connections 3370 connect a combination of internal and external ridges.

[0402] In some examples of the present technology, a single ridge connector 3370 connects multiple ridges 3372. In other examples, each ridge connector 3370 connects only a single pair of adjacent ridges 3372. In some examples, one or more ridge connectors 3370 may connect non-adjacent ridges 3372 (e.g., the first and last ridges, every other ridge, etc.).

[0403] 5.3.2.1.4 Non-extensible headband tube

[0404] The patient interface 3000 may include one or more non-extensible tube segments 3363. For example, Figures 8A-9C The patient interface 3000 shown in FIG. 3 includes a tube 3350, the lower portion of which includes a non-extensible tube segment 3363. These non-extensible tube segments 3363 are configured to cover the patient's cheeks and can be configured to contact the patient's face below the patient's cheekbones. Each non-extensible tube segment 3363 can be located on a curve extending downward from the connection between the corresponding headband tubes 3350, and then extends in a direction toward the front and middle of the seal-forming structure 3100 to avoid the patient's cheekbones.

[0405] Advantageously, the positioning and stabilizing structure 3300 of the patient interface 3000 is not located on the patient's cheekbones. The area below the patient's cheekbones is typically more fleshy, and the patient may find it easier to tolerate the headband tube 3350 being located on these areas of the face. In addition, because the cheekbone area of ​​the patient's face is relatively immobile or non-deformable, the non-extensible tube section 3363 rests firmly against the fleshy cheek area. Furthermore, the patient's cheekbones may help prevent the lower portion of the headband tube 3350 from retracting upward over the cheekbones toward the patient's eyes. When the non-extensible tube section 3363 fits snugly on the patient's cheek below the cheekbones, the hardness and prominence of the patient's cheekbones may provide an obstacle for the headband tube 3350 to retract upward toward the patient's eyes (which may affect stability and / or potentially block the patient's vision).

[0406] The cross-sectional shape of the non-extensible tube section 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rounded rectangular, for example as described in U.S. Pat. No. 6,044,844. A cross-sectional shape presenting a flat surface of the tube on the side facing and contacting the patient's face or other part of the head may be more comfortable to wear than, for example, a tube having a circular cross-section.

[0407] The cross-sectional width and / or height of the tube 3350 may be in the range of 8-25 mm, e.g., 10-20 mm. In some forms where the tubes have a D-shaped cross-section, e.g., Fig. 10C In the case of the longitudinal cross-section of the headband tubes 3350 shown in , the tubes have a width in the range of 15-25 mm (e.g., 20 mm), and a height in the range of 8-15 mm (e.g., 10 mm). The height can be considered as the dimension of the tube that extends away from the patient's face in use, i.e., the distance between the outermost portions of the patient contacting side 3348 and the non-patient contacting side 3349, while the width can be considered as the dimension across the surface of the patient's head. The cross-sectional thickness of the material forming the tubes 3350 can be in the range of 0.8-1.6 mm, such as 1.0-1.5 mm, such as 1.3 mm.

[0408] The D-shaped cross-sectional tube 3350 has rounded edges 3347 on the side of the patient contacting side 3348. The rounded edges in contact with or close to the patient's skin help the patient interface 3000 to be more comfortable to wear and avoid marking or irritating the patient's skin. Tubes with a D-shaped cross-sectional profile are also more resistant to buckling than profiles of other shapes.

[0409] Another advantage of the D-shaped cross-section of the non-extensible tube segment 3363 of the tube 3350 is that the non-extensible tube segment 3363 located in front of the patient's face during use is more resistant to bending in the vertical direction than in the horizontal direction. The D-shaped cross-section makes these non-extensible tube segments 3363 more resistant to bending parallel to the long axis of the D-shape than bending perpendicular to the long axis of the D-shape. This is advantageous because the non-extensible tube segment 3363 can bend more easily to bend inward around the front of the patient's face to the seal-forming structure 3100, while maintaining stiffness and vertical orientation so that the vertical force applied to the non-extensible tube segment 3363 from the extendable telescoping structure 3362 can be transmitted to the seal-forming structure 3100 so as to provide the necessary sealing force to the seal-forming structure 3100.

[0410] The ability to flex inwardly around the front of the patient's face enables the non-extensible tube segment 3363 to fit snugly on the patient's cheek below the patient's cheekbone. As described in more detail above, a non-extensible tube segment 3363 that sits snugly below the patient's cheekbone can provide a more stable seal than a non-extensible tube segment 3363 that sits loosely above or high above the patient's cheekbone.

[0411] In other examples, the non-extensible tube segment 3363 may include a rectangular cross section. A rectangular cross section may provide advantages similar to a D-shaped cross section. In particular, a rectangular cross section may provide the non-extensible tube segment 3363 with greater bending resistance in a direction parallel to the short side of the rectangular cross section. In other examples, the non-extensible tube segment 3363 may include an elliptical or oval cross section, which may provide similar advantages.

[0412] In some examples of the present technology, these inextensible tube segments 3363 are connected to the support cushion module 3150 at a small angle. As described above, the headband tube 3350 can extend downward along the side of the patient's head and then bend forward and inward to connect to the support cushion module 3150 in front of the patient's face. Before connecting to the support cushion module 3150, the tube 3350 can extend to a position at the same vertical position as the connection of the support cushion module 3150, or in some examples, to a position below the connection with the support cushion module 3150. That is, the tube 3350 can protrude in an at least partially higher direction before connecting to the support cushion module 3150. A portion of the tube 3350 can be located below the support cushion module 3150 and / or the seal-forming structure 3100. The low position of the tube 3350 in front of the patient's face facilitates contact with the patient's face below the patient's cheekbones.

[0413] 5.3.2.2 Headband size and stiffness

[0414] The size of the positioning and stabilizing structure 3300 can vary between different examples of the present technology. Providing different size options for the patient interface 3000 can enable more patients to be accommodated. A ring around the patient's head can be formed by a pair of headband tubes 3350 and a support 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 ring can vary to provide patient interfaces 3000 of different sizes.

[0415] In one example, the unextended length of the loop formed by the tube 3350 and the support cushion module 3150, measured along the centerline of the patient-facing side of the loop, can be in the range of 510-610 mm. In some examples, the unextended length of the loop can be in the range of 525-600 mm. In some examples, the length of the loop can be in the range of 535-590 mm.

[0416] In some specific examples, the unextended length of the above-mentioned loop can be in the range of 528-548 mm, such as in the range of 535-541 mm, for example, about 538 mm. In a further specific example, the length of this loop can be in the range of 534-554 mm, such as in the range of 539-549 mm, for example, about 544 mm or about 547 mm in the example. In a further specific example, the unextended length of this loop can be in the range of 541-561 mm, such as in the range of 546-556 mm, for example, about 551 mm.

[0417] In other specific examples, the unextended length of the loop can be in the range of 564-584 mm, such as in the range of 571-581 mm, such as about 574 mm or about 579 mm in the examples. In further examples, the unextended length of the loop can be in the range of 577-597 mm, such as in the range of 582-592 mm, for example, about 583 mm or about 587 mm.

[0418] The length of the gas delivery tube 3350 can be varied, in particular, to provide different sizes of positioning and stabilizing structures 3300. In some examples, the unextended length of the tube 3350 measured along the centerline of the patient-facing side of the tube 3350 can be in the range of 500-535 mm, such as between 510-525 mm, such as within the range of 512-522 mm, for example, about 517 mm. In further examples, the unextended length of the tube 3350 can be in the range of 460-500 mm, such as between 470-490 mm, such as within the range of 475-485 mm, for example, about 481 mm.

[0419] As described in more detail above, in some examples of the present technology, the headband tube 3350 includes an extendable portion (e.g., an extendable telescoping structure 3362). In some examples of the present technology, the extendable portion of the gas delivery tube 3350 (e.g., a single telescoping portion on one side of the positioning and stabilizing structure 3300) may include a stiffness (for extension) in the range of 2-3.5N / 10mm (e.g., 0.2-0.35N / mm). In a specific example, the extendable portion may include a stiffness in the range of 2.5-3N / 10mm (e.g., 0.25-0.3N / mm). In one example, the extendable portion may include a stiffness of approximately 2.75N / 10mm (e.g., 0.275N / mm). In a further example of the present technology, the extendable portion of the tube 3350 may require a tension between 2.5N and 3N to extend 10mm in length, and may require a tension between 5N and 5.5N to extend 20mm in length. It should be understood that in various examples of a patient interface 3000 according to the present technology, any of these disclosed stiffnesses can be provided to a tube 3350 having any of the dimensions (eg, lengths) described above.

[0420] 5.3.2.3 Headband straps

[0421] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headband in addition to the tube 3350 for positioning and stabilizing the seal-forming structure 3100 in a sealing position at the entrance to the patient's airway. Figures 8A-9C , the patient interface 3000 includes a strap 3310 that forms part of the positioning and stabilizing structure 3300. For example, the strap 3310 may be referred to as a back 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 3000 with a full face or mouth-nose cushion module according to an example of the present technology may have a second lower strap that is configured to cover the back of the patient's neck.

[0422] 5.3.2.3.1 Binding straps

[0423] exist Figures 8A-9CIn the example shown, the strap 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350, which are positioned on each side of the patient's head and around the back of the patient's head, for example, covering or lying under the occipital bone of the patient's head during use. The strap 3310 is connected to each tube above the patient's ears. In other embodiments, for example as part of an oral and nasal patient interface, the positioning and stabilizing structure 3300 includes an upper strap similar to the strap 3310 and at least one additional lower headband strap, which is connected between the tubes and / or cushion modules and below the patient's ears and around the back of the patient's head. Such a lower headband can also be connected to the upper strap (e.g., similar to the strap 3310).

[0424] In some forms of the technology, the positioning and stabilizing structure 3300 includes a mechanism for connecting the headgear straps to the headgear tubes 3350. The headgear straps may be connected directly or indirectly to the headgear tubes 3350. Figures 8A-9C In the case of the patient interface 3000 shown, for example, tabs 3320 configured to connect to the straps 3310 project outwardly in a generally rearward direction from each headband tube 3350. The tabs 3320 have a plurality of holes therein to receive the ends of the straps 3310.

[0425] In some forms of the present technology, strap 3310 is adjustable. Figures 8A-9C In the case of the patient interface shown, the strap 3310 is passed through a hole in the form of an eyelet in each tab 3320 during use. The length of the strap 3310 between the tabs 3320 can be adjusted by pulling more or less straps 3310 through one or both tabs 3320. The strap 3310 can be fastened to itself, for example, with a hook and loop fastening device after passing through the eyelets in the tabs 3320. Thus, the strap 3310 can be adjusted to fit around different head sizes. In some forms of the technology, the angle of the strap 3310 relative to the headband tube 3350 or the patient's head can be adjusted to fit around the patient's head at different positions. This adjustability helps the positioning and stabilizing structure 3300 accommodate different head shapes and sizes.

[0426] In some forms of the technology, the strap 3310 exerts a force on the headband tubes 3350 to pull them in a direction at least partially backward (e.g., backward) at the location of the tabs 3320. The strap 3310 may also exert a force on the headband tubes 3350 to pull them in a direction at least partially downward (e.g., downward). The amount of this force may be adjusted by varying the length of the strap 3310 between the tabs 3320.

[0427] In some forms of this technology, such as Figures 8A-9CIn the example shown, the direction of the force applied by the strap 3310 to the headband tube 3350 can also be changed. The direction can be changed by adjusting the angle of the strap 3310 relative to the headband tube 3350 or the patient's head. In some forms of the technology, the location where the strap 3310 applies the force on the headband tube 3350 can be changed by adjusting the location where the strap 3310 is fixed to the headband tube 3350.

[0428] The adjustability of the amount and direction of the force applied by the strap 3310 to the headband tube 3350 can advantageously enable the positioning and stabilizing structure 3300 to accommodate a range of head sizes and head shapes. The strap 3310 can balance the forces in the headband tube 3350, which can help the headband maintain its shape and an effective seal against the patient's face while maintaining comfort.

[0429] In some forms of the present technology, when worn by a patient, points on the headband tube 3350 near the tab 3320 will receive a generally upward (e.g., upper) force from the upper portion of the headband tube 3350 due to tension in the headband tube 3350 and, in some examples, due to a biasing mechanism (described in further detail below) used to keep the headband secured to the patient's head. Additionally, points on the headband tube 3350 near the tab 3320 may receive generally forward (e.g., front) and downward (e.g., lower) forces caused by the biasing mechanism that acts to push 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, for example, differences in head shape and size. In some forms of the technology, the adjustability of the rear headgear strap 3310 enables forces to be balanced across a range of head shapes and sizes to hold the positioning and stabilizing structure 3300 in a comfortable position while maintaining an effective seal.

[0430] For example, to provide a greater force in a rearward (e.g., rearward) direction on the portion of the headband tube 3350 proximate the tab 3320, the strap 3310 may be adjusted by pulling more of the strap 3310 through the slot in the tab 3320. Doing so will shorten the length of the strap 3310 and, particularly if the strap 3310 is elastic, will apply a greater force in a rearward (e.g., rearward) direction on the headband tube 3350. Similarly, the angle of the strap 3310 may be adjusted as needed to balance the vertical and horizontal components of the force on the portion of the headband tube 3350 proximate the tab 3320 over a range of head shapes and sizes.

[0431] The strap 3310 may include a rectangular cross-section along part or all of its length. Additionally, the strap 3310 may have a profile with one or more rounded edges to provide greater comfort and reduce the risk of the headband marking or irritating the patient. In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap 3310 that is flexible and, for example, non-rigid. An advantage of this aspect is that it is more comfortable for the patient to lie flat while wearing the strap 3310 while the patient is sleeping.

[0432] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap 3310 that includes two or more strap strips separated by a split. Figures 8A-9C 12A-F, the strap 3310 includes a split 3313 that is configured to be positioned against the back of the patient's head during use. In the case of some patient interface designs, the breakaway strap 3310 can secure the patient interface 3000 to the patient's head in a particularly stable manner. The back of the patient's head can have a complex geometry and the presence of the split 3313 in the strap 3310 can help the strap better conform to the back of the patient's head.

[0433] 5.3.2.3.2 Eyelets

[0434] As described above, each gas delivery tube may include 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 circular side and a straight side. The eyelet may be D-shaped, for example. Figures 8A-9C The eyelets in the exemplary patient interface 3000 shown are in the form of slits 3322. In this example, the pair of gas delivery tubes 3350 provide a pair of slits 3322 to which the strap 3310 can be connected. That is, the strap 3310 can be connected between the eyelets. The strap 3310 can be constructed and arranged to contact an area of ​​the patient's head below or covering the occipital bone of the patient's head in use. In this example, the slits 3322 are formed in tabs 3320 connected to the tube wall of the tubes 3350.

[0435] In some examples of the present technology, an eyelet may be positioned on each tube 3350 between 70 mm and 150 mm extending along the tubes 3350 from the center of the tube pair 3350 (e.g., the connection port 3600). In a further example, 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 a specific example, the 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 stabilizing structure 3300 having a slit 3322, the midpoint of the slit is located approximately 120-125 mm from the center of the pair of gas delivery tubes 3350.

[0436] Figures 8A-9C The exemplary patient interface 3000 shown includes a single rear headgear strap 3310 that passes between the slits 3322 and which generally requires the application of force in a partially inferior and partially posterior direction on the tube 3350. In order to apply force on the tube 3350 in the necessary direction, the strap 3310 should be wrapped downwardly around the back of the patient's head. Typically, the back of the patient's head generally curves downwardly and forwardly over the occipital bone of the skull, toward the point where the head connects to the patient's neck.

[0437] If the strap 3310 does not fit low enough around the back of the patient's head (e.g., not below the rear-most point of the patient's head, where the rear surface of the patient's head curves forward and partially downward), there is a risk that the strap 3310 may ride up at the back of the patient's head during use. If the strap 3310 rides up past the rear-most point of the patient's head, the strap 3310 may be located on an area of ​​the patient's head that faces in a partially upward direction. If this occurs, it is possible that tension in the strap 3310 may pull the strap further upward, which may result in a failure of the positioning and stabilizing structure 3300 to provide the necessary sealing force vector to the seal-forming structure 3100 (after which the seal to the patient's face may be compromised and the patient will need to re-apply the patient interface 3000).

[0438] like Figures 11A-11C As shown in , each gas delivery tube 3350 may include a tube wall 3352 that defines a hollow interior (eg, forming a conduit) along the length of the tube 3350 . A pressurized air flow can travel from the connection port 3600 through the hollow interior within the tube wall 3352 for delivery to the seal-forming structure 3100 .

[0439] exist Figures 11A-11CIn the example shown, the tube 3350 includes a tab 3320. In this example, the tabs 3320 of the positioning and stabilizing structure 3300 are each integrally formed with the corresponding tube wall 3352 of the tube 3350. Alternatively, these tabs 3320 can be separate parts assembled with the tube 3350. For example, the tab 3320 can include a separate component that is movably connected to the tube 3350 to enable the position and / or angle of the tab 3320 to be adjusted. By reducing the required assembly, forming the tab 3320 integrally with the tube wall 3352 can improve the usability of the positioning and stabilizing structure 3300. In addition, the integrally formed tab 3320 can achieve a seamless connection between the tab 3320 and the tube wall 3352, reducing the possibility of discomfort to the patient caused by the connection.

[0440] In the example shown, each tube 3350 includes an extendable tube segment in the form of an extendable telescoping structure 3362. Each tab 3320 is joined to the tube wall 3352 of the gas delivery tube 3350 below the extendable tube segment. In particular, each tab 3320 is joined to the tube wall 3352 of the gas delivery tube 3350 at a non-extendable tube segment 3363 below the extendable tube segment. In some examples, each tab 3320 may have an upper edge 3331 spaced from the end of the extendable tube segment along the length of the tube 3350. In other examples, the tabs 3320 may have upper edges 3331 that meet the tube wall 3352 at or adjacent to the lower end of the extendable tube segment.

[0441] exist Figures 11A-11C In the example shown, the slit 3322 of the tube 3350 is formed in the tab 3320. In other examples, the slit 3322 can be formed directly into the tube wall 3352, or can be formed into another portion of the positioning and stabilizing structure 3300, or formed into a separate component that is configured to be connected to the positioning and stabilizing structure 3300.

[0442] Each of these slits 3322 can be spaced apart from the tube wall of the corresponding tube 3350 at the rear during use. Specifically, each slit 3322 can be spaced apart from the slit adjacent portion 3355 of the tube wall 3352 at the rear beside the corresponding slit 3322. The slit adjacent portion 3355 of the tube wall 3352 can be the portion of the tube wall 3352 connected to the tab 3320. More specifically, the slit adjacent portion 3355 of the tube wall 3352 can be the portion of the tube wall 3352 that is most adjacent to the slit 3322. In some examples, the slits 3322 can be spaced apart at the rear relative to the entire length of the tube wall 3352. The slits 3322 can be located above the supra-auricular base of the patient's head during use.

[0443] exist Figures 8A-8CIn the example shown, each tube wall 3352 is configured to cover the patient's head along a path 3353 that passes between the patient's eyes and ears. A portion of the path 3353 is located between the patient's eyes and ears. Fig.11A and 11B 3353 is shown in . In some examples, path 3353 is generally a path on the surface of the patient's head, and tube wall 3350 is located on and along this path. In addition, path 3353 can be the path along which the gas flowing through tube 3350 travels from the top of the patient's head to the seal-forming structure 3100. In fact, path 3353 can include a curve in three-dimensional space (e.g., a spatial curve), because in some examples, path 3353 may not be limited to a plane. In the illustrated example, tube 3350 travels laterally and downwardly above the side of the patient's head, and then travels below, in front, and in the middle to connect with the support cushion module 3150.

[0444] like Figures 11A-11C As shown in , each slit 3322 includes an upper end 3326 and a lower end 3327. The upper end 3326 and the lower end 3327 can also be considered as a first end and a second end, respectively. In this example, the upper end 3326 is further away from the slit adjacent portion 3355 of the tube wall 3352 than the lower end 3327. Fig.11A As shown, the upper end 3326 of the slit 3322 is spaced from the tube wall 3352 by a spacing indicated by SE in the illustration. The lower end 3327 of the slit 3322 is spaced from the tube wall 3352 by a spacing indicated by IE. As shown, the spacing SE is greater than the spacing IE, and therefore, the upper end 3326 is farther from the tube wall 3352 than the lower end 3327. When the patient interface 3000 including the positioning and stabilizing structure 3300 is donned by the patient, the upper end 3326 is spaced rearwardly relative to the lower end 3327. Unless the context clearly requires otherwise, if one end of a slit or eyelet is described as being farther from the tube wall than the other end of the slit or eyelet, the spacing referenced should be understood to be relative to the portion of the tube wall that is generally adjacent to or closest to the slit or eyelet (e.g., a slit-adjacent or eyelet-adjacent portion).

[0445] like Fig. 11BAs shown, at a portion 3355 of the tube wall 3352 adjacent to the slit, the slit 3322 is oriented at an angle relative to the orientation of the tube 3350. The slit 3322 is also oriented at an angle relative to the path 3353 at the slit adjacent portion 3355 of the tube wall 3352. In this example, the slit 3322 is arcuate between the upper end 3326 and the lower end 3327. Each of these slits 3322 has 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 arc shape of these slits 3322 can advantageously enable the bandage 3310 to pass through the slit to reach the center within the slit 3322 and can also allow the slit 3322 to allow some changes in the angle of the bandage 3310 passing through the slit 3322 without causing the bandage 3310 to gather toward one end of the slit 3322.

[0446] Fig. 11B Shown is the length axis 3323 of the slot 3322. The length axis 3323 in this example is defined along the overall length of the slot 3322 because the slot is elongated. Fig.11A -C, when it is elongated, may still include a length axis. It should be understood that in the case of an arcuate slit 3322, the length axis 3323 may not be parallel to every portion of the side of the slit 3322, but may be defined by a general direction from one end to the other end 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 central portion of the slit 3322.

[0447] The slit 3322 can have a posterior-superior-anterior-inferior orientation in use. That is, the length (e.g., length axis 3323) of the slit 3322 can be aligned parallel to a line extending between the posterior-superior direction and the anterior-inferior direction. In this orientation, the upper end 3326 of the slit 3322 is spaced rearward relative to the lower end 3327 of the slit 3322. Fig. 11BShown is a tangent 3354 of the path 3353 at the slit abutment 3355 of the tube 3350. As shown, the length axis 3323 of the slit 3322 forms a slit angle 3321 with the tangent 3354 of the path 3353. In this example, the slit angle 3321 is an oblique angle. The oblique angle can be in the range of 5 to 30 degrees. In some examples, the oblique angle can be in the range of 10 to 20 degrees. For example, the oblique angle can be in the range of 12 to 18 degrees. In a specific example, the oblique angle can be about 13 degrees, 15 degrees, or 17 degrees. In some examples, the slit 3322 can be angled relative to the longitudinal axis along the length of the extendable telescopic structure 3362. In particular, when straightened, the slit 3322 can be oriented at an angle between 15 and 45 degrees relative to the longitudinal axis of the extendable telescopic structure 3362. For example, the angle can be in the range of 20 degrees and 40 degrees, such as in the range of 22 degrees and 35 degrees. In particular examples, the angle relative to the longitudinal axis of the extendable telescoping structure 3362 when straightened can be approximately 25 degrees or 31 degrees.

[0448] A slit 3322 that is angled rearward relative to the tube wall 3352 or path 3353 (e.g., the upper end 3326 is further away from the tube wall 3352 or path 3353 than the lower end 3327) can advantageously be better suited to receive a strap 3310 from a lower position around the back of a patient's head. In an ideal arrangement, the strap 3310 extends from the slit 3322 in a direction perpendicular to the length axis 3323 of the slit 3322. Thus, a more rearwardly angled slit 3322 will better accommodate a strap 3310 that is located lower around the back of a patient's head because it will be angled to receive the strap 3310 from a lower angle. Conversely, a slit 3322 that is oriented closer to a vertical orientation will be angled to receive the strap 3310 from a higher position on the patient's head. Thus, the slits 3322, which are oriented at a larger angle relative to the tube wall 3352 and / or the adjacent portion of the pathway 3353, may provide some resistance to (eg, sliding upwardly) the strap 3310 riding across the back of the patient's head.

[0449] While other methods may be used to reduce the tendency of the strap 3310 to ride up behind the patient's head (e.g., providing a split in the strap 3310 to enable the patient to tighten the strap 3310 and / or providing the slit 3322 in a low position), providing the tube 3350 with the slit 3322 at a rearwardly rotated angle may further provide resistance to the strap 3310 riding up. In some examples, each slit 3322 may be angled to receive the strap 3310 from a direction where the strap 3310 spans across an area of ​​the patient's head covering the lower portion of the occipital bone. In further examples, the slit 3322 may be angled to receive the strap 3310 from a direction where the strap 3310 covers the middle or upper portion of the patient's occipital bone.

[0450] Each slit 3322 can be oriented perpendicular to the direction of the slit from the strap anchoring area against which the strap is anchored around the patient's head. The strap anchoring area can be an area covering the patient's occipital bone, such as the lower portion of the occipital bone. In some examples, the strap anchoring area can be an area of ​​the patient's neck located below the patient's occipital bone. In some examples, the strap 3310 can cover the upper portion of the patient's trapezius muscle or a portion of the patient's neck or head below the occipital bone, and the slit 3322 can be angled to receive the strap 3310 from the corresponding direction.

[0451] For example, Figure 8C As shown, the slit 3322 is sufficiently angled rearward to receive the strap 3310 from a direction where the strap 3310 is across the posterior region of the patient's head, located below the lowest portion of the patient's head. The strap 3310 can be across the posterior surface of the patient's head that faces at least partially downward, and the slit 3322 can be sufficiently angled rearward to receive the strap 3310 from that position. Advantageously, the strap 3310 is placed across the posterior surface of the patient's head that faces at least partially downward, because the eyelet is located above the rearmost portion of the strap 3310. Once tension is applied to the strap 3310, the tube 3350 will exert a partially greater force on the strap 3310, meaning that the strap 3310 may be less likely to pull upward if anchored against the downward facing posterior surface of the patient's head.

[0452] refer to Figures 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. The longer upper edge 3331 gives the tab 3320 an asymmetrical shape, and if the upper edge 3331 and the lower edge 3332 have equal lengths, the tab 3320 will point in a more downward direction. The slit 3322 is substantially centered between the upper edge 3331 and the lower edge 3332. Therefore, the asymmetrical shape of the tab 3320 causes the slit 3322 to appear in a direction closer to the bottom. This downward pointing of the tab 3320 can advantageously reduce the tendency of the strap 3310 to retract upward from the back of the patient's head.

[0453] In addition to having an inclined slit angle 3321, the slit 3322 can also be spaced apart from the tube wall 3352 by a sufficient spacing to further reduce the tendency of the strap 3310 to pull up behind the patient's head. The large spacing between the slit or other eyelet and the tube wall 3352 can advantageously reduce the distance between the eyelet and the back of the patient's head. The relatively short distance between the eyelet and the back of the patient's head can reduce the length of the strap 3310, which is located laterally beside the patient's head, extending between the slit 3322 and the rearward-facing force of the patient's head. This reduced distance and strap length can advantageously inhibit the pivoting of the strap 3310 relative to the eyelet, thereby reducing the tendency of the strap 3310 to pull up or down during use.

[0454] 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 about 8 mm or more from the tube wall 3352.

[0455] The upper end 3326 of the slit 3322 may be spaced at least 8 mm from the tube wall 3352. In some examples, the upper end 3326 of the slit 3322 may be spaced at least 10 mm from the tube wall 3352. For example, the upper end 3326 of the slit 3322 may be spaced 12 mm or more from the tube wall 3352.

[0456] In some examples, the midpoint along the slit 3322 can be spaced from the tube wall 3352 at a spacing in the range of about 5 mm to 30 mm. Although a very large spacing between the eyelet and the tube wall 3352 is advantageous in terms of increasing the stability of the strap 3310, it may present challenges / issues in terms of manufacturability, weight, comfort, and aesthetics due to the increased size of the tab 3320. A spacing in the range of 5-30 mm, such as in the range of 0-20 mm, can provide stability benefits to prevent the rear headgear strap 3310 from riding up, which avoids or minimizes issues caused by the increased size of the tab 3320. In further examples, the spacing can be in the range of 8 mm to 15 mm, such as in the range of 9 mm to 13 mm. In some specific examples, the spacing can be about 9 mm to 11 mm, such as about 9.5 mm or 9.75 mm.

[0457] 5.3.2.3.3 Slot

[0458] Fig. 11CA close-up perspective view of one tab 3320 of the positioning and stabilizing structure 3300 is shown. As shown, in some examples, the tab 3320 of the positioning and stabilizing structure 3300 may include a slot 3324 formed in the tab and located behind the slit 3322. The slot 3324 may be formed in the body of the tab 3320 in a position below the strap 3310. In this example, the slot 3324 is disposed between the slit 3322 and the rear side 3329 of the tab 3320. The tab 3320 may include a tab surface 3328 facing outward on a side of the tab 3320 facing away from the patient (e.g., in a lateral direction). The tab surface 3328 may be substantially flat near the slit 3322. The slot 3324 may be formed by a portion of the tab 3320 at the slot 3324 having a smaller material thickness than other portions of the tab 3320. Thus, in this example, the groove 3324 is recessed relative to the tab surface 3328.

[0459] The slot 3324 may have a width substantially the same as the length of the slit 3322. That is, the slot 3324 may have an upper end adjacent to the slit 3326 and may have a lower end adjacent to the lower end 3327 of the slit 3322. In this example, the slot 3324 has a width substantially the same as the strap 3310. The slot 3324 is configured to receive the strap 3310. The slot 3324 reduces the overall thickness of the strap 3310 and the tab 3320. At the location of the slot 3324, the tab 3320 is sandwiched between the two layers of the strap 3310 (because the strap passes through the slit and loops back on itself). The volume and / or thickness of the strap 3310 and the tab 3320 at this location may create a pressure point or discomfort point for the patient when he or she sleeps on his or her side. The slot 3324 may advantageously reduce the layered thickness of the component at this location, which may reduce the pressure applied to the patient's head at this location during side sleeping.

[0460] Additionally, in this example, slot 3324 has sides that abut sides of strap 3310. The width of slot 3324 thus matches the width of strap 3310. This can advantageously help keep strap 3310 aligned and centered within slot 3324. It can also provide a visual guide to the user regarding the alignment of strap 3310.

[0461] 5.3.3 Ventilation

[0462] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0463] In certain forms, the vent 3400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 3200 to the surrounding environment when the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured so that in use the magnitude of the ventilation flow is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber. The vent 3400 can provide a continuous flow of ventilation from the interior of the plenum chamber 3200 to the surrounding environment throughout the patient's breathing cycle.

[0464] One form of a vent 3400 in accordance with the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0465] The vent 3400 may be located in the plenum 3200. Alternatively, the vent 3400 is located in a decoupling structure, for example, in a swivel (such as elbow 3610). Figures 8A-9C In the example shown, the patient interface 3000 includes a plurality of vents 3400. Specifically, 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 specifically, 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 size and configuration of the vent 3400 of the patient interface 3000 are designed to provide adequate gas flushing over the entire therapeutic pressure range.

[0466] The patient interface 3000 can include a diffuser configured to diffuse the air flow through the vent to reduce vent noise and reduce air ejected from the vent. The diffuser can be provided to a cover over the vents. In some examples, the vent 3400 can include a vent module configured to be removed from the plenum 3200. The vent module can include a diffuser.

[0467] 5.3.4 Decoupling structure

[0468] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket. Figures 9A-9CThe patient interface 3000 shown includes an elbow 3610 configured as a swivel joint 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 can form a portion of a ball joint of the positioning and stabilizing structure 3300. For example, a ring having a partially spherical inner surface can be provided to the positioning and stabilizing structure 3300 and can be configured to receive the elbow 3610. The elbow 3610 can have a partially spherical outer surface that is complementary to the partially spherical inner surface of the ring, thereby enabling the elbow 3610 to rotate relative to the ring on multiple axes.

[0469] 5.3.5 Connection Port

[0470] Connection port 3600 allows connection to air circuit 4170. Figures 8A-9C In the exemplary patient interface 3000 shown, an elbow 3610 forms a portion of the connection port 3600. The elbow 3610 acts as a decoupling structure to decouple the movement of the air circuit 4170 from the positioning and stabilizing structure 3300 so as to reduce tube resistance on the positioning and stabilizing structure 3300.

[0471] 5.3.6 Forehead support

[0472] 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, Figures 8A-9C The exemplary patient interface 3000 shown includes a positioning and stabilizing structure 3300 that is capable of maintaining the seal-forming structure 3100 in a sealing position without being connected to a forehead support or any frame or strap member located in front of the patient's face at eye level.

[0473] 5.3.7 Anti-suffocation valve

[0474] In one form, the patient interface 3000 includes an anti-asphyxia valve. In one form, the patient interface 3000 includes at least one anti-asphyxia valve. For example, where airflow is provided to the seal-forming structure 3100 via two fluid connections, two anti-asphyxia valves may be provided to the patient interface 3000, one at each fluid connection to the seal-forming structure 3100.

[0475] 5.3.8 Ports

[0476] 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 the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0477] 5.4RPT device

[0478] The 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, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0479] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or a positive pressure of at least 10 cmH2O, or a positive pressure of at least 20 cmH2O.

[0480] The RPT device can have an outer housing 4010 that is constructed in two parts, an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 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 can include a handle 4018.

[0481] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor and a flow rate sensor.

[0482] One or more air path items may be located within a removable separate structure that will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0483] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0484] 5.4.1 Mechanical and pneumatic components of RPT device

[0485] The RPT device may include one or more of the following components (including pneumatic component 4100) in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0486] 5.4.1.1 Air filter

[0487] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0488] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0489] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0490] 5.4.1.2 Silencer

[0491] An RPT device according to one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0492] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .

[0493] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0494] 5.4.1.3 Pressure generator

[0495] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure in a range from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. 2013 / 020167.

[0496] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0497] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0498] 5.4.1.4 Anti-overflow valve

[0499] In one form of the present technology, an anti-spillback valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0500] 5.4.2RPT device algorithm

[0501] As described above, in some forms of the present technology, the central controller may be configured to implement one or more algorithms represented as computer programs stored in a non-transitory computer readable storage medium such as a memory. Algorithms are generally grouped into groups called modules.

[0502] 5.5 Air circuit

[0503] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to flow between two components, such as the RPT device 4000 and the patient interface 3000, in use.

[0504] In particular, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there may be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0505] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be wound helically around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 33,349, which is incorporated herein by reference in its entirety.

[0506] 5.5.1 Oxygen delivery

[0507] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway (such as upstream of the pneumatic block 4020 ), the air circuit 4170 , and / or the patient interface 3000 .

[0508] 5.6 Humidifier

[0509] 5.6.1 Humidifier Overview

[0510] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0511] The humidifier 5000 may include a humidifier reservoir 51, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0512] 5.6.1.1 Conductive part

[0513] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to a volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes may also be equally suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., having a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, a material with a suitable geometry having a lower conductivity may be used to achieve appropriate thermal conductivity.

[0514] 5.6.1.2 Humidifier reservoir base

[0515] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 5B ), which is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking structure, such as a locking rod 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0516] 5.6.1.3 Water level indicator

[0517] The humidifier reservoir 5110 may include Figure 5A-5B Water level indicator 5150 is shown. In some forms, water level indicator 5150 may provide a user (such as patient 1000 or a caregiver) with one or more indications regarding the amount of water volume in humidifier reservoir 5110. The one or more indications provided by water level indicator 5150 may include an indication of a maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0518] 5.7 Glossary

[0519] For the purposes of this technical disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.

[0520] 5.7.1 Overview

[0521] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0522] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0523] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0524] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0525] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0526] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which therapy pressure is automatically adjusted between minimum and maximum limits, e.g., from breath to breath, based on the presence or absence of an indication of an SDB event.

[0527] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing when there is no indication of partial upper airway obstruction.

[0528] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes shortened to simply "flow" or "airflow".

[0529] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The total flow, Qt, is the air flow leaving the RPT device. The ventilation flow, Qv, is the air flow leaving the vent to allow for washout of exhaled gases. The leakage flow, Ql, is the leakage flow from the patient interface system or elsewhere. The respiratory flow, Qr, is the air flow received into the patient's breathing system.

[0530] Humidifier: The term humidifier shall be understood as a humidifying device constructed and arranged, or constructed with a physical structure, capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0531] Leakage: The term leakage is to be understood as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return bend to the ambient environment.

[0532] Noise, Conducted (Acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0533] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0534] Noise, Vent (Acoustic): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent in a patient interface.

[0535] Patient: A person, whether or not they have a respiratory illness.

[0536] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascal. 1 cmH20 is equal to 1 g-f / cm2, which is about 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in cmH2O.

[0537] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0538] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0539] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0540] 5.7.1.1 Materials

[0541] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0542] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0543] 5.7.1.2 Mechanical properties

[0544] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when deflated.

[0545] Resilient: Releases substantially all of its energy when deflated. Includes, for example, certain silicones and thermoplastic elastomers.

[0546] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus, or the indentation hardness scale measured on a standardized sample size).

[0547] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0548] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0549] Rigidity (or stiffness) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions.

[0550] Flexible structure or component: A structure or component that will change shape (eg, bend) within a relatively short period of time (eg, 1 second) when made to support its own weight.

[0551] A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such a use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient's airway, for example under a load of about 20 to 30 cmH2O pressure.

[0552] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second, orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0553] 5.7.2 Breathing cycle

[0554] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0555] 5.7.3 Anatomy

[0556] 5.7.3.1 Facial anatomy

[0557] Ala: The outer lining or "wing" of each nostril (plural: alar)

[0558] Alar tip: The outermost point on the wing of the nose.

[0559] Alar bend (or alar apex) point: The most posterior point in the base line of curvature of each ala, found in the fold formed by the union of the ala and cheek.

[0560] Auricle: The entire external visible part of the ear.

[0561] (Nose) Framework: The framework of the nose includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0562] The cartilaginous skeleton of the nose includes septal cartilages, lateral cartilages, major cartilages and minor cartilages.

[0563] Columella: The strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0564] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal plane (where both lines intersect at the lower point of the nasal septum).

[0565] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left oblique area. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0566] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0567] Transverse nasal cartilage: A generally triangular plate of cartilage with its superior margin attached to the nasal bones and the frontal process of the maxilla and its inferior margin connected to the greater alar cartilage.

[0568] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar nasal cavity.

[0569] Nare: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular form of nare is naris (nare). The nostrils are separated by the nasal septum.

[0570] Nasolabial groove or nasolabial fold: A fold or groove of skin that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0571] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0572] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0573] Auricular base: The highest point where the auricle attaches to the facial skin.

[0574] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0575] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0576] Chin forward point: located on the soft tissue, the front midpoint of the chin.

[0577] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0578] Sagittal plane: A vertical plane running from front (anterior) to back (posterior). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0579] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0580] Septal Cartilage (Nose): The septal cartilage forms part of the nasal septum and divides the front of the nasal cavity.

[0581] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (superior) lip.

[0582] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0583] Mandibular alveolar seat point: the point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0584] 5.7.3.2 Anatomy of the skull

[0585] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0586] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0587] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0588] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0589] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0590] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0591] Orbit: The bony cavity in the skull that holds the eyeball.

[0592] Parietal: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0593] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0594] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protuberances of the cheeks.

[0595] 5.7.3.3 Anatomy of the respiratory system

[0596] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0597] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0598] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0599] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nostrils.

[0600] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0601] 5.7.4 Patient Interface

[0602] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0603] Elbow: An elbow is an example of a structure that redirects the axis of the air flow directed therethrough at an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In some forms, the elbow may be rotatable relative to the adapter, such as approximately 360 degrees. In some forms, the elbow may be removable from the adapter, such as via a snap connection. In some forms, the elbow may be assembled to the adapter via a one-time snap during manufacturing, but may not be removed by the patient.

[0604] Frame: A frame will be understood to mean a mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0605] Headgear: A headgear will be understood to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more supports, straps, and reinforcements configured to position and maintain a patient interface in position on a patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0606] Film: A film is to be understood as meaning a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0607] Plenum: A mask plenum will be understood to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air inflated therein to above atmospheric pressure. The housing may form part of the walls of the mask plenum.

[0608] Seal: can be a noun form ("seal"), which refers to a structure, or a verb form ("seal"), which refers to an effect. Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without the need for a separate 'seal' element itself.

[0609] Shell: Shell will be understood to mean a curved and relatively thin structure having bendable, extendable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0610] Reinforcement: A reinforcement will be understood to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0611] Support: A support will be understood to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0612] Swivel (n): A subassembly of components configured to rotate about a common axis, preferably independently, 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 comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0613] Lace (noun): A structure designed to resist tension.

[0614] Vent (noun): A structure that allows air flow from the interior of a mask or tube to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0615] 5.7.5 Shape of the structure

[0616] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or an impeller. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the orientation, position, function, or some other characteristics of the relevant surfaces. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0617] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through the surface of the structure at a point p. FIG. 3B to FIG. 3F , which show examples of cross sections at points p on the surface and the resulting plane curves. Figures 3B to 3F Also shown is the outward normal vector at p. The outward normal vector at p away from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0618] 5.7.5.1 Curvature in one dimension

[0619] 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 a circle that touches the curve only at p).

[0620] Positive curvature: If the curve turns toward the outward normal at p, then the curvature at that point will be positive (if an imaginary person were to leave point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0621] Zero curvature: If the curve is a straight line at point p, the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally, neither up nor down). Figure 3D .

[0622] Negative curvature: If the curve turns away from the outward normal at p, then the curvature in that direction at that point will be negative (if the imaginary person leaves point p, they must be walking downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0623] 5.7.5.2 Curvature of a Two-Dimensional Surface

[0624] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane including an outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a quantity, such as a relatively small quantity. Figures 3B to 3F A plane curve in may be an example of such multiple cross sections at specific points.

[0625] Principal curvature and direction: The normal directions along which the curvature of a curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example, the maximum curvature occurs at Figure 3B and the minimum value appears at Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0626] Surface Region: A connected set of points on a surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0627] Saddle region: The region where the principal curvatures at each point have opposite signs, i.e. one is positive and the other is negative (depending on which way the imaginary person turns, they can go uphill or downhill).

[0628] Dome area: The area where the principal curvatures at every point have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0629] Cylindrical region: A region in which one of the principal curvatures is zero (or is zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0630] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0631] Surface edge: The boundary or limit of a surface or area.

[0632] Path: In some forms of the present technology, 'path' will be understood to mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0633] Path length: In some forms of the present technology, 'path length' will be understood to mean the distance along the surface from f(0) to f(1), i.e. the distance along the path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0634] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there may be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.

[0635] 5.7.5.3 Space curve

[0636] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0637] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her aircraft at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0638] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector pointing in the direction of the change in the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0639] 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 Figure 3P ) or alternatively by the left-hand rule ( Fig.3O ) to determine.

[0640] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0641] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0642] refer to Figure 3P According to the right-hand rule, a space curve that turns toward the right-hand binormal direction can be considered to have right-hand positive twist (e.g., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0643] Similarly, and referring to the left-hand rule (see Fig.3O ), a space curve that turns toward the left-handed binormal direction can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0644] 5.7.5.4 Holes

[0645] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, for example Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0646] A structure can have two-dimensional pores, such as pores defined by a surface. For example, a pneumatic tire has a two-dimensional pore defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional pore. See, for example, Figure 3L The cushions and Figure 3M and Figure 3N , showing an inner surface defining a two-dimensional hole. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Figure 3K A two-dimensional hole in the shown structure bounded by the shown surface.

[0647] 5.8 Other notes

[0648] Unless the context clearly indicates and provides a numerical range, it should be understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated or intermediate values ​​in the stated range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the range. In the case where the range includes one or both of the limits, the present technology also includes ranges excluding either or both of those included limits.

[0649] Furthermore, where a value or values ​​are described herein for implementation as part of the present technology, it should be understood that such values ​​may be approximate and, unless otherwise indicated, may be used with any suitable significant figures to the extent permitted or required by practical technical implementation.

[0650] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology, a limited number of representative methods and materials are described herein.

[0651] When a specific material is considered to be used for the construction of a component, an obvious alternative material with similar properties can be used as its substitute. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0652] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0653] All disclosures mentioned herein are incorporated by reference to disclose and describe methods and / or materials as those disclosed themes. Providing the publications discussed herein is only for the disclosures before the filing date of the present application. Anything herein should not be construed as admitting that the present technology is not entitled to the priority of these publications due to previous inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed separately.

[0654] The terms “comprises” and “comprising” should be interpreted as referring to elements, components or steps in a non-exclusive manner, indicating that the mentioned elements, components or steps may exist or be utilized or combined with other elements, components or steps not explicitly mentioned.

[0655] The main headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the inventive subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0656] Although the present technology has been described with reference to specific examples, it should be understood that these examples only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order can be modified, and / or its aspects of the order can be performed simultaneously or even synchronously.

[0657] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0658] 5.9 Reference Symbols List

[0659]

[0660]

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising 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 with an area of ​​a patient's face surrounding an entrance to the patient's airway for use throughout a breathing cycle of the patient with sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the seal-forming structure having an aperture therein such that the flow of air at said therapeutic pressure is delivered at least to the entrance of the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain said therapeutic pressure in the plenum chamber throughout a breathing cycle of the patient; A positioning and stabilizing structure providing a force to secure the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube for receiving a flow of air from a connection port on the top of the patient's head and delivering the flow of air to an entrance to the patient's airway via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base of the patient's head in use, the at least one gas delivery tube comprising: An upper tube portion, configured to cover an upper region of a patient's head in use, the upper tube portion comprising: a first end configured to cover an upper portion of the patient's head at or near a sagittal plane of the patient's head; a second end configured to cover a side of a patient's head in use; a rigidified portion between the first end and the second end configured to provide, in use, a higher resistance to relative movement between the first end and the second end in an anterior and / or posterior direction than in an upper and / or lower direction; and a lower tube portion connected between the second end of the upper tube portion and the seal-forming structure; and a vent structure configured to allow gas exhaled by a patient to flow continuously from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without a flow of pressurized air through the plenum inlet port, or wherein the patient interface is configured such that the patient's mouth is uncovered.

2. A patient interface according to claim 1, wherein: Each upper tube portion comprises two rigidifying portions.

3. A patient interface according to claim 1 or claim 2, wherein: The rigidifying portion is provided to one or both of a side of the upper tube portion configured to be forward in use and a side of the upper tube portion configured to be rearward in use.

4. A patient interface according to any one of claims 1 to 3, wherein: The upper tube portion includes an extendable portion.

5. A patient interface according to claim 4, wherein: The extendable portion includes an extendable telescopic structure formed in a tube wall of the gas delivery tube.

6. A patient interface according to claim 5, wherein: The extendable telescoping structure includes a plurality of folds in the tube wall, the folds alternately forming a plurality of ridges and a plurality of grooves.

7. A patient interface according to claim 6, wherein: The rigidifying portion includes a plurality of connecting portions formed in the tube wall, each connecting portion of the plurality of connecting portions connecting a pair of adjacent ridges.

8. A patient interface according to any one of claims 1-7, wherein: The rigidifying portion is formed integrally with the upper tube portion.

9. A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising 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 with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a breathing cycle of the patient, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to a nares of the patient, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the breathing cycle of the patient; A positioning and stabilizing structure providing a force to secure the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube receiving a flow of air from a connection port on the top of the patient's head and delivering the flow of air to an entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base point of the patient's head in use, the gas delivery tube comprising: a tube wall defining a hollow interior through which air can flow to the seal-forming structure, the tube wall having an extendable portion configured to extend to change the length of the gas delivery tube, wherein the extendable portion comprises an extension stiffness in the range of 0.2 to 0.35 N / mm; and a vent structure to permit continuous flow of gas exhaled by a patient from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without a flow of pressurized air through the plenum inlet port, or wherein the patient interface is configured such that the patient's mouth is uncovered.

10. A patient interface according to claim 9, wherein: The extension stiffness of the extendable portion is in the range of 0.25 to 0.3 N / mm.

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