Patient interface with occipital anchor

Abstract

To provide a medical device used in a treatment of respiratory disorders having improved comfort, cost, efficacy, ease of use and manufacturability.SOLUTION: A patient interface includes: a plenum chamber pressurisable to a therapeutic pressure; and a seal-forming structure to seal a region of a patient's face surrounding an entrance to a patient's airways. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle in use. The patient interface also includes a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes a rear strap arranged to contact with an occiput of the patient's head. The rear strap is constructed from a first material arranged to contact with a temple region of the patient's head, and a second material arranged to contact with the occiput of the patient's head. The second material is silicone.SELECTED DRAWING: Figure 53

Description

[Technical field]

[0001] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Australian Provisional Application No. 2020900850, filed March 20, 2020, each of which is incorporated by reference in its entirety herein. [Background technology]

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

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nostrils and mouth are the entrances to a patient's airways.

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

[0006] A range of respiratory disorders exists. Particular disorders may be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause in breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, especially in middle-aged, overweight men, but patients are asymptomatic. See U.S. Patent No. 4,944,310 to Sullivan.

[0009] A range of treatments are available to treat or ameliorate such diseases, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disorders, but these suffer from a number of deficiencies.

[0010] 2.2.2 Treatment A variety of respiratory therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT).

[0011] 2.2.2.1 Respiratory Pressure Therapy Respiratory pressure therapy is the application of a supply of air to the entrance of the airways at a controlled target pressure, which is typically positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapies such as tank ventilators or positive-negative pressure extracorporeal ventilators (cuirass)).

[0012] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0013] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist in breathing by performing some or all of the respiratory functions and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided through a non-invasive patient interface. NIV is used to treat forms of CSR and respiratory failure such as OHS, COPD, NMD, and chest wall disorders. In some forms, it may improve the comfort and effectiveness of these treatments.

[0014] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheotomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0015] 2.2.3 Respiratory Treatment Systems These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0016] The respiratory treatment system may include one of a respiratory pressure treatment (RPT) device, an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0017] Another form of treatment system is the mandibular repositioning device.

[0018] 2.2.3.1 Patient Interface The patient interface may be used to provide an interface to the respiratory appliance for the wearer, for example by providing airflow to the airway inlet. The airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the treatment being applied, the patient interface may be sealed, for example, to an area of ​​the patient's face, thereby facilitating gas delivery at a pressure with sufficient dispersion with ambient pressure for treatment to take place (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure).

[0019] In other forms of therapy, such as oxygen delivery, the patient interface may not include a sufficient seal to facilitate delivery of a gas supply to the airways at a positive pressure of approximately 10 cmH2O. For flow therapy, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0020] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0021] A particular mask may be clinically unsuitable for this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0022] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0023] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0024] There are multiple challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the jaw or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0025] Due to these challenges, some masks may be one or more of the following: intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for long periods of time or if the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may reduce patient compliance with treatment. This is especially true if the mask must be worn during sleep.

[0026] CPAP therapy is highly effective in treating certain breathing disorders if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0027] Masks for other uses (e.g., for aviators) may be inappropriate for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be appropriate for other uses.

[0028] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0029] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0030] The patient interface may be characterized in part according to the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the mouth region in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0031] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of different areas of the patient's face. For example, a swim goggle structure that rests on the patient's forehead to create a seal therebetween may be inappropriate for use on the patient's nose.

[0032] A particular seal-forming structure may be designed for mass production so that one design can fit, be comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface so that the seal-forming structure will seal against the patient's face, one or both will need to be adapted.

[0033] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaged against the patient's face. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, improper fit may result in gaps between the seal-forming structure and the face, requiring additional force to position the patient interface against the face and form a seal therebetween, which may otherwise lead to leakage. Additional force may lead to discomfort for the patient during use.

[0034] Another type of seal-forming structure uses flaps of relatively thin material located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the type of seal-forming structure described in the paragraph above, if the size and shape of the seal-forming structure does not correspond exactly to the size and shape of the patient's face, additional force may be required to seal against the patient's face, which may otherwise lead to leakage in the mask. Additional force may lead to discomfort for the patient during use. Furthermore, if the size and shape of the seal-forming structure does not correspond exactly to the size and shape of the patient, the relative thinness of the seal-forming structure may lead to wrinkling or buckling during use, which may lead to leakage.

[0035] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming structures uncomfortable.

[0036] Another form of seal-forming structure may use adhesives to achieve a seal. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0037] A range of patient interface seal forming structure techniques are disclosed in the following patent applications (assignee: ResMed Limited, Kwok et al.), International Publication No. WO1998 / 004310A1 (Davidson et al.), International Publication No. WO2006 / 074513A1 (Dravitzki et al.), and International Publication No. WO2010 / 135785A1.

[0038] One form of nasal pillow is found in the ADAM line manufactured by Puritan-Bennett Corporation. A discussion of alternative nasal pillows or nasal puffs is found in U.S. Patent No. 4,782,832 to Trimble et al. (Assignee: Puritan-Bennett Corporation).

[0039] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications (assignee: ResMed Limited): Gunaratnam et al., International Publication No. WO 2004 / 073778 A1 (describing, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); Guney et al., U.S. Publication No. 2009 / 0044808 A1 (describing, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); Davidson et al., International Publication No. WO 2005 / 063328 A1 and Lubke et al., International Publication No. WO 2006 / 130903 A1 (describing, among other things, aspects of ResMed Limited's MIRAGELIBERTY™ full face masks); Rummery et al., International Publication No. WO 2009 / 052560 A1 (describing, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0040] 2.2.3.1.2 Positioning and stabilization Seal-forming structures in patient interfaces used in positive air therapy experience corresponding forces from the air pressure that disrupt a seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0041] In one technique, adhesives are used, see, for example, Kooij et al., U.S. Publication No. 2010 / 0000534A1, but adhesives can be uncomfortable.

[0042] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulkiness, discomfort and awkwardness.

[0043] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example by activating the device to generate an air delivery flow to an interface to the airway. The air flow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0044] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., reliability requirements, size requirements, and weight requirements of medical devices). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0045] An example of a special requirement for a particular RPT device is minimization of acoustic noise, given that the patient may be asleep during operation.

[0046] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]

[0047] One known RPT device used to treat sleep-disordered breathing is the S9™ Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide invasive and non-invasive independent ventilation support for patients for a range of diseases (including, but not limited to, NMD, OHS, and COPD).

[0048] The Elis Accessory Taiguée® 150 ventilator and VS III™ ventilator manufactured by ResMed Limited can provide invasive and non-invasive dependent ventilation support suitable for adult or pediatric patients for the treatment of multiple diseases. These ventilators provide volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., a motorized blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered at positive pressure to the patient's airway. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0049] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.

[0050] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged such that, in use, airflow travels between two components of a respiratory treatment system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.

[0051] 2.2.3.4 Humidifier Delivery of the airflow without humidification can lead to drying of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the addition of warm air to the facial area surrounding the patient interface generally provides greater comfort than cool air. Thus, humidifiers often have the ability to humidify the airflow as well as heat it. Additionally, increased air temperature increases the potential for water vapor generation.

[0052] A range of artificial humidification devices and systems are known, but fail to meet the special requirements of medical humidifiers.

[0053] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but these systems also humidify and / or heat the entire room, which may be uncomfortable for the occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0054] Although a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others are difficult or inconvenient for the patient to use.

[0055] 2.2.3.5 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0056] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0057] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0058] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push exhaled carbon dioxide out, which may allow gas flow from an interior space of the patient interface (e.g., within a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0059] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.

[0060] ResMed Limited has developed several improved mask ventilation technologies, see Kwok, International Publication No. WO 1998 / 034665 A1; Gunaratnam et al., International Publication No. WO 2000 / 078381 A1; Drew et al., U.S. Patent No. 6,581,594 B1; Ng et al., U.S. Patent No. 2009 / 0050156 A1; Guney et al., U.S. Patent No. 2009 / 0044808 A1.

[0061] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]

[0062] (*Measured one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0063] Sound pressure values ​​for various targets are listed below: [Table 3]

[0064] 2.2.3.7 Heat Moisture Exchanger (HMX) Technology When a patient is undergoing the various forms of respiratory therapy described above, the patient's internal airway passages are prone to dryness. For example, CPAP therapy requires the patient to be provided with a continuous pressurized airflow at pressures above ambient, which, when combined with the high levels of positive air pressure, can cause dryness of the patient's airways. Such dryness can cause discomfort and, as a result, can negatively affect patient compliance with therapy.

[0065] To minimize the drying effects in these forms of respiratory therapy, the airflow provided to the patient may be humidified before it reaches the patient. As mentioned above, in certain forms of humidification technology, in an effort to actively provide humidified air to the patient to reduce the drying effects, a reservoir of water is heated and the air is pumped over its surface to increase the absolute humidity of the air (i.e., water vapor from the reservoir is pumped into the air). The humidified air is then pumped to the patient via the air circuit. The air circuit may be heated to avoid condensation of water vapor in the air circuit during delivery to the patient (also known as rainout). For these forms of technology, it is often necessary to fill the reservoir with water before treatment before providing it to the RPT system, so that the water can be heated to humidify the air for treatment. The reservoir often requires periodic cleaning and is at risk of overflow, which can be particularly problematic in the context of electrical components, requiring the patient to refill the reservoir before use.

[0066] Eliminating the need for a pre-supplied water source (e.g., a water-filled reservoir) and input power for water heating may provide several benefits. For example, the RPT device may be smaller since space for a water reservoir and heating plate is no longer required. Electrical costs may be reduced since electrical energy consumption for water heating is eliminated. The number of electrical components in the RPT device may also be reduced, reducing the cost and complexity of the electrical components. The RPT device may also be easier to use since the need to fill, empty, and clean the water reservoir is eliminated. The risk of overflow may also be reduced. The operation of the RPT device may also be simplified since activation of a humidification setting is no longer required.

[0067] In operation, the patient exhales air (exhalation) that has been heated in the patient's body and absorbs water vapor from the patient's airways. The heat and moisture in the exhaled breath are captured by the HMX material(s). That is, the exhaled breath is vented to the atmosphere after passing through the HMX material(s), so that the HMX material(s) is heated by the relatively warm exhaled breath and adsorbs water vapor from the relatively humid exhaled breath. During inspiration, the pressurized air flow passes through the HMX material(s) in the opposite direction to the exhaled breath before reaching the patient's airways, and the source of the incoming air is often ambient air. Thus, as the pressurized air flow passes through the HMX material(s) before reaching the patient's airways, it absorbs moisture in the form of water vapor and is heated by the heat released from the HMX material(s). Summary of the Invention [Means for solving the problem]

[0068] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0069] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0070] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0071] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0072] Another aspect of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure. The patient interface may further include a venting structure. The patient interface may be further configured to leave the patient's mouth exposed, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the environment in the absence of pressurized air flow through the plenum chamber inlet port.

[0073] Another aspect of the present technology relates to a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein such that an airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, and wherein the seal-forming structure is configured to, in use, compress said therapeutic pressure in the plenum chamber to a pressure sufficient to compress said therapeutic pressure in the plenum chamber to a pressure sufficient to compress said therapeutic pressure in the patient's breathing zone. a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged to rest at least partially on an area of ​​the patient's head above an upper ear base point of the patient's head in use; and a venting structure configured to allow a continuous flow of gas exhaled by the patient to move from within the plenum chamber to the surroundings, the venting structure sized and shaped to maintain a therapeutic pressure within the plenum chamber in use. The patient interface is configured to leave the patient's mouth exposed or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surroundings through the plenum chamber inlet port in the absence of a flow of pressurized air.

[0074] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0075] One aspect of the present disclosure is a method for manufacturing a device.

[0076] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0077] One aspect of one form of the present technology is a portable RPT device that a person can carry with them (eg, around the home).

[0078] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0079] Another aspect of the present technology is a patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said ... a positioning and stabilizing structure including an upper strap constructed and arranged to contact an area of ​​the patient's head above an upper ear base point, side straps connected to the upper straps, the side straps constructed and arranged to extend in a forward and downward direction in use to the seal-forming structure, and a rear strap connected to the upper straps and the side straps, the rear straps extending in a rear and downward direction on the patient's head and arranged to contact an occipital region of the patient's head in use, the rear straps constructed from a first material and a second material, the first material arranged to contact a temporal region of the patient's head in use and the second material arranged to contact an occipital region of the patient's head in use, the second material being non-textile (e.g., silicone), the second material being configured to limit movement of the upper straps and / or side straps in a forward and / or rearward direction when in a therapeutically effective position on the patient's head;and a vent structure for moving a continuous flow of gas exhaled by a patient from the interior of the plenum chamber to the surroundings, said vent structure being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use, wherein the patient interface is configured to allow the patient to breathe from the surroundings through his / her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port or the patient interface is configured to leave the patient's mouth exposed;

[0080] In certain configurations, the second material does not extend across the parietal bone.

[0081] In certain configurations, the rear strap does not extend across the parietal bone from the left side of the patient's head to the right side of the patient's head.

[0082] In certain configurations, the positioning and stabilizing structure does not extend across the patient's sternocleidomastoid muscle.

[0083] In certain embodiments, the second material has a higher coefficient of friction than the first material.

[0084] In certain configurations, the first material and the second material are connected at a transition, where the first material does not cross the transition and does not overlap with the second material, and the second material does not cross the transition and does not overlap with the first material.

[0085] In certain configurations, the first material and the second material are connected along the transition by sewing, gluing, ultrasonic welding, magnets and / or mechanical fasteners.

[0086] In certain configurations, the top strap and side straps are formed as a continuous structure and are not connected by fasteners.

[0087] In certain configurations, the second material is provided only over the back of the head and not along the patient's head.

[0088] In certain configurations, at least one of the plenum chamber and the seal-forming structure is at least partially constructed from a first material.

[0089] In a particular embodiment, the first material is a textile.

[0090] In certain configurations, the first material is an elastic material and is configured to increase in length due to tension in use.

[0091] In certain configurations, the second material does not contact the temporal region of the patient's head below the inferior temporal point.

[0092] In certain configurations, the positioning and stabilizing structure includes a pad constructed from a second material, the pad configured to grip the back of the head to provide an anchor point for the gas delivery tube.

[0093] In certain configurations, the pad includes an adjustment mechanism configured to vary a usable length of the pad, the usable length configured to contact the patient's head in use.

[0094] In certain configurations, the adjustment mechanism is a hook and loop fastener, a ladder lock buckle, and / or a snap.

[0095] In certain configurations, the first material and the second material of the rear strap are permanently secured to one another.

[0096] In certain configurations, the positioning and stabilizing structure further includes a tab connected between the top strap and the side strap, the rear strap being releasably connected to the tab.

[0097] In certain configurations, the first material of the rear strap extends from the tab to the second material.

[0098] In certain configurations, the positioning and stabilizing structure further includes an extender directly connected to the tab, and the rear strap is directly connected to the extender.

[0099] In certain configurations, the extender is removably coupled to the tab.

[0100] In certain configurations, the rear strap is permanently connected to the extender.

[0101] In certain configurations, the rear strap is removably connected to the extender.

[0102] In certain configurations, the extender is constructed from a second material.

[0103] In certain configurations, the extender is constructed from silicone and / or Hytrel.

[0104] In certain configurations, a gas delivery tube defined by both the top strap and the side strap is formed as a continuous structure to receive air flow from a connection port on the top of the patient's head and deliver the air flow through the seal-forming structure to the entrance of the patient's airway.

[0105] In a particular embodiment, the second material is silicone.

[0106] Another aspect of the present technology is a positioning and stabilizing structure configured to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of an airflow at a therapeutic pressure of at least 4 cmH2O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure including: a gas delivery tube configured to deliver an airflow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube constructed and arranged to, in use, contact the patient's head, the gas delivery tube having a first sealing end configured to connect to the seal-forming structure, a second sealing end spaced apart from the first sealing end, the ... a gas delivery tube including a second sealing end disposed on the first sealing end and configured to connect to a seal-forming structure, and an intermediate section disposed between the first sealing end and the second sealing end, the intermediate section including a port for receiving air flow, the intermediate section configured to contact an upper region of a patient's head in use; an eyelet coupled to the gas delivery tube between the first sealing end and the intermediate section; and a rear strap coupled to the eyelet, the rear strap configured to be routed around a rear of the patient's head in use, the rear strap including a pad configured to grip the rear of the patient's head. The rear strap includes a side portion constructed from a first material and a pad constructed from a second material different from the first material.

[0107] In a particular embodiment, the second eyelet is coupled to the gas delivery tube between the second seal end and the middle section, and the rear strap extends between the eyelet and the second eyelet.

[0108] In a particular embodiment, the first material is a textile.

[0109] In certain configurations, the first material is stretchable and configured to increase in length due to tension in use.

[0110] In a particular embodiment, the rear strap is releasably connected to the eyelet.

[0111] In certain configurations, the extender is directly connected to the eyelet.

[0112] In certain configurations, the extender is removably coupled to the eyelet.

[0113] In certain configurations, the extender is permanently secured to the eyelet.

[0114] In certain configurations, the rear strap is removably connected to the extender.

[0115] In certain configurations, the extender is constructed from a second material.

[0116] In certain configurations, the first material extends between the extender and the pad.

[0117] In certain configurations, the pad is constructed from silicone.

[0118] In certain configurations, the pad and sides are permanently joined together.

[0119] Another aspect of the present technology is a positioning and stabilizing structure configured to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of airflow at a therapeutic pressure of at least 4 cmH2O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure including: an upper strap constructed and arranged to contact the patient's head in use, the upper strap including a first sealing end configured to connect to the seal-forming structure, a second sealing end spaced apart from the first sealing end and configured to connect to the seal-forming structure, and an intermediate section disposed between the first sealing end and the second sealing end, the intermediate section a top strap configured to contact an upper region of a patient's head in use; a first eyelet connected to the top strap between a first sealing end and a middle section; a second eyelet connected to the top strap between a second sealing end and a middle section; and a back strap connected to the first eyelet and the second eyelet, the back strap configured to be routed around a rear of a patient's head in use, the back strap having a first side connected to the first eyelet and a second side connected to the second eyelet, and a pad permanently connected to the first side and the second side, the pad configured to grip the rear of the patient's head, the first side and the second side being constructed from a first material and the pad being constructed from a second material, the first material being a textile and the second material being non-textile.

[0120] In certain configurations, the upper strap is a gas delivery tube configured to deliver airflow through the seal-forming structure to the entrance of the patient's airway.

[0121] In certain configurations, the first material is stretchable and configured to increase in length due to tension in use.

[0122] In certain configurations, the second material is rigid or semi-rigid and configured to maintain its shape under a tensile load.

[0123] In a particular configuration, the first side is removably coupled to the first eyelet and the second side is removably coupled to the second eyelet.

[0124] In a particular embodiment, a first extender is directly connected to the first eyelet and positioned between the first eyelet and the first side, the first extender being constructed from a third material, and a second extender is directly connected to the second eyelet and positioned between the second eyelet and the second side, the second extender being constructed from a third material, where the third material is not a textile.

[0125] In certain configurations, the third material is rigid or semi-rigid and configured to maintain its shape under a tensile load.

[0126] In a particular embodiment, a first extender is permanently connected to the first side and a second extender is permanently connected to the second side.

[0127] In a particular embodiment, the first extender is removably coupled to the first eyelet and the second extender is removably coupled to the second eyelet.

[0128] In certain embodiments, the third material is the same as the second material.

[0129] In certain configurations, the pad includes an adjustment mechanism configured to vary a usable length of the pad, the usable length configured to contact the patient's head in use.

[0130] In certain configurations, the adjustment mechanism is a hook and loop fastener, a ladder lock buckle, a magnet, and / or a snap.

[0131] In a particular embodiment, the second material is silicone.

[0132] Another aspect of the present technology is a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including: an upper strap constructed and arranged to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head in use, a side strap connected to the upper strap, the side strap constructed and arranged to extend in a forward and downward direction to the seal-forming structure in use, and a rear strap connected to the upper strap and the side strap, the rear strap arranged to contact a posterior area of ​​the patient's head in use, the rear strap constructed from a first material and a second material.

[0133] Another aspect of the present technology is a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, and a position providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. a positioning and stabilizing structure comprising: an upper strap constructed and arranged to contact, in use, at least a region of the patient's head above an upper ear base point of the patient's head, the upper strap constructed and arranged to extend, in use, in a forward and downward direction to the seal-forming structure; a detachable arm removably connected to the upper strap, the detachable arm constructed and arranged to extend, in use, in a rearward and downward direction, the detachable arm having a first end including a clip configured to removably engage with the upper strap and a second end opposite the first end; and the detachable arm including a venting structure for moving a continuous flow of gas exhaled by the patient from an interior of the plenum chamber to the surroundings, the venting structure sized and shaped to maintain, in use, the therapeutic pressure within the plenum chamber. The patient interface is configured to allow the patient to breathe from the surroundings through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0134] Another aspect of the present technology is a detachable arm removably coupled to an upper strap, the detachable arm constructed and arranged to extend in a rearward and downward direction in use, the detachable arm including a first end including a clip configured to removably engage the upper strap and a second end opposite the first end.

[0135] Another aspect of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, and a stabilizing structure comprising: a gas delivery tube formed as a continuous structure for receiving an air flow from a connection port on the top of the patient's head and delivering the air flow through the seal-forming structure to an entrance of the patient's airway, the gas delivery tube including a tab constructed and arranged to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head in use, and a detachable arm removably connected to the tab, the detachable arm constructed and arranged to extend in a rearward and downward direction in use, the detachable arm including a first end including a clip configured to removably engage with the upper strap and a second end opposite the first end; and a venting structure for moving a continuous flow of gas exhaled by the patient from within the plenum chamber to the surroundings, the venting structure sized and shaped to maintain the therapeutic pressure in the plenum chamber in use.The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's mouth exposed.

[0136] In a particular embodiment, the second end of each detachable arm of the pair of detachable arms includes a slot.

[0137] In a particular embodiment, the slot is arcuate.

[0138] In a particular embodiment, a rear strap is connected to the second end of each detachable arm of the pair of detachable arms.

[0139] In a particular embodiment, the rear strap is configured to extend rearward and downward over the patient's head to contact the back of the patient's head in use.

[0140] In a particular embodiment, the rear strap is constructed from a first material and a second material.

[0141] In a particular form, the first material is positioned to contact the temporal region of the patient's head in use and the second material is positioned to contact the occipital region of the patient's head in use.

[0142] In a particular embodiment, the first material is a textile and the second material is a silicone.

[0143] In a particular embodiment, a rear strap is received within each slot.

[0144] In certain configurations, the width of the rear strap is less than the width of the slot, and the rear strap is configured to move within the slot and adjust the force vector.

[0145] In a particular embodiment, the opening in each tab has an opening length of about 30 mm to about 50 mm.

[0146] In certain configurations, the clip has a clip length that is less than the opening length.

[0147] In certain configurations, the clip is configured to move along the clip length for adjustment of the force vector.

[0148] In certain configurations, the clip is configured to pivot within the opening for adjustment of the force vector.

[0149] In a particular embodiment, each detachable arm is curved between the first and second ends.

[0150] In a particular embodiment, the second end is configured to contact the patient's head approximately 30 degrees below the Frankfort horizontal.

[0151] In certain configurations, each clip is biased to a closed position.

[0152] In certain configurations, the clips are movable to an open position so as to contact each of the tabs.

[0153] In certain configurations, the first end of each detachable arm further includes a post.

[0154] In certain configurations, the clip is pivotally connected to the post.

[0155] In certain configurations, the clip is freely rotatable about the post.

[0156] In certain configurations, the clip is biased against a surface of the detachable arm.

[0157] In certain configurations, the first end of each detachable arm further includes a locking portion configured to limit rotation of the clip.

[0158] In a particular embodiment, the locking portion of each detachable arm is removably connected to a respective post.

[0159] In a particular embodiment, the locking portion of each detachable arm is integrally formed with the respective post.

[0160] In a particular embodiment, the locking portion is overmolded with the post.

[0161] In certain configurations, the locking portion of each detachable arm includes a protrusion configured to selectively contact the clip and limit rotational movement of the clip.

[0162] In a particular embodiment, each detachable arm is curved between the first and second ends.

[0163] In a particular embodiment, each detachable arm is tapered as it approaches the second end.

[0164] In a particular embodiment, the patient interface includes a pair of textile sleeves.

[0165] In certain configurations, each textile sleeve of the pair of textile sleeves is configured to receive a detachable arm of the pair of detachable arms.

[0166] Another aspect of the present technology is a detachable arm removably coupled to the tab, the detachable arm constructed and arranged to extend in a rearward and downward direction in use, the detachable arm including a first end including a clip configured to removably engage the upper strap and a second end opposite the first end.

[0167] Another aspect of the present technology is a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways in use for sealed delivery of airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that airflow is delivered at the therapeutic pressure to at least the entrance to the patient's nares and forms a seal. a seal-forming structure, the forming structure being constructed and arranged to, in use, maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a gas delivery tube formed as a continuous structure for receiving an air flow from a connection port on the top of the patient's head and delivering the air flow through the seal-forming structure to an entrance to the patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to, in use, contact at least an area of ​​the patient's head above the superior ear-base point of the patient's head. each tab of the pair of tabs has an opening having an opening length, a pair of removable arms are removably coupled to the tabs, each removable arm constructed and arranged to extend in a rearward and downward direction in use, each removable arm including: a pair of removable arms including a first end including a clip configured to enable removal of one of the pair of tabs, a clip length of the clip being less than the opening length, the clip being configured to move along the clip length and / or pivot within the opening for force vector adjustment, and a second end opposite the first end; and a vent structure that moves a continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surroundings.The vent structure is sized and shaped to maintain the therapeutic pressure in the plenum chamber in use, and the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0168] In a particular embodiment, the second end of each detachable arm of the pair of detachable arms includes a slot.

[0169] In a particular embodiment, the slot is arcuate.

[0170] In a particular embodiment, a rear strap is connected to the second end of each detachable arm of the pair of detachable arms.

[0171] In certain configurations, the rear strap is configured to extend rearward and downward over the patient's head and be positioned to contact the occipital region of the patient's head in use, the rear strap being constructed from a first material and a second material, the first material being positioned to contact the temporal region of the patient's head in use, and the second material being positioned to contact the occipital region of the patient's head in use.

[0172] In a particular embodiment, the first material is a textile and the second material is a silicone.

[0173] In a particular embodiment, a rear strap is received within each slot.

[0174] In certain configurations, the width of the rear strap is less than the width of the slot, and the rear strap is configured to move within the slot and adjust the force vector.

[0175] In a particular embodiment, the opening length of each of the pair of tabs is approximately 30 mm to approximately 50 mm.

[0176] In a particular embodiment, each detachable arm is curved between the first and second ends.

[0177] In a particular embodiment, the second end is configured to contact the patient's head approximately 30 degrees below the Frankfort horizontal.

[0178] In a particular configuration, each clip is biased to a closed position and the clip is movable to an open position to connect with a respective tab.

[0179] In certain configurations, each arm of the pair of arms includes at least one bendable portion configured to allow positional adjustment between the first end and the second end.

[0180] In certain embodiments, the at least one bendable portion is a plurality of bendable portions, and each bendable portion of the plurality of bendable portions is independently adjustable.

[0181] Another aspect of the present technology is a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure receiving the airflow from a connection port on the top of the patient's head. and a gas delivery tube formed as a continuous structure for delivering an air flow through the seal-forming structure to an entrance to the patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head in use; a pair of removable arms removably connected to the tabs, each removable arm constructed and arranged to extend in a rearward and downward direction in use, each removable arm including a first end including a post, a clip configured to be movable around the post and to removably engage an upper strap, and a locking portion configured to selectively limit movement of the clip around the post, and a second end opposite the first end; and a venting structure for moving a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure sized and shaped to maintain said therapeutic pressure in the plenum chamber in use.The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed.

[0182] In certain configurations, the clip is pivotally connected to the post.

[0183] In certain configurations, the clip is free to pivot about the post when the locking portion is in the unlocked position.

[0184] In certain configurations, the clip is biased against a surface of the detachable arm.

[0185] In a particular embodiment, the locking portion of each detachable arm is removably connected to a respective post.

[0186] In a particular embodiment, the locking portion of each detachable arm is integrally formed with the respective post.

[0187] In a particular embodiment, the locking portion is overmolded with the post.

[0188] In certain configurations, the locking portion of each detachable arm includes a protrusion configured to selectively contact the clip and limit rotational movement of the clip.

[0189] In a particular embodiment, each detachable arm is curved between the first and second ends.

[0190] In a particular embodiment, each detachable arm is tapered as it approaches the second end.

[0191] In a particular embodiment, a pair of textile sleeves, each textile sleeve of the pair of textile sleeves configured to receive a detachable arm of the pair of detachable arms.

[0192] In certain configurations, the straps are not connected to a pair of detachable arms.

[0193] Another aspect of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure configured to receive an airflow from a connection port on the top of the patient's head and seal the airflow. a positioning and stabilizing structure including a gas delivery tube formed as a continuous structure for delivering gases through a forming structure to an entrance of a patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head in use; a pair of removable arms releasably connected to the tabs, the removable arms constructed and arranged to extend in a rearward and downward direction in use, each removable arm including a first end including a clip configured to releasably engage with an upper strap, a second end opposite the first end, the second end including a slot, and a rear strap extending between the pair of removable arms, the rear strap connected to each removable arm through a slot; and a venting structure for moving a continuous flow of gases exhaled by the patient from within a plenum chamber to the surroundings, the venting structure being sized and shaped to maintain said therapeutic pressure within the plenum chamber in use.The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed.

[0194] Another aspect of the present technology is a pair of removable arms removably coupled to the tab, the removable arms constructed and arranged to extend in a rearward and downward direction in use, each removable arm including a first end including a clip configured to removably engage with an upper strap, a second end opposite the first end, the second end including a slot, and a rear strap extending between the pair of removable arms, the rear strap connected to each removable arm through the slot.

[0195] Another aspect of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure configured to receive an airflow from a connection port on the top of the patient's head and seal the airflow. a positioning and stabilizing structure including a gas delivery tube formed as a continuous structure for delivering gas through a forming structure to an entrance of a patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to contact at least an area of ​​the patient's head above an upper ear base point of the patient's head in use; a pair of removable arms removably connected to the tabs, the removable arms constructed and arranged to extend in a rearward and downward direction in use, each removable arm including a first end including a clip configured to removably engage with an upper strap, a second end opposite the first end, and a locking portion connected to the first end for selectively limiting movement of the clip, the locking portion configured to bias the clip to a locked position; and a venting structure for moving a continuous flow of gas exhaled by the patient from within a plenum chamber to the surroundings, the venting structure sized and shaped to maintain the therapeutic pressure within the plenum chamber in use.The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed.

[0196] Another aspect of the present technology is a pair of detachable arms removably coupled to the tab, the detachable arms constructed and arranged to extend in a rearward and downward direction in use, each detachable arm including a first end including a clip configured to removably engage the upper strap, a second end opposite the first end, and a locking portion connected to the first end to selectively limit movement of the clip, the locking portion configured to bias the clip into a locked position.

[0197] Another example of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, and wherein the seal-forming structure maintains said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use. a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a rear strap constructed from a first material, a pair of upper straps connected to the rear straps, the pair of upper straps being constructed from a second material, and a pair of lower straps connected to the pair of upper straps, the pair of upper straps being constructed from a third material; and a venting structure for moving a continuous flow of gas exhaled by the patient from an interior of the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use. The patient interface is configured to allow the patient to breathe from the surroundings through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed.

[0198] Another example of the present technology is a positioning and stabilizing structure that includes: a posterior strap constructed from a first material; a pair of upper straps connected to the posterior strap, the pair of upper straps constructed from a second material; and a pair of lower straps connected to the pair of upper straps, the pair of upper straps constructed from a third material.

[0199] Another example of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure providing a force to hold the patient in place, the positioning and stabilizing structure including a posterior strap configured to contact the patient's head and rest on at least a portion of the occipital bone, a pair of upper straps configured to selectively apply a posteriorly directed tension, the pair of upper straps connected to the posterior straps below at least a portion of the posterior straps; and a pair of lower straps configured to selectively apply a posteriorly directed tension, the pair of lower straps connected to the pair of upper straps below at least a portion of the upper straps; and a venting structure for moving a continuous flow of gas exhaled by the patient from an interior of the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use. The patient interface is configured to allow the patient to breathe from the surroundings through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed.

[0200] In a particular configuration, the rear strap is constructed from a first material, a pair of upper straps are constructed from a second material, and a pair of lower straps are constructed from a third material.

[0201] In a particular embodiment, the first material and the third material are the same.

[0202] In certain configurations, the first material and the third material are stretchable materials.

[0203] In certain configurations, the rear strap is pre-tensioned in the non-use position.

[0204] In certain embodiments, the first material and the second material are the same.

[0205] In certain configurations, the first material and the second material are non-elastic materials.

[0206] In a particular embodiment, the rear strap is substantially triangular in shape.

[0207] In a particular configuration, the upper side of the rear strap is substantially horizontal.

[0208] In a particular embodiment, the rear strap angle formed by the lower end of the rear strap is between about 110° and about 150°, and more particularly, the rear strap angle is about 130°.

[0209] In a particular embodiment, the pair of upper straps form a substantially V-shape.

[0210] In a particular embodiment, the upper strap angle formed by the lower ends of the pair of upper straps is between about 110° and about 170°, and more particularly, the upper strap angle is about 150°.

[0211] In a particular embodiment, a pair of lower straps form a substantially V-shaped configuration.

[0212] In a particular embodiment, a pair of upper straps and a pair of lower straps are used together to form a substantially X-shaped configuration.

[0213] In a particular embodiment, a lower strap angle is formed between a lower strap of the pair of lower straps and an adjacent upper strap of the pair of upper straps, the lower strap angle being between about 30° and about 70°, and more particularly, the lower strap angle being about 50°.

[0214] In a particular embodiment, a pretension is applied to the pair of upper straps when in the non-use position.

[0215] In a particular embodiment, a pair of lower straps are removably connected to the plenum chamber.

[0216] In certain configurations, the positioning and stabilizing structure further includes a gas delivery tube formed as a continuous structure for receiving an air flow from a connection port on the top of the patient's head and delivering the air flow through the seal-forming structure to an entrance to the patient's airway. The gas delivery tube includes a pair of tabs constructed and arranged to contact at least an area of ​​the patient's head above the superior ear base point of the patient's head in use.

[0217] In a particular embodiment, each upper strap of the pair of upper straps is removably connected to one of the pair of tabs.

[0218] Another example of the present technology is a positioning and stabilizing structure that includes: a posterior strap configured to contact a patient's head and rest on at least a portion of the occipital bone; a pair of upper straps configured to selectively apply posteriorly directed tension, the pair of upper straps connected to the posterior strap below at least a portion of the posterior strap; and a pair of lower straps configured to selectively apply posteriorly directed tension, the pair of lower straps connected to the pair of upper straps below at least a portion of the upper strap.

[0219] Another example of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of an airflow at the therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that an airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, and said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold a structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: a rear strap configured to contact the patient's head and rest on at least a portion of the occipital bone, the rear strap having a substantially triangular shape; a pair of upper straps formed in a substantially V-shape and connected to a lower portion of the rear strap; a pair of lower straps formed in a substantially V-shape and connected to a lower portion of the pair of upper straps, the pair of upper straps and the pair of lower straps being connected in a substantially X-shaped configuration; and a venting structure for moving a continuous flow of gas exhaled by a patient from an interior of a plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use. The patient interface is configured to allow the patient to breathe from the surroundings through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed.

[0220] Another example of the present technology is a positioning and stabilizing structure that includes: a posterior strap configured to contact a patient's head and rest on at least a portion of the occipital bone, the posterior strap having a substantially triangular shape; a pair of upper straps formed in a substantially V-shape and connected to a lower portion of the posterior straps; a pair of lower straps formed in a substantially V-shape and connected to a lower portion of the pair of upper straps. The pair of upper straps and the pair of lower straps are connected in a substantially X-shaped configuration.

[0221] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory disorders (e.g., sleep disordered breathing).

[0222] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0223] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief description of the drawings]

[0224] 4. Brief Description of the Drawings The present technology is illustrated by way of example and not by way of limitation in the accompanying drawings in which like reference numbers include similar elements as follows:

[0225] [Figure 1]4.1 Respiratory Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device 4000 is conditioned by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Diagram 2] The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Diagram 3] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 4] An outline of the human respiratory system including the nose and oral cavity, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Diagram 5] FIG. 1 is a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 6] A front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds and corners of the mouth. The directions of superior, inferior, radially inward and radially outward are also given. [Figure 7]FIG. 1 is a lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points. The directions of superior and inferior, and anterior and posterior are also given. [Figure 8] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The coronal plane is also noted. [Figure 9] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 10] FIG. 2 is a side view of the superficial features of the nose. [Figure 11] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 12] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 13] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 14] A lateral view of the skull along with the outline of the head surface and some of the muscles. The following bones are shown: frontal, sphenoid, nasal, zygoma, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 15] Shown is the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 16] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 17] 17 is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 18]17 is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 19] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 20] 21 is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 21] 20 is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 22] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome and saddle regions are shown. [Diagram 23] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The straight line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 24] The surface of a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Diagram 25] FIG 25 is a cross-sectional view through the structure of FIG 24. The surfaces shown bound a two-dimensional hole in the structure of FIG 24. [Figure 26] 25 is a perspective view of the structure of FIG. 24 including a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 24 are also illustrated. [Figure 27] 1 shows a mask with an inflatable bladder as a cushion. [Figure 28] FIG. 28 is a cross-sectional view of the mask of FIG. 27 showing the inner surface of the bladder, which bounds a two-dimensional hole in the mask. [Figure 29] 28 shows a further cross section through the mask of Figure 27. The inner surface is also shown. [Diagram 30] Demonstrates the left hand rule. [Diagram 31] Demonstrates the right-hand rule. [Diagram 32] 1 shows the left ear including the left ear helix. [Diagram 33] 1 shows the right ear including the right ear helix. [Diagram 34] Shown is a right-handed spiral. [Diagram 35] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Diagram 36] A diagram of the plenum chamber 3200 showing the sagittal and medial contact surfaces. [Figure 37] A rear view of the plenum chamber of Figure 36. Directions in the view are perpendicular to the central contact plane. In Figure 37, a sagittal plane bisects the plenum chamber into a left hand side and a right hand side. [Figure 38] FIG. 38 is a cross-sectional view through the plenum chamber of FIG. 37, the cross-section being taken in the sagittal plane shown in FIG. The "mid-contact" plane is illustrated. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the tendon 3215. The tendon 3215 rests on the sagittal plane and only contacts the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3225 and lower point 3235). Depending on the geometry of the cushion in this region, the mid-contact plane may contact both the upper and lower points. [Figure 39] The plenum chamber 3200 of FIG. 36 is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face of the face" when the plenum chamber is in the use position. In FIG. 39, the plenum chamber 3200 is of a nasal mask, with the upper point 3225 resting approximately on the serion and the lower point 3235 resting on the upper lip. 4.4 RPT Device [Diagram 40]1 shows an RPT device in accordance with one form of the present technology. [Diagram 41] FIG. 4 is a schematic diagram of an air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Respiratory Waveforms [Diagram 42] A model of a typical human respiratory waveform during sleep is shown. 4.6 Patient interface of this technology [Diagram 43] 1 shows a one-piece textile structure used to make the seal-forming structure and the positioning and stabilizing structure. [Diagram 44] As shown in Figure 43, a seal-forming structure and a positioning and stabilizing structure are formed from a one-piece woven structure. The positioning and stabilizing structure is formed as a hollow tube that allows air to be conveyed to the seal-forming structure. [Diagram 45] 44 shows a seal-forming structure and a positioning and stabilizing structure formed from a one-piece woven structure as shown in FIG 43. The positioning and stabilizing structure is formed as a flat strap. [Diagram 46] FIG. 1 is a front perspective view of a patient interface formed from a one-piece structure of textile material. The positioning and stabilizing structure includes a hollow tube that conveys air to the seal-forming structure. Air is conveyed directly into the hollow sealing tube and the seal-forming structure. The plenum chamber is removably coupled to the seal-forming structure. Provision of air to the hollow sealing tube may be through a decoupling member positioned in the positioning and stabilizing structure or the plenum chamber. [Figure 47] FIG 47 is a rear perspective view of the patient interface of FIG 46. A pair of magnetic portions contained in the plenum chamber assist in coupling the plenum chamber to the seal-forming structure in the proper orientation. [Figure 48] FIG. 48 is a detailed view of the patient interface of FIG. 47 showing the inner surface of the hollow sealing tube. The seal-forming structure includes holes that communicate with the hollow sealing tube. These holes allow the transfer of air from the adjacent inner surface to the patient's face. [Figure 49] FIG. 1 is a perspective view of a patient interface formed from a one-piece construction of a textile material. The seal-forming structure includes a clamping structure and a magnetic portion. The plenum chamber includes a magnetic portion that is received by the clamping structure and is complementary to a portion on the seal-forming structure. The clamping structure and the magnetic portion cooperate to facilitate communication of the plenum chamber to the seal-forming structure. [Figure 50a] FIG 50 is a perspective view of the patient interface of FIG 49. The plenum chamber is partially coupled to the seal-forming structure by a clamping structure and a magnetic portion. [Figure 50b] FIG 50 is a perspective view of the patient interface of FIG 49. The plenum chamber is generally coupled to the seal-forming structure by a clamping structure and a magnetic portion. [Figure 51] FIG. 1 is a perspective view of a under-the-nose mask being worn by a patient, the mask creating a seal around the patient's nostrils and exposing the patient's mouth to the surroundings. [Figure 52] FIG. 52 is a perspective view of the under-the-nose mask of FIG. 51 coupled to a mouth seal. The under-the-nose mask and mouth seal cooperate to form a modular structure that can create a seal around a patient's nose and mouth. A plenum chamber is used in conjunction with the modular configuration to selectively circumscribe the patient's mouth and nose. [Figure 52a] FIG. 52 is a schematic diagram of the underside of the nasal mask of FIG. 51 showing the interface for connection to a mouth seal. [Figure 52b] FIG. 52 is a schematic diagram of the top surface of the nasal mask of FIG. 51, illustrating the interface for connection of the nasal mask. [Diagram 53] FIG. 52 is a side view of the under-the-nose mask of FIG. 51 with a rear strap constructed of two materials positioned around the patient's head. [Figure 54]FIG. 54 is a rear view of the under-the-nose mask of FIG. 53 showing the rear strap with a side portion constructed from a first material and a second portion constructed from a second material. [Figure 55] FIG. 52 is a side view of the under-the-nose mask of FIG. 51 with the rear straps of two materials positioned around the patient's head. An extender is used to connect the rear straps to the hollow tube. [Figure 56] FIG. 56 is a rear view of the under-the-nose mask of FIG. 55 showing the rear strap with the side portion constructed from a first material and the second portion constructed from a second material. The extender is constructed from a third material different from the first material. [Figure 57] FIG. 53 is a side view of the under-the-nose mask and mouth seal of FIG. 52 with a rear strap constructed of two materials positioned around the patient's head. An extender is used to connect the rear strap to the hollow tube and additional side straps are used to maintain the under-the-nose mask and mouth seal in a therapeutically effective position. [Figure 58] FIG. 53 is a rear view of the under-the-nose mask and mouth seal of FIG. 52 showing the rear strap with the side portion constructed from a first material and the second portion constructed from a second material. The extender is constructed from a third material different from the first material. [Figure 59] FIG. 57 is a side view of the under-the-nose mask and mouth seal of FIG. 52 with the rear strap constructed of two materials positioned around the patient's head. An extender is used to connect the rear strap to the hollow tube. The additional side straps of FIG. 57 are not used to maintain the under-the-nose mask and mouth seal in a therapeutically effective position. [Figure 60] FIG. 54 is a detailed schematic diagram of the positioning and stabilizing structure of FIG. 53, showing how the rear strap is releasably connected to the loop by a fastening mechanism. [Figure 61] FIG. 56 is a detailed schematic diagram of the positioning and stabilizing structure of FIG. 55, showing how the extender is releasably connected to the loop by a fastening mechanism. [Figure 62]FIG. 56 is a detailed schematic diagram of the positioning and stabilizing structure of FIG. 55, showing how the rear strap is releasably connected to the extender by a fastening mechanism. [Figure 63] FIG. 55 is a detailed schematic diagram of a pad of the positioning and stabilizing structure of FIG. 54, showing the first adjustment mechanism. [Figure 64] FIG. 55 is a detailed schematic diagram of a pad of the positioning and stabilizing structure of FIG. 54, showing a second adjustment mechanism. [Figure 65] FIG. 13 is a rear view of the headgear straps used in the positioning and stabilizing structure, showing how each strap is individually sewn to the back. [Figure 65-1] FIG. 66 is a rear view of another version of the headgear strap of FIG. 65, showing the curved stitching that connects the strap to the rear. [Figure 66] FIG. 66 is a side view of a patient interface including the headgear of FIG. 65 worn by a patient, showing the straps of the headgear connection adjacent the top of the patient's head. [Figure 67] FIG. 13 is a rear view of a patient interface including another example of headgear worn by a patient. [Figure 68] FIG. 68 is a side view of the patient interface of FIG. 67, wherein the patient interface is being worn. [Figure 69] FIG. 13 is a rear view of a patient interface including another example of headgear worn by a patient. [Figure 70] FIG. 70 is a side view of the patient interface of FIG. 69, showing the patient interface being worn. [Figure 71] FIG. 13 is a rear view of a patient interface including another example of headgear worn by a patient. [Figure 72] FIG. 72 is a side view of the patient interface of FIG. 71 , wherein the patient interface is being worn. [Figure 73] FIG. 13 is a rear view of a patient interface including another example of headgear worn by a patient. [Figure 74] FIG. 74 is a side view of the patient interface of FIG. 73, wherein the patient interface is being worn. [Figure 75] FIG. 13 is a rear view of a patient interface including another example of headgear worn by a patient. [Figure 75-1] FIG. 76 is a rear view of the alternative version of headgear of FIG. 75 worn by a patient. [Figure 76] FIG. 76 is a side view of the patient interface of FIG. 75, wherein the patient interface is being worn. [Figure 77] A detailed view of the detachable arm connected to the hollow tube. [Figure 78] FIG. 78 is a perspective view of the removable arm of FIG. 77 for use with a nasal cushion. [Figure 79] FIG. 78 is a perspective view of the removable arm of FIG. 77 for use with a full-face cushion. [Figure 80] FIG. 78 is a detailed view of the detachable arm of FIG. 77 in another form. [Figure 80-1] FIG. 81 is a detailed view of the removable arm of FIG. 80, showing the lock between the arm's clip and the post. [Figure 81] FIG. 81 is a perspective view of the removable arm of FIG. 80. [Figure 82] FIG. 81 is a detailed view of the detachable arm of FIG. 80, showing how the textile sleeve is connected to the arm. [Figure 83] FIG. 81 is a perspective view of the detachable arm of FIG. 80 used with a nasal cushion. [Figure 84] FIG. 81 is a perspective view of the removable arm of FIG. 80 used with a full-face cushion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0226] 5 Detailed description of examples of the present technology Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific examples described herein, and are not limiting.

[0227] The following description is provided in conjunction with various examples that may share one or more common characteristics and / or features. 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 the other examples. In addition, any single feature or combination of features in any of these examples may constitute an additional example.

[0228] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including pressurizing air to a positive pressure relative to the surroundings and directing the pressurized air to an entrance of the airways of a patient 1000.

[0229] In certain examples of the present technology, an air supply at positive pressure relative to ambient is provided to the patient's nasal passages via one or both nostrils, hi further examples, an air supply at positive pressure can be provided to the mouth in addition to the nasal passages.

[0230] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0231] 5.2 Respiratory Treatment Systems In one form, the present technology includes a respiratory treatment system for the treatment of respiratory disorders. The respiratory treatment system may include an RPT device 4000 that provides an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0232] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes one or more of the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be performed by one or more physical components. In some forms, one physical component may perform one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway to maintain positive pressure at the entrance(s) to the airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0233] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0234] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 4 cmH2O relative to ambient.

[0235] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0236] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0237] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0238] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 includes a target seal-forming area and may further include a cushioning feature. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day depending on a range of factors (e.g., placement location of the patient interface 3000 on the face, tension in the positioning and stabilizing structure 3300, and the shape of the patient's face).

[0239] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0240] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0241] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0242] A seal-forming structure 3100 in accordance with one form of the present technology may be constructed from a textile material 3101 (see, e.g., FIGS. 43-52B). As shown in FIG. 43, a single piece of textile material 3101 may be used to form the patient interface 3000. Multiple pieces of textile 3101 may be used to form different portions of the patient interface 3000.

[0243] In certain forms of the present technology, a system includes more than one seal-forming structure 3100, with each seal-forming structure 3100 configured to accommodate a different size and / or shape range. For example, a system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0244] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0245] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0246] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0247] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of the sealing flange.

[0248] In one form the seal-forming structure includes an area having a sticky or adhesive surface.

[0249] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having an adhesive or bonding surface.

[0250] In one form of the present technology (see, e.g., Figs. 27-29), a seal-forming structure 3100 includes a hollow sealing tube 3104 that receives a flow of pressurized air. In the hollow sealing tube 3104, an outer diameter OD is in contact with the environment and an inner diameter ID is positioned adjacent the patient's oral-nose region and is not exposed to the environment when the seal-forming structure 3100 is worn by a patient. An inner surface INS of the hollow sealing tube 3104 can be at least partially impermeable.

[0251] In one form (see, e.g., FIG. 44 and FIG. 46-48), the hollow sealing tube 3104 is constructed entirely of and / or lined with an impermeable material. Holes 3108 are cut through the inner surface INS toward the inner diameter ID to allow air to exit the hollow sealing tube 3104 and travel to the patient's nose and / or mouth. These holes 3108 may be evenly spaced around the inner diameter ID or may be concentrated within a particular region or regions along the inner diameter ID.

[0252] In certain configurations, the inner surface INS adjacent the outer diameter OD is constructed and / or lined with an impermeable material (e.g., silicone, thermoformed and / or laminated), and the inner surface INS adjacent the inner diameter ID is constructed and / or lined with a permeable material. Because the hollow sealing tube does not include holes 3108, the impermeable material substantially prevents air from escaping to the environment when the hollow sealing tube 3104 is filled with pressurized air. Instead, air is directed to the inner diameter ID and can leak or migrate through the permeable material to the patient's nose and / or mouth.

[0253] 5.3.1.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, is sealed onto the nasal bridge or nasal ridge region of the patient's face.

[0254] In one form, the seal-forming structure includes a saddle-like region that is constructed to seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0255] 5.3.1.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, seals over the upper lip area (ie, upper lip) of the patient's face.

[0256] In one form, the seal-forming structure includes a saddle-shaped region constructed to seal over the upper lip region of the patient's face in use.

[0257] 5.3.1.4 Jaw area In one form the non-invasive patient interface 3000 includes a seal-forming structure that, in use, seals over the chin area of ​​the patient's face.

[0258] In one form, the seal-forming structure includes a saddle-like region that is constructed to seal over the chin region of the patient's face in use.

[0259] 5.3.1.5 Frontal area In one form, the seal-forming structure seals onto the forehead area of ​​the patient's face when in use, in such a form the plenum chamber may cover the eye when in use.

[0260] 5.3.1.6 Retention mechanism In one form of the present technology, the seal-forming structure 3100 includes at least one retention feature 3112 for coupling additional components of the patient interface 3000 (eg, the plenum chamber 3200) to the seal-forming structure 3100.

[0261] 5.3.1.6.1 Magnetic retention As shown in FIG. 46, one form of the seal-forming structure 3100 includes a first magnetic portion 3114. The first magnetic portion 3114 includes a first polarity. In a particular form, the first magnetic portion 3114 is a magnet coupled (e.g., sewn, glued) into the seal-forming structure 3100. The magnet can be provided in any orientation and along any length of the seal-forming structure 3100. Multiple magnets can be provided on different sides (e.g., top / bottom, left / right) of the seal-forming structure 3100. Multiple magnets can have the same polarity as each other. In other examples, the first magnetic portion 3114 can be any similar feature (e.g., magnetic threads, iron alloy) capable of magnetic coupling.

[0262] 5.3.1.6.2 Mechanical retention As shown in Figures 49-50B, one form of the seal-forming structure 3100 includes a first mechanical retainer or clip structure 3116. In certain forms, the first clip structure 3116 may be constructed of a rigid material (e.g., plastic, rigid fabric, rigid threads) and is disposed (e.g., sewn) into the seal-forming structure 3100. The first clip structure 3116 includes clips (e.g., first clip 3116a, second clip 3116b, and gasket 3116c) that extend from a surface of the seal-forming structure 3100. The rigid material has a stiffness greater than the stiffness of at least a portion of the remaining material of the seal-forming structure 3100.

[0263] In certain configurations, the first clip structure 3116 may be part of the seal-forming structure 3100. For example, the first clip structure 3116 may be integrally formed with the seal-forming structure 3100 or may be permanently attached to the seal-forming structure 3100.

[0264] In certain configurations, the first clip structure 3116 is a male clip structure. A release mechanism 3118 may be provided with the first clip structure 3116 for use in decoupling the first clip 3116a from a corresponding structure. The release mechanism 3118 allows for movement of the first clip 3116a.

[0265] 5.3.1.7 Nasal pillow In one form (see, e.g., FIG. 22), the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to seal with a respective nostril of the patient's nose.

[0266] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum is sealed onto the underside of the patient's nose, a stalk, and a flexible region on the underside of the frustum, connecting the frustum to the stalk. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stalk. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum of the cone and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stalk is connected.

[0267] 5.3.1.8 Modular Structure In one form of the present technology (see, e.g., FIGS. 51-52B), the seal-forming structure 3100 is a under-the-nose mask 3100a that is adapted to engage the patient's upper lip LS and seal against the nares NA while leaving the nasal tip PRO free. The patient's mouth remains exposed to the environment regardless of the position of the seal-forming structure 3100.

[0268] In one form, the plenum chamber 3200 (described below) is provided as an integral or unitary structure within the seal-forming structure 3100. The plenum chamber 3200 includes an insert 3134 with a vent 3400 to assist in CO2 removal.

[0269] In one form, the insert 3134 of the plenum chamber 3200 is at least partially removable from the seal-forming structure 3100, and a mouth seal 3100b is further attached to the under-the-nose mask 3100a. The mouth seal 3100b peripherally covers the patient's mouth.

[0270] In one form, the mouth seal 3100b is removably coupled to the under-the-nose mask 3100a by a magnetic and / or mechanical coupling. The mouth seal 3100b may include a magnet or magnetic thread 3142 that is magnetically attached to the magnet or magnetic thread 3140 in the under-the-nose mask 3100a. The mouth seal 3100b may alternatively or additionally include a feature (e.g., tab 3144) that mates (e.g., via a snap fit, press fit, etc.) with a complementary feature (e.g., recess 3146) on the under-the-nose mask 3100a. The tab 3144 may be a stiffening feature (e.g., a stiff fabric, stiff thread) and is formed (e.g., integrally) with the mouth seal 3100b. Any combination of magnetic and mechanical couplings may seal the interface between the under-the-nose mask 3100a and the face mask, substantially preventing pressurized air from escaping from the seal-forming structure 3100 to the environment.

[0271] In one form, after the insert is removed from the under-the-nose mask 3100a, a separate plenum chamber 3200 is removably coupled to both the under-the-nose mask 3100a and the mouth seal 3100b. For sealing with the patient's nose and mouth, the plenum chamber 3200 includes a first end 3240 that covers the nasal opening 3152a of the nasal mask 3100a and a second end 3241 that covers the mouth opening 3152b of the mouth seal 3100b. A conduit 3242 connects the first end 3240 to the second end 3241 to provide fluid communication between the patient's nose and mouth. The conduit 3242 may include one or more holes for flushing of gas.

[0272] 5.3.2 Plenum chamber The plenum chamber 3200 may have a perimeter with a shape that is complementary to the surface contour of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogenous piece of material.

[0273] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance because they are often less intrusive and / or more comfortable for the wearer.

[0274] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., polycarbonate). The use of a transparent material can provide a less intrusive appearance to the patient interface, which can aid in improved compliance with treatment. The use of a transparent material can aid the clinician in viewing the placement and function of the patient interface.

[0275] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can provide a less intrusive appearance to the patient interface and can help improve treatment compliance.

[0276] As shown in Figures 46-50B, a particular form of plenum chamber 3200 is constructed from a textile material 3101. The textile material 3101 may lead to a reduction in weight on the patient's face, which may help improve treatment compliance.

[0277] In a particular form of the present technology, the plenum chamber 3200 includes a valve 3206 (e.g., an anti-asphyxiation valve (AAV)). The AAV 3206 includes a flap 3207 of textile material 3101 on the plenum chamber 3200. The flap 3207 selectively provides fluid communication to the plenum chamber 3200 through a first inlet port 3208. In the absence of pressurized air flow, the AAV 3206 is biased to an open position to allow the patient to breathe from the environment. This bias may be mechanical (e.g., a spring) or may be provided through magnetic repulsion (e.g., two parts of the same polarity). When pressurized air is supplied, the AAV 3206 closes and blocks communication with the environment through the first inlet port 3208.

[0278] 5.3.2.1 Removable plenum chambers In certain forms of the present technology (see, e.g., Figs. 46-50B), the plenum chamber 3200 is selectively removable from the seal-forming structure 3100. In a first or uncoupled position included in the plenum chamber 3200, the patient's nose and / or mouth are exposed to the environment. The plenum chamber 3200 also includes a second or communicating position in which the patient's nose and / or mouth are covered by the plenum chamber 3200. The plenum chamber 3200 is movable (independently of the seal-forming structure 3100) between the uncoupled and communicating positions. The seal-forming structure 3100 may be held in place (e.g., sealed against the patient's face) regardless of the position of the plenum chamber 3200.

[0279] 5.3.2.1.1 Magnetic retention 47, the second magnetic portion 3210 included in certain configurations of the plenum chamber 3200 has an opposite polarity to the first magnetic portion 3114 of the seal-forming structure 3100. A tactile response provided to the patient from the magnetic portions 3114 and 3210 indicates that the plenum chamber 3200 is properly aligned with the seal-forming structure 3100. In some examples, a third magnetic portion 3212 is also provided within the plenum chamber 3200. The polarity of the third magnetic portion 3212 is the same polarity as the first magnetic portion 3114 (i.e., opposite polarity to the second magnetic portion 3210).

[0280] In certain configurations (see, e.g., FIG. 48), the second magnetic portion 3210 is a magnet embedded in the textile covering 3204. The magnet may be provided along any length of the textile covering 3204 in any orientation. If a third magnetic portion 3212 is provided, the second magnetic portion 3210 and the third magnetic portion 3212 are positioned on opposite sides of the plenum chamber 3200 (e.g., left / right, top / bottom). The plenum chamber 3200 couples to the seal-forming structure 3100 when correctly aligned (i.e., the second magnet is adjacent to the first magnetic portion 3114) and does not couple to the seal-forming structure 3100 when improperly aligned (i.e., the second magnet is distal to the first magnetic portion 3114). In other examples, the second magnetic portion 3210 can be any similar feature capable of magnetic coupling (e.g., magnetic threads, iron alloy).

[0281] When properly aligned (e.g., the first magnetic portion 3114 is adjacent to the second magnetic portion 3210), the seal-forming structure 3100 and the plenum chamber 3200 are coupled together and relatively fixed in place. In some forms, the magnetic force is greater than the force of the pressurized air and forms a seal between the seal-forming structure 3100 and the plenum chamber 3200. No additional structure is required to hold the plenum chamber 3200 in place and prevent the pressurized air from escaping when the patient interface 3000 is in use. In some forms, the magnetic force is less than the force of the pressurized air and additional structure (e.g., mechanical fasteners (described below)) helps hold the plenum chamber 3200 in place and prevents the pressurized air from escaping when the patient interface 3000 is in use. In any form, the magnetic force is less than the force exerted by the patient's hand (e.g., when moving the plenum chamber 3200 to the uncoupled position).

[0282] 5.3.2.1.2 Mechanical retention 49-50B, one form of the plenum chamber 3200 includes a second mechanical retainer or clip structure 3216 in combination with a complementary first clip structure 3116. The second clip structure 3216 removably mates with the first clip structure 3116 to secure the plenum chamber 3200 in place relative to the seal-forming structure 3100.

[0283] In certain configurations, the second clip structure 3216 is constructed of a rigid material (e.g., plastic, rigid fabric, rigid threads) and is disposed (e.g., stapled) within the textile covering 3204. The second clip structure 3216 extends from a surface of the textile covering 3204 when mated with the first clip structure 3116. For example, the second clip structure 3216 may be integrally formed with the plenum chamber 3200.

[0284] In certain configurations, the second clip structure 3216 is a female clip structure that mates with the male clip structure of the first clip structure 3116, although they may be reversed. The patient aligns the first clip structure 3116 and the second clip structure 3216 and couples the plenum chamber 3200 to the seal-forming structure 3100 with a snap fit to obtain a seal between the plenum chamber 3200 and the seal-forming structure 3100. In particular, the patient aligns the second clip structure 3216 with the second clip 3216 (see, for example, FIG. 50A). The patient then actuates the release mechanism 3118 to pivot the first clip 3116a away from the magnetic portion 3114. The patient then positions the plenum chamber 3200 adjacent to the magnetic portion 3114 and releases the release mechanism 3118 to bring the first clip 3116a into contact with the outer surface 3204a (see, e.g., FIG. 50B). A seal is provided between the seal-forming structure 3100 and the plenum chamber 3200 by the gasket 3116c, preventing fluid flow between the interface of the seal-forming structure 3100 and the plenum chamber 3200. The female clip portion 3216 may be oriented to complement the second magnetic portion 3210. In other words, the female clip portion 3216 is oriented to couple to the male clip portion 3116 in a single orientation (e.g., one that corresponds to an orientation in which the first magnetic portion 3114 and the second magnetic portion 3210 are attracted to each other).

[0285] In certain configurations, the magnetic force between the first magnetic portion 3114 and the second magnetic portion 3210 is insufficient to hold the plenum chamber 3200 to the seal-forming structure 3100 (e.g., the weight of the plenum chamber 3200 exceeds the vertical component of the magnetic force). In this case, the magnetic portions 3114 and 3210 only provide a tactile response to the patient that the plenum chamber 3200 is properly aligned. The plenum chamber 3200 is generally held by the first clamping structure 3116 and the second clamping structure 3216.

[0286] In certain configurations, the release mechanism 3118 is used to decouple the first clamping structure 3116 and the second clamping structure 3216. The release mechanism 3118 separates the first clip structure 3116 from the second clip structure 3216 to allow the plenum chamber 3200 to move to the decoupled position. The release mechanism 3118 can be a finger-actuated release mechanism 3118 (e.g., a push button) that separates the first clip structure 3116 from the second clip structure 3216.

[0287] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0288] In one form, the positioning and stabilising structure 3300 holds the patient interface 3000 on the patient's head with at least sufficient force to overcome the effect of positive pressure in the plenum chamber 3200 (which would lift the seal-forming structure 3100 off the face).

[0289] In one form, the positioning and stabilising structure 3300 holds the patient interface 3000 on the patient's head with at least sufficient force to overcome the effects of gravity on the patient interface 3000.

[0290] In one form, the positioning and stabilizing structure 3300 holds the patient interface 3000 on the patient's head with a force that provides a safety margin to overcome the potential for disruptive forces acting on the patient interface 3000 (e.g., due to tube drag or accidental interference with the patient interface).

[0291] In one form of the present technology, the positioning and stabilizing structure 3300 is configured to be worn by the patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap (e.g., side strap 3302, rear strap 3304 and / or top strap 3306) having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0292] In one form of the present technology, the positioning and stabilizing structure 3300 is configured so as not to be excessively large or bulky in size that would interfere with the patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0293] In one form of the present technology, the positioning and stabilizing structure 3300 is configured so as not to be excessively large or bulky in size that would interfere with the patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0294] In one form of the present technology, the positioning and stabilizing structure 3300 includes a decoupling portion disposed between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be a flexible or flimsy strap. The decoupling portion is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling portion prevents forces from being transferred along the positioning and stabilizing structure 3300 to the rear portion, disrupting the seal.

[0295] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap 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. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0296] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps 3302, 3304, 3306 can be configured to be tensioned in use to direct a force that urges the seal-forming structure 3100 into contact with a portion of the patient's face. In one example, the straps 3302, 3304, 3306 can be configured as ties.

[0297] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point on the patient's head to cover a portion of the parietal bone without covering the occipital bone.

[0298] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0299] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart relative to one another.

[0300] In one form of the present technology (see, e.g., FIG. 47), the rear strap 3304 of the positioning and stabilizing structure 3300 includes a first magnetic portion 3316 (e.g., magnet, magnetic thread). The first magnetic portion 3316 is disposed near an end of the rear strap 3304. The polarity of the second magnetic portion 3318 (e.g., magnet, magnetic thread) is opposite polarity to the first magnetic portion 3316. The first magnetic portion 3316 of the rear strap 3304 is removably coupled to the second magnetic portion 3318. In the illustrated example, the first magnetic portion 3316 is disposed near an end of the rear strap 3304. The second magnetic portion is spaced apart from the first magnetic portion 3316 and includes an opposite polarity to the first magnetic portion 3316. In some examples, another coupling means (e.g., hook and loop fastener) may be used in place of the magnetic portion.

[0301] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable and non-rigid (e.g., side straps 3302, rear straps 3304 and / or top straps 3306). An advantage of this embodiment is that the straps 3302, 3304, 3306 are more comfortable when the patient lies down to sleep.

[0302] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps (e.g., side straps 3302, rear straps 3304 and / or top straps 3306) that are constructed to be breathable, thereby allowing water vapor to pass through the straps 3302, 3304 and 3306.

[0303] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 3300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0304] 46 and 47, one form of the positioning and stabilizing structure 3300 includes headgear 3324 formed from a textile material 3101. The headgear 3324 is coupled to the seal-forming structure 3100, with at least a portion of the headgear 3324 and the seal-forming structure 3100 being formed from a one-piece construction of the textile material 3101 (see, e.g., FIGS. 43-45). Yet, in other forms, the headgear 3324 and the seal-forming structure 3100 may each be formed from individual pieces of textile material 3101 and coupled together (e.g., by sewing, gluing).

[0305] In one form, the headgear 3324 of the positioning and stabilizing structure 3300 includes side straps 3302 that, when worn by a patient, are connected to the seal-forming structure 3100 and extend to a position between the patient's ears and eyes. In particular, the side straps 3302 extend from the sides of the seal-forming structure 3100 below the patient's eyes and along the patient's cheeks. The side straps 3302 are formed from a textile material 3101.

[0306] In one form, the headgear 3324 of the positioning and stabilizing structure 3300 includes a rear strap 3304 that, when worn by a patient, is connected to the seal-forming structure 3100 and engages the occipital region of the patient's head (e.g., the back of the patient's head adjacent the occipital bone). The rear strap 3304 is formed from a textile material 3101.

[0307] In one form, the headgear 3324 of the positioning and stabilizing structure 3300 includes an upper strap 3306 that is connected to the seal-forming structure 3100 and engages the top of the patient's head when worn by the patient. The upper strap 3306 is formed from a textile material 3101.

[0308] In one form, the positioning and stabilizing structure 3300 includes an earpiece 3326 that, when worn by a patient, is coupled to the seal-forming structure 3100 and partially or completely surrounds the patient's ear. The earpiece 3326 is formed from a textile material 3101.

[0309] In certain configurations, at least a portion of the positioning and stabilizing structure 3300 and the seal-forming structure 3100 are one-piece structures. That is, one or both of the side straps 3302, top straps 3306, rear straps 3304 and / or earpieces 3326 are formed as one-piece structures with the seal-forming structure 3100. For example, at least one of the side straps 3302 is integrally formed with the seal-forming structure 3100 and is not removable from the seal-forming structure 3100. The interface between the side straps and the seal-forming structure 3100 can be a seamless transition 3328.

[0310] In certain configurations, the transition 3328 may be visible to an observer (e.g., bed companion 1100) as a result of the side straps 3302 bending or flexing relative to the seal-forming structure 3100. In other words, the transition 3328 may be a crease that delineates the transition between the headgear 3324 and the seal-forming structure 3100 (e.g., the side straps 3302 may bend outward or away from the patient as they follow the contours of the patient). The transition 3328 may be due to pressurized air inflating the seal-forming structure 3100 and / or the side straps 3302 (e.g., the seal-forming structure 3100 and / or the side straps 3302 expand to different shapes on either side of the transition 3328).

[0311] In certain configurations, the earpiece 3326 is formed with the side straps 3302 as a single piece of textile material 3101 and is indirectly connected to the seal-forming structure 3100 through the side straps. The top strap 3306 is formed with the side straps 3302 or ear straps as a single piece of textile material 3101 and is indirectly connected to the seal-forming structure 3100 through the side straps 3302. The back strap 3304 is formed directly with the seal-forming structure 3100 or is formed directly with the side straps 3302 and is indirectly connected to the seal-forming structure 3100 through the side straps 3302.

[0312] 5.3.3.1 Use for airflow As shown in Figures 46-48, one form of the side strap 3302 is at least a portion of a hollow tube 3334 that conveys pressurized air to the seal-forming structure 3100. The hollow tube 3334 is constructed and / or lined with an impermeable material (e.g., silicone, thermoformed and / or laminated). The hollow tube 3334 is connected to the seal-forming structure 3100 at the sealed end 3308 with a seamless or substantially seamless transition (e.g., at joint 3328) to prevent or substantially prevent the pressurized air from escaping to the environment. In one example, the hollow tube 3334 is a dual lumen tube.

[0313] In certain configurations (see, e.g., FIG. 43), a single piece of textile 3101 is used to create the side straps 3302 and the seal-forming structure 3100. When construction of the patient interface 3000 is performed (e.g., to provide depth to the seal-forming structure 3100 and form the side straps 3302 as hollow tubes 3334), the side straps 3302 transition to the seal-forming structure 3100 at a substantially smooth juncture 3328 (see, e.g., FIG. 44 and FIG. 46). For example, while a visible transition exists at the juncture 3328 (due to the different shapes of the seal-forming structure 3100 and the side straps 3302), the same piece of textile 3101 is used on either side of the juncture 3328. In particular, when the patient interface 3000 is in use, both the inner surface 3130 of the seal-forming structure 3100 and the inner surface 3342 of the side straps 3302 rest against the patient's face. The side straps 3302 extend (eg, in a forward and downward direction along the patient's face) into the seal-forming structure 3100 so that the joint 3328 is barely visible between the inner surfaces 3130 and 3342 when viewed by the patient.

[0314] As shown in Fig. 47, a particular form of the seal-forming structure 3100 is a gasket-type seal. The seal-forming structure 3100 forms a hollow sealing tube 3104, with the hollow tube 3334 extending to an inner surface INS of the hollow sealing tube 3104. Pressurized air is conveyed into the interior of the hollow sealing tube 3104 (e.g., adjacent the inner surface INS) and inflates the hollow sealing tube 3104. The air then exits the hollow sealing tube 3104 to reach the patient's face.

[0315] In one form of the present technology, as shown in Figs. 46 and 47, a connector 3335 is used to connect two hollow tubes 3334 of a side strap 3302 together. The connector 3335 includes a second inlet port 3336, which may be positioned on the positioning and stabilizing structure 3300 (e.g., on the side strap 3302, on the upper strap 3306). The second inlet port 3336 provides communication between the environment and the hollow tubes 3334 of the side strap 3302. The second inlet port 3336 may allow the patient to breathe from the environment (in the absence of pressurized air). The connector 3335 may be formed in the middle of the hollow tube 3334 to split the hollow tube 3334 into two substantially equal lengths.

[0316] The positioning and stabilizing structure 3300 may include a valve 3339 along with a flap 3338 adjacent the second inlet port 3336 (see, e.g., FIGS. 64 and 66). As a result of pressurized air being provided (e.g., through the first inlet of the plenum chamber 3200), the flap 3338 may be biased (e.g., magnetically, mechanically) to an open position (i.e., to allow airflow through the second inlet port 3336) and moved to a closed position (i.e., substantially restricting airflow through the second inlet port 3336).

[0317] In one form (see, e.g., FIG. 51 and FIG. 52), the under-the-nose mask 3100a and the mouth seal 3100b each include side straps 3302, thereby applying tension to both the under-the-nose mask 3100a and the mouth seal 3100b. The side straps 3302a of the under-the-nose mask 3100a can be part of a hollow tube 3334. The side straps 3302b of the mouth seal 3100b are simply strips of fabric that do not allow pressurized air to be conveyed to the mouth seal 3100b.

[0318] 5.3.3.2 Ear bypass As described and illustrated in FIG. 46 and FIG. 47, the hollow tube 3334 included in the headgear 3324 of the positioning and stabilizing structure 3300 conveys pressurized air to the seal-forming structure 3100. Because the hollow tube 3334 is part of the positioning and stabilizing structure 3300, it must fit the head of the particular patient (while providing a snug fit). If the hollow tube 3334 does not fit the patient's head and is too narrow, the patient interface 3000 may be uncomfortable, reducing the likelihood of the patient's compliance with treatment. Furthermore, if the hollow tube 3334 cannot be made narrow to the patient's head, the seal-forming structure 3100 may not be able to seal against the patient's face, potentially resulting in ineffective treatment. In the illustrated example, the hollow tube 3334 may be formed from a one-piece structure, with the hollow tubes 3334 together forming a single conduit.

[0319] In particular, the relative position of the headgear 3324 to the patient's head may shift during use. For example, the patient may turn during sleep, causing at least one of the straps (e.g., side straps 3302, rear straps 3304, and top straps 3306) to move relative to the patient's head. As a result, the rear straps 3304 in particular may be affected, and may translate or move since the rear straps 3304 remain in contact with the patient's bed and / or pillow (in most sleep positions (e.g., back sleep, side sleep)). If the rear straps 3304 move too much (e.g., in an up / down direction) on the patient's head, the seal-forming structure 3100 may come loose on the patient's face and move out of a therapeutically effective position (e.g., pressurized air may leak into the environment (rather than being directed into the patient's lungs)). This may occur if the rear straps 3304 are tightened around the patient's head (at an angle relative to the Frankfort horizontal FFH) (see, e.g., FIG. 8). If the rear straps 3304 then move (e.g., upwards) to a position where the angle relative to the Frankfort horizontal FFH is less than when initially tightened, the rear straps 3304 may no longer be able to tighten and may not be able to adequately hold the seal-forming structure 3100 in place. This may be particularly problematic for patients with longer hair, which may prevent the rear straps 3304 from gripping the patient's head effectively. Longer hair alone, or in combination with sleep movement (e.g., tossing and turning in bed), may increase the movement of the rear straps 3304 into ineffective positions (i.e., positions where the rear straps 3304 are not able to provide adequate force to seal the seal-forming structure 3100).

[0320] As shown in FIGS. 53-63, the rear strap 3304 may be constructed in part from a first material 3348 having a first coefficient of friction and a second material 3349 having a second coefficient of friction higher than the first coefficient of friction. The second material 3349 helps maintain the position of the rear strap 3304 relative to the patient's head (e.g., angled in a posterior and inferior direction). The second material 3349 may also be rigid or semi-rigid. The connection between the first material 3348 and the second material 3349 may be made through sewing, ultrasonic welding, gluing, or any similar method.

[0321] The rear strap 3304 includes a side or portion 3350 and a second portion 3354. The side portion 3350 is constructed from a first material and the second portion 3354 is constructed from a second material. In the illustrated example, the second portion 3354 is positioned between the two sides 3350a and 3350b. In use of the patient interface 3000, the sides 3350a and 3350b generally extend from the second portion 3354 to either side of the hollow tube 3334 and the tab 3320, respectively.

[0322] The side portion 3350 is connected to the second portion 3354 at a transition or junction 3355. The junction 3355 may be sewn, glued, sonic welded, fused or any similar method. In the illustrated example, only one material is provided on either side of the junction 3355 (e.g., the first material 3348 or the second material 3349). In other words, the side portion 3350 does not substantially overlap with the second portion 3354. Each material 3348 and 3349 is exposed in each portion (i.e., the first portion 3350 and the second portion 3354), allowing the patient to feel and experience the appropriate physical fastening (e.g., coefficient of friction) associated with each material. As such, the first material 3348 does not extend substantially along the length of the second portion 3354 and the second material 3349 does not extend substantially along the length of the first portion 3350 .

[0323] In one form, the second portion 3354 is formed as a pad that contacts the back of the patient's head. The thickness of the pad 3354 may be greater than the thickness of the sides 3350a and 3350b. The pad 3354 may be capable of gripping or engaging the back of the head and may provide an anchoring point on the patient's head. Engagement with the patient's head may substantially limit translation of the pad 3354 along the patient's head. Increasing the thickness of the pad 3354 may provide additional grip strength and may better limit translation of the pad 3354 when the patient interface 3000 is in use. Alternatively or additionally, increasing the thickness of the pad 3354 may provide additional cushioning effect against the back of the patient's head.

[0324] In the illustrated example, the pad 3354 includes a curvature around the sagittal plane SGP (see, e.g., FIG. 6). The pad 3354 may be concave with respect to the occipital bone OCC (see, e.g., FIG. 14) and may be oriented in an upward direction. The curvature of the pad 3354 may help the rear strap 3304 to further grip and engage the occipital bone of the patient and maintain its position relative to the patient's head. In other words, the pad 3354 may engage around the base of the occipital bone to limit the upward translation of the rear strap 3304.

[0325] In one form, the sides 3350a and 3350b are constructed from a textile. The textile sides 3350a and 3350b can be flexible and abrasion resistant to the patient's head. For example, the textile can conform to the patient's head and not cause irritation around sensitive areas (e.g., the patient's temples). The textile can also be stretchable under tension to accommodate different sized patient heads. In another form, the sides 3350a and 3350b can be an elastic material and can stretch to a greater length than the textile. The elastic material can stretch when the headgear 3000 is worn by the patient to allow the headgear to be used with multiple head sizes.

[0326] The pad 3354 is constructed from a silicone or similar material (e.g., Hytrel). The pad 3354 may be more rigid than the textile of the sides 3350a and 3350b and therefore may provide a better anchor for the positioning and stabilizing structure 3300. Because the patient's hair is generally positioned between the pad 3354 and the patient's skin, the pad 3354 may not cause a substantial amount of irritation to the patient's skin.

[0327] The physical characteristics of the pad 3354 (e.g., shape, coefficient of friction, stiffness) limit the total area occupied by the rear straps 3304 on the patient's head. The rear straps 3304 can hook or engage with the rear of the head so that portions of the rear straps are not needed on the upper region of the patient's head. For example, the rear straps 3304 do not extend laterally (e.g., in the left / right direction) across the parietal bone PAR (see, e.g., FIG. 14). In particular, the second material 3349 may not contact the parietal bone PAR.

[0328] The pad 3354 may not extend into the temporal region (e.g., over the temporal bone TTEM) and may be limited to the occipital region (e.g., over the occipital bone OCC), thereby positioning the second material toward the back of the patient's head.

[0329] As shown in FIGS. 53 and 54, each side 3350a and 3350b of the rear strap 3304 is directly connected to the pad 3354 and to the middle portion 3346 of the positioning and stabilizing structure 3300. The middle portions 3346 (i.e., right middle portion and left middle portion) delineate the transition between the side strap 3302 and the top strap 3306. In the illustrated example, a tab 3320 extends from the middle portion 3346 and connects to each side portion 3350a and 3350b. The sides 3350a and 3350b are angled relative to the Frankfort Horizontal FFH so that the pad 3354 can be positioned adjacent the back of the head. When the rear strap 3304 is fastened to the patient's head, the pad 3354 is anchored into the back of the head, limiting further movement of the rear strap 3304.

[0330] In the illustrated example, the sides 3350a and 3350b extend parallel to a tangent line L1 along the helix H of each ear. Line L1 intersects with an apex axis AA. The apex axis AA extends orthogonally through the apex A of the ear at an angle φ to the Frankfort horizontal FFH. The apex A represents the top of the patient's ear. The sides 3350a and 3350b may then be disposed entirely behind the patient's ear, significantly reducing the likelihood that the sides 3350a and 3350b will intersect (i.e., touch) either ear.

[0331] In one example, the angle φ is between 0° and 60°. In one example, the angle φ is between 10° and 55°. In one example, the angle φ is between 20° and 50°. In one example, the angle φ is between 30° and 45°. In one example, the angle φ is approximately 43°.

[0332] In the illustrated example, the tabs 3320 are positioned above the patient's ears in a location that does not interfere with any of the patient's ears. For example, the tabs 3320 are positioned close enough to the top region of the patient's head that the sides 3350a and 3350b can extend to the back of the head (without crossing the patient's ears). In other words, the sides 3350a and 3350b can extend above and / or behind the ears to avoid contact with any of the ears. This provides a degree of comfort to the patient since the rear straps 3304 do not press the patient's ears against the head.

[0333] 53 and 54, the positioning and stabilizing structure 3300 may not include a lower strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends along the patient's cheek (e.g., over the masseter muscle) between the pad 3354 and / or side 3350 and the plenum chamber 3200. In other examples, the positioning and stabilizing structure 3300 may include a lower strap.

[0334] In the illustrated example of Figures 53 and 54, the positioning and stabilizing structure 3300 may not include a lower strap and / or a superior strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the positioning and stabilizing structure 3300 may include superior and / or inferior straps.

[0335] As shown in FIGS. 55 and 56, the rear strap 3304 may further include a pair of third portions or extenders 3358a and 3358b. Each extender 3358a and 3358b is directly connected to a respective tab 3320 and side portion 3350a and 3350b. In other words, each side portion 3350a and 3350b is connected to the tab 3320 through an extender 3358a and 3358b. The extenders 3358a and 3358b are constructed from a third material 3361 that is different from the first material 3348. In some examples, the third material 3361 may be the same as the second material 3349 (e.g., the material used to construct the pad 3354). In other examples, the third material 3361 may be different from both the first material 3348 and the second material 3349. The third material 3361 may also have a higher coefficient of friction than the coefficient of friction of the first material 3348. This helps to better anchor each extender 3358a and 3358b to the patient's head and limits translational movement due to tension (e.g., from the sides 3350a and 3350b).

[0336] If the third material 3361 is the same as the second material 3349, the second material 3349 may be positioned in the temporal region. However, the second material (e.g., extenders 3358a and 3358b) is positioned above the inferior ear point on the temporal region. Thus, the second material 3349 does not extend over the digastric or sternocleidomastoid muscles.

[0337] In one form, the third material is a stiffening material and the extenders 3358a and 3358b are formed as angled pieces. Each extender 3358a and 3358b includes a first or generally horizontal portion 3359 and a second or angled portion 3360. The generally horizontal portion 3359 extends generally parallel to the Frankfort horizontal FFH. The generally horizontal portion 3359 can extend in a posterior direction along the Frankfort horizontal FFH to a position beyond a majority of the patient's ear. For example, the generally horizontal portion 3359 can extend to at least the apex A of the patient's ear. In other words, the generally horizontal portion 3359 extends in a posterior direction and intersects with the apex axis AA. In some examples, the generally horizontal portion 3359 can extend in a posterior direction beyond the apex axis AA. In some embodiments, the generally horizontal portion 3359 is positioned generally over the temporal bone TTEM (see, for example, FIG. 14).

[0338] The angled portion 3360 extends further in a posterior direction relative to the generally horizontal portion 3359 and is angled relative to the generally horizontal portion (e.g., forms an acute angle relative to the Frankfort horizontal FFH). For example, each extender 3358a and 3358b is concave relative to each ear. The transition between the generally horizontal portion 3359 and the angled portion 3360 may be along the apex axis AA. The angled portion 3360 may then extend in a posterior direction parallel to a line L2 that is tangent to the helix H of the patient's ear. The line L2 intersects with the apex axis AA at an angle θ. The angled portion 3360 may then be generally behind the patient's ear, significantly reducing the likelihood that the side portions 3350a and 3350b will intersect with either ear.

[0339] In one example, the angle θ is between 0° and 60°. In one example, the angle θ is between 10° and 55°. In one example, the angle θ is between 20° and 50°. In one example, the angle θ is between 30° and 45°. In one example, the angle θ is approximately 40°.

[0340] The extenders 3358a and 3358b function to change the angle of the sides 3350a and 3350b relative to the patient's ears. The generally horizontal portion 3359 positions each side 3350a and 3350b away from the tabs 3320, eliminating the need for the sides 3350a and 3350b to extend all the way to the back of the patient's head (e.g., as compared to the example in FIG. 53). Additionally, the angle of the sides 3350a and 3350b relative to the Frankfort horizontal FFH in FIG. 55 is greater than the same angle in FIG. 53. In other words, the sides 3350a and 3350b extend in a downward direction rather than a posterior direction as compared to the sides in FIG. 53. A larger component of the force provided by the rear strap 3304 may be directed in a downward / upward direction. The same engagement force may be provided on the pad 3354 with a smaller overall force as compared to the example in FIG. 53. In other words, the patient may be able to fasten the rear straps 3304 less tightly around their head to achieve the downward / upward force vector required to anchor the pad 3354 in the rear of the head.

[0341] By extending the generally horizontal portion 3359 beyond or substantially beyond the patient's ears, the likelihood of the side portions 3350a and 3350b contacting either of the patient's ears is further reduced. By extending the generally horizontal portion 3359 beyond or substantially beyond the patient's ears, the angled portion 3360 extends further beyond the patient's ears such that the first portions 3350a and 3350b are generally behind and spaced from the patient's ears. In the example above (see, e.g., FIG. 53 and FIG. 54), the side portions 3350a and 3350b can be slid relative to the patient's head such that the ears are clamped by the rear strap 3304. In this example, the extenders cause the side portions 3350a and 3350b to be completely spaced from the ears such that even if the side portions 3350a and 3350b translate slightly, the ears are not clamped.

[0342] In certain configurations, the extenders 3358a and 3358b may be adjustable. For example, a third material may allow fine adjustment while maintaining the general shape. The patient may be able to change the angle between the generally horizontal portion 3359 and the angled portion 3360. This allows the position of the sides 3350a and 3350b to be adjusted based on the size of the patient's head. For example, for patients with longer heads, the tab 3320 may be positioned further up. Thus, the patient may be able to increase the angle between the generally horizontal portion 3359 and the angled portion 3360 to direct the sides 3350a and 3350b toward a lower region of the patient's head (e.g., toward the back of the head). The angled portion 3360 remains generally rigid or semi-rigid after being set in the desired position and substantially maintains its shape upon fastening of the rear strap 3304.

[0343] 55 and 56, the positioning and stabilizing structure 3300 may not include a lower strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends along the patient's cheek (e.g., over the masseter muscle) between the pad 3354 and / or the side 3350 and the plenum chamber 3200. In other examples, the positioning and stabilizing structure 3300 may include a lower strap.

[0344] In the illustrated example of Figures 55 and 56, the positioning and stabilizing structure 3300 may not include a lower strap and / or a superior strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the positioning and stabilizing structure 3300 may include superior and / or inferior straps.

[0345] As shown in Figures 57 and 58, the seal-forming structure 3100 may include a under-the-nose mask 3100a and a mouth seal 3100b, as opposed to only the nasal mask 3100a of Figures 53-56. The under-the-nose mask 3100a and the mouth seal 3100b may be formed as a single piece, or may be separate pieces that are connected together as described above (see, for example, Figures 51-52B). The positioning and stabilizing structure 3300 used with the seal-forming structure 3100 of Figures 57 and 58 may be similar to the positioning and stabilizing structure 3300 of Figures 53-56, and only some similarities and differences between the two will be described.

[0346] In one form, the under-the-nose mask 3100a includes side straps 3302a and the mouth seal 3100b includes side straps 3302b. The side straps 3302b extend from adjacent the patient's mouth in a direction generally parallel to the Frankfort horizontal FFH. The side straps 3302b extend along the patient's cheeks and neck and are generally positioned below the patient's ears. Thus, the side straps 3302a and 3302b and the rear strap 3304 define a perimeter around each of the patient's ears but do not contact the ears.

[0347] In certain configurations, the side straps 3302b are positioned further down than the pads 3354. The side straps 3302b may be movable relative to the pads 3354, which may lead to similar problems with the seal-forming structure 3100 (e.g., the side straps 3302b may move relative to the patient's head, causing the seal-forming structure 3100 to become too loose). To limit this movement, a connecting strap 3362 may be used to connect the pads 3354 to the side straps 3302b. The connecting straps 3362 provide a rigid engagement between the pads 3354 and the side straps 3302b, limiting the relative movement between them. In particular, the pads 3354 are fastened against the back of the patient's head, limiting the movement of the side straps 3302b.

[0348] In certain configurations, with the patient wearing the patient interface 3000, the connection strap 3362 is centrally positioned along the patient's neck. In the illustrated example, the connection strap 3362 is constructed from a first material (e.g., textile). The side strap 3302b and the connection strap 3362 may be constructed from a single piece of material. In other examples, the connection strap 3362 may be constructed from a second material and formed as a one-piece structure with the pad 3354. In this example, the connection strap 3362 may provide additional grip on the patient and prevent movement of the positioning and stabilizing structure 3300. In other examples, the connection strap 3362 is coupled to the side strap 3302b and the pad 3354 and may be formed from any material.

[0349] In the illustrated example of Figures 57 and 58, the positioning and stabilizing structure 3300 may not include an inferior strap and / or an superior strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the positioning and stabilizing structure 3300 may include an superior strap and / or an inferior strap.

[0350] As shown in FIG. 59, in some instances where the seal-forming structure 3100 is used with a under-the-nose mask 3100a and mouth seal 3100b, the side straps 3302b may not be used. The rear straps 3304 may provide sufficient force to maintain the seal-forming structure 3100 in a therapeutically effective position. In particular, the pads 3304 may maintain the seal-forming structure 3100 in the proper position (without the need for side straps 3302b or connecting straps 3362). This may increase patient comfort since the positioning and stabilizing structure 3300 does not extend beyond the patient's sternocleidomastoid muscle STE (see, e.g., FIG. 14). The side straps 3302b may be omitted (with or without the use of the extenders 3358).

[0351] 59, the positioning and stabilizing structure 3300 may not include a lower strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends along the patient's cheek (e.g., over the masseter muscle) between the pad 3354 and / or the side 3350 and the plenum chamber 3200. In other examples, the positioning and stabilizing structure 3300 may include a lower strap.

[0352] In the illustrated example of FIG. 59, the positioning and stabilizing structure 3300 may not include a lower strap and / or a superior strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the positioning and stabilizing structure 3300 may include superior and / or inferior straps.

[0353] 60, the tabs 3320 are eyelets or loops 3320 that selectively receive the rear straps 3304 (e.g., 3350a, 3350b) in certain configurations of the positioning and stabilizing structure 3300. As such, the rear straps 3304 can be releasably coupled to the loops 3320 and uncut to assist in donning and doffing the patient interface 3000.

[0354] In one form, one of the sides 3350a and 3350b is threaded through the loop 3320 and folded back on itself, thereby allowing coupling of the first magnetic portion 3316 to the second magnetic portion 3318. The second magnetic portion 3318 may be larger (i.e., includes a larger area on the sides 3350a and 3350b) than the first magnetic portion 3316, thereby allowing coupling of the first magnetic portion 3316 to the second magnetic portion 3318 in a variety of positions (e.g., corresponding to different fastening levels). Alternatively, hook and loop fasteners or any similar fasteners may be used in place of the first magnetic portion 3316 and the second magnetic portions 3316 and 3318.

[0355] In certain configurations, only one of the tabs 3320 defines a loop. In other words, the rear strap 3304 may be permanently connected to one of the tabs 3320 (e.g., the right side 3350b) and releasably connected to the other tab 3320 (e.g., the left side 3350a). The rear strap 3304 may be formed together as a one-piece structure (e.g., from a one-piece textile) with the tab 3320 permanently connected to the rear strap 3304.

[0356] 61, one extender 3358a is threaded through the loop 3320 and folded back on itself to allow for coupling of the first engagement portion 3366 to the second engagement portion 3368. The second engagement portion 3368 may be larger (i.e., comprises a larger area on the rear strap 3304) than the first engagement portion 3366, allowing for coupling of the first engagement portion 3366 to the second engagement portion 3368 in a variety of locations (e.g., corresponding to different levels of tightness). In the illustrated example, the first engagement portion 3366 and the second engagement portion 3368 are magnetic portions, although in other examples other engagement mechanisms may be used (e.g., hook and loop fasteners). The first engagement portion 3366 and the second engagement portion 3368 may be positioned on a generally horizontal portion 3359 such that engagement between the engagement portions 3366 and 3368 affects the position of the sides 3350a and 3350b relative to the tab 3320 but does not affect the angle relative to the Frankfort horizontal FFH.

[0357] In certain configurations, a loop is defined by only one of the tabs 3320. In other words, one extender 3358b may be permanently coupled to one of the tabs 3320 (e.g., the right tab 3320) and the other extender 3358a may be removably coupled to the other tab 3320 (e.g., the left loop 3320).

[0358] In certain configurations, the sides 3350a and 3350b are permanently connected to the respective extenders 3358a and 3358b. The distance between the pad 3354 and the extenders 3358 remains substantially constant. Adjustment of the posterior strap 3304 by the patient may be limited to the extender(s) 3358a and 3358b.

[0359] 62, the extender 3358a includes a loop 3380 on the angled portion. The side portion 3350a can be threaded through the loop 3380 and folded back on itself so that the side portion 3350a is releasably coupled to each of the extenders 3358a. The first magnetic portion 3316 and the second magnetic portion 3318 are used to releasably couple the side portion 3350a to the extender 3358a.

[0360] In certain instances, the extender 3358a is also removably coupled to the loop 3320 (see, e.g., FIG. 61). The patient may selectively use the extender 3358a as needed (e.g., based on the size of the patient's head, the force needed, etc.). If the extender 3358a is not needed, the patient may couple the side portion 3350a to the loop as shown in FIG.

[0361] In certain configurations, only one of the tabs 3320 defines a loop. In other words, one extender 3358b may be permanently connected to one of the tabs 3320 (e.g., the left tab 3320) and the other extender 3358a may be removably connected to the other tab 3320 (e.g., the right loop 3320). The extender 3358a may be formed as a one-piece structure (e.g., from a one-piece textile) with the tab 3320 as the permanent connection.

[0362] Similarly, only one of the extenders 3358a and 3358b may define the loop 3380. In other words, one extender 3358b may be permanently connected to one of the sides 3350b (e.g., the right tab 3320) and the other extender 3358a may be removably connected to the other side 3350a (e.g., the left loop 3320). The patient may only be able to adjust the rear strap 3304 on one side (e.g., the left side).

[0363] 63 and 64, the pad 3354 may be adjustable to fit the patient's head. In particular, the length of the pad 3354 can be adjusted by the patient to make the pad 3354 tighter or looser on the patient's head.

[0364] As shown in FIG. 63, the pad 3354 includes a side portion 3354a and a second portion 3354b that are connected together by a buckle 3370 (e.g., a ladder lock buckle). The side portion 3354a and the second portion 3354b are configured to overlap each other. The second portion 3354b is movable relative to the side portion 3354a to determine the overlap length. The usable length of the pad 3354 corresponds to the total length of the first portion 3354a and the second portion 3354b (exposed and / or in contact with the patient). The first portion 3354a and the second portion 3354b are threaded through the buckle 3370 to hold them in their desired position. For example, the patient can adjust the length of the second portion 3354b that is threaded through the buckle 3370 so that the pad 3354 is in a comfortable and fixed position relative to the head.

[0365] As shown in FIG. 64 , the pad 3354 can include a side portion 3354a including a plurality of apertures 3374 and a second portion 3354b including a plurality of protrusions 3378. Each aperture 3374 is configured to receive one of the protrusions 3378. The side portion 3354a can be selectively positioned along the length of the second portion 3354b such that at least one of the apertures 3374 can engage one of the protrusions 3378. Each aperture 3374 can receive any one of the protrusions 3378 depending on the desired length of the pad 3354. The patient can select the appropriate relative position between the first portion 3354a and the second portion 3354b such that the pad 3354 is secured to the patient's head.

[0366] In certain forms, the pad 3354 may be the only means of adjusting the length of the rear strap 3304 (e.g., via a buckle 3370, via an aperture 3374 and protrusion 3378, via a magnet, or similar mechanism). The patient may don or remove the patient interface 3000 by loosening the pad 3354 (e.g., side portion 3354a relative to second portion 3354b).

[0367] In certain configurations, the pad 3354 may be adjustable in addition to the sides 3350a and 3350b and / or the extenders 3358a and 3358b. The combination of these different forms of adjustment may allow the patient to make smaller and more limited adjustments to secure the pad 3354 against the back of the patient's head in an ideal position.

[0368] 5.3.3.3 Full-face mask specific anchors As noted above, some forms of positioning and stabilizing structures 3300 used in nasal masks (see, e.g., Figures 53-56) may also be used in full face masks (see, e.g., Figures 57-59). Additionally, the positioning and stabilizing structures may be designed specifically for full face masks to assist in improved sealing around the patient's nares and mouth.

[0369] 65-1, one form of positioning and stabilizing structure 7000 may include a substantially X-shaped headgear strap 7002. The positioning and stabilizing structure 7000 may include a rear strap or neck pad 7004 configured to contact the rear of the patient's head. For example, the rear strap 7004 may rest on the patient's occipital bone and / or trapezius muscle.

[0370] In some forms, the rear straps 7004 may be constructed from a hard and / or at least partially rigid material. For example, the rear straps 7004 may be constructed from a hard laminate material that may not be capable of significant stretching. Such hardness or stiffness may aid in anchoring the positioning and stabilizing structure behind the patient's head. Additionally, the material may be flexible to maximize patient comfort.

[0371] 65 and 65-1, four straps may extend from the rear strap 7004. A pair of upper straps 7008 may extend from an upper portion of the rear strap 7004 and a pair of lower straps 7012 may extend from a lower portion of the rear strap 7004. In some forms, the pair of upper straps 7008 may be shorter than the pair of lower straps 7012. In other examples, the same size may be provided or the upper straps 7008 may be longer than the lower straps 7012.

[0372] Each strap 7008 and 7012 may include a connector region 7016. In the illustrated example, the connector region 7016 is a hook tab (e.g., hook and loop fastener), but other types of connections may be used (e.g., magnets, mechanical snaps). Each strap 7008 and 7012 may be foldable on itself so that the connector region 7016 contacts a portion of the positioning and stabilizing structure 3300 (e.g., the same strap 7008 and 7012). The straps 7008 and 7012 may be constructed at least in part with a loop material that is releasably engaged with the hook tab 7016. The patient may releasably select where to position each connector region 7016 for length adjustment of each strap, and therefore the sealing force applied from the seal-forming structure 3100.

[0373] In some forms, the pair of upper straps 7008 can be constructed from a hard and / or at least partially rigid material. For example, the upper straps 7008 can be constructed from a hard laminate material that is not capable of significant stretching. In some forms, the rear straps 7004 and the upper straps 7008 can be constructed from the same material, although different materials can also be used.

[0374] In some forms, the lower straps 7012 can be constructed from an elastic material. For example, the lower straps 7012 can be constructed from a highly elastic laminate material that can be stretchable.

[0375] As shown in FIG. 65 , each upper strap 7008 and lower strap 7012 may be individually connected to the rear strap 7004. For example, each upper strap 7008 and lower strap 7012 may be independently stitched to the rear strap 7004. In some configurations of the rear strap 7004, an X-shaped configuration is used, in which the stitching of each strap 7008 and 7012 is spaced apart from adjacent stitching. In other examples, a different connection technique, such as ultrasonic welding, may be used. In other examples, the upper strap 7008 may be integrally formed with the rear strap 7004, in which case stitching or other connection techniques may not be necessary (e.g., because they may be formed of the same material and cut from the same sheet of material).

[0376] As shown in FIG. 65-1 , the rear strap 7004 may include a more curved edge than the rear strap 7004 of FIG. 65. This may allow the upper strap 7008 and the lower strap 7012 on each side (e.g., left or right side) to be positioned closer to each other. A single continuous stitch (or other connection technique) may be used to connect the left upper strap 7008 and the lower strap 7012 to the rear strap 7004. Additionally, a single continuous stitch (or other connection technique) may be used to connect the right upper strap 7008 and the lower strap 7012 to the rear strap 7004. In some forms, the continuous stitch on each side may be curved and may follow the circumference of the rear strap 7004.

[0377] In the illustrated example of FIG. 65 and FIG. 65-1, the headgear straps 7002 may not include lower straps and / or upper straps. In other words, the headgear straps 7002 do not include straps that extend under the patient's chin (e.g., under the mental protuberance). The headgear straps 7002 also do not include straps that extend to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the headgear straps 7002 may include upper straps and / or lower straps.

[0378] 66, the positioning and stabilizing structure 7000 may be used with a plenum chamber 3200. The plenum chamber 3200 shown is a full face plenum chamber 3200, however, the positioning and stabilizing structure 7000 may be used with a nasal plenum chamber 3200.

[0379] In some forms, the headgear straps 7002 may connect to the remainder of the patient interface 3000 (substantially similar to the straps in FIG. 57 (or any other above examples)). For example, the hollow tube 3334 may include at least one tab 3320 that may removably receive a portion of the headgear strap 7002. For example, each upper strap 7008 may be threaded through the tab 3320 to connect the headgear strap 7002 to the hollow tube 3334. As noted above, a connector region 7016 may be included on the upper strap 7008 that may be threaded through the tab 3320 and folded back on itself to connect to the same upper strap 7008. Due to the shorter length and increased tension of the upper straps 7008, the connector region 7016 may connect closer to the rear strap 7004 along each upper strap 7008.

[0380] In some forms, the tab 3320 in FIG. 66 may be located higher than the tab 3320 in FIG. 55 or FIG. 57. In other words, the tab 3320 in FIG. 66 may be located closer to the decoupling structure 3500 than the tab 3320 in FIG. 55 or FIG. 57. Due to such a higher tab 3320, the upper strap 7008 may extend in a posterior direction (parallel to a line L2 that is tangent to the helix H of the patient's ear) (without the use of an extender 3358) (the upper strap 7008 may extend along a different line). This may allow the upper strap 7008 to generate the same force vector as the sides 3350a and 3350b (e.g., directed along an angle θ measured from axis AA) and be spaced away from the patient's ears, significantly reducing the chance of the upper strap 7008 crossing either ear. In other words, the upper straps 7008 may connect to the side portions 3350a in FIG. 53 in a similar manner, but the tabs 3320 located further up may allow for a smaller angle (i.e., a more vertically directed force) (without causing the upper straps 7008 to contact the patient's ears). As in FIG. 57, the patient may not need to tighten the upper straps 7008 as much as they would if the angle θ were smaller (e.g., a larger component of the force is directed up and down, pulling the rear straps 7004 towards the back of the patient's head). This may promote patient comfort when wearing the headgear straps 7002 (e.g., because tension is applied directly from the tabs 3320 (without the use of extenders 3358)).

[0381] 66, the lower straps 7012 may be connected to the plenum chamber 3200 to provide a rearwardly directed force vector to maintain the seal-forming structure 3100 in a sealed position. As noted above, the lower straps 7012 may be longer than the upper straps 7008 to reach from the rear of the patient's head (e.g., where the rear straps 7004 rest) and the plenum chamber 3200. In the illustrated example, each lower strap 7012 may connect to a clip 7020 that connects directly to the plenum chamber 3200. In some forms, the clips 7020 may include magnets for magnetic connection to the plenum chamber 3200 (other types of connections such as mechanical fasteners may be used). The lower straps 7012 may be threaded through each clip 7020 (in a manner similar to the manner in which the upper straps 7008 are threaded through the tabs 3320). For tension adjustment, the connector region 7016 of the lower strap 7012 may be selectively connected along the same surface of the lower strap 7012. The clip 7020 may be disconnected from the plenum chamber 3200, allowing the headgear strap 7002 to be more easily removed from the patient's head (without having to reposition the connector region 7016). In other examples, the lower strap 7012 may be permanently connected to the plenum chamber. The material of the lower strap 7012 may be stretchable, allowing removal of the headgear strap 7002 (without disconnecting the lower strap 7012 (or clip 7020) from the plenum chamber 3200).

[0382] In some forms, the angle of the upper straps 7008 and the absence of a connecting strap (see, e.g., FIG. 58) may allow the rear straps 7004 to rest higher on the patient's head (e.g., closer to the lower ear point), which may lead to improved patient comfort as the lower straps 7012 may rest higher on the patient's face.

[0383] 67 and 68, another example of a positioning and stabilizing structure 8000 and headgear straps 8002 may be connected to the plenum chamber 3200. The headgear straps 8002 may be similar to the headgear straps 7002, and only some of the similarities and differences are described below.

[0384] As shown in FIG. 67, the rear strap 8004 may be included in the headgear strap 8002 and may be larger than the rear strap 7004. For example, the rear strap 8004 may include a central portion 8005 and a pair of lower portions 8006. The central portion 8005 and the pair of lower portions 8006 may be formed as dog legs. Thus, the rear strap 8004 may more closely resemble an X-shape than the rear portion 7004 of FIG. 65. This shape may allow the rear strap 8004 to rest higher on the patient's head. For example, only the central portion 8005 may be narrower than the rear strap 7004. The central portion 8005 may contact the occipital bone but may contact the trapezius muscle over a smaller area, which may lead to reduced irritation and discomfort during use. Furthermore, the lower portion 8006 may extend around the side of the patient's neck, thereby distributing the load concentration at the rear of the patient's head (e.g., substantially on the trapezius muscle). The dog-leg design of the lower portion 8006 may also promote additional patient comfort.

[0385] As shown in FIG. 68, the hollow tube 3334 may be curved further back than the hollow tube 3334 of FIG. 66. The tab 3320 may be aligned with the apex axis AA. This may allow the tab 3334 to be positioned further down on the hollow tube 3334 (e.g., further down than the tab 3320 of FIG. 66). Thus, the extender 3358 may not be needed to position the upper strap 8008 substantially relative to the line L2. Because the upper strap 7008 is located further up, the upper strap 8008 may be able to achieve the same force vector. Because the tab 3320 is positioned more rearward, the upper strap 8008 may connect (e.g., via a connector area (not shown)) on or near the rear strap 8004.

[0386] Similar to the manner described above for the lower straps 7012, the lower straps 8012 may extend from the lower portion 8006 and connect to the plenum chamber 3200. When the lower straps 8012 are tightened, tension may be applied to the lower portion 8006, which may not contact the back of the patient's head (e.g., the lower portion 8006 may not substantially contact the patient's trapezius muscle). This is beneficial for patient comfort because the dog-leg shape of the lower portion 8006 may direct forces away from sensitive areas while still providing the necessary retention and anchoring forces.

[0387] In the illustrated example of Figures 67 and 68, the headgear straps 8002 may not include lower straps and / or upper straps. In other words, the headgear straps 8002 do not include straps that extend under the patient's chin (e.g., under the mental protuberance). The headgear straps 8002 also do not include straps that extend to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the headgear straps 8002 may include upper straps and / or lower straps.

[0388] 69 and 70, another example of a positioning and stabilizing structure 9000 and headgear straps 9002 may be connected to the plenum chamber 3200. The headgear straps 9002 may be similar to the headgear straps 7002, and only some of the similarities and differences are described below.

[0389] As shown in FIG. 69, the headgear strap 9002 may include a rear strap 9004 that includes an upper portion 9005, a lower portion 9006, and a pair of side portions 9007 that connect the upper portion 9005 to the lower portion 9006. The upper portion 9005 may be positioned generally above the trapezius muscle on the patient's head (e.g., may rest generally on the occipital bone). The lower portion 9006 may be positioned generally below the occipital bone on the patient's head (e.g., may rest on the trapezius muscle). The side portions 9007 may be slanted or dog-legged between the upper portion 9005 and the lower portion 9006. In some forms, the upper portion 9005 and / or the lower portion 9006 may be positioned horizontally relative to the patient's head, and the side portions 9007 may have a radius (larger than the radius of the lower portion 8006 relative to the central portion 8005) relative to at least one of the straps (see, e.g., FIG. 67).

[0390] As shown in FIG. 70, the hollow tube 3334 may be curved further back than the hollow tube 3334 of FIG. 66. The tab 3320 may be aligned with the apex axis AA. This may allow the tab 3334 to be positioned further down on the hollow tube 3334 (e.g., further down than the tab 3320 of FIG. 66). Thus, the upper strap 9008 may not need an extender 3358 to position substantially parallel to the line L2. The upper strap 7008 may be located further up, allowing the upper strap 9008 to achieve the same force vector. The tab 3320 may be positioned further back, allowing the upper strap 9008 to connect on or near the rear strap 9004 (e.g., via a connector area (not shown)).

[0391] Similar to the manner described above for the lower straps 7012, the lower straps 9012 may extend from the lower portion 9006 and connect to the plenum chamber 3200. When the lower straps 9012 are tightened, tension may be applied to the lower portion 9006, which may help anchor the lower portion 9006 to the posterior region of the patient's head. When the upper straps 9008 are tightened, tension may be applied to the upper portion 9005, which may help anchor the upper portion 9005 to the posterior region of the patient's head. Because the upper and lower portions 9005 and 9006 are spaced apart from each other, the overall force may be distributed along the posterior region of the patient's head, which may lead to increased comfort.

[0392] In the illustrated example of Figures 69 and 70, the headgear straps 9002 may not include lower straps and / or upper straps. In other words, the headgear straps 9002 do not include straps that extend under the patient's chin (e.g., under the mental protuberance). The headgear straps 9002 also do not include straps that extend to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the headgear straps 9002 may include either upper or lower straps.

[0393] 71 and 72, another example of a positioning and stabilizing structure 10000 and headgear straps 10002 may be connected to the plenum chamber 3200. The headgear straps 10002 may be similar to the headgear straps 7002, and only some of the similarities and differences are described below.

[0394] 71, a rear strap 10004 may be included in the headgear strap 10002, which includes a central portion 10005 and a pair of side portions 10006 connected to the central portion 10005. The central portion 10005 may include a larger surface area than the rear strap 7004 and may be positioned higher on the patient's head (e.g., may rest less on the trapezius muscle). The side portions 10006 may extend laterally and medially from the central portion 10005 and may rest substantially on the trapezius muscle.

[0395] In some forms, the central portion 10005 can include an opening or slot 10024. The slot 10024 can be located near the periphery of the central portion 10005. The slot 10024 can also be located near the top end of the central portion 10005.

[0396] 72, the upper straps 10008 may be integrally formed with the hollow tube 3334. In other words, the hollow tube 3334 may not include the tabs 3320 and the upper straps 10008 may be directly connected to the hollow tube 3334 in the vicinity of where the tabs would be located.

[0397] As shown in FIG. 72, the upper straps 10008 may be formed of a rigid material and may include a shape similar to the extenders (see, for example, extenders 3358a and 3358b in FIG. 56). For example, each upper strap 10008 may include a substantially horizontal portion 10028 and an inclined portion 10032 that may be disposed at substantially the same angle as the inclined portion 3360. As such, the upper straps 10008 may extend substantially parallel to the line L2 and provide a force along substantially the same vector. In other examples, the upper straps 10008 may be removably connected to the hollow tube 3334 (e.g., as in FIG. 57).

[0398] Returning to FIG. 71 , the upper straps 10008 can be removably connected to the rear straps 10004. For example, the upper straps 10008 can be connected to the middle section 10005 through slots 10024. Each upper strap 10008 can be threaded through each slot 10024 and folded back on itself for adjustment of length and added tension.

[0399] The lower straps 10012 may extend from the lower portion 10006 and connect to the plenum chamber 3200 in a manner similar to that described above for the lower straps 7012. When the lower straps 10012 are tightened, tension may be applied to the lower portion 10006 such that the lower portion 10006 is substantially out of contact with the rear of the patient's head (e.g., the lower portion 10006 is substantially out of contact with the patient's trapezius muscle). This is beneficial for patient comfort because the dog-leg shape of the lower portion 10006 may direct forces away from sensitive areas while still providing the necessary retention and anchoring forces. Additionally, the upwardly placed central portion 10005 (e.g., substantially no overlap with the trapezius muscle) may further reduce load on the patient's neck nape, resulting in improved patient comfort.

[0400] In the illustrated example of Figures 71 and 72, the headgear straps 10002 may not include lower straps and / or upper straps. In other words, the headgear straps 10002 do not include straps that extend under the patient's chin (e.g., under the mental protuberance). The headgear straps 10002 also do not include straps that extend to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the headgear straps 10002 may include upper straps and / or lower straps.

[0401] 73 and 74, another example of a positioning and stabilizing structure 11000 and headgear straps 11002 may be connected to the plenum chamber 3200. The headgear straps 11002 may be similar to the headgear straps 7002, and only some of the similarities and differences will be described below.

[0402] 73, the rear straps 11004 that may be included in the headgear straps 11002 may include a larger surface area and may rest higher on the patient's head (e.g., rest less on the trapezius muscle) than the rear straps 7004. For example, the rear straps 11004 may rest at the same height as the rear straps 10004.

[0403] As shown in FIG. 74, the hollow tube 3334 may be curved more posteriorly than the hollow tube 3334 of FIG. 66, so that the tab 3320 may be located more posterior than the tab 3320 of FIG. 66. Additionally, the hollow tube 3334 may not be curved as far posteriorly as the hollow tube 3334 of FIG. 70, so that the tab 3320 may be located more anterior than the tab 3320 of FIG. 70. Based on this positioning, the upper strap 11008 connected to the tab 3320 may extend along an angle that is greater than the angle θ. For example, the upper strap 11008 may extend along the angle φ or along a different angle. In that case, the upper strap 11008 may not cross the patient's ear and may extend along the angle that is the source of discomfort.

[0404] 73 and 74, the lower straps 11012 may be connected to the rear straps 11004 and the plenum chamber 3200 by similar techniques as described above. In some forms, the lower straps 11012 may be a single strap connected below the rear straps 11004. The lower straps 11012 may be of sufficient length to extend from one side of the plenum chamber 3200, around the patient's head, and out the other side of the plenum chamber 3200.

[0405] In some forms, the headgear straps 11002 can include upper straps 11036 that can extend over the crown of the patient's head. For example, each upper strap 11036 can rest on the parietal bone. The upper straps 11036 can be secured (e.g., via stitching, ultrasonic welding, integral formation, etc.) to the rear straps 11004 and can be removably connected (by a tab (not shown) similar to tab 3320) to the adjacent hollow tube 3334 of the decoupling structure 3500.

[0406] In use, the patient may be able to adjust three sets of force vectors, which may allow greater control to adjust the headgear straps 11002 to their particular head. Additionally, the various force vectors from adjusting the headgear straps 11002 may allow the rear straps 11004 to rest higher on the patient's head (e.g., to reduce the amount of trapezius muscle involved), which may lead to improved patient comfort. Raising the rear straps 11004 may also raise the lower straps 11012 (or the lower straps 11012), which may also lead to improved patient comfort.

[0407] 73 and 74, the headgear straps 11002 may not include a lower strap. In other words, the headgear straps 11002 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). In other examples, the headgear straps 11002 may include a lower strap and / or may not include an upper strap 11036.

[0408] 75-76, another example of a positioning and stabilizing structure 12000 and headgear straps 12002 may be connected to the plenum chamber 3200. The headgear straps 12002 may be similar to the headgear straps 7002, and only some of the similarities and differences will be described below.

[0409] 75, the rear straps 12004 that may be included in the headgear straps 12002 may include a larger surface area than the rear straps 7004. The rear straps 12004 may include a substantially triangular shape. In some forms, the upper ends of the rear straps 12004 may rest substantially horizontally against the patient's head and may converge as they approach a point at the lower end.

[0410] In some forms, the rear straps 12004 may be constructed from an elastic or stretchable material. For example, the rear straps 12004 may be constructed from a textile material capable of elastic deformation. The textile material may be flexible and / or promote patient comfort. The rear straps 12004 may be tensioned (e.g., pre-tensioned) and then worn by the patient. This may help the rear straps 12004 to rest higher on the patient's head. For example, the rear straps 12004 may rest on the occipital bone and not substantially contact the trapezius muscle.

[0411] In some forms, the lower portion of the rear strap 12004 may converge at an angle α between about 1° and about 180°. In some forms, the lower portion of the rear strap 12004 may converge at an angle α between about 50° and about 175°. In some forms, the lower portion of the rear strap 12004 may converge at an angle α between about 90° and about 160°. In some forms, the lower portion of the rear strap 12004 may converge at an angle α between about 110° and about 150°. In some forms, the lower portion of the rear strap 12004 may converge at an angle α between about 120° and about 140°. In some forms, the lower portion of the rear strap 12004 may converge at an angle α that is about 130°.

[0412] 75 , the headgear straps 12002 can include a pair of upper straps 12008. In the illustrated example, the upper straps can be connected to the rear straps 12004 and can be constructed from a different material than the rear straps 12004. For example, the pair of upper straps 12008 can be constructed from a stiffening or semi-rigid material. The upper straps 12008 can include a stiffening or semi-rigid material covered by a textile material, or can have a lower extensibility than the rear straps 12004 by stiffening or stiffening the textile material used in the construction of the upper straps 12008.

[0413] In some forms, the connection of the upper straps 12008 to the rear straps 12004 may be made using one of the connection techniques described above. For example, the upper straps 12008 may be stapled to the rear straps along a plane that forms the angle α. In other words, at least a portion of the upper straps 12008 may be disposed lower on the patient's head than the rear straps 12004. Increasing the stiffness of the upper straps 12008 (e.g., relative to the rear straps 12004) may help limit the pulling down of the rear straps 12004 (or the entire headgear straps 12002).

[0414] In certain configurations, the upper straps 12008 may be connected to each other near the apex of the angle α. In other configurations, the upper straps 12008 may be formed from a single piece of material such that a pair of upper straps 12008 are not joined together.

[0415] In some forms, the upper straps 12008 may converge at an angle β of about 1° to about 180°. In some forms, the upper straps 12008 may converge at an angle β of about 50° to about 175°. In some forms, the upper straps 12008 may converge at an angle β of about 90° to about 170°. In some forms, the upper straps 12008 may converge at an angle β of about 110° to about 165°. In some forms, the upper straps 12008 may converge at an angle β of about 140° to about 160°. In some forms, the upper straps 12008 may converge at an angle β of about 150°. For example, the upper straps 12008 may be positioned such that the angle β is greater than the angle α, while in other examples, the angles β and α may be substantially equal.

[0416] 75 , the headgear straps 12004 may include a pair of lower straps 12012. In the illustrated example, the lower straps 12012 may be connected to the upper straps 12008 and may be constructed from a different material than the upper straps 12008. For example, the pair of lower straps 12012 may be constructed from an elastic or stretchable material (e.g., the same material as the rear straps 12004). The lower straps 12012 may include a textile material. The lower straps 12012 may be under tension (e.g., pre-tensioned) and then worn by the patient (e.g., similar to the rear straps 12004).

[0417] In some forms, the elasticity of the lower straps 12012 can lead to improved patient comfort by conforming to the patient's face during dynamic movements (eg, side-to-side head movements).

[0418] In some forms, the connection of the upper straps 12008 to the lower straps 12012 may be made using one of the connection techniques described above. For example, the lower straps 12012 may be stapled to the upper straps 12008 along a plane that forms the angle β. In other words, at least a portion of the lower straps 12012 may be disposed lower on the patient's head than the upper straps 12008. Pre-tensioning the lower straps 12012 may help limit the upper straps 12008 (or the entire headgear straps 12002) from being pulled down.

[0419] In some forms, the upper strap 12008 and the lower strap 12012 on the same side of the headgear strap 12002 (e.g., on the left or right side) may be angled relative to one another. In some forms, the angle ψ may be between about 1° and about 90°. In some forms, the angle ψ may be between about 10° and about 80°. In some forms, the angle ψ may be between about 25° and about 75°. In some forms, the angle ψ may be between about 40° and about 60°. In some forms, the angle ψ may be about 50°.

[0420] 75-1, another version of the headgear strap 12002-1 may be used with the patient interface 3000. The headgear strap 12002-1 may be substantially similar to the headgear strap 12002.

[0421] In some forms, the rear strap 12004-1 may be constructed from a stiffening or rigid material that may be the same as the material of the upper strap 12008-1. The upper strap 12008-1 and the rear strap 12004-1 may be connected together by one of the techniques listed above, or may be formed together as a single piece.

[0422] The connection of the lower strap 12012-1 to the upper strap 14008-1 may be made in a manner similar to the manner in which the upper strap 12008 is connected to the lower strap 12012. In the illustrated example, the lower strap 12012-1 may also be constructed from an elastic or stretchable material.

[0423] In some forms, the upper strap 12008-1 and the lower strap 12012-1 on the same side (e.g., left or right) of the headgear strap 12002-1 may be angled relative to one another. In some forms, the angle ω may be between about 1° and about 90°. In some forms, the angle ω may be between about 10° and about 80°. In some forms, the angle ω may be between about 25° and about 75°. In some forms, the angle ω may be between about 30° and about 50°. In some forms, the angle ω may be about 40°.

[0424] As shown in FIG. 76, the hollow tube 3334 may be curved further back than the hollow tube 3334 of FIG. 66. The tab 3320 may be aligned with the apex axis AA. This may allow the tab 3334 to be positioned further down on the hollow tube 3334 (e.g., further down than the tab 3320 of FIG. 66). Thus, the extender 3358 may not be needed to position the upper strap 14008 substantially parallel to the line L2. The upper strap 14008 may be able to achieve the same force vector because it is located further up. The tab 3320 may be positioned further back so that the upper strap 14008 may connect on or near the rear strap 14004 (e.g., via a connector area (not shown)).

[0425] The connection of the lower straps 12012 to the plenum chamber 3200 may be made in a similar manner as described above for the lower straps 7012. As the lower straps 12012 are tightened, tension may be applied to the lower straps 12012 and thus the rear straps 14004.

[0426] The shape of the headgear straps 14002 may promote patient comfort as the headgear straps 14002 rest higher on the patient's head. For example, the rear straps 14004 may rest on the occipital bone, and the larger surface area may help secure the rear straps to the patient's head. Additionally, the angle β of the upper straps 14008 may help anchor the headgear straps 14002 to the patient's head (e.g., due to the material and its location) without adding uncomfortable pressure on the patient's neck.

[0427] In the illustrated example of Figures 75-76, the headgear straps 12002 may not include lower straps and / or upper straps. In other words, the headgear straps 12002 do not include straps that extend under the patient's chin (e.g., under the mental protuberance). The headgear straps 12002 also do not include straps that extend to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the headgear straps 12002 may include upper straps and / or lower straps.

[0428] 5.3.3.4 Removable straps 77, the positioning and stabilizing structure 13000 can include a detachable arm 13004. The detachable arm 13004 can be constructed from a rigid or semi-rigid material (e.g., plastic) to maintain its shape. In some forms, the patient can bend the arm 13004 slightly to adjust the angle of the arm 13004.

[0429] The arm 13004 may include a first end with a clip 13008. The clip 13008 may be biased to a closed position. The patient may pull on the clip 13008 so that there is enough space to fit around the tab 3320 of the hollow tube 3334. The clip 13008 may then return to the biased position and snap against the tab 3320, securing the arm 13004 to the hollow tube 3334.

[0430] In some forms, the clip 13008 can be smaller than the tab 3320. This allows the clip 13008 (while connected to the tab 3320) to move within the tab 3320. Due to the application of tension, the clip 13008 can also rotate within the tab 3320. The position and / or angle within the tab 3320 can depend on the size of the patient's head, allowing the arm 13004 to be used with patients of different sizes.

[0431] In certain configurations, the clip 13008 may have a range of translational motion from about 1 mm to about 1000 mm. In certain configurations, the clip 13008 may have a range of translational motion from about 5 mm to about 100 mm. In certain configurations, the clip 13008 may have a range of translational motion from about 10 mm to about 75 mm. In certain configurations, the clip 13008 may have a range of translational motion from about 30 mm to about 50 mm.

[0432] At a second end of the arm 13004 opposite the clip 13008, a loop 13012 may be included. A strap (e.g., a lower strap (not shown)) may be threaded through the loop 13012 and adjusted for varying tension. The strap may be a single strap extending between both arms 13004 or may be a pair of straps connected to a rear strap. For example, the strap may be similar to the rear strap 3304 of FIG.

[0433] In some forms, the loop 13012 may be curved and wider than the straps, which may allow the straps to slide into the loop 13012 and adjust to an ideal position for a given patient. In this manner, each arm 13004, clip 13008 and loop 13012 may allow fine adjustments that may allow the positioning and stabilizing structure 13000 to better fit an individual patient, thereby promoting comfort and patient compliance.

[0434] In some forms, the arm 13004 may be angled between the clip 13008 and the loop 13012. For example, the arm 13004 may be shaped similarly to the extenders 3358a and 3358b of FIG. 56. In some forms, in use, the clip 13008 may be connected to a hollow tube 3334 that is substantially parallel to the Frankfort Horizontal. The angle of the arm 13004 may be such that the loop 13012 is disposed at an angle of approximately 30° to the Frankfort Horizontal.

[0435] In some forms, the arms 13004 bias at least one bendable section 13038. A patient can adjust the internal arm angle while moving one or more of the bendable sections 13038. The bendable sections 13038 can allow a patient to customize the shape of each arm 13004 (to better fit the individual patient).

[0436] In some forms, to further promote patient comfort, the arm 13004 may be covered with a flexible material. For example, a textile sleeve (not shown) may be positioned around the arm 13004. The sleeve may cover the clip 13008, exposing the loop 13012. The sleeve may be removably or permanently connected to the arm 13004.

[0437] As shown in Figs. 78 and 79, the arms 13004 may contact the sides of the patient's head and extend beyond the patient's ears. This may help reduce the chance of any straps contacting the patient's ears and causing irritation. The arms 13004 may be connected to the sides 3350a and pads 3354, which may anchor the patient interface 3000 to the patient's head as described above. The arms 13004 may be used with a nasal cushion (see, e.g., Fig. 78) or a full face cushion (see, e.g., Fig. 79). In other examples, the arms 13004 may be used without the sides 3350a and pads 3354.

[0438] 78 and 79, the patient interface 3000 may not include a lower strap. In other words, the patient interface 3000 may not include a strap that extends along the patient's cheek (e.g., over the masseter muscle) between the pad 3354 and / or side 3350 and the plenum chamber 3200. In other examples, the patient interface 3000 may include a lower strap.

[0439] In the illustrated example of Figures 78 and 79, the patient interface 3000 may not include a lower strap and / or an upper strap. In other words, the patient interface 3000 may not include a strap that extends under the patient's chin (e.g., under the mental protuberance). The patient interface 3000 may also not include a strap that extends to the crown of the patient's head (e.g., along the parietal bone to the control plane). In other examples, the patient interface 3000 may include upper and / or lower straps.

[0440] As shown in Figures 80-82, another form of the positioning and stabilizing structure 14000 may include a removable arm 14004. The removable arm 14004 may be constructed from a rigid or semi-rigid material (e.g., plastic) to maintain its shape. In some forms, the patient may bend the arm 14004 slightly to adjust the angle of the arm 14004. The arm 14004 may be substantially similar to the arm 13004, and only some of the similarities and differences are described below.

[0441] As shown in FIG. 80 and FIG. 80-1 , a clip 14008 may be included at a first end of the arm 14004 and may removably connect to a tab 3320 of the hollow tube 3334. Similar to the clip 13008 in FIG. 77 , the clip 14008 in FIG. 78 may include a locked position when the clip 14008 is snapped down onto the tab 3320. In contrast to the clip 13008, the clip 14008 may be made rotatable relative to the remainder of the arm 14004. For example, the first end of the arm 14008 may include a post 14009. The clip 14008 may be coupled to the post 14009 and made rotatable relative to the post 14009. In some forms, the clip 14008 may be freely rotatable about the post 14009. In some forms, the clip 14008 may be biased to a locked position and this bias may need to be overcome to rotate to the open position.

[0442] In some forms, the arm 14004 may include a locking portion 14010 disposed near the first end. The locking portion 14010 may include a protrusion 14011 that selectively contacts the clip 14008. The protrusion 14011 may limit rotation of the clip 14008 about the post 14009. For example, a patient may engage the protrusion 14011 with the clip 14008 upon connection of the arm 14004 to the tab 3320. This may limit rotational movement of the clip 14008 about the post 14009 and limit the occurrence of accidental disengagement of the clip 14008 from the tab 3320 (e.g., while the patient is sleeping). The patient may manually move the protrusion 14011 and / or the clip 14008 such that the protrusion 14011 and / or the clip 14008 are no longer in contact. This may allow the clip 14008 to move more freely, thereby allowing the patient to disconnect the arm 14004 from the hollow tube 3334 (e.g., allowing different positioning and stabilization structures to be used).

[0443] As shown in FIG. 81 , the locking portion 14010 may be formed as one piece with the post 14009 and / or clip 14008. For example, the locking portion 14010 may be overmolded with the post 14009 and / or clip 14008, thereby preventing complete separation of the locking portion 14010 from the arm 14004. In other examples, the connection of the locking portion 14010 to the post 14009 and / or clip may be made using fasteners (e.g., mechanical fasteners). For example, the post 14009 and locking portion 14010 may be formed together and connected to the arm 14004. This may allow rotation of the clip 14008 about the post while limiting overall movement of the clip 14008.

[0444] 81 , the arm 14004 may be curved between the first and second ends. In contrast to the second end of the arm 13004 including a loop 13012, the second end of the arm 14004 may include a tapered end 14012. The tapered end 14012 may have a curved surface and may be narrower than the remainder of the arm 14012.

[0445] In some forms, the arms 14004 may resemble the arms of eyeglasses. For example, the arms 14004 may contact the patient's head above the patient's ear and may curve downward and backward around the patient's ear. The arms 14004 may be positioned on the sides of the patient's head and may not extend to the rear region of the patient's head (e.g., may not rest on the occipital bone or trapezius muscle).

[0446] As shown in FIG. 82, the sleeve 14040 may be connected to the arm 14004. The tapered end 14012 of the arm 14004 may be inserted into the sleeve 14040. The curvature and tapering of the arm 14040 may help slide the sleeve 14040 along the length of the arm 14004 to limit bunching or snagging of the sleeve 14040. In some examples, the sleeve 14040 may be constructed from a comfortable and / or compliant material allowing it to adjust to the shape of the arm 14004. The material may be a textile that may be comfortable against the patient's face.

[0447] As shown in Fig. 83 and Fig. 84, the arm 14004 may contact the side of the patient's head and extend beyond the patient's ear. The arm 14004 may be positioned against the patient's head like eyeglasses. The arm 14004 may be usable without the need for additional straps (e.g., top strap, bottom strap, lower strap, upper strap, etc.) to support the seal-forming structure 3100 in a sealing position. The arm 14004 may be used with a nasal cushion (see, e.g., Fig. 83) or a full face cushion (see, e.g., Fig. 84). In other examples, the arm 14004 may be used with any combination of straps described above.

[0448] 5.3.4 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0449] In certain forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the ambient when pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured such that the magnitude of the ventilation flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0450] A vent 3400 in one embodiment according to the present technology includes a plurality of holes 3404 (eg, about 20 to about 80 holes 3404, or about 40 to about 60 holes 3404, or about 45 to about 55 holes 3404).

[0451] The vent 3400 may be disposed within the plenum chamber 3200. Alternatively, the vent 3400 is disposed within a decoupling structure (e.g., a swivel).

[0452] 5.3.5 Decoupling Structures (Plural or Singular) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (eg, a swivel or ball).

[0453] 46, the decoupling structure 3500 is inserted through the first entry port 3208. The decoupling structure 3500 holds the flap 3338 in an open position and prevents the flap 3338 from moving to a closed position.

[0454] In a particular embodiment, the decoupling structure 3500 is movable from the first inlet port 3208 to a third inlet port 3209 (spaced apart from the first inlet port 3208) on the plenum chamber 3200. The flap 3207 of the first inlet port 3208 is then free to move. For example, when pressurized air is supplied through the decoupling structure 3500 and the second inlet port 3336, the force of the air overcomes the bias (e.g., mechanical, magnetic) of the flap 3207. The flap 3207 moves to a closed position, substantially preventing air from escaping through the first inlet port 3208. In contrast to the second inlet port 3336, the third inlet port 3209 does not include a flap.

[0455] 5.3.6 Stoppers 46, one form of the patient interface 3000 includes a plug 3550. The plug 3550 is inserted through one of the ports 3208 and 3336 so as to substantially prevent the passage of airflow through the ports 3208 and 3336. For example, the plug 3550 may be coupled to the ports 3208, 3336 when not receiving the decoupling structure 3500.

[0456] In certain configurations, the plug 3550 may be used with ports 3208 and 3336 that include valves 3206 and 3339. The plug 3550 holds the valves 3206 and 3339 in an open position while providing the seal itself.

[0457] 5.3.7 Connection Ports The connection port 3600 allows connection to the air circuit 4170 .

[0458] 5.3.8 Forehead support In one form, the patient interface 3000 includes a forehead support 3700. In another form, the patient interface 3000 does not include a forehead support 3700.

[0459] 5.3.9 Anti-asphyxiation valves In one form, the patient interface 3000 includes an anti-asphyxiation valve (AAV) (eg, flap 3207 and flap 3338).

[0460] 46, certain forms of flaps 3207 and 3338 adjacent the first port 3208 and / or second port 3336, respectively, function as AAVs 3206 and 3339 when the decoupling structure 3500 is not coupled to the respective ports 3208 and 3336. The decoupling structure 3500 may include additional AAVs 3206 and 3339 that allow airflow through the port to which the decoupling structure 3500 is coupled.

[0461] In certain configurations, an AAV (not shown) may be provided on the decoupling structure 3500 and either the plenum chamber 3200 or the positioning and stabilizing structure 3300 may not include the respective flaps 3207 and 3338 (see, for example, FIG. 47A ). The plugs 3550 are inserted into the ports 3208 and 3336 that do not include the decoupling structure 3500.

[0462] 5.3.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a characteristic of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0463] 5.4 RPT Devices An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to pressurize an airflow delivered to a patient's airway for treatment of one or more of the respiratory ailments described anywhere herein.

[0464] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0465] The RPT device may have an outer housing 4010. The outer housing 4010 may be formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 may include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0466] The air pressure path of the RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., pressure and flow sensors).

[0467] One or more of the pneumatic path items may be disposed within a removable unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016. The pneumatic block 4020 may include one or more pneumatic components 4100.

[0468] The RPT device 4000 can have an electrical power source 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0469] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be disposed as their own separate units.

[0470] 5.4.1.1 Air filter(s) An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0471] In one form, the inlet air filter 4112 is positioned at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0472] In one form, an outlet air filter 4114 (eg, antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0473] 5.4.1.2 Muffler(s) An RPT device according to one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0474] In one form of the present technology, an inlet muffler 4122 is positioned in the pneumatic path upstream of a pressure generator 4140 .

[0475] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0476] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / min, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, when administering respiratory pressure therapy. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Pat. No. 7,866,944; U.S. Pat. No. 8,638,014; U.S. Pat. No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.

[0477] The pressure generator 4140 is under the control of the treatment device controller.

[0478] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0479] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or transfers data to the RPT device).

[0480] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure or temperature at that point in the pneumatic path).

[0481] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0482] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass or band-pass filtering).

[0483] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the motor 4144).

[0484] 5.5 Air Circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000 or 3800).

[0485] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0486] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0487] 5.5.1 Make-up Gas Delivery In one form of the present technology, a supplemental gas 4180, e.g., oxygen, can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.

[0488] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of an air stream before it is delivered to the patient's airways.

[0489] The humidifier 5000 may include a humidifier reservoir, a humidifier inlet for receiving an airflow, and a humidifier outlet for delivering a humidified airflow. In some forms, the inlet and outlet of the humidifier reservoir may be the humidifier inlet and the humidifier outlet, respectively. The humidifier 5000 may further include a humidifier base. The humidifier base may be adapted to receive the humidifier reservoir and may include a heating element.

[0490] 5.7 Respiratory waveform FIG. 42 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6 seconds; peak inhalation flow, Qpeak, 0.4L / sec; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is about 4 seconds. Humans typically breathe about 15 times per minute (BPM) and the ventilation, Vent, is about 7.5L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0491] 5.8 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0492] 5.8.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0493] Surroundings: In certain forms of the present technology, the term "surroundings" should be taken to mean: (i) outside the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0494] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0495] In another example, the ambient pressure can be pressure directly surrounding or external to the body.

[0496] In certain embodiments, ambient noise (e.g., acoustic) can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0497] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting the therapy pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0498] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0499] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.

[0500] Flow Therapy: Respiratory therapy that involves delivering airflow to the entrance to the airways at a controlled flow rate, called the therapeutic flow rate, that is usually positive pressure throughout the patient's respiratory cycle.

[0501] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to ameliorate a medical respiratory condition in a patient.

[0502] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage may occur due to an imperfect seal between the mask and the patient's face. In another example, leakage may occur at the swivel elbow to the perimeter.

[0503] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic path (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0504] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0505] Noise, Ventilation (Acoustic): In this document, ventilation noise refers to noise generated by airflow through any vents (eg, vent holes in the patient interface).

[0506] Patient: A person with or without respiratory disease.

[0507] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm2 which is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar ~ 0.001 atm). In this specification, pressure is given in units of cmH2O unless otherwise specified.

[0508] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0509] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0510] 5.8.1.1 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC® (a product family sold under this trademark) manufactured by DuPont. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness as measured by ASTM D2240 of about 35 to about 45.

[0511] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0512] Textile: A flexible material constructed from intertwined fibers by techniques (examples include, but are not limited to, weaving, knitting, crocheting, or braiding). Specific types of textiles include woven fabrics produced by specific techniques (e.g., weaving and knitting).

[0513] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0514] Elastic: Releases virtually all of the energy upon unloading. Includes, for example, certain silicone and thermoplastic elastomers.

[0515] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.

[0516] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending or torsion). A structure or component may offer different resistance in different directions. The antonym of rigidity is flexibility.

[0517] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0518] Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application might be setting up and maintaining a patient interface in a sealed manner against a patient's airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0519] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0520] 5.8.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite the patient's efforts. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0521] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0522] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0523] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.

[0524] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0525] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.

[0526] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Airway patency may be quantified, for example, with a value of 1 indicating patency and a value of 0 indicating closure (obstruction).

[0527] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0528] Respiratory flow, airflow, patient airflow, respiratory airflow (Qr): these terms may be understood to refer to the RPT device's estimate of respiratory airflow and are used in contrast to "true respiratory flow" or "true respiratory flow", which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0529] Tidal volume (Vt): The volume of air inspired or expired during normal breathing without extra effort. In principle, the inspired volume Vi (volume of air inspired) is equal to the expired volume Ve (volume of air expired), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inspired volume Vi and the expired volume Ve).

[0530] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0531] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0532] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0533] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flows per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0534] 5.8.3 Anatomy 5.8.3.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0535] Alare: The outermost point on the ala of the nose.

[0536] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each ala, found in the crease formed by the union of the ala and cheek.

[0537] Pinna: the entire visible part of the ear.

[0538] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0539] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0540] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0541] Columellar angle: the angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfort horizontal while intersecting the subnasal point.

[0542] Frankfort horizontal plane: A line extending from the inferiormost point of the orbital rim to the left auricular point, which is the deepest point above the notch to the tragus of the pinna.

[0543] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0544] Lateral nasal cartilage: A generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla and whose lower margin is connected to the greater alar cartilage.

[0545] Alar cartilage: a plate of cartilage located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0546] Nostrils (nose holes): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nares is naris (nose hole). The nostrils are separated by the nasal septum.

[0547] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth and separates the cheeks from the upper lip.

[0548] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0549] Inferior ear fundus point: lowest point of attachment of the pinna to the facial skin.

[0550] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0551] Nasal tip: the most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head part.

[0552] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0553] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0554] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0555] Sagittal Plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0556] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0557] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0558] Nasal Alar Lowest Point: The point on the lower margin of the alar base where it joins with the skin of the upper (top) lip.

[0559] Subnasal point: located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0560] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0561] 5.8.3.2 Skull anatomy Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0562] Mandible: The mandible forms the lower jaw. The mental eminence is a bony protuberance in the jaw, forming the chin.

[0563] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upwards by the side of the nose and forms part of its lateral border.

[0564] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from one individual to another. They lie side by side in the middle and upper parts of the face and their junction forms the "bridge" of the nose.

[0565] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0566] Occipital bone: The occipital bone is located at the back and lower part of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity communicates with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0567] Orbit: bony cavity in the skull that contains the eyeball.

[0568] Parietal bones: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0569] Temporal Bone: The temporal bone is located at the base and on the side of the skull and supports parts of the face known as the temples.

[0570] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0571] 5.8.3.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the base of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0572] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0573] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchiole, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0574] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, and at the back it opens into the nasopharynx via the choanae.

[0575] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (upper pharynx) (nasal portion of the pharynx), the oropharynx (mid pharynx) (oral portion of the pharynx), and the hypopharynx (low pharynx).

[0576] 5.8.4 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive rebreathing of CO2 by the patient by venting to atmosphere in a fail-safe manner.

[0577] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through 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 generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable, for example, about 360 degrees, relative to the mating component. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap at the time of manufacture, but cannot be removed by the patient.

[0578] Frame: Frame is taken to mean a mask structure that supports a tensile load between two or more points that connect the headgear. A mask frame may be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0579] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed to be used on the head. For example, the headgear may include a collection of one or more posts, ties and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0580] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0581] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, the air in the volume being above atmospheric pressure when pressurized for use. The shell may form part of the wall of the mask plenum chamber.

[0582] Seal: When used as a noun ("seal") it can refer to a structure, and when used as a verb ("seal") it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0583] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0584] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

[0585] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0586] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of mating cylindrical conduits. In use, there is little leakage of air flow from the swivel.

[0587] Tie (noun): A structure designed to resist tension.

[0588] Vent: (noun): A structure that allows airflow to the ambient air inside a mask or conduit, allowing clinically effective washout of exhaled gases. For example, flow rates of about 10 liters / minute to about 100 liters / minute may be used for clinically effective washout, depending on mask design and treatment pressure.

[0589] 5.8.5 Shape of structure A product of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be differentiated with labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0590] To facilitate the description of the shape and surfaces of a three-dimensional structure, a cross section at a point p through the surface of the structure is first considered. See Figures 17-21. Figures 17-21 show an example cross section at a point p on the surface, and an example of the resulting planar curve. Figures 17-21 also show the outward normal vector at p, which points away from the surface. In some examples, the surface is described from the perspective of a fictional little person standing upright on the surface.

[0591] 5.8.5.1 Curvature in one dimension The curvature of a plane curve at p may be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0592] Positive curvature: If the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if our imaginary little person walks away from point p, he or she will have to walk uphill). See Figure 17 (relatively large positive curvature compared to Figure 18) and Figure 18 (relatively small positive curvature compared to Figure 17). Such curves are often called concave.

[0593] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, he can walk on a horizontal plane that is neither pointing up nor down). See Figure 19.

[0594] Negative curvature: If the curve at p curves away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if our imaginary little person walks away from point p, he or she will have to walk downhill). See Figure 20 (relatively small negative curvature compared to Figure 21) and Figure 21 (relatively large negative curvature compared to Figure 20). Such curves are often called convex.

[0595] 5.8.5.2 Two-dimensional surface curvature A description of a shape at a given point on a two-dimensional surface according to the present technique may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane that includes the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each of the curvatures at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 17-21 may be examples of such multiple cross sections at a particular point.

[0596] Principal curvature and direction: The directions of the normal plane in which the curvature of the curve has a maximum and minimum value are called the principal directions. In the example of Figures 17 to 21, the maximum curvature occurs in Figure 17 and the minimum occurs in Figure 21, so Figures 17 and 21 are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0597] Surface region: A collection of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0598] Saddle Region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0599] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

[0600] Cylindrical Region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0601] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0602] Surface Edge: the boundary or limit of a surface or area.

[0603] Path: In certain forms of the technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A fictional person's path is a place to walk on a surface, similar to a path in a garden.)

[0604] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along a surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on a surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along a path on the surface.)

[0605] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.")

[0606] 5.8.5.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, i.e., it has no end point. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear includes a left-handed helix (see FIG. 32). A typical human right ear includes a right-handed helix (see FIG. 33). FIG. 34 shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) may trace a space curve. In general, a space curve may be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve may be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0607] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character was flying along a curve and fell off his vehicle at a particular point, the direction of the tangent vector is the direction he would be traveling.

[0608] Unit normal vector: If a fictional character is moving along a curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0609] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 31) or the left-hand rule (Figure 30).

[0610] Tangent Plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 30 and 31.

[0611] Torsion of a Space Curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. The torsion of a space curve that lies within the plane is zero. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). With reference to FIG. 34, the magnitude of torsion of the neighbor of the top coil of the spiral in FIG. 34 is greater than the magnitude of torsion of the bottom coil of the spiral in FIG. 34 because T2>T1.

[0612] Referring to the right-hand rule in Figure 31, a space curve that bends towards the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 34). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0613] Similarly, referring to the left-hand rule (see Figure 30), a space curve with a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 35.

[0614] 5.8.5.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a plane or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 24 are bounded by a plane curve.

[0615] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 27 and the example cross-section of FIG. 27 in FIGS. 28 and 29, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 26 and bounded by a surface as shown.

[0616] 5.9 Other Notes Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0617] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0618] Additionally, the terms "approximately," "substantially," "about" or any similar term used herein means + / - 5 to + / - 10% of the stated value.

[0619] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0620] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0621] Please note that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0622] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology has not antedated such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0623] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically stated.

[0624] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

[0625] Although the technology herein has been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of the process steps in the method may be described in an order, such order is not necessary. Those skilled in the art will recognize that such order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0626] It is therefore to be understood that numerous modifications are possible in the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0627] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3100a Nose mask 3100b Mouth seal 3101 Textile materials 3104 Hollow sealing tube 3108 Hole 3112 Retention mechanism 3114 First magnetic section 3116 First Clip Structure 3116a 1st clip 3116b 2nd Clip 3116c Gasket 3118 Removal mechanism 3130 Inside 3134 Insert 3140 Magnetic Thread 3142 Magnetic Thread 3144 Tabs 3146 Recess 3152a Nasal opening 3152b Mouth opening 3200 Plenum Chamber 3204 Textile cover 3204a Exterior 3206 Valve 3207 Flap 3208 First Inlet Port 3209 3rd Inlet Port 3210 Second magnetic section 3212 Third Magnetic Division 3216 Second Clip Structure 3240 First end 3241 Second end 3242 Conduit 3300 Positioning and stabilizing structure 3302 Side Strap 3302b Side Strap 3304 Rear strap 3306 Upper strap 3308 Seal end 3316 First Magnetic Section 3318 Second Magnetic Section 3320 Tab 3324 Headgear 3326 Earpiece 3328 Transition 3334 Hollow tube 3335 Connector 3336 Second Inlet Port 3338 Flap 3339 Valve 3342 Inside 3346 Middle section 3348 First Material 3349 Second Material 3350 Side 3350a left side 3350b right side 3354 Pad 3354a left side 3354b Second area on the right 3358 Extender 3358a Left Extender 3358b Right Extender 3359 Horizontal part 3360 Slope area 3361 Third Material 3362 Connection Strap 3366 First engagement part 3368 Second engagement part 3370 Buckling 3374 Aperture 3378 Protrusion 3380 Loop 3400 Ventilation section 3404 Hole 3500 Uncoupling structure 3550 Stopper 3600 Connection Port 3700 Forehead support ISO 3744 4000 RPT Devices 4010 Outer Housing 4012 Upper part 4014 parts 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4100 Pneumatic Components 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Refill Gas 4200 Electrical Components 4202 PCBA 4210 Electrical power supply 4220 Input Device 4230 Central Controller 4270 Converter 5000 humidifier 7000 Positioning and Stabilizing Structure 7002 Headgear Straps 7004 Rear strap 7008 Upper strap 7012 Lower strap 7016 Connector Area 7020 Clips 8000 Positioning and Stabilizing Structure 8002 Headgear Straps 8004 Rear strap 8005 Central part 8006 Lower part 8008 Upper strap 8012 Lower strap 8016 Connector Area 8020 Clip 9000 Positioning and Stabilizing Structure 9002 Headgear Straps 9004 Rear strap 9005 Upper part 9006 Lower part 9007 Side 9008 Upper strap 9012 Lower strap 9016 Connector Area 9020 Clips 10000 Positioning and stabilizing structures 10002 Headgear strap 10004 Rear strap 10005 Central part 10006 Side 10008 Upper strap 10012 Lower strap 10016 Connector Area 10020 Clips 10024 Slot 11000 Positioning and stabilizing structures 11002 Headgear straps 11004 Rear strap 11008 Upper strap 11012 Lower strap 11016 Connector Area 11020 Clips 11036 Top Strap 12000 Positioning and stabilizing structures 12002 Headgear straps 12004 Rear strap 12008 Upper strap 12012 Lower strap 12016 Connector Area 12020 Clips 12000-1 Positioning and stabilizing structures 12002-1 Headgear straps 12004-1 Rear strap 12008-1 Upper strap 12012-1 Lower strap 12016-1 Connector area 12020-1 Clip 13000 Positioning and stabilizing structures 13004 Detachable Arm 13008 Clips 13012 Loop 13038 Bendable area 14000 Positioning and stabilizing structures 14004 Detachable Arm 14008 Clips 14009 Pillar 14010 Rock 14011 Protrusion 14012 Tapered End 14040 Sleeve

Claims

1. 1. A patient interface, comprising: At least 6 cmH above ambient air pressure ２ O a plenum chamber pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of airflow at said therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that said airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout the patient's respiratory cycle; 1. A positioning and stabilising structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising: a gas delivery tube formed as a continuous structure for receiving the air flow from a connection port on the top of the patient's head and for delivering the air flow through the seal-forming structure to an entrance of the patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to contact, in use, at least an area of ​​the patient's head above an upper ear base point of the patient's head, each tab of the pair of tabs having an opening with an opening length; a pair of detachable arms removably connected to said tab, each detachable arm constructed and arranged to extend in a rearward and downward direction in use, each detachable arm comprising: a first end including a clip configured to be removably attached to one of the pair of tabs, a clip length of the clip being less than the opening length, the clip configured to move along the clip length and / or pivot within the opening for adjustment of a force vector; and a pair of detachable arms including a second end opposite the first end; and a vent structure for moving a continuous flow of gas exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

2. The patient interface of claim 1 , wherein the second end of each detachable arm of the pair of detachable arms includes a slot.

3. The patient interface of claim 1 or 2, wherein the slot is arcuate.

4. The patient interface of any one of claims 1 to 3, further comprising a rear strap connected to a second end of each detachable arm of the pair of detachable arms.

5. 5. The patient interface of claim 4, wherein the rear straps are configured to extend in a rearward and downward direction on the patient's head and be positioned to contact the occipital region of the patient's head in use, the rear straps being constructed from a first material and a second material, the first material being positioned to contact a temporal region of the patient's head in use and the second material being positioned to contact the occipital region of the patient's head in use.

6. The patient interface of claim 5 , wherein the first material is a textile and the second material is a silicone.

7. A patient interface according to any one of claims 4 to 6 when dependent on claim 2 or 3, wherein the rear straps are received within respective slots.

8. The patient interface of claim 7 , wherein a width of the rear strap is less than a width of the slot, the rear strap being configured to move within the slot and adjust a force vector.

9. A patient interface according to any one of claims 1 to 8, wherein an opening length of each of the pair of tabs is between approximately 30mm and approximately 50mm.

10. The patient interface of any one of claims 1 to 9, wherein each detachable arm is curved between the first and second ends.

11. 11. The patient interface of claim 1, wherein the second end is configured to contact the patient's head at approximately 30 degrees below Frankfort Horizontal.

12. A patient interface according to any preceding claim, wherein each clip is biased to a closed position, said clips being movable to an open position for connection to respective said tabs.

13. 13. A patient interface according to any one of claims 1 to 12, wherein each arm of the pair of arms includes at least one bendable portion configured to allow positional adjustment between the first end and the second end.

14. The patient interface of claim 13 , wherein the at least one bendable section is a plurality of bendable sections, each bendable section of the plurality of bendable sections being independently adjustable.

15. 1. A patient interface, comprising: At least 6 cmH above ambient air pressure ２ O a plenum chamber pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of airflow at said therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that said airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout the patient's respiratory cycle; 1. A positioning and stabilising structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising: a gas delivery tube formed as a continuous structure for receiving the air flow from a connection port on the top of the patient's head and for delivering the air flow through the seal-forming structure to an entrance of the patient's airway, the gas delivery tube including a pair of tabs constructed and arranged to contact, in use, at least an area of ​​the patient's head above an upper ear base point of the patient's head; a pair of detachable arms removably connected to said tab, each detachable arm constructed and arranged to extend in a rearward and downward direction in use, each detachable arm comprising: a first end including a post, a clip movable about the post and configured to releasably engage an upper strap, and a locking portion configured to selectively limit movement of the clip about the post; and a pair of detachable arms including a second end opposite the first end; and a vent structure for moving a continuous flow of gas exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

16. The patient interface of claim 15 , wherein the clip is pivotally connected to the post.

17. The patient interface of claim 16 , wherein the clip is freely pivotable about the post when the locking portion is in the unlocked position.

18. The patient interface of claim 16 , wherein the clip is biased against a surface of the detachable arm.

19. The patient interface of claim 15 , wherein the locking portion of each detachable arm is detachably connected to a respective one of the posts.

20. The patient interface of claim 15 , wherein the locking portion of each detachable arm is integrally formed with the respective post.

21. The patient interface of claim 20 , wherein the locking portion is overmolded with the post.

22. 22. A patient interface according to any one of claims 15 to 21, wherein the locking portion of each detachable arm includes a protrusion configured to selectively contact the clip and limit rotational movement of the clip.

23. The patient interface of any one of claims 15 to 22, wherein each detachable arm is curved between the first end and the second end.

24. A patient interface according to any one of claims 15 to 23, wherein each detachable arm is tapered approaching the second end.

25. 25. The patient interface of any one of claims 15 to 24, further comprising a pair of textile sleeves, each textile sleeve of the pair of textile sleeves configured to receive a detachable arm of the pair of detachable arms.

26. The patient interface of any one of claims 15 to 25, wherein a strap is not connected to the pair of detachable arms.

27. 1. A patient interface, comprising: At least 6 cmH above ambient air pressure ２ O a plenum chamber pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways for sealed delivery of airflow at said therapeutic pressure throughout the patient's respiratory cycle, said seal-forming structure having holes therein such that said airflow is delivered at said therapeutic pressure to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout the patient's respiratory cycle; 1. A positioning and stabilising structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising: a rear strap configured to contact the patient's head and rest on at least a portion of the occipital bone; a pair of upper straps configured to selectively apply rearwardly directed tension, the pair of upper straps connected to the rear strap below at least a portion of the rear strap, each upper strap of the pair of upper straps including a connector region; a pair of lower straps configured to selectively apply rearwardly directed tension, the pair of lower straps connected to the pair of upper straps below at least a portion of the upper straps, each lower strap of the pair of lower straps including a connector region; a vent structure for moving a continuous flow of gas exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

28. 28. The patient interface of claim 27, wherein the rear strap is constructed from a first material, the pair of upper straps are constructed from a second material, and the pair of lower straps are constructed from a third material.

29. 30. The patient interface of claim 28, wherein the first material and the third material are the same.

30. 30. The patient interface of claim 28 or 29, wherein the first material and the third material are stretchable materials.

31. The patient interface of any one of claims 28 to 30, wherein the rear straps are pre-tensioned in the non-use position.

32. 30. The patient interface of claim 28, wherein the first material and the second material are the same.

33. 33. The patient interface of claim 28 or claim 32, wherein the first material and the second material are non-elastic materials.

34. The patient interface of any one of claims 27 to 33, wherein the rear strap is substantially triangular in shape.

35. 35. The patient interface of claim 34, wherein an upper side of the rear strap is substantially horizontal.

36. 36. The patient interface of claim 34 or 35, wherein a rear strap angle formed by a lower end of the rear strap is between approximately 110° and approximately 150°.

37. 37. The patient interface of claim 36, wherein the rear strap angle is approximately 130 degrees.

38. The patient interface of any one of claims 27 to 37, wherein the pair of upper straps form a substantially V-shape.

39. 40. The patient interface of claim 38, wherein an upper strap angle formed by the lower ends of the pair of upper straps is between approximately 110 degrees and approximately 170 degrees.

40. 40. The patient interface of claim 39, wherein the upper strap angle is approximately 150 degrees.

41. 41. The patient interface of any one of claims 27 to 40, wherein the pair of lower straps form a substantially V-shape and the pair of upper straps and the pair of lower straps together form a substantially X-shape.

42. 42. The patient interface of claim 41, wherein a lower strap angle is formed between a lower strap of the pair of lower straps and an adjacent upper strap of the pair of upper straps, the lower strap angle being between approximately 30 degrees and approximately 70 degrees.

43. 43. The patient interface of claim 42, wherein the lower strap angle is approximately 50 degrees.

44. A patient interface according to any one of claims 37 to 43, wherein the pair of upper straps are pre-tensioned in a non-use position.

45. A patient interface according to any one of claims 27 to 44, wherein the pair of lower straps are releasably connected to the plenum chamber.

46. 46. ​​A patient interface according to any one of claims 27 to 45, wherein the positioning and stabilising structure further comprises a gas delivery conduit formed as a continuous structure for receiving the air flow from a connection port on the top of the patient's head and delivering the air flow through the seal-forming structure to an entrance to the patient's airway, the gas delivery conduit including a pair of tabs constructed and arranged to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head in use.

47. 47. The patient interface of claim 46, wherein each upper strap of the pair of upper straps is releasably connected to one of the pair of tabs.

48. 48. The patient interface of any one of claims 27 to 47, wherein the connector region of each lower strap of the pair of lower straps is a hook material and the connector region of each upper strap of the pair of upper straps is a hook material.

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