Patient interface to occipital bone anchoring

Abstract

A patient interface includes an inflation chamber pressurizable to a treatment pressure, and a seal-forming structure constructed and arranged to seal with a patient's facial region around an entrance to a patient's airway. The seal-forming structure is constructed and arranged, in use, to maintain a treatment pressure in the plenum chamber throughout a breathing cycle of the patient. The patient interface also includes 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 includes a posterior band arranged to contact the occipital bone of the patient's head. The posterior band is comprised of a first material arranged to contact a temporal region of the patient's head and a second material arranged to contact an occipital bone of the patient's head. The second material is a silicone.

Description

[0001] This application is a divisional application of the Chinese invention patent application with application date of March 19, 2021, application number 202180032514.3, and invention name “PATIENT INTERFACE WITH OCCIPTIVE ANCHORAGE”. Application number 202180032514.3 is an application entering the Chinese national phase of application number PCT / AU2021 / 050253.

[0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims the benefit of Australian Provisional Application No. 2020900850 filed on 20 March 2020, the entire contents of which are incorporated herein by reference. Background Art 2.1 Technical Field

[0006] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0007] 2.2 Description of related technologies

[0008] 2.2.1 Human respiratory system and its disorders

[0009] The human respiratory system facilitates gas exchange. The nostrils and mouth are the entrances to the patient's airway.

[0010] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the inhaled air and expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchi and the right main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0011] There is a range of breathing disorders. Some conditions can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0012] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0013] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Comorbid symptoms are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See Sullivan, U.S. Patent No. 4,944,310.

[0014] A range of treatments have been used to treat or ameliorate such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0015] 2.2.2 Treatment

[0016] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0017] 2.2.2.1 Respiratory pressure therapy

[0018] Respiratory pressure therapy is the supply of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's breathing cycle (as opposed to negative pressure therapy such as cannulated or catheter-based ventilators).

[0019] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0020] Non-invasive ventilation (NIV) provides ventilation support to patients through the upper airway to help them breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] Invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0022] 2.2.3 Respiratory therapy system

[0023] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0024] The respiratory therapy system may include at least one of: a respiratory pressure therapy (RPT) device, an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0025] Another form of treatment system is a mandibular repositioning device.

[0026] 2.2.3.1 Patient interface

[0027] The patient interface can be used to couple the respiratory apparatus to its wearer, for example by providing a flow of air to the entrance of the airway. The flow of air can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can seal with an area such as the patient's face to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to the ambient pressure) to achieve the treatment.

[0028] For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway. For flow therapy such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0029] Certain other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the surrounding environment inside.

[0030] Certain masks may be clinically disadvantageous to the present technology, for example where they block airflow through the nose and only allow it through the mouth.

[0031] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, this may be uncomfortable or impractical with the present technology.

[0032] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0033] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0034] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0035] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0036] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0037] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0038] 2.2.3.1.1 Sealing structure

[0039] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0040] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0041] A seal-forming structure that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a structure for swimming goggles that seals over a patient's forehead may not be suitable for use over a patient's nose.

[0042] Certain seal-forming structures may be designed for mass manufacturing so that one design may be suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt in order for the seal-forming structure to seal with the patient's face.

[0043] 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 while the seal-forming portion is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force may be required to force the patient interface against the face to achieve a seal, otherwise leakage may occur. The additional force may cause discomfort to the patient during use.

[0044] Another type of seal-forming structure incorporates a flap seal of relatively thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the type of seal-forming structure of the previous paragraph, if the size and shape of the seal-forming structure does not exactly match the size and shape of the patient's face, additional force may be required to press against the patient's face, otherwise the mask may leak. The additional force may cause discomfort to the patient during use. In addition, if the size and shape of the seal-forming structure does not exactly match the size and shape of the patient, the seal-forming structure may wrinkle or bend during use due to its relative thinness, which may cause leakage.

[0045] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0046] Another form of seal-forming structure may use an adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove adhesive from their face.

[0047] A range of patient interface seal forming structure technologies are disclosed in the following patent applications, assigned to ResMed Limited, Kwok et al., International Publication No. WO 1998 / 004310 A1; Davidson et al., International Publication No. WO 2006 / 074513 A1; Dravitzki et al., International Publication No. WO 2010 / 135785 A1.

[0048] One form of nasal pillow is found in the ADAM circuit manufactured by Puritan-Bennett, Inc. Another nasal pillow or nasal spray is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett, Inc.

[0049] ResMed Inc. already manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGE LIBERTY TM Full face mask. The following patent application assigned to ResMed Ltd. describes an example of a nasal pillow mask: Gunaratnam et al., International Publication No. WO 2004 / 073778 A1 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); Guney et al., U.S. Publication No. 2009 / 0044808A1 (which describes ResMed Inc. SWIFTTM LT nasal pillows); Davidson et al., International Publication No. WO 2005 / 063328 A1 and Lubke et al., International Publication No. WO 2006 / 130903 A1 (which describes the MIRAGE LIBERTY TM Other aspects of full-face masks); Rummery et al., International Publication No. WO2009 / 052560A1 (which describes ResMed Ltd. SWIFT TM Other aspects of the FX pillows).

[0050] 2.2.3.1.2 Positioning and stabilization

[0051] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0052] One technique is to use an adhesive. See, for example, Kooij et al., US Publication No. US2010 / 0000534 A1. However, the use of an adhesive may be uncomfortable for some people.

[0053] Another technique is to use one or more straps and / or stabilizing harnesses.Many such harnesses suffer from one or more of poor fit, bulk, discomfort, and awkward use.

[0054] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0055] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the various therapies described above, for example by operating the device to generate an air flow for delivery to an airway interface. 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 be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0056] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0057] An example of a special requirement for certain RPT devices is noise minimization, since the patient may sleep during the procedure.

[0058] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cm H2O in CPAP mode using the test method specified in ISO 3744).

[0059] RPT device name A-weighted sound pressure level dB(A) Years (approximately) <![CDATA[C series TANGO TM > 31.9 2007 <![CDATA[C Series TANGO with Humidifier TM > 33.1 2007 <![CDATA[S8 ESCAPE TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 ESCAPE of the humidifier TM II]]> 31.1 2005 <![CDATA[S9 AUTOSET TM ]]> 26.5 2010 <![CDATA[With H5i TM S9 AUTOSET of humidifier TM > 28.6 2010

[0060] One known RPT device for treating sleep apnea is the S9 manufactured by ResMed Limited. TM Sleep therapy system. Another example of an RPT device is a ventilator. A ventilator such as the ResMed STELLAR TM The range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0061] Manufactured by ResMed Limited 150 ventilator and VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and pressure ventilation modes with single-limb or double-limb circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0062] The designer of the device may be presented with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0063] 2.2.3.3 Air circuit

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

[0065] 2.2.3.4 Humidifier

[0066] Delivering an air stream without humidification can result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air typically applied to the facial area in and around the patient interface is more comfortable than cold air. Therefore, a humidifier typically has the ability to heat the air stream as well as humidify it. Additionally, warmer air has a greater water vapor capacity.

[0067] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0068] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the surrounding ambient air when needed, usually where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surrounding ambient environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0069] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0070] 2.2.3.5 Data Management

[0071] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the use over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0072] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0073] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0074] 2.2.3.6 Ventilation technology

[0075] Some forms of therapeutic systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space of the patient interface (eg, from within a plenum) to an exterior space of the patient interface, eg, to the surrounding environment.

[0076] The vent may include an orifice through which gas may flow when the mask is used. Many such vents are noisy. Others may become blocked when in use, thereby providing insufficient flushing. Certain vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example, by making noise or by gathering airflow.

[0077] ResMed Ltd. has developed many 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. Publication No. US 2009 / 0050156 A1; Guney et al., U.S. Publication No. 2009 / 0044808 A1.

[0078] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cm H2O at 1m)

[0079]

[0080] (*One sample only, measured using the test method specified in ISO 3744 in CPAP mode at 10 cm H2O)

[0081] The sound pressure values ​​for various objects are listed below

[0082]

[0083] 2.2.3.7 Heat and Moisture Exchanger (HMX) Technology

[0084] Patients may be susceptible to drying of the internal airway passages when undergoing various forms of respiratory therapy as described above. For example, CPAP therapy requires continuous provision of a flow of air pressurized at a pressure greater than ambient pressure to the patient, and this continuous flow of air, particularly at elevated levels combined with positive air pressure, may result in drying of the patient's airways. This dryness may cause discomfort, which in turn may adversely affect the patient's compliance with therapy.

[0085] In order to minimize the drying effects of these forms of respiratory therapy, the air flow provided to the patient can be humidified before it reaches the patient. Certain forms of humidification technology, such as the humidification technology described above, reduce the drying effect by heating a water reservoir and passing air over its surface to increase the absolute humidity of the air, i.e., the absolute humidity absorbed by the air from the water reservoir, i.e., the air absorbs water vapor from the water reservoir. The humidified air is then delivered to the patient via an air circuit. The air circuit may also be heated to prevent condensation of water vapor within the air circuit during delivery to the patient (also known as rainout). These forms of technology typically involve filling a water reservoir with water prior to treatment, which is then provided to the RPT system so that the water can be heated to humidify the air for treatment. The water reservoir typically requires regular cleaning, there is a risk of overflow, which can be particularly problematic in the case of electronic components, and the reservoir needs to be refilled by the patient before use.

[0086] Not requiring a pre-supplied water source, such as a reservoir to be filled with water, and input of electrical energy to heat the water can provide several benefits. For example, the RPT device can be made smaller because it does not require space for a reservoir and a heating plate. Since no electrical energy is consumed in the heating of the water, electrical costs can be reduced. Also, fewer electronic components may be required in the RPT device, which reduces its cost and complexity. Also, the RPT device can be easier to use because there is no reservoir to fill, empty, and clean. The risk of overflow can also be reduced. Also, the operation of the RPT device can be simplified because there is no humidification setting to operate.

[0087] In operation, a patient exhales air that has been heated within the patient's body and that has absorbed water vapor from the patient's airway. Heat and moisture in the exhaled air are captured by the HMX material, i.e., the HMX material is heated by the relatively warm exhaled air, and the HMX material absorbs water vapor from the relatively moist exhaled air as the exhaled air passes through the HMX material before being discharged into the atmosphere. During inspiration, a pressurized air stream passes through the HMX material in a direction opposite to the exhalation to reach the patient's airway, and the source of the incoming air is typically ambient air. Thus, as the pressurized air stream passes through the HMX material before reaching the patient's airway, it absorbs moisture in the form of water vapor as it desorbs from the HMX material, and the pressurized air stream is heated by the heat released from the HMX material. Summary of the invention

[0088] The present technology is intended to provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0089] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0090] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0091] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0092] Another aspect of the present technology relates to a patient interface comprising: a plenum chamber; a seal-forming structure and a positioning and stabilizing structure. The patient interface may also include a venting structure. The patient interface is configured such that the patient's mouth is uncovered, 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 surrounding environment without pressurized air flow through the plenum inlet port.

[0093] Another aspect of the present technology relates to a patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 4 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inlet port, the size and structure of the inlet port of the inlet port being set to receive an air flow at a therapeutic pressure for patient breathing; a seal-forming structure that is constructed and arranged to seal with a patient's facial area around an entrance to the patient's airway, the seal-forming structure having holes therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that is configured to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a system a strap constructed and arranged so that, in use, at least a portion covers an area of ​​the patient's head that is above the supra-auricular base of the patient's head; and a vent structure configured to allow continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surrounding ambient environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured so that the patient's mouth is uncovered, 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 surrounding ambient environment without pressurized air flowing through the plenum chamber inlet port.

[0094] Another aspect of one form of the present technology is a patient interface molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0095] One aspect of one form of the present technology is a method of making a device.

[0096] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using medical devices of this type.

[0097] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0098] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier canister that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment.

[0099] Another aspect of the present technology is a patient interface comprising: an inflatable chamber that can be pressurized to at least 6 cm above the ambient air pressure The invention relates to a method of providing a therapeutic pressure of H2O, wherein the plenum chamber includes a plenum chamber inlet port, the size and structure of which are determined to receive an air flow at the therapeutic pressure for the patient to breathe; a seal-forming structure, which is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance of the patient's airway, for sealed delivery of the air flow at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having a hole therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure, which provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a top strap, which is constructed and arranged to contact at least one area of ​​the patient's head above the supra-auricular base above the patient's head during use, and a side strap, which is connected to the top strap, and the side strap is constructed and arranged to be positioned toward one side of the seal-forming structure during use. The top strap and the side straps extend in a front and lower direction, and a rear strap connected to the top strap and the side straps, the rear strap being arranged to extend in a rear and lower direction over the patient's head so as to contact the occipital portion of the patient's head during use, the rear strap being composed of a first material and a second material, the first material being arranged to contact the temporal region of the patient's head during use, and the second material being arranged to contact the occipital portion of the patient's head during use, wherein the second material is not a textile (e.g., silicone), and wherein the second material is configured to be The invention relates to a method of limiting movement of the top strap and / or side straps in a forward and / or rearward direction when in the therapeutically effective position on the head; and a ventilation structure that allows continuous flow of gas exhaled by the patient from the interior of the inflatable chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber during use, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured so that the patient's mouth is uncovered.

[0100] In some forms, the second material does not extend through the parietal bone.

[0101] In some versions, the rear strap does not extend from the left side of the patient's head across the parietal bone to the right side of the patient's head.

[0102] In certain versions, the positioning and stabilizing structure does not extend through the patient's sternocleidomastoid muscle.

[0103] In some forms, the second material has a greater coefficient of friction than the first material.

[0104] In some forms, the first material and the second material are connected at a transition, the first material does not cross the transition and overlaps the second material, and the second material does not cross the transition and overlaps the first material.

[0105] In some forms, the first material and the second material are connected along the transition using stitching, adhesives, sonic welding, magnets and / or mechanical fasteners.

[0106] In some versions, the top strap and side straps are formed as a continuous structure and are not connected using fasteners.

[0107] In some forms, the second material is included only on the occipital region and not elsewhere along the patient's head.

[0108] In certain forms, at least one of the plenum and the seal-forming structure is at least partially constructed from a first material.

[0109] In some forms, the first material is a textile.

[0110] In some forms, the first material is elastic and is configured to increase in length due to tension during use.

[0111] In some forms, the second material does not contact the temporal region of the patient's head below the subauricular base.

[0112] In some forms, the positioning and stabilizing structure includes a pad comprised of a second material configured to clamp the occipital portion to provide an anchor point for the gas delivery tube.

[0113] In some forms, the cushion includes an adjustment mechanism configured to vary a usable length of the cushion, the usable length being configured to contact the patient's head during use.

[0114] In some forms, the adjustment mechanism is Velcro, ladder locks and / or snaps.

[0115] In some forms, the first material and the second material of the back band are permanently secured to one another.

[0116] In certain forms, the positioning and stabilizing structure further includes a tab coupled between the top strap and the side straps, the rear strap being removably coupled to the tab.

[0117] In some forms, the first material of the rear band extends from the tab to the second material.

[0118] In certain forms, the positioning and stabilizing structure further comprises an extension directly coupled to the tab, the rear strap being directly coupled to the extension.

[0119] In some forms, the extension is removably coupled to the tab.

[0120] In some forms, the rear strap is permanently connected to the extension member.

[0121] In some forms, the rear strap is removably coupled to the extension.

[0122] In some forms, the extension is comprised of a second material.

[0123] In some versions, the extension is comprised of silicone and / or polyamide.

[0124] In certain forms, the top strap and side straps together define a gas delivery tube 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 to the entrance of the patient's airway via the seal-forming structure.

[0125] In some forms, the second material is silicone.

[0126] Another aspect of the present technology is a positioning and stabilizing structure configured to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of an air flow at a therapeutic pressure of at least 4 cm H2O relative to ambient air pressure throughout the patient's breathing cycle during use, the positioning and stabilizing structure comprising: a gas delivery tube configured to deliver the air flow to the entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact the patient's head during use, the gas delivery tube comprising: a first sealing end configured to be connected to the seal-forming structure; a second sealing end spaced apart from the first sealing end and configured to be connected to the seal-forming structure; and an intermediate portion being Arranged between the first sealed end and the second sealed end, the middle portion includes a port for receiving an air flow, the middle portion is configured to contact an upper region of a patient's head during use; an eyelet, the eyelet is connected to the gas delivery tube between the first sealed end and the middle portion; and a rear strap, the rear strap is connected to the eyelet and is configured to pass around the back of the patient's head during use, the rear strap includes a pad configured to grip the occipital portion of the patient's head; wherein the rear strap includes a side portion composed of a first material and a pad composed of a second material different from the first material.

[0127] In certain forms, the second eyelet is connected to the gas delivery tube between the second sealed end and the intermediate portion, and the rear band extends between the eyelet and the second eyelet.

[0128] In some forms, the first material is a textile.

[0129] In some forms, the first material is stretchable and is configured to increase in length due to tension during use.

[0130] In certain forms, the rear strap is removably coupled to the eyelet.

[0131] In some forms, the extension is directly connected to the eyelet.

[0132] In some forms, the extension is removably coupled to the eyelet.

[0133] In some forms, the extension is permanently secured to the eyelet.

[0134] In some forms, the rear strap is removably coupled to the extension.

[0135] In some forms, the extension is comprised of a second material.

[0136] In some forms, the first material extends between the extension and the pad.

[0137] In some forms, the pad is comprised of silicone.

[0138] In some versions, the pad and side portions are permanently connected together.

[0139] Another aspect of the present technology is a positioning and stabilizing structure configured to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of an air flow at a therapeutic pressure of at least 4 cm H2O relative to ambient air pressure throughout the patient's breathing cycle during use, the positioning and stabilizing structure comprising: a top strap constructed and arranged to contact the patient's head during use, the top strap comprising: a first sealing end configured to be connected to the seal-forming structure; a second sealing end spaced apart from the first sealing end and configured to be connected to the seal-forming structure; and a middle portion disposed between the first sealing end and the second sealing end, the middle portion being configured to contact an upper area of ​​the patient's head during use; a first eyelet coupled to a on the top strap; a second eyelet, the second eyelet being connected to the top strap between the second sealed end and the middle portion; and a back strap, the back strap being connected to the first eyelet and the second eyelet, the back strap being configured to pass around the back of the patient's head when in use, the back strap comprising: a first side portion connected to the first eyelet, a second side portion connected to the second eyelet, and a pad permanently connected to the first side portion and the second side portion, the pad being configured to clamp the occipital portion of the patient's head; wherein the first side portion and the second side portion are made of a first material and the pad is made of a second material, the first material is a textile and the second material is not a textile.

[0140] In certain forms, the top strap is a gas delivery tube configured to deliver air flow to the entrance of the patient's airway via the seal-forming structure.

[0141] In some forms, the first material is stretchable and is configured to increase in length due to tension during use.

[0142] In some forms, the second material is rigid or semi-rigid and is configured to maintain its shape under a tensile load.

[0143] In some forms, the first side portion is removably connected to the first eyelet and the second side portion is removably connected to the second eyelet.

[0144] In some forms, a first extension is directly connected to the first eyelet and positioned between the first eyelet and the first side, the first extension is configured from a third material; and a second extension is directly connected to the second eyelet and positioned between the second eyelet and the second side, the second extension is configured from the third material; wherein the third material is not a textile.

[0145] In certain forms, the third material is rigid or semi-rigid and is configured to maintain its shape under a tensile load.

[0146] In some forms, the first extension is permanently connected to the first side portion and the second extension is permanently connected to the second side portion.

[0147] In some forms, the first extension is removably connected to the first eyelet and the second extension is removably connected to the second eyelet.

[0148] In some forms, the third material is the same as the second material.

[0149] In some forms, the cushion includes an adjustment mechanism configured to vary a usable length of the cushion, the usable length being configured to contact the patient's head during use.

[0150] In some forms, the adjustment mechanism is Velcro, a ladder lock, a magnet, and / or a snap.

[0151] In some forms, the second material is silicone.

[0152] Another aspect of the present technology is a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: a top strap, which is constructed and arranged to contact at least an area of ​​the patient's head above the supra-auricular base above the patient's head during use, a side strap, which is connected to the top strap, the side strap is constructed and arranged to extend in a front and downward direction toward the seal-forming structure during use, and a rear strap, which is constructed and arranged to contact a rear area of ​​the patient's head during use, and the rear strap is composed of a first material and a second material.

[0153] Another aspect of the present technology is a patient interface comprising an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port that is sized and structured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of the flow of air at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having an aperture therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; and a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a top strap that is constructed and arranged to contact the patient's head during use. a top strap configured to extend in a forward and downward direction toward the seal-forming structure in at least one area of ​​the patient's head above a supra-auricular base point; a removable arm removably connected to the top strap, the removable arm configured to extend in a rearward and downward direction in use, the removable arm comprising: a first end and a second end opposite the first end, the first end comprising a clip configured to removably engage the top strap; and a ventilation structure that allows gas exhaled by the patient from the interior of the inflatable chamber to flow continuously to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber in use, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flowing through the inlet port of the inflatable chamber, or the patient interface is configured to leave the patient's mouth uncovered.

[0154] Another aspect of the present technology is a removable arm removably connected to the top strap, the removable arm being constructed and arranged to extend in a rearward and downward direction during use, the removable arm comprising: a first end and a second end opposite to the first end, the first end comprising a clip configured to removably engage the top strap.

[0155] Another aspect of the present technology is a patient interface comprising a plenum chamber that can be pressurized to a therapeutic pressure that is at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port that is sized and structured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of the flow of air at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube that is formed as a continuous structure to receive air from a connection port on the top of the patient's head air flow and delivering the air flow to the entrance of the patient's airway via the seal-forming structure, the gas delivery tube including a tab, the tab being constructed and arranged to contact an area of ​​the patient's head substantially above the patient's head during use; a removable arm removably connected to the tab, the removable arm being constructed and arranged to extend in a posterior and inferior direction during use, the removable arm including: a first end and a second end opposite the first end, the first end including a clip configured to removably engage the top strap; and a ventilation structure that allows gas exhaled by the patient from the interior of the inflatable chamber to flow continuously to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber during use, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured to leave the patient's mouth uncovered.

[0156] In certain forms, the second end of each removable arm of the pair of removable arms includes a slot.

[0157] In some forms, the slot is arcuate.

[0158] In some forms, the rear strap is connected to the second end of each removable arm of the pair of removable arms.

[0159] In some forms, the rear strap is configured to be arranged to extend in a posterior and inferior direction over the patient's head so as to contact the occipital portion of the patient's head in use.

[0160] In some forms, the rear band is comprised of a first material and a second material.

[0161] In certain forms, the first material is arranged to contact the temporal region of the patient's head in use, and the second material is arranged to contact the occipital region of the patient's head in use.

[0162] In some forms, the first material is a textile and wherein the second material is silicone.

[0163] In some forms, a rear strap is received within each slot.

[0164] In some forms, the width of the rear band is less than the width of the slot, and the rear band is configured to move within the slot and adjust the force vector.

[0165] In certain forms, each tab includes an opening having an opening length of between about 30 mm and about 50 mm.

[0166] In some forms, the clip comprises a clip length that is less than the opening length.

[0167] In some forms, the clip is configured to move along the length of the clip to adjust the force vector.

[0168] In some forms, the clip is configured to pivot within the opening to adjust the force vector.

[0169] In some forms, each removable arm is curved between a first end and a second end.

[0170] In some forms, the second end is configured to contact the patient's head at approximately 30° below the Frankfort level.

[0171] In some forms, each clip is biased toward a closed position.

[0172] In some forms, the clip is movable to an open position to connect to a corresponding tab.

[0173] In some forms, the first end of each removable arm further comprises a post.

[0174] In some forms, the clip is pivotally connected to the post.

[0175] In some versions, the clip is free to rotate about the post.

[0176] In some forms, the clip is biased towards a surface of the removable arm.

[0177] In certain forms, the first end of each removable arm further includes a lock configured to limit rotation of the clip.

[0178] In some forms, the lock of each removable arm is removably connected to a corresponding post.

[0179] In some forms, the lock of each removable arm is integrally formed with the corresponding post.

[0180] In some forms, the lock is overmolded with the post.

[0181] In some forms, the lock of each removable arm includes a protrusion configured to selectively contact the clip and limit rotational movement of the clip.

[0182] In some forms, each removable arm is curved between the first end and the second end.

[0183] In some forms, each removable arm tapers toward the second end.

[0184] In some forms, the patient interface comprises a pair of textile sleeves.

[0185] In certain forms, each textile sleeve of the pair of textile sleeves is configured to receive one removable arm of the pair of removable arms.

[0186] Another aspect of the present technology is a removable arm removably connected to the tab, the removable arm being constructed and arranged to extend in a rearward and downward direction during use, the removable arm comprising: a first end and a second end opposite the first end, the first end comprising a clip configured to removably engage the top strap.

[0187] Another aspect of the present technology is a patient interface comprising: an inflatable chamber that can be pressurized to at least 6 cm above the ambient air pressure The invention relates to a method of providing a therapeutic pressure of H2O, wherein the plenum chamber includes a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealed delivery of the flow of air at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube formed as a continuous structure to receive a flow of air from a connection port on the top of the patient's head and deliver the flow of air to the entrance of the patient's airway via the seal-forming structure, the gas delivery tube comprising a pair of tabs constructed and Arranged to contact at least one area of ​​the patient's head above the supra-auricular base of the patient's head in use, wherein each of the pair of tabs has an opening having an opening length; a pair of removable arms detachably connected to the tabs, each removable arm being constructed and arranged to extend in a posterior and inferior direction in use, each removable arm comprising: a first end and a second end opposite the first end, the first end comprising a clip configured to remove one of the pair of tabs, wherein the clip comprises a clip length less than the opening length, wherein the clip is configured to move along the clip length and / or pivot within the opening to adjust a force vector; and a ventilation structure that allows continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surrounding ambient environment, the ventilation 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 surrounding ambient environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0188] In certain forms, the second end of each removable arm of the pair of removable arms includes a slot.

[0189] In some forms, the slot is arcuate.

[0190] In some forms, the rear strap is connected to the second end of each removable arm of the pair of removable arms.

[0191] In some forms, the rear strap is configured to be arranged to extend in a posterior and inferior direction on the patient's head so as to contact the occipital portion of the patient's head during use, and the rear strap is composed of a first material and a second material, the first material being arranged to contact the temporal region of the patient's head during use, and the second material being arranged to contact the occipital portion of the patient's head during use.

[0192] In some forms, the first material is a textile and wherein the second material is silicone.

[0193] In some forms, a rear strap is received within each slot.

[0194] In some forms, the width of the rear band is less than the width of the slot, and the rear band is configured to move within the slot and adjust the force vector.

[0195] In certain forms, the opening length of each tab of the pair of tabs is between about 30 mm and about 50 mm.

[0196] In some forms, each removable arm is curved between a first end and a second end.

[0197] In some forms, the second end is configured to contact the patient's head at approximately 30° below the Frankfort level.

[0198] In certain forms, each clip is biased toward a closed position, and wherein the clip is movable to an open position to connect to a corresponding tab.

[0199] In certain forms, each arm of the pair of arms includes at least one bendable section configured to allow positional adjustment between the first end and the second end.

[0200] In certain forms, the at least one bendable segment is a plurality of bendable segments, wherein each bendable segment of the plurality of bendable segments is independently adjustable.

[0201] Another aspect of the present technology is a patient interface comprising: an inflatable chamber that can be pressurized to at least 6 cm above the ambient air pressure a therapeutic pressure of H2O, the plenum chamber comprising a plenum chamber inlet port, the size and structure of the plenum chamber inlet port being determined to receive an air flow at the therapeutic pressure for patient breathing; a seal-forming structure, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealed delivery of the air flow at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube formed as a continuous structure to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, The gas delivery tube includes a pair of tabs constructed and arranged to contact an area of ​​the patient's head substantially above 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 posterior and inferior direction in use, each removable arm including: a first end, the first end including: a post; a clip that is movable about the post and configured to removably engage the top strap; and a lock that is configured to selectively limit movement of the clip about the post; and a second end, the second end opposite the first end; and a ventilation structure that allows continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surrounding environment, the ventilation 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 surrounding environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0202] In some forms, the clip is pivotally connected to the post.

[0203] In some forms, the clip is free to pivot about the post when the lock is in the unlocked position.

[0204] In some forms, the clip is biased towards a surface of the removable arm.

[0205] In some forms, the lock of each removable arm is removably connected to a corresponding post.

[0206] In some forms, the lock of each removable arm is integrally formed with the corresponding post.

[0207] In some forms, the lock is overmolded with the post.

[0208] In some forms, the lock of each removable arm includes a protrusion configured to selectively contact the clip and limit rotational movement of the clip.

[0209] In some forms, each removable arm is curved between the first end and the second end.

[0210] In some forms, each removable arm tapers toward the second end.

[0211] In certain forms, a pair of textile sleeves, wherein each textile sleeve of the pair of textile sleeves is configured to receive one of the pair of removable arms.

[0212] In some forms, the strap is not connected to the pair of removable arms.

[0213] Another aspect of the present technology is a patient interface comprising a plenum chamber that can be pressurized to a therapeutic pressure that is at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port that is sized and structured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of the flow of air at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube that is formed as a continuous structure to receive a flow of air from a connection port on the top of the patient's head and deliver the air flow to the patient's airway via the seal-forming structure an inlet of the gas delivery tube, the gas delivery tube comprising a pair of tabs, the pair of tabs being constructed and arranged to contact an area of ​​the patient's head substantially above the patient's head in use; a pair of removable arms detachably connected to the tabs, the removable arms being constructed and arranged to extend in a posterior and inferior direction in use, each removable arm comprising: a first end, the first end comprising a clip configured to removably engage the top strap, a second end opposite the first end, the second end comprising a slot, and a rear strap extending between the pair of removable arms, the rear strap being connected to each removable arm by the slot; and a ventilation structure that allows continuous flow of gas exhaled by the patient from the interior of the inflatable chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber in use, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured to leave the patient's mouth uncovered.

[0214] Another aspect of the present technology is a pair of removable arms removably connected to the tab, the removable arms being constructed and arranged to extend in a rearward and downward direction during use, each removable arm comprising: a first end comprising a clip configured to removably engage the top strap; a second end opposite the first end, the second end comprising a slot; and a rear strap extending between the pair of removable arms, the rear strap being connected to each removable arm via the slot.

[0215] Another aspect of the present technology is a patient interface comprising an inflatable chamber that can be pressurized to at least 6 cm above ambient air pressure. The invention relates to a method of manufacturing a plenum chamber having a therapeutic pressure of H2O, the plenum chamber including a plenum chamber inlet port, the size and structure of which are determined to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealingly delivering an air flow at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having a hole therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube formed as a continuous structure so as to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, the The gas delivery tube includes a pair of tabs constructed and arranged to contact an area of ​​the patient's head substantially above 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 posterior and inferior direction in use, each removable arm including: a first end, the first end including a clip configured to removably engage the top strap, a second end opposite the first end, the second end, and a lock connected to the first end for selectively limiting movement of the clip, the lock being configured to bias the clip toward a locked position; and a ventilation structure that allows continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surrounding environment, the ventilation 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 surrounding environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0216] Another aspect of the present technology is a pair of removable arms removably connected to the tab, the removable arms being constructed and arranged to extend in a rearward and downward direction during use, each removable arm comprising: a first end comprising: a clip configured to removably engage the top strap; a second end, opposite the first end, the second end; and a lock connected to the first end for selectively limiting the movement of the clip, the lock being configured to bias the clip toward a locked position.

[0217] Another example of the present technology is a patient interface, which includes: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inlet port, the size and structure of the inlet port being determined to receive an air flow at the therapeutic pressure for patient breathing; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealed delivery of the air flow at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having a hole therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a seal to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway The sealing structure is maintained in a therapeutically effective position on the patient's head by a force, the positioning and stabilizing structure comprising: a rear strap, which is composed of a first material; a pair of upper straps connected to the rear strap, the pair of upper straps are configured from a second material; a pair of lower straps, which are connected to the pair of upper straps, the pair of upper straps are configured from a third material; a ventilation structure, which allows the patient's exhaled gas from the interior of the inflatable chamber to flow continuously to the surrounding environment, the size and shape of the ventilation structure are designed to maintain a therapeutic pressure in the inflatable chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through his mouth without the pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured so that the patient's mouth is not covered.

[0218] Another example of the present technology is a positioning and stabilizing structure comprising: a rear band, which is composed of a first material; a pair of upper bands connected to the rear band, the pair of upper bands are configured from a second material; and a pair of lower bands connected to the pair of upper bands, the pair of upper bands are composed of a third material.

[0219] Another example of the present technology is a patient interface, the patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber that is sized and structured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealed delivery of the flow of air at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a rear strap, The rear strap is configured to contact the patient's head and cover at least a portion of the occipital portion; a pair of upper straps, the pair of upper straps being configured to selectively apply a rearwardly directed tensile force, the pair of upper straps being connected to the rear strap below at least a portion of the rear strap; a pair of lower straps, the pair of lower straps being configured to selectively apply a rearwardly directed tensile force, the pair of lower straps being connected to the pair of upper straps below at least a portion of the pair of upper straps; a ventilation structure that allows continuous flow of exhaled gas from the patient from the interior of the plenum chamber to the surrounding environment, the size and shape of the ventilation structure being designed to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through his or her mouth without a flow of pressurized air through the inlet port of the plenum chamber, or the patient interface is configured to leave the patient's mouth uncovered.

[0220] In some versions, the rear band is constructed from a first material, the pair of upper bands are constructed from a second material, and the pair of lower bands are constructed from a third material.

[0221] In some forms, the first material and the third material are the same.

[0222] In some forms, the first material and the third material are stretchable materials.

[0223] In some forms, the rear belt is pre-tensioned in the non-use position.

[0224] In some forms, the first material and the second material are the same.

[0225] In some forms, the first material and the second material are non-stretchable materials.

[0226] In some forms, the rear band is substantially triangular in shape.

[0227] In some forms, the upper side of the rear strap is substantially horizontal.

[0228] In certain forms, the lower end of the rear strap forms a rear strap angle of between about 110° and about 150°, and specifically, the rear strap angle is about 130°.

[0229] In some forms, the pair of upper straps form a generally V-shape.

[0230] In certain forms, the lower ends of the pair of upper straps form an upper strap angle between about 110° and about 170°, and specifically the upper strap angle is about 150°.

[0231] In some forms, the pair of lower straps form a generally V-shape.

[0232] In some forms, the pair of upper straps and the pair of lower straps together form a generally X-shape.

[0233] In certain forms, a lower band angle is formed between one lower band of the pair of lower bands and an adjacent upper band of the pair of upper bands, wherein the lower band angle is between about 30° and about 70°, specifically the lower band angle is about 50°.

[0234] In some forms, the pair of upper straps are pre-tensioned in the non-use position.

[0235] In some forms, the pair of lower straps are removably connected to the inflatable chamber.

[0236] In some forms, the positioning and stabilizing structure also includes a gas delivery tube formed as a continuous structure to receive a gas flow from a connection port on the top of the patient's head and deliver the gas flow to the entrance of the patient's airway through the sealing forming structure, the gas delivery tube including a pair of tabs that are constructed and arranged to contact at least one area of ​​the patient's head that is above the patient's head during use.

[0237] In some forms, each upper strap of the pair of upper straps is removably connected to one tab of the pair of tabs.

[0238] Another example of the present technology is a positioning and stabilizing structure comprising: a rear strap configured to contact the patient's head and cover at least a portion of the occipital bone; a pair of upper straps configured to selectively apply a rearwardly directed tensile force, the pair of upper straps being connected to the rear strap below at least a portion of the rear strap; and a pair of lower straps configured to selectively apply a rearwardly directed tension force, the pair of lower straps being connected to the pair of upper straps below at least a portion of the upper straps.

[0239] Another example of the present technology is a patient interface, the patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber, the size and structure of the inlet port of the inflatable chamber being determined to receive an air flow at the therapeutic pressure for patient breathing; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealed delivery of the air flow at the therapeutic pressure throughout the patient's breathing cycle during use, the seal-forming structure having a hole therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure The invention comprises: a back strap configured to contact the patient's head and cover at least a portion of the occipital bone, the back strap having a substantially triangular shape; a pair of upper straps formed in a generally V-shape and connected to a lower portion of the back strap; a pair of lower straps formed in a generally 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 generally X-shaped configuration; a ventilation structure that allows the patient's exhaled gas from the interior of the plenum chamber to flow continuously to the surrounding environment, the size and shape of the ventilation structure being designed to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through his mouth without a flow of pressurized air through the inlet port of the plenum chamber, or the patient interface is configured so that the patient's mouth is uncovered.

[0240] Another example of the present technology is a positioning and stabilizing structure comprising: a rear strap configured to contact the patient's head and cover at least a portion of the occipital bone, the rear strap having a substantially triangular shape; a pair of upper straps formed in a roughly V-shape and connected to a lower portion of the rear strap; a pair of lower straps formed in a roughly 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 roughly X-shaped configuration.

[0241] The described methods, systems, devices and apparatus can be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, a respiratory monitor and / or a respiratory therapy device. In addition, the described methods, systems, devices and apparatus can provide improvements in the art of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0242] Of course, a part of these aspects may form a sub-aspect of the present technology. Each aspect and / or each of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0243] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0244] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0245] 4.1 Respiratory therapy system

[0246] Figure 1 A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0247] Figure 2 A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0248] Figure 3 A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0249] 4.2 Respiratory system and facial anatomy

[0250] Figure 4 A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0251] Figure 5 A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0252] Figure 6is a front view of the face with several surface anatomical features labeled, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The superior, inferior, radially inward, and radially outward directions are also labeled.

[0253] Figure 7 It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal ridge, nasal apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0254] Figure 8 This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0255] Fig. 9 A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0256] Fig.10 A side view of the nasal surface features is shown.

[0257] Fig.11 The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0258] Fig.12 The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0259] Fig.13 A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0260] Fig.14 A side view of the skull is shown with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0261] Fig.15 An anterolateral view of the nose is shown.

[0262] 4.3 Patient Interface

[0263] Fig.16 A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0264] Fig.17 A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Fig.18 The curvature magnitude shown is relatively large in comparison.

[0265] Fig.18 A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Fig.17 The curvature magnitude shown is relatively small in comparison.

[0266] Fig.19 A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0267] Fig. 20 A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Fig.21 The curvature magnitude shown is relatively small in comparison.

[0268] Fig.21 A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Fig. 20 The curvature magnitude shown is relatively large in comparison.

[0269] Fig. 22 A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0270] Fig.23 A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and one dome region are indicated.

[0271] Fig.24 A surface having a structure with a one-dimensional hole on the surface is shown. The plane curves shown form the boundaries of the one-dimensional hole.

[0272] Fig.25 Shown through Fig.24 The surface shown is in Fig.24 A two-dimensional hole is defined in the structure.

[0273] Fig.26 Shows Fig.24A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig.24 The surface of the two-dimensional holes is defined in the structure.

[0274] Fig. 27 A mask with an inflatable bladder as cushion is shown.

[0275] Fig.28 Shown through Fig. 27 FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0276] Fig.29 Shown by Fig. 27 Another cross section of a mask of FIG. The inner surface is also indicated.

[0277] Fig.30 The left hand rule is shown.

[0278] Fig.31 The right hand rule is shown.

[0279] Fig.32 The left ear is shown, including the left ear helix.

[0280] Fig.33 The right ear is shown, including the right ear helix.

[0281] Fig.34 A right-hand helix is ​​shown.

[0282] Fig.35 Views of a mask are shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0283] Fig.36 A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0284] Fig.37 Shows Fig.36 A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Fig.37 The sagittal plane in the middle bisects the air chamber into left and right sides.

[0285] Fig.38 Shown through Fig.37 The cross section of the gas-filled chamber is Fig.373225 and lower point 3235). Depending on the geometry of the cushion in this area, the intermediate contact plane may be a tangent at the upper and lower points.

[0286] Fig.39 Shows Fig.36 The inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 is roughly coincident with the central sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'plane of the face'. Fig.39 In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3225 is approximately located on the root of the nose, while the lower point 3235 is located on the upper lip.

[0287] 4.4RPT device

[0288] Fig.40 One form of RPT device according to the present technology is shown.

[0289] Fig.41 is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0290] 4.5 Respiratory waveform

[0291] Fig.42 A model of a typical breathing waveform of a person during sleep is shown.

[0292] 4.6 Patient Interface of the Technology

[0293] Fig.43 A single piece textile configuration for making a seal forming structure as well as a positioning and stabilizing structure is shown.

[0294] Fig.44 It is shown that Fig.43 The single piece of fabric configuration shown forms a seal-forming structure and a positioning and stabilizing structure. The positioning and stabilizing structure is formed as a hollow tube that delivers air to the seal-forming structure.

[0295] Fig.45 It is shown that Fig.43The single piece fabric structure shown forms a seal forming structure and a positioning and stabilizing structure. The positioning and stabilizing structure is formed as a flat belt.

[0296] Fig.46 A front perspective view of a patient interface formed from a single-piece configuration of textile material is shown. The positioning and stabilizing structure includes a hollow tube that delivers air to the seal-forming structure. Air is delivered directly to the hollow sealing tube and the seal-forming structure. The plenum chamber is removably connected to the seal-forming structure. Air may be provided to the hollow sealing tube by a decoupling member positioned in the positioning and stabilizing structure or the plenum chamber.

[0297] Fig.47 Shows Fig.46 A rear perspective view of a patient interface of the invention. The inflatable chamber includes a pair of magnetic portions that assist in connecting the inflatable chamber to a seal-forming structure in the correct orientation.

[0298] Fig.48 Shows Fig.47 Detailed view of a patient interface showing the inner surface of the hollow sealing tube. The seal-forming structure includes holes in communication with the hollow sealing tube. These holes allow air to be delivered from the proximal inner surface to the patient's face.

[0299] Fig.49 A perspective view of a patient interface formed from a single-piece configuration of textile material is shown. A seal-forming structure includes a clamping structure and a magnetic portion. The plenum chamber is received by the clamping structure and includes a magnetic portion that is complementary to a portion on the seal-forming structure. The clamping structure and the magnetic portion work together to help connect the plenum chamber to the seal-forming structure.

[0300] Fig.50a Shows Fig.49 A perspective view of a patient interface of FIG. The inflatable chamber is partially coupled to a seal-forming structure using a clamping structure and a magnetic portion.

[0301] Fig.50b Shows Fig.49 A perspective view of a patient interface of the invention. The inflatable chamber is fully coupled to the seal-forming structure using a clamping structure and a magnetic portion.

[0302] Fig.51 A perspective view from below of a nasal mask worn by a patient is shown. The mask forms a seal around the patient's nostrils and exposes the patient's mouth to the surrounding environment.

[0303] Fig.52 Shows Fig.51 1 is a perspective view of a nasal mask underside coupled to a mouth seal. The nasal mask underside and the mouth seal together form a modular configuration that can form a seal around the patient's nose and mouth. An inflatable chamber is used with the modular configuration to selectively cover the patient's mouth and nose from the surrounding environment.

[0304] Fig.52a Shows Fig.51 Schematic diagram of the lower surface of a nasal mask having an interface coupled to a mouth seal.

[0305] Fig.52b Shows Fig.51 Schematic diagram of the upper surface of a mouth seal having an interface for coupling to a nasal mask.

[0306] Fig.53 Shows Fig.51 Figure 2. Side view of the underside of a nasal mask with the rear strap made of two materials positioned around the patient's head.

[0307] Fig.54 Shows Fig.53 Rear view from below a nasal mask of , showing a rear strap having a side portion constructed of a first material and a second portion constructed of a second material.

[0308] Fig.55 Shows Fig.51 A side view of the underside of a nasal mask with a back strap made of two materials positioned around the patient's head. An extension is used to connect the back strap to the hollow tube.

[0309] Fig.56 Shows Fig.55 A rear view below a nasal mask of FIG. 1 is shown having a rear band with a side portion constructed of a first material and a second portion constructed of a second material. The extension is constructed of a third material different from the first material.

[0310] Fig.57 Shows Fig.52 A side view of a nasal mask and mouth seal underneath a patient's head with a rear strap made of two materials positioned around the patient's head. An extension is used to connect the rear strap to the hollow tube, while additional side straps are used to hold the nasal mask and mouth seal in a therapeutically effective position.

[0311] Fig.58 Shows Fig.52 A rear view below a nose mask and mouth seal of FIG. 1 is shown having a rear band with a side portion constructed of a first material and a second portion constructed of a second material. The extension is constructed of a third material different from the first material.

[0312] Fig.59 Shows Fig.52 A side view of the nose and mouth seal below the nasal mask with a back strap made of two materials positioned around the patient's head. An extension is used to connect the back strap to the hollow tube. Fig.57 The additional side straps are not used to maintain the nasal mask and suboral seal in a therapeutically effective position.

[0313] Fig.60Shows Fig.53 Detailed schematic diagram of the positioning and stabilizing structure showing the rear strap removably connected to the ring using a fastening mechanism.

[0314] Fig.61 Shows Fig.55 Detailed schematic diagram of the positioning and stabilizing structure of FIG. 1 , showing an extension removably coupled to a ring using a fastening mechanism.

[0315] Fig.62 Shows Fig.55 Detailed schematic diagram of the positioning and stabilizing structure of FIG. 1 , showing the rear strap removably coupled to the extension member using a fastening mechanism.

[0316] Fig.63 Shows Fig.54 A detailed schematic diagram of a pad of a positioning and stabilizing structure showing a first adjustment mechanism.

[0317] Fig.64 Shows Fig.54 Detailed schematic diagram of the positioning and stabilizing structure of the pad, showing the second adjustment mechanism.

[0318] Fig.65 Shown is a rear view of the headgear straps used in positioning and stabilizing the structure, showing each strap individually sewn to the rear.

[0319] Fig.65 -1 shows Fig.65 Rear view of an alternative version of the headgear strap showing the curved stitching connecting the strap to the rear.

[0320] Fig.66 Shown wearing includes Fig.65 A side view of a patient of the patient interface of the headgear, showing the straps connecting the headgear near the upper portion of the patient's head.

[0321] Fig.67 A rear view of a patient wearing another example of a patient interface including headgear is shown.

[0322] Fig.68 Yes Wear Fig.67 Side view of a patient with a patient interface.

[0323] Fig.69 is a rear view of a patient wearing another example of a patient interface including a headgear.

[0324] Fig.70 Yes Wear Fig.69 Side view of a patient with a patient interface.

[0325] Fig.71 is a rear view of a patient wearing another example of a patient interface including a headgear.

[0326] Fig.72 Yes Wear Fig.71 Side view of a patient with a patient interface.

[0327] Fig.73 is a rear view of a patient wearing another example of a patient interface including a headgear.

[0328] Fig.74 Yes Wear Fig.73 Side view of a patient with a patient interface.

[0329] Fig.75 is a rear view of a patient wearing another example of a patient interface including a headgear.

[0330] Fig.75 -1 is wearing Fig.75 Rear view of a patient wearing an alternative version of the headgear.

[0331] Fig.76 Yes Wear Fig.75 Side view of a patient with a patient interface.

[0332] Fig.77 is a detailed view of the removable arm connected to the hollow tube.

[0333] Fig.78 For use with nose pads Fig.77 A perspective view of the removable arm.

[0334] Fig.79 yes Fig.77 Use with full-face pads Fig.77 A perspective view of the removable arm.

[0335] Fig.80 yes Fig.77 Detailed view of another form of the removable arm.

[0336] Fig.80 -1 Yes Fig.80 Detailed view of the removable arm showing the lock between the arm's clip and the post.

[0337] Fig.81 yes Fig.80 A perspective view of the removable arm.

[0338] Fig.82 yes Fig.80 Detailed view of the removable arm showing the textile sleeve coupled to the arm.

[0339] Fig.83 For use with nose pads Fig.80 A perspective view of the removable arm.

[0340] Fig.84 yes Fig.80 Use with full-face pads Fig.77 A perspective view of the removable arm. DETAILED DESCRIPTION

[0341] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0342] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute another example.

[0343] 5.1 Treatment

[0344] In one form, the present technology includes a method for treating a breathing disorder comprising pressurizing air to a positive pressure relative to an ambient environment and directing the pressurized air to an entrance to an airway of a patient 1000 .

[0345] In some examples of the present technology, a supply of air at a positive pressure relative to the surrounding environment is provided to the patient's nasal passages through one or both nostrils. In other examples, a positive pressure air supply may also be provided to the mouth in addition to the nasal passages.

[0346] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0347] 5.2 Respiratory therapy system

[0348] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 .

[0349] 5.3 Patient Interface

[0350] The non-invasive patient interface 3000 according to one aspect of the present technology includes one or more of the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be performed by one or more physical components. In some forms, one physical component may perform one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to maintain a positive pressure at the entrance of the airway of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0351] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0352] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 4 cm H2O relative to ambient.

[0353] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to ambient.

[0354] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 10 cm H20 relative to ambient.

[0355] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 20 cm H20 relative to ambient.

[0356] 5.3.1 Sealing structure

[0357] In one form of the present technology, the seal-forming structure 3100 includes a target seal-forming area and may additionally include a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs - the actual sealing surface - can vary from day to day and from patient to patient within a given course of treatment, depending on a range of factors including, for example, where the patient interface 3000 is placed on the face, the tension in the positioning and stabilizing structure 3300, and the shape of the patient's face.

[0358] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0359] In some forms of the present technology, the seal-forming structure 3100 is comprised of a biocompatible material such as silicone rubber.

[0360] The seal-forming structure 3100 according to the present technology may be configured from a soft, flexible and resilient material such as silicone.

[0361] A seal-forming structure 3100 according to one form of the present technology may be comprised of a textile material 3101 (see, e.g., Fig.43 -52b). Fig.43 As shown, a single piece of textile material 3101 may be used to form the patient interface 3000. Multiple pieces of textile 3101 may also be used to form different sections of the patient interface 3000.

[0362] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not small-sized heads, and another form that is suitable for small-sized heads but not large-sized heads.

[0363] 5.3.1.1 Sealing mechanism

[0364] In one form, the seal-forming structure 3100 includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on its bottom surface within the inflatable chamber 3200, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0365] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, such as about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending when in use.

[0366] In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is configured and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0367] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example, by an adjacent region of the sealing flange.

[0368] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0369] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0370] In one form of the present technology (see e.g. Figure 27-Figure 29 ), the seal-forming structure 3100 includes a hollow sealing tube 3104 that receives the pressurized air flow. The hollow sealing tube 3104 includes an outer diameter OD that contacts the surrounding ambient environment and an inner diameter ID that is located near the patient's oral and nasal area and is not exposed to the surrounding ambient environment when the seal-forming structure 3100 is worn by the patient. The inner surface INS of the hollow sealing tube 3104 can be at least partially impermeable.

[0371] In one form (see e.g. Fig.44 and Figures 46-48 ), the hollow sealed tube 3104 is made entirely of and / or lined with an impermeable material. Holes 3108 are cut through the inner surface INS toward the inner diameter ID and allow air to exit the hollow sealed tube 3104 toward the patient's nose and / or mouth. These holes 3108 can be evenly spaced around the inner diameter ID, or they can be concentrated in one or more specific areas along the inner diameter ID.

[0372] In some forms, the inner surface INS near the outer diameter OD is made of and / or lined with an impermeable material (e.g., silicon, thermoformed and / or laminated structures, etc.), while the inner surface INS near the inner diameter ID is made of and / or lined with a permeable material. The hollow sealed tube does not include holes 3108, so when pressurized air fills the hollow sealed tube 3104, the impermeable material substantially prevents air from escaping into the surrounding environment. Instead, the air is directed to the inner diameter ID and can leak toward the patient's nose and / or mouth or pass through the permeable material.

[0373] 5.3.1.2 Nose bridge or nasal ridge area

[0374] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, seals over the nasal bridge or nasal ridge region of the patient's face.

[0375] In one form, the seal-forming structure includes a saddle-shaped region configured to seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0376] 5.3.1.3 Upper lip area

[0377] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that seals over the upper lip region (ie, upper lip) of the patient's face when in use.

[0378] In one form, the seal-forming structure comprises a saddle-shaped region configured to seal on an upper lip region of a patient's face in use.

[0379] 5.3.1.4 Chin area

[0380] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that seals over the chin region of the patient's face when in use.

[0381] In one form, the seal-forming structure includes a saddle-shaped region configured to seal when used on a chin area of ​​a patient's face.

[0382] 5.3.1.5 Forehead area

[0383] In one form, the seal-forming structure seals on the forehead area of ​​the patient's face in use. In this form, the inflatable chamber can cover the eyes in use.

[0384] 5.3.1.6 Holding mechanism

[0385] In one form of the present technology, the seal-forming structure 3100 includes at least one retaining mechanism 3112 to couple an additional component of the patient interface 3000 (eg, the plenum 3200 ) to the seal-forming structure 3100 .

[0386] 5.3.1.6.1 Magnetic latching

[0387] like Fig.46 As shown, one form of the seal forming structure 3100 includes a first magnetic portion 3114. The first magnetic portion 3114 includes a first polarity. In some forms, the first magnetic portion 3114 is a magnet connected (e.g., sewn, glued, etc.) to the seal forming structure 3100. The magnet can be set in any direction and any length along the seal forming structure 3100. Multiple magnets can be set on different sides of the seal forming structure 3100 (e.g., top / bottom, left / right, etc.). Multiple magnets can have the same polarity as each other. In other examples, the first magnetic portion 3114 can be any similar feature capable of magnetic connection (e.g., magnetic wire, ferrous metal, etc.).

[0388] 5.3.1.6.2 Mechanical retention

[0389] like Fig.49As shown in Figure 50b, one form of the seal-forming structure 3100 includes a first mechanical retainer or clip structure 3116. In some forms, the first clip structure 3116 is made of a rigid material (e.g., plastic, rigid fabric, rigid wire, etc.) and is incorporated (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) extending 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.

[0390] In certain forms, the first clip structure 3116 is formed as 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 permeably connected to the seal-forming structure 3100.

[0391] In some forms, the first clip structure 3116 is a male clip structure. A separation mechanism 3118 may be included in the first clip structure 3116 and is used to separate the first clip 3116a from the corresponding structure. The separation mechanism 3118 allows the first clip 3116a to move.

[0392] 5.3.1.7 Nasal pillows

[0393] In one form (see Fig. 22 ), the sealing forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to seal with a corresponding nostril of the patient's nose.

[0394] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which seals on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0395] 5.3.1.8 Module structure

[0396] In one form of the present technology (see e.g. Fig.51 -52b), the seal-forming structure 3100 is the underside of the nasal mask 3100a, which is adapted to engage the patient's upper lip LS and seal the nostrils NA while keeping the nose tip PRO free. Regardless of the position of the seal-forming structure 3100, the patient's mouth remains exposed to the surrounding environment.

[0397] In one form, a plenum chamber 3200 (described below) is incorporated as an integral or unitary structure into the seal-forming structure 3100. The plenum chamber 3200 includes an insert 3134 having vents 3400 to aid in the removal of CO2.

[0398] In one form, the insert 3134 of the plenum chamber 3200 is at least partially removable from the seal-forming structure 3100, and the mouth seal 3100b is further attached to the underside of the nasal mask 3100a. The mouth seal 3100b covers the patient's mouth from the surrounding environment.

[0399] In one form, the mouth seal 3100b is removably coupled to the underside of the nasal mask 3100a using magnetic and / or mechanical coupling. The mouth seal 3100b may include a magnet or magnetic wire 3142 that is magnetically attracted to a magnet or magnetic wire 3140 below the nasal mask 3100a. The mouth seal 3100b may also (or additionally) include a feature (e.g., a tab 3144) that mates (e.g., via a snap fit, a press fit, etc.) with a complementary feature (e.g., a recess 3146) under the nasal mask 3100a. The tab 3144 may be a rigidified portion (e.g., a rigid fabric, a rigid wire, etc.) formed (e.g., integrally) with the mouth seal 3100b. Any combination of magnetic coupling and mechanical coupling can seal the interface between the underside of the nasal mask 3100a and the mask to substantially prevent pressurized air from escaping from the seal-forming structure 3100 to the surrounding environment.

[0400] In one form, after the insert has been removed from under the nasal mask 3100a, a separate plenum chamber 3200 is removably coupled to under the nasal mask 3100a and to the mouth seal 3100b. The plenum chamber 3200 includes a first end 3240 covering the nasal opening 3152a of the nasal mask 3100a and a second end 3241 covering the mouth opening 3152b of the mouth seal 3100b so as to seal the patient's nose and mouth. A conduit 3242 connects the first end 3240 to the second end 3241 so as to provide fluid communication between the patient's nose and mouth. The conduit 3242 may include one or more holes for flushing gas.

[0401] 5.3.2 Inflatable chamber

[0402] In the area where the seal is formed in use, the plenum 3200 may have a perimeter shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 in use. In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0403] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable to the wearer, which can improve compliance with treatment.

[0404] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as polycarbonate. The use of a transparent material can reduce the obtrusive appearance of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0405] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusive appearance of the patient interface and help improve compliance with therapy.

[0406] like Figure 46-50b As shown, some versions of the plenum 3200 are constructed from a textile material 3101. The textile material 3101 can reduce the weight experienced by the patient's face and help improve compliance with treatment.

[0407] In some forms of the present technology, the plenum chamber 3200 includes a valve 3206 (e.g., an anti-asphyxia valve (AAV)). The AAV 3206 includes a flap 3207 of textile material 3101 on the plenum chamber 3200 that selectively provides fluid communication through a first inlet port 3208 of the plenum chamber 3200. The AAV 3206 is biased to an open position, which allows the patient to breathe from the surrounding ambient environment without a flow of pressurized air. The bias can be a mechanical bias (e.g., a spring), or can be by magnetic repulsion (e.g., two parts with the same polarity). When pressurized air is supplied, the AAV 3206 closes and prevents communication with the surrounding ambient environment through the first inlet port 3208.

[0408] 5.3.2.1 Removable air chamber

[0409] In some forms of the present technology (see e.g. Figure 46-50b ), the inflatable chamber 3200 is selectively removable from the seal-forming structure 3100. The inflatable chamber 3200 includes a first or uncoupled position, in which the patient's nose and / or mouth are uncovered and exposed to the surrounding environment. The inflatable chamber 3200 also includes a second or coupled position in which the patient's nose and / or mouth are covered by the inflatable chamber 3200. The inflatable chamber 3200 is movable between the uncoupled position and the coupled position independently of the seal-forming structure 3100. Regardless of the position of the inflatable chamber 3200, the seal-forming structure 3100 can remain in an appropriate position (e.g., sealed to the patient's face).

[0410] 5.3.2.1.1 Magnetic holding

[0411] like Fig.47 As shown, some forms of the inflatable chamber 3200 include a second magnetic portion 3210 having an opposite polarity to the first magnetic portion 3114 of the seal-forming structure 3100. The magnetic portions 3114, 3210 provide a tactile response to the patient to indicate that the inflatable chamber 3200 is properly aligned with the seal-forming structure 3100. In some examples, the inflatable chamber 3200 also includes a third magnetic portion 3212. The third magnetic portion 3212 includes the same polarity as the first magnetic portion 3114 (i.e., the opposite polarity to the second magnetic portion 3210).

[0412] In some forms (see, for example, Fig.48 ), the second magnetic portion 3210 is a magnet sewn into the textile cover 3204. The magnets can be arranged in any direction and any length along the textile cover 3204. Where the third magnetic portion 3212 is included, the second and third magnetic portions 3210, 3212 are arranged on opposite sides of the plenum 3200 (e.g., left / right, top / bottom, etc.). The plenum 3200 is coupled to the seal-forming structure 3100 when properly aligned (i.e., the second magnet is adjacent to the first magnetic portion 3114) and is prevented from coupling to the seal-forming structure 3100 when improperly aligned (i.e., the second magnet is away from 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 wire, ferrous metal, etc.).

[0413] When properly aligned (e.g., the first magnetic portion 3114 is adjacent to the second magnetic portion 3210), the seal-forming structure 3100 is coupled to the plenum chamber 3200 and relatively fixed in position. In some forms, the magnetic force is greater than the force of the pressurized air, and a seal is formed 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 discussed below) helps hold the plenum chamber 3200 in place and prevent the pressurized air from escaping when the patient interface 3000 is in use. In either form, the magnetic force is less than the force applied by the patient's hand (e.g., when moving the plenum chamber 3200 to the decoupled position).

[0414] 5.3.2.1.2 Mechanical retention

[0415] like Figure 49-50bAs shown, one form of the plenum 3200 includes a second mechanical retainer or clip structure 3216 having a shape complementary to the first clip structure 3116. The second clip structure 3216 removably mates with the first clip structure 3116 and secures the plenum 3200 in place relative to the seal-forming structure 3100.

[0416] In some forms, second clip structure 3216 is made of a rigid material (e.g., plastic, rigid fabric, rigid thread, etc.) and is incorporated (e.g., sewn) into textile cover 3204. Second clip structure 3216 extends from a surface of textile cover 3204 so as to mate with first clip structure 3116. For example, second clip structure 3216 may be integrally formed with plenum chamber 3200.

[0417] In some forms, the second clip structure 3216 is a female clip structure and mates with a male clip structure of the first clip structure 3116; although these can be reversed. The patient aligns the first and second clip structures 3116, 3216 and connects the plenum chamber 3200 to the seal-forming structure 3100 via a snap fit that provides a seal between the plenum chamber 3200 and the seal-forming structure 3100. Specifically, the patient aligns the second clip structure 3216 with the second clip 3216 (see, e.g., Fig.50a ). The patient then actuates the separation mechanism 3118 to pivot the first clip 3116a away from the magnetic portion 3114. The patient then positions the inflatable chamber 3200 near the magnetic portion 3114 and releases the separation mechanism 3118 so that the first clip 3116a contacts the outer surface 3204a (see, e.g. Fig.50b ). The gasket 3116c provides a seal between the seal-forming structure 3100 and the plenum chamber 3200 to prevent fluid from flowing between the interface of the seal-forming structure 3100 and the plenum chamber 3200. The female clip portion 3216 can be oriented to be complementary to 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., corresponding to an orientation that the first magnetic portion 3114 and the second magnetic portion 3210 are attracted to).

[0418] In some forms, the magnetic force between the first magnetic portion 3114 and the second magnetic portion 3210 is insufficient to hold the plenum 3200 to the seal-forming structure 3100 (e.g., the weight of the plenum 3200 exceeds the perpendicular component of the magnetic force). In such cases, the magnetic portions 3114, 3210 provide only a tactile response to the patient that the plenum 3200 is properly aligned. The plenum 3200 is held entirely by the first and second clamping structures 3116, 3216.

[0419] In some forms, a separation mechanism 3118 is used to separate the first and second clamp structures 3116, 3216. The separation mechanism 3118 separates the first clamp structure 3116 from the second clamp structure 3216 so that the inflatable chamber 3200 can be moved to the uncoupled position. The separation mechanism 3118 can be a finger-actuated separation mechanism 3118 (e.g., a button) that separates the first clamp structure 3116 from the second clamp structure 3216.

[0420] 5.3.3 Positioning and stabilizing the structure

[0421] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state during use by the positioning and stabilizing structure 3300 .

[0422] In one form, the positioning and stabilising structure 3300 holds the patient interface 3000 on the patient's head with a force at least sufficient to overcome the effect of the positive pressure in the plenum 3200 urging the seal-forming structure 3100 to lift away from the face.

[0423] In one form, the positioning and stabilising structure 3300 holds the patient interface 3000 on the patient's head with a force sufficient to overcome the effects of gravity on the patient interface 3000 .

[0424] In one form, the positioning and stabilising structure 3300 holds the patient interface 3000 on the patient's head with a force that acts as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0425] In one form of the present technology, the positioning and stabilizing structure 3300 is configured in a manner consistent with the manner in which it is worn by the patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strap (e.g., side straps 3302, rear strap 3304, and / or top strap 3306) that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0426] In one form of the present technology, the positioning and stabilizing structure 3300 is configured so as not to be so large and bulky as to prevent the patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0427] In one form of the present technology, the positioning and stabilizing structure 3300 is configured so as not to be so large and bulky as to prevent the patient from lying in a side sleeping position with the side area of ​​the patient's head on the pillow.

[0428] In one form of the present technology, the positioning and stabilizing structure 3300 includes a decoupling portion between the front of the positioning and stabilizing structure 3300 and the back of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on the pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0429] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt configured 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 belt. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0430] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the straps 3302, 3304, 3306 can be configured to be in tension when in use and to direct a force to seal the seal-forming structure 3100 in contact with a portion of the patient's face. In one example, the straps 3302, 3304, 3306 can be configured as ties.

[0431] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that in use at least a portion of a lower edge of the first strap passes through the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0432] In one form of the present technology applicable to a nasal-only mask or to a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that in use at least a portion of an upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0433] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0434] In one form of the present technology (see e.g. Fig.47), the rear band 3304 of the positioning and stabilizing structure 3300 includes a first magnetic segment 3316 (e.g., a magnet, a magnetic wire, etc.). The first magnetic segment 3316 is disposed near the end of the rear band 3304. The second magnetic segment 3318 (e.g., a magnet, a magnetic wire) has an opposite polarity to the first magnetic segment 3316. The first magnetic segment 3316 of the rear band 3304 is detachably connected to the second magnetic segment 3318. In the illustrated example, the first magnetic segment 3316 is disposed near the end of the rear band 3304. The second magnetic segment is spaced apart from the first magnetic segment 3316 and includes an opposite polarity to the first magnetic segment 3316. In some examples, the magnetic segments can be replaced with another connecting device (e.g., Velcro).

[0435] In some forms 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 flexible and non-rigid. An advantage of this aspect is that the straps 3302, 3304, 3306 make it more comfortable for the patient to lie on them while sleeping.

[0436] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps (e.g., the side straps 3302, the rear strap 3304, and / or the top strap 3306) that are configured to be breathable to allow moisture vapor to be transmitted through the straps 3302, 3304, 3306.

[0437] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, while another form of positioning and stabilizing structure is suitable for small sized heads but not for large sized heads.

[0438] like Fig.46 and 47 As shown, one form of the positioning and stabilizing structure 3300 includes headgear 3324 formed from textile material 3101. The headgear 3324 is coupled to the seal-forming structure 3100, and at least a portion of the headgear 3324 and the seal-forming structure 3100 are formed from a single piece of textile material 3101 (see, e.g., Figure 43-45 ). Although in other forms, the headgear 3324 and the seal-forming structure 3100 may each be formed from separate textiles 3101 and coupled together (e.g., by sewing, gluing, etc.).

[0439] In one form, the headgear 3324 of the positioning and stabilizing structure 3300 includes side straps 3302 connected to the seal-forming structure 3100 and extending to a position between the patient's ears and eyes when worn by the patient. Specifically, the side straps 3302 extend from the lateral sides of the seal-forming structure 3100, below the patient's eyes and along the patient's cheeks. The side straps 3302 are formed of the textile material 3101.

[0440] In one form, the headgear 3324 of the positioning and stabilizing structure 3300 includes a rear strap 3304 that is coupled to the seal-forming structure 3100 and engages the occipital portion of the patient's head (e.g., the back of the patient's head, near the occipital bone) when worn by the patient. The rear strap 3304 is formed from the textile material 3101.

[0441] In one form, the headgear 3324 of the positioning and stabilising structure 3300 includes a top strap 3306 that is coupled to the seal-forming structure 3100 and that engages the top of the patient's head when worn by the patient. The top strap 3306 is formed from a textile material 3101.

[0442] In one form, the positioning and stabilising structure 3300 comprises an ear piece 3326 coupled to the seal-forming structure 3100 and, when worn by a patient, partially or completely surrounds the patient's ear. The ear piece 3326 is formed from the textile material 3101.

[0443] In some forms, the position and stabilizing structure 3300 and at least a portion of the seal-forming structure 3100 are a one-piece configuration. That is, one or both of the side straps 3302, the top strap 3306, the back strap 3304, and / or the ear pieces 3326 are formed as a one-piece configuration 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.

[0444] In some forms, the transition 3328 is visible to an observer (e.g., the bed partner 1100) due to the bending or flexing of the side straps 3302 relative to the seal-forming structure 3100. In other words, the transition 3328 can be a crease that delineates the transition between the headgear 3324 and the seal-forming structure 3100 (e.g., the side straps 3302 can bend outward or away from the patient as they follow the contours of the patient). The transition 3328 can also be the result of compressed air expanding 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 into different shapes on either side of the transition 3328).

[0445] In some forms, the ear pieces 3326 are formed as a single piece of textile material 3101 with the side straps 3302 and are indirectly connected to the seal-forming structure 3100 through the respective side straps. The top strap 3306 is formed as a single piece of textile material 3101 with the side straps 3302 or the ear straps 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.

[0446] 5.3.3.1 For airflow

[0447] like Figures 46-48 As shown, one form of the side band 3302 is at least a portion of a hollow tube 3334 that delivers pressurized air to the seal-forming structure 3100. The hollow tube 3334 is made of and / or lined with an impermeable material (e.g., silicon, thermoformed and / or laminated structures, etc.). The hollow tube 3334 is coupled to the seal-forming structure 3100 at the sealing end 3308 with a seamless or substantially seamless transition (e.g., at the joint 3328) to prevent or substantially prevent the pressurized air from escaping toward the surrounding environment. In one example, the hollow tube 3334 is a double-lumen tube.

[0448] In some forms (see, for example, Fig.43 ), a single piece of textile 3101 is used to make the side straps 3302 and the seal-forming structure 3100. When the patient interface 3000 is configured (e.g., to give the seal-forming structure 3100 depth and to form the side straps 3302 as hollow tubes 3334), the side straps 3302 transition to the seal-forming structure 3100 at substantially smooth joints 3328 (e.g., see Fig.44 and Fig.46 ). For example, although there is a visible transition at the joint 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 joint 3328. In particular, when the patient interface 3000 is in use, the inner surface 3130 of the seal-forming structure 3100 and the inner surface 3342 of the side straps 3302 both rest against the patient's face. The side straps 3302 extend into the seal-forming structure 3100 (e.g., in an anterior and inferior direction along the patient's face) such that there is little visible joint 3328 between the inner surfaces 3130, 3342 when viewed by the patient.

[0449] like Fig.47As shown, some forms of the seal-forming structure 3100 are gasket-type seals. The seal-forming structure 3100 forms a hollow sealing tube 3104, and the hollow tube 3334 extends to the inner surface INS of the hollow sealing tube 3104. Pressurized air is delivered to the interior of the hollow sealing tube 3104 (e.g., adjacent to the inner surface INS) and expands the hollow sealing tube 3104. The air then leaves the hollow sealing tube 3104 to reach the patient's face.

[0450] like Fig.46 and 47 As shown, in one form of the present technology, a connector 3335 is used to connect the two hollow tubes 3334 of the side strap 3302 together. The connector 3335 includes a second inlet port 3336, although the second inlet port 3336 can also be located on the positioning and stabilizing structure 3300 (e.g., on the side strap 3302, on the top strap 3306, etc.). The second inlet port 3336 provides communication between the surrounding environment and the hollow tubes 3334 of the side strap 3302. The second inlet port 3336 can allow the patient to breathe from the surrounding environment without pressurized air. The connector 3335 can be formed in the middle of the hollow tube 3334 so as to divide the hollow tube 3334 into two substantially equal lengths.

[0451] The positioning and stabilizing structure 3300 may include a valve 3339 having a flap 3338 adjacent to the second inlet port 3336 (see, e.g., Fig.64 and 66 The flap 3338 is biased (e.g., magnetically, mechanically, etc.) to an open position (i.e., to allow airflow through the second inlet port 3336) and can be moved to a closed position (i.e., substantially restricting airflow through the second inlet port 3336) by the first inlet of the plenum 3200.

[0452] In one form (see e.g. Fig.51 and Fig.52 ), the lower portion of the nose mask 3100a and the mouth seal 3100b each include side straps 3302, thereby applying tension to the lower portion of the nose mask 3100a and the mouth seal 3100b. The side straps 3302a under the nose mask 3100a can be part of the hollow tube 3334. The side straps 3302b of the mouth seal 3100b can be simply fabric straps that do not transmit pressurized air to the mouth seal 3100b.

[0453] 5.3.3.1 Bypass

[0454] As shown in the attached Fig.46 and 47As described and shown, the headgear 3324 of the positioning and stabilizing structure 3300 includes a hollow tube 3334 that transmits pressurized air toward the seal-forming structure 3100. Because the hollow tubes 3334 are part of the positioning and stabilizing structure 3300, they need to conform to the head of a specific patient while also providing a sliding fit. If the hollow tubes 3334 do not conform to the patient's head and are too tight, the patient interface 3000 may be uncomfortable, resulting in the patient being less likely to comply with treatment. In addition, if the hollow tubes 3334 cannot fit tightly against the patient's head, the seal-forming structure 3100 may not be able to seal with the patient's face, which may result in ineffective treatment. In the example shown, the hollow tubes 3334 can be formed from a single-piece configuration, and the hollow tubes 3334 together form a single conduit.

[0455] Specifically, the position of the headgear 3324 relative to the patient's head can shift during use. For example, the patient may roll in their sleep, which can cause at least one of the straps (e.g., the side straps 3302, the rear strap 3304, and the top strap 3306) to move against the patient's head. This may particularly affect the rear strap 3304, which can translate or move because it remains in contact with the patient's bed and / or pillow in most sleeping positions (e.g., supine sleeping, side sleeping, etc.). If the rear strap 3304 moves too much on the patient's head (e.g., in an up / down direction), the seal-forming structure 3100 may become loose on the patient's face and no longer be in a therapeutically effective position (e.g., pressurized air may leak into the atmosphere instead of being directed to the patient's lungs). This may occur when the rear strap 3304 is tightened around the patient's head when tilted relative to the Frankfurt Horizontal FFH (e.g., see Figure 8 ). If the rear strap 3304 is subsequently moved to a position where the angle relative to the Frankfurt Horizontal FFH is less than the angle when initially tightened (e.g., in the superior direction), the rear strap 3304 may no longer be tight enough to hold the seal-forming structure 3100 in place. Movement of the rear strap 3304 may be particularly problematic in patients with longer hair, which prevents the rear strap 3304 from effectively gripping the patient's head. Longer hair, alone or in addition to movement during sleep (e.g., rolling in bed), can increase movement of the rear strap 3304 into an ineffective position (i.e., a position where the rear strap 3304 cannot provide adequate force to seal the seal-forming structure 3100).

[0456] like Figure 53-63As shown, the back strap 3304 can be partially composed of a first material 3348 having a first friction coefficient and a second material 3349 having a second friction coefficient greater than the first friction coefficient. The second material 3349 helps to maintain the position of the back strap 3304 relative to the patient's head (e.g., angled in the posterior and inferior directions). The second material 3349 can also be rigid or semi-rigid. The first material 3348 and the second material 3349 can be connected together by suturing, sonic welding, adhesives, or in any similar manner.

[0457] The rear strap 3304 includes a side portion or sides 3350 and a second section 3354. The side portion 3350 is constructed of a first material and the second section 3354 is constructed of a second material. In the illustrated example, the second section 3354 is located between the two side portions 3350a, 3350b. When the patient interface 3000 is in use, the side portions 3350a, 3350b generally extend from the second section 3354 toward either side of the hollow tube 3334 and the corresponding tab 3320.

[0458] The side 3350 is connected to the second section 3354 at a transition or joint 3355. The joint 3355 can be sutured, glued, sonic welded, fused, or any similar method. In the example shown, there is only one material (e.g., the first material 3348 or the second material 3349) on either side of the joint 3355. In other words, the side 3350 does not substantially overlap with the second section 3354. Each material 3348, 3349 is exposed in each section (i.e., the first section 3350 and the second section 3354), which allows the patient to feel and experience the physical properties (e.g., coefficient of friction) associated with each material. Therefore, no first material 3348 extends substantially along the length of the second section 3354, and no second material 3349 extends substantially along the length of the first section 3350.

[0459] In one form, the second section 3354 is formed as a pad that contacts the occipital portion of the patient. The thickness of the pad 3354 can be greater than the thickness of the side portions 3350a, 3350b. The pad 3354 can be clamped or hooked at the occipital portion and provide an anchor point on the patient's head. The engagement with the patient's head can substantially limit the translation of the pad 3354 along the patient's head. When using the patient interface 3000, the increased thickness of the pad 3354 can provide additional gripping strength and better limit the translation of the pad 3354. Also, or in addition, the increased thickness of the pad 3354 can provide additional cushioning for the occipital portion of the patient.

[0460] In the example shown, the pad 3354 includes a curvature about the sagittal plane SGP (see, e.g. Figure 6 ). The pad 3354 can be recessed relative to the occipital bone OCC (see, e.g. Fig.14), and pointing in an upward direction. The curvature of pad 3354 can help the back strap 3304 further grasp and hook into the occipital bone of the patient and maintain the position of the back strap 3304 relative to the patient's head. In other words, pad 3354 can hook around the base of the occipital bone to limit the upward translation of the back strap 3304.

[0461] In one form, the side portions 3350a, 3350b are constructed of a textile. The textile side portions 3350a, 3350b can be flexible and non-abrasive 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 stretch when tension is applied to conform to patient heads of different sizes. In other forms, the side portions 3350a, 3350b are elastic and can stretch to a longer length than the textile. When the patient puts on the headgear 3000, the elastic can stretch to allow the headgear to be used with heads of multiple sizes.

[0462] The pad 3354 is made of silicone or a similar material (e.g., hyaluronic acid). The pad 3354 can have greater rigidity than the textile of the sides 3350a, 3350b so that it can provide a better anchor for positioning and stabilizing the structure 3300. The patient's hair is typically located between the pad 3354 and the patient's skin, so the pad 3354 does not cause a lot of irritation to the patient's skin.

[0463] The physical properties of the pad 3354 (e.g., shape, coefficient of friction, stiffness, etc.) limit the total area that the rear strap 3304 occupies on the patient's head. Because the rear strap 3304 can hook or engage the occipital bone, no portion of the rear strap is required on the upper area of ​​the patient's head. For example, the rear strap 3304 will not extend laterally (e.g., in the left / right direction) across the parietal bone PAR (e.g., see FIG. 1 ). Fig.14 ). In particular, the second material 3349 may not contact the parietal bone PAR.

[0464] The pad 3354 may also not extend in the temporal bone region (eg, across the temporal bone TTEM) and may be confined to the occipital bone region (eg, across the occipital bone OCC). This may position the second material at the back of the patient's head.

[0465] like Fig.53 and 54As shown, each side portion 3350a, 3350b of the rear strap 3304 is directly connected to the pad 3354 and the middle section 3346 of the positioning and stabilizing structure 3300. Each middle section 3346 (i.e., the right and left middle sections) depicts the transition between the corresponding side strap 3302 and the top strap 3306. In the example shown, the tab 3320 extends from the middle section 3346 and is connected to the corresponding side portion 3350a, 3350b. Each side portion 3350a, 3350b is angled relative to the Frankfurt horizontal FFH so that the pad 3354 can be positioned near the occipital region. When the rear strap 3304 is fastened on the patient's head, the pad 3354 hooks into the occipital region and limits further movement of the rear strap 3304.

[0466] In the example shown, the sides 3350a, 3350b extend parallel to the tangent line L1 along the spiral H of each respective ear. Line L1 intersects the vertex axis AA at an angle φ, which extends orthogonally through the vertex A of the ear relative to the Frankfurt horizontal FFH. Vertex A represents the uppermost portion of the patient's ear. The sides 3350a, 3350b can then be completely behind the patient's ears, so that the likelihood of the sides 3350a, 3350b intersecting (i.e., contacting) either ear is significantly reduced.

[0467] 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 about 43°.

[0468] In the example shown, each tab 3320 is located above the patient's ear, in a position that does not interfere with the patient's ear. For example, each tab 3320 is positioned sufficiently toward the upper region of the patient's head so that the side portions 3350a, 3350b can extend toward the occipital bone without intersecting the patient's ears. In other words, each side portion 3350a, 3350b is allowed to extend above and / or behind each ear to avoid contacting either ear. This provides some comfort to the patient because the rear band 3304 does not press the patient's ears against their head.

[0469] exist Fig.53 and 54 In the example shown, 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., above the masseter muscle) and 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.

[0470] exist Fig.53 and54 In the example shown, the positioning and stabilizing structure 3300 may not include a bottom strap and / or a top strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the positioning and stabilizing structure 3300 may include a top strap and / or a bottom strap.

[0471] like Fig.55 and 56 As shown, the rear band 3304 may also include a pair of third sections or extensions 3358a, 3358b. Each extension 3358a, 3358b is directly connected to the corresponding tab 3320 and the side 3350a, 3350b. In other words, each side 3350a, 3350b is connected to the tab 3320 by an extension 3358a, 3358b. The extensions 3358a, 3358b are made of a third material 3361 that is different from the first material 3348. In some examples, the third material 3361 can be the same as the second material 3349 (e.g., the material used to configure the pad 3354). In other examples, the third material 3361 can be different from the first and second materials 3348, 3349. The third material 3361 can also have a friction coefficient greater than the friction coefficient of the first material 3348. This helps to better anchor each extension 3358a, 3358b to the patient's head and limit translational movement due to tension (e.g., from the sides 3350a, 3350b).

[0472] If the third material 3361 is the same as the second material 3349, the second material 3349 can be located in the temporal region. However, the second material (e.g., extensions 3358a, 3358b) will be positioned at the base of the ear on the temporal region. Therefore, the second material 3349 will not pass through the fundus muscle or the sternocleidomastoid muscle.

[0473] In one form, the third material is a hardened material and the extensions 3358a, 3358b are formed as an angled part. Each extension 3358a, 3358b includes a first or substantially horizontal portion 3359 and a second or inclined portion 3360. The substantially horizontal portion 3359 extends substantially parallel to the Frankfurt horizontal FFH. The substantially horizontal portion 3359 may extend in a posterior direction along the Frankfurt horizontal FFH to a position exceeding a majority of the patient's ear. For example, the substantially horizontal portion 3359 may extend at least to the vertex A of the patient's ear. In other words, the substantially horizontal portion 3359 extends in a posterior direction and intersects the vertex axis AA. In some examples, the substantially horizontal portion 3359 may extend in a posterior direction beyond the vertex axis AA. In some embodiments, the substantially horizontal portion 3359 is positioned entirely on the temporal bone TTEM (see, e.g. Fig.14 ).

[0474] 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., forming an acute angle relative to the Frankfurt horizontal FFH). For example, each extension 3358a, 3358b is concave relative to the corresponding ear. The transition between the generally horizontal portion 3359 and the angled portion 3360 can be along the vertex axis AA. The angled portion 3360 then extends in a posterior direction parallel to a line L2 that is tangential to the helix H of the patient's ear. Line L2 intersects the vertex axis AA at an angle θ. The angled portion 3360 can then be completely behind the patient's ears, thereby significantly reducing the likelihood that the sides 3350a, 3350b will intersect either ear.

[0475] 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 about 40°.

[0476] The extensions 3358a, 3358b are used to change the angle of the side portions 3350a, 3350b relative to the patient's ears. The generally horizontal portion 3359 positions each side portion 3350a, 3350b away from the corresponding tab 3320 so that the side portions 3350a, 3350b do not need to extend as far as the patient's occipital bone (e.g., as far as the patient's ear). Fig.53 In addition, the side portions 3350a, 3350b are relative to Fig.55 The angle of the Frankfurt horizontal FFH is greater than Fig.53 In other words, Fig.53Compared to the side portions of the back strap 3304, the side portions 3350a, 3350b extend further in the inferior direction than in the posterior direction. The greater force component provided by the rear strap 3304 can be directed in the inferior / upper direction. Fig.53 Compared to the example of , less total force can be used to provide the same engagement force on pad 3354. In other words, the patient can tighten the back strap 3304 less on their head in order to obtain the necessary force vector in the inferior / superior direction to hook the pad 3354 into the occipital region.

[0477] Extending the generally horizontal portion 3359 beyond or substantially beyond the patient's ears further reduces the likelihood that the side portions 3350a, 3350b will contact either of the patient's ears. 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, 3350b are completely behind and spaced apart from the patient's ears. In the previous examples (see, e.g., Fig.53 and 54 ), the side portions 3350a, 3350b can slide against the patient's head and cause the rear strap 3304 to clamp the corresponding ears. In this example, the extension completely separates the side portions 3350a, 3350b from the corresponding ears, so that even a small translation of the side portions 3350a, 3350b will not cause the corresponding ears to be clamped.

[0478] In some forms, the extensions 3358a, 3358b may be adjustable. For example, the third material may allow for less adjustment while still maintaining its overall shape. The patient is able to change the angle between the generally horizontal portion 3359 and the inclined portion 3360. This allows the patient to adjust the position of the side portions 3350a, 3350b based on the size of the patient's head. For example, the tab 3320 may be positioned further up a patient with a longer head. Thus, the patient is able to increase the angle between the generally horizontal portion 3359 and the inclined portion 3360 so as to guide the side portions 3350a, 3350b toward the lower region of the patient's head (e.g., toward the occipital bone). Once the inclined portion 3360 is set to the desired position, it generally remains rigid or semi-rigid and substantially maintains its shape when the rear band 3304 is tightened.

[0479] exist Fig.55 and 56 In the example shown, 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., above the masseter muscle) and 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.

[0480] exist Fig.55 and 56 In the example shown, the positioning and stabilizing structure 3300 may not include a bottom strap and / or a top strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the positioning and stabilizing structure 3300 may include a top strap and / or a bottom strap.

[0481] like Fig.57 and 58 As shown, the seal-forming structure 3100 may include a nose mask 3100a and a lower portion of a mouth seal 3100b, which is similar to Figure 53-56 The nose mask 3100a and the lower portion of the mouth seal 3100b can be formed as a single component, or they can be a single component connected together as described above (see, for example, Fig.51 -52b). Fig.57 and 58 The seal-forming structure 3100 used together with the positioning and stabilizing structure 3300 may be Figure 53-56 The positioning and stabilizing structure 3300 is similar, and only certain similarities and differences are described.

[0482] In one form, the lower portion of the nasal mask 3100a includes side straps 3302a, and the mouth seal 3100b includes side straps 3302b. The side straps 3302b extend from near the patient's mouth in a direction generally parallel to the Frankfurt horizontal FFH. The side straps 3302b extend along the patient's cheeks and neck and are completely disposed below the patient's ears. Thus, the side straps 3302a, 3302b and the rear strap 3304 define a perimeter around each patient's ear, but do not contact the ear.

[0483] In some forms, the side straps 3302b are disposed further below the pads 3354. The side straps 3302b may move relative to the pads 3354, which may cause similar problems with the seal-forming structure 3100 (e.g., the side straps 3302b 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 strap 3362 provides a rigid joint between the pads 3354 and the side straps 3302b and limits relative movement between the two. Specifically, the side straps 3302b are restricted from moving because the pads 3354 are hooked onto the occipital region of the patient.

[0484] In some forms, when the patient wears the patient interface 3000, the connecting strap 3362 is centered along the patient's neck. In the example shown, the connecting strap 3362 is configured by a first material (e.g., a textile). The side straps 3302b and the connecting straps 3362 can be formed from a single piece of material. In other examples, the connecting straps 3362 can be configured by a second material and can be formed as a one-piece configuration with the pad 3354. In this example, the connecting straps 3362 can provide additional grip against the patient to prevent movement of the positioning and stabilizing structure 3300. In other examples, the connecting straps 3362 are coupled to the side straps 3302b and the pad 3354 and can be formed from any material.

[0485] exist Fig.57 and 58 In the example shown, the positioning and stabilizing structure 3300 may not include a bottom strap and / or a top strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the positioning and stabilizing structure 3300 may include a top strap and / or a bottom strap.

[0486] like Fig.59 As shown, some examples of the seal-forming structure 3100 with a nasal mask 3100a and a mouth seal 3100b below may not utilize the side straps 3302b. The rear strap 3304 may provide sufficient force to maintain the seal-forming structure 3100 in a therapeutically effective position. Specifically, the cushion 3304 may maintain the seal-forming structure 3100 in place without the need for the side straps 3302b or the connecting strap 3362. This may provide more comfort to the patient because the positioning and stabilizing structure 3300 does not pass over the patient's sternocleidomastoid muscle STE (see, e.g., Fig.14 ). Whether or not the extension 3358 is used, the side strap 3302b may be omitted.

[0487] exist Fig.59 In the example shown, 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., above the masseter muscle) and 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.

[0488] exist Fig.59In the example shown, the positioning and stabilizing structure 3300 may not include a bottom strap and / or a top strap. In other words, the positioning and stabilizing structure 3300 may not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The positioning and stabilizing structure 3300 may also not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the positioning and stabilizing structure 3300 may include a top strap and / or a bottom strap.

[0489] like Fig.60 As shown, in some forms of the positioning and stabilizing structure 3300, the tab 3320 is an eyelet or loop 3320 that selectively receives the rear strap 3304 (e.g., 3350a, 3350b). The rear strap 3304 is thus removably coupled to the loop 3320 and can be disconnected to assist the patient in donning and doffing the patient interface 3000.

[0490] In one form, one of the sides 3350a, 3350b passes through the loop 3320 and folds back on itself to allow the first magnetic segment 3316 to couple to the second magnetic segment 3318. The second magnetic segment 3318 can be larger than the first magnetic segment 3316 (i.e., include a larger area on the sides 3350a, 3350b) so that the first magnetic segment 3316 can couple to the second magnetic segment 3318 in multiple locations (e.g., corresponding to different tightnesses). Alternatively, the first and second magnetic segments 3316, 3318 can be replaced with Velcro or any similar fastener.

[0491] In some forms, only one tab 3320 defines a loop. In other words, the rear strap 3304 can be permanently coupled to one of the tabs 3320 (e.g., the right portion 3350b) and can be removably coupled to the other tab 3320 (e.g., the left portion 3350a). The rear strap 3304 can be formed as a one-piece configuration (e.g., made of one piece of textile) with the tab 3320 to which it is permanently coupled.

[0492] like Fig.61As shown, one extension 3358a passes through the loop 3320 and folds back on itself to allow the first engagement segment 3366 to be coupled to the second engagement segment 3368. The second engagement segment 3368 can be larger than the first engagement segment 3366 (i.e., include a larger area on the rear strap 3304) so ​​that the first engagement segment 3366 can be coupled to the second engagement segment 3368 in a variety of positions (e.g., corresponding to different tightness). In the example shown, the first engagement segment 3366 and the second engagement segment 3368 are magnetic segments, but in other examples, other engagement mechanisms (e.g., Velcro) can be used. The first and second engagement portions 3366, 3368 can be disposed on the generally horizontal portion 3359 so that the engagement between the engagement portions 3366, 3368 affects the position of the side portions 3350a, 3350b relative to the tab 3320, but does not affect the angle relative to the Frankfurt Horizontal FFH.

[0493] In some forms, only one tab 3320 defines a loop. In other words, one extension 3358b can be permanently coupled to one of the tabs 3320 (e.g., the right tab 3320) and the other extension 3358a can be removably coupled to the other tab 3320 (e.g., the left loop 3320).

[0494] In some forms, the side portions 3350a, 3350b are permanently coupled to respective extensions 3358a, 3358b. The distance between the pad 3354 and the extensions 3358 remains substantially constant. Adjustment of the rear strap 3304 by the patient may be limited to the extensions 3358a, 3358b.

[0495] like Fig.62 As shown, the extension 3358a includes a loop 3380 on the inclined portion. The side portion 3350a can pass through the loop 3380 and fold back on itself to removably connect the side portion 3350a to the corresponding extension 3358a. The first magnetic segment 3316 and the second magnetic segment 3318 are used to removably connect the side portion 3350a to the extension 3358a.

[0496] In some examples, the extension 3358a can also be removably coupled to the ring 3320 (see, e.g., Fig.61 ). The patient can selectively use the extension 3358a as needed (e.g., based on the size of the patient's head, the force required, etc.). When the extension 3358a is not needed, the patient can couple the side 3350a to the ring, such as Fig.59 shown.

[0497] In some forms, only one tab 3320 defines a loop. In other words, one extension 3358b may be permanently coupled to one of the tabs 3320 (e.g., the left tab 3320) and the other extension 3358a may be removably coupled to the other tab 3320 (e.g., the right loop 3320). The extension 3358a may be formed as a one-piece configuration with the tab 3320 permanently coupled to (e.g., by a piece of textile).

[0498] Similarly, only one of the extensions 3358a, 3358b may define one loop 3380. In other words, one extension 3358b may be permanently coupled to one of the sides 3350b (e.g., the right tab 3320) and the other extension 3358a may be removably coupled 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).

[0499] like Fig.63 and 64 As shown, pad 3354 can be adjustable, so as to conform to the patient's head. Specifically, the length of pad 3354 can be adjusted by the patient, so as to tighten or loosen pad 3354 relative to the patient's head.

[0500] like Fig.63 As shown, the pad 3354 includes a side portion 3354a and a second section 3354b, which are connected together using a buckle 3370 (e.g., a ladder buckle). The side portion 3354a and the second section 3354b are configured to overlap each other. The second section 3354b can be moved relative to the side portion 3354a to determine the length of the overlap. The available length of the pad 3354 corresponds to the total length of the first and second sections 3354a, 3354b exposed to and / or in contact with the patient. The first and second sections 3354a, 3354b pass through the buckle 3370 and are maintained in their desired positions. For example, the patient can adjust the length of the second section 3354b passing through the buckle 3370 so that the pad 3354 is comfortable and in a fixed position against his head.

[0501] like Fig.64As shown, the cushion 3354 may include a side portion 3354a having a plurality of apertures 3374 and a second section 3354b having a plurality of protrusions 3378. Each aperture 3374 is configured to receive one of the protrusions 3378. The side portion 3354a is selectively positioned along the length of the second section 3354b so that at least one of the apertures 3374 can engage one of the protrusions 3378. Depending on the desired length of the cushion 3354, each aperture 3374 can receive any one of the protrusions 3378. The patient can select the appropriate relative position between the first and second sections 3354a, 3354b so that the cushion 3354 is secured to the patient's head.

[0502] In some forms, the pad 3354 may be the only means of adjusting the length of the rear strap 3304 (e.g., via the buckle 3370, via the aperture 3374 and the protrusion 3378, via a magnet, or via a similar mechanism). The patient may loosen the pad 3354 (e.g., relative to the side 3354a of the second section 3354b) in order to put on and take off the patient interface 3000.

[0503] In some forms, the cushion 3354 may be adjustable in addition to the sides 3350a, 3350b and / or extensions 3358a, 3358b. These different forms of adjustment may allow the patient to make smaller, more limited adjustments to secure the cushion 3354 in a desired position against the patient's occipital region.

[0504] 5.3.3.3 Full-face mask dedicated anchor

[0505] As described above, certain forms of positioning and stabilizing structures 3300 used in nasal masks (see, e.g., Fig.53 -56) can also be used with full face masks (see e.g. Figure 57-59 ). Additionally, positioning and stabilizing structures may be designed specifically for use with a full face mask to better assist in sealing the patient's nostrils and mouth.

[0506] like Fig.65 and 65 As shown in FIG. 1 , one form of a positioning and stabilizing structure 7000 may include a headgear strap 7002 having a generally X-shape. The positioning and stabilizing structure 7000 may include a back strap or neck pad 7004 configured to contact the back of the patient's head. For example, the back strap 7004 may cover the patient's occipital bone and / or trapezius muscle.

[0507] In some forms, the rear strap 7004 may be constructed of a rigid and / or at least partially rigid material. For example, the rear strap 7004 may be constructed of a rigid laminate material that may not be able to stretch significantly. The rigidity or stiffness may help anchor the positioning and stabilizing structure to the back of the patient's head. Additionally, the material may be soft to maximize patient comfort.

[0508] Continue to refer to the attached Fig.65 and 65 -1, four straps may extend from the rear strap 7004. A pair of upper straps 7008 may extend from the upper portion of the rear strap 7004, and a pair of lower straps 7012 may extend from the 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, they may be the same size, or the upper straps 7008 may be longer than the lower straps 7012.

[0509] Each strap 7008, 7012 can include a connector region 7016. In the example shown, the connector region 7016 is a hook tab (e.g., Velcro), although other types of connections (e.g., magnets, mechanical snaps, etc.) can be used. Each respective strap 7008, 7012 can be folded onto itself so that the connector region 7016 contacts a portion of the positioning and stabilizing structure 3300 (e.g., the same strap 7008, 7012). The straps 7008, 7012 can be at least partially comprised of a loop material to which the hook tabs 7016 are removably engaged. The patient can removably select where to position each connector region 7016 in order to adjust the length of the respective strap, and therefore adjust the sealing force applied by the seal-forming structure 3100.

[0510] In some forms, the pair of upper straps 7008 may be constructed of a rigid and / or at least partially rigid material. For example, the upper straps 7008 may be constructed of a rigid laminate material that may not be able to stretch significantly. In some forms, the rear strap 7004 and the upper straps 7008 may be constructed of the same material, although different materials may be used.

[0511] In some forms, the lower belt 7012 can be made of an elastic material. For example, the lower belt 7012 can be made of a high-stretch laminate material that can stretch.

[0512] like Fig.65 As shown, each upper strap 7008 and lower strap 7012 can be individually connected to the back strap 7004. For example, each upper strap 7008 and lower strap 7012 can be independently sewn to the back strap 7004. Some forms of the back strap 7004 may include an X-shape so that the stitching of each strap 7008, 7012 is spaced apart from adjacent stitching. In other examples, different connection techniques may be used, such as ultrasonic welding. In other examples, the upper strap 7008 can be integrally formed with the back strap 7004, so that sewing or other connection techniques may not be necessary (for example, because they are formed of the same material and can be cut from the same sheet of material).

[0513] like Fig.65 -1, the rear belt 7004 may include Fig.65 The back strap 7004 may be provided with a more rounded edge. This may allow the upper strap 7008 and the lower strap 7012 on each side (e.g., the left or right side) to be positioned more closely relative to each other. The left upper and lower straps 7008, 7012 may be connected to the back strap 7004 using a single continuous stitching (or other connection technique). Additionally, the right upper strap 7008 and the right lower strap 7012 may be connected to the back strap 7004 using a single continuous stitching (or other connection technique). In some embodiments, the continuous stitching on each side may be curved and along the perimeter of the back strap 7004.

[0514] exist Fig.65 and 65 In the example shown in Figure 1, the headgear strap 7002 may not include a bottom strap and / or a top strap. In other words, the headgear strap 7002 does not include a strap extending below the patient's chin (e.g., below the mental protuberance). The headgear strap 7002 also does not include a strap extending toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the headgear strap 7002 may include a top strap and / or a bottom strap.

[0515] like Fig.66 As shown, the positioning and stabilizing structure 7000 can be used with an inflatable chamber 3200. The illustrated inflatable chamber 3200 is a full face inflatable chamber 3200, although the positioning and stabilizing structure 7000 can be used with a nasal inflatable chamber 3200.

[0516] In some forms, the headgear strap 7002 can be Fig.57 (or any other previous example) is connected to the rest of the patient interface 3000 in a substantially similar manner. For example, the hollow tube 3334 may include at least one tab 3320 that can removably receive a portion of the headgear strap 7002. For example, each upper strap 7008 can pass through the tab 3320 to connect the headgear strap 7002 to the hollow tube 3334. As described above, the upper strap 7008 can include a connector region 7016 that can pass through the tab 3320 and fold back to connect to the same upper strap 7008. The connector region 7016 can be connected closer to the rear strap 7004 along the corresponding upper strap 7008 to shorten the length of the upper strap 7008 and provide greater tension.

[0517] In some forms, Fig.66 The tab 3320 can be compared to Fig.55 Or the tab 3320 in 57 is superior. In other words, Fig.66 The tabs 3320 in the Fig.55The tab 3320 in or 57 is closer to the decoupling structure 3500. As a result of the higher tab 3320, the upper strap 7008 can extend in a posterior direction parallel to line L2 that is tangential to the helix H of the patient's ear without using an extension 3358 (although the upper strap 7008 can also extend along a different line). This can allow the upper strap 7008 to generate the same force vector as the side portions 3350a, 3350b (e.g., oriented along the angle θ measured from the axis AA) and be spaced apart from the patient's ears, such that the likelihood of the upper strap 7008 intersecting either ear is significantly reduced. In other words, the upper strap 7008 can be connected to the ear in a similar manner to the upper strap 7008. Fig.53 3350a, but the higher tab 3320 can allow for a smaller angle (i.e., a more vertically directed force) without the upper band 7008 contacting the patient's ear. Fig.57 As in the embodiment of the present invention, when the angle θ is smaller, the patient may not need to tighten the upper strap 7008 as much (e.g., because a larger component of the force is directed in the up-down direction, causing the rear strap 7004 to be pulled into the occipital region of the patient). This can improve the patient's comfort when wearing the headgear strap 7002 (e.g., because the tension is applied directly from the tab 3320 without using the extension 3358).

[0518] Continue to see Fig.66 , the lower strap 7012 can be connected to the inflatable chamber 3200 to provide a rearwardly directed force vector for maintaining the seal-forming structure 3100 in a sealed position. As described above, the lower strap 7012 can be longer than the upper strap 7008 so as to be accessible from the back of the patient's head (e.g., where the rear strap 7004 rests) and the inflatable chamber 3200. In the example shown, each lower strap 7012 can be connected to a clip 7020 that is directly connected to the inflatable chamber 3200. In some forms, the clip 7020 can include a magnet that is magnetically connected to the inflatable chamber 3200 (although other types of connections, such as mechanical fasteners, can be used). The lower strap 7012 can pass through the corresponding clip 7020 in a manner similar to the upper strap 7008 passing through the tab 3320. The connector area 7016 of the lower strap 7012 can be selectively connected along the surface of the same lower strap 7012 to adjust the tension. The clip 7020 can be disconnected from the plenum chamber 3200 so that the headgear strap 7002 can be more easily removed from the patient's head without changing the position of the connector area 7016. In other examples, the lower strap 7012 can be permanently connected to the plenum chamber. The stretchable material of the lower strap 7012 can allow the headgear strap 7002 to be removed without disconnecting the lower strap 7012 (or the clip 7020) from the plenum chamber 3200.

[0519] In some forms, the angle of the upper strap 7008 and the absence of the connecting strap (see e.g. Fig.58) can allow the rear band 7004 to sit higher on the patient's head (e.g., closer to the base under the ear). This can improve patient comfort because the lower band 7012 can sit higher on the patient's face.

[0520] like Fig.67 and 68 As shown, an alternative example of a positioning and stabilizing structure 8000 and a headgear strap 8002 may be connected to the plenum chamber 3200. The headgear strap 8002 may be similar to the headgear strap 7002, and only certain similarities and differences are described below.

[0521] like Fig.67 As shown, the helmet strap 8002 may include a rear strap 8004, and the rear strap 8004 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, and the lower portions 8006 may be formed as dog legs. Fig.65 The rear portion 7004 of the patient's head is closer to an X-shape. This shape can allow the rear strap 8004 to sit higher on the patient's head. For example, the central portion 8005 alone can be narrower than the rear strap 7004. The central portion 8005 can still contact the occipital bone, but can contact less of the trapezius muscle, which can reduce irritation and discomfort during use. In addition, the lower portion 8006 can extend around the sides of the patient's neck, which can disperse the load from the central location of the back of the patient's head (e.g., substantially on the trapezius muscle). The dog-leg design of the lower portion 8006 can promote additional patient comfort.

[0522] like Fig.68 As shown, the hollow tube 3334 can be Fig.66 The hollow tube 3334 is bent more backward. The tabs 3320 can be aligned with the apex axis AA. This allows the tabs 3334 to be lower on the hollow tubes 3334 (e.g., lower than Fig.66 3320 is lower). Thus, upper strap 8008 may not require extension 3358 to be positioned substantially parallel to line L2. Upper strap 8008 is able to achieve the same force vector as the superior force vector of upper strap 7008. Because tab 3320 is positioned more in the rear direction, upper strap 8008 may be connected near or on rear strap 8004 (e.g., via a connector area, not shown).

[0523] The lower strap 8012 may extend from the lower portion 8006 and connect to the plenum chamber 3200 in a similar manner as described for the lower strap 7012. Tightening the lower strap 8012 may apply tension to the lower portion 8006, which may not substantially contact the back of the patient's head (e.g., the lower portion 8006 may not substantially contact the patient's trapezius muscle). This may be 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.

[0524] exist Fig.67 and 68 In the example shown, the headgear strap 8002 may not include a bottom strap and / or a top strap. In other words, the headgear strap 8002 does not include a strap extending below the patient's chin (e.g., below the mental protuberance). The headgear strap 8002 also does not include a strap extending toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the headgear strap 8002 may include a top strap and / or a bottom strap.

[0525] like Fig.69 and 70 As shown, an alternative example of a positioning and stabilizing structure 9000 and headgear strap 9002 may be connected to the plenum chamber 3200. The headgear strap 9002 may be similar to the headgear strap 7002, and only certain similarities and differences are described below.

[0526] like Fig.69 As shown, the headgear strap 9002 may include a rear strap 9004 having a top 9005, a bottom 9006, and a pair of side portions 9007 connecting the top 9005 to the bottom 9006. The top 9005 can be located entirely on the patient's head above the trapezius muscles (e.g., entirely covering the occipital bone). The bottom 9006 can be located entirely on the patient's head below the occipital bone (e.g., covering the trapezius muscles). The side portions 9007 can be angled or dog-legged between the top and bottom portions 9005, 9006. In some forms, the top 9005 and / or the bottom 9006 can sit horizontally on the patient's head, and the side portions 9007 can have a larger radius relative to at least one of the straps than the radius of the lower portion 8006 relative to the central portion 8005 (see, e.g., Fig.67 ).

[0527] like Fig.70 As shown, the hollow tube 3334 can be Fig.66 The hollow tube 3334 is bent more backward. The tabs 3320 can be aligned with the apex axis AA. This allows the tabs 3334 to be lower on the hollow tubes 3334 (e.g., lower than Fig.66 3320 is lower). Thus, upper strap 9008 may not require extension 3358 to be positioned substantially parallel to line L2. Upper strap 9008 is able to achieve the same force vector as the superior force vector of upper strap 7008. Because tab 3320 is positioned more in the rear direction, upper strap 9008 may be connected near or on rear strap 9004 (e.g., via a connector area, not shown).

[0528] The lower strap 9012 can extend from the lower portion 9006 and connect to the plenum chamber 3200 in a similar manner as described for the lower strap 7012. Tightening the lower strap 9012 can apply tension to the lower portion 9006, which can help anchor the lower portion 9006 to the posterior region of the patient's head. Tightening the upper strap 9008 can apply tension to the top portion 9005, which can help anchor the top portion 9005 to the posterior region of the patient's head. Because the top and bottom portions 9005, 9006 are spaced apart from each other, the total force can be spread along the posterior region of the patient's head, which can improve comfort.

[0529] exist Fig.69 and 70 In the example shown, the headgear strap 9002 may not include a bottom strap and / or a top strap. In other words, the headgear strap 9002 does not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The headgear strap 9002 also does not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the headgear strap 9002 may include a top strap or a bottom strap.

[0530] like Fig.71 and 72 As shown, an alternative example of a positioning and stabilizing structure 10000 and a headgear strap 10002 can be connected to the plenum chamber 3200. The headgear strap 10002 can be similar to the headgear strap 7002, and only certain similarities and differences are described below.

[0531] like Fig.71 As shown, the headgear strap 10002 may include a rear strap 10004 having a central portion 10005 and a pair of side portions 10006 connecting the central portion 10005. The central portion 10005 may include a larger surface area than the rear strap 7004 and may sit higher on the patient's head (e.g., may cover little to no trapezius muscle). The side portions 10006 may extend from the central portion 10005 in a lateral and medial direction and may substantially not cover the trapezius muscle.

[0532] In certain forms, the central portion 10005 can include an opening or slot 10024. The slot 10024 can be disposed near the periphery of the central portion 10005. The slot 10024 can also be disposed near the upper end of the central portion 10005.

[0533] like Fig.72 As shown, the upper band 10008 may be integrally formed with the hollow tubes 3334. In other words, the hollow tubes 3334 may not include the tabs 3320, and the upper band 10008 may be directly connected to the hollow tubes 3334 where the tabs are accessible.

[0534] like Fig.72As shown, the upper band 10008 can be formed of a rigid material and can include a shape similar to the extension member (e.g., see Fig.56 3358a, 3358b in the upper strap 10008). For example, each upper strap 10008 may include a substantially horizontal portion 10028 and an inclined portion 10032, which may be included at substantially the same angle as the inclined portion 3360. The upper strap 10008 may thus extend substantially parallel to the line L2 and may provide forces along substantially the same vector. In other examples, the upper strap 10008 may be removably connected to the hollow tube 3334 (e.g., similar to Fig.57 ).

[0535] Back to Fig.71 , the upper strap 10008 can be detachably connected to the rear strap 10004. For example, the upper strap 10008 can be connected to the central portion 10005 through the slot 10024. Each upper strap 10008 can pass through a corresponding slot 10024 and can be folded on itself to adjust its length and applied tension.

[0536] The lower strap 10012 may extend from the lower portion 10006 and connect to the plenum chamber 3200 in a similar manner as described for the lower strap 7012. Tightening the lower strap 10012 may apply tension to the lower portion 10006, which may not substantially contact the back of the patient's head (e.g., the lower portion 8006 may not substantially contact the patient's trapezius muscle). This may be beneficial to 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 upper seated central portion 10005 (e.g., not substantially overlapping the trapezius muscle) may further reduce the load on the nape of the patient's neck, which may improve patient comfort.

[0537] exist Fig.71 and 72 In the example shown, the headgear strap 10002 may not include a bottom strap and / or a top strap. In other words, the headgear strap 10002 does not include a strap extending below the patient's chin (e.g., below the mental protuberance). The headgear strap 10002 also does not include a strap extending toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the headgear strap 10002 may include a top strap and / or a bottom strap.

[0538] like Fig.73 and 74 As shown, an alternative example of a positioning and stabilizing structure 11000 and a headgear strap 11002 can be connected to the plenum chamber 3200. The headgear strap 11002 can be similar to the headgear strap 7002, and only certain similarities and differences are described below.

[0539] like Fig.73As shown, the headgear strap 11002 may include a rear strap 11004, which may include a larger surface area than the rear strap 7004 and may be located higher on the patient's head (e.g., may cover little to no trapezius muscle). For example, the rear strap 11004 may be located at approximately the same height as the rear strap 10004.

[0540] like Fig.74 As shown, the hollow tube 3334 can be Fig.66 The hollow tube 3334 is bent further back. This can arrange the tab 3320 to be more Fig.66 The tab 3320 is further back. In addition, the hollow tube 3334 may be less Fig.70 The hollow tube 3334 of the embodiment of FIG. 3334 is bent in the rearward direction. This can arrange the tab 3320 to be more Fig.70 The tab 3320 of the earpiece is further forward. Based on this positioning, the upper strap 11008 connected to the tab 3320 can extend along an angle greater than the angle θ. For example, the upper strap 11008 can extend along an angle φ, or can extend along a different angle. The upper strap 11008 can still extend along an angle that does not intersect the patient's ear and cause discomfort.

[0541] like Fig.73 and 74 As shown, the lower strap 11012 can be connected to the rear strap 11004 and the plenum chamber 3200 using similar techniques as described above. In some forms, the lower strap 11012 can be a single strap connected below the rear strap 11004. The lower strap 11012 can be long enough to extend from one side of the plenum chamber 3200 around the patient's head to the other side of the plenum chamber 3200.

[0542] In some forms, the headgear strap 11002 may include a top strap 11036 that may extend over the crown of the patient's head. For example, each top strap 11036 may cover the parietal bone. The top strap 11036 may be secured to the back strap 11004 (e.g., via suturing, ultrasonic welding, integral formation, etc.) and may be removably connected to the hollow tube 3334 adjacent to the decoupling structure 3500 using a tab (not shown) similar to the tab 3320.

[0543] In use, the patient can adjust three sets of force vectors, which can provide the patient with more control to adjust the headgear strap 11002 to their particular head. In addition, the various force vectors generated by adjusting the headgear strap 11002 can allow the back strap 11004 to sit higher on the patient's head (e.g., to cover less of the trapezius muscle), which can improve patient comfort. Raising the back strap 11004 can also raise the lower strap 11012 (or lower strap 11012), which can also improve patient comfort.

[0544] exist Fig.73 and 74In the example shown, the headgear strap 11002 may not include a bottom strap. In other words, the headgear strap 11002 does not include a strap extending below the patient's chin (e.g., below the chin protuberance). In other examples, the headgear strap 11002 may include a bottom strap and / or may not include a top strap 11036.

[0545] like Fig.75 As shown in FIG. 76 , an alternative example of a positioning and stabilizing structure 12000 and a headgear strap 12002 may be coupled to the plenum chamber 3200. The headgear strap 12002 may be similar to the headgear strap 7002, and only certain similarities and differences are described below.

[0546] like Fig.75 As shown, the headgear strap 12002 may include a rear strap 12004 that may include a larger surface area than the rear strap 7004. The rear strap 12004 may include a generally triangular shape. In some forms, the upper end of the rear strap 12004 may lie substantially horizontally against the patient's head and may converge toward a point at the lower end.

[0547] In some forms, the back strap 12004 may be made of an elastic or stretchable material. For example, the back strap 12004 may be made of a textile material that is elastically deformable. The textile material may be soft and / or improve the comfort of the patient. The back strap 12004 may be under tension (e.g., pre-tensioned) before being put on by the patient. This can help the back strap 12004 sit above the patient's head. For example, the back strap 12004 may cover the occipital bone and may not substantially contact the trapezius muscle.

[0548] In certain forms, the lower portions of the rear straps 12004 may converge at an angle α between about 1° and about 180°. In certain forms, the lower portions of the rear straps 12004 may converge at an angle α between about 50° and about 175°. In certain forms, the lower portions of the rear straps 12004 may converge at an angle α between about 90° and about 160°. In certain forms, the lower portions of the rear straps 12004 may converge at an angle α between about 110° and about 150°. In certain forms, the lower portions of the rear straps 12004 may converge at an angle α between about 120° and about 140°. In certain forms, the lower portions of the rear straps 12004 may converge at an angle α of about 130°.

[0549] Continue to refer to Fig.75, the helmet strap 12002 may include a pair of upper straps 12008. In the example shown, the upper straps may be connected to the back strap 12004 and may be made of a different material than the back strap 12004. For example, the pair of upper straps 12008 may be made of a hardened or semi-rigid material. The upper straps 12008 may include a rigid or semi-rigid material covered with a textile material, or the textile material used to configure the upper straps 12008 may be hardened or reinforced so that it is less ductile than the back strap 12004.

[0550] In some forms, the upper strap 12008 can be connected to the back strap 12004 using one of the above-described connection techniques. For example, the upper strap 12008 can be sewn to the back strap along the surface forming the angle α. In other words, at least a portion of the upper strap 12008 is lower on the patient's head than the back strap 12004. The increased stiffness of the upper strap 12008 (e.g., compared to the back strap 12004) can help limit the back strap 12004 (or the headgear strap 12002 as a whole) from being pulled downward.

[0551] In certain forms, the upper straps 12008 may be connected to each other near the apex of the angle α. In other forms, the upper straps 12008 may be formed from a single piece of material such that the pair of upper straps 12008 are not connected together.

[0552] In certain forms, the upper bands 12008 may converge at an angle β between about 1° and about 180°. In certain forms, the upper bands 12008 may converge at an angle β between about 50° and about 175°. In certain forms, the upper bands 12008 may converge at an angle β between about 90° and about 170°. In certain forms, the upper bands 12008 may converge at an angle β between about 110° and about 165°. In certain forms, the upper bands 12008 may converge at an angle β between about 140° and about 160°. In certain forms, the upper bands 12008 may converge at an angle β of about 150°. For example, the upper bands 12008 may be positioned so that the angle β is greater than the angle α, although in other examples the angle β and the angle α may be substantially equal.

[0553] Continue to refer to Fig.75 , the headgear strap 12004 may include a pair of lower straps 12012. In the example shown, the lower straps 12012 may be connected to the upper strap 12008 and may be made of a different material than the upper strap 12008. For example, the pair of lower straps 12012 may be made of an elastic or stretchable material (e.g., the same material as the back strap 12004). The lower straps 12012 may include a textile material. The lower straps 12012 may be under tension (e.g., pre-tensioned) before being worn by the patient (e.g., similar to the back strap 12004).

[0554] In some forms, the stretchability of the lower strap 12012 can improve patient comfort by conforming to the patient's face during dynamic movements (e.g., turning the head from side to side).

[0555] In some forms, the upper strap 12008 can be connected to the lower strap 12012 using one of the above-described connection techniques. For example, the lower strap 12012 can be sewn to the upper strap 12008 along the surface forming the angle β. In other words, at least a portion of the lower strap 12012 may be further below the patient's head than the upper strap 12008. Pretensioning of the lower strap 12012 can help limit downward pull of the upper strap 12008 (or the headgear strap 12002 as a whole).

[0556] In certain forms, the upper strap 12008 and the lower strap 12012 on the same side (e.g., left or right) of the headgear strap 12002 can be angled relative to each other. In certain forms, the angle ψ can be between about 1° and about 90°. In certain forms, the angle ψ can be between about 10° and about 80°. In certain forms, the angle ψ can be between about 25° and about 75°. In certain forms, the angle ψ can be between about 40° and about 60°. In certain forms, the angle ψ can be about 50°.

[0557] like Fig.75 As shown in FIG. 1 , an alternative version of headgear strap 12002 - 1 may be used with patient interface 3000 . Headgear strap 12002 - 1 may be substantially similar to headgear strap 12002 .

[0558] In some forms, the rear strap 12004-1 may be constructed of the same hardened or rigid material as the upper strap 12008-1. The upper strap 12008-1 and the rear strap 12004-1 may be connected together using one of the techniques described above, or may be formed together as a single piece.

[0559] The lower strap 12012-1 can be connected to the upper strap 14008-1 in a similar manner as the upper strap 12008 is connected to the lower strap 12012. In the example shown, the lower strap 12012-1 can also be constructed of an elastic or stretchable material.

[0560] In some forms, the upper strap 12008-1 and the lower strap 12012-1 can be angled relative to each other on the same side (e.g., left or right) of the headgear strap 12002-1. In some forms, the angle ω can be between about 1° and about 90°. In some forms, the angle ω can be between about 10° and about 80°. In some forms, the angle ω can be between about 25° and about 75°. In some forms, the angle ω can be between about 30° and about 50°. In some forms, the angle ω can be about 40°.

[0561] like Fig.76 As shown, the hollow tube 3334 can be Fig.66 The hollow tube 3334 is bent more backward. The tabs 3320 can be aligned with the apex axis AA. This allows the tabs 3334 to be lower on the hollow tubes 3334 (e.g., lower than Fig.66 3320 is lower). Thus, upper strap 14008 may not require extension 3358 in order to be positioned substantially parallel to line L2. Upper strap 14008 is able to achieve the same force vector as the superior force vector of upper strap 7008. Because tab 3320 is positioned more in the rear direction, upper strap 14008 may be connected near or on rear strap 14004 (e.g., via a connector area, not shown).

[0562] The lower strap 12012 can be connected to the inflatable chamber 3200 in a similar manner as described for the lower strap 7012. Tightening the lower strap 12012 can apply tension to the lower strap 12012 as well as the rear strap 14004.

[0563] The shape of the headgear strap 14002 can improve patient comfort because the strap sits higher on the patient's head. For example, the back strap 14004 can rest on the occipital bone, and the large surface area can help secure the back strap to the patient's head. Additionally, the angle β of the upper strap 14008 can help anchor the headgear strap 14002 to the patient's head (e.g., due to the material and its position) without providing uncomfortable pressure on the patient's neck.

[0564] exist Fig.75 In the example shown in FIG. 76 , the headgear strap 12002 may not include a bottom strap and / or a top strap. In other words, the headgear strap 12002 does not include a strap extending below the patient's chin (e.g., below the chin protuberance). The headgear strap 12002 also does not include a strap extending toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the headgear strap 12002 may include a top strap and / or a bottom strap.

[0565] 5.3.3.4 Removable belt

[0566] like Fig.77 As shown, the positioning and stabilizing structure 13000 may include a removable arm 13004. The removable arm 13004 may be configured of a rigid material or a semi-rigid material (e.g., plastic) to maintain its shape. In some forms, the patient may bend the arm 13004 slightly to adjust its angle.

[0567] The arm 13004 can include a first end having a clip 13008 that can be biased toward a closed position. The patient can pull the clip 13008 to provide enough space to fit around the tab 3320 of the hollow tube 3334. The clip 13008 can then return to its biased position to strike the tab 3320 and secure the arm 13004 to the hollow tube 3334.

[0568] In some forms, the clip 13008 can be smaller than the tab 3320. This can allow the clip 13008 to move within the tab 3320 while remaining connected to the tab 3320. The clip 13008 can also rotate within the tab 3320 as a result of the applied tension. The position and / or angle within the tab 3320 can depend on the size of the patient's head, which can allow the arm 13004 to be used with patients of different sizes.

[0569] In certain forms, the clip 13008 may have a range of translational motion between about 1 mm and about 1000 mm. In certain forms, the clip 13008 may have a range of translational motion between about 5 mm and about 100 mm. In certain forms, the clip 13008 may have a range of translational motion between about 10 mm and about 75 mm. In certain forms, the clip 13008 may have a range of translational motion between about 30 mm and about 50 mm.

[0570] The second end of the arm 13004 opposite the clip 13008 may include a loop 13012. A strap (e.g., a lower strap, not shown) may be passed through the loop 13012 and adjusted to vary the tension. The strap may be a single strap extending between the two arms 13004, or may be a pair of straps connected to a rear strap. For example, the strap may be similar to Fig.56 The back strap 3304.

[0571] In some forms, the loop 13012 can be curved and can be wider than the strap. This can allow the strap to slide within the loop 13012 and adjust to an ideal position for a given patient. In this way, the clip 13008 and loop 13012 of each arm 13004 can allow for slight adjustments so that the positioning and stabilizing structure 13000 can better fit an individual patient, thereby promoting comfort and patient compliance.

[0572] In some forms, the arm 13004 can be angled between the clip 13008 and the loop 13012. For example, the shape of the arm 13004 can be similar to Fig.56 Extensions 3358a, 3358b. In some forms, the clip 13008 can be connected to a hollow tube 3334 substantially parallel to the Frankfort horizontal line when in use. The arm 13004 can be tilted so that the ring 13012 is at an angle of approximately 30° relative to the Frankfort horizontal plane.

[0573] In certain forms, the arm 13004 may include at least one bendable section 13038. The patient may adjust the inner arm angle but move one or more bendable sections 13038. The bendable sections 13038 may allow the patient to customize the shape of each arm 13004 to better fit the individual patient.

[0574] In some forms, the arm 13004 can be covered with a soft material to further improve patient comfort. For example, a textile sleeve (not shown) can be positioned around the arm 13004. The sleeve can cover the exposed clip 13008 and ring 13012. The sleeve can also be removable or permanently connected to the arm 13004.

[0575] like Fig.78 and 79 As shown, arm 13004 can contact one side of the patient's head and can extend beyond the patient's ear. This helps reduce the possibility of any strap contacting the patient's ear and causing irritation. Arm 13004 can be connected to side portion 3350a and pad 3354, which, as described above, can anchor the patient interface 3000 to the patient's head. Arm 13004 can be attached to a nasal cushion (see, e.g., Fig.78 ) or full face pads (see e.g. Fig.79 In other examples, the arm 13004 can be used without the side 3350a and the pad 3354.

[0576] exist Fig.78 and 79 In the example shown, 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., above the masseter muscle) and between the pad 3354 and / or the side 3350 and the plenum 3200. In other examples, the patient interface 3000 may include a lower strap.

[0577] exist Fig.78 and 79 In the example shown, the patient interface 3000 may not include a bottom strap and / or a top strap. In other words, the patient interface 3000 may not include a strap that extends below the patient's chin (e.g., below the mental protuberance). The patient interface 3000 may also not include a strap that extends toward the crown of the patient's head (e.g., along the parietal bone toward the control plane). In other examples, the patient interface 3000 may include a top strap and / or a bottom strap.

[0578] like Fig.80As shown in Figure 82, an alternative form of positioning and stabilizing structure 14000 may include a removable arm 14004. Removable arm 14004 may be configured from a rigid material or a semi-rigid material (e.g., plastic) to maintain its shape. In some forms, the patient can bend arm 14004 slightly to adjust its angle. Arm 14004 may be substantially similar to arm 13004, and only certain similarities and differences are described below.

[0579] like Fig.80 and 80 As shown in FIG. 1 , the first end of the arm 14004 may include a clip 14008 that may be removably connected to the tab 3320 of the hollow tube 3334. Fig.77 Similar to the clip 13008, Fig.78 The clip 14008 in the embodiment may include a locked position when the clip 14008 is clamped down on the tab 3320. Unlike the clip 13008, the clip 14008 can rotate relative to the rest of the arm 14004. For example, the first end of the arm 14008 may include a post 14009. The clip 14008 can be coupled to the post 14009 and can rotate relative to the post 14009. In some forms, the clip 14008 can rotate freely about the post 14009. In some forms, the clip 14008 can be biased toward the locked position and may have to overcome the bias to rotate toward the open position.

[0580] In some forms, arm 14004 may include a lock 14010 disposed proximate to the first end. Lock 14010 may include a protrusion 14011 that selectively contacts clip 14008. Protrusion 14011 may limit the rotation of clip 14008 around post 14009. For example, when arm 14004 is connected to tab 3320, the patient may engage protrusion 14011 with clip 14008. This may limit the rotational movement of clip 14008 around post 14009 and limit the occurrence of clip 14008 accidentally disengaging from tab 3320 (e.g., when the patient is sleeping). The patient may manually move protrusion 14011 and / or clip 14008 so that the two are no longer in contact. This may allow clip 14008 to move more freely, so that the patient may disconnect arm 14004 from hollow tube 3334 (e.g., and use a different positioning and stabilizing structure).

[0581] like Fig.81As shown, the lock 14010 can be integrally formed with the post 14009 and / or the clip 14008. For example, the lock 14010 can be overmolded with the post 14009 and / or the clip 14008 so that the lock 14010 cannot be completely separated from the arm 14004. In other examples, the lock 14010 can be connected to the post 14009 and / or the clip using a fastener (e.g., a mechanical fastener). For example, the post 14009 and the lock 14010 can be formed together and connected to the arm 14004. They can allow the clip 14008 to rotate around the post while also limiting the overall movement of the clip 14008.

[0582] Continue to refer to Fig.81 , the arm 14004 may be bent between the first end and the second end. Unlike the second end of the arm 13004 including the 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 have a smaller width than the rest of the arm 14012.

[0583] In some forms, arms 14004 may be similar to the arms of eyeglasses. For example, arms 14004 may contact the patient's head above the patient's ears and may bend around the patient's ears below and behind. Arms 14004 may remain on the sides of the patient's head and may not extend to the posterior region of the patient's head (e.g., may not cover the occipital bone or trapezius muscles).

[0584] like Fig.82 As shown, sleeve 14040 can be connected to arm 14004. The tapered end 14012 of arm 14004 can be inserted into sleeve 14040. The curvature and taper of arm 14040 can help sleeve 14040 slide along the length of arm 14004 so as to limit bunching or snagging of sleeve 14040. In some examples, sleeve 14040 can be configured from a comfortable and / or compliant material so that it can adjust to the shape of arm 14004. The material can be a textile that can fit comfortably against the patient's face.

[0585] like Fig.83 and 84 As shown, arm 14004 can contact the side of the patient's head and can extend beyond the patient's ear. Arm 14004 can rest on the patient's head like glasses. Arm 14004 can be used without the need for additional straps (e.g., top strap, bottom strap, lower strap, upper strap, etc.) and can be capable of supporting the seal-forming structure 3100 in a sealed position. Arm 14004 can be used with a nasal cushion (see, e.g., Fig.83 ) or full face pads (see e.g. Fig.84 ) In other examples, arm 14004 can be used with any combination of the above-described straps.

[0586] 5.3.4 Ventilation

[0587] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0588] In certain forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding ambient environment while the pressure within the plenum chamber is positive relative to the surrounding ambient environment. The vent 3400 is configured so that the vent flow is of sufficient magnitude to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0589] One form of a vent 3400 in accordance with the present technology includes a plurality of holes 3404 , for example, about 20 to about 80 holes 3404 , or about 40 to about 60 holes 3404 , or about 45 to about 55 holes 3404 .

[0590] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, such as a swivel.

[0591] 5.3.5 Decoupling structure

[0592] In one form, the patient interface 3000 includes at least one decoupling structure 3500, such as a swivel or a ball and socket.

[0593] like Fig.46 As shown, the decoupling structure 3500 is inserted through the first inlet port 3208. The decoupling structure 3500 holds the flap 3338 in the open position and prevents the flap 3338 from moving to the closed position.

[0594] In certain forms, the decoupling structure 3500 can be moved from a first inlet port 3208 on the plenum 3200 to a third inlet port 3209 spaced apart from the first inlet port 3208. 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 is greater than the bias (e.g., mechanical, magnetic, etc.) of the flap 3207. The flap 3207 moves to a closed position and substantially prevents air from escaping through the first inlet port 3208. Unlike the second inlet port 3336, the third inlet port 3209 does not include a flap.

[0595] 5.3.6 Plug

[0596] like Fig.46As shown, one form of the patient interface 3000 includes a plug 3550. The plug 3550 is inserted through one of the ports 3208, 3336 to substantially prevent airflow through the port 3208, 3336. For example, the plug 3550 may be coupled to the port 3208, 3336 when the decoupling structure 3500 is not received.

[0597] In certain versions, the plug 3550 may be used with a port 3208, 3336 that includes a valve 3206, 3339. The plug 3550 holds the valve 3206, 3339 in an open position while providing the seal itself.

[0598] 5.3.7 Connection Port

[0599] The connection port 3600 allows connection to the air circuit 4170 .

[0600] 5.3.8 Forehead support

[0601] 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.

[0602] 5.3.9 Anti-asphyxia valve

[0603] In one form, patient interface 3000 includes an anti-asphyxia valve (AAV) (eg, flap 3207 and flap 3338).

[0604] like Fig.46 As shown, the particular form of the fins 3207, 3338 proximate the first and / or second ports 3208, 3336 act as AAVs 3206, 3339, respectively, when the decoupling structure 3500 is not coupled to the corresponding ports 3208, 3336. The decoupling structure 3500 may include additional AAVs 3206, 3339 to allow airflow through the ports to which the decoupling structure 3500 is coupled.

[0605] In some forms, an AAV (not shown) may be included on the decoupling structure 3500 and the plenum 3200 or positioning and stabilising structure 3300 may not include corresponding tabs 3207, 3338. Plug 3550 is inserted into a port 3208, 3336 that does not include the decoupling structure 3500.

[0606] 5.3.10 Ports

[0607] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0608] 5.4RPT device

[0609] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to pressurize the flow of air delivered to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0610] In one form, the RPT device 4000 is constructed and arranged to deliver air flow 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.

[0611] The RPT device can have an outer housing 4010. The outer housing 4010 can be comprised of two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 can include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0612] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor and a flow sensor.

[0613] One or more air path items may be disposed within a removable separate structure, which will be 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 forms part of, the chassis 4016. The pneumatic block 4020 may include one or more pneumatic components 4100.

[0614] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0615] 5.4.1 Mechanical and pneumatic components of RPT device

[0616] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0617] 5.4.1.1 Air filter

[0618] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0619] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0620] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0621] 5.4.1.2 Silencer

[0622] An RPT device according to one form of the present technology may include a silencer 4120 , or a plurality of silencers 4120 .

[0623] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140 .

[0624] In one form of the present technology, an outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0625] 5.4.1.3 Pressure generator

[0626] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver air supply in other forms such as at a rate of up to about 120 liters per minute and at a positive pressure in the range of about 4 cm H2O to about 20 cm H2O or up to about 30 cm H2O when delivering respiratory pressure therapy, for example. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0627] Pressure generator 4140 is under the control of the treatment device controller.

[0628] In other words, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0629] 5.4.1.4 Converter

[0630] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit such as a patient interface. An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0631] 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 representative of a characteristic of the air flow such as flow, pressure or temperature at that point in the pneumatic path.

[0632] In one form of the present technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 .

[0633] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0634] 5.4.1.5 Anti-overflow valve

[0635] In one form of the present technology, an anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0636] 5.5 Air circuit

[0637] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000 or 3800 .

[0638] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0639] In certain forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0640] 5.5.1 Supplemental Gas Delivery

[0641] In one form of the present technology, supplemental gas 4180 , such as oxygen, is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0642] 5.6 Humidifier

[0643] 5.6.1 Overview of Humidifier

[0644] In one form of the present technology, a humidifier 5000 is provided to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to ambient air) before delivery to the patient's airway.

[0645] The humidifier 5000 may include a humidifier water reservoir, a humidifier inlet for receiving an air stream, and a humidifier outlet for delivering a humidified air stream. In some forms, the inlet and outlet of the humidifier water reservoir may be a humidifier inlet and a humidifier outlet, respectively. The humidifier 5000 may also include a humidifier base, which may be adapted to receive the humidifier water reservoir and include a heating element.

[0646] 5.7 Respiratory waveform

[0647] Fig.42 The following figure shows a typical breathing waveform of a model of a person during sleep. The horizontal axis is time and the vertical axis is respiratory flow. While the parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5L, inspiratory time Ti 1.6s, peak inspiratory flow Qpeak 0.4L / s, expiratory time Te 2.4s, peak expiratory flow Qpeak-0.5L / s. The total duration of the breath Ttot is about 4s. A person usually breathes at a rate of about 15 breaths per minute (BPM) and a ventilation rate of Vent of about 7.5L / min. The typical duty cycle, the ratio of Ti to Ttot is about 40%.

[0648] 5.8 Glossary

[0649] For purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0650] 5.8.1 General

[0651] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0652] Ambient: In certain forms of the present technology, the term ambient can have the following meanings: (i) external to a treatment system or patient, and (ii) directly surrounding a treatment system or patient.

[0653] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0654] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0655] In some forms, ambient noise (e.g., acoustic) may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0656] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0657] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the treatment pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0658] Flow: Volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, reference to flow will be to a scalar quantity, i.e. a quantity having only dimension. In other cases, reference to flow will be to a vector quantity, i.e. a quantity having both dimension and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0659] Flow Therapy: Respiratory therapy that involves delivering a flow of air to the airway entrance at a controlled flow rate, called the therapy flow, that is normally positive throughout the patient's respiratory cycle.

[0660] Humidifier: The term humidifier shall be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0661] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return bend to the surrounding ambient environment.

[0662] Noise, conducted (acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0663] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0664] Noise, Ventilation (Acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any vent, such as the vent holes of a patient interface.

[0665] Patient: A person, whether or not they have a respiratory condition.

[0666] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 , hectopascal. 1cmH20 is equal to 1g-f / cm 2 And about 0.98 hPa (1 hPa = 100 Pa = 100 N / m 2 =1 mbar to 0.001 atmosphere (atm). In this specification, unless otherwise stated, pressure is given in cm H2O.

[0667] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0668] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0669] 5.8.1.1 Materials

[0670] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer to either liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of LSR that is commercially available is (included in the range of products sold under this trademark), which is manufactured by DuPont. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0671] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0672] Textile: A flexible material made from interlaced fibers using techniques including, but not limited to, weaving, knitting, crocheting, or braiding. Specific types of textiles may include fabrics produced by specific techniques (e.g., weaving and knitting).

[0673] 5.8.1.2 Mechanical properties

[0674] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0675] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0676] Hardness: The ability of a material to resist deformation inherently (as described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0677] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0678] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0679] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions. The inverse of stiffness is compliance.

[0680] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, such as within 1 second.

[0681] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with the entrance to a patient's airway, for example at a pressure of about 20 to 30 cmH2O.

[0682] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0683] 5.8.2 Breathing cycle

[0684] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0685] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0686] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0687] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0688] Expiratory portion of the breathing cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0689] Inspiratory portion of the breathing cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the breathing cycle.

[0690]

[00136] Patency (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway patency can be quantified, for example with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0691] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0692] Respiratory flow, patient air flow, respiratory air flow (Qr): These synonymous terms may be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0693] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined to be equal to either volume. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, such as an average.

[0694] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0695] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0696] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0697] Ventilation (Vent): A measure of the rate of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given simply as volume, and is understood to be the volume per minute.

[0698] 5.8.3 Anatomy

[0699] 5.8.3.1 Facial anatomy

[0700] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0701] Alar tip: The outermost point on the wing of the nose.

[0702] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0703] Auricle: The entire external visible part of the ear.

[0704] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nose of the frontal bone.

[0705] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0706] Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

[0707] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (where both lines intersect at the lower point of the nasal septum).

[0708] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0709] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0710] External nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0711] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar nasal cavity.

[0712] Nare: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular form of nare is naris (nare). The nostrils are separated by the nasal septum.

[0713] Nasolabial Folds or Nasolabial Wrinkles: Folds or grooves of skin extending from each side of the nose to the corners of the mouth that separate the cheeks from the upper lip.

[0714] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0715] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0716] Auricular base: The highest point where the auricle attaches to the facial skin.

[0717] Nasal prominence: The most prominent point or tip of the nose which can be identified in a side view of the rest of the head.

[0718] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0719] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0720] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0721] Sagittal plane: A vertical plane that runs from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0722] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0723] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0724] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (superior) lip.

[0725] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0726] Mandibular alveolar seat point: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue.

[0727] 5.8.3.2 Anatomy of the skull

[0728] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0729] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0730] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0731] Nasal Bones: The nasal bones are two small oval bones that vary in size and form among different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0732] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0733] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0734] Orbit: The bony cavity in the skull that receives the eyeball.

[0735] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0736] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0737] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0738] 5.8.3.3 Anatomy of the respiratory system

[0739] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0740] Larynx: The larynx or voice box receives the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0741] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0742] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0743] Pharynx: The part of the throat located just below (below) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the hypopharynx (hypopharynx).

[0744] 5.8.4 Patient Interface

[0745] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0746] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling 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 or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In some forms, the elbow may be rotatable relative to a mating component, such as approximately 360 degrees. In some forms, the elbow may be removable from a mating component, such as via a snap connection. In some forms, the elbow may be assembled to a mating component via a one-time snap during manufacturing, but may not be removed by the patient.

[0747] Frame: A frame will be considered to mean a mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0748] Headgear: Headgear will be considered to mean a form of positioning and stabilizing structure configured for use on the head. For example, the headgear may include a collection of one or more support rods, straps, and reinforcements configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Certain straps are formed of soft, flexible, resilient materials, such as laminate composites of foam and fabric.

[0749] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0750] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0751] Seal: can be a noun form referring to a structure ("seal") or a verb form referring to the effect (seal). Two elements can be configured and / or arranged to 'seal' or achieve a 'seal' therebetween without requiring a separate 'seal' element itself.

[0752] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0753] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0754] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0755] Swivel: (noun) A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the component preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0756] Tie (noun): A structure used to resist tension.

[0757] Vent: (noun): A structure that allows air flow from the interior of a mask or duct to the surrounding ambient air, e.g., for effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0758] 5.8.5 Shape of the structure

[0759] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or certain other characteristics. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0760] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure, cf. Figures 17 to 21 , which show a cross section at a point p on the surface and an example of the resulting plane curve. Figures 17 to 21 The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0761] 5.8.5.1 Curvature in one dimension

[0762] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0763] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person were to leave that point p, they would have to walk uphill). Fig.17 (and Fig.18 Compared with the relatively large positive curvature) and Fig.18 (and Fig.17 Such curves are often called concave.

[0764] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Fig.19 .

[0765] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). Fig. 20 (and Fig.21 Compared to the relatively small negative curvature) and Fig.21 (and Fig. 20 Such curves are often called convex.

[0766] 5.8.5.2 Curvature of a Two-Dimensional Surface

[0767] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, such as a relatively small magnitude. Figures 17 to 21 The plane curve in can be an example of such multiple cross sections at specific points.

[0768] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. Figures 17 to 21 In the example of Fig.17 and the minimum value appears at Fig.21 Therefore Fig.17 and Fig.21 is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0769] Region of a surface: A connected set of points on a surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0770] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0771] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0772] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0773] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0774] Edge of a surface: The boundary or limit of a surface or area.

[0775] Path: In some forms of the present technology, a 'path' will be taken to mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0776] Path length: In some forms of the present technology, 'path length' will be considered to be the distance along the 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 the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0777] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there may be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.

[0778] 5.8.5.3 Space curve

[0779] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Fig.32 The typical human right ear includes a helix that is a right-handed helix, see Fig.33 . Fig.34 A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0780] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her aircraft at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0781] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector pointing in the direction of the change in the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0782] 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 Fig.31 ) or alternatively by the left-hand rule ( Fig.30 ) to determine.

[0783] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Figure 3 O and 31.

[0784] Torsion of a space curve: The torsion of a space curve at a point is the measure of the rate of change of the binormal unit vector at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Fig.34 , since T2>T1, so Fig.34 The twist near the top coil of the helix is ​​greater than Fig.34 The amount of twist in the bottom coil of the helix.

[0785] Reference Fig.31 According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g., Fig.34 A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0786] Similarly, refer to the left-hand rule (see Figure 3 O), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. Fig.35 .

[0787] 5.8.5.4 Holes

[0788] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, for example Fig.24 A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0789] A structure can have two-dimensional pores, such as pores defined by a surface. For example, a pneumatic tire has a two-dimensional pore defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional pore. See, for example, Fig. 27 The padding and the Fig.28 and Fig.29 , which shows an inner surface defining a two-dimensional hole. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Fig.26 A two-dimensional hole in the shown structure bounded by the shown surface.

[0790] 5.9 Other notes

[0791] Unless the context clearly indicates and provides a numerical range, it should be understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other such value or intervening value in the range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the range. In the case where the range includes one or both of the limits, the present technology also includes ranges excluding either or both of those included limits.

[0792] Furthermore, where a value or values ​​are used herein as part of implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated, and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0793] Furthermore, "approximately," "substantially," "about" or any similar term as used herein means + / - 5 to + / - 10% of the stated value.

[0794] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of representative methods and materials are described herein.

[0795] When a specific material is identified for configuring a component, obvious alternative materials with similar properties are used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0796] It must be noted that as used herein and the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0797] All publications mentioned herein are incorporated herein in their entirety by reference, to disclose and describe methods and / or materials as the subject of those publications. Providing the publications discussed herein is only for the disclosures before the filing date of the present application. Anything herein should not be construed as admitting that the present technology is not entitled to the priority of these publications due to previous inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed separately.

[0798] The terms "comprises" and "comprising" should be understood to refer to each element, component or step in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0799] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the disclosure or claims as a whole. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0800] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order may be modified, and / or aspects of the order may be performed simultaneously or even synchronously.

[0801] It is therefore to be understood that numerous modifications may be made to the exemplary embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0802] 5.10 Reference Symbols List

[0803]

[0804]

[0805]

[0806]

[0807]

[0808]

[0809]

[0810]

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealed delivery of a flow of air at said therapeutic pressure throughout a breathing cycle of the patient, said seal-forming structure having an aperture therein such that said flow of air at said therapeutic pressure is delivered to at least one entrance to a nares of the patient, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout a breathing cycle of said patient; A positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube formed as a continuous structure to receive the air flow from a connection port on top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, the gas delivery tube comprising a pair of tabs constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base above the patient's head in use, wherein each tab of the pair of tabs has an opening having an opening length; a pair of removable arms removably coupled to the tab, each removable arm being constructed and arranged to extend in a rearward and inferior direction in use, each removable arm comprising: a first end comprising a clip configured to remove one of the pair of tabs, wherein the clip comprises a clip length that is less than a length of the opening, wherein the clip is configured to move along the clip length and / or pivot within the opening to adjust a force vector, and a second end opposite the first end; and a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the plenum to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum during use, Wherein the patient interface is configured to allow the patient to breathe from the ambient environment through his or her mouth without a flow of pressurized air through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

2. A patient interface according to claim 1, wherein the second end of each removable arm of the pair of removable arms includes a slot.

3. A patient interface according to any one of claims 1 to 2, wherein the slot is arcuate.

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

5. A patient interface according to claim 4, wherein the rear strap is configured to extend in a posterior and inferior direction on the patient's head so as to contact the occipital portion of the patient's head during use, and the rear strap is composed of a first material and a second material, the first material is arranged to contact the temporal region of the patient's head during use, and the second material is arranged to contact the occipital portion of the patient's head during use.

6. A patient interface according to claim 5, wherein the first material is a textile, and wherein the second material is silicone.

7. A patient interface according to any one of claims 4 to 6 when dependent on any one of claims 28 to 29 wherein the rear strap is received in each slot.

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

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

10. A patient interface according to any one of claims 1 to 9, wherein each removable arm is bent between the first end and the second end.

11. A patient interface according to any one of claims 1 to 10, wherein the second end is configured to contact the patient's head at approximately 30° below the Frankfort level.

12. A patient interface according to any one of claims 1 to 11, wherein each clip is biased towards a closed position, and wherein the clip is movable to an open position so as to connect to the respective tab.

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

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

15. A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealed delivery of a flow of air at said therapeutic pressure throughout a breathing cycle of the patient, said seal-forming structure having an aperture therein such that said flow of air at said therapeutic pressure is delivered to at least one entrance to a nares of the patient, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout a breathing cycle of said patient; A positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a gas delivery tube formed as a continuous structure to receive the air flow from a connection port on top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, the gas delivery tube including a pair of tabs constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base above the patient's head in use; a pair of removable arms removably coupled to the tab, each removable arm being constructed and arranged to extend in a rearward and inferior direction in use, each removable arm comprising: a first end including a post, a clip movable about the post and configured to removably engage the top strap, and a lock configured to selectively limit movement of the clip about the post, and a second end opposite the first end; and a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the plenum to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum during use, Wherein the patient interface is configured to allow the patient to breathe from the ambient environment through his or her mouth without a flow of pressurized air through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

16. A patient interface according to claim 15, wherein the clip is pivotally connected to the post.

17. A patient interface according to claim 16, wherein when the lock is in the unlocked position, the clip is free to pivot about the post.

18. A patient interface according to claim 16, wherein the clip is biased towards a surface of the removable arm.

19. A patient interface according to claim 15, wherein the lock of each removable arm is removably connected to the corresponding post.

20. A patient interface according to claim 15, wherein the lock of each removable arm is integrally formed with the corresponding post.

21. A patient interface according to claim 20, wherein the lock is overmoulded with the post.

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

23. A patient interface according to any one of claims 15 to 22, wherein each removable 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 removable arm tapers towards the second end.

25. A patient interface according to any one of claims 15 to 24, further comprising a pair of textile sleeves, wherein each textile sleeve of the pair of textile sleeves is configured to receive a removable arm of the pair of removable arms.

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

27. A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealed delivery of a flow of air at said therapeutic pressure throughout a breathing cycle of the patient, said seal-forming structure having an aperture therein such that said flow of air at said therapeutic pressure is delivered to at least one entrance to a nares of the patient, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said plenum chamber throughout a breathing cycle of said patient; A positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a rear strap configured to contact the patient's head and cover at least a portion of the occipital bone; a pair of upper straps configured for selectively applying rearwardly directed tension, the pair of upper straps being connected to the rear strap beneath 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 for selectively applying rearwardly directed tension, the pair of lower straps being connected to the pair of upper straps beneath at least a portion of the upper straps, each lower strap of the pair of lower straps including a connector region; a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the plenum to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum during use, Wherein the patient interface is configured to allow the patient to breathe from the ambient environment through his or her mouth without a flow of pressurized air through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

28. A patient interface according to 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. A patient interface according to claim 28, wherein the first material and the third material are the same.

30. A patient interface according to any one of claims 28 to 29, wherein the first material and the third material are stretchable materials.

31. A patient interface according to any one of claims 28 to 30 wherein the rear strap is pre-tensioned in the non-use position.

32. A patient interface according to claim 28, wherein the first material and the second material are the same.

33. A patient interface according to claim 28 or claim 32, wherein the first material and the second material are non-stretchable materials.

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

35. A patient interface according to claim 34, wherein the upper side of the rear strap is substantially horizontal.

36. A patient interface according to any one of claims 34 to 35, wherein the lower end of the rear strap forms a rear strap angle of between about 110° and about 150°.

37. A patient interface according to claim 36, wherein the rear strap angle is approximately 130°.

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

39. A patient interface according to claim 38, wherein the lower ends of the pair of upper straps form an upper strap angle of between about 110° and about 170°.

40. A patient interface according to claim 39, wherein said upper strap angle is approximately 150°.

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

42. A patient interface according to 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, wherein the lower strap angle is between about 30° and about 70°.

43. A patient interface according to claim 42, wherein the lower strap angle is approximately 50°.

44. A patient interface according to any one of claims 27 to 43, wherein the pair of upper straps are pre-tensioned in the non-use position.

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

46. ​​A patient interface according to any one of claims 27 to 45, wherein the positioning and stabilizing structure further includes a gas delivery tube, which is formed as a continuous structure to receive the air flow from a connection port on the top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, and the gas delivery tube includes a pair of tabs, which are constructed and arranged to contact at least one area of ​​the patient's head above the supra-auricular base above the patient's head when in use.

47. A patient interface according to claim 46 wherein said each upper strap of said pair of upper straps is removably connected to a tab of said pair of tabs.

48. A patient interface according to 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 wherein, The connector region of each upper strap of the pair of upper straps is a hook material.

Images