Connector for positioning and stabilizing structure

Abstract

A patient interface includes an inflation chamber pressurizable to a treatment pressure, a seal-forming structure constructed and arranged to maintain the treatment pressure in the inflation chamber, a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes: at least one arm configured to be positioned adjacent a cheek of a patient; and a strap removably received around the arm and configured to contact a posterior region of a patient's head. The belt includes a first coupler having a mechanical connector configured to engage the arm and limit movement of the arm into and out of the cavity, a second coupler spaced from an outer surface of the first coupler, and a sleeve configured to sleeve the second coupler. The sleeve is folded over the second coupling and positioned between the first and second couplings.

Description

[0001] 1 Cross-reference to related applications

[0002] This application is a divisional application of a Chinese invention patent application with an application date of January 28, 2021, application number 202180024221.0, and title “Connector for positioning and stabilizing structure”. The Chinese invention patent application claims the benefit of Australian provisional application No. 2020900227 filed on January 29, 2020, the entire contents of which are incorporated herein by reference. 2 Technical Background 2.1 Technical Field

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

[0005] 2.2 Description of Related Technology

[0006] 2.2.1 Human respiratory system and its diseases

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

[0008] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the inhaled air and 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.

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

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

[0011] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and 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. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Respiratory failure is a term for a respiratory disorder in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0013] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0014] A range of therapies 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] 2.2.2.2 Flow treatment

[0021] Not all respiratory therapies are intended to deliver prescribed treatment pressures. Some respiratory therapies are intended to deliver prescribed respiratory volumes by delivering an inspiratory flow curve (possibly superimposed on a positive baseline pressure) within a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy can only supplement the patient's own spontaneous breathing with a flow of regulated or enriched gas. In one example, high flow therapy (HFT) provides a continuous, heated, humidified air flow to the airway entrance through an unsealed or opened patient interface with a "treatment flow" that remains roughly constant throughout the respiratory cycle. The treatment flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory diseases. A mechanism of action is that the high flow of air at the airway entrance improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (deadspace therapy) (DST surgery). Other benefits may include the possibility of increased warmth and humidity (possibly beneficial in secretion management) and appropriate increase in airway pressure. As an alternative to a constant flow, the therapy flow may follow a curve that varies during the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe continuous oxygen-enriched air delivered to a patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (oxygen fraction in ambient air, from 21% to 100%).

[0023] 2.2.2.3 Supplemental oxygen

[0024] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized air flow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0025] 2.2.3 Respiratory therapy system

[0026] 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.

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

[0028] 2.2.3.1 Patient interface

[0029] The patient interface can be used to engage the respiratory device to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (for example, a positive pressure of approximately 10 cm H2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway. For flow treatments such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids complete sealing. An example of such a patient interface is a nasal cannula.

[0030] 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 environment inside.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0036] 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.

[0037] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0038] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0039] 2.2.3.1.1 Sealing structure

[0040] 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.

[0041] 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. This 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.

[0042] 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 seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0043] Certain seal-forming structures may be designed for mass manufacturing so that one design is appropriate, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0044] 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 a 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 inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0045] Another type of seal-forming structure incorporates a sheet seal of 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 previous forms of seal-forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0046] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0047] 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.

[0048] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0049] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0050] 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 applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the MIRAGE LIBERTY TM Other aspects of full-face masks); International patent application WO2009 / 052,560 (which describes the SWIFT TM Other aspects of the FX pillows).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] 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.

[0053] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0054] 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.

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0056] 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.

[0057] 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.

[0058] An example of a special requirement for certain RPT devices is noise.

[0059] 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).

[0060] 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[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0061] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. 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.

[0062] ResMed Elisée TM 150 ventilator and ResMed 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.

[0063] 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.

[0064] 2.2.3.3 Air circuit

[0065] 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.

[0066] 2.2.3.4 Humidifier

[0067] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0068] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0069] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, usually where the patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. Medical humidifiers can be constructed to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, but these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0070] 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.

[0071] 2.2.3.5 Data Management

[0072] 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.

[0073] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0074] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0075] 2.2.3.6 Mandibular reduction

[0076] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom made or produced in a standard form and include a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduce vibrations of the palate.

[0077] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0078] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0079] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (such as the ResMed Narval CCTM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0080] 2.2.3.7 Ventilation technology

[0081] Some forms of therapy systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space outside the patient interface, such as to the environment.

[0082] The vent may include an orifice through which gas may flow when the mask is used. Many such vents are noisy. Others may become blocked when in use, thereby providing insufficient flushing. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example by making noise or by gathering airflow.

[0083] ResMed Inc. has developed many improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. US2009 / 0044808.

[0084] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cm H2O at 1m)

[0085]

[0086] (*One sample only, measured at 10cm H2O in CPAP mode using the test method specified in ISO 3744) The sound pressure values ​​for various objects are listed below

[0087]

[0088] 2.2.4 Screening, diagnosis and surveillance systems

[0089] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and is generally related to professional clinical personnel applying the system. PSG generally involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. The PSG of sleep-disordered breathing involves observing the patient for two nights in the clinic, one night of pure diagnosis and the second night of clinician titration of treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0090] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis can yield clinically actionable information. Screening and diagnosis tend to be one-time processes, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only for screening / diagnosis, while some can also be used for monitoring.

[0091] A clinical expert may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. 3. Summary of the invention

[0092] 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.

[0093] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0094] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0095] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0096] One form of the present technology is directed to a patient interface that may include: 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 may be further configured so that the patient's mouth is not covered, or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the ambient environment without pressurized air flowing through the plenum inlet port.

[0097] Another aspect of the present technology relates to a facial mount interface, which may include: a facial interface and a positioning and stabilizing structure. The facial interface may be configured to contact the face of a user (e.g., a patient). The positioning and stabilizing structure is configured to maintain the facial interface in an effective position against the user's face.

[0098] In some aspects, the face-mounted interface is a patient interface for screening, diagnosing, monitoring, improving, treating, or preventing breathing disorders. However, the face-mounted interface can be any device worn on the face of a user. The user can be a patient, an operator, an observer, or any other person.

[0099] Another aspect of one form of the present technology is directed to a positioning and stabilizing structure configured to connect to a facial interface (e.g., an inflatable chamber of a patient interface) and provide a force to maintain the facial interface in an effective position on a user's head.

[0100] Another aspect of one form of the present technology relates to a patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure; 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 so as to seal and deliver an air flow at the therapeutic pressure, the seal-forming structure 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 maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one rigidizing arm constructed to be positioned adjacent to the patient's cheek during use, and a strap that is removably received around the rigidizing arm and constructed to contact a posterior region of the patient's head during use.

[0101] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: at least one rigidizing arm configured to be positioned adjacent to a user's cheek during use, and a strap removably received around the rigidizing arm and configured to contact a posterior region of the user's head during use.

[0102] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; 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 an air flow at the therapeutic pressure, and the seal-forming structure 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 maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one arm, a band removably received around the arm, the band comprising a first rigid connector having a mechanical connection that engages the rigidized arm and limits movement of the rigidized arm into and out of a cavity of the band.

[0103] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: at least one arm, a strap removably received around the arm, the strap comprising a first rigid connector having a mechanical connection that engages the rigidized arm and limits movement of the rigidized arm into and out of a cavity of the strap.

[0104] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; 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 an air flow at the therapeutic pressure, and the seal-forming structure 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 maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: a band constructed to contact a posterior region of the patient's head during use, the band comprising: a first rigid connector, a second rigid connector spaced apart from an outer surface of the first rigid connector, and the sleeve folded over the second rigid connector and positioned between the first rigid connector and the second rigid connector.

[0105] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: a strap configured to contact a posterior region of a user's head during use, the strap comprising: a first rigid connector, a second rigid connector spaced apart from an outer surface of the first rigid connector, and the sleeve folded over the second rigid connector and positioned between the first rigid connector and the second rigid connector.

[0106] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure; 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 an air flow at the therapeutic pressure; and 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 first rigid connector and a sleeve made of a flexible material that is folded over the first rigid connector.

[0107] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: a first rigid connector and a sleeve formed of a flexible material that is folded over the first rigid connector.

[0108] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; 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 an air flow at the therapeutic pressure, and the seal-forming structure 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 maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one arm, and a band removably received around the rigidified arm, the band comprising: a first connector having a mechanical connector constructed to engage the arm; a second connector spaced apart from an outer surface of the first connector; and a sleeve constructed of a flexible material.

[0109] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: at least one arm, and a band removably received around the rigidified arm, the band comprising: a first connector having a mechanical connector configured to engage the arm; a second connector spaced apart from an outer surface of the first connector; and a sleeve constructed of a flexible material.

[0110] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O 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, 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 means of retaining the seal-forming structure on the patient's head. The positioning and stabilizing structure comprises: at least one rigidizing arm configured to be positioned adjacent to the cheek of the patient in use; and a band removably received around the rigidizing arm and configured to contact the posterior region of the patient's head in use, the band comprising: a first rigid connector forming an opening to a cavity, the rigidizing arm being positionable to pass through the opening and enter the cavity, the first rigid connector having a mechanical connector configured to engage the rigidizing arm and limit movement of the rigidizing arm into and out of the cavity, a second rigid connector spaced from an outer surface of the first rigid connector, and a sleeve composed of a flexible material folded over the second rigid connector and positioned between the first and second rigid connectors.

[0111] In some forms, the sleeve includes an outer surface and an inner surface, the outer surface comprising an outermost surface of the band and the inner surface comprising a boundary of the cavity.

[0112] In certain forms, the mechanical connector of the first rigid link includes a protrusion and the rigidifying arm includes a recess configured to receive the protrusion.

[0113] In some forms, the protrusion extends from the inner surface of the first rigid coupler at an angle of between 40° and 60°.

[0114] In some forms, the mechanical connector comprises a snap-fit ​​connection.

[0115] In some forms, the flexible material is a fabric.

[0116] In some forms, the flexible material is elastic and / or elastomeric.

[0117] In certain forms, the first rigid link and the second rigid link have a generally circular shape, and the rigidifying arm further includes an extension having at least a portion of the generally circular shape.

[0118] In some forms, the rigidifying arm is configured not to extend further in a posterior direction than the patient's ear.

[0119] In some forms, the strap includes a first component and a second component coupled together using a length adjuster, wherein the length adjuster is configured to change the usable length of the strap.

[0120] In some forms, the band is bifurcated.

[0121] In some forms, the at least one rigidifying arm includes a first rigidifying arm configured to be positioned on the left side of the patient's head in use, a second rigidifying arm coupled to the positioning and stabilizing structure and configured to be positioned adjacent the patient's right cheek in use, and the band is removably received around the second rigidifying arm, the band including: a third rigid coupling defining a second opening to the cavity, the second rigid arm being positionable through the second opening and into the cavity, the third rigid coupling having a mechanical connector that engages the second rigid arm and limits movement of the second rigid arm into and out of the second opening of the cavity, a fourth rigid coupling spaced apart from an outer surface of the first rigid coupling, and the sleeve being folded over the fourth rigid coupling and positioned between the third and fourth rigid couplings.

[0122] In some forms, the plenum chamber inlet port is a first plenum chamber inlet port, the plenum chamber further includes a second plenum chamber inlet port, the first plenum chamber inlet port is configured to receive an air flow at a therapeutic pressure, and the second plenum chamber inlet port is configured to receive an embolism, the embolism being configured to prevent the air flow at the therapeutic pressure from escaping.

[0123] In some forms, the rigidified arm comprises the plug.

[0124] In some forms, the plug is removable from the second opening to allow pressurized air to flow through the second opening.

[0125] In some forms, the rigidized arm is at least partially flexible so as to adjust the contour to substantially correspond to the patient's cheek.

[0126] In some forms, the seal-forming structure defines a nasal pillow or bracket.

[0127] In certain forms, the first rigid coupler, the second rigid coupler, and the sleeve are coupled together using an adhesive.

[0128] In certain forms, the width of the cavity is less than the width of the rigidizing arm, and wherein the sleeve is configured to stretch upon receiving the rigidizing arm.

[0129]

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

[0130]

[0011] One aspect of one form of the present technology is a method of manufacturing a patient interface.

[0131] In some forms, the method includes the steps of forming a strip by providing a flexible material; inserting the second coupler into a cavity of the flexible material; folding an end of the flexible material into the cavity to enclose the second coupler; and inserting the first coupler into the cavity.

[0132] In certain forms, the method includes the steps of connecting the positioning and stabilizing structure to the seal-forming structure by: providing an inflatable chamber having a connection opening; and inserting a plug of the rigidifying arm into the connection opening.

[0133] In some forms, the method includes applying an adhesive around the connection opening to secure the plug within the opening.

[0134] In some forms, the method includes removing the plug from the connection opening.

[0135] Another aspect of one form of the present technology is directed to a patient interface that may include: a plenum chamber; a seal-forming structure; and a positioning and stabilizing structure. The seal-forming structure may include an inlet port and the plenum chamber may include at least one connection port.

[0136] In certain forms, the inlet port is configured to receive pressurized air and the at least one connection port is configured to receive a plug to restrict fluid flow through the connection port.

[0137] In certain forms, the inlet port is configured to receive a cap and the at least one connection port is configured to receive pressurized air.

[0138] In some forms, the positioning and stabilizing structure is connected at the connection port. The positioning and stabilizing structure can be a catheter headband that delivers fluid from the top of the patient's head to the inflation chamber. Alternatively, the positioning and stabilizing structure can be an embolization plug connected to the rigidifying arm.

[0139] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising: at least one rigidized arm configured to be positioned adjacent to the cheek of the user during use; and a strap removably received around the rigidized arm and configured to contact a posterior region of the user's head during use, the strap comprising: a first rigid connector forming an opening to a cavity, the rigidized arm positionable to pass through the opening and into the cavity, the first rigid connector having a mechanical connector configured to engage the rigidized arm and limit movement of the rigidized arm into and out of the cavity, a second rigid connector spaced from an outer surface of the first rigid connector, and a sleeve comprised of a flexible material folded over the second rigid connector and positioned between the first and second rigid connectors.

[0140] One aspect of one form of the present technology is a method of making a positioning and stabilizing structure.

[0141] In some forms, a method of making a positioning and stabilizing structure includes the steps of forming a belt by: providing a flexible material; inserting the second connector into a cavity of the flexible material; folding one end of the flexible material into the cavity to close the second connector; and inserting the first connector into the cavity.

[0142] Another aspect of one form of the present technology is a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including a chamber inlet port sized and structured to receive a flow of air for patient respiration at the therapeutic pressure, the connecting inlet port sized and structured to receive a flow of air for patient respiration at the therapeutic pressure; 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, the seal-forming structure having an aperture therein such that the airflow at the therapeutic pressure is not greater than about 6 cmH2O above ambient air pressure; An air flow under force is delivered to at least one entrance of the patient's nostril, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's breathing cycle in use; and wherein the connecting inlet port is constructed to removably receive a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising at least one of the following: a rigidizing arm, the rigidizing arm being constructed to restrict fluid flow through the connecting inlet port, and the arm being constructed to be positioned along the patient's cheek when in use; and a conduit headband, the conduit headband being constructed to deliver the air flow through the connecting inlet port to the patient.

[0143] In certain forms, a rigidized arm is coupled to the connection access port, the rigidized arm comprising: a plug removably received within the connection access port and configured to restrict air flow through the connection access port; and a rigidized arm portion configured to be positioned adjacent to the patient's cheek.

[0144] In some forms, the plenum inlet port is configured to receive an air flow in use.

[0145] In some forms, the catheter headband is coupled to the connection access port, the catheter headband comprising: an inlet configured to receive the air flow, the inlet being arranged on the upper portion of the patient's head during use; and a hollow tube configured to deliver the air flow to the inflation chamber.

[0146] In some forms, the cover is removably received within the plenum chamber inlet while the catheter headband is connected to the connection access port, the cover restricting fluid flow through the plenum chamber inlet.

[0147] In some versions, the rigidizing arm and the catheter headband are interchangeably connectable to the connection access port.

[0148]

[0011] One aspect of one form of the present technology is a method of using a patient interface.

[0149] In some forms, the method includes: providing a seal-forming structure; selecting the positioning and stabilizing structure from one of the rigidizing arm and the catheter headband; connecting the positioning and stabilizing structure to the connection access port; connecting one of an air circuit and a cover to an inflation chamber inlet port; and providing air flow through one of the positioning and stabilizing structures and the air circuit, and restricting the air flow using the cover and one of the positioning and stabilizing structure.

[0150] Another aspect of one form of the present technology relates to a positioning and stabilizing structure configured to support a facial interface (e.g., an inflatable chamber of a patient interface), the positioning and stabilizing structure comprising at least one of: a rigidized arm configured to restrict fluid flow through the connection access port and the arm configured to be positioned along the cheek of the user when in use; and a conduit headband configured to deliver the air flow through the connection access port to the user.

[0151] One aspect of one form of the present technology is the use of a method of positioning and stabilizing a structure.

[0152] 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.

[0153] 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).

[0154] 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.

[0155] 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.

[0156] 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.

[0157] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4. Description of the drawings

[0158] 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:

[0159] 4.1 Respiratory therapy system

[0160] Figure 1A 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 humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0161] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a 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.

[0162] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a 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.

[0163] 4.2 Respiratory system and facial anatomy

[0164] Figure 2A 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.

[0165] Figure 2B 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.

[0166] Figure 2Cis 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.

[0167] Figure 2D 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.

[0168] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0169] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0170] Figure 2G A side view of the nasal surface features is shown.

[0171] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0172] Fig.2I 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.

[0173] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0174] Figure 2K 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.

[0175] Figure 2L An anterolateral view of the nose is shown.

[0176] 4.3 Patient Interface

[0177] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0178] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0179] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0180] Figure 3D 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.

[0181] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0182] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0183] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0184] Figure 3H A cushion for a face 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.

[0185] Fig. 3I 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.

[0186] Figure 3J A cross section through the structure of Figure 1 is shown. The surface shown is Fig. 3I A two-dimensional hole is defined in the structure.

[0187] Figure 3K Shows Fig. 3I A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig. 3I The surface of the two-dimensional holes is defined in the structure.

[0188] Figure 3L A mask with an inflatable bladder as cushion is shown.

[0189] Figure 3M Shown through Figure 3L 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.

[0190] Figure 3N Shown by Figure 3L Another cross section of a mask of FIG. The inner surface is also indicated.

[0191] Fig.3O The left hand rule is shown.

[0192] Figure 3P The right hand rule is shown.

[0193] Figure 3Q The left ear is shown, including the left ear helix.

[0194] Figure 3R The right ear is shown, including the right ear helix.

[0195] Figure 3S A right-hand helix is ​​shown.

[0196] Figure 3T 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.

[0197] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0198] Figure 3V Shows Figure 3U A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the air chamber into left and right sides.

[0199] Figure 3W Shown through Figure 3V The cross section of the air-filled chamber is Figure 3V 32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and contacts the liner of the plenum at just two points on the sagittal plane, the upper point 3220 and the lower point 3230. Depending on the geometry of the liner in this area, the middle contact plane can be a tangent at the upper point and the lower point.

[0200] Figure 3X Shows Figure 3U 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'. Figure 3X In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is approximately located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0201] 4.4RPT device

[0202] Figure 4A One form of RPT device according to the present technology is shown.

[0203] Figure 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0204] 4.5 Respiratory waveform

[0205] Figure 5 A model of a typical breathing waveform of a person during sleep is shown.

[0206] 4.6 Patient Interface of the Technology

[0207] Fig. 6A A perspective view of the air circuit is shown disconnected from the patient interface.

[0208] Figure 6B Shown is a device coupled to a patient interface Fig. 6A A perspective view of the air circuit.

[0209] Figure 6C Shows Fig. 6A A perspective view of a patient interface with the harness exploded to show a pair of arms.

[0210] Fig.6D Shows Fig. 6A A perspective view of a patient interface in which a shoulder strap is coupled to the pair of arms.

[0211] Fig. 6E Shows Fig. 6A Detailed view of a patient interface showing the arm of the positioning and stabilising structure and the sleeve separated from the arm.

[0212] Fig. 6F Shows Fig. 6E A perspective view of a patient interface showing the arm in a second flexed position.

[0213] Figure 6G Shows Fig. 6A A perspective view of the patient interface showing the sleeve beginning to slide along the arm.

[0214] Figure 6H Shows Fig. 6A A perspective view of the patient interface showing the sleeve fully slid along the arm.

[0215] Fig.6I Shows Fig. 6A A perspective view of a patient interface showing the sleeve removed from the arm.

[0216] Figure 6J Shown wearing Fig. 6A A perspective view of a patient with a patient interface of FIG. 4 , showing the patient donning the patient interface by sliding the sleeve along the arm.

[0217] Figure 6K Shown wearing Fig. 6A 0026] Figure 2 is a perspective view of a patient of a patient interface of FIG. 1 showing the patient adjusting the length of the sleeve after the sleeve is coupled to the seal-forming structure.

[0218] Figure 6L Shows Fig. 6A Cross-sectional view of a sleeve of a patient interface in a disassembled position with an external connector inserted into the sleeve.

[0219] Figure 6M yes Figure 6L 0024] A cross-sectional view of a sleeve of FIG. 1 and showing an external coupler positioned within the sleeve and displaced from an end of the sleeve.

[0220] Figure 6N yes Figure 6M is a cross-sectional view of a sleeve and shows the ends of the sleeve folded into the sleeve and onto the external coupler.

[0221] Fig.6O yes Figure 6M 0026] A cross-sectional view of a sleeve of FIG. 1 and showing an internal coupler inserted into the sleeve.

[0222] Figure 6P yes Figure 6M 0026] A cross-sectional view of a sleeve of FIG. 1 and showing an internal coupler housed within the sleeve.

[0223] Figure 6Q yes Figure 6P Detailed view of the sleeve, showing the angle of the protrusion.

[0224] Figure 6R yes Fig. 6A A perspective view of a patient interface showing the air circuit and arms disconnected from the seal-forming structure.

[0225] Figure 6S yes Figure 6R A rear perspective view of a seal-forming structure.

[0226] Figure 6T yes Figure 6R A perspective view of a seal-forming structure showing a plug inserted into an opening of the seal-forming structure.

[0227] Figure 6U yes Figure 6T A perspective view of a seal-forming structure showing a plug inserted into an opening of the seal-forming structure.

[0228] Figure 6V is connected to Figure 6T A perspective view of a catheter headband with a seal-forming structure.

[0229] Figure 6W is connected to Figure 6T A perspective view of a catheter headband with a seal-forming structure. 5. Specific implementation methods

[0230] 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.

[0231] 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.

[0232] 5.1 Treatment

[0233] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0234] In certain examples of the present technology, a supply of air under positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0235] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0236] 5.2 Respiratory therapy system

[0237] 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 .

[0238] In one form, the present technology includes a facial contact system for interacting with a user's face. The system may include a facial interface that engages or contacts the user's face. The facial interface may include a patient interface 3000 or any other system that interacts with a user's face.

[0239] 5.3 Patient Interface

[0240] The facial contact system may include a facial interface that is configured to rest against or near a user's face. The facial interface is positioned and arranged to interact with anatomical features on the user's face. An example of a facial interface is the non-invasive patient interface 3000.

[0241] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway 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.

[0242] 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.

[0243] 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.

[0244] 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.

[0245] 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.

[0246] 5.3.1 Sealing structure

[0247] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The seal-forming structure 3100 may also be referred to as a cushion. In other examples of face contact systems, the cushion may contact the user's face and may not seal the user's face. The target seal-forming area is the area on the seal-forming structure 3100 where sealing may 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 is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0248] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0249] In some forms of the present technology, the seal-forming structure 3100 is comprised of a biocompatible material such as silicone rubber.

[0250] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible and resilient material such as silicone.

[0251] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another form that is suitable for small-sized heads but not for large-sized heads.

[0252] 5.3.1.1 Sealing mechanism

[0253] In one form, the seal forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure inside the inflatable chamber 3200 acting on its bottom surface, so that it forms a tight sealing engagement with the face. The pressure assist mechanism can work together with the elastic tension in the positioning and stabilizing structure.

[0254] 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 during use.

[0255] 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 constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0256] 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.

[0257] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0258] 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.

[0259] 5.3.1.2 Nose bridge or nasal ridge area

[0260] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge or nasal ridge region of the patient's face.

[0261] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0262] 5.3.1.3 Upper lip area

[0263] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (ie, upper lip) of the patient's face when in use.

[0264] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0265] 5.3.1.4 Chin area

[0266] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0267] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin area of ​​a patient's face.

[0268] 5.3.1.5 Forehead area

[0269] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0270] 5.3.1.6 Nasal pillows

[0271] In one form (see e.g. Figure 3G ), the sealing forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0272] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal 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.

[0273] 5.3.1.7 Below the nose mask

[0274] like Fig. 6A - Figure 6C As shown, the seal-forming structure 3100 of the patient interface 3000 includes a nasal mask underside, which can be similar to nasal pillows in that the seal is formed near the patient's nostrils and exposes the patient's mouth to the surrounding environment. The seal-forming structure 3100 in the form of a nasal mask underside seals around the outer surface of the patient's nose.

[0275] In the illustrated form, the seal-forming structure 3100 may seal around the exterior of the nose and may include a single opening for each nostril. In other forms, the seal-forming structure 3100 may include a single opening that receives both nostrils.

[0276] 5.3.2 Inflatable chamber

[0277] In the area where the seal is formed in use, the plenum 3200 has a perimeter that is 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.

[0278] 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.

[0279] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0280] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0281] like Fig. 6A and 6B As shown, the plenum chamber 3200 includes an opening or connection port 3600. When exposed, the connection port 3600 provides fluid communication between the surrounding environment and the nostril, even when the seal-forming structure 3100 is sealed to the patient's face. In the illustrated form, the connection port 3600 defines an oval shape and is disposed in the center of the plenum chamber 3200. In other forms, the connection port 3600 may have different sizes or may define a different shape.

[0282] The connection port 3600 defines an opening for receiving a flow of pressurized fluid. Specifically, the air circuit 4170 may be connected to the connection port 3600 to provide a fluid path from the RPT device 4000 to the patient's airway. In the illustrated form, the protrusion 3212 is connected to the plenum chamber 3200 and extends into the connection port 3600 (see, for example, Fig. 6A ). The protrusion 3212 can be connected to the air circuit 4170 and hold the air circuit 4170 relative to the inflatable chamber 3200. For example, the air circuit may include a ring 4171 formed of a rigid or semi-rigid material (e.g., plastic). When the air circuit 4170 is fully connected to the inflatable chamber 3200 (see, e.g., Figure 6B ), the protrusion 3212 engages the ring 4171 in a snap-fit ​​arrangement (e.g., the engagement of the protrusion 3212 creates a substantially airtight seal that can be broken by providing a pulling force).

[0283] like Figure 6BAs shown, once the air circuit 4170 is coupled to the plenum chamber 3200, substantially no air can escape through the interface between the plenum chamber 3200 and the ring 4171. Air can be supplied directly from the air circuit 4170 into the plenum chamber 3200 to allow the patient to breathe pressurized air through their nose (or mouth if an alternative mask is used).

[0284] 5.3.3 Positioning and stabilizing the structure

[0285] The positioning and stabilizing structure 3300 may generally be referred to as a structure that maintains the position of the facial interface at a desired position on the user's face.

[0286] In some forms, a single positioning and stabilizing structure 3300 may be used with multiple types of facial interfaces. Other forms of positioning and stabilizing structures may only be used with a single type of facial interface.

[0287] 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 .

[0288] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the positive pressure in the plenum 3200 to lift off the face.

[0289] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0290] In one form, the positioning and stabilising structure 3300 provides a retaining force 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.

[0291] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a smaller 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 strip that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0292] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0293] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0294] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion located between the front of the positioning and stabilising structure 3300 and the back of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible 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 stabilising structure 3300 and disrupting the seal.

[0295] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the belt. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0296] 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 strap can be configured to be in a tensioned state when in use and to direct a force to seal the seal-forming structure 3100 with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0297] The belt of the positioning and stabilizing structure 3300 can be at least partially composed of an adaptive material (e.g., a moisture activated material, a heat activated material, an auxetic material, and / or a combination of different materials), as described in PCT / SG2020 / 050792, which is incorporated herein by reference in its entirety. Under various conditions of use, the belt can be unfolded to provide additional comfort to the patient.

[0298] 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.

[0299] 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.

[0300] 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.

[0301] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is flexible and, for example, non-rigid. An advantage of this aspect is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0302] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is configured to be breathable to allow moisture to be transmitted through the belt.

[0303] 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.

[0304] like Fig. 6A As shown in FIG. 6Q, the positioning and stabilizing structure 3300 may include a headband assembly 3302, which includes a sleeve 3304 and a pair of arms 3306 (e.g., a left arm and a right arm). Each arm 3306 may be a rigidized arm 3306. The sleeve 3304 and the arm 3306 are coupled together to the seal-forming structure 3100 and the plenum chamber 3200 to maintain them against the patient's face in a therapeutically effective position (e.g., a position where there is substantially no pressurized air leakage between the patient's face and the seal-forming structure 3100).

[0305] In the illustrated form, the sleeve 3304 is constructed of a flexible material. This allows the sleeve 3304 to bend and flex and conform to the different contours of the patient's head.

[0306] In some forms, sleeve 3304 can be made of elastic material or have elastic properties. In other words, sleeve 3304 can stretch when tension is applied, and return to its original position when tension is released. Sleeve 3304 can be made of textiles including one or more elastomeric properties, or elastomeric materials can be included in sleeve 3304 together with textiles. For example, sleeve 3304 can be at least partially made of elastomer, thermoplastic elastomer (TPE), silicone or similar materials. Sleeve 3304 can be woven, knitted, braided, molded, extruded or otherwise formed. Sleeve 3304 can include a generally flat rectangular shape, and can be formed with a cavity 3308 extending through sleeve 3304 and capable of receiving another object.

[0307] The fabric can provide comfort to the user when the sleeve 3304 rests against their face (e.g., it is non-abrasive). The elastomeric material can allow the sleeve 3304 to stretch so as to better fit around the patient's head (e.g., not too tight). A portion of the sleeve 3304 can also be bifurcated so that a portion of the sleeve 3304 includes two separate portions. For example, the sleeve 3304 can include a first rear portion 3310a and a second rear portion 3310b. When the sleeve 3304 is worn by the patient, the first and second rear portions 3310a, 3310b contact the back of the patient's head. The first rear portion 3310a can be partially spaced apart from the second rear portion 3310b and can help distribute the force from the sleeve 3304 over the patient's head.

[0308] In some forms, the sleeve 3304 can be formed into multiple parts (e.g., a first portion 3304a and a second portion 3304b) and coupled together by a fastener 3312 (e.g., a buckle). The fastener 3312 changes the available length of the sleeve 3304 (e.g., the length of the sleeve 3304 exposed to the patient's head) to adjust the fit relative to the patient's head. The available length of the sleeve 3304 plus the length of the seal-forming structure 3100 is approximately equal to the circumference of the patient's head. The patient can increase or decrease the available length (e.g., by moving the portions 3304a, 3304b relative to each other via the fastener 3312) so that the sleeve 3304 fits snugly but not against his head. In other forms, the sleeve 3304 can be formed as a single body, and the patient may not be able to adjust the available length of the sleeve 3304. Instead, the patient can choose between sleeves 3304 of different sizes (e.g., sleeves 3304 with different preselected available lengths).

[0309] The sleeve 3304 can be at least partially hardened (e.g., using hardened threads or other rigid or semi-rigid materials). The rigid or semi-rigid material in the sleeve 3304 can control the position at which the sleeve 3304 can stretch (e.g., disposed on at least one side of the elastic or elastomeric material to allow stretching in a single direction). This can prevent the sleeve 3304 from stretching too far and breaking (e.g., due to failure of the elastic or elastomeric material). The rigid or semi-rigid material can also control the bending of the sleeve 3304 and help maintain the shape of the sleeve 3304. For example, the rigid or semi-rigid material can help maintain the generally rectangular shape of the sleeve 3304. The rigid or semi-rigid material can also provide rigidity to the sleeve 3304 and provide resistance to bending.

[0310] In other forms, the sleeve 3304 can be at least partially rigidified with a rigidizing portion, which can be moldable or capable of being formed into a shape to provide a better fit with the patient's face, thereby improving comfort. For example, the material of the rigidizing portion may include a thermoplastic or thermosoftening plastic having material properties that depend on an activator, for example, when its temperature is within a predetermined range, its material properties such as stiffness are changed. In other forms, the rigidizing portion has a changed stiffness when the treatment is applied. The rigidizing portion can change its material properties, such as stiffness, under the action of other activators (in addition to temperature). Activators may include but are not limited to electric current, chemicals, pressure and / or force. Examples of rigidizing portions are described in PCT / SG2020 / 050792, the entire contents of which are incorporated herein by reference.

[0311] like Figure 6C As shown, each end of the sleeve 3304 includes an opening 3315 leading to the cavity 3308. In the case where the sleeve 3304 includes two separate parts 3304a, 3304b, the sleeve 3304 also includes two different cavities 3308 with two different openings 3315 (e.g., the cavity 3308 in the first part 3304a is not connected to the cavity 3308 in the second part 3304b). Conversely, if the sleeve 3304 is formed as a single body, the sleeve 3304 can include a single cavity 3308.

[0312] The opening 3315 leading to the cavity 3308 includes a generally circular (e.g., round, oval, etc.) shape, which is opposite to the generally rectangular shape of the rest of the sleeve 3304. The opening 3315 leading to the cavity 3308 can also be wider than the rest of the cavity 3308 (e.g., the inner diameter of the opening is wider than the rest of the sleeve). This can help the cavity 3308 receive an object because the wide opening 3315 allows for easier insertion of the object. In the example shown, the opening 3315 is rigidly maintained as a circle so that the cavity is always accessible (e.g., the sleeve 3304 does not collapse on itself, thereby closing the cavity 3308).

[0313] like Figure 6C As shown, the rigidizing arms 3306 extend from either side of the seal-forming structure 3100. In the example shown, the two rigidizing arms 3306 are substantially identical to one another (e.g., have the same length), and the following features will be described with respect to a single rigidizing arm 3306, even though they are included on both rigidizing arms.

[0314] like Fig. 6E and 6F As shown, the rigidized arm 3306 includes a plug 3316 located at one end. The plug 3316 is formed of a rigid or semi-rigid material and is positioned adjacent to the seal-forming structure 3100. In some forms, the plug 3316 and the seal-forming structure 3100 may be formed as a single piece. In other forms, the plug 3316 may be coupled to the seal-forming structure 3100 (e.g., using one or more of fasteners, adhesives, magnets, press fits, snap fits, etc.).

[0315] In some forms, the plenum 3200 includes an orifice 3202 on a side surface (see, e.g., Figure 6S ). The orifice 3202 can extend toward the center of the plenum chamber 3200 so that the orifice 3202 can provide fluid communication into and / or out of the plenum chamber 3200. The plug 3316 is inserted into the orifice 3202 and restricts the entry and exit of a fluid (e.g., pressurized gas) through the orifice 3202. The plug 3316 can be secured using a press fit so that the frictional engagement between the orifice 3202 and the plug 3316 restricts any fluid from entering or exiting the orifice 3202. In addition to the press fit, an adhesive (e.g., glue) can be used to retain the plug 3316 within the orifice 3202. The plug 3316 can be permanently secured in the orifice 3202 (e.g., during assembly of the patient interface 3000) so that fluid flow through the orifice 3202 is restricted after assembly is complete.

[0316] The clamp body 3320 is coupled to the plug 3316 and positioned outside the orifice 3202 while the plug 3316 is received within the orifice 3202. The clamp body 3320 is formed of a rigid material (e.g., a hard plastic) and is configured to retain its shape. In the example shown, the clamp body 3320 forms an at least partially circular shape (e.g., a circle, an oval, etc.). The shape of the clamp body 3320 can be formed to be substantially the same shape as the opening of the cavity 3308. This can allow the clamp body 3320 to be received within the cavity 3308.

[0317] In one form, the clamping body 3320 includes a first clamping body portion 3320a and a second clamping body portion 3320b. The clamping body portions 3320a, 3320b can be mirror images of each other and can each define a portion of a partial circular shape. There is at least one interruption (e.g., a gap) between the clamping body portions 3320a, 3320b so that the clamping body does not form an entire partial circular shape. In the example shown, there is a pair of interruptions between the clamping body portions 3320a, 3320b so that each clamping body portion 3320a, 3320b is independent of each other. In other examples, the clamping body 3320 can include a greater or lesser number of clamping body portions, depending on the number of interruptions.

[0318] In one form, the clamp body 3320 includes a hole 3324 positioned through a surface of the clamp body 3320. The hole 3324 may be rectangular in shape, or may have any other suitable shape (e.g., circular, triangular, pentagonal, etc.). In the illustrated form, each clamp body portion 3320a, 3320b includes a hole 3324. The holes 3324 are positioned approximately 180° apart from each other (e.g., a straight line passes through the center of two holes 3324; see the attached Fig. 6E and 6S ). In other words, the hole 3324 of the clamping body 3320 is located on the opposite side of the clamping body 3320.

[0319] In one form, the clamp body 3320 is rigidly coupled to the plug 3316 and is not rotatable relative to the plug 3316. The orientation of the apertures 3324 relative to each other and relative to the plug 3316 remains constant. The clamp body 3320 is able to flex (i.e., bend) relative to the plug 3316. The clamp body 3320 may be limited in the amount it can flex so that it does not break (e.g., snap).

[0320] Each rigidized arm 3306 may include an arm portion 3328. The arm portion 3328 includes a fixed end 3329 connected to the plug 3316 and a free end 3330 away from the plug 3316. The fixed end 3329 can be permanently connected to the plug 3316 so that the arm portion 3328 and the plug 3316 cannot be separated. The arm portion 3328 extends between the clamping body portions 3320a, 3320b so that the clamping body portions 3320a, 3320b are bent around the arm portion 3328. The arm portion 3328 also has a relatively flat and elongated configuration so that the arm portion 3328 is spaced apart from the clamping body portions 3320a, 3320b. The arm portion 3328 also includes rounded edges (e.g., near the free end 3330) and substantially does not include sharp edges or corners. The arm portion 3328 also includes a substantially smooth surface.

[0321] like Fig. 6E and 6F As shown, the arm portion 3328 can be made of a semi-rigid material that allows for some movement. In other words, the patient can bend the arm portion 3328 to a preferred position, and the arm portion 3328 can maintain that position after the patient removes the bending force. Specifically, the patient can impart a curvature to the arm portion 3328 (e.g., concave to the patient's head, convex to the patient's head, or both). The patient can repeatedly adjust the arm portion 3328 until the patient's preferred position is reached.

[0322] like Fig. 6E As shown, the arm portion 3328 is substantially straight (e.g., parallel to the patient's sagittal plane) and includes little or no curvature relative to the patient. The patient can grasp and bend the arm portion 3328. In the example shown, the patient grasps the arm portion 3328 near the free end 3330, although the patient can grasp the arm portion 3328 anywhere. If a single bend is made near the center of the arm portion 3328 and near any of the ends 3329, 3330, the greater length of the arm portion 3328 can be curved (i.e., concave and / or convex). The patient can grasp the arm portion 3328 at multiple locations and create multiple bends along the length of the arm portion 3328. Each bend can have the same or different radius of curvature relative to any other bend along the length of the arm portion 3328.

[0323] like Fig. 6F As shown, the free end 3330 of the arm portion 3328 is bent into a concave orientation relative to the seal-forming structure 3100. In this example, the remaining portion of the arm portion 3328 remains relatively straight (e.g., neither concave nor convex). The patient can further bend the arm portion 3328 along the remaining length, or can leave a portion of the arm portion 3328 straight. Once the patient completes the bending of the arm portion 3328, the curvature of the arm portion 3328 is maintained until the patient attempts to re-bend the arm portion 3328. In other words, the rigid or semi-rigid material of the arm portion 3328 maintains the applied curvature and does not return the arm portion 3328 to a neutral (e.g., straight) position when the bending force is removed.

[0324] like Fig. 6F and 6GAs shown, once the curvature of the arm portion 3328 is set (e.g., in a position desired by the patient), the sleeve 3304 can be slid along the length of the arm portion 3328 so as to at least partially cover the arm portion 3328. The flexible material of the sleeve 3304 allows the sleeve 3304 to conform to any curvature that the arm portion 3328 has. For example, the sleeve 3304 can be bent in all directions so that the sleeve 3304 can substantially match the shape of the arm portion 3328. The rigid or semi-rigid structure of the arm portion 3328 holds the sleeve 3304 in that shape. In other examples, the arm portion 3328 can be bent after the sleeve 3304 has been at least partially slid along it.

[0325] like Figure 6G As shown, the arm portion 3328 can be inserted into the cavity 3308 of the sleeve 3304. In other words, the sleeve 3304 can be slid over the arm portion 3328 via the cavity 3308. The free end 3330 of the arm portion 3328 is first inserted into the sleeve 3304 through the cavity 3308. The arm portion 3328 is pushed further into the sleeve 3304 (i.e., further into the cavity 3308) until substantially all of the arm portion 3328 is within the sleeve 3304. When the arm portion 3328 is inserted, the rounded edges and sides of the arm portion 3328 help limit or prevent snagging or tearing of the sleeve 3304. In other words, the arm portion 3328 does not include sharp edges that may tear the hole in the sleeve 3304. The smooth surface of the arm portion 3328 also helps limit snagging or tearing of the sleeve 3304 when the arm portion 3328 is inserted (i.e., because the rough surface is limited to the sleeve 3304).

[0326] In other forms, the rigidified arm 3306 may include a substantially small or no arm portion 3328. The sleeve 3304 may still be connected to the clamp body 3320. In some forms, the sleeve 3304 may include greater rigidity to compensate for the reduced length of the arm portion 3328.

[0327] like Figure 6G As shown, the sleeve 3304 can move (or translate) in a direction toward the plug 3316. As a result, the sleeve 3304 slides over the arm portion 3328 to a greater extent. Figure 6HAs shown, the arm portion 3328 is fully inserted into the cavity 3308 of the sleeve 3304. In other words, the opening 3315 of the cavity 3308 is located near the fixed end 3329 of the arm portion 3328. The cavity 3308 can extend beyond the length of the arm portion 3328 (e.g., the length of the cavity 3308 can be longer than the length of the arm portion 3328), but the arm portion cannot extend further into the cavity 3308 because the plug 3316 limits further translation of the sleeve 3304. The plug 3316 is wider than the opening 3315 and prevents the arm portion 3328 from further entering the cavity 3308. The sleeve 3304 receives the clamp body portions 3320a, 3320b within the cavity 3308 and engages the clamp body portions 3320a, 3320b to mechanically couple the sleeve 3304 to the rigidized arm 3306. The engagement between the sleeve 3304 and the rigidified arm 3306 facilitates easy removal of the sleeve 3304 from the arm portion 3328, as the mechanical connection can be easily disconnected (see, e.g., Fig.6I ). In contrast to how the sleeve 3304 is positioned on the arm portion 3328, the sleeve 3304 is removed. Fig.6I As shown, the sleeve 3304 can be moved in a direction away from the plug 3316. Therefore, the sleeve 3304 slides on the arm portion 3328 to a lesser extent.

[0328] like Figure 6J As shown, the first portion 3304a and the second portion 3304b of the sleeve 3304 can be slid on the arm portion 3328 substantially simultaneously, while the plenum chamber 3200 and the seal-forming structure 3100 are positioned against the oral-nasal region of the patient (e.g., the patient's nose and / or mouth). Each portion 3304a, 3304b can be slid on the corresponding arm portion 3328 as described above, so that the opening 3315 of the common cavity 3308 (or the individual cavities 3308) is positioned proximate to the corresponding plug 3316. As the portions 3304a, 3304b slide thereon, the positioning and stabilizing structure 3300 becomes tighter against the patient's head. In other words, the portions 3304a, 3304b are pulled toward the front of the patient's head, so that the sleeve 3304 is against the back of the patient's head (e.g., the sleeve 3304 is taut).

[0329] like Figure 6KAs shown, after sleeve portions 3304a, 3304b have been connected to corresponding plugs 3316, the patient can adjust the available length of sleeve 3304. The patient can use fasteners 3312 to increase or decrease the available length of sleeve 3304 so that sleeve 3304 is comfortable to the patient's head. In other words, the patient can adjust the available length so that the seal-forming structure 3100 fits snugly against the patient's face but not too tight (e.g., does not dig into the patient's face, does not produce red marks on its skin, etc.). Before adjusting the length of sleeve 3304, the patient can position sleeve 3304 along the back of his head. For example, the patient can move sleeve 3304 in an upper or lower direction to provide appropriate force to the seal-forming structure 3100, and / or maximize the patient's comfort. If sleeve 3304 is bifurcated, the patient can also change the position of each bifurcated portion relative to another bifurcated portion to adjust force and / or comfort. The patient may also adjust the available length before wearing the positioning and stabilizing structure 3300 (eg, because the available length is too small to wear).

[0330] The patient can maintain the seal-forming structure 3100 and / or the plenum chamber 3200 in a suitable position near their oral and nasal area while adjusting the usable length of the sleeve 3304. This helps to ensure a proper seal between the seal-forming structure 3100 and the patient's skin (e.g., in a suitable position, substantially no leaks, etc.). By maintaining the seal-forming structure 3100 in a desired position, the sleeve 3304 can be tightened to a suitable usable length. For example, the usable length will vary depending on the position at which the patient positions the sleeve 3304. Positioning the sleeve 3304 further up on the patient's head is equivalent to a longer usable length to achieve the same sealing force (e.g., because the position of the seal-forming structure 3100 is always positioned near the patient's nose and / or mouth).

[0331] like Figure 6L As shown in FIG. 6Q, the sleeve 3304 is assembled by positioning a first (or inner) coupling 3334 and a second (or outer) coupling 3338 within both ends of the cavity 3308 (or multiple cavities 3308). The couplings 3334, 3338 are positioned near the ends of the sleeve 3304, and an opening 3315 can be formed in the sleeve 3304. In other words, the outer coupling 3338 includes a generally circular shape. The inner coupling 3334 can also include the same generally circular shape.

[0332] like Figure 6LAs shown, when the sleeve 3304 is initially assembled, there are no couplings 3334, 3338 within the cavity 3308. The sleeve 3304 is generally flat, and the opening 3315 and the cavity 3308 are generally closed. In other words, the sides of the sleeve 3304 are close to each other, so that the internal volume within the cavity 3308 is low. The sleeve 3304 can have a generally rectangular shape, but is flexible and can change shape (e.g., to a circular cross-section). The external coupling 3338 is selected and moved to a position close to the sleeve 3304. The external coupling 3338 has a generally circular cross-section with a hollow center. In the example shown, the external coupling 3338 also has a larger diameter than the sleeve 3304.

[0333] As shown in FIG. 54 , the external coupling 3338 is positioned within the cavity 3308 of the sleeve 3304. The flexible material of the sleeve 3304 is capable of expanding to receive the external coupling 3338. In other words, the external coupling 3338 stretches the sleeve 3304 when the sleeve 3304 is inserted into the cavity 3308 so that the end on the sleeve 3304 is wider than the center of the sleeve 3304. The opening 3315 of the cavity 3308 can have a different shape than the rest of the cavity 3308. The external coupling 3338 maintains the sleeve 3304 in a wider, generally circular position while the rest of the sleeve 3304 (and therefore the rest of the cavity 3308) is maintained in a generally flat, rectangular orientation. The external coupling 3338 can be made of a rigid or semi-rigid material (e.g., a hard plastic) so that it maintains its shape under pressure. In other words, a biasing force or elastic force attempting to return the sleeve 3304 to its original position cannot change the shape of the external coupling 3338.

[0334] like Figure 6M As shown, the outer coupling 3338 slides into the cavity 3308 and is spaced apart from the initial opening 3315 of the sleeve 3304. In other words, the edge of the sleeve 3304 (e.g., the free end 3342) is not aligned with the edge of the outer coupling 3338. A portion of the sleeve 3304 is on either side (e.g., as shown in FIG. Figure 6M3308). The external coupling 3338 can be fastened to the sleeve 3304 at an appropriate position within the cavity 3308. For example, the external coupling 3338 can be fixed by using an adhesive (e.g., glue), using a mechanical fastener, using a magnetic fastener, sewing, or by any similar means. Once the external coupling 3338 is positioned in the desired position, the free end 3342 of the sleeve 3304 is folded inwardly on itself. In other words, the free end 3342 of the sleeve 3304 is folded so that it is located within the cavity 3308. The free end 3342 is folded so that it rests on the surface of the external coupling 3338. Therefore, the external coupling 3338 is at least partially sandwiched between the folded portions of the sleeve 3304. The farther the external coupling 3338 is set from the free end 3342, the greater the length of the sleeve 3304 that can be folded on the external coupling 3338. The length may only partially cover the external coupling 3338, or it may completely cover the external coupling 3338 so that it is completely surrounded by the sleeve 3304. Once the free end 3342 is folded, the outer end of the external coupling 3338 (e.g., Figure 6N 3308) is substantially aligned with the opening 3315 of the cavity 3308. Thus, once the free end 3342 is folded, the shape of the external coupling 3338 forms the shape of the opening 3315 leading to the cavity 3308.

[0335] Once the free end 3342 of the sleeve 3304 is folded over the external coupling 3338, the free end 3342 can be secured to the external coupling 3338 and / or the sleeve 3304. For example, the external coupling 3338 can be secured by using an adhesive (e.g., glue), using a mechanical fastener, using a magnetic fastener, sewing, or by any similar means. The free end 3342 is fixed so that it does not unfold and move away from the external coupling 3338. In some forms, the same device is used to couple the external coupling 3338 and the free end 3342 within the cavity 3308 to the external coupling 3338 and / or the sleeve 3304 (e.g., using only a single device). In some forms, the external coupling 3338 may not be directly coupled to the sleeve 3304. Instead, the free end 3342 can be completely folded over the external coupling 3338 and coupled to the sleeve 3304, thereby forming a pocket around the external coupling 3338. The external coupling 3338 may be removable (eg, if it is not secured to the sleeve 3304 itself), but only within the confines of the pocket.

[0336] like Fig.6OAs shown, the inner coupling 3334 is selected and moved to a position close to the sleeve 3304. The inner coupling 3334 has a generally circular cross-section with a hollow center. The outer diameter of the inner coupling 3334 is smaller than the inner diameter of the outer coupling 3338. The inner coupling 3334 is positioned at the opening 3315 of the cavity 3308 (i.e., the edge of the outer coupling 3338) and is narrower than the opening 3315 so that it can slide into the opening 3315.

[0337] The internal coupling 3334 includes at least one protrusion 3346 extending toward the center of the internal coupling 3334. In the example shown, the internal coupling 3334 includes a pair of protrusions 3346. The protrusions 3346 can extend away from the surface of the internal coupling 3334 at an angle θ (see, e.g., Figure 6Q ). Angle θ can be an angle measured from an axis 3348 that is parallel to the radial axis of the internal coupling 3334. In some forms, the angle θ is between 10° and 90°. In some forms, the angle θ is between 20° and 80°. In some forms, the angle θ is between 30° and 70°. In some forms, the angle θ is between 35° and 65°. In some forms, the angle θ is between 40° and 60°. In some forms, the angle θ is approximately 55°. In some forms, two protrusions 3346 extend at the same angle (e.g., are mirror images of each other).

[0338] The protrusions 3346 may extend to a point or may be rounded. The protrusions 3346 are spaced apart from one another so that they do not contact other protrusions 3346. The protrusions 3346 also do not extend beyond the inner coupling 3334. In other words, the protrusions 3346 are completely held within the volume of the inner coupling 3334.

[0339] like Figure 6P As shown, the inner coupling 3334 slides into the cavity 3308. The inner coupling 3334 rests on the free end 3342 of the sleeve 3304 within the cavity 3308. As shown in cross section, the sleeve 3304 includes different layers of material within the cavity 3308. For example, starting from the outside, the sleeve 3304 forms the outermost surface of the positioning and stabilizing structure 3300, the outer coupling 3338 is positioned directly within the sleeve 3304, the free end 3342 of the sleeve 3304 is folded over the outer coupling 3338, and the inner coupling 3334 is positioned directly within the free end 3342. Thus, there are four layers, where no adjacent (or contiguous) layers are the same (e.g., the positioning and stabilizing structure 3300 alternates between flexible and rigid / semi-rigid).

[0340] Once the inner coupling 3334 is positioned in the desired position, the inner coupling 3334 can be fixed in the cavity. For example, the inner coupling 3334 can be fixed by using an adhesive (e.g., glue), using a mechanical fastener, using a magnetic fastener, stitching, or by any similar means. The position can be substantially aligned with the outer coupling 3338. For example, the inner coupling 3334 and the outer coupling 3338 can be concentric, and the edges of the inner coupling 3334 and the outer coupling 3338 can be aligned. In other words, both the inner coupling 3334 and the outer coupling 3338 can be positioned at the opening 3315. The space between the protrusions 3346 leaves room through the opening 3315 and into the cavity 3308.

[0341] Return to Attachment Figure 6G -6I, the arm portion 3328 is narrower than the width between the protrusions 3346. When the sleeve 3304 slides along the arm portion 3328, the protrusions 3346 do not create resistance. In other words, although the protrusions 3346 can contact the arm portion 3328, the protrusions 3346 do not make it more difficult for the sleeve 3304 to slide along the arm portion 3328. The wider opening formed by the external coupling 3338 provides a larger target area for the patient to insert the arm portion 3328. When the arm portion 3328 is inserted, the shape of the sleeve 3304 (e.g., generally rectangular) does not change substantially.

[0342] like Figure 6H As shown, the opening 3315 of the sleeve 3304 slides upward to the plug 3316. When the arm portion 3328 is fully received in the cavity 3308, the clamp body portions 3320a, 3320b are received in the inner coupling 3334. The patient aligns the protrusion 3346 of the inner coupling 3334 with the clamp body portions 3320a, 3320b so that the protrusion 3346 can be received in the clamp body portions 3320a, 3320b. The angle θ of the protrusion 3346 helps maintain the engagement between the corresponding protrusion 3346 and the clamp body 3320. Once the protrusion 3346 enters the corresponding clamp body portion 3320a, 3320b, the sleeve 3304 is retained relative to the plug 3316 (e.g., cannot move away from the plug 3316).

[0343] With the sleeve 3304 secured in place, the positioning and stabilizing structure 3300 is secured to the patient's head. Figure 6J and 6K As shown, the arm portion 3328 extends away from the nose and mouth area and along the patient's cheeks toward the back of the patient's head. The arm portion 3328 also extends along the top of the patient's head (see, for example, Figure 6K). In some forms, the arm portion 3328 may not extend beyond the corresponding ear of the patient. In other words, the free end 3330 of the arm portion 3328 does not extend further back than the patient's ear. The arm portions 3328 extend so that they do not contact the patient's ears. For example, the arm portions 3328 extend along a line that protrudes above the patient's ears so that the arm portions 3328 do not intersect the ears (e.g., and cause discomfort to the patient). The sleeve 3304 extends from the oral and nose area to the back of the patient's head and back to the oral and nose area. The sleeve 3304 follows the same line as the arm portion 3328 so that the sleeve 3304 also does not intersect the patient's ears.

[0344] In other forms (not shown), the free end 3330 of each arm portion 3328 may extend to a point further forward than the corresponding ear and may contact the patient's face at a position above the base of the ear and above the base of the ear. The sleeve 3304 may be bifurcated so as to extend around the patient's ear and minimize contact with the patient's ear.

[0345] Back to Fig.6I , the patient can disengage the protrusion 3346 from the clamp body portion 3320a, 3320b in order to slide the sleeve 3304 away from the arm portion 3328. In some forms, the patient can apply an appropriate force directed away from the plug 3316 in order to remove the sleeve 3304. The applied force can cause the protrusion to leave the corresponding clamp body portion 3320a, 3320b so that the sleeve 3304 can move freely relative to the plug 3316 again. In other forms, a single force may not be sufficient to remove the protrusion 3346 from the clamp body portion 3320a, 3320b without destroying the protrusion 3346 (and thereby preventing future connection). Instead, the patient may have to apply a compressive force to the coupling 3334, 3338 before applying a force to the sleeve 3304 away from the plug. In other words, the patient squeezes the outer coupling 3338 so as to compress the inner coupling 3334 and cause the protrusion 3346 to move away from the clamp body portions 3320a, 3320b. At this point, the inner coupling 3334 is no longer mechanically engaged with the plug 3316 and can move relative to the plug 3316. The rigid or semi-rigid material of the coupling 3334, 3338 can allow a small amount of flexing to allow the protrusion 3346 to move in and out of the clamp body portions 3320a, 3320b.

[0346] like Figure 6RAs shown, the air circuit 4170 can be removed from the plenum chamber 3200 to expose the connection port 3600. Similarly, the plug 3316 can be removed from the plenum chamber 3200. The plug 3316, the clamp body 3320, and the arm portion 3328 are formed as a single component (e.g., they are connected to each other and cannot be separated), and each is removed from the plenum chamber 3200 together. The orifice 3202 remains in its position. Similar to the connection port 3600, the orifice 3202 provides fluid communication into the plenum chamber 3200. When the plug 3316 is located in the orifice 3202, the entry and exit of fluid (e.g., air) is substantially prevented, but when the plug 3316 is removed, air can freely enter and exit. The plug 3316 can be connected by a press fit, a snap fit, or a similar connection to allow repeated insertion and removal of the plug 3316 (e.g., as Figure 6R and 6S ), while restricting fluid flow through the corresponding orifice 3202 when the corresponding plug 3316 is inserted. This can help the patient clean the interior of the inflatable chamber 3200 (for example, after each night of use).

[0347] Alternatively, the plug 3316 can be integrally formed with the plenum chamber 3200 (or more generally, the facial interface) in a one-piece construction. This can simplify the manufacture (e.g., via molding) of the patient interface 3000 (or facial mount interface in general). The plug 3316 can still prevent or restrict the ingress or egress of airflow, although there is no airflow path due to the integral formation.

[0348] like Figure 6T-6WAs shown, the cover 3354 can be positioned above the connection port 3600 so as to substantially prevent fluid from entering and leaving the plenum chamber 3200. The cover 3354 is connected to the plenum chamber 3200 in the connection port 3600 by friction fit, press fit, snap fit, magnetic engagement or similar connection so that it can be removed, but when it is connected, it also restricts the flow of fluid through the connection port 3600. A fluid conduit 3358 (e.g., a conduit headband) can be connected to the seal-forming structure 3100 at the orifice 3202. The fluid conduit 3358 is a hollow tube and includes an inlet 3362 located in the center of the hollow tube. When worn by the patient, the fluid conduit 3358 can extend toward the upper part of the patient's head along a path similar to the arm portion 3328 (e.g., along the cheek). The air circuit 4170 can be connected to the fluid conduit 3358 at the inlet 3362 (i.e., on the upper area of ​​the patient's head), and pressurized air is provided to the plenum chamber 3200 through the fluid conduit 3358. In other words, air flows from the inlet 3362, passes through the hollow tube of the fluid conduit 3358, and reaches the plenum chamber 3200. In this form (i.e., the fluid conduit 3358 is connected), the fluid conduit 3358 can play a role in positioning and stabilizing the structure 3300, and can provide some help in keeping the seal-forming structure 3100 against the patient's face in a therapeutically effective position. In addition, the rear belt 3366 can be connected to the tab 3370 of the fluid conduit 3358. The rear belt 3366 can extend around the back of the patient's head (e.g., across the patient's head near the occipital bone). The patient can then use the patient interface 3000 modularly and choose how to deliver pressurized air to their airway. The main factor in determining this can be the patient's comfort (e.g., when the air circuit 4170 extends from the patient interface).

[0349] The fluid conduit 3358 can convey the pressurized air toward the seal-forming structure 3100. The fluid conduit 3358 is made of and / or lined with an impermeable material (e.g., silicon, thermoformed and / or laminated structures, etc.). The fluid conduit 3358 is coupled to the plenum chamber 3200 with a seamless or substantially seamless transition (e.g., within the orifice 3202) to prevent or substantially prevent the pressurized air from escaping toward the surrounding environment. In one example, the fluid conduit 3358 is a double-lumen tube.

[0350] 5.3.4 Ventilation

[0351] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0352] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured so that the vent flow is of sufficient magnitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber during use.

[0353] One form of a vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0354] 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.

[0355] 5.3.5 Decoupling structure

[0356] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0357] 5.3.6 Connection Port

[0358] The connection port 3600 allows connection to the air circuit 4170 .

[0359] 5.3.7 Forehead support

[0360] In one form, the patient interface 3000 includes a forehead support 3700. In other forms, the patient interface 3000 does not include a forehead support.

[0361] 5.3.8 Anti-asphyxia valve

[0362] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0363] 5.3.9 Ports

[0364] 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.

[0365] 5.4RPT device

[0366] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0367] 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.

[0368] The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0369] 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 transducers 4270, such as a pressure sensor and a flow sensor.

[0370] 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.

[0371] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a pressure generator 4140, and a converter 4270. 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.

[0372] 5.4.1 Mechanical and pneumatic components of RPT device

[0373] 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.

[0374] 5.4.1.1 Air filter

[0375] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0376] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0377] 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 .

[0378] 5.4.1.2 Muffler

[0379] An RPT device according to one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0380] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140 .

[0381] 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 .

[0382] 5.4.1.3 Pressure generator

[0383] 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.

[0384] The pressure generator 4140 may be under the control of the treatment device controller 4240 .

[0385] 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.

[0386] 5.4.1.4 Converter

[0387] 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.

[0388] 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.

[0389] In one form of the present technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 or 3800 .

[0390] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0391] 5.4.1.5 Anti-overflow valve

[0392] 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.

[0393] 5.4.2 RPT device electrical components

[0394] 5.4.2.1 Power supply

[0395] The power source 4210 may be positioned inside or outside of the outer housing 4010 of the RPT device 4000 .

[0396] In one form of the present technology, power supply 4210 provides power only to RPT device 4000. In another form of the present technology, power supply 4210 provides power to both RPT device 4000 and humidifier 5000.

[0397] 5.4.2.2 Input device

[0398] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may communicate wirelessly with a receiver that is electrically connected to a central controller.

[0399] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0400] 5.5 Air circuit

[0401] 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 .

[0402] 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.

[0403] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be spirally wound around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent No. 8,733,349, which is incorporated herein by reference in its entirety.

[0404] 5.5.1 Supplemental Gas Delivery

[0405] In one form of the present technology, supplemental gas, namely supplemental oxygen 4180 , is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0406] 5.6 Humidifier

[0407] In one form of the present technology, a humidifier 5000 (e.g., Figure 4B ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0408] 5.7 Respiratory waveform

[0409] Figure 5The 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%.

[0410] 5.8 Glossary

[0411] 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.

[0412] 5.8.1 General

[0413] 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 oxygen-enriched air.

[0414] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0415] 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.

[0416] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0417] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0418] 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.

[0419] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0420] 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 magnitude. In other cases, reference to flow will be to a vector quantity, i.e. a quantity having both magnitude and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0421] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow Qd is the flow of air leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas that reaches the patient interface via the air circuit. The ventilation flow Qv is the flow of air leaving the vent to allow flushing of exhaled gases. The leakage flow Ql is the leakage flow from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0422] 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.

[0423] 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.

[0424] 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 environment.

[0425] 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.

[0426] 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.

[0427] 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.

[0428] Oxygen-enriched air: Air having an oxygen concentration greater than atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes shortened to "oxygen."

[0429] Medical Oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0430] Patient: A person, whether or not they have a respiratory condition.

[0431] 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.

[0432] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.

[0433] Respiratory Pressure Therapy: The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0434] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0435] 5.8.1.1 Materials

[0436] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0437] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0438] 5.8.1.2 Mechanical properties

[0439] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0440] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0441] 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).

[0442] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0443] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0444] 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.

[0445] 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.

[0446] 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.

[0447] 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.

[0448] 5.8.2 Breathing cycle

[0449] 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.

[0450] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0451] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0452] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0453] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0454] Flow Limitation: Flow limitation is to be considered a state in the patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0455] Types of flow-limited inspiratory waveforms:

[0456] (i) Flattened: Having a rise followed by a relatively flat portion and then a fall.

[0457] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0458] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0459] (iv) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0460] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than a cessation of flow. In one form, hypopnea is considered to occur when flow decreases below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0461] (i) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0462] (ii) The patient has a decrease in breathing (but less than 50%) lasting at least 10 seconds with an associated desaturation or arousal of at least 3%.

[0463] Hyperpnea: Increased air flow to above normal levels.

[0464] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0465]

[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).

[0466] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0467] Peak Flow (Q Peak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0468] 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.

[0469] 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.

[0470] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0471] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0472] (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.

[0473] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilation Vent tend to cluster over some predetermined time scale, ie a measure of the central tendency of recent values ​​of ventilation.

[0474] Upper airway obstruction (UAO): includes partial and total upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling impedance behavior).

[0475] 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.

[0476] 5.8.3 Anatomy

[0477] 5.8.3.1 Facial anatomy

[0478] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0479] Alar tip: The outermost point on the wing of the nose.

[0480] 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.

[0481] Auricle: The entire external visible part of the ear.

[0482] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0483] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0484] Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

[0485] 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).

[0486] 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.

[0487] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0488] 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.

[0489] 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.

[0490] Nare: The roughly 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.

[0491] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0492] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0493] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0494] Auricular base: The highest point where the auricle attaches to the facial skin.

[0495] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0496] 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.

[0497] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0498] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0499] 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.

[0500] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0501] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0502] 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.

[0503] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0504] 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

[0505] 5.8.3.2 Anatomy of the skull

[0506] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to the area called the forehead.

[0507] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0508] 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.

[0509] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0510] 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.

[0511] 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.

[0512] Orbit: The bony cavity in the skull that holds the eyeball.

[0513] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0514] 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.

[0515] 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.

[0516] 5.8.3.3 Anatomy of the respiratory system

[0517] 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.

[0518] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0519] 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.

[0520] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nostrils.

[0521] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0522] 5.8.4 Patient Interface

[0523] 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.

[0524] 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.

[0525] Frame: A frame will be considered to mean the 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.

[0526] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcements that are configured to position and maintain a facial interface (e.g., a patient interface) in position on a patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0527] 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.

[0528] 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.

[0529] Seal: can be a noun form referring to a structure (seal) or a verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without the need for a separate 'seal' element itself.

[0530] 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.

[0531] 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.

[0532] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0533] 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.

[0534] Tie(noun: a structure used to resist tension.

[0535] Vent: (noun): A structure that allows air flow from the interior of a mask or duct to 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 therapy pressure.

[0536] 5.8.5 Shape of the structure

[0537] 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 some other feature. 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.

[0538] 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. FIG. 3B to FIG. 3F , which show a cross section at a point p on the surface and an example of the resulting plane curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0539] 5.8.5.1 Curvature in one dimension

[0540] 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).

[0541] 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). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0542] 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). Figure 3D .

[0543] 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). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0544] 5.8.5.2 Curvature of a Two-Dimensional Surface

[0545] 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. FIG. 3B to FIG. 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0546] 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. FIG. 3B to FIG. 3F In the example of Figure 3B and the minimum value appears at Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0547] 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.

[0548] 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).

[0549] 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").

[0550] 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.

[0551] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0552] Edge of a surface: The boundary or limit of a surface or area.

[0553] 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).

[0554] 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).

[0555] 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 can 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 can be no 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'.

[0556] 5.8.5.3 Space curve

[0557] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0558] 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.

[0559] 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 tangent vector change is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0560] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see Figure 3P ) or alternatively by the left-hand rule ( Fig.3O ) to determine.

[0561] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0562] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0563] Reference Figure 3P 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., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0564] Similarly, referring to the left-hand rule (see Fig.3O ), 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. See Figure 3T .

[0565] 5.8.5.4 Holes

[0566] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, for example Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0567] A structure can have a two-dimensional hole, such as a hole defined by a surface. For example, a pneumatic tire has a two-dimensional hole 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 hole. For example, see Figure 3L The padding and the Figure 3M and Figure 3N , 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 Figure 3K A two-dimensional hole in the shown structure is bounded by the shown surface.

[0568] 5.9 Other notes

[0569] 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.

[0570] 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.

[0571] 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.

[0572] Furthermore, "approximately," "substantially," "about" or any similar term as used herein means + / - 5 to + / - 10% of the stated value.

[0573] 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.

[0574] When a specific material is identified for use in a component of construction, 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.

[0575] 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.

[0576] 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.

[0577] 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.

[0578] 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.

[0579] 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.

[0580] 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.

[0581] 5.10 Reference Symbols List

[0582]

[0583]

[0584]

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for 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, the seal-forming structure having an aperture therein such that the flow of air at the treatment pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the treatment pressure in the plenum chamber throughout a breathing cycle of the patient; as well as 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: at least one rigidizing arm configured to be positioned adjacent a cheek of the patient in use; as well as a strap removably received about the rigidizing arm and configured to contact a posterior region of the patient's head in use, the strap comprising, a first rigid coupler forming an opening to a cavity through which the rigidized arm is positionable and into the cavity, the first rigid coupler having a mechanical connector configured to engage the rigidized arm and restrict movement of the rigidized arm into and out of the cavity, a second rigid coupler spaced from an outer surface of the first rigid coupler, and A sleeve comprised of a flexible material is folded over the second rigid coupler and positioned between the first rigid coupler and the second rigid coupler.

2. A patient interface according to claim 1, wherein the protrusion extends from the inner surface of the first rigid connector at an angle between 40° and 60°, the angle being measured relative to an axis parallel to a radial axis of the first rigid connector.

3. A method of manufacturing a patient interface according to any preceding claim, the method comprising forming the strap by: providing the flexible material; inserting the second coupler into the cavity of the flexible material; folding one end of the flexible material into the cavity to close the second coupler; and The first coupler is inserted into the cavity.

4. A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient respiration and a connecting inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient respiration; 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, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapy pressure in the plenum chamber throughout a breathing cycle of the patient; as well as wherein the connection inlet port is configured to removably receive a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising at least one of: a rigidizing arm configured to restrict fluid flow through the connection inlet port and configured to be positioned along a cheek of the patient in use; as well as A catheter headgear is configured to deliver the air flow through the connection inlet port to the patient.

5. A patient interface according to claim 4, further comprising a cover removably received within the plenum inlet port when the catheter headband is coupled to the connection inlet port, the cover restricting fluid flow through the plenum inlet port.

6. A method of using a patient interface according to any one of claims 4 to 5, the method comprising: providing the seal forming structure; selecting said positioning and stabilizing structure from one of said rigidizing arm and said catheter headband; connecting the positioning and stabilizing structure to the connection inlet port; connecting one of an air circuit and a cover to the plenum inlet port; as well as An air flow is provided through one of the positioning and stabilizing structure and the air circuit, and the air flow is restricted using one of the cover and the positioning and stabilizing structure.

7. A respiratory pressure therapy (RPT) device comprising: an outer housing including an upper portion, a lower portion, and one or more panels; a chassis that supports one or more internal components of the device; handle; The pneumatic path of the device includes one or more air path items disposed within a pneumatic block disposed within an external housing and supported by or forming part of a chassis.

8. The apparatus of claim 7, the one or more air path items being selected from the group consisting of: an inlet air filter, an inlet muffler, a pressure generator capable of supplying air at a positive pressure, an outlet muffler, and a converter.

9. A blower comprising a brushless DC motor having one or more impellers located in a volute, the blower being capable of delivering an air supply at a rate of up to about 120 liters per minute when delivering respiratory pressure therapy.

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