Patient interface

Abstract

A patient interface for treating sleep disordered breathing, the patient interface comprising a positioning and stabilizing structure that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure comprising: at least a first band portion, a first strap portion connected to each side of the plenum and configured to, in use, cover a side surface of the patient's head and cover a parietal bone and / or occipital bone of the patient's head; and a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion connected to the first strap portion in use at a location proximate a respective one of the patient's ears, the second strap portion is configured to cover an upper region of the patient's head in use.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The entire contents of each of Australian Provisional Patent Application No. 2021901506 filed on May 20, 2021, Australian Provisional Patent Application No. 2021902571 filed on August 18, 2021, Australian Provisional Patent Application No. 2021903730 filed on November 19, 2021, and International Application No. PCT / AU2021 / 051498 are hereby incorporated by reference into this document. Technical Background 1.1 Technical Field

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses. 1.2 Background Technology

[0006] 1.2.1 Human respiratory system and its disorders

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

[0008] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually divide into terminal bronchioles. The bronchi constitute the conducting airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See Respiratory Physiology, 9th edition, by John B. West, published by Lippincott Williams & Wilkins in 2012.

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

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

[0011] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by episodes that include occlusion or obstruction of the upper air passages during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall area 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. The condition often results in excessive daytime sleepiness, and it may lead to cardiovascular disease and brain damage. The syndrome is a common disorder, especially among middle-aged, overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

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

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot 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.

[0014] People with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath when exercising.

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

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

[0017] Neuromuscular disease (NMD) is a broad term that encompasses a number of diseases and conditions that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of ambulation, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders characterized by worsening muscle damage over months and leading to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); and (ii) variable or slowly progressive disorders characterized by worsening muscle damage over years with only a modest reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, dysphagia, dyspnea during exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

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

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

[0020] 1.2.2 Therapy

[0021] 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.

[0022] 1.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as tank or breastplate ventilators).

[0024] 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.

[0025] 1.2.3 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 conditions without treating them.

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

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

[0029] 1.2.3.1 Patient interface

[0030] 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 patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy 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 sufficiently different from the ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids complete sealing. An example of such a patient interface is a nasal cannula.

[0031] Certain other mask systems may not be functionally suitable for use in this field. For example, a purely decorative mask may not be able to maintain appropriate pressure. A mask system used for underwater swimming or diving may be configured to prevent the entry of water from a higher pressure outside, but will not maintain the internal air at a pressure higher than the ambient pressure.

[0032] Certain masks may be clinically undesirable for the present technology, for example if they block airflow through the nose and only allow airflow through the mouth.

[0033] Certain masks may not be comfortable or practical with the present technology if they require the patient to insert a portion of the mask structure into their mouth in order to form and maintain a seal with their lips.

[0034] Certain masks may not be practical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0035] The design of a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head is composed of bones, 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 over the course of a respiratory therapy session.

[0036] As a result of these challenges, some masks have one or more of the following disadvantages: obtrusive, unsightly, expensive, poorly fitted, difficult to use and / or uncomfortable, particularly when worn for a long time or when the patient is unfamiliar with the system. Masks of the wrong size may lead to reduced compliance, reduced comfort and poor patient results. Masks designed only for pilots, masks designed as a part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks for the administration of anesthetics are tolerable for their original applications, but despite this, such masks may be undesirably uncomfortable when worn for long periods of time (e.g., several hours). This discomfort may lead to a reduction in patient compliance with therapy. If the mask is worn during sleep, this is even more so.

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

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

[0039] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0040] 1.2.3.1.1 Sealing structure

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

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

[0043] For example, a seal-forming structure that may be effective in one area of ​​a patient's face may not be appropriate in another area due to the different shapes, structures, areas of variability, and areas of sensitivity of a patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be appropriate for use on a patient's nose.

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

[0045] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface, with the seal-forming structure 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 in order to achieve a seal.

[0046] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the seal-forming portion of the previous style, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leaks.

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

[0048] Another form of seal forming structure can use adhesive to achieve the seal. Some patients may find it inconvenient to frequently apply and remove adhesive on their face.

[0049] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

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

[0051] ResMed Inc. has manufactured the following products incorporating nasal pillows: SWIFT™ nasal pillows, SWIFT™ II nasal pillows, SWIFT™ LT nasal pillows, SWIFT™ FX nasal pillows, and MIRAGE LIBERTY™ full face mask. Examples of nasal pillows are described in the following patent applications assigned to ResMed Inc.: International Patent Application WO 2004 / 073,778 (describing, inter alia, aspects of ResMed Inc.'s SWIFT™ nasal pillows), U.S. Patent Application 2009 / 0044808 (describing, inter alia, aspects of ResMed Inc.'s SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing, inter alia, aspects of ResMed Inc.'s MIRAGE LIBERTY™ full face mask); International Patent Application WO 2009 / 052,560 (describing, inter alia, aspects of ResMed Inc.'s SWIFT™ FX nasal pillows).

[0052] 1.2.3.1.2 Positioning and stabilization

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

[0054] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0055] Another technique is to use one or more straps and / or stabilizing straps.Many of these straps suffer from one or more of poor fit, bulk, discomfort, and inconvenience in use.

[0056] 1.2.3.1.3 Pressurized air duct

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

[0058] Some patients find such interfaces unsightly or claustrophobic and therefore resist wearing them, reducing patient compliance. Additionally, the tubing that connects to the interface at the front of the patient's face can sometimes become easily entangled in bedding.

[0059] 1.2.3.1.4 Pressurized air ducts for positioning / stabilizing seal-forming structures

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

[0061] A patient interface incorporating headgear tubing may provide advantages, such as avoiding tubing connected to the patient interface in front of the patient's face, which may be unsightly and obtrusive. Ideally, a patient interface incorporating headgear tubing is comfortable for the patient to wear for extended periods of time while the patient is asleep, forms an airtight and stable seal with the patient's face, and is also capable of conforming to a range of patient head shapes and sizes.

[0062] 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0063] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an interface of the airway. The air flow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapies such as HFT). Thus, an RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0064] The designer of a device may be faced with making an infinite number of choices. Design criteria often conflict, meaning that some design choices are out of the ordinary or unavoidable. Furthermore, some aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

[0065] 1.2.3.3 Air circuit

[0066] An air circuit is a conduit or tube constructed and arranged to allow air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for inhalation and exhalation.

[0067] 1.2.3.4 Humidifier

[0068] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases airway comfort for the patient. 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.

[0069] 1.2.3.5 Data Management

[0070] There may be a clinical reason for obtaining data to determine whether a patient receiving respiratory therapy has been "compliant," e.g., the patient has used their RPT device in accordance with one or more "compliance rules." An example of an 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 therapy for a patient using the RPT device, calculate usage 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 notify a third party that the patient is compliant.

[0071] There may be other aspects of a patient's therapy that would benefit from communicating therapy data to a third party or external system.

[0072] Existing methods of transmitting and managing such data can be one or more of the following: costly, time consuming, and error prone.

[0073] 1.2.3.6 Ventilation techniques

[0074] 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.

[0075] 1.2.4 Screening, diagnosis and surveillance systems

[0076] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep-disordered breathing involves observing the patient in a clinic for two nights, one night for pure diagnosis and the second night for titration of treatment parameters by the clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosis / monitoring sleep-disordered breathing at home.

[0077] Screening and diagnosis generally describe the identification of a condition based on its signs and symptoms. Screening generally gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, whereas diagnosis can yield clinically actionable information. Screening and diagnosis tend to be a one-time process, whereas monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0078] Clinical experts can adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or may not be able to afford a clinical expert. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Summary of the invention

[0079] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0080] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0081] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0082] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0083] Another aspect of the present technology includes a patient interface comprising: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the inflatable chamber including a inlet port that is sized and structured to receive an air flow at the therapeutic pressure for patient breathing; and 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 a hole therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use.

[0084] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface that provides a force to maintain a seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including at least a first strap portion connected to each side of the plenum chamber and configured to cover the side surfaces of the patient's head and cover the parietal and / or occipital bones of the patient's head in use. The first strap portion can be configured to cover the upper portion of the patient's ear in use while leaving the lower portion of the patient's ear uncovered.

[0085] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure may include a first strap portion that is connected to each side of the inflatable chamber and is configured to cover the side surface of the patient's head and engage a posterior region of the patient's head in use, the posterior region covering the parietal and / or occipital bones of the patient's head. The positioning and stabilizing structure may also include a second strap portion having a pair of ends that are connected to the first strap portion, each end of the second strap portion being connected to the first strap portion in use at a position proximate to a corresponding one of the patient's ears, the second strap portion being configured to cover an upper region of the patient's head in use.

[0086] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface. The positioning and stabilizing structure may include at least a first belt portion, the first belt portion being connected to each side of the inflatable chamber or cushion module and being configured to cover the side surface of the patient's head and engage the posterior region of the patient's head in use, the posterior region covering the parietal and / or occipital bones of the patient's head. The first belt portion may include a pair of first rotatable portions, the first rotatable portions being disposed at respective ends of the first belt portion. The first rotatable portion may be configured to be connected to a corresponding second rotatable portion, the second rotatable portion being disposed on the inflatable chamber or cushion module. The first rotatable portion may be configured to allow the patient to selectively rotate the first rotatable portion relative to the second rotatable portion to a selected rotational position. The first rotatable portion may be configured to prevent rotation relative to the second rotatable portion away from the selected rotational position in use.

[0087] Another aspect of the present technology is a patient interface comprising a positioning and stabilizing structure according to the above aspects. The patient interface may include a seal-forming structure comprising: at least a nasal portion configured to seal around the entrance of the patient's nares; and an oral portion configured to seal around the patient's mouth.

[0088] Another aspect of the present technology includes a patient interface including a membrane portion that connects to a chassis portion and at least partially forms a plenum. The membrane portion can at least partially support a nasal portion of the seal-forming structure. The membrane portion can be more flexible than the chassis portion. The membrane portion can be constructed and arranged to allow relative movement between the nasal portion and the chassis portion of the seal-forming structure.

[0089] In some forms of the present technology, the patient interface includes a positioning and stabilising structure that is connected to the chassis portion at only one location on each side of the chassis portion.

[0090] In some forms of the present technology, the nose portion, the membrane portion and the chassis portion of the seal-forming structure are integrally formed from a resilient material.

[0091] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface for treating sleep disordered breathing, the positioning and stabilizing structure being configured to provide a force to maintain a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to seal and deliver a flow of air at a therapeutic pressure of at least 4 cmH2O above ambient air pressure throughout the patient's breathing cycle in use, the patient interface including an inflatable chamber that can be pressurized to the therapeutic pressure. The positioning and stabilizing structure may include at least a first strap portion, the first strap portion being configured to be connected to each side of the inflatable chamber and being configured to cover a side surface of the patient's head in use and engage a posterior region of the patient's head, the posterior region covering the parietal and / or occipital bones of the patient's head, the first strap portion being configured to cover an upper portion of the patient's ears in use while leaving a lower portion of the patient's ears uncovered.

[0092] Another aspect of the present technology includes a patient interface comprising:

[0093] a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0094] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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 throughout the patient's breathing cycle;

[0095] a vent that allows exhaled gas from the patient to continuously vent from the interior of the plenum to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum during use; and

[0096] a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising at least a first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and to cover the parietal and / or occipital bones of the patient's head, the first strap portion being configured to, in use, cover an upper portion of the patient's ear while leaving a lower portion of the patient's ear uncovered;

[0097] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0098] In some examples, the positioning and stabilizing structure also includes a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate a corresponding one of the patient's ears during use, and the second strap portion being configured to cover an upper region of the patient's head during use.

[0099] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface for treating sleep disordered breathing, the positioning and stabilizing structure being configured to provide a force to maintain a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to seal and deliver a flow of air at a therapeutic pressure of at least 4 cmH2O above ambient air pressure throughout the patient's breathing cycle in use, the patient interface including an inflatable chamber pressurizable to the therapeutic pressure, the positioning and stabilizing structure comprising:

[0100] a first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and engage a posterior region of the patient's head that covers the parietal and / or occipital bones of the patient's head;

[0101] A second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate a corresponding one of the patient's ears during use, the second strap portion being configured to cover an upper region of the patient's head during use.

[0102] Another aspect of the present technology includes a patient interface comprising:

[0103] a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0104] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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 throughout the patient's breathing cycle;

[0105] a vent that allows exhaled gas from the patient to continuously vent from the interior of the plenum to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum during use; and

[0106] 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:

[0107] a first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and engage a posterior region of the patient's head that covers the parietal and / or occipital bones of the patient's head;

[0108] a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion in use at a location proximate a respective one of the patient's ears, the second strap portion being configured to cover an upper region of the patient's head in use;

[0109] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0110] In examples: (a) the first strap portion is configured to cover the patient's ears when in use; (b) the first strap portion is configured to cover the upper portion of the patient's ears when in use while leaving the lower portion of the patient's ears uncovered; (c) the unextended length of the first strap portion is selectively adjustable; (d) the first strap portion is formed of an elastically extensible material; (e) the first strap portion includes a bifurcated portion that is configured to engage the rear region of the patient's head when in use; (f) the bifurcated portion includes an upper portion that is separate from a lower portion, and the separation of the upper portion from the lower portion can be adjusted by the patient to adjust the fit of the first strap portion to the patient's head; (g) the second strap portion extends from the first strap portion substantially at 90 degrees to the first strap portion on each side of the patient's head; (h) the unextended length of the second strap portion is selectively adjustable; and / or (i) the second strap portion is formed of an elastically extensible material.

[0111] In other examples: (a) the first strap portion is connected to the inflatable chamber via a rotatable headgear strap connector on each side of the inflatable chamber; (b) each rotatable headgear strap connector includes a first rotatable portion and a second rotatable portion, the first rotatable portion and the second rotatable portion being configured to be connected together and to allow the first rotatable portion to be selectively rotated by the patient relative to the second rotatable portion to a selected rotational position; (c) each rotatable headgear strap connector is configured to prevent relative rotation between the first rotatable portion and the second rotatable portion away from the selected rotational position during use; (d) each rotatable headgear strap connector is configured to prevent relative rotation away from the selected rotational position by friction; (e) the first strap portion includes two first rotatable portions, each of which is disposed at a respective end of the first strap portion, and the inflatable chamber includes two second rotatable portions, each of which is disposed at a respective end of the first strap portion The second rotatable portion is disposed on a corresponding side of the inflatable chamber; (f) each first rotatable portion includes a convex cylindrical portion, and each second rotatable portion includes a concave cylindrical portion, which is configured to receive the convex cylindrical portion and allow the convex cylindrical portion to be selectively rotated by the patient relative to the concave cylindrical portion; (g) each convex cylindrical portion includes a central portion and a flange portion, the flange portion extending outwardly from the central portion, and each concave cylindrical portion defines a cylindrical cavity and an opening leading to the cylindrical cavity, and wherein when the convex cylindrical portion is received in the concave cylindrical portion, the central portion is located in the opening and the flange portion is received in the cylindrical cavity; (h) the concave cylindrical portion is flexible and can allow the convex cylindrical portion to be inserted; (i) the concave cylindrical portion is formed of an elastic material; and / or (j) the concave cylindrical portion is integrally formed with the non-patient-facing wall of the inflatable chamber.

[0112] In another example: (a) the patient interface includes: a chassis portion that at least partially forms the inflatable chamber; and a membrane portion that at least partially forms the inflatable chamber, the membrane portion being connected to the chassis portion and being more flexible than the chassis portion, wherein the seal-forming structure includes: a nose portion that is at least partially supported by the membrane portion; and an oral portion that is configured to seal around the patient's mouth; (b) the nose portion of the seal-forming structure includes a patient-facing surface that is configured to seal at The nose of the patient is sealed against the face of the patient at or near the lower periphery of the patient's nose, the lower periphery including to or near the nasal prominence of the patient's nose, to the nasal wing and to the upper part of the lip; (c) the nasal portion of the seal-forming structure includes: a front wall including a non-patient-facing surface; and a rear wall connected to the front wall and including the patient-facing surface; (d) the front wall of the nasal portion extends upwardly from the membrane portion of the patient interface; (e) a lower portion of the rear wall of the nasal portion of the seal-forming structure is connected to the seal forming structure (f) the diaphragm portion is formed of an elastic material; (g) the diaphragm portion is formed of silicone; (i) the thickness of the diaphragm portion is 0.45 mm or less; (j) the thickness of the diaphragm portion is 0.4 mm or less; (k) the thickness of the diaphragm portion is 0.35 mm or less; (l) the nose portion and the diaphragm portion of the seal-forming structure are integrally formed; (m) the nose portion and the diaphragm portion of the seal-forming structure are formed together by injection molding in a single molding step; (n) the seal-forming structure, the diaphragm portion and The chassis portion is formed together by injection molding in the single molding step; (o) the chassis portion is formed of an elastic material; (p) the chassis portion is formed of silicone or TPE; (q) the shape of the chassis portion is configured to bend from one side of the patient's face to the other side of the patient's face during use, and the chassis portion is substantially flush with the patient's cheek on each side; (r) the shape of the chassis portion is substantially a hyperbolic parabola or a parabolic cylinder; and / or (s) the shape of the membrane portion is substantially a hyperbolic parabola or a parabolic cylinder.

[0113] Another aspect of the present technology includes a positioning and stabilizing structure for a patient interface for treating sleep disordered breathing, the positioning and stabilizing structure being configured to provide a force to maintain a seal-forming structure of the patient interface in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to sealably deliver a flow of air at a therapeutic pressure of at least 4 cmH2O above ambient air pressure throughout the patient's breathing cycle in use, the patient interface including a cushion module forming an inflatable chamber pressurizable to the therapeutic pressure, the positioning and stabilizing structure comprising:

[0114] at least a first strap portion configured to be connected to each side of the cushion module and configured to, in use, cover a side surface of the patient's head and engage a posterior region of the patient's head that covers the parietal and / or occipital bones of the patient's head;

[0115] The first belt portion includes a pair of first rotatable portions, the first rotatable portions are arranged at corresponding ends of the first belt portion, the first rotatable portions are configured to be connected to corresponding second rotatable portions, the second rotatable portions are arranged on the cushion module, the first rotatable portions are configured to allow the patient to selectively rotate the first rotatable portion to a selected rotational position relative to the second rotatable portion, and the first rotatable portion is configured to prevent rotation relative to the second rotatable portion away from the selected rotational position during use.

[0116] In an example: (a) the first strap portion is connected to the cushion module of the patient interface on each side of the cushion module; (b) each first rotatable portion is configured to resist rotation away from the selected rotational position by friction; (c) each of the first rotatable portions is disposed at a respective end of the first strap portion; (d) each first rotatable portion includes a convex cylindrical portion configured to be received by a concave cylindrical portion, the concave cylindrical portion being disposed on the cushion module and the convex cylindrical portion being selectively rotated by the patient relative to the concave cylindrical portion; and / or (e) each convex cylindrical portion includes a center portion and a flange portion extending outwardly from the center portion.

[0117] Another aspect of the present technology includes a cushion module for a patient interface for treating sleep disordered breathing, the cushion module comprising:

[0118] a chassis portion at least partially defining a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0119] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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 throughout the patient's breathing cycle;

[0120] a pair of second rotatable portions, each of the second rotatable portions being configured to connect to a pair of first rotatable portions of a positioning and stabilising structure of the patient interface, the positioning and stabilising structure being configured to provide a force in use to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0121] The second rotatable part is configured to allow the patient to selectively rotate the first rotatable part relative to the second rotatable part to a selected rotational position, and the second rotatable part is configured to prevent the first rotatable part from rotating relative to the second rotatable part away from the selected rotational position during use.

[0122] In an example: (a) the second rotatable portion is disposed on a respective side of the cushion module; (b) each second rotatable portion is configured to prevent rotation of the first rotatable portion away from the selected rotational position by friction; (c) each second rotatable portion includes a concave cylindrical portion configured to receive the convex cylindrical portion of the respective first rotatable portion and allow the convex cylindrical portion to be selectively rotated relative to the concave cylindrical portion by the patient; (d) each concave cylindrical portion defines a cylindrical cavity and an opening leading to the cylindrical cavity; (e) each concave cylindrical portion is flexible and capable of allowing insertion of the convex cylindrical portion; (f) each concave cylindrical portion is formed of an elastic material; and / or (g) each concave cylindrical portion is integrally formed with the base portion.

[0123] Another aspect of the present technology includes a patient interface comprising:

[0124] a chassis portion at least partially defining a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0125] 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 therapeutic pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum throughout the patient's breathing cycle, the seal-forming structure comprising: at least a nasal portion configured to seal around the entrance to the patient's nares; and an oral portion configured to seal around the patient's mouth;

[0126] a membrane portion connected to the chassis portion and at least partially forming the plenum, the membrane portion at least partially supporting the nose portion of the seal-forming structure, the membrane portion being more flexible than the chassis portion and constructed and arranged to allow relative movement between the nose portion of the seal-forming structure and the chassis portion; and

[0127] a vent that allows exhaled gas from the patient to continuously vent from the interior of the plenum to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum during use; and

[0128] a positioning and stabilising structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure being connected to the chassis portion and comprising one or more strap portions configured to engage the patient's head in use, wherein the positioning and stabilising structure is connected to the chassis portion at only one location on each side of the chassis portion;

[0129] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0130] In examples: (a) the membrane portion separates at least a portion of the nasal portion of the seal-forming structure from the chassis portion; (b) the membrane portion separates at least the front side of the nasal portion of the seal-forming structure from the chassis portion; (c) the membrane portion separates the front wall of the nasal portion of the seal-forming structure from the chassis portion; (d) the membrane portion is constructed and arranged to be inflated when the inflatable chamber is pressurized to the treatment pressure during use; (e) the membrane portion is stretchable; (f) the membrane portion is constructed and arranged to be stretched during inflation when the inflatable chamber is pressurized to the treatment pressure during use; (g) the membrane portion is constructed and arranged to be taut in the absence of treatment pressure in the inflatable chamber; (h) the membrane portion is constructed and arranged to be inflated when the inflatable chamber is pressurized to the treatment pressure during use The invention relates to a seal-forming structure for use inflated to conform to one or more portions of the patient's nose; (i) the base portion is flexible to at least partially separate the membrane portion from destructive forces applied to the base portion during use; (j) the base portion, the membrane portion and the nose portion of the seal-forming structure are formed of silicone; (k) the thickness of the membrane portion is less than 0.45 mm, 0.4 mm, 0.35 mm, 0.3 mm or 0.25 mm; (l) the thickness of the membrane portion is 0.2 mm or thinner; (m) the membrane portion is formed of silicone having a Shore A durometer hardness in the range of 20 to 40; and / or (n) the nose portion, membrane portion and base portion of the seal-forming structure are formed together by injection molding in a single molding step.

[0131] In further examples: (a) the nasal portion of the seal-forming structure includes a pair of nasal pillows supported on the membrane portion, each nasal pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose; (b) the membrane portion is constructed and arranged to at least partially decouple the movement of the nasal pillows from each other; (c) the membrane portion is constructed and arranged to allow each of the nasal pillows to move to align with a corresponding one of the patient's nostrils during use; (d) the membrane portion is constructed and arranged to be inflated during use to push each of the nasal pillows toward a corresponding one of the patient's nostrils; and / or (e) the membrane portion is constructed and arranged to prevent the nasal pillows from separating from the patient's nostrils when the base portion moves during use.

[0132] In other examples: (a) the nasal portion of the seal-forming structure includes a patient-facing surface configured to seal around the patient's nostrils at a lower periphery of the patient's nose, the lower periphery including to or near the nasal prominence of the patient's nose, to the nasal wing, and to the upper lip; (b) the nasal portion of the seal-forming structure includes: a front wall including a non-patient-facing surface; and a rear wall connected to the front wall and including the patient-facing surface; (c) the front wall is separated from the membrane portion of the patient interface by a plurality of diaphragms. The nasal portion of the seal-forming structure is provided with a plurality of posterior lateral corners, each of which is configured to engage the patient's face between a corresponding one of the nasal wings and a corresponding one of the nasolabial grooves, each of which is separated from the mouth portion of the seal-forming structure by the membrane portion; and (g) the membrane portion surrounds the mouth portion of the seal-forming structure. (h) the membrane portion occupies at least an anterior, lateral and posterolateral position adjacent to the lower periphery of the nasal portion of the seal-forming structure; (i) the nasal portion of the seal-forming structure includes a pair of posterolateral walls, each of which extends upwardly, laterally and rearwardly from the membrane portion; (j) a lower portion of the posterior wall of the nasal portion of the seal-forming structure is connected to the mouth portion of the seal-forming structure; (k) the membrane portion is adjacent to the lower periphery of the nasal portion of the seal-forming structure anterior and anterolateral portions of the nasal portion; (l) the membrane portion does not extend to a posterior lateral position of the nasal portion adjacent to the seal-forming structure; (m) the nasal portion of the seal-forming structure includes a pair of posterior lateral walls extending upward, forward and medially from the oral portion of the seal-forming structure; (n) the nasal portion of the seal-forming structure includes a pair of ribs extending between the posterior wall of the nasal portion and the side walls of the nasal portion; and / or (o) the ribs extend between the posterior wall of the nasal portion and a posterior portion of the anterior wall of the nasal portion.

[0133] In further examples: (a) the positioning and stabilizing structure comprises: a first strap portion connected to each side of the inflatable chamber and configured to cover the side surfaces of the patient's head and engage a posterior region of the patient's head during use, the posterior region covering the parietal bone and / or occipital bone of the patient's head; and a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate to a corresponding one of the patient's ears during use, the second strap portion being configured to cover an upper region of the patient's head during use; (b) the first strap portion is configured to cover the patient's ears during use; (c) the first strap portion is configured to cover the upper portion of the patient's ears during use, while (e) the first strap portion is formed of an elastically extensible material; (f) the first strap portion includes a bifurcated portion configured to engage the rear region of the patient's head during use; (g) the bifurcated portion includes an upper portion that is separate from a lower portion, the separation of the upper portion from the lower portion being adjustable by the patient to adjust the fit of the first strap portion to the patient's head; (h) the second strap portion extends from the first strap portion substantially at 90 degrees to the first strap portion on each side of the patient's head; (i) the unextended length of the second strap portion is selectively adjustable; and / or (j) the second strap portion is formed of an elastically extensible material.

[0134] In other examples: (a) the first strap portion is connected to the chassis portion via a rotatable headgear strap connector on each side of the chassis portion; (b) each rotatable headgear strap connector includes a first rotatable portion and a second rotatable portion, the first rotatable portion and the second rotatable portion being configured to be connected together and to allow the first rotatable portion to be selectively rotated by the patient relative to the second rotatable portion to a selected rotational position; (c) each rotatable headgear strap connector is configured to prevent relative rotation between the first rotatable portion and the second rotatable portion away from the selected rotational position during use; (d) each rotatable headgear strap connector is configured to prevent relative rotation away from the selected rotational position by friction; (e) the first strap portion includes two first rotatable portions, each of which is disposed at a respective end of the first strap portion, and the inflatable chamber includes two second rotatable portions, each of which is disposed at a respective end of the first strap portion; The second rotatable portion is disposed on a corresponding side of the inflatable chamber; (f) the first rotatable portion includes a convex cylindrical portion, and the second rotatable portion includes a concave cylindrical portion, which is configured to receive the convex cylindrical portion and allow the convex cylindrical portion to be selectively rotated by the patient relative to the concave cylindrical portion; (g) each convex cylindrical portion includes a central portion and a flange portion, the flange portion extending outwardly from the central portion, and each concave cylindrical portion defines a cylindrical cavity and an opening leading to the cylindrical cavity, and wherein when the convex cylindrical portion is received in the concave cylindrical portion, the central portion is located in the opening and the flange portion is received in the cylindrical cavity; (h) the concave cylindrical portion is flexible and can allow the convex cylindrical portion to be inserted; (i) the concave cylindrical portion is formed of an elastic material; (j) and / or (k) the concave cylindrical portion is integrally formed with the non-patient-facing wall of the inflatable chamber.

[0135] Another aspect of the present technology includes a patient interface comprising:

[0136] a chassis portion at least partially defining a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0137] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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 throughout the patient's breathing cycle, the seal-forming structure comprising: at least a nasal portion;

[0138] a membrane portion connected to the chassis portion and at least partially forming the plenum, the membrane portion at least partially supporting the nose portion of the seal-forming structure, the membrane portion being more flexible than the chassis portion and constructed and arranged to allow relative movement between the nose portion of the seal-forming structure and the chassis portion; and

[0139] a vent that allows exhaled gas from the patient to continuously vent from the interior of the plenum to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum during use;

[0140] wherein the nose portion, the membrane portion and the chassis portion of the seal-forming structure are integrally formed of a resilient material; and

[0141] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0142] In examples: (a) the membrane portion separates at least a portion of the nasal portion of the seal-forming structure from the chassis portion; (b) the membrane portion separates at least the front side of the nasal portion of the seal-forming structure from the chassis portion; (c) the membrane portion separates the front wall of the nasal portion of the seal-forming structure from the chassis portion; (d) the membrane portion is constructed and arranged to be inflated when the inflatable chamber is pressurized to the treatment pressure during use; (e) the membrane portion is stretchable; (f) the membrane portion is constructed and arranged to be stretched during inflation when the inflatable chamber is pressurized to the treatment pressure during use; and (g) the membrane portion is constructed and arranged to be stretched when there is no treatment pressure in the inflatable chamber. (h) the membrane portion is constructed and arranged to be inflated in use to conform to one or more portions of the patient's nose; (i) the base portion, the membrane portion and the nose portion of the seal-forming structure are formed of silicone; (j) the thickness of the membrane portion is less than 0.45 mm, 0.4 mm, 0.35 mm, 0.3 mm or 0.25 mm; (k) the thickness of the membrane portion is 0.2 mm or thinner; (l) the membrane portion is formed of silicone having a Shore A durometer hardness in the range of 20 to 40; and / or (m) the nose portion, membrane portion and base portion of the seal-forming structure are formed together by injection molding in a single molding step.

[0143] In other examples: (a) the inflatable chamber includes a nose portion and a mouth portion, the seal-forming structure includes the mouth portion, and the mouth portion is configured to seal around the user's mouth during use; (b) the nose portion of the inflatable chamber includes a rearward-facing side, the rearward-facing side is configured to face rearwardly and upwardly during use, and the membrane portion and the nose portion of the seal-forming structure form a majority of the rearward-facing side; (c) the membrane portion and the nose portion of the seal-forming structure substantially form the entirety of the rearward-facing side of the nose portion of the inflatable chamber; (d) the chassis portion forms a majority of the forward-facing side of the mouth portion of the inflatable chamber; (e) the chassis portion substantially (f) the mouth portion of the seal-forming structure substantially forms the entirety of the forward-facing side of the mouth portion of the inflatable chamber; (g) the shape of the base portion is configured to bend from one side of the patient's face to the other side of the patient's face during use, and the base portion is substantially flush with the patient's cheek on each side; (h) the shape of the base portion is substantially a hyperbolic parabola or a parabolic cylinder; (i) the shape of the membrane portion is substantially a hyperbolic parabola or a parabolic cylinder; and / or (j) the shape of the base portion and the membrane portion is substantially a hyperbolic parabola rotated 90 degrees relative to each other.

[0144] In further examples: (a) the nasal portion of the seal-forming structure includes a pair of nasal pillows supported on the membrane portion, each nasal pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose; (b) the membrane portion is constructed and arranged to at least partially decouple the movement of the nasal pillows from each other; (c) the membrane portion is constructed and arranged to allow each of the nasal pillows to move to align with a corresponding one of the patient's nostrils during use; (d) the membrane portion is constructed and arranged to be inflated during use to push each of the nasal pillows toward a corresponding one of the patient's nostrils; and / or (e) the membrane portion is constructed and arranged to prevent the nasal pillows from separating from the patient's nostrils when the base portion moves during use.

[0145] In other examples: (a) the nasal portion of the seal-forming structure includes a patient-facing surface configured to seal around the patient's nostrils at a lower periphery of the patient's nose, the lower periphery including to or near the nasal prominence of the patient's nose, to the nasal wings, and to the upper lips; (b) the nasal portion of the seal-forming structure includes: a front wall including a non-patient-facing surface; and a rear wall connected to the front wall and including the patient-facing surface; (c) the front wall extends upward from the membrane portion of the patient interface. (d) the membrane portion includes an oral portion that forms the oral portion of the seal-forming structure; (e) a lower portion of the posterior wall of the nasal portion of the seal-forming structure is coupled to the oral portion of the membrane portion; (f) the nasal portion of the seal-forming structure includes posterolateral corners, each of the posterolateral corners being configured to engage the patient's face between a corresponding one of the nose wings and a corresponding one of the nasolabial grooves, each posterolateral corner being separated from the oral portion of the seal-forming structure by the membrane portion; (g) the membrane portion surrounds the seal-forming structure (h) the membrane portion occupies at least an anterior, lateral and posterolateral position adjacent to the lower periphery of the nasal portion of the seal-forming structure; (i) the nasal portion of the seal-forming structure includes a pair of posterolateral walls, each of which extends upwardly, laterally and rearwardly from the membrane portion; (j) a lower portion of the posterior wall of the nasal portion of the seal-forming structure is connected to the oral portion of the seal-forming structure; (k) the membrane portion is adjacent to the anterior and anterolateral portion of the lower periphery of the nasal portion of the seal-forming structure; (l) the The membrane portion does not extend to a posterior lateral position of the nasal portion adjacent to the seal-forming structure; (m) the nasal portion of the seal-forming structure includes a pair of posterior lateral walls that extend upward, forward and medially from the oral portion of the seal-forming structure; (n) the nasal portion of the seal-forming structure includes a pair of ribs located at or near the base of the nasal portion, the ribs extending between the posterior wall of the nasal portion and the side walls of the nasal portion; and / or (o) the ribs extend between the posterior wall of the nasal portion and a posterior portion of the anterior wall of the nasal portion.

[0146] In other examples: (a) the patient interface includes 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 including a strap that is constructed and arranged so that, in use, at least a portion covers an area of ​​the patient's head that is above the supra-auricular base of the patient's head; (b) the positioning and stabilizing structure includes one or more gas delivery tubes that are configured to provide the air flow at the therapeutic pressure to the inflatable chamber; (c) the positioning and stabilizing structure includes a pair of upper straps, each of which is configured to be positioned on the patient's head; (d) each upper arm extends laterally, upwardly and rearwardly relative to the chassis portion; and / or (e) the positioning and stabilizing structure includes a pair of lower straps, each lower strap is configured to be positioned on a corresponding side of the patient's head below a corresponding sub-ear base point of the patient's head, the patient interface includes a pair of lower arms, the lower arms extend from the chassis portion, each lower arm is configured to be attached to a corresponding lower strap among the lower straps.

[0147]

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

[0148] One aspect of one form of the present technology is a method of making a device.

[0149] 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.

[0150]

[0013] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (eg, around the person's home).

[0151] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment.

[0152] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. In addition, the described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0153] Of course, parts of these aspects can form sub-aspects of the present technology. In addition, each sub-aspect and / or aspect in the sub-aspect and / or aspect can be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.

[0154] Other features of the present technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0155] 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 similar elements, including:

[0156] 1.3 Respiratory therapy system

[0157] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. Also shown is a bed partner 1100. The patient is sleeping in a supine sleeping position.

[0158] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000.

[0159] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying sleeping position.

[0160] 1.4 Respiratory system and facial anatomy

[0161] Figure 2AA 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.

[0162] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0163] Figure 2C is a front view of a face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial groove, and lip corner point. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0164] Figure 2D is a side view of the head with several surface anatomical features identified, including the glabella, nasal bridge, nasal prominence, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge point, supraauricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also indicated.

[0165] 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.

[0166] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermilion of the upper lip, nostrils, subnasal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0167] Figure 2G A side view showing the surface features of the nose.

[0168] 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.

[0169] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the midsagittal plane, particularly showing the medial crus of the septal cartilage and the greater alar cartilage.

[0170] Figure 2J A frontal view of the skull including the frontal, nasal and zygomatic bones is shown. The nasal turbinates are also indicated, as well as the maxilla and mandible.

[0171] Figure 2KA side view of the skull is shown with the outline of the surface of the head and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0172] Figure 2L An anterolateral view of the nose is shown.

[0173] 1.5 Patient Interface

[0174] Figure 3A A patient interface in the form of a nasal mask in accordance with one form of the present technology is shown.

[0175] 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 when Figure 3C The curvature magnitude shown has a relatively large magnitude in comparison.

[0176] 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 when Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0177] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0178] 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.

[0179] 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 has a relatively large magnitude in comparison.

[0180] Figure 3G A cushion for a mask including 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.

[0181] Figure 3HA cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and one dome region are indicated.

[0182] Fig. 3I A surface is shown having a structure with a one-dimensional hole in the surface. The illustrated plane curve forms the boundary of the one-dimensional hole.

[0183] Figure 3J Shown through Fig. 3I The illustrated surface defines Fig. 3I Two-dimensional holes in the structure.

[0184] Figure 3K Shows Fig. 3I A perspective view of a structure including two-dimensional holes and one-dimensional holes is also shown. Fig. 3I The surface of the two-dimensional holes in the structure.

[0185] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0186] 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 bladder. The inner surface defines a two-dimensional hole in the mask.

[0187] Figure 3N Shown through Figure 3L Another cross section of a mask. The inner surface is also indicated.

[0188] Fig.3O The diagram illustrates the left-hand rule.

[0189] Figure 3P The diagram illustrates the right-hand rule.

[0190] Figure 3Q The left ear is shown, including the left ear helix.

[0191] Figure 3R The right ear is shown, including the right ear helix.

[0192] Figure 3S A right-hand helix is ​​shown.

[0193] Figure 3T Views of a mask are shown including the symbols of the twists of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0194] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0195] Figure 3V Shows Figure 3U A view of the rear portion of the plenum chamber. The view is oriented normal to the median contact plane. Figure 3V The sagittal plane in the middle bisects the plenum into left-hand and right-hand sides.

[0196] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V 3221 and 3230. The middle contact plane is cut at the sagittal plane shown. A "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3201, which lies in the sagittal plane and contacts the liner of the plenum chamber at only two points in the sagittal plane, the upper point 3221 and the lower point 3230. Depending on the geometry of the liner in this area, the mid-contact plane can be a tangent plane at the upper point and the lower point.

[0197] Figure 3X Shown in position for use on the face Figure 3U The inflatable chamber 3200. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the "plane of the face". Figure 3X In the figure, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3221 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0198] Figure 3Y A patient interface in the form of a nasal cannula is shown in accordance with one form of the present technology.

[0199] Figure 3Z A patient interface having a catheter tip cover in accordance with one form of the present technology is shown.

[0200] 1.6RPT device

[0201] Figure 4A One form of RPT device according to the present technology is shown.

[0202] 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.

[0203] 1.7 Humidifier

[0204] Figure 5AAn isometric view of a humidifier according to one form of the present technology is shown.

[0205] Figure 5B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0206] 1.8 Respiratory waveform

[0207] Figure 6 A shows a typical breathing waveform model of a person while sleeping.

[0208] 1.9 Additional Figures of Patient Interfaces According to Examples of the Present Technology

[0209] Figure 7 is a perspective illustration of a patient interface according to an example of the present technology.

[0210] Figure 8 yes Figure 7 Illustration of a top front view of the patient interface shown.

[0211] Fig. 9 yes Figure 7 Illustration of a top rear view of the patient interface shown.

[0212] Fig.10 yes Figure 7 Front view illustration of a patient interface shown.

[0213] Fig.11 yes Figure 7 Rear view illustration of the patient interface shown.

[0214] Fig.12 Shows Figure 7 The patient interface is shown as being donned by a patient prior to pressurization of the inflatable chamber of the patient interface.

[0215] Fig.13 Shows Figure 7 The patient interface is shown as being worn by a patient while the inflatable chamber is pressurized.

[0216] Fig.14 A top view of a patient interface according to another example of the present technology is shown.

[0217] Fig.15 Shows Fig.14 Rear-superior view of the patient interface shown.

[0218] Fig.16 Shows Fig.14 Front-up view of the patient interface shown.

[0219] Fig.17 Shows Fig.14The patient interface is shown as being worn by a patient while the inflatable chamber is pressurized.

[0220] Fig.18 is an anterior-lateral perspective view of a patient interface according to another example of the present technology.

[0221] Fig.19 yes Fig.18 A front-outside perspective view of the cushion module of the patient interface is shown.

[0222] Fig. 20 yes Fig.18 A top perspective view of the cushion module of the patient interface is shown.

[0223] Fig.21 yes Fig.18 A top rear perspective view of the cushion module of the patient interface is shown.

[0224] Fig. 22 yes Fig.18 A front-outside perspective view of the cushion module of the patient interface is shown.

[0225] Fig.23 yes Fig.18 A top perspective view of the cushion module of the patient interface is shown.

[0226] Fig.24 yes Fig.18 A side perspective view of the patient interface shown in use on a patient.

[0227] Fig.25 is a front perspective view of a patient interface according to another example of the present technology.

[0228] Fig.26 yes Fig.25 Anterior-lateral perspective view of the patient interface shown.

[0229] Fig. 27 yes Fig.25 A top rear perspective view of the patient interface shown.

[0230] Fig.28 yes Fig.25 Rear perspective view of the patient interface shown.

[0231] Fig.29 yes Fig.25 An anterior-lateral perspective view of the patient interface shown being worn by a patient.

[0232] Fig.30 is a front perspective view of a patient interface according to another example of the present technology.

[0233] Fig.31 yes Fig.30 Anterior-lateral perspective view of the patient interface shown.

[0234] Fig.32 yes Fig.30 A top rear perspective view of the patient interface shown.

[0235] Fig.33 yes Fig.30 Rear perspective view of the patient interface shown.

[0236] Fig.34 yes Fig.30 A posterolateral perspective view of the patient interface is shown.

[0237] Fig.35 is an anterior-lateral perspective view of a patient interface according to another example of the present technology.

[0238] Fig.36 yes Fig.35 A side view of the cushion module of the patient interface is shown.

[0239] Fig.37 yes Fig.35 Rear view of the cushion module of the patient interface shown.

[0240] Fig.38 yes Fig.35 A top view of the cushion module of the patient interface is shown.

[0241] Fig.39 yes Fig.35 A rear lower view of the cushion module of the patient interface is shown.

[0242] Fig.40 yes Fig.35 An anterolateral view of the patient interface shown in use on a patient.

[0243] Fig.41 yes Fig.35 Supero-anterior-lateral view of the patient interface shown in use on a patient.

[0244] Fig.42 yes Fig.35 Anterior-lateral view of the patient interface shown with the positioning and stabilizing structure attached to the cushion module.

[0245] Fig.43 yes Fig.35 Detailed view of the patient interface shown with the positioning and stabilising structure not attached to the cushion module.

[0246] Fig.44 A cross-sectional view of a nasal portion of a seal-forming structure of a patient interface according to another example of the present technology is shown.

[0247] Fig.45 A rear view of a cushion module of a patient interface according to an example of the present technology is shown. DETAILED DESCRIPTION

[0248] Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present disclosure is only used to describe the specific examples discussed herein and is not intended to be limiting.

[0249] The following description is provided about each example that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any example can constitute another example.

[0250] 1.10 Therapy

[0251] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an entrance to the airway of a patient 1000 .

[0252] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

[0253] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0254] 1.11 Respiratory Therapy System

[0255] 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 or 3800 .

[0256] 1.12 Patient Interface

[0257] According to one aspect of the present technology, Figure 3A The non-invasive patient interface 3000 shown 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 can be provided by one or more physical components. In some forms, one physical component can 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 patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0258] like Figure 3ZAs shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a connector for connecting to an air circuit (such as Figures 1A to 1C The air circuit 4170 shown in FIG. 4 is a form of connection port 3600. The plenum 3200 may be formed from one or more modular components, in the sense that it or they may be replaced with different components (eg, components of different sizes).

[0259] 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.

[0260] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0261] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0262] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH20 relative to ambient.

[0263] 1.12.1 Sealing structure

[0264] The patient interface 3000 may include a seal-forming structure 3100. The seal-forming structure 3100 may be constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. In addition, the seal-forming structure 3100 may have holes therein so that, in use, a flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils. The seal-forming structure 3100 may be constructed and arranged to, in use, maintain a therapeutic pressure in the plenum 3200 throughout the patient's breathing cycle.

[0265] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal is likely to occur. The area where a seal actually occurs - the actual sealing surface - may vary over time and from patient to patient within a given treatment session, 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.

[0266] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0267] In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material, such as silicone rubber. In other forms, the seal-forming structure 3100 includes a foam base pad 3110 and a textile membrane portion 3220, as further described below.

[0268] The seal-forming structure 3100 in accordance with the present technology may be comprised of a soft, flexible, elastic material such as silicone.

[0269] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 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 of the seal-forming structure that is suitable for small-sized heads but not for large-sized heads. However, examples of the technology can be suitable for a wide range of heads, and therefore can be used by patients with relatively large heads and relatively small heads.

[0270] 1.12.1.1 Sealing mechanism

[0271] In one form, the seal forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on the underside of the sealing flange within the interior of the plenum 3200 to urge it into tight sealing engagement with the face. The pressure assist mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0272] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the 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 at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange to prevent it from bending during use.

[0273] 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.

[0274] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent region of the sealing flange.

[0275] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0276] 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.

[0277] 1.12.1.2 Nose bridge or nasal ridge area

[0278] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over a nasal bridge or nasal ridge region of the patient's face.

[0279] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal over a nasal bridge or nasal ridge region of a patient's face in use.

[0280] 1.12.1.3 Upper lip area

[0281] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0282] 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.

[0283] 1.12.1.4 Chin area

[0284] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin region of the patient's face.

[0285] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0286] 1.12.1.5 Forehead area

[0287] 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.

[0288] 1.12.1.6 Nasal pillows

[0289] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each nasal puff or pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0290] 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 underside of a patient's nose; a handle; and a flexible region located on the underside of the frustoconical body and connecting the frustoconical body to the handle. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the handle. These flexible regions can work together to facilitate a universal joint structure that accommodates displacement and angular relative movement of the frustoconical body and the structure to which the nasal pillows are connected. For example, the frustoconical body can be axially displaced toward the structure to which the handle is connected.

[0291] In one example of nasal pillows, at least a portion of the frustoconical shape of each nasal pillow can be shaped and sized to enter the patient's corresponding nostril. In another example of nasal pillows, the frustoconical shape of each nasal pillow can be shaped and sized not to enter the patient's corresponding nostril. Each nasal pillow can be configured to seal against a portion of the patient's nose that defines the corresponding nostril, including the patient's columella and the corresponding nasal ala.

[0292] In some examples of nasal pillows, each nasal pillow can be stemless. The frustoconical body of each nasal pillow can be directly attached to a portion of the patient interface 3000 that defines the plenum chamber 3200.

[0293] In some examples, each nasal pillow can include a tip and a base that is wider than the tip. The tip can be configured to be received in a corresponding nostril of the patient's nostrils. Each nasal pillow can include a tapered portion. Each nasal pillow can extend or protrude from a portion of the patient interface 3000 that supports it (such as, in examples, a portion of the plenum 3200, the seal-forming structure 3100, or the membrane portion 3220).

[0294] 1.12.1.7 Nasal mask

[0295] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal against the upper lip area (e.g., the upper lip), against at least a portion of the patient's nose bridge or nasal ridge above the pronasal point, and against the patient's face on each outer side of the patient's nose (e.g., near the patient's nasolabial grooves). Figure 1B The patient interface 3000 shown has this type of seal-forming structure 3100. This patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be referred to as a "nasal cushion", and a patient interface 3000 having such a seal-forming structure 3100 may be identified as a "nasal mask".

[0296] 1.12.1.8 Full face mask

[0297] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the patient's chin area (which may include the area below the patient's lips and / or directly below the lips), on at least a portion of the nasal ridge on the patient's nose bridge or at the nasal prominence, and on cheek areas of the patient's face. Figure 1C The patient interface 3000 shown is of this type. The patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be referred to as a "full face cushion" and the patient interface 3000 may be referred to as a "full face mask."

[0298] 1.12.1.9 Ultra-compact full face mask

[0299] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the patient's face over the patient's chin region (which may include the area below and / or directly below the patient's lips), over the lower and / or anterior surface of the patient's nasal prominence, and on each lateral side of the patient's nose (e.g., near the nasolabial grooves). The seal-forming structure 3100 may also form a seal against the upper portion of the patient's lips. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nostrils and the mouth of the patient, may have an orifice configured to provide air or breathable gas to the mouth and nostrils configured to provide air or breathable gas to the nostrils, or may have an orifice for delivering air to the patient's mouth and two nostrils for delivering air to the respective nostrils. This type of patient interface 3000 may be referred to as an ultra-compact full face mask and may include an ultra-compact full face cushion.

[0300] 1.12.1.10 Nose support mask

[0301] In one form, for example Figure 3Z As shown, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils in use. The seal-forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including the lower surface and / or the front surface to the patient's nasal prominence and to the patient's nasal wings. The seal-forming structure 3100 can form a seal against the patient's upper lips. This type of seal-forming structure 3100 may be referred to as, for example, a "cradle cushion", "nose cushion", or "nose floor cushion".

[0302] The shape of the seal-forming structure 3100 can be configured to match or fit closely to the underside of the patient's nose and may not contact the bridge area of ​​the patient's nose or any portion of the patient's nose above the nasal prominence. In one form of the nasal pad, the seal-forming structure 3100 includes a bridging portion that divides the opening into two orifices, each of which supplies air or breathable gas to a corresponding one of the patient's nostrils in use. The bridging portion can be configured to contact or seal against the patient's columella in use. Alternatively, the seal-forming structure 3100 may include a single opening to provide air flow or breathable gas to both nostrils of the patient.

[0303] 1.12.2 Inflatable Chamber

[0304] The plenum chamber 3200 may be formed by a portion of the patient interface 3000 having a perimeter shaped to complement the surface contour of an average human face in the area where a seal will be formed in use. In use, the edge of the portion of the patient interface 3000 forming the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the portion of the patient interface 3000 forming the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0305] 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 for the wearer, which can improve compliance with therapy.

[0306] In some forms of the present technology, the plenum chamber 3200 is formed of one or more components 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 therapy. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0307] In some forms of the present technology, the plenum 3200 is formed of one or more components comprised of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0308] 1.12.3 Positioning and stabilizing the structure

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

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

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

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

[0313] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with the manner in which it is worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one band having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat band.

[0314] 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 dorsal area of ​​the patient's head on a pillow.

[0315] 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-lying sleeping position with the side area of ​​the patient's head on a pillow.

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

[0317] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt comprised of 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 to engage with a hook material portion.

[0318] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be in a tensioned state during use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.

[0319] 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 its lower edge passes above the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0320] In one form of the present technology suitable for a pure nasal mask or 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 its upper edge passes below the subauricular base of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0321] In one form of the present technology suitable for a pure nasal mask or 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 move away from each other.

[0322] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a bendable and, for example, non-rigid belt. An advantage of this aspect is that the belt is more comfortable for the patient when the patient is sleeping.

[0323] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a band configured to be breathable to allow moisture to transfer through the band.

[0324] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure 3300 being configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another such positioning and stabilizing structure that is suitable for small sized heads but not for large sized heads.

[0325] 1.12.3.1 Catheter head cover

[0326] 1.12.3.1.1 Catheter head sleeve

[0327] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head cuffs 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the plenum chamber 3200 and the seal-forming structure 3100. Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface at a location other than the front of the patient's face (e.g., on the top of the patient's head). Figures 7 to 13 The illustrated patient interface 3000 also includes a gas delivery tube 3350 forming a catheter tip cover.

[0328] Because air can be contained and passed through the head cuff to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It will be appreciated that an inflatable positioning and stabilizing structure 3300 does not require that all components of the positioning and stabilizing structure 3300 be inflatable. For example, in Figure 3Z In the example shown, the positioning and stabilizing structure 3300 includes an inflatable tube 3350 and a non-inflatable belt portion 3310 .

[0329] exist Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 is positioned on a different side of the patient's head in use, and extends across a respective cheek area above a respective ear (above the supra-auricular base on the patient's head) to a curved tube 3612 on the top of the patient's head 1000. This form of technology may be advantageous because if the patient sleeps with their head on their side and one of the tubes is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek area), and the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another area) to help secure the patient interface 3000 on the patient's head.

[0330] exist Figure 3ZIn the illustrated technical form, two tubes 3350 are fluidly connected to each other and to a connection port 3600 at the upper end. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately but connected in use and can be disconnected, for example for cleaning or storage. In the case of using separate tubes, they can be connected together indirectly, for example, each can be connected to a T-shaped connector having two arms / branches and a third arm or opening, each arm / branch being fluidly connected to a corresponding one of the tubes 3350, the third arm or opening providing a connection port 3600 for fluid connection to the air circuit 4170 in use.

[0331] The tube 3350 may be formed of a flexible material, such as an elastomer, for example silicone or TPE, or one or more textile and / or foam materials. The tube 3350 may have a preformed shape and be able to bend or move into another shape when a force is applied, but may return to the original preformed shape when the force is absent. The shape of the tube 3350 may be generally arcuate or curved, with a shape that approximates the contour of the patient's head between the top of the head and the nose or mouth area.

[0332] As described in U.S. Pat. No. 6,044,844, which is incorporated herein, the tubes 3350 can be crush resistant to avoid obstruction of the flow of breathable gas through the tubes if either tube is crushed during use, such as if it is squeezed between the patient's head and the nasal pillows. In all cases, crush resistant tubes may not be necessary, as the pressurized gas in the tubes can act as a splint to prevent or at least limit the crushing of the tubes 3350 during use. Compression resistant tubes may be advantageous in situations where only a single tube 3350 is present, as if the single tube becomes blocked during use, the flow of gas will be restricted and the therapeutic efficacy will cease or be reduced. In some examples, the size of the tubes 3350 can be determined so that if one of the tubes 3350 is blocked, each tube 3350 is able to provide sufficient gas flow to the plenum chamber 3200 on its own.

[0333] Each tube 3350 can be configured to receive air flow from a connection port 3600 located on the top of the patient's head and deliver the air flow to a seal-forming structure 3100 located at the entrance of the patient's airway. Figure 3ZIn the example shown, each tube 3350 is located on a path extending from the plenum chamber 3200 across the cheek area of ​​the patient and reaching the curved tube 3612 above the patient's ear during use. For example, the portion of each tube 3350 near the plenum chamber 3200 can cover the maxillary area of ​​the patient's head during use. Another portion of each tube 3350 can cover an area of ​​the patient's head that is above the supra-auricular base point of the patient's head. Each tube 3350 can also be located on the patient's sphenoid bone and / or temporal bone and one or both of the patient's frontal bone and parietal bone. The curved tube 3612 can be located on the patient's parietal bone, on the frontal bone and / or on the junction between them (e.g., the coronal suture) when in use.

[0334] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient's head such that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some examples, the headband tube 3350 is configured to allow an upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to a lower portion of the patient interface 3000 (e.g., the plenum 3200). That is, the connection port 3600 can be at least partially separated from the plenum 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0335] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is generally positioned under the nose and seals to the lower periphery of the nose (e.g., a nasal floor cushion). The positioning and stabilizing structure 3300, including the tube 3350, can be constructed and arranged to draw the seal-forming structure 3100 into the patient's face under the nose with a sealing force vector in a posterior and superior direction (e.g., a posterior-superior direction). The sealing force vector having a posterior-superior lateral direction can facilitate the seal-forming structure 3100 to form a good seal against both the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face on both sides of the patient's nose and above the patient's lips.

[0336] 1.12.3.1.2 Extendable and non-extendable pipe sections

[0337] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments, such as formed by an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall having an extendable accordion-like structure. Figure 3ZThe illustrated patient interface 3000 comprises a tube 3350 , an upper portion of which comprises extendable tube segments, each of which is in the form of an extendable accordion-like structure 3362 .

[0338] The cross-sectional shape of the non-extensible tube segment 3363 of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example as described in U.S. Patent No. 6,044,844. A cross-sectional shape presenting a flat surface of the tube on the side facing and contacting other parts of the patient's face or head can be more comfortable to wear than, for example, a tube having a circular cross-section.

[0339] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 from a low angle. The head sleeve tube 3350 can extend downward along the side of the patient's head and then bend forward and inward to connect to the plenum chamber 3200 in front of the patient's face. Before connecting to the plenum chamber 3200, the tube 3350 can extend to the same vertical position as the connection with the plenum chamber 3200, or in some examples, at a position below it. That is, the tube 3350 can protrude in an at least partially upward direction before connecting to the plenum chamber 3200. A portion of the tube 3350 can be located below the cushion module 3150 and / or the seal-forming structure 3100. The tube 3350 is located at a low position in front of the patient's face to facilitate contact with the patient's face below the patient's cheekbones, which may be more comfortable than contacting the patient's cheekbones and may avoid excessive blurring of the patient's peripheral vision.

[0340] 1.12.3.1.3 Catheter head cover connection port

[0341] In some forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the upper portion, outer portion, or rear portion of the patient's head. Figure 3Z In the illustrated form of the present technology, the connection port 3600 is located on the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3612 that forms the connection port 3600. The elbow 3612 can be configured to be fluidly connected to a conduit of the air circuit 4170. The elbow 3612 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially separate the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3612 can be configured to rotate by rotating around a substantially vertical axis, and in some specific examples, by rotating around two or more axes. In some examples, the elbow can include a tube 3350 or be connected to the tube by a ball joint. The connection port 3600 can be located in the sagittal plane of the patient's head when in use.

[0342] A patient interface having a connection port that is not located in front of the patient's face may be advantageous because some patients may find that the conduit connected to the patient interface in front of their face is unsightly and / or unobtrusive. For example, a conduit connected to the patient interface in front of the patient's face may be prone to interfering with bedding or sheets, particularly if the conduit extends downward from the patient interface in use. A form of the present technology including a patient interface having a connection port positioned above the patient's head in use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side sleeping position, a supine position (e.g., on its back, with the overall face facing upward) or in a prone position (e.g., on its front, with the overall face facing downward). In addition, connecting the conduit to the front of the patient interface exacerbates a problem known as tube resistance, in which the conduit applies an undesirable force on the patient interface during movement of the patient's head or conduit, resulting in displacement away from the face. Tube resistance may be a lesser problem when the force received at the upper position of the patient's head is greater than the force received in front of the patient's face close to the seal-forming structure (wherein tube resistance may be more likely to destroy the seal).

[0343] 1.12.3.1.4 Headband Tube Fluid Connection

[0344] Two tubes 3350 are fluidly connected to the plenum chamber 3200 at their lower ends. In some forms of the technology, the connection between the tube 3350 and the plenum chamber 3200 is achieved by the connection of two rigid connectors. The tube 3350 and the plenum chamber 3200 can be configured so that the patient can easily connect the two components together in a reliable manner. The tube 3350 and the plenum chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a "secure click" or similar sound, which is easy to use for the patient because the patient can know that each tube 3350 has been correctly connected to the plenum chamber 3200. In one form, the tube 3350 is formed of silicone or a textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature that is configured to connect to a convex mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum 3200. In other examples, the tubes 3350 may each include a male or female connector formed from a flexible material (e.g., silicone or TPE), such as where the tubes 3350 are formed from the same material.

[0345] In other examples, a compression seal is used to connect each tube 3350 to the plenum 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard joint between the tube 3350 and the plenum 3200, each tube 3350 and / or the plenum 3200 can include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum 3200 to form or enhance the seal between the tube 3350 and the plenum 3200.

[0346] 1.12.3.1.5 Catheter headband

[0347] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap in addition to the tube 3350, the at least one headgear strap being used to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. Figure 3Z As shown, the patient interface 3000 includes a strap portion 3310 that forms part of the positioning and stabilizing structure 3300. For example, the strap portion 3310 may be referred to as a back strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 with full face padding according to examples of the present technology may have a second lower strap that is configured to rest against the patient's head proximal to the patient's neck and / or against the posterior surface of the patient's neck.

[0348] exist Figure 3Z In the example shown, the strap portion 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350 that are positioned on each side of the patient's head and around the back of the patient's head, such as covering the occipital bone of the patient's head or located below the occipital bone of the patient's head during use. The strap portion 3310 is connected to each tube above the patient's ears. Figure 3Z , the positioning and stabilizing structure 3300 includes a pair of tabs 3355. In use, the strap portion 3310 can be connected between the tabs 3355. Even when in a tensioned state in use, the strap portion 3310 can be flexible enough to pass around the back of the patient's head and rest comfortably against the patient's head.

[0349] 1.12.4 Cushion Module and Exemplary Patient Interface

[0350] exist Figures 7 to 43In the illustrated example of the present technology, the patient interface 3000 includes a chassis portion 3210 that partially forms a plenum chamber 3200. The chassis portion 3210 and the membrane portion 3220 (described below) can together form the plenum chamber 3200 by enclosing a volumetric space that can be filled with air at a therapeutic pressure (such as at least 4 cmH2O or at least 6 cmH2O above ambient air pressure). In some examples, depending on the type and / or shape of the seal-forming structure 3100, the seal-forming structure 3100 can also partially form the plenum chamber 3200.

[0351] exist Figures 7 to 43 In the example shown, the components forming the seal-forming structure 3100 and the plenum chamber 3200 form a cushion module 3150 of the patient interface 3000. Figures 7 to 13 In the example shown, Figures 7 to 11 A separate pad module 3150 is shown, Figure 12 to Figure 13 The cushion module is shown connected to the head cuff 3350. The cushion module 3150 in these examples can be separate from other components of the patient interface 3000, such as the positioning and stabilizing structure 3300. The cushion module 3150 can be separate from the head cuff 3350 of the positioning and stabilizing structure 3300. Thus, in some examples of the present technology, the patient interface 3000 includes a removable cushion module 3150.

[0352] In some examples, the cushion module 3150 can be replaced in the patient interface 3000 with another cushion module 3150 (eg, a cushion module having a different size (or at least having a seal-forming structure 3100 having a different size or shape)).

[0353] In other examples, the cushion module 3150 may not be separate from other components or portions of the patient interface 3000, such as the positioning and stabilizing structure 3300. In some examples, the cushion module 3150 may include a chassis portion 3210, at least a portion of which is integrally formed with one or both of the head cuffs 3350, or integrally formed with portions of the positioning and stabilizing structure. Unless the context clearly requires otherwise, the features of the patient interface 3000 disclosed herein should be understood to apply regardless of whether the chassis portion 3210 is part of a removable cushion module 3150.

[0354] Plenum chamber 3200 may include one or more plenum chamber inlet ports sized and configured to receive a flow of air at a therapeutic pressure for breathing by a patient.

[0355] exist Figures 7 to 13In the example shown, the plenum chamber 3200 of the patient interface 3000 has two plenum chamber inlet ports. Specifically, the chassis portion 3210 defines two openings, one on each side of the chassis portion 3210. Figures 14 to 17 In the example shown, the plenum 3200 includes a plenum inlet port. Specifically, the bottom plate portion 3210 defines an opening located at the connection with the short tube 3610 to form the plenum inlet port.

[0356] exist Figures 18 to 43 In the illustrated example of the present technology, the patient interface 3000 includes a chassis portion 3210 and a membrane portion 3220 that form a plenum chamber 3200. In these examples, the patient interface 3000 is configured to supply a pressurized air flow to the patient's mouth and nostrils. The plenum chamber 3200 is configured to be located in front of the patient's mouth in addition to being located under the patient's nose during use. The plenum chamber 3200 is therefore more Figures 7 to 13 The plenum chamber 3200 of the illustrated patient interface 3000 is larger. Figures 18 to 43 The plenum chamber 3200 in the examples shown in can be described as having: a nose portion that is configured to be positioned near the user's nose in use; and a mouth portion that is configured to be positioned near the user's mouth in use. In these examples, the chassis portion 3210 forms a majority of the forward-facing side of the mouth portion of the plenum chamber 3200. In some examples, the chassis portion 3210 forms substantially all of the forward-facing side of the mouth portion of the plenum chamber 3200. In some examples, the chassis portion 3210 and the mouth portion of the seal-forming structure 3100 form substantially all of the rearward-facing side of the mouth portion of the plenum chamber 3200. In these examples, the components that form the seal-forming structure 3100 and the plenum chamber 3200 form a cushion module 3150 of the patient interface 3000. The cushion module 3150 in these examples can be separated from other components of the patient interface (such as the positioning and stabilizing structure 3300).

[0357] exist Figures 18 to 43 In the example, the seal-forming structure 3100 includes a nose portion 3101. Figures 7 to 29 The nasal portion 3101 of the seal-forming structure 3100 in the illustrated example includes nasal pillows and Figures 30 to 43 In the example shown, the nose portion 3101 includes a bracket cushion portion. For example, the seal-forming structure 3100 in the form of a bracket cushion or nose pillow can be formed from silicone or TPE. For example, more generally, the nose portion 3101 of the seal-forming structure 3100 can be formed from an elastic material such as silicone or TPE.

[0358] exist Figures 18 to 43In the example shown, the seal-forming structure 3100 includes a mouth portion 3102, which can form the mouth portion of the inflatable chamber 3200 together with the bottom plate portion 3210. The mouth portion 3102 of the seal-forming structure 3100 is configured to form a seal around the patient's mouth, and can include a sealing flange that is configured to seal to the patient's upper lip, lower lip and cheek. The sealing flange can be formed of an elastic material (such as silicone or TPE), can be formed of foam, or can be formed of a textile with an airtight membrane (such as a thin silicone layer) or other suitable material. The sealing flange that forms the mouth portion 3102 of the seal-forming structure 3100 can be formed integrally with the mouth bottom plate portion 3217. For example, the thickness of the sealing flange can be in the range of 0.1mm to 1mm, or in the range of 0.2mm to 0.8mm or 0.25mm to 0.5mm. The thickness of the sealing flange in the upper lip region can be 0.25 mm, which can provide a comfortable and effective seal on the upper lip of the patient and can accommodate different patient geometries. In some specific examples, the thickness of the sealing flange can be 0.2 mm. In some examples, as will be described in more detail, the membrane portion 3220 of the patient interface 3000 forms the mouth portion 3102 of the seal-forming structure 3100.

[0359] Unless the context requires otherwise, features described with reference to any one of the patient interfaces 3000 described herein should be understood to be applicable to any of the other patient interfaces 3000 described herein.

[0360] 1.12.4.1 Connection to positioning and stabilizing structures and air circuits

[0361] 1.12.4.1.1 Catheter head cover

[0362] Figure 12 to Figure 13 (The pad module 3150 is Figures 7 to 11 Figure 2) and Figures 18 to 24 The patient interfaces 3000 shown each include a positioning and stabilizing structure 3300 that includes one or more gas delivery tubes 3350 configured to provide a flow of air at a therapeutic pressure to the plenum chamber 3200. Specifically, the positioning and stabilizing structure 3300 includes a pair of gas delivery tubes 3350. In these examples, the gas delivery tubes 3350 function as a catheter headgear configured to deliver a pressurized flow of air or breathable gas to the plenum chamber 3200 and also to hold the patient interface 3000 on the patient's head. Additional descriptions of the gas delivery tubes 3350, catheter headgear, positioning and stabilizing structure 3300, and their features are included elsewhere herein.

[0363] The chassis portion 3210 may include one or more outwardly projecting connection portions 3212 configured to connect to the gas delivery tube 3350 and sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient. The outwardly projecting connection portions 3212 may also partially form the plenum 3200 and other portions of the chassis portion 3210 and the membrane portion 3220. Each of the outwardly projecting connection portions 3212 may be configured to connect to and receive a flow of air from a corresponding gas delivery tube 3350 and may include an inlet to the interior of the chassis portion 3210. Each outwardly projecting connection portion 3212 may define a plenum inlet port.

[0364] The chassis portion 3210 may include a pair of connectors 3214 configured to connect to the gas delivery tubes 3350 of the positioning and stabilizing structure 3300. Figures 7 to 11 As shown, the connector 3214 is arranged on any side of the chassis part 3210, and specifically, each connector 3214 in this example is arranged on a corresponding one of the connecting parts 3212 protruding outwardly of the chassis part 3210. In this example, the connector 3214 is arranged at the opening of the connecting part 3212 protruding outwardly. Figure 12 to Figure 13 A gas delivery tube 3350 is shown connected to the connection portion 3212 protruding on the outside.

[0365] The angle of the outwardly protruding connecting portion 3212 protruding from the cushion module 3150 advantageously orients the seal-forming structure 3100 to an angle that allows the seal-forming structure 3100 to form a stable seal with the patient's face without blocking the patient's nose.

[0366] In some examples, such as Figures 18 to 24 In the patient interface 3000 shown, the cushion module 3150 does not have a connection portion 3212 protruding on the outside, but the gas delivery tube 3350 is connected to an opening in the front wall of the base portion 3210, or can be formed integrally with the base portion 3210, for example.

[0367] exist Figures 18 to 24 In the example shown, the patient interface includes a cushion module 3150 that supplies air to both the patient's nose and mouth. As described above, the positioning and stabilizing structure 3300 in this example includes a head sleeve 3350 that forms a catheter head cover. Additionally, in this example, the positioning and stabilizing structure 3300 includes a pair of lower straps 3317, such as Fig.24As shown. Each lower strap 3317 can be configured to be positioned on a respective side of the patient's head below a respective sub-ear base point of the patient's head. The lower strap 3317 can be configured to be releasably attached to the chassis portion 3210. In some examples, the connection between the lower strap 3317 and the chassis portion 3210 can be a magnetic connection and / or a mechanical connection. The lower strap 3317 can be elastically extendable, which can advantageously allow the positioning and stabilizing structure 3300 to accommodate changes in the spacing between the patient's chin and neck as the patient moves his head.

[0368] In some examples, the gas delivery tubes 3350 include a textile outer layer. The textile material can be very comfortable for the user and can make the patient interface 3000 look more like pajamas than a medical device. The gas delivery tubes 3350 can be thermoformed, can include a foam inner layer, and can include a sealing layer in the form of a film applied to the inner surface of each gas delivery tube 3350. The patient-facing outer surface of each gas delivery tube 3350 can be substantially flat and can be wide, which can distribute forces on the patient's head and face over a large area, thereby providing a comfortable fit.

[0369] The positioning and stabilizing structure 3300 may also include a back strap 3319 configured to be connected between the gas delivery tubes 3350 and configured to cover or be located below the occipital bone of the patient's head during use. The back strap 3319 may be connected to the lower strap 3317 behind the patient's head and / or neck. For example, Fig.24 As shown, a back strap 3319 is positioned on each side of the patient's head, wherein at least a portion of the back strap 3319 is positioned above the supra-auricular base. The back strap 3319 may be connected to a gas delivery tube 3350 above the supra-auricular base.

[0370] 1.12.4.1.2 Separation of positioning and stabilizing structure from air circuit

[0371] In other examples, the patient interface 3000 may not include the gas delivery tube 3350 forming a catheter head cover. In some examples, such as Figures 14 to 17 and Figures 25 to 43 In the example shown, the chassis portion 3210 includes a single opening, such as on its front side, at which the chassis portion 3210 can be fluidly connected to the air circuit 4170, such as via the short tube 3610, to receive a flow of air at a therapeutic pressure into the plenum chamber 3200. In such an example, the chassis portion 3210 can be configured to connect to the headgear straps of the positioning and stabilizing structure 3300 of the patient interface 3000 (e.g., via arms, such as rigid arms wrapped in a textile material or having textile material on at least its patient-facing side for patient comfort).

[0372] exist Figure 25 to Figure 29 and Figure 30 to Figure 34 In each of the patient interfaces 3000 shown in each of the figures, the cushion module 3150 is configured to be connected to a positioning and stabilizing structure 3300 including a pair of upper straps 3316. Each upper strap 3316 is configured to be positioned on a respective side of the patient's head above a respective supra-ear base point of the patient's head. In these examples, the patient interface 3000 includes a pair of upper arms 3311 connected to the chassis portion 3210. Each upper arm 3311 is configured to attach to a respective one of the upper straps 3316, such as Fig.29 shown.

[0373] In these examples, each upper arm 3311 extends upward and rearward relative to the chassis portion 3210. The upper arms 3311 may also extend laterally relative to the chassis portion 3210. The upper arms 3311 may be flexible in one or more directions but rigid in one or more other directions. For example, the upper arms 3311 may be able to bend in the medial and lateral directions to accommodate changes in the size of the patient's head. However, the upper arms 3311 may be configured to resist bending in the up-and-down directions, which may help transfer the force vector from the upper band 3316 to the seal-forming structure 3100. In some examples, the upper arms 3311 are overmolded to the chassis portion 3210. In other examples, the upper arms 3311 may be formed separately and then mechanically connected to the chassis portion 3210 (e.g., using a snap connection).

[0374] The upper arms 3311 each provide an upper headgear connection point at which a strap portion of the positioning and stabilising structure 3300 can be connected to the respective upper arms 3311. The upper arms 3311 may each include an upper headgear connection point in the form of an opening (e.g., an eyelet or slot) at an end thereof. Figure 25 to Figure 29 and Figure 30 to Figure 34 In the example shown, each upper strap 3316 of the positioning and stabilising structure 3300 is passed through an opening in the corresponding upper arm 3311 and is looped back and secured to itself, for example by a hook and loop connection.

[0375] Figure 25 to Figure 29 and Figure 30 to Figure 34The upper arms 3311 of the patient interface 3000 shown have a low profile relative to the chassis portion 3210, for example, they are almost flush with the outer surface of the chassis portion 3210. The chassis portion 3210 can be configured to be substantially flush with the surface of the user's cheek in use to maintain a low profile. The upper arms 3311 are also nearly flush with the outer surface of the chassis portion 3210, so that the cushion module 3150 as a whole maintains a low profile relative to the patient's face. The upper arms 3311 and the chassis portion 3210 are designed so that when worn, the patient interface 3000 is flush with the cheek and then fits the triangular shape of the nose. The final shape forms a flat, compact, round mask volume under the nose and in front of the mouth. This shape may be conducive to side sleeping during use. Advantageously, the cushion module 3150 does not include shoulder features close to the sides of the nose, which may otherwise cause the cushion module 3150 to turn sideways when sleeping on the side.

[0376] Figure 25 to Figure 29 and Figure 30 to Figure 34 The positioning and stabilizing structure 3300 of the patient interface 3000 shown also includes a pair of lower straps 3317, such as Fig.29 As shown, each lower strap 3317 is configured to be positioned on a corresponding side of the patient's head below a corresponding sub-ear base point of the patient's head. The patient interface 3000 also includes a pair of lower arms 3313 extending from the chassis portion 3210, each lower arm 3313 being configured to be attached to a corresponding lower strap of the lower straps 3317. Each lower strap 3317 can be attached to a headgear clip 3315, which is configured to be releasably attached to the corresponding lower arm 3313, for example, via a magnetic connection. Each lower arm 3313 includes a lower headgear connection point 3314, which in this example includes a magnet. Each lower arm 3313 may include a magnet attached to an end portion of the lower arm 3313 (e.g., encapsulated and attached to the lower arm 3313 by overmolding). The headgear clip 3315 may also include a magnet or may include a ferromagnetic material. In other examples, each lower headgear connection point 3314 may include a ferromagnetic material, and the headgear clip 3315 may include a magnet. In some examples, the lower arm 3313 is overmolded to the chassis portion 3210. In other examples, the lower arm 3313 can be formed separately and then mechanically connected to the chassis portion 3210 (e.g., using a snap connection).

[0377] The upper strap 3316 and the lower strap 3317 can be connected by a rear strap portion 3318, which is configured to engage the rear surface of the patient's head and / or neck. In use, the rear strap portion 3318 can resist the tension in the upper strap 3316 and the lower strap 3317 by anchoring to the rear surface of the patient's head and / or neck.

[0378] exist Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the patient interface 3000 includes a short tube 3610 that is fluidly connected to the chassis portion 3210 at a proximal end. The short tube 3610 includes a connection port 3600 at a distal end to receive a flow of air or other breathable gas from a conduit connected to the air circuit 4170 of the RPT device 4000 in use. The patient interface 3000 includes a vent 3400, which is provided at the connection of the short tube 3610 and the chassis portion 3210 in this example. The connection between the short tube 3610 and the chassis portion 3210 can be a swivel connection, allowing the short tube 3610 to rotate relative to the chassis portion 3210 to help avoid tube resistance, and can be in the form of an elbow. The short tube 3610 can extend forward and / or downward from the cushion module 3150. The patient interface 3000 includes an AAV (not shown), which can also be connected in a swivel.

[0379] 1.12.4.1.3 Plenum chamber connected to frame

[0380] Figures 14 to 17 An example of a patient interface 3000 is shown in which a seal-forming structure 3100 and a membrane portion 3220 are provided with Figures 7 to 13 The examples shown are substantially the same, although other differences exist. Unless otherwise noted or the context clearly requires, all disclosures herein regarding the plenum 3200, chassis portion 3210, membrane portion 3220, and seal-forming structure 3100 should be understood to be applicable or usable with Figures 14 to 17 The example combination shown, and vice versa. In this example, the patient interface 3000 does not have a catheter headgear. Instead, the patient interface 3000 includes a positioning and stabilizing structure 3300, which includes a pair of headgear strap portions 3310 (which can be rigid in some examples). The positioning and stabilizing structure 3300 fixes the inflatable chamber 3200 and the seal-forming structure 3100 in place during use. The patient interface 3000 also includes a frame 3320 and a short tube 3610. In this example, the inflatable chamber 3200 and the seal-forming structure 3100 form a cushion module 3150.

[0381] 1.12.4.1.3.1 Band section

[0382] Each of the band portions 3310 is located on a corresponding side of the patient's head in use. In some examples, the band portions 3310 are connected to each other behind the patient's head, for example, by a buckle connection. In other examples, the band portions 3310 are formed integrally with each other. That is, they can be part of a headgear strap of a single length. Each band portion 3310 can be higher than the corresponding ear-upper base point of the patient's head. The band portion 3310 can be configured to cover the parietal bone of the patient's head in use. In some examples, the band portion 3310 can be connected to a bifurcated band portion between two band portions 3310, or formed by the bifurcated band portion, and the two band portions are configured to rest against the rear surface and / or the upper rear surface of the patient's head.

[0383] The overall length of the strap portions 3310 may be selectively adjustable by the user, for example, via a buckle between the two strap portions 3310. In some examples, the strap portions 3310 may be elastically extensible such that, when worn by a patient, tension is created in the strap portions 3310 to pull the seal-forming structure 3100 toward the patient's airway and resist forces tending to separate the seal-forming structure 3100 from the patient's face.

[0384] 1.12.4.1.3.2 Framework

[0385] Figures 14 to 17 The patient interface 3000 in the example shown in also includes a frame 3320. In this example, the plenum chamber 3200 of the patient interface 3000 is connected to the frame 3320. The chassis portion 3210 can be configured to be connected to the frame 3320. Each of the strap portions 3310 is also connected to the frame 3320. The frame 3320 can be substantially rigid (e.g., difficult to deform by finger pressure alone) and can be formed of, for example, polycarbonate. In other examples, the frame 3320 can be semi-rigid (e.g., able to bend at least to some extent by finger pressure and / or when there is tension in the headgear strap portion 3310). The frame 3320 can be curved in a left-to-right direction and can include a curvature corresponding to the curvature of the front side of the chassis portion 3210. In some examples, the curvature of the frame 3320 can follow the curvature of the front border of the membrane portion 3220.

[0386] The plenum 3200 may be larger than the frame 3320 such that the chassis portion 3210 extends beyond the frame 3320 by approximately 2 mm to 3 mm on each side of the frame.

[0387] 1.12.4.1.3.3 Short pipe

[0388] Although Figures 7 to 13 The patient interface 3000 shown includes a catheter tip cover and a plenum chamber 3200 that receives a flow of air at a therapeutic pressure via a gas delivery tube 3350, but Figures 14 to 17The patient interface 3000 shown includes a short tube 3610 from which the plenum 3200 receives an air flow. The plenum 3200 includes a central opening through which the air flow is received from the short tube 3610. The central opening of the plenum 3200 may form a plenum inlet port.

[0389] The short tube 3610 may be a short length of tube having a connection port 3600 at its end distal to the patient. A longer conduit forming portion of the air circuit 4170 between the RPT device 4000 and the patient interface 3000 may be fluidly connected to the short tube 3610 at the connection port 3600. The short tube 3610 may include a swivel connector forming the connection port 3600. The short tube 3610 may advantageously function to at least partially separate a conduit connected to the connection port 3600 from the seal-forming structure 3100. The short tube 3610 may be considered to form part of the patient interface 3000.

[0390] The frame 3320 may also include a central opening through which air flows into the plenum 3200. The central opening in the frame 3320 may be aligned with the central opening in the plenum 3200 and may be aligned with the short tube 3610. In this particular example, the plenum 3200 is connected to the frame 3320 around the periphery of the central opening in the frame 3320. In this example, the frame 3320 includes a flange around the periphery of the central opening to which the plenum 3200 can be connected.

[0391] The plenum chamber 3200 also includes a Figures 7 to 13 The example chassis portion 3210 and membrane portion 3220 are shown. A central opening in the plenum 3200 can be formed in the chassis portion 3210. The chassis portion 3210 can be formed of silicone and can be connected to the frame 3320 around the central opening of the frame 3320 by a stretch fit connection.

[0392] 1.12.4.1.3.4 Connection between frame and belt section

[0393] exist Figures 14 to 17 In the example shown, the plenum 3200 includes two side openings through which air can be discharged from the plenum 3200, for example for gas flushing. Each side opening in the plenum 3200 can be located on a respective side of the central opening and can be formed by a hole in the chassis portion 3210. Each side opening can be aligned with a corresponding vent 3400 in the frame 3320 in use. Air from the plenum 3200 can pass through the side openings in the chassis portion 3210 and then through the corresponding vent 3400 in the frame 3320. Each vent 3400 can be formed by one or more openings in the frame 3320 through which air can pass.

[0394] The frame 3320 may include side openings corresponding to the side openings in the chassis portion 3210. The frame 3320 may include flanges around the side openings in the frame 3320, and the side openings in the chassis portion 3210 may be stretch fit over the flanges around the side openings in the frame 3320. The chassis portion 3210 may be connected to the frame 3320 at the central opening of the frame 3320 and each side opening. Figures 14 to 17 In the example shown, the side openings in the frame 3320 each include a plurality of holes forming a vent 3400 .

[0395] In this example, the headgear strap portions 3310 are configured to connect to the frame 3320 on the side of the frame 3320 opposite the plenum chamber 3200. The headgear strap portions 3310 each include a connector 3312 that is configured to connect to a corresponding connection point on the frame 3320. Each connector 3312 can be attached to a corresponding connection point in the frame at a location corresponding to a corresponding vent 3400. For example, the vent 3400 can be disposed around or formed with the headgear strap connection point. Thus, in this example, the patient interface 3000 includes a separate vent configuration.

[0396] 1.12.4.1.4 Headgear straps partially cover the ears

[0397] Figures 35 to 43 3000 according to another example of the present technology. The patient interface 3000 may include an inflatable chamber 3200, a seal-forming structure 3100, a membrane portion 3220, and a chassis portion 3210. Figure 30 to Figure 34 These components described in have some similar features, and only the specific differences will be described below. Unless the context clearly requires otherwise, reference is made to Figure 30 to Figure 34 The disclosure of the plenum 3200, seal-forming structure 3100, membrane portion 3220, and chassis portion 3210 of any other example or alternative disclosed herein should be understood to be applicable to Figures 35 to 43 Patient interface 3000 is shown. Figures 35 to 43 The positioning and stabilizing structure 3300 and the headgear connection on the inflatable chamber 3200 in the example shown are similar to those of reference Figure 30 to Figure 34 Different from what is disclosed.

[0398] 1.12.4.1.4.1 The first band

[0399] exist Figures 35 to 43In the example shown, the positioning and stabilizing structure 3300 is configured to provide a force to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head, and includes a first strap portion 3331 connected to each side of the inflatable chamber 3200. The first strap portion 3331 is configured to cover the side surface of the patient's head and cover the parietal bone and / or occipital bone of the patient's head during use. That is, the first strap portion 3331 bypasses the back side of the patient's head, from one side of the inflatable chamber 3200 to the other side thereof. The first strap portion 3331 can rest against the back region of the patient's head near the junction between the occipital bone and the parietal bone. The first strap portion 3331 can extend backward and partially upward from the inflatable chamber 3200 on each side of the patient's head toward the back region of the patient's head. The first strap portion 3331 can be located on the patient's head more than 100 degrees. Fig.29 The lower band 3317 is shown to be located higher and may be located with Fig.29 The upper band 3316 is shown at the same height or slightly lower than the height at which the upper band is located, overlapping the upper part of the patient's ear.

[0400] The first strap portion 3331 can be flexible along substantially all of its length. It can additionally or alternatively be extendable in length along part or all of its length. In some examples, the first strap portion 3331 has no inherent bend or change of direction. The first strap portion 3331 can be formed from a continuous length of material (which can be a combination of materials, e.g., a braided material), except for any connectors that allow for selective length adjustment, which can separate the second strap portion 3331 into two or more segments.

[0401] like Fig.40 and Fig.41 As specifically illustrated in , the first band portion 3331 can be configured to cover the patient's ears during use. The first band portion 3331 can rest against at least a portion of each of the patient's ears (e.g., the first band portion 3331 can cover part or all of each of the patient's ears). Fig.40 and Fig.41As shown, the first band portion 3331 is configured to cover the upper part of the patient's ear in use while leaving the lower part of the patient's ear uncovered. The first band portion 3331 may include a lower edge along its length, and the positioning and stabilizing structure 3300 may be configured so that the lower edge of the first band portion 3331 abuts against the patient's ear at or near the base point on each corresponding ear. The lower edge of the first band portion 3331 may cover the patient's ear below the uppermost part of the patient's ear. In some examples, the lower edge of the first band portion 3331 may cover the patient's ear below the base point on the ear (e.g., at or near the base point under the ear). Some forms of the first band portion 3331 may partially cover the patient's ear, such as covering the upper part of the patient's ear height of about one-quarter, or the upper third, upper half or upper three-quarters of the patient's ear height. The height may be measured in the up-down direction. In other examples, the first band portion 3331 may substantially cover all heights of the patient's ear. In some examples, the upper edge of the first band portion 3331 can be located below the uppermost portion of each of the patient's ears. It should be understood that in some examples of the present technology, the first band portion 3331 can cover the ears to different degrees for different patients depending on the patient's anatomy.

[0402] Many prior art patient interfaces have head coverings that are intended to avoid the ears, and therefore provide a strap that is positioned above the ears and around the back of the head, and a strap that is positioned below the ears and around the back of the neck. When wearing some such prior art patient interfaces, the patient may need to connect the straps after positioning the prior art patient interface on the head. For example, when wearing a prior art patient interface, the lower strap may need to be connected to the frame and then disconnected from the frame in order to take off the prior art patient interface. Figures 35 to 43 The patient interface 3000 shown has a first strap portion 3331 that covers the patient's ears rather than lower, such as around the back of the patient's neck, allowing the patient to put on and take off the patient interface 3000 without connecting or disconnecting any straps. This can advantageously make the patient interface 3000 more user-friendly than prior art patient interfaces, which require disconnecting and connecting straps during the donning and doffing process. In addition, the positioning and stabilizing structure 3300 is only at one location on each side of the cushion module 3150 (or at the Figures 35 to 43In the case of the patient interface 3000 shown, the first strap portion 3331 is connected to the cushion module 3150 at only one location on each side of the chassis portion 3210, which can make the patient interface 3000 have only two connection points with the cushion module 3150, thereby being convenient for the user. The first strap portion 3331 can have a wider width to distribute the force on the patient's head over a larger surface area, and can be formed of a soft-touch material (such as a woven textile material), which can advantageously make the first strap portion 3331 sufficiently comfortable despite resting against the patient's ear. The first strap portion 3331 can be formed of an elastically extensible material, which can advantageously provide a comfortable and secure fit during use.

[0403] In some examples, the first strap portion 3331 forms the entire positioning and stabilizing structure 3300 (i.e., it can be the only strap of the positioning and stabilizing structure 3300). In such examples, the first strap portion 3331 can be wide enough that, when properly tightened, the first strap portion 3331 provides a stable fit to the patient's head. The first strap portion 3331 can include a bifurcated portion 3339 that is configured to engage a posterior region of the patient's head during use, such as Fig.35 As shown. This can help provide sufficient stability for the first strap portion 3331 to be the only strap portion of the positioning and stabilizing structure 3300. The bifurcated portion can allow the upper half or portion of the first strap portion 3331 to abut the rear surface of the patient's head at a higher position, while allowing the lower half or portion of the first strap portion 3331 to abut the rear surface of the patient's head at a lower position, which can make the first strap portion 3331 less likely to move during use, thereby being more stable. In some examples, the upper portion of the bifurcated portion can abut a rearward-facing and partially upward-facing surface of the patient's head, while the lower portion of the bifurcated portion can abut a rearward-facing and partially downward-facing surface of the patient's head.

[0404] 1.12.4.1.4.2 Second band part

[0405] exist Figures 35 to 43 In the example shown, the positioning and stabilizing structure 3300 also includes a second strap portion 3332. The second strap portion 3332 includes a pair of ends connected to the first strap portion 3331. Each end of the second strap portion 3332 can be connected to the first strap portion 3331 at a position close to a corresponding one of the patient's ears in use. For example, the second strap portion 3332 can be connected to the first strap portion 3331 at a position aligned with the patient's ears in the front-to-back direction. In other examples, the second strap portion 3332 can be connected to the first strap portion 3331 at a position in front of the patient's ears or behind the patient's ears (although still close to the ears in many examples).

[0406] The second strap portion 3332 can be configured to cover an upper region of the patient's head during use. That is, the second strap portion 3332 can be configured to rest against a substantially upwardly facing surface of the patient's head during use. The second strap portion 3332 can extend substantially perpendicularly from the first strap portion 3331 on each side of the user's head. In some examples, the second strap portion 3332 extends substantially at 90 degrees from the first strap portion 3331 on each side of the patient's head. The second strap portion 3332 can be formed of a soft-touch material, such as a woven textile material, which can advantageously make the second strap portion 3332 feel comfortable. The second strap portion 3332 can be formed of an elastically extensible material, which can advantageously provide a comfortable and secure fit during use.

[0407] The second belt portion 3332 can supplement the first belt portion 3331 by providing additional stability for the fit of the positioning and stabilizing structure 3300, and can prevent the first belt portion 3331 from moving downward in use. In some forms, the unextended length of the first belt portion 3331 is selectively adjustable. In some forms, the unextended length of the second belt portion 3332 is selectively adjustable. In some examples, the length of both the first belt portion 3331 and the second belt portion 3332 is selectively adjustable. That is, although in some examples both the first belt portion 3331 and the second belt portion 3222 are elastically extensible, the patient can adjust the unextended length of each belt portion before elastic extension. Any suitable member for adjusting the unextended length of each belt portion can be envisioned. For example, each of the first belt portion 3331 and / or the second belt portion 3332 can include a buckle, and the patient can slide the buckle along the corresponding belt portion to adjust the effective length of the belt. In some examples, each of the first strap portion 3331 and / or the second strap portion 3332 can be looped back through the buckle and secured back to itself. The patient can selectively adjust the length of the strap portion that has been looped back through the buckle to adjust the effective length of the strap portion. The selective adjustability of the first strap portion 3331 and / or the second strap portion 3332 (as the case may be) can enable the patient to achieve a customized fit of the patient interface 3000, which can provide a good seal during use while feeling comfortable and stable. In examples where the first strap portion 3331 is bifurcated (e.g., as Fig.35), the fit of the first strap portion 3331 on the patient's head can be adjusted by the patient by separating the upper and lower portions of the bifurcated portion 3339 to different degrees so as to properly fit the back surface of their head. That is, the separation of the upper half or portion from the lower half or portion can be adjustable by the patient to adjust the fit of the first strap portion 3331. This can advantageously enable the patient to achieve a stable, comfortable and / or customized fit without the need for other features that provide selective adjustability (e.g., buckles, etc.).

[0408] In some examples, the tension in the second strap portion 3332 can cause the path of the first strap portion 3331 to change direction at the connection between the first strap portion 3331 and the second strap portion 3332. The portion of the first strap portion 3331 before the second strap portion 3332 can be non-parallel to the portion of the first strap portion 3331 after the second strap portion 3332. The second strap portion 3332 can pull the first strap portion 3331 toward the upper side near the patient's ear. For example, on the lower side of the second strap portion 3332, the angle between the portion of the first strap portion 3331 before the second strap portion 3332 and the portion of the first strap portion 3331 after the second strap portion 3332 can be less than 180 degrees.

[0409] The second strap portion 3331 can be flexible along substantially all of its length. It can additionally or alternatively be extendable in length along part or all of its length. In some examples, the second strap portion 3331 has no inherent bend or change in direction. The second strap portion 3331 can be formed from a continuous length of material (which can be a combination of materials, e.g., a braided material), except for any connectors that allow for selective length adjustment, which can separate the second strap portion 3331 into two or more segments.

[0410] 1.12.4.1.5 Rotatable headgear with connector

[0411] Figures 35 to 43Another aspect of the present technology in the illustrated example is that the first strap portion 3331 is connected to the plenum chamber 3200 by rotatable headgear strap connectors 3330 located on each side of the plenum chamber 3200. The rotatable headgear strap connectors 3330 allow for relative rotation between the ends of the first strap portion 3331 and the plenum chamber 3200. That is, the rotatable headgear strap connectors 3330 allow for changing the angle at which the first strap portion 3331 is connected to the plenum chamber 3200, or alternatively, the rotatable headgear strap connectors 3330 allow for changing the orientation of the plenum chamber 3200 relative to the first strap portion 3331. If the first strap portion 3331 is positioned on the patient's head as desired, the rotatable headgear strap connectors 3330 allow for adjustment of the orientation of the plenum chamber 3200 to achieve a good fit of the seal-forming structure 3100 to the patient's face. If the plenum chamber 3200 is positioned on the patient's face as desired, the rotatable headgear strap connector 3330 allows the first strap portion 3331 to be rotated about the rotatable headgear strap connector 3330 to the correct orientation to achieve a good fit with the patient's head.

[0412] Specific reference Fig.43 , each rotatable headgear strap connector 3330 may include a first rotatable portion 3333 and a second rotatable portion 3336 configured to be connected together. The first strap portion 3331 may include two first rotatable portions 3333, each of which is disposed at a respective end of the first strap portion 3331, and the plenum chamber 3200 may include two second rotatable portions 3336, each of which is disposed at a respective side of the plenum chamber. The connection between the first rotatable portion 3333 and the second rotatable portion 3336 allows the first rotatable portion 3333 to be selectively rotated to a selected rotational position relative to the second rotatable portion 3336 by the patient. That is, the rotatable headgear strap connector 3330 may be configured to allow the patient to selectively rotate one of the first rotatable portion 3333 and the second rotatable portion 3336 relative to the other of them to adjust the orientation of the first strap portion 3331 and the plenum chamber 3200 relative to each other to a desired (e.g., selected) orientation. This rotation allows the user to change the presentation angle of the patient interface 3000 in order to change the sealing force distribution between the nasal area and the vicinity of the chin as desired. This rotational adjustment can advantageously be performed by the patient while wearing the patient interface 3000 or even during use. This can advantageously enable the patient to easily and / or quickly achieve a particularly good fit. At least in Figures 35 to 43In the example shown, the patient can rotate the first rotatable part 3333 (relative to the second rotatable part 3336) because, in the assembled state, the first rotatable part 3333 is positioned to the side of the second rotatable part 3336 and partially covers the second rotatable part. Therefore, the first rotatable part 3333 can be more convenient for the patient to rotate than the second rotatable part 3336.

[0413] Each rotatable headgear strap connector 3330 can be configured to prevent relative rotation between the first rotatable portion 3333 and the second rotatable portion 3336 away from a selected rotational position during use. That is, once the patient has adjusted the angle of the first strap portion 3331 relative to the plenum chamber 3200, the rotatable headgear strap connector 3330 can prevent rotation away from the selected rotational position to maintain the desired angle of the first strap portion 3331 relative to the plenum chamber 3200. Advantageously, this can allow the patient to adjust the angle of the first strap portion 3331 as desired and then begin using the patient interface 3000 without accidentally changing the angle between the first strap portion 3331 and the plenum chamber 3200, which may, for example, affect sealing, stability, or comfort. The rotatable headgear strap connector 3330 can be configured to prevent relative rotation away from the selected rotational position by friction (e.g., static friction between the first rotatable portion 3333 and the second rotatable portion 3336). Friction is only one possible way that the rotatable headgear strap connector 3330 prevents relative rotation. In other examples, the first rotatable part 3333 and the second rotatable part 3336 are reliably mechanically engaged with each other to lock in place. For example, one of the first rotatable part 3333 and the second rotatable part 3336 may include one or more protrusions, and the other of the first rotatable part 3333 and the second rotatable part 3336 may include a plurality of pawls or recesses configured to receive the one or more protrusions. The protrusions and pawls can provide the first rotatable part 3333 with respect to the second rotatable part 3336 in a series of discrete positions between the indexed rotation. In another example, the first rotatable part 3333 and the second rotatable part 3336 are held in place by magnetic force.

[0414] In some examples, the first rotatable portion 3333 and the second rotatable portion 3336 may each include a cylindrical portion that can be connected by aligning the central axis of the cylindrical portion and inserting another cylindrical portion along the central axis direction. The cylindrical portions can then rotate relative to each other around the central axis. Fig.43A rotatable headgear strap connector 3330 is shown in a disconnected form. As shown, in this particular example, the first rotating portion 3333 includes a male cylindrical portion, and the second rotating portion 3336 includes a female cylindrical portion that is configured to receive the male cylindrical portion and allow the male cylindrical portion to be rotated relative to the female cylindrical portion by the patient.

[0415] Figures 35 to 43 The rotatable headgear strap connector 3330 in the example is configured to allow the patient to manually rotate the convex cylindrical portion relative to the concave cylindrical portion to selectively adjust the angle of the first strap portion 3331 to the inflatable chamber 3200. For example, the patient can rotate the convex cylindrical portion relative to the concave cylindrical portion with the thumb and index finger. During adjustment, the friction between the convex cylindrical portion and the concave cylindrical portion can be small enough so that the patient can manually rotate the two cylindrical portions relative to each other. However, in use, the friction between the convex cylindrical portion and the concave cylindrical portion can be large enough so that the convex cylindrical portion is held in place by friction during use after adjustment. This effect can be partially formed or enhanced by different forces applied to the rotatable headgear strap connector 3330 during adjustment and during use. During adjustment, the patient can use his fingers to rotate the first rotatable portion 3333 relative to the second rotatable portion 3336, and in doing so, a pure torque can be applied to the first rotatable portion 3333 around the rotation axis. Applying torque to the assembly in this manner can reduce the friction between the two rotatable parts and is also an effective way to apply force to overcome the friction and induce movement, thereby facilitating adjustment. However, in use, the tension in the first strap portion 3331 will apply a force perpendicular to the axis of rotation and will tend to lock the assembly, thereby increasing static friction, which will resist rotation between the two rotating parts, thereby promoting each rotatable headgear strap connection 3330 to maintain its adjusted configuration in use.

[0416] Advantageously, this arrangement of rotatable headgear strap connectors 3330 that maintain an adjusted configuration during use provides a patient interface 3000 that seals around both the nose and mouth, the patient interface having an inflatable chamber connected to the headgear by a single connector on each side thereof. Many prior art patient interfaces 3000 that seal around both the nose and mouth have an upper headgear strap connector and a lower headgear strap connector on each side of the inflatable chamber 3200. The relative tension of the upper and lower straps on each side is adjusted to pull the inflatable chamber 3200 toward the patient's face at the correct angle to achieve a good seal. For example, in Figures 35 to 43 In the patient interface 3000 shown, only one adjustment may need to be made at the plenum 3200 (at the rotatable headgear strap connection 3330) to adjust the patient interface 3000 to achieve a satisfactory seal, which may provide a very user-friendly patient interface 3000.

[0417] It should be understood that the cylindrical portion may be formed from one or more cylindrical shapes (eg, a tubular component, a washer-shaped component). Fig.43 In the example, each male cylindrical portion includes a central portion 3334 and a flange portion 3335 extending radially outward from the central portion 3334, and each female cylindrical portion defines a cylindrical cavity 3337 and an opening 3338 leading to the cylindrical cavity 3337. When the male cylindrical portion is received in the female cylindrical portion, the central portion 3334 is located in the opening 3338 and the flange portion 3335 is received in the cylindrical cavity 3337. Specifically, during the attachment of the male cylindrical portion to the female cylindrical portion, the flange portion 3335 passes through the opening 3338 and is then received in the cylindrical cavity 3337. After assembly, the central portion 3334 remains in the opening 3338, protruding from the cylindrical cavity 3337.

[0418] The female cylindrical portion, or at least a portion thereof, may be flexible to allow insertion of the male cylindrical portion. Figures 35 to 43 In the example shown, the concave cylindrical portion is flexible and can be formed, for example, from an elastic material such as silicone or TPE. The concave cylindrical portion or at least a portion thereof can be integrally formed with a non-patient-facing wall of the plenum chamber 3200 that is disposed in a manner that allows the patient to move freely in the patient's position. Figures 35 to 43 In the example shown, the chassis portion 3210 is. In other examples, even if the portion of the radial side defining the cylindrical cavity 3337 is not flexible, at least the portion of the concave cylindrical portion surrounding the opening 3338 is flexible. In other examples, the concave cylindrical portion can be substantially rigid and the convex cylindrical portion can be flexible. In addition, in some examples, both the first rotatable portion 3333 and the second rotatable portion 3336 can be flexible. More generally, in some examples, one of the first rotatable portion 3333 and the second rotatable portion 3336 can include a flexible portion that can be deformed to connect to the other of the first rotatable portion 3333 and the second rotatable portion 3336, which portion can also be flexible or can be substantially rigid.

[0419] Specifically, Fig.35 and Figure 40 to Figure 42As shown, the rotatable headgear strap connector 3330 has a low profile and allows the first strap portion 3331 to be connected nearly flush with the plenum chamber 3200. When the rotatable headgear strap connector 3330 protrudes only a small distance from the front wall of the plenum chamber 3200, they can advantageously have only a low susceptibility to being rotated and breaking the seal during use, such as when the patient rotates their head toward the pillow. Similarly, the shape of the plenum chamber 3200 or its chassis portion 3210 (which can be shaped as a parabolic cylinder or a hyperbolic parabola) closely conforms to the shape of the patient's face, which, combined with the nearly flush mounting connection with the first strap portion 3331, provides a patient interface 3000 that remains close to the patient's facial surface and therefore may not be particularly susceptible to damaging forces during use (e.g., when the patient interface 3000 contacts the patient's pillow when sleeping on the side).

[0420] As noted above, in some examples, the rotatable headgear strap connector 3330 can include features for providing indexed rotation, whereby the first rotatable portion 3333 and the second rotatable portion 3336 can rotate relative to each other between a series of discrete rotational positions. In one example, the first rotatable portion 3333 and the second rotatable portion 3336 can include corresponding protrusions and recesses, whereby the protrusions tend to rest or "snap into" the recesses, defining a series of discrete positions. In other examples, the rotatable headgear strap connector 3330 can be configured to prevent relative rotation away from a selected rotational position using a ratchet mechanism.

[0421] 1.12.4.2 Sealing structure

[0422] As described above, the patient interface 3000 includes a seal-forming structure 3100. The seal-forming structure 3100 may form part of a cushion module 3150.

[0423] exist Figures 7 to 13 , Figures 14 to 17 , Figures 18 to 24 and Figure 25 to Figure 29 In the example shown, the seal-forming structure 3100 includes a pair of nasal pillows. Each nasal pillow can be constructed and arranged to form a seal with a corresponding nostril of the patient's nose. Each nasal pillow can have a hole therein so that a flow of air at a therapeutic pressure can be delivered to at least the patient's nostrils.

[0424] exist Figures 18 to 24 and Figure 25 to Figure 29 In the example shown, the seal-forming structure 3100 includes a pair of nasal pillows that form a nasal portion 3101 of the seal-forming structure 3100, and also includes an oral portion 3102 of the seal-forming structure. Figures 18 to 24 and Figure 25 to Figure 29The mouth portion 3102 of the illustrated seal-forming structure 3100 can be configured to form a seal around the patient's mouth such that a flow of air (eg, at least some of the flow of air) at a therapeutic pressure is delivered to the patient's mouth.

[0425] The nasal pillows (or more generally, any seal-forming structure 3100 of a patient interface 3000 according to an example of the present technology) may be constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle.

[0426] exist Figures 7 to 29 In each of the examples shown, the nasal pillows forming the seal-forming structure 3100 are stemless. Each of the nasal pillows may include a tapered portion (e.g., a truncated cone / truncated cone portion) having a tip and a base that is wider than the tip. The base may be directly attached to the membrane portion 3220 (described in detail below). That is, there may be no stem or narrower connecting portion between the truncated cone portion of each nasal pillow and the membrane portion 3220. The absence of a stem may advantageously help keep the force applied by each pillow on the patient's nose small, which may provide a comfortable patient interface 3000. In addition, the absence of a stem makes the nasal pillow more stable, so that only less force is required to keep the nasal pillow in place in the nostrils, thereby providing comfort to the patient. In other examples, the nasal pillows each include a stem that connects the truncated cone portion of the nasal pillow to the membrane portion 3220. However, the highly flexible membrane portion 3220 may allow the nasal pillow to move sufficiently so that a stem for separation may not be required.

[0427] The frustoconical portion of each nasal pillow can seal against a corresponding nostril of the patient's nose. For example, the frustoconical portion of each nasal pillow can be configured to seal against an undersurface of the patient's nose (defining a corresponding one of the patient's nares). For example, the frustoconical portion of each nasal pillow can seal against the patient's nose at a corresponding nasal opening.

[0428] The nasal pillows that form part of the seal-forming structure 3100 can be formed separately from the membrane portion 3220 and can be attached to the membrane portion 3220 by any method that forms a seal between the nasal pillows and the membrane portion 3220 and secures the nasal pillows to the membrane portion 3220 during the expected life of the cushion module 3150. In some examples, the nasal pillows can be adhered to the membrane portion 3220. In other examples, the nasal pillows can be molded to the membrane portion 3220, such as by supporting the membrane portion 3220 or the cushion module in a mold and molding the nasal pillows in place on the membrane portion 3220. In other examples, the nasal pillows are integrally formed with the membrane portion 3220, such as where the membrane portion 3220 is formed by molding, the nasal pillows are molded together with the membrane portion 3220.

[0429] In some examples, the nasal pillows are formed of a different material than the membrane portion 3220 (eg, the nasal pillows can be formed of a first material, and the membrane portion 3220 can be formed of a second material different than the first material). Each of the nasal pillows can be formed of an elastic material. Figures 7 to 29 The nasal pillows in the examples shown are formed of silicone. In other examples, the nasal pillows can be formed of, for example, thermoplastic elastomers (TPE), foams, textiles, or combinations thereof. The nasal pillows can be formed of a single-wall or double-wall structure. In some examples, each nasal pillow is formed of a single wall. In other examples, the nasal pillows can be double-walled nasal pillows (e.g., formed of two walls, such as an inner wall and an outer wall).

[0430] exist Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the seal-forming structure 3100 or at least the nasal portion 3101 thereof includes a nose pad cushion (e.g., the seal-forming structure 3100 is configured to seal to the nasal prominence area, the nasal wings, and the upper lips of the patient). The nose pad seal-forming structure 3100 may be formed of an elastic material such as silicone or TPE, or may be at least partially formed of a textile material, optionally with a base cushion that may be formed of foam, for example. Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the nose portion 3101 of the seal-forming structure 3100 is formed from silicone.

[0431] 1.12.4.3 Chassis and membrane

[0432] The patient interface 3000 may include a membrane portion 3220 connected to a chassis portion 3210. The chassis portion 3210 and the membrane portion 3220 may together form a plenum 3200, eg, together enclosing a volume that may be filled with air at a therapeutic pressure.

[0433] In some examples of the present technology, the membrane portion 3220 supports or at least partially supports the seal-forming structure 3100 or at least a portion thereof (e.g., the nose portion 3101 of the seal-forming structure 3100). For example, the seal-forming structure 3100 can be supported on the membrane portion 3220. Figures 7 to 13 and Figures 14 to 17 In the example shown, the nasal pillows forming the seal-forming structure 3100 are supported on the membrane portion 3220. Figures 18 to 24 and Figure 25 to Figure 29 In the example shown, the nasal pillows forming the nasal portion 3101 of the seal-forming structure 3100 are supported on the membrane portion 3220. Figure 30 to Figure 34 In the example shown, the nose portion 3101 of the seal-forming structure 3100 including the bracket cushion portion is supported on the membrane portion 3220. Figures 35 to 43In the example shown, the membrane portion 3220 partially supports the nose portion 3101 of the seal-forming structure 3100. The membrane portion 3220 can separate at least a portion of the nose portion 3101 of the seal-forming structure 3100 from the chassis portion 3210. For example, the membrane portion 3220 can separate the front side of the nose portion 3101 of the seal-forming structure 3100 from the chassis portion 3210. Fig.36 As shown, for example, the membrane portion 3220 separates the front wall 3104 of the nose portion 3101 of the seal-forming structure 3100 from the chassis portion 3210. This can advantageously provide a separation effect, as well as other effects described elsewhere herein.

[0434] The chassis portion 3210 can be configured to support the membrane portion 3220, for example, by being stiffer than the membrane portion 3220. The chassis portion 3210 can be formed of a material that is stiffer than the material forming the membrane portion 3220. Additionally or alternatively, the chassis portion 3210 can be thicker than the membrane portion, such as at least 3 times thicker, at least 4 times thicker, at least 5 times thicker, at least 7 times thicker, at least 10 times thicker, or more.

[0435] The chassis portion 3210 can be a portion of the cushion module 3150 that has sufficient rigidity (e.g., as a result of the material and / or shape / structure) to maintain the shape of the cushion module 3150 and support the membrane portion 3220. The chassis portion 3210 can keep the membrane portion 3220 substantially taut when the plenum chamber 3200 is not pressurized. For example, the chassis portion 3210 can keep the membrane portion 3220 taut so that the nasal pillows (or more generally, the nasal portion 3101 of the seal-forming structure 3100) remain substantially in the in-use position before the plenum chamber 3200 is pressurized. When the patient wears the patient interface 3000 before the plenum chamber 3200 is pressurized, the membrane portion 3220 can be sufficiently tightened to align the nasal pillows with the patient's nostrils. Specifically, the chassis portion 3210 can keep the membrane portion 3220 taut but not stretched when at rest. The nasal pillows (or more generally, the seal-forming structure 3100) may also provide some support for the resting shape of the membrane portion 3220. The membrane portion 3220 at rest may be tensioned so that it generally maintains a predetermined shape. In some examples, the membrane portion 3220 at rest may be taut, but there may be no stress within the material forming the membrane portion 3220. The membrane portion 3220 at rest may be tensioned so that it generally maintains a predetermined shape and holds the seal-forming structure 3100 (e.g., nasal pillows) generally in a predetermined position relative to the chassis portion 3210, but may be easily deformed, for example, by a force acting on the membrane portion 3220 (such as finger pressure).

[0436] In some examples, the chassis portion 3210 can be formed from an elastic material. Figures 7 to 43In the example shown, the chassis portion 3210 is formed of silicone. In other examples, the chassis portion 3210 can be formed of a thermoplastic elastomer (TPE). In other examples, the chassis portion 3210 can be formed of a substantially rigid material (such as a thermoplastic material, e.g., polycarbonate, nylon, etc.). In other examples, the chassis portion 3210 can be formed of a textile material, foam, or a combination of materials (such as the combinations of materials disclosed herein).

[0437] The membrane portion 3220 may be constructed and arranged to be flexible to allow the seal-forming structure 3100 to move relative to one or more other portions of the patient interface 3000 during use. Specifically, the seal-forming structure 3100 may move relative to the chassis portion 3210. For example, in Figures 7 to 29 In the patient interface 3000 shown, the membrane portion 3220 is constructed and arranged to be flexible to allow relative movement between the nasal pillows and the chassis portion 3210. The membrane portion 3220 can allow relative movement between the nasal pillows and a portion of the cushion module 3150 (such as the chassis portion 3210) in use. The membrane portion 3220 can provide a spring cushion function, wherein the seal-forming structure 3100 (such as the nasal pillows) is maintained in an appropriate position, while the chassis portion 3210 can move relative to the nasal pillows via deformation of the membrane portion 3220. The relative movement between the seal-forming structure 3100 and the chassis portion 3210 can involve the seal-forming structure 3100 being stationary, because the seal-forming structure can be against the patient's face and / or remain fixed in the patient's nostrils, and the chassis portion 3210 can move relative to the seal-forming structure 3100 and the user's face. Advantageously, this at least partially decouples the seal-forming structure 3100 from the chassis portion 3210, which can improve stability and sealing, particularly during head movement.

[0438] The highly flexible nature of the membrane portion 3220 supporting the nasal pillows (e.g., resulting from the low thickness of the material and membrane portion 3220) can enable the cushion module 3150 to effectively prevent damaging forces from structural components / portions (such as the chassis portion 3210 and the positioning and stabilizing structure 3300) from being transmitted to the nasal pillows. Most or all of the damaging forces expected to be received by the chassis portion 3210 during use of the patient interface 3000 can be absorbed by the membrane portion 3220 and prevented from being transmitted to the nasal pillows.

[0439] In some examples, the membrane portion 3220 can be constructed and arranged to at least partially decouple the movement of the nasal pillows from each other. Specifically, the membrane portion 3220 can be constructed and arranged to allow each of the nasal pillows to move to align with a corresponding nostril in the patient's nostrils during use. The membrane portion 3220 can be constructed and arranged to stretch and / or bend before pressure is applied to allow each of the nasal pillows to move to align with a corresponding nostril in the patient's nostrils. This can allow the nasal pillows to easily fit a wider range of patient noses and / or tolerate uneven mask arrangements. In addition, disruptive forces (particularly during movement or side sleeping) can cause asymmetric loads on the nasal pillows. The membrane portion 3220 can be configured to tolerate uneven loads by decoupling the nasal pillows from each other to keep each nasal pillow in a sealed position.

[0440] The membrane portion 3220 can be constructed and arranged to be flexible to provide the effects described herein by, for example, being thin and not being held so tightly that it cannot move or deform. For example, the membrane portion 3220 can be formed of one or more thin layers of material, and held so that the membrane portion can be deformed to allow relative movement between the seal-forming structure 3100 and the chassis portion 3210. The chassis portion 3210 is formed of a flexible material (e.g., an elastomer, such as silicone or TPE), which can also advantageously contribute to the deformation of the membrane portion 3220 so that the chassis portion 3210 can move relative to the nasal pillow. In some examples, the chassis portion 3210 is able to bend, which can allow the membrane portion 3220 to further change shape over the ability of the membrane portion 3220 to bend, stretch, and inflate alone, because the boundaries of the membrane portion 3220 can move when the chassis portion 3210 is bent.

[0441] In some examples, the membrane portion 3220 may be constructed and arranged to inflate when the plenum chamber 3200 is pressurized to a therapeutic pressure in use. The membrane portion 3220 may be stretchable, and in some examples, the membrane portion may be constructed and arranged to stretch during inflation when the plenum chamber 3200 is pressurized to a therapeutic pressure in use. In some examples, the membrane portion 3220 may be formed of a stretchable material (e.g., a material that is capable of stretching during inflation when the plenum chamber 3200 is pressurized to a therapeutic pressure in use).

[0442] In some examples, the membrane portion 3220 can be constructed and arranged to be taut in the absence of therapeutic pressure in the inflatable chamber 3200. In these examples, the membrane portion 3220 can stretch (e.g., be shaped into a balloon) during inflation to have a larger surface area than when at rest in the absence of pressure in the inflatable chamber 3200. In other examples, the membrane portion 3220 can be untightened (e.g., it can be loose / soft) and can assume a taut configuration during inflation, and can then also stretch with further inflation.

[0443] As described in more detail below, the membrane portion 3220 may not be molded into a three-dimensional shape (e.g., may be formed into a sheet). Not adopting a predetermined three-dimensional shape may allow the membrane portion 3220 to allow for a large amount of movement of the nasal pillows or other seal-forming structure 3100 for deployment and separation purposes, as the membrane portion 3220 may have little or no inherent tendency to return to a predetermined shape.

[0444] In examples of the present technology where a seal-forming structure 3100 includes a nasal portion 3101 and a mouth portion 3102, portions of the membrane portion 3220 supporting the nasal portion 3101 of the seal-forming structure 3100 can be inflated in the manner described herein.

[0445] 1.12.4.3.1 Pressurization of the air chamber

[0446] Figures 7 to 11 The patient interface 3000 is shown before being worn by a patient. As shown, the membrane portion 3220 is stretched tight to a point where there are substantially no wrinkles, folds, or the like. Fig.12 and Fig.13 Shows the Figures 7 to 11 Patient Interface 3000. Fig.12 In the case where the air chamber 3200 is not pressurized, Fig.13 In the embodiment of the present invention, the plenum chamber 3200 is pressurized. Figure 12 to Figure 13 describe Figures 7 to 11 Certain aspects and behaviors of the patient interface 3000 are shown, and unless the context requires otherwise, the described aspects and behaviors should be understood to apply to Figures 14 to 17 , Figures 18 to 24 , Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 Patient interface 3000 is shown.

[0447] Fig.12 The patient interface 3000 is shown as having been worn by a patient prior to pressurization of the plenum chamber 3200. Prior to pressurization, the membrane portion 3220 may be formed to the underside of the patient's nose and / or upper lip, for example, to the underside of the patient's nasal prominence, such as Fig.12 When the inflatable chamber 3200 is not pressurized, the patient's nose is pressed against the membrane portion 3220, forming wrinkles in the membrane portion 3220 on the side facing forward and upward of the inflatable chamber 3200. At this time, the nasal pillow is held in the nose by the elastic force (e.g., spring return force) from the membrane portion 3220.

[0448] like Fig.12As shown, the membrane portion 3220 has a front edge that is spaced from the patient's nose (e.g., the front-most boundary of the membrane portion 3220, where the membrane portion 3220 is attached to the chassis portion 3210). This spacing from the patient's nose or from the upper rear side of the plenum 3200 can be considered the "depth" of the front portion of the membrane portion 3220. This depth provides room for the patient's nose to press into the membrane portion 3220 and compress the front portion of the membrane portion 3220 during deployment. The depth of the membrane portion 3220 in this area can be selected so that the patient can tighten the headgear so that the nose is pressed into this area, but not to the extent that the nose contacts the chassis portion 3210.

[0449] Fig.13 The patient interface 3000 is shown being worn by a patient and the plenum chamber 3200 is pressurized. As shown, there is no longer a fold in the membrane portion 3220 just below / in front of the patient's nose (at Fig.12 3200, there are creases before pressurization) because the membrane portion 3220 has been inflated and stretched (e.g., puffed). This inserts / buries the frustoconical sealing portion (the portion of the seal-forming structure) of the nasal pillow into the patient's nostrils. The pressure in the inflation chamber 3200 maintains an urge on the nasal pillows during use, which provides a secure seal for the mask. The inflatable nature of the membrane portion 3220 can bias the nasal pillows toward the corresponding nostrils in use to obtain a better and more secure seal, making the patient interface 3000 effectively "self-adjusting."

[0450] Inflation of the membrane portion 3220 can advantageously help push the seal-forming structure 3100 toward the patient's face. Figures 7 to 29 In the example shown, the membrane portion 3220 can be constructed and arranged to be inflated in use to push each of the nasal pillows toward a corresponding nostril in the patient's nostrils. This can advantageously promote a good seal between each nasal pillow and the corresponding nostril.

[0451] In some examples, the membrane portion 3220 can be constructed and arranged to inflate in use to adapt to one or more parts of the patient's nose. This can effectively provide a customized fit that can support the patient's nose (e.g., the underside of the nose) and distribute the sealing force, thereby achieving patient comfort and good sealing. As described above, the membrane portion 3220 can adapt to the patient's nasal prominence. The membrane portion 3220 can adapt to the downward-facing surface of the patient's nasal prominence. In some examples, the membrane portion 3220 can be configured so that the frontmost portion of the patient's nasal prominence is not covered. This can advantageously provide a non-obtrusive patient interface 3000. In some examples, the membrane portion 3220 can be configured to adapt to the downward-facing surface of the patient's nose wing. The ballooning effect of the membrane portion 3220 sealing against the downward-facing surface of the patient's nose and against the upper lip of the patient (as described below) (and the ability of the membrane portion 3220 to adapt to the patient's facial shape) can advantageously distribute the force on the patient's nose and face over a large area, which can provide comfort in use because the risk of high contact pressure areas may be low.

[0452] Inflation of the membrane portion 3220 may also help maintain a good seal during use, such as during movement of the patient's head or when the patient interface 3000 is subject to disruptive forces (such as tube resistance or forces created by contact between the patient interface 3000 and the patient's pillow or bed sheets). Figures 7 to 29 In the example shown, the membrane portion 3220 is constructed and arranged to prevent the nasal pillows from separating from the patient's nostrils when the base portion 3210 moves during use. In some examples, the geometric orientation of the conical seal relative to the pressurized membrane ensures that the conical seal is locked in the nostril.

[0453] The membrane portion 3220 can be configured to engage the upper portion of the patient's lip during use. In some examples, this can provide further support, stability, and / or sealing to supplement the seal-forming structure 3100. In some examples, this can provide a stable and comfortable fit (e.g., by distributing the load over a large area). The chassis portion 3210 can be configured not to engage the lower portion of the patient's lip during use, which may be uncomfortable. Figures 7 to 17 In the example shown, the chassis portion 3210 can be small enough and / or have a low profile so that the membrane portion 3220 contacts the upper portion of the lip during use, but the chassis portion 3210 does not contact the lower portion of the lip. The smaller and / or low-profile chassis portion 3210 can provide a less obtrusive patient interface 3000. In addition, the chassis portion 3210 can be configured to not engage the upper portion of the patient's lip during use. That is, in some examples, the membrane portion 3220 can contact the upper portion of the patient's lip, but the chassis portion 3210 may not contact the upper portion of the lip.

[0454] In some examples, such as Figures 7 to 17In the example shown, the membrane portion 3220 does not contact the patient's face except for the patient's nose and upper lip during use. The membrane portion 3220 may not contact the patient's cheek during use. In some examples, the membrane portion 3220 may not contact the patient's nasolabial groove during use. In some examples, the membrane portion 3220 may not contact the side of the patient's nose facing the face during use. The membrane portion 3220 may not contact the patient's nasal ridge during use.

[0455] In some examples, the chassis portion 3210 does not contact the patient's face during use. In some examples, the chassis portion 3210 does not contact the patient's cheek during use. In some examples, the chassis portion 3210 does not contact the patient's nasolabial folds during use.

[0456] 1.12.4.3.2 Textile membrane part

[0457] In some examples of the present technology, the membrane portion 3220 is at least partially formed of a textile material (e.g., a fabric material). The textile material can advantageously provide the membrane portion 3220 with a comfortable surface when contacting the patient's face. In some examples, the membrane portion 3220 includes a textile layer and an airtight layer. The textile layer can include a woven material, and the airtight layer can include, for example, a polymer film. In some examples, the airtight layer can be formed of silicone. In some examples, the membrane portion 3220 can be formed of an airtight membrane flocked with a textile material. Advantageously, the use of a textile material in forming the membrane portion 3220 can allow the membrane portion 3220 to have sufficient stretchability but sufficient tear resistance so that it can stretch and not tear during inflation when the inflatable chamber 3200 is pressurized (at least during the service life). In some examples, if the textile material of the membrane portion 3220 is sufficiently airtight, an additional sealing layer may not be included.

[0458] In some examples, the knitting stitch of the textile material of the membrane portion 3220 can be a single jersey weft knit. In other examples, the textile material can include an alternative knitting stitch (in some examples, a warp knit).

[0459] The textile material may include one or more synthetic fibers. In some examples, the textile material may include 80% polyamide and 20% spandex. Spandex can advantageously provide high stretchability / elasticity. In examples, the spandex content may be in the range of 5% to 20%, in the range of 10% to 20%, or in the range of 5% to 15%. In some examples, the spandex content of the textile material is 15% or 10%. In some examples, the textile material includes polyester fibers instead of polyamide. Other suitable materials may also be used to provide the effects of the membrane portion 3220 described herein.

[0460] In some examples, the thickness of the textile material is 0.27 mm. The membrane portion 3220 may include an airtight silicone backing having a thickness of approximately 0.03 mm, providing an overall thickness of 0.3 mm. In some examples, the weight of the textile material may be 105 gsm.

[0461] In some examples, a textile material is provided to the patient interface 3000 wherein the ribs extend in a generally superior-inferior direction in use and the ribs extend laterally in use. The textile material may have greater stretch in the direction of the ribs and the membrane portion 3220 may need to stretch more laterally across the patient's face than in the superior-inferior direction.

[0462] The textile membrane portion 3220 may be applied to the chassis portion 3210 by molding the chassis portion 3210 onto the textile membrane portion 3220 while the textile membrane portion 3220 is supported in a mold. Alternatively, the chassis portion 3210 may be molded separately and then the textile membrane portion 3220 may be attached (e.g., bonded, welded, taped, or otherwise attached) to the chassis portion. Similarly, the nasal pillows (or other seal-forming structures) may be molded onto the textile membrane portion 3220 or molded separately and then attached (e.g., bonded, welded, etc.).

[0463] 1.12.4.3.3 Elastic membrane part

[0464] In other examples of the present technology, such as Figures 7 to 43 In the example shown, the membrane portion 3220 can be formed from an elastomer, such as silicone or TPE. The elastomer forming the membrane portion 3220 can be thin enough and have material properties that enable the membrane portion 3220 to function in the manner of the textile membrane portion 3220 described herein. Therefore, unless the context requires otherwise, the features of the membrane portion 3220 described with reference to the textile membrane portion 3220 described herein should be understood to apply to the elastic / silicone membrane portion 3220, and vice versa. Specifically, the silicone membrane portion 3220 can be thin enough and formed from a suitable silicone material so that it can stretch during inflation when the inflatable chamber 3200 is pressurized in use, bias the nasal pillows to engage with the patient's nostrils, and / or provide relative movement between the nasal portion 3101 and the chassis portion 3210 of the seal-forming structure 3100 or between each nasal pillow. The thickness of the silicone film portion 3220 can be less than 0.25 mm, for example, 0.2 mm thick, or less than 0.2 mm, less than 0.15 mm thick, and in some examples, the thickness can be in the range of 0.05 mm to 0.2 mm or 0.1 mm to 0.15 mm. The silicone film portion 3220 can be formed of silicone having a durometer hardness in the range of D20 to D40. Other durometer values ​​are also contemplated, such as softer durometer values ​​in some examples.

[0465] In the example where the membrane portion 3220 is formed of silicone, the membrane portion 3220 can be formed separately from the chassis portion 3210. For example, the membrane portion 3220 can be formed first and placed in a mold, after which the chassis portion 3210 can be injection molded and coupled (e.g., bonded) to the membrane portion 3220. Alternatively, the chassis portion 3210 can be molded separately, and then the membrane portion 3220 can be attached to the chassis portion 3210 (e.g., by bonding, welding, etc.). In other examples, the membrane portion 3220 can be formed integrally with the chassis portion 3210, for example, as long as the membrane portion 3220 has a moldable thickness, the membrane portion 3220 can be molded together with the chassis portion 3210 by the same molding step. In some examples, the membrane portion 3220 is formed of silicone and includes a thickness of 0.2 mm. Advantageously, the silicone film portion 3220 having a thickness of 0.2 mm may be highly stretchable, may be capable of being molded with the chassis portion 3210, and may be sufficiently tear-resistant.

[0466] As described elsewhere herein, in some examples, the membrane portion 3220 is formed of an elastomer, but is not formed into a predetermined three-dimensional shape. The membrane portion 3220 may have no bias toward a predetermined shape. In some examples, the membrane portion 3220 may not be able to support itself in a predetermined three-dimensional shape in the absence of a positive pressure relative to the environment in the inflatable chamber 3200. Features such as these can provide a highly flexible membrane portion 3220, which can advantageously facilitate placement (allowing the nasal pillow or other seal-forming structure 3100 to move to form a good seal) and separation (allowing some destructive movement of the chassis portion 3210 relative to the nasal pillow or other seal-forming structure 3100 without transmitting such movement to the nasal pillow).

[0467] In some examples, the membrane portion 3220 can be formed of a first elastic material and the chassis portion 3210 can be formed of a second elastic material. For example, as an example, the membrane portion 3220 can be formed of silicone and the chassis portion 3210 can be formed of a thermoplastic elastomer, or vice versa.

[0468] 1.12.4.3.4 Plenum geometry and other aspects

[0469] As described above, the chassis portion 3210 and the membrane portion 3220 can form an inflatable chamber 3200. The inflatable chamber 3200 can include a rearwardly facing side that is configured to face rearwardly and upwardly during use. In examples of the present technology where the patient interface 3000 includes an oral portion, the rearwardly facing side described herein can be part of the nasal portion of the inflatable chamber 3200. The seal-forming structure 3100 (or the nasal portion 3101 of the seal-forming structure 3100, as the case may be) can be a portion of the nasal portion of the inflatable chamber 3200. Figures 7 to 29The nasal pillows or Figures 30 to 43 The nasal portion 3101 of the seal-forming structure 3100 of the illustrated patient interface 3000 may be disposed on the rearwardly facing upper side. The seal-forming structure 3100 may be disposed on the rearwardly facing upper side so that the seal-forming structure 3100 can face rearwardly and upwardly during use to engage the forwardly and downwardly facing surface of the patient's nose during use. The membrane portion 3220 and the seal-forming structure 3100 may form a majority of the rearwardly and upwardly facing side of the plenum chamber 3200. Figures 7 to 43 As shown, the membrane portion 3220 and the seal-forming structure 3100 form substantially the entirety of the rearward and upward facing side of the inflatable chamber 3200.

[0470] exist Figures 7 to 17 In the example shown, the plenum 3200 includes an upwardly facing front side that is configured to face upwardly facing front during use. Figures 7 to 17 As shown, the membrane portion 3220 can form a majority of the side facing forward and upward of the plenum 3200. The membrane portion 3220 can extend from the side facing backward and upward to the side facing forward and upward. The plenum 3200 can include a curved boundary where the membrane portion 3220 contacts the chassis portion 3210 at the side facing forward and upward.

[0471] The plenum 3200 may also include a rearwardly and downwardly facing side configured to face rearwardly and downwardly during use. Figures 7 to 17 As shown, the membrane portion 3220 can form a majority of the rearward and downward facing side of the plenum 3200 (or its nose portion, as the case may be). The membrane portion 3220 can extend from the rearward and upward facing side to the rearward and downward facing side. The plenum 3200 can include a curved boundary where the membrane portion 3220 contacts the chassis portion 3210 on the rearward and downward facing side.

[0472] exist Figures 18 to 43In the illustrated example of the present technology, the plenum chamber 3200 may not include a rearward and downward facing side in the nose portion. Alternatively, the rearward and upward facing side of the plenum chamber 3200 of the nose portion 3101 supporting the seal-forming structure may be adjacent to and above the mouth portion 3102 of the seal-forming structure 3100, which may be formed by the membrane portion 3220. The portion of the membrane portion 3220 that forms the mouth portion 3102 of the seal-forming structure 3100 may be identified as the mouth portion of the membrane portion 3220. Since the mouth portion 3102 of the seal-forming structure 3100 is configured to seal to the patient's face around the patient's mouth, the mouth portion of the membrane portion 3220 may be configured to face substantially rearward in use, in which example, the mouth portion is an extension of the membrane portion 3220 along the rear side of the cushion module 3150. The side portions of the mouth portion of the membrane portion 3220 may face both rearward and inward to engage the cheeks of the user.

[0473] In some examples of the present technology, such as Figures 7 to 13 In the example shown, chassis portion 3210 forms a majority of a forward and downward facing side of plenum chamber 3200 that is configured to face forward and downward in use. In this example, chassis portion 3210 includes an aperture that is configured to receive a vent module 3410 that includes vent opening 3400. Chassis portion 3210 may be stretched and fitted around vent module 3410 to enable vent module 3410 to be inserted into the aperture in chassis portion 3210.

[0474] In some examples, chassis portion 3210 and membrane portion 3220 can each provide approximately half of the surface area of ​​liner module 3150 .

[0475] exist Figures 7 to 17 In some variations of the illustrated patient interface 3000, an upper front facing side of the plenum chamber 3200, or at least a portion thereof, is substantially planar in the resting position. Similarly, an lower rear facing side of the plenum chamber 3200, or at least a portion thereof, can be substantially planar in the resting position. An upper front facing side of the plenum chamber 3200, or at least a portion thereof, can be substantially parallel to an lower rear facing side of the plenum chamber 3200, or at least a portion thereof.

[0476] exist Figures 7 to 17 In some variations of the patient interface 3000 shown, the rearmost portion of the nasal pillows is spaced rearwardly from the rearmost portion of the membrane portion 3220 during use. Substantially all of the membrane portion 3220 may be located forwardly and inferiorly of the nasal pillows. The membrane portion 3220 may not extend rearwardly beyond the tip of the nasal pillows, and in some examples may not extend rearwardly beyond the base of the nasal pillows.

[0477] In some examples, the cushion module 3150 of the patient interface 3000 does not include face-contacting portions on the sides of the nasal pillows or other nasal portions 3101 of the seal-forming structure 3100. For example, the cushion module 3150 may contact the nose and upper lips, but may not contact the patient's cheeks or nasolabial grooves. The patient interface 3000 may be constructed and / or arranged so that the nasal pillows are positioned in the patient's nostrils without the support portions of the cushion module 3150 contacting the patient's cheeks. Figures 7 to 17 In the example shown, when the nasal pillow enters the nostril, the membrane portion 3220 bends and / or stretches, and then provides a reaction force that prevents the nasal pillow from separating from the patient's nostril. The pressure within the inflation chamber 3200 also acts on the membrane portion 3220 to push the nasal pillow into the nostril. In addition, in the example where the patient interface 3000 includes a catheter head cover, the gas delivery tube 3350 can bend the flexible cushion module 3150 to wrap it around the nose and toward the nose, which can help prevent the nasal pillow from separating from the nostril.

[0478] In some forms of the present technology, the membrane portion 3220 may not have a predetermined three-dimensional shape in the absence of a positive pressure relative to atmospheric pressure in the plenum chamber 3200. In some examples of the present technology, the nasal pillow is supported on a membrane portion 3220 that is not molded into a predetermined shape. In some examples, the membrane portion 3220 may not be formed by injection molding into a predetermined shape. In some examples, the membrane portion 3220 may be formed by a process other than molding (e.g., calendaring). The membrane portion 3220 may not include a three-dimensional predetermined shape. That is, the membrane portion 3220 may be formed so that it is not biased towards a predetermined shape.

[0479] In some examples, for example, the membrane portion 3220 can be manufactured in a sheet shape, so it can be in the form of a sheet. Therefore, the membrane portion 3220 can be sheet-shaped. In some examples, the sheet-shaped membrane portion 3220 can be substantially flat, or can be formed into a substantially flat form, and then present a non-flat structure after being assembled to the chassis portion 3210. Specifically, the membrane portion 3220 can be in the form of a sheet connected to the chassis portion 3210 at the edge of the membrane portion 3220 (for example, after the membrane portion 3220 has been cut into a shape and size that fits the edge of the chassis portion). In some examples, the membrane portion 3220 may not necessarily be completely planar, but sheet-shaped, which is formed to be similar to, for example, a substantially flat sheet and has a width and length much larger than its thickness. The membrane portion 3220 can have a uniform thickness. The sheet-like membrane portion 3220 may be formed by a sheet production process such as calendaring, or may be formed by molding, for example together with the chassis portion 3210 and / or the nose portion 3101 of the seal-forming structure 3100 .

[0480] In some examples, the membrane portion 3220 is relaxed in the absence of positive pressure in the plenum 3200. The membrane portion 3220 can be formed to be relaxed in the absence of external forces. For example, the membrane portion 3220 can be relaxed or soft, although it can be kept in place by its connection with the chassis portion 3210. The membrane portion 3200 can be configured so that it cannot support itself in a predetermined shape and / or is configured not to be biased to a predetermined three-dimensional shape. The lack of a predetermined three-dimensional shape and / or the lack of a significant biasing force to form a predetermined shape can provide a particularly low amount of restriction on the movement of the nasal pillow or other nasal portion 3101 of the seal-forming structure 3100. The membrane portion 3220 can advantageously be particularly effective in separating the nasal portion 3101 of the seal-forming structure 3100 from the chassis portion 3210, and / or allowing the nasal portion 3101 of the seal-forming structure 3100 to fit or adapt to the patient's face.

[0481] If the membrane portion 3220 is a thin sheet (e.g., a thin silicone membrane or a textile membrane) that does not have an otherwise preformed geometry, the nasal pillow may be allowed to freely adapt to the patient's nose geometry. In contrast, a membrane portion 3220 that is molded into a certain shape may have a resistance to deformation, which may limit the ability of the nasal pillow to move to adapt to the patient's nose. When the membrane portion 3220 is not molded into a predetermined shape, the nasal pillow may be able to move in a less obstructed manner than when the membrane portion 3220 is molded into a shape. Specifically, the nasal pillow may be better able to swing around its base and may move up and down substantially along its axis. In addition, the absence of a molded shape for the membrane portion 3220 means that the nasal pillow is not molded in a predetermined orientation relative to the cushion module 3150. In addition, the membrane portion 3220 that is not molded into a predetermined shape may allow the nasal pillow to have a large range of motion. This can help the nasal pillows withstand destructive forces during use because they move with a high degree of freedom relative to the chassis portion 3210.

[0482] In other examples of the present technology, the membrane portion 3220 is molded into a predetermined shape, but has sufficient flexibility so that any inherent bias back to the molded shape is not significant, and the membrane portion 3220 is still able to provide the advantages described above. For example, a membrane portion 3220 molded from soft silicone (e.g., D40 durometer hardness) and having a sufficiently thin wall thickness (e.g., 0.2 mm in one specific example) can allow the nasal pillows or other nasal portion 3101 of the seal-forming structure 3100 to move sufficiently freely to achieve a good seal, and can separate the nasal portion 3101 of the seal-forming structure 3100 from the chassis portion 3210.

[0483] In some examples, the nasal pillows are not molded together. Each nasal pillow can be molded separately. Even if the nasal pillows are molded together, they can be separated from each other (e.g., by cutting) when the nasal pillows are attached to the membrane portion 3220. This can advantageously help to separate the nasal pillows from each other. In some examples, the nasal pillows are attached to the membrane portion 3220 so that the nasal pillows do not tilt toward each other in a static state before the inflatable chamber 3200 is pressurized. In use, the nasal pillows can be connected to each other only by materials that do not tend to assume a predetermined three-dimensional shape or by materials that cannot support themselves in a predetermined three-dimensional shape (such as the above-mentioned membrane portion 3220). Some prior art patient interfaces 3000 include a pair of nasal pillows that are connected by materials molded into a predetermined shape (e.g., molded integrally with the nasal pillows themselves). Although such nasal pillows can be separated to some extent, the material connecting them can have an inherent bias to return to its molded shape, which can reduce the extent to which the material can separate the nasal pillows compared to materials that do not tend to return to a predetermined three-dimensional shape (such as some membrane portions 3220 described herein). Similarly, the nasal portion 3101 of the seal forming structure 3100 in the form of a nose pad which, in use, seals to the lower periphery of the patient's nose can better adapt to changes in the shape and size of the patient's nose when supported on a membrane portion 3220 which has no inherent bias to form a predetermined three-dimensional shape, as compared to a nose pad which is supported on a material molded into a predetermined three-dimensional shape and which requires a certain force to deform (and therefore has a tendency to return to the deformed shape).

[0484] In some examples, when the plenum chamber 3200 is pressurized, the membrane portion 3220 expands toward a convex shape (e.g., a shape that bulges toward the outer surface). This can help push the nasal pillows toward the patient's nostrils and maintain a continuously adjusted seal. Due to the constrained nasal pillows and / or the conformation to the patient's nose and upper lip, the force of the patient's nose and face on this expansion can cause some or all of the membrane portion 3220 to become concave.

[0485] In some examples, the cushion module 3150 may not have a rigid frame. Without a rigid frame, the sides of the cushion module 3150 may be at least partially separated from each other, which may allow the cushion module 3150 to be adapted to a particular patient as needed to provide a good seal and may allow the cushion module 3150 to withstand damaging forces.

[0486] 1.12.4.3.5 Membrane portion forming part of the seal forming structure

[0487] In some examples, membrane portion 3220 can form one or more portions of seal-forming structure 3100. For example, membrane portion 3220 can form a mouth portion of seal-forming structure 3100.

[0488] exist Figures 18 to 43In the example shown, the seal-forming structure 3100 includes a nose portion 3101 and a mouth portion 3102. Figures 18 to 29 In the example shown, the nasal portion 3101 of the seal-forming structure 3100 includes nasal pillows supported on a membrane portion 3220, and the oral portion 3102 of the seal-forming structure 3100 is formed by the membrane portion 3220. Figures 30 to 43 In the example shown, the nose portion 3101 of the seal-forming structure 3100 includes a cradle cushion. A cradle cushion is described in more detail elsewhere herein and is configured to seal to the lower periphery of the patient's nose and the upper portion of the patient's lips and may not have a protrusion (e.g., a nasal pillow) configured to seal to the patient's nostrils during use.

[0489] refer to Figures 18 to 43 , the membrane portion 3220 may include a nose portion that forms a portion of the nose portion 3101 of the membrane portion 3220 that supports the seal-forming structure 3100, and the membrane portion 3220 may also include a mouth portion that forms the mouth portion of the seal-forming structure 3100.

[0490] The membrane portion 3220 may include a sealing flange that forms a seal with the mouth portion 3102 of the seal-forming structure 3100. Figures 18 to 43 In the example shown, the upper portion of the sealing flange is integrally formed with the nose portion of the membrane portion 3220. More generally, the portion of the membrane portion 3220 that supports the nose portion 3101 of the seal-forming structure 3100 is integrally formed with the portion of the membrane portion 3220 that forms the mouth portion 3102 of the seal-forming structure 3100. Figures 18 to 43 As shown, the nose portion of the membrane portion 3220 is integrally formed with the mouth portion of the membrane portion 3220. In some examples, in addition to the nose portion 3101 of the seal-forming structure 3100, the nose portion of the membrane portion 3220 can also seal to the patient's nose and / or face near the nose to form a seal.

[0491] The mouth portion 3102 of the seal-forming structure 3100 can be configured to seal to the patient's upper lip, lower lip, and cheeks and define a mouth opening to the plenum chamber 3200. Figures 18 to 43 In the example shown, the sealing flange is formed by a membrane portion 3220. The membrane portion 3220 is connected to and supported by the chassis portion 3210. The periphery of the sealing flange formed by the membrane portion 3220 is supported by the chassis portion 3210 at the sides and underside of the sealing flange. The inner periphery of the sealing flange formed by the membrane portion 3220 is unconstrained to allow it to fully adapt to the shape of the patient's face around the patient's mouth.

[0492] The sealing flange can include a curved cross section at one or more locations around the oral opening, such as at the upper lip and / or chin, so that the convex surface contacts the patient's face before adapting to the surface of the patient's face. In some examples, the cross section of the sealing flange can bulge at the patient's cheek. In other examples, it can be substantially flat. The curved cross section can provide a pressure-assisted seal against the patient's face, whereby the treatment pressure in the inflatable chamber 3200 helps to keep the sealing flange against the surface of the patient's face. The sealing flange formed by the membrane portion 3220 can be connected to the chassis portion 3210 so that the chassis portion 3210 does not contact the patient's face during use. For example, the connection between the chassis portion 3210 and the membrane portion 3220 in the oral portion of the inflatable chamber 3200 can be separated from the patient's face during use.

[0493] Figures 18 to 43 The membrane portion 3220 in the example shown can be formed of an elastic material such as silicone (e.g., which can be thin, such as about 0.2 mm, in some examples) or another elastic material such as TPE. The elastic material forming the membrane portion 3220 is further disclosed elsewhere herein, and this disclosure should be understood to be applicable to the membrane portion 3220 forming a portion of the seal-forming structure 3100, such as in Figures 18 to 43 In the example.

[0494] In some examples, including Figures 18 to 43 In the example shown, the chassis portion 3210 can be flexible to at least partially decouple the membrane portion 3220 from disruptive forces applied to the chassis portion 3210 during use. The disruptive forces can be forces that may adversely affect the seal formed between the seal-forming structure 3100 and the patient's face, such as tube resistance or forces exerted on the patient interface 3000 by the patient's pillow / bed when sleeping on their side. While providing some flexibility to achieve this decoupling effect, the chassis portion 3210 has sufficient rigidity to serve as a structure supporting the membrane portion 3220 (e.g., to maintain the peripheral shape of the membrane portion 3220, and in some examples, to keep the membrane portion 3220 substantially taut).

[0495] In some examples, the chassis portion 3210 may be at least partially formed by a textile material, which may be a textile material capable of supporting its own shape, such as a thick and slightly hard textile material, such as a breathable synthetic material. For example, the chassis portion 3210 may be formed by a breathable synthetic material having a thickness of 2.5 mm. In other examples, the chassis portion 3210 may be formed by a polymer material, which is flexible due to thickness and geometry. Such polymer materials may be substantially rigid at greater thicknesses, but the chassis portion 3210 may have a sufficiently small thickness so that the material can be deformed to at least partially absorb destructive forces. The chassis portion 3210 may be flexible to absorb destructive forces, but has sufficient rigidity to support its own shape and support the membrane portion 3220 in use.

[0496] In some examples, the chassis portion 3210 is formed of polyester film. The thickness of the polyester film material can be in the range of 0.2 mm to 0.5 mm, such as 0.25 mm. In other examples, the chassis portion 3210 can be formed of polycarbonate, which has a thickness in the range of 0.4 mm to 1 mm, such as in the range of 0.5 mm to 0.75 mm. The chassis portion 3210 can include a molded shell or sheet that has been vacuum formed (and trimmed to size as needed). In other examples, the chassis portion 3210 can be formed of an elastic material (such as silicone or TPE).

[0497] exist Figures 18 to 43 In the example shown, the bottom plate portion 3210 is shaped so as to bend from one side of the patient's face to the other side of the patient's face during use. The bottom plate portion 3210 may be substantially flush with the patient's cheek on each side. For example, Fig.40 and Fig.41 As shown, on either side of the patient's face, the chassis portion 3210 is substantially flush with the patient's cheek, e.g., a line following the curvature of the chassis portion 3210 is substantially aligned with the surface of the patient's cheek. This flush relationship can help maintain a low profile of the patient interface 3000 and / or provide a more comfortable side sleeping compared to a situation where the sides of the chassis portion 3210 are raised above the patient's cheek. Figures 18 to 43 The illustrated patient interface 3000 may have such a structure and curvature of the cushion module 3150 that helps avoid damaging forces, particularly during side sleeping.

[0498] The shape of the chassis portion 3210 may be substantially a hyperbolic paraboloid. The shape of the membrane portion 3220 may also be substantially a hyperbolic paraboloid. Figures 18 to 43In the example shown, the chassis portion 3210 and the membrane portion 3220 are each in the shape of a hyperbolic parabola. It should be understood that although the chassis portion 3210 and the membrane portion 3220 have one or more parts or features that do not form a part of the hyperbolic parabola shape, their respective shapes can be substantially hyperbolic paraboloids. The shapes of the chassis portion 3210 and the membrane portion 3220 can be substantially hyperbolic paraboloids rotated 90 degrees relative to each other, and can be connected to each other around the edge. In some examples, the shape of either or both of the chassis portion 3210 and the membrane portion 3220 can be substantially parabolic. That is, in some examples, the chassis portion 3210 and / or the membrane portion 3220 can be as described elsewhere herein, but can have a parabolic shape in an undeformed state before being worn by the patient. In other examples, the chassis portion 3210 and / or the membrane portion 3220 can have a shape other than a hyperbolic parabola or a parabolic column.

[0499] For example, the membrane portion 3220 may have a curvature in a sagittal plane that curves upward from the chin area of ​​the patient's face toward the patient's nose and then forward in the in-use orientation and prior to engagement with the patient's face. After the patient interface 3000 is donned and the membrane portion 3220 engages the patient's face, its shape will have a more complex curvature to match the contours on the patient's facial surface.

[0500] In a plane perpendicular to the sagittal plane (e.g., a horizontal plane or a posterior-superior-anteroinferior oriented plane), in the orientation in use, the membrane portion 3220 may have no curvature before engaging the patient's face due to being fully tightened by the chassis portion 3210. After the patient wears the patient interface 3000 and the membrane portion 3220 engages the patient's face, the membrane portion 3220 may adapt to the geometry of the patient's face, bending forward from the side of the patient's face along one of the patient's cheeks, then bending medially toward the sagittal plane of the user's head, then bending laterally, and then bending backward along the other of the cheeks to the other side of the patient's face. In the same plane, the chassis portion 3210 may also bend forward from one side of the patient's face along one of the user's cheeks, then bend medially toward the sagittal plane, and then bend laterally and backward along the other of the user's cheeks to the other side.

[0501] 1.12.4.3.6 Integrally formed chassis, membrane and seal forming structure

[0502] In some forms of the present technology, a patient interface 3000 may include a chassis portion 3210 and a membrane portion 3220, each of which partially forms a plenum chamber 3200 and is integrally formed with each other and a portion of a seal-forming structure 3100 of the patient interface 3000. For example, the chassis portion 3210 and the membrane portion 3220 may be integrally formed with at least the nasal portion 3101 of the seal-forming structure 3100. Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the nose portion 3101, the membrane portion 3220 and the chassis portion 3210 of the seal-forming structure 3100 can be integrally formed from an elastic material.

[0503] It should be understood that in some examples, a patient interface 3000 (such as a Figures 7 to 17 The patient interface shown may include a chassis portion 3210, a membrane portion 3220 and a seal-forming structure 3100 (the seal-forming structure as a whole 3100 may be considered the nasal portion of the seal-forming structure as it seals only around the patient's nose), all of which are integrally formed from, for example, an elastic material.

[0504] It should also be understood that in some examples, the patient interface 3000 (such as Figures 18 to 24 The patient interface shown may include a chassis portion 3210, a membrane portion 3220 and at least a nose portion 3101 of a seal-forming structure 3100, all of which are integrally formed, for example, from an elastic material.

[0505] In examples of the present technology in which the membrane portion 3220, the chassis portion 3210, and one or more portions of the seal-forming structure 3100 are integrally formed, the membrane portion 3220 can have any features or properties as described elsewhere herein, such as, for example, being inflatable and stretchable.

[0506] exist Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the chassis portion 3210 is flexible to at least partially decouple the membrane portion 3220 from disruptive forces applied to the chassis portion 3210 during use, such as tube resistance or interference with the chassis portion 3210 formed by the patient's pillow during side sleeping. The chassis portion 3210, the membrane portion 3220, and at least the nose portion 3101 of the seal-forming structure 3100 can be formed, for example, from silicone. In other examples, these portions of the cushion module 3150 can be formed from TPE.

[0507] The thickness of the membrane portion 3220 can be, for example, less than 0.45 mm, less than 0.4 mm, less than 0.35 mm, less than 0.3 mm, or less than 0.2 mm. In some examples, the thickness of the membrane portion 3220 is 0.2 mm or less. In some forms, the membrane portion 3220 can be formed of a silicone having a durometer hardness in the range of A20 to A40 or in the range of A20 to D30. In a specific example, the membrane portion 3220 can be formed of a silicone having a 20 Shore A or 30 Shore A durometer hardness.

[0508] The nose portion 3101, the membrane portion 3220 and the chassis portion 3210 of the seal-forming structure 3100 can be formed together by injection molding in a single molding step. This can provide rapid and / or cost-effective manufacturability of the cushion module 3150 of the patient interface 3000.

[0509] exist Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 In the examples shown, the plenum chamber 3200 may be described as including a nasal portion (e.g., a portion that is proximate to a patient's nose during use) and an oral portion (e.g., a portion that is proximate to a patient's mouth during use). As described above, in these examples, the seal-forming structure 3100 includes an oral portion 3102 that is configured to seal around a user's mouth during use. In these examples, the nasal portion of the plenum chamber 3200 includes a rearward-upward facing side that is configured to face rearward-upward during use (e.g., a portion that faces the underside of a patient's nose). The membrane portion 3220 and the nasal portion 3101 of the seal-forming structure 3100 form a majority of the rearward-upward facing side of the nasal portion plenum chamber 3200.

[0510] The bottom plate portion 3210 may form a majority of the forward facing side of the mouth portion of the plenum 3200. Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 As shown, the bottom plate portion 3210 forms substantially all of the forward-facing side of the mouth portion of the plenum 3200. For example, Fig.28 , Fig.33 and Fig.37As shown, the mouth portion 3102 of the seal-forming structure 3100 can substantially form the entirety of the rearward-facing side of the mouth portion of the plenum chamber 3200. As described in more detail elsewhere herein, the shape of the chassis portion 3210 in these examples can be configured to bend from one side of the patient's face to the other side of the patient's face during use, with the chassis portion 3210 being substantially flush with the patient's cheek on each side. The chassis portion 3210 and / or the membrane portion 3220 can each be shaped substantially in the form of a hyperbolic parabola or a parabolic cylinder. In some examples, the chassis portion 3210 and the membrane portion 3220 can each be shaped substantially in the form of a hyperbolic parabola or a parabolic cylinder rotated 90 degrees relative to each other.

[0511] exist Figure 25 to Figure 29 In the example shown, the nasal portion 3101 of the seal-forming structure 3100 includes a pair of nasal pillows supported on a membrane portion 3220, each nasal pillow being constructed and arranged to form a seal with a corresponding nasal cavity of the patient's nose. The nasal pillows can be integrally formed with the membrane portion 3220. In some examples, the nasal pillows can be molded together with the membrane portion 3220 (e.g., in a single molding step / injection molding). The interaction between the membrane portion 3220 and the nasal pillows can be as described elsewhere herein, for example with reference to other examples of the present technology.

[0512] In other examples, the nasal portion 3101 of the seal-forming structure 3100 may not include nasal pillows. Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the nose portion 3101 of the seal-forming structure 3100 includes a patient-facing surface that is configured to seal around the patient's nostrils at the lower periphery of the patient's nose, the lower periphery including to the nasal prominence of the patient's nose at or near the nasal prominence, to the nose wing and to the upper lip. This type of cushion portion can be identified as a nose pad cushion. The area at or near the nasal prominence can be identified as the nasal prominence area, so that the seal-forming structure 3100 seals to the nasal prominence area. The nasal prominence area can be the dome-shaped inner and lower portion of the nose that defines the nose tip. The upper innermost portion of the seal-forming structure can engage the user's nose in the nasal prominence area. The seal-forming structure 3100 can be configured not to engage the user's nose bridge and can leave the user's nose bridge uncovered. In some examples, the seal-forming structure 3100 is configured to leave the user's nasal prominence uncovered.

[0513] form Figure 30 to Figure 34 and Figures 35 to 43 The bracket cushion structure of the nasal portion 3101 of the seal-forming structure 3100 of the patient interface shown can be formed integrally with the membrane portion 3220, such as by molding the nasal portion 3101 and the membrane portion 3220 together in a single molding step / injection molding.

[0514] 1.12.4.3.7 Alternative nose portion of seal-forming structure

[0515] As described above, while in some examples the nasal portion 3101 of the seal-forming structure 3100 takes the form of a nasal pillow, in other examples, such as Figure 30 to Figure 34 and Figures 35 to 43 In the example shown, the nose portion 3101 can take the form of a bracket cushion structure, which includes a patient-facing surface that is configured to seal around the patient's nostrils at a lower periphery of the patient's nose, including to the nasal prominence of the patient's nose at or near the nasal prominence, to the nasal wing, and to the upper lip.

[0516] Figure 30 to Figure 34 and Figures 35 to 43 The nose portion 3101 of the seal-forming structure 3100 in the illustrated examples includes: a front wall 3104 including a non-patient-facing surface; and a rear wall 3105 connected to the front wall and including a patient-facing surface. In these examples, the front wall 3104 faces forward on the sagittal plane and faces forward and outward on each side of the sagittal plane. The rear wall 3105 can face in the posterior-superior direction on the sagittal plane, and can partially face in the medial direction and partially face in the posterior-superior direction on each lateral side of the sagittal plane. The lower portion of the rear wall 3105 of the nose portion 3101 is configured to seal against the upper lip and can be connected to the mouth portion 3102 of the seal-forming structure 3100. The portion of the seal-forming structure 3100 that seals to the upper lip can form a portion of both the nose portion 3101 and the mouth portion 3102 of the seal-forming structure 3100.

[0517] Specifically, Fig.31 and Fig.35 As shown, the front wall 3104 can extend upwardly from the membrane portion 3220 of the patient interface 3000. For example, the membrane portion 3220 at the base of the front wall 3104 can be substantially horizontal, at least close to the sagittal plane, and the front wall 3104 can extend from the horizontal membrane portion in an upward direction, for example, as shown in FIG. Fig.363210 . The front wall 3104 of the nasal portion 3101 of the seal-forming structure 3100 is connected to a substantially upwardly facing portion of the membrane portion 3220, which can advantageously provide a spring cushion effect, whereby the front wall 3104 of the nasal portion 3101 can move upwardly and downwardly relative to the chassis portion 3210 during use. This ability to move can advantageously allow the nasal portion 3101 of the seal-forming structure 3100 to fit a wide range of patients during use, tolerate misalignment, bias the nasal portion 3101 of the seal-forming structure 3100 toward the nose, and / or significantly decouple the nasal portion 3101 of the seal-forming structure 3100 from the chassis portion 3210 and, therefore, the headgear connection. For example, prior art patient interfaces in which the nasal portion of the seal-forming structure is more directly connected to the shell may not have this effect.

[0518] exist Figure 30 to Figure 34 In the example shown, specifically Fig.32 As shown, the membrane portion 3220 includes a mouth portion that forms the mouth portion 3102 of the seal-forming structure 3100. That is, the membrane portion 3220 that supports the nose portion 3101 of the seal-forming structure 3100 also forms the mouth portion 3102 of the seal-forming structure 3100. Aspects of the membrane portion 3220 that supports both the nose portion 3101 of the seal-forming structure 3100 and the mouth portion 3102 of the seal-forming structure 3100 are described in more detail elsewhere herein, for example with reference to Figures 18 to 24 and Figure 25 to Figure 29 , and unless the context clearly requires otherwise, this aspect should be understood to apply to Figure 30 to Figure 34 Example shown.

[0519] exist Figure 30 to Figure 34 In the example shown, a lower portion of the rear wall 3105 of the nose portion 3101 of the seal-forming structure 3100 is coupled to the mouth portion of the membrane portion 3220 (also the mouth portion 3102 of the seal-forming structure 3100 in this example).

[0520] Specifically, Fig.32 , Fig.33 and Fig.34 As shown, the nose portion 3101 of the seal-forming structure 3100 includes posterolateral corners 3106, each of which is configured to engage the patient's face between a corresponding one of the nose wings and a corresponding one of the nasolabial grooves. In this particular example, each posterolateral corner 3106 is separated (e.g., at least partially) from the mouth portion 3102 of the seal-forming structure 3100 by a membrane portion 3220. Figure 30 to Figure 34As shown, the membrane portion 3220 surrounds a majority of the lower periphery of the nose portion of the seal-forming structure 3100. For example, the membrane portion 3220 occupies at least an anterior, lateral, and posterolateral positions adjacent to the lower periphery of the nose portion 3101 of the seal-forming structure 3100. The nose portion 3101 of the seal-forming structure 3100 includes a pair of posterolateral walls, each of which extends upwardly, laterally (e.g., outwardly), and rearwardly from the membrane portion 3220, for example, as shown in FIG. Fig.34 As shown. The posterolateral corner 3106, and in some examples, the surrounding portion of the nose portion 3101 of the seal-forming structure 3100 can be dome-shaped. In some examples, such as Figure 32 to Figure 34 As shown, the upper portion of the oral portion 3102 of the seal-forming structure 3100 can be joined to the nasal portion 3101 of the seal-forming structure 3100 below and inside the posterolateral corner 3106. This arrangement can advantageously prevent leakage at the lower corner of the patient's nose during use.

[0521] This arrangement in which a majority of the nasal portion 3101 of the seal-forming structure 3100, including the posterolateral corner 3106, is separated from the oral portion 3102 of the seal-forming structure 3100 may allow the nasal portion 3101 of the seal-forming structure 3100 to be particularly highly separated from the chassis portion 3210 and to be easily moved relative to the chassis portion 3210 to engage the patient's nose during arrangement.

[0522] Figures 35 to 43 The patient interface 3000 in FIG. 3 has an alternative arrangement in which the patient interface 3000 includes a membrane portion 3220 but does not form the oral portion 3102 of the seal-forming structure 3100. In this example, a lower portion of the rear wall 3105 of the nasal portion 3101 of the seal-forming structure 3100 is coupled to the oral portion 3102 of the seal-forming structure 3100. The membrane portion 3220 is adjacent to the front and anterior lateral portion of the lower periphery of the nasal portion 3101 of the seal-forming structure 3100, as specifically shown in FIG. 38. The membrane portion 3220 may include a rear boundary located on the side of the nasal portion 3101 of the seal-forming structure 3100. In this example, the membrane portion 3220 does not extend to a posterior lateral position adjacent to the nasal portion 3101 of the seal-forming structure 3100.

[0523] Specifically, Figure 36 to Figure 39 As shown, the nose portion 3101 of the seal-forming structure 3100 includes a pair of posterolateral walls that extend upward, forward, and medially from the mouth portion 3102 of the seal-forming structure 3100. The posterolateral walls form a posterolateral angle 3106. Figure 30 to Figure 34 In the example shown, the posterolateral corner 3106 is partially separated from the mouth portion 3102 of the seal-forming structure 3100 by the membrane portion 3220 and is Figures 35 to 43In the example shown, the posterolateral corner 3106 is directly connected to the mouth portion 3102 of the seal-forming structure 3100. This arrangement can provide a particularly good seal between the nose wing and the nasolabial groove near the lateral corner of the nose.

[0524] Fig.44 Shown with Figures 35 to 43 A cross-sectional view of a nasal portion 3101 of a seal-forming structure 3100 of a patient interface 3000 similar to the patient interface 3000 shown. Fig.44 Two features that may be found in some examples of the present technology are shown.

[0525] In some examples, such as through Fig.44 As shown in the example in , the nose portion 3101 of the seal-forming structure 3100 may include a rib 3107 that extends between the rear wall 3105 and the rear portion of the front wall 3104 of the nose portion 3101 of the seal-forming structure 3100. Fig.45 The location, size, and shape of the rib 3107 are schematically shown. In some examples, the rib 3107 can extend between the posterolateral corner 3106 and the front wall 3104. In some examples, the rib 3107 can extend between the posterior wall 3105 and the side walls of the nasal portion 3101 of the seal-forming structure. The rib 3107 can be located at or near the base of the nasal portion 3101, such as at or near the boundary between the posterolateral corner 3106 and the mouth portion 3102 of the seal-forming structure 3100. The rib 3107 can help support this transition and help maintain the curved shape of the posterolateral corner 3106. The rib 3107 can reinforce the posterolateral corner 3106, or more generally, can reinforce the area of ​​the nasal portion 3101 of the seal-forming structure 3100 that is configured to seal to the lower and lateral areas of the patient's face near their nose, such as between the nose ala and the nasolabial groove. The ribs 3107 may be integrally formed with the nose portion 3101 of the seal-forming structure 3100, or may be formed separately and attached (eg, bonded, overmolded, or otherwise added to an already formed nose portion 3101).

[0526] In some examples, such as through Fig.36 and Fig.44As shown in the example of , the nasal portion 3101 of the seal-forming structure 3100 may include a reinforcement portion 3108 disposed in the front wall 3104. The reinforcement portion 3108 may be harder than adjacent portions of the nasal portion 3101 of the seal-forming structure 3100, and may help prevent collapse of the nasal portion 3101, and may provide support for the patient contacting portion of the seal-forming structure 3100. The reinforcement portion 3108 may be provided by a portion of the nasal portion 3101 formed with a greater material thickness than adjacent portions of the nasal portion 3101, or may be formed separately from a material that is harder than the material forming the nasal portion 3101. The reinforcement portion 3108 may extend from one side of the nasal portion 3101 to the other side along the front wall 3104. As shown in FIG. Fig.36 As shown, the height of the reinforcement portion 3108 can taper downward toward the front portion of the nose portion 3101 of the seal-forming structure 3100. That is, in some examples, the height of the reinforcement portion 3108 can be higher at the side portions of the front wall 3104 than at the inner portion of the front wall 3104.

[0527] In an alternative example, a patient interface 3000 having a nasal portion 3101 of a seal-forming structure 3100 in the form of a nose pad (e.g., to seal to the nasal prominence area, the wings of the nose, and the upper lip) may include a membrane portion 3220 formed from a textile material, as described elsewhere herein. The nasal portion 3101 of the seal-forming structure may be molded separately and then attached to the textile membrane portion 3220, such as by bonding, or, by way of example only, the nasal portion 3101 of the seal-forming structure 3100 may be molded to the membrane portion 3220.

[0528] and Figure 25 to Figure 29 , Figure 30 to Figure 34 and Figures 35 to 43 The membrane portion 3220 of the patient interface 3000 shown can be formed by injection molding, in other examples, the membrane portion 3220 can be formed by a process other than injection molding (such as calendaring), as described elsewhere herein. In such alternative examples, the membrane portion 3220 can be formed as a sheet, and in the patient interface 3000, the membrane portion 3220 may not have a predetermined three-dimensional shape in the absence of positive pressure, as described elsewhere herein. The thickness of such a membrane portion 3220 can be less than 0.2 mm, such as less than 0.18 mm or less than 0.15 mm.

[0529] As described in more detail elsewhere herein, Figures 35 to 43The patient interface 3000 shown includes a positioning and stabilizing structure 3300 having some advantageous features. Specifically, the positioning and stabilizing structure 3300 is connected to the chassis portion 3210, and the positioning and stabilizing structure includes one or more strap portions that are configured to engage the patient's head in use and are connected to the chassis portion 3210 at only one location on each side of the chassis portion 3210. This arrangement can make the patient interface 3000 convenient for the user. In addition, the nose portion 3101 of the seal-forming structure 3100 is supported on the membrane portion 3220 and is separate from the chassis portion 3210, which, together with the positioning and stabilizing structure 3300 being connected to only two locations on the chassis portion (or other portions of the plenum 3200 or cushion module 3150, as the case may be), can provide synergy. Many prior art patient interfaces have a four-point connection headgear to provide a high degree of control over adjustability to ensure a good seal. However, the disclosed membrane portion 3220 that allows a high level of movement and separation of the nasal pillows or other nasal portion 3101 of the seal-forming structure 3100 means that for at least some patients, a good seal may be achieved with only a two-point connection headgear, which may be more user-friendly and / or more desirable than a four-point connection headgear, which may help improve patient compliance with therapy.

[0530] 1.12.4.3.8 Base pad

[0531] In some examples of the present technology, the patient interface 3000 includes a base cushion. Figures 18 to 24 The patient interface 3000 shown includes a base cushion 3225 located behind the membrane portion 3220, such as Fig.21 and Fig. 22 As shown. The base cushion 3225 can be attached to the chassis portion 3210 and can be configured to engage the inner surface of the membrane portion 3220 to support the membrane portion 3220 during use. The base cushion 3225 can be configured to engage any one or more of the following: a chin area of ​​the membrane portion 3220, the chin area of ​​the membrane portion being configured to contact the chin area of ​​the patient's face during use; a cheek area of ​​the membrane portion 3220, the cheek area of ​​the membrane portion being configured to contact the cheek of the patient during use; and a nose area of ​​the membrane portion 3220, the nose area of ​​the membrane portion being configured to contact the nose of the patient during use. In some examples, the base cushion 3225 can be located behind the cheek area of ​​the membrane portion 3220 and behind the chin area of ​​the membrane portion 3220. In some examples, the base cushion can be located only behind the chin area of ​​the membrane portion 3220. It should be understood that in some examples of the present technology, for example, such as Figures 25 to 43 In the example shown, the patient interface 3000 does not include a base cushion.

[0532] In some examples, base gasket 3225 is configured to engage membrane portion 3220 around the entire periphery of membrane portion 3220 .

[0533] The bottom pad 3225 can be formed by a flexible and elastic material, such as an elastomer (e.g., silicone or TPE). The bottom pad 3225 can be molded on the chassis portion 3210, for example, if the bottom pad 3225 and the chassis portion 3210 are formed by different materials. The bottom pad 3225 can be in the form of a flange and can extend inward from the periphery of the chassis portion 3210. The bottom pad 3225 can be configured as a cantilever seat to keep the membrane portion 3220 against the patient's face during use. In some examples, the bottom pad 3225 is formed by the same material as the chassis portion 3210 and can be formed integrally with the chassis portion 3210. In some examples, the chassis portion 3210, the bottom pad 3225 and the membrane portion 3220 can all be formed integrally with each other. In other examples, the bottom pad 3225 can be adhered to the chassis portion 3210.

[0534] When engaged with the patient's face, the bottom pad 3225 can be deformed with the membrane portion 3220 to adapt to the shape of the patient's face. The upper portion of the bottom pad 3225 can be configured to bend to adapt to the patient's nose and cheeks when the patient wears the patient interface 3000. The thickness of the upper portion of the bottom pad 3225 can be in the range of 0.5mm to 1.5mm, in the range of 0.75mm to 1.25mm, or for example, the thickness can be 1mm. The lower portion of the bottom pad 3225 is configured to bend to adapt to the chin area (e.g., near the patient's supramental point and the lower lip, higher than the chin protuberance). The lower portion of the bottom pad 3225 can have a variable thickness. For example, the inner portion of the lower portion of the bottom pad 3225 can be thinner than the outer portion of the lower portion of the bottom pad 3225. This can bring comfort to the patient during use.

[0535] In some examples, the base pad 3225 can be formed from multiple separate parts. Figures 18 to 24 In the example shown, the base cushion 3225 is a unitary structure. The base cushion 3225 can define an opening through which air can flow from the plenum 3200 to the patient's airway via the opening in the seal-forming structure 3100.

[0536] In one example, Fig. 22The bottom pad 3225 is shown by the hidden details behind the chassis portion 3210. In this view, together with the peripheral edge of the mouth opening in the membrane portion 3220, the base of the nasal pillows forming the nose portion 3101 of the seal-forming structure 3100 is also visible as a hidden detail. In this example of the present technology, the bottom pad 3225 does not extend around the entire periphery of the chassis portion 3210. The bottom pad 3225 extends downward and medially from a position close to one of the cheeks of one patient in use to intersect with the sagittal plane, and then extends laterally and upwardly to a position close to the other cheek of the patient's cheek. The bottom pad 3225 can be configured to engage the chin area of ​​the membrane portion 3220, which is configured to contact the chin area of ​​the patient; and can be configured to engage the cheek area of ​​the membrane portion 3220, which is configured to contact the cheek of the patient in use. However, the bottom pad 3225 does not extend into the nose portion of the cushion module 3150. That is, in this example, there is no base pad 3225 behind the nasal portion of the membrane portion 3220, which is configured to contact the patient's nose. The base pad 3225 may include an end behind the membrane portion 3220 at the user's cheek on either side of the patient's upper lip and / or nose. The absence of a base pad 3225 behind the membrane portion 3220 at the patient's nose can provide a cushion module 3150 that can be manufactured more easily or cost-effectively, while still having a base pad that supports the membrane portion 3220 against at least the patient's cheek and chin. The absence of a base pad 3225 in the nasal area of ​​the cushion module 3150 can also provide better comfort because the patient's nose is not pressed into the base pad 3225, and can also provide a better seal because the membrane portion 3220 can be freely deformed to allow the nasal pillow to surround the nose and move to the correct orientation to seal to the extent necessary for the patient's specific facial geometry. In addition, the tension only in the membrane portion 3220 can be sufficient to keep the nasal pillow in place for deployment and use.

[0537] 1.12.5 Ventilation

[0538] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases (eg, carbon dioxide).

[0539] In some forms, the vent 3400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to the environment. The vent 3400 is configured so that the vent flow is of a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0540] 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.

[0541] 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.

[0542] In some forms, the patient interface 3000 may include a vent 3400 to allow gases exhaled by the patient to continuously vent from the interior of the plenum 3200 to the environment throughout the patient's breathing cycle, for example, and the vent 3400 is sized and shaped to maintain a therapeutic pressure in the plenum during use. Figures 7 to 13 The patient interface 3000 in the illustrated example includes a ventilation module 3410 that includes a vent 3400. The ventilation module 3410 may be a component or assembly formed of a substantially rigid material and include a plurality of holes forming the vent 3400. The ventilation module 3410 may be disposed on the front side of the chassis portion 3210. Figures 7 to 13 In the example shown, the ventilation module 3410 is disposed on the front lower side of the chassis portion 3210. The chassis portion 3210 includes a hole for receiving the ventilation module 3410, which is a front lower hole in the example shown, and may be a hole facing the front lower in other examples. In some examples, the ventilation module 3410 is configured to support a diffuser through which the patient's exhaled gas can be continuously discharged to the environment. In some examples, the ventilation module 3410 is configured to allow the patient's exhaled gas to bypass the diffuser rather than being continuously discharged to the environment from the interior of the plenum 3200 through the diffuser.

[0543] In other examples, the vent 3400 can be disposed on the bottom plate portion 3210 near (e.g., in front of) the mouth portion 3102 of the seal-forming structure 3100. The vent module 3410 can be disposed on the front side of the bottom plate portion 3210. The bottom plate portion 3210 can include a forward-facing hole to accommodate, for example, a vent module 3410 including the vent 3400. Although not shown in the drawings, Figures 18 to 24 The patient interface 3000 shown may be configured with such a vent 3400. Figures 25 to 43 As shown, the patient interface 3000 includes a vent 3400 disposed on a connector that connects the plenum chamber 3200 to the short tube 3610 .

[0544] 1.12.6 Disconnection Structure

[0545] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0546] 1.12.7 Connection Port

[0547] The connection port 3600 allows connection to the air circuit 4170 .

[0548] 1.12.8 Forehead support

[0549] In one form, the patient interface 3000 includes a forehead support 3700 .

[0550] 1.12.9 Anti-suffocation valve

[0551] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0552] Figures 18 to 43 The patient interfaces 3000 shown or described with reference to these figures each also include an anti-asphyxia valve (AAV) not shown in the drawings. The AAV can be disposed at the mouth portion of the patient interface 3000. In some examples, the AAV is integrated into the ventilation module 3410. The ventilation module 3410 may include a gas flushing vent 3400 and an AAV. In some examples, the AAV is disposed in the chassis portion 3210 (or the mouth chassis portion 3217) of the patient interface 3000. In other examples, the AAV is disposed at the connection port 3600 of the patient interface 3000 or at the connection (such as an inlet port connector) between the plenum chamber 3200 and the short tube 3610.

[0553] 1.12.10 Ports

[0554] 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.

[0555] 1.13RPT device

[0556] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to 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.

[0557] 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.

[0558] The RPT device can have an outer housing 4010 formed of two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 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.

[0559] 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.

[0560] One or more air path items may be located within a removable unitary structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0561] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 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.

[0562] 1.13.1 Mechanical and pneumatic components of RPT device

[0563] The RPT device may include one or more of the following components in an integral unit. In the alternative, one or more of the following components may be located as respective separate units.

[0564] 1.13.1.1 Air filter

[0565] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0566] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0567] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0568] 1.13.1.2 Silencer

[0569] An RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120 .

[0570] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .

[0571] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0572] 1.13.1.3 Pressure generator

[0573] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. 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.

[0574] The pressure generator 4140 may be under the control of a therapy device controller.

[0575] In other forms, 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.

[0576] 1.13.1.4 Anti-overflow valve

[0577] In one form of the present technology, an anti-spillback valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0578] 1.13.2RPT device algorithm

[0579] As described above, in some forms of the present technology, the central controller of the RPT device 4000 may be configured to implement one or more algorithms represented as computer programs stored in a non-transitory computer-readable storage medium such as a memory. Algorithms are typically grouped into groups called modules.

[0580] In other forms of the present technology, some parts or all of the algorithm may be implemented by a controller of an external device such as a local external device or a remote external device. In this form, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm executed at the external device may be transmitted to the external device via a local external communication network or a remote external communication network. In this form, the portion of the algorithm to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute a portion of the algorithm.

[0581] In this form, therapy parameters generated by the external device via the therapy engine module (if so forming part of the algorithm executed by the external device) may be transmitted to the central controller for transfer to the therapy control module.

[0582] 1.14 Air circuit

[0583] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to travel between two components (such as the RPT device 4000 and the patient interface 3000) in use.

[0584] In particular, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches of the circuit for inhalation and exhalation. In other cases, a single branch is used.

[0585] 1.15 Humidifier

[0586] 1.15.1 Humidifier Overview

[0587] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0588] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0589] 1.15.2 Humidifier components

[0590] 1.15.2.1 Water storage tank

[0591] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or retain a volume of liquid (e.g., water) to be evaporated to humidify the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source, such as a building's water supply.

[0592] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0593] According to one form, the reservoir 5110 may be, for example, along a Figure 5A and Figure 5B The sideways orientation is shown removed from the humidifier 5000.

[0594] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifices and / or among its subcomponents, such as when the reservoir 5110 is displaced and / or rotated from its normal operating orientation. Since the air flow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0595] 1.15.2.2 Conductive part

[0596] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are also suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (e.g., having a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved with a material of suitable geometry that is less conductive.

[0597] 1.15.2.3 Humidifier reservoir base

[0598] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 5B ), the humidifier reservoir base 5130 is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking feature, such as a locking rod 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0599] 1.15.2.4 Water level indicator

[0600] The humidifier reservoir 5110 may include FIG. 5A to FIG. 5B Water level indicator 5150 is shown. In some forms, water level indicator 5150 can provide a user (such as patient 1000 or a caregiver) with one or more indications of the amount of volume of water in humidifier reservoir 5110. The one or more indications provided by water level indicator 5150 may include an indication of a maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200 ml, 300 ml, or 400 ml.

[0601] 1.15.2.5 Heating elements

[0602] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive heating track. One suitable example of a heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0603] In some forms, the heating element 5240 may be disposed in the humidifier base 5006, where heat may be provided to the humidifier reservoir 5110 primarily by conduction, such as Figure 5B shown.

[0604] 1.16 Respiratory waveform

[0605] Figure 6 A shows a typical breathing waveform model of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow. Although the parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5 L, inhalation time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, exhalation time Te 2.4 s, peak expiratory flow Qpeak -0.5 L / s. The total duration of breathing Ttotal is about 4 s. People usually breathe at a rate of about 15 breaths per minute (BPM), and the ventilation volume Vent is about 7.5 L / minute. The typical duty cycle (the ratio of Ti to Ttot) is about 40%.

[0606] 1.17 Glossary

[0607] For purposes of this technology disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0608] 1.17.1 General Concepts

[0609] Air: In some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.

[0610] Environment: In certain forms of the present technology, the term environment will be taken to mean both (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0611] For example, relative to the environment of the humidifier humidity This may be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0612] In another example, ambient pressure may be the pressure immediately adjacent to or external to the body.

[0613] In some forms, ambient (eg, acoustic) noise may be considered to be the background noise level in the room the patient is in, rather than, for example, noise generated by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources external to the room.

[0614] Automatic positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted (eg, varies with each breath) between a minimum and a maximum limit, depending on whether there is an indication of a SDB event.

[0615] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapy pressure may be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the entrance to the airway is slightly higher during exhalation and slightly lower during inhalation. 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.

[0616] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate will be references to a scalar quantity, i.e. a quantity having only magnitude. In other cases, references to flow rate will be references to a vector quantity, i.e. a quantity having both magnitude and direction. Flow rate may be given by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow" or "airflow".

[0617] 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 flow that leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0618] Flow Therapy: Respiratory therapy that involves delivering air flow to the airway entrance at a controlled flow rate, called the therapy flow, which is usually positive throughout the patient's respiratory cycle.

[0619] Humidifier: The term humidifier shall be deemed to mean a humidifying device constructed and arranged or physically configured to provide a therapeutically beneficial amount of water (H2O) vapor to an air flow to relieve a patient's medical respiratory condition.

[0620] Leak: The term leak is to be considered as unintended air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow leading to the environment.

[0621] Conducted noise (acoustics): Conducted noise in this document refers to the noise transmitted 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.

[0622] Radiated noise (acoustics): Radiated noise in this document refers to the noise transmitted to the patient by the ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0623] Vent Noise (Acoustic): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent hole of a patient interface.

[0624] Oxygen-enriched air: Air having an oxygen concentration greater than that of 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 abbreviated to "oxygen."

[0625] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0626] Patient: A person, whether or not they have a respiratory condition.

[0627] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascals. 1 cmH2O is equal to 1 gf / cm 2 And it is roughly 0.98 hPa (1 hPa = 100 Pa = 100 N / m 2 =1 mbar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0628] 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.

[0629] Respiratory Pressure Therapy: The application of a supply of air to the entrance of the airways at a therapeutic pressure that is usually positive relative to atmosphere.

[0630] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0631] 1.17.1.1 Materials

[0632] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including 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 ranging from about 35 to about 45 as measured using ASTM D2240.

[0633] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0634] 1.17.1.2 Mechanical properties

[0635] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0636] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, some silicones and thermoplastic elastomers.

[0637] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0638] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0640] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0642] 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 antonym of stiffness is flexibility.

[0643] Flexible structure or component: A structure or component that will change shape (e.g., bend) when made to support its own weight for a relatively short period of time, such as 1 second.

[0644] Rigid structure or component: A structure or component that will not substantially change shape when subjected to loads typically 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 under a load of pressure of approximately 20 to 30 cmH2O.

[0645] 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 floppy in a first direction and rigid in a second direction.

[0646] 1.17.2 Respiratory cycle

[0647] Apnea: According to some definitions, an apnea is considered to have occurred when flow drops below a predetermined threshold for a period of time (e.g., 10 seconds). Obstructive apnea is considered to have occurred when some obstruction to the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to have occurred when apnea is detected due to reduced or absent breathing effort despite a patent airway. Mixed apnea is considered to have occurred when reduced or absent breathing effort occurs simultaneously with an obstructed airway.

[0648] Expiratory ...

Claims

1. A patient interface, comprising: a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port that is sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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; a vent that allows gases exhaled by the patient to continuously vent from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber 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 first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and engage a posterior region of the patient's head, the posterior region covering the parietal and / or occipital bones of the patient's head; and a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate a respective one of the patient's ears in use, the second strap portion being configured to cover an upper region of the patient's head in use; Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

2. A patient interface according to claim 1, wherein the first strap portion is configured to cover the patient's ears in use.

3. A patient interface according to claim 2, wherein the first strap portion is configured to cover an upper portion of the patient's ear while leaving a lower portion of the patient's ear uncovered during use.

4. A patient interface according to any one of claims 1 to 3, wherein the unextended length of the first strap portion is selectively adjustable.

5. A patient interface according to any one of claims 1 to 4, wherein the first strap portion is formed from an elastically extensible material.

6. A patient interface according to any one of claims 1 to 5, wherein the first strap portion includes a bifurcated portion configured to engage the rear region of the patient's head in use.

7. A patient interface according to any one of claims 1 to 6, wherein the second strap portion extends from the first strap portion substantially at 90 degrees to the first strap portion on each side of the patient's head.

8. A patient interface according to any one of claims 1 to 7, wherein the unextended length of the second strap portion is selectively adjustable.

9. A patient interface according to any one of claims 1 to 8, wherein the second strap portion is formed from an elastically extensible material.

10. A patient interface according to any one of claims 1 to 9, wherein the first strap portion is connected to the plenum chamber by rotatable headgear strap connections on each side of the plenum chamber.

11. A patient interface according to claim 10, wherein each rotatable headgear strap connection comprises a first rotatable portion and a second rotatable portion, wherein the first rotatable portion and the second rotatable portion are configured to be connected together and to allow the first rotatable portion to be selectively rotated relative to the second rotatable portion to a selected rotational position by the patient.

12. A patient interface according to claim 11, wherein each rotatable headgear strap connection is configured to, in use, prevent relative rotation between the first rotatable portion and the second rotatable portion away from the selected rotational position.

13. A patient interface according to claim 12, wherein each rotatable headgear strap connection is configured to resist relative rotation away from the selected rotational position by friction.

14. A patient interface according to any one of claims 11 to 13, wherein the first belt portion includes two first rotatable portions, each of which is arranged at a corresponding end of the first belt portion, and the inflatable chamber includes two second rotatable portions, each of which is arranged on a corresponding side of the inflatable chamber.

15. A patient interface according to claim 14, wherein each first rotatable portion includes a convex cylindrical portion and each second rotatable portion includes a concave cylindrical portion, wherein the concave cylindrical portion is configured to receive the convex cylindrical portion and allow the convex cylindrical portion to be selectively rotated relative to the concave cylindrical portion by the patient.

16. A patient interface according to claim 15, wherein each convex cylindrical portion includes a center portion and a flange portion, the flange portion extending outwardly from the center portion, and each concave cylindrical portion defines a cylindrical cavity and an opening leading to the cylindrical cavity, and wherein when the convex cylindrical portion is received in the concave cylindrical portion, the center portion is received in the opening and the flange portion is received in the cylindrical cavity.

17. A patient interface according to claim 15 or claim 16, wherein the female cylindrical portion is flexible to allow insertion of the male cylindrical portion.

18. A patient interface according to any one of claims 15 to 17, wherein the concave cylindrical portion is formed from a resilient material.

19. A patient interface according to any one of claims 15 to 18, wherein the concave cylindrical portion is integrally formed with a non-patient-facing wall of the plenum chamber.

20. A patient interface according to any one of claims 1 to 19, wherein the patient interface comprises: a chassis portion at least partially forming the plenum; and a membrane portion that at least partially forms the plenum, the membrane portion being connected to the chassis portion and being more flexible than the chassis portion, wherein the seal-forming structure comprises: a nose portion that is at least partially supported by the membrane portion; and a mouth portion configured to seal around the patient's mouth.

21. A patient interface according to claim 20, wherein the nasal portion of the sealing forming structure includes a patient-facing surface, and the patient-facing surface is configured to seal against the patient's face at or near the lower periphery of the patient's nose, and the lower periphery includes to the nasal prominence of the patient's nose at or near the nasal prominence, to the nasal wings and to the upper part of the lips.

22. A patient interface according to claim 21, wherein the nasal portion of the seal-forming structure comprises: an anterior wall comprising a non-patient-facing surface; and a rear wall connected to the front wall and comprising the patient-facing surface.

23. A patient interface according to claim 22, wherein the front wall of the nose portion extends upwardly from the membrane portion of the patient interface.

24. A patient interface according to claim 22 or 23, wherein a lower portion of the rear wall of the nasal portion of the seal-forming structure is connected to the oral portion of the seal-forming structure.

25. A patient interface according to any one of claims 20 to 24, wherein the membrane portion is formed from a resilient material.

26. A patient interface according to any one of claims 20 to 25, wherein the nose portion and the membrane portion of the seal-forming structure are integrally formed.

27. A patient interface according to claim 26, wherein the nose portion and the membrane portion of the seal-forming structure are formed together by injection molding in a single molding step.

28. A patient interface according to claim 27, wherein the seal-forming structure, the membrane portion and the chassis portion are formed together by injection molding in the single molding step.

29. A patient interface, comprising: a plenum chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port that is sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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; a vent that allows gases exhaled by the patient to continuously vent from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; and a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising at least a first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and to cover the parietal and / or occipital bones of the patient's head, the first strap portion being configured to, in use, cover an upper portion of the patient's ear while leaving a lower portion of the patient's ear uncovered; Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

30. A patient interface according to claim 29, wherein the positioning and stabilizing structure further comprises a second strap portion, the second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate to a corresponding one of the patient's ears during use, the second strap portion being configured to cover an upper region of the patient's head during use.

31. A patient interface, comprising: a chassis portion at least partially defining a plenum chamber that is pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 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 therapeutic pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle, the seal-forming structure comprising: at least a nasal portion configured to seal around the entrance to the patient's nares; and an oral portion configured to seal around the patient's mouth; a membrane portion connecting the chassis portion and at least partially forming the plenum, the membrane portion at least partially supporting the nose portion of the seal-forming structure, the membrane portion being more flexible than the chassis portion and constructed and arranged to allow relative movement between the nose portion of the seal-forming structure and the chassis portion; and a vent that allows exhaled gas from the patient to continuously vent from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; and a positioning and stabilising structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure being connected to the chassis portion and comprising one or more strap portions configured to engage the patient's head in use, wherein the positioning and stabilising structure is connected to the chassis portion at only one location on each side of the chassis portion; Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

32. A patient interface according to claim 31, wherein the membrane portion separates at least a portion of the nasal portion of the seal-forming structure from the chassis portion.

33. A patient interface according to claim 31 or claim 32, wherein the membrane portion separates at least the front side of the nasal portion of the seal-forming structure from the chassis portion.

34. A patient interface according to any one of claims 31 to 33, wherein the membrane portion separates a front wall of the nasal portion of the seal-forming structure from the chassis portion.

35. A patient interface according to any one of claims 31 to 34, wherein the membrane portion is constructed and arranged to inflate when the inflatable chamber is pressurised to the treatment pressure in use.

36. A patient interface according to either claim 31 or claim 35, wherein the chassis portion is flexible to at least partially decouple the membrane portion from destructive forces applied to the chassis portion in use.

37. A patient interface according to claim 36, wherein the nose portion, membrane portion and chassis portion of the seal-forming structure are formed together by injection molding in a single molding step.

38. A patient interface according to any one of claims 31 to 37, wherein the nasal portion of the seal-forming structure includes a pair of nasal pillows supported on the membrane portion, each nasal pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

39. A patient interface according to any one of claims 31 to 37, wherein the nasal portion of the sealing structure includes a patient-facing surface, the patient-facing surface being configured to seal around the patient's nostrils at a lower periphery of the patient's nose, the lower periphery including to or near the nasal prominence of the patient's nose, to the nasal wings, and to the upper part of the lips.

40. A patient interface according to any one of claims 31 to 39, wherein the positioning and stabilising structure comprises: a first strap portion connected to each side of the plenum chamber and configured to, in use, cover a lateral surface of the patient's head and engage a posterior region of the patient's head, the posterior region covering the parietal and / or occipital bones of the patient's head; and a second strap portion having a pair of ends connected to the first strap portion, each end of the second strap portion being connected to the first strap portion at a position proximate a respective one of the patient's ears in use, the second strap portion being configured to cover an upper region of the patient's head in use.

41. A patient interface according to claim 40, wherein the first strap portion is configured to cover the patient's ears in use.

42. A patient interface according to claim 41, wherein the first strap portion is configured to cover an upper portion of the patient's ear while leaving a lower portion of the patient's ear uncovered in use.

43. A patient interface according to any one of claims 40 to 42, wherein the unextended length of the first strap portion is selectively adjustable.

44. A patient interface according to claim 41 wherein said first strap portion is formed from an elastically extensible material.

45. A patient interface according to any one of claims 40 to 44, wherein the first strap portion comprises a bifurcated portion configured to engage the rear region of the patient's head in use.

46. ​​A patient interface according to claim 45, wherein the bifurcated portion includes an upper portion, the upper portion being separate from a lower portion, the separation of the upper portion from the lower portion being adjustable by the patient to adjust the fit of the first strap portion to the patient's head.

47. A patient interface according to any one of claims 40 to 46 wherein the second strap portion extends from the first strap portion substantially at 90 degrees to the first strap portion on each side of the patient's head.

48. A patient interface according to any one of claims 40 to 47, wherein the unextended length of the second strap portion is selectively adjustable.

49. A patient interface according to any one of claims 40 to 48, wherein the second strap portion is formed from an elastically extensible material.

50. A patient interface according to any one of claims 40 to 49 wherein the first strap portion is connected to the chassis portion by rotatable headgear strap connections on each side of the chassis portion.

51. A patient interface according to claim 50, wherein each rotatable headgear strap connection comprises a first rotatable portion and a second rotatable portion, wherein the first rotatable portion and the second rotatable portion are configured to be connected together and to allow the first rotatable portion to be selectively rotated by the patient relative to the second rotatable portion to a selected rotational position.

52. A patient interface according to claim 51 , wherein each rotatable headgear strap connection is configured to, in use, prevent relative rotation between the first rotatable portion and the second rotatable portion away from the selected rotational position.

53. A patient interface, comprising: a chassis portion at least partially defining a plenum chamber that is pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that 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 throughout the patient's breathing cycle, the seal-forming structure comprising: at least a nasal portion; a membrane portion connecting the chassis portion and at least partially forming the plenum, the membrane portion at least partially supporting the nose portion of the seal-forming structure, the membrane portion being more flexible than the chassis portion and constructed and arranged to allow relative movement between the nose portion of the seal-forming structure and the chassis portion; and a vent that allows gases exhaled by the patient to continuously vent from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; wherein the nose portion, the membrane portion and the chassis portion of the seal-forming structure are integrally formed of a resilient material; and Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

54. A patient interface according to claim 53, wherein the membrane portion separates at least a portion of the nasal portion of the seal-forming structure from the chassis portion.

55. A patient interface according to claim 53 or claim 54, wherein the membrane portion separates at least the front side of the nasal portion of the seal-forming structure from the chassis portion.

56. A patient interface according to any one of claims 53 to 55, wherein the membrane portion separates a front wall of the nasal portion of the seal-forming structure from the chassis portion.

57. A patient interface according to any one of claims 53 to 56, wherein the membrane portion is constructed and arranged to inflate in use when the inflatable chamber is pressurised to the treatment pressure.

58. A patient interface according to any one of claims 53 or 57, wherein the chassis portion, the membrane portion and the nose portion of the seal-forming structure are formed of silicone.

59. A patient interface according to any one of claims 53 to 58, wherein the nose portion, membrane portion and chassis portion of the seal-forming structure are formed together by injection moulding in a single moulding step.

60. A patient interface according to any one of claims 53 to 59 wherein the inflatable chamber comprises a nasal portion and an oral portion, the seal-forming structure comprising the oral portion configured to seal around a user's mouth in use.

61. A patient interface according to claim 60, wherein the nasal portion of the seal-forming structure includes a pair of nasal pillows supported on the membrane portion, each nasal pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

62. A patient interface according to claim 61, wherein the membrane portion is constructed and arranged to prevent the nasal pillows from separating from the patient's nostrils when the chassis portion moves during use.

63. A patient interface according to claim 60, wherein the nasal portion of the seal-forming structure includes a patient-facing surface, the patient-facing surface being configured to seal around the patient's nostrils at a lower periphery of the patient's nose, the lower periphery including to or near the nasal prominence of the patient's nose, to the nasal wings, and to the upper part of the lips.

64. A patient interface according to claim 63, wherein the nasal portion of the seal-forming structure comprises: an anterior wall comprising a non-patient-facing surface; and a rear wall connected to the front wall and comprising the patient-facing surface.

65. A patient interface according to claim 64, wherein said front wall extends upwardly from said membrane portion of said patient interface.

66. A patient interface according to any one of claims 64 to 65 wherein the membrane portion comprises a mouth portion forming the mouth portion of the seal-forming structure.

67. A patient interface according to claim 66 wherein a lower portion of the rear wall of the nasal portion of the seal-forming structure is joined to the oral portion of the membrane portion.

68. A patient interface according to claim 66 or 67, wherein the nasal portion of the seal-forming structure includes posterolateral corners, each of the posterolateral corners being configured to engage the patient's face between a corresponding one of the nasal wings and a corresponding one of the nasolabial grooves, and each posterolateral corner being separated from the oral portion of the seal-forming structure by the membrane portion.

69. A patient interface according to any one of claims 66 to 68, wherein the membrane portion surrounds a majority of the lower periphery of the nasal portion of the seal-forming structure.

70. A patient interface according to any one of claims 66 to 69 wherein the membrane portion occupies at least an anterior, lateral and posterolateral positions adjacent a lower periphery of the nasal portion of the seal-forming structure.

71. A patient interface according to any one of claims 66 to 70 wherein the nasal portion of the seal-forming structure comprises a pair of posterior lateral walls, each of which extends upwardly, laterally and rearwardly from the membrane portion.

72. A patient interface according to any one of claims 64 to 65 wherein a lower portion of the rear wall of the nasal portion of the seal-forming structure is coupled to the oral portion of the seal-forming structure.

73. A patient interface according to claim 72, wherein the membrane portion is adjacent to the front and anterior outer side of the lower periphery of the nasal portion of the seal-forming structure.

74. A patient interface according to claim 72 or claim 73, wherein the membrane portion does not extend to a posterolateral position of the nasal portion adjacent to the seal-forming structure.

75. A patient interface according to any one of claims 72 to 74 wherein the nasal portion of the seal-forming structure comprises a pair of posterior lateral walls extending upwardly, forwardly and medially from the oral portion of the seal-forming structure.

76. A patient interface according to any one of claims 72 to 75, wherein the nasal portion of the seal-forming structure includes a pair of ribs located at or near the base of the nasal portion, the ribs extending between the rear wall of the nasal portion and the side walls of the nasal portion.

77. A patient interface according to claim 76 wherein said rib extends between said rear wall of said nasal portion and a rear portion of said front wall of said nasal portion.

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