Patient interface, frame and system for providing pressurized air to patient

Abstract

The utility model relates to a patient interface. A frame is used for a system for providing pressurized air for a patient. A patient interface includes a pneumatic chamber, a first seal-forming structure for forming a seal around a patient's mouth, and a second seal-forming structure for forming a seal around a patient's nostril. The patient interface also includes at least one stop rib disposed in the cavity of the pneumatic chamber, spaced from the first seal-forming structure in a rest position. The first seal-forming structure is configured to contact the at least one stop rib in an operative position. The at least one stop rib is configured to resist compression of the first seal-forming structure in a forward direction. The second seal-forming structure is not configured to contact the at least one stop rib.

Description

[0001] This application is a divisional application of the patent application with application number 202222367545.9 filed on September 6, 2022, and the utility model name is "PATIENT INTERFACE AND SYSTEM FOR PROVIDING PRESSURIZED AIR TO A PATIENT". Technical Field

[0002] The present technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. The present technology also relates to medical devices or equipment and their uses. Background Art

[0003] 2.2 Description of Related Technologies

[0004] 2.2.1 Human respiratory system and its disorders

[0005] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to a person's airways.

[0006] The airway comprises a series of branch tubes, and when the branch trachea penetrates deeper into the lungs, it becomes narrower, shorter and more numerous. The main function of the lungs is gas exchange, thereby allowing oxygen to enter the venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further airway division leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is where gas exchange occurs and is referred to as the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

[0007] There are a range of respiratory disorders. Some disorders can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0008] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. It often leads to excessive daytime sleepiness and may cause cardiovascular disease and brain damage. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. Referring to U.S. Patent No. 4,944,310 (Sullivan).

[0010] 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 hypoxia and reoxygenation of arterial blood. Due to the repeated lack of oxygen, CSR can be harmful. In some patients, CSR is associated with repeated arousals from sleep, which leads to severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a term for respiratory 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.

[0012] People with respiratory insufficiency (a form of respiratory failure) may become abnormally short of breath during exercise.

[0013] 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.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These conditions include increased resistance to air flow, a prolonged expiratory phase of breathing, and a 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: difficulty breathing on exertion, a chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function 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 are characterized by muscle damage that worsens over months and leads to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders are characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapulohumeral and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0016] Chest wall disorders are a group of chest deformities that result in inefficient connections between the respiratory muscles and the rib cage. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of treatments have been used to treat or improve such conditions. In addition, these treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0018] 2.2.2 Treatment

[0019] 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.

[0020] 2.2.2.1 Respiratory pressure therapy

[0021] Respiratory pressure therapy is the supply of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as cannulated or tube-based ventilators).

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

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

[0024] Invasive ventilation (IV) provides ventilation support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0025] 2.2.2.2 Flow therapy

[0026] Not all respiratory therapies are intended to deliver prescribed treatment pressures. Some respiratory therapies are intended to deliver prescribed respiratory volumes by delivering an inspiratory flow curve (possibly superimposed on a positive baseline pressure) within a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy can only supplement the patient's own spontaneous breathing with a stream of regulated or enriched gas. In one example, high flow therapy (HFT) provides a continuous, heated, humidified air flow to the airway entrance through an unsealed or open patient interface at a "treatment flow" that remains roughly constant throughout the respiratory cycle. The treatment flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory diseases. A mechanism of action is that the high flow of air at the airway entrance improves ventilation efficiency by flushing or washing away exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST surgery). Other benefits may include increased warmth and humidity (possibly beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow, the therapy flow may follow a curve that varies during the respiratory cycle.

[0027] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. A physician can prescribe a continuous flow of oxygen-enriched air at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (the fraction of ambient air oxygen, ranging from 21% to 100%), delivered to the patient's airway.

[0028] 2.2.2.3 Supplemental oxygen

[0029] For some patients, oxygen therapy can be combined with respiratory pressure therapy, or HFT, by adding supplemental oxygen to the pressurized air flow. When oxygen is added to respiratory pressure therapy, it is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is called HFT with supplemental oxygen.

[0030] 2.2.3 Respiratory therapy system

[0031] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0032] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0033] Another form of treatment system is a mandibular repositioning device.

[0034] 2.2.3.1 Patient interface

[0035] The patient interface can be used, for example, to connect a respiratory device to its wearer by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal (e.g., a seal) with an area of ​​the patient's face to facilitate delivery of gas at a positive pressure of approximately 10 cmH2O relative to ambient pressure and at a pressure that varies substantially from ambient pressure to achieve treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids complete sealing. An example of such a patient interface is a nasal cannula.

[0036] Certain other mask systems may not be functionally suitable for this application. For example, a purely cosmetic mask may not maintain adequate pressure. A mask system used for underwater swimming or diving may be configured to prevent the ingress of water from a higher external pressure, but will not maintain the internal air at a pressure higher than the ambient pressure.

[0037] Certain masks may be clinically unsuitable for this technology, for example, if they block airflow through the nose and only allow it through the mouth.

[0038] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal through their lips, this may be uncomfortable or impractical with the present technology.

[0039] Certain masks may not be practical for use while sleeping, for example, while sleeping on one's side in bed with the head on a pillow.

[0040] Designing a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly between individuals. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. And the entire head can move during a period of respiratory therapy.

[0041] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. For example, masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0042] CPAP therapy is very effective in treating certain breathing disorders, assuming patient compliance. If the mask is uncomfortable or difficult to use, the patient may not comply with the treatment. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0043] While a mask used for other applications (eg, navigators) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0044] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0045] 2.2.3.1.1 Sealing structure

[0046] 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.

[0047] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed, for example, to cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0048] A seal-forming structure that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0049] Certain seal-forming structures can be designed for mass manufacturing so that one design fits and is 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.

[0050] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in facing engagement with the patient's face. The seal-forming structure may comprise an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made from an elastomer, such as rubber. With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0051] Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal-forming portions, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, causing leaks.

[0052] Another type of seal-forming structure may include friction-fit elements, for example, for insertion into a nostril, however some patients find these uncomfortable.

[0053] Another form of seal-forming structure may use an adhesive to achieve the seal. Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

[0054] A range 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.

[0055] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett. Another nasal pillow or snus is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0056] ResMed Ltd. manufactures the following products containing nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGE LIBERTY TM Full face mask. The following patent application assigned to ResMed describes an example of a nasal pillow mask: The following patent application assigned to ResMed Ltd describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073,778 (which describes the ResMed Ltd SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Ltd. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the ResMed Ltd. MIRAGE LIBERTYTM Other aspects of full face masks); International patent application WO 2009 / 052,560 (which describes the ResMed Ltd SWIFT TM Other aspects of the FX Nasal Pillows).

[0057] 2.2.3.1.2 Positioning and stabilization

[0058] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various technologies have been used to position the seal-forming structure and keep it in a sealing relationship with the appropriate part of the face.

[0059] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0060] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0061] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0062] 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 airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy, such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0063] 2.2.3.3 Air circuit

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

[0065] 2.2.3.4 Humidifier

[0066] Delivering an air stream without humidification can lead to airway dryness. Using a humidifier with an RPT device and a patient interface to generate humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air, typically applied to the facial area in and around the patient interface, is more comfortable than cold air. Therefore, humidifiers typically have the ability to heat the air stream as well as humidify it.

[0067] 2.2.3.5 Oxygen source

[0068] Experts in this area have recognized that exercising provides long-term benefits to patients with respiratory failure, which slows the progression of the disease, improves quality of life and prolongs the patient's lifespan. However, most fixed forms of exercise, such as treadmills and stationary bicycles, are too strenuous for these patients. Therefore, it has long been recognized that mobility is needed. Until recently, this mobility has been facilitated by using small compressed oxygen tanks or cylinders mounted on a cart with small wheels. The disadvantage of these tanks is that they contain a limited amount of oxygen and are heavy, weighing about 50 pounds when installed.

[0069] Oxygen concentrators have been used for about 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and cumbersome, making ordinary lifesaving activities difficult and impractical. Recently, companies that manufacture large, fixed oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. In order to make these devices smaller for mobility, the various systems used to produce oxygen-rich gas need to be condensed. POCs seek to use the oxygen they produce as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses or "bolis", with each boli timed to coincide with the start of inspiration. In contrast to traditional continuous flow delivery, which is more suitable for fixed oxygen concentrators, this mode of treatment is called pulsed or on-demand (oxygen) delivery (POD).

[0070] 2.2.3.6 Data Management

[0071] There may be a clinical reason for obtaining data to determine whether a patient who has been prescribed a respiratory therapy has been "compliant," e.g., that the patient has used their RPT device according to one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that, in order to be considered compliant, a patient use the respiratory pressure therapy device for at least four hours each night on at least twenty-one (21) days out of thirty (30) consecutive days. To determine patient compliance, a provider of the RPT device (such as a healthcare provider) may manually obtain data describing treatment for a patient using the RPT device, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0072] There may be other aspects of patient treatment that would benefit from the communication of treatment data to a third party or external system.

[0073] Existing processes for communicating and managing such data can be one or more of expensive, time consuming, and error prone.

[0074] 2.2.3.7 Mandibular reduction

[0075] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite-impression portion that is designed to allow it to fit over the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, puts tension on the pharyngeal walls to reduce collapse of the airway and reduces vibrations of the palate.

[0076] In some embodiments, the mandibular advancement device may include an upper plate intended to engage or cooperate with teeth on the maxilla or maxilla, and a lower plate intended to engage or cooperate with teeth on the maxilla or mandible. The upper and lower plates are laterally connected via a pair of connecting rods. The pair of connecting rods are symmetrically secured to the upper and lower plates.

[0077] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in a protruded position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0078] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (such as ResMed Narval CC) TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0079] 2.2.3.8 Vent Technology

[0080] Some forms of treatment systems may include a vent to allow exhaled carbon dioxide to escape. The vent may allow gas to flow from the interior space of the patient interface (eg, a pneumatic chamber) to the exterior of the patient interface (eg, to the surrounding environment).

[0081] The vent may include a vent through which gas can flow when the mask is in use. Many such vents are noisy. Other vents may become blocked during use, thereby providing insufficient ventilation. Some vents may, for example, disrupt the sleep of the patient's 1000 bed partner 1100 by making noise or concentrating airflow.

[0082] ResMed Ltd. has developed many improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0083] Noise table of existing masks (ISO 17510-2:2007 at 1m, 10cmH2O pressure)

[0084]

[0085]

[0086] (*One sample only, measured using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O)

[0087] The sound pressure values ​​for various objects are listed below

[0088]

[0089] 2.2.4 Screening, diagnosis and monitoring systems

[0090] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and typically involves a clinical specialist to apply the system. PSG typically 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 for two nights in the clinic, one night for pure diagnosis, and another night for the clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0091] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically produces a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis can yield clinically actionable information. Screening and diagnosis tend to be one-time procedures, while monitoring progression can continue indefinitely. Some screening / diagnostic systems are suitable for screening / diagnosis only, while others can also be used for monitoring.

[0092] Clinical experts can adequately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may have different opinions on a patient's condition. In addition, a given clinical expert may apply different criteria at different times. Utility Model Content

[0093] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0094] A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0095] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0096] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0097] One form of the present technology includes a patient interface comprising:

[0098] a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0099] a first 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 mouth such that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0100] a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose such that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0101] a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0102] Characterized in that the patient interface further comprises:

[0103] at least one region disposed in the pneumatic chamber and spaced apart from the first seal-forming structure, the at least one region being configured to resist compression of the first seal-forming structure in a forward direction;

[0104] Therein, the at least one region is formed integrally with the pneumatic chamber.

[0105] Another form of the present technology includes a patient interface comprising:

[0106] A pneumatic chamber, comprising:

[0107] a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and

[0108] a groove formed on a surface of the pneumatic chamber outside the cavity and exposed to ambient pressure, the pneumatic chamber being formed entirely of a flexible material;

[0109] a seal-forming structure constructed and arranged to form a seal with a facial area of ​​the patient surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle, the seal-forming structure comprising:

[0110] a first 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 mouth;

[0111] a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's nostril;

[0112] The patient interface further comprises a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0113] a frame coupled to the pneumatic chamber, the frame comprising:

[0114] a central portion removably positioned within said recess,

[0115] a pair of upper arms extending away from the central portion, and

[0116] a pair of lower arms extending away from the central portion; and

[0117] a headgear strap coupled to the pair of upper arms and the pair of lower arms of the frame and configured to provide tension to the seal-forming structure in the patient's face via the frame;

[0118] Wherein, a groove is provided on the pneumatic chamber below the second seal-forming structure and opposite to the first seal-forming structure.

[0119] Yet another form of the present technology includes a system for providing pressurized air to a patient, the system comprising:

[0120] a respiratory therapy system (RPT) device configured to provide a flow of air at said therapy pressure;

[0121] Characterized in that the system further comprises:

[0122] A patient interface according to another form above; and

[0123] A conduit connecting the RPT device to the patient interface is configured to deliver the flow of air to the patient interface.

[0124] One form of the present technology includes a patient interface comprising:

[0125] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0126] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0127] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0128] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0129] The patient interface also includes:

[0130] A pair of support portions are provided on opposite sides of the interface between the second seal-forming structure and the front wall of the pneumatic chamber, wherein the support portions are configured to resist compression in the fore-aft direction.

[0131] In the examples:

[0132] a) the support portion is connected to a portion of the second seal-forming structure which, in use, seals against the patient's upper lip;

[0133] b) a portion of the support portion connected to the second seal-forming structure which, in use, seals to the patient above the lip and directly below the lower corner of the patient's nose;

[0134] c) the support portion is curved when viewed in a cross section parallel to the sagittal plane;

[0135] d) the supports are curved when viewed in cross section parallel to the front plane;

[0136] e) the pneumatic chamber includes a mouth and a nose;

[0137] f) each support portion is connected to the mouth of the pneumatic chamber adjacent to a boundary of the lateral side wall portion of the mouth and the lateral side wall portion of the nose;

[0138] g) each support portion is connected to the mouth of the housing adjacent to a boundary of the front wall portion of the mouth and the front wall portion of the nose;

[0139] h) the lateral sidewall portions of the pneumatic chamber are curved inwardly adjacent a boundary with the nose portion, wherein each support portion is generally adjacent to an adjacent lateral sidewall portion;

[0140] i) the second seal-forming structure comprises at least one nostril configured to deliver a flow of air at the treatment pressure to an entrance of a naris of the patient, wherein, in use, no part of either support portion is directly below the or each nostril;

[0141] j) the interface further comprising a positioning and stabilizing structure configured to generate a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0142] k) the pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing; and / or

[0143] 1) The support portion is connected to the second seal-forming structure and to the front wall of the pneumatic chamber.

[0144] Another form of the present technology includes a patient interface comprising:

[0145] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0146] a first seal-forming structure connected to the mouth of the pneumatic chamber, the first seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0147] a second seal-forming structure connected to the nasal portion of the pneumatic chamber, the second 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 nose such that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0148] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0149] in

[0150] The first front wall portion of the nose of the pneumatic chamber is adjacent to the boundary of the mouth of the pneumatic chamber and is more flexible than the adjacent area of ​​the mouth of the pneumatic chamber. The second front wall portion of the nose of the pneumatic chamber is adjacent to the first front wall portion and is less flexible than the adjacent portion of the front wall on the side of the first front wall portion opposite to the boundary of the mouth of the pneumatic chamber.

[0151] In the example:

[0152] a) the first front wall portion is thinner than an immediately adjacent portion of the pneumatic chamber wall;

[0153] b) the second front wall portion is thicker than an immediately adjacent portion of the pneumatic chamber wall;

[0154] c) the first front wall portion and the second front wall portion are made of the same material;

[0155] d) the first front wall portion extends across substantially the entire width of the nose of the pneumatic chamber;

[0156] e) the second front wall portion extends across at least a majority of the width of the nose of the pneumatic chamber;

[0157] f) the first front wall portion extends upward around at least one lateral edge of the second front wall portion;

[0158] g) the second front wall portion extends across substantially the entire width of the nose of the pneumatic chamber;

[0159] h) the central portion of the first front wall portion extends further in the upper direction than the lateral portion of the first front wall portion;

[0160] i) an upper boundary of the first front wall portion is curved;

[0161] j) a lower boundary of the first front wall portion is curved;

[0162] k) the pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing;

[0163] 1) the second front wall portion includes a belt extending through the first front wall portion and configured to extend through the pneumatic chamber toward the patient;

[0164] m) the transition between the first front wall portion and the second front wall portion within the pneumatic chamber is a substantially stepped surface;

[0165] n) the transition between the first front wall portion and the second front wall portion on the exterior of the pneumatic chamber is a substantially smooth surface; and / or

[0166] o) In use, the first front wall portion extends further up than at least a portion of the belt.

[0167] Another form of the present technology includes a patient interface comprising:

[0168] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0169] a first seal-forming structure connected to the mouth of the pneumatic chamber, the first seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0170] a second seal-forming structure connected to the nasal portion of the pneumatic chamber, the second 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 nose such that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0171] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0172] in

[0173] The rear surface of the lateral portion of the second seal-forming structure is inclined upward-forward from the boundary of the first seal-forming structure and the second seal-forming structure.

[0174] In the example:

[0175] a) the inclined surface of each lateral portion forms an angle between 20 degrees and 90 degrees with the middle contact plane of the mask;

[0176] b) in use, no part of the patient interface contacts the patient's pterygoid crest;

[0177] c) the interface is configured to prevent, or at least reduce, blockage of the patient's nares relative to prior art interfaces; and / or

[0178] d) The pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing.

[0179] Another form of the present technology includes a patient interface comprising:

[0180] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0181] a first seal-forming structure connected to the mouth of the pneumatic chamber, the first seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0182] a second seal-forming structure connected to the nasal portion of the pneumatic chamber, the second 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 nose such that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0183] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0184] in

[0185] The boundary between the first seal-forming structure and the second seal-forming structure includes a ridge.

[0186] In the example:

[0187] A) the ridge has a radius of curvature less than 2 mm;

[0188] b) the ridge extends substantially across the entire boundary between the first seal-forming structure and the second seal-forming structure;

[0189] c) in use, the ridge engages the patient's face near the entrance to the nostril where the nose wing meets the face above the lip;

[0190] d) the ridge resists wrinkles forming in the first and / or second seal-forming structures adjacent the ridge; and / or

[0191] e) In use, the pneumatic chamber is at least partially formed by the housing and the vent structure is provided to the housing.

[0192] Another form of the present technology includes a patient interface comprising:

[0193] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0194] a first seal-forming structure connected to the mouth of the pneumatic chamber, the first seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0195] a second seal-forming structure connected to the nasal portion of the pneumatic chamber, the second 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 nose such that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0196] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0197] in,

[0198] At least a portion of the mouth of the pneumatic chamber includes a flexible housing, wherein the flexible housing is formed from a material having a Young's modulus less than 0.4 GPa.

[0199] In the example:

[0200] a) The flexible housing is formed of a material with a Young's modulus of less than 0.1 GPa, preferably between 0.3 and 0.7 MPa.

[0201] b) connecting at least one component to the flexible shell, wherein the at least one component is stiffer than a portion of the flexible shell adjacent to the component;

[0202] c) the at least one component comprises one or more of the following: a ventilation module; a headgear connector; a headband connector connected to a rigidifying arm; a rigidifying member; a less flexible shell portion;

[0203] d) the at least one component is releasably connected to the flexible housing;

[0204] e) the at least one component is permanently connected to the flexible housing;

[0205] f) overmolding the at least one component onto the flexible housing;

[0206] g) the flexible shell includes a plurality of reinforcements having a greater thickness than immediately adjacent portions of the flexible shell;

[0207] h) the at least one component is configured as a reinforcing rib or strip;

[0208] i) the center portion of the mouth of the pneumatic chamber has a greater stiffness than the rest of the pneumatic chamber; and / or

[0209] j) The pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing.

[0210] Another form of the technology includes a frame configured to couple to a pneumatic chamber, the frame including a central portion coupled to the pneumatic chamber exterior and a plurality of connectors including a pair of upper connectors and a pair of lower connectors, the pair of lower connectors being flush with the central portion and the pair of upper connectors extending away from the central portion in a direction configured to pass through a rear portion of the pneumatic chamber.

[0211] In the example:

[0212] a) each upper connector of the pair of upper connectors includes a slot configured to receive a headgear strap;

[0213] b) each slot includes a protrusion adjacent the corresponding arm;

[0214] c) each protrusion has a curved shape;

[0215] d) each upper connector includes a rib adjacent the central portion;

[0216] e) the combined width of the ribs and arms near the center portion is approximately equal to the width of the arms near the slots;

[0217] f) each lower connector of the pair of lower connectors includes a magnet;

[0218] g) Each lower connector of the pair of lower connectors includes a groove configured to act as a hinge and allow each lower connector to flex relative to the central portion.

[0219] Another form of the technology includes a frame configured to be coupled to a pneumatic chamber, the frame including a central portion coupled to the pneumatic chamber exterior and a pair of arms configured to extend in a rearward direction away from the central portion through the pneumatic chamber, the pair of arms being more flexible than the central portion.

[0220] In the example:

[0221] a) each arm of the pair of arms is more flexible than the frame;

[0222] b) the central portion is thicker than each arm of the pair of arms;

[0223] c) the central portion and each arm of the pair of arms are constructed of the same material;

[0224] d) each arm of the pair of arms includes a first connection point, the headgear strap being coupled to the first connection point of each arm;

[0225] e) the first connection point is a loop, and the headgear strap is coupled to the loop such that the strap is perpendicular to an edge of each loop and applies a force vector perpendicular to the edge;

[0226] f) the first connection point is a loop and includes an area of ​​reduced thickness that the headgear strap can contact;

[0227] g) overmolding a first magnet onto a central portion of the frame, the headgear strap including a second magnet removably coupled to the first magnet;

[0228] h) the first magnet includes a housing at least partially surrounding the magnetic material, the housing including a planar surface and a lip extending from the planar surface;

[0229] i) a pendant spaced apart from the second magnet and configured to engage the lip when the second magnet is coupled to the magnetic material;

[0230] j) the central portion is configured to be positioned within a recess of the pneumatic chamber;

[0231] k) the center portion is removably positioned within the recess;

[0232] l) the groove includes a protrusion and the central portion includes a complementary slot configured to receive the protrusion;

[0233] m) the slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to be received through the wider opening before the narrower opening;

[0234] n) a sleeve covering at least a portion of one of the pair of arms;

[0235] o) the slot has a protrusion having a curvature configured to conform to the curvature of the sleeve; and / or

[0236] p) Each arm of the pair of arms includes a rib proximate the central portion, the friction being configured to retain the sleeve.

[0237] Another form of the present technology includes a patient interface comprising:

[0238] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0239] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0240] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0241] a vent structure that permits continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber during use; and

[0242] a positioning and stabilizing structure configured for maintaining the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0243] a frame coupled to the pneumatic chamber, the frame comprising:

[0244] a central portion coupled to a pneumatic chamber outside the cavity, and

[0245] a pair of arms extending in a rearward direction away from the central portion through the second seal-forming structure, the pair of arms being more flexible than the central portion; and

[0246] A headgear strap is coupled to the frame and is configured to provide tension to the first and second seal-forming structures via the frame into the patient's face.

[0247] In the example:

[0248] a) each arm of the pair of arms is more flexible than the frame;

[0249] b) the central portion is thicker than each arm of the pair of arms;

[0250] c) the central portion and each arm of the pair of arms are constructed of the same material;

[0251] d) each arm of the pair of arms includes a first connection point, the headgear strap being coupled to the first connection point of each arm;

[0252] e) the first connection point is a loop, and the headgear strap is coupled to the loop such that the strap is perpendicular to an edge of each loop and applies a force vector perpendicular to the edge;

[0253] f) the first connection point is a loop and includes an area of ​​reduced thickness that the headgear strap can contact;

[0254] g) overmolding a first magnet onto a central portion of the frame, the headgear strap including a second magnet removably coupled to the first magnet;

[0255] h) the first magnet includes a housing at least partially surrounding the magnetic material, the housing including a planar surface and a lip extending from the planar surface;

[0256] i) a pendant spaced apart from the second magnet and configured to engage the lip when the second magnet is coupled to the magnetic material;

[0257] j) the pneumatic chamber includes a groove, and the central portion is located within the groove;

[0258] k) the center portion is removably positioned within the recess;

[0259] l) the groove includes a protrusion and the central portion includes a complementary slot configured to receive the protrusion;

[0260] m) the slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to be received through the wider opening before the narrower opening;

[0261] n) the protrusion includes a depending member configured to extend over the slot and retain the frame relative to the pneumatic chamber;

[0262] o) the pneumatic chamber includes a protrusion disposed adjacent the groove, the protrusion being configured to retain the central portion within the groove;

[0263] p) an outer surface of the central portion is flush with an outer surface of the pneumatic chamber, the outer surface of the central portion and the outer surface of the pneumatic chamber being configured to face away from the patient in use;

[0264] q) the central portion comprises an annular shape, the pneumatic chamber inlet port is radially disposed within the central portion, and the frame is coupled to the pneumatic chamber;

[0265] r) the pneumatic chamber inlet port is configured for an elbow, the elbow being configured to be spaced apart from the central portion when received within the pneumatic chamber inlet port;

[0266] s) each arm is formed as a cantilever structure relative to the central portion;

[0267] t) the thickness of each arm decreases from the fixed end to the free end;

[0268] u) the arm includes a scalloped area on an inner surface configured to face the patient's skin;

[0269] v) each arm is pivotable relative to the central portion about a pivot point; and / or

[0270] W) The pivot point is a living hinge.

[0271] Another form of the present technology includes a patient interface comprising:

[0272] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0273] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face so that a flow of air at the therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0274] A positioning and stabilizing structure is configured to maintain the seal-forming structure in a therapeutically effective position.

[0275] Another aspect of one form of the present technology is an oral-nasal patient interface that is more compact and less intrusive to the patient.

[0276] Another aspect of one form of the present technology is an oral-nasal patient interface having a nasal pad portion that provides an improved fit to the inferior angle of the nose.

[0277] Another aspect of one form of the present technology is an oronasal patient interface that reduces obstructive contact on the nose.

[0278] Another aspect of one form of the present technology is an oronasal patient interface that can self-adjust to accommodate patients having various nasolabial angles.

[0279] Another aspect of one form of the present technology is an oral-nasal patient interface having a relatively flexible housing.

[0280] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed to have a perimeter shape that complements the anatomy of the intended wearer.

[0281] Another form of the present technology includes a patient interface comprising:

[0282] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0283] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0284] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0285] a vent structure that permits continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber during use; and

[0286] a positioning and stabilizing structure configured for maintaining the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0287] a headgear strap configured to provide tension to the first and second seal-forming structures in the patient's face via the frame, wherein the headgear strap comprises a first width and a second width greater than the first width; and

[0288] The headgear strap is selectively passed through an opening to adjust tension, the first width is configured to fit through the opening, and the second width is configured to prevent passing through the opening.

[0289] Another form of the present technology includes a positioning and stabilizing structure configured to maintain a seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0290] a headgear strap configured to provide tension to the seal-forming structure in the patient's face via the frame, wherein the headgear strap comprises a first width and a second width greater than the first width; and

[0291] The headgear strap is selectively passed through an opening to adjust tension, the first width is configured to fit through the opening, and the second width is configured to prevent passing through the opening.

[0292] Another form of the present technology includes a pneumatic chamber comprising:

[0293] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0294] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0295] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0296] a positioning and stabilizing structure configured for maintaining the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0297] a frame coupled to the pneumatic chamber, the frame comprising:

[0298] a pair of upper arms, and

[0299] a pair of lower arms, and

[0300] A headgear strap is coupled to the pair of upper arms and the pair of lower arms, and the headgear strap is configured to provide tension to the first seal-forming structure and the second seal-forming structure in the patient's face via the frame.

[0301] Another form of the present technology includes a framework comprising:

[0302] Central Department;

[0303] a pair of upper arms extending in a posterior direction away from the central portion, the pair of arms being more flexible than the central portion;

[0304] a pair of first connectors coupled to the pair of upper arms, the pair of first connectors configured to selectively connect to a pair of upper straps;

[0305] a pair of lower arms extending away from the central portion;

[0306] A pair of second connectors are coupled to the pair of lower arms, the pair of second connectors being configured to selectively connect to the pair of lower straps.

[0307] In the example:

[0308] a) the pair of first connectors is different from the pair of second connectors;

[0309] b) the pair of first connectors are selected from the group consisting of: a slot, a plurality of ladder locks, and a stop;

[0310] c) the pair of first connectors are slots;

[0311] d) the pair of first connectors each include a first ring segment and a second ring segment;

[0312] e) the pair of second connectors are magnets; and / or

[0313] f) The pair of first connectors is longer than the pair of second connectors.

[0314] Another form of the present technology includes a patient interface comprising:

[0315] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0316] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0317] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0318] a positioning and stabilizing structure configured for maintaining the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0319] a frame including a center portion coupled to the pneumatic chamber;

[0320] Wherein the pneumatic chamber includes a recess configured to removably receive the central portion of the frame.

[0321] In the example:

[0322] a) at least a portion of the central portion of the frame is spaced apart from the groove in the engaged position;

[0323] b) the upper stem of the central portion is spaced apart from the groove when the central portion is coupled to the frame; and / or

[0324] c) the second seal-forming structure is spaced apart from the upper stem before use, and the second seal-forming structure is configured to contact the upper stem in use.

[0325] Another form of the present technology includes a patient interface comprising:

[0326] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0327] a first 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 mouth such that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0328] a second 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 nose such that a flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle; and

[0329] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0330] The patient interface also includes:

[0331] At least one region is disposed in the pneumatic chamber spaced apart from the first seal-forming structure, the at least one region being configured to resist compression of the first seal-forming structure in the front direction.

[0332] In the example:

[0333] a) the at least one region is at least one stop rib;

[0334] b) the at least one stop rib comprises a plurality of stop ribs spaced apart from one another;

[0335] c) the plurality of stop ribs are arranged in a C-shape;

[0336] d) the plurality of stop ribs extending around substantially the entire periphery of the first seal-forming structure;

[0337] e) the at least one stop rib is an elongated member;

[0338] f) the at least one stop rib comprises a beveled edge;

[0339] g) the inclined edge is a rear edge;

[0340] h) the inclined edge is configured to contact the first seal-forming structure in use so as to limit forward movement of the first seal-forming structure;

[0341] i) the at least one stop rib comprises a length measured generally perpendicular to the first seal-forming structure and a width measured generally perpendicular to the length;

[0342] j) the length is greater than the width;

[0343] k) the first seal-forming structure is configured to, in use, contact the at least one stop rib along the width;

[0344] 1) the at least one region is at least one reinforced region;

[0345] m) the at least one reinforced region comprises a plurality of reinforced regions;

[0346] n) the at least one reinforced region comprises a first thickness proximate the inlet port and a second thickness distal to the inlet port, the second thickness being less than the first thickness;

[0347] o) the at least one reinforced area is arranged on the front surface of the pneumatic chamber; and / or

[0348] p) The at least one region is formed integrally with the pneumatic chamber.

[0349] Another form of the present technology includes a patient interface comprising:

[0350] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0351] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway such that the flow of air at the therapeutic pressure is delivered to the nose, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0352] a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0353] a frame coupled to the pneumatic chamber, the frame comprising:

[0354] a center portion that is removably positioned within a recess on the pneumatic chamber exterior to the cavity, and

[0355] a pair of upper arms extending away from the central portion; and

[0356] a pair of lower arms extending away from the central portion;

[0357] A headgear strap is coupled to the frame and is configured to provide tension to the first and second seal-forming structures via the frame into the patient's face.

[0358] In the example:

[0359] a) the pair of upper arms is longer than the pair of lower arms;

[0360] b) the pair of upper arms each include a first connector and the pair of lower arms each include a second connector different from the first connector;

[0361] c) the first connector is selected from the group consisting of: a ring, a ladder lock, and a cord stopper;

[0362] d) the first connector is a ring comprising a first ring portion and a second ring portion adjacent to the first ring portion;

[0363] e) the ring includes a dividing wall at least partially separating the first ring portion from the second ring portion;

[0364] f) the strap of the headgear strap is configured to be selectively inserted into the first loop portion and contact the dividing wall at an optimal tension in use, and wherein the strap is configured to move into the second loop portion at a tension greater than the optimal tension;

[0365] g) the second connector is a magnetic member;

[0366] h) the magnetic member comprises a generally oval shape;

[0367] i) the second connector is a magnetic member;

[0368] j) a housing removably and magnetically connected to the magnetic member;

[0369] k) the housing includes a strap connector for connecting to the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stopper;

[0370] l) the housing is configured to engage a lip of an outer shell;

[0371] m) at least one of the headgear straps comprises a first width and a second width greater than the first width;

[0372] n) the first width is selectively receivable through the first connector, and wherein the second width is substantially prevented from passing through the first connector; and / or

[0373] o) The pair of first arms and the pair of second arms are integrally formed with the central portion.

[0374] Another form of the present technology includes a pneumatic chamber comprising:

[0375] a pneumatic chamber comprising a chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing;

[0376] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway such that the flow of air at the therapeutic pressure is delivered to the nose, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0377] A positioning and stabilizing structure is configured to maintain the seal-forming structure in a therapeutically effective position.

[0378] Wherein the pneumatic chamber includes a lip extending around at least a portion of the inlet port and into the cavity.

[0379] Another form of the present technology includes a pneumatic chamber comprising:

[0380] Another form of the present technology includes a system for providing pressurized air to a patient, the system comprising:

[0381] a pneumatic chamber comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; wherein the pneumatic chamber includes a lip extending at least partially around the pneumatic chamber inlet port;

[0382] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway such that the flow of air at the therapeutic pressure is delivered to the nose, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0383] a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position; and

[0384] an air circuit removably connected to the pneumatic chamber and configured to provide a flow of air at the therapeutic pressure from the flow generator to the cavity, the air circuit comprising a vent ring configured for at least partial insertion through the pneumatic chamber inlet port, the vent ring comprising:

[0385] a rear surface having a first diameter,

[0386] a front surface having a second diameter smaller than the first diameter, and

[0387] a ring body extending between the front surface and the rear surface;

[0388] wherein the rear surface is configured to be positioned within the cavity and the front surface is configured to remain outside of the cavity when connected to the pneumatic chamber;

[0389] wherein the lip is configured to contact the vent ring along the ring body between the rear surface and the front surface; and

[0390] The first diameter is greater than the diameter of the lip.

[0391] In the example:

[0392] a) the vent body is inclined between the rear surface and the front surface;

[0393] b) the rear surface is configured to contact the lip and a front wall of the pneumatic chamber within the cavity in use;

[0394] c) the ring body comprises an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall;

[0395] d) positioning the annular seal within the groove;

[0396] e) the outer diameter of the annular seal is smaller than the outer diameter of the groove;

[0397] f) the ring body includes a central opening configured to receive an elbow connector;

[0398] g) the system includes a quick release connector;

[0399] h) the quick release connector is a rotatable connector or a latch connector;

[0400] i) the quick release connector is configured to connect to a complementary connector; and / or

[0401] j) The seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring.

[0402] Another form of the present technology includes a patient interface comprising:

[0403] a pneumatic chamber having a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure;

[0404] a first 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 mouth, said first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in the cavity of said pneumatic chamber throughout a breathing cycle of the patient;

[0405] a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrances to the patient's nares, the second seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in the cavity of the pneumatic chamber throughout the patient's breathing cycle; and

[0406] a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use,

[0407] The patient interface also includes:

[0408] at least one stop rib disposed in the cavity pneumatic chamber and spaced apart from the first seal-forming structure in a rest position, the first seal-forming structure being configured to contact the at least one stop rib in an operative position, the at least one stop rib being configured to resist compression of the first seal-forming structure in a forward direction; and

[0409] Wherein, the second seal-forming structure is not configured to contact the at least one stop rib.

[0410] In the example:

[0411] a) a lip upper portion disposed below the second seal-forming structure and configured to contact the lip upper portion;

[0412] b) the lip upper portion is not configured to contact the at least one stop rib;

[0413] c) the plurality of stop ribs are arranged in a C-shape;

[0414] d) the plurality of stop ribs are unequally spaced from one another within the cavity;

[0415] e) the plurality of stop ribs extending around a majority of the periphery of the seal-forming structure;

[0416] f) the at least one stop rib is an elongated member;

[0417] g) the at least one stop rib comprises a beveled edge;

[0418] h) the inclined edge is a rear edge;

[0419] i) the inclined edge is configured to contact the seal-forming structure in use so as to limit forward movement of the seal-forming structure in the operative position;

[0420] j) the inclined edge is arranged in the rest position further from the seal-forming structure towards the center of the pneumatic chamber;

[0421] k) the at least one stop rib comprises a length measured generally perpendicular to the seal-forming structure and a width measured generally perpendicular to the length, and wherein the length is greater than the width;

[0422] 1) a first seal-forming structure configured to contact the at least one stop rib along the width in the operational position;

[0423] m) the width is substantially uniform along the length of the at least one stop rib;

[0424] n) the width varies along the length of the at least one stop rib; and / or

[0425] o) The at least one stop rib is formed integrally with the pneumatic chamber.

[0426] Another form of the present technology includes a patient interface comprising:

[0427] a pneumatic chamber comprising a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and a groove formed on a surface exterior of the cavity of the pneumatic chamber and exposed to ambient pressure, the pneumatic chamber being formed entirely of a flexible material;

[0428] a seal-forming structure constructed and arranged to form a seal with a facial region of the patient surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient;

[0429] a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0430] a frame coupled to the pneumatic chamber, the frame comprising:

[0431] a center portion removably positioned within the recess,

[0432] a pair of upper arms extending away from the central portion, and

[0433] a pair of lower arms extending away from the central portion; and

[0434] A headgear strap is coupled to the pair of upper arms and the pair of lower arms of the frame and is configured to provide tension to the seal-forming structure in the patient's face via the frame.

[0435] In the example:

[0436] a) the pair of upper arms is longer than the pair of lower arms;

[0437] b) the pair of upper arms each include a first type of connector and the pair of lower arms each include a second type of connector different from the first type of connector;

[0438] c) the first type of connector is selected from the group consisting of: a ring, a ladder lock, and a cord stopper;

[0439] d) the first type of connector is a ring comprising a first ring portion and a second ring portion adjacent to the first ring portion;

[0440] e) the ring includes a dividing wall at least partially separating the first ring portion from the second ring portion;

[0441] f) the strap of the headgear strap is configured to be selectively inserted into the first loop portion and contact the dividing wall under optimal tension during use;

[0442] g) the strap is configured to move into the second loop portion when under a tension greater than the optimal tension;

[0443] h) The second type of connector is a magnetic member;

[0444] i) the magnetic member comprises a generally elliptical shape;

[0445] j) a housing removably and magnetically connected to the magnetic member;

[0446] k) the housing includes a strap connector for connecting to the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stopper;

[0447] l) the housing is configured to engage a lip of an outer shell;

[0448] m) at least one of the headgear straps comprises a first width and a second width greater than the first width;

[0449] n) the first width is selectively receivable through the first connector, and wherein the second width is substantially prevented from passing through the first connector;

[0450] o) the pair of upper arms and the pair of lower arms are integrally formed with the central portion;

[0451] p) the pneumatic chamber includes at least one protrusion extending from the recess;

[0452] q) the central portion of the frame includes at least one slot configured to selectively receive the at least one protrusion;

[0453] r) the pair of lower arms are substantially flush with the central portion;

[0454] s) the seal-forming structure further comprises a first 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 mouth;

[0455] t) the seal-forming structure further comprising a second 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 nostril;

[0456] u) the groove is arranged on the pneumatic chamber below the second seal-forming structure and opposite the first seal-forming structure;

[0457] v) a system for providing pressurized air to a patient, the system comprising: a patient interface of any of the preceding examples; a respiratory therapy system (RPT) device configured to provide a flow of air at the therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the conduit configured to deliver the flow of air to the patient interface;

[0458] w) the conduit is connected to an inlet port of the pneumatic chamber, the pneumatic chamber being spaced from an inner periphery of the central portion of the frame;

[0459] x) a center portion comprising an inner periphery and an outer periphery removably positionable within the recess;

[0460] y) the groove is formed radially outside the inlet port, and the groove forms a closed periphery; and / or

[0461] z) The inner periphery is configured to be spaced apart from the inlet port when positioned within the groove.

[0462] Another form of the present technology includes a patient interface comprising:

[0463] a pneumatic chamber comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; wherein the pneumatic chamber includes a lip extending at least partially around the pneumatic chamber inlet port and into the cavity;

[0464] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway such that the flow of air at the therapeutic pressure is delivered to the nose, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0465] a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position; and

[0466] an air circuit removably connected to the pneumatic chamber and configured to provide a flow of air at the therapeutic pressure from the flow generator to the cavity, the air circuit comprising a vent ring configured for at least partial insertion through the pneumatic chamber inlet port, the vent ring comprising:

[0467] a rear surface having a first diameter,

[0468] a front surface having a second diameter smaller than the first diameter, and

[0469] a ring body extending between the front surface and the rear surface, the ring body comprising an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall;

[0470] in:

[0471] the rear surface being configured to be positioned within the cavity and the front surface being configured to remain outside of the cavity when connected to the pneumatic chamber;

[0472] the rear surface comprising at least one vent configured to provide communication between the cavity and a surrounding environment through the groove;

[0473] The lip is configured to contact the vent ring along the ring body between the rear surface and the front surface; and

[0474] The first diameter is greater than the diameter of the lip.

[0475] In the example:

[0476] a) the ring body is inclined between the rear surface and the front surface;

[0477] b) the rear surface is configured to contact the lip and a front wall of the pneumatic chamber within the cavity in use;

[0478] c) positioning the annular seal within the groove;

[0479] d) the outer diameter of the annular seal is smaller than the outer diameter of the groove;

[0480] e) the ring body includes a central opening and the system further includes an elbow connector, the central opening being configured to receive the elbow connector;

[0481] f) the elbow connector is rotatably connected to the ring body, and wherein the ring body is rotatably connected to the pneumatic chamber;

[0482] g) the at least one vent is a plurality of vents spaced around a perimeter of the groove;

[0483] h) the system includes a quick release connector;

[0484] i) the quick release connector is a rotatable connector or a latching connector;

[0485] j) wherein the quick release connector is configured to connect to a complementary connector;

[0486] k) the quick release connector includes at least one flat surface;

[0487] l) the at least one flat surface is a pair of flat surfaces spaced approximately 180° apart;

[0488] m) the at least one flat surface is configured to redistribute leakage of air flow from the system;

[0489] n) the seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring;

[0490] o) the quick release connector includes a plurality of vents configured to exhaust a portion of the air flow to the surrounding environment;

[0491] p) the ring body includes an extension;

[0492] q) the ring includes a disc configured to be positioned within the cavity and to restrict exhaled air from being discharged to the surrounding environment; and / or

[0493] r) The disc extends radially beyond a portion of the rear surface including the at least one vent.

[0494] In the example:

[0495] a) the elbow connector includes at least one button configured to be selectively actuated to release the connection between the elbow connector and the central opening;

[0496] b) The at least one button is formed as a cantilever structure.

[0497] c) the at least one button includes a button lip configured to selectively engage the ring and move relative to a remainder of the elbow when the at least one button is actuated;

[0498] d) the button lip is configured to selectively engage an inner periphery of an inner wall of the ring body;

[0499] e) the at least one button includes a finger configured to selectively engage the ring and move relative to a remainder of the elbow when the at least one button is actuated;

[0500] f) the fingers are configured to selectively engage the ring radially outwardly of the inner wall; and / or

[0501] g) The pneumatic chamber inlet port includes an extension, and the ring body is connected to the extension and is spaced apart from a surface of the pneumatic chamber.

[0502] Another form of the present technology includes an elbow configured to be removably connected to a pneumatic chamber, the elbow including a button selectively engageable by a patient.

[0503] Another form of the present technology includes an elbow configured to be removably connected to a pneumatic chamber, the elbow comprising:

[0504] a body comprising a first end configured to be at least partially inserted into a cavity of the pneumatic chamber and a second end configured to be connected to an air circuit, the body further comprising:

[0505] a button having a fixed end proximate to the first end and a free end extending away from the free end;

[0506] an outer lip extending generally around at least a portion of the periphery of the body; and

[0507] Wherein the button is selectively engageable by a patient to selectively disengage the body from the pneumatic chamber.

[0508] In the example:

[0509] a) the button forms part of the periphery of the body;

[0510] b) an inner lip spaced from the outer lip and arranged closer to the first end than the outer lip,

[0511] c) the width of the inner lip is substantially the same as the width of the button;

[0512] d) the inner lip extends along a portion of the periphery of the body;

[0513] e) the channel extends around a portion of the button to form a free end;

[0514] f) the button is a first button, and the body further includes a second button;

[0515] g) the second button is approximately 180° apart from the first button;

[0516] h) the first button and the second button are configured to move toward each other due to selective engagement by the patient;

[0517] i) the outer lip is configured to abut the vent ring and limit translational movement of the elbow;

[0518] j) the button is selectively engageable by the patient to selectively move the inner lip relative to the outer lip;

[0519] k) the inner lip is configured to be in a pressurized volume when connected to the pneumatic chamber and supplied with pressurized air;

[0520] 1) the inner lip is configured to selectively engage the groove and is configured to disengage the groove when the button(s) are applied; and / or

[0521] m) The outer lip extends generally around the periphery of the body.

[0522] In the example:

[0523] a) the button includes a finger extending from the fixed end;

[0524] b) the finger extends toward the first end of the body;

[0525] c) the finger-like member is formed as a cantilever structure relative to the button;

[0526] d) the button is a first button, and the body further includes a second button;

[0527] e) the second button is spaced approximately 180° from the first button;

[0528] f) the first button and the second button are configured to move toward each other due to selective engagement by the patient;

[0529] g) the outer lip is disposed between the first button and the second button;

[0530] h) a distance between one end of the finger and the first end of the body is less than a distance between the outer lip and the first end of the body;

[0531] i) the outer lip is configured to abut the vent ring and limit translational movement of the elbow;

[0532] j) the finger is configured to selectively connect to a vent ring external to the pressurized volume; and / or

[0533] k) Selective engagement of the button is configured to further space the finger from the surface of the body.

[0534] Another form of the present technology includes an elbow configured to be removably connected to a pneumatic chamber, the elbow comprising:

[0535] a body comprising a first end configured to be at least partially inserted into a cavity of the pneumatic chamber and a second end configured to be connected to an air circuit, the body further comprising:

[0536] a button spaced apart from a surface of the body; and

[0537] a finger coupled to the button;

[0538] wherein the button is selectively engageable by the patient to move the button relative to a surface of the body; and

[0539] The finger-shaped piece can move along with the button.

[0540] In the example:

[0541] a) the button is configured to move toward a surface of the body, and the finger is configured to move away from the surface of the body when the button is engaged;

[0542] b) the button is a first button, and the body further includes a second button;

[0543] c) the second button is spaced approximately 180° from the first button;

[0544] d) the first button and the second button are configured to move toward each other due to selective engagement by the patient; and / or

[0545] e) The finger is configured to selectively connect to a vent ring external to the pressurized volume.

[0546] Another form of the present technology includes an elbow configured to be removably connected to a pneumatic chamber, the elbow comprising:

[0547] a body comprising a first end configured to be at least partially inserted into a cavity of the pneumatic chamber and a second end configured to be connected to an air circuit, the body further comprising:

[0548] a button forming a portion of a surface of the body, the button being configured to move into an interior of the body due to an external force; and

[0549] A finger is coupled to the button and spaced apart from a surface of the body, the finger being configured to move due to an external force applied to the button.

[0550] In the example:

[0551] a) the finger is configured to engage an outer surface of the vent ring;

[0552] b) biasing the button toward a relaxed position in which the button is flush with the surrounding surface of the body;

[0553] c) the finger is spaced a first distance from the surface of the body in the relaxed position and a second distance from the surface of the body when the external force is applied, the second distance being greater than the first distance;

[0554] d) the button is a first button, and the body further includes a second button;

[0555] e) the second button is spaced approximately 180° from the first button;

[0556] f) the finger is generally hook-shaped; and / or

[0557] g) The fulcrum is located between the button and the finger-shaped member, the button is formed into a cantilever structure relative to the fulcrum, and the finger-shaped member is formed into a cantilever structure relative to the fulcrum.

[0558] Another form of the present technology includes a vent ring configured to connect to a pneumatic chamber and increase humidity within the pneumatic chamber, the vent ring comprising:

[0559] a rear surface configured to be positioned within a pressurized environment, the rear surface comprising at least one vent configured to exhaust air from the pneumatic chamber; and

[0560] A front surface is spaced apart from the rear surface and configured to be positioned outside of the pressurized environment.

[0561] In the example:

[0562] a) a disc coupled to the rear surface and configured to be positioned within the pressurized environment;

[0563] b) the width of the disc is substantially the same as the width of the rear surface;

[0564] c) the disc extends radially beyond the location of the at least one vent on the rear surface;

[0565] d) the disc is configured to deflect exhaled air back into the pneumatic chamber;

[0566] e) a connectable portion, the extension connectable to the vent ring adjacent the rear surface, the extension configured to space the at least one vent from a surface of the pneumatic chamber;

[0567] f) the at least one vent is a plurality of vents spaced around a perimeter of the rear surface;

[0568] g) the plurality of vents are equally spaced around the perimeter of the rear surface; and / or

[0569] h) The plurality of vents extend around less than half of the circumference of the rear surface.

[0570] Another form of the present technology is a connector member having a first side and a second side opposite the first side. The first side and the second side each include a connector material. The connector material is configured to be removably connected to a positioning and stabilizing structure of a patient interface.

[0571] In the example:

[0572] a) the first side comprises the same connector material as the second side;

[0573] b) wherein the connector material is a hook material or a loop material; and / or

[0574] c) The connector can be connected to an unlimited number of positions.

[0575] Another form of the present technology includes a positioning and stabilizing structure comprising at least one side strap having an inner surface configured to cover a patient's temporal bone and an outer surface opposite the inner surface; and a connecting member removably connected to the outer surface, the connecting member having a first side and a second side, the first side and the second side each comprising a connecting material; wherein the connecting member is connectable to a plurality of locations along the length of the at least one side strap.

[0576] In the example:

[0577] a) the first and second sides of the attachment member comprise hook material;

[0578] b) the outer surface comprises a ring material;

[0579] c) the connecting member is connectable to an unlimited number of locations along the length of the at least one side strap;

[0580] d) a patient interface comprising a frame and a positioning stabilizing structure; wherein the frame comprises a loop configured to removably receive the at least one side strap; and wherein the at least one strap is folded after being passed through the loop such that the other side of the connecting member is removably connected to the at least one strap;

[0581] e) in use, the first side and the second side are removably connected to the at least one strap;

[0582] f) the positioning and stabilizing structure further comprises a rear strap configured to cover the patient's occipital bone, and wherein the at least one side strap comprises a pair of lower side straps configured to be removably connected to the frame and a pair of upper side straps configured to be removably connected to the frame. The pair of upper side straps and the pair of lower side straps each comprise a connecting member; and / or

[0583] g) The connecting member on each upper and lower strap is removably connectable to an unlimited number of locations along the length of the respective strap.

[0584] Another form of the present technology includes a positioning and stabilizing structure that includes at least one side strap, at least one strap including an elastic portion stretchable between a first length and a second length, the at least one strap including a portion that is generally hidden in a first position and is visible when the strap is extended in the second position.

[0585] In the example:

[0586] a) the hidden portion is a different color from the rest of the at least one strap;

[0587] b) the hidden portion is luminous;

[0588] c) the hidden portion includes an electroluminescent element (e.g., an LED);

[0589] d) the at least one strap includes tactile-responsive elements on either side of the concealed portion, the tactile-responsive elements configured to couple together in the first position and separate in the second position;

[0590] e) the tactile responsive element is a magnet; and / or

[0591] f) The tactile responsive element is a mechanical connector.

[0592] Another form of the present technology includes a positioning and stabilizing structure having a rear strap configured to cover the patient's occipital bone, a pair of lower side straps configured to be removably connected to the frame, and a pair of upper side straps configured to be removably connected to the frame. The pair of upper side straps and the pair of lower side straps each include a connecting member.

[0593] In the example:

[0594] a) the connecting member is removably connected to a corresponding strap;

[0595] b) the connecting members each include hook material on each side to facilitate removable connection;

[0596] c) at least one strap including a first portion having a first width, a second portion having a second width, and a transition between the first portion and the second portion;

[0597] d) the second width is greater than the first width and is configured to be larger than a loop on the frame that receives the strap;

[0598] e) the at least one strap includes a plurality of protrusions;

[0599] f) the plurality of protrusions are evenly spaced along at least a portion of the at least one strap;

[0600] g) the at least one strap comprises a first density of protrusions and a second density of protrusions;

[0601] h) at least one of the straps includes a cut edge;

[0602] i) the cutting edge is a square edge, a triangular edge or a circular edge;

[0603] j) the cutting edges are evenly spaced along at least a portion of the at least one strap;

[0604] k) the at least one strap comprises a first cut edge density and a second cut edge density;

[0605] l) at least one strap includes an elastic portion stretchable between a first length and a second length;

[0606] m) the at least one strap includes a portion that is substantially concealed in the first position and is visible when the strap is extended in the second position;

[0607] n) the concealed portion has a different color and / or texture than the rest of the strap;

[0608] o) the at least one strap includes tactile-responsive elements on either side of the concealed portion, the tactile-responsive elements configured to couple together in the first position and separate in the second position;

[0609] p) a top strap configured to cover the patient's temporal and / or frontal bones, the top strap having a first section and a second section and selectively connected by a buckle; and / or

[0610] q) A patient interface removably connected to the positioning and stabilising structure.

[0611] One aspect of one form of the present technology is a method of manufacturing a device.

[0612] 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, a person with limited dexterity, limited vision, or a person with limited experience using this type of medical device.

[0613] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0614] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier canister that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment.

[0615] The described methods, systems, devices, and apparatus can be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Furthermore, the described methods, systems, devices, and apparatus can provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0616] Of course, a part of these aspects may form a sub-aspect of the present technology. In addition, each of the sub-aspects and / or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0617] Other features of the technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0618] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0619] 4.1 Respiratory therapy system

[0620] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and flows along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0621] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and flows along an air circuit 4170 to the patient 1000.

[0622] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask, receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and flows along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying position.

[0623] 4.2 Respiratory system and facial anatomy

[0624] Figure 2A An overview of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0625] Figure 2B A view of the human upper airway is shown, including the nasal cavity, nasal bones, external nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0626] Figure 2C It is a frontal view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal ala, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0627] Figure 2DIt is a side view of the head with several surface anatomical features identified, including the glabella, nasal bridge, nasal prominence, subseptal point, upper lip, lower lip, supramental point, nasal ridge, alar apex, and superior and inferior auricular bases. The directions of superior and inferior as well as anterior and posterior are also indicated.

[0628] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0629] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0630] Figure 2G A side view of the nasal surface features is shown.

[0631] 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 bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0632] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the midsagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0633] Figure 2J Shown is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible, are also labeled.

[0634] Figure 2K A side view of the skull is shown, showing the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0635] Figure 2L An anterolateral view of the nose is shown.

[0636] 4.3 Patient Interface

[0637] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0638] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at point is indicated. The curvature at this point has a positive sign and when compared to Figure 3C The curvature magnitude shown is relatively large in comparison.

[0639] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at point is indicated. The curvature at point has a positive sign and when Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0640] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at point is indicated. The curvature at point has a value of zero.

[0641] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and when Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0642] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0643] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0644] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle areas and one dome area are indicated.

[0645] Figure 3I A surface having a structure with one-dimensional holes on the surface is shown. The plane curves shown form the boundaries of the one-dimensional holes.

[0646] Figure 3J Shown through Figure 3I The surface shown is in the cross section of the structure. Figure 3I A two-dimensional hole is defined in the structure.

[0647] Figure 3K Shown Figure 3I A perspective view of the structure of , including two-dimensional holes and one-dimensional holes. Also shown is the Figure 3I The surface defining the two-dimensional pores in the structure.

[0648] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0649] Figure 3M Shown through Figure 3L A cross-section of a mask with the inner surface of the airbag shown. The inner surface defines a two-dimensional hole in the mask.

[0650] Figure 3N Shown through Figure 3L Another cross section of a mask. The inner surface is also indicated.

[0651] Figure 3O The diagram illustrates the left-hand rule.

[0652] Figure 3P The right-hand rule is shown.

[0653] Figure 3Q The left ear is shown, including the left ear helix.

[0654] Figure 3R The right ear is shown, including the right ear helix.

[0655] Figure 3S A right-handed helix is ​​shown.

[0656] Figure 3T Shown are views of a mask including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different areas of the mask.

[0657] Figure 3U A view of the pneumatic chamber 3200 is shown, illustrating the sagittal plane and the medial contact plane.

[0658] Figure 3V Shown Figure 3U View of the rear of the pneumatic chamber. The view is perpendicular to the middle contact plane. Figure 3V The mid-sagittal plane divides the pneumatic chamber into left and right sides.

[0659] Figure 3W Shown through Figure 3V The cross section of the pneumatic chamber is Figure 3V 32. The middle contact plane is taken at the sagittal plane shown. The 'mid-contact' plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The direction of the mid-contact plane corresponds to the direction of the chord 3210, which lies on the sagittal plane and just contacts the cushion of the pneumatic chamber at the following two points on the sagittal plane: the upper point 3220 and the lower point 3230. Depending on the geometry of the cushion in this area, the mid-contact plane can be tangent at both the upper and lower points. For an oral-nasal interface configured with a pneumatic chamber with separate mouth and nose portions, for example, an ultra-compact full face mask (UCFF), the upper point and the lower point are on the seal-forming structure of the mouth portion of the mask.

[0660] Figure 3X Shown Figure 3UThe pneumatic chamber 3200 is positioned on the face when in use. When the pneumatic chamber 3200 is in the position of use, the sagittal plane of the pneumatic chamber generally coincides with the mid-sagittal plane of the face. When the pneumatic chamber is in the position of use, the median contact plane generally corresponds to the 'facial plane'. Figure 3X In FIG, the pneumatic chamber 3200 is the pneumatic chamber of the nasal mask, and the upper point 3220 is approximately located on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0661] 4.4RPT device

[0662] Figure 4A One form of RPT device according to the present technology is shown.

[0663] Figure 4B Schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are shown 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 given moment. Items within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0664] 4.5 Humidifier

[0665] Figure 5A is an isometric view of a humidifier according to one form of the present technology.

[0666] Figure 5B An isometric view of a humidifier in accordance with one form of the present technology is shown showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130 .

[0667] 4.6 Respiratory Waveform

[0668] Figure 6 A typical breathing waveform of a model of a sleeping person is shown.

[0669] 4.75 Current Technology Patient Interface

[0670] Figure 7 is a rear perspective view of a pneumatic chamber according to one form of the present technology, with the inlet port not shown.

[0671] Figure 8 yes Figure 7 Rear view of the pneumatic chamber.

[0672] Figure 9 yes Figure 7 Front view of the pneumatic chamber.

[0673] Figure 10 yes Figure 7 Side view of the pneumatic chamber.

[0674] Figure 11 yes Figure 7 Top view of the pneumatic chamber.

[0675] Figure 12 It is a cross section of the pneumatic chamber through plane 12-12.

[0676] Figure 13 yes Figure 7 Bottom view of the pneumatic chamber.

[0677] Figure 14 It is a cross section of the pneumatic chamber through plane 14-14.

[0678] Figure 15 It is a cross section of the pneumatic chamber through plane 15-15.

[0679] Figure 16 It is a cross section of the pneumatic chamber through plane 16-16.

[0680] Figure 16-1 It is a cross section of the pneumatic chamber through plane 16-1-16-1.

[0681] Figure 16-2 yes Figure 16-1 0026] A cross-sectional view of the pneumatic chamber of FIG. 1, illustrating the pneumatic chamber in a deformed position.

[0682] Figure 16-3 yes Figure 16 Another cross-sectional view of the pneumatic chamber is shown illustrating the gasket of a first size.

[0683] Figure 16-4 yes Figure 16 Another cross-sectional view of the pneumatic chamber is shown illustrating a second size gasket.

[0684] Figure 16-5 yes Figure 16 Another cross-sectional view of the pneumatic chamber is shown, illustrating a third size of gasket.

[0685] Figure 17 It is a cross section of the pneumatic chamber through plane 17-17.

[0686] Figure 18 It is a cross section of the pneumatic chamber through plane 18-18.

[0687] Figure 18-1 It is the cross section of the pneumatic chamber through plane 18-1-18-1.

[0688] Figure 18-2 It is the cross section of the pneumatic chamber through plane 18-2-18-2.

[0689] Figure 19A side view of the pneumatic chamber is shown in the use position on the patient's face, with the pneumatic chamber shown in outline for clarity.

[0690] Figure 20 A patient's face is shown with specific areas engaged by the seal-forming structure shown.

[0691] Figure 21 is a front perspective view of another form of patient interface according to the present technology.

[0692] Figure 21-1 is a front perspective view of another form of patient interface according to the present technology.

[0693] Figure 22 is a front perspective view of yet another form of patient interface in accordance with the present technology, with the vent removed.

[0694] Figure 23 is a front perspective view of a patient interface having a frame for connecting headgear straps to a pneumatic chamber.

[0695] Figure 23-1 Yes Figure 23 Front perspective view of a patient with a patient interface.

[0696] Figure 23-2 is a front perspective view of an alternative version of a patient interface having a frame for connecting headgear straps to the pneumatic chamber.

[0697] Figure 24 yes Figure 23 Exploded view of the patient interface.

[0698] Figure 24-1 yes Figure 23-2 Exploded view of the patient interface.

[0699] Figure 25 is a front view of a frame and pneumatic chamber according to one form of the present technology.

[0700] Figure 26 is a front view of another form of frame and pneumatic chamber according to the present technology.

[0701] Figure 26-1 yes Figure 26 Side perspective view of the frame and pneumatic chamber.

[0702] Figure 26-2 yes Figure 26-1 A cross-sectional view of the frame and the pneumatic chamber along section 26-26.

[0703] Figure 26-2a yes Figure 26-1 Another example of a frame and pneumatic chamber is shown in cross-sectional view along section 26-26.

[0704] Figure 26-3 yes Figure 26 Top view of the frame and pneumatic chamber.

[0705] Figure 26-4 yes Figure 26 A perspective view of a frame and a pneumatic chamber illustrating an arm of the frame movable between a first position and a second position.

[0706] Figure 26-5 yes Figure 26-4 1 and 2. Rear perspective view of the frame and pneumatic chamber illustrating the bending of the pneumatic chamber in the second position.

[0707] Figure 27 yes Figure 26 Rear view of the frame, illustrating the tapered opening.

[0708] Figure 27-1 yes Figure 26 A top perspective view of the frame illustrating the reduced thickness of the arms of the frame.

[0709] Figure 27-2 yes Figure 26 A perspective view of a frame illustrating the ring on the free end of the frame.

[0710] Figure 27-3 yes Figure 26 A perspective view of a frame illustrating a cross section of an arm of the frame.

[0711] Figure 28 is a front view of a frame and a pneumatic chamber according to yet another form of the present technology.

[0712] Figure 28-1 is a perspective view of a second connection point that may be used with one form of a frame of the present technology.

[0713] Figure 28-2 yes Figure 28 A cross-sectional view of the frame and pneumatic chamber, illustrating Figure 28-1 The connection between the magnet and the second connection point.

[0714] Figure 29 is a detailed view of a pneumatic chamber according to yet another form of the present technology, illustrating a clip support configured to selectively contact the frame.

[0715] Figure 30 is connected to the frame Figure 29 Bottom view of the pneumatic chamber, with the frame in contact with the clip supports.

[0716] Figure 31 is a front view of yet another form of pneumatic chamber according to the present technology connected to a frame including a clip support.

[0717] Figure 32 is a front view of yet another form of frame according to the present technology, illustrating ribs for limiting movement of connecting members.

[0718] Figure 33 is a front view of yet another form of frame according to the present technology, illustrating a pair of ribs for limiting movement of the connecting member.

[0719] Figure 34 is a front view of yet another form of frame according to the present technology, illustrating arms with connection points.

[0720] Figure 35 is a perspective view of yet another form of frame according to the present technology, illustrating the protrusions adjacent the eyelets.

[0721] Figure 35-1 is a side perspective view of a frame according to another example.

[0722] Figure 35-2 yes Figure 35 Detail of the eyelet.

[0723] Figure 36 is a front view of yet another form of a frame according to the present technology, illustrating the upper rod of the frame connected to the pneumatic chamber closer to the elbow.

[0724] Figure 37 is a front view of yet another form of frame according to the present technology, illustrating the upper bar of the frame spaced apart from the pneumatic chamber.

[0725] Figure 38 yes Figure 37 perspective view of the frame.

[0726] Figure 39 yes Figure 37 Top view of the frame.

[0727] Figure 40 is a side perspective view of a gasket according to yet another aspect of the present technology, illustrating a protrusion extending from a front surface of a pneumatic chamber.

[0728] Figure 41 It can be used with Figure 23 Detailed view of a strap of a positioning and stabilizing structure for use with a patient interface, the strap having a first width and a second width.

[0729] Figure 41-1 It can be used with Figure 23 Detailed view of an alternative example of a strap having a protrusion for use with a positioning and stabilizing structure for use with a patient interface.

[0730] Figure 41-1-1 Is a Figure 23 Detailed view of an alternative example of a strap for positioning and stabilizing a patient interface having a plurality of straps with Figure 41-1 The convex portion is in an alternative configuration of the convex portion.

[0731] Figure 41-2 It can be used with Figure 23 Detailed view of an alternative example of a strap of a positioning and stabilizing structure for use with a patient interface, the strap having a cut edge.

[0732] Figure 41-3 It can be used with Figure 23 Detailed view of an alternative example of a strap of a positioning and stabilizing structure for use with a patient interface, the strap being positioned in a first position.

[0733] Figure 41-4 yes Figure 41-3 Detailed view of the strap illustrating the strap in a second extended position wherein the indicator becomes visible.

[0734] Figure 41-5 It can be used with Figure 23 Detailed view of an alternative example of a strap of a positioning and stabilizing structure for use with a patient interface of FIG, the strap being positioned in a second, extended position in which an indicator becomes visible.

[0735] Figure 41-6 is a perspective view of a double-sided fastener with hook or loop material.

[0736] Figure 41-7 yes Figure 41-6 A rear view of the double-sided connecting member on the headband in a first position.

[0737] Figure 41-8 yes Figure 41-6 A rear view of a double-sided connecting member connected to the headband in the second position.

[0738] Figure 42 is used Figure 41 The straps Figure 23 Front perspective view of the patient interface.

[0739] Figure 42-1 It's a picture Figure 42 Front perspective view of an alternative version of the , showing the patient interface with sleeves on the arms of the frame.

[0740] Figure 42-2 yes Figure 23 Front perspective view of a patient interface using an alternative version of the strap.

[0741] Figure 43is a rear view of an alternative form of the liner showing the stop ribs in dotted lines.

[0742] Figure 44 Observed along Route 44-44 Figure 43 A cross-sectional view of a gasket illustrating the shape of the stop rib.

[0743] Figure 45 yes Figure 44 A side view of a cross-sectional view of the .

[0744] Figure 45-1 Observed along line 45-1-45-1 Figure 43 A cross-sectional view of a gasket illustrating the shape of the stop rib.

[0745] Figure 46 yes Figure 26 Front view of the pneumatic chamber showing the groove for receiving the frame.

[0746] Figure 47 is a rear view of yet another form of a mat according to the present technology, illustrating the reinforced areas in phantom lines.

[0747] Figure 47-1 yes Figure 47 Cross-sectional view of a mat illustrating the reinforced areas.

[0748] Figure 48 is a cross-sectional view of yet another form of cushion according to the present technology, illustrating an alternative form of reinforced region.

[0749] Figure 49 yes Figure 48 Cross-section of the mat shown.

[0750] Figure 50 is a cross-sectional view of yet another form of a gasket according to the present technology illustrating the spacing between the seal-forming structure and the front surface of the pneumatic chamber.

[0751] Figure 50-1 is a cross-sectional view of yet another form of gasket according to the present technology, illustrating a vent ring having an offset to create a space between the seal-forming structure and the elbow.

[0752] Figure 51 It's a picture Figure 50 Cross-sectional view of the cushion worn by the patient.

[0753] Figure 52 is a perspective view of an arm of a frame according to another example, the frame including a first ring portion and a second ring portion.

[0754] Figure 53 yes Figure 52A perspective view of an arm of FIG, illustrating a headgear strap connected to a first loop portion at an optimal tension level.

[0755] Figure 54 52 is a perspective view illustrating the headgear strap connected to the second loop portion under an amount of tension exceeding an optimal amount of tension.

[0756] Figure 55 is a perspective view of a patient interface according to another example, illustrating a frame with a ladder lock connected to a headgear strap.

[0757] Figure 55-1 is a perspective view of a patient interface according to yet another example, illustrating a frame with a ladder lock connected to a headgear strap.

[0758] Figure 56 is a perspective view of a patient interface according to another example, illustrating a frame with cord plugs connected to headgear straps.

[0759] Figure 56-1 is a perspective view of a patient interface according to yet another example, illustrating a frame with cord plugs connected to headgear straps.

[0760] Figure 57 is a cross-sectional view of a patient interface according to another example illustrating a vent ring on a lip connected to an inlet port of a pneumatic chamber.

[0761] Figure 58 is used to connect to Figure 57 Exploded view of the air circuit for the patient interface.

[0762] Figure 58-1 is used for Figure 58 Perspective view of the quick-release connector in the air circuit.

[0763] Figure 59 yes Figure 57 Perspective view of the vent ring.

[0764] Figure 60 yes Figure 59 Bottom view of a vent ring showing multiple vent holes.

[0765] Figure 61 is a bottom view of an alternative form of housing for a magnet that is removably connected to an attachment point on the frame of any of the previous examples.

[0766] Figure 62 is a perspective view of a decoupling structure including a connector for engaging within a vent ring according to another form.

[0767] Figure 63 is based on the Figure 62A perspective view of a vent ring of another example of a decoupling structure engaging the vent ring.

[0768] Figure 63-1 is connected to Figure 63 On the ventilation ring Figure 62 Cross-sectional view of the decoupling structure.

[0769] Figure 64 is a perspective view of a decoupling structure including a connector for engaging an exterior of a vent ring according to another form.

[0770] Figure 65 is a perspective view of a decoupling structure according to yet another form, the decoupling structure including a connector for engaging within a vent ring.

[0771] Figure 66 is based on the Figure 64 A perspective view of a vent ring of another example of a decoupling structure engaging a vent ring of 65 .

[0772] Figure 66-1 is connected to Figure 66 On the ventilation ring Figure 64 Perspective view of the decoupling structure.

[0773] Figure 66-2 is connected to Figure 66 On the ventilation ring Figure 65 Perspective view of the decoupling structure.

[0774] Figure 66-3 yes Figure 66-2 Cross-sectional view of the decoupling structure and vent ring, which is coupled to the pneumatic chamber.

[0775] Figure 67 is a perspective view of a decoupling structure including a connector for engaging an exterior of a vent ring according to yet another form.

[0776] Figure 68 According to another example, Figure 67 A perspective view of the decoupling structure engaging the vent ring.

[0777] Figure 69 is connected to Figure 68 The ventilation ring Figure 67 0026] A perspective view of a decoupling structure illustrating the arms of the decoupling structure engaged to the vent ring.

[0778] Figure 69-1 is connected to Figure 68 On the ventilation ring Figure 67 A perspective view of a decoupling structure illustrating arms of the decoupling structure.

[0779] Figure 70 Connected to the pneumatic chamber Figure 69Cross-sectional view of the decoupling structure and vent ring.

[0780] Figure 71 is a perspective view of another form of an elbow connector connected to a pneumatic chamber and spaced apart from a surface of the pneumatic chamber when fully connected.

[0781] Figure 71-1 yes Figure 71 Cross-sectional view of the elbow connector and pneumatic chamber.

[0782] Figure 72 is a side perspective view of yet another form of elbow pipe connector including a chevron shape.

[0783] Figure 73 yes Figure 72 Front perspective view of an elbow connector.

[0784] Figure 73-1 is connected to the pneumatic chamber Figure 73 Cross-sectional view of an elbow connector.

[0785] Figure 74 It is a perspective view of another form of elbow connector with fewer vent holes.

[0786] Figure 75 is with Figure 74 A perspective view of a swivel joint used with an elbow connector, illustrating the vent hole. DETAILED DESCRIPTION

[0787] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this utility model is only used to describe the specific examples discussed herein and is not intended to be limiting.

[0788] The following description is provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any example may constitute a further example.

[0789] Where anatomical directional terms are used to describe aspects and examples of the present technology, such as "anterior," "posterior," "superior," etc., the directions are to be read in the context of the present technology during use by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is in front of the patient when the patient has donned the interface in the intended manner.

[0790] Where a surface or portion is described as facing in one direction, for example, "facing upward," "facing forward," etc., unless the context clearly requires otherwise, the surface or portion will be understood to be at least partially facing in the particular direction. A portion may be "facing upward" if it generally faces in an upward direction even if it also partially faces in another direction.

[0791] 5.1 Treatment

[0792] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0793] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0794] In some examples of the present technology, mouth breathing is restricted, restricted, or prevented.

[0795] 5.2 Respiratory therapy system

[0796] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0797] 5.3 Patient Interface

[0798] A non-invasive patient interface 3000 according to one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a pneumatic chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to maintain a positive pressure at the entrance to the airway of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0799] In some examples of the present technology, the pneumatic chamber is at least partially formed by the housing 3250. In examples, the housing 3250 or a portion of the housing 3250 can be somewhat flexible, as discussed further below.

[0800] In some examples of the present technology, the patient interface is an oronasal patient interface, i.e., the patient interface is configured to seal around both the nasal and oral airways of the patient. In some examples, the patient interface includes separate seals around each of the nasal and oral airways.

[0801] exist Figure 7-22 In the example shown, the seal-forming structure at the nose is not located on the nasal bridge area or nasal ridge area of ​​the patient's face, but rather seals on the lower surface of the patient's nose.

[0802] 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.

[0803] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 6 cmH20 relative to ambient.

[0804] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 10 cmH20 relative to ambient.

[0805] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 20 cmH20 relative to ambient.

[0806] 5.3.1 Sealing structure

[0807] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given course of treatment, depending on a number of factors, including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0808] As described in more detail below, in certain forms of the present invention, the seal-forming structure 3100 includes a first seal-forming structure 3101 connected to the mouth portion 3201 of the pneumatic chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's mouth, and a second seal-forming structure 3102 connected to the nose portion 3202 of the pneumatic chamber 3200 and constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's nose. The phrase "connected to" is used herein to refer to parts or components that are formed as a single piece and parts or components that are formed separately and subsequently joined together. In some cases, the components may be connected by an intermediate component.

[0809] In some forms, the first seal-forming structure 3101 seals against the patient's face independently of the second seal-forming structure 3102 .

[0810] In certain forms, the first seal-forming structure 3101 and the second seal-forming structure 3102 cooperate to form a single common seal against the patient's face.

[0811] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0812] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, such as silicone rubber.

[0813] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material such as silicone.

[0814] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 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 heads but not small heads, and another form of seal-forming structure 3100 that is suitable for small heads but not large heads.

[0815] 5.3.1.1 Sealing mechanism

[0816] In one form, the seal-forming structure comprises a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure acting on the interior of the pneumatic chamber 3200 on its underside, thereby forming a tight sealing engagement with the face. The pressure-assist mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0817] 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, for example, about 0.25 mm to about 0.45 mm, which extends around the periphery of the pneumatic chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is arranged between the sealing flange and the edge of the pneumatic chamber 3200 and extends at least a portion of the way around the periphery. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use. Limiting the occurrence of buckling can limit the formation of wrinkles in the seal-forming structure 3100, which can lead to leakage and loss of treatment pressure.

[0818] In one form, the seal-forming structure 3100 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.

[0819] In one form, the seal-forming structure 3100 includes a tensioning portion that, in use, is maintained in tension, for example, by an adjacent region of the sealing flange.

[0820] In one form, the seal-forming structure 3100 includes a region having a sticky or adhesive surface.

[0821] In certain forms of the present technology, the seal-forming structure 3100 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.

[0822] 5.3.1.2 Nasal area

[0823] See next Figures 7 to 18 In some forms of the present technology, the second seal-forming structure 3102 includes a central portion 3110 that is configured to seal against a surface of the patient's nose during use. The central portion can seal to a lower periphery of the patient's nose (e.g., around the patient's nostrils) as well as to the patient's upper lip. In examples, a portion of the seal-forming structure can engage the patient's septum. The second seal-forming structure 3102 can also include lateral portions 3111 on lateral sides of the central portion 3110. In examples, the seal-forming structure 3102 can be configured to contact the patient's face below the bridge of the nose or below the frontal nasal region.

[0824] like Figure 10 As best shown in Figures 16-19, the rear surface 3112 of the lateral portion 3111 is inclined forwardly in the superior / anterior direction from the boundary 3103 of the first seal-forming structure 3101 and the second seal-forming structure 3102, so that the posterior lateral anterior inclination of the nose of the mask in profile.

[0825] In embodiments where a ridge 3120 is provided (as further described below), the rear surface 3112 of the lateral portion 3111 may be angled forward from the ridge 3120 .

[0826] In some forms of the technology, the rear surface 3112 of the lateral portion 3111 forms an angle of between 20° and 90° with the median contact plane of the mask. The median contact plane can be perpendicular to the sagittal plane and can extend generally along the length of the ridge 3120 and chord 3210. This angle can be between Figure 16 , although the angle may also be measured in a counterclockwise direction such that the measured angle is the supplementary angle of the angles listed above (ie, between 90° and 160°).

[0827] like Figures 16-3 to 16-5As shown, the second seal-forming structure 3102 can be formed at different angles relative to the median contact plane so that patients with different sized noses can each comfortably wear the patient interface 3000. As shown, the two separate angles of the second seal-forming structure 3102 can be modified on patient interfaces 3000 of different sizes to provide a better fit for a wide range of patients.

[0828] The first angle 6056 can be measured from the median contact plane to a first sealing axis 6060 extending along the upper boundary 3247 of the second front wall portion 3242 and intersecting the nostril 3135. In some forms, the first angle 6056 can be between about 50° and about 150°. In some forms, the first angle 6056 can be between about 75° and about 125°. In some forms, the first angle 6056 can be between about 100° and about 110°. For example, Figure 16-3 may include a first angle 6056-1 of approximately 108°, Figure 16-4 may include a first angle 6056-2 of approximately 105°, and Figure 16-5 A first angle 6056-3 of about 109° may be included. As shown, the first angle 6056 is along Figures 16-3 to 16-5 However, the first angle 6056 can be measured in a clockwise direction so that the measured angle is the supplementary angle of the above-mentioned angle.

[0829] The second angle 6064 can be measured from the mid-contact plane to a second seal axis 6068 extending along a surface of the second seal-forming structure 3102 that is configured to contact the patient and intersect the nostril 3135. In some forms, the second angle 6064 can be between about 50° and about 160°. In some forms, the second angle 6064 can be between about 100° and about 145°. In some forms, the second angle 6064 can be between about 110° and about 130°. For example, Figure 16-3 may include a second angle 6064-1 of approximately 127.5°, Figure 16-4 may include a second angle 6064-2 of approximately 116.5°, and Figure 16-5 A second angle 6064-3 of about 122° may be included. As shown, the second angle 6064 is along Figures 16-3 to 16-5 However, the second angle 6064 can be measured in a clockwise direction so that the measured angle is the supplementary angle of the above-mentioned angle.

[0830] The difference between the first angle 6056 and the second angle 6064 can form an inclination of the second seal-forming structure 3102. As described above, in some forms, the difference can be between about 1° and about 110°. In some forms, the difference can be between about 5° and about 50°. In some forms, the difference can be between about 10° and about 20°. For example, Figure 16-3 can include a difference of approximately 19.5°, Figure 16-4 can include a difference of approximately 11.5°, and Figure 16-5 A difference of approximately 13° may be included. In some forms, this difference may be similar to the angle measured between the rear surface 3112 and the aforementioned intermediate contact plane, although these are separate angles.

[0831] Figures 16-3 to 16-5 The different angles shown in may correspond to patients with different nasolabial angles (see, e.g., Figure 2E ). The patient interface 3000 shown in each of the three figures can represent different sized interfaces (e.g., small, medium, or large), each of which can comfortably fit a patient within a range of nasolabial angles.

[0832] like Figure 50 and 51 As shown, Figures 16-3 to 16-5 The first angle 6056 and the second angle 6064 can provide relief for patients with proboscis noses (e.g., a large distance between the pronasal point and the alar apex). For example, the second front wall portion 3242 can be sufficiently spaced from the second seal-forming structure 3102 so that contact between the patient's nostrils and the second seal-forming structure 3102 remains a sufficient distance from the second front wall 3242 to allow airflow. The distance 6072 can extend between the second front wall portion 3242 and the nostril 3135. The distance 6072 can be the shortest distance between the second front wall portion 3242 and the second seal-forming structure 3102 being sufficiently spaced, and the distance may not extend along the first axis 6060. Although in other examples, the first distance 6072 can extend generally along the first seal axis 6060. This can enable the second seal-forming structure 3102 to extend in a forward direction without contacting the second front wall portion 3242 (e.g., when the patient has a proboscis nose).

[0833] like Figure 19 As shown, in some embodiments, the lateral portion 3111 is configured such that no portion of the patient interface 3000 contacts the alar apex 1020 of the patient when in use.

[0834] Configuring the lateral portion 3111 to be angled in this manner results in a smaller portion of the nose of the interface 3000 extending laterally on the ala of the nose than in some similar interfaces of the prior art. In some forms of the art, this results in a reduction in the portion of the ala of the nose that contacts the seal-forming structure 3100 relative to the interface with the lateral portion, which is angled rearwardly toward the patient's face, thereby reducing the proportion of the ala that can be deformed and blocked by the seal-forming structure 3100, for example, when the patient sleeps on the side of the ala that contacts the pillow.

[0835] 5.3.1.3 Mouth and nose boundary

[0836] See Figure 7 , 8 and 16-18, in one form of the technology, the boundary between the first seal-forming structure 3101 and the second seal-forming structure 3102 forms or includes a corner or ridge 3120. In use, the corner or ridge 3120 can engage the patient's face above the lips and just below the nose.

[0837] In an embodiment, the corner or ridge 3120 forms a sharper angle than equivalent portions or areas of some prior art oral and nasal masks, for example, those described in PCT Application No. PCT / AU2019 / 050278.

[0838] The sharper angle reduces the likelihood of wrinkles forming in the first seal-forming structure 3101 and / or the second seal-forming structure 3102 at or near the corners or ridges 3120 when the mask is worn and treatment is performed. Some oral-nasal patient interfaces that do not use such a structure may require a very thin, rounded structure in this area, which may not be very resistant to wrinkling. In contrast, the corners or ridges 3120 can be stiffer than such an interface and can better maintain their shape and, therefore, can better seal against the depressions and wrinkles that exist around the patient's nose. In embodiments where a support portion is provided, such as the support portion 3260 described herein, which resists or opposes compression of this area, this effect can be enhanced.

[0839] In some forms of the technology, the radius of the corner or ridge 3120 may be less than 2 mm, for example, about 1.75 mm. In one form of the technology, the radius may vary from about 1.75 mm at the center of the ridge to about 0.75 mm at the lateral portion.

[0840] The angle formed by the first sealing structure and the second sealing structure may be between 20 degrees and 90 degrees, for example, 36 degrees.

[0841] In some forms of the technology, the corner or ridge 3120 can extend across substantially the entire boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102. In embodiments, the corner or ridge 3120 can engage the patient's face at least proximate the entrance to the nostrils, for example, where the nose meets the face above the lips, as in Figure 20 As shown in area 1010 in FIG.

[0842] 5.3.1.4 Oral area

[0843] As described above, in one form, the non-invasive patient interface 3000 comprises a first seal-forming structure 3101 which, in use, forms a seal around the patient's mouth. The first seal-forming structure 3101 may form a seal over the chin region of the patient's face.

[0844] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin region of a patient's face.

[0845] The seal-forming structure 3100 includes a lower lip portion 3130 that forms a seal against the patient's chin area and / or the patient's lower lip and / or supramental area. The lower lip portion 3130 can be connected to (e.g., adjacent to) the upper lip portion 3131 via an orifice perimeter portion 3132, as shown. Figure 16 shown.

[0846] The seal-forming structure 3100 includes a relatively low wall thickness (compared to other portions of the interface), for example, less than 0.7 mm, at the oral perimeter portion 3132, the lower lip portion 3130 of the seal-forming structure against the chin area, and at least the center of the lower lip portion 3130. The low wall thickness in these locations helps achieve an effective and comfortable seal. The seal-forming structure in these areas can easily conform to any complex geometry.

[0847] In some forms of the technology, the mouth opening 3133 is generally trapezoidal rather than oval or elliptical, so as to more accurately correspond to the shape of the patient's nose. This shape of the mouth opening can allow the interface 3000 to be particularly compact and not substantially wider than the width of the patient's nostrils.

[0848] like Figure 51 As shown, the patient's mouth can be spaced apart from the inlet port 3604 (and thus Figure 503504 in the elbow 3500 and / or vent ring 3504. The distance 6076 may be measured in a direction substantially parallel to the distance 6072. The distance 6076 provides sufficient clearance for the patient's lips, which extend into the cavity 3272 and further forward of the second seal-forming structure 3102. The patient may slightly compress the second seal-forming structure 3102 in a forward direction, and the distance 6076 may be large enough to prevent contact with the elbow 3500 and / or vent ring 3504. However, the distance 6076 may not be too large so that the patient interface 3000 maintains a compact profile.

[0849] Likewise or additionally, Figure 50-1 As shown, the vent ring 3504 (described in more detail below) can include an offset to create additional spacing between the elbow 3500 and the first seal-forming structure 3101 (and therefore the patient's lips). The vent ring 3504 can include a biasing member 3506 (described below) that can space the elbow 3500 from the cavity 3272 of the pneumatic chamber 3200. For example, Figure 57 As shown, the elbow 3500 contacts the front surface 3512 of the vent ring 3504 and extends beyond the rear surface 3508 of the pneumatic chamber 3200. This allows for a more compact design (e.g., because it minimizes extension in a forward direction away from the patient's face), but the elbow 3500 extends into the distance 6076. In other words, the distance 6076 (as shown in FIG. Figure 51 ) is no longer the maximum separation distance between the patient's lips and the front of the patient interface 3000. Applying the offset 3506 can increase the distance the patient interface 3000 extends in front of the patient's face, while also spacing the elbow 3500 from the patient's lips so that the distance 6076 remains at the maximum separation distance between the patient's lips and the patient interface 3000 in the anterior direction.

[0850] 5.3.1.5 Nasal pillows

[0851] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal masks or pillows, each constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0852] A nasal pillow according to one aspect of the present technology comprises: a frustoconical body, at least a portion of which forms a seal against the bottom surface of a patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can work together to facilitate forming a universal connection structure that is adjustable with both displacement and angular movement of the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0853] 5.3.2 Pneumatic chamber

[0854] In some forms, the pneumatic chamber 3200 (or at least a portion of the pneumatic chamber 3200) and the seal-forming structure 3100 are formed from a single homogeneous piece of material (eg, molded silicone). The combination of the seal-forming structure 3100 and the pneumatic chamber 3200 can be considered a gasket.

[0855] 5.3.2.1 Adjustable nose angle

[0856] See Figure 9 、 10 16 to 18-2, in one form of the technology, a first front wall portion 3240 of the nose 3202 of the pneumatic chamber 3200 is more flexible than the immediately adjacent area of ​​the mouth 3201. The first front wall portion 3240 may be positioned near a boundary 3241 between the nose and mouth of the pneumatic chamber 3200. In embodiments, the first front wall portion 3240 may be symmetrical about the mid-sagittal plane and may extend across at least 50%, for example, at least 80%, of the width of the nose 3202 of the pneumatic chamber. In some embodiments, the first front wall portion 3240 may extend across substantially the entire width of the nose 3202 of the pneumatic chamber.

[0857] In some forms of this technology, the second front wall portion 3242 is less flexible than the immediately adjacent portions of the front wall. In some embodiments, the second front wall portion 3242 is immediately adjacent to the first front wall portion 3240 on opposite sides of the boundary 3241 between the nose and mouth of the pneumatic chamber. In embodiments, the second front wall portion 3242 may be symmetrical about the mid-sagittal plane and may extend across at least 50%, for example, at least 80%, of the width of the nose 3202 of the pneumatic chamber. In some embodiments, the second front wall portion 3242 may extend across substantially the entire width of the nose 3202 of the pneumatic chamber.

[0858] The flexible first front wall portion 3240 can allow the patient contacting portion 3110 of the second seal-forming structure 3102 to pivot or articulate about an area on the back side of the interface 3000. This can help allow the interface to accommodate patients at various angles between the bottom of the nose and the top of the lip (i.e., the nasolabial angle).

[0859] In embodiments featuring a corner or ridge 3120 between the first seal-forming structure 3101 and the second seal-forming structure 3102, such as those described above, the patient contacting portion 3110 can pivot or articulate about an area at or near the corner or ridge 3120. In embodiments where one or more supports 3260 are provided (described further below), the articulation or pivoting area can be directly above the supports 3260.

[0860] like Figure 9As shown, the first front wall portion 3240 can have an upper boundary 3243 and a lower boundary 3244. One or both of the upper boundary 3243 and the lower boundary 3244 can be curved, for example, such that the center portion of the boundary is lower than the lateral portions, as shown. The first front wall portion 3240 can be substantially the same height across its width (i.e., the upper boundary and the lower boundary can be substantially parallel), or the height can vary across the width, for example, such that the center portion of the first front wall portion 3240 is higher than the lateral portions, as shown. Figure 9 Changing the curvature of one or both of the boundaries 3243, 244 and / or the height of the first front wall portion 3240 can change the stiffness of the first front wall portion 3240, that is, its resistance to collapsing or folding in response to a force on the patient contacting portion 3110 of the second seal-forming structure 3102.

[0861] Similarly, the second front wall portion 3242 can have an upper boundary 3247 and a lower boundary 3248. In some forms of the technology, the lower boundary 3248 of the second front wall portion 3242 is the same as the upper boundary 3243 of the first front wall portion 3240. Both the upper boundary 3247 and the lower boundary 3248 of the second front wall portion 3242 can be curved, for example, such that the center portion of the boundary is lower than the lateral portions. The second front wall portion 3242 can be of substantially the same height across its width (i.e., the upper boundary and the lower boundary can be substantially parallel), or the height can vary across its width, for example, such that the center portion of the second front wall portion 3242 is less than the height of the lateral portions.

[0862] In some forms of the technology, in addition to or in lieu of a curved border, other ways of configuring the first front wall portion 3240 to have a desired stiffness can be used. For example, the thickness of the first front wall portion 3240 can be selected to provide the desired stiffness. In an example, the first front wall portion 3240 can be thinner than the adjacent portion of the pneumatic chamber wall. Additionally and / or alternatively, the first front wall portion 3240 can extend in an upward direction around the lateral edge of the second front wall portion 3242, such as Figure 21 As shown, this provides reduced stiffness / resistance to compression or collapse compared to embodiments in which the first front wall portion 3240 is not shaped in this manner.

[0863] The second front wall portion 3242 (e.g., strap 3270) can help prevent the nose 3202 from collapsing and can provide support for the patient contacting portion 3110 of the second seal-forming structure 3102, which is typically relatively thin. An inadequately supported patient contacting portion may suffer from bursting of the sealing engagement with the patient's face. In one form, the second front wall portion 3242 is thicker than the immediately adjacent portion of the pneumatic chamber wall. In some forms, the second front wall portion 3242 is provided as a thickened strip of material 3270, such as Figure 16-19The first front wall portion 3240 and the second front wall portion 3242 can be made of the same material, for example, as part of an integrally molded housing 3250 .

[0864] In some forms, the first front wall portion 3240 and the second front wall portion 3242 can include different thicknesses. For example, the thickness of the second front wall portion 3242 can be greater than the thickness of the first front wall portion 3240, which can provide increased stiffness in the second front wall portion 3242 (e.g., compared to the first front wall portion 3240). Specifically, the second front wall portion 3242 can be a band 3270 that extends into the cavity 3272 of the pneumatic chamber 3200. For example, the band 3270 can extend through the first front wall portion 3240 and toward the patient wearing the patient interface 3000. The outer surface of the nose 3202 can be generally smooth, while the inner surface of the nose (e.g., within the cavity 3272) can be stepped (or otherwise include discontinuities).

[0865] like Figure 16-1 and 16-2 As shown, the first front wall portion 3240 can act as a hinge and allow the nose 3202 to flex. The first front wall portion 3240 can be the thinnest area of ​​the nose 3202 and, therefore, most susceptible to bending moments. The increased thickness of the band 3270 directs the bending moment away from the second front wall portion 3242 and toward the thinner first front wall portion 3240. The greater height of the band 3270 (i.e., the greater distance between the upper boundary 3247 and the lower boundary 3248) can also make the nose 3202 stiffer and less able to bend about the first front wall portion 3240. When bending occurs, the first and second front wall portions 3240, 3242 can move in a forward direction (e.g., away from the patient).

[0866] like Figure 18-1 and 18-2 As shown, the upper boundary 3243 of the first front wall portion 3240 is different from the lower boundary 3248 of the second front wall portion 3242. Instead, the upper boundary 3243 is at least partially higher than the lower boundary 3248 and can be at least partially aligned with the upper boundary 3247 of the second front wall portion 3242. This allows the first front wall portion 3240 to be arranged at least partially alongside the strap 3270 (e.g., surrounding the strap 3270 on two or more sides). In other words, the first front wall portion 3240 can be disposed on at least one end of the strap 3270. This can provide greater flexibility to the first front wall portion 3240, enabling the nose portion 3202 to bend further (e.g., in a forward direction).

[0867] like Figure 21-1As shown, the nose portion 3202 can also be formed without a hinge. In other words, no band can be formed on the second front wall portion 3242, so that the first front wall portion 3240 and the second front wall portion 3242 have a substantially uniform thickness. The nose portion 3202 can still bend even without a band because it can be formed of silicone, which allows some compliance in the nose portion 3202 to accommodate different nasolabial angles.

[0868] 5.3.2.2 Flexible enclosure

[0869] In some forms of the technology, the housing 3250 may be made of a rigidified material such as polycarbonate. However, in other forms of the technology, the housing 3250 or portions of the housing 3250 may be somewhat flexible. For example, in an example, the housing 3250 may be formed of a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the technology, the housing 3250 may be made of a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the technology, the housing 3250 may be made of a material having a Young's modulus of 0.7 MPa or less, such as between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0870] In an example, the housing 3250 and one or both of the first seal-forming structure 3101 and the second seal-forming structure 3102 can be formed from the same material (e.g., silicone, textile, etc.).

[0871] In some forms of this technology (see, e.g., Figure 23 to Figure 28-2 ), the housing 3250 can be constructed substantially entirely of flexible material, which can provide the housing 3250 with maximum freedom of movement (i.e., substantially no rigid and / or thickened portions that restrict bending). The housing 3250 can be sufficiently flexible that one or more components are added to provide the desired stiffness in one or more areas of the housing 3250 (e.g., the area of ​​the contact area 1010). For example, one or more ventilation modules; connection ports; headgear connectors; headband connectors connected to rigidizing arms and rigidizing members can be connected to the housing 3250 in such a manner as to increase the stiffness of the pneumatic chamber 3200 in areas adjacent to the components, for example, as further described below. In some forms of the technology, these components can be releasably connected to the flexible housing 3250. Additionally or alternatively, one or more components can be permanently connected to the housing 3250, for example, by bonding and / or overmolding. The rigidizing member can also be used to increase stiffness and / or support the shape of the seal-forming structure 3100.

[0872] In some forms of the technology, the housing 3250 may be generally flexible but may include a reinforcement portion having a greater thickness than immediately adjacent portions of the housing 3250. Such reinforcement portion may be configured as a rib or band, for example, extending laterally across the housing and / or extending in an up-down direction, although many other configurations are possible. In some forms, the housing may include a generally rigid portion, for example, made of polycarbonate, and a slightly flexible portion.

[0873] In some forms of the technology, the central portion 3251 of the front side of the mouth 3201 of the pneumatic chamber may preferably have a greater stiffness than the rest of the pneumatic chamber 3200. In some forms of the technology, the area of ​​increased stiffness may be just below the nose 3202, such as Figure 21 3201. As shown and further described below, and / or just above the mouth 3201. In one form of the technology, part or all of the first front wall portion 3240 can be an area of ​​increased stiffness rather than an area of ​​increased flexibility. Providing increased stiffness in one or more of these areas can provide form stability and can limit the extent to which the shell 3250 deforms due to headband forces. Excessive deformation can cause the second seal-forming structure 3102 to block the nostrils. Avoiding such deformation can be particularly advantageous for patients with relatively wide noses and may be less important, or in some cases undesirable, for patients with narrow noses. In addition, the described areas of increased stiffness can help to reduce torsional deformation of the interface that would otherwise cause one side of the second seal-forming structure 3102 to lose contact with the patient's nose, thereby creating a leak path.

[0874] like Figure 21 and 21-1 As shown, in one form of the technology, the housing 3250 can be provided with a rigid portion 3263, or at least a portion of one or more connection ports 3600 that is more rigid than the rest of the housing, for example, molded therein. In one form of the technology, the rigid portion 3263 can be made of polycarbonate. This can provide greater rigidity than a housing made solely of silicone. In one form, the technical holes forming the vents 3400 are molded into the rigid portion 3263. In some forms of the technology, the connector 3310, which is used to position and stabilize the structure, is mounted on an arm 3320, which provides some rigidity to the housing.

[0875] In one form of the technology, the rigid portion 3263 extends laterally across the front of the pneumatic chamber near the upper boundary of the first front wall portion 3240, for example, directly below the second front wall portion 3242. The rigid portion 3263 may extend continuously between the connection ports 3600 and may provide an airflow path for pressurized air flowing into the pneumatic chamber 3200 through the connection ports 3600.

[0876] In some forms of the technology, the connection ports 3600 may have a generally oval cross-section.The connection ports 3600 may be oriented such that the centerline of each port is generally parallel to the outer surface of the pneumatic chamber adjacent to the port.

[0877] In some forms of the technology, the rigid portion 3263 may project in a forward direction relative to an adjacent face of the first front wall portion 3240 and may be shaped to increase resistance to bending.

[0878] In some forms of this technology (see, e.g., Figure 21 ), a connector 3310 and an arm 3320 are provided below the connection port 3600, toward the lateral edge of the pneumatic chamber 3200. The connector 3310 may be provided at a lateral end of the arm 3320. The connector 3310 may provide additional rigidity to the pneumatic chamber 3200 and / or the seal-forming structure 3100.

[0879] In some forms of this technology (see, e.g., Figure 21-1 ), the connector 3310 does not include the arm 3320, but is directly connected to the pneumatic chamber 3200. This can make the pneumatic chamber 3200 smaller than Figure 21 The pneumatic chamber 3200 is more flexible.

[0880] Figure 22 The pneumatic chamber 3200 is shown having a vent mounting hole 3410 into which a suitable vent portion or module may be inserted. The vent portion may be made of a relatively stiff material to increase the stiffness of the pneumatic chamber. In some forms of the present technology, the vent mounting hole 3410 may be generally elliptical in shape, with the minor axis of the ellipse being generally parallel to the sagittal plane.

[0881] exist Figure 22 In the illustrated embodiment, the vent mounting hole is positioned toward the upper boundary of the mouth portion 3201 of the pneumatic chamber 3200 .

[0882] Figure 22 The illustrated embodiment is provided with a connector 3310 for positioning and stabilizing the structure. The connector 3310 can be mounted in a relatively thick area of ​​the housing 3250. In the illustrated embodiment, the connector 3310 is below the vent mounting hole 3410 and toward the lateral side of the pneumatic chamber 3200. In some forms of the present technology, the connector 3310 is a generally circular head strap connector.

[0883] Although Figure 7-19 The drawings of the pneumatic chamber are shown without inlet or connection ports, but a person skilled in the art will appreciate that in practice one or more inlet ports will be provided, e.g. Figure 21-22Inlet port 3600 is shown. Inlet port 3600 allows for interface connection to air circuit 4170, as further described herein. In some forms of the present technology, one or more components of air circuit 4170 may also serve as components of a positioning and stabilizing structure.

[0884] like Figure 24 As shown, some versions of the patient interface 3000 may include a single inlet port 3604. The inlet port 3604 may be generally circular in shape and may be centered about the mouth 3201 of the pneumatic chamber 3200.

[0885] like Figure 57 As shown, the inlet port 3604 may include a lip 3608 extending around at least a portion of the perimeter of the inlet port 3604 (see, e.g., Figure 49 ). For example, the lip 3608 can extend around the entire circumference of the circular inlet port 3604. The lip 3608 can extend into the cavity 3272 (see, e.g., Figure 18-1 ). The lip 3608 can be inclined relative to the periphery of the circumference of the inlet port 3604.

[0886] In some versions, the lip 3608 is generally perpendicular to the perimeter of the circumference of the inlet such that the diameter of the inlet port 3604 is generally equal to the diameter of the opening formed by the lip 3608 within the cavity 3272. In other words, the lip 3608 can extend generally parallel to a port axis 3612 extending through the inlet port 3604.

[0887] In other forms, the lip 3608 is inclined at between about 1° and about 60° relative to the port axis 3612. In some forms, the lip 3608 is inclined at between about 2° and about 50° relative to the port axis 3612. In some forms, the lip 3608 is inclined at between about 5° and about 30° relative to the port axis 3612. In some forms, the lip 3608 is inclined at between about 10° and about 15° relative to the port axis 3612.

[0888] In some forms of the present technology, the pneumatic chamber 3200 is constructed of a transparent material, such as clear polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve treatment compliance. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0889] In some forms of the present technology, the pneumatic chamber 3200 is constructed of a translucent material, such as translucent silicone. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0890] In some forms of the present technology, dedicated reinforcement members or rigid members (e.g., without other functions) may be included on the pneumatic chamber 3200. These members may be formed from a material that is more rigid than the pneumatic chamber 3200 (e.g., more rigid than silicone). The dedicated reinforcement members may be overmolded onto the pneumatic chamber 3200 to provide greater stiffness than the rigid portion 3263 of the housing 3250 or the arms 3320.

[0891] 5.3.3 Support

[0892] like Figure 12 and 14 As best shown in FIG. 18 , in one form of the technology, support portions 3260 are provided on opposite sides of the interface 3000 between the second seal-forming structure 3102 and the front wall of the pneumatic chamber 3200. Figure 12 As shown, in one example, each support portion 3260 extends to a lateral edge of the interface.

[0893] The support portion 3260 does not function as an under-cushion, but rather is configured to resist or impede compression in the anterior-posterior direction. The support portion 3260 thereby supports and / or reinforces the portion of the second seal-forming structure 3102 that engages the patient's upper lip. In particular, the support portion 3260 can support and / or reinforce an area of ​​the second seal-forming structure 3102 that can contact an area 1010 of the patient's face near the entrance to the nostril where the alar flap meets the area above the upper lip, as shown. Figure 20 In other words, region 1010 can be directly below each lower corner of the patient's nose.

[0894] The support portion 3260 helps ensure that wrinkles do not form in the seal-forming structure 3100. Wrinkles in the seal-forming structure can form as a result of a very flexible seal-forming structure having a large radius of curvature to conform to the patient's face. Due to excessive flexibility, the seal-forming structure can fold over or wrinkle on itself and cause leaks in the seal-forming structure. Wrinkles can be of particular concern where the seal-forming structure seals area 1010 of the patient's face. The support portion 3260 can be particularly advantageous when the seal-forming structure is configured to create corners and / or ridges 3120 as described herein. The corners and / or ridges 3120 can be sharper curves (e.g., curves with a lower radius of curvature) than a seal-forming structure without the support portion 3260. The added support and / or stiffness provided by the support portion 3260 reduces the ability of the second seal-forming structure 3102 to conform to the patient's face. To maintain patient comfort, the corners and / or ridges 3120 are selected and / or sized to generally match the geometry (e.g., contours) of the patient's face. For example, the seal-forming structure 3100 for a particular patient can be selected from a variety of sizes to roughly conform to the alar region (i.e., proximal region 1010). The sharper curvature allows the second seal-forming structure 3102 to seal over various crevices around the patient's nose, reducing the likelihood of crevices forming.

[0895] Specific as Figure 14-16 As shown, in one form of the technology, the support portion 3260 is connected to the front side of the mouth 3201 of the pneumatic chamber, adjacent to the boundary 3241 of the mouth 3201 and the nose 3202. In some embodiments, when viewed in a cross-section parallel to the sagittal plane (e.g., Figure 16-18 ) and / or when viewed in cross-section parallel to the front plane (as Figure 14 and 15 As shown), the support portion 3260 can be curved. The curvature can be positive or negative. In the example shown, the curvature can be negative (e.g., relative to the patient's nose). In some examples, the lateral sidewall portion 3245 of the pneumatic chamber 3200 can bend inward near the boundary 3241 with the nose 3202, and the support portion 3260 can be substantially adjacent to the adjacent lateral sidewall portion 3245. Figure 18As shown in FIG, at least a portion of the support portion 3260 can decrease in thickness between a first end 3261 proximate the front wall of the pneumatic chamber 3200 and a second end 3262 proximate the seal-forming structure 3100 when viewed in a cross-section parallel to the sagittal plane. For example, the support portion 3260 can be thicker near the first end 3261, which can help provide increased support and / or stiffness to the second seal-forming structure 3102. In some examples, the support portion 3260 can vary in thickness between 0.1 mm (e.g., near the second end 3262) and 3.5 mm (e.g., near the first end 3261). In some examples, the support portion 3260 can vary in thickness between 0.3 mm (e.g., near the second end 3262) and 3 mm (e.g., near the first end 3261). In some examples, the support portion 3260 can vary between a thickness of 1.3 mm (eg, near the second end 3262 ) and a thickness of 2.5 mm (eg, near the first end 3261 ).

[0896] Support portions 3260 having different geometries can be used for different patients. For example, a patient who requires more support and / or stiffness in the second seal-forming structure 3102 can use a seal-forming structure 3100 having a thicker (e.g., near the first end 3261 and / or at any location along the length) and / or more curved (e.g., a lower radius of curvature) support portion 3260. For example, a patient who desires a more flexible second seal-forming structure 3102 can use a seal-forming structure 3100 having a thinner (e.g., near the first end 3261 and / or at any location along the length) and / or less curved (e.g., a larger radius of curvature) support portion 3260.

[0897] Especially Figure 14 and 15 As shown, in one form of the technology, a support portion 3260 is connected to the mouth 3201 of the pneumatic chamber adjacent a boundary of a lateral sidewall portion 3245 of the mouth 3201 and a lateral sidewall portion 3246 of the nose 3202 .

[0898] In some forms of the technology, the support portion 3260 is shaped to provide a generally clear flow path from the mouth 3201 of the pneumatic chamber to the nostrils 3135 during inhalation. In some forms of the technology, no portion of either support portion 3260 is directly below the nostrils 3135.

[0899] 5.3.4 Over-tensioning of supports

[0900] like Figures 43-45As shown, the patient interface 3000 can include a stop rib 6040 within the cavity 3272 of the pneumatic chamber 3200. The stop rib 6040 can be positioned within the mouth 3201 of the pneumatic chamber 3200 and provide support around the patient's mouth. The stop rib 6040 can be integrally formed with the pneumatic chamber 3200 (e.g., during the same molding process) such that the stop rib 6040 is formed as a single piece with the remainder of the pneumatic chamber 3200.

[0901] like Figure 43 As shown, the patient interface 3000 may include a plurality of stop ribs 6040 that extend at least partially around the periphery of the mouth 3201 of the pneumatic chamber 3200 and the first seal-forming structure 3101. Figure 43 As shown, the stop rib 6040 may extend only partially around the patient interface 3000 (e.g., in a C-shape or U-shape), and no stop rib 6040 may be disposed adjacent to (e.g., directly in front of) the upper lip portion 3131. In other forms, the stop rib 6040 may extend around the entire perimeter of the mouth portion 3201 and the first seal-forming structure 3101, or may extend around the mouth portion 3201 and the first seal-forming structure 3101. Figure 43 The different sections shown are extended.

[0902] Continue to refer to Figure 43 , the stop ribs 6040 are spaced apart from one another such that no stop rib 6040 contacts any other stop rib 6040. In some forms, the stop ribs 6040 may be equally spaced such that an equal distance exists between each pair of adjacent stop ribs 6040. In other forms, the stop ribs 6040 may be unevenly spaced such that at least some pairs of stop ribs 6040 are closer together than other stop ribs. For example, the stop ribs 6040 may be closer together at a location that is more suitable for contacting a patient's face with force (e.g., near the nasolabial groove).

[0903] like Figures 44 to 45-1 As shown, the stop ribs 6040 can be elongated members extending from the inner surface of the pneumatic chamber 3200 toward the seal-forming structure 3100. The stop ribs 6040 can be connected to the mouth 3201 of the pneumatic chamber 3200 and at least partially spaced apart from the first seal-forming structure 3101 in the rest or non-use position. For example, the edge 6042 (e.g., the rear edge) of each stop rib 6040 can be angled (e.g., not perpendicular to the front-to-back direction). This can provide additional spacing between the stop ribs 6040 and the first seal-forming structure 3101 in the non-use position.

[0904] In use, the patient's face contacts the seal-forming structure 3100 and pushes the first seal-forming structure 3101 in a forward direction. Because each patient can individually tighten the headgear straps 3354 (described in more detail below), the patient may overtighten the headgear straps 3354 and cause the seal-forming structure 3100 to be pressed too firmly against the patient's face. If the overtightened seal-forming structure 3100 folds or wrinkles and allows pressurized air to escape the pneumatic chamber 3200, this may cause discomfort to the patient and / or may reduce the quality of the seal. To limit the occurrence of overtightening, the stop ribs 6040 are spaced apart from the first seal-forming structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the first seal-forming structure 3101 contacts each stop rib 6040 along its width (e.g., a narrow width measured generally parallel to the first seal-forming structure 3101) at an edge 6042. Because the stop ribs 6040 are longer than they are wide, the stop ribs 6040 act as reinforcements and limit the total distance that the first seal-forming structure 3101 can move. The stop ribs 6040 can also be thicker than the first seal-forming structure 3101 in any direction. This can allow the stop ribs 6040 to be sized so that the patient can tighten the headgear straps 3354 to a desired point to form a desired seal, but not beyond that desired point to minimize discomfort and / or seal degradation. The inclination of the edge 6042 can allow the patient's face to have enough room to fit comfortably within the pneumatic chamber 3200, while also limiting excess space (e.g., which could result in over-tightening) and providing support for the patient's face. The stop ribs 6040 can also include a curvature along the width surface (see, e.g., Figure 45-1 ).

[0905] Additionally, each stop rib 6040 can extend more than half (eg, two-thirds, three-quarters, etc.) along the length of the first seal-forming structure 3101 . This can help ensure that movement is limited to substantially the entire first seal-forming structure 3101 .

[0906] like Figures 47-49 As shown, the patient interface 3000 can include a reinforced region 6044 within the cavity 3272 of the pneumatic chamber 3200. The reinforced region 6044 can be disposed within the mouth 3201 of the pneumatic chamber 3200 and provide support around the patient's mouth. The reinforced region 6044 can be integrally formed with the pneumatic chamber 3200 (e.g., during the same molding process) such that the reinforced region 6044 is formed as a single piece with the remainder of the pneumatic chamber 3200.

[0907] A reinforced region 6044 can be formed on a front surface 6046 of the pneumatic chamber 3200 within the cavity 3272 and proximate a lateral side of the mouth 3201. The reinforced region 6044 can be positioned directly across from the patient when the patient interface 3000 is worn. The reinforced region 6044 can be generally symmetrical on either side of the mouth 3201 and can extend around a side region 6048 of the pneumatic chamber 3200.

[0908] like Figure 47 As shown, the reinforced region 6044 can have substantially the same height as the inlet port 3604. In other words, the reinforced region 6044 can extend generally along the length of the mouth 3201 of the pneumatic chamber 3200. In some forms, the thickness can vary along the reinforced region 6044. For example, the reinforced region 6044 can be thicker near the inlet port 3604 and can decrease in thickness away from the inlet port 3604 (although this can also be reversed). In other examples, the reinforced region 6044 can be thicker near the lower portion of the mouth 3201 and thinner near the upper portion of the mouth 3201 (e.g., near the nose 3202), although these can be reversed.

[0909] like Figure 47-1 As shown, some forms of the reinforced area 6044 may be about 0.01mm to about 10mm thicker than the surrounding unreinforced areas. In some forms, the reinforced area 6044 may be about 0.1mm to about 5mm thicker than the surrounding unreinforced areas. In some forms, the reinforced area 6044 may be about 1mm to about 2mm thicker than the surrounding unreinforced areas. In some forms, the reinforced area 6044 may be about 1.8mm thicker than the surrounding unreinforced areas. In some forms, this may be a constant thickness across the reinforced area 6044, while in other examples, this may be a maximum value across the variable thickness of the reinforced area 6044.

[0910] like Figure 48 and 49 As shown, an alternative form of the reinforced area 6044 can be smaller than Figure 47 In an alternative embodiment, the reinforced region 6044 may be provided near the lower portion of the mouth 3201 of the pneumatic chamber 3200. The reinforced region 6044 may also extend in an inclined direction. For example, each reinforced region 6044 may be inclined in an up-down direction such that the reinforced region 6044 is located further up near the inlet port 3604 than it is away from the inlet port 3604.

[0911] Figure 48 and 49Some forms of the reinforced area 6044 may extend only along the front surface 6046 of the cavity 3272 and may not extend along the side areas 6048 of the pneumatic chamber 3200. During use, the reinforced area 6044 may be positioned directly in front of the patient's face. Figure 49 As shown, the reinforcement region 6044 can extend to the side region 6048 (e.g., adjacent to or contacting the side region 6048), but may not extend around the side region 6048.

[0912] like Figure 48 As shown, the thickness of the reinforced region 6044 can vary across its surface. For example, the reinforced region 6044 can be thicker near the center and thinner near the sides. Although this can be reversed in other examples. In some forms, the reinforced region 6044 can be stepped so that there is no gradual transition between the thicker and thinner portions. In other examples, the transition can be gradual.

[0913] When using Figures 47-49 When the patient interface 3000 is positioned, the patient's face contacts the seal-forming structure 3100 and pushes the first seal-forming structure 3101 in a forward direction. Because each patient can individually tighten the headgear straps 3354 (described in more detail below), the patient may overtighten the headgear straps 3354 and cause the seal-forming structure 3100 to be pressed too firmly against the patient's face. If an overtightened seal-forming structure 3100 folds or wrinkles and allows pressurized air to escape the pneumatic chamber 3200, this may cause discomfort to the patient and / or may reduce the quality of the seal. To limit the occurrence of overtightening, the reinforced region 6044 is spaced apart from the first seal-forming structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the reinforced region 6044 limits compression of the first seal-forming structure 3101 in the forward direction. The reinforced region 6044 can function similarly to the stop rib 6040 and limit the total distance that the first seal-forming structure 3101 can move. However, the reinforced area 6044 may not provide a stop, but rather may limit compression because thicker areas require more force to compress. The reinforced area 6044 may be sized so that the patient can tighten the headgear strap 3354 to the desired point to form the desired seal, but not beyond the desired point to minimize discomfort and / or seal degradation.

[0914] 5.3.5 Positioning and stabilizing the structure

[0915] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state during use by a positioning and stabilizing structure 3300 .

[0916] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the positive pressure in the pneumatic chamber 3200 to lift off the face.

[0917] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0918] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potentially damaging effects of forces acting on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0919] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0920] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0921] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0922] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front portion of the positioning and stabilizing structure 3300 and the back portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible strap or soft band. The decoupling portion is constructed and arranged such that when a patient lays their head on the pillow, the presence of the decoupling portion prevents forces at the back portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0923] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap configured from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material to partially engage with the hook material.

[0924] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is extendable, for example, elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0925] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that in use at least a portion of a lower edge of the first strap passes over the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0926] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that, in use, at least a portion of an upper edge of the second strap passes below the subauricular base of the patient's head and overlies or lies below the occipital bone of the patient's head.

[0927] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a third strap that is constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0928] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0929] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises straps that are configured to be breathable to allow moisture vapor to be transferred through the straps.

[0930] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide a retention force corresponding 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 heads but not for small heads, while another form of positioning and stabilizing structure is suitable for small heads but not for large heads.

[0931] Figure 21 and 22 An embodiment is shown having a connector 3310 (eg, a magnetic connector) for connecting to the positioning and stabilizing structure 3300.

[0932] In some versions, the straps of the positioning and stabilizing structure 3300 can be constructed of a stretchable (e.g., elastic) material. The positioning and stabilizing structure 3300 can stretch to accommodate patients with different head sizes.

[0933] In some embodiments, the straps of the positioning and stabilizing structure 3300 can be constructed from at least partially inextensible material. This can limit the straps' ability to stretch. Different sized straps can be used for patients of different sizes to accommodate different head sizes. The straps of the positioning and stabilizing structure 3300 can also be adjustable in length.

[0934] like Figure 23-2 、 24-1 , 42-2, 55-1 and 56-1, some forms of the positioning and stabilizing structure 3300 may include an upper strap 3357 that covers the patient's parietal and / or frontal bones during use. The upper strap 3357 can be adjustable in length to accommodate heads of different sizes (e.g., using buckles 3369). Each patient can tighten or loosen the upper strap 3357 to fit their individual head. Tightening or loosening the strap adjusts the tension in the upper strap 3357 to provide comfort for the patient wearing the positioning and stabilizing structure 3300.

[0935] 5.3.5.1 Framework

[0936] like Figures 23 to 28-2 As shown, the frame 3350 is coupled to the pneumatic chamber 3200 and helps maintain the seal-forming structure 3100 in a therapeutically effective position. Figures 23 to 28-2 The illustrated pneumatic chamber 3200 specifically shows an elbow 3500 connected to the front of the patient's face, although the frame can be used with other types of pneumatic chambers 3200 (e.g., Figure 21-22 The pneumatic chamber 3200 is used in conjunction with a catheter headband.

[0937] In some versions, the frame 3350 is constructed of a rigid or semi-rigid material and provides support for the seal-forming structure 3100 and / or the pneumatic chamber 3200. For example, the frame 3350 can help maintain the shape of the seal-forming structure 3100 and / or the pneumatic chamber 3200 to reduce leakage of pressurized air due to folding and / or wrinkling when the seal-forming structure 3100 engages the patient's face.

[0938] In some embodiments, the frame 3350 provides at least one connection point 3352 that can help indirectly connect the headgear strap 3354 to the pneumatic chamber 3200 and / or the seal-forming structure 3100. The connection point 3352 can be a loop (e.g., having a fully formed perimeter) that accommodates a portion of the headgear strap 3354. For example, a length of the upper left headgear strap 3356 can be passed through the first loop 3352a and pulled away from the pneumatic chamber 3200 to apply tension to the upper left headgear strap 3356. The upper left headgear strap 3356 can be folded against itself and retained at a selected length (e.g., using Velcro, magnets, adhesive, etc.) to maintain the applied tension. Similar steps can be performed with respect to adjusting the tension in the upper right headgear strap 3358 in the second loop 3352b. In other embodiments, the connection point 3352 can include an open perimeter (e.g., U-shaped or C-shaped).

[0939] In some forms, each loop 3352a, 3352b can be oriented such that the force vector applied by the corresponding upper headgear strap 3356, 3358 is substantially perpendicular to the loop inner surface 3351 that the upper headgear strap 3356, 3358 contacts. Figure 23 As shown, the right upper headgear strap 3358 engages the ring 3352b approximately at the center of the ring's inner surface 3351. When the right upper headgear strap 3358 is tightened, the force vector is applied in a substantially straight direction, rather than being angled relative to the ring's inner surface 3351. This can improve the seal of the seal-forming structure 3100 because the force is directed along the arm 3362, rather than being angled relative to the arm 3362, which may require further tightening of the upper headgear straps 3356, 3358 to achieve the same sealing effect (e.g., at the expense of patient comfort) and / or can prevent the seal-forming structure 3100 from properly engaging the patient's face (e.g., causing leakage).

[0940] like Figure 41 and 42 As shown, the upper headgear straps 3356, 3358 can include varying widths along their lengths. For example, a first portion of each strap 3356, 3358 can be formed to have a first width 3359, and a second portion of each strap 3356, 3358 can be formed to have a second width 3361 that is greater than the first width. In some embodiments, a majority of the upper headgear straps 3356, 3358 can be formed to have the second width 3361.

[0941] Although not shown, the lower headgear straps 3366, 3368 may also include different widths (e.g., and include a tapered shape) similar to the description of the upper headgear straps 3356, 3358. Thus, any description related to the upper headgear straps 3356, 3358 may apply to the lower headgear straps 3366, 3368.

[0942] In the example shown, each upper headgear strap 3356, 3358 can taper between a first width 3359 and a second width 3361. The upper headgear straps 3356, 3358 can include a substantially linear side 3363 between the first width 3359 and the second width 3361. In other examples, the upper headgear straps 3356, 3358 can curve between the first width 3359 and the second width 3361. In other examples, the upper headgear straps 3356, 3358 can include no transition between the first width 3359 and the second width 3361, and can instead be stepped between the first width 3359 and the second width 3361.

[0943] like Figure 41-1 and 41-2 As shown, additional feedback features may be used to warn the patient that the upper headgear straps 3356, 3358 are over-tightened. The illustrated example shows these features independently incorporated into the upper headgear straps 3356, 3358 (e.g., in straps having a substantially uniform width). However, Figure 41-1 and 41-2 The feedback feature can be combined with Figure 41 In the tapered structure (or stepped strap).

[0944] like Figure 41-1 As shown, the upper straps 3356, 3358 may include dots 6128 (e.g., silicone dots). The dots 6128 may provide increased resistance when the straps are threaded through the corresponding loops 3352a, 3352b of the frame 3350. In other words, these dots 6128 may rub against the corresponding loops 3352a, 3352b and provide a tactile response to the patient, which may alert the patient that the upper headgear straps 3356, 3358 are overtightened.

[0945] In some forms, the point 6128 may be raised from the surface of the straps 3356, 3358 so as to contact the loops 3352a, 3352b and provide a tactile response to the patient.

[0946] In the illustrated form, point 6128 is used with a strap of substantially uniform width. The width can be approximately the width of the corresponding loop 3352a, 3352b (e.g., at least a portion of the strap width can be slightly larger than the width of the loop 3352a, 3352b). If a patient attempts to pull either of the upper straps 3356, 3358 through the corresponding loop 3352a, 3352b, point 6128 will provide further resistance to movement through the loop 3352a, 3352b. For example, the patient may feel a vibration of point 6128 contacting the loop 3352a, 3352b.

[0947] In another embodiment, point 6128 is used in addition to the tapered shape of upper straps 3356, 3358. Thus, point 6128 can serve as an additional signal to the patient that upper straps 3356, 3358 are overtightened. In other words, point 6128 can be located on the portion of each upper strap 3356, 3358 having second width 3361. If the patient attempts to pull the second width 3361 of either upper strap 3356, 3358 through the corresponding loop 3352a, 3352b, point 6128 will provide further resistance to movement through the loop 3352a, 3352b.

[0948] In some embodiments, the dots 6128 may be evenly distributed across the upper straps 3356, 3358. In other embodiments, the dots 6128 may be unevenly distributed. For example, the concentration of dots 6128 may increase in a direction away from the free end of the respective strap 3356, 3358. This may provide an initial warning to the patient of possible overtightening and may transition to a greater number of dots 6128 to warn the patient that overtightening has occurred.

[0949] In other examples (see, e.g., Figure 41-1-1 ), points 6128 can be used to help guide the patient to the correct position. For example, points 6128 can be arranged in a linear pattern that is evenly spaced. As the patient passes straps 3356, 3358 through corresponding loops 3352a, 3352b, points 6128 can provide feedback at each interval to convey how far the straps have been inserted (e.g., similar to holes in a belt). In other words, the patient can adjust the straps to a specific position based on the number of discrete feedback signals they receive.

[0950] In some forms, this can help provide a more customized adjustment for the patient's head. Point 6128 can alert the patient to a specific strap length that is beneficial for their head, rather than simply warning of over-tightening.

[0951] In some embodiments, the shape, size, and / or density of the points 6128 can vary along the length of the straps 3356, 3358. For example, the points 6128 can be evenly (or substantially evenly) spaced before overstretching to help the patient select the appropriate length, as described above. The configuration of the points 6128 can change (e.g., become more densely packed) at locations on the strap that would cause the patient to overtighten the straps 3356, 3358. The change in the configuration of the points 6128 can produce a different tactile response, which can warn the patient of overtightening.

[0952] In some forms, the points 6128 may extend substantially across the entire length of the respective straps 3356, 3358. This may provide a tactile cue for patients with a wide range of head sizes. In this example, the points 6128 may be substantially evenly spaced (although variations are possible in the configurations described above). The points 6128 may allow the patient to consistently select a desired position, rather than being warned of a specific over-tightened position.

[0953] Although the above description refers to "dots", any suitable shape may be used. For example, the silicone gel (or other similar material) may comprise a triangle, rectangle or any other similar shape.

[0954] like Figure 41-2 As shown, upper straps 3356, 3358 may include cut edges 6132 (e.g., square cuts, triangular cuts, circular cuts, etc.). Cut edges 6132 may provide a tactile response to the patient, which may warn the patient that upper straps 3356, 3358 are too tight.

[0955] In the illustrated form, the cutting edge 6132 is used with a strap having a substantially uniform width. The width can be approximately the width of the corresponding loop 3352a, 3352b (e.g., at least a portion of the strap width can be slightly greater than the width of the loop 3352a, 3352b). If the patient attempts to pull the upper strap 3356, 3358 through the corresponding loop 3352a, 3352b, the change between the full width and the discontinuity of the cutting edge 6132 will provide further guidance to the patient to stop tightening the upper strap 3356, 3358 through the loop 3352a, 3352b.

[0956] In other embodiments, cutting edges 6132 are used in addition to the tapered shape of upper straps 3356, 3358. Thus, cutting edges 6132 can serve as an additional signal to the patient that upper straps 3356, 3358 are being overtightened. In other words, cutting edges 6132 can be positioned on the portion of each upper strap 3356, 3358 having second width 3361. If the patient attempts to pull the second width 3361 of upper straps 3356, 3358 through the corresponding loops 3352a, 3352b, the change between the discontinuity of second width 3361 and cutting edges 6132 will provide a further indication to the patient to stop tightening upper straps 3356, 3358 through the loops 3352a, 3352b.

[0957] In some embodiments, the cutting edges 6132 may be evenly distributed along a portion of the upper straps 3356, 3358. In other words, the distance between each adjacent cut on each cutting edge 6132 may be equal. In other embodiments, the cutting edges 6132 may be unevenly distributed. For example, the distance between each cut and / or the size of the cuts on the cutting edge 6132 may decrease in a direction away from the free end of each upper strap 3356, 3358.

[0958] In other examples, the cutting edges 6132 can be used to help guide the patient into the correct position. For example, the cutting edges 6132 can be arranged in a linear pattern that is evenly spaced apart. As the patient passes the straps 3356, 3358 through the corresponding loops 3352a, 3352b, the cutting edges 6132 can provide feedback at each interval to convey how far the straps have been inserted (e.g., similar to holes in a strap). In other words, the patient can adjust the straps to a specific position based on the number of discrete feedback signals they receive.

[0959] In some forms, this can help provide a more customized adjustment for the patient's head. The cutting edge 6132 can alert the patient to a specific strap length that is beneficial for their head rather than simply warning of over-tightening.

[0960] In certain embodiments, the shape, size, and / or density of the cutting edges 6132 may vary along the length of the straps 3356, 3358. For example, the cutting edges 6132 may be evenly (or substantially evenly) spaced apart before overstretching to help the patient select an appropriate length, as described above. The configuration of the cutting edges 6132 may be changed (e.g., made smaller and / or closer together) at locations on the strap that would cause the patient to overtighten the straps 3356, 3358. Changes in the configuration of the cutting edges 6132 may produce different tactile responses, which may warn the patient of overtightening.

[0961] In some embodiments, the cutting edges 6132 may extend substantially the entire length of the respective straps 3356, 3358. This may provide a tactile cue for patients with a wide range of head sizes. In this example, the cutting edges 6132 may be substantially evenly spaced (although variations are possible in the configuration described above). Instead of warning of a specific over-tensioning position, the cutting edges 6132 may allow the patient to consistently select a desired position.

[0962] In use, each upper headgear strap 3356, 3358 is threaded through the corresponding loop 3352a, 3352b as described above. Because the first width is smaller than the width of the loops 3352a, 3352b, the first width 3359 can be selectively inserted through the opening of the corresponding loop 3352a, 3352b. The width of at least some transitions can also be smaller than the width of the loops 3352a, 3352b so that the transitions can also be received through the openings. However, the second width 3361 can be larger than the width of the loops 3352a, 3352b and may not be able to slide through either opening. The larger second width 3361 can provide a stop and limit the total length that can be passed through the corresponding loop 3352a, 3352b. Due to the second width 3361, this can reduce excessive strain on the patient. In some embodiments, the length of the upper headgear straps 3356, 3358 having the first width 3359 (or the length of the first width 3359 plus the transition 3363) can be designed for patients with larger heads. Thus, the upper headgear straps 3356, 3358 can be adjusted to achieve a desired tightness before or after the second width reaches the corresponding loops 3352a, 3352b. For patients with smaller heads, if the upper headgear straps 3356, 3358 are adjusted to the second width 3361, they may be under greater tension. However, the second width 3361 still prevents the patient from over-tightening the upper headgear straps 3356, 3358 and limits deformation of the seal-forming structure 3100 and leakage. Alternatively, different sizes of positioning and stabilising structure 3300 may be constructed for patients with different sized heads (ie, such that second width 3361 acts as a stop to limit over-straining for patients with a variety of head sizes).

[0963] In other examples, strap extensions may be connected to the upper headgear straps 3356, 3358 to provide a greater length of the first width 3359. This may allow a single positioning and stabilizing structure 3300 designed for smaller patient heads to be used with larger patient heads.

[0964] In some embodiments, the strap extension may have dual-sided connectors. The illustrated examples show the same type of connector on each side, but the connectors may be different on each side. For example, the strap extension may include hook and loop material. In some embodiments, loop material is formed on both sides, while in other embodiments, hook material is formed on both sides. In other embodiments, hook material is formed on one side and loop material is formed on the other side.

[0965] In some forms, strap extensions may be used to provide additional length so that the patient does not overstretch the straps (eg, upper straps 3356, 3358 and / or lower straps 3366, 3368).

[0966] In some forms, the strap extension may include Figures 41 to 41-5 For example, the strap extensions may include features similar to those shown in FIG. Figure 41 The tapered shape shown may also include a stepped shape. This may limit the distance the strap extension may pass through loops 3352a, 3352b to prevent over-tightening. The strap extension may also include a point 6128 as described above (see, e.g., Figure 41-1 ) and / or cutting edges (see, e.g., Figure 41-2 ) to provide an indication of over-tightening (e.g., a tactile response). The strap extension may also include a similar Figures 41-3 to 41-5 The hidden portion 3365 can provide a visual and / or tactile indication of over-tensioning. The hidden portion 3365 can also be referred to as an alarm portion.

[0967] exist Figures 41 to 41-5 Any features described in and included in the strap extender can alert the patient to adjust the strap extender relative to the headgear strap 3354. In some forms, this can involve adjusting the attachment location of the strap extender relative to the corresponding strap on the headgear (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368). For example, the patient can attach the strap extender closer to the portion having the second width 3361 to shorten the effective length of the strap, or can attach the strap extender closer to the portion having the first width to increase the effective length of the strap.

[0968] In some forms, the straps of the headgear strap 3354 (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368) may include extended lengths of connectors configured to interface with connectors on strap extensions. For example, the upper straps 3356, 3358 may include hook or loop material along at least a portion of the first width 3359 and / or a portion of the second width 3361.

[0969] The patient can adjust the position of the strap extensions along the length of the corresponding strap to select the appropriate usable length for the patient (eg, such that there is sufficient sealing force without over-extending the strap).

[0970] In some versions, there may be different sizes of strap extensions (e.g., small, medium, large) so that the patient can make the appropriate adjustment for their particular head and reduce the variation of overstretching the strap extensions.

[0971] Alternatively, or in addition, the upper headgear straps 3356, 3358 may be constructed from an elastic material. As the elastic material stretches under tension, it may change visual appearance (e.g., may change color). The expansion of the headgear straps 3356, 3358 may also provide the patient with a tactile response that the straps 3356, 3358 are overstretched. This change in visual appearance may alert the patient (or a third party, such as a bed partner) that the upper headgear straps 3356, 3358 are over-tensioned. This may be beneficial if the patient has fully tightened the upper headgear straps 3356, 3358 before the second width reaches the corresponding loops 3352a, 3352b.

[0972] For example, Figures 41-3 to 41-5 Examples of straps (e.g., upper headgear straps 3356, 3358) are illustrated that may include features that warn the patient that the straps have been overstretched, which may warn the patient that the straps should be loosened and / or that a different sized (e.g., larger) headgear strap 3354 is required.

[0973] exist Figure 41-3 , an exemplary strap is shown in a first position. This may be a position prior to use by a patient, wherein the strap is unstretched. Figure 41-3 Also shown is a strap tightened to the correct length. For example, the strap can be used by a patient and adjusted to the appropriate length so that it is not overstretched.

[0974] exist Figure 41-4 , an exemplary strap is shown in a second position, stretched and / or extended from the initial position. As described above, the strap can include a portion 3365 that is normally hidden but exposed in the second position. For example, hidden portion 3365 can be elastic and extend to a different length when the tension applied to the strap exceeds a threshold. Hidden portion 3365 can be a different color and / or texture to alert the patient that the tension in the strap has exceeded a predetermined limit. This change in appearance and / or feel can alert the patient that the strap is overstretched.

[0975] In some forms, the hidden portion 3365 can be luminous and can glow when exposed. In a dark room, the glow from the hidden portion 3365 can be observed, thereby warning the patient of an overstretch of the headgear strap 3354.

[0976] In some forms, the concealed portion 3365 may include a noise output device (e.g., a speaker) that outputs a sound to alert the patient when the concealed portion 3365 is exposed.

[0977] In some embodiments, the concealed portion 3365 may include electronic components (e.g., light-emitting elements) that output light when the concealed portion 3365 is exposed. The output of light may alert the patient that the headgear strap 3354 is overstretched. In certain embodiments, the headgear strap 3354 may include a battery (not shown) and / or electrical wiring for powering the electrical components.

[0978] In some forms, the patient may not be able to see that the strap has exceeded a threshold tension and hidden portion 3365 has been exposed (e.g., when worn by the patient, the strap may no longer be visible to the patient). Figure 41-5 As shown, the strap may include a tactile responsive element 3367 that may provide a tactile response to the patient to provide an indication that the tension in the strap has exceeded a certain threshold.

[0979] In some embodiments, tactile responsive element 3367 is a pair of magnets. When the strap is in the first position, magnets 3367 are connected to each other. When the tension in the strap exceeds the magnetic force, magnets 3367 separate, revealing hidden portion 3365. Thus, before magnets 3367 separate, the strap can be under tension and can stretch (e.g., if elastic).

[0980] When the magnets 3367 separate, the patient can receive a release response. This can be in the form of a disconnection from the magnets 3367 along the strap and / or a vibration in an audible signal. Either or both of these situations may alert the patient that the strap is too tight. Removing excess tension in the strap allows the magnets 3367 to reconnect with each other.

[0981] In other forms, the tactile response element 3367 can be an alternative connector (e.g., a mechanical connector). For example, the tactile response element 3367 can be constructed of plastic and / or silicone. Instead of magnetic force, the tactile response element 3367 can be connected using a mechanical connection (e.g., a snap fit) or similar connection (e.g., a hook and loop connector). These alternative tactile response elements 3367 can have a retention force that allows some extension below the separation threshold before the tactile response element 3367 is separated. Similar to the magnet 3367, the separation of the tactile response element 3367 can generate a vibration that the patient can detect and determine that the strap is overstretched.

[0982] In some forms, the tactile responsive element 3367 can be wider than the strap. This can provide an additional visual cue for the patient to determine that the strap tension has exceeded a threshold.

[0983] Although not shown, Figures 41-3 to 41-5The overstretching feature shown and described in can also be incorporated into other straps on the headgear strap 3354. For example, the lower headgear straps 3366, 3368 can be tightened on the magnets in a similar manner so that overstretching can occur. Additionally or alternatively, the adjustable upper strap 3357 (see, e.g., Figure 23-2 、 24-1 , 42-2, 55-1, and 56-1) may include a hidden portion 3365 to warn the patient of over-tightening. The adjustable upper strap 3357 may also include a tapered strap to limit over-stretching. The tapered strap may be used with a strap extension to allow a single headgear strap 3354 to be used with multiple head sizes.

[0984] like Figures 41-6 to 41-8 As shown, the headgear strap 3354 may utilize a double-sided connecting member 6136 to allow the patient to adjust the available length. Figure 41-6 As shown, the double-sided connecting member 6136 can include hook material (or loop material) on both sides (e.g., the first side 6136-1 and the second side 6136-2 can be functionally identical). The patient can connect the hook material to the loop material (or hook material) of the headgear strap 3354 at the desired location. For example, the entire length of the headgear strap 3354 can include hook material, so that there are an unlimited number of positions to position the double-sided connecting member 6136. The patient can adjust the position as needed. For example, the patient can repeatedly connect and disconnect the double-sided connecting member 6136 from the headgear strap 3354. Once connected, the patient can use the headgear strap 3354 like other headgear straps 3354 and fold the free end of the strap back on itself to connect the exposed side of the double-sided connecting member 6136 to the headgear strap 3354 (e.g., in use, both sides are connected to the corresponding headgear strap 3354).

[0985] Because the double-sided connection member 6136 can include the same connection material on either side, the patient can connect either side to the headgear strap 3354.

[0986] In some forms, the double-sided connecting member 6136 may be used with a headgear strap 3354 that does not have a fixed connector.

[0987] like Figure 41-7 As shown, the double-sided connecting member 6136 can be positioned in a first position (e.g., near the free ends of the various straps). This can allow for a longer usable length of the headgear straps 3354. For example, a patient with a larger head can attach the double-sided connecting member 6136 in the first position to achieve a proper fit.

[0988] In the first position, a person with a smaller head may overtighten the headgear straps 3354 to achieve a proper fit. Thus, the patient may move the bilateral connecting members 6136 to the second position (i.e., away from the headgear). Figure 41-8 3354 ). This can create a smaller usable length so that patients with smaller heads can achieve a snug fit with the same headgear straps 3354 without excessive tension.

[0989] In some embodiments, the patient may cut the free ends of the straps beyond the location of the bilateral connecting members 6136. In other embodiments, the excess free ends may remain so that different patients (e.g., with different sized heads) may readjust the bilateral connecting members 6136 to fit their heads.

[0990] In some forms, a double-sided connecting member may have hook material on one side and loop material on the other side, such that the two sides are functionally different.

[0991] like Figure 27-2 As shown, some forms of the rings 3352a, 3352b may include an eyelet cutout 3353 that can be formed on the patient side of the corresponding ring 3352a, 3352b (e.g., the side that is closer to the patient's skin when in use). The eyelet cutout 3353 can form an area of ​​reduced thickness along the periphery of the corresponding ring 3352a, 3352b. The eyelet cutout 3353 can extend around a portion of the periphery of the corresponding ring 3352a, 3352b (e.g., less than 360°). In the example shown, when received by the ring 3352a, 3352b, the corresponding headgear strap 3354 can contact the eyelet cutout 3353. The reduced thickness of the eyelet cutout 3353 can result in less material being used to manufacture the rings 3352a, 3352b, which can result in lower manufacturing time and / or lower manufacturing costs. The eyelet cutouts 3353 may also (or instead) result in reduced skin markings and improved patient comfort.

[0992] In one embodiment, at least one of the loops 3352a, 3352b may not be formed completely around the outer periphery. In other words, the loops 3352a, 3352b may be C-shaped and / or U-shaped. The left and / or right upper headgear straps 3356, 3358 may be individually folded against themselves and then inserted through the respective loops 3352a, 3352b. This may allow the patient to maintain the same length adjustment in the respective upper headgear straps 3356, 3358 when the seal-forming structure 3100 is removed from the therapeutically effective position.

[0993] like Figure 35-2As shown, some versions of the frame 3350 include a ring 3352 having a raised profile. For example, the ring 3352b shown includes a protrusion 3390 adjacent to the arm 3362b. The sleeve 6124 can bend due to its connection to the arm 3362b. The protrusion 3390 can reflect the curvature of the sleeve to provide a more consistent interface between the ring 3352b and the sleeve 6124.

[0994] The projection 3390 may comprise a circular shape (e.g., a semicircular shape). In some forms, the projection 3390 may protrude by about 0.01 mm to about 1 cm. In some forms, the projection 3390 may protrude by about 0.05 mm to about 5 mm. In some forms, the projection 3390 may protrude by about 0.1 mm to about 3 mm. In some forms, the projection 3390 may protrude by about 0.5 mm to about 1.5 mm. In some forms, the projection 3390 may protrude by about 1.2 mm.

[0995] like Figures 52-54 As shown, some versions of the frame 3350 include alternative examples of rings 6080. In the example shown, the rings 6080 may include a double eye shape. For example, each ring 6080 may include the shape of two adjacent rings 3352a, 3352b with a dividing wall 6084 formed therebetween. The dividing wall 6084 may separate the rings 6080 into a first ring segment 6080-1 and a second ring segment 6080-2. The first ring segment 6080-1 may be adjacent to the corresponding arm 3362, and the second ring segment 6080-2 may form the free end of the frame 3350. The dividing wall 6084 may not extend completely across the width of the rings 6080, such that each ring 6080 includes a single opening (e.g., as opposed to if the dividing wall 6084 fully extended across two openings). In other words, the first and second ring segments 6080-1, 6080-2 are not completely separated, and the strap can move between these segments. The partition wall 6084 may be formed into two sections with a central space 6088 formed therebetween.

[0996] like Figure 53 As shown, the upper headgear straps 3356, 3358 can be connected to the corresponding rings 6080 in a similar manner as the rings 3352a, 3352b described above. For example, the upper headgear straps 3356, 3358 can be passed through the corresponding rings 6080 and apply a substantially perpendicular force against the dividing wall 6084 to maintain the seal-forming structure 3100 in a suitable sealing position.

[0997] Continue to refer to Figure 53The dividers 6084 can help the patient limit over-tightening of the upper headgear straps 3356, 3358. The width of each upper headgear strap 3356, 3358 can be greater than the space between the dividers 6084. Each upper headgear strap 3356, 3358 can rest on the corresponding divider wall 6084 and provide a rearward force when the strap is tightened. When the upper headgear straps 3356, 3358 remain slack or within the desired tension range, the upper headgear straps 3356, 3358 contact the divider wall 6084 and remain within the corresponding first loop segment 6080-1.

[0998] like Figure 54 As shown, if the user applies excessive tension (e.g., tightens the respective upper headgear straps 3356, 3358 at the upper end of the desired tension range), the upper headgear straps 3356, 3358 may move into the second loop section 6080-2. As a result of the excessive tension, the upper headgear straps 3356, 3358 may bend or fold. In other words, the excessive force pulls the respective upper headgear straps 3356, 3358 through the central space 6088 and into the second loop section 6080-2. The stiffness of the upper headgear straps 3356, 3358 may resist this bending motion (e.g., being pulled through the central space 6088) while the applied force remains within or below the desired tension range. Once the tension exceeds this range, the applied tension exceeds the stiffness of the upper headgear straps 3356, 3358 and causes the center of each upper headgear strap 3356, 3358 to bend (i.e., because the center is not supported by the dividing wall 6084). Once the upper headgear straps 3356, 3358 move through the central space 6088, the upper headgear straps 3356, 3358 contact the second loop segment 6080-2 and apply a vertical force. The movement of the upper headgear straps 3356, 3358 can alert the patient or a third party (e.g., via visual and / or tactile stimulation) that the upper headgear straps 3356, 3358 are tightened. The patient can loosen the upper headgear straps 3356, 3358 and reposition the upper headgear straps 3356, 3358 against the corresponding dividing wall 6084.

[0999] As a result of moving from the first loop segment 6080-1 to the second loop segment 6080-2, the tension in the upper headgear straps 3356, 3358 may also decrease because the upper headgear straps 3356, 3358 do not need to stretch as much in the second loop segment 6080-2. This may temporarily reduce the tension in the respective upper headgear straps 3356, 3358. However, there is nothing to prevent the tension from increasing further.

[1000] like Figure 55As shown, some versions of the frame 3350 can include ladder locks 6092 in place of the rings (rings 3352a, 3352b or ring 6080). The upper headgear straps 3356, 3358 can be threaded through the respective ladder locks 6092 to secure the seal-forming structure 3100 to the patient's face. In some versions, the ladder locks 6092 can be molded onto the arms 3362 of the frame 3350. In other examples, the ladder locks 6092 can be a separate element (e.g., if the two straps are connected together, such as on the upper region of the patient's head). For example, the housing 3371 can include the ladder locks 6092.

[1001] like Figure 56 As shown, some versions of the frame 3350 may include a stop 6096 that can help adjust the length of the upper headgear straps 3356, 3358. The stop 6096 can be connected to the arm 3362 and used in place of a loop (e.g., loops 3352a, 3352b or loop 6080). Each upper headgear strap 3356, 3358 can pass through a corresponding stop 6096. The stop 6096 may include a spring-loaded button 6100 that secures the corresponding upper headgear strap 3356, 3358 in place. The patient can actuate the button 6100 and move the corresponding upper headgear strap 3356, 3358 (e.g., tighten or loosen) to establish a proper fit. For example, the housing 3371 may include the stop 6096.

[1002] like Figures 24-28 As shown, some versions of frame 3350 include a central portion 3360 coupled to pneumatic chamber 3200. Central portion 3360 may have an annular shape and may have a profile corresponding to the shape of pneumatic chamber 3200 (eg, approximately a perfect dome curvature).

[1003] In one form, a single size of central portion 3360 can be used with various sizes of pneumatic chambers 3200 and / or seal-forming structures 3100. For example, the seal-forming structure 3100 can have multiple sizes (e.g., small, medium, large, etc.) and / or shapes (e.g., narrow, wide, etc.) to better seal with patients with various facial shapes. The engagement area of ​​central portion 3360 can remain substantially the same regardless of the size of pneumatic chamber 3200 and / or seal-forming structure 3100. Thus, central portion 3360 can be coupled to cushions of various shapes and / or sizes and provide substantially the same support.

[1004] In one form, the central portion 3360 can be removably coupled to the pneumatic chamber 3200. A patient can use the same frame 3350 with multiple pneumatic chambers 3200. This can be useful when a patient is first beginning treatment and trying out pneumatic chambers 3200 of different sizes in order to find the proper fit. Removing the frame 3350 is also helpful when cleaning the patient interface 3000, as different elements of the patient interface 3000 can be cleaned separately to help ensure a more thorough cleaning.

[1005] In other forms, different frames having differently sized and / or shaped central portions may be used with differently sized pneumatic chambers 3200 and / or differently sized patients to provide a comfortable fit for a wide variety of patients. Figures 36-39 As shown, the central portion 13360, 23360 of the frame 13350, 23350 may include a shape that allows for a comfortable seal when the patient uses a larger nose length (e.g., the distance between the patient's alar apex and nasal protuberance measured in the anterior-posterior direction).

[1006] like Figure 36 As shown, frame 13350 may include less than Figure 25 For example, when the corresponding frames 3350, 13350 are connected to the pneumatic chamber 3200, the upper rods 16036 on the frame 13350 can be positioned below the similar upper rods 6036. This can allow the upper portion of the pneumatic chamber 3200 (e.g., the nose 3202) and / or the seal-forming structure 3100 (e.g., the second seal-forming structure 3102) to move or flex when worn by the patient. This can be helpful for patients with larger noses. Although the higher upper rods 6036 (e.g., similar to the Figure 25 ) can provide a more rigid support, but the pneumatic chamber 3200 and / or the seal-forming structure 3100 may not be able to move enough to accommodate a larger nose. Lower the height of the upper rod 16036 (e.g., at Figure 36 Center) provides a bend and better fit in patients with larger noses.

[1007] like Figures 37-39As shown, the frame 23350 can include a center portion 23360 having an upper rod 26036 that is out of plane with respect to the remainder of the center portion 23360. For example, the upper rod 26036 can extend in a forward direction from the remainder of the center portion 23360 (e.g., when connected to the pneumatic chamber 3200). Thus, the upper rod 26036 can be spaced apart from the nose 3202 of the pneumatic chamber 3200. The center portion 23360 can include a substantially similar footprint as the center portion 3360 so that it can be used with the same pneumatic chamber 3200. However, the spacing between the pneumatic chamber 3200 and the upper rod 26036 can allow the pneumatic chamber 3200 and / or the seal-forming structure 3100 to further deform and comfortably accommodate a larger nose.

[1008] In some embodiments, the upper bar 26036 can still provide support for the patient during use. For example, by wearing the patient interface 3000, the patient can deform the nose 3202 of the pneumatic chamber 3200 so that the nose 3202 contacts the upper bar 26036. The upper bar 26036 can be far enough in the neutral (i.e., not worn) position to allow the nose 3202 to expand comfortably when worn by the patient, but contact the upper bar 26036, which provides support and limits excessive bending of the nose 3202. This can simulate the frame 3350, but its size is beneficial for patients with larger noses.

[1009] In some forms, the frame 3350 includes arms 3362 extending away from the central portion 3360. Rings 3352a, 3352b are formed at the ends of the arms 3362. In use, the arms 3362 can extend at least partially in a posterior direction, which can position the rings 3352a, 3352b further posteriorly than the pneumatic chamber 3200 and / or the seal-forming structure 3100. The arms 3362 can also extend in a lateral direction (e.g., left or right, respectively) so as to generally follow the contours of the patient's face.

[1010] In some embodiments, the arm 3362 engages a portion of the patient's face when the patient wears the patient interface 3000. For example, the arm 3362 may contact the patient's cheek. The arm 3362 may be shaped to correspond to the curvature of the patient's face (e.g., extending in a posterior and lateral direction).

[1011] In some embodiments, the arms 3362 may be substantially inextensible (e.g., the arms 3362 may be rigid and / or inextensible) due to the tension applied by the respective headgear straps 3356, 3358 via the respective loops 3352a, 3352b. Tension may be transferred along the arms 3362 to the pneumatic chamber 3200 and / or the seal-forming structure 3100 to maintain a therapeutically effective pressure and limit leakage.

[1012] In one form, the arms 3362 are constructed of a material that is more flexible than the material used to construct the center portion 3360. The two materials can be molded together so that the frame 3350 is configured as a one-piece, integral construction. The arms 3362 can have some rigidity to help maintain their shape. However, the arms 3362 can be flexible so that the patient can adjust the shape to correspond to their facial structure. Allowing the patient to adjust the shape of the arms 3362 can increase the comfort experienced by the patient, which can increase patient compliance with treatment. In this way, the arms 3362 can bend or flex relative to the center portion 3360 (e.g., due to a cantilevered configuration), but may not be able to extend further in a posterior direction (e.g., due to its inextensibility). Additionally, the relatively flexible material used to construct each of the arms 3362 can help reduce facial marking and increase patient comfort.

[1013] In one form, the arms 3362 and the center portion 3360 are made of the same material. The material provides sufficient flexibility to allow shape adjustment, and also provides sufficient rigidity to maintain the adjusted shape. Since the center portion 3360 is connected to the pneumatic chamber 3200, the center portion 3360 can be more rigid than the arms 3362. In addition or alternatively, the center portion 3360 can be thicker than the arms 3362, which can also result in an increase in the stiffness of the center portion 3360. Each arm 3362 is formed in a cantilever shape so that the end adjacent to the corresponding ring 3352a, 3352b is unsupported. In addition, the thickness of the frame 3350 can decrease along the length of each arm 3362 in the direction of the corresponding ring 3352a, 3352b (see, for example, Figure 27-1 ). This can provide each arm 3362 with the necessary flexibility to bend and / or shape to roughly correspond to the shape of the patient's face (e.g., cheek). Reducing the width of each arm 3362 can also reduce cheek contact between the corresponding arm 3362 and the patient's cheek, which can improve patient comfort. Reducing the width along the length of each arm 3362 can also allow greater flexibility in accessing each corresponding ring 3352a, 3352b.

[1014] In one form, the sleeve 6124 can be used with the arm 3362 to provide additional comfort to the patient. Figure 42-1 As shown, the sleeves 6124 can extend generally along the length of both arms 3362. For example, each sleeve 6124 can extend from a fixed end of each arm 3362 proximate the central portion 3360 of the frame 3350. Each sleeve 6124 can extend toward a free end of each arm 3362 proximate the ring 3352 (or 6080) of the frame 3350.

[1015] In the example shown, the sleeve 6124 may not cover the central portion 3360 or the ring 3352 (or 6080) of the frame 3350. In this way, the sleeve 6124 may not obscure the connection of the straps to the ring 3352 and / or may not obscure the connection of the central portion 3360 to the pneumatic chamber 3200. In other examples, the sleeve may be used with the central portion 3360 (e.g., to give the patient interface 3000 the appearance of bedding).

[1016] In some embodiments, the sleeve 6124 can be constructed of a comfortable material that is flexible and / or soft to the touch. As described above, the arms 3362 can be curved and / or shaped to conform to the shape of the patient's face (e.g., the patient's cheek). As a result, at least a portion of the arms 3362 is in close contact with the patient's skin. By including the sleeve 6124, the patient's skin can be in contact with a material that is comfortable to wear for extended periods of time. The material can be fabric and / or foam, or any similar material.

[1017] In some embodiments, the sleeves 6124 can be constructed of an elastic material. This can allow the sleeves to be stretched over the rings 3352, allowing the sleeves 6124 to be removed from the arms 3362 (e.g., for cleaning). In other examples, the sleeves 6124 can be wrapped around the arms 3362 using a hook and loop, magnetic, or mechanical connection. To remove the sleeves 6124 from the arms 3362, the connection can be disconnected.

[1018] In one form, each ring 3352 may include a protrusion 3390 having a circular shape. The protrusion 3390 may include a smooth surface in the direction from the ring 3352 toward the arm 3362, which may allow the sleeve 6124 to slide over the ring 3352 without obstruction. The end 3392 of the protrusion 3390 near the arm 3362 may be formed as a protrusion or overhang. This may limit the sleeve from sliding in the opposite direction (i.e., disengaging from the ring frame 3350 by sliding on the ring 3352).

[1019] In other forms (not shown), the arm 3362 may be formed only on the inner surface of the arm 3362 (e.g., including the scalloped portion 3373 (see, e.g., Figure 27 ) surface). This can be a piece of material that is connected to the surface of the sleeve that contacts the patient's skin during use instead of the sleeve. This material can be connected to the arm 3362 with an adhesive and can be removed and / or replaced with a new piece of material (e.g., a clean piece of material).

[1020] In some forms, the fixed end of each arm 3362 may have a thickness between about 2 mm and about 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 2.5 mm and about 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 3 mm and about 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 4 mm.

[1021] In some forms, the free end of each arm 3362 may have a thickness between about 0 mm and about 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 0.5 mm and about 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 1 mm and about 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 2 mm.

[1022] like Figure 27-3 As shown, some forms of the cross-section of each arm 3362 can be generally rectangular. The corners of the generally rectangular shape (e.g., one corner, two corners, four corners, etc.) can be rounded. This can help improve patient comfort by reducing sharp surfaces that contact the patient's skin. Each arm 3362 can also have a height that is greater than its thickness. The height can be designed to comfortably distribute pressure on the patient's skin (e.g., by increasing the height) without obstructing the patient's peripheral vision or otherwise causing discomfort to the patient.

[1023] In some forms, the height of each arm 3362 may be between about 5 mm and about 15 mm. In some forms, the height of each arm 3362 may be between about 6.5 mm and about 13.5 mm. In some forms, the height of each arm 3362 may be between about 8 mm and about 12 mm. In some forms, the height of each arm 3362 may be between about 9.5 mm and about 10.5 mm. In some forms, the height of each arm 3362 may be approximately 10 mm.

[1024] like Figure 35 As shown, some versions of the arms 3362 of the frame 3350 can include a rib 3394 that can extend from a lower surface of each arm 3362. Each arm 3362 can include at least one rib 3394. For example, the illustrated frame 3350 includes one rib 3394 on each arm 3362, with the ribs 3394 being arranged proximate the center portion 3360 of the frame 3350. In other examples, each arm 3362 can have more than one rib 3394, and / or the ribs 3394 can be arranged at different locations along the length of the arm 3362 (e.g., proximate the corresponding ring 3352 and / or on different surfaces of the arm 3362).

[1025] In some forms, each rib 3394 can comprise a rounded profile (e.g., having a semi-circular shape). The rounded profile can reduce or limit discomfort caused by sharp or angled shapes.

[1026] As described above, the sleeve 6124 can be positioned around each arm 3362 to provide additional comfort for the patient. The dimensions of the arm 3362 (e.g., the thickness, height, and cross-section described above) provide a surface for the sleeve 6124 to extend around. However, in some examples, the sleeve 6124 can be larger than the arm 3362 (e.g., due to passing over the ring 3352) and can sag on the corresponding arm 3362. For example, the height of the arm 3362 close to the ring 3352 can be greater. This may make the patient wearing the patient interface 3000 look and / or feel uncomfortable. The one or more ribs 3394 on each arm 3362 can provide additional height (and / or thickness, depending on the positioning of the rib 3394) to the arm 3362 so that the sleeve 6124 extends out and minimizes slack (e.g., to match the height of the arm 3362 close to the ring 3352).

[1027] The smooth profile of the ribs 3394 can limit snagging and / or tearing of the sleeve 6124 on the ribs 3394. It can also allow the sleeve 6124 to be connected to or removed from the arm 3362 without damaging the sleeve 6124.

[1028] like Figure 26-4 and 26-5 As shown, some forms of the frame 3350 can allow for pivotable movement between each arm 3362 and the central portion 3360. The pivotable movement can be the bending movement described above because the pivot point 6012 can connect each arm 3362 to the central portion 3360 and allow all arms 3362 to move approximately the same angular distance. As described above, in addition to pivoting, each arm 3362 can also bend.

[1029] In one form, the pivot point 6012 is positioned at approximately the same location on either side of the frame 3350. In other words, each arm 3362 can be connected to the central portion 3360 at approximately the same height, and each arm 3362 can extend approximately the same length past the pivot point 6012. This can allow the patient to make mirrored adjustments to the arms 3362. The patient can then flex or bend each arm individually to make specific adjustments to one side.

[1030] In one form, each pivot point 6012 is a living hinge. In other words, the frame 3350 can be constructed of a substantially uniform material (or the transition between each arm 3362 and the central portion 3360 can be constructed of a substantially uniform material). The thickness at each hinge 6012 can be significantly less than the thickness of the arm 3362 and the central portion 3360 immediately adjacent to the hinge 6012. For example, the hinge 6012 can be formed as a groove on the surface of the frame 3350 that faces away from the patient during use. Uniformly and integrally constructing the hinge 6012 from substantially the same material as the arms 3362 and central portion 3360 can help reduce manufacturing costs (e.g., compared to including hinges constructed from different materials).

[1031] Each arm 3362 can pivot between a first position and a second position about a corresponding hinge 6012. The rings 3352a, 3352b can be spaced closer together in the second position than in the first position.

[1032] In one form, the first position can be a relaxed position and the second position can be a biased position. When an external force is applied, the arm 3362 moves to the second position and can return to the first position when the external force is removed.

[1033] In one embodiment, the arms 3362 can be positioned in the first position or the second position without further application of external force. The arms 3362 can be moved into the second position so that the arms 3362 overlap each other (e.g., like glasses). This helps provide a small footprint for packaging and / or storage.

[1034] In other forms (not shown), each arm 3362 may be separate from the central portion 3360 and may be coupled to the central portion 3360 via a rotating hinge (e.g., a pin joint). In other forms, each arm 3362 may be coupled to the central portion 3360 by overmolding a flexible member therebetween, which may allow for some pivotal movement.

[1035] In some forms, the frame 3350 further includes at least one second connection point 3364 spaced apart from the rings 3352a, 3352b. The second connection point 3364 provides an additional connection location that can further help indirectly connect the headgear strap 3354 to the pneumatic chamber 3200 and / or the seal-forming structure 3100.

[1036] In some embodiments, the frame 3350 includes two second connection points 3364 (e.g., a left second connection point 3364a and a right second connection point 3364b). When the patient interface 3000 is worn by the patient, the second connection points 3364a, 3364b can be lower than the rings 3352a, 3352b. The headgear straps 3354 can also include a left lower headgear strap 3366 and a right lower headgear strap 3368, each of which is configured to couple to the corresponding second connection points 3364a, 3364b. The headgear straps 3354 as a whole can then provide force to the upper and lower regions of the seal-forming structure 3100 and / or the pneumatic chamber 3200.

[1037] In some forms, these second connection points 3364a, 3364b are formed directly on the central portion 3360. When the patient interface 3000 is worn by the patient, the second connection points 3364a, 3364b may be more anterior than the rings 3352a, 3352b.

[1038] In certain forms, these second connection points 3364a, 3364b may be formed from a single component, which may help reduce processing and / or manufacturing costs.

[1039] In some embodiments, the left and / or right lower headgear straps 3366, 3368 are removably coupled to respective second connection points 3364a, 3364b. The second connection points 3364a, 3364b can be magnetic, and the left and / or right lower headgear straps 3366, 3368 can be threaded through a housing 3371 that includes magnets 3370 having opposite polarity to the second connection points 3364a, 3364b. The housing 3371 can be flexible or semi-rigid to facilitate coupling and better retain the magnets in place. The length of the left and / or right lower headgear straps 3366, 3368 can be adjusted by folding the respective straps 3366, 3368 around the crossbar 3386 (e.g., as with the left and / or right upper headgear straps 3356, 3358). Additionally, the lower headgear straps 3366 , 3368 can include a first width 3359 and a second width 3361 . Figure 41 The straps shown in FIG33 may similarly be used as part of the lower headgear straps 3366, 3368. Thus, the lower headgear straps 3366, 3368 may include a stop having a second width 3361 to prevent or limit over-tightening. In some forms (not shown), the housing 3371 may include a pair of loops and the crossbar 3386 may not extend completely between the two loops. Thus, the housing 3371 may include Figures 52-54 , and can similarly warn the patient when the lower headgear straps 3366, 3368 are over-tightened. This can be combined with lower headgear straps 3366, 3368 having a first width 3359 and a second width 3361, or can be used instead.

[1040] Alternatively or additionally, the left and / or right lower headgear straps 3366, 3368 may include points 6128 and / or cut edges 6132 as shown on the upper headgear straps 3356, 3358 (see, e.g., Figure 41-1 and 41-2 ). The description of the points 6128 and / or cut edges 6132 on the upper headgear strap may also be applied to the lower headgear straps 3366, 3368 to warn the patient that the straps are overly tight.

[1041] In other examples, ladder locks 6092 and / or stops 6096 can be coupled to the frame 3350 to provide adjustment for the lower headgear straps 3366 , 3368 .

[1042] Each magnet 3370 can be removed from the corresponding second connection point 3364a, 3364b without changing the length adjustment of the left and / or right lower headgear straps 3366, 3368. The patient can don and / or doff the patient interface 3000 while only removing the magnet 3370 from the corresponding second connection point 3364a, 3364b (e.g., without having to remove the left and / or right upper headgear straps 3356, 3358 from the corresponding loops 3352a, 3352b).

[1043] like Figure 28-1 and 28-2 As shown, each second connection point 3364a, 3364b can be configured to improve retention with the corresponding magnet 3370. The housing 3376 of each second connection point 3364a, 3364b can include a generally flat (e.g., planar) surface 3378 and a lip 3380 extending from the flat surface 3378.

[1044] In the illustrated example, the outer shell 3376 can have a generally elliptical shape, and the lip 3380 can extend near the vertex of the planar surface 3378. The lip 3380 can also extend only a portion (e.g., less than 360°) around the planar surface 3378. In some examples, the lip 3380 can extend less than 180° around the planar surface 3378 (e.g., the lip 3380 may not extend to any common vertex of the generally elliptical planar surface 3378).

[1045] like Figure 28-2 As shown, each second connection point 3364a, 3364b can be coupled to the frame 3350 such that the lip 3380 is disposed proximate the center of the frame 3350. In other words, each second connection point 3364a, 3364b can be oriented such that the lip 3380 is disposed adjacent to the elbow 3500 when the frame 3350 is coupled to the pneumatic chamber 3200.

[1046] The magnet 3370 includes a substantially flat surface that can engage with the substantially flat surface 3378 of the housing 3376. While engaging the flat surface 3378, the magnet 3370 can magnetically couple to the magnetic element 3382 of the second connection points 3364a, 3364b. The overhang 3384 can be spaced apart from the magnet 3370. As shown, the overhang 3384 can be positioned on one side (e.g., the inner side) of the lip 3380, and the magnet 3370 can be positioned on the other side (e.g., the outer side) of the lip 3380. During use, the patient can adjust the length of the corresponding lower headgear strap 3366, 3368. Tightening one of the lower headgear straps 3366, 3368 can apply a force directed away from the center of the frame 3350 (e.g., in a laterally outward direction). This force can be greater than the magnetic force between the magnet 3370 and the magnetic element 3382 and can cause the magnet 3370 to move relative to the flat surface 3378.

[1047] The overhang 3384 can prevent the magnet 3370 from disengaging from the magnetic material 3382 due to tightening of the corresponding lower headgear straps 3366, 3368. When the magnet 3370 begins to move, the overhang 3384 can contact the lip 3380, thereby limiting further movement away from the center of the frame 3350. Thus, the engagement between the lip 3380 and the overhang 3384 helps reduce the inadvertent disconnection of the magnet 3370 from the corresponding second connection point 3364a, 3364b when tightening the corresponding lower headgear straps 3366, 3368, but does not limit the patient's ability to move the magnet 3370 generally perpendicular to the frame 3350 (e.g., to take off the positioning and stabilization structure 3300).

[1048] like Figure 29-35 As shown, other configurations may be used to improve retention of the connection points 3364a, 3364b with the corresponding magnets 3370. Figure 29-35 The forms described in can be used alone or in any combination with each other. Figure 29-35 Any of the forms described in Figure 28-1 and 28-2 for use with the lip 3380 shown in .

[1049] like Figure 29 and 30 As shown, the mouth 3201 of the pneumatic chamber 3200 may include at least one clip support 6016. Figure 29 As shown, the clip support 6016 can be radially arranged at the edge of the groove 3280 near the mouth 3201. In some forms, the second clip support 6016 can be arranged on the other side of the pneumatic chamber 3200 as shown. Figure 29. When the frame 3350 is connected to the pneumatic chamber 3200, the clip supports 6016 can be spaced apart from the frame 3350 (and therefore from the connection points 3364a, 3364b).

[1050] like Figure 29 As shown, some forms of the clip support 6016 can be spaced apart from the groove 3280 so that the distance between the corresponding connection points 3364a, 3364b and the clip support 6016 is approximately the length of the housing or connecting member 3371. In other words, the overhang 3384 (see, e.g., Figure 28-2 ) and crossbar 3386 (see, e.g., Figure 28 ) is approximately the length between the corresponding connection points 3364a, 3364b and the clip support 6016.

[1051] Continue to refer to Figure 29 , some forms of the clip support 6016 may protrude from the surface of the mouth 3201. The clip support 6016 may be integrally formed with the mouth 3201 as a single-piece construction (e.g., using an injection molding process). Accordingly, the clip support 6016 may be formed from the same material as the mouth 3201. For example, the clip support 6016 may be constructed from a silicone material and may be flexible, bendable, and / or compressible. The increased thickness of the clip support 6016 (e.g., compared to the rest of the mouth 3201) may limit the flexibility, bendability, and / or compressibility of the clip support 6016. The increased thickness may also enable the clip support 6016 to serve as an additional rigidifying member (e.g., in addition to the frame 3350) to further increase the stiffness of the mouth 3201.

[1052] In some forms, the clip support 6016 may also be curved or extend along an arcuate path. Figure 29 As shown, the clip support 6016 can include a constant curvature (although a varying curvature can be utilized). The center of curvature can be the location of the corresponding connection points 3364a, 3364b.

[1053] like Figure 46 As shown, some forms of the clip support 6016 can be connected to the channel rib 6052 and can be formed as a single molded piece. The shape can be changed along the length to separately form the clip support 6016 and the channel rib 6052. In other forms, the clip support 6016 can be spaced apart from the channel rib 6052.

[1054] like Figure 30As shown, the frame 3350 can be connected to the mouth 3201, and the magnets 3370 can be connected to the corresponding connection points 3364a, 3364b. The ends of the connecting members 3371 near the crossbar 3386 can extend upward to and / or slightly beyond the corresponding clip supports 6016. In some embodiments where the connecting members 3371 are rotatable relative to the frame 3350, the rotation of the connecting members 3371 can generally follow the curvature of the clip supports 6016, so that the connecting members 3371 extend the same distance relative to the clip supports 6016 throughout their angular movement.

[1055] In some forms, the height of the clip support 6016 from the mouth 3201 can be less than the distance between the cross bar 3386 and the mouth 3201. Thus, the cross bar 3386 and the clip support 6016 can be slightly spaced apart in an intermediate position. This spacing can provide clearance for the respective lower straps 3366, 3368 to extend around the cross bar 3386. Once the respective lower straps 3366, 3368 are connected to the respective connecting member 3371, the connecting member 3371 can be substantially close to or in contact with the clip support 6016. This can limit or prevent the connecting member 3371 from rocking and / or pivoting toward the surface of the mouth 3201. If the lip 3380 and the overhang 3384 (see, e.g., Figure 28-2 ) is not fully engaged, and / or if the patient presses against the connecting member 3371 near the cross bar 3386 (e.g., while the patient is sleeping), rocking or pivoting may occur. Due to the inclusion of the clip supports 6016, the cross bar 3386 contacts the clip supports 6016 prior to the substantial rocking or pivoting motion. Thus, if the patient inadvertently contacts the connecting member 3371 while sleeping, the magnets 3370 can remain connected to the corresponding connection points 3364a, 3364b, thereby helping to ensure that the seal-forming structure 3100 remains in its proper position. During use, the clip supports 6016 can be at least partially covered so that the patient interface 3000 can maintain its compact appearance.

[1056] like Figure 31As shown, an alternative form may include a clip support 6020 on the frame 3350 rather than on the pneumatic chamber 3200. The clip support 6020 can be integrally formed with the frame 3350. The clip support 6020 and the frame 3350 can be constructed of the same material, or different materials can be used to construct each (e.g., separate materials can be introduced into a mold to form the clip support 6020). The clip support 6020 can be shaped generally similar to the clip support 6016. For example, the clip support 6020 can extend beyond the corresponding connection points 3364a, 3364b by approximately the length of the connection member 3371. The clip support 6020 can also extend in a curved or arcuate path that can include a constant curvature around the corresponding connection points 3364a, 3364b.

[1057] In some forms, the clip support 6020 may be at least partially flush with the central portion 3360 of the frame 3350. For example, the interface between the proximal end of the clip support 6020 and the central portion 3360 may be substantially flush, such that the central portion 3360 and the clip support 6020 each have the same thickness. In other forms, the clip support 6020 may have a thickness that is less than that of the central portion 3360. In such cases, the clip support 6020 may be flush with only a portion of the central portion 3360 (e.g., the clip support 6020 may be flush with either the upper or lower edge of the central portion 3360).

[1058] In some forms, the distal end 6021 of the clip support 6020, opposite the proximal end, can be curved or bent and extend away from the surface of the mouth 3201. The curve or bend at the distal end 6021 can be Figure 29 and 30 A similarly shaped protrusion is formed in the clip support 6016. In other words, the distal end portion 6021 can extend the same distance from the surface of the mouth 3201. Therefore, the joined connecting member 3371 can be restricted or prevented from swinging or pivoting in substantially the same manner as the clip support 6016.

[1059] like Figure 32 and 33 As shown, the frame 3350 can include at least one rib 6024 near each connection point 3364a, 3364b. The ribs 6024 can limit the rotational movement of the connection member 3371, which can maintain the desired orientation of the lower straps 3366, 3368 (e.g., to maintain the appropriate force vector).

[1060] like Figure 32As shown, the central portion 3360 of the frame 3350 can include a pair of ribs 6024 adjacent to each connection point 3364a, 3364b. In the illustrated example, one rib 6024 can be positioned higher than the corresponding connection point 3364a, 3364b, and one rib 6024 can be positioned lower than the corresponding connection point 3364a, 3364b. In some embodiments, the ribs 6024 can be evenly spaced around the corresponding connection points 3364a, 3364b.

[1061] In the example shown, the ribs 6024 can be generally rectangular in shape, although any similar shape can be used (e.g., oval, circular, triangular, etc.). The ribs 6024 can protrude from the surface of the central portion 3360. In some forms, the ribs 6024 can extend to a height generally equal to the height of the connecting member 3371, although the ribs 6024 can extend to a position below the upper surface of the connecting member 3371.

[1062] When connected, each connection member 3371 fits between a corresponding pair of ribs 6024. Each rib 6024 can be in contact with the corresponding connection member 3371, or can be substantially adjacent to the corresponding connection member 3371. This limits or prevents the connection members 3371 from rotating about a vertical axis passing through each corresponding connection point 3364a, 3364b. This can help maintain the desired orientation of the force vector of each lower strap 3366, 3368 and also help minimize accidental detachment of the magnet 3370 from the corresponding connection point 3364a, 3364b.

[1063] like Figure 33 As shown, another form of the frame 3350 may include ribs 6024 disposed adjacent respective connection points 3364a, 3364b. This form may include only a single rib 6024 associated with each connection point 3364a, 3364b, although it may also include ribs 6024 from Figure 32 A pair of ribs 6024. A single rib 6024 can be arranged so that it is approximately aligned with the center of the corresponding connection point 3364a, 3364b (e.g., neither higher nor lower than the center of the connection point 3364a, 3364b).

[1064] The connecting member 3371 may include a cutout 6028 between the overhang portion 3384 and the crossbar 3386. The cutout 6028 may be shaped to generally correspond to the shape of the rib 6024. When the connecting member 3371 engages the corresponding connection points 3364a, 3364b, the cutout 6028 receives the rib 6024. The rib 6024 may contact the cutout 6028 or be generally proximate to the cutout 6028 to prevent or limit rotational movement of the corresponding connecting member 3371. Thus, a single rib 6024 can achieve substantially the same benefits as multiple ribs 6024.

[1065] like Figure 34 and 35 As shown, the connection points 3364a, 3364b may not be formed directly on the central portion 3360 of the frame 3350. Instead, the frame 3350 may include arms 6032 extending radially outward from either side of the central portion 3360. Each arm 6032 may be formed at the same angle as the connection points 3364a, 3364b in the previous examples (e.g., Figure 28 ) is connected to the frame 3350 at approximately the same location as the connection in ). Each connection point 3364a, 3364b can be connected to the distal end of the corresponding arm 6032 instead.

[1066] Positioning the connection points 3364a, 3364b at one end of the arm 6032 can move the connection points 3364a, 3364b in a lateral and / or rearward direction. In some forms, the connection points 3364a, 3364b on either arm 6032 can be spaced apart from the center portion 3360 (e.g., measured along the surface of the arm 6032) by between about 5 mm and about 50 mm. In some forms, the connection points 3364a, 3364b on either arm 6032 can be spaced apart from the center portion 3360 by between about 10 mm and about 40 mm. In some forms, the connection points 3364a, 3364b on either arm 6032 can be spaced apart from the center portion 3360 by between about 20 mm and about 30 mm. In some forms, the connection points 3364a, 3364b on either arm 6032 can be spaced apart from the center portion 3360 by approximately 29 mm. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced approximately 21 mm from the central portion 3360.

[1067] In some forms, the arms 6032 can be integrally formed with the center portion 3360 in a single-piece construction. In this example, the center portion 3360 and the arms 6032 can be constructed of substantially the same material. In other examples, the arms 6032 can be constructed of different materials but formed integrally with the center portion 3360 (e.g., introducing multiple materials during the injection molding process). In other examples, the arms 6032 can be formed using a process separate from the center portion 3360 and can be connected to the frame 3350 using an attachment device (e.g., adhesive, magnets, mechanical fasteners). In this example, the arms 6032 can be permanently attached or can be removable.

[1068] like Figure 35 and 35-1As shown, the arms 6032 can be generally flush with the upper surface of the central portion 3360. This can help promote a compact aesthetic, as the arms 6032 do not protrude further in the forward direction than the frame 3350. This can also help promote patient compliance, as the compact design can generally not interfere with the patient's field of view.

[1069] Figures 34 to 35-1 The arm 6032 in the device is arranged in a cantilever configuration so that the distal end including the connection points 3364a, 3364b is unsupported. In some examples, the arm 6032 can be flexible or semi-rigid and can bend or flex. For example, due to the patient tightening the connected lower straps 3366, 3368, the arm 6032 can flex in the posterior direction. Although the arm 6032 can bend, the total distance that the arm 6032 can bend can be minimal. In this way, the arm 6032 can maintain the force vector of the lower straps 3366, 3368. If the arm 6032 bends, then when the force is removed (for example, when the magnet 3370 is removed from the corresponding connection points 3364a, 3364b), the arm 6032 returns to its original position.

[1070] like Figure 35-1 As shown, some versions of the arm 6032 may include a groove 6033, which may be located on the front surface and / or the rear surface. The groove 6033 may act as a hinge to help bend the corresponding arm 6032. Figure 35-1 The frame 3350 in the embodiment may be a separate frame, or the groove 6033 may be incorporated into the Figure 34 and / or the framework of 35 (or any other framework described herein).

[1071] In use, the patient can connect the connecting member 3371 to the corresponding connection points 3364a, 3364b in a manner similar to when the connection points 3364a, 3364b are directly connected to the central portion 3360. Therefore, there may be no effect on the patient's ability to connect the magnet 3370 and the connection points 3364a, 3364b. In addition, creating wider connection points 3364a, 3364b (i.e., spaced further apart from the central portion 3360 of the frame 3350) can limit the occurrence of the magnet 3370 unintentionally detaching from the corresponding connection points 3364a, 3364b. For example, the at least partially flexible nature of the arm 6032 can allow bending in the rear direction, which can limit the swinging of the connecting member 3371 on the corresponding connection points 3364a, 3364b. Therefore, the magnet 3370 is less likely to be accidentally detached, and the seal between the patient's face and the seal-forming structure 3100 can be better maintained.

[1072] In some forms, the arms 6032 can bend or flex relative to the central portion 3360. For example, the arms 6032 can bend inwardly toward the pneumatic chamber 3200 (and toward the patient's face when the patient interface 3000 is worn). The bending or flexing can be the result of forces acting on the positioning and stabilizing structure 3300 (e.g., tightening the straps 3366, 3368 can cause a bending motion in the arms 6032). As a result of the bending, the arms 6032 can be positioned near or in contact with the pneumatic chamber 3200 and / or the patient's face. This helps reduce the occurrence of wobbling or accidental detachment of the magnets 3370.

[1073] In some embodiments, the connection points 3364a, 3364b on the arm 6032 may not include the lip 3380. Instead, the connection points 3364a, 3364b may be generally planar. The displacement of the connection points 3364a, 3364b away from the center portion 3360 and the flexibility of the arm 6032 can reduce the possibility of accidental disengagement of the magnet during use. Specifically, the rearward positioning of these connection points 3364a, 3364b can reduce the torque on the housing 3371 and the magnet 3370, which can cause decoupling.

[1074] like Figure 61 As shown, some versions of the patient interface 3000 may include a flexible housing 6104 that can removably connect the straps to the frame 3350. The flexible housing 6104 can be substantially similar to the housing 3371. For example, the flexible housing 6104 can include a magnet 6108 (or a similar type of connector) to removably engage with the connection points 3364a, 3364b. In addition, the flexible housing 6104 includes a crossbar 6112 to receive a strap (e.g., any one of the straps 3356, 3358, 3366, 3368). A flexible section 6116 can be disposed between the magnet 6108 and the crossbar 6112. The flexible section 6116 can be a thin section of the flexible housing 6104 that is capable of elastically flexing without breaking. For example, the flexible section 6116 can bend about a bending axis 6120, causing the crossbar 6112 to pivot relative to the magnet 6108. When the magnets 6108 are connected to the corresponding connection points 3364a, 3364b, bending about the bending axis 6120 can occur as a result of the tension applied in the corresponding strap around the crossbar 6112. Movement about the bending axis 6120 can be preferred over movement of the magnets 6108 so that the housing 6104 does not accidentally disengage the corresponding connection points 3364a, 3364b. In some forms, the flexible housing 6104 can be used in place of the arms 6032 (e.g., when the connection points 3364a, 3364b are on the central portion 3360). In some forms, the flexible housing 6104 can be used in conjunction with the arms 6032.

[1075] The length of the bendable section 6116 can determine the amount of bending allowed in the bendable housing 6104. A longer bendable section 6116 can allow for more bending than a shorter bendable section 6116. In some forms, the bendable section 6116 is between approximately 0.1 mm and approximately 20 mm. In some forms, the bendable section 6116 is between approximately 1 mm and approximately 10 mm. In some forms, the bendable section 6116 is approximately 5 mm.

[1076] like Figure 24 As shown, the engagement area of ​​the pneumatic chamber 3200 may include a groove 3280. In the example shown, the groove 3280 may be included on the mouth 3201 of the pneumatic chamber 3200 and may be radially outward of the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the groove 3280. The shape of the central portion 3360 may generally correspond to the shape of the groove 3280, which may help the patient correctly orient the frame 3350 relative to the pneumatic chamber 3200 (e.g., in examples where the frame 3350 is removably coupled to the pneumatic chamber 3200).

[1077] like Figures 37-39 As shown, the upper rod 6036 of the central portion 3360 can extend in a forward direction from the remainder of the central portion 3360 and can be spaced apart from the groove 3280. In other words, the upper rod 6036 can not contact the groove 3280 or any other portion of the pneumatic chamber 3200 prior to use.

[1078] In some forms, the groove 3280 can have a fully formed perimeter that is generally annular in shape. In any size mat, the perimeter can have substantially the same length.

[1079] In some forms, the groove 3280 is recessed relative to the rest of the outer surface of the pneumatic chamber 3200. The groove 3280 may not extend substantially into the pneumatic chamber 3200 and obstruct the patient's face. The groove 3280 may have substantially the same depth throughout its entire circumference.

[1080] In some forms, the width of the groove 3280 can be less than the width of the central portion 3360 of the frame 3350. The compliant nature of the gasket can allow the wider central portion 3360 to be received within the groove 3280. This can allow the central portion 3360 to couple to the groove 3280 via a press fit, a friction fit, and / or a snap fit. The engagement between the groove 3280 and the central portion 3360 can help provide rigidity to the pneumatic chamber 3200 and / or the seal-forming structure 3100, as the rigidity of the frame 3350 (e.g., compared to the pneumatic chamber 3200) alone can limit some of the flexibility of the pneumatic chamber 3200.

[1081] In some forms, the gasket can be molded to the frame 3350 so that the groove 3280 can be created during the molding process. The material of the pneumatic chamber 3200 (e.g., silicone) can be molded at least partially around the central portion 3360 of the frame 3350 and can restrict the central portion 3360 from being removed from the groove 3280.

[1082] like Figure 25 As shown, frame 3350 can be composed of multiple components (e.g., each component is composed of a different material). For example, the center portion can be composed of a first material (e.g., hard plastic). Arms 3362 can be coupled to center portion 3360 (e.g., via glue, molding, etc.) and can be composed of a second material that is more flexible than the first material (e.g., flexible plastic, foam, etc.). A third material can be a magnetic material and can be coupled to center portion 3360 (e.g., via an adhesive). Once coupled together, arms 3362 can move similarly as in the integrated, one-piece construction described above.

[1083] like Figure 26 and 27 As shown, the frame 3350 can be constructed from a single piece of material. For example, the frame 3350 can be made from a TPE material such as Hytrel. As described above, the material used to construct the frame 3350 can provide the frame 3350 with both rigidity and flexibility. The magnet 3370 can be overmolded (or otherwise coupled to) the center portion 3360.

[1084] In some forms, the central portion 3360 includes a slot 3372 that may be formed on either lateral side of the central portion 3360. The slot 3372 may have a generally elongated shape (e.g., rectangular, oval, etc.) and may be formed entirely within the boundaries of the central portion 3360.

[1085] like Figure 27 As shown, some versions of the center portion 3360 may include a tapered slot 3372. Specifically, the opening to the slot 3372 may be wider near the rear surface of the center portion 3360 (e.g., the surface in contact with the pneumatic chamber 3200). The opening to the slot 3372 may decrease uniformly toward the front surface of the center portion 3360.

[1086] Figure 27Also shown are some versions of arm 3362a (or arm 3362b) that can include a notch or scallop 3373. The scallop 3373 can be formed on the inner surface of the arm 3362a and can be positioned adjacent to the patient's skin when the positioning and stabilizing structure 3300 is worn by the patient. The scallop 3373 reduces the thickness along a portion of the arm 3362a and can reduce the likelihood of sink marks forming in the arm 3362a during the manufacturing (e.g., injection molding) process. The scallop 3373 can also result in less material being used to manufacture the arm 3362a, which can result in lower manufacturing time and / or lower manufacturing costs.

[1087] return Figures 26 to 26-2a , the pneumatic chamber 3200 can include a protrusion 3284 on the mouth 3201. The protrusion can be elongated and can have a similar shape (e.g., a cone) to the slot 3372. The protrusion 3284 can be arranged within the groove 3280 so that they cooperate with the frame 3350 during assembly.

[1088] like Figure 40 As shown, the protrusion 3284 may extend generally obliquely to the front surface of the pneumatic chamber 3200. The front surface of the pneumatic chamber 3200 may be partially curved or angled, and the protrusion 3284 may extend in a non-perpendicular direction relative to the surface, such that the protrusion 3284 is aligned along the insertion direction of the frame 3350. In other words, when the patient interface 3000 is worn, the protrusion 3284 may extend in the anterior-posterior direction.

[1089] like Figure 26-2 and 26-2a As shown, some forms of the protrusion 3284 may include an overhang 6000 that extends at least partially above the groove 3280. The overhang 6000 may be formed asymmetrically around the perimeter of the protrusion 3284. In other words, the overhang 6000 may extend further over the groove 3280 on one side than on the other side. Figure 26-2a As shown, the opposite side 6002 may extend outwardly and form a slight overhang. For example, the opposite side 6002 may be larger than Figure 26-2 The example shown in further extends between about 1° and about 20° (e.g., 10°), which can add about 0.1 mm to about 5 mm (e.g., about 1 mm) to the length of the opposite side 6002. This can provide additional retention force for holding the frame 3350 in the groove 3280.

[1090] like Figure 40As shown, the top surface of the protrusion 3284 can be slightly angled so that the overhang 6000 can extend generally parallel to the surface of the groove 3280. This can allow a larger portion of the protrusion 3284 to extend over the groove 3280. As described in more detail below, this can help better retain the frame 3350 within the groove 3280 and limit accidental disengagement.

[1091] In some embodiments, the recess 3280 may also be asymmetrical. The recess 3280 may include an undercut 6004 and an inclined surface 6008 on one side of the protrusion 3284. The overhang 6000 may extend further over the undercut 6004 than over the inclined surface 6008. The length of the overhang 6000 extending above the undercut 6004 may limit the ability of the frame 3350 to be removed from the pneumatic chamber 3200 in a vertical direction. The angle of the inclined surface 6008 may be directed toward the overhang 6000 and limit the ability of the frame 3350 to be removed in an inclined direction.

[1092] When the frame 3350 is assembled to the pneumatic chamber 3200 (e.g., via a press fit, friction fit, snap fit, etc.), the patient can align the protrusions 3284 with the slots 3372 so that the protrusions 3284 are received within the slots 3372 during use. The wider opening of the slots 3372 near the rear surface can help the patient align each protrusion 3284 within the corresponding slot 3372. The protrusions 3284 can be slightly wider than the front opening of each slot 3372, but can be received within the slots 3372 due to the flexible nature of the pneumatic chamber 3200 (e.g., constructed of an elastic material such as silicone). The protrusions 3284 can be slightly deformed (e.g., due to the narrowing of the slots 3372) as they enter the corresponding slots 3372.

[1093] Once the protrusion 3284 passes through the slot 3372, the protrusion 3284 returns to approximately its original shape. For example, when the slot 3372 receives the protrusion 3284, the overhang 6000 can deform (e.g., elastically deform) and return to its initial position once the central portion 3360 is received within the recess 3280. To more easily observe the proper connection between the frame 3350 and the pneumatic chamber 3200, the patient can experience this deformation as a tactile response. In the relaxed or initial position, the overhang 6000 of the protrusion 3284 can be wider than the front opening of the corresponding slot 3372.

[1094] Additionally, the width of the undercut 6004 can be approximately the same as the center portion 3360, such that the frame 3350 fits snugly within the groove 3280. The flexible material of the pneumatic chamber 3200 can allow the undercut 6004 to be slightly smaller than the center portion 3360, such that the undercut 6004 can flex and receive the frame 3350 via a snap fit, friction fit, snap fit, etc.

[1095] Therefore, the frame 3350 may not be easily removed from the pneumatic chamber 3200. The patient may have to apply force to the frame 3350 to remove it from the recess 3280. This user-applied force may allow the frame 3350 to move in a vertical or inclined direction and overcome the retaining force provided by the overhang 6000. For example, the patient may lift the frame 3350 from the area contacting the center portion 3360 of the inclined surface 6008 to provide a force for disengaging the frame 3350 from the pneumatic chamber 3200.

[1096] This force can exceed the force generated by normal movement of the pneumatic chamber 3200 and / or the seal-forming structure 3100. In other words, the seal-forming structure 3100 and / or the pneumatic chamber 3200 can move relative to the frame 3350 while the protrusions 3284 are received within the corresponding slots 3372. This can allow the seal-forming structure 3100 and / or the pneumatic chamber 3200 to flex and conform to the patient's face without loosening from the frame 3350 and without inadvertently causing the slots 3372 to disengage from the protrusions 3284.

[1097] In other versions, the pneumatic chamber 3200 may be molded onto the frame 3350 and the protrusions 3284 may be created by the molding process to permanently maintain the position of the frame 3350 relative to the pneumatic chamber 3200 .

[1098] like Figure 26-3 As shown, when the frame 3350 and the pneumatic chamber 3200 are worn by a patient, some forms of the frame 3350 can be oriented to reduce cheek contact. For example, the arms 3362a, 3362b can be oriented (e.g., curved) to roughly complement at least a portion of the patient's face (e.g., their cheek). However, in some examples, the entire length of each arm 3362 may not contact the patient's skin, as the patient may find it uncomfortable to have a foreign object in contact with their face. Instead, a portion of each arm 3362 may be spaced apart from the patient's face, so that a smaller surface area of ​​the arm 3362 contacts the patient's face. While maintaining a substantially uniform curvature in each arm 3362, moving the point of contact between each arm 3362 and the pneumatic chamber 3200 (e.g., via the manufacturing process) can change the total length of each arm 3362 that contacts the patient's face. For example, if each arm 3362 contacts the pneumatic chamber 3200 closer to the elbow 3500, the maximum gap between each arm 3362 and the patient's face is greater. This means that a greater portion of each arm 3362 will be spaced apart from the patient's face (e.g., as opposed to if each arm 3362 contacted the pneumatic chamber 3200 distal to the elbow 3500). Less contact between each arm 3362 and the patient's face can improve patient comfort.

[1099] Additionally, each arm 3362 that contacts the pneumatic chamber 3200 proximal to the elbow and therefore distal to the rear surface 3112 can create less support at the lateral portion 3111 of the pneumatic chamber 3200 (e.g., because the rigid or semi-rigid arm engages less of the lateral portion 3111). The lateral portion 3111 can therefore have a greater degree of flexibility and can be better able to conform to the shape of the patient's nose and create an effective seal.

[1100] like Figure 26-4 and 26-5 As shown, some versions of the frame 3350 can include a hinge 6012 between each arm 3362 and the central portion 3360. The hinge 6012 can allow movement (e.g., pivotal movement) of the arms 3362 without affecting the connection between the frame 3350 and the pneumatic chamber 3200. In other words, pivoting any arm 3362 about the corresponding hinge 6012 can occur without causing the protrusion 3284 to disengage from the slot 3372.

[1101] In some embodiments, the patient can move the arm 3362 to the second position to provide a better fit. For example, the distance between the loops 3352a, 3352b in the first position can be greater than the size of the patient's head. Thus, the patient can move the arm 3362 toward the second position to provide a proper fit (e.g., contact between the arm 3362 and the patient's head). The arm 3362 can be maintained in the second position by adjusting the upper headgear straps 3356, 3358 (i.e., the upper headgear straps 3356, 3358 can provide external force).

[1102] Similar to the arms 3362, the pneumatic chamber 3200 and / or the seal-forming structure 3100 can be larger than the dimensions of an average patient's face. For example, the seal-forming structure 3100 may not fit snugly into the patient's mouth and / or nose. The pneumatic chamber 3200 and / or the seal-forming structure 3100 can also be moved toward a more compact position to better fit an individual patient's face.

[1103] like Figure 26-5 As shown, movement of the arm 3362 to the second position can directly cause the seal-forming structure 3100 and / or the pneumatic chamber 3200 to move to a more compact position. The arm 3362 can contact the pneumatic chamber 3200 along the second front wall portion 3242. The arm 3362 c...

Claims

1. A patient interface, comprising: a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first 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 mouth so that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient, when in use; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose so that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; and a vent structure to allow continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use, Characterized in that the patient interface further comprises: at least one region disposed in the pneumatic chamber, the at least one region configured to resist compression of the first seal-forming structure in a forward direction; Therein, the at least one region is formed integrally with the pneumatic chamber.

2. A patient interface according to claim 1, wherein: The at least one region is at least one retaining rib.

3. A patient interface according to claim 2, wherein: The at least one stopping rib includes a plurality of stopping ribs spaced apart from each other.

4. A patient interface according to claim 3, wherein: The plurality of stopper ribs are arranged in a C-shape.

5. A patient interface according to claim 4, wherein: The plurality of stop ribs extend around a majority of a perimeter of the first seal-forming structure.

6. A patient interface according to any one of claims 2 to 5, wherein: The at least one stop rib is an elongated member.

7. A patient interface according to any one of claims 2 to 5, wherein: The at least one stop rib includes a beveled edge.

8. A patient interface according to claim 7, wherein: The inclined edge is a rear edge.

9. A patient interface according to claim 8, wherein: The inclined edge is configured to contact the first seal-forming structure in use so as to restrict forward movement of the first seal-forming structure.

10. A patient interface according to any one of claims 2 to 5, wherein: The at least one stop rib includes a length measured perpendicular to the first seal-forming structure and a width measured perpendicular to the length.

11. A patient interface according to claim 10, wherein: The length is greater than the width.

12. A patient interface according to claim 11, wherein: The first seal-forming structure is arranged, in use, to contact the at least one stop rib along the width.

13. A patient interface according to claim 1, wherein: The at least one region is at least one reinforced region.

14. A patient interface according to claim 13, wherein: The at least one reinforced region comprises a plurality of reinforced regions.

15. A patient interface according to any one of claims 13 to 14, wherein: The at least one reinforced region includes a first thickness proximate the inlet port and a second thickness distal from the inlet port, the second thickness being less than the first thickness.

16. A patient interface according to any one of claims 13 to 14, wherein: The at least one reinforced area is arranged on a front surface of the pneumatic chamber.

17. A patient interface according to claim 1, wherein: The at least one region includes a pair of supports disposed on opposite sides of the patient interface between the second seal-forming structure and a front wall of the pneumatic chamber, wherein the supports are configured to resist compression in an anterior-posterior direction.

18. A patient interface comprising: a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first 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 mouth so that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient, when in use; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose so that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; and a vent structure to allow continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use; Characterized in that the patient interface further comprises: A pair of supports are disposed on opposite sides of the interface between the second seal-forming structure and the front wall of the pneumatic chamber, wherein the supports are configured to resist compression in a front-to-rear direction.

19. A patient interface according to claim 18, wherein: The support portion is connected to a portion of the second seal-forming structure which, in use, seals against the patient's upper lip.

20. A patient interface according to claim 18, wherein: The support portion is connected to a portion of the second seal-forming structure which, in use, seals to the patient's lips directly below the lower corner of the patient's nose.

21. A patient interface according to claim 18, wherein: When viewed in a cross section parallel to the sagittal plane, the support portion is curved.

22. A patient interface according to claim 18, wherein: When viewed in a cross section parallel to the front plane, the support portion is curved.

23. A patient interface according to claim 18, wherein: The pneumatic chamber includes a mouth and a nose.

24. A patient interface according to claim 23, wherein: Each support portion is connected to the mouth of the pneumatic chamber adjacent to a boundary of a lateral side wall portion of the mouth and a lateral side wall portion of the nose.

25. A patient interface according to claim 23, wherein: Each support portion is connected to the mouth of the housing adjacent to a boundary of the front wall portion of the mouth and the front wall portion of the nose.

26. A patient interface according to claim 23, wherein: The lateral sidewall portions of the pneumatic chamber are bent inwardly adjacent to the boundary with the nose portion, wherein each support portion is substantially adjacent to an adjacent lateral sidewall portion.

27. A patient interface according to claim 18, wherein: The second seal-forming structure comprises at least one nostril configured to deliver a flow of air at the treatment pressure to an entrance of a naris of the patient, wherein, in use, no part of either support portion is directly below the or each nostril.

28. A patient interface according to claim 18, wherein: The interface also includes a positioning and stabilizing structure configured to generate a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

29. A patient interface according to claim 18, wherein: The pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing.

30. A patient interface according to claim 18, wherein: The support portion is connected to the second seal-forming structure and to the front wall of the pneumatic chamber.

31. A patient interface comprising: a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth of the pneumatic chamber, the first 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 mouth so that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged, in use, to maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; a second seal-forming structure connected to a nasal portion of the pneumatic chamber, the second seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose so that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; and a vent structure to allow continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use; Characterized in that the patient interface comprises: a first front wall portion of the nose of the pneumatic chamber, the first front wall portion being adjacent to a boundary of the mouth of the pneumatic chamber, the first front wall portion being more flexible than an adjacent area of ​​the mouth of the pneumatic chamber, and a second front wall portion of the nose of the pneumatic chamber, the second front wall portion being adjacent to the first front wall portion and on a side of the first front wall portion opposite to the boundary of the mouth of the pneumatic chamber, the second front wall portion being less flexible than an adjacent portion of the front wall.

32. A patient interface according to claim 31, wherein: The first front wall portion is thinner than an immediately adjacent portion of the pneumatic chamber wall.

33. A patient interface according to claim 31, wherein: The second front wall portion is thicker than an immediately adjacent portion of the pneumatic chamber wall.

34. A patient interface according to claim 31, wherein: The first front wall portion and the second front wall portion are made of the same material.

35. A patient interface according to claim 31, wherein: The first front wall portion extends across substantially an entire width of the nose portion of the pneumatic chamber.

36. A patient interface according to claim 31, wherein: The second front wall portion extends across at least a majority of the width of the nose portion of the pneumatic chamber.

37. A patient interface according to claim 31, wherein: The first front wall portion extends in an upper direction around at least one lateral edge of the second front wall portion.

38. A patient interface according to claim 31, wherein: The second front wall portion extends across substantially the entire width of the nose of the pneumatic chamber.

39. A patient interface according to claim 31, wherein: The central portion of the first front wall portion extends further in the upper direction than the lateral portion of the first front wall portion.

40. A patient interface according to claim 31, wherein: An upper boundary of the first front wall portion is curved.

41. A patient interface according to claim 31, wherein: The lower boundary of the first front wall portion is curved.

42. A patient interface according to claim 31, wherein: The pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing.

43. A patient interface according to claim 31, wherein: The second front wall portion includes a strap extending through the first front wall portion and configured to extend through the pneumatic chamber toward a patient.

44. A patient interface according to claim 31, wherein: The transition within the pneumatic chamber between the first front wall portion and the second front wall portion is a generally stepped surface.

45. A patient interface according to claim 31, wherein: The transition outside the pneumatic chamber between the first front wall portion and the second front wall portion is a generally smooth surface.

46. ​​A patient interface according to claim 43, wherein: In use, the first front wall portion extends further up than at least a portion of the belt.

47. A patient interface comprising: A pneumatic chamber formed entirely of flexible material, the pneumatic chamber comprising: A cavity that can be pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, an inlet port configured to provide fluid communication between the cavity and a surrounding environment, and Characterized in that the pneumatic chamber further comprises: a groove formed on a surface of the pneumatic chamber outside the cavity and exposed to ambient pressure, the groove being formed radially outside the inlet port, and the groove forming a closed perimeter; a seal-forming structure constructed and arranged to form a seal with a facial region of a patient surrounding an entrance to an airway of the patient, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in said pneumatic chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: A frame coupled to the pneumatic chamber, the frame comprising: a center portion including an inner perimeter and an outer perimeter removably positionable within the groove, the inner perimeter being configured to be spaced apart from the inlet port when positioned within the groove, a pair of upper arms extending away from the central portion, and a pair of lower arms extending away from the central portion; and A headgear strap is coupled to the pair of upper arms and the pair of lower arms of the frame and is configured to provide tension to the seal-forming structure in the patient's face via the frame.

48. A patient interface according to claim 47, wherein: The pair of upper arms is longer than the pair of lower arms.

49. A patient interface according to claim 47, wherein: The pair of upper arms each include a first type connector, and the pair of lower arms each include a second type connector different from the first type connector.

50. A patient interface according to claim 49, wherein: The first type connector is selected from the group consisting of a ring, a ladder lock, and a cord stopper.

51. A patient interface according to claim 50, wherein: The first type connector is a ring including a first ring portion and a second ring portion adjacent to the first ring portion.

52. A patient interface according to claim 51, wherein The ring includes a dividing wall at least partially separating the first ring portion from the second ring portion.

53. A patient interface according to claim 52, wherein: The strap of the headgear strap is configured to be selectively inserted into the first loop portion and contact the dividing wall at an optimal tension in use, and wherein the strap is configured to move into the second loop portion at a tension greater than the optimal tension.

54. A patient interface according to claim 49, wherein: The second type connector is a magnetic member.

55. A patient interface according to claim 54, wherein The magnetic member includes an oval shape.

56. A patient interface according to claim 54, wherein: A housing is removably and magnetically connected to the magnetic member.

57. A patient interface according to claim 56, wherein: The housing includes a strap connector for connecting to a strap of the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stopper.

58. A patient interface according to claim 56, wherein: The housing is configured to engage a lip of the outer shell.

59. A patient interface according to claim 47, wherein: At least one of the headgear straps includes an elastic portion stretchable between a first position and a second position, and wherein the at least one strap includes an alarm portion configured to be visible in the second position and substantially hidden in the first position.

60. A patient interface according to claim 59, wherein: The at least one strap further includes a tactile response element including a first portion and a second portion disposed on either side of the alarm portion, and wherein the first portion and the second portion of the tactile response element are connected in the first position and are configured to be separated in the second position to alert the patient.

61. A patient interface according to claim 60, wherein: The tactilely responsive element is a magnet.

62. A patient interface according to claim 49, wherein: At least one of the headgear straps includes a first width and a second width greater than the first width.

63. A patient interface according to claim 62, wherein: The first width is selectively receivable through the first type of connector, and wherein the second width prevents passage through the first type of connector.

64. A patient interface according to claim 63, wherein: At least one of the headgear straps includes a plurality of protrusions configured to provide a tactile response when passed through the first type connector.

65. A patient interface according to claim 64, wherein The plurality of protrusions are glue dots.

66. A patient interface according to claim 49, wherein: At least one of the headgear straps includes a cut edge configured to provide a tactile response when passed through the first type connector.

67. A patient interface according to claim 66, wherein: The cutting edge includes a triangle, a rectangle and / or a circle.

68. A patient interface according to claim 47, wherein: The pair of upper arms and the pair of lower arms are integrally formed with the center portion.

69. A patient interface according to claim 47, wherein: The pneumatic chamber includes at least one protrusion extending from the recess, and wherein the central portion of the frame includes at least one slot configured to selectively receive the at least one protrusion.

70. A patient interface according to claim 47, wherein: The pair of lower arms are flush with the central portion.

71. A patient interface according to claim 47, wherein: The seal forming structure further comprises: a first 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 mouth; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to a nares of the patient; Wherein, the groove is arranged on the pneumatic chamber, below the second seal-forming structure and opposite to the first seal-forming structure.

72. A patient interface according to claim 47, wherein: A fabric sleeve is connected to each upper arm of the pair of upper arms.

73. A system for providing pressurized air to a patient, characterized in that The system comprises: A patient interface according to any one of claims 47 to 72; a respiratory therapy system apparatus configured to provide a flow of air at said therapy pressure; and a conduit connecting the respiratory therapy system device to the patient interface, the conduit being configured to deliver the flow of air to the patient interface; Wherein, the conduit is connected to the inlet port of the pneumatic chamber.

74. A system for providing pressurized air to a patient, the system comprising: a pneumatic chamber comprising a chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, characterised in that the pneumatic chamber includes a lip extending at least partially around the pneumatic chamber inlet port and extending into the cavity; and a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway such that a flow of air at said therapeutic pressure is delivered to the nose, said seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in said pneumatic chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position; and an air circuit removably connected to the pneumatic chamber and configured to provide a flow of air at the treatment pressure from a flow generator to the cavity, the air circuit comprising a vent ring configured for at least partial insertion through the pneumatic chamber inlet port, the vent ring comprising: a rear surface having a first diameter, a front surface having a second diameter smaller than the first diameter, and a ring body extending between the front surface and the rear surface, the ring body comprising an inner wall, an outer wall and a groove disposed between the inner wall and the outer wall; in: the rear surface being configured to be positioned within the cavity and the front surface being configured to remain outside of the cavity when connected to the pneumatic chamber; at least one vent configured to provide communication between the cavity and a surrounding environment through the groove; The lip is configured to contact the vent ring along the ring body between the rear surface and the front surface; and The first diameter is greater than a diameter of the lip.

75. The system of claim 74, wherein: The ring body is inclined between the rear surface and the front surface.

76. The system of claim 74, wherein: The rear surface is configured to contact the lip and a front wall of the pneumatic chamber within the cavity in use.

77. The system according to claim 74, characterized in that The system also includes an annular seal positioned within the groove.

78. The system of claim 77, wherein: The outer diameter of the annular seal is smaller than the outer diameter of the groove.

79. The system of claim 74, wherein: The ring includes a central opening, and the system further includes an elbow connector, the central opening being configured to receive the elbow connector.

80. The system of claim 79, wherein: The elbow connector is rotatably connected to the ring body, and wherein the ring body is rotatably connected to the pneumatic chamber.

81. The system of claim 79, wherein: The elbow connector includes at least one button configured to be selectively actuated to disengage the elbow connector from the pneumatic chamber inlet port.

82. The system of claim 81, wherein: The at least one button is formed as a cantilever structure.

83. The system of claim 81, wherein: An arm connects the at least one button to the body of the elbow connector, the arm having an S-shape.

84. The system of claim 81, wherein: The at least one button includes a button lip configured to selectively engage the ring and move relative to the remainder of the elbow connector when the at least one button is actuated.

85. The system of claim 84, wherein: The button lip is configured to selectively engage an inner perimeter of an inner wall of the ring.

86. The system of claim 81, wherein: The at least one button includes a finger configured to selectively engage the ring and move relative to a remainder of the elbow connector when the at least one button is actuated.

87. The system of claim 86, wherein: The fingers are configured to selectively engage the ring radially outwardly of the inner wall.

88. The system of claim 74, wherein: The at least one vent is a plurality of vents spaced around a perimeter of the groove.

89. The system of claim 74, wherein: The pneumatic chamber inlet port includes an extension, and the ring body is connected to the extension and is spaced apart from a surface of the pneumatic chamber.

90. The system of claim 74, wherein: The system also includes a quick release connector.

91. The system of claim 90, wherein: The quick release connector is a rotatable connector or a latching connector.

92. The system of claim 90, wherein: The quick release connector is configured to connect to a complementary connector.

93. The system of claim 91, wherein: The quick release connector includes at least one flat surface.

94. The system of claim 93, wherein: The at least one flat surface is a pair of flat surfaces spaced approximately 180° apart.

95. The system of claim 90, wherein: The quick release connector includes a vent configured to exhaust a portion of the air flow to an ambient environment.

96. The system of claim 74, wherein: The seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring.

97. The system of claim 74, wherein: The ring body includes an extension portion.

98. The system of claim 74, wherein: The ring includes a disk configured to be positioned within the cavity and to restrict exhaled air from being discharged to the surrounding environment.

99. The system of claim 98, wherein: The disk extends radially beyond a portion of the rear surface including the at least one vent.

100. A patient interface comprising: a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth of the pneumatic chamber, the first 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 mouth so that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged, in use, to maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; a second seal-forming structure connected to a nasal portion of the pneumatic chamber, the second seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose so that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; and a vent structure to allow continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use, It is characterized in that A rear surface of the lateral portion of the second seal-forming structure is inclined in an upper-anterior direction from a boundary of the first seal-forming structure and the second seal-forming structure.

101. A patient interface according to claim 100, wherein: The inclined surface of each lateral portion forms an angle between 20 degrees and 90 degrees with the middle contact plane of the mask; b) in use, no part of the patient interface contacts the alar ridge of the patient; c) relative to prior art interfaces, the interface is configured to prevent blockage of the patient's nares, or at least reduce blockage; and / or d) The pneumatic chamber is at least partially formed by a housing and the vent structure is provided to the housing.

102. A patient interface comprising: a pneumatic chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth of the pneumatic chamber, the first 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 mouth so that the flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure being constructed and arranged, in use, to maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; a second seal-forming structure connected to a nasal portion of the pneumatic chamber, the second seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's nose so that the flow of air at the therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the pneumatic chamber throughout a breathing cycle of the patient; and a vent structure to allow continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use, It is characterized in that The boundary between the first seal-forming structure and the second seal-forming structure includes a ridge.

103. A patient interface according to claim 102, wherein: The ridges have a radius of curvature of less than 2 mm.

104. A patient interface according to claim 102, wherein: The ridge extends substantially across the entire boundary between the first seal-forming structure and the second seal-forming structure.

105. A patient interface according to claim 102, wherein: In use, the ridge engages the patient's face where the nose wing near the entrance to the nostrils meets the face above the lips.

106. A patient interface according to claim 102, wherein: The ridge resists wrinkles that form in the first seal-forming structure and / or the second seal-forming structure adjacent to the ridge.

107. A patient interface according to claim 102, wherein: In use, the pneumatic chamber is at least partly formed by a housing and the vent structure is provided to the housing.

108. A frame configured to couple to a pneumatic chamber having a cavity, the frame comprising a central portion of the pneumatic chamber coupled to an exterior of the cavity and a plurality of connectors comprising a pair of upper connectors and a pair of lower connectors, It is characterized in that The pair of lower connectors are flush with the central portion, and the pair of upper connectors are configured to extend away from the central portion in a rearward direction past the pneumatic chamber.

109. The framework of claim 108, wherein: Each upper connector of the pair of upper connectors includes a slot configured to receive a headgear strap.

110. The framework of claim 109, wherein: Each slot includes a protrusion adjacent a corresponding arm.

111. The frame of claim 110, wherein: Each convex portion has a curved shape.

112. The frame of claim 109, wherein: Each upper connector includes a rib adjacent the central portion.

113. The framework of claim 112, wherein: The combined width of the rib and arm proximate the central portion is substantially equal to the width of the arm proximate the slot.

114. The framework of claim 108, wherein: Each lower connector of the pair of lower connectors includes a magnet.

115. The framework of claim 108, wherein: Each lower connector of the pair of lower connectors includes a groove configured to act as a hinge and allow each lower connector to bend relative to the central portion.

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