Patient interface

Abstract

The utility model relates to a patient interface. 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 patent application No. 202222367545.9, filed on September 6, 2022, entitled "Patient Interface and System for Providing Pressurized Air to a Patient". Technical Field

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

[0003] 2.2 Description of related technologies

[0004] 2.2.1 The human respiratory system and its disorders

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

[0006] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway and do not participate in gas exchange. Further airway divisions result in respiratory bronchioles, which eventually lead to alveoli. The alveolar regions of the lungs are where gas exchange occurs and are known as respiratory zones. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0007] A range of respiratory disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[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 involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected individuals to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. It frequently leads to excessive daytime sleepiness and can potentially cause cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is an impairment of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0012] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormally rapid breathing during exercise.

[0013] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without 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 diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term encompassing 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 mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens within months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapular humerus, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, 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 pleural cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of treatments have been used to treat or improve such symptoms. Furthermore, these treatments can be used by other healthy individuals to prevent respiratory distress. However, these treatments have many drawbacks.

[0018] 2.2.2 Treatment

[0019] Various respiratory therapies, such as continuous positive airway pressure (CPAP), 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 involves supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or duct ventilators).

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

[0023] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels by performing some or all of their breathing work. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

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

[0025] 2.2.2.2 Flow Therapy

[0026] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In others, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (potentially beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.

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

[0028] 2.2.2.3 Supplementing oxygen

[0029] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this 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 respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor symptoms without treating them.

[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 type of treatment system is the mandibular repositioning device.

[0034] 2.2.3.1 Patient Interface

[0035] Patient interfaces can be used, for example, to connect a breathing device to its wearer by providing an airflow to an inlet in the airway. The airflow 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 the delivery of gas at a pressure sufficiently varied from ambient pressure at a positive pressure of approximately 10 cmH2O relative to ambient pressure. For other forms of treatment, such as oxygen delivery, the patient interface may not contain a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow-based therapies such as nasal HFT, the patient interface is configured to blow through the nostrils, but complete sealing is specifically avoided. An example of such a patient interface is a nasal cannula.

[0036] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving can be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

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

[0038] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0039] Some face masks may not be suitable for use while sleeping, for example, when sleeping on your side with your head on the pillow.

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

[0041] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced adherence, decreased comfort, and poorer patient outcomes. For example, face shields designed solely for pilots, face shields designed to be part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or face shields designed for administering anesthetics may be acceptable for their original application, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

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

[0043] While masks designed for other applications (e.g., navigators) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0044] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0045] 2.2.3.1.1 Sealing Formation Structure

[0046] The patient interface may include a sealing structure. Since the sealing structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0047] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may comprise a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may comprise a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover, the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may comprise an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may comprise a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces can be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0048] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0049] Certain seal-forming structures can be designed for mass production, making a design suitable and comfortable and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0050] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face. The seal-forming structure may comprise an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, 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 periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0052] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0053] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0054] A series of patient interface sealing 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 nose pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nose pillow or snuff 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, including nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent applications assigned to ResMed describe examples of nose pillow masks: The following patent applications assigned to ResMed Ltd. describe examples of nose pillow masks: International Patent Application WO 2004 / 073,778 (which describes ResMed Ltd. SWIFT) TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Ltd. SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY)TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (which describes ResMed Ltd. SWIFT) TM Other aspects of the FX nose pillow).

[0057] 2.2.3.1.2 Positioning and Stability

[0058] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that threatens to break the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0059] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0060] Another technique involves using one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and difficulty in use.

[0061] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0062] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, such as by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy, such as HFT). Therefore, RPT devices can also be used as flow therapy devices. 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 constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single-branch air circuit is used for both inspiratory and expiratory breathing.

[0065] 2.2.3.4 Humidifier

[0066] Delivering an airflow without humidifying it can lead to airway dryness. Humidifiers using an RPT device and patient interface produce humidified air, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around it is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to heat the airflow and humidify it.

[0067] 2.2.3.5 Oxygen Source

[0068] Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, this mobility was facilitated by using small compressed oxygen cylinders or tanks mounted on a handcart with wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0069] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making routine rescue operations difficult and impractical. Recently, companies that manufacture large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices smaller and more portable, the various systems used to produce oxygen-enriched gas need to be condensed. POCs aim to utilize the oxygen they produce as efficiently as possible while minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, or “boli,” each pulse timed to coincide with the start of inspiration. In contrast to the traditional continuous flow delivery more suited to stationary 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 clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has been “adherent,” for example, the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is that, in order to be considered adherent, a patient is required to use a respiratory pressure therapy device for at least twenty-one (21) days out of thirty (30) consecutive days, for at least four hours each night. To determine patient adherence, the RPT device provider (such as a healthcare provider) may manually obtain data describing the patient’s treatment using the RPT device, calculate usage over a predetermined period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider may notify a third party that the patient is adherent.

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

[0073] Existing processes for communicating and managing such data are likely to be one or more of the following: expensive, time-consuming, and error-prone.

[0074] 2.2.3.7 Mandibular repositioning

[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 vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0076] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together via a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

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

[0078] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as ResMed Narval CC) TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This 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 ventilation ports to allow the exhaled carbon dioxide to escape. Ventilation ports allow gas to flow from the interior of the patient interface (e.g., a pneumatic chamber) to the exterior of the patient interface (e.g., to the surrounding environment).

[0081] The vent may contain an air vent through which gas can flow during the use of the mask. Many such vents are noisy. Other vents may become blocked during use, thus providing insufficient airflow. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0082] ResMed, Inc. has developed numerous 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. US2009 / 0044808.

[0083] The noise level of the existing face mask (ISO 17510-2:2007, 10cmH2O pressure at 1m)

[0084]

[0085]

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

[0087] The sound pressure levels for various objects are listed below.

[0088]

[0089] 2.2.4 Screening, Diagnosis and Monitoring System

[0090] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves clinical specialists in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for diagnosis alone, 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 provides a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0092] Clinicians can adequately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Utility Model Content

[0093] This technology relates to providing medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0094] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0095] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0096] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0097] One form of this technology includes a patient interface, which includes:

[0098] A pneumatic chamber, pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive the airflow at the treatment pressure for the patient to breathe;

[0099] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth opening, such that the airflow of the treatment pressure is transmitted to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0100] A second sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the nasal inlet, such that the airflow of the therapeutic pressure is transmitted to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0101] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0102] The patient interface is characterized in that it further includes:

[0103] At least one region, disposed in the pneumatic chamber and spaced apart from the first sealing structure, is configured to resist compression of the first sealing structure in the forward direction;

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

[0105] Another form of this technology includes a patient interface that includes:

[0106] Pneumatic chamber, the pneumatic chamber comprising:

[0107] A cavity that can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, and

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

[0109] A sealing structure is configured and arranged to form a seal with the patient's facial region surrounding the patient's airway inlet, the sealing structure being configured and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use, the sealing structure comprising:

[0110] The first sealing structure is constructed and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth.

[0111] The second sealing structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nostrils;

[0112] The patient interface is characterized in that it further includes a positioning and stabilizing structure configured to maintain the sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0113] A frame, connected to the pneumatic chamber, the frame comprising:

[0114] The central portion is removably positioned within the groove.

[0115] The pair of upper arms extending away from the center, and

[0116] A pair of forearms extending away from the center; and

[0117] A headband strap is attached to the pair of upper arms and the pair of lower arms of the frame and is configured to provide tension to the sealing structure in the patient's face via the frame;

[0118] In this configuration, a groove is provided on the pneumatic chamber below the second sealing structure and opposite to the first sealing structure.

[0119] Another form of this technology includes a system for providing pressurized air to a patient, the system comprising:

[0120] A respiratory therapy system (RPT) device is configured to provide an airflow at the therapeutic pressure;

[0121] The system is characterized in that it further comprises:

[0122] According to the other form of patient interface described above; and

[0123] The RPT device is connected to a catheter of the patient interface, the catheter being configured to deliver the airflow to the patient interface.

[0124] One form of this technology includes a patient interface, which includes:

[0125] A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure.

[0126] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0127] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow at the therapeutic pressure is delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0128] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0129] The patient interface also includes:

[0130] A pair of supports are disposed on opposite sides of the interface between the second sealing structure and the front wall of the pneumatic chamber, wherein the supports are configured to resist compression in the front-rear direction.

[0131] In the embodiment:

[0132] a) The support portion is connected to the portion of the second sealing structure, which abuts against the patient's upper lip for sealing during use;

[0133] b) The portion of the support connected to the second sealing structure, which in use seals above the patient's lips and directly below the lower corner of the patient's nose;

[0134] c) When viewed in a cross-section parallel to the sagittal plane, the support appears curved;

[0135] d) When viewed in a cross-section parallel to the front plane, these supports appear curved;

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

[0137] f) The boundary of each support adjacent to the lateral sidewall of the mouth and the lateral sidewall of the nose is connected to the mouth of the pneumatic chamber;

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

[0139] h) The transverse sidewall portions of the pneumatic chamber curve inward adjacent to the boundary of the nose, wherein each support portion is substantially adjacent to the adjacent transverse sidewall portion.

[0140] i) The second sealing structure includes at least one nostril, which is configured to deliver an airflow to the inlet of the patient's nostril at the treatment pressure, wherein, in use, no part of any support is directly below the nostril or each nostril.

[0141] j) The interface also includes a positioning and stabilizing structure configured to generate forces to hold 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 the outer shell and the vent structure is provided to the outer shell; and / or

[0143] l) The support is connected to the second sealing structure and to the front wall of the pneumatic chamber.

[0144] Another form of this technology includes a patient interface, which comprises:

[0145] A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient respiration at the treatment pressure.

[0146] A first sealing structure is connected to the opening of the pneumatic chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth, so that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient's respiratory cycle during use.

[0147] A second sealing structure, connected to the nasal portion of the pneumatic chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the nasal inlet, allowing airflow at the therapeutic pressure to be delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0148] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0149] in

[0150] The first front wall 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 of the nose of the pneumatic chamber is adjacent to the first front wall and is less flexible than the adjacent part of the first front wall on the side 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 the adjacent portion of the pneumatic chamber wall;

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

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

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

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

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

[0158] g) The second front wall extends across approximately 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 upward direction than the transverse portion of the first front wall portion;

[0160] i) The upper boundary of the first anterior wall is curved;

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

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

[0163] l) The second anterior wall portion includes a strip that extends through the first anterior wall portion and is configured to extend through the pneumatic chamber toward the patient;

[0164] m) The transition between the first front wall and the second front wall in the pneumatic chamber is a generally stepped surface;

[0165] n) The transition between the first front wall and the second front wall of the pneumatic chamber is a generally smooth surface; and / or

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

[0167] Another form of this technology includes a patient interface, which comprises:

[0168] A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient respiration at the treatment pressure.

[0169] A first sealing structure is connected to the opening of the pneumatic chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth, so that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient's respiratory cycle during use.

[0170] A second sealing structure, connected to the nasal portion of the pneumatic chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the nasal inlet, allowing airflow at the therapeutic pressure to be delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0171] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0172] in

[0173] The rear surface of the lateral portion of the second sealing structure slopes upward and forward from the boundary between the first and second sealing structures.

[0174] In the example:

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

[0176] b) During use, no part of the device without a patient interface comes into contact with the patient's pterygium;

[0177] c) Compared to existing interfaces, this interface is configured to prevent, or at least reduce, obstruction of the patient's nasal passages; and / or

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

[0179] Another form of this technology includes a patient interface, which comprises:

[0180] A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient respiration at the treatment pressure.

[0181] A first sealing structure is connected to the opening of the pneumatic chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth, so that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient's respiratory cycle during use.

[0182] A second sealing structure, connected to the nasal portion of the pneumatic chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the nasal inlet, allowing airflow at the therapeutic pressure to be delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0183] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0184] in

[0185] The boundary between the first sealing structure and the second sealing structure includes a ridge.

[0186] In the example:

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

[0188] b) The ridge extends substantially across the entire boundary between the first sealing structure and the second sealing structure;

[0189] c) In use, the ridge engages with the patient’s face near the entrance of the nostril, where the nasal wing meets the face above the lips;

[0190] d) The ridge resists wrinkling formed in the first and / or second sealing formation adjacent to the ridge; and / or

[0191] e) In use, the pneumatic chamber is at least partially formed by the outer shell, and the vent structure is disposed on the outer shell.

[0192] Another form of this technology includes a patient interface, which comprises:

[0193] A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient respiration at the treatment pressure.

[0194] A first sealing structure is connected to the opening of the pneumatic chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth, so that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient's respiratory cycle during use.

[0195] A second sealing structure, connected to the nasal portion of the pneumatic chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the nasal inlet, allowing airflow at the therapeutic pressure to be delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0196] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0197] in,

[0198] At least a portion of the opening of the pneumatic chamber includes a flexible shell, wherein the flexible shell is formed of a material with a Young's modulus of less than 0.4 GPa.

[0199] In the example:

[0200] a) The flexible shell 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) Attach at least one component to the flexible housing, wherein the at least one component is more rigid than a portion of the flexible housing adjacent to the component;

[0202] c) The at least one component includes one or more of the following: a ventilation module; a headgear connector; a headband connector connected to the rigid arm; a rigid member; a shell with less flexibility;

[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 at least one component onto the flexible housing;

[0206] g) The flexible housing includes multiple reinforcing portions, which have a greater thickness than the adjacent portions of the flexible housing;

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

[0208] i) The central portion of the opening of the pneumatic chamber has greater stiffness than the rest of the pneumatic chamber; and / or

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

[0210] Another form of the technology includes a frame configured to be coupled to a pneumatic chamber, the frame including a central portion of the pneumatic chamber coupled to the outside of the cavity 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 the rear of the pneumatic chamber.

[0211] In the example:

[0212] a) Each of the upper connectors in the pair includes a slot configured to receive a headband strap;

[0213] b) Each slot includes a protrusion near the corresponding arm;

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

[0215] d) Each upper connector includes a rib adjacent to the center portion;

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

[0217] f) Each of the lower connectors in the pair includes a magnet;

[0218] g) Each of the lower connectors in the pair includes a recess configured to act as a hinge and allow each lower connector to bend relative to the center portion.

[0219] Another form of the technology includes a frame configured to be coupled to a pneumatic chamber, the frame including a central portion of the pneumatic chamber coupled to the outside of the cavity and a pair of arms configured to extend rearward 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 of the arms of the pair;

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

[0224] d) Each of the arms in the pair includes a first connection point, to which the headband strap is attached;

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

[0226] f) The first connection point is a loop and includes a region of reduced thickness, which the headband strap can contact;

[0227] g) The first magnet is overmolded onto the center of the frame, and the headband strap includes a second magnet removably connected to the first magnet;

[0228] h) The first magnet includes a shell that at least partially surrounds a magnetic material, the shell including a flat surface and a lip extending from the flat surface;

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

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

[0231] k) The central portion is removably positioned within the groove;

[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 received through the wider opening before the narrower opening;

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

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

[0236] p) Each of the arms in the pair includes a rib near the center, and the friction is configured to retain the sleeve.

[0237] Another form of this technology includes a patient interface, which comprises:

[0238] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure;

[0239] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0240] A second sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s nasal inlet, such that an airflow at the treatment pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber during the patient’s entire respiratory cycle in use.

[0241] A ventilation port structure that allows continuous flow of exhaled air from the patient's pneumatic chamber to the surrounding environment; the size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use; and

[0242] A positioning and stabilizing structure configured to maintain the first sealing structure and the second sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0243] A frame, which is connected to the pneumatic chamber, includes:

[0244] The central part, which is connected to the pneumatic chamber outside the cavity, and

[0245] A pair of arms extending rearward away from the center portion through the second sealing structure, the pair of arms being more flexible than the center portion; and

[0246] A headband strap, which is attached to the frame, is configured to provide tension to the first sealing structure and the second sealing structure via the frame to enter 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 of the arms of the pair;

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

[0251] d) Each of the arms in the pair includes a first connection point, to which the headband strap is attached;

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

[0253] f) The first connection point is a loop and includes a region of reduced thickness, which the headband strap can contact;

[0254] g) The first magnet is overmolded onto the center of the frame, and the headband strap includes a second magnet removably connected to the first magnet;

[0255] h) The first magnet includes a shell that at least partially surrounds a magnetic material, the shell including a flat surface and a lip extending from the flat surface;

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

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

[0258] k) The central portion is removably positioned within the groove;

[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 received through the wider opening before the narrower opening;

[0261] n) The protrusion includes a hanger configured to extend over the slot and hold the frame relative to the pneumatic chamber;

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

[0263] p) The outer surface of the central portion is flush with the outer surface of the pneumatic chamber, and the outer surfaces of the central portion and the pneumatic chamber are configured to be away from the patient during use;

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

[0265] r) The pneumatic chamber inlet port is configured for a bend, which is configured to be spaced apart from the center portion when received within the pneumatic chamber inlet port;

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

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

[0268] u) The arm includes a scallop-shaped region on its inner surface, which is configured to face the patient's skin;

[0269] v) Each arm is pivotable relative to the central portion around the pivot point; and / or

[0270] W) The pivot point is the movable hinge.

[0271] Another form of this technology includes a patient interface, which includes:

[0272] The pneumatic chamber includes a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure. The pneumatic chamber includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure.

[0273] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face, allowing airflow at the therapeutic pressure to be delivered to the airway. This sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber throughout the patient's respiratory cycle during use.

[0274] Positioning and stabilizing structures are configured to hold the sealing structure in a therapeutically effective position.

[0275] Another aspect of this technology is a more compact and less disruptive mouth-nose patient interface.

[0276] Another aspect of this technology is a mouth-nose patient interface having a nasal pad that provides improved fit to the inferior nasal angle.

[0277] Another aspect of this technology is a mouth-nose patient interface that reduces obstructive contact on the nose.

[0278] Another aspect of this technology is that it can self-adjust to accommodate patients with various nasolabial angles in the oral-nasal interface.

[0279] Another aspect of this technology is an oral-nasal patient interface with a relatively flexible shell.

[0280] Another aspect of this technology is a patient interface in which the patient structure is molded or otherwise constructed to have a peripheral shape that complements the body shape of the intended wearer.

[0281] Another form of this technology includes a patient interface, which includes:

[0282] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure;

[0283] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0284] A second sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s nasal inlet, such that an airflow at the treatment pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber during the patient’s entire respiratory cycle in use.

[0285] A ventilation port structure that allows continuous flow of exhaled air from the patient's pneumatic chamber to the surrounding environment; the size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use; and

[0286] A positioning and stabilizing structure configured to maintain the first sealing structure and the second sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0287] A headband strap configured to provide tension to the first and second sealing structures in the patient's face via the frame, wherein the headband strap includes a first width and a second width greater than the first width; and

[0288] The headband strap selectively passes through an opening to adjust tension, a first width is configured to fit through the opening, and a second width is configured to prevent it from passing through the opening.

[0289] Another form of this technology includes a positioning and stabilizing structure configured to hold the sealing-forming structure in a therapeutically effective location, the positioning and stabilizing structure comprising:

[0290] A headband strap configured to provide tension to the sealing structure in the patient's face via the frame, wherein the headband strap includes a first width and a second width greater than the first width; and

[0291] The headband strap selectively passes through an opening to adjust tension, a first width is configured to fit through the opening, and a second width is configured to prevent it from passing through the opening.

[0292] Another form of this technology includes a pneumatic chamber, which comprises:

[0293] The pneumatic chamber includes a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure. The pneumatic chamber includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure.

[0294] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0295] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow at the therapeutic pressure is delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0296] A positioning and stabilizing structure configured to maintain the first sealing structure and the second sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0297] A frame, which is connected to the pneumatic chamber, includes:

[0298] A pair of upper arms, and

[0299] A pair of forearms, and

[0300] A headband is attached to the pair of upper arms and the pair of lower arms, and the headband is configured to provide tension to the first sealing structure and the second sealing structure in the patient's face via the frame.

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

[0302] Central part;

[0303] A pair of upper arms that extend in a posterior direction away from the center, and the pair of arms are more flexible than the center.

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

[0305] A pair of forearms extending away from the center;

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

[0307] In the example:

[0308] a) The first connector pair is different from the second connector pair;

[0309] b) The first connector is selected from the group consisting of: slot, multiple ladder locks and stop;

[0310] c) The first connector is a slot;

[0311] d) Each of the first connectors includes a first ring segment and a second ring segment;

[0312] e) The second connector is a magnet; and / or

[0313] f) The first connector is longer than the second connector.

[0314] Another form of this technology includes a patient interface, which includes:

[0315] The pneumatic chamber includes a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure. The pneumatic chamber includes a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure.

[0316] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0317] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow at the therapeutic pressure is delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0318] A positioning and stabilizing structure configured to maintain the first sealing structure and the second sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0319] A frame, including a central portion connected to the pneumatic chamber;

[0320] The pneumatic chamber includes a recess configured to removably receive the center 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 engagement position;

[0323] b) When the central portion is connected to the frame, the upper rod of the central portion is spaced apart from the groove; and / or

[0324] c) The second sealing structure is spaced apart from the upper rod before use, and the second sealing structure is configured to contact the upper rod during use.

[0325] Another form of this technology includes a patient interface, which includes:

[0326] A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure;

[0327] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the mouth of the patient, such that an airflow at the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0328] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow at the therapeutic pressure is delivered to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure within the pneumatic chamber during use throughout the patient's entire respiratory cycle.

[0329] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0330] The patient interface also includes:

[0331] At least one region in the pneumatic chamber is arranged at a distance from the first sealing structure, and the at least one region is configured to resist compression of the first sealing structure in the forward 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 includes a plurality of stop ribs spaced apart from each other;

[0335] c) The multiple stop ribs are arranged in a C-shape;

[0336] d) The plurality of stop ribs extend around the substantially entire periphery of the first sealing structure;

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

[0338] f) The at least one stop rib includes an inclined edge;

[0339] g) The sloping edge is the rear edge;

[0340] h) The inclined edge is configured to contact the first sealing structure during use in order to limit the forward movement of the first sealing structure;

[0341] i) The at least one stop rib includes a length that is substantially perpendicular to the length of the first sealing structure and a width that is substantially perpendicular to the length.

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

[0343] k) The first sealing structure is configured to contact the at least one stop rib along the width during use;

[0344] l) The at least one region is at least one reinforced region;

[0345] m) The at least one reinforced region includes multiple reinforced regions;

[0346] n) The at least one reinforced region includes a first thickness near the inlet port and a second thickness away from the inlet port, the second thickness being less than the first thickness;

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

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

[0349] Another form of this technology includes a patient interface, which includes:

[0350] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure;

[0351] A sealing structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway, such that an airflow at the therapeutic pressure is delivered to the nose. The sealing structure is constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber during use throughout the patient's respiratory cycle.

[0352] A positioning and stabilizing structure configured to maintain the sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0353] A frame, which is connected to the pneumatic chamber, includes:

[0354] The central portion, which is removably positioned within a recess on the pneumatic chamber outside the cavity, and

[0355] A pair of upper arms extending away from the center; and

[0356] A pair of forearms extending away from the center;

[0357] A headband strap, which is attached to the frame, is configured to provide tension to the first sealing structure and the second sealing structure via the frame to enter the patient's face.

[0358] In the example:

[0359] a) The upper arm is longer than the lower arm;

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

[0361] c) The first connector is selected from the following group: ring, ladder lock, and rope stopper;

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

[0363] e) The ring includes a partition wall that at least partially separates the first ring portion from the second ring portion;

[0364] f) The headband strap is configured to selectively insert into the first loop and contact the partition wall under optimal tension during use, and wherein the strap is configured to move into the second loop under tension greater than the optimal tension;

[0365] g) The second connector is a magnetic component;

[0366] h) The magnetic component comprises a generally elliptical shape;

[0367] i) The second connector is a magnetic component;

[0368] j) A housing that is removably and magnetically connected to the magnetic component;

[0369] k) The housing includes a strap connector for connection to the headband strap, the strap connector being selected from a group consisting of a free loop, a ladder lock, and a rope stopper;

[0370] l) The housing is configured to engage the lip of the outer housing;

[0371] m) At least one of the headband straps includes a first width and a second width greater than the first width;

[0372] n) The first width is selectively receptive to passage through the first connector, and the second width is substantially blocked from passing through the first connector; and / or

[0373] o) The first arm and the second arm are integrally formed with the central part.

[0374] Another form of this technology includes a pneumatic chamber, which comprises:

[0375] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of which are configured to receive an airflow for patient breathing at the treatment pressure;

[0376] A sealing structure is constructed and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s airway, such that an airflow at the therapeutic pressure is delivered to the nose. The sealing structure is constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber during use throughout the patient’s respiratory cycle.

[0377] Positioning and stabilizing structures are configured to hold the sealing structure in a therapeutically effective position.

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

[0379] Another form of this technology includes a pneumatic chamber, which comprises:

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

[0381] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the pneumatic chamber inlet port being sized and structured to receive an airflow for patient breathing at the treatment pressure; wherein the pneumatic chamber includes a lip extending at least partially around the pneumatic chamber inlet port;

[0382] A sealing structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway, such that an airflow at the therapeutic pressure is delivered to the nose. The sealing structure is constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber during use throughout the patient's respiratory cycle.

[0383] A positioning and stabilizing structure configured to hold the sealing-forming structure in a therapeutically effective position; and

[0384] An air circuit, removably connected to the pneumatic chamber and configured to provide an airflow at the treatment pressure from a flow generator to the cavity, the air circuit including a vent ring configured to at least partially insert through an inlet port of the pneumatic chamber, the vent ring comprising:

[0385] The rear surface has a first diameter.

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

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

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

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

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

[0391] In the example:

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

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

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

[0395] d) Position 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 a bend connector;

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

[0399] h) The quick-release connector is a rotatable connector or a latching connector;

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

[0401] j) The sealing structure is spaced apart from the ventilation ring, and the patient's face is not configured to contact the ventilation ring.

[0402] Another form of this technology includes a patient interface, which includes:

[0403] A pneumatic chamber having a cavity that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure;

[0404] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the cavity of the pneumatic chamber during use throughout the patient's respiratory cycle.

[0405] A second sealing structure, configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nostrils, is configured and arranged to maintain the therapeutic pressure within the cavity of the pneumatic chamber during use throughout the patient's entire respiratory cycle; and

[0406] The ventilation port structure allows for a continuous flow of air exhaled by the patient from inside the pneumatic chamber into the environment. The size and shape of the ventilation port structure are configured to maintain the treatment pressure within the pneumatic chamber during use.

[0407] The patient interface also includes:

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

[0409] The second sealing structure is not configured to contact the at least one stop rib.

[0410] In the example:

[0411] a) Upper portion of the lip edge, which is disposed below the second sealing structure and configured to contact the upper portion of the lip edge;

[0412] b) The upper part of the lip edge is not configured to contact the at least one stop rib;

[0413] c) The multiple stop ribs are arranged in a C-shape;

[0414] d) The multiple stop ribs are spaced unequally apart from each other within the cavity;

[0415] e) The multiple stop ribs extend around most of the periphery of the sealing structure;

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

[0417] g) The at least one stop rib includes an inclined edge;

[0418] h) The sloping edge is the rear edge;

[0419] i) The inclined edge is configured to contact the sealing structure during use in order to limit the forward movement of the sealing structure in the operating position;

[0420] j) The inclined edge is arranged in the rest position to extend further from the sealing structure toward the center of the pneumatic chamber;

[0421] k) The at least one stop rib includes a length that is substantially perpendicular to the length of the sealing structure and a width that is substantially perpendicular to the length measurement, wherein the length is greater than the width;

[0422] l) A first sealing structure configured to contact the at least one stop rib along the width in the operating position;

[0423] m) The width is approximately 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 integrally formed with the pneumatic chamber.

[0426] Another form of this technology includes a patient interface, which includes:

[0427] A pneumatic chamber comprising a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure and a groove formed on the surface outside the cavity of the pneumatic chamber and exposed to ambient pressure, the pneumatic chamber being formed entirely of a flexible material.

[0428] A sealing structure is configured and arranged to form a seal with the patient’s facial region surrounding the patient’s airway inlet, and the sealing structure is configured and arranged to maintain the treatment pressure in the pneumatic chamber throughout the patient’s respiratory cycle during use.

[0429] A positioning and stabilizing structure configured to maintain the sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0430] A frame, which is connected to the pneumatic chamber, includes:

[0431] The central portion includes a removably positioned portion within the recess.

[0432] A pair of upper arms extending away from the center, and

[0433] A pair of forearms extending away from the center; and

[0434] A headband strap, which is attached to the pair of upper arms and the pair of lower arms of the frame, is configured to provide tension to the sealing structure in the patient's face via the frame.

[0435] In the example:

[0436] a) The upper arm is longer than the lower arm;

[0437] b) Each of the upper arms includes a first type of connector and each of the lower arms includes a second type of connector, which is different from the first type of connector;

[0438] c) The connector of the first type is selected from the group consisting of: rings, ladder locks and rope stoppers;

[0439] d) The connector of the first type is a ring, which includes a first ring portion and a second ring portion adjacent to the first ring portion;

[0440] e) The ring includes a partition wall that at least partially separates the first ring portion from the second ring portion;

[0441] f) The strap in the headband is configured to selectively insert into the first loop and contact the partition wall under optimal tension during use;

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

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

[0444] i) The magnetic component comprises a generally elliptical shape;

[0445] j) A housing that is removably and magnetically connected to the magnetic component;

[0446] k) The housing includes a strap connector for connection to the headband strap, the strap connector being selected from a group consisting of a free loop, a ladder lock, and a rope stopper;

[0447] l) The housing is configured to engage the lip of the outer housing;

[0448] m) At least one of the headband straps includes a first width and a second width greater than the first width;

[0449] n) The first width is selectively accommodating through the first connector, and the second width is substantially blocked 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 groove;

[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 lower arms are roughly flush with the center portion;

[0454] s) The sealing structure further includes a first sealing structure configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth;

[0455] t) The sealing structure also includes a second sealing structure, which is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nostrils;

[0456] u) The groove is arranged on the pneumatic chamber, below the second sealing structure and opposite to the first sealing 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 an airflow at the therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the conduit being configured to deliver the airflow to the patient interface;

[0458] w) The conduit is connected to the inlet port of the pneumatic chamber, which is spaced apart from the inner periphery of the center of the frame;

[0459] x) The central portion includes an inner periphery and an outer periphery removably positioned within the groove;

[0460] y) The groove is formed radially outward at the inlet port, and the groove forms a closed perimeter; and / or

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

[0462] Another form of this technology includes a patient interface, which comprises:

[0463] A pneumatic chamber including a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the size and structure of the pneumatic chamber inlet port being configured to receive an airflow for patient breathing at the treatment pressure; wherein the pneumatic chamber includes a lip that extends at least partially around the pneumatic chamber inlet port and extends into the cavity;

[0464] A sealing structure is constructed and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s airway, such that an airflow at the therapeutic pressure is delivered to the nose. The sealing structure is constructed and arranged to maintain the therapeutic pressure in the pneumatic chamber during use throughout the patient’s respiratory cycle.

[0465] A positioning and stabilizing structure configured to hold the sealing-forming structure in a therapeutically effective position; and

[0466] An air circuit, removably connected to the pneumatic chamber and configured to provide an airflow at the treatment pressure from a flow generator to the cavity, the air circuit including a vent ring configured to at least partially insert through an inlet port of the pneumatic chamber, the vent ring comprising:

[0467] The rear surface has a first diameter.

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

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

[0470] in:

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

[0472] The rear surface includes at least one vent, which is configured to provide communication between the cavity and the surrounding environment via the recess;

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

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

[0475] In the example:

[0476] a) The annulus is inclined between the rear surface and the front surface;

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

[0478] c) Position 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 also includes a bend connector, the central opening being configured to receive the bend connector;

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

[0482] g) The at least one vent is a plurality of vents spaced apart around the periphery 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 the leakage of airflow from the system;

[0489] n) The sealing structure is spaced apart from the ventilation ring, and the patient's face is not configured to contact the ventilation ring;

[0490] o) The quick-release connector includes multiple vents configured to discharge a portion of the airflow into the surrounding environment;

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

[0492] q) The annulus includes a disc configured to be positioned within the cavity and to restrict the release of exhaled air into the surrounding environment; and / or

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

[0494] In the example:

[0495] a) The bend connector includes at least one button configured to be selectively actuated to disconnect the bend connector from 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 annulus and move relative to the remainder of the bend when the at least one button is actuated;

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

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

[0500] f) The finger is configured to selectively engage the annulus on the radially outer side of the inner wall; and / or

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

[0502] Another form of this technology includes a bend configured to be removably connected to the pneumatic chamber, the bend including a button that can be selectively engaged by the patient.

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

[0504] The body includes a first end configured to be at least partially inserted into a cavity of the pneumatic chamber, and a second end configured to connect to an air circuit. The body also includes:

[0505] The button has a fixed end near the first end and a free end extending away from the free end;

[0506] The outer lip margin, with air extending roughly around at least a portion of the periphery of the body; and

[0507] The button can be selectively engaged by the patient to selectively disengage the body from the pneumatic chamber.

[0508] In the example:

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

[0510] b) An inner lip edge that is spaced apart from the outer lip edge and arranged closer to the first end than the outer lip edge.

[0511] c) The width of the inner lip is approximately 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, thus forming a free end;

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

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

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

[0517] i) The outer lip is configured to adjoin the vent ring and restrict the translational movement of the bend;

[0518] j) The button can be selectively engaged 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] l) The inner lip is configured to selectively engage the groove, and is configured to disengage from the groove when the button or buttons are applied; and / or

[0521] m) The outer lip extends roughly around the perimeter of the main 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 is formed as a cantilever structure relative to the button;

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

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

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

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

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

[0531] i) The outer lip is configured to adjoin the vent ring and restrict the translational movement of the bend;

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

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

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

[0535] The body includes a first end configured to be at least partially inserted into a cavity of the pneumatic chamber, and a second end configured to connect to an air circuit. The body also includes:

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

[0537] Finger-shaped component connected to the button;

[0538] The button is selectively engaged by the patient to allow it to move relative to a surface of the body; and

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

[0540] In the example:

[0541] a) The button is configured to move toward the 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) This button is the first button, and the main body also includes a second button;

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

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

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

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

[0547] The body includes a first end configured to be at least partially inserted into a cavity of the pneumatic chamber, and a second end configured to connect to an air circuit. The body also includes:

[0548] A button, forming part of the surface of the body, is configured to move into the interior of the body due to external force; and

[0549] A finger-like element is attached to the button and spaced apart from the surface of the body, the finger-like element 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 the outer surface of the vent ring;

[0552] b) Offset the button toward a relaxed position, where the button is flush with the surrounding surface of the body;

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

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

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

[0556] f) The finger-like component is generally hook-shaped; and / or

[0557] g) The fulcrum is located between the button and the finger, with the button forming a cantilever structure relative to the fulcrum and the finger forming a cantilever structure relative to the fulcrum.

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

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

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

[0561] In the example:

[0562] a) A disc, which is attached to the rear surface and configured to be positioned within the pressurized environment;

[0563] b) The width of the disk is approximately the same as the width of the rear surface;

[0564] c) The disk 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) Connectable portion, the extension adjacent to the rear surface can be connected to the vent ring, the extension being configured to space the at least one vent from the surface of the pneumatic chamber;

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

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

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

[0570] Another form of this technology is a connector member having a first side and a second side opposite to the first side. Each of the first and second sides includes connector material. The connector material is configured to be removably attached to a positioning and stabilizing structure of the 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 ring material; and / or

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

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

[0576] In the example:

[0577] a) The first and second sides of the connecting component include hook material;

[0578] b) The outer surface includes a ring material;

[0579] c) The connecting member can be connected to an unlimited number of locations along the length of the at least one side strap;

[0580] d) The patient interface includes a frame and a positioning stabilization structure; wherein the frame includes a ring configured to removably receive the at least one side strap; and wherein the at least one strap is folded after passing through the ring, 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 also includes a posterior bandage configured to cover the patient's occipital bone, wherein the at least one lateral bandage includes a pair of inferior lateral bandages configured to be removably connected to the frame and a pair of superior lateral bandages configured to be removably connected to the frame. The pair of superior lateral bandages and the pair of inferior lateral bandages each include a connecting member; and / or

[0583] g) The connecting members on each upper and lower strap can be removably connected to an unlimited number of locations along the length of the corresponding strap.

[0584] Another form of the technology includes a positioning and stabilizing structure comprising at least one side strap, the 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 substantially hidden in the first position and visible when the strap is extended in the second position.

[0585] In the example:

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

[0587] b) The hidden part is luminous;

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

[0589] d) The at least one strap includes a tactile-responsive element on either side of the concealed portion, the tactile-responsive element being configured to be joined together in the first position and separated in the second position;

[0590] e) The tactile response element is a magnet; and / or

[0591] f) Tactile response elements are mechanical connectors.

[0592] Another form of this technology includes a positioning and stabilizing structure having a posterior band configured to cover the patient's occipital bone, a pair of inferior bandages configured to be removably connected to a frame, and a pair of superior bandages configured to be removably connected to the frame. Each of the superior and inferior bandages includes a connecting member.

[0593] In the example:

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

[0595] b) Each of these connecting members includes hook material on each side to facilitate removable connection;

[0596] c) At least one strap includes 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 the 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 includes a first density protrusion and a second density protrusion;

[0601] h) At least one strap includes a cut edge;

[0602] i) The cut edge is a square edge, a triangular edge, or a circular edge;

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

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

[0605] l) At least one strap includes an elastic portion that can be stretched between a first length and a second length;

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

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

[0608] o) The at least one strap includes a tactile-responsive element on either side of the concealed portion, the tactile-responsive element being configured to be joined together in the first position and separated in the second position;

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

[0610] q) The patient interface is detachably connected to the positioning and stabilizing structure.

[0611] One aspect of this technology is a method for manufacturing equipment.

[0612] One aspect of certain forms of this technology is an easy-to-use medical device, for example, one that is easy to use by people who have not received medical training, people with limited dexterity or vision, or people with limited experience using this type of medical device.

[0613] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0614] One aspect of this technology is a patient interface that can be washed in a patient's home, for example, with soapy water, without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be washed in a patient's home, for example, with soapy water, without the need for specialized cleaning equipment.

[0615] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of processors, such as processors for dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0616] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0617] Other features of the present technology will become apparent from the following detailed description, abstract, drawings and claims. Attached Figure Description

[0618] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0619] 4.1 Respiratory Therapy System

[0620] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and flows to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

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

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

[0623] 4.2 Respiratory System and Facial Anatomy

[0624] Figure 2A This diagram illustrates an overview of the human respiratory system, which includes the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0625] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alar cartilage, 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 a face with several identifiable surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0627] Figure 2DIt is a side view of the head with several recognizable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. It also indicates the directions of above and below, as well as the anterior and posterior aspects.

[0628] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0629] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0630] Figure 2G A side view showing the surface features of the nose.

[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 bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

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

[0633] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

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

[0635] Figure 2L The frontal lateral view of the nose is shown.

[0636] 4.3 Patient Interface

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

[0638] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0639] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

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

[0641] Figure 3E A schematic diagram of a cross-section of 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 amplitude shown has a relatively small amplitude compared to that shown.

[0642] Figure 3F A schematic diagram of a cross-section of 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 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

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

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

[0645] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0646] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

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

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

[0649] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. The inner surface defines the two-dimensional openings in the mask.

[0650] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0651] Figure 3O The left-hand rule is illustrated.

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

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

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

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

[0656] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

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

[0658] Figure 3V It shows Figure 3U This is a view of the rear of the pneumatic chamber. The view is oriented perpendicular to the center contact plane. Figure 3V The sagittal plane in the middle divides the pneumatic chamber into left and right sides.

[0659] Figure 3W It shows crossing Figure 3V The cross-section of the pneumatic chamber, which is in Figure 3V The image shows a cut-off point in the sagittal plane. The 'intermediate contact' plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The direction of the intermediate contact plane corresponds to the direction of chord 3210, which lies in the sagittal plane and contacts the pneumatic chamber pad at the following two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the pad in this region, the intermediate contact plane can be tangent at both the upper and lower points. For mouth-nose interfaces configured with pneumatic chambers having separate mouths and noses, such as ultra-compact full-face masks (UCFF), the upper and lower points are on the sealing formation structure of the mouth of the mask.

[0660] Figure 3X It shows Figure 3UThe pneumatic chamber 3200 is positioned on the face for use. When the pneumatic chamber 3200 is in the use position, the sagittal plane of the pneumatic chamber typically coincides with the midsagittal plane of the face. When the pneumatic chamber is in the use position, the intermediate contact plane typically corresponds to the 'facial plane'. Figure 3X In the middle, the air chamber 3200 is the air chamber of the nasal mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0661] 4.4RPT device

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

[0663] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to the present technology. The upstream and downstream directions are shown with reference to the blower and patient interface. The blower is defined upstream of the patient interface, and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any given moment. Articles 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 This is an isometric view of one form of humidifier according to this technology.

[0666] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, which shows the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0667] 4.6 Respiratory waveform

[0668] Figure 6 The diagram shows a typical breathing waveform of a person during sleep.

[0669] 4.75 Patient Interface of Current Technology

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

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

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

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

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

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

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

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

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

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

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

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

[0682] Figure 16-3 yes Figure 16 Another cross-sectional view of the pneumatic chamber shown illustrates the liner of the first dimension.

[0683] Figure 16-4 yes Figure 16 Another cross-sectional view of the pneumatic chamber shown illustrates the second-dimension liner.

[0684] Figure 16-5 yes Figure 16 Another cross-sectional view of the pneumatic chamber shown illustrates the liner of the third dimension.

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

[0686] Figure 18 It is the 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 in its use position on the patient's face is shown, with the pneumatic chamber outlined for clarity.

[0690] Figure 20 The patient's face is shown with a specific area joined by the sealing structure shown.

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

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

[0693] Figure 22 This is a front perspective view of another form of patient interface according to the present technology, in which the ventilation port has been removed.

[0694] Figure 23 This is a front perspective view of the patient interface with a frame for connecting the headband strap to the pneumatic chamber.

[0695] Figure 23-1 Is wearing Figure 23 The patient interface provides a front perspective view of the patient.

[0696] Figure 23-2 This is a front perspective view of a replacement version with a patient interface for connecting the headband strap to the pneumatic chamber.

[0697] Figure 24 yes Figure 23 A breakdown diagram of the patient interface.

[0698] Figure 24-1 yes Figure 23-2 A breakdown diagram of the patient interface.

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

[0700] Figure 26 This is a front view of another form of frame and pneumatic chamber according to this 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 The frame and pneumatic chamber are shown in a sectional view along section 26-26.

[0703] Figure 26-2a yes Figure 26-1 Another example of the frame and pneumatic chamber is a sectional view taken 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 the frame and pneumatic chamber, illustrating the arm of the frame that can move between a first position and a second position.

[0706] Figure 26-5 yes Figure 26-4 The rear perspective view of the frame and the pneumatic chamber illustrates the bending of the pneumatic chamber in the second position.

[0707] Figure 27 yes Figure 26 The rear view of the frame shows the tapered opening.

[0708] Figure 27-1 yes Figure 26 The top perspective view of the frame shows the reduction in the thickness of the frame's arms.

[0709] Figure 27-2 yes Figure 26 A perspective view of the frame, illustrating the rings on the free ends of the frame.

[0710] Figure 27-3 yes Figure 26 A perspective view of the frame, showing the cross-section of the frame's arms.

[0711] Figure 28 This is a front view of another form of frame and pneumatic chamber based on this technology.

[0712] Figure 28-1 This is a perspective view of the second connection point that can be used with a frame of one form of this 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 This is a detailed view of a pneumatic chamber according to another form of the present technology, illustrating a clamp support configured to selectively contact the frame.

[0715] Figure 30 It is connected to the frame. Figure 29 The bottom view of the pneumatic chamber, with the frame in contact with the clamp support.

[0716] Figure 31 This is a front view of a pneumatic chamber of another form according to the present technology, connected to a frame including clamp supports.

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

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

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

[0720] Figure 35 This is a perspective view of another form of frame according to the present technology, illustrating the protrusion near the eyelet.

[0721] Figure 35-1 It is a side perspective view of a frame based on another example.

[0722] Figure 35-2 yes Figure 35 Detailed diagram of the eyelets.

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

[0724] Figure 37 This is a front view of a frame according to another form of the present technology, illustrating the upper rod of the frame separated from the pneumatic chamber.

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

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

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

[0728] Figure 41 Is it possible to... Figure 23 A detailed view of a positioning and stabilizing strap used with a patient interface, the strap having a first width and a second width.

[0729] Figure 41-1 Is it possible to... Figure 23 A detailed view of an alternative example of a positioning and stabilizing strap used with a patient interface, the strap having a protrusion.

[0730] Figure 41-1-1 It has Figure 23 Detailed view of an alternative example of a patient interface positioning and stabilizing structure strap, the strap having the same... Figure 41-1 The convex portion is located in the convex portion of the alternative configuration.

[0731] Figure 41-2 Is it possible to... Figure 23 Detailed view of an alternative example of a positioning and stabilizing strap used with a patient interface, the strap having a cut edge.

[0732] Figure 41-3 Is it possible to... Figure 23 Detailed view of an alternative example of a positioning and stabilizing strap used with a patient interface, the strap being positioned in a first position.

[0733] Figure 41-4 yes Figure 41-3 A detailed view of the strap, illustrating the strap in its second extended position, where the indicator becomes visible.

[0734] Figure 41-5 Is it possible to... Figure 23 A detailed view of an alternative example of a positioning and stabilizing strap used with the patient interface, the strap being positioned in a second extended position where the indicator becomes visible.

[0735] Figure 41-6 It is a perspective view of a double-sided connector with hook or ring material.

[0736] Figure 41-7 yes Figure 41-6 Rear view of the dual-sided connecting member on the headband in the first position.

[0737] Figure 41-8 yes Figure 41-6 Rear view of the dual-sided connecting member, which is connected to the headband in the second position.

[0738] Figure 42 Is using Figure 41 The straps Figure 23 The front perspective view of the patient interface.

[0739] Figure 42-1 It's a diagram. Figure 42 An alternative version of the front perspective view shows a patient interface with a sleeve on the arm of the frame.

[0740] Figure 42-2 yes Figure 23 The front perspective view of the patient interface, which uses an alternative version of the bandage.

[0741] Figure 43This is a rear view of an optional form of the liner, with the stop ribs shown in dashed lines.

[0742] Figure 44 It is observed along line 44-44. Figure 43 A cross-sectional view of the liner, illustrating the shape of the stop rib.

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

[0744] Figure 45-1 It is observed along line 45-1-45-1. Figure 43 A cross-sectional view of the liner, illustrating the shape of the stop rib.

[0745] Figure 46 yes Figure 26 A front view of the pneumatic chamber, illustrating the groove for receiving the frame.

[0746] Figure 47 This is a rear view of a mat according to another form of the present technology, with the reinforced area shown in dashed lines.

[0747] Figure 47-1 yes Figure 47 A cross-sectional view of the mat, illustrating the reinforced area.

[0748] Figure 48 This is a cross-sectional view of another type of liner according to the present technology, illustrating alternative forms of the reinforcing region.

[0749] Figure 49 yes Figure 48 The cross-sectional view of the mat shown.

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

[0751] Figure 50-1 This is a cross-sectional view of another form of gasket according to the present technology, illustrating a vent ring with offset to create a gap between the sealing structure and the bend.

[0752] Figure 51 It's a diagram. Figure 50 The pad is shown in a cross-sectional view of the patient wearing it.

[0753] Figure 52 This is a perspective view of the arm of a frame based on another example, which includes a first ring section and a second ring section.

[0754] Figure 53 yes Figure 52A perspective view of the arm, illustrating the headband strap connected to the first ring under optimal tension.

[0755] Figure 54 It is a perspective view of 52, illustrating the headband strap connected to the second loop under tension exceeding the optimal tension.

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

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

[0758] Figure 56 This is a perspective view of a patient interface based on another example, illustrating a frame with a wire plug that connects to a headband strap.

[0759] Figure 56-1 This is a perspective view of a patient interface based on yet another example, illustrating a frame with a wire plug that connects to a headband strap.

[0760] Figure 57 The image is a cross-sectional view of a patient interface based on another example, illustrating a ventilation ring on the lip that connects to the inlet port of the pneumatic chamber.

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

[0762] Figure 58-1 It is used for Figure 58 A perspective view of a quick-release connector in an air circuit.

[0763] Figure 59 yes Figure 57 A perspective view of the ventilation ring.

[0764] Figure 60 yes Figure 59 The bottom view of the vent ring shows multiple vent holes.

[0765] Figure 61 This is a bottom view of an alternative form of housing for the magnet, which is detachably connected to the connection point of the frame in any of the previous examples.

[0766] Figure 62 It is a perspective view of another form of decoupling structure including a connector for engagement within the vent ring.

[0767] Figure 63 It is based on the use of with Figure 62A perspective view of another example of a decoupled structural connection, showing a vent ring.

[0768] Figure 63-1 It is connected to Figure 63 On the ventilation ring Figure 62 A cross-sectional view of the decoupled structure.

[0769] Figure 64 It is a perspective view of a decoupled structure based on another form, including a connector for engaging the outside of the vent ring.

[0770] Figure 65 This is a perspective view of yet another form of decoupling structure, which includes a connector for engaging within a vent ring.

[0771] Figure 66 It is based on the use of with Figure 64 A perspective view of another example of a decoupled structure joining 65, or a vent ring.

[0772] Figure 66-1 It is connected to Figure 66 On the ventilation ring Figure 64 A perspective view of the decoupled structure.

[0773] Figure 66-2 It is connected to Figure 66 On the ventilation ring Figure 65 A perspective view of the decoupled structure.

[0774] Figure 66-3 yes Figure 66-2 The decoupling structure and cross-sectional view of the vent ring are coupled to the pneumatic chamber.

[0775] Figure 67 It is a perspective view of a decoupled structure according to another form, including a connector for engaging the outside of the vent ring.

[0776] Figure 68 This is based on yet another example used with Figure 67 A perspective view of the decoupled structure of the vent ring.

[0777] Figure 69 It is connected to Figure 68 The ventilation ring Figure 67 A perspective view of the decoupling structure, illustrating the arm of the decoupling structure engaged with the vent ring.

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

[0779] Figure 70 It is connected to the pneumatic chamber. Figure 69The decoupled structure and cross-sectional view of the vent ring.

[0780] Figure 71 This is another perspective view of a bent tube connector that is connected to the pneumatic chamber and spaced apart from the surface of the pneumatic chamber when fully connected.

[0781] Figure 71-1 yes Figure 71 A cross-sectional view of the bend connector and the pneumatic chamber.

[0782] Figure 72 This is another form of side perspective view including herringbone-shaped bend connectors.

[0783] Figure 73 yes Figure 72 Front perspective view of the bend connector.

[0784] Figure 73-1 It is connected to the pneumatic chamber. Figure 73 A cross-sectional view of a bend connector.

[0785] Figure 74 This is a perspective view of another type of bend connector with fewer vents.

[0786] Figure 75 Is with Figure 74 A perspective view of a rotary joint used with a bend connector, showing the vent. Detailed Implementation

[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, and the specific examples described herein may be modified. It should also be understood that the terminology used in this invention is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0788] The following description provides various examples of things that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another instance or other examples. Furthermore, any single feature or combination of features in any instance can constitute further instances.

[0789] When using anatomical directional terms to describe aspects and examples of this technology, such as "anterior," "posterior," and "upper," the direction is read in the context of this technology during patient use. For example, the anterior side of the patient interface refers to the side of the patient interface relative to the patient when the patient has already worn the interface in the intended manner.

[0790] When a surface or part is described as facing one direction, such as "facing upwards," "facing forwards," etc., the surface or part will be understood to be at least partially facing that particular direction unless the context explicitly requires it. If a part generally faces upwards, even if it is also partially facing another direction, then that part can be "facing upwards."

[0791] 5.1 Treatment

[0792] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0793] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0794] In some examples of this technique, mouth breathing is restricted, constrained, or prevented.

[0795] 5.2 Respiratory Therapy System

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

[0797] 5.3 Patient Interface

[0798] According to one aspect of the present technology, the non-invasive patient interface 3000 includes the following functional aspects: a sealing formation structure 3100, a pneumatic chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection 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, a single physical component may provide one or more functional aspects. In use, the sealing formation structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0799] In some examples of this technology, the pneumatic chamber is at least partially formed by the housing 3250. In these examples, the housing 3250 or a portion thereof may be slightly flexible, as discussed further below.

[0800] In some examples of this technology, the patient interface is an oronasal patient interface, that is, the patient interface is configured to seal around both the patient's nasal airway and oral airway. 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 sealing structure at the nose is not located on the bridge or ridge of the nose on the patient's face, but rather on the lower surface of the patient's nose.

[0802] If the 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] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the environment.

[0804] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the environment.

[0805] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the environment.

[0806] 5.3.1 Sealing Formation Structure

[0807] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface 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 some forms of the present invention, the sealing forming structure 3100 includes a first sealing forming structure 3101 and a second sealing forming structure 3102. The first sealing forming structure is connected to the opening 3201 of the pneumatic chamber and is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth. The second sealing forming structure is connected to the nose 3202 of the pneumatic chamber 3200 and is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nose. The phrase "connected to" herein is used to refer to a part or component formed as a single piece as well as parts or components formed separately and subsequently joined together. In some cases, components may be connected by intermediate components.

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

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

[0811] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0812] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0813] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material such as silicone.

[0814] In some forms of this technology, a system is provided comprising more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0815] 5.3.1.1 Sealing Mechanism

[0816] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting within the pneumatic chamber 3200 on its underside, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0817] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the pneumatic chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the pneumatic chamber 3200 and extends at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange during use and prevent it from bending. Limiting buckling can prevent the formation of wrinkles in the sealing structure 3100, which can lead to leakage and loss of therapeutic pressure.

[0818] In one embodiment, the sealing structure 3100 may include a compression sealing portion or a gasket sealing portion. In use, the compression sealing portion or the gasket sealing portion is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0819] In one form, the sealing structure 3100 includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0820] In one form, the sealing forming structure 3100 includes a region having an adhesive or bonding surface.

[0821] In some forms of this technology, the sealing 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 an adhesive or bonding surface.

[0822] 5.3.1.2 Nasal region

[0823] See next. Figures 7 to 18 In some forms of this technology, the second sealing structure 3102 includes a central portion 3110 configured to seal the surface of a patient's nose in use. This central portion may seal to the lower periphery of the patient's nose (e.g., around the patient's nostrils) and to the patient's upper lip. In an example, a portion of the sealing structure may engage a patient's septum. The second sealing structure 3102 may also include a lateral portion 3111 on the lateral side of the central portion 3110. In an example, the sealing structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the anterior nasal region.

[0824] like Figure 10 As best shown in 16-19, the rear surface 3112 of the lateral portion 3111 slopes forward in the upward / forward direction from the boundary 3103 of the first sealing structure 3101 and the second sealing structure 3102, such that the rear lateral portion of the nose of the mask slopes forward in the profile.

[0825] In an embodiment with a ridge 3120 (as further described below), the rear surface 3112 of the transverse portion 3111 can be tilted forward from the ridge 3120.

[0826] In some forms of this technology, the rear surface 3112 of the transverse portion 3111 forms an angle between 20° and 90° with the intermediate contact plane of the mask. The intermediate contact plane may be perpendicular to the sagittal plane and may extend approximately along the length of the ridge 3120 and the chord 3210. This angle can be... Figure 16 The angle is measured in the clockwise direction, although it can also be measured in the counterclockwise direction, such that the measured angle is the supplement of the angles listed above (i.e., between 90° and 160°).

[0827] like Figures 16-3 to 16-5As shown, the second sealing structure 3102 can be formed at different angles relative to the intermediate contact plane, allowing patients with different nasal sizes to comfortably wear the patient interface 3000. As also shown, the two separate angles of the second sealing structure 3102 can be modified on patient interfaces 3000 of different sizes to provide better fit for a wide range of patients.

[0828] The first angle 6056 can be measured from the intermediate contact plane to the first sealing axis 6060 extending along the upper boundary 3247 of the second front wall portion 3242 and intersecting with 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 It may include a first angle of approximately 108°, 6056-1. Figure 16-4 It may include a first angle of approximately 105°, 6056-2, and Figure 16-5 This can include a first angle 6056-3 of approximately 109°. As shown in the figure, the first angle 6056 is along... Figures 16-3 to 16-5 The measurement is shown in the counterclockwise direction. However, the first angle 6056 can be measured in the clockwise direction, such that the measured angle is the supplement of the aforementioned angle.

[0829] The second angle 6064 can be measured from the intermediate contact plane to the second sealing axis 6068 extending along the surface of the second sealing forming structure 3102, which is configured to contact the patient and intersect with 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 It may include a second angle of approximately 127.5°, 6064-1. Figure 16-4 It may include a second angle of approximately 116.5°, 6064-2, and Figure 16-5 This can include a second angle 6064-3 of approximately 122°. As shown in the figure, the second angle 6064 is along... Figures 16-3 to 16-5 The measurement is shown in the counterclockwise direction. However, the second angle 6064 can be measured in the clockwise direction, such that the measured angle is the supplement of the aforementioned angle.

[0830] The difference between the first angle 6056 and the second angle 6064 can form an inclination of the second sealing structure 3102. As described above, in some forms, this difference can be between about 1° and about 110°. In some forms, this difference can be between about 5° and about 50°. In some forms, this difference can be between about 10° and about 20°. For example, Figure 16-3 This could include a difference of approximately 19.5°. Figure 16-4 This can include a difference of approximately 11.5°, and Figure 16-5 This can include a difference of approximately 13°. In some forms, this difference can 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 may correspond to patients with different nasolabial angles (see, for example, Figure 2E The patient interface 3000 shown in each of the three figures can represent interfaces of different sizes (e.g., small, medium, or large), each of which can comfortably fit the patient within the range of the nasolabial angle.

[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 long nasal tips (e.g., a large distance between the nasal tip and the apex of the nostrils). For example, the second anterior wall portion 3242 can be sufficiently spaced from the second sealing structure 3102 such that the contact between the patient's nostril and the second sealing structure 3102 is kept at a sufficient distance from the second anterior wall 3242 to allow airflow. This distance 6072 can extend between the second anterior wall portion 3242 and the nostril 3135. The distance 6072 can be the shortest distance between the second anterior wall portion 3242 and the second sealing structure 3102, and this distance may not extend along the first axis 6060. Although in other examples, the first distance 6072 may extend approximately along the first sealing axis 6060. This allows the second sealing structure 3102 to extend in the forward direction without contacting the second anterior wall portion 3242 (e.g., when the patient has a long nasal tip).

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

[0834] The lateral portion 3111 is configured to tilt in such a way that the portion of the nose portion of the interface 3000 extending on the side of the nasal ala is smaller compared to some similar interfaces in the prior art. In some forms of this technology, this results in a reduction in the portion of the nasal ala that contacts the sealing structure 3100 relative to the interface with the lateral portion, which tilts backward toward the patient's face, thereby reducing the proportion of the nasal ala, which can be deformed and blocked by the sealing structure 3100, for example, when the patient sleeps on the side of its interface that contacts the pillow.

[0835] 5.3.1.3 Mouth and nose boundary

[0836] See details Figure 7 In one form of this technology, 8 and 16-18, the boundary between the first sealing structure 3101 and the second sealing structure 3102 forms or includes a corner or ridge 3120. In use, the corner or ridge 3120 can be engaged on the patient's face above the lips and directly 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 mouth and nose masks, such as those described in PCT application PCT / AU2019 / 050278.

[0838] A sharper angle reduces the likelihood of wrinkling forming in the first sealing structure 3101 and / or the second sealing structure 3102 on or near the corner or ridge 3120 when the mask is worn and treatment is performed. Some oronasal patient interfaces that do not use this structure may require a very thin, rounded structure in this area, which may be less resistant to wrinkling. Conversely, the corner or ridge 3120 can be more rigid than such an interface and can better maintain its shape, and therefore can better seal indentations and wrinkles present around the patient's nose. In embodiments provided with a support, such as the support 3260 described herein, which resists or resists compression in the area, this effect can be enhanced.

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

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

[0841] In some forms of this technology, the corner or ridge 3120 may extend across substantially the entire boundary 3103 between the first sealing formation 3101 and the second sealing formation 3102. In embodiments, the corner or ridge 3120 may engage with the patient's face at least near the nasal opening, for example, where the face meets above the nostrils, such as... Figure 20 As shown in region 1010.

[0842] 5.3.1.4 Oral region

[0843] As described above, in one form, the non-invasive patient interface 3000 includes a first sealing structure 3101 that forms a seal around the patient's mouth during use. The first sealing structure 3101 can form a seal on the chin area of ​​the patient's face.

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

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

[0846] The sealing structure 3100 includes a relatively low wall thickness (compared to other parts of the interface) at the orifice periphery 3132, for example, less than 0.7 mm. The lower lip portion 3130 of the sealing structure abuts against the chin region, and at least at the center of the lower lip portion 3130. This low wall thickness at these locations contributes to an effective and comfortable seal. The sealing structure in these regions can easily conform to any complex geometry.

[0847] In some forms of this technology, the orifice 3133 is generally trapezoidal rather than oval or elliptical in order to more precisely correspond to the shape of the patient's nose. This shape of the orifice allows the interface 3000 to be particularly compact and generally no 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 (therefore with Figure 50The bend 3500 and / or ventilation ring 3504 are spaced apart. This distance 6076 can be measured in a direction substantially parallel to distance 6072. This distance 6076 provides sufficient clearance for the patient's lips to extend into the cavity 3272 and further forward than the second sealing structure 3102. The patient can slightly compress the second sealing structure 3102 in the forward direction, and the distance 6076 can be large enough to prevent contact with the bend 3500 and / or ventilation ring 3504. However, the distance 6076 may not be too large, so that the patient interface 3000 maintains a compact profile.

[0849] Similarly or otherwise, such as Figure 50-1 As shown, the ventilation ring 3504 (described in more detail below) may include an offset to create an additional gap between the bend 3500 and the first sealing formation 3101 (and thus the patient's lips). The ventilation ring 3504 may include a biasing member 3506 (described below) that can space the bend 3500 from the cavity 3272 of the pneumatic chamber 3200. For example, as Figure 57 As shown, the bend 3500 contacts the front surface 3512 of the ventilation 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 the extension in the forward direction away from the patient's face), but the bend 3500 extends into the distance 6076. In other words, the distance 6076 (as...) Figure 51 The distance measured in the image is no longer the maximum distance between the patient's lips and the front of the patient interface 3000. Applying offset 3506 can increase the distance the patient interface 3000 extends in front of the patient's face, and also separate the bend 3500 from the patient's lips, so that distance 6076 remains the maximum separation distance in the front direction between the patient's lips and the patient interface 3000.

[0850] 5.3.1.5 Nasal pillow

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

[0852] According to one aspect of the present invention, a nasal pillow comprises: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the stem. Additionally, the nasal pillow connection structure of the present invention includes a flexible region adjacent to the bottom of the stem. The flexible regions can work together to facilitate the formation of a universal connection structure, which is adjustable with relative movement of displacement and angular motion between the truncated cone and the nasal pillow connection structure. For example, the position of the truncated cone can be axially moved toward the stem connection structure.

[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 sealing structure 3100 are formed from a single homogeneous sheet of material (e.g., molded silicone). The combination of the sealing structure 3100 and the pneumatic chamber 3200 can be considered as a gasket.

[0855] 5.3.2.1 Adjustable nose angle

[0856] See details Figure 9 , 10 In one form of this technology, as shown in 16 to 18-2, the first front wall portion 3240 of the nose portion 3202 of the pneumatic chamber 3200 is more flexible than the adjacent region of the mouth portion 3201. The first front wall portion 3240 may be disposed near the boundary 3241 between the nose and mouth portions of the pneumatic chamber 3200. In embodiments, the first front wall portion 3240 may be symmetrical about the midsagittal plane and may extend across at least 50%, for example, at least 80%, of the width of the nose portion 3202 of the pneumatic chamber. In some embodiments, the first front wall portion 3240 may extend across substantially the entire width of the nose portion 3202 of the pneumatic chamber.

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

[0858] The flexible first anterior wall portion 3240 allows the patient contact portion 3110 of the second sealing formation 3102 to pivot or hinge around a region on the rear side of the interface 3000. This can help allow the interface to accommodate the patient at various angles between the base of the nose and the top of the lip (i.e., the nasolabial angle).

[0859] In embodiments characterized by an angle or ridge 3120 between the first sealing structure 3101 and the second sealing structure 3102, as described above, the patient contact portion 3110 may pivot or hinge around an area at or near the angle or ridge 3120. In embodiments provided with one or more supports 3260 (further described below), the hinged or pivoting area may be directly above the supports 3260.

[0860] like Figure 9As shown, the first front wall portion 3240 may have an upper boundary 3243 and a lower boundary 3244. One or both of the upper boundary 3243 and the lower boundary 3244 may be curved, for example, such that the center of the boundary is lower than the transverse portion, as shown. The first front wall portion 3240 may have approximately the same height in its width (i.e., the upper and lower boundaries may be approximately parallel), or the height may vary in its width, for example, such that the height of the center of the first front wall portion 3240 is greater than the height of the transverse portion, as shown. Figure 9 As shown in the embodiment. 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 forces on the patient contact portion 3110 of the second sealing forming structure 3102.

[0861] Similarly, the second front wall portion 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of this 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 may be curved, for example, such that the center of the boundary is lower than the transverse portion. The second front wall portion 3242 may have approximately the same height in its width (i.e., the upper and lower boundaries may be approximately parallel), or the height may vary in its width, for example, such that the height of the center of the second front wall portion 3242 is less than the height of the transverse portion.

[0862] In some forms of this technology, in addition to or instead of the curved boundary, the first front wall portion 3240 can be configured to have the desired stiffness in other ways. For example, the thickness of the first front wall portion 3240 can be selected to provide the desired stiffness. In the example, the first front wall portion 3240 may be thinner than the adjacent portion of the pneumatic chamber wall. Additionally and / or alternatively, the first front wall portion 3240 may 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 formed in this manner.

[0863] The second anterior wall portion 3242 (e.g., a band 3270) helps prevent collapse of the nose portion 3202 and can provide support for the patient contact portion 3110 of the second seal-forming structure 3102, which is typically relatively thin. An insufficiently supported patient contact portion may suffer bursting at the seal against the patient's face. In one form, the second anterior wall portion 3242 is thicker than the adjacent portion of the pneumatic chamber wall. In some forms, the second anterior wall portion 3242 is configured as a thickened band of material 3270, such as... Figure 16-19As shown. The 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 may include different thicknesses. For example, the thickness of the second front wall portion 3242 may be greater than the thickness of the first front wall portion 3240, which may provide increased rigidity in the second front wall portion 3242 (e.g., compared to the first front wall portion 3240). Specifically, the second front wall portion 3242 may be a band 3270 extending into a cavity 3272 of the pneumatic chamber 3200. For example, the band 3270 may extend through the first front wall portion 3240 and toward a patient wearing the patient interface 3000. The outer surface of the nose portion 3202 may be generally smooth, while the inner surface of the nose portion (e.g., within the cavity 3272) may be stepped (or otherwise include discontinuous portions).

[0865] like Figure 16-1 and 16-2 As shown, the first anterior wall portion 3240 can act as a hinge and allow the nose portion 3202 to bend. The first anterior wall portion 3240 can be the thinnest area of ​​the nose portion 3202, and therefore most susceptible to bending moments. The increased thickness of the band 3270 directs bending moments away from the second anterior wall portion 3242 and towards the thinner first anterior 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) also makes the nose portion 3202 more rigid and less able to bend around the first anterior wall portion 3240. When bending occurs, the first anterior wall portion 3240 and the second anterior wall portion 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 differs 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 adjacent to the belt 3270 (e.g., and around the belt 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 belt 3270. This can provide greater flexibility to the first front wall portion 3240, allowing the nose portion 3202 to bend further (e.g., in the forward direction).

[0867] like Figure 21-1As shown, the nose portion 3202 can also be formed without a hinge. In other words, a band may not be formed on the second front wall portion 3242, allowing the first front wall portion 3240 and the second front wall portion 3242 to have a substantially uniform thickness. The nose portion 3202 can still bend even without a band because it can be made of silicone, which allows for some conformability in the nose portion 3202 to accommodate different nasolabial angles.

[0868] 5.3.2.2 Flexible outer shell

[0869] In some forms of this technology, the housing 3250 can be made of a rigid material such as polycarbonate. However, in other forms of this technology, the housing 3250, or multiple portions thereof, can be slightly flexible. For example, in one example, the housing 3250 can be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the housing 3250 can be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the housing 3250 can be made of a material with a Young's modulus of 0.7 MPa or less, for example, a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone resin.

[0870] In the example, the housing 3250 and one or both of the first sealing structure 3101 and the second sealing structure 3102 may be formed of the same material (e.g., silicone, textiles, etc.).

[0871] In some forms of this technology (see, for example, Figures 23 to 28-2 The housing 3250 can be constructed substantially entirely of a flexible material, which provides maximum freedom of movement for the housing 3250 (i.e., virtually no rigid and / or thickened portions restricting bending). The housing 3250 can be flexible enough that one or more components can be added to provide the desired stiffness in one or more areas of the housing 3250 (e.g., the area of ​​contact area 1010). For example, one or more ventilation modules; connection ports; headband connectors; headband connectors connected to the rigidified arms and rigidified members can be attached to the housing 3250 in such a way as to increase the stiffness of the pneumatic chamber 3200 in the area adjacent to the components, for example, as further described below. In some forms of this technology, these components can be releasably attached to the flexible housing 3250. Alternatively or additionally, one or more components can be permanently attached to the housing 3250, for example, by bonding and / or overmolding. The rigidified members can also be used to increase stiffness and / or support the shape of the sealing formation 3100.

[0872] In some forms of this technology, the housing 3250 may be generally flexible, but may include reinforcing portions with a greater thickness than the adjacent portions of the housing 3250. Such reinforcing portions may be configured as ribs or strips, for example, extending laterally through the housing and / or extending vertically, although many other configurations are also possible. In some forms, the housing may include, for example, a generally rigid portion made of polycarbonate, as well as slightly flexible portions.

[0873] In some forms of this technology, the central portion 3251 on the front side of the opening 3201 of the pneumatic chamber can preferably have greater stiffness than the rest of the pneumatic chamber 3200. In some forms of this technology, the area of ​​increased stiffness can be just below the nose 3202, such as... Figure 21 As shown and further described below, and / or just above the mouth portion 3201. In one form of this technology, part or all of the first anterior wall portion 3240 may be a region of increased stiffness rather than increased flexibility. Providing increased stiffness in one or more of these regions can provide shape stability and limit the degree to which the housing 3250 deforms due to head-carrying forces. Excessive deformation can cause the second sealing structure 3102 to obstruct the nostrils. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important for patients with narrow noses, or in some cases undesirable. Furthermore, the described regions of increased stiffness can help reduce torsional deformation of the interface, which would otherwise cause one side of the second sealing structure 3102 to lose contact with the patient's nose, thus creating a leakage path.

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

[0875] In one form of this 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 can extend continuously between the connection ports 3600 and can provide an airflow path for pressurized airflow entering the pneumatic chamber 3200 through the connection ports 3600.

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

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

[0878] In some forms of this technology (see, for example, Figure 21 Connector 3310 and arm 3320 are provided below connection port 3600, toward the lateral edge of pneumatic chamber 3200. Connector 3310 may be located at the lateral end of arm 3320. Connector 3310 may provide additional rigidity to pneumatic chamber 3200 and / or sealing structure 3100.

[0879] In some forms of this technology (see, for example, Figure 21-1 Connector 3310 does not include arm 3320, but connects directly to pneumatic chamber 3200. This allows pneumatic chamber 3200 to be more... Figure 21 The pneumatic chamber 3200 is more flexible.

[0880] Figure 22 A pneumatic chamber 3200 with a vent mounting hole 3410 is shown, into which a suitable vent or module can be inserted. The vent can be made of a relatively rigid material to increase the rigidity of the pneumatic chamber. In some forms of this art, the vent mounting hole 3410 can be generally elliptical in shape, wherein the minor axis of the ellipse is generally parallel to the sagittal plane.

[0881] exist Figure 22 In the embodiment shown, the vent mounting hole is positioned facing the upper boundary of the opening 3201 of the pneumatic chamber 3200.

[0882] Figure 22 The illustrated embodiment includes a connector 3310 for positioning and stabilizing the structure. The connector 3310 can be mounted in a relatively thicker area of ​​the housing 3250. In the illustrated embodiment, the connector 3310 is located below the vent mounting hole 3410 and faces the lateral side of the pneumatic chamber 3200. In some forms of this technology, the connector 3310 is a generally circular magnetic head-attached connector.

[0883] Although Figure 7-19 The accompanying drawings of the pneumatic chamber do not show inlet or connection ports, but those skilled in the art will understand that one or more inlet ports will actually be provided, for example, Figure 21-22The inlet port 3600 is shown. Inlet port 3600 allows an interface to be connected to air circuit 4170, as further described herein. In some forms of this art, one or more components of air circuit 4170 may also serve as components for positioning and stabilizing the structure.

[0884] like Figure 24 As shown, some forms 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 on the opening 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 periphery of the inlet port 3604 (see, for example, Figure 49 For example, the lip 3608 may extend around the entire circumference of the circular inlet port 3604. The lip 3608 may extend into the cavity 3272 (see, for example, Figure 18-1 The lip edge 3608 may be tilted relative to the periphery of the circumference of the inlet port 3604.

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

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

[0888] In some forms of this technology, the pneumatic chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The use of a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0889] In some forms of this technology, the pneumatic chamber 3200 is constructed of a translucent material, such as translucent silicone. The use of translucent materials can reduce the protrusion of the patient interface and help improve treatment adherence.

[0890] In some forms of this technology, dedicated reinforcing or rigid members (e.g., without other function) may be included on the pneumatic chamber 3200. These members may be formed of a material that is more rigid than the pneumatic chamber 3200 (e.g., more rigid than silicone). The dedicated reinforcing members may be overmolded onto the pneumatic chamber 3200 to provide greater stiffness than the rigid portion 3263 or arm 3320 of the housing 3250.

[0891] 5.3.3 Support section

[0892] like Figure 12 and 14 As shown in Figure -18, in one form of this technology, the support portion 3260 is disposed on the opposite side of the interface 3000 between the second sealing structure 3102 and the front wall of the pneumatic chamber 3200. (As shown in Figure -18) Figure 12 As shown, in one example, each support 3260 extends to the lateral edge of the interface.

[0893] The support portion 3260 does not function as a lower pad but is configured to resist or impede compression in the anteroposterior direction. The support portion 3260 thereby supports and / or reinforces a portion of the second sealing structure 3102, which engages the patient's upper lip. Specifically, the support portion 3260 may support and / or reinforce an area of ​​the second sealing structure 3102 that may contact an area 1010 of the patient's face near the nasal inlet, in which the flap meets the area above the upper lip, such as... Figure 20 As shown. 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 no wrinkling forms in the sealing structure 3100. Wrinkling in the sealing structure can result from a very flexible sealing structure with a large radius of curvature that conforms to the patient's face. Due to its excessive flexibility, the sealing structure can fold or wrinkle itself, leading to leakage within the sealing structure. Wrinkling may be of particular concern when the sealing structure seals the area 1010 of the patient's face. The support portion 3260 can be particularly advantageous when the sealing structure is configured to produce 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) compared to a sealing structure without the support portion 3260. The increased support and / or stiffness provided by the support portion 3260 reduces the ability of the second sealing 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 approximately match the geometry (e.g., contour) of the patient's face. For example, the sealing structure 3100 for a particular patient can be selected from a variety of sizes to roughly conform to the nasal alar region (i.e., proximity region 1010). A sharper curvature allows the second sealing structure 3102 to seal over various gaps around the patient's nose, reducing the likelihood of gap formation.

[0895] Specifically, such as Figure 14-16 As shown, in one form of this technology, the support 3260 is connected to the front side of the inlet 3201 of the pneumatic chamber, adjacent to the boundary 3241 of the inlet 3201 and the nose 3202. In some embodiments, when viewed in a cross-section parallel to the sagittal plane (e.g. Figure 16-18 (as shown) and / or when viewed in a cross-section parallel to the front plane (e.g.) Figure 14 and 15 As shown), the support portion 3260 may be curved. The curvature may be positive or negative. In the example shown, the curvature may be negative (e.g., relative to the patient's nose). In some examples, the lateral sidewall portion 3245 of the pneumatic chamber 3200 may be curved inward near the boundary 3241 with the nose portion 3202, and the support portion 3260 may be substantially abutting the adjacent lateral sidewall portion 3245. Figure 18As shown, when viewed in a cross-section parallel to the sagittal plane, at least a portion of the support 3260 may have a reduced thickness between a first end 3261 adjacent to the front wall of the pneumatic chamber 3200 and a second end 3262 adjacent to the sealing structure 3100. For example, the support 3260 may be thicker near the first end 3261, which can help provide increased support and / or stiffness to the second sealing structure 3102. In some examples, the support 3260 may 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 3260 may 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 may vary in thickness between 1.3 mm (e.g., near the second end 3262) and 2.5 mm (e.g., near the first end 3261).

[0896] Support portions 3260 with different geometries can be used for different patients. For example, a patient requiring more support and / or rigidity in the second sealing structure 3102 can use a sealing structure 3100 with a support portion 3260 that is thicker (e.g., closer to the first end 3261 and / or at any location along the length) and / or more curved (e.g., a lower radius of curvature). For example, a patient wanting a more flexible second sealing structure 3102 can use a sealing structure 3100 with a support portion 3260 that is thinner (e.g., closer to the first end 3261 and / or at any location along the length) and / or less curved (e.g., a larger radius of curvature).

[0897] Especially Figure 14 and 15 As shown, in one form of this technology, the support portion 3260 is connected to the opening portion 3201 of the pneumatic chamber, which is adjacent to the boundary of the lateral sidewall portion 3245 of the opening portion 3201 and the lateral sidewall portion 3246 of the nose portion 3202.

[0898] In some forms of this technology, the support 3260 is shaped to provide a generally clear flow path from the mouth 3201 of the pneumatic chamber to the nostril 3135 during inhalation. In some forms of this technology, no part of any support 3260 is directly below the nostril 3135.

[0899] 5.3.4 Over-tensioned support

[0900] like Figures 43-45As shown, the patient interface 3000 may include a stop rib 6040 within the cavity 3272 of the pneumatic chamber 3200. The stop rib 6040 may be disposed within the opening 3201 of the pneumatic chamber 3200 and provide support around the patient's oral cavity. The stop rib 6040 may 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 rest 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 opening 3201 of the pneumatic chamber 3200 and the first sealing formation 3101. Figure 43 As shown, the stop rib 6040 may extend only partially around the patient interface 3000 (e.g., in a C- or U-shape), and no stop rib 6040 may be arranged adjacent to (e.g., directly in front of) the supralipal portion 3131. In other forms, the stop rib 6040 may extend around the entire periphery of the mouth portion 3201 and the first sealing structure 3101, or around the mouth portion 3201 and the first sealing structure 3101. Figure 43 The different parts shown extend.

[0902] Continue to refer to Figure 43 The stop ribs 6040 are spaced apart from each other such that no stop rib 6040 contacts any other stop rib 6040. In some forms, the stop ribs 6040 may be equidistantly spaced such that there is an equal distance 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 in a location more suitable for receiving force on the patient's face (e.g., near the nasolabial fold).

[0903] like Figures 44 to 45-1 As shown, the stop rib 6040 may be an elongated member extending from the inner surface of the pneumatic chamber 3200 toward the sealing structure 3100. The stop rib 6040 may be connected to the opening 3201 of the pneumatic chamber 3200 and at least partially spaced from the first sealing structure 3101 in a resting or unused position. For example, the edge 6042 (e.g., the rear edge) of each stop rib 6040 may be inclined (e.g., not perpendicular to the front-rear direction). This can provide additional spacing between the stop rib 6040 and the first sealing structure 3101 in the unused position.

[0904] In use, the patient's face contacts the sealing structure 3100 and pushes the first sealing structure 3101 forward. Because each patient can individually tighten the headband strap 3354 (described in more detail below), the patient may overtighten the headband strap 3354 and cause the sealing structure 3100 to press too firmly against the patient's face. If the overtightened sealing structure 3100 folds or wrinkles and allows pressurized air to escape from the pneumatic chamber 3200, this may cause patient discomfort and / or potentially reduce the quality of the seal. To limit the occurrence of overtightening, the stop ribs 6040 are spaced apart from the first sealing structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the first sealing structure 3101 contacts each stop rib 6040 at its edge 6042 along its width (e.g., a narrow width measured approximately parallel to the first sealing structure 3101). Because the stop ribs 6040 are longer than their width, they act as reinforcements and limit the total distance the first seal-forming structure 3101 can move. The stop ribs 6040 may also be thicker than the first seal-forming structure 3101 in any direction. This allows the stop ribs 6040 to be sized such that the patient can fasten the headband strap 3354 to the desired point to form the desired seal, but not beyond that point to minimize discomfort and / or seal degradation. The slope of the edge 6042 allows sufficient space for the patient's face to fit comfortably within the pneumatic chamber 3200, while also limiting excess space (e.g., which could lead to over-tightening) and providing support for the patient's face. The stop ribs 6040 may also include curvature along the width surface (see, for example, Figure 45-1 ).

[0905] Additionally, each stop rib 6040 may extend more than half (e.g., two-thirds, three-quarters, etc.) along the length of the first sealing structure 3101. This can help ensure that movement is restricted to approximately the entire first sealing structure 3101.

[0906] like Figures 47-49 As shown, the patient interface 3000 may include a reinforcing region 6044 within the cavity 3272 of the pneumatic chamber 3200. The reinforcing region 6044 may be disposed within the opening 3201 of the pneumatic chamber 3200 and provide support around the patient's mouth. The reinforcing region 6044 may be integrally formed with the pneumatic chamber 3200 (e.g., during the same molding process), such that the reinforcing region 6044 is formed as a single piece with the remainder of the pneumatic chamber 3200.

[0907] A reinforcement region 6044 may be formed on the front surface 6046 of the pneumatic chamber 3200 within the cavity 3272, and near the lateral side of the mouth 3201. When the patient interface 3000 is worn, the reinforcement region 6044 can be positioned directly across the patient. The reinforcement region 6044 may be substantially symmetrical on either side of the mouth 3201 and may extend around the lateral region 6048 of the pneumatic chamber 3200.

[0908] like Figure 47 As shown, the reinforcing region 6044 may have substantially the same height as the inlet port 3604. In other words, the reinforcing region 6044 may extend approximately along the length of the opening 3201 of the pneumatic chamber 3200. In some forms, the thickness may vary along the reinforcing region 6044. For example, the reinforcing region 6044 may be thicker near the inlet port 3604 and may decrease in thickness away from the inlet port 3604 (although this can also be reversed). In other examples, the reinforcing region 6044 may be thicker near the lower part of the opening 3201 and thinner near the upper part of the opening 3201 (e.g., near the nose 3202), although these can also be reversed.

[0909] like Figure 47-1 As shown, in some forms, the reinforced region 6044 may be about 0.01 mm to about 10 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be about 0.1 mm to about 5 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be about 1 mm to about 2 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be about 1.8 mm thicker than the surrounding unreinforced region. In some forms, this may be a constant thickness on the reinforced region 6044, while in other examples, this may be the maximum value of a variable thickness on the reinforced region 6044.

[0910] like Figure 48 and 49 As shown, the alternative forms of the enhanced region 6044 can be smaller than Figure 47 The reinforcing region described herein. In an alternative form, the reinforcing region may be located near the lower part of the opening 3201 of the pneumatic chamber 3200. The reinforcing region 6044 may also extend in an inclined direction. For example, each reinforcing region 6044 may be inclined in a vertical direction such that the reinforcing region 6044 is higher near the inlet port 3604 than far from the inlet port 3604.

[0911] Figure 48 and 49Some forms of the reinforcing region 6044 may extend only along the front surface 6046 of the cavity 3272 and may not extend along the side region 6048 of the pneumatic chamber 3200. In use, the reinforcing region 6044 can be positioned directly in front of the patient's face. For example... Figure 49 As shown, the reinforcement region 6044 may extend to the side region 6048 (e.g., adjacent to or in contact with the side region 6048), but may not extend around the side region 6048.

[0912] like Figure 48 As shown, the thickness of the reinforcing region 6044 can vary across its entire surface. For example, the reinforcing 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 reinforcing 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 engaged, the patient's face contacts the sealing structure 3100 and pushes the first sealing structure 3101 forward. Because each patient can individually tighten the headband strap 3354 (described in more detail below), the patient may overtighten the headband strap 3354, causing the sealing structure 3100 to press too firmly against the patient's face. If the overtight sealing structure 3100 folds or wrinkles and allows pressurized air to escape from the pneumatic chamber 3200, this may cause patient discomfort and / or potentially reduce the quality of the seal. To limit the occurrence of overtightening, a reinforcing region 6044 is spaced apart from the first sealing structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the reinforcing region 6044 restricts the compression of the first sealing structure 3101 in the forward direction. The reinforcing region 6044 may function similarly to the stop rib 6040 and limit the total distance that the first sealing structure 3101 can move. However, the reinforced area 6044 may not provide a stop, but rather can limit compression, as thicker areas require greater force to compress. The dimensions of the reinforced area 6044 can be determined such that the patient can fasten the headband strap 3354 to the intended point to form the desired seal, but not beyond that intended point to minimize discomfort and / or seal degradation.

[0914] 5.3.5 Positioning and Stabilization Structure

[0915] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0916] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the pneumatic chamber 3200 to lift the face away.

[0917] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0918] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of forces acting on the patient interface 3000 that could cause damage, such as those from tube resistance or accidental interference with the patient interface.

[0919] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one instance, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0920] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0921] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0922] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient rests their head on the pillow, the presence of the decoupling portion prevents forces at the rear from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0923] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap configured as a laminate of a fabric patient contact 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 another form, the fabric outer layer includes a loop material to engage with a hook material portion.

[0924] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0925] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum that is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraaural base of the patient’s head and covers a portion of the parietal bone but not the occipital bone.

[0926] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0927] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is constructed and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0928] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0929] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to be transported through the straps.

[0930] In some forms of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0931] Figure 21 and 22 An embodiment is shown with a connector 3310 (e.g., a magnetic connector) for connection to the positioning and stabilizing structure 3300.

[0932] In some forms, the straps of the positioning and stabilizing structure 3300 may be constructed from a stretchable (e.g., elastic) material. The positioning and stabilizing structure 3300 can be extended to accommodate patients with different head sizes.

[0933] In some forms, the bandage of the positioning and stabilizing structure 3300 may be made of at least partially non-stretchable material. This may limit the bandage's stretchability. Different sizes of bandages can be used for patients of different sizes to accommodate different head sizes. The bandage of the positioning and stabilizing structure 3300 may also be adjustable in length.

[0934] like Figure 23-2 , 24-1 As shown in 42-2, 55-1, and 56-1, certain forms of positioning and stabilizing structures 3300 may include an upper bandage 3357 that covers the patient's parietal and / or frontal bones during use. The upper bandage 3357 may be adjustable in length to accommodate different head sizes (e.g., using a buckle 3369). Each patient can tighten or loosen the upper bandage 3357 to fit their individual head. Tightening or loosening the bandage adjusts the tension in the upper bandage 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 connected to the pneumatic chamber 3200 and helps maintain the effective therapeutic position of the sealed forming structure 3100. Figures 23 to 28-2 The pneumatic chamber 3200 shown specifically illustrates a curved tube 3500 connected to the front of the patient's face, although this frame can be used with other types of pneumatic chambers 3200 (e.g., Figure 21-22 (The pneumatic chamber 3200 is used together with the catheter headband.)

[0937] In some forms, the frame 3350 is made of a rigid or semi-rigid material and provides support for the sealing-forming structure 3100 and / or the pneumatic chamber 3200. For example, the frame 3350 can help maintain the shape of the sealing-forming structure 3100 and / or the pneumatic chamber 3200 to reduce leakage of pressurized air due to folding and / or wrinkling when the sealing-forming structure 3100 engages with the patient's face.

[0938] In some forms, frame 3350 provides at least one connection point 3352 that helps to indirectly connect headband strap 3354 to pneumatic chamber 3200 and / or sealing formation 3100. Connection point 3352 may be a loop (e.g., having a fully formed periphery) that accommodates a portion of headband strap 3354. For example, a length of upper left headband strap 3356 may pass through the first loop 3352a and be pulled away from pneumatic chamber 3200 to apply tension via upper left headband strap 3356. Upper left headband strap 3356 may be folded against itself and held at a selected length (e.g., using Velcro, magnets, adhesives, etc.) to maintain the applied tension. Similar steps may be performed to adjust the tension in upper right headband strap 3358 in second loop 3352b. In other forms, connection point 3352 may include an open periphery (e.g., U-shaped or C-shaped).

[0939] In some configurations, each ring 3352a, 3352b can be oriented such that the force vector applied by the corresponding upper headband straps 3356, 3358 is substantially perpendicular to the inner surface 3351 of the ring in contact with the upper headband straps 3356, 3358. For example... Figure 23 As shown, the upper right headband strap 3358 engages ring 3352b approximately at the center of the inner surface 3351 of the ring. When the upper right headband strap 3358 is tightened, the force vector is applied in a substantially straight direction, rather than being inclined relative to the inner surface 3351 of the ring. This can improve the seal of the seal-forming structure 3100 because the force is oriented along the arm 3362, rather than being inclined relative to the arm 3362, which may require further tightening of the upper headband straps 3356, 3358 to achieve the same sealing effect (e.g., in cases where patient comfort is compromised), and / or may prevent the seal-forming structure 3100 from properly engaging the patient's face (e.g., leading to leakage).

[0940] like Figure 41 and 42 As shown, the headband straps 3356 and 3358 may include different widths along their length. For example, a first portion of each strap 3356 and 3358 may be formed with a first width 3359, and a second portion of each strap 3356 and 3358 may be formed with a second width 3361 greater than the first width. In some forms, a majority of the headband straps 3356 and 3358 may be formed with the second width 3361.

[0941] Although not shown, the lower headband straps 3366, 3368 may also include different widths (e.g., and include a tapered shape) similar to those described for the upper headband straps 3356, 3358. Therefore, any description relating to the upper headband straps 3356, 3358 may apply to the lower headband straps 3366, 3368.

[0942] In the example shown, each headband strap 3356, 3358 may taper between a first width 3359 and a second width 3361. The headband straps 3356, 3358 may include a generally linear side 3363 between the first width 3359 and the second width 3361. In other examples, the headband straps 3356, 3358 may bend between the first width 3359 and the second width 3361. In other examples, the headband straps 3356, 3358 may not include the transition between the first width 3359 and the second width 3361, but may 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 can be used to warn the patient that the upper headband straps 3356 and 3358 are being pulled too tight. The examples shown illustrate these features independently incorporated into the upper headband straps 3356 and 3358 (e.g., in straps with a substantially uniform width). However, Figure 41-1 and 41-2 The feedback characteristics can be combined with Figure 41 In the conical structure (or stepped straps) of the middle.

[0944] like Figure 41-1 As shown, the upper straps 3356, 3358 may include dots 6128 (e.g., silicone dots). Dots 6128 provide increased resistance as the straps pass through the corresponding loops 3352a, 3352b of the frame 3350. In other words, these dots 6128 can rub against the corresponding loops 3352a, 3352b and provide a tactile response to the patient, which can alert the patient that the upper headband straps 3356, 3358 are being pulled too tight.

[0945] In some configurations, point 6128 may rise from the surface of straps 3356, 3358 to contact rings 3352a, 3352b and provide a tactile response to the patient.

[0946] In the form shown, point 6128 is used with a bandage of substantially uniform width. The width can be approximately the width of the corresponding loops 3352a, 3352b (e.g., at least a portion of the bandage width can be slightly larger than the width of loops 3352a, 3352b). If the patient attempts to pull either of the upper bandages 3356, 3358 through the corresponding loops 3352a, 3352b, point 6128 will provide further resistance to movement through the loops 3352a, 3352b. For example, the patient can feel the vibration of point 6128 contacting the loops 3352a, 3352b.

[0947] In another form, in addition to the tapered shape of the upper straps 3356, 3358, a point 6128 is used. Therefore, the point 6128 can serve as an additional signal that the upper straps 3356, 3358 are being overstretched. In other words, the point 6128 can be located on the portion of each upper strap 3356, 3358 with a second width 3361. If the patient attempts to pull the second width 3361 of any of the upper straps 3356, 3358 through the corresponding loops 3352a, 3352b, the point 6128 will provide further resistance to movement through the loops 3352a, 3352b.

[0948] In some configurations, dots 6128 may be evenly distributed on the upper straps 3356, 3358. In other configurations, dots 6128 may be unevenly distributed. For example, the concentration of dots 6128 may increase in the direction away from the free ends of the corresponding straps 3356, 3358. This can provide an initial warning to the patient of potential overtension and can be converted into a larger number of dots 6128 to warn the patient that overtension has already occurred.

[0949] In other examples (see, for example, Figure 41-1-1 Point 6128 can be used to help guide the patient to the correct position. For example, points 6128 can be arranged in a linear pattern with uniform intervals. As the patient passes the straps 3356, 3358 through the corresponding loops 3352a, 3352b, points 6128 can provide feedback at each interval to communicate how far the strap has been passed (e.g., similar to holes on a strap). In other words, the patient can adjust the strap 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 to their head, rather than simply warning against excessive tightness.

[0951] In some configurations, the shape, size, and / or density of the dots 6128 may vary along the length of the bandages 3356 and 3358. For example, the dots 6128 may be spaced evenly (or substantially evenly) before overstretching to help the patient select the appropriate length, as described above. The configuration of the dots 6128 may be altered at the location of the bandages (e.g., becoming denser), which would cause the patient to overstretch the bandages 3356 and 3358. Changes in the configuration of the dots 6128 may produce different tactile responses, which could alert the patient to overstretching.

[0952] In some configurations, point 6128 may extend approximately across the entire length of the corresponding straps 3356, 3358. This can provide tactile cues for patients with a wide range of head sizes. In this example, point 6128 may be spaced approximately evenly (although this can vary in the configuration described above). Point 6128 allows the patient to consistently select the desired location, rather than being warned of specific over-tightened areas.

[0953] Although the above description uses the word "point," any suitable shape can be used. For example, silicone sealant (or other similar materials) can include triangles, rectangles, or any other similar shapes.

[0954] like Figure 41-2 As shown, the upper bandages 3356 and 3358 may include a cut edge 6132 (e.g., a square cut, a triangular cut, a circular cut, etc.). The cut edge 6132 can provide a tactile response to the patient, which can warn the patient that the upper bandages 3356 and 3358 are too tight.

[0955] In the form shown, the cut edge 6132 is used with a bandage of substantially uniform width. The width may be approximately the width of the corresponding loops 3352a, 3352b (e.g., at least a portion of the bandage width may be slightly larger than the width of the loops 3352a, 3352b). If the patient attempts to pull the upper bandages 3356, 3358 through the corresponding loops 3352a, 3352b, the variation in the overall width and discontinuity of the cut edge 6132 will provide further indication to the patient to stop pulling the upper bandages 3356, 3358 through the loops 3352a, 3352b.

[0956] In other forms, in addition to the tapered shape of the upper bandages 3356, 3358, a cutting edge 6132 is used. Therefore, the cutting edge 6132 can serve as an additional signal to the patient that the upper bandages 3356, 3358 are being overstretched. In other words, the cutting edge 6132 can be positioned on the portion of each upper bandage 3356, 3358 having a second width 3361. If the patient attempts to pull on the second width 3361 of the upper bandages 3356, 3358 through the corresponding loops 3352a, 3352b, the variation between the entire second width 3361 and the discontinuity of the cutting edge 6132 will provide the patient with further indication to stop pulling on the upper bandages 3356, 3358 through the loops 3352a, 3352b.

[0957] In some forms, 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 forms, 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 edges 6132 may decrease in a direction away from the free end of each upper strap 3356, 3358.

[0958] In other examples, the cutting edge 6132 can be used to help guide a patient to the correct position. For example, the cutting edge 6132 can be arranged in a linear pattern with uniform spacing. As the patient passes the straps 3356, 3358 through the corresponding loops 3352a, 3352b, the cutting edge 6132 can provide feedback at each interval to convey how far the strap has been passed (e.g., similar to holes in the strap). In other words, the patient can adjust the strap 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 cut edge 6132 can alert the patient to a specific strap length that is beneficial to their head, rather than simply warning of excessive tightness.

[0960] In some forms, the shape, size, and / or density of the cut edges 6132 may vary along the length of the straps 3356, 3358. For example, the cut edges 6132 may be evenly (or substantially evenly) spaced before overstretching to help the patient select the appropriate length, as described above. The configuration of the cut edges 6132 may be altered at locations where the straps 3356, 3358 would cause the patient to overstretch (e.g., becoming smaller and / or closer together). Changes in the configuration of the cut edges 6132 can produce different tactile responses, which can alert the patient to overstretching.

[0961] In some configurations, the cutting edge 6132 may extend approximately across the entire length of the corresponding straps 3356, 3358. This can provide tactile cues for patients with a wide range of head sizes. In this example, the cutting edges 6132 may be spaced approximately evenly (although this can vary in the configuration described above). Instead of warning of specific over-tightening locations, the cutting edge 6132 allows the patient to consistently select the desired position.

[0962] In use, each headband strap 3356, 3358 passes through the corresponding loops 3352a, 3352b as described above. Because the first width is smaller than the width of the loops 3352a, 3352b, the first width 3359 can selectively insert through the openings of the corresponding loops 3352a, 3352b. At least some transition widths 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 any opening. The larger second width 3361 can provide a stop and limit the total length that can pass through the corresponding loops 3352a, 3352b. Due to the second width 3361, this can reduce excessive tension on the patient. In some configurations, the length of the upper headband straps 3356, 3358 with a first width 3359 (or the first width 3359 plus the length of the transition 3363) can be designed for patients with larger heads. Therefore, the upper headband straps 3356, 3358 can be adjusted to achieve the desired tightness when the second width reaches the corresponding loops 3352a, 3352b or before the second width reaches the corresponding loops 3352a, 3352b. In cases with smaller heads, if the upper headband straps 3356, 3358 are adjusted to the second width 3361, the upper headband straps 3356, 3358 may be under greater tension. However, the second width 3361 still prevents the patient from excessively tightening the upper headband straps 3356, 3358 and limits deformation and leakage of the sealing structure 3100. Alternatively, positioning and stabilizing structures 3300 of different sizes can be constructed for patients with different head sizes (i.e., the second width 3361 serves as a stop to limit excessive tension in patients with multiple head sizes).

[0963] In other examples, the strap extension can be attached to the upper headband straps 3356, 3358 to provide a greater length for the first width 3359. This allows a single positioning and stabilizing structure 3300 designed for smaller patient heads to be used with larger patient heads.

[0964] In some forms, the strap extension may have connectors on both sides. The illustrated examples show the same type of connector on either side, but the connectors may differ on each side. For example, the strap extension may include hook and loop material. In some forms, loop material is formed on both sides, while in other forms, hook material is formed on both sides. In still other forms, hook material is formed on one side, and loop material is formed on the other side.

[0965] In some forms, a bandage extension can be used to provide additional length so that the patient does not overstretch the bandage (e.g., upper bandages 3356, 3358 and / or lower bandages 3366, 3368).

[0966] In some forms, the strap extension may include... Figures 41 to 41-5 Features similar to those shown on the straps. For example, strap extensions may include, for instance... Figure 41 The tapered shape shown may also include a stepped shape. This limits the distance the strap extension can pass through rings 3352a, 3352b to prevent over-tightening. The strap extension may also include point 6128 as described above (see, for example, Figure 41-1 ) and / or cutting edges (see, for example, Figure 41-2 This allows for the provision of an indication of over-tension (e.g., tactile response). The strap extension may also include features similar to... Figures 41-3 to 41-5 The concealed part 3365 provides a visual and / or tactile indication of excessive tension. The concealed part 3365 may also be referred to as an alarm part.

[0967] exist Figures 41 to 41-5 Any features described herein and included in the bandage extension may alert the patient to adjust the bandage extension relative to the headband strap 3354. In some forms, this may involve adjusting the connection position of the bandage extension relative to the corresponding straps on the headband (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368). For example, the patient may connect the bandage extension closer to the portion having the second width 3361 to shorten the effective length of the bandage, or the patient may connect the bandage extension closer to the portion having the first width to increase the effective length of the bandage.

[0968] In some forms, the straps of the headband 3354 (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368) may include an extension length of a connector configured to mate with a connector on a strap extension. For example, upper straps 3356, 3358 may include hook or loop material along at least a portion of a first width 3359 and / or a portion of a second width 3361.

[0969] The patient can adjust the position of the bandage extension along the length of the corresponding bandage to select the appropriate available length for the patient (e.g., to provide sufficient sealing without overstretching the bandage).

[0970] In some forms, different sizes of strap extensions (e.g., small, medium, large) can be available to allow patients to make appropriate adjustments for their specific head and reduce the variation of overstretching the strap extensions.

[0971] Furthermore, or additionally, the upper headband straps 3356, 3358 may be made of an elastic material. Due to stretching under tension, the elastic material can alter its visual appearance (e.g., change color). The unfolding of the headband straps 3356, 3358 can also provide the patient with a tactile response indicating that the straps 3356, 3358 are overstretched. This change in visual appearance can alert the patient (or a third party, such as a bed partner) to excessive tension in the upper headband straps 3356, 3358. This may be beneficial if the patient has fully tightened the upper headband straps 3356, 3358 before the second width reaches the corresponding loops 3352a, 3352b.

[0972] For example, Figures 41-3 to 41-5 Examples of bandages (e.g., upper headband bandages 3356, 3358) are illustrated, which may include features that warn patients that the bandage has been overstretched, which may warn patients that the bandage should be loosened and / or that a different size (e.g., a larger headband bandage 3354) is needed.

[0973] exist Figure 41-3 The illustration shows an exemplary bandage in a first position. This could be a position before patient use, where the bandage is not stretched. Figure 41-3 The strap is also shown stretched to the correct length. For example, the patient can use the strap and adjust it to the appropriate length so that it is not overstretched.

[0974] exist Figure 41-4 In the illustration, an exemplary bandage is shown in a second position, extending and / or stretching from its initial position. As described above, the bandage may include a portion 3365 that is normally concealed but exposed in the second position. For example, the concealed portion 3365 may be elastic and extend to a certain length when the tension applied to the bandage exceeds a threshold. The concealed portion 3365 may be a different color and / or texture to alert the patient that the tension in the bandage has exceeded a predetermined limit. This change in appearance and / or feel can alert the patient to overstretching of the bandage.

[0975] In some forms, the concealment 3365 may be luminescent and may glow when exposed. In a dark room, the glow emanating from the concealment 3365 may be observed, thus alerting the patient to excessive stretching of the headband strap 3354.

[0976] In some forms, the concealment 3365 may include a noise output device (e.g., a speaker) that outputs sound when the concealment 3365 is exposed in order to warn the patient.

[0977] In some forms, the concealed portion 3365 may include electronic components (e.g., a light-emitting element) that output light when the concealed portion 3365 is exposed. The light output may warn the patient that the headband strap 3354 is being overstretched. In some forms, the headband strap 3354 may include a battery (not shown) and / or wires for supplying power to the electrical components.

[0978] In some forms, the patient may not be able to see that the strap has exceeded the threshold tension and the hidden portion 3365 is exposed (e.g., the strap may no longer be visible to the patient when worn by the patient). Figure 41-5 As shown, the bandage may include a tactile response element 3367, which can provide a tactile response to the patient to indicate that the tension in the bandage has exceeded a certain threshold.

[0979] In some forms, the tactile response element 3367 is a pair of magnets. When the strap is in a first position, the magnets 3367 are connected to each other. When the tension in the strap exceeds the magnetic force, the magnets 3367 separate, and the hidden portion 3365 is exposed. Therefore, the strap can be under tension and can stretch (e.g., if it is elastic) before the magnets 3367 separate.

[0980] When magnet 3367 disengages, the patient can receive a release response. This can take the form of disconnection from magnet 3367 along the strap and / or vibration in an auditory signal. Either or both of these situations may alert the patient that the strap is too tight. Releasing excessive tension in the strap allows magnet 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 made of plastic and / or silicone. Instead of magnetism, the tactile response element 3367 can be connected using mechanical connections (e.g., snap-fit) or similar connections (e.g., hook-and-loop connectors). These alternative tactile response elements 3367 can have a retaining force that allows for some extension below a separation threshold preceding the tactile response element 3367. Similar to the magnet 3367, 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 response element 3367 can be wider than the bandage. This can provide the patient with additional visual cues to determine if the bandage tension has exceeded a threshold.

[0983] Although not shown, Figures 41-3 to 41-5The overstretching features shown and described may also be incorporated into other straps on the headband strap 3354. For example, the lower headband straps 3366, 3368 may be tightened onto the magnet in a similar manner, making overstretching possible. Additionally or optionally, the adjustable upper strap 3357 (see, for example, Figure 23-2 , 24-1 (42-2, 55-1, and 56-1) may include a concealed portion 3365 to warn the patient of excessive tension. The adjustable upper band 3357 may also include a tapered band to limit excessive stretching. The tapered band may be used with a band extension to allow a single headband 3354 to be used with multiple head sizes.

[0984] like Figures 41-6 to 41-8 As shown, the headband strap 3354 can utilize the bilateral connecting members 6136 to allow the patient to adjust the available length. Figure 41-6 As shown, the bilateral connecting member 6136 may include hook material (or loop material) on both sides (e.g., the first side 6136-1 and the second side 6136-2 may be functionally identical). The patient can attach the hook material to the loop material (or hook material) of the headband strap 3354 at the desired location. For example, the entire length of the headband strap 3354 may include hook material, such that there are an unlimited number of locations to position the bilateral connecting member 6136. The patient can adjust this position as needed. For example, the patient can repeatedly connect and disconnect the bilateral connecting member 6136 from the headband strap 3354. Once connected, the patient can use the headband strap 3354 like any other headband strap 3354, and fold the free end of the strap back to connect the exposed side of the bilateral connecting member 6136 to the headband strap 3354 (e.g., in use, both sides are connected to the respective headband strap 3354).

[0985] Because the bilateral connecting member 6136 can include the same connecting material on either side, the patient can connect either side to the headband strap 3354.

[0986] In some forms, the double-sided connecting member 6136 can be used with a headband strap 3354 that does not have a fixed connector.

[0987] like Figure 41-7 As shown, the bilateral connecting member 6136 can be positioned in a first position (e.g., near the free end of the various straps). This allows for a longer usable length of the headband strap 3354. For example, patients with larger heads can attach the bilateral connecting member 6136 in the first position to achieve a proper fit.

[0988] In the first position, individuals with smaller heads can overtighten the headband strap 3354 to achieve proper fit. Therefore, the patient can move the bilateral connecting members 6136 to the second position (i.e., away from...). Figure 41-8 (The free ends of the various headbands shown). This results in a smaller usable length, allowing patients with smaller heads to achieve a close fit with the same headband strap 3354 without excessive tension.

[0989] In some configurations, the patient can cut off the free end of the strap beyond the location of the bilateral connecting member 6136. In other configurations, the excess free end can be retained so that different patients (e.g., with different head sizes) can readjust the bilateral connecting member 6136 to fit their head.

[0990] In some forms, the double-sided connecting member may have a hook material on one side and a ring material on the other side, so that the two sides are functionally different.

[0991] like Figure 27-2 As shown, certain forms of rings 3352a, 3352b may include an eyelet 3353, which may be formed on the patient side of the respective ring 3352a, 3352b (e.g., the side closer to the patient's skin during use). The eyelet 3353 may form a region of reduced thickness along the periphery of the respective ring 3352a, 3352b. The eyelet 3353 may extend around a portion of the periphery of the respective ring 3352a, 3352b (e.g., less than 360°). In the illustrated example, the corresponding headband strap 3354 may contact the eyelet 3353 when received through the ring 3352a, 3352b. The reduced thickness of the eyelet 3353 can result in less material being used to manufacture the rings 3352a, 3352b, which can lead to lower manufacturing time and / or lower manufacturing costs. The 3353 perforated incision can also (or instead) result in reduced skin scarring and improved patient comfort.

[0992] In one configuration, at least one of the loops 3352a and 3352b may not be formed entirely around the outer periphery. In other words, loops 3352a and 3352b may be C-shaped and / or U-shaped. The left and / or right upper headband straps 3356 and 3358 may be individually folded against themselves and then inserted through the corresponding loops 3352a and 3352b. This allows the patient to maintain the same length adjustment in the corresponding upper headband straps 3356 and 3358 when the sealing structure 3100 is removed from the therapeutically effective position.

[0993] like Figure 35-2As shown, some forms of the frame 3350 include a ring 3352 with a raised profile. For example, the ring 3352b shown includes a protrusion 3390 near the arm 3362b. The sleeve 6124 can be bent due to its connection to the arm 3362b. The protrusion 3390 can reflect the curvature of the sleeve to provide a more constant interface between the ring 3352b and the sleeve 6124.

[0994] The protrusion 3390 may include a circle (e.g., a semicircle). In some forms, the protrusion 3390 may protrude from about 0.01 mm to about 1 cm. In some forms, the protrusion 3390 may protrude from about 0.05 mm to about 5 mm. In some forms, the protrusion 3390 may protrude from about 0.1 mm to about 3 mm. In some forms, the protrusion 3390 may protrude from about 0.5 mm to about 1.5 mm. In some forms, the protrusion 3390 may protrude about 1.2 mm.

[0995] like Figures 52-54 As shown, some forms of frame 3350 include alternative examples of rings 6080. In the illustrated example, ring 6080 may comprise a double-eye shape. For example, each ring 6080 may comprise the shape of two adjacent rings 3352a, 3352b, with a partition wall 6084 formed between them. The partition wall 6084 divides the ring 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 a corresponding arm 3362, and the second ring segment 6080-2 may form the free end of frame 3350. The partition wall 6084 may not extend completely across the width of the ring 6080, such that each ring 6080 includes a single opening (e.g., the opposite of if the partition wall 6084 extended completely across two openings). In other words, the first ring segment 6080-1 and the second ring segment 6080-2 are not completely separated, and the straps can move between these portions. The partition wall 6084 can be formed into two sections, with a central space 6088 in between.

[0996] like Figure 53 As shown, the headband straps 3356 and 3358 can be connected to the corresponding rings 6080 in a similar manner to the rings 3352a and 3352b described above. For example, the headband straps 3356 and 3358 can pass through the corresponding rings 6080 and apply a substantially perpendicular force relative to the partition wall 6084 in order to hold the sealing structure 3100 in the proper sealing position.

[0997] Continue to refer to Figure 53The partition wall 6084 helps the patient limit excessive tension of the headband straps 3356, 3358. The width of each headband strap 3356, 3358 may be greater than the space between the partition walls 6084. Each headband strap 3356, 3358 may rest on the corresponding partition wall 6084 and provide a backward force when the strap is tightened. When the headband straps 3356, 3358 remain slack or within the required tension range, the headband straps 3356, 3358 contact the partition 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., tightening the corresponding headband straps 3356, 3358 at the upper limit of the desired tension range), the headband straps 3356, 3358 may move into the second loop section 6080-2. As a result of the excessive tension, the headband straps 3356, 3358 may bend or fold. In other words, excessive force pulls the corresponding headband straps 3356, 3358 through the central space 6088 and into the second loop section 6080-2. The stiffness of the headband straps 3356, 3358 can resist this bending movement (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 headband straps 3356, 3358, causing the center of each headband strap 3356, 3358 to bend (i.e., because the center is not supported by the partition wall 6084). Once the headband straps 3356, 3358 move through the central space 6088, they contact the second ring segment 6080-2 and apply a vertical force. The movement of the headband straps 3356, 3358 can alert the patient or a third party (e.g., via visual and / or tactile stimulation) that the headband straps 3356, 3358 are being tightened. The patient can loosen the headband straps 3356, 3358 and reposition them against the corresponding partition wall 6084.

[0999] As the headband moves from the first loop segment 6080-1 to the second loop segment 6080-2, the tension in the upper headband straps 3356 and 3358 can be reduced because they do not need to be stretched as much in the second loop segment 6080-2. This temporarily reduces the tension in the corresponding upper headband straps 3356 and 3358. However, nothing can prevent a further increase in tension.

[1000] like Figure 55As shown, certain forms of frame 3350 may include a ladder lock 6092 instead of a ring (ring 3352a, 3352b, or ring 6080). Headband straps 3356, 3358 may pass through the corresponding ladder lock 6092 to secure the sealing structure 3100 to the patient's face. In some forms, the ladder lock 6092 may be molded onto the arm 3362 of frame 3350. In other examples, the ladder lock 6092 may be a separate element (e.g., if two straps are joined together, such as on the upper region of the patient's head). For example, housing 3371 may include a ladder lock 6092.

[1001] like Figure 56 As shown, certain forms of the frame 3350 may include a stop 6096 that helps adjust the length of the headband straps 3356, 3358. The stop 6096 may be attached to the arm 3362 and used in place of a ring (e.g., rings 3352a, 3352b, or ring 6080). Each headband strap 3356, 3358 may pass through the corresponding stop 6096. The stop 6096 may include a spring-loaded button 6100 that holds the corresponding headband strap 3356, 3358 in place. The patient may actuate the button 6100 and move the corresponding headband 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 Figure 24-28 As shown, some forms of the frame 3350 include a central portion 3360 connected to the pneumatic chamber 3200. The central portion 3360 may have an annular shape and may have a profile corresponding to the shape of the pneumatic chamber 3200 (e.g., an approximate dome curvature).

[1003] In one configuration, the single dimension of the central portion 3360 can be used with pneumatic chambers 3200 and / or sealing structures 3100 of various sizes. For example, the sealing structure 3100 can have various sizes (e.g., small, medium, large, etc.) and / or shapes (e.g., narrow, wide, etc.) to better seal patients with various facial shapes. The engagement area of ​​the central portion 3360 can remain substantially the same, regardless of the size of the pneumatic chamber 3200 and / or the sealing structure 3100. Thus, the central portion 3360 can be attached to pads of various shapes and / or sizes, providing substantially the same support.

[1004] In one configuration, the central portion 3360 can be detachably attached to the pneumatic chamber 3200. The patient can use the same frame 3350 with multiple pneumatic chambers 3200. This can be useful when the patient begins treatment and tries different sizes of pneumatic chambers 3200 to find a suitable fit. Removing the frame 3350 is also helpful when cleaning the patient interface 3000, as the different components of the patient interface 3000 can be cleaned separately to help ensure a more thorough cleaning.

[1005] In other forms, different frames with central sections of different sizes and / or shapes can be used with pneumatic chambers 3200 of different sizes and / or patients of different sizes to provide a comfortable fit for a wide variety of patients. For example... Figures 36-39 As shown, the central portions 13360 and 23360 of frames 13350 and 23350 may include a shape that allows for a comfortable seal when the patient uses a larger nasal length (e.g., the distance between the apex of the nasal ala and the nasal protuberance as measured in the anterior-posterior direction).

[1006] like Figure 36 As shown, frame 13350 may include less than Figure 25 The central portion 3360 of the central portion 13360. For example, when the corresponding frames 3350, 13350 are connected to the pneumatic chamber 3200, the upper rod 16036 on the frame 13350 may be positioned below a similar upper rod 6036. This allows the upper portion of the pneumatic chamber 3200 (e.g., the nose 3202) and / or the sealing structure 3100 (e.g., the second sealing structure 3102) to move or flex when worn by a patient. This may be helpful for patients with larger noses. Although the higher upper rod 6036 (e.g., similar to Figure 25 This can provide more rigid support, but the pneumatic chamber 3200 and / or sealing structure 3100 may not be able to move enough to accommodate a larger nose. Lowering the height of the upper rod 16036 (e.g., in...) Figure 36 (The middle) provides flexibility and better fit for patients with larger noses.

[1007] like Figures 37-39As shown, the frame 23350 may include a central portion 23360 having an upper rod 26036 that extends out of plane from the rest of the central portion 23360. For example, the upper rod 26036 may extend forward from the rest of the central portion 23360 (e.g., when connected to the pneumatic chamber 3200). Thus, the upper rod 26036 may be spaced apart from the nose 3202 of the pneumatic chamber 3200. The central portion 23360 may include a footprint substantially similar to that of the central portion 3360, allowing it to be used with the same pneumatic chamber 3200. However, the spacing between the pneumatic chamber 3200 and the upper rod 26036 may allow the pneumatic chamber 3200 and / or the sealing formation 3100 to further deform and comfortably accommodate a larger nose.

[1008] In some configurations, 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., unworn) position to allow the nose 3202 to expand comfortably when worn by the patient, but contact with the upper bar 26036 provides support and limits excessive bending of the nose 3202. This can mimic the frame 3350, but its size is advantageous for patients with larger noses.

[1009] In some forms, frame 3350 includes arms 3362 extending away from the center portion 3360. Rings 3352a, 3352b are formed at the ends of arms 3362. In use, these arms 3362 may extend at least partially in a rearward direction, which may position the rings 3352a, 3352b further rearward than the pneumatic chamber 3200 and / or the sealing formation 3100. Arms 3362 may also extend in a lateral direction (e.g., to the left or right, respectively) so as to generally follow the contours of the patient's face.

[1010] In some forms, when a patient wears the patient interface 3000, the arm 3362 engages with a portion of the patient's face. 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 the posterior and lateral directions).

[1011] In some forms, the arm 3362 may be substantially non-extended due to the tension applied by the corresponding headband straps 3356, 3358 via the corresponding rings 3352a, 3352b (e.g., the arm 3362 may be rigid and / or may be non-extendable). The tension may be transmitted along the arm 3362 to the pneumatic chamber 3200 and / or the sealing structure 3100 to maintain effective therapeutic pressure and limit leakage.

[1012] In one form, the arms 3362 are constructed from a material that is more flexible than the material used to construct the central portion 3360. These two materials can be molded together, allowing the frame 3350 to be configured as a single, monolithic construction. The arms 3362 may have some stiffness to help maintain their shape. However, the arms 3362 can be flexible, allowing the patient to adjust their shape to correspond to their facial structure. Allowing the patient to adjust the shape of the arms 3362 can increase patient comfort, which can increase patient adherence to treatment. In this way, the arms 3362 can bend or flex relative to the central portion 3360 (e.g., due to the cantilever configuration), but may not be able to extend further in the posterior direction (e.g., due to their non-extensibility). Additionally, the relatively flexible materials used to construct each of the arms 3362 can help reduce facial imprinting and increase patient comfort.

[1013] In one configuration, the arm 3362 and the center portion 3360 are made of the same material. This material provides sufficient flexibility to allow for shape adjustment and sufficient rigidity to maintain the adjusted shape. Since the center portion 3360 is coupled to the pneumatic chamber 3200, the center portion 3360 can be more rigid than the arm 3362. Alternatively, the center portion 3360 can be thicker than the arm 3362, which can also result in increased rigidity of the center portion 3360. Each arm 3362 is formed in a cantilever shape such that the ends adjacent to the corresponding rings 3352a, 3352b are unsupported. Additionally, the thickness of the frame 3350 can decrease along the length of each arm 3362 in the direction of the corresponding rings 3352a, 3352b (see, for example, Figure 27-1 This provides each arm 3362 with the flexibility necessary for bending and / or shaping to roughly correspond to the shape of the patient's face (e.g., cheek). Reducing the width of each arm 3362 also reduces 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 also allows for greater flexibility in accessing each corresponding ring 3352a, 3352b.

[1014] In one configuration, sleeve 6124 can be used with arm 3362 to provide additional comfort for the patient. For example... Figure 42-1 As shown, the sleeve 6124 can extend approximately along the length of the two arms 3362. For example, each sleeve 6124 can extend from the fixed end of each arm 3362 near the center portion 3360 of the frame 3350. Each sleeve 6124 can extend toward the free end of the ring 3352 (or 6080) of each arm 3362 near the frame 3350.

[1015] In the illustrated example, sleeve 6124 may not cover the center portion 3360 or ring 3352 (or 6080) of frame 3350. In this way, sleeve 6124 may not obscure the strap connection to ring 3352, and / or may not obscure the connection of center portion 3360 to pneumatic chamber 3200. In other examples, sleeve may be used with center portion 3360 (e.g., to give patient interface 3000 a bedding appearance).

[1016] In some forms, the sleeve 6124 may be made of a comfortable material, which may be flexible and / or soft to the touch. As described above, the arm 3362 may 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 arm 3362 is in close contact with the patient's skin. By including the sleeve 6124, the patient's skin can be in prolonged contact with a comfortable material. This material may be fabric and / or foam, or any similar material.

[1017] In some forms, the sleeves 6124 may be made of an elastic material. This allows the sleeves to extend over the rings 3352, thus enabling the sleeves 6124 to be removed from the arms 3362 (e.g., for cleaning). In other examples, the sleeves 6124 may be wound around the arms 3362 using hooks, magnetic, or mechanical connections. To remove the sleeves 6124 from the arms 3362, the connection can be disconnected.

[1018] In one embodiment, 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 allows 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 projection or overhang. This restricts 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), arm 3362 may include only the inner surface of arm 3362 (e.g., including a sector 3373 (see example, ...). Figure 27 The surface of the sleeve includes a comfort material. This can be a piece of material attached to the surface that comes into contact with the patient's skin during use, instead of a sleeve. This material can be attached to the arm 3362 with an adhesive and can be removed and / or replaced with a new material sheet (e.g., a clean material sheet).

[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, 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 the number of sharp surfaces in contact with the patient's skin. Each arm 3362 can also have a height 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.

[1023] In some configurations, the height of each arm 3362 can be between approximately 5 mm and approximately 15 mm. In some configurations, the height of each arm 3362 can be between approximately 6.5 mm and approximately 13.5 mm. In some configurations, the height of each arm 3362 can be between approximately 8 mm and approximately 12 mm. In some configurations, the height of each arm 3362 can be between approximately 9.5 mm and approximately 10.5 mm. In some configurations, the height of each arm 3362 can be approximately 10 mm.

[1024] like Figure 35 As shown, some forms of the arms 3362 of the frame 3350 may include ribs 3394 that extend from the lower surface of each arm 3362. Each arm 3362 may include at least one rib 3394. For example, the illustrated frame 3350 includes one rib 3394 on each arm 3362, wherein these ribs 3394 are arranged near the center portion 3360 of the frame 3350. In other examples, each arm 3362 may have more than one rib 3394, and / or these ribs 3394 may be arranged at different locations along the length of the arm 3362 (e.g., near the corresponding ring 3352 and / or on different surfaces of the arm 3362).

[1025] In some forms, each rib 3394 may include a circular profile (e.g., having a semi-circular shape). Circular profiles can reduce or limit discomfort caused by sharp or angular shapes.

[1026] As described above, the sleeve 6124 may 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 around which the sleeve 6124 extends. However, in some examples, the sleeve 6124 may be larger than the arm 3362 (e.g., due to its extension over the ring 3352) and may droop over the corresponding arm 3362. For example, the height of the arm 3362 near the ring 3352 may be greater. This may make the patient wearing the patient interface 3000 look and / or feel uncomfortable. One or more ribs 3394 on each arm 3362 may provide additional height (and / or thickness, depending on the positioning of the ribs 3394) to extend the sleeve 6124 and minimize slack (e.g., to match the height of the arm 3362 near the ring 3352).

[1027] The smooth profile of rib 3394 can limit obstruction and / or tearing of sleeve 6124 on rib 3394. It also allows sleeve 6124 to be attached to or removed from arm 3362 without damaging sleeve 6124.

[1028] like Figure 26-4 and 26-5 As shown, certain forms of the frame 3350 allow for pivotable movement between each arm 3362 and the center portion 3360. This pivotable movement can be the bending movement described above, because the pivot point 6012 connects each arm 3362 to the center portion 3360 and allows the entire arm 3362 to move approximately the same angular distance. In addition to pivoting, each arm 3362 is also capable of bending, as described above.

[1029] In one configuration, pivot point 6012 is positioned approximately at the same location on either side of 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 pivot point 6012. This allows the patient to make mirror adjustments to the arms 3362. The patient can then individually flex or bend each arm to make specific adjustments to one side.

[1030] In one configuration, each pivot point 6012 is a movable hinge. In other words, the frame 3350 may be constructed of a generally uniform material (or the transition between each arm 3362 and the center portion 3360 may be constructed of a generally uniform material). The thickness at each hinge 6012 may be significantly less than the thickness of the arm 3362 and the center portion 3360 immediately adjacent to the hinge 6012. For example, the hinge 6012 may be formed as a recess in the surface of the frame 3350 facing away from the patient during use. Constructing the hinge 6012 uniformly and integrally from substantially the same material as the arms 3362 and the center portion 3360 can help reduce manufacturing costs (e.g., compared to hinges constructed from different materials).

[1031] Each arm 3362 can pivot about the corresponding hinge 6012 between a first position and a second position. Rings 3352a and 3352b can be spaced closer together in the second position than in the first position.

[1032] In one configuration, the first position can be a relaxed position, while the second position can be an offset position. When an external force is applied, arm 3362 moves to the second position and can return to the first position when the external force is removed.

[1033] In one configuration, arm 3362 can also be positioned in either a first or second position without further external force being applied. Arm 3362 can be moved to the second position such that arms 3362 overlap each other (e.g., like eyeglasses). This helps to provide a small footprint for packaging and / or storage.

[1034] In other forms (not shown), each arm 3362 may be separate from the center portion 3360 and may be coupled to the center portion 3360 via a rotary hinge (e.g., a pin joint). In other forms, each arm 3362 may be coupled to the center portion 3360 by overlaying a molded flexible element in the middle, which may allow some pivotable movement.

[1035] In some forms, the frame 3350 also 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 facilitate the indirect connection of the headband strap 3354 to the pneumatic chamber 3200 and / or the sealing formation 3100.

[1036] In some configurations, frame 3350 includes two second connection points 3364 (e.g., left second connection point 3364a and right second connection point 3364b). When the patient wears patient interface 3000, the second connection points 3364a, 3364b may be lower than rings 3352a, 3352b. Headband straps 3354 may also include a lower left headband strap 3366 and a lower right headband strap 3368, both configured to engage with the respective second connection points 3364a, 3364b. The headband straps 3354 as a whole are then capable of providing force to the upper and lower regions of the sealing structure 3100 and / or the pneumatic chamber 3200.

[1037] In some configurations, these second connection points 3364a, 3364b are formed directly on the central portion 3360. When the patient wears the patient interface 3000, the second connection points 3364a, 3364b can be positioned further forward than the rings 3352a, 3352b.

[1038] In some forms, these second connection points 3364a, 3364b can be made up of a single component, which can help reduce processing and / or manufacturing costs.

[1039] In some forms, the left and / or right lower headband straps 3366, 3368 are detachably connected to corresponding second connection points 3364a, 3364b. The second connection points 3364a, 3364b may be magnetic, and the left and / or right lower headband straps 3366, 3368 may pass through a housing 3371, which includes a magnet 3370 having the opposite polarity to the second connection points 3364a, 3364b. The housing 3371 may be flexible or semi-rigid to facilitate connection and better hold the magnet in the connected position. The lengths of the left and / or right lower headband straps 3366, 3368 can be adjusted by folding the respective straps 3366, 3368 themselves around a crossbar 3386 (e.g., as with the left and / or right upper headband straps 3356, 3358). Additionally, the headband straps 3366 and 3368 may include a first width 3359 and a second width 3361. Figure 41 The straps shown can similarly be used as part of the lower headband straps 3366, 3368. Therefore, the lower headband straps 3366, 3368 may include a stop having a second width 3361 to prevent or limit over-tensioning. In some forms (not shown), the housing 3371 may include a pair of rings and the crossbar 3386 may not extend entirely between these two rings. Therefore, the housing 3371 may include... Figures 52-54 The shape described herein can similarly warn the patient when the lower headband straps 3366 and 3368 are excessively tightened. This can be combined with, or used alternatively with, the lower headband straps 3366 and 3368 having a first width 3359 and a second width 3361.

[1040] Alternatively or additionally, the lower left and / or right headband straps 3366, 3368 may include a dot 6128 and / or a cut edge 6132, as shown on the upper headband straps 3356, 3358 (see, for example, Figure 41-1 and 41-2 The description of point 6128 and / or cut edge 6132 on the upper headband strap can also be applied to the lower headband straps 3366, 3368 to warn the patient of excessive tension on the strap.

[1041] In other examples, ladder lock 6092 and / or stop 6096 may be connected to frame 3350 to provide adjustment for lower head straps 3366, 3368.

[1042] Each magnet 3370 can be removed from the corresponding second connection points 3364a, 3364b without altering the length adjustment of the left and / or right lower headband straps 3366, 3368. The patient can put on and / or remove the patient interface 3000 while removing the magnet 3370 only from the corresponding second connection points 3364a, 3364b (e.g., without needing to remove the left and / or right upper headband 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 constructed to improve the holding force with the corresponding magnet 3370. The housing 3376 of each second connection point 3364a, 3364b may include a generally flat (e.g., flat) surface 3378 and a lip 3380 extending from the flat surface 3378.

[1044] In the illustrated example, the outer shell 3376 may have a generally elliptical shape, and the lip 3380 may extend near the vertices of the planar surface 3378. The lip 3380 may also extend only around a portion of the planar surface 3378 (e.g., less than 360°). In some examples, the lip 3380 may 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 connected to the frame 3350 such that the lip 3380 is arranged close to the center of the frame 3350. In other words, each second connection point 3364a, 3364b can be oriented such that when the frame 3350 is connected to the pneumatic chamber 3200, the lip 3380 is arranged adjacent to the bend 3500.

[1046] Magnet 3370 includes a substantially flat surface that engages with a substantially flat surface 3378 of housing 3376. While engaging the flat surface 3378, magnet 3370 can be magnetically coupled to magnetic element 3382 at second connection points 3364a, 3364b. A pendant 3384 can be spaced apart from magnet 3370. As shown, pendant 3384 can be positioned on one side (e.g., the inner side) of lip 3380 and magnet 3370 can be positioned on the other side (e.g., the outer side) of lip 3380. In use, the patient can adjust the length of the corresponding lower headband straps 3366, 3368. Tightening one of the lower headband straps 3366, 3368 can apply a force directed away from the center of frame 3350 (e.g., in a laterally outward direction). This force can be greater than the magnetic force between magnet 3370 and magnetic element 3382 and can move magnet 3370 relative to plane 3378.

[1047] The dangling member 3384 prevents the magnet 3370 from disengaging from the magnetic material 3382 due to tightening of the corresponding lower headband straps 3366, 3368. When the magnet 3370 begins to move, the dangling member 3384 can contact the lip edge 3380, thereby limiting further movement away from the center of the frame 3350. Therefore, the engagement between the lip edge 3380 and the dangling member 3384 helps reduce accidental disengagement of the magnet 3370 from the corresponding second connection points 3364a, 3364b when the corresponding lower headband straps 3366, 3368 are tightened, but does not limit the patient's ability to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., to remove the positioning and stabilizing structure 3300).

[1048] like Figures 29-35 As shown, other configurations can be used to improve the retention of connection points 3364a, 3364b with the corresponding magnet 3370. Figures 29-35 The forms described herein can be used individually or in any combination thereof. Figures 29-35 Any form described herein may also be related to Figure 28-1 and 28-2 Used together with the lip edge 3380 shown.

[1049] like Figure 29 and 30 As shown, the opening 3201 of the pneumatic chamber 3200 may include at least one clamp support 6016. For example... Figure 29 As shown, the clamp support 6016 can be radially arranged at the edge of the recess 3280 near the opening 3201. In some forms, the second clamp support 6016 can be arranged on the other side of the pneumatic chamber 3200, such as... Figure 29In the mirror position of the clamp support 6016 shown in the figure. When the frame 3350 is connected to the pneumatic chamber 3200, the clamp support 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, such 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, for example, Figure 28-2 ) and crossbar 3386 (see example, Figure 28 The length between them is approximately the length between the corresponding connection points 3364a, 3364b and the clamp support 6016.

[1051] Continue to refer to Figure 29 Some forms of the clip support 6016 may protrude from the surface of the opening 3201. The clip support 6016 may be integrally formed with the opening 3201 as a single-piece construction (e.g., using an injection molding process). Therefore, the clip support 6016 may be formed from the same material as the opening 3201. For example, the clip support 6016 may be made of 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 opening 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 act as an additional rigidifying member (e.g., in addition to the frame 3350) to further increase the rigidity of the opening 3201.

[1052] In some forms, the clip support 6016 may also be curved or extend along an arcuate path. For example... Figure 29 As shown, the clamp support 6016 may include a constant curvature (although a varying curvature may be used). The center of curvature may be the location of the corresponding connection points 3364a, 3364b.

[1053] like Figure 46 As shown, in some forms, the clip support 6016 can be connected to the slot rib 6052 and can be formed as a single molded part. The shape can be varied along the length to form the clip support 6016 and the slot rib 6052 separately. In other forms, the clip support 6016 can be spaced apart from the slot rib 6052.

[1054] like Figure 30As shown, frame 3350 can be connected to opening 3201, and magnet 3370 can be connected to corresponding connection points 3364a, 3364b. The end of connecting member 3371 near crossbar 3386 can extend upwards and / or slightly beyond the corresponding clamp support 6016. In some forms where connecting member 3371 is rotatable relative to frame 3350, the rotation of connecting member 3371 can approximately follow the curvature of clamp support 6016, such that connecting member 3371 extends the same distance relative to clamp support 6016 throughout its angular motion.

[1055] In some forms, the height of the clip support 6016 from the opening 3201 can be less than the distance between the crossbar 3386 and the opening 3201. Therefore, the crossbar 3386 and the clip support 6016 can be slightly spaced apart in the middle. This spacing provides a gap for the corresponding lower straps 3366, 3368 extending around the crossbar 3386. Once the corresponding lower straps 3366, 3368 are connected to the corresponding connecting member 3371, the connecting member 3371 can be approximately close to or in contact with the clip support 6016. This can limit or prevent the connecting member 3371 from swaying and / or pivoting toward the surface of the opening 3201. When the lower straps 3366, 3368 are tightened, the lip 3380 and the overhang 3384 (see, for example, Figure 28-2 Incomplete engagement and / or swaying or pivoting may occur if the patient presses against the connecting member 3371 near the crossbar 3386 (e.g., when the patient is sleeping). Due to the inclusion of the clip support 6016, the crossbar 3386 contacts the clip support 6016 before any substantial swaying or pivoting movement. Therefore, if the patient inadvertently contacts the connecting member 3371 while sleeping, the magnet 3370 can remain connected to the corresponding connection points 3364a, 3364b, thus helping to ensure that the seal-forming structure 3100 remains in its correct position. During use, the clip support 6016 can be at least partially covered, allowing the patient interface 3000 to maintain its compact appearance.

[1056] like Figure 31As shown, an alternative form may include a clamp support 6020 on the frame 3350 instead of on the pneumatic chamber 3200. The clamp support 6020 may be integrally formed with the frame 3350. The clamp support 6020 and the frame 3350 may be constructed of the same material, or different materials may be used for each (e.g., separate materials may be introduced into a mold to form the clamp support 6020). The clamp support 6020 may be shaped to be generally similar to the clamp support 6016. For example, the clamp support 6020 may extend beyond approximately the length of the connecting member 3371 beyond the corresponding connection points 3364a, 3364b. The clamp support 6020 may also extend in a curved or arcuate path, which may 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 center portion 3360 of the frame 3350. For example, the interface between the proximal end of the clip support 6020 and the center portion 3360 may be substantially flush, such that the center portion 3360 and the clip support 6020 each have the same thickness. In other forms, the clip support 6020 may have a thickness less than that of the center portion 3360. In this case, the clip support 6020 may be flush with only a portion of the center portion 3360 (e.g., the clip support 6020 may be flush with the upper or lower edge of the center portion 3360).

[1058] In some forms, the distal end 6021 of the clip support 6020, opposite the proximal end, may be curved or bent and extend away from the surface of the opening 3201. The curve or bend at the distal end 6021 may... Figure 29 and 30 A protrusion of a similar shape is formed in the clip support 6016. In other words, the distal portion 6021 can extend the same distance from the surface of the opening 3201. Therefore, the engaging 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, frame 3350 may include at least one rib 6024 near each connection point 3364a, 3364b. Rib 6024 may restrict rotational movement of connection member 3371, which may maintain the desired orientation of lower straps 3366, 3368 (e.g., to maintain appropriate force vector).

[1060] like Figure 32As shown, the central portion 3360 of the frame 3350 may include a pair of ribs 6024 adjacent to each connection point 3364a, 3364b. In the illustrated example, one rib 6024 may be arranged above the corresponding connection point 3364a, 3364b, and another rib 6024 may be arranged below the corresponding connection point 3364a, 3364b. In some forms, these ribs 6024 may be evenly spaced around the corresponding connection points 3364a, 3364b.

[1061] In the example shown, rib 6024 can be generally rectangular in shape, although any similar shape (e.g., ellipse, circle, triangle, etc.) can be used. Rib 6024 may protrude from the surface of the central portion 3360. In some forms, rib 6024 may extend to a height approximately equal to the height of the connecting member 3371, although rib 6024 may extend to a position below the upper surface of the connecting member 3371.

[1062] When connected, each connecting member 3371 engages between a corresponding pair of ribs 6024. Each rib 6024 may contact or be approximately close to the corresponding connecting member 3371. This limits or prevents the connecting member 3371 from rotating about a vertical axis passing through each corresponding connection point 3364a, 3364b. This helps maintain the desired orientation of the force vector of each lower strap 3366, 3368 and also helps minimize accidental detachment of the magnet 3370 from the corresponding connection point 3364a, 3364b.

[1063] like Figure 33 As shown, another form of frame 3350 may include ribs 6024 arranged adjacent to the corresponding 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 may be arranged such that it is approximately aligned with the center of the corresponding connection points 3364a, 3364b (e.g., neither higher nor lower than the center of the connection points 3364a, 3364b).

[1064] The connecting member 3371 may include a cutout 6028 between the suspension member 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 or be substantially close to the cutout 6028 to prevent or limit rotational movement of the corresponding connecting member 3371. Therefore, a single rib 6024 can achieve substantially the same benefits as multiple ribs 6024.

[1065] like Figure 34 and 35 As shown, connection points 3364a and 3364b may not be directly formed on the center portion 3360 of the frame 3350. Instead, the frame 3350 may include arms 6032 extending radially outward from either side of the center portion 3360. Each arm 6032 may be connected to connection points 3364a and 3364b in the previous example (e.g., Figure 28 The connections are made at approximately the same locations as those in the frame 3350. Each connection point 3364a, 3364b can be modified to connect to the distal end of the corresponding arm 6032.

[1066] Positioning connection points 3364a and 3364b at one end of arm 6032 allows them to move laterally and / or rearward. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the center portion 3360 by approximately 5 mm to approximately 50 mm (e.g., measured along the surface of arm 6032). In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the center portion 3360 by approximately 10 mm to approximately 40 mm. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the center portion 3360 by approximately 20 mm to approximately 30 mm. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the center portion 3360 by approximately 29 mm. In some configurations, the connection points 3364a and 3364b on either arm 6032 may be spaced approximately 21 mm apart from the center portion 3360.

[1067] In some forms, arm 6032 may be integrally formed with center portion 3360 as a single piece. In this example, center portion 3360 and arm 6032 may be made of substantially the same material. In other examples, arm 6032 may be constructed of different materials but integrally formed with center portion 3360 (e.g., multiple materials are introduced during the injection molding process). In other examples, arm 6032 may be formed using a process separate from center portion 3360 and may be attached to frame 3350 using attachment means (e.g., adhesives, magnets, mechanical fasteners). In this example, arm 6032 may be permanently attached or may be detachable.

[1068] like Figure 35 and 35-1As shown, arm 6032 can be approximately flush with the upper surface of center portion 3360. This contributes to a compact aesthetic, as arm 6032 does not protrude further than frame 3350 in the forward direction. This also helps improve patient compliance, as the compact design does not significantly obstruct the patient's line of sight.

[1069] Figures 34 to 35-1 Arm 6032 is arranged in a cantilever configuration, such that the distal ends, including connection points 3364a, 3364b, are unsupported. In some examples, arm 6032 may be flexible or semi-rigid and capable of bending or flexing. For example, arm 6032 may flex in the posterior direction as the patient tightens the lower straps 3366, 3368. Although arm 6032 can bend, the total distance that arm 6032 can bend can be minimized. In this way, arm 6032 can maintain the force vector of lower straps 3366, 3368. If arm 6032 bends, it returns to its original position when the force is removed (e.g., when magnet 3370 is removed from the corresponding connection points 3364a, 3364b).

[1070] like Figure 35-1 As shown, some forms of arm 6032 may include a groove 6033, which may be positioned on the front and / or rear surfaces. The groove 6033 may serve as a hinge to aid in bending the corresponding arm 6032. Figure 35-1 The frame 3350 can be a separate frame, or the groove 6033 can be combined with it. Figure 34 In and / or in the 35 frame (or any other frame described herein).

[1071] In use, the patient can connect the connecting member 3371 to the corresponding connecting points 3364a and 3364b in a similar manner to when the connecting points 3364a and 3364b are directly connected to the central portion 3360. Therefore, it is unlikely to affect the patient's ability to connect the magnet 3370 to the connecting points 3364a and 3364b. Furthermore, creating wider connecting points 3364a and 3364b (i.e., more spaced from the central portion 3360 of the frame 3350) can limit the occurrence of unintentional detachment of the magnet 3370 from the corresponding connecting points 3364a and 3364b. For example, the at least partially flexible nature of the arm 6032 allows bending in the rearward direction, which can limit the swaying of the connecting member 3371 at the corresponding connecting points 3364a and 3364b. Therefore, the magnet 3370 is less likely to detach accidentally, and a better seal can be maintained between the patient's face and the sealing structure 3100.

[1072] In some configurations, arm 6032 may bend or flex relative to the center portion 3360. For example, arm 6032 may bend inward toward the pneumatic chamber 3200 (and toward the patient's face when the patient interface 3000 is worn). Bending or flexing may be a result of forces that position and stabilize the structure 3300 (e.g., tightening straps 3366, 3368 may cause bending motion in arm 6032). As a result of bending, arm 6032 may be positioned near or in contact with the pneumatic chamber 3200 and / or the patient's face. This helps reduce the occurrence of swaying or accidental disengagement of the magnet 3370.

[1073] In some forms, the connection points 3364a and 3364b on arm 6032 may not include the lip 3380. Instead, the connection points 3364a and 3364b may be generally planar. The displacement of the connection points 3364a and 3364b away from the center 3360, along with the flexibility of arm 6032, can reduce the likelihood of accidental detachment of the magnet during use. Specifically, the rearward positioning of these connection points 3364a and 3364b can reduce the torque on housing 3371 and magnet 3370, which can cause decoupling.

[1074] like Figure 61 As shown, some forms of the patient interface 3000 may include a flexible housing 6104 that can removably attach the straps to the frame 3350. The flexible housing 6104 may be generally similar to the housing 3371. For example, the flexible housing 6104 may include a magnet 6108 (or a connector of a similar type) to removably engage with connection points 3364a, 3364b. Additionally, the flexible housing 6104 includes a crossbar 6112 to receive straps (e.g., any of straps 3356, 3358, 3366, 3368). A flexible section 6116 may be disposed between the magnet 6108 and the crossbar 6112. The flexible section 6116 may be a thin section of the flexible housing 6104 and be able to flex elastically without breaking. For example, the flexible section 6116 may be bent about a bending axis 6120, such that the crossbar 6112 pivots relative to the magnet 6108. When the magnet 6108 is connected to the corresponding connection points 3364a, 3364b, bending about the bending axis 6120 can occur as a result of tension applied to the corresponding straps around the crossbar 6112. Movement about the bending axis 6120 is preferred over movement of the magnet 6108, so that the housing 6104 does not accidentally disengage from the corresponding connection points 3364a, 3364b. In some forms, the flexible housing 6104 can be used in place of the arm 6032 (e.g., when the connection points 3364a, 3364b are at the center 3360). In some forms, the flexible housing 6104 can be used in conjunction with the arm 6032.

[1075] The length of the bendable section 6116 determines the total amount of bending allowed in the bendable housing 6104. A longer bendable section 6116 allows for more bending than a shorter bendable section 6116. In some forms, the bendable section 6116 is between about 0.1 mm and about 20 mm. In some forms, the bendable section 6116 is between about 1 mm and about 10 mm. In some forms, the bendable section 6116 is about 5 mm.

[1076] like Figure 24 As shown, the engagement area of ​​the pneumatic chamber 3200 may include a recess 3280. In the example shown, the recess 3280 may be included on the opening 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 recess 3280. The shape of the central portion 3360 may substantially correspond to the shape of the recess 3280, which may help the patient to correctly orient the frame 3350 relative to the pneumatic chamber 3200 (e.g., in an example where the frame 3350 is removably attached to the pneumatic chamber 3200).

[1077] like Figures 37-39 As shown, the upper rod 6036 of the central portion 3360 can extend forward from the rest of the central portion 3360 and can be spaced apart from the groove 3280. In other words, the upper rod 6036 can be in contact with the groove 3280 or any other part of the pneumatic chamber 3200 before use.

[1078] In some forms, the groove 3280 may have a fully formed periphery that is approximately annular in shape. In any size pad, the periphery may have substantially the same length.

[1079] In some configurations, the recess 3280 is recessed relative to the remainder of the outer surface of the pneumatic chamber 3200. The recess 3280 may not extend substantially into the pneumatic chamber 3200 and obstruct the patient's face. The recess 3280 may have approximately the same depth over its entire periphery.

[1080] In some forms, the width of the recess 3280 may be smaller than the width of the center portion 3360 of the frame 3350. The conforming characteristics of the gasket may allow a wider center portion 3360 to be received within the recess 3280. This may allow the center portion 3360 to be engaged to the recess 3280 via press fit, friction fit, and / or snap fit. The engagement between the recess 3280 and the center portion 3360 can help provide stiffness to the pneumatic chamber 3200 and / or the sealing structure 3100, because the stiffness of the frame 3350 (e.g., compared to the pneumatic chamber 3200) can individually limit some of the flexibility of the pneumatic chamber 3200.

[1081] In some forms, the liner 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 center portion 3360 of the frame 3350 and can restrict the removal of the center portion 3360 from the groove 3280.

[1082] like Figure 25 As shown, frame 3350 can be composed of multiple components (e.g., each component is made of a different material). For example, the central portion can be made of a first material (e.g., rigid plastic). Arm 3362 can be attached to the central portion 3360 (e.g., via glue, molding, etc.) and can be made 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 attached to the central portion 3360 (e.g., via adhesive). Once attached, arm 3362 can move similarly to that in the monolithic, one-piece construction described above.

[1083] like Figure 26 and 27 As shown, frame 3350 can be constructed from a single material. For example, frame 3350 can be made of a TPE material such as Hytrel. As described above, the material used to construct frame 3350 can provide rigidity and flexibility to frame 3350. Magnet 3370 can cover (or otherwise attach to) the central portion 3360.

[1084] In some forms, the central portion 3360 includes a slot 3372 that can be formed on any lateral side of the central portion 3360. The slot 3372 may have a generally elongated shape (e.g., rectangular, elliptical, etc.) and may be formed entirely within the boundary of the central portion 3360.

[1085] like Figure 27 As shown, some forms of the central portion 3360 may include a tapered slot 3372. Specifically, the opening leading to the slot 3372 may be wider near the rear surface of the central portion 3360 (e.g., the surface in contact with the pneumatic chamber 3200). The opening leading to the slot 3372 may uniformly decrease in size towards the front surface of the central portion 3360.

[1086] Figure 27Some forms of arm 3362a (or arm 3362b) are also shown, which may include a notch or fan-shaped portion 3373. The fan-shaped portion 3373 may be formed on the inner surface of arm 3362a and may be positioned adjacent to the patient's skin when the positioning and stabilizing structure 3300 is worn by the patient. The fan-shaped portion 3373 reduces the thickness along a portion of arm 3362a and may reduce the likelihood of sink marks forming in arm 3362a during manufacturing (e.g., injection molding) processes. The fan-shaped portion 3373 may also result in less material being used to manufacture arm 3362a, which may lead to lower manufacturing time and / or lower manufacturing costs.

[1087] return Figures 26 to 26-2a The pneumatic chamber 3200 may include a protrusion 3284 on the opening 3201. The protrusion may be elongated and may have a shape similar to the slot 3372 (e.g., conical). The protrusion 3284 may be arranged within the recess 3280 such that they cooperate with the frame 3350 during assembly.

[1088] like Figure 40 As shown, the protrusion 3284 may extend approximately 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 direction not perpendicular to this 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 a front-back direction.

[1089] like Figure 26-2 and 26-2a As shown, some forms of the protrusion 3284 may include a pendant 6000 extending at least partially over the recess 3280. The pendant 6000 may be formed asymmetrically around the periphery of the protrusion 3284. In other words, the pendant 6000 may extend further over the recess 3280 on one side than on the other. Figure 26-2a As shown, the opposite side 6002 may extend outward and form a slight overhang. For example, the opposite side 6002 may be larger than... Figure 26-2 The example shown further extends between about 1° and about 20° (e.g., 10°), which can increase the length of about 0.1 mm to about 5 mm (e.g., about 1 mm) toward the opposite side 6002. This can provide additional holding force for retaining the frame 3350 in the recess 3280.

[1090] like Figure 40As shown, the top surface of the protrusion 3284 can be slightly inclined, allowing the pendant 6000 to extend approximately parallel to the surface of the recess 3280. This allows a larger portion of the protrusion 3284 to extend over the recess 3280. As described in more detail below, this helps to better retain the frame 3350 within the recess 3280 and limits accidental disengagement.

[1091] In some forms, 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 on the undercut 6004 than on 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 the vertical direction. The angle of the inclined surface 6008 may point towards the overhang 6000 and limit the ability of the frame 3350 to be removed in the inclined direction.

[1092] When the frame 3350 is assembled into the pneumatic chamber 3200 (e.g., via press-fit, friction fit, snap-fit, etc.), the patient can align the protrusion 3284 with the slot 3372 such that the protrusion 3284 is received within the slot 3372 during use. A wider opening in the slot 3372 near the rear surface helps the patient align each protrusion 3284 within the corresponding slot 3372. The protrusion 3284 may be slightly wider than the front opening of each slot 3372, but can be received within the slot 3372 due to the flexible nature of the pneumatic chamber 3200 (e.g., constructed of a silicone-like elastic material). The protrusions 3284 may deform slightly as they enter the corresponding slot 3372 (e.g., due to the narrowing of the slot 3372).

[1093] Once the protrusion 3284 passes through the slot 3372, it generally returns to its original shape. For example, when the slot 3372 receives the protrusion 3284, the pendant 6000 is deformable (e.g., elastically deformable), and once the center portion 3360 is received within the recess 3280, the pendant 6000 returns to its initial position. To more easily observe the correct 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 pendant 6000 of the protrusion 3284 may be wider than the front opening of the corresponding slot 3372.

[1094] Furthermore, the width of the undercut 6004 can be approximately the same as that of the center portion 3360, allowing the frame 3350 to be tightly accommodated within the recess 3280. The flexible material of the pneumatic chamber 3200 allows the undercut 6004 to be slightly smaller than the center portion 3360, enabling the undercut 6004 to flex and receive the frame 3350 via snap-fit, friction fit, or other similar mechanisms.

[1095] Therefore, frame 3350 may not be easily removed from pneumatic chamber 3200. The patient may have to apply force to frame 3350 to remove it from recess 3280. This force applied by the user can allow frame 3350 to move in a vertical or inclined direction and overcome the holding force provided by suspension 6000. For example, the patient can lift frame 3350 from the area of ​​the center 3360 of the contact inclined surface 6008 to provide a force for disengaging frame 3350 from pneumatic chamber 3200.

[1096] This force can exceed the force generated by the normal movement of the pneumatic chamber 3200 and / or the sealing structure 3100. In other words, the sealing structure 3100 and / or the pneumatic chamber 3200 can move relative to the frame 3350 while the protrusion 3284 is received within the corresponding slot 3372. This allows the sealing 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 unintentionally causing the slot 3372 to detach from the protrusion 3284.

[1097] In other forms, the pneumatic chamber 3200 can be molded onto the frame 3350, and the protrusion 3284 can be generated 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 frame 3350 and pneumatic chamber 3200 are worn by a patient, some forms of frame 3350 can be oriented to reduce cheek contact. For example, arms 3362a, 3362b can be oriented (e.g., curved) to substantially complement at least a portion of the patient's face (e.g., their cheeks). However, in some examples, the entire length of each arm 3362 may not contact the patient's skin, as the patient may feel uncomfortable having a foreign object in contact with their face. Instead, a portion of each arm 3362 can be spaced apart from the patient's face, such that a smaller surface area of ​​the arm 3362 contacts the patient's face. While maintaining substantially the same curvature in each arm 3362, moving the contact point between each arm 3362 and pneumatic chamber 3200 (e.g., via a 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 bend 3500, the maximum gap between each arm 3362 and the patient's face is larger. This means that a larger portion of each arm 3362 will be spaced apart from the patient's face (e.g., as opposed to if each arm 3362 were in contact with the pneumatic chamber 3200 on the distal side of the bend 3500). Less contact between each arm 3362 and the patient's face can improve patient comfort.

[1099] Additionally, each arm 3362 that is closer to the bend and therefore further away from the rear surface 3112 in contact with the pneumatic chamber 3200 can provide less support at the transverse portion 3111 of the pneumatic chamber 3200 (e.g., because the rigid or semi-rigid arms engage less of the transverse portion 3111). The transverse portion 3111 can therefore have a greater degree of flexibility and can better conform to the shape of the patient's nose and produce an effective seal.

[1100] like Figure 26-4 and 26-5 As shown, some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the center portion 3360. The hinge 6012 allows movement of the arms 3362 (e.g., pivotable movement) 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 does not cause the protrusion 3284 to disengage from the slot 3372.

[1101] In some configurations, the patient can move arm 3362 into a second position to provide better fit. For example, the distance between rings 3352a and 3352b in the first position may be greater than the size of the patient's head. Therefore, the patient can move arm 3362 toward the second position to provide proper fit (e.g., contact between arm 3362 and the patient's head). Arm 3362 can be held in the second position by adjusting the upper headband straps 3356 and 3358 (i.e., the upper headband straps 3356 and 3358 can provide external force).

[1102] Similar to arm 3362, the pneumatic chamber 3200 and / or sealing structure 3100 may be larger than the average size of a patient's face. For example, the sealing structure 3100 may engage the patient's mouth and / or nose without fitting snugly. The pneumatic chamber 3200 and / or sealing structure 3100 may also be moved toward a more compact position for better engagement with an individual patient's face.

[1103] like Figure 26-5 As shown, moving arm 3362 to the second position can directly cause the sealing structure 3100 and / or the pneumatic chamber 3200 to move to a more compact position. Arm 3362 can contact the pneumatic chamber 3200 along the second front wall portion 3242. Arm 3362 can also contact the second front wall portion 3242 near the center of the pneumatic chamber 3200 and on the distal side of the transverse portion 3111.

[1104] The pivoting motion of each arm 3362 about hinge 6012 can provide an inward force to the pneumatic chamber 3200. This can reduce the distance between the lateral portions 3111 of the second sealing structure 3102 and position the second sealing structure 3102 tightly against the patient's nose. Compression of the sealing structure 3100 and / or the pneumatic chamber 3200 can provide a better seal to the patient's face (e.g., by limiting the occurrence of leaks). Additionally, applying an inward force near the center of the pneumatic chamber 3200 (e.g., as per...) Figure 26-3 (As described) wrinkling in the sealing structure 3100 can be limited by limiting the total compression of the pneumatic chamber 3200.

[1105] like Figure 46 As shown, the pneumatic chamber 3200 may include a groove 6052, which may be positioned in front of the recess 3280 when the patient wears the patient interface 3000. The groove 6052 may be integrally formed with the pneumatic chamber 3200 and may be formed together during the molding process. The groove 6052 may project forward from the surface of the pneumatic chamber 3200 and may form the lower boundary of the recess 3280. The groove 6052 may be thicker than the surrounding portion of the pneumatic chamber 3200 and may serve as a reinforcing member. The groove 6052 may restrict bending or deflection of the lower portion of the opening 3201. This helps maintain the shape of the recess 3280, which may help retain the frame 3350 within the recess 3280.

[1106] like Figure 28 As shown, the shape of frame 3350 can be similar to Figure 26 and 27 The frame 3350 can be made of a single material (e.g., having semi-rigid properties). The frame 3350 can be thicker near the center 3360 and thinner toward each corresponding ring 3352a, 3352b.

[1107] In some forms, the c...

Claims

1. A patient interface, comprising: a pneumatic chamber capable of being pressurized 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; 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 an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a 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 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 nares such that a flow of air at the therapeutic pressure is delivered to the nose, the second 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; as well as a vent structure to allow a continuous flow of gas exhaled by a patient from the interior of the pneumatic chamber to be vented to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use, Features: The nose of the pneumatic chamber includes a first front wall portion and a second front wall portion, wherein the first front wall portion is disposed proximate to a boundary between the nose and the mouth of the pneumatic chamber, the first front wall portion being more flexible than an area proximate to the mouth and more flexible than the second front wall portion.

2. A patient interface according to claim 1, wherein: The second front wall portion is provided in the form of a band and is configured to help prevent the nose from collapsing.

3. A patient interface according to claim 2, wherein: The second front wall portion is configured to support a patient contacting portion of the second seal-forming structure, the patient contacting portion being relatively thin compared to the belt.

4. A patient interface according to claim 1, wherein: The second front wall portion is thicker than an immediately adjacent portion of the pneumatic chamber wall.

5. The patient interface of claim 1, wherein: The first front wall portion and the second front wall portion are made of the same material.

6. A patient interface according to claim 1, wherein: The first front wall portion and the second front wall portion include different thicknesses.

7. A patient interface according to claim 6, wherein: The thickness of the second front wall portion is greater than the thickness of the first front wall portion.

8. The patient interface of claim 1, wherein: The second front wall portion comprises a strip extendable into the cavity of the pneumatic chamber.

9. A patient interface according to claim 8, wherein: The band extends across the first front wall portion, and an outer surface of the nose is smooth, while an inner surface of the nose is stepped or includes a discontinuity.

10. The patient interface of claim 1, wherein: The first anterior wall portion and / or the second anterior wall portion are symmetrical about the mid-sagittal plane.

11. The patient interface of claim 1, wherein: The second front wall portion extends across at least 50% of the width of the nose of the pneumatic chamber.

12. A patient interface, comprising: a pneumatic chamber capable of being pressurized 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; a seal-forming structure comprising a first seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's mouth such that a flow of air at said treatment pressure is delivered to the mouth, said first seal-forming structure constructed and arranged, in use, to maintain said treatment pressure in said pneumatic chamber throughout a breathing cycle of the patient; the seal-forming structure 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 nares such that a flow of air at the treatment pressure is delivered to the nose, the second seal-forming structure constructed and arranged, in use, to maintain the treatment pressure in the pneumatic chamber throughout a breathing cycle of the patient; as well as a vent structure to permit a continuous flow of exhaled gas from a patient from the interior of the pneumatic chamber to be vented to the surrounding 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 seal-forming structure in a forward direction; wherein the at least one region is formed integrally with the pneumatic chamber, wherein the at least one region does not serve as an underlay, and Therein, the at least one region comprises at least one reinforced region.

13. A patient interface according to claim 12, wherein: The at least one reinforced region includes a front wall region disposed on opposite sides of the interface, wherein the front wall region is configured to resist compression in a front-to-back direction.

14. A patient interface according to claim 12, 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.

15. A patient interface according to claim 12, 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 greater than the first thickness.

16. A patient interface according to claim 12, wherein: The at least one reinforced area is arranged on the front surface of the pneumatic chamber.

17. A patient interface comprising: a pneumatic chamber comprising a cavity capable of being pressurized 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; a seal-forming structure constructed and arranged to form a seal with a region of a patient's face such that a flow of air at said therapeutic pressure is delivered to the airway, said seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in said pneumatic chamber throughout a breathing cycle of the patient; as well as a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position; Characterized in that the patient interface includes a pair of reinforced regions disposed on opposite sides of the pneumatic chamber, wherein the reinforced regions are configured to resist compression in an anterior-posterior direction.

18. A patient interface according to claim 17, wherein: The seal-forming structure includes a first seal-forming structure, which is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's mouth so that the air flow at the treatment pressure is delivered to the mouth, and a second seal-forming structure, which is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's nostrils so that the air flow at the treatment pressure is delivered to the nose.

19. A patient interface according to claim 18, wherein: The seal-forming structure includes a lower lip portion, which forms a part of the first seal-forming structure and is configured to seal against the patient's chin area and / or the patient's lower lip and / or suprachinal area, and wherein the seal-forming structure includes an upper lip portion located between the first seal-forming structure and the second seal-forming structure.

20. A patient interface according to claim 18, wherein: The reinforced region is connected to a portion of the second seal-forming structure which, in use, seals to an upper portion of the patient's lips just below the inferior corner of the patient's nose.

21. 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 any reinforced region is directly beneath the or each nostril.

22. A patient interface according to claim 17, wherein: The interface further 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.

23. A patient interface according to claim 17, wherein: The positioning and stabilizing structure comprises: A frame coupled to the pneumatic chamber, the frame comprising: Central Department, 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.

24. A patient interface according to claim 23, wherein: The pair of upper arms is longer than the pair of lower arms.

25. A patient interface according to claim 23, wherein: The pair of upper arms each include a first type connector, and the pair of lower arms each include a second type connector, wherein the first type connector and the second type connector are selected from the group consisting of a loop, a ladder lock, and a cord stopper.

26. A patient interface according to claim 23, wherein: The pair of upper arms and the pair of lower arms are integrally formed with the center portion.

27. A patient interface according to claim 23, wherein: The pair of lower arms are flush with the central portion.

28. A patient interface according to claim 17, 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; and A second seal-forming structure is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's nostrils.

29. A patient interface comprising: a pneumatic chamber capable of being pressurized 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; 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 an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a 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 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 nares such that a flow of air at the therapeutic pressure is delivered to the nose, the second 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; as well as a vent structure to permit a continuous flow of exhaled gas from a patient from the interior of the pneumatic chamber to be vented to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the pneumatic chamber when in use; Features: The nose portion of the pneumatic chamber includes a first front wall portion and a second front wall portion, and the first front wall portion is thinner than the second front wall portion.

30. A patient interface according to claim 29, wherein: The second front wall portion is provided in the form of a laterally extending band and is configured to help prevent the nose from collapsing.

31. A patient interface according to claim 30, wherein: The second front wall portion is configured to support a patient contacting portion of the second seal-forming structure, the patient contacting portion being relatively thin compared to the belt.

32. A patient interface according to claim 29, wherein: The second front wall portion is thicker than an adjacent portion of the pneumatic chamber wall.

33. A patient interface according to claim 29, wherein: The first front wall portion and the second front wall portion are made of the same material.

34. A patient interface according to claim 29, wherein: The second front wall portion comprises a strip extendable into the cavity of the pneumatic chamber.

35. A patient interface according to claim 34, wherein: The band extends across the first front wall portion, and the outer surface of the nose is smooth, while the inner surface of the nose is stepped or includes discontinuities.

36. A patient interface according to claim 29, wherein: The first anterior wall portion and / or the second anterior wall portion are symmetrical about a mid-sagittal plane.

37. A patient interface according to claim 29, wherein: The second front wall portion extends across at least 50% of the width of the nose portion of the pneumatic chamber.

Images