Full Face Patient Interface

Abstract

The patient interface includes a plenum chamber, a first seal-forming structure for forming a seal around the patient's mouth, and a second seal-forming structure for forming a seal around the patient's nares. The patient interface also includes at least one stopper rib disposed within the cavity of the plenum chamber and spaced apart from the first seal-forming structure in a rest position. The first seal-forming structure is configured to contact the at least one stopper rib in an actuated position. The at least one stopper rib is configured to resist forward compression of the first seal-forming structure. The second seal-forming structure is not configured to contact the at least one stopper rib.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of SG Provisional Patent Application No. 10202105065S, filed May 14, 2021, and SG Provisional Patent Application No. 10202102386Q, filed March 9, 2021, each of which is incorporated by reference herein in its entirety.

[0002] International Application No. PCT / AU2020 / 050953, filed September 9, 2020, which claims priority to U.S. Provisional Patent Application No. 63 / 058,001, filed July 29, 2020, each of which is incorporated by reference herein in its entirety.

[0003] 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. [Background technology]

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0005] The airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they penetrate the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. The alveolar regions of the lungs, where gas exchange occurs, are called respiratory regions. See Respiratory Physiology by John B. West, Lippincott Williams & Wilkins (9th ed., 2012).

[0006] There are a variety of respiratory disorders, and particular disorders may be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving the obstruction or closure of the upper airway during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall region during sleep. This condition forces affected patients to pause their breathing, typically for 30 to 120 seconds, sometimes 200 to 300 times each night. It often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system, characterized by rhythmic alternating periods of incremental increases and decreases in ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, causing severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is a general term for breathing problems that occur when the lungs are unable to take in enough oxygen or expel enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following problems:

[0011] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract disorders that share certain characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0014] Neuromuscular diseases (NMDs) are a broad term encompassing numerous disorders and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment that leads to inability to walk, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive disorders. (i) Rapidly progressive disorders are characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)). (ii) Variable or slowly progressive disorders are characterized by muscle impairment that worsens over years but only results in a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. They are usually characterized by restrictive dysfunction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A variety of therapies have been used to treat or ameliorate such diseases, and even otherwise healthy individuals may utilize such therapies to prevent the development of respiratory disorders, but these suffer from a number of deficiencies.

[0017] 2.2.2 Therapy A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, noninvasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) have been used to treat one or more of the aforementioned respiratory disorders.

[0018] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of an air supply to the entrance to the airways at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank ventilator or positive-negative pressure extracorporeal ventilator (cuirass)).

[0019] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint, such as by pushing the soft palate and tongue forward against and backward from the posterior oropharyngeal wall, which can prevent closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to comply with therapy if they find one or more of the devices used to deliver such therapy uncomfortable, difficult to use, expensive, and aesthetically unattractive.

[0020] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing by performing some or all of the work of breathing and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided via a noninvasive patient interface. NIV has been used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0021] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies may be improved.

[0022] 2.2.2.2 Flow therapy Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, perhaps by delivering an inspiratory flow profile superimposed on a positive baseline pressure for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a flow of conditioned or concentrated gas may be used solely to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow to the entrance to the airway through an unsealed or open patient interface at a "therapeutic flow" that remains nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that a high flow of air at the airway entrance improves ventilatory efficiency by flushing or sweeping exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits may include increased warmth and humidification (possibly with the benefit of secretion management) and the possibility of a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the respiratory cycle.

[0023] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched gas at a specified oxygen concentration (21% to 100% of the oxygen fraction in ambient air) delivered to a patient's airways at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0024] 2.2.2.3 Supplemental oxygen For certain patients, oxygen therapy may 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 therapy is called HFT with supplemental oxygen.

[0025] 2.2.3 Respiratory Therapy Systems These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0026] The 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.

[0027] Another form of treatment system is the mandibular repositioning device.

[0028] 2.2.3.1 Patient Interface A patient interface can be used to provide a wearer with an interface to a respiratory prosthesis, for example, by providing airflow to an entrance to the airway. Airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment being applied, the patient interface can facilitate gas delivery at a pressure sufficiently different from ambient pressure, e.g., approximately 10 cmH2O above ambient pressure, by forming a seal with a portion of the patient's face to effectively implement the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not provide a sufficient seal to facilitate delivery of a gas supply to the airway at a positive pressure of approximately 10 cmH2O. For flow treatments, such as nasal HFT, the patient interface insufflates the nares but is specifically positioned to not provide a complete seal. An example of such a patient interface is a nasal cannula.

[0029] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures, but not to maintain internal air at pressures higher than ambient.

[0030] For example, a particular mask may not be clinically suitable for this technology if it blocks airflow through the nose and only allows airflow through the mouth.

[0031] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal with their lips, which can be uncomfortable or impractical in this technology.

[0032] Certain masks may be impractical for use while sleeping (e.g., when sleeping on your side in bed with your head resting on a pillow).

[0033] Designing a patient interface presents multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Because the head contains bone, cartilage, and soft tissue, different regions 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 throughout the respiratory treatment period.

[0034] As a result of these challenges, some masks suffer from one or more of the following: intrusiveness, aesthetic undesirability, high cost, poor fit, difficulty to use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. Using the wrong size mask can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), masks designed as part of SCUBA masks, or masks for anesthesia administration may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true when the mask must be worn during sleep.

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

[0036] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0037] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0038] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0039] Patient interfaces may be characterized in part according to the design intent of the seal-forming structure when it is intended to engage the face in use. In one form of patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region in use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both the nostril region and the mouth region in use. These different types of patient interfaces may be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0040] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swimming goggles that rests on the patient's forehead may be inappropriate for use over the patient's nose.

[0041] A particular seal-forming structure can be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be adapted to form a seal.

[0042] Some types of seal-forming structure extend around the periphery of the patient interface and are intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, an improper fit can result in gaps between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0043] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor conformance between the face and the mask can require additional force to achieve a seal or cause the mask to leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leakage.

[0044] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these uncomfortable.

[0045] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0046] A range of patient interface seal forming construction techniques are disclosed in patent applications WO 1998 / 004,310, WO 2006 / 074,513 and WO 2010 / 135,785 assigned to ResMed Limited.

[0047] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0048] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGELIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0049] 2.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure therapy are subject to the corresponding forces of air pressure, which can compromise their seal. Therefore, various techniques have been used to position and maintain the seal-forming structures in sealing relationship with the appropriate portion of the face.

[0050] One technique involves the use of adhesives. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, adhesives can be uncomfortable.

[0051] Another technique uses one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following: poor fit, bulk, discomfort, and cumbersomeness. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0052] Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the numerous therapies described above, such as by operating the device to generate an airflow for delivery to an interface to the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). As such, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0053] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged to allow airflow to travel between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) in use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-limb air circuit is used for both inhalation and exhalation. 2.2.3.4 Humidifier

[0054] Delivery of the airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, it produces humidified gas, minimizing drying of the nasal mucosa and increasing comfort in the patient's airway. Additionally, in cooler climates, application of warm air to the facial area within and around the patient interface generally provides greater comfort than cool air. Therefore, humidifiers often have the ability to humidify the airflow in addition to heating it.

[0055] 2.2.3.5 Oxygen source Experts in the field have long recognized that exercise for patients with respiratory failure can have long-term benefits that slow disease progression, improve quality of life, and extend the patient's 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 using cylinders or small compressed oxygen tanks mounted on carts with trolley wheels. These tanks have the disadvantage of being limited in the amount of oxygen they can hold and heavy (approximately 50 pounds when worn).

[0056] Oxygen concentrators have been used to provide oxygen for respiratory therapy for approximately 50 years. Traditional oxygen concentrators are heavy and bulky, making it difficult and impractical to carry them while performing normal ambulatory activities. Recently, manufacturers of large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can generate a theoretically unlimited supply of oxygen. Making these devices compact for mobility requires a diverse system for producing condensed, oxygen-enriched gas. To minimize weight, size, and power consumption, POCs attempt to utilize the oxygen they produce as efficiently as possible. This can be achieved by delivering oxygen as a series of pulses or "boluses," timing each bolus to coincide with the onset of inspiration. This therapy modality is known as pulse-on-demand (POD) delivery, as opposed to the traditional continuous-flow delivery suitable for stationary oxygen concentrators.

[0057] 2.2.3.6 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient is using their RPT device in accordance with one or more "compliance rules"). An example compliance rule for CPAP treatment may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If the healthcare provider determines that the patient used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0058] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0059] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0060] 2.2.3.7 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (mandible) in a forward position during sleep. MRDs are removable devices that are inserted into the mouth before and removed after sleep. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include a bite impression portion designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal wall, reducing airway collapse and palatal vibration.

[0061] In certain instances, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the maxilla or maxilla, and a lower splint intended to engage or mate with teeth on the maxilla or mandible. The upper and lower splints are laterally connected to one another via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0062] In such a design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of the mandibular protrusion. The dentist can determine the level of the protrusion relative to the mandible, and the length of the connecting rod is determined accordingly.

[0063] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC™ MRD, are designed to hold the mandible in a forward position. The devices also reduce or minimize dental and temporomandibular joint (TMJ) side effects. Therefore, the devices are configured to minimize or prevent any movement of one or more of the teeth.

[0064] 2.2.3.8 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0065] The vent may include an orifice through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt the sleep of the patient's bed companion 1100, for example, due to noise or concentrated airflow.

[0066] ResMed Limited has developed several 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. 2009 / 0050156, U.S. Patent Application Publication No. 2009 / 0044808.

[0067] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 1]

[0068] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0069] The sound pressure values ​​for various subjects are listed below. [Table 2]

[0070] 2.2.4 Screening, diagnostic and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases and typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the patient to record various body signals, including electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing requires the patient to be observed for two nights in a clinic: the first night is purely diagnostic, and the second night is for the clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing in the home is particularly unsuitable.

[0071] In general, screening and diagnosis are the identification of a condition from signs and symptoms of disease. Screening typically provides a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are adapted solely for screening / diagnosis, while some can also be used for monitoring.

[0072] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Clinical experts may differ in their opinions about a patient's condition. Furthermore, a clinical expert may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0073] The present technology relates to the provision of medical devices used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders, having one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0075] Another aspect of the present technology relates to methods used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders.

[0076] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0077] One form of the present technology includes a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth, the first seal-forming structure constructed and arranged to, in use, maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal inlets, the first seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The patient interface is The support further includes a pair of supports located on opposite sides of the interface between the second seal-forming structure and the front wall of the plenum chamber, the supports configured to resist compression in the fore-and-aft direction.

[0078] In various instances, a) the support portion is connected to a portion of the second seal-forming structure that, in use, seals against the patient's upper lip; b) the support portion is connected to a portion of the second seal-forming structure that, in use, seals against the patient's upper lip directly beneath the lower corners of the patient's nose; c) the support is curved when viewed in a cross section parallel to the sagittal plane; d) the support is curved when viewed in a cross section parallel to the frontal plane; e) the plenum chamber includes a mouth portion and a nose portion; f) each support is connected to the mouth of the plenum chamber adjacent the boundary between the mouth sidewall and the nose sidewall; f) each support is connected to the mouth of the shell adjacent the boundary between the front wall of the mouth and the front wall of the nose; h) the sidewalls of the plenum chamber curve inward adjacent their interface with the nose, and each support portion is substantially continuous with an adjacent sidewall portion; I) the second seal-forming structure includes at least one nasal opening configured to deliver a flow of air at the treatment pressure to the entrance of the patient's nostril, and in use, no support is directly under the or each nasal opening; j) the interface further comprises a positioning and stabilizing structure configured to generate a force that holds the seal-forming structure in a therapeutically effective position on the patient's head; and / or k) The plenum chamber is at least partially formed by the shell, and the ventilation structure is provided in the shell. l) The support is connected to the second seal-forming structure and to the front wall of the plenum chamber.

[0079] Another form of the present technology includes a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to the mouth of the plenum chamber, the first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that airflow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; where: A first front wall portion of the nose of the plenum chamber adjacent the mouth of the plenum chamber is more flexible than an area adjacent the mouth of the plenum chamber, and a second front wall portion of the nose of the plenum chamber adjacent the first front wall portion and located on the opposite side of the boundary between the first front wall portion and the mouth of the plenum chamber is less flexible than an adjacent portion of the front wall.

[0080] In various instances, a) the first front wall portion is thinner than an immediately adjacent portion of the plenum chamber wall; b) the second front wall portion is thicker than the portion immediately adjacent the plenum chamber wall; c) the first and second front wall portions are made from the same material; d) the first front wall portion extends across substantially the entire width of the nose of the plenum chamber; e) the second front wall portion extends across at least a majority of the width of the nose of the plenum chamber; f) the first front wall portion extends upwardly around at least one side edge of the second front wall portion; g) the second front wall portion extends across substantially the entire width of the nose of the plenum chamber; h) the central portion of the first front wall portion extends further upward than the lateral portions of the first front wall portion; i) the upper boundary of the first front wall portion is curved; j) the lower boundary of the first front wall portion is curved; and / or k) the plenum chamber is at least partially formed by the shell, and the ventilation structure is provided in the shell; l) the second anterior wall portion includes a band extending through the first anterior wall portion and is configured to extend through the plenum chamber toward the patient; m) the transition within the plenum chamber between the first front wall portion and the second front wall portion is a substantially stepped surface; n) the transition outside the plenum chamber between the first front wall portion and the second front wall portion is a substantially smooth surface; and / or o) In use, the first front wall portion extends higher than at least a portion of the band.

[0081] Another form of the present technology includes a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to the mouth of the plenum chamber, the first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that airflow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; where: The rear surface of the side of the second seal-forming structure slopes forward and upward from the boundary of the first and second seal-forming structures.

[0082] In various instances, a) the inclined surface of each side forms an angle between 20 degrees and 90 degrees with respect to the intermediate contact surface of the mask; b) no part of the patient interface contacts the patient's nasal alar apex during use; c) the patient interface is configured to prevent blockage of the patient's nares, or at least reduce blockage compared to prior art patient interfaces; and / or d) The plenum chamber is at least partially formed by the shell, and the ventilation structure is provided in the shell.

[0083] Another form of the present technology includes a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to the mouth of the plenum chamber, the first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that airflow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; where: b) the ridge extends across substantially the entire interface between the first seal-forming structure and the second seal-forming structure; In various instances, a) the radius of curvature of the raised portion is less than 2 mm; b) the ridge extends across substantially the entire interface between the first seal-forming structure and the second seal-forming structure; c) in use, the ridges engage the patient's face adjacent the entrances to the nostrils where the alae meet the face above the upper lip; d) the ridges inhibit wrinkles from forming in the first and / or second seal-forming structures adjacent the ridges; and / or e) In use, the plenum chamber is at least partly defined by the shell, and the vent structure is provided in the shell.

[0084] Another form of the present technology includes a patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to the mouth of the plenum chamber, the first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that airflow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; where: At least a portion of the mouth of the plenum chamber includes a flexible shell, the flexible shell being formed from a material having a Young's modulus of less than 0.4 GPa. In various instances, a) the flexible shell is formed from a material having a Young's modulus of less than 0.1 GPa, preferably 0.3 to 0.7 MPa; b) at least one component is connected to the flexible shell, the at least one component being stiffer than a portion of the flexible shell adjacent to the component; c) the at least one component includes one or more of a ventilation module, a headgear connector, a headgear connector connected to a stiffening arm, a stiffening member, and a less flexible shell portion; d) at least one component is removably connected to the flexible shell; e) at least one component is permanently connected to the flexible shell; f) at least one component is overmolded onto the flexible shell; g) the flexible shell includes a reinforcement section having a thickness greater than an immediately adjacent portion of the flexible shell; h) at least one component is configured as a reinforcing rib or band; i) the central portion of the mouth of the plenum chamber has a higher stiffness than the remainder of the plenum chamber; and / or j) The plenum chamber is at least partially formed by the shell, and the ventilation structure is provided in the shell.

[0085] Another form of the present technology includes a frame configured to connect to a plenum chamber, the frame including a central portion connected to the plenum chamber outside of a cavity, and a plurality of connectors including a pair of upper connectors and a pair of lower connectors flush with the central portion and extending away from the central portion in a rearward direction configured to pass through the plenum chamber.

[0086] In various instances, a) each of the pair of upper connectors includes a slot configured to receive a headgear strap; b) each slot has a protrusion near the corresponding arm; c) each protrusion has a curved shape; d) each upper connector has a rib near its center; e) the width of the rib and arm combination near the center is substantially equal to the width of the arm near the slot; f) each of the pair of lower connectors includes a magnet; g) each of the pair of lower connectors includes a groove configured to function as a hinge and allow each lower connector to bend relative to the central portion;

[0087] Another form of the present technology includes a frame configured to be connected to a plenum chamber, the frame including: a central portion connected to the plenum chamber outside of a cavity; and a pair of arms extending rearwardly away from the central portion and configured to pass through the plenum chamber, the pair of arms being more flexible than the central portion.

[0088] In various instances, a) each of the pair of arms is more flexible than the frame; b) a central portion is thicker than each of said pair of arms; c) The central part and each arm of the pair are made of the same material; d) each of the pair of arms has a first connection point, and a head strap is connected to the first connection point of each arm; e) the first connection points are loops, and the headgear straps are connected to the loops in a manner that is perpendicular to an edge of each loop and applies a force vector perpendicular to the edge; f) the first connection point is a loop and includes a region of reduced thickness to which a head strap can contact; g) a first magnet is overmolded in a central portion of the frame, and the headgear strap includes a second magnet removably coupled to the first magnet; h) the first magnet includes a casing at least partially enclosing a magnetic material, the casing including a flat surface and a lip extending from the flat surface; i) the overhang is spaced from the second magnet and configured to engage with the lip when the second magnet is coupled to the magnetic material; j) configured to be centrally located within the groove of the plenum chamber; k) the central portion is removably disposed within the groove; l) the groove includes a protrusion and the central portion includes a complementary slot configured to receive the protrusion; m) the slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to be received through the wider opening before the narrower opening; n) the sleeve covers at least a portion of one of the pair of arms; o) the slot has a protrusion whose curvature is configured to match the curvature of the sleeve; and / or p) Each of the pair of arms includes a rib adjacent the center portion configured for frictional retention of the sleeve.

[0089] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that air at the therapeutic pressure is delivered to the patient's mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the patient's nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure configured to hold the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, a central section coupled to the plenum chamber outside the plenum chamber; and a frame including a pair of arms extending rearwardly away from the central portion through the second seal-forming structure, the arms being more flexible than the central portion, and a pair of arms extending in a direction away from the central portion through the second seal-forming structure; and a headgear strap coupled to the frame and configured to provide tension through the frame to the first seal-forming structure and the second seal-forming structure into the patient's face.

[0090] In various instances, a) each of the pair of arms is more flexible than the frame; (b) a central portion is thicker than each of said pair of arms; (c) the central portion and each arm of the pair are made of the same material; d) each of the pair of arms has a first connection point, and a head strap is connected to the first connection point of each arm; e) the first connection points are loops, and the headgear straps are connected to the loops in a manner that is perpendicular to an edge of each loop and applies a force vector perpendicular to the edge; f) the first connection point is a loop and includes a region of reduced thickness to which a head strap can contact; g) a first magnet is overmolded in a central portion of the frame, and the headgear strap includes a second magnet removably coupled to the first magnet; h) the first magnet includes a housing at least partially enclosing a magnetic material, the casing including a flat surface and a lip extending from the flat surface; i) the overhang is spaced from the second magnet and configured to engage with the lip when the second magnet is coupled to the magnetic material; j) the plenum chamber includes a groove having a central portion located therein; k) the central portion is removably disposed within the groove; l) the groove includes a protrusion and the central portion includes a complementary slot configured to receive the protrusion; m) the slot is tapered and includes a wider opening and a narrower opening, and is configured such that the protrusion is received through the wider opening before the narrower opening; n) the protrusion includes an overhang extending above the slot and configured to hold the frame against the plenum chamber; o) the plenum chamber has a protrusion disposed adjacent the groove, the protrusion configured to retain the core within the groove; p) an outer surface of the central section is flush with an outer surface of the plenum chamber, and the outer surfaces of the central section and the plenum chamber are configured to face away from a patient during use; q) the central portion is annular, the plenum chamber inlet port is radially disposed within the central portion, and the frame is connected to the plenum chamber; r) the plenum chamber inlet port is configured to receive the elbow and is configured to be spaced apart from the center when received within the plenum chamber inlet port; s) Each arm is formed in a cantilever structure relative to the center, t) The thickness of each arm decreases from the fixed end to the free end, u) the arm has a sectorial area on its inner surface configured to face the patient's skin; v) each arm is pivotable about a pivot point relative to the central portion; and / or w) The fulcrum is a living hinge.

[0091] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with a patient's face so that a flow of air at said therapeutic pressure is delivered to the patient's airway, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within said plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure that holds the seal-forming structure in a therapeutically effective position.

[0092] Another aspect of one form of the present technology is an oronasal patient interface that is more compact and less obtrusive to the patient.

[0093] Another aspect of one form of the present technology is an oronasal patient interface having a nasal cushion portion that provides an improved fit to the lower corners of the nose.

[0094] Another aspect of one form of the present technology is an oronasal patient interface that reduces nasal obstructive contact.

[0095] Another aspect of one form of the present technology is an oronasal patient interface that is self-adjustable to accommodate patients with various nasolabial angles.

[0096] Another aspect of one form of the present technology is an oronasal patient interface having a relatively flexible shell.

[0097] Another aspect of one form of the present technology is a patient interface that is shaped or constructed to have a perimeter shape that is complimentary to that of the intended wearer.

[0098] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure configured to hold the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a headgear strap configured to provide tension through the frame to the first seal-forming structure and the second seal-forming structure into the patient's face, the headgear strap including a first width and a second width greater than the first width; The headgear straps selectively pass through the openings to adjust tension, with a first width configured to pass through the openings and a second width configured to prevent passage through the openings.

[0099] Another form of the present technology includes a positioning and stabilizing structure configured to hold a seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a headgear strap configured to provide tension to a seal-forming structure having a first width and a second width greater than the first width through the frame and into the patient's face; The headgear straps selectively pass through the openings to adjust tension, with a first width configured to pass through the openings and a second width configured to prevent passage through the openings.

[0100] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a positioning and stabilizing structure configured to hold the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, a pair of upper arms, a pair of lower arms, and The headgear straps include headgear straps connected to the pair of upper arms and the pair of lower arms, the headgear straps configured to apply tension to the first seal-forming structure and the second seal-forming structure through the frame and into the patient's face.

[0101] Another form of the present technology includes a frame, the frame comprising: The center and a pair of upper arms extending rearward and away from the central portion and more flexible than the central portion; and a pair of upper arms more flexible than the central portion; a pair of first connectors coupled to the pair of upper arms and configured to selectively connect to the pair of upper straps; a pair of lower arms extending away from the central portion; and a pair of second connectors coupled to the pair of lower arms and configured to selectively connect to the pair of lower straps.

[0102] In various instances, a) the pair of first connectors and the pair of second connectors are different; b) the pair of first connectors is selected from the group consisting of a slot, a ladder lock, and a stopper; c) the pair of first connectors are slots; d) each of the pair of first connectors has a first loop portion and a second loop portion; e) the pair of second connectors are magnetic; and / or f) The first connector of the pair is longer than the second connector of the pair.

[0103] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance so that airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a positioning and stabilizing structure configured to hold the first seal-forming structure and the second seal-forming structure in a therapeutically effective position; a frame including a central portion coupled to a plenum chamber; The plenum chamber includes a groove configured to removably receive a central portion of the frame.

[0104] In various instances, a) at least a portion of the central portion of the frame is spaced from the groove in the engagement position; b) if the central section is attached to the frame, the upper bar of the central section is spaced from the groove; and / or c) the second seal-forming structure is configured to be spaced from the top bar before use and to contact the top bar during use;

[0105] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal inlets such that airflow at the therapeutic pressure is delivered to the nasal inlets, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The patient interface is The device further includes at least one region disposed within the plenum chamber, spaced apart from the first seal-forming structure, and configured to resist forward compression of the first seal-forming structure.

[0106] In various instances, a) the at least one region is at least one stop rib; b) the at least one stop rib includes a plurality of stop ribs spaced apart from one another; c) the plurality of stopper ribs are arranged in a c-shape; d) the plurality of stopper ribs extend substantially around the entire circumference of the first seal-forming structure; e) at least one stop rib is an elongated member; f) at least one stop rib has a beveled edge; g) the beveled edge is the trailing edge; h) the beveled edge is configured to contact the first seal-forming structure in use to limit forward movement of the first seal-forming structure; i) the at least one stopper rib includes a length measured substantially perpendicular to the first seal-forming structure and a width measured substantially perpendicular to the length; j) The length is greater than the width, k) the first seal-forming structure is configured to contact at least one stop rib along the width direction in use; l) at least one region is at least one reinforced region; m) at least one reinforced region comprises a plurality of reinforced regions; n) at least one reinforced region includes a first thickness near the inlet port and a second thickness far from the inlet port, the second thickness being less than the first thickness; o) at least one reinforced region is located at the front of the plenum chamber; and / or p) at least one region is integrally formed with the plenum chamber;

[0107] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway so that a flow of air at the therapeutic pressure is delivered to the airway, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, a central portion removably disposed within a groove on the plenum chamber outside the plenum chamber; a pair of upper arms extending away from the midsection; and a frame including a pair of lower arms extending away from a central portion; and a headgear strap coupled to the frame and configured to provide tension through the frame to the first seal-forming structure and the second seal-forming structure into the patient's face.

[0108] In various instances, a) One pair of upper arms is longer than one pair of lower arms b) each of the pair of upper arms has a first connector and each of the pair of lower arms has a second connector different from the first connector; c) the first connector is selected from the group consisting of a loop, a ladder lock, and a cord stopper; d) the first connector is a loop including a first loop portion and a second loop portion adjacent to the first loop portion; e) the loop includes a partition at least partially separating the first loop portion from the second loop portion; f) one of the headgear straps is configured to be selectively inserted into the first loop portion under optimal tension in use to contact the bulkhead, and configured to move to the second loop portion under tension greater than the optimal tension; g) the second connector is a magnetic member; h) the magnetic member has a substantially elliptical shape; i) the second connector is a magnetic member; j) the housing is removably magnetically connected to the magnetic member; k) the housing includes a strap connector for connecting to a strap of the headgear strap selected from the group consisting of a loop, a ladder lock, and a cord stopper; l) the housing is configured to engage a lip of the outer casing; m) at least one of the headgear straps has a first width and a second width greater than the first width; n) the first width is selectively receivable through the first connector and the second width is substantially prevented from passing through the first connector; and / or o) The pair of first arms and the pair of second arms are integrally formed with the central portion.

[0109] Another form of the present technology includes a patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway so that a flow of air at the therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; and a positioning and stabilizing structure that holds the seal-forming structure in a therapeutically effective position; The plenum chamber extends around at least a portion of the inlet port and includes a lip that extends into the cavity.

[0110] Another form of the present technology involves a patient interface.

[0111] Another form of the present technology involves a system for supplying pressurized air to a patient, the system comprising: a plenum chamber including a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient, the plenum chamber including a lip extending at least partially into the cavity around the plenum chamber inlet port; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway so that a flow of air at said therapeutic pressure is delivered to the patient's airway, the seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within said plenum chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position; an air circuit removably connected to the plenum chamber and configured to supply airflow at a therapeutic pressure from an airflow generator to the cavity, the air circuit including a vent ring configured to pass at least partially through the plenum chamber inlet port, the vent ring comprising: a posterior surface having a first diameter a front surface having a second diameter smaller than the first diameter; and a ring body extending between the front surface and the rear surface, the ring body including an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall; the rear surface is configured to be positioned within the cavity and the front surface is configured to be retained outside the cavity when connected to the plenum chamber; the lip is configured to contact the vent ring along the ring body between the rear surface and the front surface; The first diameter is greater than the diameter of the lip.

[0112] In various instances, a) the vent body is inclined between the rear and front surfaces; b) the rear surface is configured to contact the lip and front wall within the cavity of the plenum chamber in use; c) the ring body has an inner wall, an outer wall, and a groove provided between the inner wall and the outer wall; d) The ring seal is located in the groove; e) The outer diameter of the ring seal is smaller than the outer diameter of the groove, f) the ring body includes a central opening configured to receive an elbow connector; g) the system includes a quick release connector; h) A quick release connector is a rotating or latching connector; i) the quick release connector is configured to connect to an auxiliary connector; and / or j) The seal-forming structure is separate from the venting ring and is not configured to allow the patient's face to contact the venting ring.

[0113] Another form of the present technology includes a patient interface, comprising: a plenum chamber having a cavity pressurizable to a treatment pressure at least 6 cmH2O above ambient air pressure; a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth so that a flow of air at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to form a seal with areas of the patient's face surrounding the entrances to the patient's nares, the second seal-forming structure constructed and arranged to, in use, maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle; and a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The patient interface is at least one stopper rib disposed within the cavity of the plenum chamber spaced apart from the first seal-forming structure in a rest position, the first seal-forming structure configured to contact the at least one stopper rib in an actuated position, the at least one stopper rib configured to resist forward compression of the first seal-forming structure; The second seal-forming structure is not configured to contact the at least one stop rib.

[0114] In various instances, a) the upper lip is positioned below the second seal-forming structure and configured to contact the upper lip; b) the upper lip is not configured to contact the at least one stop rib; c) the plurality of stopper ribs are arranged in a c-shape; d) the plurality of stopper ribs are unevenly spaced apart from one another within the plenum chamber; e) a plurality of stop ribs extending around a majority of the seal-forming structure; f) at least one stop rib is an elongated member; g) at least one stop rib has a beveled edge; h) the beveled edge is the trailing edge; i) the beveled edge is configured to contact the seal-forming structure in use to limit forward movement of the seal-forming structure in the activated position; j) in the rest position, the beveled edge is positioned away from the seal-forming structure toward the center of the plenum chamber; k) at least one stopper rib includes a length measured substantially perpendicular to the seal-forming structure and a width measured substantially perpendicular to the length, the length being greater than the width; l) the first seal-forming structure is configured to contact at least one stop rib in the width direction in the actuated position; m) said width is substantially uniform along the length of at least one said stopper rib; n) the width varies along the length of at least one stop rib, and / or o) At least one stop rib is integrally formed with the plenum chamber.

[0115] Another form of the present technology includes a patient interface, comprising: a plenum chamber formed entirely of a flexible material, the plenum chamber including a cavity pressurizable to a treatment pressure at least 6 cmH2O above ambient air pressure, and a groove formed in an outer surface of the plenum chamber cavity and exposed to ambient pressure; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway entrance, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, a central portion removably disposed within the groove; a pair of upper arms extending away from the midsection; and a frame including a pair of lower arms extending away from a central portion; and headgear straps connected to a pair of upper arms and a pair of lower arms of the frame and configured to provide tension to the seal-forming structure through the frame and into the patient's face.

[0116] In various instances, a) One pair of upper arms is longer than one pair of lower arms b) each of the pair of upper arms includes a first type of connector, and each of the pair of lower arms includes a second type of connector different from the first type of connector; c) the first type of connector is selected from the group consisting of a loop, a ladder lock, and a cord stopper; d) the first type connector is a loop including a first loop portion and a second loop portion adjacent to the first loop portion; e) the loop includes a partition at least partially separating the first loop portion from the second loop portion; f) one of the headgear straps is configured to be selectively inserted into the first loop portion under optimal tension in use to contact the bulkhead; g) the strap is configured to move to the second loop portion under greater than optimal tension; h) the second type of connector is a magnetic member; i) the magnetic member has a substantially elliptical shape; j) the housing is removably magnetically connected to the magnetic member; k) the housing includes a strap connector for connecting to a strap of a headgear strap, the strap connector being selected from the group consisting of a loop, a ladder lock, and a cord stopper; l) the housing is configured to engage the housing lip; m) at least one of the headgear straps has a first width and a second width greater than the first width; n) the first width is selectively receivable through the first connector and the second width is substantially prevented from passing through the first connector; o) a pair of upper and lower arms integrally formed with the central portion; and p) the plenum chamber includes at least one protrusion extending from the groove; q) a central portion of the frame includes at least one slot configured to selectively receive at least one protrusion; r) a pair of lower arms substantially flush with the central portion; s) the patient interface includes a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's mouth; t) the patient interface includes a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nostril openings; u) the groove is provided below the second seal-forming structure and on the plenum chamber opposite the first seal-forming structure; v) a system for supplying pressurized air to a patient, comprising: a patient interface according to any of the above examples; a respiratory treatment system (RPT) device configured to supply a flow of air under therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the RPT device configured to deliver the flow of air to the patient interface; w) the conduit is connected to an inlet port of a plenum chamber, the plenum chamber being spaced from an inner periphery of a central portion of the frame; x) the central portion includes inner and outer peripheries removably disposed within the groove; y) the grooves are formed radially outward from the inlet port and form a closed periphery; and / or z) the inner periphery is configured to be spaced from the inlet port when positioned within the groove.

[0117] Another form of the present technology includes a patient interface, comprising: a plenum chamber including a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient, the plenum chamber including a lip extending at least partially into the cavity around the plenum chamber inlet port; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway so that a flow of air at the therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; and a positioning and stabilizing structure that holds the seal-forming structure in a therapeutically effective position; an air circuit removably connected to the plenum chamber and configured to supply airflow at a therapeutic pressure from an airflow generator to the cavity, the air circuit including a vent ring configured to pass at least partially through the plenum chamber inlet port, the vent ring comprising: a posterior surface having a first diameter; a front surface having a second diameter smaller than the first diameter; and a ring body extending between the front surface and the rear surface, the ring body including an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall; the rear surface is configured to be positioned within the cavity and the front surface is configured to be retained outside the cavity when connected to the plenum chamber; the rear surface includes at least one vent opening configured to communicate between the cavity and an ambient environment through the groove; the lip is configured to contact the vent ring along the ring body between the rear surface and the front surface; The first diameter is greater than the diameter of the lip.

[0118] In various instances, a) the ring body is tapered between the rear surface and the front surface; b) the rear surface is configured to contact the lip and front wall within the cavity of the plenum chamber in use; c) The ring seal is located in the groove; d) The outer diameter of the ring seal is smaller than the outer diameter of the groove, e) the ring body includes a central opening, the system further includes an elbow connector, the central opening configured to receive the elbow connector; f) the elbow connector is rotatably connected to the ring body, and the ring body is rotatably connected to the plenum chamber; g) the at least one vent opening is a plurality of openings spaced around the periphery of the groove; h) the system includes a quick release connector; i) A quick release connector is a rotating or latching connector; j) the quick release connector is configured to connect to the auxiliary connector; k) the quick release connector includes at least one flat surface; l) at least one of the flat surfaces is a pair of flat surfaces spaced approximately 180° apart; m) the at least one flat surface is configured to redistribute airflow leakage from the system; n) the seal-forming structure is separate from the venting ring and is not configured to allow the patient's face to contact the venting ring; o) the quick release connector includes a vent opening configured to vent a portion of the airflow to the surroundings; p) the ring body has an extension; q) the ring body includes a disk located within the plenum chamber and configured to restrict exhaled air from being released to the environment; and / or r) the disc extends radially beyond a portion of the rear surface that includes at least one vent opening.

[0119] In various instances, a) the elbow connector includes at least one button configured to be selectively actuated to release a connection between the elbow connector and the central opening; b) at least one of the buttons is formed as a cantilever structure; c) the at least one button includes a button lip configured to selectively engage the ring body and move relative to a remainder of the elbow when the at least one button is actuated; d) the button lip is configured to selectively engage an inner periphery of the inner wall of the ring body; e) the at least one button includes a finger configured to selectively engage the ring body and move relative to a remainder of the elbow when the at least one button is actuated; f) the fingers are configured to selectively engage the ring body radially outward of the inner wall; and / or g) the plenum chamber inlet port includes an extension, the ring body being connected to the extension and separated from the surface of the plenum chamber;

[0120] Another form of the present technology includes an elbow configured to be removably connected to a plenum chamber, the elbow including a button selectively engageable by the patient.

[0121] Another form of the present technology includes an elbow configured to be removably connected to a plenum chamber, the elbow comprising: a body including a first end configured to be at least partially inserted into a cavity of a plenum chamber and a second end configured to be connected to an air circuit, said body comprising: a button having a fixed end adjacent the first end and a free end extending away from the free end; an outer lip extending substantially around at least a portion of the periphery of the body; The button is selectively engageable by the patient to selectively separate the body from the plenum chamber.

[0122] In various instances, a) the button forms part of the periphery of the body; b) the inner lip is spaced from the outer lip and closer to the first end than the outer lip; c) The width of the inner lip is approximately the same as the width of the button, d) the inner lip extends along a portion of the periphery of the body; e) the channel extends around a portion of the button to form a free end; f) the button is a first button, and the body further includes a second button; g) The distance between the second button and the first button is approximately 180°; h) the first button and the second button are configured to move relative to one another as a result of selective engagement by the patient; i) the outer lip is configured to abut the vent ring to limit translational movement of the elbow; j) a button selectively engageable by the patient to selectively move the inner lip relative to the outer lip; k) the inner lip is configured to be in the pressurized volume when connected to the plenum chamber and supplied with pressurized air; l) the inner lip is configured to selectively engage the groove and disengage from the groove when the button(s) are applied; and / or m) The outer lip extends essentially around the periphery of the body.

[0123] In various instances, a) the button includes a finger extending from a fixed end; b) the fingers extend toward the first end of the body; c) the finger is formed as a cantilever structure relative to the button; d) the button is a first button, and the body further includes a second button; e) the second button is spaced approximately 180 degrees from the first button; f) the first button and the second button are configured to move toward each other as a result of selective engagement by the patient; g) the outer lip is disposed between the first button and the second button; 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; i) the outer lip is configured to abut the vent ring to limit translational movement of the elbow; j) the fingers are configured to selectively connect to a vent ring outside the pressurized volume; and / or k) selective engagement of the button is configured to move the finger away from the surface of the body;

[0124] Another form of the present technology includes an elbow configured to be removably connected to a plenum chamber, the elbow comprising: a body including a first end configured to be at least partially inserted into a cavity of a plenum chamber and a second end configured to be connected to an air circuit, said body comprising: A button spaced apart from the surface of the device; a finger connected to the button; the button is selectively engageable by the patient to move the button relative to the body surface; The finger is movable with the button.

[0125] In various instances, a) the button is configured to move toward the body surface and the finger is configured to move away from the body surface when the button is engaged; b) the button is a first button, and the body further includes a second button; c) the second button is spaced approximately 180° from the first button; d) the first button and the second button are configured to deflect relative to one another as a result of selective engagement by the patient; and / or e) the fingers are configured to selectively connect to a vent ring outside the pressurized volume;

[0126] Another form of the present technology includes an elbow configured to be removably connected to a plenum chamber, the elbow comprising: a body including a first end configured to be at least partially inserted into a cavity of the plenum chamber and a second end configured to be connected to an air circuit, the body comprising: a button forming a part of a surface of the body and configured to move into the body in response to an external force; The device further includes a finger connected to the button, spaced apart from the body surface, and configured to move in response to an external force applied to the button.

[0127] In various instances, a) the fingers are configured to engage an outer surface of a vent ring; b) the button is biased to a relaxed position such that the button is approximately flush with the surrounding surface of the body; c) the finger is spaced a first distance from the surface of the body in a relaxed position and a second distance from the surface of the body when an external force is applied, the second distance being greater than the first distance; d) the button is a first button, and the body further includes a second button; e) the second button is spaced approximately 180 degrees from the first button; f) the fingers are substantially hook-shaped; and / or g) There is a fulcrum between the button and the finger, the button has a cantilever structure relative to the fulcrum, and the finger has a cantilever structure relative to the fulcrum.

[0128] Another form of the present technology includes a venting ring connected to a plenum chamber and configured to increase humidity in the plenum chamber, the venting ring comprising: a rear surface configured to be located in a pressurized environment, the rear surface including at least one vent configured to exhaust air from the plenum chamber; a front surface spaced from the rear surface and configured to be outside the pressurized environment.

[0129] In various instances, a) the disc is connected to the rear surface and configured to be located in a pressurized environment; b) the width of the disc is substantially the same as the width of the rear face; c) the disc extends radially outwardly of the location of the at least one vent opening on the rear surface; d) a disc configured to deflect exhaled air into said plenum chamber; e) the extension is connectable to a vent ring near the rear surface configured to separate the at least one vent opening from a surface of the plenum chamber; f) the at least one ventilation opening is a plurality of ventilation openings spaced apart around the periphery of the rear surface; g) the ventilation openings are evenly spaced around the periphery of the rear face; and / or h) The plurality of vent openings extend around less than half of the perimeter of the rear face.

[0130] Another form of the present technology is a connector member having a first side and a second side opposite the first side, the first side and the second side each comprising a connector material, the connector material configured to removably connect to a positioning and stabilizing structure of a patient interface.

[0131] In various instances, a) the first side includes the same connector material as the second side; b) the connector is a hook or loop material; and / or c) The connector can be connected to an infinite number of positions.

[0132] Another form of the present technology includes a positioning and stabilizing structure comprising at least one side strap having an inner surface configured to cover a patient's temporal bone and an outer surface opposing the inner surface, and connecting members removably connected to the outer surface, the connecting members having first and second sides each including connector material, the connecting members connectable to a plurality of locations along a length of the at least one side strap.

[0133] In various instances, a) the first side and the second side of the connecting member include hook material; b) the outer surface comprises a loop material; c) the connecting member is connectable to at least one of the side straps at an infinite number of positions along the length of the side strap; d) a patient interface including a frame and a positioning and stabilizing structure, wherein the frame includes a loop configured to releasably receive at least one side strap, and wherein the at least one strap is folded after passing through the loop such that the other side of the connecting member is releasably connected to the at least one strap; e) in use, the first side and the second side are removably attached to at least one strap; f) the positioning and stabilizing structure further includes a rear strap configured to cover the patient's occipital bone, and the at least one side strap includes a pair of lower straps configured to be removably connected to the frame and a pair of upper straps configured to be removably connected to the frame, each of the pair of upper straps and the pair of lower straps including a connecting member; and / or g) The connecting members of each of the upper and lower straps are releasably connected at an infinite number of points along the length of the corresponding strap.

[0134] Another form of the present technology includes a positioning and stabilizing structure including at least one side strap including an elastic portion stretchable between a first length and a second length, the at least one strap including a portion that is substantially concealed in the first position and visible when extended in the second position.

[0135] In various instances, a) the concealment portion is a different color from the rest of at least one strap;

[0136] b) The concealed part is shiny, c) the concealing portion includes an electro-optical light emitting element (e.g., an LED); d) at least one strap includes tactilely responsive elements located on either side of the concealment portion, the tactilely responsive elements configured to be coupled to one another in a first position and separated from one another in a second position; e) the tactile response element is a magnet, and / or f) The tactile response element is a mechanical connector.

[0137] Another form of the present technology includes a positioning and stabilizing structure having a rear strap configured to cover a patient's occipital bone, a pair of lower straps configured to be removably connected to a frame, and a pair of upper straps configured to be removably connected to the frame, wherein the pair of upper straps and the pair of lower straps each include a connecting member.

[0138] In various instances, a) the connecting members are removably connected to corresponding straps; b) the connecting member is provided with hook material on both sides to facilitate a removable connection; c) at least one strap includes a first portion having a first width, a second portion having a second width, and a transition portion between the first and second portions; d) the second width is larger than the first width and larger than the loop on the frame that receives the strap; e) at least one strap has a plurality of protrusions; f) the plurality of protrusions are evenly spaced along at least a portion of at least one of the straps; g) at least one of said straps includes a first density of ridges and a second density of ridges; h) at least one strap includes a cutting edge; i) the cutting edge is square, triangular or circular; j) the cutting edges are evenly spaced along at least a portion of the at least one strap; k) at least one of said straps includes a first density cut edge and a second density cut edge; l) at least one strap has an elastic portion stretchable between a first length and a second length; m) at least one of the straps includes a portion that is substantially hidden in the first position, and the strap is visible when extended in the second position; n) The cover-up is of a different color and / or texture than the rest of the strap; o) at least one strap includes tactilely responsive elements located on either side of the concealment portion, the tactilely responsive elements configured to be coupled to one another in a first position and separated from one another in a second position; p) an upper strap configured to cover the patient's temporal and / or frontal bones, having a first portion and a second portion, selectively connected by a buckle; and / or q) The patient interface is removably connected to the positioning and stabilizing structure.

[0139] One aspect of the present technology is a method for manufacturing a device.

[0140] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0141] One aspect of one form of the present technology is a portable RPT device that can be carried by a person, for example, around their home.

[0142] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned at the patient's home, for example, with soapy water, without the need for special cleaning equipment.

[0143] The above-described methods, systems, devices, and apparatus may be implemented to improve the functionality of processors of special purpose computers, respiratory monitors, and / or respiratory treatment devices, etc. Additionally, the above-described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0144] Of course, some of the above aspects may form sub-aspects of the present technology, and various of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0145] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]

[0146] The present technology is illustrated by way of example, and not by way of limitation, in the diagrammatic representations of the accompanying drawings in which like reference numerals refer to similar elements, including: 4.1 Respiratory Therapy Systems [Figure 1A] The system is shown including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. [Figure 1C]The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy, including the upper lip, vermilion, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and cheilion. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] A schematic cross-section of a structure cut at a point, showing the outward normal at this point, and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point having a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3F] 3B is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point having a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. 3E. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion, the edge of the surface, and the dome and saddle regions. [Figure 3H] Shown is a mask cushion. Shown is the outer surface of the cushion. Shown is the edge of the surface. Shown is the path on the surface between points A and B. Shown is the linear distance between A and B. Shown are the two saddle regions and the dome region. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W]3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is illustrated. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the chord 3210. The chord 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the upper and lower points. In the case of an oral-nasal interface configured with a plenum chamber having separate mouth and nose sections, such as an Ultra Compact Full Face (UCFF) mask, the upper and lower points are on the seal-forming structure of the mouth of the mask. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 located approximately on the selion and the lower point 3230 located on the upper lip. 4.4RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 4.5 Humidifiers [Figure 5A]

[0023] Fig. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B]5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory Waveform [Figure 6] A model of a typical breathing waveform of a sleeping human is shown. 4.7 Example of a patient interface using this technology [Figure 7] FIG. 10 is a rear perspective view of a plenum chamber, inlet ports not shown, in accordance with one form of the present technology. [Figure 8] FIG. 8 is a rear view of the plenum chamber of FIG. [Figure 9] FIG. 8 is a front view of the plenum chamber of FIG. [Figure 10] FIG. 8 is a side view of the plenum chamber of FIG. [Figure 11] FIG. 8 is a top view of the plenum chamber of FIG. [Figure 12] FIG. 12 is a cross-sectional view of the plenum chamber through the plane 12-12. [Figure 13] FIG. 8 is a bottom view of the plenum chamber of FIG. [Figure 14] FIG. 14 is a cross-sectional view of the plenum chamber through the plane 14-14. [Figure 15] FIG. 15 is a cross-sectional view of the plenum chamber through the plane 15-15. [Figure 16] FIG. 16 is a cross-sectional view of the plenum chamber through the plane 16-16. [Figure 16-1] FIG. 16 is a cross-sectional view of the plenum chamber through the plane 16-1-16-1. [Figure 16-2] 16-2 is a cross-sectional view of the plenum chamber of FIG. 16-1, showing the plenum chamber in a deformed position. [Figure 16-3] 17 is another cross-sectional view of the plenum chamber shown in FIG. 16, showing a first size cushion. [Figure 16-4] FIG. 17 is a cross-sectional view of the plenum chamber shown in FIG. 16, illustrating a second size cushion. [Figure 16-5] FIG. 17 is a cross-sectional view of the plenum chamber shown in FIG. 16, illustrating a third size cushion. [Figure 17]FIG. 17 is a cross-sectional view of the plenum chamber through plane 17-17. [Figure 18] FIG. 18 is a cross-sectional view of the plenum chamber through the plane 18-18. [Figure 18-1] FIG. 18 is a cross-sectional view of the plenum chamber through the plane 18-1-18-1. [Figure 18-2] FIG. 18 is a cross-sectional view of the plenum chamber through the plane 18-2-18-2. [Figure 19] FIG. 1 is a side view of the plenum chamber in an in-use position on a patient's face, the plenum chamber being shown diagrammatically for clarity. [Figure 20] 1 is a patient's face showing specific areas of engagement by the seal-forming structure. [Figure 21] FIG. 10 is a front perspective view of a patient interface according to another aspect of the present invention. [Figure 21-1] FIG. 10 is a front perspective view of a patient interface according to another aspect of the present invention. [Figure 22] FIG. 10 is a front perspective view of a patient interface according to another embodiment of the present invention, with the vent removed. [Figure 23] FIG. 10 is a front perspective view of a patient interface having a frame for connecting headgear straps to a plenum chamber. [Figure 23-1] FIG. 24 is a rear perspective view of the patient interface of FIG. 23. [Figure 23-2] FIG. 10 is a front perspective view of a patient interface having a frame for connecting headgear straps to a plenum chamber. [Figure 24] FIG. 24 is an exploded view of the patient interface of FIG. 23. [Figure 24-1] FIG. 23-3 is an exploded view of the patient interface of FIG. 23-2. [Figure 25] FIG. 1 is a front view of a frame and plenum chamber according to one aspect of the present invention. [Figure 26] FIG. 10 is a front view of a frame and plenum chamber according to another aspect of the present invention. [Figure 26-1] FIG. 27 is a side view of the plenum chamber of FIG. [Figure 26-2] FIG. 2 is a cross-sectional view of the frame and plenum chamber of FIG. 1, showing sections 26-1 and 26-26. [Figure 26-2a] 26-26 is a cross-sectional view of an alternative embodiment of the frame and plenum chamber of FIG. 26-1, taken along section 26-26. [Figure 26-3] FIG. 27 is a top view of the plenum chamber of FIG. 26. [Figure 26-4] FIG. 27 is a perspective view of the frame and plenum chamber of FIG. 26 showing the frame arms movable between a first position and a second position. [Figure 26-5] 26-5 is a rear perspective view of the frame and plenum chamber of FIG. 26-4, showing the curvature of the plenum chamber in a second position. [Figure 27] FIG. 27 is a rear view of the frame of FIG. 26 showing the tapered opening. [Figure 27-1] FIG. 27 is a top perspective view of the frame of FIG. 26, showing the thinning of the arms of the frame. [Figure 27-2] FIG. 27 is a perspective view of the frame of FIG. 26 showing the loop at the free end of the frame. [Figure 27-3] FIG. 27 is a perspective view of the frame of FIG. 26 showing a cross section of the arm of the frame. [Figure 28] FIG. 10 is a front view of a frame and plenum chamber according to yet another aspect of the present invention. [Figure 28-1] FIG. 13 is a perspective view of an auxiliary connection point that may be used with a frame in one form of the present technology. [Figure 28-2] 2 is a cross-sectional view of the frame and plenum chamber of FIG. 1. FIG. 28 shows the connection between the magnet and the secondary connection point of FIG. 28-1. [Figure 29] FIG. 10 is a detailed view of a plenum chamber in accordance with yet another form of the present technology showing a clip support configured to selectively contact a frame; [Figure 30] FIG. 30 is a plan view of the plenum chamber of FIG. 29 connected to a frame contacting a clip support. [Figure 31] FIG. 10 is a front view of a frame and plenum chamber according to yet another aspect of the present invention. [Figure 32] FIG. 13 is a front view of a frame in accordance with yet another form of the present technology, showing a rib limiting movement of a connecting member; [Figure 33] FIG. 13 is a front view of a frame in accordance with yet another form of the present technology, showing a pair of ribs limiting movement of a connecting member. [Figure 34] FIG. 13 is a front view of a frame in accordance with yet another form of the present technology, showing arms with connection points; [Figure 35] 10 is a perspective view of another form of frame according to the present technology, showing a protrusion near the eyelet; [Figure 35-1] FIG. 10 is a side perspective view of a frame according to another example. [Figure 35-2] FIG. 36 is a detailed view of the eyelet of FIG. 35. [Figure 36] FIG. 10 is a front view of a frame in accordance with yet another form of the present technology, showing a top bar of the frame coupled to a plenum chamber near an elbow; [Figure 37] FIG. 10 is a front view of a frame in accordance with yet another form of the present technology, showing the top bar of the frame separated from the plenum chamber; [Figure 38] FIG. 38 is a perspective view of the frame of FIG. 37. [Figure 39] FIG. 38 is a top view of the frame of FIG. 37. [Figure 40] FIG. 10 is a side perspective view of a cushion in accordance with another illustration of the present technology showing a protrusion extending from the front face of the plenum chamber; [Figure 41] FIG. 24 is a detailed view of a strap of a positioning and stabilizing structure having a first width and a second width that may be used with the patient interface of FIG. 23. [Figure 41-1] FIG. 24 is a detailed view of an alternative example of a strap of the positioning and stabilizing structure having convex portions that may be used with the patient interface of FIG. 23. [Figure 41-1-1] 41-1 is a detailed view of an alternative strap having a positioning and stabilizing structure of the patient interface of FIG. 23, with ridges alternating with those of FIG. 41-1. [Figure 41-2]FIG. 24 is a detailed view of an alternative example of a strap of the positioning and stabilizing structure having cutting edges that may be used with the patient interface of FIG. 23. [Figure 41-3] FIG. 24 is a detailed view of an alternative example of a strap of a positioning and stabilizing structure that may be used with the patient interface of FIG. 23, positioned in a first position. [Figure 41-4] FIG. 41-4 is a detailed view of the strap of FIG. 41-3, showing the indicator in a visible second extended position. [Figure 41-5] FIG. 24 is a detailed view of an alternative example of a strap of the positioning and stabilizing structure that may be used with the patient interface of FIG. 23 positioned in a second extended position with the indicator visible. [Figure 41-6] FIG. 1 is a perspective view of a double-sided connecting member having hook or loop material. [Figure 41-7] 41-6 is a rear view of the double-sided connecting member connected to the headgear in a first position. FIG. [Figure 41-8] 41-6 is a rear view of the double-sided connecting member connected to the headgear in a second position. FIG. [Figure 42] FIG. 42 is a front perspective view of the patient interface of FIG. 23 using the strap of FIG. 41. [Figure 42-1] FIG. 43 is a front perspective view of an alternative embodiment of FIG. 42 showing a patient interface with sleeves on the arms of the frame. [Figure 42-2] FIG. 24 is a front perspective view of the patient interface of FIG. 23 using an alternative to the strap. [Figure 43] FIG. 10 is a rear view of another embodiment of the cushion with the stopper ribs shown in hidden lines. [Figure 44] FIG. 44 is a cross-sectional view taken along the cushions 44-44 in FIG. 43, showing the shape of the stopper rib. [Figure 45] FIG. 45 is a cross-sectional side view of FIG. 44. [Figure 45-1] FIG. 45 is a cross-sectional view of the cushion of FIG. 43 taken along line 45-1-4-5-1, showing the shape of the stopper rib. [Figure 46]FIG. 27 is a front view of the plenum chamber of FIG. 26 showing the grooves that receive the frame. [Figure 47] FIG. 10 is a rear view of a cushion in accordance with yet another form of the present technology, showing reinforced areas in hidden lines; [Figure 47-1] FIG. 48 is a cross-sectional view of the cushion showing the reinforced region of FIG. 47. [Figure 48] 13 is a cross-sectional view of a pad in accordance with another form of the present technology, showing an alternative form of a reinforced region; [Figure 49] FIG. 49 is a cross-sectional view of the cushion of FIG. 48. [Figure 50] FIG. 10 is a cross-sectional view of a cushion in accordance with another form of the present technology, illustrating the spacing between the seal-forming structure and the front face of the plenum chamber; [Figure 50-1] FIG. 10 is a cross-sectional view of a cushion in accordance with another form of the present technology, showing a vent ring with an offset that creates spacing between the seal-forming structure and the elbow; [Figure 51] FIG. 51 is a cross-sectional view showing the cushion of FIG. 50 worn by a patient. [Figure 52] FIG. 10 is a perspective view of an arm of a frame having a first loop portion and a second loop portion. [Figure 53] FIG. 53 is a perspective view of the arm of FIG. 52 showing the headgear strap connected to the first loop portion under optimal tension. [Figure 54] FIG. 52 is a perspective view of a headgear strap connected to the second loop portion under tension greater than optimal tension. [Figure 55] FIG. 10 is a perspective view of a patient interface according to another example, showing a frame having ladder locks connected to headgear straps. [Figure 55-1] FIG. 10 is a perspective view of a patient interface according to another example, showing a frame having ladder locks coupled to headgear straps. [Figure 56] FIG. 10 is a perspective view of another example patient interface showing a frame with cord stoppers connected to headgear straps. [Figure 56-1]FIG. 10 is a perspective view of another example patient interface showing a frame with cord stoppers connected to headgear straps. [Figure 57] FIG. 10 is a cross-sectional view of another example patient interface showing a vent ring connected to the lip of the plenum chamber inlet port. [Figure 58] FIG. 58 is an exploded view of the air circuit connected to the patient interface of FIG. 57. [Figure 58-1] FIG. 59 is a perspective view of a quick release connector used in the air circuit of FIG. 58. [Figure 59] FIG. 58 is a perspective view of the venting ring of FIG. 57. [Figure 60] FIG. 60 is a plan view of the vent ring of FIG. 59 showing multiple vent holes. [Figure 61] FIG. 10 is a plan view of an alternative example of a housing for a magnet removably coupled to a connection point of the frame of any of the previous examples. [Figure 62] 10 is a perspective view of a separation structure including a connector for engaging within a vent ring according to another embodiment. FIG. [Figure 63] 63 is a perspective view of another example vent ring for engaging with the separation structure of FIG. 62. FIG. [Figure 63-1] 64 is a cross-sectional view of the decoupling structure of FIG. 62 connected to the venting ring of FIG. 63. [Figure 64] FIG. 10 is a perspective view of a decoupling structure including a connector that engages the exterior of the vent ring according to another embodiment. [Figure 65] 10 is a perspective view of a separation structure including a connector for engaging within a vent ring according to another embodiment. FIG. [Figure 66] 66 is a perspective view of another example vent ring for engaging with the separation structure of FIG. 64 or FIG. 65. [Figure 66-1] 67 is a perspective view of the decoupling structure of FIG. 64 connected to the vent ring of FIG. 66. FIG. [Figure 66-2] 67 is a perspective view of the decoupling structure of FIG. 65 connected to the venting ring of FIG. 66. FIG. [Figure 66-3]A cross-sectional view of the decoupling structure and vent ring of Figure 66-2 coupled to a plenum chamber. [Figure 67] 10 is a perspective view of a separation structure including a connector for engaging the exterior of the vent ring according to another embodiment. FIG. [Figure 68] 68 is a perspective view of another example vent ring for engaging with the separation structure of FIG. 67. FIG. [Figure 69] 69 is a perspective view of the isolation structure of FIG. 67 connected to the venting ring of FIG. 68, showing the arms connected to the isolation structure of the venting ring. [Figure 69-1] 69 is a perspective view of the isolation structure of FIG. 67 connected to the venting ring of FIG. 68, showing the arms of the isolation structure separated from the venting ring. [Figure 70] FIG. 70 is a cross-sectional view of the decoupling structure and vent ring of FIG. 69 coupled to a plenum chamber. [Figure 71] FIG. 10 is a perspective view of another form of elbow connector that connects to a plenum chamber and is spaced apart from the surface of the plenum chamber when fully connected. [Figure 71-1] FIG. 72 is a cross-sectional view of the elbow connector and plenum chamber of FIG. 71. [Figure 72] FIG. 10 is a side perspective view of another form of elbow connector including chevrons. [Figure 73] FIG. 73 is a front perspective view of the elbow connector of FIG. 72. [Figure 73-1] FIG. 74 is a cross-sectional view of the elbow connector of FIG. 73 coupled to a plenum chamber. [Figure 74] FIG. 10 is a perspective view of another form of elbow connector having fewer vent holes. [Figure 75] FIG. 75 is a perspective view of a rotary joint for use with the elbow connector of FIG. 74, showing the vent holes. DETAILED DESCRIPTION OF THE INVENTION

[0147] Before describing the present technology in further detail, it is to be understood that the present technology is not limited to particular examples described herein, as such examples may vary, and it is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0148] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute an additional example.

[0149] When anatomical directional terms such as "anterior," "posterior," "superior," etc. are used in describing aspects and examples of the present technology, these directions are to be read in relation to the technology as it will be used by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is anterior to the patient when the patient is wearing the interface in its intended manner.

[0150] When a surface or portion is described as facing in a certain direction, e.g., "upward-facing," "forward-facing," etc., it is understood that the surface or portion faces at least partially in the particular direction, unless the context clearly indicates otherwise. A portion can be "upward-facing" if it faces generally upward, even if it faces partially in another direction.

[0151] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0152] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0153] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0154] 5.2 Respiratory Therapy Systems In one form, the present technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0155] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes, as functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of 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 seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway to maintain positive pressure at the entrance to the patient's 1000 airway. As such, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0156] In some examples of the present technology, the plenum chamber is formed at least in part by the shell 3250. In examples, the shell 3250 or a portion of the shell 3250 may be somewhat flexible, as described further below.

[0157] The patient interface in some examples of the present technology is an oronasal patient interface, i.e., the patient interface is configured to seal against both the patient's nasal and oral airways, hi some examples, the patient interface includes separate seals around each of the nasal and oral airways.

[0158] In the examples shown in Figures 7-22, the nasal seal-forming structure does not rest on the bridge or ridge areas of the patient's face, but instead seals against the underside of the patient's nose.

[0159] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0160] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0161] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0162] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0163] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may also provide a cushioning function. The target seal-forming area is the area where sealing may occur in the seal-forming structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) may vary from patient to patient during a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0164] As described in more detail below, in certain forms of the invention, the seal-forming structure 3100 includes a first seal-forming structure 3101 connected to the mouth portion 3201 of the plenum chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's mouth, and a second seal-forming structure 3102 connected to the nose portion 3202 of the plenum chamber 3200 and constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's nose. As used herein, the phrase "connected to" is used to refer to parts or components that are formed as a single piece, as well as parts or components that are formed separately and then joined. In some cases, components may be connected by an intermediate component.

[0165] In certain configurations, the first seal-forming structure 3101 seals against the patient's face independently of the second seal-forming structure 3102.

[0166] In certain configurations, the first seal-forming structure 3101 and the second seal-forming structure 3102 cooperate to form a single common seal against the patient's face.

[0167] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0168] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0169] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0170] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0171] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure in the plenum chamber 3200 acting thereunder to form a tight, sealing engagement with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0172] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the periphery. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use. Limiting the occurrence of buckling can limit the formation of wrinkles in the seal-forming structure 3100, which can lead to leakage and loss of treatment pressure.

[0173] In one form, the seal-forming structure 3100 may include a compressive or gasket sealing portion that is constructed and arranged to be in a compressed state in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0174] In one form, the seal-forming structure 3100 includes a tension section that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0175] In one form, the seal-forming structure 3100 includes an area having a sticky or adhesive surface.

[0176] In certain forms of the present technology, the seal-forming structure 3100 may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or adhesive surface.

[0177] 5.3.1.2 Nasal area 7-18 , in certain forms of the present technology, the second seal-forming structure 3102 includes a central portion 3110 configured to seal against the surface of the patient's nose in use. The central portion may seal against the lower rim of the patient's nose (e.g., around the patient's nostrils) and the patient's upper lip. In some examples, a portion of the seal-forming structure may engage the patient's nasal septum. The second seal-forming structure 3102 may further include lateral portions 3111 lateral to the central portion 3110. In some examples, the seal-forming structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the tip of the nose.

[0178] As can be best seen in Figures 10 and 16-19, the rear surfaces 3112 of the side portions 3111 are angled upward / forward from the boundary 3103 of the first and second seal-forming structures 3101, 3102 such that, in profile, the rear of the nose portion of the mask is angled forward.

[0179] In embodiments including ridges 3120 (as described further below), the rear surfaces 3112 of the side portions 3111 may slope forward from the ridges 3120.

[0180] In some forms of the present technology, the posterior surfaces 3112 of the lateral portions 3111 form an angle with the central contact plane of the mask of between 20° and 90°. The central contact plane may be perpendicular to the sagittal plane and may extend substantially along the length of the ridges 3120 and chords 3210. This angle is measured clockwise in FIG. 16, but it can also be measured counterclockwise, so that the measured angle is the complement of the angle above (between 90° and 160°).

[0181] 16-3 to 16-5, the second seal-forming structure 3102 may be formed at different angles relative to the intermediate contact surface to allow patients with different sized noses to comfortably wear the patient interface 3000. As shown, the two independent angles of the second seal-forming structure 3102 may be altered with different sizes of the patient interface 3000 to provide a better fit for a wider range of patients.

[0182] The first angle 6056 may be measured from the mid-contact plane to a first seal axis 6060 extending along the upper boundary 3247 of the second front wall portion 3242 and intersecting the nasal opening 3135. In some embodiments, the average width may be between about 5 mm and about 15 mm. In some embodiments, the first angle 6056 may be between about 75° and about 125°. In some embodiments, the first angle 6056 may be between about 100° and about 110°. For example, FIG. 16-3 may include a first angle 6056-1 of about 108°, FIG. 16-4 may include a first angle 6056-2 of about 105°, and FIG. 16-5 may include a first angle 6056-3 of about 109°. As shown, the first angle 6056 is measured in a counterclockwise direction as shown in FIGS. 16-3 through 16-5. However, the first angle 6056 may be measured in a clockwise direction such that the measured angle is the complement of the angle described above.

[0183] The second angle 6064 may be measured from the mid-contact plane to a second seal axis 6068 extending along a surface of the second seal-forming structure 3102 configured to contact the patient and intersect with the nasal opening 3135. In some forms, the first angle 6056 may be between about 50° and about 150°. In some forms, the second angle 6064 may be between about 100° and about 145°. In some forms, the second angle 6064 may be between about 110° and about 130°. For example, FIG. 16-3 may include a second angle 6064-1 of about 127.5°, FIG. 16-4 may include a second angle 6064-2 of about 116.5°, and FIG. 16-5 may include a second angle 6064-3 of about 122°. As shown, the second angle 6064 is measured in the counterclockwise direction shown in Figures 16-3 through 16-51. However, the second angle 6064 may also be measured in the clockwise direction such that the measured angle is the complement of the angle described above.

[0184] The difference between the first angle 6056 and the second angle 6064 may define the slope of the second seal-forming structure 3102. As discussed above, in some embodiments, this difference may be between about 1° and about 110°. In some embodiments, the difference may be between about 5° and about 50°. In some embodiments, the difference may be between about 10° and about 20°. For example, FIG. 16-3 may include a difference of about 19.5°, FIG. 16-4 may include a difference of about 11.5°, and FIG. 16-5 may include a difference of about 13°. In some embodiments, the angle may be different but similar to the angle measured between the trailing surface 3112 and the intermediate contact surface.

[0185] The different angles shown in Figures 16-3-16-5 may correspond to patients with different nasolabial angles (see, e.g., Figure 2E). The patient interface 3000 shown in each of the three figures may represent a different size interface (e.g., small, medium, or large), each of which may comfortably fit patients within a range of nasolabial angles.

[0186] As shown in FIGS. 50 and 51 , the first angle 6056 and the second angle 6064 in FIGS. 16-3 through 16-5 may provide relief for patients with long nasal tips (e.g., a long distance between the nasal tip and the alar crest). For example, the second anterior wall portion 3242 may be spaced sufficiently from the second seal-forming structure 3102 so that contact between the patient's nares and the second seal-forming structure 3102 remains a sufficient distance from the second anterior wall 3242 to permit airflow. The distance 6072 may extend between the second anterior wall portion 3242 and the nasal opening 3135. The distance 6072 may be the shortest distance between the second anterior wall portion 3242 and the second seal-forming structure 3102, and this distance need not extend along the first axis 6060. As another example, the first distance 6072 may extend substantially along the first seal axis 6060. This allows the second seal-forming structure 3102 to extend in a forward direction without contacting the second front wall portion 3242 (for example, if the patient has a long nose tip).

[0187] As shown in FIG. 19, in some embodiments, the lateral portions 3111 are configured so that no part of the patient interface 3000 contacts the patient's alar apex points 1020 during use.

[0188] By configuring the lateral portions 3111 to be angled in this manner, a smaller portion of the nasal portion of the interface 3000 extends over the sides of the ala of the nose than some similar interfaces of the prior art. In some forms of the present technology, this reduces the portion of the ala that contacts the seal-forming structure 3100 relative to interfaces with lateral portions that slope back toward the patient's face, thereby reducing the percentage of the ala that can be deformed and occluded by the seal-forming structure 3100 when, for example, the patient sleeps on their side with the interface in contact with a pillow.

[0189] 5.3.1.3 Boundary between the mouth and nose regions 7, 8 and 16-18, in one form of the present technology, the interface between the first seal-forming structure 3101 and the second seal-forming structure 3102 forms or includes a corner or ridge 3120. In use, the corner or ridge 3120 can engage the patient's face above the upper lip and just below the nose.

[0190] In embodiments, the corner or ridge 3120 forms a sharper angle than the equivalent portion or area of ​​some prior art oral-nasal masks such as those described in the prior art, for example, International Application No. PCT / AU2019 / 050278.

[0191] The sharper angles reduce the likelihood of wrinkles forming in the first and / or second seal-forming structures 3101, 3102 on or adjacent the corners or ridges 3120 when the mask is donned and therapy is applied. Some oral-nasal patient interfaces that do not use such structures may require a very thin, rounded structure in this area, which may be less resistant to wrinkles. In contrast, the corners or ridges 3120 may be stiffer than such interfaces and may hold their shape better, thus better able to seal against depressions and wrinkles that exist around the patient's nose. This effect may be enhanced in embodiments that include supports that resist or oppose compression in this area, such as the support 3260 described herein.

[0192] In some forms of the technique, the radius of the corners or ridges 3120 may be less than 2 mm, for example about 1.75 mm. In one form of the technique, the radius may vary from about 1.75 mm in the center of the ridge to about 0.75 mm on the sides.

[0193] The angle formed by the first and second sealing structures may be between 20 degrees and 90 degrees, for example 36 degrees.

[0194] In some forms of the present technology, the horns or ridges 3120 can extend across substantially the entire boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102. In embodiments, the horns or ridges 3120 can engage the patient's face at least proximate the entrances to the nostrils, for example, where the ala of the nose connects with the face above the upper lip as shown by region 1010 in FIG.

[0195] 5.3.1.4 mouth area As mentioned above, in one form the non-invasive patient interface 3000 includes a first seal-forming structure 3101 which, in use, forms a seal in the mouth area of ​​the patient. The first seal-forming structure 3101 may form a seal over the chin area of ​​the patient's face.

[0196] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0197] The seal-forming structure 3100 includes a lower lip portion 3130 that forms a seal against the patient's chin area and / or the patient's lower lip and / or supramenton. The lower lip portion 3130 may be connected (e.g., continuous) with the upper lip portion 3131 via a mouth perimeter portion 3132, as shown in FIG.

[0198] The seal-forming structure 3100 includes a mouth hole perimeter 3132, a lower lip 3130 of the seal-forming structure that contacts the chin area, and a relatively thin wall thickness (compared to other portions of the interface) at least in the center of the lower lip 3130, e.g., less than 0.7 mm. The thin wall thickness in this area helps to achieve an effective and comfortable seal. The seal-forming structure in this region can easily conform to any complex shape.

[0199] In some forms of the present technology, the orifice portion 3133 is substantially trapezoidal, rather than oval or elliptical, to more closely correspond to the shape of the patient's nose. An orifice of this shape can make the interface 3000 particularly compact, allowing it to be no substantially wider than the width of the patient's nostrils.

[0200] 51, the patient's mouth may be spaced from the inlet port 3604 (and therefore may be spaced from the elbow 3500 and / or vent ring 3504, as shown in FIG. 50). This distance 6076 may be measured in a direction substantially parallel to the distance 6072. This distance 6076 provides sufficient clearance for the patient's lips, which extend into the cavity 3272 and are proximate the second seal-forming structure 3102. The patient may compress the second seal-forming structure 3102 slightly in a forward direction, and the distance 6076 may be large enough to prevent contact with the elbow 3500 and / or vent ring 3504. However, the distance 6076 need not be too large so that the patient interface 3000 maintains a compact profile.

[0201] Additionally, as shown in FIG. 50-1 , the vent ring 3504 (described in more detail below) may include an offset to create additional spacing between the elbow 3500 and the first seal-forming structure 3101 (and, consequently, the patient's lips). The vent ring 3504 may include an offset 3506 (described below) that spaces the elbow 3500 away from the cavity 3272 of the plenum chamber 3200. For example, as shown in FIG. 57 , the elbow 3500 contacts the front surface 3512 of the vent ring 3504 and extends beyond the rear surface 3508 of the plenum chamber 3200. This allows for a more compact design (e.g., by minimizing forward extension away from the patient's face), but the elbow 3500 extends a distance 6076. In other words, the distance 6076 (measured in FIG. 51 ) is no longer the maximum distance of spacing between the patient's lips and the front of the patient interface 3000. Applying the offset 3506 can increase the distance that the patient interface 3000 extends forward of the patient's face, but can also move the elbow 3500 away from the patient's lips such that the distance 6076 maintains the maximum forward separation between the patient's lips and the patient interface 3000.

[0202] 5.3.1.5 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0203] Nasal pillows according to one aspect of the present technology include a frustum cone, at least a portion of which forms a seal under the patient's nose, a handle, and a flexible region below the frustum cone that connects the frustum to the handle. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the handle. The flexible regions can work together to facilitate a universal joint structure that accommodates relative movement (both displacement and angle) between the frustum cone and the structure to which the nasal pillows are connected. For example, the frustum cone can be displaced axially toward the structure to which the handle is connected.

[0204] 5.3.2 Plenum chamber In some forms, the plenum chamber 3200 (or at least a portion of the plenum chamber 3200) and the seal-forming structure 3100 are formed from a single homogenous piece of material (e.g., molded silicone). The combination of the seal-forming structure 3100 and the plenum chamber 3200 can be considered a cushion.

[0205] 5.3.2.1 Adjustable nose angle 9, 10 and 16-18-2, in one form of the present technology, a first anterior wall 3240 of the nose portion 3202 of the plenum chamber 3200 is more flexible than the area immediately adjacent the mouth portion 3201. The first anterior wall 3240 may be provided adjacent the boundary 3241 of the nose and mouth portions of the plenum chamber 3200. In embodiments, the first anterior wall 3240 may be symmetrical about the midsagittal plane and may extend across at least 50%, such as at least 80%, of the width of the nose portion 3202 of the plenum chamber. In some embodiments, the first anterior wall 3240 may extend across substantially the entire width of the nose portion 3202 of the plenum chamber.

[0206] In some forms of the present technology, the second anterior wall portion 3242 is less flexible than the immediately adjacent portion of the anterior wall. In some embodiments, the second anterior wall portion 3242 is immediately adjacent to the first anterior wall portion 3240 on the opposite side from the boundary 3241 of the nose and mouth of the plenum chamber. In embodiments, the second anterior wall portion 3242 may be symmetrical about the midsagittal plane and may extend across at least 50%, such as at least 80%, of the width of the nose portion 3202 of the plenum chamber. In some embodiments, the second anterior wall portion 3242 may extend across substantially the entire width of the nose portion 3202 of the plenum chamber.

[0207] The flexible first front wall portion 3240 may allow the patient-contacting portion 3110 of the second seal-forming structure 3102 to pivot or hinge about a posterior region of the interface 3000. This may help to allow the interface to accommodate patients with various angles between the bottom of the nose and the upper lip (i.e., nasolabial angles).

[0208] As discussed above, in embodiments featuring a corner or ridge 3120 between the first seal-forming structure 3101 and the second seal-forming structure 3102, the patient-contacting portion 3110 may pivot or hinge about an area at or adjacent the corner or ridge 3120. In embodiments providing one or more supports 3260 (described further below), the hinge or pivot area may be directly above the supports 3260.

[0209] 9, the first front wall portion 3240 may have an upper boundary 3243 and a lower boundary 3244. One or both of the upper and lower boundaries 3243, 3244 may be curved, for example, as shown, such that the central portion of the boundary is lower than the lateral portions. The first front wall portion 3240 may be of substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across its width, such that the central portion of the first front wall portion 3240 is higher than the lateral portions, for example, as shown in the embodiment of FIG. 9. Varying the curvature of one or both of the boundaries 3243, 3244 and / or the height of the first front wall portion 3240 can vary the stiffness of the first front wall portion 3240, i.e., its resistance to collapsing or folding in response to a force against the patient-contacting portion 3110 of the second seal-forming structure 3102.

[0210] Similarly, the second front wall 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of the present technology, the lower boundary 3248 of the second front wall 3242 is the same as the upper boundary 3243 of the first front wall 3240. Both the upper and lower boundaries 3247, 3248 of the second front wall 3242 may be curved, for example, such that the central portion of the boundary is lower than the lateral portions. The second front wall 3242 may be of substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across its width such that the height of the central portion of the second front wall 3242 is lower than the height of the lateral portions.

[0211] In some forms of the present technology, other methods of configuring the first front wall portion 3240 to have the required stiffness may be used in addition to or instead of a curved boundary. For example, the thickness of the first front wall portion 3240 may be selected to provide the required stiffness. In some examples, the first front wall portion 3240 may be thinner than the portion immediately adjacent the plenum chamber wall. Additionally and / or alternatively, the first front wall portion 3240 may extend upwardly around the lateral edges of the second front wall portion 3242, as shown in FIG. 21 , thereby providing reduced stiffness / resistance to compression or collapse compared to embodiments in which the first front wall portion 3240 is not so formed.

[0212] The second front wall portion 3242 (e.g., band 3270) may help prevent collapse of the nose portion 3202 and may provide support to the patient-contacting portion 3110 of the second seal-forming structure 3102, which is typically relatively thin. Insufficient support in the patient-contacting portion may result in leakage in the sealing engagement with the patient's face. In one form, the second front wall portion 3242 is thicker than the portion immediately adjacent the plenum chamber wall. In certain forms, the second front wall portion 3242 is provided as a thickened band 3270 of material, as shown in FIGS. 16-19. The first and second front walls 3240, 3242 may be made from the same material, for example, as part of an integrally molded shell 3250.

[0213] In some forms, the first and second anterior wall portions 3240, 3242 may include different thicknesses. For example, the thickness of the second anterior wall portion 3242 may be greater than the thickness of the first anterior wall portion 3240, thereby providing the second anterior wall portion 3242 with increased rigidity (e.g., compared to the first anterior wall portion 3240). Specifically, the second anterior wall portion 3242 may be a band 3270 that may extend into a cavity 3272 of the plenum chamber 3200. For example, the band 3270 may extend beyond the first anterior wall portion 3240 and extend toward a patient wearing the patient interface 3000. The outer surface of the nose portion 3202 may be substantially smooth, while the inner surface of the nose portion (e.g., within the cavity 3272) may be stepped (or otherwise include discontinuities).

[0214] As shown in FIGS. 16-1 and 16-2 , the first anterior wall portion 3240 may act as a hinge, allowing the nasal portion 3202 to bend. The first anterior wall portion 3240 may be the thinnest region of the nasal portion 3202 and therefore may be most susceptible to bending moments. The increased thickness of the band 3270 directs the bending moment away from the second anterior wall portion 3242 and toward the thinner first anterior wall portion 3240. A greater height of the band 3270 (i.e., a greater distance between the upper boundary 3247 and the lower boundary 3248) may also make the nasal portion 3202 stiffer and less likely to bend relative to the first anterior wall portion 3240. The first and second anterior walls 3240, 3242 may move in an anterior direction (e.g., away from the patient) when bending occurs.

[0215] As shown in FIGS. 18-1 and 18-2 , the upper boundary 3243 of the first front wall portion 3240 is not the same as the lower boundary 3248 of the second front wall portion 3242. Instead, the upper boundary 3243 may be at least partially above the lower boundary 3248 and 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 at least partially aligned with the band 3270 (e.g., surrounding the band 3270 on two or more sides). In other words, the first front wall portion 3240 may be disposed on at least one of both ends of the band 3270. This may provide greater flexibility to the first front wall portion 3240, allowing the nose portion 3202 to bend further (e.g., forward).

[0216] 21-1, the nasal portion 3202 may be formed without a hinge. In other words, a band may not be formed in the second anterior wall portion 3242, such that the first and second anterior wall portions 3240, 3242 have a substantially uniform thickness. The nasal portion 3202 may be constructed from silicone that allows the nasal portion 3202 some compliance to accommodate different nasolabial angles, so that it can still bend without a band.

[0217] 5.3.2.2 Flexible shell In some forms of the present technology, the shell 3250 may be made from a rigid material such as polycarbonate. However, in other forms of the present technology, the shell 3250 or portions of the shell 3250 may be somewhat flexible. For example, in various instances, the shell 3250 may be formed from a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the present technology, the shell 3250 may be formed from a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the present technology, the shell 3250 may be formed from a material having a Young's modulus of 0.7 MPa or less, for example, between 0.7 MPa and 0.3 MPa. One example of such a material is silicone.

[0218] In examples, the shell 3250 and one or both of the first and second seal-forming structures 3101, 3102 may be formed from the same material (eg, silicone, fabric, etc.).

[0219]

[00130] In some forms of the present technology (see, e.g., FIGS. 23-28), the shell 3250 may be constructed substantially entirely from a flexible material, which may provide the shell 3250 with maximum freedom of movement (i.e., substantially no rigid and / or thickened portions that restrict bending). The shell 3250 may be sufficiently flexible that one or more components are added to provide the necessary rigidity in one or more areas or regions of the shell 3250 (e.g., areas in contact with area 1010). For example, one or more of the ventilation module, connection port, headgear connector, stiffening arm, and headgear connector connected to a stiffening member may be connected to the shell 3250 in a manner that increases the stiffness of the plenum chamber 3200 in areas adjacent the component, e.g., as described further below. In some forms of the present technology, such components may be removably connected to the flexible shell 3250. Additionally or alternatively, one or more components may be permanently connected to the shell 3250, for example, by adhesive bonding and / or overmolding. The stiffening member may also serve to increase the stiffness and / or provide geometric support to the seal-forming structure 3100 .

[0220] In some forms of the present technology, the shell 3250 may be generally flexible, but may include stiffening portions having a greater thickness than immediately adjacent portions of the shell 3250. Such stiffening portions may be configured, for example, as ribs or bands extending laterally and / or upwardly-downwardly across the shell, although many other configurations are possible. In some forms, the shell may include a substantially rigid portion, for example made from polycarbonate, and a somewhat flexible portion.

[0221] In some forms of the present technology, it may be preferable for the front central portion 3251 of the mouth 3201 of the plenum chamber to have a higher stiffness than the remainder of the plenum chamber 3200. In some forms of the present technology, the region of increased stiffness may be just below the nose portion 3202 and / or just above the mouth 3201, as shown in FIG. 21 and described further below. In one form of the present technology, part or all of the first front wall portion 3240 may be a region of increased stiffness rather than a region of increased flexibility. Providing increased stiffness in one or more of these regions may provide shape stability and limit the extent to which the shell 3250 deforms as a result of headgear forces. Excessive deformation may result in the second seal-forming structure 3102 occluding the nares. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important or possibly undesirable for patients with narrow noses. Additionally, the described areas of increased stiffness can help reduce torsional deformation of the interface that could otherwise result in one side of the second seal-forming structure 3102 losing contact with the patient's nose, thereby creating a leak path.

[0222] 21 and 21-1, in one form of the present technology, the shell 3250 may include a rigid section 3263, or at least a section that is more rigid than the remainder of the shell, in which one or more connection ports 3600 are provided, for example, molded in. In one form of the present technology, the rigid section 3263 may be made from polycarbonate, which can provide more rigidity than a shell made solely from silicone. In one form of the present technology, holes that form the vent section 3400 are molded into the rigid section 3263. In some forms of the present technology, the connector 3310 for the positioning and stabilizing structure is attached to an arm 3320 that provides some rigidity to the shell.

[0223] In one form of the present technology, the rigid portion 3263 extends transversely to the front of the plenum chamber, for example near the upper boundary of the first front wall portion 3240 just below the second front wall portion 3242. The rigid portion 3263 may extend continuously between the connection ports 3600 and may provide an airflow path for the flow of pressurized air entering the plenum chamber 3200 through the connection ports 3600.

[0224] In some forms of the present technology, the connection ports 3600 may have a substantially oval cross-sectional shape. The connection ports 3600 may be oriented such that the centerline of each port is substantially parallel to the outer surface of the plenum chamber adjacent the port.

[0225] In some forms of the present technology, the stiff portion 3263 may protrude forward relative to an adjacent surface of the first front wall portion 3240 and may be shaped to increase resistance to bending.

[0226] In some forms of the present technology (see, for example, FIG. 21 ), the connector 3310 and arm 3320 are provided below the connection port 3600, towards the lateral end of the plenum chamber 3200. The connector 3310 may be provided at a lateral end of the arm 3320. The connector 3310 may provide additional rigidity to the plenum chamber 3200 and / or the seal-forming structure 3100.

[0227] In some forms of the present technology (see, for example, FIG. 21-1), the connector 3310 does not include the arms 3320, but instead connects directly to the plenum chamber 3200. This may allow the plenum chamber 3200 to be more flexible than the plenum chamber 3200 of FIG.

[0228] 22 shows a plenum chamber 3200 having a vent mounting opening 3410 into which a suitable vent or module may be inserted. The vent may be made from a relatively rigid material to increase the rigidity of the plenum chamber. In some forms of the present technology, the vent mounting opening 3410 may be substantially elliptical, with the minor axis of the ellipse being substantially parallel to the sagittal plane.

[0229] In the embodiment shown in FIG. 22, the vent mounting opening is located towards the upper boundary of the mouth 3201 of the plenum chamber 3200.

[0230] 22 includes a connector 3310 for the positioning and stabilizing structure. The connector 3310 may be attached to a relatively thick region of the shell 3250. In the illustrated embodiment, the connector 3310 is below the vent mounting opening 3410 and faces the lateral surface of the plenum chamber 3200. In some forms of the present technology, the connector 3310 is a substantially circular magnetic headgear connector.

[0231] Although the drawings of the plenum chamber shown in Figures 7-19 do not show inlet or connection ports, one skilled in the art will understand that in practice one or more inlet ports will be provided, such as inlet port 3600 as shown in Figures 21-22. The inlet port 3600 allows for connection of an interface to an air circuit 4170, as described further herein. In some forms of the present technology, one or more components of the air circuit 4170 may also function as components of the positioning and stabilizing structure.

[0232] 24, some forms of the patient interface 3000 may include a single inlet port 3604. The inlet port 3604 may be substantially circular and may be centered at the mouth 3201 of the plenum chamber 3200.

[0233] As shown in FIG. 57, the inlet port 3604 may include a lip 3608 that extends around at least a portion of the periphery of the inlet port 3604 (see, e.g., FIG. 49). For example, the lip 3608 may extend around the entire circumference of a circular inlet port 3604. The lip 3608 may extend into the cavity 3272 (see, e.g., FIG. 18-1). The lip 3608 may be angled relative to the periphery of the inlet port 3604.

[0234] In some forms, the lip 3608 is approximately perpendicular to the periphery of the inlet port such that the diameter of the inlet port 3604 is approximately equal to the diameter of the opening formed by the lip 3608 in the cavity 3272. In other words, the lip 3608 can extend substantially parallel to a port axis 3612 that extends through the inlet port 3604.

[0235] In other embodiments, the lip 3608 is angled between about 1° and about 60° relative to the port axis 3612. In some embodiments, the lip 3608 is angled between about 2° and about 50° relative to the port axis 3612. In some embodiments, the lip 3608 is angled between about 5° and about 30° relative to the port axis 3612. In some embodiments, the lip 3608 is angled between about 10° and about 15° relative to the port axis 3612.

[0236] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0237] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material (e.g., translucent silicone). The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0238] In certain forms of the present technology, dedicated reinforcing or stiffening members (e.g., having no other function) may be included on the plenum chamber 3200. These members may be formed from a material that is more rigid (e.g., more rigid than silicone) than the plenum chamber 3200. The dedicated stiffening members may be overmolded onto the plenum chamber 3200 to provide greater stiffness than the shell 3250 or rigid portion 3263 of the arm 3320.

[0239] 5.3.3 Support part 12 and 14-18, in one form of the present technology, supports 3260 are provided on opposite sides of the interface 3000 between the second seal-forming structure 3102 and the front wall of the plenum chamber 3200. As shown in FIG. 12, in one example, each support 3260 extends to a lateral edge of the interface.

[0240] The support portion 3260 does not function as an undercushion, but instead is configured to resist or impede anterior-posterior compression. The support portion 3260 thereby supports and / or stiffens the portion of the second seal-forming structure 3102 that engages the patient's upper lip. In particular, the support portion 3260 may support and / or stiffen a region of the second seal-forming structure 3102 that may contact a region 1010 of the patient's face proximate the entrances to the nostrils where the ala of the nose meets the region above the upper lip, as shown in FIG. 20 . In other words, the region 1010 may be directly beneath each of the lower corners of the patient's nose.

[0241] The support portion 3260 helps ensure that the seal-forming structure 3100 does not wrinkle. A very flexible seal-forming structure with a large radius of curvature may conform to the patient's face, resulting in wrinkles in the seal-forming structure. If the seal-forming structure is too flexible, it may fold or wrinkle on itself, potentially leading to leakage of the seal-forming structure. Wrinkling may be of particular concern when the seal-forming structure seals against the area 1010 of the patient's face. The support portion 3260 may be particularly advantageous when the seal-forming structure is configured to form corners and / or ridges 3120, as described herein. The corners and / or ridges 3120 may have sharper curves (e.g., curves with a lower radius of curvature) compared to a seal-forming structure without the support portion 3260. The support and / or rigidity added by the support portion 3260 reduces the ability of the second seal-forming structure 3102 to conform to the patient's face. To maintain patient comfort, the corners and / or ridges 3120 are selected and / or sized to substantially match the shape (e.g., contours) of the patient's face. For example, the seal-forming structure 3100 for a particular patient may be selected from a variety of sizes to substantially fit the alar region (i.e., proximate region 1010). A sharper curvature allows the second seal-forming structure 3102 to seal various gaps around the patient's nose, reducing the likelihood of wrinkles forming.

[0242] 14-16 , in one form of the present technology, the support portion 3260 is connected to the anterior side of the mouth portion 3201 of the plenum chamber, adjacent the boundary 3241 between the mouth portion 3201 and the nasal portion 3202. In some embodiments, the support portion 3260 may be curved when viewed in a cross section parallel to the sagittal plane (as shown in FIGS. 16-18 ) and / or when viewed in a cross section parallel to the frontal plane (as shown in FIGS. 14 and 15 ). The curvature may be positive or negative. In the illustrated example, the curvature may be negative (e.g., relative to the patient's nose). In some examples, the sidewalls 3245 of the plenum chamber 3200 may curve inward adjacent the boundary 3241 with the nasal portion 3202, and the support portion 3260 may be substantially continuous with the adjacent sidewalls 3245. 18 , when viewed in cross section parallel to the sagittal plane, at least a portion of the support portion 3260 may decrease in thickness between a first end 3261 adjacent the front wall of the plenum chamber 3200 and a second end 3262 adjacent the seal-forming structure 3100. For example, the support portion 3260 may be thicker adjacent the first end 3261, which can help provide increased support and / or rigidity to the second seal-forming structure 3102. In some examples, the support portion 3260 may vary between a thickness of 0.1 mm (e.g., adjacent the second end 3262) and a thickness of 3.5 mm (e.g., adjacent the first end 3261). In some examples, the support portion 3260 may vary between a thickness of 0.3 mm (e.g., adjacent the second end 3262) and a thickness of 3 mm (e.g., adjacent the first end 3261). In some examples, the support portion 3260 may vary between 1.3 mm thick (eg, near the second end 3262) and 2.5 mm thick (eg, near the first end 3261).

[0243] Support portions 3260 having different shapes may be used for different patients. For example, a patient needing more support and / or rigidity in the second seal-forming structure 3102 may use a seal-forming structure 3100 having a thicker (e.g., proximate the first end 3261 and / or at any location along the length) and / or more curved (e.g., with a lower radius of curvature) support portion 3260. For example, a patient desiring a more flexible second seal-forming structure 3102 may use a seal-forming structure 3100 having a thinner (e.g., proximate the first end 3261 and / or at any location along the length) and / or less curved (e.g., with a larger radius of curvature) support portion 3260.

[0244] 14 and 15, in one form of the present technology, the support portion 3260 is connected to the mouth 3201 of the plenum chamber adjacent the boundary of the side wall 3245 of the mouth portion 3201 and the side wall 3246 of the nose portion 3202.

[0245] In some forms of the present technology, the supports 3260 are shaped to provide a substantially clear flow path from the mouth 3201 of the plenum chamber to the nasal opening(s) 3135 during inspiration. In some forms of the present technology, no part of any of the supports 3260 is directly under the nasal opening(s) 3135.

[0246] 5.3.4 Overtightened Support 43-45, the patient interface 3000 may include a stopper rib 6040 within the cavity 3272 of the plenum chamber 3200. The stopper rib 6040 may be disposed within the mouth 3201 of the plenum chamber 3200 to provide support around the patient's oral cavity. The stopper rib 6040 may be formed integrally with the plenum chamber 3200 (e.g., during the same molding process) such that it is integrally formed with the remainder of the plenum chamber 3200.

[0247] As shown in Figure 43, the patient interface 3000 may include a plurality of stopper ribs 6040 that extend at least partially around the mouth 3201 of the plenum chamber 3200 and the first seal-forming structure 3101. As shown in Figure 43, the stopper ribs 6040 may extend only partially around the patient interface 3000 (e.g., in a C- or U-shape), and the stopper ribs 6040 may not be located near (e.g., immediately before) the upper lip 3131. In other forms, the stopper ribs 6040 may extend around the entire mouth 3201 and first seal-forming structure 3101, or may extend around portions of the mouth 3201 and first seal-forming structure 3101 not shown in Figure 43.

[0248] 43 , the stopper ribs 6040 are spaced apart from one another so that they do not contact any other stopper ribs 6040. In some forms, the stopper ribs 6040 may be evenly spaced such that there is an equal distance between each adjacent pair of stopper ribs 6040. In other forms, the stopper ribs 6040 may be unevenly spaced such that at least some of one pair of stopper ribs 6040 are closer together than the other stopper ribs. For example, the stopper ribs 6040 may be closer together in locations that contact areas of the patient's face suitable for receiving force (e.g., near the nasolabial folds).

[0249] As shown in FIGS. 44-45-11, the stopper ribs 6040 may be elongated members extending from the inner surface of the plenum chamber 3200 toward the seal-forming structure 3100. The stopper ribs 6040 may be connected to the mouth 3201 of the plenum chamber 3200 and may be at least partially spaced apart from the first seal-forming structure 3101 in the resting or non-use position. For example, the edge 6042 (e.g., trailing edge) of each stopper rib 6040 may be sloped (e.g., not perpendicular to the front-to-rear direction), thereby providing additional spacing between the stopper rib 6040 and the first seal-forming structure 3101 in the non-use position.

[0250] During use, the patient's face contacts the seal-forming structure 3100, pushing the first seal-forming structure 3101 forward. Because each patient can individually tighten the headgear straps 3354 (described in more detail below), a patient may overtighten the headgear straps 3354, causing the seal-forming structure 3100 to press too hard against the patient's face. If an overly tight seal-forming structure 3100 folds or wrinkles, allowing pressurized air to escape from the plenum chamber 3200, this may cause discomfort to the patient and / or reduce the quality of the seal. To limit the occurrence of overtightening, the stopper rib 6040 is spaced from the first seal-forming structure 3101 to allow only a predetermined amount of forward movement. For example, the first seal-forming structure 3101 contacts each stopper rib 6040 at an edge 6042 along its width (e.g., a narrow width measured substantially parallel to the first seal-forming structure 3101). Because the length of the stopper rib 6040 is greater than its width, the stopper rib 6040 acts as a stiffening member, limiting the total distance the first seal-forming structure 3101 can travel. The stopper rib 6040 may be thicker than the first seal-forming structure 3101 in either direction. The stopper rib 6040 may be dimensioned to allow the patient to tighten the headgear straps 3354 to a predetermined point to form a desired seal, but not beyond that point to minimize discomfort and / or seal degradation. The slope of the edge 6042 may allow enough space for the patient's face to fit comfortably within the plenum chamber 3200, while limiting excess space (e.g., which could result in overtightening) and providing support for the patient's face. The stopper rib 6040 may include a curvature along its width (see, e.g., FIG. 45-1).

[0251] Additionally, each stopper rib 6040 may extend more than halfway (e.g., two-thirds, three-quarters, etc.) along the length of the first seal-forming structure 3101. This helps to ensure that movement is restricted along substantially all of the first seal-forming structure 3101.

[0252] 47-49, the patient interface 3000 may include a reinforced region 6044 within the cavity 3272 of the plenum chamber 3200. The reinforced region 6044 may be disposed within the mouth 3201 of the plenum chamber 3200 to provide support around the patient's mouth. The reinforced region 6044 may be formed integrally with the plenum chamber 3200 (e.g., in the same molding process) such that it is integrally formed with the remainder of the plenum chamber 3200.

[0253] The reinforced region 6044 may be formed on the front surface 6046 of the plenum chamber 3200 within the cavity 3272 and adjacent to the sides of the mouth 3201. The reinforced region 6044 may be located directly in front of the patient when the patient interface 3000 is worn. The reinforced region 6044 may be substantially symmetrical on either side of the mouth 3201 and may extend around the side regions 6048 of the plenum chamber 3200.

[0254] 47, the reinforced region 6044 may be substantially the same height as the inlet port 3604. In other words, the reinforced region 6044 may extend substantially along the length of the mouth 3201 of the plenum chamber 3200. In some forms, the thickness may vary along the reinforced region 6044. For example, the reinforced region 6044 may be thicker near the inlet port 3604 and thinner distal to the inlet port 3604 (or vice versa). In other examples, the reinforced region 6044 may be thicker near the bottom of the mouth 3201 and thinner near the top of the mouth 3201 (e.g., near the nose 3202), or vice versa.

[0255] As shown in FIG. 47-1, the reinforced region 6044 in some embodiments may be about 0.01 mm to about 10 mm thicker than the surrounding non-reinforced regions. In some embodiments, the reinforced region 6044 may be about 0.1 mm to about 5 mm thicker than the surrounding non-reinforced regions. In some embodiments, the reinforced region 6044 may be about 1 mm to about 2 mm thicker than the surrounding non-reinforced regions. In some embodiments, the reinforced region 6044 may be about 1.8 mm thicker than the surrounding non-reinforced regions. In some embodiments, this may be a constant thickness throughout the reinforced region 6044, or in other instances, this may be a maximum throughout the variable thickness of the reinforced region 6044.

[0256] As shown in Figures 48 and 49, alternative configurations of the reinforced regions 6044 may be smaller than the reinforced regions shown in Figure 47. Alternatively, the reinforced regions may be located near the bottom of the mouth 3201 of the plenum chamber 3200. The reinforced regions 6044 may extend in a diagonal direction. For example, each reinforced region 6044 may be angled upward or downward such that the reinforced regions closer to the inlet port 3604 are superior to the reinforced regions further from the inlet port 3604.

[0257] 48 and some forms of the reinforced region 6044 in FIG. 49 may extend only along the front surface 6046 of the cavity 3272, or may extend along the lateral regions 6048 of the plenum chamber 3200. In use, the reinforced region 6044 may be placed directly in front of the patient's face. As shown in FIG. 49, the reinforced region 6044 may extend up to (e.g., adjacent to or in contact with) the lateral regions 6048, but may not extend around the lateral regions 6048.

[0258] As shown in Figure 48, the thickness of the reinforced region 6044 may vary along its surface. For example, the reinforced region 6044 may be thicker near the center and thinner near the sides, although in other examples, the reverse may be true. In some forms, the reinforced region 6044 may be stepped so that there is no gradual transition between the thicker and thinner portions. In other examples, the transition may be gradual.

[0259] When the patient interface 3000 of FIGS. 47-49 is used, the patient's face contacts the seal-forming structure 3100, pushing the first seal-forming structure 3101 forward. Because each patient can individually tighten the headgear straps 3354 (described in more detail below), a patient may overtighten the headgear straps 3354, causing the seal-forming structure 3100 to press too hard against the patient's face. If an overly tight seal-forming structure 3100 folds or wrinkles, allowing pressurized air to escape from the plenum chamber 3200, this may cause discomfort to the patient and / or reduce the quality of the seal. To limit the occurrence of overtightening, the reinforced region 6044 is spaced from the first seal-forming structure 3101 to only allow a predetermined amount of forward movement. For example, the reinforced region 6044 limits forward compression of the first seal-forming structure 3101. The reinforced regions 6044 can function similarly to the stop ribs 6040 and can limit the total distance the first seal-forming structure 3101 can travel. However, the reinforced regions 6044 do not provide a stop and may instead limit compression because thicker regions require more force to compress. The reinforced regions 6044 may be sized to allow the patient to tighten the headgear straps 3354 to a predetermined point to form the desired seal, but not beyond this point to minimize discomfort and / or seal degradation.

[0260] 5.3.5 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealing position during use by a positioning and stabilizing structure 3300.

[0261] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure of the plenum chamber 3200 separating it from the face.

[0262] In one form, the positioning and stabilising structure 3300 provides a holding force sufficient to overcome the effects of attractive forces on the patient interface 3000.

[0263] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0264] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0265] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0266] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0267] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling does not resist compression and can be a flexible or pliable strap, for example. The decoupling is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0268] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0269] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0270] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point on the patient's head, covering a portion of the parietal bone without covering the occipital bone.

[0271] In one form of the present technology, suitable for a nasal-only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base of the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0272] In one form of the present technology suitable for a nasal or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first and second ties in a manner that reduces the tendency of the first and second ties to move away from one another.

[0273] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient is lying down while sleeping.

[0274] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0275] In certain forms of the present technology, a system is provided that includes multiple positioning and stabilizing structures 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large head sizes but not for small head sizes, and another form of positioning and stabilizing structure 3300 that is suitable for small heads but not for large heads.

[0276] 21 and 22 show an embodiment provided with a connector 3310, for example a magnetic connector, for connection to a positioning and stabilizing structure.

[0277] In some forms, the straps of the positioning and stabilizing structure 3300 may be constructed of a stretchable (e.g., elastic) material. The positioning and stabilizing structure 3300 may stretch to accommodate patients with different head sizes.

[0278] In some forms, the straps of the positioning and stabilizing structure 3300 may be at least partially constructed of a non-stretchable material. This may limit the stretchability of the straps. Different size straps may be used for different size patients to accommodate different head sizes. The straps of the positioning and stabilizing structure 3300 may also be adjustable in length.

[0279] As shown in FIGS. 23-2, 24-1, 42-2, 55-1, and 56-11, certain forms of the positioning and stabilizing structure 3300 may include an upper strap 3357 that covers the parietal and / or frontal bones of a patient in use. The upper strap 3357 may be adjustable in length (e.g., using a buckle 3369) to accommodate different sized heads. Each patient can tighten or loosen the upper strap 3357 to fit their individual head. By tightening or loosening the strap, tension in the upper strap 3357 may be adjusted to provide comfort to the patient wearing the positioning and stabilizing structure 3300.

[0280] 5.3.5.1 Frame As shown in Figures 23-28-2, a frame 3350 is coupled to the plenum chamber 3200 and assists in maintaining a therapeutically effective position of the seal-forming structure 3100. While the plenum chamber 3200 shown in Figures 23-28-2 specifically depicts an elbow 3500 connected in front of the patient's face, the frame may be used with other types of plenum chambers 3200 (e.g., the plenum chamber 3200 of Figures 21-22 used with conduit headgear).

[0281] In some forms, the frame 3350 is constructed from a rigid or semi-rigid material and provides support to the seal-forming structure 3100 and / or plenum chamber 3200. For example, the frame 3350 can help maintain the shape of the seal-forming structure 3100 and / or plenum chamber 3200 to reduce leakage of pressurized air as a result of folding and / or wrinkling as the seal-forming structure 3100 engages the patient's face.

[0282] In some forms, the frame 3350 provides at least one connection point 3352 that may help indirectly connect the headgear strap 3354 to the plenum chamber 3200 and / or the seal-forming structure 3100. The connection point 3352 may be a loop (e.g., with a fully formed perimeter) that receives a portion of the headgear strap 3354. For example, a length of the upper left headgear strap 3356 may be threaded through a first loop 3352a and pulled away from the plenum chamber 3200 to apply tension through the upper left headgear strap 3356. The upper left headgear strap 3356 may be folded upon itself and held at a selected length (e.g., using Velcro, a magnet, adhesive, etc.) to maintain the applied tension. A similar process may be performed with respect to adjusting the tension of the upper right headgear strap 3358 in the second loop 3352b. In other forms, the connection point 3352 may include an open perimeter (e.g., U-shaped or C-shaped).

[0283] In some forms, each loop 3352a, 3352b may be oriented so that the force vector applied by the respective upper headgear strap 3356, 3358 is substantially perpendicular to the loop inner surface 3351 where the upper headgear straps 3356, 3358 contact. As shown in FIG. 23 , the right upper headgear strap 3358 engages the loop 3352b substantially in the center of the loop inner surface 3351. When the right upper headgear strap 3358 is tightened, the force vector is applied in a substantially linear direction rather than at an angle to the loop inner surface 3351. This may improve sealing of the seal-forming structure 3100 because the force is directed along the arm 3362 and not at an angle to the arm 3362, which may require the upper headgear straps 3356, 3358 to be tightened further to achieve the same sealing effect (e.g., to the detriment of patient comfort) and / or may prevent the seal-forming structure 3100 from properly securing the patient's face (e.g., resulting in leakage).

[0284] 41 and 42, the upper headgear straps 3356, 3358 may have different widths along their lengths. For example, a first portion of each strap 3356, 3358 may be formed with a first width 3359, and a second portion of each strap 3356, 3358 may be formed with a second width 3361 that is greater than the first width. In some forms, the majority of the upper headgear straps 3356, 3358 may be formed with the second width 3361.

[0285] Although not shown, the lower headgear straps 3366, 3368 may have different widths (e.g., tapered), similar to the description of the upper headgear straps 3356, 3358. Thus, any description of the upper headgear straps 3356, 3358 may also apply to the lower headgear straps 3366, 3368.

[0286] In the illustrated example, the straps 3356, 3358 of each upper head strap may gradually taper between the first width 3359 and the second width 3361. The upper headgear straps 3356, 3358 may include substantially straight sides 3363 between the first width 3359 and the second width 3361. In other examples, the upper headgear straps 3356, 3358 may curve between the first width 3359 and the second width 3361. In other examples, the upper headgear straps 3356, 3358 may not include a transition between the first width 3359 and the second width 3361, but may be stepped between the first width 3359 and the second width 3361.

[0287] As shown in FIGS. 41-1 and 41-2, additional feedback features can be used to warn the patient if the upper headgear straps 3356, 3358 are too tight. The illustrated examples show these features incorporated independently into the upper headgear straps 3356, 3358 (e.g., straps having a substantially uniform width). However, the feedback features of FIGS. 41-1 and 41-2 can also be incorporated into the tapered structure (or stepped straps) of FIG.

[0288] As shown in FIG. 41-1 , the upper straps 3356, 3358 may include dots 6128 (e.g., silicone adhesive dots). The dots 6128 may provide increased resistance as the straps pass through the respective loops 3352 a, 3352 b of the frame 3350. In other words, the dots 6128 rub against the respective loops 3352 a, 3352 b to provide a tactile response to the patient, which may alert the patient that the upper straps 3356, 3358 are too tight.

[0289] In some forms, the dots 6128 may be raised from the surface of the straps 3356, 3358 to contact the loops 3352a, 3352b and provide a tactile response to the patient.

[0290] In the illustrated embodiment, the dots 6128 are used with straps of substantially uniform width. The width may be about the width of each loop 3352a, 3352b (e.g., at least a portion of the strap width may be slightly greater than the width of the loops 3352a, 3352b). When a patient attempts to pull either of the upper straps 3356, 3358 through its respective loop 3352a, 3352b, the dots 6128 provide additional resistance to movement through the loops 3352a, 3352b. For example, the patient may feel the vibration of the dots 6128 contacting the loops 3352a, 3352b.

[0291] In another form, the dot 6128 is used in addition to the tapered shape of the upper straps 3356, 3358. Thus, the dot 6128 may be provided to the patient as an additional signal that the upper straps 3356, 3358 are too tight. In other words, the dot 6128 may be located on the portion of each upper strap 3356, 3358 where the second width 3361 is present. When the patient attempts to pull the second width 3361 of either upper strap 3356, 3358 through its respective loop 3352a, 3352b, the dot 6128 will provide additional resistance to movement through the loop 3352a, 3352b.

[0292] In some forms, the dots 6128 may be evenly distributed on the upper straps 3356, 3358. In other forms, the dots 6128 may be unevenly distributed. For example, the density of the dots 6128 may increase in a direction away from the free end of each strap 3356, 3358. This may provide the patient with an initial warning that overtightening may be occurring, and may transition to a greater number of dots 6128 to alert the patient that overtightening has occurred.

[0293] In another example (see, e.g., FIG. 41-1-1), the dots 6128 may be used to help guide the patient to the correct position. For example, the dots 6128 may be arranged in an evenly spaced linear pattern. As the patient threads the straps 3356, 3358 through each of the loops 3352a, 3352b, the dots 6128 may provide feedback at each interval to tell the patient how far the straps have been threaded (e.g., similar to holes on the straps). In other words, the patient may adjust the straps to a particular position based on the number of distinct feedback signals received.

[0294] In certain configurations, this can be useful for providing a more customized adjustment to the patient's head. Rather than simply warning against overtightening, the dot 6128 may alert the patient to a particular strap length that is beneficial for their head.

[0295] In certain forms, the shape, size, and / or density of the dots 6128 may vary along the length of the straps 3356, 3358. For example, the dots 6128 may be evenly (or substantially evenly) spaced to aid the patient in selecting the appropriate length before overstretching, and as described above, the placement of the dots 6128 may vary (e.g., be more densely packed) at locations on the straps that cause the patient to overtighten the straps 3356, 3358. The variation in the configuration of the dots 6128 may result in a different tactile response to alert the patient to overtightening.

[0296] In certain configurations, the dots 6128 may extend substantially the entire length of each strap 3356, 3358. This may provide tactile feedback to patients with a wide range of head sizes. In this example, the dots 6128 may be substantially evenly spaced (although configuration variations may exist as discussed above). The dots 6128 may allow the patient to consistently select a desired position rather than alerting to a specific overtight position.

[0297] Although the above description describes "dots," any suitable shape may be used. For example, the silicone adhesive (or other similar material) may include a triangle, rectangle, or other similar shape.

[0298] As shown in FIG. 41-2, the upper straps 3356, 3358 may include a cutting edge 6132 (e.g., a square cut, a triangular cut, a circular cut, etc.). The cutting edge 6132 can provide a tactile response to the patient, which can alert the patient that the upper straps 3356, 3358 are too tight.

[0299] In the illustrated embodiment, the cutting edge 6132 is used with straps of a substantially uniform width. The width may be on the order of the width of each loop 3352 a, 3352 b (e.g., at least a portion of the strap width may be slightly greater than the width of the loops 3352 a, 3352 b). As the patient attempts to pull the upper straps 3356, 3358 through their respective loops 3352 a, 3352 b, the variation between the full width and the discontinuity of the cutting edge 6132 provides the patient with additional guidance to stop pulling the upper straps 3356, 3358 through the loops 3352 a, 3352 b.

[0300] In another embodiment, the cutting edge 6132 is used in addition to the tapered shape of the upper straps 3356, 3358. Thus, the cutting edge 6132 may provide an additional signal to the patient that the upper straps 3356, 3358 are too tight. That is, the cutting edge 6132 may be located at the portion of each upper strap 3356, 3358 having the second width 3361. When the patient attempts to pull the second width 3361 of either upper strap 3356, 3358 through the respective loops 3352a, 3352b, the transition between the full second width 3361 and the discontinuity of the cutting edge 6132 provides the patient with an additional indication to stop pulling the upper strap 3356, 3358 through the loops 3352a, 3352b.

[0301] In some forms, the cutting edges 6132 may be evenly distributed along a portion of the upper strap 3356, 3358. In other words, the distance between adjacent cuts 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 edge 6132 may decrease in a direction away from the free end of each upper strap 3356, 3358.

[0302] In other examples, the cutting edges 6132 may be used to help guide the patient to the correct position. For example, the cutting edges 6132 may be evenly spaced and arranged in a straight line. As the patient threads the straps 3356, 3358 through each loop 3352a, 3352b, the cutting edges 6132 may provide feedback at intervals to tell the patient how far the straps have passed (e.g., similar to holes on the straps). In other words, the patient may adjust the straps to a particular position based on the number of distinct feedback signals received.

[0303] In certain embodiments, this can be useful for providing a more customized adjustment to the patient's head. Instead of simply warning against overtightening, the cutting edge 6132 may alert the patient to a particular strap length that is beneficial for their head.

[0304] In certain forms, the shape, size, and / or density of the cutting edges 6132 may vary along the length of the straps 3356, 3358. For example, the cutting edges 6132 may be evenly (or substantially evenly) spaced apart to aid the patient in selecting the appropriate length before overstretching, and as described above, the configuration of the cutting edges 6132 may be changed (e.g., smaller and / or closer) at locations on the straps that would cause the patient to overtighten the straps 3356, 3358. The change in the configuration of the cutting edges 6132 may create a different tactile response, which can alert the patient to overtightening.

[0305] In certain configurations, the cutting edges 6132 may extend substantially the entire length of each strap 3356, 3358. This may provide tactile feedback for patients with a wide range of head sizes. In this example, the cutting edges 6132 may be substantially equally spaced (although variations in configuration may exist as discussed above). The cutting edges 6132 may allow the patient to consistently select a desired position instead of being warned of a specific overtight position.

[0306] In use, as described above, each upper strap 3356, 3358 passes through a respective loop 3352a, 3352b. The first width 3359 is smaller than the width of the loops 3352a, 3352b, so that it may be selectively inserted through the openings in each loop 3352a, 3352b. At least a portion of the transition section may have a width smaller than the width of the loops 3352a, 3352b, so that the transition section may also be received through the openings. However, the second width 3361 may be larger than the width of the loops 3352a, 3352b and may not cross either opening. The larger second width 3361 may provide a stop, limiting the total length that can pass through each loop 3352a, 3352b. This may reduce over-tightening of the patient due to the second width 3361. In some forms, the length of the upper headgear straps 3356, 3358 having the first width 3359 (or the length of the first width 3359 plus the transition section 3363) may be designed for patients with larger heads. Thus, the upper headgear straps 3356, 3358 may be adjusted to an ideal slack before the second width reaches each loop 3352a, 3352b. For patients with smaller heads, the upper headgear straps 3356, 3358 may be under greater tension once they are adjusted to the second width 3361. However, the second width 3361 may prevent the patient from overtightening the upper headgear straps 3356, 3358, limiting deformation of the seal-forming structure 3100 and the occurrence of leaks. Alternatively, different sizes of positioning and stabilizing structures 3300 may be constructed for patients with different head sizes (i.e., so that the second width 3361 acts as a stop to limit overtightening for patients with various head sizes).

[0307] In other examples, strap extenders may be connected to the upper headgear straps 3356, 3358 to provide a longer first width 3359. This allows a single positioning and stabilizing structure 3300 designed for a patient's smaller head to be used with a patient's larger head.

[0308] In some configurations, the strap extender may have a double-sided connector. While the illustrated example shows the same type of connector on both sides, the connectors on each side may be different. For example, the strap extender may include hook and loop material. In some configurations, loop material is formed on both sides, while hook material is formed on both sides. In still other configurations, hook material is formed on one side and loop material is formed on the other side.

[0309] In some forms, strap extenders can be used to provide additional length to prevent the patient from overstretching the straps (eg, the upper straps 3356, 3358 and / or the lower straps 3366, 3368).

[0310] In certain embodiments, the strap extender may include features similar to those of the straps shown in FIGS. 41-41-5. For example, the strap extender may include a tapered or stepped shape, as shown in FIG. 41, which may limit the distance the strap extender can pass through the loops 3352a, 3352b to prevent overtightening. The strap extender may further include a dot 6128 (e.g., see FIG. 41-1) and / or a cut edge (e.g., see FIG. 41-2), as described above, to provide an indication (e.g., a tactile response) of overtightening. Similar to FIGS. 41-3-41-5, the strap extender may further include a concealed portion 3365, which may provide a visual and / or tactile indication of overtightening. The concealed portion 3365 may alternatively be referred to as a warning portion.

[0311] Any of the features described in FIGS. 41-51 and included on the strap extenders may alert the patient to adjust the strap extenders relative to the headgear 3354. In some forms, this may include adjusting the connection location of the strap extenders on the straps relative to their respective straps on the headgear (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368). For example, the patient may connect the strap extenders near the portion 3361 having the second width to shorten the effective length of the straps, or may connect the strap extenders near the portion 3361 having the first width to lengthen the effective length of the straps.

[0312] In certain forms, the straps of the headgear 3354 (e.g., the upper straps 3356, 3358 and / or the lower straps 3366, 3368) may include extended length connectors configured to interface with connectors on the strap extenders. For example, the upper straps 3356, 3358 may include hook or loop material along at least a portion of the first width 3359 and / or a portion of the second width 3361.

[0313] The patient may adjust the position of the strap extenders along the length of each strap to select an appropriate usable length for the patient (e.g., to provide sufficient sealing force without overstretching the straps).

[0314] In certain configurations, there may be different sized strap extenders (e.g., small, medium, large) to allow a patient a more customized adjustment for their particular head and to reduce variability in overstretching the strap extenders.

[0315] Alternatively, or in addition, the upper headgear straps 3356, 3358 may be constructed of an elastic material. The elastic material may change appearance (e.g., change color) as it stretches under tension. The expansion of the headgear straps 3356, 3358 may also provide the patient with a tactile feedback that the straps 3356, 3358 are overstretched. Such a visual change may alert the patient (or a third party, such as a bedside person) that the upper headgear straps 3356, 3358 are overly taut. This may be beneficial if the patient fully tightens the upper headgear straps 3356, 3358 before the second width reaches the respective loops 3352a, 3352b.

[0316] For example, Figures 41-3 to 41-5 show examples of straps (e.g., upper headgear straps 3356, 3358) that may include a feature to warn the patient that the strap is overstretched, which may warn the patient that the strap should be loosened and / or that a different size (e.g., larger) headgear strap 3354 is needed.

[0317] An example of the band is shown in Figure 41-3 in a first position. This may be the position in which the strap is not stretched prior to use by the patient. Figure 41-3 shows the strap pulled to the correct length. For example, the patient may use the strap and adjust it to the appropriate length to avoid excessive stretching.

[0318] FIG. 41-4 shows an exemplary strap in a second position, stretched and / or elongated from its initial position. As described above, the strap may include a portion 3365 that is normally hidden but is exposed in the second position. For example, the hidden portion 3365 may be elastic and extend to an extended length when tension applied to the strap exceeds a threshold. The hidden portion 3365 may be a different color and / or texture to alert the patient that tension in the strap has exceeded a predetermined limit. Such a change in appearance and / or feel may alert the patient that the strap is overstretched.

[0319] In some forms, the concealed portion 3365 may be luminous and may glow when exposed. In a darkened room, the glow from the concealed portion 3365 may be observable and may alert the patient to excessive tension in the headgear straps 3354.

[0320] In some forms, the concealed portion 3365 may include a noise output device (eg, a speaker) that outputs a sound when the concealed portion 3365 is exposed to alert the patient.

[0321] In some forms, the concealed portion 3365 may include an electrical component (e.g., a light-emitting element) that outputs light when the concealed portion 3365 is exposed. The light output may alert the patient that the headgear straps 3354 are overly taut. In certain forms, the headgear straps 3354 may include a battery (not shown) and / or electrical wiring to power the electrical component.

[0322] In some forms, it may be invisible to the patient that the strap has exceeded the threshold tension, and the concealed portion 3365 may be externally exposed (e.g., the strap may not be visible to the patient when the patient is wearing it). As shown in FIG. 41-5, the strap may include a tactile response element 3367 that can provide a tactile response to the patient to provide an indication that the tension in the strap has exceeded a certain threshold.

[0323] In certain forms, the tactile response element 3367 is a pair of magnets. The magnets 3367 connect to each other when the strap is in the first position. When the tension in the strap overcomes the magnetic force, the magnets 3367 disengage, exposing the concealed portion 3365. This allows the strap to be placed under tension and stretched (e.g., if elastic) before the magnets 3367 disengage.

[0324] When the magnets 3367 are separated, the patient may receive an unauthorized response. This may be in the form of a vibration along the strap that has broken from the magnet 3367 and / or an audible signal. Either or both may alert the patient that the strap is tightening. Removing the excess tension in the strap allows the magnets 3367 to reconnect.

[0325] In other forms, the tactile response element 3367 may be an alternative connector (e.g., a mechanical connector). The tactile response element 3367 may be constructed, for example, of plastic and / or silicone. Instead of magnetic forces, the tactile response elements 3367 may be connected using a mechanical connection (e.g., a snap fit) or similar connection (e.g., a hook-and-loop connector). These alternating tactile response elements 3367 may have a holding force that allows some extension below the separation threshold before the tactile response elements 3367 separate. Like the magnet 3367, separation of the tactile response elements 3367 can generate vibrations that the patient can detect and determine when the strap is overtensioned.

[0326] In some forms, the tactile response element 3367 may be wider than the strap, which may provide the patient with an additional visual clue to determine when the tension in the strap has exceeded a threshold.

[0327] Although not shown, the overextension feature shown and described in FIGS. 1 and 2 may be incorporated into other straps of the headgear straps 3354. For example, the lower headgear straps 3366, 3368 may be fastened onto the magnets in a similar manner to prevent overtightening. Additionally or alternatively, the adjustable upper strap 3357 (see, e.g., FIGS. 23-2, 24-1, 42-2, 55-1, and 56-1) may include a concealed portion 3365 to warn the patient of overtightening. The adjustable upper strap 3357 may further include a tapered strap to limit overextension. The tapered strap may be used with a strap extender to allow a single headgear strap 3354 to be used with multiple head sizes.

[0328] As shown in FIGS. 41-6 to 41-8, the headgear straps 3354 may utilize a double-sided connecting member 6136 to allow the patient to adjust the length of the headgear straps 3354. As shown in FIG. 41-6, the double-sided connecting member 6136 may include hook (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 may connect the hook material to the loop (or hook) material of the headgear straps 3354 at a desired position. For example, the entire length of the headgear straps 3354 may be configured with hook material so that there are an infinite number of positions for positioning the double-sided connecting member 6136. The patient may adjust the position as needed. For example, the patient may repeatedly connect and disconnect the double-sided connecting member 6136 to the headgear straps 3354. Once connected, the patient can connect the exposed side of the double-sided connecting member 6136 to the headgear strap 3354 by using the headgear strap 3354 like any other headgear strap 3354 and folding its free end back over themselves (e.g., when in use, both sides are connected to the respective headgear strap 3354).

[0329] The double-sided connecting member 6136 can include the same connecting material on either side so that the patient can connect either side to the headgear strap 3354.

[0330] In some forms, the double-sided connecting member 6136 may be used with headgear straps 3354 without an attached connector.

[0331] As shown in FIG. 41-7, the double-sided connecting member 6136 may be located in a first position (e.g., near the free ends of the various straps), which may allow for a longer usable length of the headgear straps 3354. For example, patients with larger heads may connect the double-sided connecting member 6136 in the first position to allow for a proper fit.

[0332] In the first position, a person with a smaller head may overtighten the headgear straps 3354 to achieve a proper fit. Therefore, the patient may move the double-sided connecting member 6136 to the second position (i.e., away from the free ends of the various straps, as shown in FIG. 41-8), thereby shortening the usable length and allowing a patient with a smaller head to achieve a snug fit with the same headgear straps 3354 without overtightening.

[0333] In certain configurations, the patient may cut the free end of the strap beyond the location of the double-sided connecting member 6136. In other configurations, an excess free end may be left so that another patient (e.g., with a different sized head) can readjust the double-sided connecting member 6136 to fit their head.

[0334] In certain aspects, a double-sided connecting member may have hook material on one side and loop material on the other side, with the two sides being functionally different.

[0335] As shown in FIG. 27-2, certain configurations of loops 3352a, 3352b may include an eyelet cut 3353 that may be formed on the patient side of each loop 3352a, 3352b (e.g., the side closest to the patient's skin in use). The eyelet cut 3353 may form a region of reduced thickness along the circumference of each loop 3352a, 3352b. The eyelet cut 3353 may extend partially around the circumference of each loop 3352a, 3352b (e.g., less than 360°). In the illustrated example, each headgear strap 3354 may contact the eyelet cut 3353 when received through the loop 3352a, 3352b. A reduced thickness of the eyelet cut 3353 may result in less material being used to manufacture the loops 3352a, 3352b, which may lead to reduced manufacturing time and / or reduced manufacturing costs. The eyelet cut 3353 may also result in reduced skin marks, which may result in (or instead of) improved patient comfort.

[0336] In one form, at least one of the loops 3352 a, 3352 b may not be completely formed around the periphery. That is, the loops 3352 a, 3352 b may be C-shaped and / or U-shaped. The upper left and / or upper right headgear straps 3356, 3358 may be individually folded over on themselves and then inserted through the respective loops 3352 a, 3352 b. This may allow the patient to maintain the same length adjustment in each upper headgear strap 3356, 3358 when the seal-forming structure 3100 is removed from the therapeutically effective position.

[0337] As shown in FIG. 35-2, certain configurations of the frame 3350 include loops 3352 with raised contours. For example, the illustrated loop 3352b has a protrusion 3390 near the arm 3362b. The sleeve 6124 may curve as a result of its connection to the arm 3362b. The protrusion 3390 may mirror the curvature of the sleeve to provide a more consistent interface between the loop 3352b and the sleeve 6124.

[0338] The protrusion 3390 may have a rounded shape (e.g., a semicircular shape). In some embodiments, the protrusion 3390 may protrude from about 0.01 mm to about 1 cm. In some embodiments, the protrusion 3390 may protrude from about 0.05 mm to about 5 mm. In some embodiments, the protrusion 3390 may protrude from about 0.1 mm to about 3 mm. In some embodiments, the protrusion 3390 may protrude from about 0.5 mm to about 1.5 mm. In some embodiments, the protrusion 3390 may protrude from about 1.2 mm.

[0339] As shown in FIGS. 52-54, certain configurations of the frame 3350 include alternative loops 6080. In the illustrated example, the loops 6080 may include a double eyelet shape. For example, each loop 6080 may include two adjacent loops 3352a, 3352b with a partition 6084 formed therebetween. The partition 6084 may divide the loop 6080 into a first loop section 6080-1 and a second loop section 6080-2. The first loop section 6080-1 may be adjacent to each arm 3362, and the second loop section 6080-2 may form a free end of the frame 3350. The partition 6084 may not extend completely across the width of the loop 6080, such that each loop 6080 includes a single opening (e.g., as opposed to two openings, if the partition 6084 were fully extended). In other words, the first and second loop sections 6080-1, 6080-2 are not completely separated and the strap can move between the sections. The bulkhead 6084 may be formed as two segments that define a central space 6088.

[0340] 53, upper headgear straps 3356, 3358 may be connected to respective loops 6080, similar to loops 3352a, 3352b described above. For example, the upper headgear straps 3356, 3358 may pass through respective loops 6080 and apply a substantially perpendicular force against the septum 6084 to maintain the seal-forming structure 3100 in a proper sealing position.

[0341] 53 , the partitions 6084 can help limit the patient from overtightening the upper headgear straps 3356, 3358. The width of each upper headgear strap 3356, 3358 can be greater than the spacing between the partitions 6084. Each upper headgear strap 3356, 3358 can rest on the corresponding partition 6084 to provide a rearward force when the strap is tightened. While the upper headgear straps 3356, 3358 remain slack or within a desired tension range, the upper headgear straps 3356, 3358 contact the partitions 6084 and remain within their respective first loop sections 6080-1.

[0342] As shown in FIG. 54 , if a user applies excessive tension (e.g., tightening each upper headgear strap 3356, 3358 at the high end of the desired tension range), the upper headgear straps 3356, 3358 may move into the second loop section 6080-2. The excessive tension may result in the upper headgear straps 3356, 3358 bending or folding. In other words, the excessive force pulls each upper headgear strap 3356, 3358 through the central space 6088 and into the second loop section 6080-2. The stiffness of the upper headgear straps 3356, 3358 may resist such bending (e.g., being pulled through the central space 6088) as long as the force is maintained within or below the desired tension range. If the tension exceeds this range, the applied tension exceeds the stiffness of the upper headgear straps 3356, 3358, causing the center of each upper headgear strap 3356, 3358 to bend (i.e., because the center is not supported by the bulkhead 6084). As the upper headgear straps 3356, 3358 move through the central space 6088, the upper headgear straps 3356, 3358 contact the second loop section 6080-2 and apply a vertical force. The movement of the upper headgear straps 3356, 3358 may alert the patient or a third party (e.g., via visual and / or tactile stimulation) that the upper headgear straps 3356, 3358 have been overtightened. The patient can loosen the upper headgear straps 3356, 3358 and reposition the upper headgear straps 3356, 3358 against their respective bulkheads 6084.

[0343] Also, as one moves from the first loop section 6080-1 to the second loop section 6080-2, the tension in the upper headgear straps 3356, 3358 may be reduced because the upper headgear straps 3356, 3358 do not need to be as tight in the second loop section 6080-2. This may temporarily reduce the tension in each upper headgear strap 3356, 3358. However, there may be nothing to prevent the tension from increasing further.

[0344] As shown in FIG. 55 , certain forms of the frame 3350 may include a ladder lock 6092 instead of a loop (loop 3352a, 3352b, or loop 6080). The upper headgear straps 3356, 3358 may be threaded through their respective step locks 6092 to seal the seal-forming structure 3100 against the patient's face. In some forms, the ladder lock 6092 may be molded into the arm 3362 of the frame 3350. In other examples, the ladder lock 6092 may be a separate element (e.g., when two straps are connected together, such as in the upper region of the patient's head). For example, the housing 3371 may include the ladder lock 6092.

[0345] As shown in FIG. 56 , certain forms of the frame 3350 may include stops 6096 that can help adjust the length of the upper headgear straps 3356, 3358. The stops 6096 may be connected to either arm 3362 and used in place of a loop (e.g., loops 3352a, 3352b, or loop 6080). Each upper headgear strap 3356, 3358 may be threaded through a respective stopper 6096. The stops 6096 may include a spring-loaded button 6100 that secures each upper headgear strap 3356, 3358 in the appropriate position. The patient may activate the button 6100 to move (e.g., either tighten or loosen) each upper headgear strap 3356, 3358 to establish a proper fit. For example, the housing 3371 may include the stops 6096.

[0346] 24-28, some forms of the frame 3350 include a central portion 3360 that is coupled to the plenum chamber 3200. The central portion 3360 may have an annular shape and may have a profile that corresponds to the shape of the plenum chamber 3200 (e.g., approximating a positive dome-like curvature).

[0347] In one form, a single size of central portion 3360 may be used with various sizes of plenum chamber 3200 and / or seal-forming structure 3100. For example, the seal-forming structure 3100 may come in multiple sizes (e.g., small, medium, large, etc.) and / or shapes (e.g., narrow, wide, etc.) to better seal with patients having various facial shapes. The engagement area of ​​the central portion 3360 may remain substantially the same regardless of the size of the plenum chamber 3200 and / or seal-forming structure 3100. Thus, the central portion 3360 may be coupled to cushions of various shapes and / or sizes and provide substantially the same support.

[0348] In one form, the central portion 3360 may be removably coupled to the plenum chamber 3200. A patient can use the same frame 3350 with multiple plenum chambers 3200. This can be useful when a patient is just starting treatment and trying out different sized plenum chambers 3200 to find the right fit. Removing the frame 3350 is also useful when cleaning the patient interface 3000, as it allows different elements of the patient interface 3000 to be washed separately, helping to ensure a more thorough clean.

[0349] To provide a comfortable fit for a wide variety of patients, different frames having different sized and / or shaped center portions may be used for different sized plenum chambers 3200 and / or different sized patients. As shown in Figures 36-39, the center portions 13360, 23360 of the frames 13350, 23350 may include a shape that allows for a comfortable seal when used by patients with large nasal lengths (e.g., the distance measured in the anterior-posterior direction between the patient's alar crest and nasal tip).

[0350] As shown in FIG. 36, the frame 13350 may include a central portion 13360 that is smaller than the central portion 3360 of FIG. 25. For example, when each frame 3350, 13350 is connected to the plenum chamber 3200, the top bar 16036 of the frame 13350 may be positioned below a similar top bar 6036. This allows the top of the plenum chamber 3200 (e.g., nose portion 3202) and / or the seal-forming structure 3100 (e.g., second seal-forming structure 3102) to move or flex while attached to the patient, which may be helpful for patients with larger noses. A taller top bar 6036 (e.g., as shown in FIG. 25) may provide more support, but the plenum chamber 3200 and / or the seal-forming structure 3100 may not be able to move enough to accommodate larger noses. Lowering the height of the top bar 16036 (e.g., FIG. 36) may provide buckling and a better fit for patients with larger noses.

[0351] As shown in FIGS. 37-39 , the frame 23350 may include a central portion 23360 having an upper bar 26036 that is out of plane with the remainder of the central portion 23360. For example, the upper bar 26036 may extend forward from the remainder of the central portion 23360 (e.g., when connected to a plenum chamber 3200). This may space the upper bar 26036 from the nose portion 3202 of the plenum chamber 3200. The central portion 23360 may include a substantially similar footprint as the central portion 3360 so that it can be used with the same plenum chamber 3200. However, the spacing between the plenum chamber 3200 and the upper bar 26036 allows the plenum chamber 3200 and / or the seal-forming structure 3100 to further deform and comfortably accommodate a larger nose.

[0352] In some forms, the upper bar 26036 may provide support to the patient during use. For example, by donning the patient interface 3000, the patient may deform the nose portion 3202 of the plenum chamber 3200 so that the nose portion 3202 contacts the upper bar 26036. The upper bar 26036 may be far enough apart in the neutral position (i.e., unworn position) to allow the nose 3202 to expand comfortably when worn by the patient, yet still contact the upper bar 26036 to provide support and limit excessive bending of the nose 3202. This can simulate a frame 3350, but in a size that is advantageous for patients with larger noses.

[0353] In some forms, the frame 3350 includes arms 3362 extending away from the central portion 3360. The loops 3352a, 3352b are formed at the ends of the arms 3362. During use, the arms 3362 may extend at least partially rearward, such that the loops 3352a, 3352b can be located rearward of the plenum chamber 3200 and / or the seal-forming structure 3100. The arms 3362 may also extend laterally (e.g., left or right, respectively) to generally follow the contours of the patient's face.

[0354] In some forms, the arms 3362 engage a portion of the patient's face while the patient interface 3000 is worn by the patient. For example, the arms 3362 may contact the patient's cheek. The arms 3362 may be shaped to accommodate the curvature of the patient's face (e.g., extending posteriorly and laterally).

[0355] In some forms, the arms 3362 may not stretch substantially (e.g., the arms 3362 may be rigid and / or non-stretchable) as a result of tension applied by the respective headgear straps 3356, 3358 via the respective loops 3352a, 3352b. Tension may be transmitted along the arms 3362 to the plenum chamber 3200 and / or the seal-forming structure 3100 to maintain a therapeutically effective pressure and limit the occurrence of leaks.

[0356] In one form, the arms 3362 are constructed from a more flexible material than the material used to construct the central portion 3360. The two materials may be molded together so that the frame 3350 is constructed of a unitary, single-piece structure. The arms 3362 may have some rigidity to help maintain their shape. However, the arms 3362 may be bendable so that the patient can adjust the shape to accommodate their facial structure. Allowing the patient to adjust the shape of the arms 3362 may increase the comfort experienced by the patient and potentially improve patient compliance with treatment. In this manner, the arms 3362 can bend or flex relative to the central portion 3360 (e.g., due to a cantilever configuration) but cannot extend further in a posterior direction (e.g., due to their inextensibility). Additionally, the relatively flexible material used to construct each of the arms 3362 can help reduce facial imprinting and increase patient comfort.

[0357] In one form, the arms 3362 and the central portion 3360 are constructed from the same material. This material provides sufficient flexibility to allow shape adjustment and sufficient rigidity to maintain the adjusted shape. The central portion 3360 may be more rigid than the arms 3362 as a result of being coupled to the plenum chamber 3200. Additionally or alternatively, the central portion 3360 may be thicker than the arms 3362, thereby increasing the rigidity of the central portion 3360. Each arm 3362 is cantilevered such that the end proximate the respective loop 3352a, 3352b is unsupported. Additionally, the thickness of the frame 3350 may decrease along the length of each arm 3362 in the direction of the respective loop 3352a, 3352b. This may provide each arm 3362 with the necessary flexibility to bend and / or shape to substantially correspond to the shape of the patient's face (e.g., cheek). Reducing the width of each arm 3362 can also reduce cheek contact between the respective arm 3362 and the patient's cheek, which can improve patient comfort. Reducing the width along the length of each arm 3362 can also allow for greater flexibility proximate each respective loop 3352a, 3352b.

[0358] In one form, sleeves 6124 may be used with the arms 3362 to provide additional comfort to the patient. As shown in FIG. 42-1 , the sleeves 6124 may extend substantially along the length of the two arms 3362. For example, each sleeve 6124 may extend from a fixed end of each arm 3362 proximate the central portion 3360 of the frame 3350. Each sleeve 6124 may extend toward a free end of each arm 3362 proximate the loop 3352 (or 6080) of the frame 3350.

[0359] In the illustrated example, the sleeve 6124 may not cover the central portion 3360 or the loops 3352 (or 6080) of the frame 3350. In this way, the sleeve 6124 may connect without obstructing the strap connections to the loops 3352 and / or without obstructing the central portion 3360 to the plenum chamber 3200. In other examples, the sleeve may be used in conjunction with the central portion 3360 (e.g., so that the patient interface 3000 has a bedding-like appearance).

[0360] In some forms, the sleeve 6124 may be constructed of a comfortable material that may be flexible and / or soft to the touch. The arms 3362 may be curved and / or shaped to conform to the shape of the patient's face (e.g., the patient's cheeks), as described above. As a result, at least a portion of the arms 3362 fits snugly against the patient's skin. By including the sleeve 6124, the patient's skin may come into contact with a material that is comfortable to wear for extended periods of time. This material may be fabric and / or foam, or any similar material.

[0361] In certain forms, the sleeve 6124 may be constructed of an elastic material, which allows the sleeve to be stretched over the loop 3352 so that the sleeve 6124 can be removed (e.g., cleaned) from the arm 3362. In other examples, the sleeve 6124 may be wrapped around the arm 3362 using a hook-and-loop, magnetic, or mechanical connection, which can be released to remove the sleeve 6124 from the arm 3362.

[0362] In one form, each loop 3352 may include a protrusion 3390 having a rounded shape. The protrusion 3390 may include a smooth surface in the direction from the loop 3352 toward the arm 3362, which allows the sleeve 6124 to slide over the loop 3352 without getting caught. The end 3392 of the arm 3362 near the protrusion 3390 may be formed as a protrusion or overhang, which may limit the sleeve from sliding in the opposite direction (i.e., sliding over the loop 3352 and thereby removing it from the loop frame 3350).

[0363] In another form (not shown), the arm 3362 may include comfort material only on the interior surface of the arm 3362 (e.g., including the sector 3373 (see, e.g., FIG. 27)). Instead of a sleeve, this may be a piece of material that is connected to the surface that contacts the patient's skin in use. This material is connected to the arm 3362 by adhesive and may be removed and / or replaced with a new piece of material (e.g., a clean piece of material).

[0364] 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.

[0365] 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.

[0366] As shown in FIG. 27-3, some configurations of the cross section of each arm 3362 may be substantially rectangular. The corners (e.g., one corner, two corners, four corners, etc.) may be rounded. This helps improve patient comfort by reducing sharp surfaces that come into contact with the patient's skin. Each arm 3362 may have a height greater than its thickness. This height may be designed to comfortably distribute pressure across the patient's skin (e.g., by increasing the height) without obstructing the patient's peripheral vision or otherwise causing discomfort to the patient.

[0367] In some embodiments, the height of each arm 3362 may be between about 5 mm and about 15 mm. In some embodiments, the height of each arm 3362 may be between about 6.5 mm and about 13.5 mm. In some embodiments, the height of each arm 3362 may be between about 8 mm and about 12 mm. In some embodiments, the height of each arm 3362 may be between about 9.5 mm and about 10.5 mm. In some embodiments, the height of each arm 3362 may be about 10 mm.

[0368] 35 , some forms of arms 3362 of frame 3350 may include ribs 3394 extending from the underside of each arm 3362. Each arm 3362 may include at least one rib 3394. For example, the illustrated frame 3350 includes ribs 3394 on each arm 3362, the ribs 3394 being located near the central portion 3360 of the frame 3350. In other examples, each arm 3362 may have one or more ribs 3394, and / or the ribs 3394 may be located at different locations along the length of the arm 3362 (e.g., near the respective loops 3352 and / or on different surfaces of the arm 3362).

[0369] In some forms, each rib 3394 may include a circular profile (e.g., having a semicircular shape), which reduces or limits discomfort caused by sharp or angular shapes.

[0370] As described above, the sleeve 6124 may be positioned around each arm 3362 to provide additional comfort to the patient. The dimensions of the arms 3362 (e.g., thickness, height, and cross-section as described above) provide an extended surface for the sleeve 6124. However, in some examples, the sleeve 6124 may be larger than the arms 3362 (e.g., to pass through the loops 3352) and may droop over the respective arms 3362. For example, the height of the arms 3362 may be closer to the loops 3352. This may appear and / or feel uncomfortable to the patient wearing the patient interface 3000. The ribs 3394 on each arm 3362 may provide additional height (and / or thickness depending on the location of the ribs 3394) to the respective arms 3362 to stretch the sleeve 6124 and minimize sagging (e.g., to match the height of the arms 3362 closer to the loops 3352).

[0371] The smooth profile of the ribs 3394 may limit the sleeve 6124 from getting caught and / or tearing on the ribs 3394. Also, the sleeve 6124 can be removed from the arm 3362 without damaging the sleeve 6124.

[0372] As shown in FIGS. 26-4 and 26-51, certain configurations of the frame 3350 may allow for pivoting movement between each arm 3362 and the central portion 3360. The pivoting movement may differ from the bending movement described above because a pivot point 6012 connects each arm 3362 to the central portion 3360, allowing the entire arm 3362 to move substantially the same angular distance. As described above, each arm 3362 may bend in addition to pivoting.

[0373] In one form, the pivot points 6012 are located at approximately the same location on either side of the frame 3350. In other words, each arm 3362 may be connected to the central section 3360 at approximately the same height, and each arm 3362 may extend past the pivot point 6012 to approximately the same length. This allows the patient to make mirrored adjustments to the arms 3362. The patient can then bend each arm individually or to make specific adjustments to one side.

[0374] In one form, the pivot points 6012 are living hinges. In other words, the frame 3350 may be constructed of a substantially uniform material (or the transitions between each arm 3362 and the central portion 3360 may be constructed of a substantially uniform material). The thickness of each hinge 6012 may be significantly less than the thickness of the arms 3362 and central portion 3360 adjacent to the hinge 6012. For example, the hinges 6012 may be formed as grooves in the surface of the frame 3350 that faces away from the patient during use. Constructing the hinges 6012 uniformly and integrally from substantially the same material as the arms 3362 and central portion 3360 may contribute to reduced manufacturing costs (e.g., compared to including hinges constructed of different materials).

[0375] Each arm 3362 is pivotable between a first position and a second position about a respective hinge 6012. The loops 3352a, 3352b may be spaced apart in the second position than in the first position.

[0376] In one form, the first position can be a relaxed position and the second position can be a biased position, and the arm 3362 can be movable to the second position when an external force is applied and can return to the first position when the external force is removed.

[0377] In one form, the arms 3362 may be in a first position or a second position without constant external force. The arms 3362 may be movable into the second position so that they overlap each other (e.g., like eyeglasses), thereby reducing the footprint for packaging and / or storage.

[0378] In other forms (not shown), each arm 3362 may be separate from the central portion 3360 and connected to the central portion 3360 via a rotating hinge (e.g., a pin joint). In other forms, each arm 3362 may be connected to the central portion 3360 by overmolding a flexible member in between, thereby allowing some pivotable movement.

[0379] In some forms, the frame 3350 further includes at least one secondary connection point 3364 spaced apart from the loops 3352 a, 3352 b. The secondary connection point(s) 3364 provide an additional connection location that may further help indirectly connect the headgear straps 3354 to the plenum chamber 3200 and / or the seal-forming structure 3100.

[0380] In certain forms, the frame 3350 includes two secondary connection points 3364 (e.g., a left secondary connection point 3364a and a right secondary connection point 3364b). The secondary connection points 3364a, 3364b may be lower than the loops 3352a, 3352b while the patient interface 3000 is worn on the patient. The headgear straps 3354 may further include a lower left headgear strap 3366 and a lower right headgear strap 3368, each configured to couple to a respective secondary connection point 3364a, 3364b. The headgear 3354 may then collectively be able to apply force to upper and lower regions of the seal-forming structure 3100 and / or plenum chamber 3200.

[0381] In certain forms, the secondary connection points 3364a, 3364b are formed directly on the central portion 3360. The secondary connection points 3364a, 3364b may be above the loops 3352a, 3352b while the patient interface 3000 is worn on a patient.

[0382] In certain forms, the secondary connection points 3364a, 3364b may be constructed from a single component, which can help reduce tooling and / or manufacturing costs.

[0383] In certain configurations, the lower left and / or lower right headgear straps 3366, 3368 are removably coupled to respective secondary connection points 3364a, 3364b. The secondary connection points 3364a, 3364b may be magnetic, and the lower left and / or lower right headgear straps 3366, 3368 may be threaded through magnets 3370 having opposite polarity to the secondary connection points 3364a, 3364b. The housing 3371 may be flexible or semi-rigid to facilitate coupling and better hold the magnets in the coupled position. The length of the lower left and / or lower right headgear straps 3366, 3368 can be adjusted by folding the respective straps 3366, 3368 back on themselves (e.g., as is done with the upper left and / or upper right headgear straps 3356, 3358). Additionally, the lower headgear straps 3366, 3368 may include a first width 3359 and a second width 3361. The straps shown in FIG. 41 may similarly be used as part of the straps 3366, 3368 of the lower headgear straps. Accordingly, the lower headgear straps 3366, 3368 may include a stopper having the second width 3361 to prevent or limit overtightening. In some forms (not shown), the housing 3371 may include a pair of loops, and the crossbar 3386 may not extend completely between the two loops. Thus, the housing 3371 may have the shape described in FIGS. 52-54 and similarly alert the patient if the lower headgear straps 3366, 3368 become too tight. This may be used in combination with, or as an alternative to, the lower headgear straps 3366, 3368 having the first and second widths 3359, 3361.

[0384] Additionally or alternatively, the left and / or right lower headgear straps 3366, 3368 may include dots 6128 and / or cut edges 6132 as shown on the upper headgear straps 3356, 3358 (see, e.g., FIGS. 41-1, 41-21). The descriptions of dots 6128 and / or cut edges 6132 on the upper headgear straps may also apply to the lower headgear straps 3366, 3368 to warn the patient that the straps are too tight.

[0385] In other examples, ladder locks 6092 and / or stops 6096 may be connected to the frame 3350 to provide for adjustment of the lower headgear straps 3366, 3368.

[0386] Each magnet 3370 can be removed from its respective secondary connection point 3364a, 3364b without changing the length adjustment of the lower left and / or lower right headgear straps 3366, 3368. The patient may be able to don and / or doff the patient interface 3000 by simply removing the magnet 3370 from its respective secondary connection point 3364a, 3364b (e.g., without having to remove the upper left and / or upper right headgear straps 3356, 3358 from their respective loops 3352a, 3352b).

[0387] As shown in FIGS. 28-1 and 28-21 , each secondary connection point 3364a, 3364b may be configured to improve retention with the respective magnet 3370. The casing 3376 of each secondary connection point 3364a, 3364b may include a substantially flat (e.g., planar) surface 3378 and a lip 3380 extending from the flat surface 3378.

[0388] In the illustrated example, the casing 3376 may be substantially elliptical, and the lip 3380 may extend proximate to an apex of the plane 3378. The lip 3380 may extend only partially around the plane 3378 (e.g., less than 360°). In some examples, the lip 3380 may extend less than 180° around the plane 3378 (e.g., the lip 3380 may not extend to any common apex of the substantially elliptical plane 3378).

[0389] 28-2, each secondary connection point 3364a, 3364b may be coupled to the frame 3350 such that the lip 3380 is located near the center of the frame 3350. In other words, each secondary connection point 3364a, 3364b may be oriented such that the lip 3380 is located near the elbow 3500 when the frame 3350 is coupled to the plenum chamber 3200.

[0390] The magnet 3370 includes a substantially flat surface that is engageable with the substantially flat surface 3378 of the casing 3376. The magnet 3370 may be magnetically coupled to the magnetic element 3382 of the secondary connection points 3364a, 3364b when the flat surfaces 3378 are joined. The overhang 3384 may be spaced apart from the magnet 3370. As shown, the overhang 3384 may be located on one side (e.g., the inside) of the lip 3380 and the magnet 3370 may be located on the other side (e.g., the outside) of the lip 3380. In use, the patient may adjust the length of each lower headgear strap 3366, 3368. Pulling on one of the lower headgear straps 3366, 3368 may apply a force in a direction away from the center of the frame 3350 (e.g., laterally outward). This force may be greater than the magnetic force between magnet 3370 and magnetic element 3382 and may cause magnet 3370 to move relative to plane 3378.

[0391] The overhang 3384 may prevent the magnet 3370 from becoming disengaged from the magnetic material 3382 due to tensioning of the respective lower headgear straps 3366, 3368. When the magnet 3370 begins to move, the overhang 3384 can abut the lip 3380, restricting further movement from the center of the frame 3350. Thus, the engagement between the lip 3380 and the overhang 3384 helps to reduce inadvertent disengagement of the magnet 3370 from the respective auxiliary connection points 3364a, 3364b when the respective lower headgear 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 disengage the positioning and stabilizing structure 3300).

[0392] As shown in Figures 29-35, other structures may be used to improve retention of connection points 3364a, 3364b by each magnet 3370. The configurations described in Figures 29-35 may be used alone or in any combination. Any of the configurations described in Figures 29-35 may be used with the lip 3380 shown in Figures 28-1 and 28-2.

[0393] 29 and 30, the mouth 3201 of the plenum chamber 3200 may include at least one clip support 6016. The clip support 6016 may be positioned radially outside the groove 3280 near the edge of the mouth 3201, as shown in FIG. 29. In some forms, a second clip support 6016 may be positioned in a mirror image position on the opposite side of the plenum chamber 3200, as shown in FIG. 29. The clip support 6016 may be positioned spaced apart from the frame 3350 (and thus spaced apart from the connection points 3364a, 3364b) when the frame 3350 is connected to the plenum chamber 3200.

[0394] 29, some forms of clip support 6016 may be spaced from groove 3280 such that the distance between the corresponding connection point 3364a, 3364b and the clip support 6016 is on the order of the length of the housing or connecting member 3371. That is, the length between overhang 3384 (see, e.g., FIG. 28-2) and crossbar 3386 (see, e.g., FIG. 28) is on the order of the length between the respective connection point 3364a, 3364b and the clip support 6016.

[0395] Continuing with reference to FIG. 29 , some configuration of the clip support 6016 may protrude from the surface of the mouth 3201. The clip support 6016 may be integrally formed with the mouth 3201 in a unitary structure (e.g., using an injection molding process). As such, the clip support 6016 may be formed from the same material as the mouth 3201. For example, the clip support 6016 may be constructed of a silicone material and may be flexible, bendable, and / or compressible. Increasing the thickness of the clip support 6016 (e.g., compared to the remainder of the mouth 3201) may limit the flexibility, bendability, and / or compressibility of the clip support 6016. The increased thickness may also allow the clip support 6016 to function as an additional stiffening member (e.g., in addition to the frame 3350) to further increase the rigidity of the mouth 3201.

[0396] In some forms, the clip support 6016 may be curved or extend along an arcuate path. As shown in FIG. 29, the clip support 6016 may include a constant curvature (although varying curvatures may also be utilized). The center of curvature may be located at each connection point 3364a, 3364b.

[0397] 46, some forms of the clip support 6016 may be connected to the groove rib 6052 or may be formed as a single molding. The shape may vary along the length to form the clip support 6016 and groove rib 6052, respectively. In other forms, the clip support 6016 may be spaced apart from the groove rib 6052.

[0398] 30 , the frame 3350 may be connected to the mouth 3201, and the magnets 3370 may be connected to respective connection points 3364a, 3364b. The ends of the connecting members 3371 near the crossbars 3386 may extend above and / or slightly beyond the respective clip supports 6016. In some configurations in which the connecting members 3371 are rotatable relative to the frame 3350, the rotation of the connecting members 3371 may substantially follow the curvature of the clip supports 6016, such that the connecting members 3371 extend the same distance relative to the clip supports 6016 in their angular movement.

[0399] In some forms, the height of the clip support 6016 from the mouth 3201 may be less than the distance between the crossbar 3386 and the mouth 3201. This may allow the crossbar 3386 and the clip support 6016 to be slightly spaced apart at an intermediate position. This spacing may provide a gap extending around the crossbar 3386 for each lower strap 3366, 3368. When each lower strap 3366, 3368 is connected to its respective connecting member 3371, the connecting member 3371 may be substantially close to or in contact with the clip support 6016. This may limit or prevent the connecting member 3371 from swinging and / or pivoting toward the surface of the mouth 3201. If the lip 3380 and overhang 3384 (see, e.g., FIG. 28-2) are not fully engaged when the lower straps 3366, 3368 are being tensioned, and / or if the patient is pressed against the connecting member 3371 near the crossbar 3386 (e.g., when the patient is sleeping), rocking or pivoting may occur. By including the clip support 6016, the crossbar 3386 contacts the clip support 6016 prior to any substantial rocking or pivoting movement. This may ensure that the magnets 3370 remain connected to their respective connection points 3364a, 3364b even if the patient inadvertently contacts the connecting member 3371 while sleeping, thereby maintaining the seal-forming structure 3100 in the correct position. The clip support 6016 may be at least partially covered during use, allowing the patient interface 3000 to maintain a compact appearance.

[0400] As shown in FIG. 31 , an alternative embodiment may include clip supports 6020 on the frame 3350 rather than on the plenum chamber 3200. The clip supports 6020 may be integrally formed with the frame 3350. The clip supports 6020 and the frame 3350 may be constructed of the same material, or each may be constructed of a different material (e.g., another material may be introduced into a mold to form the clip support 6020). The clip supports 6020 may have a shape substantially similar to the clip supports 6016. For example, the clip supports 6020 may extend beyond approximately the length of the connecting members 3371 at their respective connection points 3364 a, 3364 b. The clip supports 6020 may also extend in a curved or arcuate path, which may include a constant curvature around their respective connection points 3364 a, 3364 b.

[0401] In some forms, the clip support 6020 may be at least partially flush with the central portion 3360 of the frame 3350. For example, the interface between the proximal end of the clip support 6020 and the central portion 3360 may be substantially flush, such that the central portion 3360 and the clip support 6020 each have the same thickness. In other forms, the clip support 6020 may have a smaller thickness than the central portion 3360. In this case, the clip support 6020 may be flush with only a portion of the central portion 3360 (e.g., the clip support 6020 may be flush with the top or bottom edge of the central portion 3360).

[0402] In some forms, the distal end 6021 of the clip support 6020, opposite the proximal end, may be curved or bent, extending away from the surface of the mouth 3201. The curve or bend in the distal end 6021 may form a similarly shaped protrusion to the clip support 6016 of FIGS. 29 and 30 . In other words, the distal end 6021 may extend the same distance from the surface of the mouth 3201. This may limit or prevent the engaging connecting member 3371 from swinging or pivoting in substantially the same way as the clip support 6016.

[0403] 32 and 33, the frame 3350 may include at least one rib 6024 proximate each connection point 3364a, 3364b. The rib 6024 may limit rotational movement of the connection member 3371, which may maintain a desired orientation of the lower straps 3366, 3368 (e.g., to maintain a proper force vector).

[0404] 32, 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 positioned above each connection point 3364a, 3364b, and one rib 6024 may be positioned below each connection point 3364a, 3364b. In some forms, the ribs 6024 may be equally spaced around each connection point 3364a, 3364b.

[0405] In the illustrated example, the shape of the ribs 6024 may be substantially rectangular, although similar shapes (e.g., oval, circular, triangular, etc.) may also be utilized. The ribs 6024 may protrude from the surface of the central portion 3360. In some forms, the ribs 6024 may extend below the top surface of the connecting member 3371, but to a height substantially equal to the height of the connecting member 3371.

[0406] When connected, each connecting member 3371 is mounted between a respective pair of ribs 6024. Each rib 6024 may contact or be substantially close to its respective connecting member 3371, thereby limiting or preventing rotation of the connecting members 3371 about a vertical axis passing through each connection point 3364 a, 3364 b. This helps maintain the desired direction of the force vector of each lower strap 3366, 3368 and minimizes accidental disengagement of the magnet 3370 from its respective connection point 3364 a, 3364 b.

[0407] As shown in Figure 33, another configuration of the frame 3350 may include ribs 6024 located adjacent each connection point 3364a, 3364b. This configuration may include only a single rib 6024 associated with each connection point 3364a, 3364b, but may also include the pair of ribs 6024 of Figure 32. The individual ribs 6024 may be positioned to approximately coincide with the centers of the respective connection points 3364a, 3364b (e.g., not higher or lower than the centers of the connection points 3364a, 3364b).

[0408] The connecting member 3371 may include a notch 6028 between the overhang 3384 and the crossbar 3386. The notch 6028 may be formed in a shape that substantially corresponds to the rib 6024. The notch 6028 receives the rib 6024 when the connecting member 3371 engages with each of the connection points 3364a, 3364b. The rib 6024 may contact or be substantially adjacent to the notch 6028 to prevent or limit rotational movement of the respective connecting member 3371. Thus, a single rib 6024 can achieve substantially the same benefits as multiple ribs 6024.

[0409] 34 and 35, the connection points 3364a, 3364b do not have to be formed directly on the central portion 3360 of the frame 3350. Instead, the frame 3350 may include arms 6032 extending radially outward from either side of the central portion 3360. Each arm 6032 may be connected to the frame 3350 at approximately the same location as the connection points 3364a, 3364b in the previous example (e.g., FIG. 28). Each connection point 3364a, 3364b may instead be connected to the distal end of the respective arm 6032.

[0410] Positioning the connection points 3364a, 3364b at the ends of the arms 6032 may allow the connection points 3364a, 3364b to be moved laterally and / or rearward. In some forms, the connection points 3364a, 3364b on either arm 6032 may be about 5 mm to about 50 mm away from the central portion 3360 (e.g., measured along the surface of the arm 6032). In some forms, the connection points 3364a, 3364b on either arm 6032 may be about 10 mm to about 40 mm away from the central portion 3360. In some forms, the connection points 3364a, 3364b on either arm 6032 may be about 20 mm to about 30 mm away from the central portion 3360. In some forms, the connection points 3364a, 3364b on either arm 6032 may be about 29 mm away from the central portion 3360. In some forms, the connection points 3364a, 3364b of either arm 6032 may be approximately 21 mm from the center portion 3360.

[0411] In some forms, the arms 6032 may be integrally formed with the central portion 3360 having a unitary construction. In this example, the central portion 3360 and the arms 6032 may be composed of substantially the same material. In other examples, the arms 6032 may be composed of different materials but may be integrally formed with the central portion 3360 (e.g., multiple materials may be introduced during injection molding). In other examples, the arms 6032 may be formed using a different process than the central portion 3360 and may be coupled to the frame 3350 using coupling means (e.g., adhesive, magnets, mechanical fasteners). In this example, the arms 6032 may be permanently connected or may be detachable.

[0412] 35 and 35-1, the arms 6032 may be substantially flush with the top surface of the central portion 3360. This has the advantage of compactness and appearance, as the arms 6032 do not protrude forward of the frame 3350. This also helps to promote patient compliance, as the compact design does not substantially obstruct the patient's line of sight.

[0413] The arm 6032 shown in FIGS. 34-35-1 may be configured as a cantilever structure such that the distal end, including the connection points 3364a, 3364b, is unsupported. In some examples, the arm 6032 may be flexible or semi-rigid and may be bendable or deflectable. For example, the arm 6032 may bend backward as the patient tightens the connected lower straps 3366, 3368. Although the arm 6032 may deflect, the total distance the arm 6032 deflects may be minimal. In this manner, the arm 6032 may maintain the force vector of the lower straps 3366, 3368. If the arm 6032 deflects, the arm 6032 will return to its original position when the force is released (e.g., when the magnets 3370 are disengaged from their respective connection points 3364a, 3364b).

[0414] As shown in FIG. 35-1, some forms of arms 6032 may include grooves 6033 that may be located on the front and / or rear surfaces. The grooves 6033 may function as hinges to aid in bending each arm 6032. The frame 3350 of FIG. 35-1 may be a separate frame, or the grooves 6033 may be incorporated into the frame of FIG. 34 and / or FIG. 35 (or other frames described herein).

[0415] In use, a patient may connect the connection member 3371 to each of the connection points 3364a, 3364b as if the connection points 3364a, 3364b were directly connected to the central portion 3360. Therefore, the patient's ability to connect the magnet 3370 to the connection points 3364a, 3364b may not be affected. Additionally, by forming the connection points 3364a, 3364b wider (i.e., farther from the central portion 3360 of the frame 3350), the magnet 3370 may be less likely to become detached from its respective connection point 3364a, 3364b. For example, at least a portion of the flexibility of the arm 6032 may allow for flexion in a backward direction, which may limit the rocking of the connection member 3371 about its respective connection point 3364a, 3364b. Therefore, the magnet 3370 is less likely to become detached inadvertently, and the seal between the patient's face and the seal-forming structure 3100 may be better maintained.

[0416] In some forms, the arms 6032 may bend or flex relative to the central portion 3360. For example, the arms 6032 may bend inward toward the plenum chamber 3200 (and point toward the patient's face when the patient interface 3000 is worn). The bending or flexing may be the result of a force from the positioning and stabilizing structure 3300 (e.g., tightening the straps 3366, 3368 may cause the arms 6032 to bend). As a result of the bending, the arms 6032 may be positioned in close proximity to or in contact with the plenum chamber 3200 and / or the patient's face. This may help reduce the occurrence of rocking or accidental disengagement of the magnets 3370.

[0417] In some forms, the connection points 3364a, 3364b of the arms 6032 may not include the lip 3380. Conversely, the connection points 3364a, 3364b may be substantially planar. The displacement of the connection points 3364a, 3364b away from the central portion 3360, combined with the flexibility of the arms 6032, may reduce the likelihood of the magnets becoming inadvertently detached during use. Specifically, the rearward positioning of the connection points 3364a, 3364b may reduce the torque applied to the housing 3371 and the magnet 3370, thereby resulting in decoupling.

[0418] As shown in FIG. 61 , some forms of the patient interface 3000 may include a bendable housing 6104 that can removably connect the strap of the strap to the frame 3350. The bendable housing 6104 may be substantially similar to the housing 3371. For example, the bendable housing 6104 may include a magnet 6108 (or a similar type of connector) that removably engages connection points 3364a, 3364b. Additionally, the bendable housing 6104 includes a crossbar 6112 that receives the strap (e.g., any of straps 3356, 3358, 3366, 3368). A bendable section 6116 may be provided between the magnet 6108 and the crossbar 6112. The bendable section 6116 may be a thin-walled portion of the bendable housing 6104 and may be elastically flexible without breaking. For example, the bendable section 6116 may bend about a bending axis 6120 such that the crossbar 6112 pivots relative to the magnet 6108. When the magnets 6108 are connected to their respective connection points 3364a, 3364b, bending about the bending axis 6120 can be the result of tension applied to the corresponding straps around the crossbar 6112. The movement about the bending axis 6120 can be dominant over the movement of the magnets 6108 so that the housing 6104 does not accidentally detach from its respective connection points 3364a, 3364b. In some forms, a bendable housing 6104 can be used in place of the arms 6032 (e.g., using the bendable housing 6104 when the connection points 3364a, 3364b are on the central portion 3360). In some forms, the bendable housing 6104 can be used in conjunction with the arms 6032.

[0419] The length of the bendable section 6116 may determine the amount of bending allowed in the bendable housing 6104. Longer bendable sections 6116 allow more bending than shorter bendable sections 6116. In some forms, the bendable section 6116 may be between about 0.1 mm and about 20 mm. In some forms, the bendable section 6116 may be between about 1 mm and about 10 mm. In some forms, the bendable section 6116 is about 5 mm.

[0420] 24, the engagement region of the plenum chamber 3200 may include a groove 3280. In the illustrated example, the groove 3280 may be included in the mouth 3201 of the plenum chamber 3200 and may be radially outward of the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the groove 3280. The shape of the central portion 3360 may substantially correspond to the shape of the groove 3280, which may assist the patient in properly orienting the frame 3350 relative to the plenum chamber 3200 (e.g., in examples where the frame 3350 is removably coupled to the plenum chamber 3200).

[0421] 37-39, the top bar 6036 of the central portion 3360 may extend forward from the remainder of the central portion 3360 and may be spaced apart from the groove 3280. In other words, prior to use, the top bar 6036 may not contact the groove 3280 or other portions of the plenum chamber 3200.

[0422] In some forms, the groove 3280 may have a fully formed perimeter having a substantially annular shape. The perimeter may have substantially the same length for any size cushion.

[0423] In some forms, the groove 3280 is recessed relative to the remainder of the exterior surface of the plenum chamber 3200. The recessed groove 3280 does not extend substantially into the plenum chamber 3200 and may not obstruct the patient's face. The groove 3280 may have substantially the same depth around its entire perimeter.

[0424] In some forms, the width of the groove 3280 may be less than the width of the central portion 3360 of the frame 3350. The flexible nature of the cushion may allow the wider central portion 3360 to be received within the groove 3280. This may allow the central portion 3360 to couple to the groove 3280 via a press fit, a friction fit, and / or a snap fit. The engagement between the groove 3280 and the central portion 3360 may help provide rigidity to the plenum chamber 3200 and / or the seal-forming structure 3100, as the rigidity of the frame 3350 (e.g., relative to the plenum chamber 3200) may limit the flexibility of only a portion of the plenum chamber 3200.

[0425] In some forms, the cushion may be molded into the frame 3350 so that the groove 3280 may be created during the molding process. The material of the plenum chamber 3200 (e.g., silicone) may be at least partially molded around the central portion 3360 of the frame 3350 and may restrict the central portion 3360 from being removed from the groove 3280.

[0426] As shown in FIG. 25 , the frame 3350 may be constructed from multiple pieces (e.g., each may be constructed from a different material). For example, the central portion may be constructed from a first material (e.g., a rigid plastic). The arms 3362 may be coupled to the central portion 3360 (e.g., via adhesive, molding, etc.) and may be constructed from a second material (e.g., a flexible plastic, foam, etc.) that is more flexible than the first material. The third material may be a magnetic material and may be coupled to the central portion 3360 (e.g., via adhesive). Once coupled, the arms 3362 may be able to move in a similar manner as the integral, single-piece structure described above.

[0427] 26 and 27, the frame 3350 may be constructed from a single piece of material. For example, the frame 3350 may be constructed from a TPE material such as Hytrel. As mentioned above, the material used in constructing the frame 3350 may provide both rigidity and flexibility to the frame 3350. The magnet 3370 may be overmolded (or otherwise coupled) to the central portion 3360.

[0428] In some forms, the central portion 3360 includes slots 3372, which may be formed on either side of the central portion 3360. The slots 3372 may have a generally elongated shape (e.g., rectangular, oval, etc.) and may be formed entirely within the boundaries of the central portion 3360.

[0429] 27, some configurations of the central portion 3360 may include a tapered slot 3372. Specifically, the opening to the slot 3372 may be wider proximate the rear face of the central portion 3360 (e.g., the face that contacts the plenum chamber 3200). The opening to the slot 3372 may decrease uniformly toward the front face of the central portion 3360.

[0430] FIG. 27 also shows that some configurations of the arm 3362a (or arm 3362b) may include an indentation or scallop 3373. The scallop 3373 may be formed on the inner surface of the arm 3362a and may be positioned adjacent to the patient's skin when the positioning and stabilizing structure 3300 is worn on the patient. The scallop 3373 may reduce the thickness along a portion of the arm 3362a and reduce the likelihood of sink marks developing in the arm 3362a during the manufacturing (e.g., injection molding) process. The scallop 3373 may also result in less material being used to manufacture the arm 3362a, which may translate into faster manufacturing time and / or lower manufacturing costs.

[0431] 26-2a, the plenum chamber 3200 may include a protrusion 3284 at the mouth 3201. The protrusion may be elongated and may have a shape similar to the slot 3372 (e.g., tapered). The protrusion 3284 may be positioned within the groove 3280 to cooperate with the frame 3350 during assembly.

[0432] 40, the protrusion 3284 may extend at a substantial angle relative to the front surface of the plenum chamber 3200. The front surface of the plenum chamber 3200 may be partially curved or angled, and the protrusion 3284 may extend in a non-perpendicular direction relative to the surface so as to be aligned along the insertion direction of the frame 3350. That is, when the patient interface 3000 is worn, the protrusion 3284 may extend along the anterior-posterior direction.

[0433] As shown in FIGS. 26-2 and 26-2a, some configurations of the protrusion 3284 may include an overhang 6000 that extends at least partially over the groove 3280. The overhang 6000 may be asymmetrically formed around the periphery of the protrusion 3284. In other words, the overhang 6000 may extend further on one side than the other. As shown in FIG. 26-2a, the opposite side 6002 may extend outward to form a slight overhang. For example, the opposite side 6002 may extend between about 1° and about 20° (e.g., 10°) beyond the example shown in FIG. 26-2, which may be about 0.1 mm to about 5 mm (e.g., about 1 mm) longer than the opposite side 6002. This may provide additional retention force to hold the frame 3350 in the groove 3280.

[0434] 40, the top surface of the protrusion 3284 may be slightly angled so that the overhang 6000 extends generally parallel to the surface of the groove 3280. This may allow a larger portion of the protrusion 3284 to extend above the groove 3280. As explained in more detail below, this helps to better retain the frame 3350 within the groove 3280 and limit accidental disengagement.

[0435] In some forms, the groove 3280 may be asymmetric. The groove 3280 may include an undercut 6004 and a sloped surface 6008 on the protrusion 3284 side. The overhang 6000 may extend further above the undercut 6004 than the sloped surface 6008. The length of the overhang 6000 that extends above the undercut 6004 may limit the ability to remove the frame 3350 vertically from the plenum chamber 3200. The angle of the sloped surface 6008 may be directed toward the overhang 6000 and may limit the ability to remove the frame 3350 in an angled direction.

[0436] When the frame 3350 is assembled to the plenum chamber 3200 (e.g., via a press fit, friction fit, snap fit, etc.), the patient may align the protrusions 3284 with the slots 3372 such that the protrusions 3284 are received within the slots 3372 during use. The wider openings of the slots 3372 adjacent the rear face may assist the patient in aligning each protrusion 3284 within its respective slot 3372. The protrusions 3284 may be slightly wider than the front opening of each slot 3372, but can be received within the slots due to the flexibility of the plenum chamber 3200 (e.g., being constructed from a resilient material such as silicone). The protrusions 3284 may deform slightly when entering their respective slots 3372 (e.g., as a result of the slots 3372 narrowing).

[0437] When the protrusion 3284 enters the slot 3372, the protrusion 3284 may substantially return to its original shape. For example, the overhang 6000 may deform (e.g., elastically deform) when the slot 3372 receives the protrusion 3284, and may return the overhang 6000 to its original position when the central portion 3360 is received within the groove 3280. The patient may experience this deformation as a tactile response to more easily observe the correct connection between the frame 3350 and the plenum chamber 3200. The overhang 6000 of the protrusion 3284 may be wider than the forward opening of the corresponding slot 3372 in the relaxed or initial position.

[0438] Additionally, the width of the undercut 6004 may be approximately the same as the center portion 3360 so that the frame 3350 is tightly received within the groove 3280. The flexible material of the plenum chamber 3200 may cause the undercut 6004 to be narrower than the center portion 3360, so that the undercut 6004 may flex, receive the frame 3350 with a press fit, a friction fit, a snap fit, etc.

[0439] Therefore, the frame 3350 may not be easily removed from the plenum chamber 3200. The patient may have to apply force to the frame 3350 to remove it from the grooves 3280. This user-applied force may move the frame 3350 vertically or diagonally and may overcome the holding force provided by the overhang 6000. For example, the patient may lift the frame 3350 from the area where the center portion 3360 contacts the sloped surface 6008 to provide a force that separates the frame 3350 from the plenum chamber 3200.

[0440] This force may exceed that caused by normal movement of the plenum chamber 3200 and / or seal-forming structure 3100. In other words, the seal-forming structure 3100 and / or plenum chamber 3200 may move relative to the frame 3350 when the protrusions 3284 are received in their respective slots 3372. This allows the seal-forming structure 3100 and / or plenum chamber 3200 to flex and conform to the patient's face without loosening from the frame 3350 and allowing the slots 3372 to unintentionally disengage from the protrusions 3284.

[0441] In other forms, the plenum chamber 3200 may be molded into the frame 3350 and the protrusions 3284 may result from the molding process to permanently maintain the position of the frame 3350 relative to the plenum chamber 3200.

[0442] As shown in FIG. 26-3 , some configurations of the frame 3350 may be oriented to reduce cheek contact when the connected frame 3350 and plenum chamber 3200 are worn by a patient. For example, the arms 3362a, 3362b may be oriented (e.g., curved) to substantially complement at least a portion of the patient's face (e.g., cheek). However, in some instances, the entire length of each arm 3362 may not contact the patient's skin because the patient may find it uncomfortable to have a foreign object contact their face. Conversely, a portion of each arm 3362 may be spaced away from the patient's face so that a smaller surface area of ​​the arm 3362 contacts the patient's face. While maintaining substantially the same curvature for each arm 3362, the overall length of each arm 3362 that contacts the patient's face may be changed by shifting (e.g., through a manufacturing process) the contact point between each arm 3362 and the plenum chamber 3200. For example, if each arm 3362 contacts the plenum chamber 3200 closer to the elbow 3500, the maximum clearance between each arm 3362 and the patient's face will be greater. This means that a larger portion of each arm 3362 will be spaced away from the patient's face (as opposed to, for example, if each arm 3362 contacts the plenum chamber 3200 at the distal end of the elbow 3500). Reducing contact between each arm 3362 and the patient's face can improve patient comfort.

[0443] Additionally, each arm 3362 that contacts the plenum chamber 3200 closer to the elbow and therefore further from the rear face 3112 may provide less support at the side 3111 of the plenum chamber 3200 (e.g., because less of the rigid or semi-rigid arm engages the side 3111). This may allow the side 3111 to have more flexibility and better conform to the shape of the patient's nose to create an effective seal.

[0444] As shown in FIGS. 26-4 and 26-5 , some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the central portion 3360. The hinges 6012 may allow movement (e.g., pivotal movement) of the arms 3362 without affecting the connection between the frame 3350 and the plenum chamber 3200. In other words, pivoting either arm 3362 about its respective hinge 6012 may not disengage the protrusion 3284 from the slot 3372.

[0445] In some forms, the patient may move the arm 3362 to a second position to provide a better fit. For example, the distance between the loops 3352a, 3352b in the first position may be larger than the size of a typical patient's head. Thus, the patient may move the arm 3362 toward the second position to provide a proper fit (e.g., contact between the arm 3362 and the patient's head). The arm 3362 may be held in the second position by adjusting the upper headgear straps 3356, 3358 (i.e., the upper headgear straps 3356, 3358 may provide an external force).

[0446] Similar to the arms 3362, the plenum chamber 3200 and / or the seal-forming structure 3100 may be larger than the size of a typical patient's face. For example, the seal-forming structure 3100 may loosely engage the patient's mouth and / or nose. The plenum chamber 3200 and / or the seal-forming structure 3100 may also be moved toward a more compact position to better engage the individual patient's face.

[0447] 26-5, moving the arm 3362 to the second position may directly translate to moving the seal-forming structure 3100 and / or the plenum chamber 3200 to a more compact position. The arm 3362 may contact the plenum chamber 3200 along the second front wall portion 3242. The arm 3362 can also contact the second front wall portion 3242 that is closer to the center of the plenum chamber 3200 and farther from the side portion 3111.

[0448] Pivoting of each arm 3362 about the hinge 6012 may provide an inward force on the plenum chamber 3200. This may reduce the distance between the sides 3111 of the second seal-forming structure 3102 and position the second seal-forming structure 3102 snugly against the patient's nose. Compression of the seal-forming structure 3100 and / or plenum chamber 3200 may provide a better seal against the patient's face (e.g., by limiting the occurrence of leaks). Additionally, applying an inward force near the center of the plenum chamber 3200 (e.g., as described with reference to FIG. 26-3) may limit the formation of wrinkles in the seal-forming structure 3100 by limiting the overall compression of the plenum chamber 3200.

[0449] As shown in FIG. 46 , the plenum chamber 3200 may include a groove rib 6052 that is positioned in front of the groove 3280 when the patient interface 3000 is worn by the patient. The groove rib 6052 may be integrally formed with the plenum chamber 3200 or formed during molding. The groove rib 6052 may protrude forward from the surface of the plenum chamber 3200 and form the lower boundary of the groove 3280. The groove rib 6052 may be thicker than the surrounding portions of the plenum chamber 3200 and may serve as a reinforcing member. The groove rib 6052 can limit bending or flexing of the lower portion of the mouth 3201. This can help maintain the shape of the groove 3280, which can help retain the frame 3350 within the groove 3280.

[0450] As shown in Figure 28, the frame 3350 may be formed similarly to the frames of Figures 26 and 27. In other words, the frame 3350 may be constructed from a single material (e.g., semi-rigid). The frame 3350 may be thicker near the central portion 3360 and thinner toward each respective loop 3352a, 3352b.

[0451] In some forms, the central portion 3360 of the frame 3350 may be substantially solid throughout and may not include the slot 3372, and the plenum chamber 3200 may not include the protrusion 3284 within the groove 3280. Instead, the plenum chamber 3200 may include a protrusion 3288 disposed radially inward of the groove 3280. The protrusion 3288 may rise from the remainder of the front surface of the plenum chamber 3200. The protrusion 3288 may also extend at least partially radially outward. In other words, the protrusion 3288 may extend at least partially over the groove 3280 (e.g., the protrusion 3288 is spaced from the groove 3280).

[0452] During assembly of the removable frame 3350 to the plenum chamber 3200, the patient may be required to position the frame 3350 so that it extends into the grooves 3280 and under the protrusions 3288. Once the central portion 3260 is positioned, the protrusions 3288 can help hold the central portion 3360 in place. To remove the frame 3350 from the plenum chamber 3200, the patient may press on at least one of the protrusions 3288 (e.g., laterally towards the other protrusions 3288) so that the protrusions do not extend over the grooves 3280. In other forms, the plenum chamber 3200 may be molded into the frame 3350, and the protrusions 3288 may prevent the central portion 3360 from being removed.

[0453] In some forms, the frame 3350 of any of the examples described above may be substantially flush with the exterior surface of the plenum chamber 3200 when positioned within the groove 3280. The depth of the groove 3280 substantially corresponds to the thickness of the central portion 3360. Similarly, the shape of the central portion may substantially approximate the shape of the cushion, as described above. The resulting assembly may have a substantially uniform surface. This helps maintain the low-profile appearance of the patient interface 3000, as the frame 3350 does not protrude in front of the cushion, which may obstruct the patient's line of sight.

[0454] 5.3.6 Ventilation section In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases, for example carbon dioxide.

[0455] In certain forms, the vent 3400 is configured to allow continuous airflow from the interior of the plenum chamber 3200 to the ambient while the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is configured such that the magnitude of the airflow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure within the plenum chamber in use.

[0456] Ventilation section 3400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0457] The vent 3400 may be located on the plenum chamber 3200. Alternatively, the vent 3400 is located on a decoupling structure, such as a swivel.

[0458] Although no vent structure is shown in Figures 7-18, the embodiments of the present technology shown in Figures 7-18 may be provided with a suitable vent structure, for example in the plenum chamber (an example of which is shown in Figure 21).

[0459] 5.3.7 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (e.g., a swivel or a bulb). In some examples, the decoupling structure may be an elbow 3500 that connects (e.g., removably connects, permanently connects, etc.) to the plenum chamber 3200 (e.g., a plenum chamber inlet port).

[0460] As shown in FIGS. 23-28 , the central portion 3360 of the frame 3350 is annularly shaped, so that the central region of the mouth 3201 of the plenum chamber 3200 is not covered by the frame 3350. In some examples, the mouth 3201 includes an opening for receiving the elbow 3500. The opening may be significantly wider than the opening for receiving the elbow 3500 so that the frame 3350 is completely spaced from the opening. In other words, there is a length between the inner edge of the central portion 3360 and the opening for receiving the elbow 3500. The arms 3362 a, 3362 b and the secondary connections 3342 a, 3342 b are spaced apart from the opening and the elbow 3500, respectively, so that the headgear strap 3358 does not interfere with the movement (e.g., rotation) of the elbow.

[0461] Although not explicitly shown in the drawings of the plenum chamber shown in Figures 7-19, those skilled in the art will appreciate that in practice an elbow 3500 may be provided (e.g., as shown in Figure 23) to allow connection of the interface to the air circuit 4170.

[0462] 57, the elbow 3500 may be connected to the plenum chamber 3200 to provide airflow through the inlet port 3604. In the example shown, the elbow 3500 is indirectly connected to the plenum chamber 3200, although in other examples the elbow 3500 may be directly connected to the plenum chamber 3200.

[0463] As shown in Figures 57 and 58, an elbow 3500 is connected to the vent ring 3504. The vent ring 3504 may be directly connected to the plenum chamber 3200 and elbow 3500 to establish an indirect connection and air flow path between the air circuit 4170 (via the elbow) and the patient (via the plenum chamber 3200).

[0464] 59, the venting ring 3504 includes a rear surface 3508, a front surface 3512, and a ring body 3516 extending therebetween. In the illustrated example, the venting ring 3504 includes a substantially cylindrical shape in which the rear surface 3508 and the front surface 3512 are circular (although other shapes such as oval, triangular, rectangular, etc. may also be used). In some forms, the rear surface 3508 and / or the front surface 3512 may extend outside the ring body 3516 (i.e., have a larger diameter than the ring body 3516). This may result in the ring body 3516 being formed in a recessed groove shape.

[0465] In some forms, the posterior surface 3508 has a larger diameter than the anterior surface 3512 (although these diameters may be reversed). In some forms, the diameter of the posterior surface 3508 may be between about 1 mm and about 100 mm. In some forms, the diameter of the posterior surface 3508 may be between about 10 mm and about 75 mm. In some forms, the diameter of the posterior surface 3508 may be between about 20 mm and about 50 mm. In some forms, the diameter of the posterior surface 3508 may be between about 30 mm and about 40 mm. In some forms, the diameter of the posterior surface 3508 may be about 39 mm.

[0466] In some forms, the ring body 3516 may extend at an angle between the rear surface 3508 and the front surface 3512. For example, the diameter of the ring body 3516 near the front surface 3512 may be larger than the diameter near the rear surface 3508 (or vice versa). In some forms, the angle between the rear surface 3508 and the ring body 3516 may be approximately the same as the slope of the lip 3608, so that the vent ring 3504 may engage the lip 3608 in a sealing configuration.

[0467] Returning to FIG. 57 , the vent ring 3504 may be connected to the plenum chamber 3200 by engaging the lip 3608. In the illustrated example, the length of the lip 3608 may be approximately the same as the length of the ring body 3516. The substantially similar angle between the ring body 3516 and the lip 3608 allows the lip 3608 to be closely parallel to the surface of the ring body 3516. Because the length of the lip 3608 is substantially the same as the ring body 3516, when the vent ring 3504 engages the plenum chamber 3200, the lip 3608 may contact the posterior surface 3508 and the anterior surface 3508, 3512. The length of the lip 3608 may limit or prevent movement of the vent ring 3504 (e.g., along the port axis 3612) during use of the patient interface 3000. This contact may create a sealing engagement so that gas flow cannot escape between the vent ring 3504 and the inlet port 3604.

[0468] Continuing with reference to FIG. 57 , the vent ring 3504 may be connected to the plenum chamber 3200 such that the rear surface 3508 is located within the cavity 3272 (e.g., in the pressurized environment during use) and the front surface remains outside the cavity 3272 (e.g., exposed to the environment during use). The flexible material of the plenum chamber 3200 allows the vent ring 3504 to be partially inserted into an operating position through the inlet port 3604. Once correctly positioned, the rear surface 3508 may extend outside the lip 3608. In other words, the diameter of the rear surface 3508 is larger than the diameter of the lip within the cavity 3272 of the plenum chamber 3200. This may facilitate securing or locking the vent ring 3504 in place and may limit or prevent accidental disengagement between the vent ring 3504 and the inlet port 3604.

[0469] In some examples, the diameter of the rear surface 3508 may extend closely or adjacent to the inner surface of the plenum chamber 3200 within the cavity 3272. For example, the diameter of the rear surface 3508 may substantially match the contour of the plenum chamber 3200. The close proximity between the rear surface 3508 and the wall of the plenum chamber 3200 may create two simultaneous contact areas (i.e., the lip 3608 and the wall of the plenum chamber 3200). Multiple contact areas can increase the overall retention force of the vent ring 3504, thereby making accidental removal more difficult.

[0470] In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force between about 1 N and about 50 N. In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force between about 20 N and about 45 N. In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force between about 25 N and about 40 N. In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force between about 30 N and about 35 N. In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force of about 33 N. In some forms, the combination of the vent ring 3504 and lip 3608 may create a retention force of greater than about 20 N. A greater retention force may limit accidental disengagement of the vent ring 3504 during use (and may retain pressurized breathable gas towards the patient).

[0471] In some forms, the vent ring 3504 may include openings or vent holes 3520 that allow air (e.g., exhaled carbon dioxide) to exit the cavity 3272 of the plenum chamber 3200. In some forms, there may be at least two vent holes 3520. In other forms, there may be four or five vent holes 3520. As shown in FIG. 60 , a particular vent hole 3520 may extend around substantially the entire circumference of the vent ring 3504. In certain forms, the vent holes 3520 may be evenly spaced around the circumference of the vent ring 3504.

[0472] 57 and 58, the ring body 3516 may include an inner wall 3524 and an outer wall 3528. The outer wall 3528 may be sloped, and the inner wall 3524 may be substantially perpendicular to the rear and front portions 3508, 3512. The inner wall 3524 and the outer wall 3528 may be spaced apart to form a groove 3532. A vent hole 3520 may extend through the rear surface 3508 into the groove 3532 to vent to the surrounding environment.

[0473] In some forms, the ring seal 3536 may be located within the groove 3532. The ring seal 3536 may extend around the outer surface of the inner wall 3524 of the ring body 3516. In certain forms, the ring seal 3536 may not completely fill the groove 3532, leaving space for air to exit the plenum chamber 3200 through the vent holes 3520 and into the environment.

[0474] In certain configurations, a washer 3540 may be positioned within the groove 3532 and may contact the ring seal 3536. The washer 3540 may include an outer diameter greater than or equal to the outer diameter of the ring seal 3536 to shield the ring seal 3536 from view (e.g., from a bed partner). The washer 3540 may appear visually similar (e.g., color, texture, etc.) to provide the appearance of a substantially continuous front surface 3512 between the inner and outer walls 3524, 3528.

[0475] As shown in FIG. 57 , the vent ring 3504 may have an elbow 3500 inserted therein. For example, when the elbow 3500 is inserted into the inner diameter of the inner wall 3524, the elbow 3500 may be coupled to the vent ring 3504 via a snap fit, friction fit, and / or press fit. The elbow 3500 may further include a flange 3544 having an outer diameter that is larger than the outer diameter of the inner wall 3524 but smaller than the inner diameter of the outer wall 3528. In other words, the flange 3544 may extend partially through, but not completely through, the width of the groove 3532. As such, the flange 3544 may abut the washer 3540 (or ring seal 3536) but not completely block the flow path through the vent hole 3520. The contact between the flange 3544 and the washer 3540 helps to retain the ring seal 3536 and the washer 3540 within the groove 3532.

[0476] As noted above, in some forms, the elbow 3500 may exte...

Claims

1. 1. A patient interface, comprising: A plenum chamber formed entirely of a flexible material, a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure; an inlet port configured to provide fluid communication between the cavity and the surroundings; and a groove formed in a surface of the plenum chamber outside the cavity and exposed to ambient pressure, the groove being formed radially outward of the inlet port and the groove forming a closed periphery. A plenum chamber; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway entrance, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within a cavity of said plenum chamber throughout a patient's respiratory cycle; a positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position; Including, The positioning and stabilizing structure comprises: A frame coupled to the plenum chamber, a central portion including an inner periphery and an outer periphery, the inner periphery and the outer periphery being removably disposed within the groove, the inner periphery being configured to be spaced from the inlet port when disposed within the groove; a pair of upper arms extending rearwardly from the central portion and configured to extend over the patient's cheeks in use; and a frame including a pair of lower arms extending away from the central portion; and Headgear straps coupled to the pair of upper arms and the pair of lower arms of the frame and configured to provide tension to the seal-forming structure through the frame and onto the patient's face. a patient interface including

2. The patient interface of claim 1 , wherein the pair of upper arms is longer than the pair of lower arms.

3. A patient interface according to any one of claims 1 to 2, wherein each of the pair of upper arms includes a first type of connector and each of the pair of lower arms includes a second type of connector different from the first type of connector.

4. 4. A patient interface according to claim 3, wherein the first type of connector is selected from the group consisting of a loop, a ladder lock, and a cord stopper.

5. A patient interface according to any one of claims 3 to 4, wherein the first type connector is a loop, the loop including a first loop portion and a second loop portion adjacent to the first loop portion.

6. The patient interface of claim 5 , wherein the loop includes a partition at least partially separating the first loop portion from the second loop portion.

7. 7. A patient interface as described in claim 6, wherein a strap of the headgear strap is configured to be selectively inserted into a first loop portion under an optimal tension in use to contact the bulkhead, and the strap is configured to move to the second loop portion under tension greater than the optimal tension.

8. A patient interface according to any one of claims 3 to 7, wherein the second type of connector is a magnetic member.

9. The patient interface of claim 8 , wherein the magnetic member includes a generally oval shape.

10. A patient interface as described in any one of claims 8 to 9, wherein a housing is removably magnetically connected to the magnetic member.

11. 11. The patient interface of claim 10, wherein the housing includes a strap connector for connecting to a strap of the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stopper.

12. A patient interface according to any one of claims 10 to 11, wherein the housing is configured to engage a lip of an outer casing.

13. 13. A patient interface according to any one of claims 3 to 12, wherein at least one of the headgear straps includes an elastic portion stretchable between a first position and a second position, and at least one of the straps includes a warning portion configured to be visible in the second position and hidden in the first position.

14. At least one of the straps further includes a tactile response element including a first portion and a second portion disposed on either side of the warning portion; 14. The patient interface of claim 13, wherein the first and second portions of the tactile response element are configured to connect at the first location and to separate to alert a patient at the second location.

15. The patient interface of claim 14 , wherein the tactile responsive element is a magnet.

16. A patient interface according to any one of claims 3 to 13, wherein at least one of the headgear straps includes a first width and a second width that is greater than the first width.

17. 17. The patient interface of claim 16, wherein the first width is selectively receivable through the first type of connector and the second width is prevented from passing through the first type of connector.

18. 14. A patient interface according to any one of claims 3 to 13, wherein at least one of the headgear straps includes a plurality of ridges configured to provide a tactile response when passing through the first type connector.

19. 20. A patient interface according to claim 18, wherein the plurality of ridges are adhesive dots.

20. 14. A patient interface according to any one of claims 3 to 13, wherein at least one of the headgear straps includes a cutting edge configured to provide a tactile response when passing through the first type connector.

21. 21. A patient interface according to claim 20, wherein the cutting edge comprises a triangular, rectangular, and / or circular shape.

22. A patient interface according to any preceding claim, wherein the pair of upper arms and the pair of lower arms are integrally formed with the central portion.

23. 23. A patient interface according to any one of the preceding claims, wherein the plenum chamber includes at least one protrusion extending from the groove, and wherein a central portion of the frame includes at least one slot configured to selectively receive the at least one protrusion.

24. A patient interface according to any preceding claim, wherein the pair of lower arms are flush with the central portion.

25. The seal forming structure, a first seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth; a second seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's nasal entrance; and Further comprising: A patient interface according to any one of claims 1 to 24, wherein the groove is located below the second seal-forming structure and on a plenum chamber opposite the first seal-forming structure.

26. A patient interface according to any preceding claim, wherein each of the pair of upper arms has a woven sleeve connected thereto.

27. 1. A system for providing pressurized air to a patient, comprising: A patient interface according to any one of claims 1 to 26; a respiratory therapy system (RPT) device configured to generate an airflow at a therapeutic pressure; a conduit configured to connect the RPT device to the patient interface and deliver the airflow to the patient interface; The conduit is connected to an inlet port of the plenum chamber.

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