Ventilation arrangement for patient interface

Abstract

The patient interface includes a plenum chamber, a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, and a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings. The plenum chamber includes a front portion including an inlet configured to receive an air flow at a therapeutic pressure for the patient to breathe. The ventilation structure is configured, in use, to ventilate the gas flow from the interior of the plenum chamber generally laterally. The patient interface further includes a deflector configured to redirect the ventilated gas flow laterally. The patient interface further includes a diffuser for diffusing the ventilated gas flow.

Description

[Technical Field]

[0001] 1.1 Technical 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]

[0002] 1.2 Description of Related Art 1.2.1 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.

[0003] 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).

[0004] There are a variety of respiratory disorders, and particular disorders may be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0005] 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.

[0006] 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).

[0007] 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).

[0008] 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:

[0009] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0010] 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.

[0011] 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.

[0012] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases 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: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over several 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.

[0013] 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.

[0014] 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.

[0015] 1.2.2 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.

[0016] 1.2.2.1 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)).

[0017] 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 and backward against the posterior oropharyngeal wall, which may 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 perceive one or more of the following about the devices used to deliver such therapy: discomfort, difficulty to use, high cost, and poor aesthetics.

[0018] 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 through 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, it can improve the comfort and effectiveness of these treatments.

[0019] 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 treatments may be improved.

[0020] 1.2.2.2 Flow therapy Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some aim to deliver a prescribed respiratory volume by delivering an inspiratory flow profile, perhaps superimposed on a positive baseline pressure, for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's spontaneous breathing with a flow of regulated or enriched gas. 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 can be maintained 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 entrance to the airway 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.

[0021] 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 air at a specific oxygen concentration (the fraction of oxygen in ambient air, from 21% to 100%) delivered to a patient's airways at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0022] 1.2.3 Respiratory Therapy Systems These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0023] 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.

[0024] 1.2.3.1 Patient Interface The 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, for example, about 10 cmH2O positive pressure above ambient pressure, by forming a seal with, for example, a portion of the patient's face, to effectively perform the treatment.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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).

[0029] Some masks may cause patients to feel claustrophobic, anxious, and / or overly conspicuous.

[0030] Designing a patient interface posed many 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.

[0031] 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.

[0032] CPAP therapy is highly effective in treating certain respiratory conditions if patients comply with the treatment. Patients may not comply if the mask is uncomfortable or difficult to use.

[0033] 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.

[0034] 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.

[0035] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0036] 1.2.3.1.1 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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).

[0047] 1.2.3.1.2 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.

[0048] Several factors are considered when comparing different positioning and stabilization techniques. These include the effectiveness of the technique in maintaining the seal-forming structures in the desired position and engaging the face seal during use of the patient interface, the comfort of the interface to the patient, whether the patient feels intrusive and / or claustrophobic when the patient interface is worn, and aesthetics.

[0049] One technique involves the use of adhesives. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, adhesives can be uncomfortable.

[0050] 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.

[0051] 1.2.3.1.3 Pressurized air conduit In one type of treatment system, a flow of pressurized air is supplied to the patient interface via a conduit in the air circuit that is fluidly connected to the patient interface at a position in front of the patient's face when the patient interface is positioned against the patient's face in use. The conduit may extend from the patient interface in a direction forward from the patient's face.

[0052] 1.2.3.1.4 Pressurized air conduit for positioning and stabilizing the seal-molding structure Another type of treatment system includes a patient interface, and a tube delivering pressurized air to the patient's airway is also used as part of the headgear to position and stabilize the seal-forming portion of the patient interface on the patient's face. This type of patient interface is sometimes referred to as having "conduit-type headgear" or "headgear tubing." This patient interface allows a conduit in an air circuit providing pressurized airflow from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. One example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to a tube internal to the patient interface through a port located on the patient's head during use.

[0053] It is desirable for a patient interface incorporating headgear tubes to be comfortable for the patient to wear for extended periods of time while sleeping, to form an airtight and stable seal with the patient's face, and at the same time accommodate a variety of patient head shapes and sizes.

[0054] 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices 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.

[0055] A device designer may be presented with a myriad of choices. Design criteria are often in conflict, meaning that certain design choices are unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be highly sensitive to small changes in one or more parameters.

[0056] 1.2.3.3 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 inspiration and expiration. In other cases, a single-limb air circuit is used for both inspiration and expiration.

[0057] 1.2.3.4 Humidifier Airflow delivery 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 that minimizes drying of the nasal mucosa and increases comfort in the patient's airway. Additionally, in cooler climates, warm air applied to the interior of the patient interface and the facial area surrounding the patient interface is generally more comfortable than cold air.

[0058] 1.2.3.5 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).

[0059] 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.

[0060] 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.

[0061] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 1]

[0062] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0063] The sound pressure values ​​for various subjects are listed below. [Table 2] Summary of the Invention [Problem to be solved by the invention]

[0064] The shear effect or contact between airflows flowing in different directions within the patient interface can cause turbulence, which can result in noise. This effect can be affected by the patient's respiratory cycle, resulting in noise that is periodic. Within the patient interface, air received from the delivery tube can move in a different direction than the air exhaled by the patient, potentially moving in the opposite direction. During exhalation, the airflow exhaled by the patient can shear against or contact the airflow entering the patient interface from the tube. This can result in turbulence and noise. During inhalation or breath-holding (i.e., the period between inhalation and exhalation), the airflow entering the patient interface from the tube can shear against or contact the airflow within the patient interface. This can result in turbulence and noise. The periodic nature of the noise can be particularly undesirable.

[0065] Noise can also be generated when a patient sleeping on their side uses a patient interface when air is exhausted laterally from the patient interface. While the patient is sleeping, the airflow can come into contact with objects, such as pillows, or other parts of the patient's body, such as the patient's hands, which can generate noise. This can increase discomfort and, therefore, can prevent treatment from being received. In some embodiments, when a patient using a patient interface is sleeping on their back, air exhausted laterally from the patient interface can flow toward the patient's sleeping partner, disrupting their sleep. This can be confusing or uncomfortable for the patient's sleeping partner and can increase patient noncompliance.

[0066] Diffusing the airflow exiting the patient interface can help reduce noise and can also reduce disturbance to the patient's sleeping partner by diffusing the airflow vented toward them during use. However, diffusers require additional components / parts for the mask, which can increase manufacturing cost and complexity. [Means for solving the problem]

[0067] The present technology relates to providing medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, having one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0068] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0069] Another aspect of the present technology relates to methods used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders.

[0070] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0071] One aspect of the present technology relates to a ventilation structure for a patient interface. Another aspect relates to a patient interface including a ventilation structure. Yet another aspect includes a positioning and stabilizing structure for maintaining the patient interface in a therapeutically effective position on the patient's head.

[0072] Another aspect of the present technology includes a patient interface, the patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include an inlet configured to receive a flow of air at the therapeutic pressure for breathing by the patient. The patient interface includes a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber in use.

[0073] In various instances, The plenum chamber may include a front portion. - The front portion may include an entrance. The plenum chamber may include an interior portion. The medial portion may be positioned such that, in use, the patient's midsagittal plane passes through the medial portion. ●The entrance may be located on the inside. • The patient interface may include a delivery tube connected to the plenum chamber and configured to be in fluid communication with the inlet.

[0074] In various instances, The ventilation structure may be configured, in use, to vent gas flow from within the plenum chamber in a generally transverse direction. The ventilation structure may include a plurality of ventilation holes. • The ventilation structure may be located on a portion of the patient interface that is to the side of the inlet when in use. • The ventilation structure may be located above the plenum chamber. The ventilation structure may include a ventilation module. • The patient interface may include a ventilation module opening. • The ventilation module may be configured to connect to a portion of the patient interface that includes a ventilation module opening. ●The ventilation structure may be a first ventilation structure configured to ventilate a first gas flow from within the plenum chamber in use, and the patient interface may include a second ventilation structure configured to ventilate a second gas flow from within the plenum chamber. • The first ventilation structure may be configured, in use, to vent the first gas flow from the interior of the plenum chamber in a first generally lateral direction. The second ventilation structure may be configured, in use, to vent the second gas flow from the interior of the plenum chamber in a second generally lateral direction. The first generally lateral direction may be essentially opposite to the second generally lateral direction. • The first ventilation structure may be located laterally of the inlet on one side of the patient interface. • A second ventilation structure may be located laterally of the inlet on the other side of the patient interface.

[0075] In various instances, • The patient interface may include a deflector configured to redirect at least a portion of the ventilated gas flow in use. • The patient interface may include a deflector configured to redirect a substantial amount of ventilated gas flow in use. • The patient interface may include a deflector configured, in use, to redirect at least a portion of the laterally ventilated gas flow in a direction having a forward component relative to the patient. • The patient interface may include a deflector configured to, in use, redirect a substantial amount of laterally ventilated gas flow in a direction having a forward component relative to the patient. • The patient interface may include a deflector configured to, in use, redirect a substantial amount of laterally ventilated gas flow substantially in a forward direction. • The deflector may include an arrangement of one or more deflector walls. The deflector may be configured to direct the directionally ventilated gas flow towards said inner portion. - The deflector may be configured, in use, to redirect a substantial amount of laterally ventilated gas flow towards said front of the plenum chamber. • The deflector may be configured to, in use, redirect a substantial amount of the transversely vented gas flow towards a portion of the delivery tube. The deflector may be used as part of a ventilation structure. The deflector may include a first deflector configured to, in use, redirect a first ventilation gas flow, and the patient interface may include a second deflector configured to redirect a second ventilation gas flow. ●The patient interface may include a first deflector configured to, in use, redirect at least a substantial amount of a first gas flow in a first direction, and the patient interface may include a second deflector configured to, in use, redirect a substantial amount of a second gas flow in a second direction. The positioning and stabilising structure may include a first deflector configured to, in use, redirect at least a substantial amount of a first gas flow in a first direction, and the positioning and stabilising structure may include a second deflector configured to, in use, redirect a substantial amount of a second gas flow in a second direction. The first ventilation gas flow may be a first lateral ventilation gas flow. The second ventilation gas flow may be a second lateral ventilation gas flow. • The first deflector may be configured, in use, to divert a substantial amount of the first lateral ventilation gas flow in a forward direction. • The second deflector may be configured, in use, to divert a substantial amount of the second lateral ventilation gas flow in a forward direction.

[0076] In various instances, • The patient interface may include a spacer that provides a gap between the surface of the ventilation structure and the surface of the deflector. The spacer may include at least one rib, preferably a plurality of ribs. • The ribs may provide multiple flow paths for redirecting gas flow from the ventilation structure. The spacer may include part of the ventilation structure. The spacer may include a portion of the deflector. The spacer may include at least one deflector wall.

[0077] In various instances, • The patient interface may include a pair of connectors to facilitate attachment of the plenum chamber to the positioning and stabilizing structure. At least one of the connectors may be included as part of the ventilation structure. At least one of the connectors may be included as part of the deflector.

[0078] In various instances, - The patient interface may include positioning and stabilising structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilising structure may include at least one headgear strap, preferably a plurality of headgear straps. At least one headgear strap may be removably attached to the connector by a button fastening. At least one headgear strap may include a buttonhole. At least one headgear strap includes a sleeve-like structure that receives insertion of a portion of the connector into the at least one headgear strap via the buttonhole.

[0079] In various instances, The positioning and stabilising structure may include a diffuser. • The diffuser may be positioned to diffuse the gas flow from the ventilation structure. The positioning and stabilising structure may include components. - This component may include a diffuser. - The component may include a vent-facing surface. • The ventilation-facing surface may, in use, be located in the path of ventilation gas flow from the ventilation structure. • The diffuser may be located on the ventilation-facing side of the component. • A component may include a frame. • The frame may be configured to facilitate indirect attachment of the plenum chamber to at least one headgear strap. • The component may include at least one tube. The at least one tube may be configured, in use, to direct air flow from an air circuit fluidly connected to the at least one tube to the interior of the plenum chamber via the inlet. At least one of the tubes may be a headgear tube. - This component may include a rigidiser arm. The rigidiser arm may be configured to stiffen at least one headgear strap for positioning and stabilizing construction. • The diffuser may be removably attached to the component. • The diffuser may be removably attached to the frame. • The diffuser may be removably attached to at least one tube. • The diffuser may be removably attached to the rigidiser arm.

[0080] In various instances, The positioning and stabilizing structure may include a frame. • The frame may be configured to facilitate indirect attachment of the plenum chamber to at least one headgear strap. ● The frame may be attached to the plenum chamber, and at least one headgear strap may be attached to the frame. The delivery tube may be attached to the frame and / or the plenum chamber. The delivery tube may be attached to the frame. - The frame may include an opening. • The delivery tube may be configured, in use, to be in fluid communication with the inlet through an opening in the frame. • The frame may include a diffuser positioned to diffuse gas flow from the ventilation structure. - The covering portion of the frame may cover at least part of the ventilation structure in use. The diffuser may be located on a covering portion of the frame. • The diffuser may be removably attached to the frame. • The frame may include at least one of connectors, preferably a pair of connectors, to facilitate attachment of the frame to at least one headgear strap. At least one headgear strap may be removably attached to the connector(s) of the frame. The frame may include a deflector. • Part of the frame may be positioned to redirect gas flow from the ventilation structure, in use.

[0081] In various instances, The positioning and stabilising structure may include at least one tube. The at least one tube may be configured, in use, to direct air flow from an air circuit fluidly connected to the at least one tube to the interior of the plenum chamber via the inlet. At least one of the tubes may be a headgear tube. • At least one tube may include a diffuser arranged to diffuse gas flow from the ventilation structure. - The covering portion of the at least one tube may cover at least part of the ventilation structure in use. The diffuser may be located on the covering of at least one tube. • The diffuser may be removably attached to at least one tube.

[0082] In various instances, ●The ventilation structure is safe even when positioned on the positioning and stabilizing structure. The positioning and stabilising structure may include a conduit portion. • The plenum chamber may include an opening, and the conduit portion may be configured, in use, to be in fluid communication with the interior of the plenum chamber via the opening. • The patient interface may include a connector configured to facilitate attachment of the conduit portion to the opening. ●The ventilation structure may be located on the duct section. The conduit portion may be a first conduit portion including a ventilation structure as the first ventilation structure and an opening as the first opening, the first conduit portion configured to be in fluid communication with the interior of the plenum chamber via the first opening in use, and the positioning and stabilising structure may include a second conduit portion including a second ventilation structure, the plenum chamber including a second opening, and the second conduit portion configured to be in fluid communication with the interior of the plenum chamber via the second opening in use. ●The connector may be a first connector configured to facilitate attachment of the first conduit portion to the first opening, and the patient interface may include a second connector configured to facilitate attachment of the second conduit portion to the second opening. - The conduit portion may be configured to be relatively rigid. - The conduit portion may be configured to be relatively flexible. • The conduit section may include support structures to limit and / or prevent blockage of the conduit section. • The support structure may be provided by one or more of a reinforcing structure, a thickened region, and a reinforced region. • The positioning and stabilising structure may include a lower end connected, in use, to the plenum chamber, and the conduit portion includes the lower end. • The ventilation structure may be located near the lower end of the positioning and stabilising structure when in use. The plenum chamber may include a laterally protruding connection portion with the opening located on the laterally protruding connection portion. ●The laterally protruding connection portion may be a first laterally protruding connection portion including a first opening, and the plenum chamber includes a second laterally protruding connection portion, and the second opening is located on the second laterally protruding connection portion. At least one headgear strap may be connected to the conduit portion. At least a portion of at least one headgear strap covers at least a portion of the conduit portion and at least a portion of the ventilation structure. • The ventilation structure may be located to the side of the plenum chamber when in use. • The ventilation structure may be located near the lower end of the positioning and stabilising structure when in use. The conduit portion may include a deflector.

[0083] In various instances, • The patient interface may include a diffuser arranged to diffuse the gas flow from the ventilation structure. • The diffuser may be configured to diffuse the ventilated gas flow from the interior of the patient interface through the ventilation structure to the surroundings. At least one headgear strap may include a diffuser. At least one headgear strap may include a covering portion that may be configured to cover at least a portion of the ventilation structure when in use. The diffuser may be located on a covering portion of at least one headgear strap. The diffuser may be removably attached to at least one headgear strap. • The diffuser may be formed from a woven material. • The diffuser may be formed by raising part of the surface of a woven material. The diffuser may be formed separately and attached to at least one headgear strap. • The diffuser may be formed from the headgear strap material. • The diffuser may be formed by raising part of the surface of the headgear strap material. - The diffuser may form at least part of the deflector.

[0084] In various instances, • The patient interface may be in the form of a nasal mask. - The seal-forming structure may be configured to form a seal with the underside of the nose around the nostrils in use. • The seal-forming structure may be configured to form a seal around the patient's nostrils in use, rather than around the patient's mouth.

[0085] In various instances, • The seal-forming structure may be configured to form a seal around the patient's nose and mouth in use.

[0086] One form of the present technology relates to a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The plenum chamber may include a front portion including an inlet configured to receive airflow at the therapeutic pressure for breathing by the patient. The patient interface includes a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the periphery. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber in use. The ventilation structure may be configured to ventilate the gas flow from the interior of the plenum chamber generally laterally in use. The patient interface may also include a deflector configured to redirect a substantial amount of the laterally ventilated gas flow in a direction having a component in front of the patient in use.

[0087] In examples, the patient interface may include a patient interface as described in any one or more of the previously described aspects and / or examples of the present invention.

[0088] Another form of the present technology relates to a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The plenum chamber may include an inlet configured to receive an air flow at the therapeutic pressure for breathing by the patient. The patient interface includes a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber in use. The patient interface includes a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include at least one headgear strap, the at least one headgear strap including a diffuser. The diffuser may be positioned to diffuse the gas flow from the ventilation structure.

[0089] In examples, the patient interface may include a patient interface as described in any one or more of the previously described aspects and / or examples of the present invention.

[0090] Another form of the present technology relates to a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The plenum chamber may include an inlet configured to receive airflow at the therapeutic pressure for breathing by the patient. The patient interface includes a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to be ventilated from the interior of the plenum chamber to the ambient. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber in use. The patient interface includes a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a component. The component may include a ventilation-facing surface. The ventilation-facing surface may be located in the path of ventilation gas flow from the ventilation structure in use. The patient interface may further include a diffuser. The diffuser may be located on the ventilation-facing surface of the component. The diffuser may be positioned to diffuse ventilation gas flow from the ventilation structure.

[0091] In one example, the patient interface may include a patient interface as described in any one or more of the previously described aspects and / or examples of the present invention.

[0092] One form of the present technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure may include a diffuser. The diffuser may be configured to diffuse ventilated gas flow from an interior of the patient interface to the surroundings via ventilation structure configured on the patient interface.

[0093] In one example, the positioning and stabilizing structure may include a positioning and stabilizing structure according to any one or more of the above-described aspects and / or examples of the present invention.

[0094] One form of the present technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure may include a component. The component may include a vent-facing surface. The vent-facing surface may be located in a path of ventilation gas flow from the ventilation structure of the patient interface, in use. The positioning and stabilizing structure may further include a diffuser. The diffuser may be located on the vent-facing surface of the component. The diffuser may be configured to diffuse the ventilation gas flow of gas from the ventilation structure.

[0095] In one example, the positioning and stabilizing structure may include a positioning and stabilizing structure according to any one or more of the above-described aspects and / or examples of the present invention.

[0096] Another form of the present technology relates to a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may further include a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may further include a positioning and stabilizing structure for maintaining the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a conduit portion, and the plenum chamber may include an opening. The conduit portion may be configured to be in fluid communication with the interior of the plenum chamber through the opening in use. The conduit portion may include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings. The ventilation structure may be configured to maintain the therapeutic pressure within the patient interface in use.

[0097] In examples, the patient interface may include a patient interface as described in any one or more of the previously described aspects and / or examples of the present invention.

[0098] Another form of the present technology relates to a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head. The positioning and stabilizing structure may include a conduit configured to be in fluid communication with an interior of the patient interface in use. The conduit may include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the patient interface to the surroundings. The ventilation structure may be configured to maintain a therapeutic pressure within the patient interface in use.

[0099] In one example, the positioning and stabilizing structure may include a positioning and stabilizing structure according to any one or more of the above-described aspects and / or examples of the present invention.

[0100] Another form of the present technology relates to a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may further include a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may further include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber to the periphery. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber in use. The patient interface may also include a deflector configured to redirect a volume of ventilated gas flow in use. The positioning and stabilizing structure may include the deflector.

[0101] In one example, the patient interface may include a patient interface according to any one or more of the previously described aspects and / or examples of the present invention.

[0102] Another aspect of the present technology relates to a method of manufacturing a diffuser that includes part of a headgear strap of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head, the method may include the following steps, performed in any order: (a) forming a diffusion layer on a surface of a headgear belt material, the diffusion layer configured to diffuse the gas flow ventilated through a ventilation structure disposed in a patient interface in use; and (b) forming a headgear strap from the headgear strap material;

[0103] In various instances, Step (a) may include raising a portion of the surface of the headgear strap material. Step (a) may include trimming the napped portion of the surface of the headgear strap material. Step (a) may include forming a diffusion layer from a woven material and attaching the diffusion layer to the surface of the headgear strap material using an adhesive or other known attachment method. • The diffusion layer may be formed by cutting a woven material.

[0104] In various instances, • Step (b) may include cutting the headgear strap material into headgear straps. • The headgear strap material may comprise a woven material.

[0105] Another aspect of the present technology relates to a method of manufacturing a diffuser that includes a portion of at least one headgear tube of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head, the method may include the following steps, performed in any order: (a) forming a diffusion layer on a surface of at least one headgear tube, the diffusion layer configured to diffuse ventilated gas flow through a ventilation structure disposed in a patient interface during use; and (b) Forming headgear tubes.

[0106] In various instances, Step (a) may include raising a portion of the surface of the headgear tube, wherein the headgear conduit is formed from a layer of textile material. Step (a) may comprise trimming the napped portion of the surface of the textile material. Step (a) may include forming a diffusion layer from a woven material and attaching the diffusion layer to the surface of the headgear conduit using an adhesive or other known attachment method. • The diffusion layer may be formed by cutting the woven material and raising the woven material, in either order.

[0107] In various instances, • Step (b) may include forming the headgear tubes 3350 from one or more materials (eg, silicone resin). The textile material may comprise a fleece material.

[0108] Another aspect of the present technology relates to a method of manufacturing a diffuser that includes part of a frame of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head, the method may include the following steps, performed in any order: (a) forming a diffusion layer on a surface of the frame, the diffusion layer configured to diffuse a ventilated gas flow through a ventilation structure disposed in a patient interface during use; and (b) Form a frame.

[0109] In various instances, Step (a) may include raising a portion of the surface of the frame, the frame being formed from a layer of textile material. Step (a) may comprise trimming the napped portion of the surface of the textile material. Step (a) may include forming a diffusion layer from a woven material and attaching the diffusion layer to the surface of the frame using an adhesive or other known attachment method. • The diffusion layer may be formed by cutting the woven material and raising the woven material, in either order.

[0110] In various instances, Step (b) may include forming the frame from one or more materials (e.g., polymers). Suitable polymers may include thermoplastics or elastomers such as silicone. The textile material may comprise a fleece material.

[0111] 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.

[0112] 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.

[0113] An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0114] 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.

[0115] 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]

[0116] The present technology is illustrated by way of example and not limitation in the diagrammatic representations of the accompanying drawings in which like reference numerals refer to similar elements, including:

[0117] [Figure 1A]3.1 shows a respiratory therapy system including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives positively pressurized air supplied by an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine sleep 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. 3.2 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. 3.3 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, where the cross-section is taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. 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. [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. [Figure 3Y] 3 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B]1 is a schematic diagram of the air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items in the air pressure path between the blower and patient interface are downstream of the blower and upstream of the patient interface. 3.5 Humidifier [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. 3.6 Other Forms of Patient Interface [Figure 6] 1 shows a cross-sectional view of a first portion of a patient interface according to the prior art. [Figure 6A]

[0033] Fig. 10 shows a perspective view of a patient interface in use in accordance with one form of the present technology. [Figure 6B] FIG. 6B shows an enlarged perspective view of the patient interface of FIG. 6A. [Figure 6C] FIG. 6B shows a cross-sectional view of a first portion of the patient interface of FIG. 6A. [Figure 6C-1] FIG. 13 shows a top view of an exemplary headgear strap including buttonholes in accordance with one form of the present technology. [Figure 6D] FIG. 6B shows a cross-sectional view of a second portion of the patient interface of FIG. 6A. [Figure 7A] FIG. 10 is a perspective view of a patient interface in accordance with another form of the present technology, showing the patient interface without the positioning and stabilising structure connected thereto; [Figure 7B] FIG. 7B is a perspective view of the patient interface of FIG. 7A showing a portion of the positioning and stabilizing structure connected thereto. [Figure 8A]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with another form of the present technology. [Figure 8B] FIG. 8B shows a cross-sectional view of a first portion of the patient interface of FIG. 8A. [Figure 8C] FIG. 8B shows a perspective view of the patient interface of FIG. 8A without the positioning and stabilizing structure connected to it. [Figure 9A]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with another form of the present technology. [Figure 9B] FIG. 9B shows a cross-sectional view of a first portion of the patient interface of FIG. 9A. [Figure 9C] FIG. 9B shows a perspective view of the patient interface of FIG. 9A without the positioning and stabilizing structure connected thereto. [Figure 9D] FIG. 9B shows a perspective view of a portion of a positioning and stabilizing structure for use with the patient interface of FIG. 9A. [Figure 10A]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with another form of the present technology. [Figure 10B] FIG. 10B shows a cross-sectional view of a first portion of the patient interface of FIG. 10A. [Figure 10C] FIG. 10B shows an enlarged cross-sectional view of a first portion of the patient interface of FIG. 10A. [Figure 11A]

[0033] Fig. 14 shows a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 11B] FIG. 11B shows a perspective view of the patient interface of FIG. 11A. [Figure 11C] FIG. 11B shows a cross-sectional view of a first portion of the patient interface of FIG. 11A. [Figure 12A]

[0033] Fig. 14 shows a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 12B] FIG. 12B shows a perspective view of the patient interface of FIG. 12A. [Figure 12C] FIG. 12B shows a cross-sectional view of a first portion of the patient interface of FIG. 12A. [Figure 12D] FIG. 12B shows a perspective view of the patient interface of FIG. 12A without the air circuit connected. [Figure 12E] FIG. 12B shows an enlarged perspective view of a portion of the patient interface of FIG. 12A , excluding the headgear strap material attached to the ventilation module. [Figure 13A]

[0033] Fig. 14 shows a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 13B] FIG. 13B shows a perspective view of the patient interface of FIG. 13A. [Figure 13C] FIG. 13B shows a cross-sectional view of a first portion of the patient interface of FIG. 13A. [Figure 14A] FIG. 10 is a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 14B] FIG. 14B shows an enlarged perspective view of the patient interface of FIG. 14A. [Figure 15A]

[0033] Fig. 14 shows a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 15B] FIG. 15B shows a perspective view of the patient interface of FIG. 15A. [Figure 15C] FIG. 15B shows a side view of the patient interface of FIG. 15A. [Figure 15D] FIG. 15B shows a cross-sectional view of a first portion of the patient interface of FIG. 15A. [Figure 16A] 14 shows a diffuser included as part of a positioning and stabilizing structure provided in a patient interface in accordance with one form of the present technology. [Figure 16B] FIG. 13 is a side view of a portion of a headgear strap including a diffuser in accordance with one form of the present technology. [Figure 16C] FIG. 13 shows a top view of a portion of a headgear strap including a diffuser in accordance with another form of the present technology. [Figure 16D] FIG. 16D is a side perspective view of the headgear strap of FIG. 16C. [Figure 17]

[0033] Fig. 14 shows a perspective view of a patient interface in use in accordance with another form of the present technology. [Figure 18] 18 shows an enlarged, partial cross-sectional perspective view of the patient interface of FIG. 17. [Figure 19] FIG. 18 shows an enlarged cross-sectional view of a first portion of the patient interface of FIG. 17. [Figure 20] FIG. 18 is a perspective view of the patient interface of FIG. 17, showing the patient interface without the positioning and stabilizing structure connected thereto. [Figure 21] FIG. 18 shows an enlarged perspective view of the positioning and stabilizing structure of the patient interface of FIG. 17; [Figure 22]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with another form of the present technology. [Figure 23] FIG. 23 shows an enlarged cross-sectional view of a first portion of the patient interface of FIG. 22. [Figure 24] FIG. 23 is an enlarged perspective view of the positioning and stabilizing structure of the patient interface of FIG. 22; DETAILED DESCRIPTION OF THE INVENTION

[0118] 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.

[0119] 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 be arranged into additional examples.

[0120] 4.1 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.

[0121] 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.

[0122] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0123] 4.2 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.

[0124] 4.3 Patient Interface 3A , a non-invasive patient interface 3000 in accordance with one aspect of the present technology includes, as functional features, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a ventilation section 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. 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.

[0125] 6A-24 , a patient interface 3000 in accordance with one aspect of the present technology includes a seal-forming structure 3100, a plenum chamber 3200, a connection port 3600 for connection to an air circuit 4170, and a ventilation structure 3400 or pair of ventilation structures 3400 configured to ventilate gas flow from the interior of the plenum chamber 3200. In the illustrated form, the ventilation structure 3400 or pair of ventilation structures 3400 are configured to ventilate gas flow in a generally lateral direction in use.

[0126] References to directions (e.g., "lateral," etc.) should be understood to refer to the anatomical direction relative to the body when the patient interface 3000 is worn by a patient in a normal use position, unless the context requires otherwise. References to "substantially" with respect to such directions, such as "substantially lateral," can be understood to mean extending at least partially in the associated direction. In one example, a direction may be "lateral" if it generally extends perpendicular to the midsagittal plane of the patient's face (as shown in FIG. 2C) and / or relative to the midsagittal plane of the plenum chamber (as shown in FIGS. 3U-3W). Laterally extending components may also extend in other directions.

[0127] Thus, forms of the present technology relate to a patient interface 3000 that is configured to achieve "side ventilation," in which air is ventilated substantially laterally (i.e., sideways) from a patient in use through a portion of the patient interface (e.g., the plenum chamber 3200 or conduit). As explained, another component may deflect the airflow from that direction before it dissipates into the surroundings.

[0128] In some forms, the patient interface 3000 includes an air circuit 4170, such as a delivery tube 4172. In the examples shown in FIGS. 6A-16A and 17-24, the patient interface 3000 is configured to connect to a delivery tube 4172 (not shown in some figures). As shown in these examples, the delivery tube 4172 is connected to the plenum chamber 3200 via a connection port 3600. The connection port 3600 may be provided on the plenum chamber and the delivery tube 4172 may be directly connected to the plenum chamber 3200. Alternatively, the connection port 3600 may be provided on another component, and the delivery tube 4172 may be indirectly connected to the plenum chamber 3200 via one or more other components. In the example shown in FIG. 22, the patient interface 3000 is configured to connect to a delivery tube (not shown). In this example, the delivery tube may be connected to the plenum chamber 3200 via at least one headgear tube 3350 that includes a connection port 3600.

[0129] 6A-24, the patient interface 3000 includes a deflector 3500, preferably a pair of deflectors 3500, configured to redirect or rotate at least a portion of the ventilated gas flow before the air flow meets the surrounding body of air and dissipates. Unless the context requires otherwise, references to "redirection," "rotation," etc. should be understood as a change in direction between the direction of the ventilation gas flow and the direction of the gas flow after being redirected or rotated by the deflector 3500, i.e., the direction of the gas flow after being redirected or rotated by the deflector 3500.

[0130] In the form of the present technology shown in FIGS. 6A-24, the patient interface 3000 includes a positioning and stabilizing structure 3300 that provides force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's face. In certain forms, the positioning and stabilizing structure 3300 includes at least one headgear strap 3310, preferably multiple headgear straps 3310 or headgear strap assemblies, as shown, for example, in FIGS. 6A, 11A, 12A, 13A, 14A, 15A, and 17. The positioning and stabilizing structure 3300 may also include a frame 3360, as shown, for example, in FIGS. 22-24. In other forms, the positioning and stabilizing structure 3300 may include one or more headgear tubes 3350 that deliver pressurized air received from, for example, a conduit. A delivery tube 4172 passes, for example, through the plenum chamber 3200 and the seal-forming structure 3100 to the patient's airway.

[0131] In some forms of the present technology shown in FIGS. 6A-15D, the patient interface 3000 includes a pair of connectors 3800 to facilitate attachment of the patient interface 3000 to the positioning and stabilizing structure 3300.

[0132] In some forms of the present technology, as shown in, for example, FIGS. 6A-9D, 11A-15D, and 17-24, the patient interface 3000 may include a diffuser 3900 to diffuse the airflow. This may help reduce or prevent noise. In some forms of the present technology, the plenum chamber 3200 and the seal-forming structure 3100 are provided by a single physical component. In the example shown in FIGS. 6A-23, the patient interface 3000 includes a connection module 3150. In this example, the connection module 3150 provides the plenum chamber 3200 and the seal-forming structure 3100 of the patient interface 3000. The seal-forming structure 3100 and other walls of the connection module 3150 form the plenum chamber 3200 in this example. In other forms of the present technology, the plenum chamber 3200 and the seal-forming structure 3100 are provided by multiple physical components, for example, one component for the plenum chamber 3200 and another component for the seal-forming structure 3100.

[0133] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 4.3.1 Plenum chamber A patient interface 3000 according to some examples of the present technology includes a plenum chamber 3200 that is pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber 3200 is capable of receiving a flow of air at the therapeutic pressure for breathing by the patient.

[0138] In some forms of the present technology, the plenum chamber 3200 is provided at least in part by the treatment module 3150 of the patient interface 3000.

[0139] According to some examples (eg, the examples shown in FIGS. 6A-24), the action module 3150 may include a frame portion 3210 and a seal-forming structure 3100.

[0140] The plenum chamber 3200 may be defined, at least in part, by both the frame portion 3210 and the seal-forming structure 3100. The frame portion 3210 may support the seal-forming structure 3100 against the patient's face in use. The frame portion 3210 and the seal-forming structure 3100 may partially enclose a volume of space having air at a pressure higher than atmospheric pressure in use to form the plenum chamber 3200.

[0141] In particular, the frame portion 3210 may at least partially define a plenum chamber 3200 that is pressurizable to a treatment pressure of at least 6 cmH2O above ambient air pressure.

[0142] 10A-10C and 10C. The frame portion 3210 may include one or more laterally protruding connection portions 3212 configured to connect to the positioning and stabilizing structure 3300. The laterally protruding connection portions 3212 may also partially form the plenum chamber 3200 with other portions of the action module 3150, i.e., the laterally protruding connection portions 3212 may be configured to include respective volumes, where the volume within the laterally protruding connection portions 3212 is a portion of the volume within the plenum chamber 3200.

[0143] The seal-forming structure 3100 may be disposed on the frame portion 3210 and may at least partially form the plenum chamber 3200. The seal-forming structure 3100 may be permanently or removably connected to the frame portion 3210. The seal-forming structure 3100 may be supportable by the frame portion 3210.

[0144] In certain configurations, the plenum chamber 3200 has a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 3200 is placed in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend about the entire periphery of the plenum chamber 3200.

[0145] In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous sheet of material. In some forms, the plenum chamber 3200 may be formed from a homogenous sheet of material with connectors formed from other materials. In other forms, the plenum chamber 3200 is constructed from multiple materials, for example, one material is used to form the frame portion 3210 and another material is used to form the seal-forming structure 3100, and the plenum chamber 3200 includes the frame portion 3210 and at least a portion of the seal-forming structure 3100.

[0146] In certain forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0147] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). For example, in the examples shown in FIGS. 6A-24, the majority of the treatment module 3150 is formed from silicone. Specifically, in these examples, the frame portion 3210 and the seal-forming structure 3100 are both formed from silicone. 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.

[0148] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0149] In the exemplary embodiment of the technology shown in FIGS. 6A-23, the frame portion 3210 may be flexible, e.g., formed from a material having a relatively low modulus of elasticity, thereby allowing the frame portion 3210 to flex or bend. The seal-forming structure 3100 may be flexible, e.g., formed from the same material or another material having a relatively low modulus of elasticity. In some examples, the frame portion 3210 and the seal-forming structure 3100 may be integrally formed and formed from a deformable material. The frame portion 3210 may be formed from a resilient material, such as silicone. The seal-forming structure 3100 may be formed from a resilient material. The frame portion 3210 and the seal-forming structure 3100 may be integral. In these examples, the frame portion 3210 and the seal-forming structure 3100 are molded together as a single part formed from a resilient material (e.g., silicone). The seal-forming structure 3100 and the frame portion 3210 (or at least a majority of the frame portion 3210) may be formed (e.g., constructed, molded, etc.) together from a single homogenous sheet of deformable material (e.g., a resilient material such as silicone). The frame portion 3210 and the seal-forming structure 3100 may be of unitary construction.

[0150] In other examples of the present technology, the seal-forming structure 3100 may be removably connected to the frame portion 3210. The seal-forming structure 3100 may be connected to the frame portion 3210 by a soft-to-soft, soft-to-hard, or hard-to-hard connection.

[0151] 6A-23, the plenum chamber 3200 includes an inlet 3220 configured to receive a flow of air at a therapeutic pressure for breathing by the patient. In the example shown in FIGS. 6A-15D, the plenum chamber 2300 includes the inlet 3220 and a pair of openings 3240 configured to fluidly communicate with the interior of the plenum chamber 3200. In the example shown in FIGS. 6A-15D, the inlet 3220 and openings 3240 may be located on the frame portion 3210. In the example shown in FIGS. 17-24, the plenum chamber 2300 includes the inlet 3220 and does not include any additional openings 3240 beyond those necessary for delivery of gases to the patient's airways.

[0152] In some embodiments, the inlet 3220 may be circular. For example, in the examples of FIGS. 6A-9D, the inlet 3220 is substantially circular. In some embodiments, the inlet 3220 may be non-circular. For example, the inlet 3220 may be approximately elliptical or oval, as shown in FIGS. 10A-13C and 15-15D. As shown in FIG. 20, in some embodiments, the inlet 3220 may be generally triangular in shape with curved corners when viewed from an angle. The shape of the inlet 3220 may not be completely flat, but rather the contour of the inlet 3220 may form a three-dimensional space curve, such as the shape of FIG. 20. In these examples, the inlet 3220 may have a width (i.e., the distance between the first and second side edges of the inlet 3220) that is greater than its height (i.e., the distance between the top and bottom edges of the inlet 3220).

[0153] 6A-24, the plenum chamber 3200 includes a front surface 3211. The frame portion 3210 may include a front portion 3211. The inlet 3220 may be located within the front portion 3211.

[0154] In some forms, the inlet 3220, or a portion thereof, may be located on the side 3213 of the plenum chamber 3200. For example, as shown in Figures 10A-13C, 15A-15D, and 20, at least a portion of the inlet 3220 is located on the side 3213 of the plenum chamber 3200.

[0155] 10A-10C, 13A-13C, and 15A-15D, the frame portion 3210 may include a pair of laterally protruding connecting portions 3212. Each laterally protruding connecting portion 3212 includes an opening 3240 configured to be in fluid communication with the interior of the plenum chamber 3200.

[0156] In some examples, a rigidizer may be provided to make the frame portion 3210 more rigid (while still being flexible). In some examples, the frame portion 3210 and the seal-forming structure 3100 are formed of a material having a relatively low modulus of elasticity (e.g., silicone, TPE, etc.), and the frame portion 3210 includes a rigidizer. In particular, the patient interface 3000 or the action module 3150 may include a rigidizer. The rigidizer may be provided on the frame portion 3210. The rigidizer may be configured to stiffen the frame portion 3210. The rigidizer may be configured to resist deformation of the frame portion 3210. The rigidizer may be configured to provide support to the frame portion 3210. The rigidizer may be more rigid than the frame portion 3210. For example, the rigidizer may be formed of a material with a higher modulus of elasticity than the material forming the frame portion 3210.

[0157] 22-24, the frame 3360 may function as a rigidizer. Other aspects of the frame 3360 are described elsewhere herein.

[0158] However, in other examples, the frame portion 3210 may be relatively rigid. For example, the relatively rigid frame portion 3210 may be formed from a material with a relatively high modulus of elasticity.

[0159] 17, the plenum chamber 3200 includes an inlet 3220 and at least one headgear tube 3350 is configured to be in fluid communication with the inlet 3220, in use. For example, as best shown in FIG. 21, the at least one headgear tube 3350 includes an opening 3356 positioned and shaped such that the headgear tube 3350 is in fluid communication with the inlet 3220, in use.

[0160] 17 and 18 , the inlet 3220 may be configured to provide a lead-in to the plenum chamber 3200 when connecting the at least one headgear tube 3350 to the plenum chamber 3200. The size, location, and shape of the inlet 3220 may be selected to provide a lead-in. For example, the portion of the inlet 3220 located on the side 3213 of the plenum chamber 3200 may have a size and shape to match the shape of the at least one headgear tube 3350. This can facilitate assembly of the patient interface 3000 even when placing and attaching the at least one headgear tube 3350 to the plenum chamber 3200.

[0161] Additionally, the inlets 3220 located on the side(s) 3213 of the plenum chamber 3200 may provide a side flow path to the interior of the plenum chamber 3200. In other words, the inlets 3220 allow air flow delivered by at least one headgear tube 3350 from the air circuit 4170 to flow generally laterally through the inlets 3220 and into the interior of the plenum chamber 3200.

[0162] 4.3.2 Seal molding structure A patient interface 3000 according to some examples of the present technology includes a seal-forming structure 3100 configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure 3100 may be configured to maintain a therapeutic pressure within a plenum chamber 3200 throughout the patient's respiratory cycle, in use.

[0163] In some forms, the seal-forming structure 3100 is configured to form a seal with or around a portion of the patient's nose in use. It should therefore be understood that in some forms the patient interface 3000 may be solely a nasal mask, and may also be referred to as a nasal mask.

[0164] In other forms not shown, the seal-forming structure 3100 may be configured to form a seal when used with other portions of a patient's face, such as, for example, the portion having or surrounding the patient's nose and the portion having or surrounding the patient's mouth. Thus, in some forms the patient interface 3000 may be a nasal mask, also referred to as a full face or nasal mask, and it should be understood that forms of the present technology are not limited to only nasal masks or nasal masks.

[0165] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further 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 day to day and from patient to patient within a given treatment session depending on various factors such as, for example, placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0166] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0167] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0168] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0169] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100, each configured to accommodate a range of different sizes and / or shapes. 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.

[0170] 4.3.2.1 Sealing mechanism In one form, the seal-forming structure 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 on its underside 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.

[0171] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum 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 to prevent it from buckling during use.

[0172] In one form, the seal-forming structure may include a compression or gasket seal that is constructed and arranged to be in compression, in use, due to, for example, elastic tension in the positioning and stabilizing structure.

[0173] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0174] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0175] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0176] 4.3.2.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used over the bridge or nasal ridge area of ​​the patient's face.

[0177] In one form, the seal-forming structure includes a saddle region positioned to form a seal when in use over the bridge or ridge region of the patient's face.

[0178] 4.3.2.3 Upper lip In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used on the patient's face in the upper lip region (ie, above the lips).

[0179] In one form, the seal-forming structure includes a saddle region positioned to form a seal l when in use over the upper lip region of a patient's face.

[0180] 4.3.2.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used on the chin region of the patient's face.

[0181] 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.

[0182] 4.3.2.5 Forehead area In one form, the seal-forming structure forms a seal when used on the forehead region of the patient's face, in such a form the plenum chamber may cover the eyes when in use.

[0183] 4.3.2.6 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.

[0184] 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.

[0185] 4.3.2.7 Nasal mask In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airways but not around the patient's mouth. The seal-forming structure 3100 may be configured to seal over the patient's lips. The patient interface 3000 may leave the patient's mouth uncovered. The patient interface 3000 may deliver air or breathable gas to the two nostrils of the patient 1000 rather than to the oral cavity. This type of patient interface may be identified as a nasal mask only.

[0186] A nasal mask-only form of the present technology is what is traditionally thought of as a "nasal mask" and has a seal-forming structure 3100 configured to seal around the nose and above the bridge of the nose on a patient's face. Nasal masks may typically be triangular in shape. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal with the upper lip area (e.g., upper lip), at least a portion of the patient's nasal bridge or nasal ridge above the anterior nostrils, and the patient's face on each side of the patient's nose (e.g., the patient's nearby nasolabial folds). The patient interface 3000 shown in FIG. 1B has this type of seal-forming structure 3100. The patient interface 3000 may deliver air or breathable gas to the patient's 1000's two nostrils via a single orifice.

[0187] Another form of nasal-only mask may seal around the underside of the patient's nose without engaging the user's nasal bridge. For example, this type of patient interface 3000 is identified as a "nasal cradle" mask, and the seal-forming structure 3100 is identified as a "nasal cradle closure." In one form, as shown, for example, in FIG. 3Y, the seal-forming structure 3100 is configured to form a seal with the underside of the nose around the nostrils during use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including the underside and / or anterior surface of the anterior nasal region of the patient's nose and the alae of the patient's nostrils. The seal-forming structure 3100 may also seal against the patient's upper lip. The shape of the seal-forming structure 3100 may be configured to conform to or fit snugly against the underside of the patient's nose, but may be configured to avoid contacting the bridge region of the patient's nose or any portion above the anterior nasal bridge of the patient's nose. In one form of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides the opening into two holes, each opening providing air or breathable gas to a corresponding one of the patient's nostrils in use. The bridge portion may be configured to contact or seal with the patient's trabeculae in use. Alternatively, the seal-forming structure 3100 may include a single opening that provides airflow or air or breathable gas to both of the patient's nostrils.

[0188] In some configurations, the nasal mask may only include nasal pillows, as described above.

[0189] 6A-15D, the seal-forming structure 3100 is configured to form a seal with the underside of the patient's nose around the patient's nostrils in use. In the example shown in Figures 6A-15D, the patient interface 3000 is in the form of a nasal or nasal mask.

[0190] In the illustrated configurations of FIGS. 6A-15D, the seal-forming structure 3100 includes at least one hole 3110 or a pair of holes 3110 configured to allow delivery of airflow to a patient's nostrils at a therapeutic pressure. Each hole 3110 is aligned with a corresponding portion of the patient during use. In some examples, the seal-forming structure 3100 may include a single hole 3110 configured to allow delivery of airflow to two nostrils of the patient. In one example, the closure module 3150 includes at least one hole 3110. In some examples, the at least one hole 3110 is formed in a central portion of the seal-forming structure 3100.

[0191] 4.3.2.8 Oral-nasal mask In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airways and around the patient's oral cavity. The seal-forming structure 3100 may be configured to seal against the patient's face near the chin region. The patient interface 3000 may deliver air or breathable gas to the patient's nares and oral cavity. This type of patient interface may be identified as a nose and mouth mask.

[0192] One form of oronasal mask according to the present technology is what is traditionally thought of as a "full face mask," having a seal-forming structure 3100 configured to seal around the patient's nose, under the mouth, and over the bridge of the nose. Typically, full face masks may be triangular in shape. In one form, the patient interface 3000 includes the seal-forming structure 3100 that, in use, forms a seal with the patient's chin region (which may include the patient's lower lip and / or the area directly below the lower lip), at least a portion of the patient's nasal bridge or nasal ridge above the anterior nostrils, and the cheek region of the patient's face. The patient interface 3000 shown in FIG. 1C is of this type. The patient interface 3000 may deliver air or breathable gas to the patient's nares and oral cavity through a single orifice. This type of seal-forming structure 3100 may be referred to as a "full face mask."

[0193] In another form, the patient interface 3000 includes a seal-forming structure 3100 that forms a seal in use with the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), the underside and / or front of the anterior nasal portion of the patient's nose, the nostrils of the patient's nose, and the patient's face on each side of the patient's nose (e.g., near the nasolabial folds). The seal-forming structure 3100 can also form a seal with the patient's upper lip. A patient interface 3000 with this type of seal-forming structure may have a single opening configured to deliver a gas flow or breathable gas to the patient's nostrils and oral cavity, may have an oral opening configured to deliver air or breathable gas to the oral cavity and a nostril configured to deliver air or breathable gas to the nostril, or may have an oral opening for delivering air to the patient's oral cavity and two nostrils for delivering air to the corresponding nostril. This type of patient interface 3000 may have nasal and oral portions that seal against the patient's face in a position similar to a nasal cradle mask.

[0194] In another form of a nose and mouth mask, the patient interface 3000 may include a seal-forming structure 3100 having a nasal portion including nasal pillows and an oral portion configured to form a seal against the patient's face around the patient's mouth.

[0195] In some forms, the seal-forming structure 3100 may have a distinct nasal portion that is separate from the oral portion, hi other forms, the seal-forming structure 3100 may form a continuous seal around the patient's nose and mouth.

[0196] It should be understood that the above examples of different forms of the patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, the patient interface 3000 may include different combinations of features of the nasal-only and oronasal mask-only examples described above.

[0197] 17 to 24, the seal-forming structure 3100 is configured to form a seal around the patient's nares and oral cavity in use. In these examples, the patient interface 3000 is in the form of an oronasal mask or a full face mask.

[0198] In some forms, the seal-forming structure 3100 includes at least one hole 3110 or at least a pair of holes (at least one hole for the nostrils and one hole for the oral cavity) configured to allow a flow of gas under therapeutic pressure to be delivered to the patient's nostrils and oral cavity. In one example, the filtration module 3150 includes at least one hole 3110. In some examples, the at least one hole 3110 is formed in a central portion of the seal-forming structure 3100. In the example shown in Figures 17-24, the seal-forming structure 3100 includes a single hole 3110 configured to allow an air flow to be delivered to the patient's nostrils and oral cavity.

[0199] 4.3.3 Connection Port The connection port 3600 allows the patient interface 3000 to be connected to an air circuit 4170. As shown in Figures 6A-24, the patient interface 3000 includes a connection port 3600 for connecting to an air circuit 4170. In the illustrated example, the air circuit 4170 is in the form of a delivery tube 4172.

[0200] 4.3.3.1 Connection to the plenum chamber The delivery tube 4172 may be connected to the plenum chamber 3200 via a connection port 3600 such that the delivery tube 4172 is in fluid communication with the inlet 3220 in use. In some forms of the present technology, the connection port 3600 is attached to or forms the inlet 3220, as shown, for example, in Figures 7A-7B, 9A-11C, and 13A-15D.

[0201] In some embodiments, the connection port 3600 may be located on a front region of the plenum chamber 3200 during use. As shown in the examples of FIGS. 6A-15D and 22-24, the connection port 3600 is located on a medial region of the plenum chamber 3200 during use. The medial region of the plenum chamber 3200 is central during use, i.e., the patient's midsagittal plane passes through the medial portion during use. In the example of FIGS. 22-24, a frame 3360 provides the connection port 3600. The frame 3360 may include an opening 3362. An air circuit (not shown in FIGS. 22-24) is connected to the inlet 3220 via the opening 3362 in the frame 3360 and is configured to be in fluid communication with the inlet 3220 during use. That is, in some forms, the delivery tube 4172 may be physically connected to the frame 3360 to deliver breathable gas into the plenum chamber 3200 via the inlet port 3220, and in other forms, the delivery tube 4172 may be physically connected to the inlet port 3220 of the plenum chamber 3200 through an opening 3362 in the frame 3360.

[0202] In the examples of FIGS. 6A-15D and 22-24, the air circuit 4170 is connected to the front portion 3211. As shown, the connection port 3600 may be located in the medial region of the front portion 3211. In use, the medial region may be centrally located, i.e., the patient's midsagittal plane may pass through the medial portion in use. As shown in FIGS. 6A-15D, the air circuit 4170 is connected to the frame portion 3210 via the connection port 3600. In the examples of FIGS. 22-24, an air circuit (not shown) may be connected to the frame 3360. In other forms not shown, the air circuit may be connected to the frame 3360 and / or the plenum chamber 3200, for example, the frame portion 3210.

[0203] 4.3.3.2 Connecting to headgear tubes In some forms of the present technology, the air circuit 4170 is connected to at least one headgear tube 3350. This is described in more detail below. For example, as shown in FIG. 17 , a connection port 3600 is positioned on at least one headgear tube 3350 such that it connects to a portion of the headgear tube 3350 that is configured to be located above the patient's head in use. In this example, the connection port 3600 receives a flow of breathable gas from a delivery tube 4172 and delivers the gas flow to the headgear tube 3350.

[0204] 4.3.4 Positioning and stabilizing structures One form of the present technology includes a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure 3300 may also be referred to as "headgear" because it engages the patient's head to hold the patient interface 3000 in a sealing position.

[0205] 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 stabilising structure 3300.

[0206] 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.

[0207] 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.

[0208] 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).

[0209] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 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 having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0210] 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.

[0211] 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 regions of the patient's head resting on pillows.

[0212] 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.

[0213] 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.

[0214] 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 may be configured to be tensioned in use to direct a force that urges the seal-forming structure into contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0215] 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 of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0216] 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.

[0217] 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 tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move away from one another.

[0218] 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.

[0219] 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.

[0220] In certain forms of the present technology, a system is provided that includes multiple positioning and stabilizing structures 3300, each configured to provide a holding force for 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.

[0221] 4.3.4.1 Frame 22-24, in some forms, the positioning and stabilizing structure 3300 includes a frame 3360. The frame 3360 is configured to facilitate indirect attachment of the plenum chamber 3200 to at least one headgear strap (not shown) of the positioning and stabilizing structure 3300.

[0222] The frame 3360 may be constructed and arranged to extend through at least a portion of the plenum chamber 3200 when in use. The frame 3360 may extend laterally across the front portion 3211, and in some forms, may extend across the sides 3213 of the plenum chamber 3200. As shown in FIG. 22 , in some forms, the frame 3360 may extend through the entire width of the plenum chamber 3200 (i.e., the distance between the lateral edges or ends of the frame portion 3210). As shown, the ends of the frame 3360 may extend beyond the side edges or ends of the plenum chamber 3200. In other forms, the frame 3360 may be shorter, having a length that is less than the lateral width of the plenum chamber 3200.

[0223] 22 and 24, in some forms, the frame 3360 may be substantially elongated, i.e., the distance between the upper and lower edges of the frame 3360 is less, e.g., substantially less, than the width of the frame 3360 (i.e., the distance between the side edges of the frame 3360).

[0224] 22 and 24, in some forms, the opening 3362 may be located on an inner region of the frame 3360. The inner region of the frame 3360 is centered in use, i.e., the patient's midsagittal plane passes through the inner portion of the frame 3360 in use.

[0225] The frame 3360 may be generally arcuate when viewed from above or below (not shown), with the concave surface of the frame 3360 facing the patient's face during use. Additionally, the surface of the plenum chamber 3200 to which a frame, such as the frame portion 3210, is attached or engaged during use may also be generally arcuate when viewed from the same direction. Thus, as shown in FIG. 22 , the shape of the frame 3360 and the shape of the frame portion 3210 may have complementary contours that allow the two components to mate. In some forms, the frame 3360 may have a preformed or predefined arcuate shape, while in other forms, the frame 3360 may flex into an arcuate or greater shape when tension from the headgear straps is applied to the ends of the frame 3360.

[0226] The frame 3360 may include at least one of connectors, preferably a pair of connectors 3364, to facilitate attachment of the frame 3360 to at least one headgear strap (not shown in FIGS. 22 and 23). The at least one headgear strap may be removably attached to the connector 3800. In the illustrated form of the technology, each of the connectors 3364 includes a slot 3364a. The slot 3364a is configured to receive a portion of the headgear strap to connect the headgear strap to the frame 3360.

[0227] In the illustrated embodiment, the connector 3364 is located at a side end of the frame 3360. The connector 3364 may be formed as part of the frame 3360, for example, integrally with the frame, as shown in Figures 22 and 24. In other embodiments not shown, the connector 3364 may be formed separately and may be removable or permanently connected to the frame 3360.

[0228] 22 and 24, the frame 3360 includes a body portion 3368 and a pair of arms 3366 extending laterally outward from the body portion 3368. Each arm 3366 may be provided at its end with one of a pair of connectors 3364. The body portion 3368, arms 3366 and connectors 3364 may be formed together to provide, for example, an integrally formed frame 3360.

[0229] In some forms, the patient interface 3000 is in the form of a full face mask, as previously described, and is configured to provide a two-point headgear connection rather than a four-point headgear connection. As shown, the frame 3350 is configured to provide a two-point headgear connection. That is, the frame includes two connectors 3364, one on each side. Fewer headgear connection points can make the patient interface 3000 easier to don, reduce a feeling of claustrophobia when wearing the patient interface, and reduce the amount of facial marks caused by the effect of the headgear straps contacting the patient's skin and hair.

[0230] In other forms not shown, the connector 3364 may include any other suitable connector or connection mechanism, such as a clip or button fastening. It should be understood that in other forms, the at least one headgear strap may be permanently attached to the frame 3360 or may be formed with the frame 3360.

[0231] As shown in FIG. 22, the frame 3360 may be configured to be maintained in a suitable position relative to the plenum chamber 3200 .

[0232] In some examples, the frame 3360 may be attached to the plenum chamber 3200; for example, the patient (rear) face of the frame 3360 may be attached to the frame portion 3210 on the front side of the plenum chamber. In the illustrated example, the frame 3360 is removably attached to the frame portion 3210. This may facilitate replacement, cleaning, and / or storage of the frame 3360. The frame 3360 may include a connector (not shown in FIGS. 22-24) that removably connects the frame 3360 to the plenum chamber 3200 and facilitates holding the frame 3360 in place. For example, the connector may include a lip extending around at least a portion of the opening 3362, and the lip may be connected to the plenum chamber 3200 by an interference fit or a friction fit. For example, the lip may interlock with the periphery of the inlet 3220 in the plenum chamber 3200. However, in other forms, the connector may comprise any other suitable connector or attachment mechanism that facilitates removable attachment between two components, including interlocks, clips, hook-and-loop connectors, high-friction surfaces, etc.

[0233] In some forms, the frame 3360 may not be directly connected to the plenum chamber 3200. For example, a force applied rearward to the frame 3360 may be used to hold the frame 3360 in place over the plenum chamber 3200. That is, tension in the headgear straps may hold the frame 3360 in place. The outer (i.e., front) surface of the plenum chamber 3200 may include a recess 3230 as shown in FIG. 20 and described below. The recess may be elongated and extend laterally across the plenum chamber 3200. The recess may be configured to allow the frame 3360 to nest within the recess to help hold the plenum chamber 3200 in place during use.

[0234] In some forms, the frame 3360 may at least partially form the plenum chamber 3200 with the frame portion 3210 and the seal-forming structure 3100. For example, the perimeter of the frame opening 3362 may be greater than the perimeter of the inlet 3220. This may result in a portion of the frame 3360 forming a portion of the plenum chamber 3200. However, the frame portion 3210 and the seal-forming structure 3100 may form a major portion of the plenum chamber 3200.

[0235] The frame may be formed from a material or combination of materials such as a polymer. Suitable polymers may include thermoplastics or elastomers such as silicone.

[0236] 4.3.4.2 Conduit headgear 4.3.4.2.1 Conduit-type headgear tubes In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, via the plenum chamber 3200 and the seal-forming structure 3100. Thus, in use, the at least one headgear tube 3350 is configured to deliver air flow from the air circuit 4170 fluidly connected to the at least one headgear tube 3350 to the interior of the plenum chamber 3200 via the inlet 3220.

[0237] 3Y and 17, the positioning and stabilising structure 3300 includes two tubes 3350 which deliver air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of the patient interface 3000 and position and stabilise the seal-forming structure 3100 of the patient interface over the appropriate part of the patient's face (e.g. nose and / or mouth). This allows the conduit of the air circuit 4170 which provides the pressurised air flow to be connected to the connection port 3600 of the patient interface in a location other than in front of the patient's face.

[0238] 3Y and 17, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head in use, extending through a respective cheek region and above a respective ear (above the upper ear base of the patient's head) to an elbow 3610 at the top of the patient's 1000's head. This form of the technology can be advantageous because when the patient turns their head while sleeping and one of the tubes compresses, blocking or partially blocking gas flow along the tube, the other tube remains open and provides pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, for example one tube, or three or more tubes. In examples where the patient interface has one tube 3350, the single tube 3350 is placed on one side of the patient's head in use (e.g., across the cheek area) and the strap forms part of the positioning and stabilizing structure 3300 and is placed on the other side of the patient's head in use (e.g., across another area) to help secure the patient interface 3000 to the patient's head.

[0239] 3Y and 17, two tubes 3350 are fluidly connected at their upper ends to each other and to a connection port 3600. In some embodiments, the two tubes are integrally formed, while in other embodiments, the tubes are separate components that are connected together in use and can be disconnected, for example for cleaning or storage. When separate tubes are used, they may be indirectly connected together, for example, each tube may be connected to a T-shaped conduit having two conduit arms fluidly connectable to the tubes 3350 and a third conduit arm or opening that acts as the connection port 3600 and that, in use, is connectable to the air circuit 4170.

[0240] The tube 3350 can be formed of a flexible material, such as an elastomer, such as silicone or TPE, and / or one or more fabrics and / or foam materials. The tube 3350 can have a preformed shape, allowing it to bend or move to other shapes when a force is applied, but return to its original preformed shape when the force is removed. The tube 3350 can have a generally arcuate or curved shape, shaped to approximate the contours of the patient's head between the crown and the nasal or oral region.

[0241] In some instances, one or more of the tubes 3350 are not compressed to prevent jamming when compressed during use, such as when compressed between the patient's head and a pillow, especially when there is only one tube 3350. The tube 3350 may be formed to have sufficient structural rigidity to resist collapse and may be configured as in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0242] Each tube 3350 may be configured to receive airflow from the connection port 3600 at the top of the patient's head and deliver the airflow to the seal-forming structure 3100 at the entrance to the patient's airway. In the example shown in FIGS. 3Y and 17, each tube 3350 extends from the plenum chamber 3200 through the patient's cheek region and is positioned on a path from above the patient's ear to the elbow 3610 in use. For example, a portion of each tube 3350 near the plenum chamber 3200 may overlie the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the region of the patient's head above the base of the ear at the top of the patient's head. Each of the one or more tubes 3350 may also be positioned over the patient's sphenoid and / or temporal bone, and one or both of the patient's frontal and parietal bones. The connection port 3600 and elbow 3610 may be positioned over the patient's parietal bone, frontal bone, or the junction therebetween in use.

[0243] In certain forms of the present technology, the patient interface 3000 is configured so that the connection port 3600 is positioned at a series of positions across the top of the patient's head, thereby positioning the patient interface 3000 to suit the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are configured to allow an upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to a lower portion of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this manner, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position (at least within a predetermined range of positions) of the connection port 3600 on the patient's head.

[0244] As mentioned above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is typically located below the nose and sealed around the underside of the nose. The positioning and stabilizing structure 3300 may be constructed and arranged to draw the seal-forming structure 3100 onto the patient's face below the nose with a sealing force vector having a posterior and superior direction (e.g., a posterior-superior direction). The sealing force vector having a posterior-superior direction facilitates the seal-forming structure 3100 forming a good seal around the underside of the patient's nose and with the forward-facing surfaces of the patient's face on either side of the patient's nose and upper lip.

[0245] 4.3.4.2.2 Extendable and non-extendable tube sections In some examples of the present technology, the length of one or two of the tubes 3350 is non-extensible. However, in some forms, the tube 3350 may include one or more extensible tube sections, for example, formed with an extensible bellows-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall with an extensible bellows-like structure. The patient interface 3000 shown in FIG. 3Y includes a tube 3350 having an upper portion including extensible tube sections, each tube section being in the form of an extensible bellows-like structure 3362.

[0246] The cross-sectional shape of the non-extensible segment 3363 of the tube 3350 can be circular, oval, elliptical, D-shaped, or rectangular with rounded corners, for example, as described in U.S. Patent No. 6,044,844. Cross-sectional shapes that present a flatter surface of the tube on the side that faces and contacts other parts of the patient's face or head may be proportionately more comfortable to wear as tubes having circular cross-sections.

[0247] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward along both sides of the patient's head and then curve forward and midway to connect to the plenum chamber 3200 in front of the patient's face. The tube 3350 may extend to the same vertical position as (or, in some examples, lower than) the connection to the plenum chamber 3200 before connecting to the plenum chamber 3200. That is, the tube 3350 may protrude at least partially in an elevated direction before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the fusion module 3150 and / or the seal-forming structure 3100. The tube 3350 may contact the patient's face below the patient's cheekbones, which may be more comfortable than contacting above the patient's cheekbones and may avoid excessive blurring of the patient's peripheral vision.

[0248] 4.3.4.2.3 Conduit-type headgear connection port In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the form of the present technology shown in FIGS. 3Y and 17, the connection port 3600 is located on the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 at which the connection port 3600 is provided. The elbow 3610 may be configured to fluidly connect to a conduit of the air circuit 4170. The elbow 3610 is rotatable relative to the positioning and stabilizing structure 3300 to isolate movement of the conduit connected to the connection port 3600 from the positioning and stabilizing structure 3300. The elbow 3610 may be configured to rotate by rotating about a substantially vertical axis in some examples, and in some specific examples, may be configured to rotate by rotating about two or more axes. In some examples, the elbow may include a tube 3350 or be connected to the tube 3350 via a ball-and-socket joint. The connection port 3600 may be located in the sagittal plane of the patient's head during use.

[0249] A patient interface with a connection port that is not positioned in front of the patient's face can be advantageous because some patients find it unsightly and intrusive when the conduit is connected to the patient interface in front of the face. For example, a conduit that connects to a patient interface in front of the face can easily become tangled in bedding or bed linens (especially if the conduit extends downward from the patient interface during use). Forms of the present technology include a patient interface with a connection port that is located above the patient's head during use, allowing the patient to sleep more easily or comfortably in one or more of a side-sleeping position, a supine position (e.g., a supine position, a substantially upward-facing position), or a prone position (e.g., a prone position, a substantially downward-facing position). Furthermore, connecting the conduit to the front of the patient interface can exacerbate a problem known as tube drag, in which the conduit exerts an undesirable force on the patient interface during movement of the patient's head or the conduit, causing it to become dislodged from the face. Tube resistance may not be an issue (where tube resistance is more likely to disrupt the seal) if the force is applied at a higher position on the patient's head than at the front of the patient's face, closer to the seal-forming structures.

[0250] 4.3.4.2.4 Headgear Tube Fluid Connections In the example of FIG. 3Y, the two tubes 3350 are fluidly connected at their lower ends to the plenum chamber 3200. In certain forms of the present technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by the connection of two rigidizer connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow the patient to easily connect the two components in a secure manner. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or auditory feedback in the form of a "reassurance click" or similar sound so that the patient can easily know when each tube 3350 is properly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed of silicone, and the lower end of each silicone tube 3350 is overmolded into a rigid connector, for example, with polypropylene, polycarbonate, nylon, etc. The rigid connector may include a male mating feature configured to connect to a female mating feature on the cradle cushion module 3150. Alternatively, the rigid connector may include a female mating feature configured to connect to a male mating feature on the cradle cushion module 3150. In other examples, the tube 3350 may include a male or female connector formed from a flexible material such as silicone or TPE, such as the same material forming the tube 3350.

[0251] In other examples, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, a resilient, flexible (e.g., silicone) tube 3350 without a rigid connector needs to be slightly extruded to reduce its diameter so that it can fit into a port in the plenum chamber 3200, and the inherent resilience of the silicone can push the tube 3350 outward, hermetically sealing the tube 3350 to the port. Alternatively, for a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange presses against the junction between the tube and the inner circumferential surface of the port in the plenum chamber 3200, strengthening the seal therebetween.

[0252] The tube 3350 may be configured to be held in place relative to the plenum chamber 3200 .

[0253] 17, in some forms, at least one headgear tube 3350 may be attached to the plenum chamber 3200, for example, with a patient (rear) facing side of the headgear tube 3350 attached to the frame portion 3210. In the example shown, the at least one headgear tube 3350 is removably connected to the frame portion 3210. This may facilitate replacement, cleaning, and / or storage of the headgear conduit 3350.

[0254] 21 , the at least one headgear tube 3350 includes a connector 3358 that facilitates removably attaching the at least one headgear tube 3350 to the plenum chamber 3200. As shown, the connector 3358 includes a lip that extends around at least a portion of the opening 3356, and the lip may be connected to the plenum chamber 3200 by an interference fit or a friction fit. For example, the lip may interlock around the inlet 3220 in the plenum chamber 3200. However, in other forms, the connector 3358 may include any other suitable connector or connection mechanism for facilitating removably attachment between two components, including an interlock, a clip, a shackle connector, a high-friction surface, etc.

[0255] In some forms, the at least one headgear tube 3350 may not be directly connected to the plenum chamber 3200. For example, the at least one headgear tube 3350 may be held in place over the plenum chamber 3200 using a force applied rearward to the at least one headgear tube 3350. That is, tension in the headgear straps may hold the frame 3360 in place. The outer (i.e., front) surface of the plenum chamber 3200 may include a recess 3230 as shown in FIG. 20 and described below. The recess may be elongated and extend laterally across the plenum chamber 3200. The recess may be configured to allow a lower portion of the tube 3350 to nest within the groove to help hold the plenum chamber 3200 in place during use.

[0256] 17-21, the positioning and stabilizing structure 3300 includes two tubes 3350. As shown in FIGS. 17 and 18, in some forms, the two tubes 3350 are fluidly connected to each other at their lower ends and connected to the inlet 3220. The two tubes 3350 may be integrally formed as shown in FIG. 18, or may be formed separately but connected and disconnected during use as shown in FIGS. 17 and 21. This may allow for easy cleaning, replacement or storage of the tubes 3350.

[0257] 17 and 21, the positioning and stabilising structure 3300 may include a tube portion 3354. The tube portion 3354 may be located forward of the plenum chamber 3200 in use.

[0258] The tube portion 3354 may be constructed and arranged to extend, in use, through at least a portion of the plenum chamber 3200. The tube portion 3354 may extend through the front 3211 and side 3213 of the plenum chamber 3200. As shown in Figures 17 and 18, in some forms, the tube portion 3354 may extend through the entire width of the plenum chamber 3200 (i.e., the distance between the lateral edges or ends of the plenum chamber 3200).

[0259] In some forms, the tube portion 3354 is configured to connect the lower ends of the two tubes 3350. As shown in FIG.

[0260] 17 and 21, the tube portion 3354 is formed separately and has two tubes 3350 attached to it. However, in some configurations, the tube portion 3354 may be integrally formed with the two tubes 3350 to form a single tube structure, as shown, for example, in FIG.

[0261] Tube portion 3354 may be formed of a different material(s) than the two tubes 3350. For example, tube portion 3354 may be stiffer or less stiff than the two tubes 3350. Tube portion 3354 may be formed of the same material as tube 3350.

[0262] In some forms, the tube portion 3354 may be considered to function as a rigidizer for the plenum chamber 3200 as described above.

[0263] 4.3.4.2.5 Conduit-type headgear Headgear straps In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap acting on more than just the tube 3350 to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in FIGS. 3Y and 17, the patient interface 3000 includes a headgear strap 3310 forming part of the positioning and stabilizing structure 3300. The headgear strap 3310 is also known as, for example, a back strap or rear head strap. The strap 3310 may be connected between two tubes 3350 positioned on either side of the patient's head and, when worn, passes around the back of the patient's head, for example, lying above or below the occipital bone during use. The strap 3310 may be connected to each tube above the patient's ears. Referring to FIGS. 3Y and 17, the positioning and stabilizing structure 3300 includes a pair of tabs 3352 provided on the front side of the tube 3350. In use, the strap 3310 can be connected between the tabs 3352. The tabs 3352 facilitate connection of the straps 3310 to the tube 3350. For example, the tabs 3352 may include holes through which the straps 3310 can pass. The straps 3310 are flexible enough to circumvent the back of the patient's head and rest comfortably against the patient's head when under tension in use.

[0264] In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 according to an example of the present technology employing a full-face mask configuration may have two connections to the plenum chamber and / or action module on either side of the patient's face, forming a "four-point connection" (as opposed to the two-point connection of FIG. 17). In these configurations, the positioning and stabilizing structure may include a second strap connected between the plenum chamber and / or action module and a portion of the positioning and stabilizing structure, and positioned above and / or behind the patient's head in use. For example, the second strap may be located below the conduit-type headgear tube 3350 when worn and may be configured to conform to the patient's head near the patient's neck and / or the back of the patient's neck.

[0265] 4.3.4.3 Headgear Rigidizer As shown in FIGS. 6A-9D and 11A-15D, the positioning and stabilizing structure 3300, in some configurations, includes a headgear rigidizer, such as a rigidiser arm 3330 and / or a ventilation module 3420. For example, in FIGS. 6A-9D and 11A-12E, the positioning and stabilizing structure 3300 includes a rigidiser arm 3330. In the example of FIGS. 11A-12E, the ventilation module 3420 functions as the headgear rigidizer. In another example, in FIGS. 13A-15D, the positioning and stabilizing structure 3300 includes a ventilation module 3420 that functions as the headgear rigidizer. In these configurations, the ventilation module 3420 can be considered to function as the rigidiser arm 3330.

[0266] 4.3.4.4 Connectors In some forms, the patient interface 3000 includes a pair of connectors 3800 to facilitate attachment of the plenum chamber 3200 to the positioning and stabilizing structure 3300.

[0267] According to various aspects of the present technology, as shown in Figures 6A-12E, a connector 3800 may be included as part of a ventilation structure 3400. For example, a portion of a ventilation module 3420 may be configured to provide the connector 3800. These aspects of the present technology will become more apparent from the following formal description.

[0268] In certain configurations, the patient interface 3000 may include other types of connectors, such as those shown in Figures 10A-10C and 13A-15D. The plenum chamber 2300 includes a pair of connectors 3214 configured to connect the plenum chamber 2300 to the conduit portion 3320. The connectors 3214 may be provided on either side of the frame portion 3210. As shown, each connector 3214 is provided on a respective laterally protruding connection portion 3212. In the illustrated example, the connectors 3214 are provided in openings 3240 of the laterally protruding connection portions 3212.

[0269] The patient interface 3000 may have a connector 3214 that also functions as the connector 3800. For example, the connector connecting the plenum chamber 2300 to the conduit portion 3320 may also be used to connect the patient interface 3000 to the positioning and stabilizing structure 3300, as the conduit portion 3320 forms part of the positioning and stabilizing structure 3300. This is the case, for example, in the configurations shown in Figures 13C and 15D, where the conduit portion 3320 is formed as part of the positioning and stabilizing structure 3300 that is connected to the patient interface 3000 using the connector 3214. Alternatively, the patient interface may have a connector 3214 for connecting the plenum chamber 2300 to the conduit portion 3320, which is separate from the connector 3800 that connects the patient interface 3000 to the positioning and stabilizing structure 3300. In other forms, the connector 3214 may connect the ventilation structure 3400 (e.g., ventilation module 3240) to the plenum chamber 3200, and the positioning and stabilizing structure 3300 is connected to the patient interface 3000 via a separate connector 3800. In the example shown in Figures 10A-10C, the connector 3214 is configured to connect to the ventilation module 3420, which includes a separate connector 3800 that connects to headgear straps 3310 in use, as described below.

[0270] 4.3.4.5 Attaching the Headgear Strap to the Connector 6A and 6D, the headgear straps 3310 may be removably attached to the connector 3800. For example, in the example of Figures 10A-10C, the headgear straps 3310 (not shown) may be removably attached to the connector 3800, which includes a slot 3820. In the example of Figures 6A-6D, the headgear straps 3310 may be removably attached to the connector by button fastenings.

[0271] 6C-1 , the headgear strap 3310 may include a buttonhole 3312. In this configuration, the headgear strap 3310 includes a tubular or sleeve-like configuration that receives a portion of a connector 3800 that is inserted into at least one headgear strap 3310 via the buttonhole 3312. This allows a portion of the headgear strap 3310 to encase the connector 3800 upon connection. Referring to the illustrated configuration of FIG. 6B , the rigidiser arm 3330, or a portion thereof, may be connected to the headgear strap 3310 and function as the connector 3800, for example, which may be packaged by the headgear strap 3310. In these configurations, the headgear strap 3310 may be removably attached to the rigidiser arm 3330.

[0272] 6C-1 , the buttonhole 3312 may be located on the inner surface of the headgear strap 3310 and adapted to receive a connector 3800, such as a rigidiser arm 3330, which, as described above, can be inserted and removed from within the headgear strap 3310, which may have a tubular or sleeve-like configuration. The buttonhole 3312 may be oriented and / or shaped to allow the rigidiser arm 3330 to be inserted and / or removed therethrough to assemble the positioning and stabilizing structure 3300, and to prevent the rigidiser arm 3330 from being inadvertently removed or separated from the strap 3310 during use. As shown in FIG. 6C-1 , the buttonhole 3312 may have a slit-like structure oriented longitudinally or transversely relative to the length of the headgear strap 3310. In other words, the elongated extension of the buttonhole 3312 may extend substantially coaxially with the longitudinal axes of the headgear strap 3310 and the rigid arm 3330. This allows the rigidiser arm 3330 to be easily inserted into the tubular or sleeve-like headgear strap 3310 or a portion of the headgear strap 3310, particularly due to the elasticity of the headgear strap 3310, and prevents inadvertent removal. The end of the headgear strap 3310 between the tip of the headgear strap 3310 and the buttonhole 3312 can be wrapped around the edge of the rigidiser arm 3330 to serve as an anchor point. This edge or anchor of the rigidiser arm 3330 may be used as a capture member. This end of the headgear strap 3310 may also be referred to as the pocket end 3311. This prevents the headgear straps 3310 from slipping off the inserted rigidiser arms 3330 when the headgear straps 3310 are stretched and adjusted when putting on or taking off the patient interface 3000.

[0273] 4.3.5 Ventilation structure A patient interface 3000 according to some examples of the present technology includes a ventilation structure 3400 configured to allow gases exhaled by the patient to flow to the ambient from the interior of the plenum chamber 3200. The ventilation structure 3400 may be configured to have a ventilation flow rate that is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure within the plenum chamber 3200 in use.

[0274] As mentioned above, in the form of the present technology shown in Figures 6A-23, the ventilation structure 3400 may be configured to ventilate gas flow generally laterally from the interior of the plenum chamber 3200 in use.

[0275] As shown in FIGS. 6A and 23, each ventilation structure 3400 is located to the side of the inlet 3220 on a side or sides of the patient interface 3000, for example, the side 3213 of the plenum chamber 3200.

[0276] 10A-11C, 13A-13C, and 15A-15C, the patient interface 3000 may include a separate ventilation structure 3400A configured to vent a separate gas flow from the interior of the plenum chamber 3200. The ventilation structure 3400A may be configured to vent the gas flow substantially forward in use. The ventilation structure 3400A may be located near an inlet 3220 located in an interior region of the plenum chamber 3200. The ventilation structure 3400A may be included as part of a connection port 3600 connected to the inlet 3220.

[0277] In a preferred form, the ventilation structure 3400 includes a plurality of ventilation holes 3410. In the embodiments shown in Figures 6A-9D, 11A-15D, and 17-23, the ventilation structure 3400 may include a ventilation wall 3412 that includes the ventilation holes 3410. In some forms, as shown in Figures 6A, 8B, 9B, and 11C, the diameter of the inlet opening of each ventilation hole 3410 may be larger than the diameter of the outlet opening of each ventilation hole 3410. Thus, opposing inner walls of each ventilation hole 3410 may converge toward each other.

[0278] 10B-10C, the ventilation holes 3410 are provided in the form of flow paths, e.g., channels, defined by the arrangement of the ventilation walls 3414. In other words, in this example, the ventilation structure 3400 may not include multiple individual ventilation holes 3410 formed in the ventilation walls 3412.

[0279] 4.3.5.1 Location of ventilation structure 6A-23, the ventilation structure 3400 is positioned laterally in an interior region of the patient interface 3000, for example in an interior region of the plenum chamber 3200. The ventilation structure 3400 may be oriented substantially laterally in use, i.e., positioned on a surface that is at least partially angled laterally.

[0280] In prior art patient interfaces or masks, ventilation holes or structures are typically located in the front region of the mask, particularly the medial region, with inlets connected to delivery tubes located near the ventilation holes in the same region of the mask. In other words, the ventilation openings and inlets are typically located in the front and / or central region of the mask. As shown in FIG. 6 , prior art mask 3000, during exhalation, air entering mask 3000 from air circuit 3700 through inlet 3220 collides with air exhaled by the patient and travels at a significant angle (approximately 180° in the case of FIG. 6 ) away from mask 3000 through outlet 3400. In some configurations, as indicated by the arrows in FIG. 6 , this can result in a lot of shear and contact between the airflow entering through inlet 3220 and the air exhaled through the patient's nostrils. During inhalation or apnea, air entering plenum chamber 3200 through inlet port 3220 and / or the patient's inhaling airflow collides with the air in plenum chamber 3200. The air in the plenum chamber 3200 may include air exhaled by the patient, which flows at a significant angle, e.g., approximately 180°, relative to the direction of airflow into the plenum chamber 3200. These two airflows collide, creating shear between the airflow entering through the inlet 3220 and the air within the mask 3000 (which may include the patient's exhaled breath). This shear and contact increases the turbulence and cyclic noise generated by the patient interface 3000 during use. The amount of shear and contact, and therefore the amount of turbulence and noise, during inspiration may be greater than during expiration. This is because the volume and / or velocity of the airflow entering the mask 3000 through the inlet port 3220 during inspiration, e.g., the volume and / or velocity of the airflow delivered by the delivery tube 4172, may be greater than the volume and / or velocity of the airflow during expiration. This relatively large inflow airflow helps maintain positive pressure within the mask 3000 during inhalation, while less air needs to flow in through the inlet port 3220, for example from the delivery tube 4172, to maintain pressure within the mask 3000 during exhalation.

[0281] Compared to the prior art, the arrangement of the ventilation structure 3400 of the present technology reduces static acoustic power and cyclic noise by reducing the angle at which the direction of gas flow changes direction between entering the interior of the plenum chamber 3200 via the inlet 3220 and exiting the interior of the plenum chamber 3200 via the ventilation structure 3400 compared to the prior art mask shown in Figure 6. For example, the ventilation arrangement of the prior art mask shown in Figure 6 moves air through an angle of approximately 180° (i.e., air enters the plenum chamber 3200 in a generally posterior direction and air is exhausted through the ventilation structure 3400 in a generally anterior direction). In contrast, in forms of the present technology, the ventilation arrangement, for example, the position and / or orientation of the ventilation structure 3400 on the patient interface 3000, is configured to reduce the angle at which the direction of gas flow is turned or deflected from the inlet to the outlet. For example, the position and / or orientation of the ventilation structure 3400 may reduce the redirection or shift of gas flow entering the plenum chamber 3200 through the inlet 3220 at an angle of approximately 60°. This can reduce shear and turbulence between the air entering the plenum chamber 3200 and the exhaled air, which can reduce noise. The ventilation arrangement of the present technology can also separate the air flow during inhalation, as described in more detail below.

[0282] In this form of technology, the air circuit 4170 is connected to the plenum chamber 3200, and as shown in the example of Figures 6A-15D, the ventilation structure 3400 is spaced laterally from the inlet 3220 rather than located near either side of the inlet 3220. In the example of Figure 22, the ventilation structure 3400 is located near the side edges of the inlet 3220, however, as described herein, the connection ports 3600 provided in the frame 3360 effectively reduce the size of the inlet 3220. Thus, in this example, the ventilation structure 3400 is also spaced laterally from the connection ports 3600. By locating the ventilation structure 3400 away from the inlet 3220 and / or connection ports 3600 on the side of the patient interface 3000, the angle at which gas flow into the plenum chamber 3200 is directed away from the plenum chamber 3200 can be reduced, thereby reducing air shear, turbulence, and noise. Referring to Figures 9B, 10B, 11C, 12C, 13C, and 15D, the location and / or orientation of each ventilation structure 3400 can reduce the angle at which the airflow turns before leaving the ventilation structure 3400 compared to prior art designs. This can reduce shear, turbulence, and noise compared to the prior art. As shown in the prior art mask of Figure 6, sharper turns or redirections of the airflow or larger redirection or redirection angles can cause more exhaust noise. By positioning the ventilation structure 3400 laterally away from the inlet 3220 and / or connection port 3600, turbulence resulting from mixing of the gas flow entering the plenum chamber 3200 from the air circuit and the gas flow entering the plenum chamber 3200 from the patient's nostrils during exhalation can be reduced. Turbulence generated near the ventilation structure 3400 can negatively impact patient interface acoustics by generating noise in the ventilation structure 3400 and limiting its ability to insulate or absorb the noise before it reaches the patient or their sleeping partner. As shown in Figure 6, in prior art patient interfaces where the ventilation structure is located close to the inlet, it has been observed that the gas flows entering the plenum chamber from the air circuit and the patient's nares collide, causing turbulence near the ventilation structure.As shown by the arrows in Figures 9B, 10B, 11C, 12C, 13C, and 15D, exhaust devices of various forms of the present technology can split the gas flow entering the plenum chamber 3200 from the air circuit 4170 and the patient's nares into two spaced apart ventilation structures 3400 that arc in separate directions toward each ventilation structure 3400. This can contribute to gas diffusion. It should be understood that the examples of Figures 17, 18, and 22 have similar exhaust devices.

[0283] The ventilation structure 3400 may be located on the plenum chamber 3200, for example on the frame portion 3210. As shown in Figures 6A-9D, 11A-12E, and 18, 20, and 22, the ventilation structure 3400 may be located on a portion of the plenum chamber 3200 near a side end of the plenum chamber 3200.

[0284] 10A-10C and 13A-15D, the ventilation structure 3400 may be provided on a portion of the patient interface 3000 that is located to the side of the plenum chamber 3200 in use. As shown, the ventilation structure 3400 may be located to the side of the action module 3150 in use. The ventilation structure 3400 may be separate from the side end of the plenum chamber 3200, for example the side end of the action module 3150. In these configurations, a portion of the positioning and stabilizing structure 3300 may include the ventilation structure 3400, as described further below.

[0285] 4.3.5.2 Ventilation module 9A-13C and 15A-15D, each ventilation structure 3400 includes a ventilation module 3420. The ventilation module 3420 is a component that may be formed separately from other components that are connected to the patient interface 3000 during manufacture or use. For example, during manufacture, the ventilation module 3420 may be connected to a portion of the patient interface 3000, such as the plenum chamber 2300. The ventilation module 3420 may be permanently or removably connected to the patient interface 300. In examples where the ventilation module 3420 is removable from the patient interface 3000, this may facilitate cleaning or replacement of the ventilation module 3420.

[0286] 9A-13C and 15A-15D, the ventilation module 3420 may include a ventilation wall 3412 that includes one or more ventilation holes 3410 vented laterally from the patient interface 3000. In some examples, one or more other walls may form a conduit portion 3320.

[0287] The ventilation module 3420 may be configured to connect to a portion of the plenum chamber 3200 that includes an opening 3240 or a ventilation module opening. In some forms, the laterally protruding connection portion 3212 includes an opening 3240, as shown in FIGS. 10B, 10C, 13C, and 15D. In some forms, the opening 3240 is provided in the frame portion 3210, for example, in the front portion 3211, as shown in FIGS. 6C, 6D, 8B, 9B, 11C, and 12C. The opening 3240 may be provided in a lateral region of the front portion 3211, the lateral region facing laterally relative to the inlet 3220. The lateral region may face substantially laterally or may be angled laterally.

[0288] 6A-15D, the plenum chamber 3200 includes a rigidizer. The rigidizer may be in the form of a ventilation module 3420 and / or a connection port 3600. The rigidizer may be used to increase the rigidity of the plenum chamber 3200. For example, the frame portion 3210 is rigidified by the ventilation module 3420 and / or the connection port 3600. The rigidizer is configured as a relatively rigid component, for example, by being formed from a material having a relatively high modulus of elasticity and / or by forming a relatively rigid shape.

[0289] 4.3.5.3 Positioning and stabilizing structures, including ventilation structures In some forms of the present technology, for example, as shown in Figures 13A-15D, a positioning and stabilizing structure 3300 includes a ventilation structure 3400. In the illustrated example of Figures 13-15, the positioning and stabilizing structure may include a conduit portion 3320, and the conduit portion 3320 may include the ventilation structure 3400.

[0290] 13C and 15D, the plenum chamber 3100 may include lateral openings 3240, and the conduit sections 3320 are configured to be in fluid communication with the interior of the plenum chamber 3100, in use, through the lateral openings 3240. Each conduit section 3320 may be connected to a respective connector 3214 provided in each opening 3240.

[0291] In the examples of FIGS. 13C and 15D, the headgear straps 3310 may be included as part of the conduit portion 3320. For example, the headgear straps 3310 may be permanently attached to the conduit portion 3320. As shown in FIGS. 13B, 13C, 15C, and 15D, at least a portion of the headgear strap material may cover at least a portion of the conduit portion 3320, which in turn may cover at least a portion of the ventilation structure 3400. The portion of the ventilation structure 3400 that covers the headgear strap material may serve to diffuse the ventilation airflow, i.e., form a diffuser 3900. In these embodiments, the conduit portion 3320 is considered to be part of the positioning and stabilizing structure 3300. As shown in FIGS. 13A-15D, the conduit portion 3320 is included as part of the ventilation module 3420.

[0292] 13A, 14A, and 15A, the lower end of the positioning and stabilizing structure 3300 is connected to the plenum chamber 3200 during use, and the upper end of the positioning and stabilizing structure 3300 is located in the upper and / or rear region of the patient's head during use. The conduit portion 3320 may comprise a lower end portion of the positioning and stabilizing structure 3300, such that the ventilation structure 3400 may be located near the lower end during use.

[0293] 13A-13C, the patient interface 3000 includes the deflector 3500 described above. In the example of Figures 15A-15D, the patient interface 3000 may not have the deflector 2500 described above. However, in some forms, as shown in Figures 15C and 15D, a ventilation structure 3400, such as a ventilation module 3420, may include a rear wall 3514 configured to redirect some ventilation.

[0294] In some forms, the conduit portion 3320 may be configured to be relatively rigid, such as by being formed from a material with a relatively high modulus of elasticity or by being formed into a shape that promotes rigidity, as shown in FIGS. 13A and 15D . In some forms, the conduit portion 3320 may be formed from a relatively flexible material, and the conduit portion 3320 may include a support structure (not shown) to increase stiffness and limit and / or prevent blockage of the conduit portion 3320, thereby preventing or limiting the release of air into the environment. This can help to limit and / or prevent blockage from forces applied while the patient is sleeping on their side, for example. The support structure may be provided by one or more of a reinforcing structure, a thickened region, and a reinforced region.

[0295] 4.3.5.4 Plenum chamber with ventilation structure 17-23, for example, the plenum chamber 3200 includes a ventilation structure 3400. For example, the ventilation structure 3400 may be disposed on a side of the inner region of the plenum chamber 3200, i.e., in a side region of the plenum chamber 3200.

[0296] 20, ventilation holes 3410 may be formed in the sides 3213 of the frame portion 3210 of the plenum chamber 3200. In this configuration, the plenum chamber 3200 provides ventilation walls 3412.

[0297] 4.3.6 Deflector In some forms of the present technology, for example as shown in Figures 6A-13C, a patient interface 3000 includes a deflector 3500 configured to redirect or rotate at least a portion of the ventilated gas flow. In certain forms, the patient interface 3000 includes a pair of deflectors 3500 positioned symmetrically, for example on either side of the patient interface 3000.

[0298] 4.3.6.1 The vented gas flow is redirected forward. In some forms of the present technology, as shown in, for example, FIGS. 6A-13C, each deflector 3500 is configured to divert a portion of the ventilated gas flow laterally in any direction toward the front of the patient. That is, the air flow redirected by the deflector 3500 has a velocity, which is a vector having a magnitude (velocity) and a direction. In some forms, the forward direction is generally understood as the velocity vector of the redirected air flow having a positive component relative to the front of the patient. The velocity vector of the redirected gas flow may also have a positive component in a direction perpendicular to the frontal direction, such as upward, downward, or laterally. For example, the velocity vector may be in any of the following directions: upper-forward, lower-forward, upper-forward-lateral, or lower-forward-lateral.

[0299] For purposes of later discussion, when referring to the direction of ventilation gas flow redirected by deflector 3500, for convenience, any direction that has a forward component relative to the patient (i.e., as described above) will be referred to as "one forward direction" (this is intended to be distinguished from "the forward direction").

[0300] In some configurations, the direction of the velocity vector of the redirected gas flow may be substantially forward, which may be understood to mean that the maximum component of the velocity vector in the reference frame of the mutually perpendicular axes of the body is forward in that direction, i.e., the redirected gas flow may be moving forward in any other direction.

[0301] In some forms, each deflector 3500 is configured to redirect a majority of laterally ventilated gas flow in a forward direction when in use. In some forms, each deflector 3500 is configured to redirect all of the laterally ventilated gas flow in a forward direction when in use. The forward direction is shown in FIG. 2D. In other words, the deflectors 3500 are configured to redirect some, preferably at least a majority, of the laterally ventilated air forward when in use, away from the patient's face.

[0302] The deflector 3500 may be configured to redirect laterally ventilated air toward the front of the patient's face in the midsagittal plane during use. In some forms, the deflector 3500 may be configured to redirect a majority of the laterally ventilated gas flow toward a portion of the air delivery tube 4172 during use. These aspects of the technology are described in more detail below.

[0303] In the illustrated example of FIGS. 6A-13C, each deflector 3500 includes an arrangement of one or more deflector walls 3512, 3514, 3516, 3518.

[0304] 6A-13C, at least a portion of at least one deflector wall 3512, 3514, 3516, 3518 is configured to be located in the path of ventilated air flow laterally from at least a portion of the ventilation structure 3400 during use. This can be referred to as a deflector 3500 "covering" the ventilation structure. It should be understood that the deflector 3500 may be separate from the ventilation structure 3400 while located in the flow path of air ventilated from the ventilation structure 3400. At least one wall may be a side wall 3512 configured to restrict / prevent ventilated air from flowing laterally away from the patient's face, i.e., in the same direction as the air exits.

[0305] 6C, 6D, 8B, 9B, 11C, 12C, and 13C, the side wall 3512 has a vent-facing surface 3512a that is spaced apart from a surface 3412a on the opposite side of the ventilation wall 3412 in use, thereby providing a gap 3520 between the side wall 3512 and the ventilation wall 3412 through which air can be ventilated.

[0306] 6A-9D and 13A-13C, a portion of the side wall 3512 covering a portion of the ventilation structure 3400 may extend in a direction substantially perpendicular to the direction in which air is ventilated from the ventilation structure 3400. In some forms, as shown in FIGS. 6A-9D and 13A-13C, a portion of the side wall 3512 covering a portion of the ventilation structure 3400 may extend in a direction substantially parallel to the direction in which the surface of the ventilation wall 3412 extends.

[0307] In some embodiments, the deflector 3500 includes multiple other deflector walls, such as a rear wall 3514, an upper wall 3516, and a lower wall 3518. The rear wall 3514 may be configured to restrict / prevent rearward airflow, i.e., airflow from the rearward direction. The rearward direction may be toward the patient's face, eyes, and / or ears, for example. The upper wall 3516 may be configured to restrict / prevent airflow from the upward direction, e.g., upward along the patient's face. The lower wall 3518 may be configured to restrict / prevent airflow from the downward direction, e.g., downward along the patient's face. For example, in some embodiments, gas flow is meant to uniformly exit the gap 3520 between the deflector walls 3512, 3514, 3516, 3518 and the ventilation wall 3412. This can evenly distribute redirected air as it leaves the gap 3520. The gap 3520 may be configured to surround a portion of the ventilation structure 3400. The gap 3520 may be configured to surround a majority of the ventilation structure 3400. The gap 3520 may be configured to allow air flow such that the angle A between the highest and lowest gas flow directions is between about 0° and about 280°. FIG. 9A illustrates the angle A according to one form of the present technology. The gap 3520 may be configured to allow a forward flow of gas such that the angle A between the highest and lowest gas flow directions is between about 0° and about 280°, preferably between about 0° and about 180°, and in some examples is between about 0° and about 120°, between about 0° and about 100°, between about 20° and about 180°, between about 30° and about 120°, between about 10° and about 90°, or between about 45° and about 90°.

[0308] In some forms, the gap 3520 may be configured such that angle α limits / prevents concentration of airflow and promotes diffusion of airflow. In some forms, the gap 3520 may be configured such that angle A improves patient comfort during use by limiting / preventing airflow to the patient, such as the patient's face, eyes, and / or ears. The temperature of the airflow may be lower than the ambient temperature, such as cool air, and may cause discomfort to the patient if the airflow contacts the patient's face, eyes, ears, or other temperature-sensitive areas. Thus, the gap 3520 may be configured to provide an angle α between the direction of the airflow at the top and bottom tiers that is large enough to limit and prevent concentration of gas flow and promote some diffusion, but small enough to limit and prevent patient discomfort from the gas flow contacting the patient.

[0309] The other deflector walls 3514, 3516, 3518 may extend from the lateral surface 3412a. For example, as shown in Figures 6A-13C, the other deflector walls 3514, 3516, 3518 may extend in a direction substantially perpendicular to the direction in which the lateral surface 3412a extends. Gaps 3520 are provided between the other deflector walls 3514, 3516, 3518 and the side wall 3512 and ventilation wall 3412.

[0310] 6A-13C, the deflector 3500 may include a spacer 3530 that positions the side wall 3512 over the ventilation wall 3412 in use. In some examples, the spacer 3530 may extend from one of the lateral-facing surface 3412a and the vent-facing surface 3512a. The spacer 3530 may extend in a direction substantially perpendicular to the direction in which the lateral-facing surface 3412a extends.

[0311] One or more other deflector walls 3514 , 3516 , 3518 may provide a spacer 3530 .

[0312] 6A-13C, deflector 3500 or at least a portion thereof, e.g., one or more of deflector walls 3512, 3514, 3516, 3518, may be included as part of ventilated structure 3400. In some forms, as shown in the example shown in FIGS. 6A-13C, deflector 3500 or at least a portion thereof may be included as part of connector 3800, e.g., one or more of deflector walls 3512, 3514, 3516, 3518 may be included as part of connector 3800. In some forms, connector 3800 is included as part of ventilated structure 3400. For example, referring to the embodiment of FIGS. 6A-12E, a portion of each ventilation module 3420 is configured to provide connector 3800.

[0313] 4.3.6.2 Air-impermeable deflectors In certain forms of technology, such as those shown in Figures 6A-10C, the deflector 3500 is air impermeable. As shown in Figures 9A, 9B, 10B, and 10C, the sidewall 3512 deflects exhaled air away from the deflector 3500 through a gap 3520 in the direction indicated by the arrows included for illustrative purposes.

[0314] As shown in the example of FIGS. 10B and 10C, the deflector walls 3512, 3514, 3516, and 3518 are arranged to form a turning portion 3414 that turns or redirects air ventilated laterally from the interior of the plenum chamber 3200 through the ventilation holes 3410. In the illustrated embodiment of FIGS. 10A-10C, the ventilation module 3420 is configured so that the deflector walls 3512, 3514, 3516, and 3518 are spaced apart from the ventilation wall 3412. The deflector 3500 in this example can rotate the air approximately 180°. Referring to FIGS. 10A-10C, the ventilation module 3420 includes a connector 3800. For example, the connector 3800 may be located at a side end of the ventilation module 3420. In the illustrated example of FIGS. 10A-10C, the connector 3800 is a slot 3810 configured to receive a portion of the headgear strap 3310 to connect the headgear strap 3310 to the patient interface 3000.

[0315] 6A-6D, the deflector 3500 does not include other deflector walls 3514, 3516, 3518. It includes a side wall 3512 and a spacer 3530. In this configuration, the ventilated air may be directed rearward, upward, and / or downward in addition to the forward direction. In this configuration, the lower surface of the spacer 3530 may function as the upper wall of the ventilation holes 3410 located below the spacer 3530, and the upper surface of the spacer may function as the lower wall of the ventilation holes located above the spacer 3530.

[0316] In some forms, as shown in FIGS. 7A-9D , the deflector 3500 may include one or more other walls 3514, 3516, 3518. For example, the deflector 3500 includes a rear wall 3514. The rear wall 3514 may have a substantially arcuate or curved shape when the patient interface 3000 is viewed substantially laterally (i.e., from the side). As shown in FIGS. 8A-8C , the rear wall 3514 may extend to form at least a portion of the lower wall 3518 and the upper wall 3516. In FIGS. 7A-8C , the upper wall 3516 and the lower wall 3518 may extend through portions of the respective upper and lower regions of the ventilation structure 3400. This may allow some air to be redirected upward or downward through a gap 3520 between the side wall 3512 and the ventilation wall 3412. 9A-9D, however, the upper wall 3516 and the lower wall 3518 may extend through most of the respective upper and lower regions of the ventilation wall 3412. This can limit and prevent the amount of air diverted up or down. This can help to focus the diverted airflow substantially in the forward direction.

[0317] In the example of FIGS. 6A-9D, the connector 3800 is included as part of the deflector 3500, i.e., the deflector 3500 is configured to function as the connector 3800 connecting the positioning and stabilizing structure 3300 to the patient interface 3000.

[0318] 6A-9D, the positioning and stabilizing structure 3300 includes a headgear rigidizer. The rigidizer may include a rigidiser arm 3330, for example, on each side of the patient interface, for connecting to a corresponding headgear strap. A deflector 3500 may be included as part of the rigid arm 3330, such that a portion of the rigid arm 3330 functions as both the deflector 3500 and the connector 3800. In these configurations, the sidewall 3512 is included as part of the rigidiser arm 3332.

[0319] 8A-9D, the rigidiser arm 3330 is removably connected to the connector 3800, for example, by a snap fit. The rigidiser arm 3332 includes an opening 3332 that engages with a protrusion 3810 of the connector 3800 to connect the rigidiser arm 3332 to the patient interface 3000. This removably connects a portion of the deflector 3500, for example, the side wall 3512, to the connector 3800.

[0320] In the configurations of FIGS. 6A-9D, the headgear straps 3310 may be attached to the rigidiser arms 3330. In the examples of FIGS. 6A-8C, the headgear straps 3310 are attached to the deflector 3500. A portion of the headgear straps 3310 may cover the ventilation-facing surface 3512a. As shown, the headgear straps 3310 may be positioned to diffuse ventilated air when in use. Although not shown in FIG. 9, in this configuration the headgear straps 3310 are attached to the rigidiser arms 3330 but do not cover the ventilation-facing surface 3512a. As shown, a diffuser 3900 may be attached to the ventilation-facing surface 3512a so that it is positioned to diffuse ventilated air when in use. These aspects of the present technology are described in more detail below.

[0321] 6A-6D, the headgear straps 3310 may be removably attached to the deflector 3500 using, for example, the buttonhole attachment mechanism described above. It should also be appreciated that the headgear straps 3310 may be removably attached to the deflector 3500 in other manners, such as using mechanical fasteners or snaps, or other suitable attachment mechanisms.

[0322] 8A-9D, the headgear straps 3310 may be permanently attached to the deflector 3500. For example, welding, lamination, overmolding, adhesives may be used to achieve the permanent attachment.

[0323] In some configurations, one or more of the deflector walls 3512, 3514, 3516, 3518 and / or the spacer 3530 may be integrally formed as part of the ventilation module 3420. The ventilation module 3420 may be connected to a portion of the plenum chamber 3200 that forms the perimeter of the opening 3240. In one configuration, shown in FIGS. 6A-6D, the side wall 3512, the ventilation wall 3412, and the spacer 3530 are integrally formed as the ventilation module 3420. In another configuration, shown in FIGS. 8A-9D, the ventilation wall 3412, the rear wall 3414, the top wall 3416, and the bottom wall 3418 are integrally formed as the ventilation module 3420.

[0324] In some forms, the patient interface 3000 may include one or more ribs 3430 provided on or near the ventilation structure 3400 and / or deflector 3500. For example, Figures 9A-9C show a patient interface 3000 having one or more ribs 3430 provided on the ventilation wall 3412. The ribs 3430 may extend outward from the surface of the ventilation wall 3412 and may have a length extending along the surface of the ventilation wall 3412 from the posterior region toward the anterior region. The ribs 3430 may provide a plurality of flow paths 3432, such as channels, that can help diffuse the airflow from the deflector 3500.

[0325] 4.3.6.3 Deflectors with air-permeable sections 11A-13C, a portion of the deflector 3500 may include an air permeable portion 3512b. For example, the side wall 3512 may include the air permeable portion 3512b. In some embodiments, the air permeable portion 3512b may be provided in addition to the air impermeable portion 3512c of the deflector 3500.

[0326] As shown in the example of FIGS. 11A-13C, the deflector 3500 may be configured to operate similarly to the other deflectors 3500 described above. Alternatively, for example, the side wall 3512 may have an air permeable portion 3512b that allows some air to pass through. By allowing some of the air flow to pass through the air permeable portion 3512b, the air permeable portion 3512b may serve to diffuse the ventilated air flow. The air permeable portion 3512b may redirect some of the air flow away from the deflector 3500 through the gap 3520. In the example shown in FIGS. 11A-13C, air may leave the deflector 3500 through the gap 3520, and a certain amount of air may leave through the air permeable portion 3512b. More air may exit the gap 3520 than exit the air permeable portion 3512b. For example, the air permeable portion 3512b may be formed of a breathable material, such as a woven material, such as headgear strap material, that doubles as a diffuser 3900, as shown in Figures 11A-13C. Various aspects of the diffuser 3900 are described in more detail below.

[0327] 11A-13C, the ribs 3430 may space the headgear strap material a predetermined distance (e.g., the height of the ribs) from the lateral surface 3412a. The ribs 3430 can help inhibit / prevent the breathable material from sagging toward the ventilation structure 3400 during use. This can help inhibit / prevent blockage of the ventilation structure 3400 when the headgear strap material is submerged in water and / or becomes blocked. The spacer 3530 may provide one or more ribs 3430, as shown in FIGS. 11A-12E.

[0328] 11A-12E, the majority of the side wall 3512 may be breathable. The side wall 3512 may include an air impermeable portion 3512c. The air impermeable portion 3512c may be configured with one or more openings 3512d. The headgear strap material forming the air permeable portion 3512b may be attached to the air impermeable portion 3512c such that the openings 3512d are covered by the headgear strap material. In the illustrated example, the headgear strap material may be attached to the side surfaces of the air impermeable portion 3512c.

[0329] 11A-12E, in some forms, the deflector 3500 may include a portion of the positioning and stabilizing structure 3300. For example, the deflector 3500 may include a portion of the headgear strap 3310. The headgear strap 3310 may be permanently attached to the non-breathable section 3512c, for example, by welding, stitching, or adhesive.

[0330] 11A-12E, headgear straps may also be provided on the rigidiser arms 3330. Referring to the example of Figures 12A-12E, the rigidiser arms 3330 may be substantially longer than the rigidiser arms 3330 shown in Figures 11A-11C.

[0331] In the example shown in FIG. 13, the entire side wall 3512 may be breathable.

[0332] 4.3.6.4 Further Deflector Forms In some forms of the present technology, for example as shown in FIGS. 17-24 , the positioning and stabilizing structure 3300 includes a deflector 3500. That is, a portion of the positioning and stabilizing structure 3300 is used to deflect the airflow exiting the ventilation structure 3400.

[0333] In these configurations, the ventilation structure 3400 is at least partially obscured by the deflector 3500, and preferably the majority of the ventilation structure 3400 is obscured (from the angle of an observer positioned in front of the patient interface during use). In the configurations shown in Figures 17, 18, 19, 22 and 23, the ventilation holes 3410 are completely obscured by the deflector 3410. Thus, in some configurations, the patient interface 3000 may include a substantially hidden or concealed ventilation structure 3400. This may improve the aesthetic appeal of the patient interface 3000 and potentially improve patient compliance with treatment.

[0334] The deflector 3500 in these examples has one or more of the same components as the deflector 3500 described above, such as a side wall 3512, a vent-facing surface 3512a, and one or more deflector walls. The vent structure 3400 in these examples also has one or more of the same components as the vent wall 3412 and side-facing surface 3412a as the vent structure 3400 described above. As in the above examples, the vent-facing surface 3512a of the deflector 3500 in these examples is spaced apart from the vent wall 3412 in use, forming a gap 3520 therebetween for gas flow to pass through.

[0335] In the examples shown in FIGS. 19 and 23, similar to the examples described above, the ventilation-facing surface 3512a may extend in a direction generally perpendicular to the direction of air discharge from the ventilation structure 3400. As shown in FIGS. 19 and 23, the ventilation wall 3412 / lateral-facing surface 3412a of the plenum chamber 3200 is substantially concave in some configurations when viewed in side cross section. As shown in FIGS. 19 and 23, in some configurations, the side wall 3512 / ventilation-facing surface 3350a of the deflector 3500 is substantially convex in side cross section. This allows the shape of the lateral-facing surface 3412a to be complementary to the shape of the ventilation-facing surface 3512a. In other configurations (not shown in these figures), the lateral-facing surface 3412a and / or the ventilation-facing surface 3512a may have any other suitable shape, such as being substantially planar.

[0336] Thus, in some forms, the portion of the exterior surface of the plenum chamber 3200 that faces away from the patient during use may include a recess 3230. This portion may be recessed or recessed relative to the surrounding or adjacent portions of the plenum chamber 3200. This helps make the patient interface 3000 less obtrusive and bulky, which can improve patient comfort and compliance. As shown in FIGS. 17, 18, and 22, at least a portion of the patient interface assembly, such as the frame 3360 or headgear tube(s) 3350, may be positioned within the recess 3230 during use. A recessed ventilation wall 3412 may provide at least a portion of the recess 3230, as shown in FIGS. 19-21. The recess may also facilitate holding the frame 3360 or headgear tube(s) 3350 in the proper position during use.

[0337] 18 and 20, the patient interface 3000 may include a spacer 3530 that positions the vent-facing surface 3512a of the deflector 3500 spaced apart from the lateral-facing surface 3412a of the plenum chamber 3200 during use. In one example, the spacer 3530 may extend from at least one of the lateral-facing surface 3412a and the vent-facing surface 3512a. That is, the spacer 3530 may be formed of multiple structures. The spacer 3530 may extend in a direction substantially perpendicular to the direction in which the lateral-facing surface 3412a extends.

[0338] The spacer 3530 may include at least one rib 3430, as shown in the example of FIGS. 18 and 20. FIGS. 18 and 20 show one or more ribs 3430, e.g., multiple ribs 3430, projecting outward from the ventilation wall 3412. In another embodiment, the spacer may include at least one rib 3430 projecting outward from the ventilation-facing surface 3512a. In an embodiment with multiple ribs 3430, the ribs may be arranged parallel to one another. In the embodiment of the technology shown in FIGS. 18 and 20, the ribs may be arranged to extend substantially in a vertical direction when the patient interface 3000 is worn by a patient. In other embodiments, the ribs may be arranged in a different direction. The spacer 3530 may include any other suitable components in other embodiments not shown; for example, the spacer 3530 may include one or more protrusions.

[0339] The ribs 3430 can form a plurality of flow paths, e.g., channels, therebetween to direct gas flow from the ventilation structure 3400 through the gap 3520. This can diffuse the gas flow away from the gap 3520.

[0340] The spacer 3530, e.g., the rib(s) 3430, may comprise a portion of the ventilation structure 3400. The rib 3430 may be formed, for example, as part of the plenum chamber 3200. In other forms, the spacer 3530, e.g., the rib(s) 3430, may comprise a portion of the deflector 3500. For example, the spacer 3540 may comprise at least one of the deflector walls.

[0341] 4.3.6.4.1 Headgear tubes with deflectors In some forms, as shown in the examples of FIGS. 17-21 , the positioning and stabilizing structure 3100 of the patient interface 3000 includes at least one headgear tube 3350 for routing airflow from the connection port 3600 to the plenum chamber 3200, and at least one headgear tube 3350 includes a deflector 3500. That is, as shown in these figures, a portion of each headgear tube 3350 may function as the deflector 3500. This portion of each headgear tube 3350 is positioned to redirect gas flow from the ventilation structure 3400. In this example, this portion of each headgear tube 3350 is provided by the corresponding vent-facing surface 3350 a of the headgear tube, which vent-facing surface 3350 a forms the vent-facing surface 3512 a described above. This portion of each headgear tube 3350 may be provided by a tube portion 3354. In another form, the deflected portion of each headgear tube 3350 may be at or adjacent to the lower end of the headgear tube 3350. In use, the deflected portion of each headgear tube 3350 may be positioned to cover the cheek area of ​​the patient.

[0342] In these examples, at least one headgear tube 3350 conceals the ventilation structure 3400 (from the angle of an observer positioned in front of the patient interface during use).

[0343] In the illustrated example, the portion of the deflector 3350 that functions as at least one headgear tube 3350 is essentially air impermeable. However, as explained further below, at least one headgear tube 3350 may include a diffuser 3900. However, the diffuser 3900 that is considered part of the headgear tube(s) 3350 in these configurations may be air permeable.

[0344] 4.3.6.4.2 Frame with deflector In some embodiments, as shown in the examples of Figures 22-24, the positioning and stabilizing structure 3100 of the patient interface 3000 includes a frame 3360 that facilitates engagement with the plenum chamber 3200. In these embodiments, the frame 3360 includes a deflector 3500. That is, as shown in Figure 22, a portion of the frame 3360 functions as the deflector 3500. A portion of the frame 3360 is positioned to redirect gas flow exiting the ventilation structure 3400. In this example, the deflection of the frame 3360 is provided by a vent-facing surface 3360a that forms the vent-facing surface 3512a as described above. The side of the frame 3360 that faces the patient during use is provided with the vent-facing surface 3360a.

[0345] In these examples, the frame 3360 hides the ventilation structure 3400 (from the perspective of an observer positioned in front of the patient interface 3000).

[0346] In the illustrated example, the frame 3360 is essentially air impermeable. However, the frame 3360 may include a diffuser 3900, as described further below. However, the diffuser 3900, which is considered part of the frame 3360 in these embodiments, may be air permeable.

[0347] It should be understood that in other configurations not shown, a portion of the frame 3360 may include an air permeable portion similar to the air permeable portion 3512b described above. Thus, the frame 3360 may include these other configurations of air permeable and air impermeable portions.

[0348] 4.3.6.5 Upward and / or downward redirection of ventilated gas flow In some forms, as shown in the examples of FIGS. 17-23 , the deflector 3500 is configured, in use, to redirect at least a portion of the ventilation gas flow (e.g., a majority of the laterally ventilated gas flow) into at least one of an upward direction and a downward direction (e.g., a substantially upward direction and a substantially downward direction). References to “upward” and “downward,” as well as the similar term “forward” used above, are intended to mean any direction having an upper or internal component relative to the patient, respectively. A component extending in the height direction may also extend in one or more other directions, and similarly, a component extending in the low direction may also extend in one or more other directions. For example, a gas flow redirected in a substantially upward direction may be redirected in a laterally and / or forward direction, but not in a low direction; similarly, a gas flow redirected in a substantially low direction may also be redirected in a laterally and / or forward direction, but not in a high direction. Examples of these are described further below. Similarly, references to a "substantially higher direction" or a "substantially lower direction" are understood to refer to a direction in which an object has a maximum component of its velocity vector in a frame of reference of mutually orthogonal axes in a higher or lower direction, respectively.

[0349] The shape and / or orientation of the vent-facing surface 3512a, as well as the shape and / or arrangement of the outer surface of the plenum chamber 3200, can indicate the direction(s) that gas flow leaves through the gap 3520. In some forms, the spacers 3430 and / or ribs 3530 can also indicate the direction(s) that gas flow leaves through the gap 3520. For example, as shown in FIGS. 19 and 23 , the convex vent-facing surface 3350a of at least one headgear tube 3350, or the convex vent-facing surface 3360a of the frame 3360, and the concave ventilation wall 3412 and / or lateral-facing surface 3412a can direct gas flow substantially downward and / or upward from the gap 3520.

[0350] As shown in FIGS. 19 and 23, when the gas flow is redirected substantially upward and / or downward, the gas flow may also be redirected partially forward. As shown in FIG. 22, the gas flow may be redirected partially laterally. Thus, the gas flow may be redirected in the superior anterior-lateral and / or inferior anterior-lateral directions. This may help direct the ventilated gas flow away from the patient's face, which may improve patient comfort and treatment compliance. This allows the openings in the gap 3520 (through which the redirected gas flow is ventilated) to be oriented in the superior frontal and / or inferior frontal directions.

[0351] The channel(s) created by the gap 3520 may extend substantially upward and / or downward. However, as shown in the figures, in some configurations, the channel(s) may extend partially anteriorly. Also, as shown in the figures, in other configurations, a portion of the channel(s) may extend laterally. Thus, the channel(s) extend in a superior anterior-lateral direction and / or an inferior anterior-lateral direction. In use, the channel(s) may be angled anteriorly superiorly and / or anteriorly inferiorly relative to the patient's coronal plane as shown in FIG. 2E, and angled laterally superiorly and / or lateral inferiorly relative to the patient's sagittal plane as shown in FIG. 2C, for example.

[0352] The rib(s) 3430 may extend in a substantially upward direction, as shown in FIGS. 18-20 . In some forms, the rib(s) 3430 extend to a higher or higher area of ​​the plenum chamber 3200 than the ventilation hole(s) 3410. The rib(s) 3430 extend generally downward as shown. In some forms, the rib(s) 3430 extend to a lower or lower area of ​​the plenum chamber 3200 than the ventilation hole(s) 3410. The direction in which the ribs 3430 extend helps to limit or prevent ventilation gas flow from being blocked by the gap 3520 and helps to direct the ventilation flow in a desired direction.

[0353] The rib(s) 3430 may extend between the ventilation holes 3410, as shown in FIGS. 18-20. For example, the rib 3530 may extend between a pair of ventilation holes 3410 as shown. In the example shown, the ventilation structure 3400 may include multiple pairs of ventilation holes, such as three pairs, separated by ribs 3530. However, it should be understood that any number of ventilation holes 3400 adapted to provide sufficient gas scavenging while maintaining treatment pressure within the plenum chamber 3200 during use may be provided. Additionally, any number of ribs 3539 may be provided extending in one or more other directions.

[0354] 4.3.7 Diffuser A patient interface 3000 according to some examples of the present technology includes a diffuser 3900 that diffuses the gas flow. The diffuser 3900 may be positioned to diffuse the gas flow from the ventilation structure 3400.

[0355] In some forms, the deflector 3500 may function at least in part as the diffuser 3900. That is, the deflector 3500 may act as a deflector / redirector, diffusing the ventilated gas flow in the process. Alternatively or additionally, the ventilation structure 3400 may function as a ventilator and diffuser of the gas flow.

[0356] In other embodiments, as shown in Figures 6A-9D, 11A-16A, and 17-24, the diffuser 3900 is configured to allow gas to flow therethrough and diffuse the gas flow as it does so. For example, the diffuser 3900 may include an air-permeable layer, such as a woven material. In the illustrated embodiment, the diffuser 3900 is positioned in the gas flow path from the ventilation structure 3400, for example, to cover at least a portion of the ventilation structure 3400 during use, preferably the entire ventilation structure 3400. The diffuser 3900 may be positioned immediately before the ventilation structure 3400 or may be separate from the ventilation structure 3400 and be positioned in the flow path of the ventilation gas during use. A spacer 3530, such as a rib 3430, may offset the diffuser 3900 from the ventilation wall 3412.

[0357] The diffuser 3400 may be at least partially hidden by the deflector 3500, for example, from the perspective of an observer positioned in front of the patient interface 3000. As shown in FIGS. 17 and 22, the diffuser 3900 may be substantially hidden as shown. In some forms, as shown in FIGS. 18, 19, and 23, the ventilation holes 3410 are completely hidden by the deflector 3410. Thus, in some forms, the patient interface 3000 may include a substantially hidden or concealed diffuser 3900. This may improve the aesthetic appeal of the patient interface 3000 and potentially improve patient compliance with treatment.

[0358] In some forms, the spacers 3530, e.g., the ribs 3430, are configured to ensure that the diffuser is positioned a selected distance from the ventilation wall 3412 and maintained in that position during use. This distance may be set by the size of the ribs, particularly the height of the ribs. The distance between the diffuser 3900 and the ventilation wall 3412 can limit or prevent noise during use.

[0359] In some forms, the diffuser 3900 is formed from a woven material, such as a fleece material. The woven material may be a headgear strap material. In one example, the diffuser 3900 is formed by raising a portion of the surface of the woven material.

[0360] In some embodiments, for example those shown in FIGS. 6A-9D, 11A-16A, and 17-24, the positioning and stabilizing structure 3300 includes a diffuser 3900.

[0361] In some embodiments, for example, those shown in FIGS. 6A-8C and 11A-15D, the headgear straps 3310 include a diffuser 3900.

[0362] 8A-9D and 17-24, the positioning and stabilizing structure 3300 includes a component. As shown, the component may have a vent-facing surface 3512a that, in use, is located in the path of ventilation gas flow from the ventilation structure 3400. A diffuser may be located on the vent-facing surface 3512a of the component. In some forms, the described component may be a frame 3360, and in other forms, it may be a headgear tube 3350.

[0363] In some forms, the diffuser 3900 may be removable from the remainder of the positioning and stabilizing structure 3300. This may allow for easier cleaning, replacement and / or storage of the component.

[0364] In some forms, the diffuser 3900 may be formed into or permanently connected to a positioning and stabilizing structure 3300 that is removable from the remainder of the patient interface 3000. This may reduce the number of patient interface assemblies and may facilitate cleaning, replacement and / or storage of the assemblies.

[0365] 4.3.7.1 Headgear straps with diffusers 6A-8C and 11A-15D, the headgear straps 3310 may include a diffuser 3900. That is, a portion of the headgear straps 3310 is used to diffuse the ventilated gas flow.

[0366] The use of headgear straps 3310 to carry the diffuser 3900 can contribute to lower manufacturing costs compared to patient interfaces in which the diffuser and headgear straps are separate components. It can also reduce the number of parts that require manufacturing, replacement, and / or cleaning compared to such interfaces. The diffuser 3900 is removable by the headgear straps 3310.

[0367] In the exemplary form, the headgear straps 3310 include a portion configured to cover at least a portion of the ventilation structure 3400 during use. This covering portion includes the diffuser 3900. The headgear straps 3310 are therefore connected to the patient interface 3000 so as to cover at least a portion of the ventilation structure 3400, preferably the entire ventilation structure 3400. In examples, the headgear straps 3310 may be connected to the patient interface 3000 using buttonhole attachments or snap fit connections as described above.

[0368] In these configurations, the diffuser 3900 is formed from the headgear strap material. In Figure 16B, the diffuser 3900 is formed by raising a portion of the surface of the headgear strap material to form a raised portion 3310a. The headgear strap material may include a woven material.

[0369] 16C and 16D, the diffuser 3900 may be formed separately and attached to the headgear straps 3310. The diffuser 3900 may be formed, for example, from a woven material. In some forms, the diffuser 3900 may be removably connected to a portion of the headgear straps 3310.

[0370] 4.3.7.2 Rigidiser Arm with Diffuser In some forms, for example as shown in FIGS. 8A-9D, the components of the positioning and stabilizing structure 3300 described above include rigidiser arms 3330.

[0371] For example, in some forms, the rigidiser arm 3330 may include a diffuser 3900. As shown in FIG. 9D , in some forms, the diffuser 3900 may be formed separately, e.g., from a woven material, and attached to the vent-facing surface 3512a of the rigidiser arm 3330, such that the diffuser 3900 covers at least a portion of the vent structure 3400 to diffuse gas flow from the vent structure 3400. In this example, the headgear straps 3310 are attached to other portions of the rigidiser arm 3330. In other words, the headgear straps 3310 do not form a diffuser 3900 in this particular form. The diffuser 3900 may be permanently or removably connected to the vent-facing surface 3512a. This allows the diffuser 3900 to be replaced, removed, cleaned, and reconnected. As previously described, in some forms, the deflector 3500 may be detachable from the patient interface 3000. Thus, the diffuser 3900 may be removed along with the diffuser 3500 .

[0372] In the embodiment shown in Figures 8A-9D, the rigidiser arm 3330 (and attached headgear strap 3310) can be detached from the connector 3800, thereby improving access to the diffuser 3900 for removal and / or cleaning.

[0373] 4.3.7.3 Headgear tube with diffuser In some forms, the positioning and stabilizing structure 3300 components include at least one headgear tube 3350, as shown, for example, in FIGS.

[0374] 17-21, at least one headgear tube 3350 includes a diffuser 3900. That is, a portion of at least one headgear tube 3350 is used to diffuse the ventilated airflow.

[0375] In these exemplary configurations, the headgear tube(s) 3350 include one or more portions configured to be located in the path of ventilation gas flow from the ventilation structure 3400 during use. For example, the diffuser 3900 may be located on a covering portion of the headgear tube 3350. As shown in the examples of Figures 17 and 18, the tube portion 3354 of the headgear tube 3350 provides the covering portion.

[0376] At least one headgear tube 3350 may include a vent-facing surface 3350a. For example, as shown in Figures 18 and 19, the vent-facing surface 3350a may be positioned, in use, to cover at least a portion of the ventilated structure 3400 in use. As shown in the examples of Figures 19 and 21, a diffuser 3900 may be located on the vent-facing surface 3350a of at least one headgear tube 3350. The vent-facing surface 3350a may be included as part of the covering portion.

[0377] The vent facing surface 3350a may be the patient facing surface in use. At least one headgear tube 3350 may have a non-patient facing surface in use.

[0378] In these examples, one or more portions of at least one headgear tube 3350 cover the diffuser 3900, e.g., a covering portion obscures the diffuser 3900 (as well as from the perspective of an observer positioned in front of the patient). In this way, the ventilation-facing surface 3350a may obscure the diffuser 3900. Additionally, the non-patient-facing surface may obscure the diffuser 3900.

[0379] The diffuser 3900 may be formed separately and connected to the covering part(s). In the example of Figure 19, the diffuser 3900 is attached to the ventilation-facing surface 3350a of the headgear tube(s) 3350.

[0380] In some forms, the diffuser 3900 may be removably connected to the covering portion(s), such that the diffuser 3900 may be removed from the remainder of the headgear tube 3350. This may allow for easier cleaning, replacement, and / or storage of the component.

[0381] In some forms, the diffuser 3900 may be permanently attached to the headgear tube(s) 3350 using overmolding, adhesives, lamination, thermoforming, welding, or one or more other well-known attachment methods. As mentioned above, the headgear tube(s) 3350 may be detached from the remainder of the patient interface 3000. Thus, the diffuser 3900 may be removed by the headgear tubes 3350 from the remainder of the patient interface 3000. This may reduce the number of patient interface assemblies and may facilitate cleaning, replacement, and / or storage of the assemblies.

[0382] In other configurations, the headgear tubes 3350 may be formed with a layer of textile material, for example, on at least the patient-contacting surface of the headgear tubes 3350. An example of this configuration is a headgear tube 3350 having a removable or permanently attached textile sleeve, or a headgear tube 3350 having an integrally formed layer of textile material. The textile layer of textile material may be brushed as described above. The brushed layer of textile material can form the diffuser 3900. In such configurations, the layer of textile material can serve the dual purpose of providing comfort where the headgear tubes 3350 contact the patient's skin and diffusing the ventilated gas flow.

[0383] 4.3.7.4 Frame with diffuser In some forms, for example as shown in FIGS. 22-24, the components of the positioning and stabilizing structure 3300 include a frame 3360.

[0384] 22-24, the frame 3360 includes a diffuser 3900. That is, a portion of the frame 3360 is used to diffuse the ventilated gas flow.

[0385] In an exemplary form, the frame 3360 includes one or more components configured to be located in the path of ventilation gas flow from the ventilation structure 3400 during use. For example, the diffuser 3900 may be located on a covering portion of the frame 3360. In the example shown in Figures 22 and 24, at least one of the body portion 3368 and arms 3366 of the frame 3360 provides a covering portion.

[0386] The frame 3360 may include a vent-facing surface 3360a. For example, as shown in Figures 22 and 23, the vent-facing surface 3360a may be positioned, in use, to cover at least a portion of the ventilated structure 3400 in use. As shown in the examples of Figures 23 and 24, a diffuser 3900 may be located on the vent-facing surface 3360a of the frame 3360. The vent-facing surface 3360a may be included as part of the covering portion.

[0387] The vent facing surface 3350a may be the patient facing surface in use. The frame 3360 may have a non-patient facing surface in use.

[0388] In these examples, one or more portions of the frame 3360 may cover the diffuser 3900, e.g., a covering portion may obscure the diffuser 3900. In this way, the vent-facing surface 3360a may obscure the diffuser 3900. Additionally, the non-patient-facing surface may obscure the diffuser 3900.

[0389] The diffuser 3900 may be formed separately and connected to various parts or parts of the frame 3360. As shown in Figure 23, the diffuser may be attached to the ventilation-facing surface 3360a of the frame 3360.

[0390] In some forms, the diffuser 3900 may be removably attached to a part or parts of the frame 3360. Thus, the diffuser 3900 may be removed from the rest of the frame 3360. This allows for easy cleaning, replacement, and storage of the component.

[0391] In some forms, the diffuser 3900 may be permanently attached to the frame 3360 using overmolding, adhesives, lamination, thermoforming, welding, or one or more other known attachment methods. Thus, the diffuser 3900 may be detached from the rest of the patient interface 3000 by the frame 3360. This may reduce the number of components of the patient interface and may facilitate cleaning, replacement, and storage.

[0392] 4.3.8 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0393] 4.3.9 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0394] 4.3.10 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0395] 4.3.11 Port In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property (e.g., pressure) of the gas within the plenum chamber 3200 to be measured directly.

[0396] 4.4 Manufacturing method of headgear strap diffuser Forms of the present technology provide methods of manufacturing a diffuser 3900 as part of the headgear straps 3310 of a positioning and stabilizing structure 3300 for holding a patient interface 3000 in a therapeutically effective position on a patient's head. In these forms, the diffuser 3900 may be incorporated into the headgear straps 3310.

[0397] In particular embodiments, the method may include the following steps, performed in any order: (a) forming a diffusion layer 3900 on a surface of the headgear strap material, the diffusion layer 3900 configured to diffuse the ventilated gas flow through a ventilation structure 3400 disposed on the patient interface 3000 in use; and (b) Headgear strap material is formed into headgear straps 3310.

[0398] 4.4.1 Diffusion layer formation method 4.4.1.1 Brushed headgear strap material In certain embodiments, step (a) may include raising a portion of the surface of the headgear strap material, thereby forming a raised portion 3310a on the headgear strap 3310. Step (a) may be performed by a raising device including a roller configured to raise the headgear tape material when the headgear tape material contacts the roller. Step (a) may also include trimming the raised portion 3310a on the surface of the headgear strap material. This trimming step may be performed by a raising device or a trimming device.

[0399] In one form, the diffuser 3900 may be integrated into the headgear straps using a localized nap treatment on the headgear strap material forming the headgear straps 3310. The localized nap treatment creates a napped portion 3310a. The nap helps to raise a soft, velvety surface composed of a variety of napped fibers. The napped portion 3310a may include napped fibers. The napped fibers can then be sheared / shaved to achieve a consistent height. This ensures that the height of the napped fibers in the napped portion 3310a is relatively consistent.

[0400] In some forms, a roll of fabric, such as headgear strap material, may be raised by a raising device, and then the fabric may be cut to form the headgear straps 3310 or portions thereof. In other forms, the headgear tape 3310 or portions thereof may be cut and then raised using rollers of a narrower raising device.

[0401] 4.4.1.2 Use of adhesives In certain embodiments, step (a) includes forming the diffusion layer 3900 from a woven material and attaching it to the surface of the headgear straps 3310 using an adhesive.

[0402] In one form, the diffuser 3900 may be integrated into the headgear straps 3310 by using an adhesive, by potting, or by applying an adhesive film.

[0403] The diffusing layer 3900 may be formed by cutting a piece of woven material to the desired shape, which may then be attached to the headgear straps 3310.

[0404] It should be understood that in other forms of the present technology, the diffusing layer 3900 may be attached to the surface of the headgear straps 3310 using a connection means such as fasteners or sutures, etc. In some forms, the diffusing layer 3900 may be removably attached to the surface of the headgear straps 3310 using another fastener or connection means.

[0405] 4.4.2 Forming the headgear straps In certain aspects, step (b) includes cutting the headgear strap material into headgear straps. Step (b) may be performed by a cutting device. The headgear strap material may include a woven material.

[0406] 4.5 Manufacturing method of headgear duct diffuser Forms of the present technology provide methods of manufacturing a diffuser 3900 as part of at least one headgear conduit 3350 of a positioning and stabilizing structure 3300 to hold a patient interface 3000 in a therapeutically effective position on a patient's head. In these forms, the diffuser 3900 may be incorporated within the headgear conduit 3350.

[0407] In particular embodiments, the method may include the following steps, performed in any order: forming a diffusion layer 3900 on a surface of the headgear conduit 3350, the diffusion layer 3900 being configured to diffuse the ventilated gas flow through a ventilation structure 3400 disposed on the patient interface 3000 in use; and A headgear conduit 3350 is formed.

[0408] 4.5.1 Diffusion layer formation method Step (a) includes raising a portion of the surface of the headgear tube 3350, the headgear tube 3350 being formed from a layer of woven material.

[0409] Step (a) may include trimming the nap on the surface of the textile material.

[0410] Step (a) may include forming the diffusive layer 3900 from a woven material and attaching the diffusive layer 3900 to a surface of the headgear conduit 3350 using an adhesive or other known attachment method.

[0411] The diffusion layer 3900 may be formed by cutting the woven and brushed woven materials in either order.

[0412] The textile material may include a fleece material.

[0413] 4.5.2 Forming the headgear tube Step (b) may include forming the conduit from one or more materials (e.g., silicone). For example, a silicone headgear tube 3350 may be formed separately, and the diffuser 3900 may be attached to the silicone headgear tube 3350. In another form, the headgear tube 3350 may be formed to include a layer of woven material formed as the diffusing layer 39000.

[0414] 4.6 Manufacturing method of frame diffuser Forms of the present technology provide methods of manufacturing a diffuser 3900 as part of a frame 3360 of a positioning and stabilizing structure 3300 for holding a patient interface 3000 in a therapeutically effective position on a patient's head. In these forms, the diffuser 3900 may be incorporated into the frame 3360.

[0415] In particular embodiments, the method may include the following steps, performed in any order: (a) forming a diffusion layer 3900 on a surface of the frame 3360, the diffusion layer 3900 being configured to diffuse the ventilated gas flow through a ventilation structure 3400 disposed on the patient interface 300 in use; and (b) Forming a frame 3360.

[0416] 4.6.1 Diffusion layer formation method Step (a) involves raising a portion of the surface of the frame 3360, the frame 3360 being formed from a layer of woven material.

[0417] Step (a) may include trimming the nap on the surface of the textile material.

[0418] Step (a) may include forming the diffusing layer 3900 from a woven material and attaching the diffusing layer 3900 to a surface of the frame 3360 using an adhesive or other known attachment method.

[0419] The diffusion layer 3900 may be formed by cutting a woven material.

[0420] The diffusion layer 3900 may be formed by cutting the woven and brushed woven materials in either order.

[0421] The textile material may include a fleece material.

[0422] 4.6.2 Forming the headgear tube Step (b) may include forming a frame from one or more materials. For example, the frame 3360 may be formed separately and the diffuser 3900 may be attached to the frame 3650. In another form, the frame 3360 may be formed to include a layer of woven material formed as the diffusing layer 3900.

[0423] 4.7RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electronic components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate a flow of air for delivery to a patient's airway, such as to treat one or more respiratory conditions described elsewhere herein.

[0424] 4.7.1 RPT Device Algorithm As previously mentioned, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium, such as the memory 4260. The algorithms 4300 are essentially grouped into groups called modules.

[0425] In other forms of the present technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In such forms, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm 4300 executed on the external device may be communicated to the external device via a local external communications network 4284 or a remote external communications network 4282. In such forms, the portion of the algorithm 4300 executed on the external device may be expressed as a computer program stored on a non-transitory computer-readable storage medium accessible to the controller of the external device, with processor control instructions, etc., executed by one or more processor(s). Such a program configures the controller of the external device to execute the portion of the algorithm 4300.

[0426] In such a configuration, therapy parameters generated by the external device via the therapy engine module 4320 (if such a configuration forms part of the algorithm 4300 executed by the external device) may be communicated to the central controller 4230 and sent to the therapy control module 4330.

[0427] 4.8 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0428] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, the circuit may have separate branches for inhalation and exhalation. In other cases, a single branch is used.

[0429] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, e.g., to maintain or increase the temperature of the air. The heating elements may take the form of a heated wire circuit and may include one or more transducers, e.g., temperature sensors. In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller, e.g., the central controller 4230. An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, the entire contents of which are incorporated herein by reference.

[0430] 4.9 Humidifier 4.9.1 Humidifier Overview In one form of the present technology, a humidifier 5000 (e.g., as shown in FIG. 5A) is provided for modifying the absolute humidity of air or gas for delivery to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the air stream (relative to the ambient air) before delivering the air to the patient's airways.

[0431] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006 adapted to house the humidifier reservoir 5110 and may include a heating element 5240.

[0432] 4.10 Terminology For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, alternative definitions may apply.

[0433] 4.10.1 Overview Air: In certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as, for example, oxygen-enriched air.

[0434] Periphery: In certain forms of the present technology, the term periphery is considered to mean (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0435] For example, the ambient humidity for a humidifier may be the humidity of the air adjacent to the humidifier, such as the humidity of the room the patient is sleeping in. Such ambient humidity may differ from the humidity outside the room in which the patient is sleeping.

[0436] In another example, ambient pressure can be the pressure immediately surrounding the body or pressure outside the body.

[0437] In certain embodiments, ambient (e.g., acoustic) noise may be considered the background noise level within the room in which the patient is located, as opposed to, for example, noise generated by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated from sources outside the room.

[0438] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits, for example, on a breath-by-breath basis, depending on the presence or absence of signs of an SDB event.

[0439] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing in the absence of signs of partial upper airway obstruction.

[0440] Flow Rate: The amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is to a scalar quantity, i.e., a quantity that has only magnitude. In other cases, a reference to flow rate is to a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes written simply as "flow" or "air flow."

[0441] In the example of a patient breath, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and negative for the expiratory portion of the patient's respiratory cycle. The device flow rate, Qd, is the flow rate of air leaving the RPT device. The total flow rate, Qt, is the flow rate of air and any supplemental gases that arrives at the patient interface via the air circuit. The ventilator flow rate, Qv, is the flow rate of air leaving the vent to allow for the pushing out of exhaled gases. The leak flow rate, Ql, is the flow rate of leakage from the patient interface system or elsewhere. The respiratory flow rate, Qr, is the flow rate of air admitted to the patient's respiratory system.

[0442] Flow Therapy: Respiratory therapy that involves delivering airflow to the entrance of the airways at a controlled flow rate, called the therapeutic flow rate, that is typically positive throughout the patient's respiratory cycle.

[0443] Humidifier: The word humidifier is taken to mean a humidifying device positioned, installed, or physically constructed to provide a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0444] Leak: The word leak refers to unintended airflow. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur in a swivel elbow around the circumference.

[0445] Conducted (Acoustic) Noise: Conducted noise, as used herein, refers to noise carried to the patient by pneumatic pathways, such as the air circuit and patient interface, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0446] Radiated (acoustic) noise: Radiated noise herein refers to noise carried to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the volume / pressure level of the object in question according to ISO 3744.

[0447] Ventilation (acoustic) noise: Ventilation noise herein refers to noise generated by airflow through any vents, such as the vents of the patient interface.

[0448] Oxygen-enriched air: Air with an oxygen concentration greater than atmospheric (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes referred to as "oxygen" for short.

[0449] Medical Oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0450] Patient: A person, whether or not suffering from a respiratory condition.

[0451] Pressure: Force per unit area. Pressure is measured in cmH2O or gf / cm 2 1 cmH2O can be expressed in a variety of units, including 1 g-f / cm 2 is equal to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 mbar to 0.001 atm). In this specification, pressures are given in units of cmH2O unless otherwise stated.

[0452] The pressure in the patient interface is given the symbol Pm, and the treatment pressure, which represents the target value achieved by the interface pressure Pm at the current moment, is given the symbol Pt.

[0453] Respiratory pressure therapy: The application of air to the entrance of the airways at a treatment pressure that is typically positive relative to the atmosphere.

[0454] Ventilator: A mechanical device that provides pressure support to a patient and performs some or all of the work of breathing.

[0455] 4.10.1.1 Material Silicone or silicone elastomer: Synthetic rubber. References herein to silicone are references to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included within the range of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured by ASTM D2240.

[0456] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0457] 4.10.1.2 Mechanical properties Resilience: The ability of a material to absorb energy when elastically deformed and to release the energy when the load is removed.

[0458] Resilience: Virtually all of the energy is released when unloaded. Examples include certain silicone and thermoplastic elastomers.

[0459] Hardness: The ability of a material to resist deformation (e.g., expressed by Young's modulus or by the indentation hardness scale measured on a standardized sample size). ● "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and may not easily deform under finger pressure, for example.

[0460] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment (e.g., compression, tension, bending, or torsion). The structure or component may offer different resistance in different directions. The opposite of stiffness is flexibility.

[0461] Floppy structure or component: A structure or component that, when made to support its own weight, changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second).

[0462] Rigid Structure or Component: A structure or component that does not change shape substantially when subjected to loads typically encountered during use. An example of such an application is establishing and maintaining a patient interface in a sealing relationship with the entrance to a patient's airway, e.g., under a pressure load of approximately 20-30 cmH2O.

[0463] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0464] 4.10.2 Respiratory cycle Apnea: According to some definitions, apnea occurs when airflow falls below a predetermined threshold for a period of time, e.g., 10 seconds. Obstructive apnea occurs when a partial obstruction of the airway prevents airflow despite the patient's efforts. Central apnea occurs when apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea occurs when reduced or absent respiratory effort coincides with an obstructed airway.

[0465] Respiratory rate: The patient's rate of spontaneous breathing, usually measured in breaths per minute.

[0466] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0467] Effort (breathing): The effort required by a spontaneous breather to breathe.

[0468] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0469] Flow limitation: Flow limitation is considered to be a condition in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation.

[0470] Flow-limited inspiratory waveform types: (i) Flattening: A rise followed by a relatively flat section, followed by a decline. (ii) M-shaped: It has two local peaks, one at the leading edge and one at the trailing edge, and has a relatively flat area between the two peaks. (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat portion. (iv) Reverse chair shape: A relatively flat section followed by a single local peak, which is at the trailing edge.

[0471] Hypopnea: By some definitions, hypopnea is considered a reduction in flow but not a cessation of flow. In one form, hypopnea may be said to have occurred when flow is reduced below a threshold rate for a period of time. Central hypopnea is said to have occurred when hypopnea is detected due to a reduction in respiratory effort. In one form in adults, any of the following may be considered hypopnea: (i) A 30% decrease in patient breathing for at least 10 seconds and an associated 4% desaturation; or (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds and associated desaturation or agitation of at least 3%.

[0472] Hyperventilation: An increase in airflow to a higher than normal level.

[0473] Inspiratory Portion of the Respiratory Cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0474] Patency (Airway): The degree to which the airway is open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example, as a value of one (1) for an open state or a value of zero (0) for a closed (occluded) state.

[0475] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmosphere that exists at the end of expiration.

[0476] Peak flow (Q peak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0477] Respiratory flow, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the estimate of respiratory flow by an RPT device, as distinct from "true respiratory flow" or "true respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0478] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra effort is exerted. In principle, the inhalation volume Vi (volume of air inhaled) is equal to the exhalation volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhalation volume Vi and the exhalation volume Ve).

[0479] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0480] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0481] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0482] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be central).

[0483] Upper Airway Obstruction (UAO): Includes both partial and complete upper airway obstruction. This can be associated with a state of flow limitation in which flow increases slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistance behavior).

[0484] Ventilation (airflow): A measure of the amount of gas exchanged by a patient's respiratory system. Measures of ventilation may include either or both inspiratory and expiratory flow per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0485] 4.10.3 Respirator Adaptive servo-ventilator (ASV): A servo-ventilator with a variable, rather than fixed, target ventilation that can learn from some characteristics of the patient, such as the patient's breathing characteristics.

[0486] Backup Rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0487] Cycled: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering breaths.

[0488] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are applied within a breath to produce the desired interface pressure that the ventilator attempts to achieve at a given time.

[0489] End-Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of exhalation. If the pressure waveform template ( ) is zeroed at the end of exhalation when ρ = 1, i.e., ρ = 0, then EEP is equal to EPAP.

[0490] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0491] Pressure Support: A numerical value indicating the increase in ventilator pressure during inspiration over that during expiration, essentially referring to the difference in pressure between peak and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0492] Servo-ventilator: a ventilator that measures patient ventilation, has a target ventilation, and adjusts the level of pressure support to move patient ventilation toward the target ventilation.

[0493] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. If the device does not detect a breath within a predetermined period, the device automatically begins delivering a breath.

[0494] Swing: A term equivalent to pressure support.

[0495] Triggering: When a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator device) delivers a constant volume of breathable gas to a spontaneously breathing patient, this is called a trigger. Due to patient effort, the trigger usually occurs at or near the beginning of the respiratory portion of the respiratory cycle.

[0496] 4.10.4 Biological Structure 4.10.4.1 Facial Anatomy Alar: The outer wall or "wing" of each nostril (complex number: alar)

[0497] Alar angle:

[0498] Alar point: The outermost point of the ala of the nose.

[0499] Alar curvature (or alar apex) point: The last point on the base line of the flexion of each ala, located in the crease formed by the joining of the ala with the cheek.

[0500] Pinna: The entire externally visible part of the ear.

[0501] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal of the frontal bone.

[0502] (Nasal) Cartilaginous Skeleton: The cartilaginous skeleton of the nose includes the nasal septum, lateral cartilages, major cartilages, and minor cartilages.

[0503] Columella: The strip of skin that separates the nostrils and extends from the front nostril to the upper lip.

[0504] Columellar angle: the angle between a line passing through the midpoint of the nostril and a line intersecting the subnasal point and perpendicular to the Frankfurt plane.

[0505] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point, which is the deepest point of the recess of the auricle above the tragus.

[0506] Glabella: Located on the soft tissue, it is the most prominent point in the midsagittal plane of the forehead.

[0507] Lateral nasal cartilage: A generally triangular cartilage plate whose upper edge is attached to the nasal bone and the frontal process of the maxilla, and whose lower edge is connected to the greater alar cartilage.

[0508] Lip, lower side (lower lip: labrale inferius):

[0509] Lip, upper side (upper lip: labrale superius):

[0510] Greater alar cartilage: A plate of cartilage located below the lateral nasal cartilage. The greater alar cartilage curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar.

[0511] Nostrils: Roughly oval openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nostril). The nostrils are separated by the nasal septum.

[0512] Nasolabial fold or nasolabial fold: A fold or groove of skin that runs from either side of the nose to the corners of the mouth and separates the cheek from the upper lip.

[0513] Nasolabial angle: the angle between the bridge of the nose and the upper lip, where it intersects with the subnasal point.

[0514] Superior ear base: the uppermost point of attachment of the pinna to the skin of the face.

[0515] The uppermost point of attachment of the auricle to the skin of the upper ear base and face.

[0516] Nasal tip: the most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0517] Philtrum: A midline groove that runs from the lower border of the nasal septum to the apex of the lip in the upper lip area.

[0518] Pogonion: Located in the soft tissue, at the mid-anterior most point of the jaw.

[0519] Ridge (nasal): The nasal ridge is a midline protrusion of the nose, extending from the selion to the apex.

[0520] Sagittal plane: A vertical plane from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0521] Therion: the most concave point located on the soft tissue, covering the area of ​​the frontonasal suture.

[0522] Nasal Septal Cartilage (Nose): The nasal septal cartilage forms part of the nasal septum, separating the front of the nasal cavity.

[0523] Alar sinus: the point on the lower edge of the base of the nasal alar where it joins the skin of the upper lip.

[0524] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0525] The most concave point on the midline of the lower lip between the supraminal point, the midpoint of the lower lip, and the soft tissue pogonion.

[0526] Skull anatomy

[0527] Frontal bone: The frontal bone contains a large vertical portion called the prefrontal scale, which corresponds to the area called the forehead.

[0528] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony prominence of the lower jaw that forms the jaw.

[0529] Maxilla: The maxilla forms the upper jaw and is located superior to the mandible and inferior to the orbit. The frontal process of the maxilla projects upward through the side of the nose and forms part of its lateral border.

[0530] Nasal bones: The nasal bones are two small, oval bones that vary in size and shape in different individuals. They are located side by side in the mid and lower parts of the face and their junction forms the "bridge" of the nose.

[0531] Nasion: the area at the intersection of the frontal bone and the two nasal bones, the depression between the eyes and just above the bridge of the nose.

[0532] Occipital bone: The occipital bone is located at the lower back of the skull. It contains an oval opening, the foramen magnum, through which the cranial cavity opens into the spinal canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0533] Orbit: bony cavity in the skull that houses the eyeball.

[0534] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0535] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the parts of the face called the temples.

[0536] Cheekbones: The face contains two cheekbones that are located on the top and sides of the face and form the cheek ridges.

[0537] 4.10.4.2 Respiratory system structure Diaphragm: sheet of muscle that spans the base of the thoracic cavity. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, drawing air into the lungs.

[0538] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0539] Lungs: the human respiratory system. The conducting region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0540] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, which merges dorsally into the nasopharynx via the choanae.

[0541] Pharynx: part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is usually divided into three parts: the epipharynx (nasal part of the pharynx), the mesopharynx (oral part of the pharynx), and the hypopharynx.

[0542] 4.10.5 Patient Interface Anti-Asphyxiation Valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathing carbon monoxide (CO2) by venting to the atmosphere in a fail-safe manner.

[0543] Elbow: An elbow is an example of a structure that guides the airflow axis to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0544] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0545] Functional dead space:

[0546] Headgear: Headgear is a positioning and stabilizing structure designed for the head. For example, the headgear may include one or more sets of posts, ties, and stiffeners configured to position and hold a patient interface in position for respiratory treatment on the patient's face. Some ties are formed of a soft, flexible, and resilient material, such as a laminated composite of foam and fabric.

[0547] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0548] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0549] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to achieve a "seal" or "seal" between them, but without the need for a separate "seal" element itself.

[0550] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0551] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0552] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0553] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle less than 360 degrees. When used in connection with a delivery tube, the subassembly of components preferably includes a mating cylindrical conduit. In use, there may be little or no leakage of air flow from the swivel.

[0554] Tie (noun): A structure designed to resist tension.

[0555] Vent: (noun): A structure that allows airflow from the interior of the mask or conduit to the ambient air, providing a clinically effective flush of exhaled gases. For example, for clinically effective flushing, flow rates of about 10 L / min to about 100 L / min may be used depending on mask design and therapeutic pressure.

[0556] 4.10.6 Shape of structure Products of the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or impeller. The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., exterior) surface and a separate non-face-contacting (e.g., bottom or interior) surface. In another example, the structure may include a first surface and a second surface.

[0557] To facilitate describing the shape of three-dimensional structures and surfaces, first consider a cross section across the surface of the structure at point p. Referring to Figures 3B-3F, examples of cross sections at point p on a surface and the resulting planar curves are shown. Figures 3B-3F also show the outward normal vector at p. The outward normal vector of p points away from the surface. In some examples, we describe the surface from the perspective of a fictitious small person standing upright on the surface.

[0558] 4.10.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the radius of a circle that touches the curve at 1 / p).

[0559] Positive curvature: If the curve at p bends outward toward the normal, the curvature at that point is considered positive (as if the hypothetical little person were to leave point p and walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are commonly called concave curves.

[0560] Zero curvature: If the curve at p is a straight line, the curvature is considered to be zero (when the virtual little person leaves point p, they can walk horizontally, neither up nor down). See Figure 3D.

[0561] Negative curvature: If the curve at p moves away from the outer normal, the curvature in that direction at that point is considered negative (as if a hypothetical little person were to leave point p and walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are commonly called convex curves.

[0562] 4.10.6.2 Curvature of two-dimensional surfaces A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section produces a plane curve with a corresponding curvature. Different curvatures at the point may have the same sign or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0563] Principal curvatures and directions: The directions in the normal plane where the curvature of a curve has its maximum and minimum values ​​are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0564] Surface region: A set of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0565] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one is positive and the other is negative) (a hypothetical person might walk uphill or downhill depending on which way they are facing).

[0566] Dome region: A region in which the principal curvatures at each point have the same sign (e.g., both positive (a "concave dome"), or both negative (a "convex dome")).

[0567] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0568] Planar Region: The region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0569] Surface Edge: The boundary or limit of a surface or area.

[0570] Journey: In certain forms of the present technology, a "journey" is taken to mean a journey in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain forms of the present technology, a "journey" may be described, for example, as a route or course that includes a set of points on a surface. (For a hypothetical person, a journey is where they walk on a surface, similar to a garden path.)

[0571] Path Length: In certain forms of the present technology, "path length" is taken to mean the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths. (For a hypothetical person, the path length is the distance that person would have to walk along the path on the surface.)

[0572] Straight-line distance: Straight-line distance is the distance between two points on a surface, but independent of the surface. On a planar area, there is a distance on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (To a hypothetical person, straight-line distance corresponds to the "as the crow flies" distance.)

[0573] 4.10.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily lie on a particular plane. A space curve can be closed, i.e., it has no endpoint. A space curve can be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) can trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized by reference to the tangent, normal, and binormal vectors at that point.

[0574] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and amplitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person were flying along the curve and fell off the car at a particular point, the direction of the tangent vector would be the direction she was traveling.

[0575] Unit normal vector: As the hypothetical person moves along the curve, this tangent vector itself changes. A unit vector that points in the same direction as the tangent vector is changing is called a unit principal normal vector. It is perpendicular to the tangent vector.

[0576] Binormal unit vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (see Figure 3O).

[0577] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See Figures 3O and 3P.

[0578] Torsion of a Space Curve: The torsion of a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangent plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangent plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangent plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, the amount of torsion near the top coil of the spiral in Figure 3S is greater than the amount of torsion near the bottom coil of the spiral in Figure 3S because T2>T1.

[0579] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0580] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.

[0581] 4.10.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or spatial curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.

[0582] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's interior surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the interior surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and a two-dimensional hole bounded by the conduit's inner surface. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0583] 4.11 Other Notes A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to anyone copying this patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0584] Unless the context clearly dictates otherwise, when a range of values ​​is provided, it is understood that, to the tenth of the unit of the lower limit, each intervening value between the upper and lower limits of that range, and any other stated or intervening value in that stated range, is encompassed within the technology. The upper and lower limits of these intervening ranges, which may independently be included within the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limits in the stated ranges. When a stated range includes one or both of the limits, ranges excluding one or both of those included limits are also encompassed within the technology.

[0585] Furthermore, when a value or values ​​are described herein as being implemented as part of the present technology, unless otherwise stated, it is understood that such values ​​may be approximate and that such values ​​may be utilized to any suitable significant digit, to the extent that may be tolerated or required in practical technical implementations.

[0586] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this technology belongs.Any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of this technology, but only a limited number of exemplary methods and materials are described herein.

[0587] Although particular materials are described as being suitable for use in the construction of a component, obvious alternative materials having similar properties may be substituted. Furthermore, unless otherwise specified, all components described herein are understood to be manufacturable and therefore may be manufactured together or separately.

[0588] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0589] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of the publication.The publications discussed herein are provided solely for their disclosure prior to the filing date of this application.Nothing herein should be construed as an admission that the present technology is not entitled to antedate such publication by prior invention.Furthermore, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

[0590] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive manner, indicating that a referenced element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically referenced.

[0591] The subject headings used in the detailed description are included for ease of reference only and should not be used to limit the subject matter found throughout this disclosure or the claims. The subject headings should not be used in interpreting the claims or their limitations.

[0592] While the technology herein has been described with reference to particular examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, terms and symbols may suggest specific details unnecessary to the practice of the technology. For example, while the terms "first" and "second" may be used, unless otherwise specified, these terms are not intended to indicate any order but may be utilized to distinguish between separate elements. Furthermore, while process steps in a methodology may be described or illustrated in a sequence, such ordering is not required. Those skilled in the art will recognize that such ordering may be changed and / or aspects may occur simultaneously or even synchronously.

[0593] It is therefore to be understood that numerous modifications may be made to the illustrative examples and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0594] 1000 patients 1100 Companion 3000 Patient Interface 3100 Seal forming structure 3110 holes 3150 Action Module 3200 Plenum Chamber 3210 Frame Section 3211 Front 3212 Lateral protruding connection 3213 Side 3214 Connector 3220 Entrance 3230 Recess 3240 Opening 3300 Positioning and Stabilizing Structures 3310 Headgear Strap 3310a Raised part 3312 Buttonhole 3320 Conduit section 3330 Rigidiser Arm 3332 Opening 3350 tube 3350a Ventilation facing side 3352 tabs 3354 Tube section 3356 Opening 3358 Connector 3360 frames 3360a Ventilation facing side 3362 Opening 3364 Connector 3364a Slot 3366 Arm 3400 Ventilation structure 3400A Other ventilation structures 3410 Ventilation hole 3412 Ventilation wall 3412a Horizontal surface 3414 Rotating part 3420 Ventilation Module 3430 Rib 3500 Deflector 3512 side wall 3512a Ventilation facing side 3512b Air permeable section 3512c Air-impermeable section 3512d opening 3514 Deflector rear wall 3516 Deflector upper wall 3518 Deflector lower wall 3520 Gap 3530 Spacer 3600 connection port 3800 Connector 3810 Protrusion 3820 Slots 3900 Diffuser 4000 RPT devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 chassis 4018 Handle 4020 Pneumatic Block 4100 Blower Housing 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor

Claims

1. 1. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including a front portion including an inlet configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure configured, in use, to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a ventilation structure configured to allow a flow of gases exhaled by a patient to flow from an interior of the plenum chamber to the environment, the ventilation structure being configured to maintain a therapeutic pressure within the plenum chamber in use, and configured to ventilate a flow of gases from the interior of the plenum chamber in a generally lateral direction in use; a deflector configured to, in use, redirect a generally laterally ventilated gas flow into a direction having a forward component relative to a patient, the redirected gas flow in use being more forward than any other direction; a patient interface including:

2. 2. The patient interface of claim 1, wherein the plenum chamber includes a medial portion positioned such that, in use, a patient's midsagittal plane passes through the medial portion, and wherein the inlet is located on the medial portion.

3. The patient interface of claim 1 or 2, further comprising a delivery tube connected to the plenum chamber and configured to be in fluid communication with the inlet.

4. A patient interface according to any preceding claim, wherein the ventilation structure comprises a plurality of ventilation holes.

5. A patient interface according to any preceding claim, wherein the ventilation structure is located in a portion of the patient interface that, in use, is to the side of the inlet.

6. A patient interface according to any preceding claim, wherein the ventilation structure is located above the plenum chamber.

7. A patient interface according to any preceding claim, wherein the ventilation structure includes a ventilation module.

8. a ventilation module opening; The patient interface of claim 7 , wherein the ventilation module is configured to be attached to a portion of the patient interface that includes the ventilation module opening.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the ventilation structure is a first ventilation structure configured, in use, to vent a first flow of gas from the interior of the plenum chamber in a first generally lateral direction, and the patient interface includes a second ventilation structure configured, in use, to vent a second flow of gas from the interior of the plenum chamber in a second generally lateral direction, the first generally lateral direction being essentially opposite to the second generally lateral direction.

10. 10. The patient interface of claim 9, wherein the first ventilation structure is located on one side of the patient interface, flanking an inlet, and the second ventilation structure is located on the other side of the patient interface, flanking an inlet.

11. A patient interface according to any preceding claim, wherein the deflector comprises an arrangement of one or more deflector walls.

12. 12. A patient interface according to any preceding claim, wherein the deflector, in use, redirects a substantial amount of laterally ventilated gas flow towards an inner and / or front portion of the plenum chamber.

13. A patient interface according to any preceding claim, wherein the deflector, in use, redirects a substantial amount of laterally ventilated gas flow towards a portion of the delivery tube.

14. A patient interface according to any preceding claim, wherein the deflector is included as part of the ventilation structure.

15. 15. A patient interface according to any preceding claim, wherein the deflector is a first deflector configured to, in use, divert a substantial first laterally ventilated gas flow in a forward direction, and the patient interface includes a second deflector configured to, in use, divert a substantial second laterally ventilated gas flow in a forward direction.

16. A patient interface according to any preceding claim, including a pair of connectors that facilitate attachment of the plenum chamber to a positioning and stabilising structure.

17. 17. A patient interface according to claim 16, wherein at least one of the connectors is included as part of the ventilation structure.

18. 18. A patient interface according to claim 16 or 17, wherein at least one of the connectors is included as part of the deflector.

19. A patient interface according to any preceding claim, including positioning and stabilising structure for holding the seal-forming structure in a therapeutically effective position on the patient's head.

20. 20. A patient interface according to claim 19, wherein the positioning and stabilizing structure includes at least one headgear strap.

21. A patient interface according to any one of claims 16 to 20, removably attached to the connector by button fastening.

22. 22. A patient interface according to claim 21, wherein the headgear straps include buttonholes.

23. 23. A patient interface according to claim 22, wherein the headgear strap includes a sleeve-like formation that receives insertion of a portion of the connector into at least one headgear strap through the buttonhole.

24. A patient interface according to any one of claims 19 to 23, wherein the ventilation structure is located on the positioning and stabilising structure.

25. 25. A patient interface according to claim 24, wherein the positioning and stabilising structure includes a conduit portion, the plenum chamber including an opening, the conduit portion configured, in use, to be in fluid communication with an interior of the plenum chamber via the opening, and the ventilation structure located on the conduit portion.

26. 26. A patient interface according to claim 25, wherein the conduit portion includes a support structure to limit and / or prevent blockage of the conduit portion.

27. A patient interface according to any preceding claim, including a diffuser arranged to diffuse gas flow from the ventilation structure.

28. 28. A patient interface according to claim 27, wherein the diffuser comprises a woven material.

29. 29. A patient interface according to claim 27 or 28, wherein a headgear strap comprises the diffuser.

30. A patient interface according to any one of claims 27 to 29, wherein the diffuser forms at least a part of the deflector.

31. A patient interface according to any preceding claim, wherein the seal-forming structure is configured to, in use, form a seal around the patient's nares but not around the patient's mouth.

32. A patient interface according to any preceding claim, wherein the seal-forming structure is configured to form a seal with the underside of the nose around the nostrils in use.

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