Gas flow regulation device for respiratory therapy

Abstract

A flow regulating gas flushing vent is configured to expel breathing gas from a patient interface. The gas flush vent includes a base configured to anchor the gas flush vent to the patient interface. The gas flush vent also includes a movable member opposite the base and forming a variable conduit with the base. The movable member is configured to move toward the base to narrow the variable catheter and to move away from the base to widen the variable catheter. A cantilevered biasing mechanism is attached to the movable member and is configured to urge the movable member away from the base. The cantilevered biasing mechanism includes a fixed anchor end and a movable free end.

Description

Background Art 1.1 Technical Field

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of respiratory-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0002] 1.2 Description of Related Technologies

[0003] 1.2.1 Human respiratory system and its disorders

[0004] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airways.

[0005] The airway includes a series of branch tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are ultimately divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is referred to as the respiratory zone. Referring to John B.West, published in 2012 by Lippincott Williams & Wilkins, "Respiratory Physiology," 9th edition.

[0006] There are a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall area during sleep. The condition causes the affected patient to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness, and it may cause cardiovascular disease and brain damage. The syndrome is a common obstacle, especially in middle-aged overweight men, although the affected person may not be aware of this problem. Referring to U.S. Patent No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there is a rhythmic alternation of boom-and-bust ventilation cycles known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated micro-arousals from sleep, which cause severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

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

[0012] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These common characteristics include increased resistance to air flow, a prolonged expiratory phase of breathing, and loss of the lungs' normal elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: difficulty breathing on exertion, a chronic cough, and sputum production.

[0014] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of the ability to walk, confinement to a wheelchair, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents; (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of therapies have been used to treat or ameliorate these conditions. Furthermore, these therapies can be used to prevent breathing problems in otherwise healthy individuals. However, these therapies have a number of drawbacks.

[0017] 1.2.2 Therapy

[0018] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0019] 1.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy is the application of air to the entrance of the airway at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank or breastplate ventilator).

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway obstruction, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and therefore patients may choose not to comply with therapy if they find the devices used to provide such therapy to be one or more uncomfortable, difficult to use, expensive, and unsightly.

[0022] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which is in the form of OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0023] 1.2.3 Respiratory therapy system

[0024] These respiratory therapies can be provided by respiratory therapy systems or devices.Such systems and devices can also be used to screen for, diagnose, or monitor conditions without treating them.

[0025] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0026] 1.2.3.1 Patient Interface

[0027] The patient interface can be used to connect the respiratory equipment to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can form a seal with an area of the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (for example, a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate the delivery of the gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically to avoid complete sealing. An example of such a patient interface is a nasal cannula.

[0028] Some mask systems may not be functionally suitable for this application. For example, a purely cosmetic mask may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to prevent water from entering due to higher external pressure, but will not maintain the internal air at a pressure higher than the ambient pressure.

[0029] Certain masks may be clinically unsuitable for this technology, for example if they block airflow through the nose and only allow airflow through the mouth.

[0030] Certain masks may be uncomfortable or impractical with the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0031] Some masks may not be practical to use while sleeping, for example, when sleeping on your side in bed with your head resting on a pillow.

[0032] Certain masks may make some patients feel claustrophobic, uneasy, and / or may feel overly obtrusive.

[0033] Designing a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head is composed of bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. And the entire head can move over the course of a respiratory therapy session.

[0034] Therefore, some masks have the disadvantages of being protruding, aesthetically undesirable, expensive, poorly fitting, difficult to use and / or uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks for the administration of anesthetics are tolerable for their original applications, but despite this, such masks may be undesirably uncomfortable when worn for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with therapy, especially when the mask is worn during sleep.

[0035] CPAP therapy is very effective for treating certain breathing disorders, provided the patient adheres to the therapy. If the mask is uncomfortable or difficult to use, the patient may not adhere to the therapy. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, and this may affect patient compliance.

[0036] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0037] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0038] 1.2.3.1.1 Sealing structure

[0039] 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.

[0040] The patient interface may be characterized in part based on the design intent of the seal-forming structure to engage with the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region during use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0041] For example, due to the different shapes, structures, areas of variability, and areas of sensitivity of a patient's face, a seal-forming structure that may be effective in one area of the patient's face may not be suitable in another area. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0042] Certain seal-forming structures can be designed for mass manufacturing so that one design can fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must be adjusted to form a seal.

[0043] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface, with the seal-forming structure engaging the patient's face face-to-face. The seal-forming structure may include an air- or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made from an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0044] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous style of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leaks.

[0045] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these seal-forming structures uncomfortable.

[0046] Another form of seal-forming structure may use an adhesive to achieve the seal.

[0047] A series of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0048] One form of nasal pillow is found in the Adam Circuit, manufactured by Puritan-Bennett, Inc. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0049] ResMed Limited has manufactured the following products that incorporate nasal pillows: the SWIFT™ nasal pillows mask, the SWIFT™ II nasal pillows mask, the SWIFT™ LT nasal pillows mask, the SWIFT™ FX nasal pillows mask, and the MIRAGE LIBERTY™ full-face mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073778 (describing additional aspects of ResMed's SWIFT™ nasal pillows), U.S. Patent Application 2009 / 0044808 (describing additional aspects of ResMed's SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing additional aspects of ResMed's MIRAGE LIBERTY™ full-face mask); and International Patent Application WO 2009 / 052560 (describing additional aspects of ResMed's SWIFT™ FX nasal pillows).

[0050] 1.2.3.1.2 Positioning and stabilizing the structure

[0051] The seal-forming structure of a patient interface used for positive air pressure therapy is subject to forces acting against the air pressure that disrupts the seal. Consequently, a variety of techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: how effective the technique is in maintaining the seal-forming structure in a desired position and in sealing engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient experiences intrusion and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0052] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US2010 / 0000534.

[0053] Another technique is to use one or more straps and / or stabilizing bands.Many of these bands suffer from one or more problems of poor fit, bulk, discomfort, and inconvenience in use.

[0054] 1.2.3.1.3 Pressurized air duct

[0055] In one type of therapy system, a flow of pressurized air is provided to a patient interface via a conduit in an air circuit that is fluidly connected to the patient interface at a location forward of the patient's face when the patient interface is positioned on the patient's face during use. The conduit may extend forward from the patient interface, away from the patient's face.

[0056] 1.2.3.1.4 Pressurized air ducts for positioning / stabilizing seal-forming structures

[0057] Another type of treatment system includes a patient interface of the type in which the tube that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize the seal-forming portion of the patient interface on the appropriate portion of the patient's face. This type of patient interface may be referred to as having a "conduit headgear" or "headcuff tube." This type of patient interface allows the conduit in the air circuit that provides the pressurized air flow 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. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to the tube in the patient interface via a port that is positioned on the top of the patient's head during use.

[0058] Ideally, a patient interface combined with headgear tubing would be comfortable for the patient to wear for extended periods while the patient is asleep, form an airtight and stable seal with the patient's face, and also be able to conform to a range of patient head shapes and sizes.

[0059] 1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0060] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an interface of the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0061] 1.2.3.3 Air circuit

[0062] An air circuit is a conduit or tube constructed and arranged to allow air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiration and expiration. In other cases, a single branch air circuit is used for both inspiration and expiration.

[0063] 1.2.3.4 Humidifier

[0064] Delivering an air stream without humidification may cause airway drying. Using a humidifier with an RPT device and patient interface to produce humidified gas minimizes nasal mucosal drying and increases patient airway comfort. Additionally, in colder climates, warm air, typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0065] 1.2.3.5 Vent Technology

[0066] Some forms of therapy systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from the interior space of the patient interface (eg, a plenum) to the exterior of the patient interface (eg, to the environment).

[0067] The vent may include an orifice through which gas can flow when the mask is in use. Many such vents are noisy. Other vents may become clogged during use and thus provide inadequate flushing. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example, through noise or concentrated airflow.

[0068] ResMed Inc. has developed many improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0069] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0070]

[0071] (*One sample only, measured using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O)

[0072] The sound pressure values for each object are listed below

[0073] Summary of the Invention

[0074] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0075] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0076] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0077] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0078] One form of the present technology includes a positioning and stabilizing structure configured to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one strap.

[0079] One form of the present technology includes a patient interface comprising an inflatable chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0080] One form of the present technology includes a patient interface comprising a plenum that is pressurizable to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure. The plenum includes at least one plenum inlet port that is sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient. The patient interface also includes a seal-forming structure that is constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The seal-forming structure has apertures therein such that the flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares. The seal-forming structure is constructed and arranged to, in use, maintain the therapeutic pressure in the plenum throughout the patient's breathing cycle. The patient interface also includes a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

[0081] Another aspect of one form of the present technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0082] In one form, each modular element has at least two versions or styles that can be used interchangeably with one another to form different modular assemblies.

[0083] One form of the present technology includes a flow-regulated gas irrigation vent configured to exhaust breathing gas from a patient interface.

[0084] Another form of the present technology includes a flow-regulated gas washout vent configured to exhaust breathing gas from a patient interface, the flow-regulated gas washout vent comprising: a base configured to anchor the gas washout vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; and a cantilevered biasing mechanism attached to the movable member and configured to urge the movable member away from the base, the cantilevered biasing mechanism comprising a fixed anchoring end and a movable free end.

[0085] The gas flushing vent may be a coil spring.Additionally, the anchoring end of the cantilevered biasing mechanism may be located at a periphery of the cantilevered biasing mechanism, and the free end of the cantilevered biasing mechanism may be positioned radially inwardly from the periphery of the cantilevered biasing mechanism.

[0086] The free end may be at a central region of the cantilevered biasing mechanism.

[0087] The cantilevered biasing mechanism may be configured such that the anchor end and the free end are coplanar when the cantilevered biasing mechanism is in a neutral position.

[0088] The movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.

[0089] The flexibility of the cantilevered biasing mechanism may be greatest at a central region of the cantilevered biasing mechanism.

[0090] The cantilevered biasing mechanism and the movable member may be located on the same side of the base.

[0091] The base, the movable member and the cantilevered biasing mechanism may be integrally formed.

[0092] The gas flushing vent may be formed by a 3D printing process.

[0093] The variable conduit may include an inlet configured to receive a gas flush from the base, the inlet of the variable conduit being located at a central region of the variable conduit.

[0094] The variable conduit may include an outlet configured to discharge the gas flush to atmosphere, the outlet of the variable conduit being located at a periphery of the gas flush vent.

[0095] The movable member may be configured to move toward the base when a pressure of the gas flush in the variable conduit is less than a biasing force of the cantilevered biasing mechanism.

[0096] The movable member may be configured to cease moving closer to the base when the pressure of the gas flush in the variable conduit is equal to or greater than the biasing force of the cantilevered biasing mechanism.

[0097] The gas flush vent may further include a housing enclosing the movable member and the cantilevered biasing mechanism.

[0098] The housing is connected to the base via one or more spacers such that the variable conduit is between the housing and the base.

[0099] The cantilevered biasing mechanism may be connected to the housing at the periphery of the gas flushing vent.

[0100] The cantilevered biasing mechanism may be connected to the housing at the anchor end.

[0101] The base may be configured to be removably secured to the patient interface.

[0102] The base may be permanently secured to the patient interface.

[0103] Another aspect of one form of the present technology is a patient interface configured to deliver pressurized breathing gas to the airway of a patient. The patient interface may include: a seal-forming structure configured to sealingly engage the patient's face; and a gas washout vent including any of the features disclosed above.

[0104] The patient interface may further include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas irrigation vent to the patient's face.

[0105] Another aspect of one form of the present technology is a flow-regulated gas washout vent configured to exhaust respiratory gas from a patient interface. The gas washout vent includes a base configured to anchor the gas washout vent to the patient interface; a movable member opposing the base and forming a variable conduit therewith, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; and a cantilevered biasing mechanism configured to urge the movable member toward the base, the cantilevered biasing mechanism including a fixed anchor end and a movable free end. The cantilevered biasing mechanism and the movable member are positioned on opposite sides of the base.

[0106] The gas flush vent may also include a shaft extending through the opening in the base and connecting the movable member to the cantilevered biasing mechanism.

[0107] The anchored end of the cantilevered biasing mechanism may be attached to the base and the free end of the cantilevered biasing mechanism attached to the shaft.

[0108] The cantilevered biasing mechanism may be configured to be located internally to the patient interface and the movable member configured to be located externally to the patient interface.

[0109] The cantilevered biasing mechanism may be a coil spring.

[0110] The anchored end of the cantilevered biasing mechanism may be located at a periphery of the cantilevered biasing mechanism, and the free end of the cantilevered biasing mechanism is located radially inward from the periphery of the cantilevered biasing mechanism.

[0111] The free end may be at a central region of the cantilevered biasing mechanism.

[0112] The cantilevered biasing mechanism may be configured such that the anchor end and the free end are coplanar when the cantilevered biasing mechanism is in a neutral position.

[0113] The flexibility of the cantilevered biasing mechanism may be greatest at a central region of the cantilevered biasing mechanism.

[0114] The base, the movable member and the cantilevered biasing mechanism may be integrally formed.

[0115] The gas flushing vent may be formed by a 3D printing process.

[0116] The variable conduit may include an inlet configured to receive a gas flush from the base, the inlet of the variable conduit being located at a central region of the variable conduit.

[0117] The variable conduit may include an outlet configured to discharge the gas flush to atmosphere, the outlet of the variable conduit being located at a periphery of the movable member.

[0118] The base may be configured to be removably secured to the patient interface.

[0119] Another aspect of one form of the present technology is a patient interface configured to deliver pressurized breathing gas to the airway of a patient. The patient interface includes: a seal-forming structure configured to sealingly engage the patient's face; and a gas washout vent including any of the features discussed above.

[0120] The base may be a wall of the patient interface.

[0121] The patient interface may include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas irrigation vent to the patient's face.

[0122] Another aspect of one form of the present technology is a flow-regulated gas washout vent configured to exhaust respiratory gas from a patient interface. The gas washout vent includes a base configured to anchor the gas washout vent to the patient interface; a movable member opposing the base and forming a variable conduit therewith, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; and a cantilevered biasing mechanism pivotally attached to the movable member such that the movable member can pivot relative to the cantilevered biasing mechanism, the cantilevered biasing mechanism configured to urge the movable member away from the base. The cantilevered biasing mechanism includes a fixed anchor end and a movable free end.

[0123] The cantilevered biasing mechanism may be connected to the movable member by a living hinge.

[0124] The cantilevered biasing mechanism may be connected to the movable member by a ball and socket connection.

[0125] The movable member may be configured such that pivotal movement of the movable member relative to the cantilevered biasing mechanism causes the width of the variable conduit to become non-uniform along the flow path of the gas flush.

[0126] The cantilevered biasing mechanism may be a coil spring.

[0127] The anchored end of the cantilevered biasing mechanism may be located at a periphery of the cantilevered biasing mechanism, and the free end of the cantilevered biasing mechanism is located radially inward from the periphery of the cantilevered biasing mechanism.

[0128] The free end may be at a central region of the cantilevered biasing mechanism.

[0129] The movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.

[0130] The base, the movable member and the cantilevered biasing mechanism may be integrally formed.

[0131] The gas flushing vent may be formed by a 3D printing process.

[0132] The gas flush vent may further include a housing enclosing the movable member and the cantilevered biasing mechanism.

[0133] The housing may be connected to the base via one or more spacers such that the variable conduit is between the housing and the base.

[0134] The anchor end of the cantilevered biasing mechanism may be rigidly connected to the housing at the periphery of the gas flushing vent.

[0135] Another aspect of one form of the present technology is a patient interface configured to deliver pressurized breathing gas to the airway of a patient. The patient interface includes: a seal-forming structure configured to sealingly engage the patient's face; and a gas washout vent having any of the elements disclosed above.

[0136] The patient interface may further include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas irrigation vent to the patient's face.

[0137] Another aspect of one form of the present technology is a flow-regulated gas washout vent configured to exhaust respiratory gas from a patient interface. The gas washout vent includes: a base configured to anchor the gas washout vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; at least one sensor attached to the base and / or the movable member, the at least one sensor configured to generate a signal indicative of a condition within the variable conduit; and a cantilevered biasing mechanism attached to the movable member and configured to urge the movable member away from the base. The cantilevered biasing mechanism includes a fixed anchoring end and a movable free end.

[0138] The at least one sensor may include a flow sensor, and the condition inside the variable conduit may be a flow rate of gas flushing flowing through the variable conduit.

[0139] The at least one sensor may include a pressure sensor, and the condition inside the variable conduit may be a pressure of a gas flush flowing through the variable conduit.

[0140] The at least one sensor may be embedded within the movable member and / or the base.

[0141] The at least one sensor may be positioned on a surface of the movable member and / or the base.

[0142] The cantilevered biasing mechanism may be a coil spring.

[0143] The anchored end of the cantilevered biasing mechanism may be located at a periphery of the cantilevered biasing mechanism, and the free end of the cantilevered biasing mechanism is located radially inward from the periphery of the cantilevered biasing mechanism.

[0144] The free end may be at a central region of the cantilevered biasing mechanism.

[0145] The movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.

[0146] The base, the movable member and the cantilevered biasing mechanism may be integrally formed.

[0147] The gas flushing vent may be formed by a 3D printing process.

[0148] The gas flush vent may further include a housing enclosing the movable member and the cantilevered biasing mechanism.

[0149] The housing may be connected to the base via one or more spacers such that the variable conduit is between the housing and the base.

[0150] The anchor end of the cantilevered biasing mechanism may be rigidly connected to the housing at the periphery of the gas flushing vent.

[0151] The cantilevered biasing mechanism may be pivotally attached to the movable member such that the movable member may pivot relative to the cantilevered biasing mechanism.

[0152] Another aspect of one form of the present technology is a fatigue detection system comprising: a gas flush having any of the elements disclosed above; and a controller configured to receive a signal from the at least one sensor of the gas flush vent indicative of a condition within the variable conduit and to generate an output indicative of a fatigue level of the gas flush vent.

[0153] The controller may include a user interface, and the controller may be configured to send a signal to the user interface indicative of the fatigue level of the gas-wash vent.

[0154] The fatigue detection system may also include a patient interface to which the gas washout vent is anchored, the patient interface configured to deliver pressurized breathing gas to the airway of the patient.

[0155] The patient interface may also include a positioning and stabilizing structure configured to secure the patient interface and the gas irrigation vent to the patient's face.

[0156] Another aspect of one form of the present technology is a gas wash flow regulation system configured to exhaust respiratory gas from a patient interface. The gas wash flow regulation system may include a flow regulating vent. The flow regulating vent may include: a base configured to anchor the gas wash vent to the patient interface; and a movable member opposing the base and forming a variable conduit with the base. The movable member is configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit. The flow regulating vent may also include an electrical actuator configured to move the movable member toward and away from the base. The electrical actuator may include a coil winding and a magnet movable relative to the coil winding. A housing may enclose the movable member and the electrical actuator. Furthermore, a controller may be configured to supply current to the coil winding to regulate the flow of gas wash through the flow regulating vent. The controller may adjust the magnitude of the current supplied to the coil winding in response to detection of a leak at the patient interface.

[0157] The controller can be configured to reduce the flow rate of the gas flush in response to the detection of a leak at the patient interface. The movable member can be configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit. Furthermore, the controller can be configured to supply current to the coil winding in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flush flowing through the variable conduit.

[0158] The gas flushing flow regulation system may further include a biasing mechanism. The movable member may be attached to the housing via the biasing mechanism. The coil winding may be located on the housing, and the magnet may be located on the movable member. Alternatively, the winding may be located on the movable member, and the magnet may be located on the housing.

[0159] The coil winding may include a recessed portion configured to accommodate at least a portion of the magnet. The magnet may include a recessed portion configured to accommodate at least a portion of the coil winding.

[0160] The gas flushing flow regulation system may further include: a patient interface configured to sealingly engage a patient's face; an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface. The flow regulating vent may be mounted to the patient interface. The RPT device may include a first leak detection sensor, and the patient interface may include a second leak detection sensor.

[0161] Another aspect of one form of the present technology is a gas wash flow regulation system configured to exhaust respiratory gas from a patient interface. The gas wash flow regulation system may include a flow regulating vent. The flow regulating vent may include: a base configured to anchor the gas wash vent to the patient interface; and a movable member opposing the base and forming a variable conduit with the base. The movable member is configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit. The flow regulating vent may also include an electrical actuator configured to move the movable member toward and away from the base. The electrical actuator may include a coil winding and a magnet movable relative to the coil winding. A housing may enclose the movable member and the electrical actuator. Furthermore, a controller may be configured to supply current to the coil winding to regulate the flow of gas wash through the flow regulating vent. The controller may adjust the magnitude of the current supplied to the coil winding in response to CO2 levels detected in the patient interface.

[0162] The controller may be configured to reduce the flow of the gas flush through the flow-regulated vent in response to determining that the CO2 level in the patient interface is below a predetermined threshold. The controller may be configured to increase the flow of the gas flush through the flow-regulated vent in response to determining that the CO2 level in the patient interface is above a predetermined threshold.

[0163] The movable member can be configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit. In addition, the controller can be configured to supply current to the coil winding in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flushing through the variable conduit.

[0164] The flow control valve may further include a biasing mechanism, and the movable member may be attached to the housing via the biasing mechanism. Furthermore, the coil winding may be located on the housing, and the magnet may be located on the movable member. Alternatively, the coil winding may be located on the movable member, and the magnet may be located on the housing.

[0165] The coil winding may comprise a recess configured to receive at least a portion of the magnet. Alternatively, the magnet may comprise a recess configured to receive at least a portion of the coil winding.

[0166] The gas flushing flow regulation system may also include: a patient interface configured to sealingly engage a patient's face; an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface. The flow regulating vent may be mounted to the patient interface. The RPT device may include a first leak detection sensor, and the patient interface may include a second leak detection sensor.

[0167] Another aspect of one form of the present technology is a gas flush flow regulation system configured to exhaust breathing gas from a patient interface. The gas flushing flow regulation system includes a flow regulating vent comprising: a base configured to anchor the gas flushing vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; an electrical actuator configured to move the movable member toward and away from the base, the electrical actuator including a motor having a movable part attached to the movable member and configured to move the movable member; and a housing enclosing the movable member and the electrical actuator; and a controller configured to supply current to the motor to regulate the flow of gas flushing through the flow regulating vent, wherein the controller adjusts the magnitude of the current supplied to the motor in response to detection of a leak at the patient interface.

[0168] The controller of the gas flush flow regulation system can be configured to reduce the flow rate of the gas flush in response to the detection of a leak at the patient interface. Furthermore, the movable member can be configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit, and the controller can be configured to supply current to the motor in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flush flowing through the variable conduit.

[0169] The gas flushing flow regulation system may further include a biasing mechanism, wherein the movable member is attached to the housing by the biasing mechanism. In addition, the motor may include a linear actuator and a shaft, and the linear actuator may be fixed to an outer surface of the housing, and the shaft may be movable through the housing and attached to the movable member.

[0170] The linear actuator may be configured to move the shaft in discrete steps.

[0171] The linear actuator may be configured to move continuously.

[0172] The shaft may be configured such that rotation of the shaft causes the shaft and the movable member to move toward and away from the base.

[0173] The gas flushing flow regulation system may also include: a patient interface configured to sealingly engage a patient's face; an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface. The flow regulating vent may be mounted to the patient interface. Furthermore, the RPT device may include a first leak detection sensor, and the patient interface may include a second leak detection sensor.

[0174] Another aspect of one form of the present technology is a gas wash flow regulated vent configured to exhaust respiratory gas from a patient interface, the gas wash flow regulated vent comprising: a base configured to anchor the gas wash flow vent to the patient interface; a movable member opposing the base and forming a variable conduit therewith, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; a sealing member; and a housing enclosing the movable member and the sealing member and including an inlet port. The sealing member is positioned between the movable member and the housing and sealingly attached to the housing to form a chamber pneumatically isolated from the movable member.

[0175] The chamber is configured so that gas is only allowed to enter or leave the chamber through the inlet port. The sealing member is configured to apply a biasing force on the movable member. The biasing force can push the movable member away from the base. The chamber can be configured so that a relatively high pressure in the chamber pushes the movable member toward the base. The chamber can be configured so that a relatively low pressure in the chamber allows the movable member to move away from the base. The chamber can be configured to be pneumatically connected to a pressurized supply source of breathing gas supplied to the patient interface. The chamber can be configured to be pneumatically connected to a pump and / or valve.

[0176] Another aspect of one form of the present technology is a gas wash flow regulation system configured to exhaust respiratory gas from a patient interface, the gas wash flow regulation system comprising: a flow regulating vent, the flow regulating vent comprising: a base configured to anchor the gas wash vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member configured to move toward the base to narrow the variable conduit and away from the base to widen the variable conduit; an electrical actuator configured to move the movable member toward and away from the base, the electrical actuator comprising a coil winding and a magnet movable relative to the coil winding; a housing enclosing the movable member and the electrical actuator; and a flexible suspension member attached to the housing and the movable member, the flexible suspension member configured to suspend the movable member from the housing and decouple movement of the movable member from the housing.

[0177] The suspension member may be configured to bias the movable member toward a predetermined direction. The suspension member may be formed of foam. The magnet may be attached to the movable member so that the movable member moves with the magnet. The magnet may be surrounded by the winding. The gas flushing flow regulation system may include a controller configured to supply current to the coil winding to regulate the flow of gas flushing through the flow regulating vent. The controller may adjust the magnitude of the current supplied to the coil winding in response to a CO2 level and / or pressure detected within the patient interface.

[0178] Another aspect of one form of the present technology is a gas flushing flow regulation system comprising: a patient interface configured to sealingly engage a patient's face; an RPT device configured to pressurize a flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface, wherein the flow regulating vent is mounted to the patient interface.

[0179] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0180] One aspect of one form of the present technology is a method of manufacturing a device.

[0181] Another aspect of one form of the present technology is a method of assembling a modular system, the method comprising: selecting a positioning and stabilizing structure; and connecting the positioning and stabilizing structure to a first liner or a second liner.

[0182] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity and vision, or by a person with limited experience in using medical devices of this type.

[0183] An aspect of one form of the present technology is a portable RPT device that can be carried by a person (eg, within the person's home).

[0184] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example, in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be cleaned in the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0185] The described methods, systems, devices, and apparatus can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, devices, and apparatus can provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0186] Certainly, each part of these aspects can form sub-aspects of the present technology.In addition, each sub-aspect and / or aspect in these sub-aspects and / or aspects can be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.

[0187] Other features of the present technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0188] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to similar elements, including:

[0189] 3.1 Respiratory therapy system

[0190] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. Also shown is a bed partner 1100. The patient is sleeping in a supine sleeping position.

[0191] Figure 1BThe system is shown including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000.

[0192] Figure 1C The system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying position.

[0193] 3.2 Respiratory system and facial anatomy

[0194] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0195] Figure 2B A view of the human upper airway is shown, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0196] Figure 2C is a front view of a face with several identified surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, medial canthus, ala nosae, nasolabial groove, and lip corner. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0197] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, and supra-auricular base and subauricular base. The superior-inferior and anterior-posterior directions are also indicated.

[0198] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0199] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermilion of the upper lip, nostrils, inferior nasal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0200] Figure 2G A side view showing the surface features of the nose.

[0201] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0202] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the midsagittal plane, particularly showing the septal cartilage and the medial crus of the greater alar cartilage.

[0203] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible are also indicated.

[0204] Figure 2K A side view of the skull is shown with the outline of the head's surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital bones. The mental protuberance is indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0205] Figure 2L An anterolateral view of the nose is shown.

[0206] 3.3 Patient Interface

[0207] Figure 3A A patient interface in the form of a nasal mask in accordance with one form of the present technology is shown.

[0208] Figure 3A-1 Shows the effect when used Figure 3A The force on the patient interface.

[0209] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3C The curvature magnitude shown is relatively large in comparison.

[0210] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0211] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0212] Figure 3EA schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0213] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3E The curvature magnitude shown is relatively large in comparison.

[0214] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0215] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between A and B is indicated. Two saddle areas and one dome area are indicated.

[0216] Figure 3I A surface having a structure with a one-dimensional hole in the surface is shown. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0217] Figure 3J Shown through Figure 3I The illustrated surface defines Figure 3I Two-dimensional holes in the structure.

[0218] Figure 3K Shown Figure 3I A perspective view of a structure including two-dimensional holes and one-dimensional holes is also shown. Figure 3I The surface of the two-dimensional holes in the structure.

[0219] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0220] Figure 3M Shown through Figure 3L FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the bladder. The inner surface defines a two-dimensional hole in the mask.

[0221] Figure 3N Shown through Figure 3L Another cross section of the mask. The inner surface is also indicated.

[0222] Figure 3O Exemplifies the left-hand rule.

[0223] Figure 3P Illustrate the right-hand rule.

[0224] Figure 3Q The left ear is shown, including the left ear helix.

[0225] Figure 3R The right ear is shown, including the right ear helix.

[0226] Figure 3S A right-hand helix is shown.

[0227] Figure 3T A view of a mask is shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0228] Figure 3U A view of the plenum chamber 3200 is shown, illustrating the sagittal and medial contact planes.

[0229] Figure 3V Shown Figure 3U A view of the rear of the plenum chamber. The view is oriented normal to the median contact plane. Figure 3V The mid-sagittal plane bisects the chamber into left-hand and right-hand sides.

[0230] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V The sectional view of the plenum chamber is taken in the sagittal plane shown. A "median contact" plane is shown. This median contact plane is perpendicular to the sagittal plane. The orientation of the median contact plane corresponds to the orientation of the chord 3210, which lies in the sagittal plane and contacts the plenum chamber cushion at only two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the cushion in this area, the median contact plane can be a tangent plane at the upper and lower points.

[0231] Figure 3X Shown in position for use on the face Figure 3U When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the "plane of the face". Figure 3X In FIG, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0232] Figure 3Y A patient interface with a catheter tip cover in accordance with one form of the present technology is shown.

[0233] Figure 3Y-1 Shows the effect when used Figure 3Y The force on the patient interface.

[0234] 3.4RPT device

[0235] Figure 4A One form of RPT device according to the present technology is shown.

[0236] Figure 4B is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0237] Figure 4C is a schematic diagram illustrating the interconnection of the various electrical components of an RPT device.

[0238] 3.5 Humidifier

[0239] Figure 5A Shown is an isometric view of a humidifier according to one form of the present technology.

[0240] Figure 5B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0241] 3.6 Modularity

[0242] Figure 6A A perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to the patient's nose and the patient's mouth is shown.

[0243] Figure 6B A perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to the patient's nose is shown.

[0244] Figure 6C Shows that Figure 6A Pad or Figure 6B A perspective view of a tube used together with a gasket.

[0245] Figure 6D Shows that Figure 6A Pad or Figure 6B A perspective view of the hardener arm used with the liner.

[0246] Figure 6E Shows that Figure 6A A perspective view of the headgear strap used together with the padding.

[0247] Figure 6FShows that Figure 6B A perspective view of the headgear strap used together with the padding.

[0248] Figure 6G Shown is a removable mount to Figure 6C tube or Figure 6D Front view of a pair of sleeves for a hardener arm.

[0249] Figure 6H Shown is a removable mount to Figure 6D Front view of the complete sleeve on the hardener arm.

[0250] Figure 6I Shown is a removable mount to Figure 6D Front perspective view of yet another alternative form of a complete sleeve for a hardener arm.

[0251] Figure 6J Is worn connected to Figure 6C The tube, Figure 6E Headband and Figure 6G The sleeve Figure 6A Front view of the patient with the liner.

[0252] Figure 6K Is worn connected to Figure 6D Hardener arm, Figure 6E Headband and Figure 6H The sleeve Figure 6A Front view of the patient with the liner.

[0253] Figure 6L Is worn connected to Figure 6C The catheter tip and Figure 6F Headgear Figure 6B Front view of the patient with the liner.

[0254] Figure 6M Is worn connected to Figure 6D Hardener arm, Figure 6F Headband and Figure 6I The sleeve Figure 6B Front view of the patient with the liner.

[0255] Figure 6N It is a perspective view of the vent.

[0256] Figure 6O is a perspective view of an air circuit with a ventilation elbow and air delivery ducts.

[0257] Figure 6P Illustrative ways in which different elements may be combined to form different patient interfaces are shown.

[0258] 3.7 Flow regulation vent

[0259] Figure 7A A schematic diagram of a flow regulating valve is shown.

[0260] Figure 7B A schematic diagram of another flow regulating valve is shown.

[0261] Figure 7C A schematic diagram of another flow regulating valve is shown.

[0262] Figure 7D A schematic diagram of another flow regulating valve is shown.

[0263] Figure 7E Shown are experimentally derived flow curves for a flow regulating vent in accordance with one form of the present technology.

[0264] Figure 7F Shown are experimentally derived flow curves for another flow regulating vent according to another form of the present technology.

[0265] Figure 7G Flow curves derived from a number of experiments are shown for flow regulating vents of varying sizes according to other forms of the present technology.

[0266] Figure 7H A cross-sectional view illustrating an exemplary configuration of a flow regulating vent is shown.

[0267] Figure 8A Shown is a perspective view of a flow regulating vent attached to a seal-forming structure.

[0268] Figure 8B A perspective view of the flow regulating vent is shown attached to another seal-forming structure.

[0269] Figure 8C A perspective view of the flow regulating vent is shown in isolation.

[0270] Figure 8D A cross-sectional view of the flow regulating vent is shown.

[0271] Figure 8E A perspective view of a movable member of a flow regulating vent is shown.

[0272] Figure 8F A perspective view of the biasing mechanism of the flow regulating vent is shown.

[0273] Figure 8G A perspective view of the flow regulating vent is shown without the housing.

[0274] Figure 8H Another perspective view of the flow regulating vent is shown without the housing.

[0275] Figure 8IAnother perspective view of the flow regulating vent is shown without the housing.

[0276] Figure 8J A cross-sectional view of another flow regulating vent is shown.

[0277] Figure 8K A schematic diagram of a system for sensing vent failure is shown.

[0278] Figure 8L A perspective view of another flow regulating vent is shown.

[0279] Figure 8M Shown Figure 8L Cross-sectional view of the flow regulating vent.

[0280] Figure 8N Shown Figure 8L Another perspective view of the flow regulating vent.

[0281] Figure 8O A perspective view of another flow regulating vent is shown.

[0282] Figure 8P Shown Figure 8O Cross-sectional view of the flow regulating vent.

[0283] Figure 8Q Shown Figure 8O Another perspective view of the flow regulating vent.

[0284] Figure 8R A schematic diagram of a system for sensing vent failure is shown.

[0285] Figure 9A A control system for regulating the flow of gas flushing is illustrated.

[0286] Figure 9B The response of the vent to the flow signal is shown.

[0287] Figure 9C An exemplary flow regulating vent is shown.

[0288] Figure 9D An exemplary flow regulating vent is shown.

[0289] Figure 9E An exemplary flow regulating vent is shown.

[0290] Figure 9F An exemplary flow regulating vent is shown.

[0291] Figures 9G to 9K An exemplary flow regulating vent is shown.

[0292] Figure 9L Shows the control Figures 9G to 9K An exemplary circuit diagram of a flow regulating vent.

[0293] Figure 9M Is shown using Figures 9G to 9K Flowchart of a method of regulating a flow vent.

[0294] Figure 9N Is shown using Figures 9G to 9K Another flow chart of a method of regulating a flow vent.

[0295] Figure 9O An exemplary flow regulating vent is shown.

[0296] Figure 10A An exemplary flow regulating vent is shown.

[0297] Figure 10B An exemplary flow regulating vent is shown.

[0298] Figure 10C An exemplary flow regulating vent is shown.

[0299] Figure 10D An exemplary flow regulating vent is shown. DETAILED DESCRIPTION

[0300] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples discussed herein only and is not intended to be limiting.

[0301] The following description is provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute another example.

[0302] 4.1 Therapy

[0303] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an entrance to the airway of a patient 1000 .

[0304] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

[0305] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0306] 4.2 Respiratory therapy system

[0307] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0308] 4.3 Patient Interface

[0309] According to one aspect of the present technology, Figure 3A The illustrated non-invasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to maintain a positive pressure at the entrance to the patient's airway. Thus, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0310] like Figure 3Y As shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a circuit for connecting to an air circuit (e.g., Figures 1A to 1C The air circuit 4170 shown in FIG. 4 is a form of connection port 3600. The plenum 3200 can be formed from one or more modular components in the sense that it or they can be replaced with different components (e.g., components of different sizes).

[0311] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0312] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure above ambient, for example at least 2, 4, 6, 10 or 20 cmH20 relative to ambient.

[0313] 4.3.1 Sealing structure

[0314] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs (the actual sealing surface) may vary over time and from patient to patient within a given treatment session depending on a number of factors including, for example, the location of the patient interface on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0315] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0316] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0317] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material such as silicone.

[0318] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large heads but not for small heads, and another form of seal-forming structure that is suitable for small heads but not for large heads.

[0319] 4.3.1.1 Sealing mechanism

[0320] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure acting on the underside of the sealing flange within the interior of the plenum 3200 to urge it into tight sealing engagement with the face. The pressure-assist mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0321] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange to prevent it from bending during use.

[0322] In one form, the seal-forming structure may comprise a compression seal portion or a gasket seal portion which, in use, is constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilising structure.

[0323] In one form, the seal-forming structure includes a tensioning portion that is held in tension, for example, by an adjacent region of the sealing flange, during use.

[0324] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0325] In certain forms of the present technology, the seal-forming structure may include one or more of: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0326] 4.3.1.2 Nose bridge or nasal ridge area

[0327] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge region or nasal ridge region of the patient's face.

[0328] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal over a nasal bridge region or nasal ridge region of a patient's face in use.

[0329] 4.3.1.3 Upper lip area

[0330] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0331] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0332] 4.3.1.4 Chin area

[0333] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin region of the patient's face.

[0334] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0335] 4.3.1.5 Nasal pillows

[0336] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0337] A nasal pillow according to one aspect of the present technology includes a frustoconical body, at least a portion of which forms a seal against the underside of a patient's nose; a stem; and a flexible region located on the underside of the frustoconical body and connecting the frustoconical body to the stem. Furthermore, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. These flexible regions can cooperate to facilitate a universal joint structure that accommodates relative displacement and angular movement of the frustoconical body and the structure to which the nasal pillow is connected. For example, the frustoconical body can be displaced axially toward the structure to which the stem is connected.

[0338] 4.3.1.6 Nasal mask only

[0339] In one form, the patient interface 3000 includes a seal-forming structure 3100 that is configured to seal around the entrance of the patient's nasal airways but not around the patient's mouth. The seal-forming structure 3100 can be configured to form a seal with the upper portion of the patient's lips. The patient interface 3000 can leave the patient's mouth uncovered. The patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 rather than to the mouth. This type of patient interface can be identified as a nasal-only mask.

[0340] One form of a nasal-only mask in accordance with the present technology is a mask conventionally identified as a "nasal mask" having a seal-forming structure 3100 configured to seal around the nose and over the bridge of the nose on the patient's face. The nasal mask is generally triangular in shape. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal against the upper lip region (e.g., above the lip), against at least a portion of the nasal ridge in the patient's nose or above the pronasal point, and against the patient's face on each side of the patient's nose, such as near the patient's nasolabial grooves. Figure 1B The illustrated patient interface 3000 has this type of seal-forming structure 3100. The patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice.

[0341] Another form of a nasal-only mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose support" mask, and the seal-forming structure 3100 can be identified as a "nose support cushion." In one form, for example, Figure 3YAs shown, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The seal-forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing against the lower and / or front surfaces of the patient's nose in the nasal canthus region and against the patient's nostrils. The seal-forming structure 3100 can form a seal with the upper portion of the patient's lips. The shape of the seal-forming structure 3100 can be configured to match or closely fit the underside of the patient's nose and may not contact the nasal bridge region or any portion of the patient's nose above the nasal canthus. In one form of the nasal support cushion, the seal-forming structure 3100 includes a bridging portion that divides the opening into two orifices. In use, each of the two orifices supplies air or breathable gas to a corresponding nostril of the patient's nares. The bridging portion can be configured to contact or seal against the patient's columella during use. Alternatively, the seal-forming structure 3100 can include a single opening to provide a flow of air or breathable gas to both nostrils of the patient.

[0342] In some versions, only the nasal mask may include the nasal pillows described above.

[0343] 4.3.1.7 Nose and mouth masks

[0344] In one form, the patient interface 3000 includes a seal-forming structure 3100 that is configured to seal around the entrance of the patient's nasal airways and also around the patient's mouth. The seal-forming structure 3100 can be configured to form a seal with the patient's face near the chin area. The patient interface 3000 can deliver a supply of air or breathable gas to both nostrils and the mouth of the patient 1000. This type of patient interface can be identified as a nose and mouth mask.

[0345] One form of nose and mouth mask according to the present technology is conventionally identified as a "full face mask" having a seal-forming structure 3100 configured to seal on the patient's face around the nose, below the mouth, and over the bridge of the nose. The nose and mouth mask may be generally triangular in shape. In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the patient's chin area (which may include the patient's lower lip and / or the area just below the lower lip), on at least a portion of the patient's nasal ridge over the patient's nose bridge or at the nasal protuberance, and on the cheek areas of the patient's face. Figure 1C The patient interface 3000 shown is of this type. The patient interface 3000 can deliver a supply of air or breathable gas to both nostrils and the mouth of the patient 1000 through a single orifice. This type of seal-forming structure 3100 can be referred to as a nose and mouth cushion.

[0346] In another form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), with the lower surface and / or front surface of the nasal prominence portion of the patient's nose, with the ala of the patient's nose, and with the patient's face on each side of the patient's nose (e.g., near the nasolabial grooves). The seal-forming structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nostrils and the mouth of the patient, may have an oral aperture configured to provide air or breathable gas to the mouth and nasal apertures configured to provide air or breathable gas to the nostrils, or may have an oral aperture for delivering air to the patient's mouth and two nasal apertures for delivering air to the respective nostrils. This type of patient interface 3000 may have a nasal portion and an oral portion, with the nasal portion forming a seal with the patient's face in a position similar to a nasal support mask.

[0347] In yet another form of nose and mouth mask, a 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 with the patient's face around the patient's mouth.

[0348] In some forms, the seal-forming structure 3100 can have a nasal portion that is separate and distinct from the oral portion. In other forms, the seal-forming structure 3100 can form a continuous seal around the patient's nose and mouth.

[0349] 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 a combination of different features of the above nasal mask only and nasal and mouth mask examples.

[0350] 4.3.2 Inflatable chamber

[0351] The plenum 3200 has a perimeter shaped to complement the surface contours of an average human face in the area where a seal will be formed during use. In use, the boundary edge of the plenum 3200 is positioned 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 around the entire perimeter of the plenum 3200 during use. In some embodiments, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0352] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0353] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material (e.g., clear polycarbonate). Using a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. Using a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0354] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0355] In some versions, the plenum 3200 is constructed of a rigid material such as polycarbonate. The rigid material can provide support to the seal-forming structure.

[0356] In some forms, the plenum 3200 is constructed of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textile, foam, etc.). For example, in an example, it can be formed of a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the technology, the plenum 3200 can be made of a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the technology, the plenum 3200 can be made of a material having a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0357] 4.3.2.1 Multiple openings

[0358] like Figure 6A and Figure 6B As shown, the different plenums 3200-1, 3200-2 can be formed as part of a multi-opening cushion 3050-1, 3050-2. In the illustrated example, the cushions 3050-1, 3050-2 each include three openings, although alternative cushions can be formed with more or fewer openings.

[0359] In some forms, different openings may serve different functions. For example, some openings may be only inlet openings, while other openings may be only outlet openings.

[0360] In other forms, at least one opening can serve two different functions. For example, during the same breathing cycle, one opening can serve as both an inlet and an outlet.

[0361] The plurality of openings can allow for a variety of configurations for delivering air to the plenum chambers 3200-1, 3200-2. For example, a patient can use a given cushion 3050-1, 3050-2 in an "up-the-tube" configuration (e.g., using a catheter headgear—described below) or a "down-the-tube" configuration (e.g., using a single catheter in front of the patient's face), depending on the patient's needs and / or the patient's comfort.

[0362] 4.3.2.1.1 Nose and mouth masks

[0363] like Figure 6A As shown, the plenum 3200-1 includes a pair of plenum inlet ports 3254-1 that can be used to deliver gas into and / or out of the plenum 3200-1. The plenum inlet ports 3254-1 can be disposed on opposite sides (e.g., left and right sides) of the plenum 3200-1.

[0364] In some forms, the plenum 3200-1 may also include at least one vent opening 3402-1 (see, e.g., Figure 6A The vent opening 3402-1 can be located at the center of the plenum 3200-1. For example, the vent opening 3402-1 can be located between the plenum inlet ports 3254-1.

[0365] In some forms, the plenum 3200-1 can include a pair of grooves 3266-1. Each groove 3266-1 can be positioned adjacent one of the plenum inlet ports 3254-1. Each groove 3266-1 can form a partially concave surface.

[0366] 4.3.2.1.2 Nasal mask only

[0367] The plenum chamber 3200-2 of the nose-only cushion 3050-2 may be similar to the plenum chamber 3200-1 of the mouth and nose cushion 3050- 1. Only some of the similarities and differences between the plenum chambers 3200-1, 3200-2 are described below.

[0368] like Figure 6B As shown, the plenum 3200-2 includes a pair of plenum inlet ports 3254-2 that can be used to deliver gas into and / or out of the plenum 3200-2. The plenum inlet ports 3254-2 can be disposed on opposite sides (eg, left and right sides) of the plenum 3200-2.

[0369] In some forms, the plenum 3200-2 may also include at least one vent opening 3402-2 (see, e.g., Figure 6B The ventilation opening 3402-2 can be located at the center of the plenum 3200-2. For example, the ventilation opening 3402-2 can be located between the plenum inlet ports 3254-2.

[0370] In some forms, the plenum 3200-2 can include a pair of grooves 3266-2. Each groove 3266-2 can be positioned adjacent one of the plenum inlet ports 3254-2. Each groove 3266-2 can form a partially concave surface.

[0371] 4.3.3 Positioning and stabilizing the structure

[0372] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be maintained in a sealed position during use by a positioning and stabilizing structure 3300. Because the positioning and stabilizing structure 3300 engages the patient's head to maintain the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 can include and function as a "headgear." Examples of positioning and stabilizing structures can include: Figure 3A and Figure 3A-1 shown.

[0373] In one form, the positioning and stabilizing structure 3300 provides a holding force (ie, F) at least sufficient to overcome the positive pressure effect in the plenum 3200 to lift the face. 充气 ).

[0374] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0375] Continue to refer Figure 3A-1 , positioning and stabilizing structure 3300 provides force F PSS , which helps maintain the inflatable chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSS The force F may be the sum of various forces from different elements of the positioning and stabilising structure 3300. For example, the headgear strap may alone provide the strap force F 带 , so as to maintain the seal-forming structure 3100 against the patient's face. The force F may also be directed at least partially in an upward direction. 带 , in order to overcome the gravity F g The gravity F can be specifically shown for the seal-forming structure 3100 and the plenum 3200. g , but gravity will act on the entire patient interface 3000 (ie, along the same lines as the illustrated gravity F g same direction).

[0376] Gravity F g Can be combined with the friction force F f Instead, the friction force can be g When gravity pulls the seal forming structure 3100 and the inflatable chamber 3200 in the downward direction (such as Figure 3A-1 As shown), the friction force Ff The friction force F will act in an upward direction (e.g., against the patient's face). For example, the patient may experience a friction force F on the upper portion of their lip (and / or other surface of the patient's face that contacts the seal-forming structure 3100). f , in order to resist movement in the downward direction (this can help stabilize the pad in place). Although the friction force F f Specifically shown is the gravity F with the seal forming structure 3100 and the plenum 3200 g A relative, but total, frictional force component (not shown) will also be associated with the weight force F associated with the positioning and stabilising structure 3300 and any other parts of the patient interface 3000. g Frictional force F may act anywhere along the patient interface 3000 where it contacts the patient's skin (or hair). f In gravity F g In some forms, gravity F g It can also be counteracted by the vertical component of the reaction force from the patient's face, which acts on the seal-forming structure 3100, such as at the nasal ridge area and chin area of the patient's face.

[0377] In some forms, the sum of the various forces may be equal to zero, such that the patient interface 3000 is in equilibrium (eg, does not move along the patient's face during use). g and blowing force F 充气 Tends to move the seal-forming structure 3100 away from the desired sealing position. Applying a positioning and stabilizing force F PSS , in order to counteract the gravity F g and blowing force F 充气 (and any friction F f ) and keeps the seal forming structure 3100 correctly positioned. Although the positioning and stabilizing force F PSS May exceed gravity F g and blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F PSS The seal-forming structure 3100 is maintained in a proper sealing position, but patient comfort may be sacrificed. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F is balanced by the reaction force from the patient's head acting on various parts of the patient interface 3000, the seal-forming structure 3100 is maintained in a proper sealing position, but patient comfort may be sacrificed. PSS When the positioning and stabilizing structure 3300 is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable so that when assembled, the positioning and stabilizing force F PSS Greater than the precise balance gravity F g and blowing force F 充气The force required to hold the patient interface 3000 tightly enough against the patient's head so that damaging forces that may be experienced during use (such as tube resistance or external shunts in the plenum 3200 during side-lying) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilizing force F necessary to achieve balance. PSS .

[0378] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential impact of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0379] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with how the device is worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0380] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of the patient's head on a pillow.

[0381] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side region of the patient's head on a pillow.

[0382] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a breakaway coupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The breakaway coupling portion does not resist compression and may be, for example, a flexible or floppy strap. The breakaway coupling portion is constructed and arranged such that when a patient rests their head on the pillow, the presence of the breakaway coupling portion prevents forces on the rear portion from being transferred along the positioning and stabilizing structure 3300 and disrupting the seal.

[0383] In one form of the present technology, a positioning and stabilizing structure 3300 comprises a strap comprised of a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., perspiration) to pass through the strap. In one form, the fabric outer layer comprises a loop material to engage with a hook material portion.

[0384] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure against a portion of the patient's face. In an example, the strap can be configured as a lace.

[0385] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that, in use, at least a portion of a lower edge of the first strap passes above the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0386] In one form of the present technology applicable to a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that, in use, at least a portion of the upper edge of the second strap passes below the subauricular base point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0387] In one form of the present technology suitable for a nasal-only mask or a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to move away from each other.

[0388] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a flexible and, for example, non-rigid strap. An advantage of this aspect is that the strap is more comfortable for the patient lying on it while the patient sleeps.

[0389] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a belt that is configured to be breathable to allow moisture vapor to transfer through the belt.

[0390] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each of which is configured to provide a retention force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of the positioning and stabilizing structure 3300 that is suitable for large heads but not for small heads, and another form of the positioning and stabilizing structure that is suitable for small heads but not for large heads.

[0391] 4.3.3.1 Catheter headgear

[0392] 4.3.3.1.1 Catheter head sleeve

[0393] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head cuffs 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the plenum 3200 and seal-forming structure 3100. Figure 3Y In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170, which provides the pressurized air flow, to be connected to the connection port 3600 of the patient interface at a location other than the front of the patient's face, such as at the top of the patient's head.

[0394] exist Figure 3Y In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head in use and extending above the respective ear (above the back of the ear on the patient's head) through the respective cheek area to an elbow 3610 at the top of the patient's head 1000. This form of technology can be advantageous because if the patient sleeps with their head on their side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 can include a different number of tubes, such as one tube, or two or more tubes.

[0395] In one example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., across one cheek region) during use, and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head (e.g., across another region) during use to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and strap may each be under tension during use to help maintain the seal-forming structure 3100 in a sealed position.

[0396] In one form, the tube 3350 can be at least partially extendable so that the tube 3350 and the belt can be adjusted to substantially equal lengths when worn by the patient. This can allow for substantially symmetrical adjustment between the tube 3350 and the belt so that the seal-forming structure remains substantially centered.

[0397] exist Figure 3YIn the illustrated form of the technology, two tubes 3350 are fluidly connected to each other and to a connection port 3600 at their upper ends. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are separately formed but are connected in use and can be separated, for example for cleaning or storage. Where separate tubes are used, they can be connected together indirectly, for example each can be connected to a T-connector. The T-connector can have two arms / branches, each of which can be fluidly connected to a respective one of the tubes 3350. Additionally, the T-connector can have a third arm or opening that provides for fluid connection to the connection port 3600 of the air circuit 4170 in use. The opening can be an inlet 3332 for receiving a flow of pressurized air (see, e.g. Figure 6C ).

[0398] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0399] In some forms, the third arm of the T-shaped connector may be formed obliquely relative to each of the first two arms.

[0400] In some versions, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be angled relative to each other, and the third arm can be angled relative to the first two arms. The angled configuration of the first two arms can resemble the shape of the patient's head so as to conform to the head shape.

[0401] In some forms, at least one arm of the T-shaped connector (or Y-shaped connector) can be flexible. This can allow the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0402] In some forms, at least one arm of a T-shaped connector (or Y-shaped connector) can be at least partially rigidified. This can help maintain the shape of the connector so that bending of the connector does not close the airflow path.

[0403] Tube 3350 can be formed from a flexible material, such as an elastomer, for example, silicone or TPE, and / or one or more textile and / or foam materials. Tube 3350 can have a preformed shape and bend or move into another shape when a force is applied, but can return to its original preformed shape when the force is absent. Tube 3350 can be generally arcuate or curved, approximating the contours of the patient's head between the top of the head and the nasal or oral regions.

[0404] In some examples, the one or more tubes 3350 are crush resistant to resist becoming blocked if crushed during use (e.g., if pressed between a patient's head and a pillow, particularly if there is only one tube 3350). The tube 3350 can be formed with sufficient structural rigidity to resist crushing, or can be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0405] Each tube 3350 can be configured to receive air flow from a connection port 3600 on the top of the patient's head and deliver the air flow to the seal-forming structure 3100 at the entrance to the patient's airway. Figure 3Y In the example shown, each tube 3350 is located on a path that extends from the inflatable chamber 3200 through the patient's cheek area and reaches the curved tube 3610 above the patient's ear during use. For example, the portion of each tube 3350 near the inflatable chamber 3200 can cover the maxillary area of the patient's head during use. Another portion of each tube 3350 can cover an area of the patient's head that is above the supra-auricular base point of the patient's head. Each tube 3350 can also be located on the patient's sphenoid bone and / or temporal bone and one or both of the patient's frontal bone and parietal bone. The curved tube 3610 can be located on the patient's parietal bone, on the frontal bone and / or on the junction between them (e.g., the coronal suture) during use.

[0406] In some forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient's head such that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some examples, the headcuff 3350 is configured to allow an upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to a lower portion of the patient interface 3000 (e.g., the plenum 3200). That is, the connection port 3600 can be at least partially decoupled from the plenum 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the location of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0407] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is generally positioned under the nose and seals to the lower periphery of the nose (e.g., a nasal floor cushion). The positioning and stabilizing structure 3300, including the tube 3350, can be constructed and arranged to draw the seal-forming structure 3100 under the nose into the patient's face using a sealing force in a posterior and superior direction (e.g., a posterior-superior direction). Having a sealing force in a posterior-superior direction can enable the seal-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and forward-facing surfaces of the patient's face, such as on either side of the patient's nose and on the upper portion of the patient's lips.

[0408] The conduit forming part of the positioning and stabilizing structure 3300, such as a headgear strap, can provide a force F that assists in positioning and stabilizing the headgear. PSS The force. Figure 3Y-1 As illustrated, the positioning and stabilizing force F PSS The force F may be the sum of various forces from different elements of the positioning and stabilizing structure 3300. For example, each conduit may provide a force F directed in the posterior direction and a corresponding lateral direction. 导管 , so that the seal-forming structure 3100 is held against the patient's face (to the upper lip and under the nose) and against the action of the positive pressure in the plenum 3200 to lift off the face (i.e., F 充气 ). Guided force F 导管 It can also be guided at least partially upwards in order to overcome the force of gravity F g .

[0409] In some embodiments, the catheter can provide a force directed against the patient's head when filled with pressurized air. This force can help clamp the patient's head. This force can be caused by inflation of the catheter during normal use. In some embodiments, this force can provide a cushioning effect for the patient's head. The catheter can be designed to limit expansion to prevent over-clamping of the patient's head.

[0410] The position of the patient's head can also change the clamping force of the tubes. For example, if the patient sleeps on their side, the weight of the patient's head may compress one tube, while the other tube (e.g., the side not between the patient's head and the sleeping surface (such as a pillow)) may expand more to maintain substantially the same pressurized air flow.

[0411] Gravity F g Can be combined with the friction force F f Instead, the friction force can be g When gravity pulls the seal forming structure 3100 and the inflatable chamber 3200 in the downward direction (such as Figure 3A-1 As shown), the friction force F fThe friction force F will act in an upward direction (e.g., against the patient's face). For example, the patient may experience a friction force F on the upper portion of their lip (and / or other surface of the patient's face that contacts the seal-forming structure 3100). f , in order to resist movement in the downward direction (this can help stabilize the pad in place). Although the friction force F f Specifically shown is the gravity F with the seal forming structure 3100 and the plenum 3200 g A relative, but total, frictional force component (not shown) will also be associated with the weight force F associated with the positioning and stabilising structure 3300 and any other parts of the patient interface 3000. g Frictional force F may act anywhere along the patient interface 3000 where it contacts the patient's skin (or hair). f In gravity F g in the opposite direction of the patient's skin (or hair) and extends along the patient's skin (or hair).

[0412] In some forms, the sum of the various forces may be equal to zero, such that the patient interface 3000 is in equilibrium (eg, does not move along the patient's face during use). g and blowing force F 充气 Tends to move the seal-forming structure 3100 away from the desired sealing position. Applying a positioning and stabilizing force F PSS , in order to counteract the gravity F g and blowing force F 充气 (and any friction F f ) and keeps the seal forming structure 3100 correctly positioned. Although the positioning and stabilizing force F PSS May exceed gravity F g and blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F PSS The seal-forming structure 3100 is maintained in a proper sealing position, but patient comfort may be sacrificed. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F is balanced by the reaction force from the patient's head acting on various parts of the patient interface 3000, the seal-forming structure 3100 is maintained in a proper sealing position, but patient comfort may be sacrificed. PSS When the positioning and stabilizing structure 3300 is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable so that when assembled, the positioning and stabilizing force F PSS Greater than the precise balance gravity F g and blowing force F 充气The force required to hold the patient interface 3000 tightly enough against the patient's head so that damaging forces that may be experienced during use (such as tube resistance or external shunts in the plenum 3200 during side-lying) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilizing force F required to achieve balance. PSS .

[0413] 4.3.3.1.2 Extensible and non-extensible tube sections

[0414] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments, such as formed from an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube including a tube wall having an extendable accordion-like structure. Figure 3Y The patient interface 3000 shown comprises a tube 3350 , an upper portion of which comprises extendable tube segments, each of which is in the form of an extendable accordion-like structure 3362 .

[0415] In some embodiments, the extendable accordion-like structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3328 can be biased toward a retracted position and can be moved to an extended position when the positioning and stabilizing structure 3300 is worn by the patient. Because portions of the tube 3350 can be substantially inextensible (e.g., the inextensible tube segment 3363), the accordion-like structure 3328 allows the positioning and stabilizing structure 3300 to stretch to fit heads of different sizes. This can allow a single-sized tube 3350 to be used with multiple-sized heads. For example, as a result of the accordion-like structure 3328, the positioning and stabilizing structure 3300 can be "one-size-fits-all." Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, and large). The patient can select the length that most closely fits their head, and the accordion-like structure 3328 can be adjusted slightly to suit the individual patient.

[0416] In some forms, the inlet 3332 can be disposed in the middle of the conduit 6320. For example, the tube 3350 can be symmetrical about the inlet 3332 through at least one axis.

[0417] The cross-sectional shape of the non-extensible tube segment 3363 of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface of the tube on the side that faces and contacts other parts of the patient's face or head can be more comfortable to wear than, for example, a tube with a circular cross-section.

[0418] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 from a low angle. The headcuff tube 3350 can extend downward to the side of the patient's head and then bend forward and medially to connect to the plenum chamber 3200 in front of the patient's face. Prior to connecting to the plenum chamber 3200, the tube 3350 can be extended to the same vertical position as the connection to the plenum chamber 3200, or in some examples, at a position below it. That is, the tube 3350 can protrude in an at least partially upward direction before connecting to the plenum chamber 3200. A portion of the tube 3350 can be located below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 can contact the patient's face below the patient's cheekbone, which can be more comfortable than contacting on the patient's cheekbone and can avoid excessively blurring the patient's peripheral vision.

[0419] 4.3.3.1.3 Catheter head cover connection port

[0420] In some forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. Figure 3Y In the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 can be configured to be fluidically connected to the conduit of the air circuit 4170. The elbow 3610 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially separate the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3610 can be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the elbow can include a tube 3350 or be connected to the tube 3350 by a ball joint. The connecting portion 3600 can be located in the sagittal plane of the patient's head when in use.

[0421] A patient interface having a connection port that is not located in front of the patient's face may be advantageous because some patients may find that the conduit connected to the patient interface in front of their face is unsightly and / or unobtrusive. For example, the conduit connected to the patient interface in front of the patient's face may be prone to interfering with bedding or sheets, particularly if the conduit extends downwards from the patient interface during use. Forms of the present technology comprising a patient interface having a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side sleeping position, a supine position (e.g., on its back, with the overall top facing upwards) or a prone position (e.g., on its front, with the overall top facing downwards). In addition, the front portion of the patient interface having the conduit connected to the conduit may exacerbate a problem known as tube resistance, in which the conduit applies an undesirable force on the patient interface during movement of the patient's head or conduit, thereby causing displacement away from the face. Tube resistance may not be a problem when receiving force at a position above the patient's head rather than near a seal-forming structure in front of the patient's face (where tube resistance is more likely to destroy the seal).

[0422] 4.3.3.1.4 Head-casing fluid connection

[0423] Two tubes 3350 are fluidically connected to the plenum 3200 at their lower ends. In certain forms of the technology, the connection between the tubes 3350 and the plenum 3200 is achieved by connecting two rigid connectors. The tubes 3350 and the plenum 3200 can be configured so that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the plenum 3200 can be configured to provide tactile and / or audible feedback in the form of a "reassuring click" or similar sound so that the patient can easily know that each tube 3350 has been properly connected to the plenum 3200. In one form, the tubes 3350 are formed from silicone or a textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made, for example, of polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a female mating feature that is configured to connect with a male mating feature on the plenum 3200. Alternatively, the rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum 3200. In other examples, the tubes 3350 may each include a male or female connector formed from a flexible material such as silicone or TPE (e.g., the same material from which the tubes 3350 are formed).

[0424] In other examples, a compression seal is used to connect each tube 3350 to the plenum 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be extruded to reduce its diameter so that it can be compressed into a port in the plenum 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard type joint between the tube 3350 and the plenum 3200, each tube 3350 and / or the plenum 3200 can include a pressure-activated seal (e.g., a peripheral sealing flange). When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum 3200 to form or enhance the seal between the tube 3350 and the plenum 3200.

[0425] 4.3.3.2 Headgear strap

[0426] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 having at least one strap that can be worn by the patient to assist in properly orienting the seal-forming structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

[0427] As described above, some versions of the headgear 3302 can be constructed from a textile material that can fit comfortably against the patient's skin. The textile can be flexible to conform to various facial contours. While the textile can include stiffeners along a selected length, this can limit the bending, flexing, and / or stretching of the headgear 3302.

[0428] In some embodiments, the headgear 3302 can be at least partially extensible. For example, the headgear 3302 can include elastic or a similar extensible material. For example, the entire headgear 3302 can be extensible, or selected portions can be extensible (or more extensible than surrounding portions). This can allow the headgear 3302 to stretch under tension, which can help provide a sealing force to the seal-forming structure 3100.

[0429] 4.3.3.2.1 Four-point connection

[0430] like Figure 6E As shown, some versions of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be connected to the plenum 3200, to the frame of the plenum 3200, and / or to the arms of the plenum 3200 at four separate locations. The headgear 3302-1 can include four different straps that provide tension to help maintain the seal-forming structure 3100 in a sealed position. Figure 3A The positioning and stabilizing structure 3300 can also be viewed as a four-point connection headgear.

[0431] In some embodiments, the headgear 3302-1 may include a lower strap 3304-1 that can be connected to the lower portion of the cushion 3050-1. The lower strap 3304-1 can extend along the patient's cheeks toward the back of the patient's head. For example, the lower strap 3304-1 can cover the masseter muscles on either side of the patient's face. Thus, the lower strap 3304-1 can contact the patient's head below the patient's ears. The lower strap 3304-1 can meet at the back of the patient's head and can cover the occipital bone and / or the trapezius muscles.

[0432] The headgear 3302-1 can also include an upper strap 3305-1 that can cover the temporal bones, parietal bones, and / or occipital bones. The upper strap 3305-1 can also be connected to the tube 3350 (e.g., by connecting to the tab 3320).

[0433] The back strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower and upper straps 3304-1, 3305-1 on a given side (e.g., left or right) can also be connected to the back strap 3307-1 adjacent to each other. Thus, the height of the back strap 3307-1 can be approximately the combined height of the lower strap 3304-1 and the upper strap 3305-1. The back strap 3307-1 can cover the occipital bone and / or the parietal bone during use. This can allow the back strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0434] In the illustrated example, the headgear 3302-1 may be formed in a generally X-shape. The lower strap 3304-1 and the upper strap 3305-1 may be connected to the rear strap 3307-1 using sewing, ultrasonic welding, or any similar process.

[0435] In some embodiments, the lower strap 3304-1 is connected to the magnetic member 3306-1. For example, each lower strap 3304-1 can be threaded through the magnetic member 3306-1 so that the length of each lower strap 3304-1 can be adjusted. The magnetic member 3306-1 can be removably connected to the magnet 3370-1 (described below) so that the lower strap 3304-1 can be disconnected from the inflatable chamber 3200, but the length of the lower strap 3304-1 can be unaffected.

[0436] In some forms, the upper strap 3305-1 can be directly connected to the tab 3320 of the tube 3350. The upper straps 3305 can be passed through the tab 3320 to adjust the length and control the tension of each upper strap 3305.

[0437] In some versions, the headgear 3302-1 can be used with only the nose and mouth cushions 3050-1 (e.g., because only the nose cushions 3050-1 do not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tubes 3350 and the rigidizer arms 3340.

[0438] 4.3.3.2.2 Two-point connection

[0439] like Figure 6F As shown, some versions of the headgear 3302-2 can be a two-point connection headgear. This means that the headgear 3302-2 can be connected to two separate locations.

[0440] In some embodiments, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps that are connected (e.g., sewn) together. This may be comfortable for the patient because they do not come into contact with any seams or joints connecting the different straps. In other embodiments, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) that are connected together (e.g., by sewing, ultrasonic welding, etc.).

[0441] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap in addition to the tube 3350, which is used to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in FIG3Z , the patient interface 3000 includes a strap 3307-2 that forms part of the positioning and stabilizing structure 3300. For example, the strap 3307-2 may be referred to as a back strap or a rear headgear strap. The rear strap 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 with a nose and mouth cushion according to examples of the present technology may have a second lower strap configured to rest against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0442] exist Figure 3Y In the example shown, the strap 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350, which are positioned on each side of the patient's head and pass around the back of the patient's head, for example, covering or located below the occipital bone of the patient's head during use. The strap 3310 is connected to each tube above the patient's ears. Referring to FIG3Z , the positioning and stabilizing structure 3300 includes a pair of tabs 3320. During use, the strap 3310 can be connected between the tabs 3320. Even when tensioned during use, the strap 3310 can be flexible enough to pass around the back of the patient's head and rest comfortably against the patient's head.

[0443] like Figure 6EAs shown, some versions of the headgear 3302-2 can be at least partially bifurcated. For example, the rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) can be wider than the peripheral portion of the headgear 3302-2. The middle section 3308-2 of the rear strap 3307-2 can include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear strap 3307-2 can move relative to the lower section. This can allow the patient to have greater strap coverage over the back region of their head, which can help better anchor the headgear 3302-2 to the patient's head because the lower strap (e.g., 3304-1) is absent.

[0444] In some versions, the headgear 3302-2 can be used only with the nose cushion 3050-2 (e.g., because the nose and mouth cushion 3050-1 does not have four connection points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the rigidizer arm 3340.

[0445] 4.3.3.3 Hardener Arm

[0446] like Figure 6D As shown, the stiffener arm 3340 can be an elongated rigid member that helps maintain a cushion (e.g., nose and mouth cushion 3050-1 or nose cushion 3050-2) in an operating position. The stiffener arm 3340 can contact the side of the patient's head and provide a force to restrict the seal-forming structure 3100 from sliding out of the patient's nose and / or mouth.

[0447] In some embodiments, the hardener arm 3340 is constructed of a rigid material (e.g., plastic). The rigid material may not allow the hardener arm 3340 to stretch. Additionally, the hardener arm 3340 may be substantially inflexible and may not bendable. The hardener arm 3340 may be pre-molded into a desired shape to conform to the patient's head. For example, the hardener arm 3340 may be molded into a curved shape to substantially correspond to the shape of the side of the patient's head (e.g., to cover the masseter muscle and / or temporal bone).

[0448] In some forms, the hardener arm 3340 can be molded to conform to a specific patient's head (e.g., a custom hardener arm 3340).

[0449] In some embodiments, the stiffener arm 3340 can be flexible in at least one direction. For example, the stiffener arm 3340 can be flexible in its width but not in its length. In other words, the stiffener arm 3340 can bend about an axis along the width of the stiffener arm 3340, but not about an axis perpendicular to the stiffener arm 3340. This can allow individual patients to adjust the stiffener arm 3340 to better fit their individual head.

[0450] In some forms, the stiffener arm 3340 can remain in the new position after being bent. This can allow the patient to adjust the shape of the stiffener arm 3340 for their specific head, and the stiffener arm 3340 will then maintain the desired shape during use to increase patient comfort.

[0451] In some embodiments, the first end 3342 of the stiffener arm 3340 can be free, while the second end 3344 of the stiffener arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved to minimize sharp edges that could cause discomfort to the patient. In use, the first end 3342 can also cover the patient's head adjacent to the temporal bone. The second end 3344 can be fixed to the arm connection structure 3504.

[0452] In some forms, the arm connection structure 3504 can be similar to the catheter connection structure 3500. For example, the arm connection structure 3504 and the catheter connection structure 3500 can have substantially the same shape. This can allow the catheter connection structure 3500 or the arm connection structure 3504 to fit into the recess (e.g., 3266-1 or 3266-2) and connect to the plenum inlet port 6254. The arm connection structure 3504 can be connected to the nose and mouth cushion 3050-1 or the nose-only cushion 3050-2 in substantially the same manner as the catheter connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

[0453] 3254. In some forms, the arm connection structure 3504 can act as a plug for the plenum inlet port 3254. Unlike the tube 3350, the stiffener arm 3340 does not deliver pressurized air to the plenum 3200. The stiffener arm 3340 can be used with a "down tube" configuration, where a hose is connected to the vent opening 3402 and air is delivered into the plenum 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the plenum inlet opening 3254. Thus, the arm connection structure 3504 can form a seal with the plenum inlet opening 3254 to restrict air flow into or out of the plenum 3200.

[0454] 4.3.4 Ventilation

[0455] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases (eg, carbon dioxide).

[0456] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to the environment. The vent 3400 is configured to provide a ventilation flow rate of sufficient magnitude to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0457] One form of a vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0458] The vent 3400 may be located in the plenum 3200. Alternatively, the vent 3400 is located in a decoupling structure, such as a swivel.

[0459] like Figure 6N As shown, a vent 3450 may be used with the patient interface 3000. The vent 3450 may have a substantially similar shape (eg, a substantially circular shape) as the vent opening 3402-1.

[0460] The vent 3450 may be connected to the mouth and nose plenum 3200-1 (e.g., Figure 6A illustrated) or only the nasal plenum 3200-2 (e.g., Figure 6B exemplified) together.

[0461] Continue to refer Figure 6N The vent 3450 may include a vent housing 3404 that may be configured to engage the vent opening 3402. The vent housing 3404 may be constructed from a rigid or semi-rigid material. For example, the vent housing 3404 may be constructed from plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable flexure that may affect the position of the seal-forming structure 3100 on the patient's face).

[0462] The vent housing 3404 may include a front surface 3408, a rear surface 3412, and a recess (or channel) 3416. The front surface 3408 faces away from the patient's face during use and may be positioned outside the pressurized volume of the plenum chamber 3200. The rear surface 3412 is disposed opposite the front surface 3408. In use, the rear surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200. The recess 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the plenum chamber 3200 may be received within the recess 3416 to hold the vent 3400 in place.

[0463] In some forms, a diffuser 3448 may be used with the ventilation housing 3404. The diffuser 3448 may help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 may help limit the decibel level associated with the output of air (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 may limit the decibel level at any point in the patient interface.

[0464] In some forms, the diffuser 3448 can diffuse and thereby slow the exhaust gases exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3348 can help avoid spraying and associated discomfort to the patient and / or bed partner (e.g., noise caused by spraying onto pillows, sheets, bedding, etc.).

[0465] In some forms, the diffuser can include a front surface 3456 that faces away from the patient during use. The outer diameter of the front surface 3456 can be smaller than the inner diameter of the ventilation housing 3404 near the front surface 3408. This can form a gap 3464 through which air can travel.

[0466] 4.3.4.1 Flow regulating vent

[0467] It is contemplated that the vent 3400 can be in the form of a flow regulating vent and / or can include a flow regulating valve. For example, the flow regulating vent can be configured to regulate the flow of gas exhausted from the respiratory therapy system.

[0468] It may be advantageous for a respiratory therapy system to be able to control (e.g., regulate to a certain range) the flow rate of gas discharged therefrom. In one form, the flow-regulated vent maintains the gas flow rate within a predetermined range within a certain pressure range (e.g., the pressure difference between the inlet and outlet of the flow-regulated vent).

[0469] For example, assuming an outlet pressure of 0 cmH2O (i.e., atmospheric pressure), the flow regulating vent can be configured such that when the pressure at the vent inlet ranges from 5 to 30 cmH2O, the flow rate through the vent 3400 can be approximately between 20 and 25 L / min. In another example, the flow regulating vent can be configured such that when the pressure at the vent inlet ranges from 10 to 20 cmH2O, the flow rate through the vent can be approximately between 17 and 20 L / min.

[0470] The preferred range of flow through the vent 3400 and its relationship to pressure (eg, inlet pressure and / or differential pressure) can depend on many factors, such as the type of therapy and the patient.

[0471] 7A to 7DA schematic diagram of an exemplary flow regulating vent 7010 is shown, illustrating the principles of controlling the operation of the flow regulating vent. The flow regulating vent 7010 may include an inlet 7012, an outlet 7014, and a variable conduit 7016 through which exhaust gas flows from the vent inlet 7012 to the vent outlet 7014.

[0472] The variable conduit 7016 can be formed in part by a movable member (or disc) 7018. The movable member 7018 can be configured to move toward and away from opposite sides of the variable conduit 7016 to widen or narrow the variable conduit 7016. The impedance (i.e., resistance to gas flow) of the variable conduit 7016 depends at least in part on the width (W) of the variable conduit 7016. 导管 ). Thus, the movement of the movable member 7018 affects the impedance of the variable conduit 7016.

[0473] For example, the impedance of the variable conduit 7016 can be increased by moving the movable member 7018 toward the opposite side of the variable conduit 7016 because such movement narrows the variable conduit 7016 (or reduces the size of its cross-section). Conversely, the impedance of the variable conduit 7016 can be decreased by moving the movable member 7018 away from the opposite side of the variable conduit 7016 because such movement widens the variable conduit 7016 (or increases the size of its cross-section). It should be understood that changes in the shape of the cross-section of the variable conduit 7016 can also increase or decrease the impedance of the variable conduit 7016.

[0474] It should also be understood that, generally, discussions regarding the cross-section of the variable duct 7016 relate to the cross-section whose normal is consistent with the direction of air flow exiting the variable duct 7016.

[0475] The movable member 7018 may include a first side 7020 facing the exterior of the variable conduit 7016 and a second side 7022 facing the interior of the variable conduit 7016. As the exhaust gas flows through the variable conduit 7016, the pressure inside the variable conduit 7016 begins to decrease. At the same time, the pressure outside the variable conduit (e.g., a reference pressure, ambient pressure, or atmospheric pressure) remains constant. Therefore, the pressure difference between the exterior of the variable conduit 7016 and the interior of the variable conduit 7016 increases as the flow rate of the exhaust gas increases.

[0476] The increased pressure difference between the inside and outside of the variable conduit 7016 causes the movable member 7018 to move (e.g., displace and / or deform) toward the opposite side of the variable conduit 7016, which in turn narrows the variable conduit 7016 (or reduces its cross-section), thereby increasing the impedance (or resistance to gas flow) of the variable conduit 7016. The increased impedance of the variable conduit 7016 provides resistance to the flow of exhaust gas and acts to reduce the flow rate of the exhaust gas.

[0477] The competing forces created by the reduced pressure and increased impedance in the variable conduit 7016 continue to affect the movement of the movable member 7018 until equilibrium is reached. At this point, the movement of the movable member 7018 stops and the pressure and flow inside the variable conduit become constant. This Figures 7E to 7G The flow diagram shown is shown in the example. Figures 7E to 7G The illustrated flow rates are exemplary. The actual flow rate depends on the specific parameters of the flow regulating vent 7010.

[0478] The flow regulating characteristics of the flow regulating vent 7010 can be "tuned" to achieve a desired flow rate at various pressures. For example, the diameter and / or shape of the inlet 7012 and outlet 7014 can be adjusted. In addition, the type of material (e.g., polycarbonate, thermoplastic polymer, acrylonitrile butadiene styrene (ABS), thermoplastic resin, and silicone) forming the housing of the flow regulating vent 7010 can affect the flow regulating characteristics.

[0479] In addition, the size of the movable member 7018, the length and width of the variable conduit 7016, and the material of the movable member 7018 can also be adjusted to "tune" the noise reduction performance. The movable member 7018 can be formed from, for example, polycarbonate, thermoplastic polymers, acrylonitrile butadiene styrene (ABS), thermoplastic resins, thermoplastic elastomers, and silicone.

[0480] Figure 7E An experimentally derived flow curve for an exemplary flow regulating vent is shown. Figure 7E It is shown that at a pressure of about 1.3 cmH2O, the air flow rate increases with a steep gradient to about 18.5 L / min as a function of flow rate (see measurement 7024). At measurement 7026, at a pressure increase to about 5 cmH2O, the flow rate is about 20 L / min. It can also be seen that at 20 cmH2O (see measurement 7028), the flow rate has increased to about 24 L / min, indicating that the rate of increase of flow rate as a function of pressure is decreasing.

[0481] Therefore, it is advantageous to have Figure 7E The flow characteristics of the vent device shown can achieve the minimum flow rate for adequate flushing at low pressures while preventing excessive flushing of air through the vent device at high pressures.

[0482] Figure 7F An experimentally derived flow curve for another exemplary flow-regulated vent is shown. As can be seen from this figure, the low-pressure behavior (e.g., between 0 and 6 cmH2O) can be significantly varied without significantly changing the high-pressure behavior (e.g., between 10 and 20 cmH2O).

[0483] For example, at a pressure of about 5 cmH2O, it can be seen that Figure 7F The flow rate in the graph shown (see measured value 7030) is significantly higher (approximately 50%) Figure 7E The flow rate in the graph shown (see measurement value 7026), while at a pressure of about 20 cmH2O, Figure 7F The flow rate in the graph shown (see measured value 7032) is slightly lower (approximately 10%) Figure 7E Flow rate in the graph shown (see measured value 7028).

[0484] Figure 7G The flow curves of various flow regulating vents are shown. Specifically, seven different flow regulating vents (1 to 7) were tested using a mask flow test bench. Each flow regulating vent was connected to a tube with a diameter of 19 mm and a length of 2 m, a flow computer (for recording test results), and a computer-controlled flow generator. During each test run, the flow generator was driven to generate a pressure of 43 cmH2O. Each flow regulating vent was tested four times under the above conditions. Figure 7G The flow curves show the average of four test runs for each flow-regulated vent.

[0485] The design parameters of each flow regulating vent were modified, and the results showed that the flow curve of the flow regulating vent can be modified to suit different applications. These parameters include the diameter d of the inlet 7012, the starting width w of the variable conduit 7016, and the thickness t of the movable member 7018 (see Figure 7H ). The starting width w of the variable conduit 7016 is the width of the variable conduit 7016 when the flow regulating vent 7010 is in a neutral state (e.g., before pressurized gas (from a flow generator or patient interface) flows through the flow regulating vent).

[0486] For the first flow regulating vent, the thickness t of the movable member 7018 is 1.25 mm, the starting width w of the variable conduit is 1.25 mm, and the thickness t of the movable member 7018 is 4 mm. For the second regulating vent, the thickness t of the movable member 7018 is 1.25 mm, the starting width w of the variable conduit is 1.25 mm, and the thickness t of the movable member 7018 is 3 mm. For the third regulating vent, the thickness t of the movable member 7018 is 0.75 mm, the starting width w of the variable conduit is 1.50 mm, and the thickness t of the movable member 7018 is 4 mm. For the fourth regulating vent, the thickness t of the movable member 7018 is 0.75 mm, the starting width w of the variable conduit is 1.75 mm, and the thickness t of the movable member 7018 is 4 mm. For the fifth adjustment vent, the thickness t of the movable member 7018 is 0.75 mm, the starting width w of the variable conduit is 2.0 mm, and the thickness t of the movable member 7018 is 4 mm. For the sixth adjustment vent, the thickness t of the movable member 7018 is 1.25 mm, the starting width w of the variable conduit is 1.5 mm, and the thickness t of the movable member 7018 is 4 mm. For the seventh adjustment vent, the thickness t of the movable member 7018 is 1.25 mm, the starting width w of the variable conduit is 1.75 mm, and the thickness t of the movable member 7018 is 4 mm.

[0487] Figure 8A An exemplary flow regulating vent 8000 is shown positioned within a ventilation opening 3402-1 in an oral-nasal seal-forming structure (patient interface or patient interface assembly) 3100. As shown, the flow regulating vent 8000 can be positioned between the plenum inlet ports 3254-1. It is contemplated that the flow regulating vent 8000 can be located at other locations on the seal-forming structure 3100. For example, in a configuration utilizing only one inlet port, the flow regulating vent 8000 can be located above, below, or to the side of the inlet port. Additionally, the flow regulating vent 8000 can be permanently or removably fixed within the ventilation opening 3402-1.

[0488] In addition, a flow regulating vent 8000 can be used with a nasal seal-forming structure 3100 that includes a vent opening 3402-2. Similar to the configuration with the oral-nasal seal-forming structure 3100, the flow regulating vent 8000 can be positioned between the plenum inlet ports 3254-2. In addition, the flow regulating vent 8000 can be located at other locations on the seal-forming structure 3100. For example, in a configuration that utilizes only one inlet port, the flow regulating vent 8000 can be located above, below, or to the side of the inlet port. In addition, the flow regulating vent 8000 can be permanently or removably fixed within the vent opening 3402-2.

[0489] like Figure 8C and Figure 8D As illustrated, the flow regulating vent 8000 can include a base portion 8010, a housing (or cover portion) 8020, a movable member (or disc or movable portion) 8030, and a biasing mechanism 8040. The base portion 8010 can secure the vent 8000 to the seal-forming structure 3100, while the housing 8020 can enclose the movable member 8030 and the biasing mechanism 8040. In addition, the base portion 8010 can be connected to the housing 8020 via one or more bridging portions 8050. The one or more bridging portions (or spacers) 8050 can maintain a gap (or variable conduit) 8060 between the base portion 8010 and the housing 8020. It is contemplated that the one or more bridging portions (or spacers) 8050 can be incompressible.

[0490] The shape of the perimeter of the base portion 8010 (e.g., the footprint of the base portion 8010) can be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100. For example, if the vent opening is circular, the perimeter of the base portion 8010 can also be circular. Alternatively, the perimeter of the base portion 8010 can be rectangular, square, triangular, oval, hexagonal, or any other shape that can secure the vent 8000 to the seal-forming structure 3100.

[0491] The base portion 8010 may include a pair of flanges 8070 and 8080 that together form a channel 8090. The flanges 8070 and 8080 may extend radially outward from a circumferential wall 8095 of the base portion 8010, such that the channel 8090 opens radially outward. Furthermore, the channel 8090 may accommodate the edge of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. To secure the edge of the vent opening 3402-1 (or 3402-2) within the channel 8090, the diameter of the flanges 8070 and 8080 may be larger than the diameter of the vent opening 3402-1 (or 3402-2).

[0492] It is contemplated that for configurations in which the vent 8000 is permanently attached to the seal-forming structure 3100, the base may be an integral part of the plenum wall of the seal-forming structure 3100. In such configurations, the flanges 8070 and 8080 and the channel 8090 may be replaced with the edge of the vent opening 3402-1 or 3402-2.

[0493] The base portion 8010 may have an inlet side and an outlet side. The inlet side of the base portion 8010 may include an inlet opening 8100 that receives a gas flush from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. The inlet opening 8100 may be defined by a circumferential wall 8095 such that the diameter of the inlet opening 8100 is the same size as the diameter of the base portion 8010 at the circumferential wall 8095. Alternatively, the diameter of the inlet opening 8100 may be smaller than the diameter of the base portion 8010 at the circumferential wall 8095.

[0494] The outlet side of the base portion 8010 may include a central wall 8110 having a central opening 8120. The central wall 8110 may span radially outward from the central portion of the base to the circumferential wall 8095. Furthermore, the central wall 8110 may form one of the walls of the gap 8060. Unlike the movable member 8030, the central wall 8110 may be fixed.

[0495] The intermediate opening 8120 can be located in a central region of the intermediate wall 8110 (and / or a central region of the gap 8060) and can be positioned to allow gas to flush out of the base portion 8010 and into the gap 8060. The intermediate opening 8120 can be smaller than or equal to the size of the inlet opening 8100. It is contemplated that the size (e.g., diameter) of the intermediate opening 8120 and / or the inlet opening 8100 can be fixed or adjustable.

[0496] A flush of gas from the plenum 3200 can enter the base portion 8010 in a direction parallel to the central axis α of the vent 8000. Upon exiting the base portion 8010 through the intermediate opening 8120, the flush of gas can enter the gap 8060. Upon entering the gap 8060, the flush of gas can be deflected by the movable member 8030 to change direction, causing the flush of gas to flow through the gap 8060 in a radially outward direction. Thus, the flush of gas changes direction from an axial direction (i.e., a direction parallel to the central axis α of the vent 8000) to a radially outward direction (i.e., a direction radially outward from the central axis α of the vent 8000) as it flows through the vent 8000. The gap 8060 provides an outlet conduit for the flush of gas, allowing the flush of gas to exit the vent 8000 through the gap 8060 and out the circumferential side (or periphery) of the vent 8000.

[0497] The movable member 8030 can form another wall of the gap 8060 and can be opposite the intermediate wall 8110. In addition, the movable member 8030 can be movable in the axial direction (i.e., a direction parallel to the central axis α of the vent 8000) so that movement of the movable member 8030 can reduce or increase the width of the gap 8060, which narrows or widens the flow path of the gas flush as it leaves the vent 8000. Thus, the gap 8060 acts as a variable conduit. The movable member 8030 can take the form of a disc or any other shape with a width (in the radial direction) significantly greater than its thickness (in the axial direction). In addition, the movable member 8030 can be larger than the intermediate opening 8120 and can extend to the periphery of the housing 8020 and / or the periphery of the vent 8000.

[0498] The movable member 8030 can be biased by the biasing mechanism 8040 toward a position that provides the maximum width of the gap 8060. In other words, the biasing mechanism 8040 can be biased away from the intermediate wall 8110. As the velocity of the gas flush flowing through the vent 8000 increases, the gas pressure in the gap 8060 can decrease, thereby overcoming the biasing force of the biasing mechanism 8040 and pulling the movable member 8030 closer to the intermediate wall 8110 of the base portion 8010. As the movable member 8030 is pulled closer to the intermediate wall 8110, the smaller width of the gap 8060 can increase the impedance (flow resistance) of the gap 8060, thereby slowing or stopping the increase in gas flow through the gap 8060. As long as the gas flush flows through the gap 8060, this process will continue until a balance is reached between the biasing force of the biasing mechanism 8040 and the pressure of the gas flush flowing through the gap 8060. Once the balance is reached, the flow rate of the gas flush through the vent 8000 will remain substantially constant. Thus, the configuration of the vent 8000 creates a feedback loop that regulates the flow of gas flush through the vent 8000 to achieve a target flow.

[0499] The movable member 8030 can be attached to the biasing mechanism 8040 at a central location on the movable member 8030 and at a central location on the biasing mechanism 8040 (eg, at the central axis α of the vent 8000). The remainder of the movable member 8030 can be separate from the biasing mechanism 8040.

[0500] The biasing mechanism 8040 can be in the form of a spring. For example, the biasing mechanism 8040 can have a spiral shape that spirals radially inward from the periphery of the vent 8000. In addition, the biasing mechanism 8040 can be cantilevered (e.g., a cantilevered spiral rod). The cantilevered structure of the biasing mechanism 8040 can have a fixed anchoring end 8130 and a movable free end 8132. The biasing mechanism 8040 is anchored to the housing 8020 at the anchoring end 8130. In addition, the anchoring end 8130 can be located at the outer periphery (or circumference) portion of the biasing mechanism 8040.

[0501] Additionally, the biasing mechanism 8040 may be secured to the movable member 8030 via an axis 8134 located at a free end 8132 of the biasing mechanism 8040. Figure 8D As shown, the free end 8132 can be positioned at a central location. It is contemplated that the shaft 8134 can be positioned at any location radially inward from the anchoring end 8130. The free end of the cantilever structure can also be positioned at any location radially inward from the anchoring end 8130. Furthermore, when the biasing mechanism 8040 is in a neutral state (i.e., without any force acting on the biasing mechanism 8040), the anchoring end 8130 and the free end 8132 can be coplanar.

[0502] When the pressure in gap 8060 is low enough to overcome the biasing force of biasing mechanism 8040, at least a portion of biasing mechanism 8040 can move in the axial direction. For a spiral cantilever configuration, the biasing mechanism 8040 can move more in the central region than at the periphery. This is because the central region is farthest from the anchoring end 8130 along the spiral shape. Therefore, movable member 8030 can be attached to the portion of biasing mechanism 8040 that has the greatest movement. In other words, biasing mechanism 8040 can be most flexible at free end 8132 and most rigid at anchoring end 8130.

[0503] The flow regulating characteristics of the flow regulating vent 8000 can be "tuned" to achieve a desired flow rate at various pressures. For example, the cross-sectional shape and size of the biasing mechanism 8040, the material from which the biasing mechanism 8040 is made, and the spring constant of the biasing mechanism 8040 can affect the biasing force, which in turn affects the balance of the system and the flow curve of the vent 8000.

[0504] It is contemplated that the cross-sectional shape of the biasing mechanism 8040 can be a square with each side of the square being 1.5 mm. The length of the biasing mechanism 8040 can be 165.39 mm. In addition, the biasing mechanism 8040 can be made of nylon (with or without additives such as glass beads or adhesives), polypropylene, thermoplastic elastomers, thermoplastic polyurethanes, polyaryletherketones, jet melt materials, or any combination of the foregoing. It should be understood that the biasing mechanism 8040 is not limited to the above-mentioned sizes, shapes, and materials, and they can vary depending on the target flow curve or flow rate. It should also be understood that the movable member 8030 can be made of the same material as the biasing mechanism 8040, or it can be made of a different material. In addition, the connection location between the housing 8020 and the biasing mechanism 8040 and the connection location between the biasing mechanism and the movable member 8030 can be adjusted from Figure 8D and Figure 8J Those positions shown are moved radially to adjust the flow profile of the vent 8000.

[0505] Other parameters of the vent 8000 can be adjusted to "tune" the characteristics of the vent 8000. For example, the diameter of the central opening 8120 or the diameter of the base portion 8010 can be adjusted. In addition, the axial length of the bridge portion 8050 can be adjusted to "tune" the initial ventilation flow rate (L / min) and the correct pressure start. The diameter or maximum length of the movable member 8030 can be adjusted. For example, by reducing the diameter or maximum length of the movable member 8030, the initial low-pressure flow rate can be changed to start at a higher flow rate.

[0506] It is contemplated that the connection between the biasing mechanism 8040 and the movable member 8030 may be rigid such that the entire movable member 8030 moves the same distance and the cross-sectional width of the gap 8060 is consistent throughout the gap 8060. Alternatively, the connection between the biasing mechanism 8040 and the movable member 8030 may not be rigid. For example, Figure 8J As illustrated, the connection can be a ball-and-socket connection, wherein the movable member 8030 includes a ball portion 8160 and the biasing mechanism 8040 includes a socket portion 8170 (or vice versa). The ball-and-socket connection can allow the movable member 8030 to pivot relative to the biasing mechanism 8040. The pivoting of the movable member 8030 can result in a nonuniform cross-sectional width of the gap 8060 (e.g., one portion of the gap 8060 is narrower than another portion of the gap 8060), which can enable the movable member 8030 to compensate for differences in pressure distribution in the gap 8060 that may occur during operation. Compensating for such differences can result in less turbulent flow and more laminar flow through the vent 8000, which in turn can result in less noise.

[0507] It is also contemplated that the connection between the biasing mechanism 8040 and the movable member 8030 can be a hinged arrangement (e.g., a living hinge) or can simply be formed of a flexible material. These configurations can also enable the movable member 8030 to pivot relative to the biasing mechanism 8040 and compensate for differences in pressure distribution in the gap 8060 that may occur during operation.

[0508] The housing 8020 may include one or more openings. For example, the housing 8020 may include a central opening 8140 surrounded by one or more additional openings 8150. The openings 8140, 8150 may facilitate the manufacture of the flow regulating vent 8000 (i.e., may provide a path for removing excess material during the manufacturing process). Furthermore, although the central opening 8140 is shown as circular, the central opening 8140 may have any shape, such as a triangle, an ellipse, a quadrilateral, a pentagon, a hexagon, etc. Similarly, although the additional openings 8150 are shown as curved slits, the additional openings 8150 may have any shape. The openings 8140 and 8150 may be formed to provide a path for removing excess material left during the manufacturing process. The openings 8140 and 8150 may be located outside the flow path of the gas flush so that the gas flush does not flow through the openings 8140 and 8150.

[0509] As previously discussed, the biasing mechanism can be attached to the housing 8020 at the anchoring end 8130. Figure 8D and Figure 8J As shown, the anchoring end 8130 may be in the form of a shaft. However, the attachment structure may be in any form. For example, although Figure 8D and Figure 8J The majority of the biasing mechanism 8040 is shown spaced apart from the housing 8020 such that there is a gap between the housing 8020 and the biasing mechanism 8040, but the biasing mechanism 8040 can be attached to the housing 8020 in such a manner that when the biasing mechanism 8040 is in its fully biased state (or when the gap 8060 is in its widest state), the entire biasing mechanism 8040 presses against the housing 8020. Furthermore, the connection between the biasing mechanism 8040 and the housing 8020 at the anchor end 8130 can be rigid, semi-rigid, or flexible.

[0510] In addition, all parts of the vent 8000 can be formed integrally. The base portion 8010, the movable member 8030 and the biasing mechanism 8040 can be formed integrally. For example, the vent 8000 can be formed by a 3D printing process (e.g., selective laser sintering (SLS)). Therefore, all of the above parts can be a continuous (and / or seamless) structure. The movable member 8030 can be attached to the biasing mechanism 8040 at a center point. Therefore, the movable member 8030 is attached to the housing 8020 via the biasing mechanism 8040. In addition, the movable member 8030 is attached to the base portion 8010 via the biasing mechanism 8040, the housing 8020 and the bridging portion 8050. Alternatively, the vent 8000 can be made by injection molding.

[0511] Over time, the materials and components forming the vent 8000 may fatigue, resulting in a reduction in the functionality of the vent 8000. For example, the spring constant of the biasing mechanism 8040 may change over time due to wear. Such fatigue may result in a decrease in control over the flow rate of the gas flush. For example, the flow rate may remain higher than a desired value and / or the flow rate may fluctuate undesirably. Therefore, the vent 8000 may optionally include one or more sensors 8180. The sensors 8180 may be positioned within the interior of the base portion 8010 (e.g., on the inner surface of the intermediate wall 8110) and / or in the gap 8060 (e.g., on the outer surface of the intermediate wall 8110 or on the movable member 8030).

[0512] The one or more sensors 8180 may be flow sensors, pressure sensors, displacement sensors, or any combination thereof. The one or more sensors 8180 may transmit signals along a wire 8190 (or wirelessly) to the controller 8200. Figure 8K ). These signals may indicate conditions of the gas flushing, such as, for example, gas pressure, gas flow, and / or displacement of the movable member 8030. The controller 8200 may be a stand-alone controller, a controller for a flow generator, or a controller for a humidifier.

[0513] The controller 8200 can analyze the signals generated by one or more sensors 8180 and determine whether the vent 8000 has failed. The vent can be determined to have failed when the pressure leaving the vent 8000 is higher and / or lower than a threshold pressure. Failure can also be determined when the pressure difference between the gas pressure in the base portion 8010 and the gas pressure in the gap 8060 is higher than a threshold pressure and / or lower than another threshold pressure. Failure can also be determined when the flow rate of gas flowing through the gap 8060 is higher than a target flow rate and / or lower than another target flow rate. In addition, failure can also be determined when the distance traveled by the movable member 8030 is less than a threshold distance for a specific pressure in the plenum and / or greater than another threshold distance. Upon determining that the vent 8000 has failed, the controller 8200 can send a signal to the user (via the user interface 8210 or other methods) that the vent 8000 has failed and needs to be replaced.

[0514] Figures 8L to 8N Another flow regulating vent 9000 is illustrated. Similar to flow regulating vent 8000, flow regulating vent 9000 can include a movable member 9010 and a biasing mechanism 9020. Movable member 9010 and biasing mechanism 9020 can be connected to each other via an axis 9030. Thus, the central portion of movable member 9010 and the central portion of biasing mechanism 9020 can be connected to each other via axis 9030. It is contemplated that movable member 9010 and biasing mechanism 9020 can have the same structure, the same materials, and the same dimensions as movable member 8030 and biasing mechanism 8040 of vent 8000.

[0515] Similar to vent 8000, vent 9000 can be attached to vent opening 3402-1 in the oronasal seal-forming structure 3100 or vent opening 3402-2 in the nasal seal-forming structure 3100. Vent 9000 can also be attached to other components, such as an elbow, an air delivery tube, etc. In other words, vent 9000 can be connected to any component that forms a plenum or gas flow path.

[0516] like Figure 8L and Figure 8M As shown, the movable member 9010 and the biasing mechanism 9020 can be located on opposite sides of a wall (or base) 9040 that defines a plenum (or airflow path) 9050. The biasing mechanism 9020 can be positioned inside the plenum or airflow path 9050, while the movable member 9010 can be positioned outside the plenum or airflow path 9050.

[0517] The movable member 9010 can be moved between a closed position and a vent position. When in the closed position, the movable member 9010 can be pulled against the wall 9040 so that the opening 9060 is covered by the movable member 9010. In other words, the movable member 9010 can block or prevent gas from flushing out of the plenum or airflow path 9050 through the opening 9060 in the wall 9040. When in the vent position, the movable member 9010 can be spaced apart from the wall 9040 to form a gap (or variable conduit) 9070 between the wall 9040 and the movable member 9010. The gap 9070 can be a variable conduit outside the plenum or airflow path 9050, wherein the movable member 9010 forms one side of the gap 9070 (variable conduit) and the wall 9040 of the plenum or airflow path 9050 forms the other side of the variable conduit, the other side being opposite the movable member 9010.

[0518] The movable member 9010 can be movable in a direction perpendicular to the wall 9040, such that movement of the movable member 9010 can reduce or increase the width of the gap 9070, which narrows or widens the flow path of the gas flush as it exits the vent 9000. The movable member 9010 can take the form of a disk or any other shape capable of covering the opening 9060 in the wall 9040. In addition, the perimeter of the movable member 9010 can be larger than the perimeter of the opening 9060, such that the movable member 9010 forms the gap 9070 when in the vent position. The longer the flow path of the gas flush through the gap (variable conduit) 9070, the less turbulence in the gas flush flow and the less noise at the outlet of the vent 9000.

[0519] The movable member 9010 can be biased toward a closed position (i.e., a position in which the movable member is pulled against the wall 9040) by atmospheric or ambient pressure and the biasing mechanism 9020. As the pressure in the plenum or gas flow path 9050 increases, the combined biasing force of the biasing mechanism 9020 and the ambient or atmospheric pressure can be overcome, and the movable member 9010 can be pushed away from the wall 9040 to create a gap 9070. As the movable member 9010 is pushed away from the wall 9040, the width of the gap 9070 can increase and the impedance (flow resistance) of the gap 9070 can decrease, thereby increasing the flow rate of gas through the gap 9070. However, as the flow rate of gas flushing through the gap 9070 increases, the pressure in the gap 9070 decreases. Thus, at some point, an equilibrium will be reached between the biasing force of the biasing mechanism 9020 and the ambient or atmospheric pressure (which pushes the movable member 9010 toward the wall 9040) and the pressure of the gas flush flowing through the gap 9070 (which pushes the movable member 9010 away from the wall 9040). Once equilibrium is reached, the flow rate of the gas flush through the vent 9000 will remain substantially constant. Thus, the configuration of the vent 9000 creates a feedback loop that regulates the flow rate of the gas flush through the vent 9000 to achieve a target flow rate.

[0520] The biasing mechanism 9020 can be in the form of a spring. For example, the biasing mechanism 9020 can have a spiral shape that spirals radially inward from the periphery of the vent 9000. In addition, the biasing mechanism 9020 can be cantilevered (e.g., a cantilevered spiral rod). The cantilevered structure of the biasing mechanism 9020 can have a fixed anchor end 9080 and a movable free end 9090. The biasing mechanism 9020 can be anchored to the inside of the wall 9040 at the anchor end 9080 at the outer periphery (or circumference) portion of the biasing mechanism 9020.

[0521] Additionally, the biasing mechanism 9020 may be secured to the movable member 9010 via an axis 9030 located at the free end 9090. Figure 8M As shown, the free end 9090 can be positioned at a central location. It is contemplated that the shaft 9030 can be positioned at any location radially inward from the anchoring end 9080. The free end 9090 of the cantilever structure can also be positioned at any location radially inward from the anchoring end 9080. Furthermore, when the biasing mechanism 9020 is in a neutral state (i.e., with no force acting on the biasing mechanism 9020), the anchoring end 9080 and the free end 9090 can be coplanar.

[0522] When the pressure in the plenum or airflow path 9050 is great enough to overcome the biasing forces of the biasing mechanism 9020 and the ambient or atmospheric pressure, a portion of the biasing mechanism 9020 can move toward the wall 9040. For a spiral cantilever configuration, the biasing mechanism 9020 can move more at the central end 9090 than at the periphery. This is because the central end 9090 is farthest from the anchor end 9080 along the spiral. Therefore, the movable member 9010 can be attached to the portion of the biasing mechanism 9020 that has the greatest movement. It is also contemplated that the biasing mechanism 9020 can be spaced apart from the inside of the wall 9040, except for the portion near the central end 9090. Alternatively, the majority of the biasing mechanism 9020 can be positioned against the inside of the wall 9040, except for the portion near the central end 9090. The greater the separation of the biasing mechanism 9020 from the wall 9040, the greater the range of movement of the movable member 9010.

[0523] The flow regulating characteristics of the flow regulating vent 9000 can be "tuned" to achieve a desired flow rate at various pressures. For example, the cross-sectional shape and size of the biasing mechanism 9020, the material from which the biasing mechanism 9020 is made, and the spring constant of the biasing mechanism 9020 can affect the biasing force, which in turn affects the balance of the system and the flow curve of the vent 9000.

[0524] It is contemplated that the cross-sectional shape of the biasing mechanism 9020 may be a square with each side of the square being 1.5 mm. The length of the biasing mechanism 9020 may be 165.39 mm. Furthermore, the biasing mechanism 9020 may be made of nylon (with or without additives such as glass beads or adhesives), polypropylene, thermoplastic elastomers, thermoplastic polyurethanes, polyaryletherketones, jet-molded materials, or any combination thereof. It should be understood that the biasing mechanism 9020 is not limited to the aforementioned sizes, shapes, and materials, and that they may vary depending on the target flow curve or flow rate. It should also be understood that the movable member 9010 may be made of the same material as the biasing mechanism 9020, or may be made of a different material.

[0525] It is contemplated that the connection between the biasing mechanism 9020 and the movable member 9010 (i.e., the shaft 9030) can be rigid such that the entire movable member 9010 moves the same distance and the cross-sectional width of the gap 9070 is consistent throughout the gap 9070. Alternatively, the connection between the biasing mechanism 9020 and the movable member 9010 may not be rigid. For example, the shaft 9030 may be made of a flexible material that allows the shaft 9030 to bend. Alternatively, the shaft 9030 may be attached to the biasing mechanism 9020 and / or the movable member 9010 by an articulated device (e.g., a living hinge) such that the movable member 9010 and / or the biasing mechanism 9020 can pivot relative to the shaft 9030 and / or each other. It is contemplated that the shaft 9030 may be attached to the biasing mechanism 9020 and / or the movable member 9010 by an articulated device (e.g., a living hinge) such that the movable member 9010 and / or the biasing mechanism 9020 can pivot relative to the shaft 9030 and / or each other. Figure 8J The illustrated ball and socket configuration is connected to the movable member 9010 and / or the biasing mechanism 9020. Any of the movable member 9010, the biasing mechanism 9020, and the shaft 9030 can have a "ball" portion of the ball and socket connection and the other component including a "socket" portion of the ball and socket connection, or vice versa.

[0526] Furthermore, all parts of the vent 9000 can be integrally formed. The base 9040, the movable member 9010, and the biasing mechanism 9020 can be integrally formed. For example, the vent 9000 can be formed using a 3D printing process (e.g., selective laser sintering (SLS)). Thus, all of the above parts can be a continuous (and / or seamless) structure. Alternatively, the vent 9000 can be made by injection molding.

[0527] Similar to vent 8000, vent 9000 may optionally include one or more sensors 9100. Sensors 9100 may be positioned on or embedded in movable member 9010, or positioned on or embedded in the outer surface of wall 9040. One or more sensors 9100 may be flow sensors, pressure sensors, displacement sensors, or any combination thereof. One or more sensors 9100 may transmit signals along wires 9110 (or wirelessly) to controller 9120. Figure 8R ). These signals may indicate the condition of the gas flushing, such as, for example, gas pressure, gas flow, and / or displacement of the movable member 9010. The controller 9120 may be a stand-alone controller, a controller for a flow generator, or a controller for a humidifier.

[0528] The controller 9120 can analyze the signals generated by one or more sensors 9100 and determine whether the vent 9000 has failed. A vent failure can be determined when the pressure exiting the vent 9000 is above and / or below a threshold pressure. A failure can also be determined when the pressure difference between the gas pressure in the plenum or gas flow path 9050 and the gas pressure in the gap 9070 is above a threshold pressure and / or below another threshold pressure. A failure can also be determined when the flow rate of gas flowing through the gap 9070 is above a target flow rate and / or below another target flow rate. Furthermore, a failure can also be determined when the distance traveled by the movable member 9010 is less than a threshold distance for a particular pressure in the plenum or gas flow path 9050 and / or greater than another threshold distance. Upon determining that the vent 9000 has failed, the controller 9120 can signal the user (via the user interface 9130 or other means) that the vent 9000 has failed and needs to be replaced.

[0529] The vents 7010, 8000, 9000, and 9050 discussed above regulate the flow of gas flushing through the vents via a self-regulating feedback loop that relies on the flow of gas through the patient interface to actuate the vents. However, it is contemplated that the flow-regulating vent designs described above may be supplemented or enhanced with external mechanisms that actuate the flow-regulating vents in conjunction with the flow of gas through the patient interface, or in lieu of gas flowing through the patient interface. It is contemplated that such actuating mechanisms may be located external to the gas flow path.

[0530] In one configuration, the actuation mechanism can be electric. Using an electric mechanism to actuate a flow regulating vent (e.g., vents 7010, 8000, 9000, 9050) can improve the efficiency of the vent. For example, an electrically actuated flow regulating vent (e.g., 7010, 8000, 9000, 9050) can take into account additional factors present in the patient interface, such as leaks. If the flow regulating vent does not take into account leaks in the patient interface, the vent may be susceptible to excessive ventilation flow because some ventilation of the patient interface may occur through leaks. By reducing excess flow, moisture removed from the patient can be reduced, which will help maintain humidity in the mask.

[0531] Furthermore, when a leak develops in the mask, a pressure drop occurs at the mask due to the increased area through which air exits the system. In response, the flow rate at the flow generator is typically increased to maintain the therapy pressure at the mask. Thus, as seen in equation (1), the flow rate at the flow generator can be considered a function of the vent, the leak, and the patient flow rate.

[0532] Q 流量发生器 =Q 患者 +Q泄漏 +Q 通气口 (1)

[0533] Increased flow leads to increased mask noise, which, in addition to vent noise, can be irritating and potentially disruptive to the patient's sleep. Increased flow can also be associated with increased drying of the mouth, eyes, and nasal cavity, as more moisture is removed from the airways. Furthermore, this can lead to excessive CO2 washout, which can induce hypocapnia.

[0534] Since mask leaks during sleep are typically caused by movement of the mask resulting in an incomplete seal, it is difficult to mitigate mask leaks while the patient is sleeping. However, when a leak occurs, the adverse effects of the leak can be reduced by controlling the ventilation flow rate, and accordingly, the leak is effectively compensated by reducing the total airflow from the blower, as seen in equation (2).

[0535] Q 流量发生器 =Q 患者 +Q 泄漏 ↑+Q 通气口 ↓(2) Figure 9A An exemplary control system 9500 for an electrically actuated flow-regulated vent 9510 is illustrated. The control system 9500 may include a controller 9512 that receives feedback signals from one or more sensors in the patient interface 3000 indicating the pressure, flow, and / or CO2 level of respiratory gas in the patient interface 3000. The controller 9512 may also receive feedback signals from a sensor or sensing system 9514 located at or near the outlet of the RPT device 4000. The sensor 9514 may be a pressure sensor or a flow sensor. It is contemplated that the controller 9512 may be similar in structure and function to the controller for the vent 9000 discussed above.

[0536] The controller 9512 can rely on feedback from a sensor or sensing system 9514 at or in the RPT device 4000. In addition, the controller 9512 can also include a leak detection algorithm. When a leak is detected at the RPT device 4000, the vent 9510 can be actuated to reduce the ventilation flow. Figure 9B An exemplary response to leak detection is shown.

[0537] It is contemplated that sensors may be provided in or at the patient interface 3000 to measure flow and / or pressure, and these sensors may be used to detect changes in flow due to leaks at the patient interface. This information may be applied to a leak detection algorithm. One advantage of incorporating a flow or pressure sensor at the patient interface is that leaks at the RPT device can be distinguished from leaks at the patient interface. This may be a desirable feature, as leaks at the RPT device (perhaps due to improperly aligned humidifier tubing or incompletely sealed tubing) may result in incorrect leak detection, potentially mistaking a leak at the RPT device for a leak at the patient interface. If the flow-regulating ventilator is actuated in response to a leak at the RPT device by reducing ventilation flow, CO2 levels in the patient interface may rise, posing a potential risk. This is because there may not be any (or sufficient) leakage at the patient interface to compensate for the reduced ventilation flow. It is also contemplated that the controller 9512 may receive feedback from sensors in or at the patient interface 3000, rather than from the sensor or sensing system 9514.

[0538] The flush flow of gas and the venting of mask leakage can also perform the function of flushing CO2 from the patient interface and even the entire system. Therefore, the vent 9510 can also be actuated in response to the CO2 level in the patient interface. Specifically, the patient interface can include a CO2 sensor configured to detect the CO2 level in the patient interface. The CO2 sensor can be part of a feedback loop to actuate the vent 9510 when the CO2 in the patient interface is too high or too low. In the event that the CO2 level in the patient interface is too high, the vent 9510 can be actuated to increase ventilation and flush out excess CO2. This will reduce the "stuffy" feeling of the mask and improve the patient's breathing comfort. A CO2 level in the patient interface below a predetermined threshold can indicate that hyperventilation is occurring. Therefore, in response to the CO2 level falling below the threshold, the vent 9510 can be actuated to reduce ventilation and conserve CO2.

[0539] A simple vent control strategy may aim to control a low-pass or average flow generator flow signal by varying the resistance of the vent 9510. In some configurations, the target average flow generator flow rate can be set as a function of the volume inside the patient interface plenum chamber. For example, a smaller plenum chamber typically results in a smaller volume of CO2 being retained in the system, thus requiring less flow to flush the CO2 out of the system. In contrast, a larger plenum chamber may require more flow to achieve the same level of CO2 rebreathing.

[0540] For smaller nasal or pillow masks, the target average flow generator flow for vent control might be 15 to 20 LPM, while for larger full-face masks, the target for vent control might be 20 to 25 LPM. With this control strategy, as the leak flow increases, the vent resistance can be increased to maintain a constant flow generator flow within the target range.

[0541] Figures 9C to 9F Various configurations of an exemplary flow regulating vent 9510 including an electrically actuated mechanism are illustrated. Similar to non-electrically actuated configurations of flow regulating vents, flow regulating vent 9510 can include a base portion 9516, a housing (or cover portion) 9518, a movable member (or disc or movable portion) 9520, a biasing mechanism 9522, a permanent magnet 9526 attached to movable member 9520, and a coil winding 9528. The base portion 9516 can secure the vent 9510 to the seal-forming structure 3100, while the housing 9518 can enclose the movable member 9520 and the biasing mechanism 9522. In addition, the base portion 9516 can be connected to the housing 9518 via one or more bridging portions. The one or more bridging portions (or spacers) can maintain a gap (or variable conduit) 9524 between the base portion 9516 and the housing 9518. It is contemplated that the one or more bridging portions (or spacers) can be incompressible.

[0542] The shape of the perimeter of the base portion 9516 (e.g., the footprint of the base portion 9516) can be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100. For example, if the vent opening is circular, the perimeter of the base portion 9516 can also be circular. Alternatively, the perimeter of the base portion 9516 can be rectangular, square, triangular, oval, hexagonal, or any other shape that can secure the vent 9510 to the seal-forming structure 3100.

[0543] The base portion 9516 may include a pair of flanges that together form a channel. These flanges may extend radially outward from the circumferential wall of the base portion 9516 so that the channel opens radially outward. In addition, the channel may accommodate the edge of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. In order to secure the edge of the vent opening 3402-1 (or 3402-2) within the channel, the diameter of these flanges may be greater than the diameter of the vent opening 3402-1 (or 3402-2).

[0544] It is contemplated that for configurations in which the vent 9510 is permanently attached to the seal-forming structure 3100, the base may be an integral part of the plenum wall of the seal-forming structure 3100. In such configurations, the flanges and channels may be replaced with the edges of the vent opening 3402-1 or 3402-2.

[0545] The base portion 9516 can have an inlet side and an outlet side. The inlet side of the base portion 9516 can include an inlet opening that receives a gas flush from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. The inlet opening can be defined by a circumferential wall such that the diameter of the inlet opening is the same size as the diameter of the base portion at the circumferential wall. Alternatively, the diameter of the inlet opening can be smaller than the diameter of the base portion at the circumferential wall.

[0546] The outlet side of the base portion 9516 may include a central wall having a central opening. The central wall may extend radially outward from the central portion of the base to the circumferential wall. In addition, the central wall may form one of the walls of the gap 9524. Unlike the movable member 9520, the central wall may be fixed.

[0547] The intermediate opening can be located in a central region of the intermediate wall (and / or a central region of the gap 9524) and can be positioned to allow gas to flush out of the base portion 9516 and into the gap 9524. The intermediate opening can be smaller than or equal to the size of the inlet opening. It is contemplated that the size (e.g., diameter) of the intermediate opening and / or the inlet opening can be fixed or adjustable.

[0548] The gas flush from the plenum 3200 can enter the base portion 9516 in a direction parallel to the central axis of the vent 9510. Upon exiting the base portion 9516 through the intermediate opening, the gas flush can enter the gap 9524. Upon entering the gap 9524, the gas flush can be deflected by the movable member 9520 to change direction so that the gas flush flows through the gap 9524 in a radially outward direction. Thus, the gas flush changes direction from an axial direction (i.e., a direction parallel to the central axis α of the vent 9510) to a radially outward direction (i.e., a direction radially outward from the central axis α of the vent 9510) as it flows through the vent 9510. The gap 9524 provides an outlet conduit for the gas flush, so that the gas flush exits the vent 9510 through the gap 9524 and out the circumferential side (or periphery) of the vent 9510.

[0549] The movable member 9520 can form another wall of the gap 9524 and can be opposite to the middle wall. In addition, the movable member 9520 can be movable in the axial direction (i.e., the direction parallel to the central axis of the vent 9510) so that the movement of the movable member 9520 can reduce or increase the width of the gap 9524, which narrows or widens the flow path of the gas flush when the gas flush leaves the vent 9510. Therefore, the gap 9524 acts as a variable conduit. The movable member 9520 can take the form of a disc or any other shape, and its width (in the radial direction) is significantly greater than its thickness (in the axial direction). In addition, the movable member 9520 can be larger than the middle opening and can extend to the periphery of the housing 9518 and / or the periphery of the vent 9510.

[0550] The movable member 9520 can be biased by a biasing mechanism 9522 toward a position that provides the minimum width of the gap 9524. In other words, the biasing mechanism 9522 can be biased away from the intermediate wall. The movable member 9520 can be attached to the biasing mechanism 9522 at a central position on the movable member 9520 or at any other position on the movable member 9520. The biasing mechanism 9522 can take the form of a spring. For example, the biasing mechanism 9522 can have a spiral or helical shape.

[0551] As discussed above, the magnet 9526 can be attached to the movable member 9520. The magnet 9526 can be permanently affixed to the movable member 9520 or can be removable from the movable member 9520. It is contemplated that the magnet 9526 can be integrally formed with the movable member 9520. For example, the entire movable member 9520 can be formed with the magnet 9526. Furthermore, the biasing mechanism 9522 can be connected to the movable member 9520 via the magnet 9526.

[0552] The coil winding 9528 can be attached to the housing 9518 so that the magnet 9526 and the movable member 9520 can move relative to the coil winding 9528. The magnet 9526 and the coil winding 9528 can together form an electric actuator 9530 that moves the movable member 9520 in response to an electric current applied to the coil winding 9528. Specifically, when an electric current is applied to the coil winding 9528, a magnetic field can be generated around the coil winding 9528, which in turn can interact with the magnetic field of the magnet 9526 to cause the magnet 9526 to move the movable member 9520 toward the base portion 9516 and narrow the gap 9524.

[0553] The force acting on the magnet 9526 to move the movable member 9520 can be proportional to the magnetic field generated by the current. Thus, the movement of the movable member 9520 can be controlled by varying the magnitude of the current applied to the coil winding 9528. Increasing the current will move the movable member 9520 toward the base portion 9516 and narrow the gap 9524. Furthermore, decreasing the current will allow the biasing mechanism 9522 and the pressure of the flushing gas flowing through the gap 9524 to push the movable member 9520 away from the base portion 9516, thereby increasing the gap 9524. The controller 9512 can regulate the movement of the movable member 9520 by supplying current to the coil winding 9528 in response to CO2 levels, flow, pressure, leakage, and / or other factors related to the condition of the respiratory gas in the patient interface 3000. Thus, the size of the gap 9524 can be variable (e.g., an unlimited number of potential widths) and is not limited to being fully open or fully closed.

[0554] It is contemplated that the vent 9510 can be permitted to operate in a similar manner to the vents 7010, 8000, and 9000. That is, the movable member can be permitted to move in response to the flow rate of the gas flush flowing through the gap 9524, such that the vent 9510 self-regulates the flow rate of the gas flush exhausted through the vent 9510. The controller 9512 can be configured to override the self-regulation of the vent 9510 by applying a current to the coil winding 9528 to counteract the pressure of the gas flush flowing through the gap 9524.

[0555] For example, the vent 9510 can be allowed to regulate the flow of gas flushing through the vent 9510 without intervention by the controller 9512 until the controller 9512 determines that the pressure, flow, or CO2 level in the patient interface 3000 is at an undesirable level. The controller 9512 can then supply current to the coil winding 9528 (or adjust the magnitude of the current) to actuate the movable member 9520 toward the base portion 9516, thereby narrowing the gap 9524 and increasing the flow of the gas flushing vent (or moving the movable member 9520 away from the base portion 9516, thereby decreasing the flow of the gas flushing vent). In other words, the controller 9512 can work in conjunction with the gas flushing flowing through the vent 9510 to provide hybrid control over the flow of gas flushing through the vent 9510.

[0556] Alternatively, the controller 9512 may always supply current to the coil windings 9528, and may vary the magnitude of the current in response to conditions within the patient interface 3000. In this configuration, the controller 9512 may control the movable member 9520 such that the pressure of the gas flush flowing through the gap 9524 does not affect the position of the movable member 9520. Only the magnitude of the current supplied to the coil windings 9528 will affect the position of the movable member 9520.

[0557] Figure 9D Illustrated with Figure 9C However, the position of the coil winding 9528 and the position of the magnet 9526 are interchanged. Specifically, the coil winding 9528 is positioned on the movable member 9520, and the magnet 9526 is attached to the housing 9518. In addition, the biasing mechanism 9522 can take the form of a diaphragm attached to the periphery of the movable member 9520. In this configuration, the magnet 9526 can include a channel or recessed portion configured to accommodate the coil winding 9528. This configuration can be similar to Figure 9C The illustrated configuration operates in a similar manner.

[0558] Figure 9E A configuration is illustrated in which the magnet 9526 is located on the inside surface of the housing 9518 and the coil winding 9528 is in the form of a flat coil on the surface of the movable member 9520. In this configuration, the biasing mechanism 9522 is in the form of a diaphragm attached to the periphery of the movable member 9520. In addition, this configuration can be used in conjunction with Figure 9C The illustrated configuration operates in a similar manner.

[0559] Figure 9F Shown with Figure 9E However, the magnet 9526 and the coil winding 9528 are interchanged so that the magnet 9526 is located on the movable member 9520 and the coil winding 9528 is located on the housing 9518. In addition, the magnet 9526 is in the form of a flat magnet and the coil winding 9528 is in the form of a flat coil. In addition, this configuration can be used in the same manner as the Figure 9C The illustrated configuration operates in a similar manner.

[0560] Figures 9G to 9I Another flow regulating vent 9600 having a "voice coil" type configuration is illustrated. Similar to the passive actuation configuration and the previous electrically actuated configuration of the flow regulating vent, the flow regulating vent 9600 can include a base portion 9610, a housing (or cover portion) 9612, a movable member (or disc or movable portion) 9614, and a suspension mechanism 9616. The base portion 9610 can secure the vent 9600 to the seal-forming structure 3100, while the housing 9612 can enclose the movable member 9614 and the suspension mechanism 9616.

[0561] The shape of the perimeter of the base portion 9610 (e.g., the footprint of the base portion 9610) can be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100. For example, if the vent opening is circular, the perimeter of the base portion 9610 can also be circular. Alternatively, the perimeter of the base portion 9610 can be rectangular, square, triangular, oval, hexagonal, or any other shape that can secure the vent 9600 to the seal-forming structure 3100.

[0562] The base portion 9610 may include a pair of flanges 9618 and 9620 that together form a channel 9622. The flanges 9618 and 9620 may extend radially outward from a circumferential wall 9624 of the base portion 9610, such that the channel 9622 opens radially outward. Furthermore, the channel 9622 may accommodate the edge of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. To secure the edge of the vent opening 3402-1 (or 3402-2) within the channel 9622, the diameters of the flanges 9618 and 9620 may be larger than the diameter of the vent opening 3402-1 (or 3402-2).

[0563] It is contemplated that for configurations in which vent 9600 is permanently attached to seal-forming structure 3100, the base may be an integral part of the plenum wall of seal-forming structure 3100. In such configurations, flanges 9618 and 9620 and channel 9622 may be replaced with the edge of vent opening 3402-1 or 3402-2.

[0564] The base portion 9610 may have an inlet side and an outlet side. The inlet side of the base portion 9610 may include an inlet opening 9626 that receives a gas flush from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. The inlet opening 9626 may be defined by a circumferential wall 9624 such that the diameter of the inlet opening 9626 is the same size as the diameter of the base portion 9610 at the circumferential wall 9624. Alternatively, the diameter of the inlet opening 9626 may be smaller than the diameter of the base portion 9610 at the circumferential wall 9624.

[0565] The outlet side of the base portion 9610 may include a central wall 9628 having a central opening 9630. The central wall 9628 may span radially outward from the central portion of the base to the circumferential wall 9624. Furthermore, the central wall 9628 may form one of the walls of the gap 9632 between the movable member 9614 and the base portion 9610. Unlike the movable member 9614, the central wall 9628 may be fixed.

[0566] The intermediate opening 9630 can be located in a central region of the intermediate wall 9628 (and / or a central region of the gap 9632) and can be positioned to allow gas to purge out of the base portion 9610 and into the gap 9632. The intermediate opening 9630 can be smaller than or equal to the size of the inlet opening 9626. It is contemplated that the size (e.g., diameter) of the intermediate opening 9630 and / or the inlet opening 9626 can be fixed or adjustable.

[0567] A flush of gas from the plenum 3200 can enter the base portion 9610 in a direction parallel to the central axis β of the vent 9600. Upon exiting the base portion 9610 through the intermediate opening 9630, the flush of gas can enter the gap 9632. Upon entering the gap 9632, the flush of gas can be deflected by the movable member 9614 to change direction, causing the flush of gas to flow through the gap 9632 in a radially outward direction. Thus, the flush of gas changes direction as it flows through the vent 9600 from an axial direction (i.e., a direction parallel to the central axis β of the vent 9600) to a radially outward direction (i.e., a direction radially outward from the central axis β of the vent 9600). The gap 9632 provides an outlet conduit for the flush of gas, causing the flush of gas to exit the vent 9600 through the gap 9632 and out the circumferential side (or periphery) of the vent 9600.

[0568] Movable member 9614 can form another wall of gap 9632 and can be opposite intermediate wall 9628. Furthermore, movable member 9614 can be movable in an axial direction (i.e., a direction parallel to the central axis β of vent 9600), such that movement of movable member 9614 can reduce or increase the width of gap 9632, thereby narrowing or widening the flow path of the gas flush as it exits vent 9600. Thus, gap 9632 functions as a variable conduit. Movable member 9614 can take the form of a circular disc or any other shape with a width (in the radial direction) that is significantly greater than its thickness (in the axial direction). Furthermore, movable member 9614 can be larger than intermediate opening 9630 and can extend to the periphery of housing 9612 and / or the periphery of vent 9600.

[0569] The suspension mechanism 9616 can simply suspend the movable member 9614 from the housing 9612. However, it is contemplated that the movable member 9614 can be biased by the suspension mechanism 9616 toward a position that provides the maximum width of the gap 9632. In other words, the suspension mechanism 9616 can be biased away from the intermediate wall 9628. Alternatively, the suspension mechanism 9616 can be biased toward a position that provides the minimum width of the gap 9632, or closes the gap 9632. In other words, the suspension mechanism 9616 can be biased toward the intermediate wall 9628. The suspension mechanism 9616 can be configured to oppose the force caused by the electrical signal from the electrical actuator, which causes the movable member 9614 to move.

[0570] The suspension mechanism 9616 can take the form of a spring or a suspension membrane. For example, the suspension mechanism 9616 can be formed from a memory foam or silicone foam material. It is contemplated that the suspension mechanism 9616 can alternatively be formed from a resilient silicone or rubber material. It is also contemplated that the suspension mechanism 9616 can be hollow so that it forms a sac that can be filled with a fluid (i.e., a gas, liquid, or gel). The shape of the suspension mechanism 9616 can be circular with a central opening in the middle (see FIG. Figure 9J and Figure 9K ). The outer diameter D1 of the suspension mechanism 9616 may be 20 mm to 30 mm (eg, 28.8 mm), and the inner diameter D2 of the suspension mechanism 9616 may be 15 mm to 25 mm (eg, 18 mm).

[0571] As shown, the suspension mechanism 9616 can have an outer flat portion 9634 at the periphery of the suspension mechanism 9616 and an inner flat portion 9636 forming the edge of a central opening. Both sides of the suspension mechanism 9616 (i.e., the sides facing and away from the base portion 9610) can be substantially flat at the outer flat portion 9634 and the inner flat portion 9636. A curved portion 9638 can connect the outer flat portion 9634 to the inner flat portion 9636 and can be positioned to decouple movement of the outer flat portion 9634 from that of the inner flat portion 9636. The side of the suspension mechanism 9616 facing the base portion 9610 can be concave at the curved portion 9638, while the side of the suspension mechanism 9616 facing away from the base portion 9610 can be convex at the curved portion 9638. Furthermore, the thickness t of the material can be consistent throughout the suspension mechanism 9616 (e.g., approximately 1 mm).

[0572] The suspension mechanism 9616 can connect the movable member 9614 to the housing 9612 in a manner that suspends the movable member 9614 from the housing 9612. The outer flat portion 9634 can be attached to the movable member 9614, while the inner flat portion 9636 can be attached to the housing 9612. In this way, the curved portion 9638 can decouple the movement of the movable member 9614 from the housing 9612.

[0573] The housing 9612 can be designed to surround at least a portion of the movable member 9614 and the suspension mechanism 9616 and can have a wall thickness of, for example, 1 mm to 2 mm. In addition, the base portion 9610 can be connected to the housing 9612 via one or more bridging portions 9640. The one or more bridging portions (or spacers) can maintain the gap (or variable conduit) 9632. It is conceivable that the one or more bridging portions 9640 can be incompressible. In addition, the bridging portion 9640 can be part of a snap-fit connection. For example, the bridging portion 9640 can be a protrusion extending from the housing 9612. The end of the bridging portion 9640 can include an undercut. When the housing 9612 is pressed against the base portion 9610, the bridging portion 9640 can bend elastically outward until the lip of the base portion 9610 enters the undercut of the bridging portion 9640. The bridge portion 9640 can then spring back to its unbent configuration, securing the housing 9612 to the base portion 9610. The housing 9612 can be released from the base portion 9610 by bending the bridge portion 9640 outward so that the lip of the base portion 9610 can be removed from the undercut on the bridge portion 9640.

[0574] The housing 9612 can include a recessed portion 9642 in a central region. It is contemplated that the central axis β of the vent 9600 can extend through the center of the recessed portion 9642. An opening 9644 can be located at the bottom of the recessed portion 9642. The opening 9644 can have a diameter or be sufficiently wide that the magnet 9646 can pass through the opening 9644 without contacting the housing 9612. The magnet 9646 can be positioned on the central surface of the movable member 9614 in such a manner as to allow the magnet 9646 to move back and forth through the opening 9644 as the movable member 9614 moves toward and away from the base portion 9610.

[0575] The coil winding 9648 can be positioned on the sidewall of the recessed portion 9642 so that the coil winding 9648 surrounds the magnet 9646 without contacting the magnet 9646. Figure 9H The coil windings 9648 are shown inside the recessed portion 9642, but the coil windings 9648 can be positioned on the sidewalls outside the recessed portion 9642. In addition, the coil windings 9648 can be positioned so that the magnets 9646 can move relative to the coil windings 9648.

[0576] The movable member 9614 can be attached to the suspension mechanism 9616 at a central location on the movable member 9614 and at a central location on the suspension mechanism 9616 (e.g., at the central axis β of the vent 9600). The remainder of the movable member 9614 can be separate from the suspension mechanism 9616.

[0577] During operation, an electrical current may be supplied to the coil windings 9648, which may generate a magnetic field that may cause the magnet 9646 to move relative to the coil windings in a direction parallel to the central axis β of the vent 9600. The magnitude of the electrical signal may depend on the signal received by the controller from a sensor located on the RPT device 4000, the air circuit 4170, or the patient interface 3100. Furthermore, the current supplied to the coil windings 9648 may be sufficient to move the movable member 9614 from the maximum width of the gap 9632 to a position that fully closes the gap 9632, or any position therebetween.

[0578] It is also contemplated that the polarity of the electrical signal can be used to cause the magnet 9646 and movable member 9614 to move back and forth. For example, a first polarity can cause the magnet 9646 and movable member 9614 to move toward the base portion 9610, while an opposite polarity can cause the magnet 9646 and movable member 9614 to move away from the base portion 9610. In addition, the suspension mechanism 9616 can provide a biasing force that can move the magnet 9646 and movable member 9614 back to a neutral position in the absence of an electrical signal from a controller or power supply. Furthermore, the suspension mechanism 9616 can be replaced with a simple membrane or capsule that does not provide any biasing force.

[0579] It should be understood that the suspension mechanism 9616 may be used in any of the previously disclosed gas flow regulating vents.

[0580] Figure 9L An exemplary circuit 9650 for powering coil winding 9648 is illustrated. As shown, power supply 9652 can provide 7V to circuit 9650. A 4-ohm resistor 9654 can be provided to achieve a voltage drop of approximately 3.5V. A diode 9656 can be positioned in parallel with coil winding 9648 to mitigate interference from electric and magnetic fields (EMF). This configuration can provide a maximum current of 0.866A to coil winding 9648. It should be understood that circuit 9650 may not be limited to the above parameters, and such parameters are merely exemplary.

[0581] Figure 9MAn exemplary algorithm or method 9800 for operating the vent 9600 is illustrated. The method 9800 begins at step 9810 of determining a target pressure level in the patient interface 3000. The target pressure level can be a therapy pressure level, such as, for example, 10 cmH2O relative to ambient pressure. For bi-level therapy, the target pressure level can be an EPAP level (target pressure during exhalation) (e.g., 4 cmH2O relative to ambient pressure).

[0582] The controller may receive a signal indicative of pressure within the patient interface 3000 from a sensor located on or within the patient interface 3000 (step 9812). The sensor may be any type of sensor capable of detecting a condition within the patient interface 3000 that is indicative of pressure within the patient interface 3000 (e.g., gas flow or pressure).

[0583] The controller can then determine whether the pressure inside the patient interface 3000 is above the target level (step 9814). A pressure above the target pressure can be an indication that insufficient gas is being expelled through the vent 9600. Therefore, if the controller determines that the pressure in the patient interface 3000 is above the target pressure, the controller can actuate the coil winding 9648 in the vent 9600 to move the magnet 9646 and the movable member 9614 in a direction away from the base portion 9610 (step 9816). This can be achieved by increasing or decreasing the voltage across the coil winding 9648 and / or changing the polarity of the voltage across the coil winding 9648. After adjusting the voltage across the coil winding 9648, step 9812 can be repeated (i.e., the pressure in the patient interface 3000 can be determined).

[0584] However, if the pressure inside the patient interface 3000 is not above the target pressure, the controller can determine whether the pressure inside the patient interface is below the target pressure (step 9818). A pressure below the target pressure can be an indication that too much gas is being displaced and / or that the patient interface is experiencing a leak. If the controller determines that the pressure is below the target pressure, the coil windings 9648 can be actuated to reduce the flow of gas through the vent 9600 (step 9820). In this way, ventilation through the vent 9600 can compensate for any undesirable gas leakage from the patient interface 3000.

[0585] Similar to step 9816, the coil windings 9648 may be actuated to reduce airflow through the vent 9600 by increasing or decreasing the voltage across the coil windings 9648 and / or changing the polarity of the voltage across the coil windings 9648. After adjusting the voltage across the coil windings 9648, step 9812 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).

[0586] If the controller determines that the pressure in the patient interface 3000 is not below the target pressure, the flow of gas flushing through the vent 9600 can be maintained at the current level (i.e., the voltage across the coil winding 9648 can remain unchanged) and step 9812 can be repeated (i.e., the pressure in the patient interface 3000 can be determined).

[0587] Figure 9N Another exemplary algorithm or method 9850 for operating the vent 9600 is illustrated. Similar to method 9800, method 9850 begins at step 9852 of determining a target pressure level in the patient interface 3000. A threshold level of CO2 in the patient interface 3000 may also be determined. The target pressure level may be a therapy pressure level, such as, for example, 10 cmH2O relative to ambient pressure. For bi-level therapy, the target pressure level may be an EPAP level (target pressure during exhalation) (e.g., 4 cmH2O relative to ambient pressure). Additionally, the threshold level of CO2 may be a level determined to be dangerous to the patient.

[0588] The controller may receive signals indicative of pressure and CO2 levels within the patient interface 3000 from a sensor located on or within the patient interface 3000 (step 9854). The sensor may be any type of sensor capable of detecting conditions within the patient interface 3000 that are indicative of pressure and CO2 levels within the patient interface 3000 (e.g., gas flow or pressure). It is contemplated that more than one sensor may be used to determine these two conditions.

[0589] The controller can then determine whether the pressure inside the patient interface 3000 is above the target level (step 9856). A pressure above the target pressure can be an indication that insufficient gas is being expelled through the vent 9600. Therefore, if the controller determines that the pressure in the patient interface 3000 is above the target pressure, the controller can actuate the coil winding 9648 in the vent 9600 to move the magnet 9646 and the movable member 9614 in a direction away from the base portion 9610 (step 9858). This can be achieved by increasing or decreasing the voltage across the coil winding 9648 and / or changing the polarity of the voltage across the coil winding 9648. After adjusting the voltage across the coil winding 9648, step 9854 can be repeated (i.e., the pressure in the patient interface 3000 can be determined).

[0590] However, if the pressure inside the patient interface 3000 is not above the target pressure, the controller may determine whether the pressure inside the patient interface is below the target pressure (step 9859). A pressure below the target pressure may be an indication that too much gas is being displaced and / or that the patient interface is experiencing a leak. If the controller determines that the pressure is below the target pressure, the controller may then determine whether the CO2 level in the patient interface 3000 is above a threshold level (step 9860).

[0591] The CO2 level in the patient interface 3000 may take precedence over the pressure level in the patient interface 3000. Thus, even if the pressure is below the threshold pressure, the coil windings 9648 may be actuated to increase the flow of gas through the vent 9600, thereby reducing the CO2 level in the mask (step 9858). Figure 9N The determination of whether the pressure is below the target level is shown as being performed before determining whether the CO2 level is below the threshold level, but these steps can be reversed such that the CO2 determination (step 9860) is performed before the pressure level determination (step 9859). In this case, step 9859 would be performed if it is determined that the CO2 level is above the threshold level, and step 9859 (determining whether the pressure is below the threshold) would be performed if it is determined that the CO2 level is not above the threshold level.

[0592] If the CO2 level is below the threshold level and the pressure is below the target level, the coil windings 9648 can be actuated to reduce the flow of gas through the vent 9600 (step 9862). In this way, ventilation through the vent 9600 can compensate for any undesirable gas leakage from the patient interface 3000.

[0593] Similar to step 9858, the coil windings 9648 may be actuated to reduce airflow through the vent 9600 by increasing or decreasing the voltage across the coil windings 9648 and / or changing the polarity of the voltage across the coil windings 9648. After adjusting the voltage across the coil windings 9648, step 9854 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).

[0594] If the controller determines that the pressure in the patient interface 3000 is not below the target pressure, the controller may determine whether the CO2 level is above a threshold value (step 9864). If the CO2 level is above the threshold value, the airflow through the vent 9600 may be increased even if the pressure is below the target value (step 9866). However, if the CO2 level is not above the threshold value, the flow of gas flushing through the vent 9600 may be maintained at the current level (step 9868, i.e., the voltage across the coil winding 9648 may remain unchanged), and step 9854 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).

[0595] Figure 9O Replace the "magnet and coil" electric actuator with the electric motor 9532. Similar to Figures 9C to 9K In the illustrated configuration, the vent 9510 may include a base portion 9516, a shell (or cover portion) 9518, and a movable member (or disc or movable portion) 9520. The base portion 9516 may secure the vent 9510 to the seal-forming structure 3100, while the shell 9518 may surround the movable member 9520. In addition, the base portion 9516 may be connected to the shell 9518 by one or more bridging portions. The one or more bridging portions (or spacers) may maintain a gap (or variable conduit) 9524 between the base portion 9516 and the shell 9518. It is contemplated that the one or more bridging portions (or spacers) may be incompressible. In addition, although not shown, the configuration may also include a configuration similar to Figures 9C to 9K Biasing mechanism of the illustrated configuration.

[0596] The motor 9532 can be attached to the center of the movable member 9520 on the side opposite the gap 9524. Alternatively, the motor 9532 can be attached to the movable member 9520 at a location that is radially offset from the center of the movable member 9520.

[0597] The motor 9532 can include a shaft 9534 connected to a linear actuator 9536. The shaft 9534 can be the portion of the motor 9532 that is attached to the movable member 9520, while the linear actuator 9536 can be fixed to an outer surface of the housing 9518. Thus, the shaft 9534 can extend through the housing 9518.

[0598] When the motor 9532 is actuated, the linear actuator 9536 can rotate, which in turn can cause the shaft 9534 to rotate. The outer surface of the shaft 9534 can be threaded so that the rotational movement of the shaft 9534 can cause the shaft 9534 to move linearly into and out of the housing 9518. Such linear movement can cause the movable member 9520 to move toward and away from the base portion 9516, thereby causing the gap 9524 to narrow and widen accordingly. Furthermore, the movement of the shaft 9534 can be performed in discrete steps, or can be continuous.

[0599] Similar to other configurations, the motor 9532 can be connected to the controller 9512. Furthermore, it is contemplated that the vent 9510 can be operated in two modes. In a passive mode, the movable member can be allowed to move in response to the flow of gas flush flowing through the gap 9524, such that the vent self-regulates the flow of gas flush discharged through the vent 9510. In an actuated mode, the controller 9512 can override the self-regulation of the vent 9510 by applying current to the motor 9532 to position the movable member 9520 in a specific position.

[0600] It should be understood that the vent 9510 can alleviate CO2 flushing as a secondary goal of flow control. For example, a CO2 sensor can be used to establish a feedback loop with the vent actuator and effectively actuate the vent 9510 when the CO2 in the patient interface is too high or too low. In the event that the CO2 level in the patient interface is too high, the vent 9510 can increase the width of the gap 9524 between the movable member 9520 and the base portion 9516 to increase ventilation and flush out excess CO2. This can alleviate the "stuffy" feeling of the mask and improve the patient's breathing comfort. If the CO2 level is too low, indicating that hyperventilation is occurring, the width of the gap 9524 can be reduced to retain CO2.

[0601] In addition, when the controller detects an increase in the flow of gas inside the patient interface 3000, which is identified as an unintentional leak at the mask, the controller 9512 can reduce the width of the gap 9524 to reduce the ventilation flow. By reducing the ventilation flow, in addition to the excess ventilation flow, excessive CO2 flushing can also be reduced because the leak at the patient interface 3000 can compensate for the ventilation flow.

[0602] 10A to 10D Various configurations of an exemplary flow regulating vent 9700 including a pneumatic actuation mechanism are illustrated. Similar to the passively actuated and electrically actuated configurations of the flow regulating vent, the flow regulating vent 9700 can include a base portion 9710, a housing (or cover portion) 9712, a movable member (or disc or movable portion) 9714, and a sealing member 9716. The base portion 9710 can secure the vent 9700 to the seal-forming structure 3100, while the housing 9712 can enclose the movable member 9714 and the sealing member 9716. In addition, the base portion 9710 can be connected to the housing 9712 via one or more bridging portions. The one or more bridging portions (or spacers) can maintain a gap (or variable conduit) 9718 between the base portion 9710 and the housing 9712. It is contemplated that the one or more bridging portions (or spacers) can be incompressible.

[0603] The shape of the perimeter of the base portion 9710 (e.g., the footprint of the base portion 9710) can be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100. For example, if the vent opening is circular, the perimeter of the base portion 9710 can also be circular. Alternatively, the perimeter of the base portion 9710 can be rectangular, square, triangular, oval, hexagonal, or any other shape that can secure the vent 9700 to the seal-forming structure 3100.

[0604] The base portion 9710 may include a pair of flanges that together form a channel. These flanges may extend radially outward from the circumferential wall of the base portion 9710 so that the channel opens radially outward. In addition, the channel may accommodate the edge of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. In order to secure the edge of the vent opening 3402-1 (or 3402-2) within the channel, the diameter of these flanges may be larger than the diameter of the vent opening 3402-1 (or 3402-2).

[0605] It is contemplated that for configurations in which the vent 9700 is permanently attached to the seal-forming structure 3100, the base may be an integral part of the plenum wall of the seal-forming structure 3100. In such configurations, the flanges and channels may be replaced with the edges of the vent opening 3402-1 or 3402-2.

[0606] The base portion 9710 may have an inlet side and an outlet side. The inlet side of the base portion 9710 may include an inlet opening that receives a gas flush from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100. The inlet opening may be defined by a circumferential wall such that the diameter of the inlet opening is the same size as the diameter of the base portion at the circumferential wall. Alternatively, the diameter of the inlet opening may be smaller than the diameter of the base portion at the circumferential wall.

[0607] The outlet side of the base portion 9710 may include a central wall having a central opening. The central wall may extend radially outward from the central portion of the base to the circumferential wall. Furthermore, the central wall may form one of the walls of the gap 9718. Unlike the movable member 9714, the central wall may be fixed.

[0608] The intermediate opening can be located in a central region of the intermediate wall (and / or a central region of the gap 9718) and can be positioned to allow gas to flush out of the base portion 9710 and into the gap 9718. The intermediate opening can be smaller than or equal to the size of the inlet opening. It is contemplated that the size (e.g., diameter) of the intermediate opening and / or the inlet opening can be fixed or adjustable.

[0609] A flush of gas from the plenum 3200 can enter the base portion 9710 in a direction parallel to the central axis of the vent 9700. Upon exiting the base portion 9710 through the intermediate opening, the flush of gas can enter the gap 9718. Upon entering the gap 9718, the flush of gas can be deflected by the movable member 9714 to change direction so that the flush of gas flows in a radially outward direction through the gap 9718. Thus, the flush of gas changes direction as it flows through the vent 9700 from an axial direction (i.e., a direction parallel to the central axis α of the vent 9700) to a radially outward direction (i.e., a direction radially outward from the central axis α of the vent 9700). The gap 9718 provides an outlet conduit for the flush of gas, such that the flush of gas exits the vent 9700 through the gap 9718 and out the circumferential side (or periphery) of the vent 9800.

[0610] The movable member 9714 can form another wall of the gap 9718 and can be opposite to the middle wall. In addition, the movable member 9714 can be movable in the axial direction (i.e., a direction parallel to the central axis of the vent 9700) so that movement of the movable member 9714 can reduce or increase the width of the gap 9718, which narrows or widens the flow path of the gas flush as it leaves the vent 9700. Thus, the gap 9718 acts as a variable conduit. The movable member 9714 can take the form of a disc or any other shape with a width (in the radial direction) significantly greater than its thickness (in the axial direction). In addition, the movable member 9714 can be larger than the middle opening and can extend to the periphery of the housing 9714 and / or the periphery of the vent 9700.

[0611] The movable member 9700 can be biased by the sealing member 9716 toward a position that provides the minimum width of the gap 9718. In other words, the sealing member 9716 can generate a biasing force on the movable member 9714 toward the middle wall. The movable member 9714 can be attached to the sealing member 9716 at a central position on the movable member 9714 or at any other position on the movable member 9714. The sealing member 9716 can take the form of a spring or any type of damping device. It is also contemplated that the sealing member 9716 may not provide a biasing force on the movable member 9716. In addition, the vent 9700 may include a biasing member that is different from the sealing member 9716.

[0612] Additionally, the sealing member 9716 can take the form of a flexible bladder and can be secured to the inner edge of the housing 9712. The engagement between the sealing member 9716 and the housing 9712 can form a seal that is impermeable to airflow. It is contemplated that the inside of the housing 9712 can have a protrusion or ridge 9720 to which the outer periphery of the sealing member 9716 can be attached.

[0613] The surface of the housing 9712 can be continuous only within one opening or pressure port 9722. Because the sealing member 9716 is sealingly attached to the housing 9712, the housing 9712 and the sealing member 9716 form a pneumatically sealed chamber 9724 on one side of the sealing member 9716 that is pneumatically isolated from the movable member 9714. Gas can only enter and exit the chamber 9724 through the pressure port 9722. In addition, a hose 9726 can be attached to the pressure port 9722. The hose can deliver pressurized gas to the chamber 9724 through the pressure port 9722 to increase or decrease the gas pressure in the chamber 9724. It is contemplated that the chamber 9724 can have a separate outlet port having a valve or other mechanism to maintain pressure in the chamber 9724.

[0614] The gas pressure in chamber 9724 can be used to control the movement of movable member 9714, which in turn controls the width of gap 9718 to control the flow of gas flush through vent 9700. Specifically, increased gas pressure in chamber 9724 can overcome the biasing force of sealing member 9716 to move sealing member 9716 toward base portion 9710 and narrow gap 9718. Additionally, decreased gas pressure in chamber 9724 can move sealing member 9716 away from base portion 9710 and widen gap 9718.

[0615] The diameter of movable member 9714 can be in the range of 15 to 30 mm (e.g., 17, 20 or 27 mm). In addition, the movement of movable member 9714 can be limited to change the width of gap 9718 in the range of 0.5 to 1.5 mm (e.g., the gap can be 0.5, 1, 1.2 or 1.5 mm). The inner diameter of pressure port 9722 can be in the range of 3.5 to 6.5 mm (e.g., 3.5, 5, 5.5 or 6 mm). Therefore, the inner diameter of hose 9726 can be slightly larger or slightly smaller to allow hose 9726 to be attached to pressure port 9722. In addition, the hardness of sealing member 9716 can be 40 to 50 hardness (e.g., 40 or 50 hardness). In addition, the inlet opening of gap 9718 can have a diameter between 3.5 and 6.5 mm.

[0616] It has been found that a pressure port larger than 6.5 mm can produce greater flow rate changes. It has also been found that a laminar flow of 20 L / min at 20 cmH2O can be achieved with the following combination: a movable member 9714 with a diameter of 20 mm, a sealing member 9716 with a durometer of 40, a pressure port 9722 with a diameter of 5 mm, and a gap width of 1 mm.

[0617] The hose 9726 can be attached to the air circuit 4170 at a location downstream of the outlet of the RPT device 4000. Alternatively, the hose 9726 can be connected to a port in the patient interface 3000. In both configurations, the pressure in the chamber 9724 can be regulated based on the pressure in the air circuit 4170 or the patient interface 3000.

[0618] It is contemplated that the hose 9726 may include a valve to further control the pressure in the chamber 9724. It is also contemplated that the hose 9726 may be connected to a pump (e.g., a piezoelectric pump). The piezoelectric pump may be attached to the RPT device 4000, the air circuit 4170 downstream of the RPT device 4000, or the patient interface 3000. The valve and / or the pump may be connected to the controller 9512, which in turn may regulate the operation of the pump and / or the valve to control the pressure in the chamber 9724.

[0619] It is contemplated that the vent 9700 can be permitted to operate in a similar manner to the vents 7010, 8000, 9000, and 9510. That is, the movable member 9714 can be permitted to move in response to the flow rate of the gas flush flowing through the gap 9718, such that the vent 9700 self-regulates the flow rate of the gas flush exhausted through the vent 9700. The controller 9512 can be configured to override the self-regulation of the vent 9700 by controlling the pump and / or valve to adjust the pressure in the chamber 9724 to offset the pressure of the gas flush flowing through the gap 9718.

[0620] For example, the vent 9700 can be allowed to regulate the flow of gas flushing through the vent 9700 without intervention by the controller 9512 until the controller 9512 determines that the pressure, flow, or CO2 level in the patient interface 3000 is at an undesirable level. The controller 9512 can then actuate the pump and / or valve to regulate the pressure in the chamber 9724 and actuate the movable member 9714 toward the base portion 9710, thereby narrowing the gap 9718 and increasing the flow of the gas flushing vent (or moving the movable member 9714 away from the base portion 9710, thereby decreasing the flow of the gas flushing vent). In other words, the controller 9512 can work in conjunction with the gas flushing flowing through the vent 9700 to provide hybrid control over the flow of gas flushing through the vent 9700.

[0621] Alternatively, the controller 9700 may operate the pump and / or valve at all times and may vary the magnitude of the pressure in the chamber 9724 in response to conditions within the patient interface 3000. In this configuration, the controller 9512 may control the movable member 9714 such that the pressure of the gas flush flowing through the gap 9718 does not affect the position of the movable member 9714. Only the magnitude of the pressure generated by the pump and / or valve will affect the position of the movable member 9714.

[0622] 4.3.5 Decoupling Structure

[0623] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0624] 4.3.6 Connection Port

[0625] The connection port 3600 allows connection to the air circuit 4170 .

[0626] 4.3.7 Forehead support

[0627] In one form, the patient interface 3000 includes a forehead support 3700 .

[0628] 4.3.8 Anti-suffocation valve

[0629] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0630] 4.3.9 Ports

[0631] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0632] 4.3.10 Modularity

[0633] As described above, the cushions, headgear, and sleeves can come in different styles, which can correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). The patient or clinician can select certain combinations of cushions, headgear, and sleeves to optimize the effectiveness of the therapy and / or comfort for the individual patient.

[0634] In some embodiments, different styles of cushions, headgear, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be beneficial from a manufacturing perspective because fewer components can be used to create a wider variety of patient interfaces. Additionally or alternatively, the various combinations can allow the patient to change the style of the patient interface without changing every component.

[0635] Air can be delivered to the patient in one of two main ways. In one example, the patient can be delivered to the patient through a head cannula 3350 (see, e.g., Figure 3Y ) receives the pressurized air flow. This may be referred to as an "up tube" configuration, and the connection port may be positioned at the top of the patient's head. In other examples, the patient may be connected to the plenum 3200 via a conduit (e.g., via the connection port 3600 (see, e.g., FIG. Figure 3A )) receives the pressurized air flow. This may be referred to as a "down tube" configuration, where the airflow conduit is positioned in front of the patient's face. Different patients may be more comfortable with one style of air delivery than another (e.g., due to the patient's sleeping pattern). Therefore, it may be beneficial to allow a single type of patient interface to be used in either an "up tube" or "down tube" configuration.

[0636] The patient interface may be part of a modular assembly having various interchangeable components that the patient and / or clinician may swap out for one or more components of a different type.The following description describes various combinations that may be created by assembling different components together.

[0637] 4.3.10.1 Sleeve

[0638] In some forms, to allow for modularity, a sleeve may be used with the tube 3350 and / or the hardener arm 3340. The sleeve may at least partially surround the tube 3350 and / or the hardener arm 3340. Figures 6G to 6I As shown, sleeves of different shapes can be used, which can correspond to different types of positioning and stabilizing structures 3300. In some forms, the configuration of the sleeve can be customized to fit the face of a specific user. For example, the sleeve can be constructed in a relatively more posterior area of the patient's head.

[0639] In some forms, the sleeve can be made of a comfortable material. For example, the sleeve can be made of a textile material, a foam material, or a combination of the two. The comfortable material can contact the patient during use and can feel soft against the patient's skin to improve patient compliance.

[0640] The material can also be flexible to facilitate donning and doffing the sleeve from the tube 3350 or stiffener arm 3340. For example, the material can allow the sleeve to bend to conform to the shape of the catheter tip 6319 or stiffener arm 3340, which can vary depending on the shape of an individual patient's head.

[0641] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or the hardener arm 3340. The elastic material can then return to an initial position where it fits snugly against the tube 3350 or the hardener arm 3340 to restrict the sleeve from sliding during use.

[0642] As described in more detail below, some forms of sleeves may be specific to a rigidizing element (e.g., tube 3350 and / or stiffener arm 3340). However, a sleeve may help the rigidizing element be interchangeably connected to different versions or styles of cushions (e.g., mouth and nose cushion 3050-1, nose only cushion 3050-2, etc.).

[0643] 4.3.10.1.1 Catheter sleeve

[0644] like Figure 6G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the tube 3350 described above.

[0645] like Figure 6G As shown, the catheter sleeve 3351 may include a Figure 6C The curved shape shown is a reflection of the shape of the tube 3350. The flexible material used to construct the catheter sleeve 3351 can allow the catheter sleeve 3351 to bend further to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0646] In some forms, the catheter sleeve 3351 can include a first or upper opening 3352. The upper opening 3352 can be disposed at one end of the catheter sleeve 3351. The upper opening 3352 can be the opening of a passage extending along at least a portion of the catheter sleeve 3351.

[0647] like Figure 6G As shown, some versions of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 may be customized to fit the face of a specific user. For example, the lower extension 6354 of the catheter sleeve 6350 may be configured to fit relatively more posteriorly or more anteriorly on the patient's head.

[0648] Some versions of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the sleeve 3351). The rigid or semi-rigid member may be constructed of a plastic material or similar material. Alternatively, the lower extension 3354 may be reinforced using manufacturing techniques (e.g., stitching stiffened thread, flat knitting, using thicker material).

[0649] like Figure 6GAs shown, some versions of the lower extension 3354 can include a connecting member 3356. In the illustrated example, the connecting member 3356 can be a magnet, although in other examples, the connecting member 3356 can be a different type of connector (e.g., a mechanical fastener, an adhesive, a hook and loop material, etc.). The connecting member 3356 can also be located at one end of the lower extension 3354, although the connecting member 3356 can alternatively be located anywhere along the lower extension 3354.

[0650] In some forms, a connection member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (see, e.g., FIG. 7J ), the magnet 3370-1 connected to the lower strap 3304-1 can be removably connected to the connection member 3356 to provide tension.

[0651] 4.3.10.1.2 Four-point arm sleeve

[0652] like Figure 6H As shown, another example of a sleeve is a four point arm sleeve 3380, which can be used with the hardener arm 3340 described above.

[0653] like Figure 6H As shown, the four-point arm sleeve 3380 may include a Figure 6D The curved shape shown is a representation of the shape of the rigidifier arm 3340. The flexible material used to construct the four-point arm sleeve 3380 can allow the four-point arm sleeve 3380 to bend further to correspond to the shape of the rigidifier arm 3340 (e.g., when worn by a patient and / or bent by the patient).

[0654] like Figure 6H As shown, some versions of the four-point arm sleeve 3380 can include a lower extension 3384. The lower extension 3384 can be positioned at one end of the four-point arm sleeve 3380.

[0655] In the illustrated example, the shape and / or structure of lower extension 3384 is substantially the same as the shape of lower extension 3354. For example, lower extension 3384 may be more rigid than the remainder of four-point arm sleeve 3380 (e.g., due to stiffening the wire or rigid material).

[0656] like Figure 6HAs shown, some versions of the lower extension 3384 can include a connecting member 3386. In the illustrated example, the connecting member 3386 can be a magnet, although in other examples, the connecting member 3386 can be a different type of connector (e.g., a mechanical fastener, an adhesive, a hook and loop material, etc.). The connecting member 3386 can also be located at one end of the lower extension 3384, although the connecting member 3386 can alternatively be located anywhere along the lower extension 3384.

[0657] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (see, e.g., Figure 6K ), the magnet 3370 connected to the lower band 3304-1 can be removably connected to the connecting member 3386 to provide tension.

[0658] like Figure 6H As shown, the four-point arm sleeve 3380 can include a pair of tabs 3394 that can be similar to the tabs 3320 on the tube 3350. When the four-point arm sleeve 3380 is worn by a patient, the tabs 3394 can be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0659] 4.3.10.1.3 Two-point arm sleeve

[0660] like Figure 6I As shown, yet another example of a sleeve is a two point arm sleeve 3380-1, which can be used with the hardener arm 3340 described above.

[0661] In some forms, the two-point arm sleeve 3380-1 may be similar to the above-described four-point arm sleeve 3380. Only some of the similarities and differences are described below.

[0662] like Figure 6I As shown, the two-point arm sleeve 3380-1 can include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 can form an opening for a passage through the two-point arm sleeve 3380-1. In the illustrated example, the lower opening 3388-1 can open to a surface of the catheter sleeve 3380-1.

[0663] like Figure 6IAs shown, the two-point arm sleeve 3380-1 can include a pair of tabs 3394-1 that can be similar to the tabs 3320 on the catheter tip 6319. When the two-point arm sleeve 3380-1 is worn by a patient, the tabs 3394-1 can be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0664] 4.3.10.2 Assembled patient interface

[0665] like Figures 6J to 6M As illustrated, the various elements described above can be combined into four different patient interfaces. The different patient interfaces can allow patients to use different styles based on their respective comfort levels. The modularity of the different elements (e.g., the ability to use multiple styles of patient interfaces) can simplify manufacturing and / or can allow patients to more easily switch between multiple styles of patient interfaces.

[0666] 4.3.10.2.1 Nose and mouth mask tube configuration

[0667] like Figure 6J As illustrated, a patient may wear the cushion 3050-1 in an over-the-tube configuration with the tube 3350 and the four-point headgear 3302-1. This assembly may form an over-the-tube nose and mouth patient interface 3000-1.

[0668] In some embodiments, a catheter sleeve can be used with the tube 3350 to enable the patient to experience an "over-the-tube" air delivery method through the mouth and nose cushion 3050-1. As described below, the catheter sleeve provides an additional connection location for connecting to the four-point headgear 3302-1. However, other forms of connectors besides or in addition to the catheter sleeve can be used.

[0669] In the illustrated example, the catheter sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the catheter connection structure 3500) can be used to connect the tube 3350 to the liner 3050-1. The catheter sleeve provides a magnet for connecting to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example, Figure 6E ). Alternatively, a different connection form may be used.

[0670] like Figure 6J As illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension to maintain the cushion 3050-1 in a sealing position on the patient's head.

[0671] For example, the lower strap 3304-1 can be removably connected to the magnet of the catheter sleeve (e.g., via magnetic member 3306-1). In use, each lower strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend below the patient's ear.

[0672] 4.3.10.2.2 Configuration of nose and mouth mask tubes

[0673] like Figure 6K As illustrated, a patient may wear the cushion 3050-1 in a downtube configuration with the stiffener arms 3340 and the four-point headgear 3302-1. This assembly may form a downtube nose and mouth patient interface 3000-2.

[0674] In some embodiments, a catheter sleeve can be used with the stiffener arm 3340 to enable the patient to experience a "down the tube" air delivery method through the mouth and nose cushion 3050-1. As described below, the catheter sleeve provides an additional connection location for connecting to the four-point headgear 3302-1. However, other forms of connectors besides or in addition to the catheter sleeve can be used.

[0675] In the illustrated example, the catheter sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 can be used to connect the hardener arm 3340 to the liner 3050-1 (via the catheter connection structure 3504). The catheter sleeve provides a magnet for connecting to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example Figure 6E ). Alternatively, a different connection form may be used.

[0676] like Figure 6K As illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension to maintain the cushion 3050-1 in a sealing position on the patient's head.

[0677] For example, the lower strap 3304-1 can be removably connected to the magnet of the catheter sleeve (e.g., via magnetic member 3306-1). In use, each lower strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend below the patient's ear.

[0678] 4.3.10.2.3 Nasal mask upper tube configuration

[0679] like Figure 6L As illustrated, a patient can wear the cushion 3050-2 in an over-the-tube configuration with the tube 3350 and the two-point headgear 3302-2. This assembly can form an over-the-tube, nasal-only patient interface 3000-3.

[0680] A catheter sleeve can be used with the tube 3350 and can provide additional comfort for the patient. The sleeve can connect the positioning and stabilizing structure 3300 to the cushion 3050-2 without adding additional connection points. In the illustrated example, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0681] like Figure 6L As illustrated, a two-point headgear 3302-2 can be connected to tabs 3320 on the tube 3350 to provide tension to maintain the cushion 3050-2 in a sealing position on the patient's head.

[0682] 4.3.10.2.4 Nasal mask lower tube configuration

[0683] like Figure 6M As illustrated, a patient can wear the cushion 3050-2 in an over-tube configuration with the stiffener arms 3340 and the two-point headgear 3302-2. This assembly can form a down-tube nasal-only patient interface 3000-4.

[0684] The catheter sleeve can be used with the stiffener arm 3340 and can provide additional comfort for the patient. The sleeve can not add additional connection points to connect the positioning and stabilizing structure 3300 to the liner 3050-2. In the illustrated example, the stiffener arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0685] like Figure 6M As illustrated, a two-point headgear 3302-2 can be connected to tabs 3320 on the sleeve to provide tension to maintain the cushion 3050-2 in a sealing position on the patient's head.

[0686] 4.3.10.2.5 Component modularity

[0687] Figure 6P This diagram illustrates how different components can be combined to form the four different patient interfaces described above. As illustrated, different components can be reused for different patient interface styles. This can make manufacturing and assembly easier, as large quantities of the same components can be produced and used across a variety of styles. The only component that might not be used across multiple styles is the sleeve. However, the sleeve can be easier to manufacture.

[0688] 4.4RPT device

[0689] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate a flow of air for delivery to the airway of a patient, such as for treating one or more of the respiratory conditions described elsewhere in this document.

[0690] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0691] The RPT device 4000 can have an outer housing 4010 formed from two parts: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 can include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0692] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0693] One or more of the air path items may be located within a removable unitary structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0694] like Figure 4C As shown, the RPT device 4000 can have a power source 4210 , one or more input devices 4220 , a central controller 4230 , a pressure generator 4140 , and one or more output devices 4290 .

[0695] 4.4.1 Mechanical and pneumatic components of the RPT device

[0696] The RPT device may include one or more of the following components in an integral unit. In the alternative, one or more of the following components may be located as respective separate units.

[0697] 4.4.1.1 Air filter

[0698] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0699] exist Figure 4B In one illustrated form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0700] exist Figure 4B In one illustrated form, an outlet air filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800 .

[0701] 4.4.1.2 Silencer

[0702] An RPT device according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120 .

[0703] In one form of the present technology (see e.g. Figure 4B ), the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0704] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800 .

[0705] 4.4.1.3 Pressure generator

[0706] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower may be capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when performing respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0707] The pressure generator 4140 may be under the control of the therapy device controller 4240 .

[0708] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0709] 4.4.1.4 Transducer

[0710] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit (e.g., a patient interface). The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0711] In one form of the present technology (see e.g. Figure 4B ), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 can be constructed and arranged to generate a signal representative of a characteristic of the air flow, such as flow, pressure, or temperature at that point in the pneumatic path.

[0712] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800 .

[0713] In one form, the signal from the transducer 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0714] 4.4.1.5 Anti-overflow valve

[0715] like Figure 4B As shown, in one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0716] 4.4.2 RPT device electrical components

[0717] 4.4.2.1 Power supply

[0718] The power source 4210 may be located inside or outside the outer housing 4010 of the RPT device 4000 .

[0719] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0720] like Figure 4CAs illustrated, power supply 4210 can provide power to input device 4220, central controller 4230, output device 4290, and pressure generator 4140. Power supply 4210 can also provide power to other components of RPT device 4000 (or humidifier 5000, as described above).

[0721] 4.4.2.2 Input device

[0722] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may communicate wirelessly with a receiver that is electrically connected to a central controller 4230.

[0723] In one form, input device 4220 may be constructed and arranged to allow a person to select values and / or menu options.

[0724] 4.4.2.3 Central Controller

[0725] In one form of the present technology, the central controller 4230 is a processor or multiple processors adapted to control the RPT device 4000. The central controller 4230 is shown in Figure C.

[0726] Suitable processors may include x86 Intel processors, processors based on In some alternative forms of the present technology, a 32-bit RISC CPU, such as the STR9 series microcontroller from STMicroelectronics, or a 16-bit RISC CPU, such as the MSP430 family of microcontrollers manufactured by Texas Instruments, may also be suitable.

[0727] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0728] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0729] The central controller 4230 may be configured to receive input signals from one or more transducers 4270 , one or more input devices 4220 , and / or the humidifier 5000 .

[0730] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290 , the pressure generator 4140 , the therapy device controller, the data communication interface, and / or the humidifier 5000 .

[0731] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that may be implemented with processor control instructions represented as a computer program stored in a non-transitory computer-readable storage medium. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine control settings for the ventilator or detect a respiratory-related event by analyzing stored data, such as from any of the sensors described herein.

[0732] 4.4.3RPT device algorithm

[0733] As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms represented as computer programs stored in a non-transitory computer-readable storage medium. Algorithms are typically grouped into groups called modules.

[0734] In other forms of the present technology, some or all of the algorithm may be implemented by a controller of an external device, such as a local external device or a remote external device. In such forms, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm executed at the external device may be transmitted to the external device via a local external communication network or a remote external communication network. In such forms, the portion of the algorithm to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute the portion of the algorithm.

[0735] 4.4.3.1.1 Ventilation Flow Estimation

[0736] In one form of the present technology, a ventilation flow estimation algorithm receives as input the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm, and estimates the ventilation flow Qv of air from the vent 3400 in the patient interface 3000 or 3800. For the particular vent 3400 in use, the dependence of the ventilation flow Qv on the interface pressure Pm can be modeled by the ventilation characteristic Qv(Pm).

[0737] 4.4.3.1.2 Determination of ventilation volume

[0738] In one form of the present technology, a ventilation determination algorithm 4323 receives an input of respiratory flow Qr and determines a measure indicative of current patient ventilation Vent.

[0739] In some embodiments, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is an estimate of actual patient ventilation. One such embodiment is to take half the absolute value of the respiratory flow Qr, which is optionally filtered by a low pass filter such as a second order Bessel low pass filter with a corner frequency of 0.11 Hz.

[0740] In other embodiments, ventilation determination algorithm 4323 determines a measure of ventilation Vent that is approximately proportional to actual patient ventilation. One such embodiment estimates peak respiratory flow Qpeak over the inspiratory portion of the cycle. If the flow waveform shape does not vary much (here, two breaths are considered similar in shape when their flow waveforms normalized in time and amplitude are similar), this procedure and many other procedures involving sampling respiratory flow Qr produce a measurement that is approximately proportional to ventilation. Some simple examples include the median of positive respiratory flow, the median of absolute respiratory flow, and the standard deviation of flow. Any linear combination of any order statistics of absolute respiratory flow using positive coefficients, or even some linear combination of any order statistics of absolute respiratory flow using both positive and negative coefficients, is approximately proportional to ventilation. Another example is the average of respiratory flow over K proportions (by time) of the middle of the inspiratory portion, where 0<K<1. If the flow shape is constant, there are an arbitrarily large number of measurements that are exactly proportional to ventilation.

[0741] 4.4.3.1.3 Determination of target ventilation

[0742] In one form of the present technology, the central controller 4230 takes as input a measurement of current ventilation Vent and executes one or more target ventilation determination algorithms for determining a target value Vtgt for the measurement of ventilation.

[0743] In some forms of the present technology, there is no target ventilation determination algorithm, and the target value Vtgt is predetermined, for example, by hard coding during construction of the RPT device 4000 or by manual entry via input device 4220.

[0744] In other forms of the present technology, such as adaptive servo-ventilation (ASV), a target ventilation determination algorithm calculates a target value Vtgt based on a value Vtyp indicative of the patient's typical recent ventilation.

[0745] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high fraction of the typical recent ventilation Vtyp, but less than the typical recent ventilation. The high fraction in such forms can be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0746] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as an integer multiple slightly larger than the typical recent ventilation Vtyp.

[0747] The typical recent ventilation Vtyp is the value at which the distribution of the current ventilation measurements Vent at multiple moments in time tends to converge on some predetermined time scale, that is, a measure of the central tendency of the current ventilation measurements in the recent history. In one specific implementation of the target ventilation determination algorithm, the recent history is on the order of minutes, but in any case should be longer than the time scale of the Cheyne-Stokes rise and fall cycle. The target ventilation determination algorithm can use any of a variety of known measures of central tendency to determine the typical recent ventilation Vtyp based on the current ventilation measurements Vent. One such measure is the output of a low-pass filter on the current ventilation measurements Vent, where the time constant is equal to one hundred seconds.

[0748] 4.5 Air circuit

[0749] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000 or 3800, in use.

[0750] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. This air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches of the circuit for inhalation and exhalation. In other cases, a single branch is used.

[0751] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0752] 4.6 Humidifier

[0753] 4.6.1 Humidifier Overview

[0754] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0755] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0756] 4.7 Glossary

[0757] For purposes of this technology disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0758] 4.7.1 General terms

[0759] Air: in some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.

[0760] Environment: In certain forms of the present technology, the term environment is taken to mean (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0761] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room where the patient sleeps. Such ambient humidity can be different from the humidity outside the room where the patient sleeps.

[0762] In another example, ambient pressure may be the pressure immediately adjacent to or external to the body.

[0763] In some forms, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, rather than, for example, noise generated by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0764] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the treatment pressure is automatically adjusted (eg, varies with each breath) between a minimum and a maximum limit, depending on whether there is an indication of an SDB event.

[0765] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, this pressure will vary between different respiratory cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0766] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, references to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, references to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate can be given using the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow rate" or "airflow."

[0767] In the example of a patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow 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 gas that reaches the patient interface via the air circuit. The ventilation flow rate, Qv, is the flow rate of air leaving the vent to allow for flushing of exhaled gases. The leakage flow rate, Ql, is the flow rate that leaks from the patient interface system or elsewhere. The respiratory flow rate, Qr, is the flow rate of air received into the patient's respiratory system.

[0768] Flow therapy: Respiratory therapy that involves delivering air flow to the airway entrance at a controlled flow rate, called a therapy flow, which is generally positive throughout the patient's respiratory cycle.

[0769] Humidifier: The term humidifier will be deemed to mean a humidifying device that is constructed and arranged or physically configured to provide a therapeutically beneficial amount of water (H2O) vapor to an air flow to alleviate a patient's medical respiratory condition.

[0770] Leak: The term leak is considered to be an unintended flow of air. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow leading to the environment.

[0771] Conducted noise (acoustics): Conducted noise in this document refers to the noise transmitted to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0772] Radiated noise (acoustics): Radiated noise in this document is the noise transmitted to the patient by the ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0773] Vent Noise (Acoustics): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent hole of a patient interface.

[0774] Oxygen-enriched air: air having an oxygen concentration greater than that of atmospheric air (21%), e.g., at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated to "oxygen."

[0775] Medical oxygen: Medical oxygen is defined as enriched air with an oxygen concentration of 80% or greater.

[0776] Patient: A person, whether or not they have a respiratory condition.

[0777] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 And it is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m 2 =1 mbar to 0.001 atm). In this specification, pressure is given in cmH2O unless otherwise specified.

[0778] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.

[0779] Respiratory pressure therapy: The application of a supply of air to the entrance of the airways at a therapeutic pressure that is usually positive relative to atmosphere.

[0780] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0781] 4.7.1.1 Materials and their properties

[0782] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on standardized sample dimensions). May refer to durometer or indentation hardness, which is a material property measured by indentation with an indenter (e.g., measured according to ASTM D2240).

[0783] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0784] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not deform easily under finger pressure, for example.

[0785] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR 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 using ASTM D2240.

[0786] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0787] 4.7.1.2 Mechanics

[0788] axis:

[0789] a. Neutral axis: The axis in the cross section of a beam or plate about which there is no longitudinal stress or strain.

[0790] b. Longitudinal Axis: The axis that runs along the length of a shape. This axis usually passes through the center of the shape.

[0791] c. Circumferential axis: An axis oriented perpendicularly relative to the longitudinal axis. This axis may be present in particular in pipes, tubes, cylinders or similar shapes with a circular and / or elliptical cross section.

[0792] d. Radial axis

[0793] Deformation: The process by which a component changes its original geometric shape when subjected to a force (e.g., a force in a direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0794] Elasticity: The ability of a material to return to its original geometry after deformation.

[0795] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, such as 1 second.

[0796] Resilience: The ability of a material to absorb energy during elastic deformation and release that energy when unloaded.

[0797] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0798] Rigid structure or component: A structure or component that will not substantially change shape when subjected to loads typically encountered in use. An example of such use might be placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway, for example, under a load of a pressure of approximately 20 to 30 cmH2O.

[0799] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction.In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0800] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions. The antonym of stiffness is flexibility.

[0801] Viscosity: A material's resistance to flow.

[0802] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0803] Yielding: The condition when a material no longer returns to its original geometry after being deformed.

[0804] 4.7.1.3 Structural elements

[0805] Compression Member: A structural element that resists compressive forces.

[0806] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater 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 some forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap connection. In some forms, the elbow may be assembled to the mating component via a disposable snap during manufacturing, but may not be removed by the patient.

[0807] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame can be a non-airtight, load-bearing structure in a mask. However, some forms of mask frames can also be airtight.

[0808] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0809] Lace (noun): A structure designed to resist tension.

[0810] Thin structure:

[0811] e. Liang,

[0812] i. The beam can be relatively long in one dimension compared to the other two dimensions, making the smaller dimension relatively thin compared to the long dimension.

[0813] f. membrane,

[0814] i. Relatively long in two dimensions and relatively thin in one dimension. Deforms readily in response to bending forces. Resists stretching (and possibly compression).

[0815] g. board,

[0816] i. They can be relatively long in two dimensions and relatively thin in one dimension. They can have bending, tensile and / or compressive stiffness.

[0817] Thick structure: solid

[0818] Seal: can be a noun referring to a structure ("seal") or a verb referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve a "seal" therebetween without requiring a separate "seal" element itself.

[0819] Shell: Shell will be understood to mean a curved, relatively thin structure that has flexural, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0820] Reinforcement: Reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0821] Strut: A strut will be considered a structural component designed to increase the compression resistance of another component in at least one direction.

[0822] 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 of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. In use, little or no air flow leaks from the swivel.

[0823] 4.7.2 Respiratory Cycle

[0824] Apnea: According to some definitions, apnea is considered to have occurred when flow drops below a predetermined threshold for a period of time (e.g., 10 seconds). Obstructive apnea is considered to have occurred when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to have occurred when apnea is detected due to reduced or absent breathing effort despite a patent airway. Mixed apnea is considered to have occurred when reduced or absent breathing effort occurs simultaneously with an obstructed airway.

[0825] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0826] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0827] Effort (of breathing): The work done by a spontaneously breathing person to try to breathe.

[0828] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0829] Flow Limitation: Flow limitation is considered a state in a patient's breathing in which an increase in patient effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0830] Types of flow-limited inspiratory waveforms:

[0831] (i) Flat top: It rises first, followed by a relatively flat part, and then falls.

[0832] (ii) M-shaped: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0833] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0834] (iv) Inverse chair shape: has a relatively flat portion followed by a single local peak at the trailing edge.

[0835] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than an interruption in flow. In one form, hypopnea is considered to occur when flow decreases below a threshold rate for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0836] (i) The patient experiences a 30% decrease in respiration lasting at least 10 seconds, with an associated 4% desaturation; or

[0837] (ii) The patient's breathing is reduced (but less than 50%) for at least 10 seconds, with associated desaturations or arousals of at least 3%.

[0838] Hyperpnea: Increased air flow to a higher than normal level.

[0839] Inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow will be considered the inspiratory portion of the respiratory cycle.

[0840] Patency (airway): The degree of openness of the airway or the extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, with a value of (1) being open and a value of zero (0) being closed (obstructed).

[0841] Positive End-Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0842] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0843] Respiratory flow, patient airflow, respiratory airflow (Qr): These terms should be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0844] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, such as an average.

[0845] Inspiratory time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0846] Exhalation time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0847] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0848] Typical Recent Ventilation: The ventilation value around which recent values of ventilation Vent tend to cluster over some predetermined timeframe, ie a measure of the central tendency of recent ventilation values.

[0849] Upper airway obstruction (UAO): includes partial and complete upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or may even decrease, with increasing pressure differential across the upper airway (Starling impedance behavior).

[0850] Ventilation (Vent): A measurement of the total amount of gas exchanged by a patient's respiratory system. Measurements of ventilation can include either or both inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume, understood as volume per minute.

[0851] 4.7.3 Ventilation

[0852] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be determined based on a characteristic of the patient (e.g., the patient's breathing characteristics).

[0853] Backup Rate: A parameter of a ventilator that establishes the minimum respiratory rate (usually in breaths per minute) that the ventilator will deliver to a patient if not triggered by spontaneous respiratory effort.

[0854] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator is said to periodically stop delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0855] Expiratory Positive Airway Pressure (EPAP): The base pressure to which intra-breath varying pressures are added to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0856] End-Expiratory Pressure (EEP): The desired interface pressure that the ventilator will attempt to achieve at the end of the expiratory portion. If the pressure waveform template () is zero value at the end of exhalation, that is, when () = 1 and () = 0, then EEP is equal to EPAP.

[0857] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator will attempt to achieve during the inspiratory portion of a breath.

[0858] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually refers to the difference between the maximum and baseline pressures during inspiration (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0859] Servo ventilator: A ventilator that measures patient ventilation, has a target ventilation volume, and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation volume.

[0860] 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. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0861] Swing: A term equivalent to pressure support.

[0862] Triggering: When a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a volume of breathable gas to a spontaneously breathing patient, it is considered to be triggered to do so. Triggering typically occurs at or near the beginning of the respiratory portion of the patient's breathing cycle under effort.

[0863] 4.7.4 Anatomy

[0864] 4.7.4.1 Facial anatomy

[0865] Ala: The outer lining or "wing" of each nostril (plural: alar).

[0866] Alae angle: The angle formed between the nostrils of each nostril.

[0867] Alar tip: The outermost point on the wing of the nose.

[0868] Alar curvature (or alar ridge) point: The posteriormost point in the base of the curvature of each ala, found in the crease where the nose joins the cheek.

[0869] Pinna: The entire external, visible part of the ear.

[0870] (Nose) Bony framework: The bony framework of the nose includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0871] (Nose) Cartilage framework: The cartilage framework of the nose includes the septal cartilage, lateral cartilage, major cartilage and minor cartilage.

[0872] Columella: The strip of skin that separates the nostrils and extends from the protruding point of the nose to the upper lip.

[0873] Columellar angle: The angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the Frankfort horizontal plane and intersecting the subnasale.

[0874] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point, which is the deepest point in the notch above the tragus of the auricle.

[0875] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0876] Lateral nasal cartilage: A roughly triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla, and its lower edge connected to the greater alar cartilage.

[0877] Lower lip (midpoint of lower lip): The lip extending between the lower point of the nose and the mouth.

[0878] Upper lip (midpoint of upper lip): The part of the lip extending between the mouth and the suprachin point.

[0879] The greater alar cartilage is a cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four minor cartilages of the alar.

[0880] Nostrils (nares / nostrils): The roughly oval openings that form the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nostrils are separated by the nasal septum.

[0881] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0882] Nasolabial angle: The angle between the columella and upper lip (which intersect at the subnasal point).

[0883] Auricular base: the lowest point where the auricle is attached to the facial skin.

[0884] Auricular base: the highest point where the auricle attaches to the facial skin.

[0885] Nasal protuberance: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0886] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0887] Chin point: Located on the soft tis...

Claims

1. A gas flush flow regulation system, the gas flush flow regulation system being configured to exhaust respiratory gas from a patient interface, the gas flush flow regulation system comprising: A flow regulating vent, the flow regulating vent comprising: a base configured to anchor the gas irrigation vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electric actuator configured to move the movable member toward and away from the base, the electric actuator comprising a coil winding and a magnet movable relative to the coil winding; and a housing surrounding the movable member and the electric actuator; and a controller configured to supply current to the coil winding to regulate the flow of gas flushing through the flow regulating vent, Wherein the controller adjusts the magnitude of the current supplied to the coil winding in response to detection of a leak at the patient interface. 2 . The gas flushing flow regulation system of claim 1 , wherein the controller is configured to reduce the flow of the gas flushing in response to the detection of a leak at the patient interface.

3. The gas flushing flow regulation system of any one of claims 1 to 2, wherein the movable member is configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit, and wherein the controller is configured to supply current to the coil winding in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flushing flowing through the variable conduit. 4 . The gas flushing flow regulation system according to claim 1 , further comprising a biasing mechanism, wherein the movable member is attached to the housing by the biasing mechanism.

5. The gas flushing flow regulation system according to any one of claims 1 to 4, wherein the coil winding is located on the housing and the magnet is located on the movable member.

6. The gas flushing flow regulation system of any one of claims 1 to 4, wherein the winding is located on the movable member and the magnet is located on the housing.

7. The gas flushing flow regulation system of any one of claims 1 to 6, wherein the coil winding includes a recessed portion configured to accommodate at least a portion of the magnet.

8. The gas flushing flow regulation system of any one of claims 1 to 6, wherein the magnet includes a recessed portion configured to accommodate at least a portion of the coil winding.

9. The gas flushing flow regulating system according to any one of claims 1 to 8, further comprising: a patient interface configured to sealingly engage a patient's face; and an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface, Wherein the flow regulating vent is mounted to the patient interface.

10. The gas flushing flow regulation system of claim 9, wherein the RPT device includes a first leak detection sensor, and wherein the patient interface includes a second leak detection sensor.

11. A gas flush flow regulation system, the gas flush flow regulation system being configured to exhaust respiratory gas from a patient interface, the gas flush flow regulation system comprising: A flow regulating vent, the flow regulating vent comprising: a base configured to anchor the gas irrigation vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electric actuator configured to move the movable member toward and away from the base, the electric actuator comprising a coil winding and a magnet movable relative to the coil winding; and a housing surrounding the movable member and the electric actuator; and a controller configured to supply current to the coil winding to regulate the flow of gas flushing through the flow regulating vent, wherein the controller adjusts the magnitude of the current supplied to the coil winding in response to a CO2 level detected in a patient interface.

12. The gas flushing flow regulation system of claim 11, wherein the controller is configured to reduce the flow of the gas flushing through the flow-regulated vent in response to determining that the CO2 level in the patient interface is below a predetermined threshold.

13. The gas flushing flow regulation system of any one of claims 11 to 12, wherein the controller is configured to increase the flow of the gas flushing through the flow-regulated vent in response to determining that the CO2 level in the patient interface is above a predetermined threshold.

14. The gas flushing flow regulation system of any one of claims 11 to 13, wherein the movable member is configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit, and wherein the controller is configured to supply current to the coil winding in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flushing flowing through the variable conduit.

15. The gas flushing flow regulation system according to any one of claims 11 to 14, further comprising a biasing mechanism, wherein the movable member is attached to the housing by the biasing mechanism.

16. The gas flushing flow regulation system of any one of claims 11 to 15, wherein the coil winding is located on the housing and the magnet is located on the movable member.

17. The gas flushing flow regulation system of any one of claims 11 to 15, wherein the winding is located on the movable member and the magnet is located on the housing.

18. The gas flushing flow regulation system of any one of claims 11 to 17, wherein the coil winding includes a recess configured to accommodate at least a portion of the magnet.

19. The gas flushing flow regulation system of any one of claims 11 to 17, wherein the magnet includes a recess configured to accommodate at least a portion of the coil winding.

20. The gas flushing flow regulating system according to any one of claims 11 to 19, further comprising: a patient interface configured to sealingly engage a patient's face; and an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface, Wherein the flow regulating vent is mounted to the patient interface.

21. The gas flushing flow regulation system of claim 20, wherein the RPT device includes a first leak detection sensor, and wherein the patient interface includes a second leak detection sensor.

22. A gas flush flow regulation system, the gas flush flow regulation system being configured to exhaust respiratory gas from a patient interface, the gas flush flow regulation system comprising: A flow regulating vent, the flow regulating vent comprising: a base configured to anchor the gas irrigation vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electric actuator configured to move the movable member toward and away from the base, the electric actuator comprising a motor having a movable component attached to the movable member and configured to move the movable member; and a housing surrounding the movable member and the electric actuator; and a controller configured to supply current to the motor to regulate the flow of gas flushing through the flow regulating vent, Wherein the controller adjusts the magnitude of the current supplied to the motor in response to detection of a leak at the patient interface.

23. The gas flush flow regulation system of claim 22, wherein the controller is configured to reduce the flow of the gas flush in response to the detection of a leak at the patient interface.

24. The gas flushing flow regulation system of any one of claims 22 to 23, wherein the movable member is configured to move toward and away from the base in response to the flow rate of gas flowing through the variable conduit, and wherein the controller is configured to supply current to the motor in response to the detection of the leak at the patient interface to override the movement of the movable member caused by the gas flushing flowing through the variable conduit.

25. The gas flushing flow regulation system of any one of claims 22 to 24, further comprising a biasing mechanism, wherein the movable member is attached to the housing by the biasing mechanism.

26. The gas flushing flow regulation system of any one of claims 22 to 25, wherein the electric motor comprises a linear actuator and a shaft, and wherein the linear actuator is fixed to an outer surface of the housing and the shaft is movable through the housing and attached to the movable member.

27. The gas flush flow regulation system of any one of claims 22 to 26, wherein the linear actuator is configured to move the shaft in discrete steps.

28. The gas flush flow regulation system of any one of claims 22 to 26, wherein the linear actuator is configured to move continuously.

29. The gas flushing flow regulation system of any one of claims 22 to 28, wherein the shaft is configured such that rotation of the shaft causes the shaft and the movable member to move toward and away from the base.

30. The gas flushing flow regulating system according to any one of claims 22 to 29, further comprising: a patient interface configured to sealingly engage a patient's face; and an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface, Wherein the flow regulating vent is mounted to the patient interface.

31. The gas flushing flow regulation system of claim 30, wherein the RPT device includes a first leak detection sensor, and wherein the patient interface includes a second leak detection sensor.

32. A gas wash flow regulated vent configured to exhaust respiratory gas from a patient interface, the gas wash flow regulated vent comprising: a base configured to anchor the gas irrigation vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; sealing member; and a housing surrounding the movable member and the sealing member and including an inlet port, wherein the sealing member is positioned between the movable member and the housing, and The sealing member is sealingly attached to the housing to form a chamber pneumatically isolated from the movable member.

33. The gas flushing flow regulating vent of claim 32, wherein the chamber is configured such that gas is only permitted to enter or exit the chamber through the inlet port.

34. The gas flushing flow regulating vent of any one of claims 32 to 33, wherein the sealing member is configured to exert a biasing force on the movable member.

35. The gas flushing flow regulating vent of claim 34, wherein the biasing force urges the movable member away from the base.

36. A gas flushing flow regulating vent according to any one of claims 32 to 35, wherein the chamber is configured such that a relatively high pressure in the chamber urges the moveable member towards the seat.

37. A gas flushing flow regulating vent according to any one of claims 32 to 36, wherein the chamber is configured such that a relatively low pressure in the chamber allows the moveable member to move away from the base.

38. The gas flushing flow regulated vent of any one of claims 32 to 37, wherein the chamber is configured to be pneumatically connected to a pressurized supply of breathing gas supplied to the patient interface.

39. A gas flushing flow regulating vent according to any one of claims 32 to 38, wherein the chamber is configured to be pneumatically connected to a pump and / or a valve.

40. The gas flushing flow regulating system according to any one of claims 32 to 39, further comprising: a patient interface configured to sealingly engage a patient's face; and an RPT device configured to pressurize the flow of breathing gas; an air delivery tube configured to deliver the pressurized gas to the patient interface; and a hose removably attached to the inlet port, Wherein the flow regulating vent is mounted to the patient interface.

41. The gas flushing flow regulation system of claim 40, further comprising a pump pneumatically connected to the hose.

42. A gas flush flow regulation system, the gas flush flow regulation system being configured to exhaust respiratory gas from a patient interface, the gas flush flow regulation system comprising: A flow regulating vent, the flow regulating vent comprising: a base configured to anchor the gas irrigation vent to the patient interface; a movable member opposite the base and forming a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electric actuator configured to move the movable member toward and away from the base, the electric actuator comprising a coil winding and a magnet movable relative to the coil winding; a housing surrounding the movable member and the electric actuator; and A flexible suspension member is attached to the housing and the movable member, the flexible suspension member being configured to suspend the movable member from the housing and decouple movement of the movable member from the housing.

43. The gas purge flow regulation system of claim 42, wherein the suspension member is configured to bias the movable member toward a predetermined direction.

44. A gas flushing flow regulation system according to any one of claims 42 to 43, wherein the suspension member is formed of foam.

45. The gas flushing flow regulation system of any one of claims 42 to 44, wherein the magnet is attached to the movable member such that the movable member moves with the magnet.

46. A gas flushing flow regulation system according to any one of claims 42 to 45, wherein the magnet is surrounded by the winding.

47. The gas flushing flow regulation system according to any one of claims 42 to 46, further comprising a controller configured to supply current to the coil winding to regulate the flow of gas flushing through the flow regulation vent. Wherein the controller adjusts the magnitude of the current supplied to the coil winding in response to CO2 levels and / or pressure detected within the patient interface.

48. The gas flushing flow regulating system according to any one of claims 42 to 47, further comprising: a patient interface configured to sealingly engage a patient's face; and an RPT device configured to pressurize the flow of breathing gas; and an air delivery tube configured to deliver the pressurized gas to the patient interface, Wherein the flow regulating vent is mounted to the patient interface.

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