Patient Interface

Abstract

The patient interface is configured to deliver a pressurized flow of respiratory gas to a patient's airway. The patient interface includes a cradle base configured to cradlingly support the patient's nose in use. Two prongs extend from the cradle base and are configured to be inserted into the patient's nares in use. Each prong defines an opening configured to allow a continuous flow of air to pass therethrough. Additionally, a plenum base defines a plenum chamber with the cradle base. The cradle base is configured such that movement of the cradle base is decoupled from the plenum base.

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit of Australian Application No. 2019903362, filed 10 September 2019, which is incorporated herein by reference in its entirety. [Background technology]

[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The lungs' primary function is gas exchange, allowing oxygen from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory zone. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory disorders exists, and particular diseases may be characterized by particular manifestations such as apnea, hypopnea, and hyperpnea.

[0006] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. It results from an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. As a result of this disorder, affected individuals experience breathing pauses typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0010] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous illnesses and conditions that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disease characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); and (ii) degenerative or slowly progressive disease characterized by muscle damage that worsens over years but only mildly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive dysfunction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of therapies are available to treat or ameliorate such diseases. In addition, otherwise healthy individuals can benefit from preventative therapies for respiratory disorders. However, these suffer from several deficiencies.

[0016] 2.2.2 Therapy A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to therapy if they perceive one or more of the following about the device used to deliver the therapy: it is uncomfortable, difficult to use, expensive, or aesthetically unattractive.

[0018] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these therapies.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies may be improved.

[0020] 2.2.3 Treatment System These therapies may be provided by therapeutic systems or devices. Such systems and devices may also be used to diagnose disease without treating it.

[0021] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with ambient pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0025] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, the patient must insert part of the mask structure into their mouth to create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0027] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0028] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory therapy session.

[0029] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with therapy. This is especially true if the mask must be worn while sleeping.

[0030] CPAP therapy is highly effective in treating certain breathing disorders when patients comply with the therapy. If the mask is uncomfortable or difficult to use, patients may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0031] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0034] Patient interfaces can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure can include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can 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 patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0035] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swimming goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure may be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both must be adapted to form a seal.

[0037] 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 while the seal-forming structure is engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and the mask can require additional force to achieve a seal or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can fold or buckle during use, causing leakage.

[0039] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0040] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0041] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0042] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGELIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0043] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0044] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0045] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0046] In patient interfaces included in other types of treatment systems, the tube or substantially hollow elongated structure that delivers pressurized air to the patient's airway also functions as part of the structure (e.g., headgear) that positions and stabilizes the seal-forming portion of the patient interface against the appropriate portion of the patient's face; i.e., the headgear forms part of the air circuit. For purposes of this specification, the terms "tube" and "conduit" shall be considered interchangeable unless the context clearly indicates otherwise.

[0047] When this type of patient interface is referred to as including "headgear tubing" or "conduit headgear," it should be understood that these terms are synonymous for purposes of this specification, unless the context clearly indicates otherwise. Such a patient interface allows a conduit in an air circuit providing pressurized airflow from a respiratory pressure therapy device to be provided to the patient interface in 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. 2007 / 0246043, the contents of which are incorporated herein by reference. In this publication, the conduit connects into the patient interface through a port positioned on the top of the patient's head during use.

[0048] Philips' DreamWear™ mask includes such conduit headgear / headgear tubing. The length of the DreamWear™ headgear tubing is not adjustable. Therefore, DreamWear™ headgear is supplied in three different sizes to accommodate patients with different face sizes. A larger number of different sizes can increase the complexity and cost of manufacturing the headgear and lead to larger packaging. Furthermore, supplying masks in separate sizes can limit the range of patients with different head sizes that can be accommodated. Forcing a certain number of patients to select individual sizes that cannot be adjusted in length can increase the likelihood that they will not achieve a fit that they perceive as "comfortable." 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0049] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the above-mentioned therapies, for example, by generating a flow of air delivery to the airway entrance. This flow of air can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0050] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., reliability, size, and weight requirements of medical devices). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0051] One example of a special requirement for a particular RPT device is acoustic noise.

[0052] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]

[0053] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar™ series of adult and pediatric ventilators) can provide invasive and non-invasive independent respiratory support for patients with a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0054] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII™ ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple diseases. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0055] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters.

[0056] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing patient airway comfort. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0057] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0058] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0059] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use.

[0060] 2.2.3.4 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0061] The vents may include orifices through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0062] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 34,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0063] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]

[0064] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0065] The sound pressure values ​​of various objects are listed below [Table 3] Summary of the Invention [Means for solving the problem]

[0066] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0067] A first aspect of the present technology relates to devices for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders.

[0068] Another aspect of the present technology relates to methods for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders.

[0069] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0070] One aspect of the present technology relates to a patient interface that includes a plenum structure, a seal-forming structure, and a positioning and stabilizing structure configured to support the seal-forming structure and the plenum structure on a patient's head. The patient interface may include a ventilation system.

[0071] Another aspect of the present technology relates to a patient interface configured to deliver a flow of pressurized breathing gas to a patient's airway. The patient interface may include a cradle base configured to cradle support the patient's nose in use, and two prongs extending from the cradle base and configured to be inserted into the patient's nares in use.

[0072] Another aspect of the present technology relates to a seal-forming structure for a patient interface configured to form a seal with a patient's nares. The seal-forming structure may include a base and two protrusions on the base, each having an opening formed therein configured to allow continuous airflow therethrough. In an exemplary form of the present technology, the protrusions are constructed and arranged to be inserted or partially inserted into each of the patient's nares in use. The protrusions may be constructed and arranged to seal against the inner periphery of each nostril in use. The protrusions may include ends that seal against the inner periphery of each nostril in use.

[0073] In an example, the base further includes lateral extensions extending outward laterally on either side of the two protrusions, each configured to seal against the lateral or lower portion of each of the patient's alae in use.

[0074] In an example, the base is formed so that when there is no force acting on the base, the base has a positive curvature in the lateral direction, and when worn by a patient, the positive curvature of the base decreases when the base engages with the nose.

[0075] One aspect of the present technology relates to a seal-forming structure for a patient interface configured to form a seal with a patient's nares. The seal-forming structure may include a base and at least one opening in the base configured to allow a continuous airflow therethrough. In an exemplary form of the present technology, the base is provided with a plenum chamber. One or more folds may be formed by a portion of the base and / or a portion of the plenum chamber. In an example, the seal-forming structure includes two protrusions provided on the base, each of which defines one of the openings.

[0076] One aspect of the present technology is a patient interface, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a seal-forming structure configured and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle. a venting structure that allows a continuous flow of exhaled gases from within a plenum chamber to the surroundings, said venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use, wherein the seal-forming structure further includes a base and two protrusions on the base, each having an opening formed therein that is configured to allow a continuous flow of air therethrough, the protrusions being constructed and arranged to be inserted or partially inserted into each of the patient's nares in use to provide a flow of air to the patient's nares at said therapeutic pressure.

[0077] One aspect of the present technology relates to a patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, wherein the seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and a vent structure to allow continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use, wherein the seal-forming structure comprises a base and at least one opening in the base configured to provide a flow of air at the therapeutic pressure to the patient's nares in use, wherein the base is disposed in the plenum chamber, and one or more folds are formed by a portion of the base and / or a portion of the plenum chamber. In an example, the seal-forming structure includes two protrusions on a base, with one of the openings formed within each of the protrusions.

[0078] In an example, the base further includes lateral extensions extending laterally outward on either side of the two protrusions, the lateral extensions being configured to seal against the lateral or lower portions of each of the patient's alae in use, respectively.

[0079] In an example, the base is formed such that when there is no force acting on the base, the base has a positive curvature, and when worn by a patient, the positive curvature of the base decreases when the base engages with the nose.

[0080] In examples, the patient interface further includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. In one example, the positioning and stabilizing structure includes a tie, the tie being constructed and arranged so that at least a portion of the tie, in use, covers an area of ​​the patient's head above the superior ear-base point of the patient's head. In another example, the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to contact, in use, at least an area of ​​the patient's head above the superior ear-base point of the patient's head, the portion of the gas delivery tube above the superior ear-base point of the patient's head including or being provided with a connection port configured to receive an air flow from the air circuit and deliver the air flow through the seal-forming structure to an entrance to the patient's airway.

[0081] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a surrounding shape that is complimentary to the shape of the intended wearer.

[0082] One aspect of the present technology is a method for manufacturing a device.

[0083] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0084] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a humidifier tank that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0085] Another aspect of the present technology includes a patient interface configured to deliver a pressurized flow of respiratory gas to a patient's airway. The patient interface may include a cradle base configured to cradlingly support the patient's nose in use. Two prongs may extend from the cradle base and may be configured to be inserted into the patient's nares in use. An opening configured to pass a continuous flow of air therethrough may be formed within each of the prongs. The plenum base may form a plenum chamber with the cradle base. The cradle base may be configured such that movement of the cradle base is decoupled from the plenum base.

[0086] The protrusions may be constructed and arranged to seal against the inner periphery of each nostril in use. Additionally, the protrusions may include ends that seal against the inner periphery of each nostril in use.

[0087] The cradle base may include lateral extensions extending outward laterally on either side of the two protrusions. Each lateral extension may be configured to seal against a lateral or lower portion of each of the patient's alae when in use. Additionally, the cradle base may be configured to flex outwardly with the patient's nose when worn by the patient.

[0088] The protrusion may have a frusto-conical shape. Additionally, the opening of the protrusion may be angled relative to the portion of the cradle base surface from which the protrusion begins to extend.

[0089] The plenum base may include a pair of air inlets on opposite lateral sides. Additionally, the plenum base and the cradle base may be inflatable.

[0090] A buffer or damper between the cradle base and the plenum base may be configured to decouple movement of the cradle base from the plenum base. The buffer or damper may not be configured to decouple movement between the two sealing surfaces. Also, the buffer or damper may not be configured to decouple movement between the nose seal and the mouth seal. The patient interface may not include a mouth seal. Also, the protrusion may not include a stem.

[0091] Another aspect of the present technology includes a patient interface configured to deliver a pressurized flow of respiratory gas to a patient's airway. The patient interface may include a plenum base and a cradle base attached to the plenum base. The plenum base may be configured to cradle support the patient's nose during use. The plenum base and the cradle base together may form a plenum chamber. A channel in a surface of the plenum base adjacent to the cradle base may be configured to decouple movement of the cradle base from the plenum base. Additionally, a pair of protrusions may extend from the cradle base. The pair of protrusions may be configured to be inserted into the patient's nares during use. The pair of protrusions may form a gas flow path from the plenum chamber to the patient's airway during use.

[0092] The channel may completely surround the cradle base. Additionally, the cradle base may be U-shaped or V-shaped. The plenum base and cradle base may be expandable. Also, the sides of the cradle base may be configured to flex proximally and distally relative to the plenum base.

[0093] Each of the protrusions may extend from a respective side portion of the cradle base, and the side portions of the cradle base may extend laterally beyond each of the protrusions.

[0094] The plenum base may include a pair of gas inlets, one located on each lateral side of the plenum base.

[0095] Each protrusion may be configured to seal against the inside of a patient's nostril, while the cradle base may be configured to seal against the outer surface of the patient's nostril.

[0096] Another aspect of the present technology includes a patient interface configured to deliver a pressurized respiratory gas flow to a patient's airway. The patient interface may include a plenum base pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum base may include a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient. The seal-forming structure may be constructed and arranged to surround the patient's nostrils on the patient's face and form a seal with areas inside the patient's nostrils. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. A spring or damper may be disposed between the plenum chamber and the seal-forming structure. The spring or damper may be configured to decouple movement of the seal-forming structure from the plenum base. The seal-forming structure may further include a cradle base and two protrusions on the cradle base. Each of the protrusions may have an opening formed therein configured to allow a continuous air flow therethrough. The prongs may be constructed and arranged to be inserted or partially inserted into each of the patient's nostrils in use, so that airflow is provided to the patient's nostrils at said therapeutic pressure.

[0097] The protrusions may be configured to form a seal with the inside of the patient's nares. Additionally, the cradle base may be configured to cradle the patient's nose and form a seal with the outer surfaces of the patient's nares in use.

[0098] Only the center portion of the cradle base may be attached to the plenum base. The sides of the cradle base may be flexible proximally and distally relative to the plenum base. Additionally, the protrusions may be angled relative to the surface of the cradle base from which the protrusions extend.

[0099] Another aspect of the present technology includes a patient interface configured to deliver a pressurized flow of respiratory gas to a patient's airway. The patient interface may include a plenum base pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum base may include an inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient. The seal-forming structure may be constructed and arranged to surround the patient's nostrils on the patient's face and form a seal with areas inside the patient's nostrils. The seal-forming structure may also be constructed and arranged to maintain the therapeutic pressure within the plenum base throughout the patient's respiratory cycle in use. The seal-forming structure may include a cradle base and a pair of protrusions extending from the cradle base. An opening may be formed within each protrusion configured to convey an air flow at the therapeutic pressure to the patient's nares in use. Each protrusion may be configured to be inserted or partially inserted into one of the patient's nares in use. The cradle base may be supported on the plenum base and a portion of the cradle base may form one or more folds configured to decouple movement of the cradle base from the plenum base.

[0100] The one or more folds may be part of a concertina structure. Additionally, the cradle base may further include lateral extensions extending laterally outward on either side of the protrusion. The lateral extensions may be configured to seal against the lateral or lower portions of each of the patient's alae in use.

[0101] The patient interface may further include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a tie constructed and arranged so that at least a portion of the tie covers an area of ​​the patient's head above the superior ear-base point in use. The positioning and stabilizing structure may also include at least one gas delivery tube constructed and arranged to contact at least an area of ​​the patient's head above the superior ear-base point in use. The portion of the gas delivery tube above the superior ear-base point of the patient's head includes or is provided with a connection port configured to receive an air flow from the air circuit and deliver the air flow through the seal-forming structure to an entrance to the patient's airway.

[0102] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0103] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0104] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]

[0105] [Figure 1A] 4.1 Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B]A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E] 1 is a further lateral view of the head, showing the approximate locations of the Frankfurt horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G]FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] An anterior lateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber (cushion assembly) 3200 showing the sagittal and medial contact surfaces. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., superior point 3220 and inferior point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip. [Figure 3Y] FIG. 10 is a front perspective view of a patient interface in accordance with an aspect of the present technology. [Figure 3Z] FIG. 10 is a front-superior view of a patient interface in accordance with another aspect of the present technology. [Figure 3AA] FIG. 10 is a side view of a patient interface in accordance with another aspect of the present technology. [Figure 3BB] FIG. 10 is a side view of a patient interface in accordance with another aspect of the present technology. [Figure 3CC] FIG. 10 is a side view of a patient interface in accordance with another aspect of the present technology. [Figure 3DD] FIG. 2 is a top view of the foam layer. [Figure 3EE]FIG. 10 is a front perspective view of a patient interface in accordance with another aspect of the present technology. [Figure 3FF] Anterior and superior view of the patient interface of Figure 3EE. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 4.5 Humidifiers [Figure 5A] FIG. 10 is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] FIG. 4 is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory Waveforms [Figure 6A] 1 shows a model of a typical human breathing waveform during sleep. DETAILED DESCRIPTION OF THE INVENTION

[0106] 5 Detailed description of examples of this technology 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 the present disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0107] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any of these examples may constitute an additional example.

[0108] 5.1 Therapy In one form, the present technology includes a method for treating disordered breathing, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0109] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0110] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0111] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0112] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0113] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0114] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0115] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0116] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0117] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0118] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0119] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0120] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0121] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0122] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0123] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0124] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0125] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0126] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having an adhesive or adhesive surface.

[0127] 5.3.1.2 Nose seal 3Y-3CC show a patient interface 3000 including a seal-forming structure 3100 and a plenum base 3105 in accordance with another aspect of the present technology. A damper or buffer 3106 may be disposed between the seal-forming structure 3100 and the plenum base 3105 to decouple movement of the seal-forming structure 3100 from the plenum base 3105.

[0128] The seal-forming structure 3100 of the patient interface 3000 may be a nasal cradle including an anchoring portion configured to anchor the nasal cradle to the patient's nostrils. Each seal-forming structure 3100 may include a pair of protrusions 3110 extending from a cradle base 3120. The protrusions 3110 may be constructed and arranged to form a seal with each nostril of the patient's nose. Alternatively, the protrusions 3110 may engage only a portion of the patient's nostrils and not form a seal with the nostrils of the patient's nose.

[0129] The protrusions 3110 may be constructed and arranged to be inserted or partially inserted into a respective nostril of the patient during use. Each protrusion 3110 may be hollow and may have an opening 3130 at a terminal end of the protrusion 3110. Each protrusion 3110 may be configured to pass a pressurized flow of breathing gas therethrough, such that the pressurized flow of breathing gas may be able to flow into the patient's nares when the patient interface 3000 is being worn.

[0130] In some forms of the present technology, each protrusion 3110 can be configured to extend partially into a respective one of the patient's nostrils. For example, each protrusion 3110 can be constructed and arranged to engage and seal (or only engage) with the inner periphery of each nostril in use. The height of each protrusion 3110 can be less than a conventional nasal pillow patient interface. For example, the height of each protrusion 3110 from the cradle base 3120 can be less than 2 cm. It is contemplated that the height of each protrusion 3110 from the cradle base 3120 can be less than 1 cm. It is further contemplated that the height of the protrusion 3110 from the cradle base 3120 can be less than 0.5 cm. The end (or edge) of each protrusion 3110 that forms the opening 3130 can be configured to engage and seal (or only seal) with the inner periphery of each nostril.

[0131] Each projection 3110 may have a proximal end 3140 adjacent the cradle base 3120 and an outlet end 3150 opposite the proximal end 3140. The opening 3130 may be provided in the outlet end 3150. Because the projections 3110 are hollow structures, a peripheral wall 3160 of the projections 3110 may form a gas passageway for the flow of pressurized breathing gas.

[0132] Each protrusion 3110 may be tapered so that the footprint of the protrusion 3110 is greatest at the proximal end 3140 and least at the outlet end 3150. The structure of the protrusions 3110 may differ from conventional nasal pillows by eliminating thinner stems between the widest portion and the base that allow substantial flexure and / or bending relative to the base of the nasal pillows. Eliminating the stems may minimize relative movement between the protrusions 3110 and the surface of the cradle base 3120 from which the protrusions 3110 extend, thereby facilitating anchoring by the protrusions 3110.

[0133] It is contemplated that the protrusion 3110 may have a frusto-conical or similar shape. For example, as shown in FIGS. 3Y and 3Z, the peripheral wall 3160 of the protrusion 3110 may taper from the proximal end 3140 toward the outlet end 3150, while the cross-sectional shape of the protrusion 3110 may be elliptical rather than circular. It is further contemplated that the shape of the protrusion 3110 is not limited to that shown in FIGS. 3Y and 3Z. For example, the cross-sectional shape of the protrusion 3110 may be circular, rectangular, triangular, or any combination thereof. It is contemplated that the cross-sectional shape may be open on at least one side. For example, the cross-sectional shape may be C-shaped. In a configuration in which the cross-sectional shape is open on at least one side, the protrusion 3110 may not form part of a gas flow path. Instead, the protrusion 3110 may function solely to anchor the seal-forming structure 3100 to the patient's nose.

[0134] Alternatively, the peripheral wall 3160 of the projection 3110 may not be tapered, and the footprint of the projection 3110 remains constant from the proximal end 3140 to the outlet end 3150. It is also contemplated that more than one peripheral wall 3160 may be provided (depending on the cross-sectional shape of the projection 3110).

[0135] As shown in FIG. 3BB, the opening 3130 may extend along the surface 3170. Additionally, the projection 3110 may have a longitudinal axis 3175 that is perpendicular to the surface 3170 and extends through the proximal end 3140 and the outlet end 3150 of the projection 3110. Additionally, the peripheral wall 3160 may be tapered at an angle α relative to the longitudinal axis 3175. The taper angle α may vary in a direction perpendicular to the longitudinal axis 3175. For example, the taper angle α of the peripheral wall 3160 may be smallest at the central opposing side 3180 of the projection 3110 (i.e., the side of the projection 3110 closest to the other projection 3110). At the same time, the taper angle α of the peripheral wall 3160 may be largest at the outward-facing side 3190 of the projection 3110 (i.e., the side of the projection 3110 farthest from the other projection 3110). In this configuration, the length of the peripheral wall 3160 from the proximal end 3140 to the outlet end 3150 may be greatest at the centrally facing side 3180 and may be smallest at the outwardly facing side 3190 .

[0136] By varying the taper angle α, the protrusion 3110 and the opening 3130 can be angled relative to the portion of the cradle base 3120 where the protrusion 3110 begins to extend, which can be angled relative to the opening in the patient's nostril. Thus, by angling the protrusion 3110 and the opening 3130 relative to the cradle base 3120, the protrusion 3110 can be aligned with the patient's nostril so that the entire outlet end 3150 is received within the patient's nostril.

[0137] Alternatively, the taper angle α can be constant in a direction perpendicular to the longitudinal axis 3175. In this configuration, the length of the peripheral wall 2160 from the proximal end 3140 to the outlet end 3150 can be the same on the centrally facing side 3180 and the outwardly facing side 3190.

[0138] It is contemplated that the opening 3130 may have an oval shape so that it may more easily fit the shape of a patient's nostrils, however, it should be understood that the opening 3130 may be any other shape (e.g., circular).

[0139] The protrusions 3110 may improve seal stability. For example, in use, the protrusions 3110 may be placed in contact with the periphery of the patient's nares and may function to position the cradle base 3120 (and thus the patient interface 3000) in its intended position on the patient's face and to maintain the patient interface 3000 in that position during use. In other words, the protrusions 3110 may be configured to prevent the patient interface 3000 from moving laterally across the patient's face during use.

[0140] To perform its function of anchoring the cradle base 3120 to the patient's nostril, each protrusion 3110 need only engage the rim of the opening with the patient's nasal airway. Thus, the protrusions 3110 need only be long enough to engage the rim of the opening with or adjacent to the patient's nasal airway. In other words, the protrusions 3110 may be designed so that they do not penetrate as deeply into the patient's nasal passages as traditional nasal prongs or even traditional nasal pillows.

[0141] The protrusions 3110 may preferably not extend beyond the rim of the opening of the patient's nasal airway (or far beyond the rim of the opening of the patient's nasal airway), thereby increasing the area of ​​the opening 3140 at the end of the protrusions 3110. In particular, a patient's nasal airway becomes smaller as it extends into the patient's nose. Therefore, with conventional nasal prongs, in order to fit within the patient's nasal airway, it is necessary to reduce the size of the opening at the distal end of the nasal prongs by decreasing in diameter as it approaches the distal end. By limiting the extent to which the protrusions 3110 extend into the patient's nasal airway, the opening 3140 at the end of the protrusions 3110 may be sized larger than is typically the case with conventional nasal prongs. The increased size of the opening 3140 may reduce flow restriction and improve breathing comfort while minimizing blowout.

[0142] Alternatively, the protrusions 3110 may be designed to penetrate deep into the patient's nasal passages (i.e., beyond the adjacent portion of the rim of the opening to the patient's nasal airways) in a manner similar to conventional nasal prongs or nasal pillows.

[0143] It is contemplated that the cradle base 3120 and the protrusion 3110 may be formed from the same material and, in certain configurations, may be formed as one piece (e.g., integrally molded). It is further contemplated that the protrusion 3110 and the cradle base 3120 may be made of a flexible material (e.g., silicone).

[0144] The cradle base 3120 may include a central portion 3240 between a pair of side portions 3250. Each protrusion 3110 may be disposed on each side portion 3250 such that the protrusions 3110 are provided on opposite sides of the central portion 3240. Additionally, the cradle base 3120 may include a sealing surface 3260 that spans the space between the protrusions 3110 and surrounds the proximal ends 3140 of the protrusions 3110. Thus, a portion of the sealing surface 3260 of the cradle base 3120 may extend beyond the footprint of the protrusions 3110 and form a rim 3270 around the protrusions 3110. The sealing surface 3260 may be sized and oriented such that the sealing surface 3260 (and rim 3270) can engage the patient's skin and seal against the lateral and / or lower portions of the patient's nasal alar when the patient interface 3000 is worn.

[0145] Thus, the patient interface 3000 may form a first seal and a second seal against the patient's nose (e.g., a first seal between the inner wall of the patient's nostril and the protrusion 3110, and a second seal between the sealing surface 3260 (and rim 3270) and the exterior of the patient's nose). This may improve the quality of the overall seal between the patient interface 3000 and the patient's face (or nose) and may also stabilize the seal-forming structure during use, thereby reducing the risk of the overall seal being compromised during use.

[0146] The cradle base 3120 may be flexible and may have a generally cradle-, cup-, U-, or V-shape that cradles the patient's nose in use. The flexibility of the cradle base 3120 may allow the side portions 3250 to flex relative to the central portion 3240, which may allow the side portions 3250 (and protrusions 3110) to move proximally and distally relative to one another.

[0147] As can be seen in FIG. 3CC, the lateral portions 3250 may be oriented at an angle β relative to a plane 3280 that bisects the patient interface 3000 between the protrusions 3110. At rest (or when not engaged with the patient's nose), the lateral portions 3250 may be oriented at a preset (or resting) angle β. However, when the patient interface 3000 is donned by a patient, the lateral portions 3250 (along with the protrusions 3110) may flex outward due to the patient's nose, increasing angle β. Because the cradle base 3120 may have elastic properties, the lateral portions 3250 may be biased towards the preset angle β. This biasing force may cause the lateral portions 3250 to press (or push) against the patient's nose, thereby maintaining a seal against the patient's nose and stabilizing the patient interface 3000 on the patient's face.

[0148] It is contemplated that the cradle base 3120 may be hollow. It is further contemplated that the material of the cradle base 3120 may be inflatable and / or flexible such that supplying pressurized breathing gas to the interior of the cradle base 3120 may cause the cradle base 3120 to expand (i.e., the chamber within the cradle base 3120 to expand). As the cradle base 3120 expands, the sealing surface 3260 may press against the patient's nose, which may maintain a seal against the patient's nose and assist in stabilizing the patient interface 3000 on the patient's face.

[0149] Because different cradle bases 3120 may be sized differently, it is contemplated that differently sized cradle bases 3120 may have different rest angles β. Utilizing differently sized cradle bases 3120 and different rest angles β may allow for increased design flexibility to accommodate patients with different sizes and / or shapes of noses and / or faces. For example, a cradle base 3120 having a larger rest angle β may be more suitable for patients with larger, wider, and / or flatter noses.

[0150] As shown in FIGS. 3AA and 3DD, the seal-forming structure 3100 may optionally include a foam layer 3285 on the sealing surface 3260. The foam layer 3285 may extend over the entire sealing surface 3260 and may include openings 3286 for the protrusions 3110. The foam layer 3285 may improve the comfort of the seal-forming structure 3100 and may be made of open-cell or closed-cell foam. It is contemplated that the seal-forming structure 3100 may include the foam layer 3285 without an underlying sealing surface 3260. It is further contemplated that a layer of textile material may be used in place of the foam layer 3285. Alternatively, the foam layer may be encapsulated within a textile skin. Each of these materials is known to provide improved tactile comfort compared to elastomeric silicone.

[0151] The foam layer 3285 may be configured to support a seal between the patient interface 3000 and the patient's face. For example, the foam layer 3285 may be adapted to provide a compressive seal against the user's face. The compressive seal provided by the foam layer 3285 may cooperate with the lower sealing surface 3260 to provide an improved seal. When the seal-forming structure 3100 is internally pressurized, the lower sealing surface 3260 may urge the foam layer against the user's face. This sealing mechanism may function through a combination of compression of the foam material provided within the foam layer 3285, which may be further supported by internal pressurization of the seal-forming structure 3100. The foam layer 3285 may also improve patient comfort.

[0152] The foam layer 3285 may be permanently attached to the cradle base 3120 or may be removable from the cradle base 3120. It is contemplated that the foam layer 3285 may be secured to the cradle base 3120 by clips, snaps, adhesive, a hook and loop arrangement, or bonding. The foam layer 3285 may also optionally take the form of a sleeve, enclosing the entire cradle base 3120 with the protrusion 3110 extending through the opening 3286. The foam layer 3285 may optionally have one or more flaps 3287. One portion of the securing mechanism (e.g., hook, loop, clip) may be disposed on the flap 3287, while the other portion of the securing mechanism (e.g., hook, loop, clip) may be provided on a corresponding location on the cradle base 3120.

[0153] Although four flaps 3287 are shown in Fig. 3DD, any number of flaps 3287 may be used (e.g., 1, 2, 3, 4) depending on what is needed to secure the foam layer 3285 over the cradle base 3120. Additionally, the location of the flaps 3287 is not limited to that shown in Fig. 3DD. The flaps 3287 may be positioned in any manner around the foam layer 3285.

[0154] It is further contemplated that the foam layer 3285 may be held in place by the protrusions 3110. Specifically, the diameter (or footprint) of the opening 3286 may be slightly smaller than the footprint of the proximal end 3140 of the protrusion 3110 so that the opening 3286 may be stretched by the protrusions 3110 when mounted on the cradle base 3120 and may be held in place by friction between the protrusions 3110 and the rim of the opening 3286.

[0155] It is contemplated that the cradle base 3120 may be generally U-shaped when viewed from the anterior side in use. The curvature of the cradle base 3120 in the anterior-posterior direction (i.e., sagittal plane) may be positive, negative, or zero. If the curvature of the cradle base 3120 in the lateral direction is positive, a protrusion 3110 may be provided for each nostril, and the portion of the cradle base 3120 between the protrusions 3110 may be positioned further in the anterior direction to avoid contact with the bridge of the patient's nose.

[0156] The cradle base 3120 may be configured such that, in the absence of any force acting on it, the cradle base 3120 may have a certain amount of positive curvature in the lateral direction, such that engagement of the cradle base 3120 with the nose when worn by a patient may reduce the positive curvature of the cradle base 3120. That is, the "natural" or "rest" curvature of the cradle base 3120 may be greater than the curvature of the cradle base 3120 when worn. In examples where the cradle base 3120 is formed from a resilient material or configured to resiliently return to its original shape when not worn, the lateral portions 3250 of the cradle base 3120 may be forced inward against the patient's nose when the patient interface 3000 is worn. This may assist in forming a seal against the nose and stabilizing the patient interface 3000 in a desired position.

[0157] It is understood that different patient interfaces 3000 may include different amounts of positive curvature of the cradle base 3120 in the "at rest" state to accommodate patients with different sizes and / or shapes of noses and / or faces.

[0158] The plenum base 3105 may support the cradle base 3120 and the protrusion 3110. Additionally, the plenum base 3105 and the cradle base 3120 together may form a combined plenum chamber that receives the pressurized flow of breathing gas. A portion of the plenum base 3105 may have a surface that, in use, is complementary in shape to the contours of an average human face. In some forms, the plenum base 3105 and the seal-forming structure 3100 may be formed from a single, homogenous piece of material (e.g., silicone).

[0159] In certain forms of the present technology, the plenum base 3105 may be constructed from a transparent material (e.g., a transparent polycarbonate or silicone material), or alternatively, the plenum base 3105 may be constructed from a translucent material.

[0160] In certain forms of the present technology, the plenum base 3105 may be formed from the same material as the seal-forming structure 3100 and may be integrally formed.

[0161] One or more positioning and stabilizing structure connectors (or headgear connectors) 3290 may be provided on the plenum base 3105. The positioning and stabilizing structure connectors 3290 are configured to connect to the positioning and stabilizing structure 3300 in use. The positioning and stabilizing connectors 3290 may be located on opposite lateral sides of the plenum base 3105. It is contemplated that the positioning and stabilizing structure connectors 3290 may include clips, buckles, or any other connectors that are or can be connected to the positioning and stabilizing structure 3300 (e.g., headgear straps and headgear conduits).

[0162] The positioning and stabilizing structure connector 3290 may take the form of or may include an inlet tube 3310 protruding from a side of the plenum base 3105. The inlet tube 3310 may be configured to receive pressurized breathing gas from one or more air delivery tubes and / or one or more conduits within the positioning and stabilizing structure (or headgear) 3300. If the positioning and stabilizing structure (or headgear) 3300 includes headgear conduits, it is contemplated that the plenum base 3105 (and patient interface 3000) may be connected to the positioning and stabilizing structure (or headgear) 3300 at the same time that the inlet tube 3310 is connected to the air delivery conduits.

[0163] A damper or buffer 3106 may be interposed between the cradle base 3120 and the plenum base 3105. The damper or buffer 3106 may decouple movement of the cradle base 3120 (and movement of the protrusion 3110) from the plenum base 3105. The damper or buffer 3106 may completely surround the cradle base 3120 or may only partially surround the cradle base 3120. It is contemplated that the side portions 3250 of the cradle base 3120 may extend beyond the damper or buffer 3106. Additionally, the damper or buffer 3106 may take the form of a channel (FIG. 3Z), a concertina (FIG. 3AA), a bellows, a spring, or other structure between the cradle base 3120 and the plenum base 3105 that may decouple movement of the cradle base 3120 from the plenum base 3105.

[0164] The buffer or damper 3106 may absorb side loads acting on the cradle base 3120 (before the side loads are transferred to the plenum base 3105). It is contemplated that the buffer or damper 3106 may allow the sides 3250 of the cradle base 3120 to flex or move (independently of the plenum base 3105). It is further contemplated that the plenum base 3105 may expand along with the buffer or damper 3106 due to internal pressurization within the plenum chamber formed by the cradle base 3120 and the plenum base 3105. The expansion of the plenum base 3105 and channel 3320 may urge the protrusion 3110 and sealing surface 3260 against the patient's nose, which further supports the seal formed by the protrusion 3110 and sealing surface 3260.

[0165] Additionally, the side portions 3250 of the cradle base 3120 may protrude away from the plenum base 3105 and the buffer or damper 3106, such that only the central portion 3240 is directly attached to the plenum base 3105. It is contemplated that the portions of the side portions 3250 closest to the central portion 3240 may be directly attached to the plenum base 3105. Thus, at least a portion of the side portions 3250 may be separated from the plenum base 3105 and the buffer or damper 3106, such that the surface 3330 of the side portions 3250 opposite the sealing surface 3260 may face the surface of the buffer or damper 3106 and / or the plenum base 3105. Flexibility of the buffer or damper 3106 may allow the surface 3330 to move proximally and distally relative to the surface of the plenum base 3105. Such flexible movement may assist in maintaining a seal against the patient's nose during use.

[0166] The buffer or damper 3106 may be a separate component. Alternatively, the buffer or damper 3106 may form part of the cradle base 3120 and / or part of the plenum base 3105 of the seal-forming structure 3100. As a concertina or bellows structure, the buffer or damper 3106 may form one or more folds. For example, one or more folds 3340 may be provided in a portion of the cradle base 3120 that connects to and / or is adjacent to the plenum base 3105. Additionally (or alternatively), one or more folds 3340 may be provided in a portion of the plenum base 3105 that connects to and / or is adjacent to the cradle base 3120. As a channel structure, the buffer or damper 3106 may form a recess in the surface of the plenum base 3105.

[0167] As shown in Figures 3Y-3CC, the cradle base 3120 may connect to the plenum base 3015 along a generally oval or elongated region (extending less than the outer extent of the cradle base 3120). Additionally, the buffer or damper 3106 may project inward toward the interior of the portion of the plenum chamber formed by the plenum base 3105. In other forms, the buffer or damper 3106 may project outward, away from the portion of the plenum chamber formed by the plenum base 3105. If the buffer or damper 3106 includes a concertina or bellows structure, a portion of the buffer or damper 3106 may project inward and another portion may project outward.

[0168] The buffer or damper 3106 may function to at least partially decouple movement of the cradle base 3120 from the plenum base 3105 during use. Additionally or alternatively, the buffer or damper 3106 may allow the seal-forming structure 3100 to adapt to different patient facial anatomy. Additionally or alternatively, the buffer or damper 3106 may act like a spring, so that when the patient dons the patient interface 3000 and presses the cradle base 3120 against the plenum base 3105, the buffer or damper 3106 may urge the cradle base 3120 toward the patient's face, thereby helping to maintain sealing engagement between the seal-forming structure 3100 and the patient's face. Additionally or alternatively, the buffer or damper 3106 may be configured to inflate or partially inflate when pressurized air enters the plenum base 3105 and / or the seal-forming structure 3100. Such expansion may assist in biasing the cradle base 3120 against the patient's face, thereby assisting in maintaining sealing engagement between the seal-forming structure 3100 and the patient's face.

[0169] The plenum base 3105 may include a vent including one or more openings. Additionally, the patient interface 3000 may not include a mouth seal or cushion (e.g., a cushion configured to seal around the patient's mouth). Also, the buffer or damper 3106 may not be configured to decouple movement between the two sealing surfaces. The buffer or damper 3106 may not be configured to decouple movement between the mouth seal and the nose seal.

[0170] 5.3.1.3 Nasal pillow 3EE and 3BB show another patient interface 3000 including a seal-forming structure 3100 in accordance with examples of the present technology. In these examples, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs 7100. These nasal puffs 7100 may be or may be referred to as nasal pillows. Each nasal puff or nasal pillow 7100 is constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0171] Nasal pillows 7100 in accordance with this form of technology include protrusions 7120 that are constructed and arranged to be inserted into or partially enter each of a patient's nostrils during use. Openings 7140 formed within each nasal pillow 7100 are configured to allow a continuous flow of air to pass therethrough, thereby transferring airflow into the patient's nares when the patient interface 3000 is being worn.

[0172] In certain forms of the present technology, each protrusion 7120 is configured to extend partially into a respective nostril of the patient. For example, each protrusion 7120 can be constructed and arranged to seal against the inner periphery of each nostril in use. As such, the height of each protrusion 7120 is less than the protrusions 7120 on conventional nasal pillows patient interfaces. The edge of each protrusion 7120 that forms the opening 7140 is configured to seal against the inner periphery of each nostril.

[0173] Each protrusion 7120 may be formed in a frustoconical shape.

[0174] In use, the protrusions 7120 may be placed in contact with the periphery of the patient's nostrils and function to position the patient interface 3000 in its intended position on the patient's face and maintain it in that position during use.

[0175] The protrusions 7120 can be formed such that the openings 7140 are angled in a manner that matches the angle of the patient's nares, i.e., the openings 7140 formed by the angle of the edge of each protrusion 7120 have an orientation that is aligned or substantially aligned with the plane formed by the inner periphery of each nostril.

[0176] 5.3.1.3.1 Seal-forming structures with bases In the exemplary patient interface 3000 shown in Figures 3EE and 3FF, the nasal pillows 7100 include a base 7160 with a protrusion 7120 provided thereon. The protrusion extends from the rear of the base 7160. The base 7160 and the protrusion 7120 may be formed from the same material and, in certain configurations, are formed as one piece, e.g., integrally molded.

[0177] 3EE and 3FF, in some forms of the present technology, the base 7160 includes lateral extensions 7180 that extend outward from the base of the protrusion 7120 on the lateral sides of each protrusion 7120. The lateral extensions 7180 are sized and oriented such that each lateral extension seals against the side or bottom of one of the patient's alae when the patient interface 3000 is worn. This improves the quality of the seal and also stabilizes the seal-forming structure during use, reducing the risk of the seal being compromised during use.

[0178] The base 7160 is formed to have a generally positive curvature in the lateral direction. For example, the base 7160 may be generally U-shaped when viewed from the anterior side in use. The curvature of the base in the anterior-posterior direction (i.e., sagittal plane) may be positive, negative, or zero. When the base 7160 has a positive curvature in the lateral direction, a protrusion 7120 is provided for each nostril, and the base 7160 between the protrusions 7120 is positioned further anteriorly to avoid contact with the bridge of the patient's nose.

[0179] The base 7160 may be configured such that when there is no force acting on the base 7160, the base 7160 has a certain amount of positive curvature in the lateral direction, such that when worn by a patient, engagement of the base and nose reduces the positive curvature of the base 7160. That is, the "natural" or "rest" curvature of the base 7160 is greater than the curvature of the base 7160 when worn. In examples where the base 7160 is formed from a resilient material or configured to resiliently return to its original shape when not worn, the sides of the base are forced inward against the patient's nose when the patient interface is worn. This assists in creating a seal against the nose and stabilizing the patient interface in a desired position.

[0180] It will be appreciated that different patient interfaces may include bases with different amounts of positive curvature in an "at rest" state, and thus may accommodate patients with noses and / or faces of different sizes and / or shapes. For example, the base 7160 shown in Figure 3EE has a lower positive curvature than the base 7160 shown in Figure 3FF, and therefore may be more suitable for patients with larger, wider, and / or flatter noses.

[0181] 5.3.1.3.2 Plenum chamber The plenum chamber 3200 has a periphery with a shape that is complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edge of the plenum chamber 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 periphery of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0182] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with therapy. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0183] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with therapy.

[0184] In certain forms of the present technology, the plenum chamber 3200 is formed from the same material as the seal-forming structure 3100. In the form of the technology shown in Figures 3EE and 3FF, the plenum chamber 3200 and the seal-forming structure 3100 are integrally formed.

[0185] One or more positioning and stabilizing structure connectors 7500 may be provided in the plenum chamber 3200. The positioning and stabilizing structure connectors 7500 are configured to connect to the positioning and stabilizing structure 3300 in use. In one form, the positioning and stabilizing structure connectors 7500 may include a clip, a buckle, or any other connector (e.g., a headgear strap) (capable of connecting to or by the positioning and stabilizing structure 3300).

[0186] 3EE and 3FF, the positioning and stabilizing structure connector 7500 includes a tube 7520 that projects laterally outward and rearward from the lateral sides of the plenum chamber 3200. In a form of the technology in which the positioning and stabilizing structure 3300 includes one or more gas delivery tubes for delivering air flow to the plenum chamber (i.e., "conduit headgear"), the gas delivery tubes of the positioning and stabilizing structure 3300 fluidly connect to the tubes 7520 that project outward from the plenum chamber 3200. The tubes 7520 are fluidly connected to the plenum chamber 3200 to deliver gas flow from the gas delivery tubes of the positioning and stabilizing structure 3300 to the plenum chamber 3200.

[0187] 5.3.1.3.3 Decoupling creases in seal-forming structures / plenum chambers In certain forms of the present technology, one or more folds 7220 are formed by a portion of the base 7160 and / or a portion of the plenum chamber 3200 of the seal-forming structure 3100. For example, the one or more folds 7220 may be provided in a portion of the base 7160 that connects to and / or is adjacent to the plenum chamber 3200. Alternatively, the one or more folds 7220 may be provided in a portion of the plenum chamber 3200 that connects to and / or is adjacent to the base 7160. Alternatively, the one or more folds 7220 may form part of the portion connected between the base 7160 and the plenum chamber 3200.

[0188] In the form of the technology shown in Figures 3EE and 3FF, the patient interface 3000 includes a single fold 7220 between the base 7160 and the plenum chamber 3200. The base 7160 connects to the plenum chamber 3200 along a generally oval or elongated region (smaller than the outer extent of the base 7160). That is, the fold 7220 is an inner fold. In other forms, the one or more folds may include an outer fold. In other forms, the one or more folds may include at least one inner and at least one outer fold (e.g., in the manner of a concertina or bellows).

[0189] 3EE and 3FF, the folds 7220 extend around the entire periphery of the base 7160. In other embodiments, one or more folds 7220 may extend around only a portion of the periphery of the base 7160. That is, the periphery of the base 7160 may include one or more portions with one or more folds 7220 and one or more portions without any folds.

[0190] The one or more folds 7220 may function to at least partially decouple movement of the base 7160 from the plenum chamber 3200 during use. Additionally or alternatively, the one or more folds 7220 may allow the seal-forming structure 7100 to conform to different patient facial anatomy. Additionally or alternatively, the one or more folds 7220 may act like a spring, so that when a patient dons the patient interface 3000 and presses the base 7160 against the plenum chamber 3200, the one or more folds 7220 tend to bias the base 7160 toward the patient's face, helping the seal-forming structure 3100 maintain sealing engagement with the patient's face. Additionally or alternatively, the one or more folds 7220 may be configured to inflate or partially inflate (when pressurized air enters the plenum chamber 3200 and / or the seal-forming structure 3100). Such expansion may assist in biasing the base 7160 against the patient's face, helping to maintain the seal-forming structure 3100 in sealing engagement with the patient's face.

[0191] 5.3.2 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0192] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0193] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0194] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate any potential destructive effects on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0195] In one form of the present technology, the positioning and stabilizing structure 3300 is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low-profile 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.

[0196] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0197] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0198] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling 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 decoupling portion does not resist compression and can be a flexible or flimsy strap, for example. The decoupling portion is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling portion prevents forces from being transmitted along the positioning and stabilizing structure 3300 to the rear portion, disrupting the seal.

[0199] 5.3.2.1 Headgear strap(s) In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0200] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap can be configured to be tensioned in use to direct a force that causes the seal-forming structure to seal with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0201] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-auricular point on the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0202] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0203] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps that are constructed to be breathable to allow water vapor to pass through the interior.

[0204] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0205] 5.3.2.2 Gas delivery pipe(s) In some forms of the present technology, one or more conduits in the form of gas delivery tubes provided in the positioning and stabilizing structure 3300 deliver pressurized air received from the air circuit 4170 from the RPT device to the patient's airway (e.g., via the plenum chamber 3200 and the seal-forming structure 3100). In these forms, the positioning and stabilizing structure 3300 may be referred to as conduit headgear, and in addition to delivering pressurized air to the airway, it functions to position and stabilize the seal-forming structure 3100 of the patient interface against the appropriate portion of the patient's face. As used herein, unless otherwise indicated by context, the terms "tube" and "conduit" should be understood as synonymous. In these forms, the conduit headgear contacts at least the region of the patient's head above the superior ear-base point. As shown in FIG. 2D, the superior ear-base point is a point on the side of the patient's head that connects to the top of the ear.

[0206] In one example, the tube can be substantially cylindrical, but in other examples, the tube can be formed with a variety of cross-sectional shapes. For example, a substantially D-shaped cross-sectional profile can be used, in which case the flat side of this profile can contact the patient's face when worn and can be more comfortable than a semicircular profile.

[0207] In some forms of the present technology, a pair of tubes included in the conduit headgear deliver pressurized air from the downstream end of the air circuit to the seal-forming structure. As an example, these tubes may be joined at their upper ends to a crown connector that supports a connection port for fluid engagement with the downstream end of the air circuit and forms an integral part of the positioning and stabilizing structure of the patient interface. These tubes may be separated, for example, for cleaning or storage.

[0208] In some forms of the present technology, the conduit headgear includes left and right tubes that fluidly engage or otherwise connect to the patient interface 3000 at their lower ends for pressurized air delivery to the seal-forming structure. A connection port for engagement with the downstream end of the air circuit 4170 is provided at the top of the conduit headgear where the two arms of the tubes meet. In this example, the conduit headgear is a substantially unitary structure.

[0209] In certain examples, the connection ports are primarily located at the top of the patient's head when the conduit headgear is worn. However, it should be understood that the connection ports may be located in different locations to accommodate the shape of the conduit headgear. For example, instead of meeting across the top of the patient's head, the tubes may be positioned to meet further back on the patient's head. This would result in the connection ports being located near a portion of the back of the patient's head (rather than at the top). Alternatively, the connection ports may be located in a different location (e.g., on one of the two tubes) than where the tubes meet.

[0210] In certain examples of the present technology, the conduit headgear is formed of a suitable spring material that provides sufficient stabilizing force to accurately place the patient interface in a sealing arrangement on the patient's head. In other specific examples, the positioning and stabilizing structure includes a mechanism for connecting headgear straps or other stabilizing components to the headgear tube. The headgear straps can reinforce the stabilizing force provided by the conduit headgear and can assist in accurately placing the patient interface in a sealing arrangement on the patient's head.

[0211] In these examples, the headgear straps may be connected directly or indirectly to the headgear tubes. In one form of patient interface, tabs configured to connect to the back straps project away from the tubes in a generally posterior direction. The tabs have slits therein that receive the strap ends.

[0212] The back straps may be secured to themselves (e.g., by hook-and-loop fastening material) after passing through slits in the tabs, thereby allowing the back straps to be adjusted to fit around different head sizes. In some forms of the technology, more than one tab may be provided on the tube, providing the patient with a range of alternative back strap placement options. This may be useful in ensuring application of a sealing force to the face.

[0213] In some examples, the tubes of the conduit headgear may be formed from textile, spacer fabric, and / or foam material. The portions of the tubes that contact the patient may be formed with textile or fabric for improved patient comfort. In some examples, the tubes may be formed from a semi-rigid material, such as an elastomeric material (e.g., silicone). In these examples, the tubes may include a thin-walled sleeve covered with fabric or textile. These sleeves may be more comfortable against the patient's face than tubes that are not covered at all.

[0214] In some instances, the tubes of the conduit headgear may have a natural, preformed shape that conforms to the general shape of a patient's head. In some instances, the tubes may have at least some ability to deform or conform to the patient's head upon application of force to the tubes. For example, the tubes may generally assume an arcuate or curved shape that resembles the contours of the patient's head between the top of the head and the nose or mouth area.

[0215] Conduit headgear may be described as inflatable because air can be contained and routed through the conduit headgear tubes for delivery of pressurized air from the air circuit 4170 to the patient's airway. It is understood that for inflatable conduit headgear, it is not necessary for all components of the conduit headgear to be inflatable. For example, if the positioning and stabilizing structure includes headgear tubes and back straps, the headgear tubes are inflatable and the back straps are non-inflatable.

[0216] 5.3.3 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).

[0217] In certain forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the ambient when the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is configured such that the magnitude of the ventilation flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0218] Ventilation section 3400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0219] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure (e.g., a swivel).

[0220] The vent 3400 in the plenum chamber 3200 may include a plurality of openings 3402. The openings 3402 may be arranged in two groups symmetrical about the centerline of the plenum chamber 3200. The plurality of openings 3402 may reduce noise and diffuse ventilation flow concentrations.

[0221] The opening 3402 may be positioned close enough to the centerline of the plenum chamber 3200 so that the opening 3402 is not blocked when the patient is lying down and sleeping. The opening 3402 may be spaced away from the centerline to avoid weakening the chassis in the narrower areas.

[0222] The opening 3402 may have a circular profile.

[0223] In the example of a patient interface shown in Figures 3EE and 3FF, the vent 3400 may be provided forward of the plenum chamber 3200. For example, the plenum chamber 3200 may include an opening 7300 on the forward side (configured to receive the vent 3400 in use). The vent 3400 may be provided as a vent module that can be removed and reinserted into the opening 7300 (e.g., upon cleaning and / or replacement of the vent 3400).

[0224] 5.3.4 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (e.g., a swivel or a ball and socket). The decoupling structure 3500 may take the form of an elbow. The decoupling structure 3500 may include a swivel that connects to the air circuit 4170 and a patient interface connector that connects to the patient interface 3000. The patient interface connector may allow the tubing of the decoupling structure 3500 to rotate relative to the patient interface 3000. The decoupling structure 3500 may also include a vent 3400. The vent 3400 of the decoupling structure 3500 may include at least one opening through a portion of the patient interface connector and / or through a portion of the tubing.

[0225] In one form of the present technology, the decoupling structure may connect to an opening 7300 on the front side of the plenum chamber 3200 in use.

[0226] In another form of the present technology, the decoupling structure may, in use, connect to a connection port 3600. The connection port 3600 is contained within or provided within one or more gas delivery tubes provided as part of the positioning and stabilizing structure 3300 and, in use, is positioned adjacent to a region of the patient's head above the superior ear base point of the patient's head.

[0227] 5.3.5 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0228] In certain forms of the present technology, the connection port 3600 may be an opening 7300 on the forward side of the plenum chamber 3200. The connection port 3600 may be configured to connect to the air circuit 4170 and / or the decoupling structure 3500 (e.g., an elbow provided in the air circuit 4170).

[0229] In alternative forms of the present technology employing the patient interface 3000 shown in Figures 3EE and 3FF, for example, the patient interface includes a connection port included in or on one or more gas delivery tubes provided as part of the positioning and stabilizing structure 3300. In such examples, the connection port may be located adjacent to a region of the patient's head above the superior ear base point of the patient's head in use. In such examples, air flow is delivered to the seal-forming structure 3100 via the connection port and gas delivery tubes included as part of the positioning and stabilizing structure 3300.

[0230] 5.3.6 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0231] 5.4 RPT Device 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. The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airways for the treatment of one or more of the respiratory disorders described anywhere herein, for example.

[0232] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0233] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0234] The air pressure path of the RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).

[0235] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0236] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0237] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.

[0238] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0239] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0240] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0241] 5.4.1.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0242] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0243] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0244] 5.4.1.3 Pressure generator In one form of the present technology, pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, blower 4142 may include a brushless DC motor 4144 with one or more impellers housed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, 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 WO 2013 / 020167.

[0245] The pressure generator 4140 is under the control of the therapy device controller.

[0246] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a pressurized air reservoir), or a bellows.

[0247] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).

[0248] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0249] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0250] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).

[0251] 5.4.1.4.1 Flow Sensor A flow sensor according to the present technology may be based on a differential pressure transducer (eg, the SDP600 series differential pressure transducer from SENSIRION).

[0252] In one form, a signal indicative of flow rate from a flow sensor is received by a central controller.

[0253] 5.4.1.4.2 Pressure Sensors A pressure sensor according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0254] In one form, the signal from the pressure sensor may be received by a central controller.

[0255] 5.4.1.4.3 Motor Speed ​​Converter In one form of the present technology, a motor speed transducer may be used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed transducer may be provided to a therapy device controller. The motor speed transducer may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0256] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., towards the motor 4144).

[0257] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0258] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0259] 5.4.2.2 Input Devices 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 human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to a central controller in another form.

[0260] In one form, input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0261] 5.4.2.3 Central Controller In one form of the present technology, the central controller is one or more processors suitable for controlling the RPT device 4000.

[0262] Suitable processors may include x86 INTEL processors, such as processors based on the ARM™ Cortex™-M processor from ARM Holdings (e.g., the S™32 series of microcontrollers from ST Micro Electronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series microcontrollers from ST Micro Electronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0263] In one form of the present technology, the central controller is a dedicated electronic circuit.

[0264] In one form, the central controller is an application specific integrated circuit. In another form, the central controller includes discrete electronic components.

[0265] The central controller may be configured to receive input signals from one or more transducers 4270, one or more input devices 4220 and the humidifier 5000.

[0266] The central controller may be configured to provide output signal(s) to one or more of the output device, the therapy device controller, the data communication interface, and the humidifier 5000.

[0267] In some forms of the present technology, the central controller is configured to implement one or more methods described herein (e.g., one or more algorithms expressed as a computer program stored in a non-transitory computer-readable recording medium (e.g., memory)). In some forms of the present technology, the central controller 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 ventilator control settings or detect respiratory-related events through analysis of recorded data (e.g., from any of the sensors described herein).

[0268] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0269] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0270] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0271] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0272] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0273] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 that receives an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0274] 5.6.2 Humidifier components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0275] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0276] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in a lateral direction, for example as shown in Figures 5A and 5B.

[0277] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0278] 5.6.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive portion 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0279] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).

[0280] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0281] 5.6.2.5 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable example of a heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.

[0282] In some forms, the heating element 5240 may be provided in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0283] 5.7 Respiratory waveform Figure 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time, and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4 L / sec; expiratory time, Te, 2.4 seconds; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of a breath, Ttot, is approximately 4 seconds. Humans typically breathe at approximately 15 breaths per minute (BPM), with a ventilation, Vent, of approximately 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0284] 5.8 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0285] 5.8.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).

[0286] Surroundings: In certain forms of the present technology, the term "surroundings" should be taken to mean (i) outside the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0287] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0288] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0289] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0290] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0291] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0292] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, reference to flow rate refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be simply called "flow."

[0293] In the example of a patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion of the patient's respiratory cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0294] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to ameliorate a medical respiratory condition in a patient.

[0295] Leakage: The term "leakage" refers to unintended airflow. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the perimeter.

[0296] Noise Conduction (Acoustic): In this document, conducted noise refers to noise carried to the patient by the pneumatic path (e.g., 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.

[0297] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.

[0298] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0299] Patient: A person with or without a respiratory disease.

[0300] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0301] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this time, is designated by the symbol Pt.

[0302] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to the atmosphere.

[0303] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.

[0304] 5.8.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. References herein to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness, as measured by ASTM D2240, in the range of about 35 to about 45.

[0305] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0306] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0307] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0308] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.

[0309] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0310] Floppy structure or component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0311] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application would be setting up and maintaining a patient interface in a sealed manner against a patient's airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0312] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0313] 5.8.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a predetermined threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0314] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0315] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0316] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0317] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0318] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0319] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat section, followed by a downswing. (ii) M-shaped: has two local peaks, one on the rising edge and one on the falling edge, with a relatively flat region between these two peaks. (iii) Chair-like: A single local peak occurs at the rising edge, followed by a relatively flat region. (iv) Inverted chair: A relatively flat section is followed by a single local peak, which occurs on the trailing edge.

[0320] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when flow is reduced below a threshold rate for a sustained period of time. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form, hypopnea may be considered when any of the following occur in adults: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting at least 10 seconds and associated desaturation of at least 3% or arousal occurs.

[0321] Hyperventilation: An increase in flow to a level higher than normal flow.

[0322] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0323] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0324] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0325] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0326] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow, and are used in contrast to "true respiratory flow" or "true respiratory flow," which is the patient's actual respiratory flow, usually expressed in liters per minute.

[0327] Tidal Volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort.

[0328] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0329] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0330] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0331] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be centered).

[0332] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0333] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may 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 and is understood as volume per minute.

[0334] 5.8.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0335] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered by the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0336] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.

[0337] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added during a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.

[0338] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0339] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0340] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).

[0341] Servo-ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the level of pressure support to bring the patient ventilation closer to the target ventilation.

[0342] 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 fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0343] Swing: A term equivalent to pressure assistance.

[0344] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0345] Typical Recent Ventilation: Typical recent ventilation Vtyp is a range of values ​​around which recent ventilation measurements tend to cluster over a given time scale. For example, a measure of the central tendency of ventilation measurements over recent history may be an appropriate value for typical recent ventilation.

[0346] 5.8.4 Anatomy 5.8.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0347] Alar angle:

[0348] Alare: The outermost point on the ala of the nose.

[0349] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.

[0350] Pinna: the entire visible part of the ear.

[0351] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0352] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.

[0353] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0354] Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasal point.

[0355] Frankfurt horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.

[0356] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0357] Lateral nasal cartilage: a generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.

[0358] Lip, lower side (lower lip: labrale inferius):

[0359] Lip, upper side (upper lip: labrale superius):

[0360] Greater alar cartilage: a cartilaginous plate located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0361] Nostrils (nares): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.

[0362] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0363] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0364] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0365] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0366] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0367] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0368] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0369] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0370] Midsagittal plane: a vertical plane running from anterior (front) to posterior (back) that divides the body into right and left halves.

[0371] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0372] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0373] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.

[0374] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0375] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0376] 5.8.4.2 Skull anatomy Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.

[0377] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0378] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.

[0379] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape from person to person. They lie side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0380] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0381] Occipital bone: The occipital bone is located at the back and underside of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity communicates with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0382] Orbit: bony cavity in the skull that contains the eyeball.

[0383] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0384] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.

[0385] Cheekbones: The face contains two cheekbones, located in the upper and lateral parts of the face, that form the cheek ridges.

[0386] 5.8.4.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0387] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0388] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchi, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0389] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. The nasal cavity is anteriorly connected to the nose, and posteriorly to the choanae, which open into the nasopharynx.

[0390] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0391] 5.8.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.

[0392] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough, changing direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0393] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0394] Functional dead space:

[0395] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more posts, ties, and stiffeners configured to position and hold a patient interface in place on a patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0396] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0397] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0398] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal"), it can refer to an effect. Two elements can be constructed and / or arranged to achieve a "sealing" or "enclosure" effect between them without the need for a separate "sealing" element itself.

[0399] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0400] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0401] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0402] 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 constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0403] Tie (noun): A structure designed to resist tension.

[0404] Venting: (noun): A structure that allows airflow into the ambient atmosphere inside a mask or conduit, allowing clinically effective washout of exhaled gases. For example, for clinically effective washout, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure. 5.8.6 Structural Shape

[0405] Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.

[0406] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictitious little person standing upright on the surface.

[0407] 5.8.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0408] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0409] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.

[0410] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this fictitious little person were to walk away from point p, they would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0411] 5.8.6.2 Two-dimensional surface curvature A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0412] Principal curvature and direction: The directions of the normal plane in which the curvature of a curve reaches its maximum and minimum values ​​are called principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0413] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0414] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0415] Dome area: an area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")

[0416] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, within a manufacturing tolerance) and the other principal curvature is non-zero.

[0417] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0418] Surface Edge: The boundary or limit of a surface or area.

[0419] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)

[0420] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface.)

[0421] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. For non-planar surfaces, there cannot be a path with the same path length as the straight-line distance between two points (for a fictional human, this straight-line distance corresponds to the distance "in a straight line").

[0422] 5.8.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0423] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character were flying along the curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.

[0424] Unit normal vector: As the fictional character moves along the curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0425] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0426] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See Figures 3O and 3P.

[0427] Torsion of a Space Curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, because T2 > T1, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S.

[0428] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0429] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.

[0430] 5.8.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or spatial curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.

[0431] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0432] 5.9 Other Notes A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0433] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0434] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0435] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0436] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0437] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0438] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0439] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically described.

[0440] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0441] Although the technology herein has been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0442] It is therefore to be understood that numerous modifications may be made in the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0443] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3105 Plenum Base 3106 Damper 3110 Protrusion 3120 Cradle Base 3130 Opening 3140 Proximal end 3150 outlet end 3160 Peripheral wall 3170 plane 3175 Longitudinal axis 3180 Center opposite side 3190 outward facing side 3200 Plenum Chamber 3210 Tendon 3220 Upper point 3230 Down 3240 Central part 3250 Lateral section 3260 sealing surface 3270 Rim 3280 plane 3285 Buffer or Damper 3290 Positioning and Stabilizing Structural Connector 3300 Positioning and Stabilizing Structures 3310 Inlet pipe 3330 Surface 3400 Ventilation section 3500 Uncoupling structure 3600 connection port 3700 Forehead support 4000 RPT devices 4010 Outer Housing 4012 Upper 4014 parts 4015 Panel 4016 chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Supplemental Oxygen 4200 Electrical Components 4202 PCBA 4210 Power supply 4220 input devices 4270 Converter 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5240 heating element 7100 Nasal puff / pillow 7120 Protrusion 7140 Opening 7160 base 7180 Lateral extension 7220 One or more folds 7300 Opening 7500 Positioning and Stabilizing Structure Connector 7520 tube

Claims

1. 1. A patient interface configured to deliver a pressurized flow of breathing gas to an airway of a patient, the patient interface comprising: a cradle base configured to cradlingly support the patient's nose and form a seal with the patient's nose in use, the cradle base comprising a pair of side portions on opposite sides of the cradle base; two prongs extending from the cradle base and configured to be inserted into the patient's nares in use, each prong having an opening formed therein configured to allow a continuous flow of air to pass therethrough; and a plenum base that forms a plenum chamber with the cradle base and is attached to the cradle base by a flexible interface; the cradle base is configured such that movement of the cradle base decouples from the plenum base; the side portions of the cradle base extend laterally outward beyond the flexible interface such that there is a gap between the plenum base and at least a portion of the side portions of the cradle base; A patient interface, wherein the plenum base and the cradle base are inflatable so as to press a sealing surface of the cradle base against the patient's nose in use.

2. The patient interface of claim 1 , wherein the protrusions are constructed and arranged to seal against the inner periphery of each of the nostrils in use.

3. 3. The patient interface of claim 1 or 2, wherein the protrusions include ends that, in use, seal against the inner periphery of each of the nostrils.

4. 4. A patient interface according to claim 1, wherein the cradle base includes lateral extensions extending laterally outward on either side of the two protrusions, each of the lateral extensions being configured to seal against a lateral or lower portion of each of the patient's nasal alars in use.

5. A patient interface according to any preceding claim, wherein the cradle base is configured to be deflected outwardly by the patient's nose when worn by the patient.

6. A patient interface according to any preceding claim, wherein the protrusion has a frusto-conical shape.

7. A patient interface according to any preceding claim, wherein the opening of the protrusion is angled relative to the surface of the cradle base from which the protrusion begins to extend.

8. A patient interface according to any preceding claim, wherein the plenum base includes a pair of air inlets on opposite lateral sides.

9. 9. The patient interface of claim 1, wherein a buffer or damper between the cradle base and the plenum base is configured to decouple movement of the cradle base from the plenum base.

10. A patient interface according to any preceding claim, wherein the buffer or damper is not configured to decouple movement between the two sealing surfaces.

11. 11. The patient interface of claim 9 or 10, wherein the buffer or damper is not configured to decouple movement between the nose seal and the mouth seal.

12. The patient interface of any one of claims 1 to 11, wherein the patient interface does not include a mouth seal.

13. A patient interface according to any preceding claim, wherein the protrusion does not include a stem.

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