Patient interface with foam cushioning

Abstract

To provide a patient interface with a foam cushion.SOLUTION: A patient interface is configured to deliver a flow of positive pressure respiratory gas to an entrance of a patient airways. The patient interface includes an elastomeric support wall forming at least part of a plenum chamber configured to receive the flow of positive pressure respiratory gas. The patient interface also includes an elastomeric support flange positioned at an end of the elastomeric support wall and extending radially inward from the support wall. The support flange has a flap portion at a central upper region of the support flange that extends further in the radially inward direction than the rest of the support flange. In addition, a foam cushion is mounted on the support flange. The foam cushion is configured to form a seal with the patient face and includes an attachment surface that is in contact with an outer surface of the support flange.SELECTED DRAWING: Figure 20

Description

Technical Field

[0001] 1 Background of the Technology 1.1 Technical Field The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatuses and their use.

Background Art

[0002] 1.2 Description of Related Technologies 1.2.1 Human Respiratory System and Its Disorders The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0003] These airways include a series of bronchial tubes, which become narrower, shorter, and more numerous as they proceed deeper into the lungs. The main function of the lungs is gas exchange, which takes in inhaled air oxygen into venous blood and expels carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory disorders exist. Certain disorders can be characterized by specific incidences (e.g., apnea, hypopnea, and hyperventilation).

[0005] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0006] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected patients typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although patients often experience no symptoms. See Patent Document 1 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CSR is accompanied by recurrent sleep-wake cycles, which result in severe insomnia, increased sympathetic nervous system activity, and increased afterload. See Patent Document 2 (Berthon-Jones).

[0008] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders:

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

[0010] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0011] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0012] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) Degenerative or slowly progressive disorders: Characterized by muscle damage that worsens over several years but with only a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, exertional and resting dyspnea, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0013] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0014] A range of treatments are used to treat or improve this condition. Furthermore, even otherwise healthy individuals can benefit from preventive treatment for respiratory disorders. However, these methods have several drawbacks. 1.2.2 Treatment

[0015] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the respiratory disorders described above. 1.2.2.1 Respiratory pressure therapy

[0016] Respiratory pressure therapy (unlike negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) is the application of supplying air to the airway entrance at a controlled target pressure, which is normally positive pressure relative to the atmosphere, throughout the patient's entire respiratory cycle.

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, the continuous positive airway pressure acting as an air pressure splint by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway obstruction. Since CPAP therapy for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved. 1.2.2.2 Flow Treatment

[0020] In all respiratory therapies, the delivery of a prescribed therapeutic pressure is not intended. In some respiratory therapies, the delivery of a prescribed tidal volume is intended by delivering an inspiratory flow profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a controlled or high-concentration gas flow may only be used as an aid to the patient's own spontaneous breathing. In one example, high-flow therapy (HFT) involves delivering a continuous, heated, humidified airflow at a "therapeutic flow rate" maintained nearly constant throughout the respiratory cycle through an unsealed or open patient interface. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that providing a high flow of air to the airway inlet improves ventilation efficiency by allowing flushing or flushing of exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits include improved warmth and humidification (perhaps due to secretion control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, therapeutic flow rates can follow a fluctuating profile throughout the respiratory cycle.

[0021] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe a continuous flow of oxygen-enriched gas delivered to the patient's airways at a specified flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM) at a specified oxygen concentration (the oxygen fraction in the ambient air is 21% to 100%). 1.2.2.3 Supplementary Oxygen

[0022] In the case of certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplementary oxygen to a pressurized air flow. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplementary oxygen. When oxygen is added to HFT, the resulting treatment is referred to as HFT with supplementary oxygen. 1.2.3 Respiratory Therapy System

[0023] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating a disease.

[0024] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 1.2.3.1 Patient Interface

[0025] The patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with the ambient pressure for treatment execution (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0026] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a purely decorative mask, it may not be able to maintain appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0027] Certain masks may be clinically unfavorable in the present technology (for example, when the mask blocks the airflow through the nose and only allows the airflow through the mouth).

[0028] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0029] Certain masks may be impractical for use during sleep (for example, when sleeping on the side in bed with the head on the pillow).

[0030] There are multiple challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0031] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable for one or more reasons. Using an incorrectly sized mask can lead to decreased compliance, reduced comfort, and a poorer patient outcome. While pilot-specific masks, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks used for anesthesia may be tolerable for their original purpose, they can be undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask needs to be worn during sleep.

[0032] CPAP therapy is highly effective in treating certain respiratory disorders when the patient consents to the treatment. Patients may refuse treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may be unable to clean the mask, which can affect patient compliance.

[0033] Masks designed for other purposes (e.g., for pilots) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0034] For these reasons, the patient interface for CPAP delivery during sleep forms a distinct field. 1.2.3.1.1 Seal-forming structure

[0035] The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0036] Patient interfaces can be partially characterized 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 may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the bridge of the nose of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces may be known by a variety of names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0037] A seal-forming structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different facial shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0038] A specific seal-forming structure can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, one or both the patient's facial shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0039] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap may form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0040] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve the seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, it may crease or buckle during use, leading to leakage.

[0041] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find this uncomfortable.

[0042] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0043] Regarding the technology for forming a patient interface seal within a certain range, disclosures are made in the following patent applications, which have been transferred to ResMed Limited: Patent Document 3; Patent Document 4; Patent Document 5.

[0044] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6 (Trimble et al.), which was transferred to Puritan-Bennett Corporation.

[0045] ResMed Limited manufactures the following products using nasal pillows: SWIFT® nasal pillow mask, SWIFT® II nasal pillow mask, SWIFT® LT nasal pillow mask, SWIFT® FX nasal pillow mask, and MIRAGELIBERTY® full face mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: Patent Document 7 (in particular describing the features of ResMed Limited's SWIFT® nasal pillow), Patent Document 8 (in particular describing the features of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 9 and 10 (in particular describing the features of ResMed Limited's MIRAGE LIBERTY® full face mask); and Patent Document 11 (in particular describing the features of ResMed Limited's SWIFT® FX nasal pillow). 1.2.3.1.2 Positioning and Stabilization

[0046] The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can interfere with the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0047] In one technology, adhesive joints are used. For example, see Patent Document 12. However, when adhesive joints are used, discomfort may occur.

[0048] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling. 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0049] Respiratory pressure therapy (RPT) devices can be used individually or as part of a system for the delivery of one or more of the above-mentioned therapies, for example, by activating the device to generate an air delivery flow to the airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0050] Pneumatic pressure generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic pressure generators for medical applications have specific requirements that cannot be met by more general pneumatic pressure generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects 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 specific requirement for a particular RPT device is acoustic noise.

[0052] Table of noise output levels of conventional RPT devices (measured using only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0053] [Table 1]

[0054] 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 assistance for invasive and non-invasive independent ventilation for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0055] The ResMed Elisee® 150 and ResMed VSIII® ventilators can provide invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators provide volumetric ventilation and pneumatic 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 supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0056] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters. 1.2.3.3 Air Circuit

[0057] An air circuit is a conduit or tube constructed and positioned so that airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation. 1.2.3.4 Humidifier

[0058] Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is generated, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air. Therefore, humidifiers often possess not only the ability to heat airflow but also the ability to humidify it.

[0059] While a certain range of artificial humidification devices and systems are known, they do not meet the specific requirements of medical humidifiers.

[0060] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled by the patient, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0061] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they may be difficult or inconvenient for patients to use.

[0062] 1.2.3.5 Ventilation Technology

[0063] Some forms of therapeutic systems may include a vent for expelling exhaled carbon dioxide. This vent may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0064] These vents may include orifices, through which gas can flow when the mask is in use. In the case of numerous such vents, noise is generated. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of the patient 1000 and the person sharing the bed 1100 may be disturbed, for example, due to noise or concentrated airflow.

[0065] ResMed Limited has developed several improved mask ventilation technologies. See below: Patent Document 13; Patent Document 14; Patent Document 15; Patent Document 16; Patent Document 17.

[0066] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m)

[0067] [Table 2]

[0068] ( * (Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

[0069] The sound pressure values ​​of various objects are listed below.

[0070] [Table 3] [Prior art documents] [Patent Documents]

[0071] [Patent Document 1] U.S. Patent No. 4944310 [Patent Document 2] U.S. Patent No. 6532959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Patent No. 4782832 [Patent Document 7] International Publication No. 2004 / 073778 [Patent Document 8] U.S. Patent Application No. 2009 / 0044808 [Patent Document 9] International patent application WO2005 / 063328 [Patent Document 10] International Publication No. 2006 / 130903 [Patent Document 11] International Publication No. 2009 / 052560 [Patent Document 12] U.S. Patent Application Publication No. 2010 / 0000534 [Patent Document 13] International Patent Application Publication No. 1998 / 034665 [Patent Document 14] International Patent Application Publication No. 2000 / 078381 [Patent Document 15] U.S. Patent No. 6581594 [Patent Document 16] U.S. Patent Application Publication No. 2009 / 0050156 [Patent Document 17] U.S. Patent Application Publication No. 2009 / 0044808 [Overview of the project]

[0072] 2. A brief explanation of the technology This technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory disorders, which have one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability.

[0073] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0074] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0075] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0076] Another aspect of one embodiment of the present technology relates to a patient interface which may include a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure. The patient interface may further include a ventilation structure. The patient interface may be further configured to leave the patient's mouth exposed, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe through their mouth from the surroundings when there is no pressurized airflow through the plenum chamber inlet port.

[0077] Another aspect of one form of the present technology relates to a patient interface including: a plenum chamber pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and a seal-forming structure constructed and positioned to seal an area of ​​the patient's face surrounding the entrance to the patient's airway, the seal-forming structure having holes inside so that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nostrils, and the seal-forming structure, when in use, delivers the therapeutic pressure within the plenum chamber to the patient's breathing. A seal-forming structure constructed and positioned to be maintained throughout the entire inhalation cycle; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a tie, the tie being constructed and positioned such that at least a portion of it rests on the patient's head above the upper earlobe of the patient's head during use; and a ventilation structure configured to allow a continuous gas flow exhaled by the patient to move from inside the plenum chamber outwards, the ventilation structure being sized and shaped to maintain therapeutic pressure within the plenum chamber during use. The patient interface is configured to leave the patient's mouth exposed, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe outwards through the plenum chamber inlet port when there is no pressurized airflow.

[0078] Another aspect of one embodiment of this technology relates to a patient interface which may include: an elastomer support wall, an elastomer flange at the end of the elastomer support wall, and a foam cushion mounted on the elastomer support flange.

[0079] Another aspect of the present technology may relate to a patient interface configured to deliver a positive pressure respiratory gas flow to the entrance of the patient's airway, including at least the entrance of the patient's nostrils. The patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient pressure throughout the patient's respiratory cycle when used during the patient's sleep for the improvement of sleep-disordered breathing. The patient interface may include an elastomer support wall that forms at least a portion of a plenum chamber configured to receive a positive pressure respiratory gas flow. The patient interface may also include an elastomer support flange positioned at the end of the elastomer support wall and extending radially inward from the support wall, wherein the support flange includes a flap portion in the central upper region of the support flange that extends further radially inward than the rest of the support flange. A foam cushion may be mounted on the support flange, and the foam cushion includes a mounting surface that contacts the outer surface of the support flange and is configured to form a seal with the patient's face.

[0080] In any further example of any of the embodiments described in the preceding paragraph: (a) the foam cushion may have a mounting surface that contacts the outer surface of the support flange, the mounting surface of the foam cushion being widest at the location corresponding to the flap; (b) the outer surface of the support flange at the flap may have a positive curvature; (c) the central lower region of the support flange may have a positive curvature; (d) the curvature of the support flange within the flap may be greater than the curvature of the support flange within the central lower region; (e) the central lower region of the support flange is located between a first pair of negative curvature regions of the support flange. (f) The flap portion may be provided between a second pair of negative curvature regions of the support flange, (g) The support flange may include eight transition regions where the curvature of the outer surface of the support flange transitions from positive to negative or negative to positive, (h) The foam cushion may include a sealing surface configured to come into contact with the patient's face during use, (i) The sealing surface of the foam cushion may have positive curvature where the outer surface of the support flange has positive curvature, (j) The sealing surface of the foam cushion may have negative curvature where the outer surface of the support flange has negative curvature, (k) Flap portion (l) The outer surface of the inner support flange may be saddle-shaped, (m) The outer surface of the support flange in the central lower region may be saddle-shaped, (n) The outer surface of the support flange in the flap portion may be located between a first pair of dome regions, (o) The foam cushion may overhang the support flange, (p) The patient interface may further include a shell with an inlet opening configured to receive a flow of positive pressure respiratory gas, (q) The support wall may be attached to the shell, (r) The patient The interface may further include a positioning and stabilizing structure configured to support a shell, a support wall, and a foam cushion over the patient's head, (s) the positioning and stabilizing structure may be removablely attachable to the shell, (t) the positioning and stabilizing structure may include a shroud and a number of headgear straps, (u) the shroud may be removablely attachable to the shell at an inlet opening, and / or (v) the patient interface may further include an air delivery tube connectable to the shroud and the shell.

[0081] Another aspect of this technology may relate to a patient interface configured to deliver a positive pressure flow of respiratory gas to the entrance of the patient's airway, including at least the entrance of the patient's nostrils. The patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient pressure throughout the patient's respiratory cycle when used during the patient's sleep for the improvement of sleep-disordered breathing. The patient interface may include an elastomer support wall that forms at least a portion of a plenum chamber configured to receive a positive pressure flow of respiratory gas. The patient interface may also include an elastomer support flange positioned at the end of the elastomer support wall and extending radially inward from the support wall. A foam cushion may be mounted on the support flange and configured to form a seal with the patient's face. The elastomer wall thickness of the support flange may vary from the central upper region of the support flange to the central lower region of the support flange.

[0082] In any further example of any aspect of the preceding paragraph: (a) the elastomer wall thickness of the support flange may be thinner in the upper and lower central regions than in the intermediate region between the upper and lower central regions; (b) the elastomer wall thickness of the support flange may be thinner in the upper central region than in the lower central region; (c) the elastomer wall thickness of the support wall may vary from the upper central region to the lower central region of the support wall; (d) the elastomer wall thickness of the support wall may vary in the intermediate region between the upper and lower central regions. (e) The elastomer wall thickness of the support wall may be thinner in the central upper region and the central lower region of the support wall than in the central lower region; (f) The central upper region of the support wall may include an upper gusset; (g) The central lower region of the support wall may include a lower gusset; (g) The lower gusset may be more collapsible than the upper gusset; (h) The thickness of the foam cushion may be consistent throughout the foam cushion; (i) The patient interface may further include a pair of compressible ribs in the lower region of the patient interface. (j) Compressible ribs may be attached to the support wall and support flange, respectively, and may be configured to prevent at least a portion of the support flange from flexing due to positive pressure in the plenum chamber; (k) The support flange may include a flap portion in the central upper region of the support flange that extends further radially inward than the rest of the support flange; (l) The flap portion may be configured to prevent at least a portion of the support flange from flexing due to positive pressure in the plenum chamber; (m) The foam cushion may overhang the support flange. (n) The patient interface may further include a shell having an inlet opening configured to receive a flow of positive pressure respiratory gases, (o) a support wall may be attached to the shell, (p) the patient interface may further include a positioning and stabilizing structure configured to support the shell, the support wall and a foam cushion over the patient's head, (q) the positioning and stabilizing structure may be removablely attached to the shell, (r) the positioning and stabilizing structure may include a shroud and a plurality of headgear straps, (s) the shroud isThe patient interface may be removablely attached to the shell at the entrance opening, and (t) the patient interface may further include an air delivery tube connectable to the shroud and shell.

[0083] Another aspect of this technology relates to a patient interface. This patient interface may include: a shell having an inlet opening configured to receive a flow of respiratory gases; a support wall mounted on the shell; a support flange positioned at the end of the support wall; and a foam cushion mounted on the support flange.

[0084] Another aspect of this technology may relate to a patient interface configured to deliver a positive pressure flow of respiratory gas to the entrance of the patient's airway, including at least the entrance of the patient's nostrils. The patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient pressure throughout the patient's respiratory cycle when used during the patient's sleep for the improvement of sleep-disordered breathing. The patient interface may include a shell with an inlet opening configured to receive a positive pressure flow of respiratory gas. The patient interface may also include an elastomer support wall attached to the shell. The shell and the elastomer support wall may cooperate to form at least a portion of a plenum chamber configured to receive a positive pressure flow of respiratory gas. An elastomer support flange may be positioned at the end of the elastomer support wall and may extend radially inward from the support wall. A foam cushion may be attached on the support flange. The foam cushion may be configured to form a seal with the patient's face. The elastomer support wall and foam cushion may be configured such that, when the patient interface is mounted over the patient's face, a portion of the central longitudinal axis of the entrance opening, outside the patient interface, extends at least partially downward.

[0085] In any further example of any aspect of the preceding paragraph: (a) the support wall may be configured to pivot about a transverse axis extending through the lateral side of the support wall; (b) the configuration of the support wall may be configured such that when the support wall pivots from a neutral position, the entrance opening of the shell rotates so that the portion of the central longitudinal axis of the entrance opening outside the patient interface rotates downward; (c) the lower part of the support wall may include a lower gusset; (d) the lower gusset may be configured so that when the lower gusset is crushed, the support wall pivots about a transverse axis; (e) the upper part of the support wall may include an upper gusset. (f) The patient interface may further include a positioning and stabilizing structure configured to support a shell, a support wall, and a foam cushion over the patient's head; (g) the positioning and stabilizing structure may be removablely attachable to the shell; (h) the positioning and stabilizing structure may include a shroud and a number of headgear straps; (i) the shroud may be removablely attachable to the shell at an inlet opening and / or; and / or; (j) the patient interface may further include an air delivery tube connectable to the shroud and the shell.

[0086] Another aspect of the present technology may relate to a patient interface configured to deliver a positive pressure flow of respiratory gas to the entrance of the patient's airway, including at least the entrance of the patient's nostrils. The patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient pressure throughout the patient's respiratory cycle when used during the patient's sleep for the improvement of sleep-disordered breathing. The patient interface may include an elastomer support wall that forms at least a portion of a plenum chamber configured to receive a positive pressure flow of respiratory gas. The patient interface may further include an elastomer support flange positioned at the end of the elastomer support wall and extending radially inward from the support wall. A foam cushion may be mounted on the support flange. The foam cushion may include a mounting surface configured to be attached to the support flange and a sealing surface configured to contact the patient's face and form a seal. The foam cushion may be bent around a bisecting plane. This bisecting plane divides the foam cushion in half and extends through the central upper region and central lower region of the foam cushion. The mounting surface and sealing surface may be wider in the bisecting surface than in the rest of the foam cushion.

[0087] In any further example of any aspect of the preceding paragraph: (a) the foam cushion may include a circumferential surface extending from the mounting surface to the sealing surface, (b) the circumferential surface may be concave in the central lower region, (c) the mounting surface and the sealing surface may have the same width throughout the foam cushion, (d) the foam cushion may overhang the support flange by the same amount throughout the foam cushion, (e) the patient interface may include a shell with an inlet opening configured to receive a flow of positive pressure breathing gas, (f) the support wall may be attached to the shell, (g) the patient The interface may further include a positioning and stabilizing structure configured to support a shell, a support wall, and a foam cushion over the patient's head, (h) the positioning and stabilizing structure may be removablely attachable to the shell, (i) the positioning and stabilizing structure may include a shroud and a number of headgear straps, (j) the shroud may be removablely attachable to the shell at an inlet opening, and / or (k) the patient interface may further include an air delivery tube connectable to the shroud and the shell.

[0088] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0089] One embodiment of this technology is a method for manufacturing an apparatus.

[0090] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0091] One embodiment of this technology is a portable RPT device that can be carried by a person (for example, around their home).

[0092] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment.

[0093] The methods, systems, devices, and apparatus described may be embodied in a way that enables improvements in the functionality of processors (e.g., processors in purpose-specific computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory diseases (e.g., sleep-disordered breathing).

[0094] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute even further embodiments or sub-embodiments of the present technology.

[0095] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0096] 3. Brief Description of the Drawings This technology is illustrated non-limitingly as an example in the attached drawings. In the drawings, similar reference numerals include the following similar elements. 3.1 Respiratory Therapy Systems [Figure 1] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 2]The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 removes a full face mask and receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 3.2 Anatomy of the respiratory system and face [Figure 3] This diagram outlines the human respiratory system, including the nose and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 4] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 5] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. Superior, inferior, radially inward, and radially outward directions are also depicted. [Figure 6] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 7] This is a further lateral view of the head. The approximate locations of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also depicted. [Figure 8] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 9] This is a lateral view of the surface features of the nose. [Figure 10] This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, the frontal process of the maxilla, and fibrous adipose tissue. [Figure 11]This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 12] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 13] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 14] An anterior lateral view of the nose is shown. 3.3 Patient Interface [Figure 15] This shows a patient interface in the form of a nasal mask, representing one embodiment of this technology. [Figure 16] This is a perspective view of an exemplary patient interface. [Figure 17] Another perspective of an exemplary patient interface. [Figure 18] An exploded view of an exemplary patient interface is shown. [Figure 19] This is a side view of an exemplary foam cushion. [Figure 20] This is a rear view of an exemplary patient interface. [Figure 21] This is a rear view showing the product with an example foam cushion attached. [Figure 22] This is another rear view showing the product without the example foam cushion attached. [Figure 23] This is another side view of an exemplary patient interface. [Figure 24] This is a side view showing an exemplary patient interface mounted on a patient's face. [Figure 24A] This is a side view of the patient interface in Figure 24, without the patient's face. [Figure 24B] Figure 24 is a side view of the patient interface when the patient interface is pivoted. [Figure 25] This is a perspective view of an exemplary frame assembly. [Figure 26] An exemplary positioning and stabilization system is shown. 3.3.1 Surface shape and reference points [Figure 27] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the curvature shown in Figure 28. [Figure 28] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 27. [Figure 29] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 30] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 31. [Figure 31] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 30. [Figure 32] A mask cushion containing two pillows is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The dome region and saddle region are illustrated. [Figure 33] A mask cushion is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 34] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 35]This is a cross-sectional view through the structure shown in Figure 34. The illustrated surface defines the two-dimensional hole in the structure shown in Figure 34. [Figure 36] Figure 34 is a perspective view of the structure including two-dimensional and one-dimensional holes. The surface that borders the two-dimensional holes in the structure of Figure 34 is also shown. [Figure 37] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 38] Figure 37 is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 39] Figure 37 shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 40] This demonstrates the left-hand rule. [Figure 41] I will demonstrate the right-hand rule. [Figure 42] Shows the left ear, including the left ear spiral. [Figure 43] Shows the right ear, including the right ear spiral. [Figure 44] The right hand shows a spiral. [Figure 45] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 46] This is a diagram of the patient interface 3000, showing the sagittal plane and the central contact surface. [Figure 47] Figure 46 is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 47, the sagittal plane divides the patient interface 3000 into left-hand and right-hand sides. [Figure 48] Figure 47 is a cross-sectional view through the patient interface, taken in the sagittal plane shown in Figure 47. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. This tendon rests on the sagittal plane and contacts only the cushion of the patient interface at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 49] Figure 46 shows the patient interface 3000 in the use position on the face. The sagittal plane of the patient interface 3000 generally coincides with the midline sagittal plane of the face when the patient interface is in the use position. The central contact surface generally corresponds to the “face plane” when the patient interface is in the use position. In Figure 49, the patient interface 3000 is a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip. 3.4 RPT Device [Figure 50] This shows an RPT device based on one form of this technology. [Figure 51] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items placed in the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface. [Figure 52] This is a schematic diagram of the electrical components of an RPT device according to one aspect of this technology. [Figure 53] This is a schematic diagram of the algorithm executed in an RPT device according to one form of this technology. 3.5 Humidifier [Figure 54] This is an isometric view of a humidifier based on one embodiment of this technology. [Figure 55] This is an isometric view of a humidifier according to one embodiment of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 56] This is a schematic diagram of a humidifier based on one form of this technology. [Modes for carrying out the invention]

[0097] 4. Detailed explanation of examples of this technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for illustrative purposes only and are not limiting.

[0098] The following description is provided in relation to a variety of examples that may share one or more common properties 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 any other example. In addition, any single feature or combination of features in any of these examples may constitute further examples. 4.1 Treatment

[0099] In one embodiment, the technology includes a method for treating respiratory disorders. This method includes applying positive pressure to the airway entrance of 1000 patients.

[0100] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0101] In certain examples of this technology, mouth breathing is restricted, limited, or prevented. 4.2 Respiratory Therapy Systems

[0102] In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800. 4.3 Patient Interface

[0103] A non-invasive patient interface 3000 according to one aspect of this technology may include the following functional modes: a seal-forming structure 3100, a shell or chassis 3200, a frame assembly 3300, a positioning and stabilization structure 3400, a vent 3500, and a connection port 3210 in one form for connection to an air circuit 4170. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 may be positioned to surround the patient's airway inlet(s)

[0104] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0105] A patient interface 3000 according to one embodiment of this technology may be constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0106] A patient interface 3000 according to one embodiment of this technology can be constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0107] A patient interface 3000 according to one embodiment of this technology may be constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings. 4.3.1 Seal-forming structure

[0108] In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region may be the region in the seal-forming structure 3100 where sealing occurs. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0109] In one embodiment, the target seal-forming region may be located on the outer surface of the seal-forming structure 3100.

[0110] In certain embodiments of this technology, the seal-forming structure 3100 may be (at least partially) made of a biocompatible material (e.g., silicone rubber).

[0111] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0112] In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads. 4.3.1.1 Sealing mechanism

[0113] In one embodiment, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and positioned such that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0114] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface. 4.3.1.2 Nasal bridge or nasal ridge region

[0115] In one embodiment, the non-invasive patient interface 3000 may include a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0116] In one embodiment, the seal-forming structure may include a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use. 4.3.1.3 Upper lip area

[0117] In one embodiment, the non-invasive patient interface 3000 may include a seal-forming structure that forms a seal on the upper lip region of the patient's face (i.e., the upper lip) when in use.

[0118] In one embodiment, the seal-forming structure may include a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use. 4.3.1.4 Jaw region

[0119] In one embodiment, the non-invasive patient interface 3000 may include a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

[0120] In one embodiment, the seal-forming structure may include a saddle-like region constructed to form a seal on the jaw region of the patient's face when in use. 4.3.1.5 Foam cushions and undercushions

[0121] As shown in Figures 16 to 24B, a foam cushion 3105, which may be included in the seal-forming structure 3100, is mounted on an undercushion 3110, and the undercushion 3110 may be mounted on a shell or chassis 3200. When the seal-forming structure 3100 is attached to the patient's face, the foam cushion 3105 can engage tightly with the patient's face. The undercushion 3110 can provide support for the foam cushion 3105 and assist in seal formation with the patient's face. The shell or chassis 3200 can provide rigid support for maintaining the shape of the seal-forming structure 3100. The shell or chassis 3200 can also provide an interface for holding the frame assembly 3300.

[0122] The foam cushion 3105 may be a soft memory foam. For example, the foam cushion 3105 may be made of polyether and / or polyurethane material. In addition, the foam cushion 3105 may be configured to maintain a compression seal against the patient's skin.

[0123] The foam cushion 3105 shown in Figure 22 is in its state before attachment and / or fixation to the under cushion 3110. As shown, the foam cushion 3105 may have a sealing surface 3115 configured to engage tightly with the patient's face. The mounting surface 3120 may face the sealing surface 3115 and engage with the corresponding surface of the under cushion 3110. When the foam cushion 3105 is not attached, the sealing surface 3115 and the mounting surface 3120 may be substantially planar. Manufacturing the foam cushion 3105 as a substantially planar component may make the manufacturing process simpler and easier. In addition, since the thickness of the foam cushion 3105 may be substantially consistent throughout the foam cushion 3105, the distance between the sealing surface 3115 and the mounting surface 3120 may be substantially the same throughout the foam cushion 3105. Maintaining a consistent thickness for the foam cushion 3105 can simplify the manufacturing process, leading to easier production and improved cost-effectiveness. This consistent thickness also facilitates the assembly of the foam cushion 3105 into the under cushion 3110.

[0124] The hole 3125 may be formed through the central region of the foam cushion 3105 and bounded by the inner surface 3126, thereby forming a gas channel through the foam cushion 3105. At the same time, the periphery of the foam cushion 3105 may be formed by the circumferential surface 3127. In addition, the sealing surface 3115 may meet the inner surface 3126 at the first rim 3130 at one end of the hole 3125, and the mounting surface 3120 may meet the inner surface 3126 at the second rim 3135 at the other end of the hole 3125. The widths of the sealing surface 3115 and the mounting surface 3120 (i.e., the distance between the rims of the hole 3125 and the circumferential surface 3127 of the foam cushion 3105) may vary.

[0125] For example, as can be seen from Figure 22, the widths of the sealing surface 3115 and the mounting surface 3120 may be greater in the central upper region (or bridge of nose region) 3140 and the central lower region (or upper lip region) 3142 of the foam cushion 3105 than in other regions of the foam cushion 3105. The central upper region 3140 may be configured to engage with the patient's bridge of nose, and the central lower region 3142 may be configured to engage with the patient's upper lip region (upper lip) and / or the patient's columella.

[0126] The increase in width (wider regions 3145 and 3150) may create a depression within the hole 3125, thereby making the hole 3125 narrower in the central upper region 3140 and the central lower region 3142. In addition, the circumferential surface 3127 of the foam cushion 3105 may be turned inward in the central lower region 3142, thereby creating a concave (or positively curvilinear) portion on the circumferential surface 3127. By turning the circumferential surface 3127 inward, a depression may be generated within the foam cushion 3105, which may help improve comfort in the patient's upper lip area. The remaining portion of the circumferential surface 3127 may be convex (or have negative curvature). At the same time, the inner surface 3126 in the central upper region 3140 and the central lower region 3142 may be convex (or have negative curvature), while the remaining portion of the inner surface 3126 may be concave (or have positive curvature).

[0127] As can be seen from Figure 22, the shape of the hole 3125 may differ from the shape of the surrounding foam cushion 3105 due to the recess in the central lower area and the wider portions of the mounting surface 3115 and sealing surface 3120 in the central upper region 3140 and the central lower region 3142.

[0128] The shape of the foam cushion 3105 can conform to subtle differences and / or undulations on the user's face. In addition, when attached to the under cushion 3110 (as shown in Figure 21), the foam cushion 3105 can be folded or bent along the bisecting plane 3155. The bisecting plane 3155 bisects the foam cushion 3105 and extends through the central upper region 3140 and the central lower region 3142. When attached to the under cushion 3110, the central upper region 3140 of the foam cushion 3105 can be positioned to engage with the patient's nasal bridge. In addition, the central lower region 3142 of the foam cushion 3105 can be positioned to engage with the patient's upper lip region (upper lip) and / or nasal columella. Thus, the foam cushion 3105 can have an expanded sealing area in the wider regions 3145 and 3150 (i.e., in the patient's nasal bridge and upper lip region (or upper lip)). The sealed area of ​​the foam cushion 3105 in the remaining region (i.e., the portion of the foam cushion 3105 that comes into contact with the patient's face and forms a seal against the patient's face) can be smaller than that in the wider regions 3145 and 3150.

[0129] Increasing the sealing area in the wider regions 3145 and 3150 can lead to an additional surface area that engages with the user's nasal bridge and upper lip region (or upper lip). In addition, the additional surface area in the central upper region 3140 of the foam cushion 3105 (i.e., the portion configured to engage with the patient's nasal bridge) can improve the seal between the foam cushion 3105 and the patient's nasal bridge and the upper part of the patient's nose by providing sufficient surface area to maintain the seal with the patient's nose in dynamic situations (e.g., when the seal-forming structure 3100 moves relative to the user's nose). Furthermore, the additional surface area in the central lower region 3142 can create a raised area. This raised area can prevent the patient's nostrils from being blocked by the foam cushion 3105 (when the seal-forming structure 3100 moves relative to the patient's nose (e.g., when the mask rides up)). In detail, the raised portion can engage with the patient's columella before the remaining lower portion of the foam cushion 3105 can reach the patient's nostril opening, thereby preventing the remaining lower portion of the foam cushion 3105 from reaching the patient's nostril opening and obstructing it. Without the raised portion, there would be nothing to prevent the lower part of the foam cushion 3105 from reaching the patient's nostril opening when the patient interface is mounted.

[0130] When mounted on the undercushion 3110, the shape of the foam cushion 3105 may deform, thereby allowing the curvature of the sealing surface 3115 in the central lower region 3142 (which may be configured to engage tightly with the patient's nasal columella and / or upper lip) to be positive across the bisecting surface 3155. The central lower region 3142 is intended to also be a saddle region. The sides of the central lower region 3142 may be provided with a pair of lower corner regions 3156 configured to engage with the lower corners of the patient's nose. The sealing surface 3115 in the pair of lower corner regions 3156 may have negative curvature. In addition, each of the pair of lower corner regions 3156 is intended to be dome-shaped.

[0131] The sealing surface 3115 in the central upper region 3140 (which may be formed to engage tightly with the patient's nasal bridge) may fold along the bisecting plane 3155. Alternatively, the sealing surface 3115 in the central upper region 3140 may have positive curvature across the bisecting plane 3155. The central upper region 3140 is intended to be saddle-shaped. The positive curvature in the central upper region 3140 is further intended to be greater than the positive curvature in the central lower region 3142. In addition, a pair of upper regions 3157 are provided on the sides of the central upper region 3140 and are configured to engage with the upper part of the patient's nose. The sealing surface 3115 in the upper regions 3157 may have negative curvature. In addition, each of the pair of upper regions 3157 is intended to be dome-shaped.

[0132] The upper left region 3157 and the lower left corner region 3156 can be separated from each other by an intermediate region 3158 with positive curvature. Similarly, the upper right region 3157 and the lower right corner region 3156 can be separated from each other by an intermediate region 3159 with positive curvature. The positive curvature of both intermediate regions 3158 and 3159 can extend along a transverse axis 3161 that runs from intermediate region 3158 to intermediate region 3159. In addition, both intermediate regions 3158 and 3159 can be saddle-shaped.

[0133] As described above, the sealed surface 3115 of the foam cushion 3105 may have four dome-shaped regions, four saddle-shaped regions (or three saddle-shaped regions if the central upper region 3140 is not saddle-shaped), and eight transition regions between the dome regions and the saddle regions. In these eight transition regions, the shape of the sealed surface 3115 transitions from saddle to dome or vice versa.

[0134] The undercushion 3110 may be constructed of a single-wall translucent silicone rubber. The elastomer wall thickness of the undercushion wall can be varied in different sections to ensure a wider fit range and to fine-tune the spring force generated by the undercushion 3110 to maximize the compression of the foam cushion 3105. The undercushion 3110 itself cannot create a seal with the patient's face (i.e., the seal can be created between the foam cushion 3105 and the patient's face). Instead, the undercushion 3110 can provide additional refractiveness, allowing the seal-forming structure 3100 to move dynamically along the patient's face (while minimizing compression loss to the foam cushion 3105). Comfort can be optimized by intentionally making the undercushion 3110 thinner in highly sensitive areas of the patient's face (particularly the nasal bridge area and / or the upper lip area).

[0135] A support wall 3160, which may be included in the undercushion 3110, extends from the chassis 3200 to the foam cushion 3105 and provides structural support to the foam cushion 3105. The support wall 3160 may terminate at a support flange 3165. The support flange 3165 may be cantilever-supported from the support wall 3160. In addition, the support flange 3165 may extend radially inward from the support wall 3160 to the center of the air passage within the patient interface 3000. The support flange 3165 may have an outer surface 3162. A mounting surface 3120 of the foam seal 3105 may be fixed to the outer surface 3162. The mounting surface 3120 to the support flange 3165 may be fixed by bonding or adhesive. The adhesive may be liquid silicone rubber.

[0136] The support wall 3160 may include an upper gusset 3170 in the upper region of the support wall 3160 corresponding to the patient's nasal bridge. The upper gusset 3170 may span the bisecting plane 3155. In addition, the thickness of the support wall 3160 in the central upper region (or apex or nasal bridge region) 3140 may be thinner than the thickness in other regions of the support wall 3160. In addition, the thickness of the support wall 3160 in the central upper region (or apex or nasal bridge region) 3140 may decrease from the upper gusset 3170 to the support flange 3165. For example, the thickness of the support wall 3160 in the upper gusset 3170 (or at least the recessed portion of the gusset 3170) may be 0.70 to 0.75 mm (e.g., 0.72 mm), while the thickness of the portion of the support wall 3160 between the upper gusset 3170 and the support flange 3165 may be 0.40 to 0.45 mm (e.g., 0.42 mm).

[0137] The upper gusset 3170 and the thinner elastomer wall may allow for increased refractive power of the nasal bridge portion of the seal-forming structure 3100 (without increasing the compression of the foam cushion 3105). Such increased refractive power may lead to improved comfort, reduced pressure across the patient's nasal bridge, and reduced redness on the patient's face.

[0138] The support wall 3160 may include a pair of thickened regions 3175 on the sides of the upper gusset 3170. The thickened regions 3175 may provide stable support for a proper seal at the patient's nasal / facial junction. The thickened regions 3175 may be the thickest part of the support wall 3160. For example, the thickness of the thickened regions 3175 may be 1.80–1.90 mm (e.g., 1.85 mm). The thickened regions 3175 may not extend all the way to the support flange 3165. Alternatively, the thickened regions 3175 may not extend all the way to the support flange 3165. The thickened regions 3175 may increase seal stability in areas where leakage and discomfort are most likely to occur.

[0139] The lower gusset 3180 may be located on the opposite side of the upper gusset 3170 in the central lower region 3142 of the seal-forming structure 3100. The lower gusset 3180 may straddle the bisecting plane 3155. The elastomer wall thickness of the lower gusset 3180 and the support wall 3160 in the central lower region (flexible upper lip region) 3142 may be thinner than the elastomer wall thickness of the rest of the support wall 3160 (except for the portion of the support wall 3160 in the upper gusset 3170 and the central upper region 3140). For example, the elastomer wall thickness 3160 of the support wall in the central lower region 3142 and the lower gusset 3180 may be in the range of 0.55 mm to 0.85 mm. The bottom of the support wall 3160 (for example, the central part of the lower gusset 3180) may be 0.55 mm thick, and the portion of the support wall 3160 that spans the bottom (for example, the lateral portion of the lower gusset 3180) may be 0.85 mm thick.

[0140] The remaining portion of the support wall 3160 may be 1.50 to 1.70 mm (e.g., 1.60 mm). The arrangement of the upper gusset 3170 and the lower gusset 3180 may be such that the collapse of the lower gusset 3180 allows the seal-forming structure 3100 to pivot around an axis 3185 extending through the seal-forming structure 3100 between the upper gusset 3170 and the lower gusset 3180. In some configurations, the axis 3185 and the lateral axis 3161 are intended to be the same axis. In other configurations, these axes may be parallel to each other. A pivot point may be formed on the support wall 3160 by the thickened region 3175, and it is further intended that the seal-forming structure 3100 can pivot around this pivot point. Alternatively, the pivot point on the support wall 3160 may be located between the thickened region 3175 and the lower gusset 3180 (i.e., outside the thickened region 3175).

[0141] The depth of one or more recesses in the lower gusset 3185 may be consistent or may vary. For example, the depth of one or more recesses may increase as one approaches the lateral side of the lower gusset 3185, so that one or more recesses in the central region of the lower gusset 3185 may be shallower than those in the lateral region. Alternatively, one or more recesses may be deepest in the central region and become shallower as one approaches the lateral region.

[0142] In addition, if there are multiple depressions, their depths may vary. For example, the depth of one or more depressions may be consistent, while the thickness of one or more depressions may vary as described in the paragraph above. As stated above, it should be understood that the depth of one or more depressions in the upper gusset 3170 may vary or may be consistent.

[0143] The support flange 3165 may have a surface (i.e., an outer surface 3162) to which the foam cushion 3105 can be attached. The angle α between the support wall 3160 and the support flange 3165 is intended to be 90 degrees or less. In addition, the support flange 3165 may extend from the periphery of the seal-forming structure 3100 into the interior of the seal-forming structure 3100 (i.e., from the periphery inward). Furthermore, since the support flange 3165 may be flexible, it may be possible to change the angle α between the support flange 3165 and the support wall 3160 depending on the amount of force acting on the foam cushion 3105 (and thus the amount of force acting on the support flange 3165). In the neutral state (i.e., when there is no force acting on the seal-forming structure 3100), the angle α may vary in different regions of the support flange 3165. Such different angles α may allow the foam cushion 3105 to follow the contours of the patient's face.

[0144] The support flange 3165 may be constructed from the same material as the support wall 3160. In addition, the support flange 3165 may be integrally formed with the support wall 3160. The support flange 3165 is intended to be simply an extension of the support wall 3160 that is radially bent inward into the interior of the seal-forming structure 3100. Alternatively, the support flange 3165 may be formed separately from the support wall 3160 and assembled to the support wall 3160. In this configuration, the support flange 3165 may be fixed to the support wall 3160 by mechanical fasteners, adhesives, or joints.

[0145] Because the support flange 3165 is flexible, it may bend due to the pressure of the breathing gas within the patient interface 3000. When the support flange 3165 bends in this way, the angle α between the support flange 3165 and the support wall 3160 exceeds a predetermined threshold, resulting in an undesirable condition called "rupture." The occurrence of "rupture" can lead to a compromise in the sealing ability of the foam cushion 3105. The threshold may be greater than 90 degrees. In some cases, the threshold may be less than 90 degrees. The threshold angle is intended to be any angle that compromises the sealing ability of the foam cushion 3105. Alternatively, the threshold angle may be the angle α that exists between the support flange 3165 and the support wall 3160 when the seal-forming structure 3100 is in a neutral state (i.e., when there is no force acting on the support flange 3165).

[0146] To prevent "rupture," the seal-forming structure 3100 may include preventative components. For example, the seal-forming structure 3100 may include one or more ribs 3190 connected to the support flange 3165 and the support wall 3160. These ribs 3190 can prevent the portion of the support flange 3165 attached to the ribs from bending outward, increasing the angle α. These ribs 3190 can also reduce the amount by which the support flange 3165 bends outward in the region adjacent to the ribs 3190. Since the ribs 3190 may be flexible and / or compressible, it is intended that the support flange 3165 can move relative to the support wall 3160 when the foam cushion 3105 is subjected to a compressive force. For example, the ribs 3190 may allow the support flange 3165 to move, reducing the angle α between the support wall 3160 and the support flange 3165.

[0147] As shown in Figure 20, a pair of ribs 3190 may be positioned adjacent to the lower gusset 3180 (this pair of second ribs 3190 is covered by the foam cushion 3105). The thickness of each rib 3190 is intended to be 0.60 to 0.80 mm (e.g., 0.70 mm). In addition, bisecting surfaces 3155 may be provided on the sides of the ribs 3190 within the area below the foam cushion 3105.

[0148] As can be seen from Figures 20 and 23, the support flange 3165 may extend a certain distance from the support wall 3160. The distance the support flange 3165 extends from the support wall 3160 is the width of the support flange 3165. The width of the support flange 3165 can provide a platform or surface to which the mounting surface 3120 of the foam cushion 3105 can be attached. As can be seen from Figure 23, the width of the support flange 3165 may be less than the width of the mounting surface 3120 of the foam cushion 3105. Therefore, a portion of the mounting surface 3120 may overhang the support flange 3165. By allowing the foam cushion 3105 to overhang the support flange 3165, rotation of the foam cushion 3105 can be promoted, making it more resistant to "bursting". However, if the rotation is too inward, discomfort may occur due to contact with the under cushion 3110, and the load on the patient's face may also increase. Therefore, overhang in areas prone to discomfort (e.g., the bridge of the nose and the upper lip area (or upper lip)) can be relatively reduced.

[0149] Another component configured to prevent "rupture" of the seal-forming structure 3100 may be an extension (or flap) 3195 of the support flange 3165. The extension 3195 may be located in the central upper region of the seal-forming structure 3100 (i.e., the portion of the seal-forming structure 3100 configured to engage with the patient's nasal bridge) and may be a region of the support flange 3165 in which the width of the support flange 3165 is greatest. The extension 3195 may take the form of a flap and extend beyond the width of the adjacent portion of the support flange 3165.

[0150] In addition, the extension region 3195 may span the bisecting surface 3155 that bisects the seal-forming structure 3100 through the central upper region 3140 and the central lower region 3142 of the seal-forming structure 3100. The extension region 3195 may have positive curvature (i.e., a concave shape) across the bisecting surface 3155. In addition, it is intended that the outer surface 3162 of the extension region 3195 may have a saddle shape. The increased width and curved surface of the extension region 3195 may help to withstand the reversal of the curvature of the extension region 3195 due to pressure in the plenum chamber (i.e., the positive curvature of the outer surface 3162 changing to negative curvature), thereby supporting resistance to "bursting". Thus, the extension region 3195 may eliminate the need for ribs in the upper region of the seal-forming structure 3100. As can be seen from Figure 23, increasing the width of the extension region 3195 can make the overhang of the central upper region 3140 of the foam cushion 3105 less than the overhang of the central lower region 3142 of the foam cushion 3105. Alternatively, increasing the width of the wide region 3145 can make the overhang of the foam cushion 3105 across the support flange 3165 consistent throughout the entire seal-forming structure 3100.

[0151] The extension region 3195 of the support flange 3165 may correspond to the central upper region 3140 of the foam cushion 3105. In addition, the upper region 3157 may overlap with the lateral side of the extension region 3195 of the support flange 3165. Alternatively, the upper region 3157 may be adjacent to the extension region 3195 of the support flange 3165.

[0152] The elastomer wall thickness of the support flange 3165 is intended to vary in different regions. For example, the elastomer wall thickness of the support flange 3165 may be thinner in the central upper region 3140 and the central lower region 3142 than in other regions of the support flange 3165. By making the elastomer wall of the support flange 3165 thinner, it may be possible to increase the flexurality of the foam cushion in regions that are more sensitive to pressure. In addition, by providing the rib 3190 in the lower region of the seal-forming structure 3100 and the extension region 3195 in the central upper region 3140, it may be possible to make the support flange 3165 thinner in these regions without compromising resistance to "bursting".

[0153] It is further intended that the elastomer wall thickness of the support flange 3165 may increase as it approaches the support wall 3160. For example, the end of the support flange 3165 furthest from the support wall 3160 (i.e., the cantilever end) may be thinner than the end of the support flange 3165 attached to the support wall 3160. The elastomer wall thickness of the support flange 3165 may change abruptly in a "step" manner, or it may change gradually in a tapered manner. In addition, the support flange 3165 may change tapered or "stepwise" in a specific region of the support flange 3165 (the central lower region 3145), and have a consistent elastomer wall thickness in other regions (e.g., the intermediate region). Alternatively, the elastomer wall thickness may be consistent throughout the entire support flange. By increasing the thickness of the support flange 3165 at the point where it connects to the support wall 3160, the support flange 3165 can be reinforced or its resistance to deflection or "bursting" can be increased.

[0154] The curvature of the outer surface 3162 of the support flange 3165 may correspond to the curvature of the sealing surface 3115 of the foam cushion 3105. For example, as described above, the outer surface 3162 in the extension region 3195 may have a positive curvature (concave shape) that spans the bisecting surface 3155 (similar to the curvature of the sealing surface 3115 in the central upper region 3140). In addition, the extension region 3195 is intended to be saddle-shaped.

[0155] The outer surface 3162 in the central lower region 3142 may have a positive curvature (concave shape) that spans the bisecting surface 3155 (similar to the curvature of the sealing surface 3115 in the central lower region 3142). In addition, the central lower region 3142 of the support flange 3165 is intended to be saddle-shaped.

[0156] A pair of lower corner regions 3196 may be provided on the sides of the central lower region 3142 of the support flange 3165, corresponding to the lower corner region 3156 of the foam cushion 3105. The outer surface 3162 of the lower corner region 3196 may have negative curvature (convex shape). In addition, the lower corner region 3196 may be dome-shaped.

[0157] It is further intended that the positive curvature of the outer surface 3162 in the extension region 3195 may be higher than the positive curvature of the outer surface 3162 in the central lower region 3142. In addition, a pair of upper regions 3197 may be provided on the sides of the extension region 3195 in locations corresponding to the upper region 3157 of the foam cushion 3105. The outer surface 3162 in the upper region 3197 may have negative curvature (convex shape). In addition, it is intended that the upper region 3197 may be dome-shaped.

[0158] The upper left region 3197 and the lower left corner region 3196 can be separated from each other by an intermediate region 3198 with positive curvature. Similarly, the upper right region 3197 and the lower right corner region 3196 can be separated from each other by an intermediate region 3199 with positive curvature. The positive curvature of both intermediate regions 3198 and 3199 can be provided along the transverse axis 3161. In addition, both intermediate regions 3198 and 3199 can be saddle-shaped.

[0159] As described above, the outer surface 3162 of the support flange 3165 may have four dome-shaped regions, four saddle-shaped regions, and eight transition regions. These eight transition regions are provided between the dome regions and the saddle regions, and a shape transition from saddle-shaped to dome-shaped or vice versa occurs on the outer surface 3162.

[0160] 4.3.2 Shell or Chassis

[0161] The shell or chassis 3200 has a perimeter shape that is complementary to the surface outline of an average human face in the area where a seal is formed during use. Actual contact with the face may be provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the shell or chassis 3200 during use.

[0162] The connection of the shell or chassis 3200 to the undercushion 3110 may be permanent (e.g., co-molding, overmolding) or removable (e.g., mechanical interlock). The undercushion 3110 may be constructed from a relatively flexible or bendable material (e.g., silicone), and the shell or chassis 3200 may be constructed from a relatively rigid material (e.g., polycarbonate). The shell or chassis 3200 and the undercushion 3110 may cooperate to form a plenum chamber 3205. Alternatively, the shell or chassis 3200 and the undercushion 3110 may be formed from a single piece of homogeneous material.

[0163] The shell or chassis 3200 does not cover the patient's eyes during use. In other words, the eyes may be outside the pressurized space defined by the shell or chassis 3200. In this configuration, the pressure is often reduced and / or the wearer's comfort is increased, which can improve treatment compliance.

[0164] The shell or chassis 3200 may be constructed from a transparent material (e.g., transparent polycarbonate). The use of transparent materials may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0165] Alternatively, the shell or chassis 3200 may be constructed from a translucent material. Using a translucent material can reduce the intrusiveness of the patient interface and help improve compliance with treatment.

[0166] An opening 3211, which may be contained within the shell or chassis 3200, allows breathable gas to be delivered to the plenum chamber 3205. The opening 3211 may be bounded by an annular flange 3215. The annular flange 3215 may be adapted to connect to a frame assembly 3300 and to interface (e.g., seal) with the air circuit 4170.

[0167] The shell or chassis 3200 may provide a flexible sealing membrane or lip seal 3225 that provides a seal with the air circuit 4170. The lip seal 3225 may be mounted on the rim of the opening 3211 and may include a free end that extends radially inward into the opening 3211. The end of the air circuit 4170 may be constructed and positioned to engage tightly with the lip seal 3225 to form a seal for the air passage. The sealing mechanism between the air circuit 4170 and the shell or chassis 3200 may be provided separately from retaining features, which are intended to connect the air circuit 4170 to the shell or chassis 3200 or the frame assembly 3300.

[0168] The shell or chassis 3200 may form a plenum chamber 3205 for delivery of pressurized gas to the inlet of the patient's airway. The shell or chassis is a rigid structure and directs forces for sealing against the patient's face onto the seal-forming structure 3100. Forces may be provided by tension generated from the fastening of the headgear straps of the positioning and stabilizing structure 3400. These forces may be transferred from a pair of upper and lower headgear straps to the corresponding upper and lower arms of the frame assembly 3300.

[0169] The opening 3211 within the shell or chassis 3200 may be oriented relative to the foam cushion 3105 such that the opening 3211 faces downward (when worn by the user). As shown in Figures 24 and 24B, the central longitudinal axis 3212 of the opening 3211 may be oriented such that a portion of the central longitudinal axis 3212 outside the patient interface 3000 extends downward. As understood, the central longitudinal axis 3212 may form an angle β with respect to the user's Frankfort horizontal plane 3213. The angle β is intended to be between 10 and 50 degrees (e.g., 20 and 30 degrees). By oriented the opening 3211 downward, the opening 3211 may be better oriented relative to the patient's nostrils for improved CO2 flushing.

[0170] As described above, the support wall 3160 may include a lower gusset 3180. The lower gusset 3180 may be configured to be more flexible than the upper gusset 3170 (i.e., more easily crushed than the upper gusset 3170), so that the support wall 3160 is bent around the lateral axis 3185. Due to this bending of the support wall 3160, the orientation of the opening 3211 shifts, and the angle β increases when the lower gusset 3180 is compressed. In addition, the portion of the central longitudinal axis 3212 of the opening 3211 that is outside the patient interface 3000 may rotate downward.

[0171] Bending of the support wall 3160 due to the collapse of the lower gusset 3180 may occur when the patient interface 3000 is fixed to the patient's face by the positioning and stabilizing structure 3400. More specifically, due to tension from the positioning and stabilizing structure 3400, the seal-forming structure 3100 may be pressed against the contour of the patient's face. When pressed against the contour of the patient's face, the lower gusset 3180 may be subjected to a compressive force and at least partially collapse, thereby causing the seal-forming structure 3100 to move (or pivot) from its neutral position (i.e., the position where the lower gusset 3180 is not subjected to a compressive force). Due to the pivot of the seal-forming structure 3100, a portion of the central longitudinal axis 3212 outside the patient interface 3000 may rotate toward a downward direction, and the angle β with respect to the patient's Frankfort horizontal plane may increase. 4.3.3 Frame Assembly

[0172] The frame assembly 3300 may include a shroud (or anchor wall) 3305 and a headgear connector 3310 attached to the shroud 3305, thereby providing a four-point connection to the positioning and stabilization structure 3400. The shroud 3305 (e.g., constructed of a relatively rigid plastic material such as polycarbonate) may include an opening 3315 with an annular rim structured to engage with the air circuit 4170. Multiple locking tabs or spring arms 3320 (e.g., two, three, four, five or more tabs or spring arms) that may be included on the rear or rear side of the shroud 3305 are spaced apart around the opening 3315 and structured to provide a mechanical interlock (e.g., a snap-fit ​​connection) with the shell or chassis 3200.

[0173] The headgear connector 3310 may include a shroud connector 3325 connected to the shroud 3305, a pair of (i.e., right and left) upper headgear connector arms 3330 configured to connect to each upper headgear strap of the stabilization structure 3400, a pair of (i.e., right and left) lower headgear connector arms 3335 configured to connect to each lower headgear strap of the stabilization structure 3400, and an intermediate portion 3340 for interconnecting the upper and lower arms 3330, 3335 with the shroud connector 3325.

[0174] Each upper headgear connector arm 3330 may include an upper headgear connection point. This upper headgear connection point takes the form of a slot 3345 configured to receive each upper headgear strap of the stabilization structure 3400. Each lower headgear connector arm 3335 may include a lower headgear connection point in the form of a magnetic connector 3350 configured to be located on and connected to magnets associated with each lower headgear strap of the stabilization structure 3400. However, it should be understood that the upper and lower headgear connector arms 3330, 3335 may be connected to the headgear straps of the headgear by other suitable means.

[0175] The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can be stiffened or reinforced so that they can maintain a pre-formed 3D shape (not a floppy disk shape) (structured to conform to the face profile and position the upper headgear connection point appropriately). The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can each maintain their pre-formed shape due to their own stiffness or rigidity (more specifically, orientation). The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can be constructed to have low resistance (lower stiffness or rigidity) to bending inward and outward from the face in order to accommodate a variety of face widths. The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can be made rigid so as not to deform substantially under the tension applied from the headgear strap, thereby acting as an intermediate between the headgear strap and the chassis 3200, converting the tension from the headgear strap into a compressive force applied to the seal-forming structure 3100, thereby providing a seal and stability over the face. The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can also be shaped to apply an appropriate force vector to the seal-forming structure 3100 via the shell or chassis 3200, thereby resulting in a stable and comfortable seal. In an example, the seal-forming structure 3100 can be drawn into the patient's face under an appropriate compressive force and can also coincide with the Frankfort horizontal plane 3213 (which is drawn directly into the face).

[0176] The upper and lower headgear connector arms 3330 and 3335 can also be made rigid, so that torsional rigidity can provide resistance to deformation under twisting. The upper and lower headgear connector arms 3330 and 3335 can also be resistant to bending deformation in the vertical up-and-down direction along the face (e.g., remaining at the correct height relative to the ears). However, the upper and lower headgear connector arms 3330 and 3335 can also be constructed to allow bending by providing a predetermined level of deformation (allowing bending in the direction of approaching / awaying from the face), thus allowing adjustment to different face widths. In addition, the upper and lower headgear connector arms 3330 and 3335 can be elastic / resilient in this orientation, so that they can return to their original positions. This feature can also prevent discomfort by minimizing the load / force applied to the face from the frame assembly when the headgear strap is tightened (by absorbing some of these tensions through flexibility). In some places, the upper headgear connector arm 3330 and the lower headgear connector arm 3335 can provide rigidity / stiffness to avoid contact with the face, where the upper and lower headgear connector arms 3330 and 3335 can function as supports that withstand bending deformation or compression into the face from headgear tension. Conversely, in other places, the flexibility of the upper and lower headgear connector arms 3330 and 3335 can collapse under tension or compression from lateral loads (for example, when the patient is sleeping in a lateral position), thereby applying the lateral load to the patient interface. The upper headgear connector arm 3330 and the lower headgear connector arm 3335 can absorb the compressive force applied from the lateral load, thereby preventing the seal forming structure 3100 from being pushed aside.This flexibility can lead to improved fit to the patient's face, thereby increasing comfort and preventing seal instability from lateral loads.

[0177] The lower headgear connector arm 3335 can optionally be made more flexible than the upper headgear connector arm 3330. For example, the lower headgear connector arm 3335 may have lower torsional resistance, thereby allowing it to twist together with the lower headgear strap of the stabilization structure 3400. This flexibility allows the lower headgear connector arm 3335 to twist and rotate together with the lower headgear strap, thereby preventing the retaining features from becoming disconnected under these forces (i.e., maintaining the connection of the lower headgear connector arm 3335 to the lower headgear strap).

[0178] Each intermediate portion 3340 of the headgear connector 3310 assembly may include a flexible portion 3355 that conforms to a variety of face profiles (e.g., to accommodate a variety of face widths). The flexible portion 3355 includes recesses (on the front and / or rear sides) so that the hinge section is intended to be formed adjacent to the shell or chassis 3200.

[0179] The headgear connector 3310 may include a multilayer structure (e.g., layers of different materials to provide the desired flexibility). The headgear connector is intended to be more rigid than the headgear strap of the stabilization structure 3400.

[0180] The inner surface (or rear surface) of the shroud 3305 may engage with the outer surface of the shell or chassis 3200. The shell or chassis 3200 may include separate retaining features or may be structured to removably connect to the inner surface of the frame assembly 3300. The patient interface 3000 may be modular in that a single-size frame assembly can be connected to shroud sizes or chassis sizes (e.g., small to large). Thus, the shell or chassis 3200 may also be removably connected to the frame assembly 3300, thereby allowing the frame assembly 3300 to be connected to predetermined configurations corresponding to each shell size or chassis size. For example, the overall height of a smaller shell or chassis 3200 may be relatively low relative to a medium to large cushion assembly. By connecting the frame assembly 3300 in a position relative to the cushion assembly, the upper headgear attachment point 3345 is positioned correctly (between the eyes and ears) while providing an attachment point for the upper headgear strap to avoid the ears. In other words, the frame assembly 3300 may be connected at a higher position on the shell or chassis 3200 compared to a medium or large-sized shell or chassis. In the example, the medium and / or large sizes may not have this requirement and may be connected so that the frame assembly 3300 is positioned substantially the same. 4.3.4 Positioning and stabilization structure

[0181] The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3400 during use.

[0182] In one embodiment, the positioning and stabilizing structure 3400 can provide at least sufficient holding force to overcome the effect of positive pressure in the plenum chamber that causes the face to lift away from the face.

[0183] In one embodiment, the positioning and stabilizing structure 3400 can provide sufficient holding force to overcome the attractive force on the patient interface 3000.

[0184] In one embodiment, the positioning and stabilizing structure 3400 can provide a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (e.g., due to tube dragging or accidental interference with the patient interface).

[0185] In one embodiment of this technology, a positioning and stabilization structure 3400 may be provided, configured to be worn by a patient while sleeping. In one example, the positioning and stabilization structure 3400 may have an inconspicuous profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3400 may include at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3400 may include at least one flat strap.

[0186] In one embodiment of this technology, a positioning and stabilizing structure 3400 may be provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0187] In one embodiment of this technology, a positioning and stabilizing structure 3400 may be provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of the patient's head resting on a pillow.

[0188] In one embodiment of this technology, the positioning and stabilizing structure 3400 may include a release portion positioned between the front portion and the rear portion of the positioning and stabilizing structure 3400. This release portion is not compressible and may be, for example, a flexible or flimsy strap. The release portion may be constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits force along the positioning and stabilizing structure 3400 to the rear portion, thereby interfering with the seal.

[0189] In one embodiment of this technology, the positioning and stabilizing structure 3400 may include a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam may be porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer may include a loop material that engages with a hook material portion.

[0190] In certain embodiments of this technology, the positioning and stabilizing structure 3400 may include a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the seal-forming structure into contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0191] In one embodiment of this technology, the positioning and stabilizing structure may include a first tie, which is constructed and positioned such that, in use, at least a portion of its lower edge passes over the patient's head to the upper base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0192] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure may include a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers or rests on the occipital bone of the patient's head.

[0193] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure may include a third tie constructed and positioned to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to move apart in different directions.

[0194] In certain embodiments of this technology, the positioning and stabilizing structure 3400 may include a flexible and, for example, non-rigid strap. An advantage of this embodiment may be that the strap is more comfortable when the patient is lying down during sleep.

[0195] In certain embodiments of this technology, the positioning and stabilizing structure 3400 may include a strap configured to be breathable, allowing water vapor to pass through its interior.

[0196] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3400. Each positioning and stabilizing structure is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3400 that is suitable for a large head rather than a small head, and for another small head rather than a large head.

[0197] In the illustrated example, the seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a stabilization structure (headgear) 3400 during use. The headgear 3400 may include an upper side strap 3410 and a pair of lower side straps 3420 connected to a circular crown strap 3430 that encloses the top of the patient's head. For example, via a headgear clip, the upper side strap 3410 may be connected to an upper headgear connector arm 3330 of a frame assembly 3300, and the lower side strap 3420 may be connected to a lower headgear connector arm 3335 of the frame assembly 3300. The side straps 3410 and 3420 may include an adjustable hook-and-loop (Velcro®) connection mechanism (e.g., hook tabs such as Velcro®) to facilitate connection and / or adjustment. Alternatively, the lower side strap 3420 may include a magnetic connector corresponding to the corresponding magnetic connector on the lower headgear connector arm 3335 of the frame assembly 3300. 4.3.5 Ventilation

[0198] In one embodiment, the patient interface 3000 may include a vent 3500 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0199] In certain configurations, the vent 3500 may be configured to allow a continuous airflow from the inside of the plenum chamber to the surroundings when the pressure inside the plenum chamber is positive relative to the surroundings. The vent 3500 may be configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0200] One embodiment of the ventilation section 3500 according to this technology may include a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0201] The ventilation section 3500 may be located within the shell or chassis 3200. Alternatively, the ventilation section 3500 may be located within a release structure (e.g., a swivel). 4.4 RPT Devices

[0202] An RPT device 4000 according to one aspect of this technology comprises mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow delivered to a patient's airway for the treatment of one or more respiratory diseases described in any of the documents.

[0203] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts: an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 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.

[0204] The pneumatic path of the pneumatic 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 4272 and a flow sensor 4274).

[0205] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0206] The RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapeutic device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202. 4.4.1 RPT Device Mechanical and Pneumatic Components

[0207] An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units. 4.4.1.1 Air filter (single or multiple)

[0208] An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0209] In one embodiment, the inlet air filter 4112 is positioned at the beginning of the upstream air pressure path of the pressure generator 4140.

[0210] In one embodiment, the outlet air filter 4114 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800. 4.4.1.2 Muffler (singular or plural)

[0211] An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0212] In one embodiment of this technology, the inlet muffler 4122 is positioned upstream of the pressure generator 4140 within the pneumatic path.

[0213] In one embodiment of this technology, the outlet muffler 4124 is positioned within the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800. 4.4.1.3 Pressure Generator

[0214] In one embodiment of this technology, a pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be positioned within a volute. The blower can deliver an air supply at a rate of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O, when respiratory pressure therapy is being administered. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference: 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 WO2013 / 020167.

[0215] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0216] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows. 4.4.1.4 Converters (singular or plural)

[0217] The converter may be located inside the RPT device or outside the RPT device. The external converter may be located on an air circuit, for example, or may form part of an air circuit (e.g., a patient interface). The external converter may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0218] In one embodiment of this 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 positioned to generate signals that describe the characteristics of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0219] In one embodiment of this technology, one or more transducers 4270 may be located near a patient interface 3000 or 3800.

[0220] In one embodiment, the signal from the converter 4270 may be filtered (for example, by low-pass, high-pass, or band-pass filtering). 4.4.1.4.1 Flow Sensor

[0221] The flow sensor 4274 according to this technology can be obtained based on a differential pressure transducer (for example, an SDP600 series differential pressure transducer from SENSIRION).

[0222] In one configuration, a signal representing the flow rate, generated by the flow sensor 4274, is received by the central controller 4230. 4.4.1.4.2 Pressure Sensor

[0223] The pressure sensor 4272 using this technology can be positioned in communication with both pneumatic and fluid pathways. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the GENERAL ELECTRIC NPA series.

[0224] In one configuration, the signal generated by the pressure sensor 4272 is received by the central controller 4230. 4.4.1.4.3 Motor Speed ​​Converter

[0225] In one form of the present technology, a motor speed converter 4276 may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter 4276 may be provided to the treatment device controller 4240. The motor speed converter 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor). 4.4.1.5 Anti-spillback valve

[0226] In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the motor 4144). 4.4.2 RPT device electrical components 4.4.2.1 Power supply

[0227] The power supply 4210 may be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0228] In one form of the present technology, the power supply 4210 supplies power only to 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. 4.4.2.2 Input device

[0229] 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 that enable a human to interact with the device. The buttons, switches or dials may be physical devices or software devices accessible via a touch screen. 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 the central controller 4230 in another form.

[0230] In one embodiment, the input device 4220 may be constructed and configured to allow a human to select a value and / or a menu option. 4.4.2.3 Central Controller

[0231] In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0232] Suitable processors may include x86 Intel processors, which are based on ARM® Cortex®-M processors from ARM Holdings (e.g., STM32 series microcontrollers from ST MICROELECTRONICS). In certain alternative forms of this technology, 32-bit RISC CPUs (e.g., STR9 series microcontrollers from ST MICROELECTRONICS) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) may also be suitable.

[0233] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0234] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 comprises discrete electronic components.

[0235] The central controller 4230 may be configured to receive input signals (one or more) from one or more transducers 4270, one or more input devices 4220, and humidifiers 5000.

[0236] The central controller 4230 may be configured to provide output signals (one or more) to one or more of the output devices 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0237] In some embodiments of this technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms 4300 expressed as computer programs stored in a non-temporary computer-readable storage medium (e.g., memory 4260)). In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methods may be performed by remotely located devices. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein). 4.4.2.4 Clocks

[0238] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 4.4.2.5 Therapeutic device controllers

[0239] In one embodiment of this technology, the therapeutic device controller 4240 is a therapeutic control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.

[0240] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used. 4.4.2.6 Protection circuit

[0241] One or more protection circuits 4250 in this technology may include electrical protection circuits, temperature and / or pressure safety circuits. 4.4.2.7 Memory

[0242] According to one aspect of the present technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some aspects, the memory 4260 may include a battery-backed static RAM. In some aspects, the memory 4260 may include volatile RAM.

[0243] The memory 4260 may be disposed on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or NAND flash.

[0244] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260 (e.g., a memory card manufactured according to the Secure Digital (SD) standard).

[0245] In one aspect of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium. Computer program instructions (e.g., one or more algorithms 4300) representing one or more of the methods described herein are recorded on this recording medium. 4.4.2.8 Data Communication System

[0246] In one aspect of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0247] In one aspect, the data communication interface 4280 is part of the central controller 4230. In another aspect, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0248] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0249] In one configuration, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol).

[0250] In one embodiment, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by a properly authorized person (e.g., a clinician).

[0251] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control. 4.4.2.9 Optional output devices including displays and alarms

[0252] The output device 4290 according to this technology may take the form of one or more of visual, auditory, and haptic units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display. 4.4.2.9.1 Display Driver

[0253] The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands to display these characters, symbols, or images on the display 4294. 4.4.2.9.2 Display

[0254] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 translates each character or symbol (e.g., the digit "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol. 4.5 Air Circuit

[0255] An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000 or 3800) during use.

[0256] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called 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.

[0257] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller 4230). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety. 4.5.1 Delivery of replenishment gas

[0258] In one embodiment of this technology, a supplemental gas, such as 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 or 3800. 4.6 Humidifier 4.6.1 Overview of Humidifiers

[0259] In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 54). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of an airflow before it is delivered to the patient's airway.

[0260] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some embodiments, such as those shown in Figures 54 and 55, 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. 4.6.2 Humidifier components 4.6.2.1 Water Reservoir

[0261] In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., an overnight 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 other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0262] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through the RPT device 4000. In one embodiment, the water reservoir 5110 may be configured to facilitate the movement of the airflow along a meandering path within the reservoir 5110 while the airflow comes into contact with a certain amount of water in the reservoir 5110.

[0263] In one embodiment, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction, for example, as shown in Figures 54 and 55.

[0264] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating direction (e.g., through any aperture and / or between its subcomponents). Since the airflow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure through flow impedance. 4.6.2.2 Conductive portion

[0265] In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed amount of liquid in the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may be made 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 by a less conductive material in an appropriate geometry. 4.6.2.3 Humidifier reservoir dock

[0266] In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 55) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking function (for example, a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130). 4.6.2.4 Water Level Indicator

[0267] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 54-55. In some forms, the water level indicator 5150 may provide a user, such as a patient or caregiver, with one or more indications of the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of the maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75%, or by volume (e.g., 200 ml, 300 ml, or 400 ml)). 4.6.2.5 Humidifier Converter (Single or Multiple)

[0268] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 56. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller. 4.6.2.5.1 Pressure Converter

[0269] One or more pressure transducers 5212 may be provided in the humidifier 5000 in addition to or instead of the pressure sensors 4272 provided in the RPT device 4000. 4.6.2.5.2 Flow Converter

[0270] In addition to the flow sensor 4274 provided in the RPT device 4000, or in place of the flow sensor 4274 provided in the RPT device, one or more flow converters 5214 may be provided in the humidifier 5000. 4.6.2.5.3 Temperature Converter

[0271] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (for example, the temperature of the heating element 5240 and / or the temperature downstream of the airflow at the humidifier outlet 5004). In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air. 4.6.2.5.4 Humidity Converter

[0272] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors. 4.6.2.6 Heating elements

[0273] In some cases, the heating element 5240 may be provided in a humidifier 5000 that provides a heat input to one or more of the water volume in the humidifier reservoir 5110 and / or the water volume to the airflow. The heating element 5240 may include heat-generating components such as an electrical resistance heating track. One suitable example of the heating element 5240 is the layered heating element described, for example, in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0274] In some configurations, the heating element 5240 may be located within the humidifier base 5006. Within the humidifier base 5006, heat can be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 55. 4.6.2.7 Humidifier Controller

[0275] In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250 as shown in Figure 56. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller capable of communicating with the central controller 4230.

[0276] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as input (e.g., measurements of airflow and water in the reservoir 5110 and / or humidifier 5000). The humidifier controller 5250 may also be configured to execute or perform humidifier algorithms and / or deliver one or more output signals.

[0277] As shown in Figure 56, the humidifier controller 5250 may include one or more controllers (for example, a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240). 4.7 Glossary

[0278] For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology. 4.7.1 General

[0279] Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0280] Surroundings: In certain forms of this technology, the term “surroundings” should be understood to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0281] For example, the surroundings of the humidifier humidity This could be the humidity of the air directly surrounding the humidifier (for example, the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0282] In another example, ambient pressure could be pressure directly surrounding or outside the body.

[0283] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, the RPT device or from the mask or patient interface. Ambient noise may originate from sources outside the room.

[0284] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the treatment pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0285] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0286] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Flow rate is sometimes simply called "flow" or "airflow."

[0287] In the example of patient respiration, the flow rate can be negative relative to the expiratory portion of the patient's respiratory cycle, as it can be nominally positive relative to the inspiratory portion of the patient's respiratory cycle. Device flow rate Qd is the flow rate of air exiting the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface through the air circuit. Vent flow rate Qv is the flow rate of air exiting the vent to allow the exhaled gas to escape. 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.

[0288] Flow therapy: Respiratory therapy that involves delivering airflow to the airway entrance at a controlled flow rate, called therapeutic flow rate, which is usually positive pressure, throughout the patient's entire respiratory cycle.

[0289] Humidifier: The term "humidifier" is interpreted as a humidifying device that is constructed, positioned, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into an airflow to improve a patient's medical respiratory illness.

[0290] Leakage: The term "leakage" is taken to mean an unintended flow of air. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow relative to the surroundings.

[0291] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0292] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0293] Noise, Ventilation (Acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0294] Patient: A person who has or does not have a respiratory illness.

[0295] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm³ 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2(=1 millibar to 0.001 atm). In this specification, unless otherwise specified, pressure is given in cmH2O units.

[0296] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value that the interface pressure Pm should achieve at the current moment, is denoted by the symbol Pt.

[0297] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0298] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion. 4.7.1.1 Materials

[0299] Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240-15e1, is approximately 35 to approximately 45.

[0300] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate. 4.7.1.2 Mechanical properties

[0301] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0302] Elastic: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0303] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or indentation hardness scale measured on a standardized sample size). ● "Flexible" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. ● "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0304] 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 provide different resistance in different directions. The opposite of stiffness is flexibility.

[0305] Floppy structure or component: A structure or component that changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second) when subjected to its own weight.

[0306] Rigid structure or component: A structure or component that remains substantially unchanged in shape when subjected to loads typically encountered during use. An example of such an application might be setting up and maintaining a patient interface in a sealed state to the patient's airway inlet under a pressure load of, for example, approximately 20-30 cmH2O.

[0307] For example, an I-beam may have different bending stiffnesses (resistance to bending loads) 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. 4.7.2 Respiratory cycle

[0308] Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0309] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0310] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0311] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0312] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0313] Flow restriction: Flow restriction is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it may be referred to as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it may be referred to as expiratory flow restriction.

[0314] Types of flow-restricted intake waveforms: (i) Flattening: A relatively flat section follows an upward rise, followed by a downward drop. (ii) M-shaped: Two local peaks, one in the rising section and one in the falling section, with a relatively flat section between these two peaks. (iii) Chair-shaped: A single local peak occurs in the rising section, followed by a relatively flat section. (iv) Inverted chair-shaped: A single local peak follows a relatively flat section, with this peak occurring in the falling section.

[0315] Respiratory depression: According to some definitions, respiratory depression refers to a decrease in flow, rather than an interruption of flow. In one morphology, respiratory depression is said to have occurred if a decrease in flow below a threshold velocity persists for a period of time. If respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one morphology of an adult, respiratory depression may be considered if either of the following occurs: (i) a 30% decrease in patient respiration for at least 10 seconds plus associated 4% desaturation, or (ii) a decrease in patient respiration (less than 50%) for at least 10 seconds with associated desaturation of at least 3% or the occurrence of awakening.

[0316] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

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

[0318] Airway patency: The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified, for example, using a value of (1) indicating patency and a value of (0) indicating closure (obstruction).

[0319] Positive end-respiratory pressure (PEEP): This is the pressure that exceeds the atmospheric pressure in the lungs and is present at the end of exhalation.

[0320] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0321] Respiratory flow rate, airflow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the estimate of respiratory airflow rate by an RPT device and are used in contrast to "true respiratory flow rate" or "true respiratory flow rate," which is the patient's actual respiratory flow rate, usually expressed in liters / minute.

[0322] Tidal volume (Vt): This is the amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since inspiratory volume Vi (amount of inhaled air) is equal to expiratory volume Ve (amount of exhaled air), a single tidal volume Vt can be defined as being equal to either of these amounts. In practice, tidal volume Vt is estimated as some combination (for example, the average of inspiratory volume Vi and expiratory volume Ve).

[0323] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0324] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0325] (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.

[0326] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of tendency towards the median of recent ventilation values).

[0327] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with flow-limiting conditions in which flow rate may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0328] Ventilation: A measurement of the rate of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute. 4.7.3 Ventilation

[0329] Adaptive servo ventilators (ASVs): Servo ventilators that have a variable target ventilation rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0330] Backup rate: A ventilator parameter that establishes the minimum respiratory rate (typically respiratory rate per minute) delivered from the ventilator to the patient (when not triggered by spontaneous respiratory effort).

[0331] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers air to a patient who is breathing spontaneously, it is said that the ventilator cycles to stop delivering air at the end of the inspiratory portion of the respiratory cycle.

[0332] Positive expiratory airway pressure (EPAP): Base pressure to which varying pressures within respiration are added in order to generate the desired interface pressure that the ventilator attempts to achieve at a given time.

[0333] End-of-Expiratory Pressure (EEP): The desired interface pressure that the ventilator aims to achieve at the end of the expiratory portion of respiration. When the pressure waveform template Π(Φ) is zero at the end of exhalation (i.e., Π(Φ)=0 when Φ=1), EEP is equal to EPAP.

[0334] Positive Inspiratory Airway Pressure (IPAP): The maximum desired interface pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0335] Pressure assist: A number indicating the pressure increase during exhalation of a ventilator from the inspiratory phase, primarily representing the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist refers to the difference the ventilator aims to achieve (rather than the difference it actually achieves).

[0336] Servo ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0337] Spontaneous / Timing (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device fails to detect breathing within a predetermined period, the device automatically initiates respiratory delivery.

[0338] Swing: A term equivalent to pressure assistance.

[0339] Trigger: When a ventilator delivers air to a patient who is breathing spontaneously, the ventilator is said to be triggered to deliver air when the patient initiates the respiratory portion of the respiratory cycle. 4.7.4 Anatomy 4.7.4.1 Anatomical structure of the face

[0340] Wing (Ala): The "wing" of the outer wall or each nostril (plural: alar)

[0341] Alar angle:

[0342] Alare: The outermost point on the nasal ala.

[0343] Wing curvature (or nostril apex) point: The furthest point on the curved reference line of each wing, found at the fold formed by the joining of the wing and cheek.

[0344] Auricle: The entire visible part of the ear.

[0345] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0346] (Nasal) cartilage: The cartilage of the nose includes the septal cartilage, lateral cartilage, macrocartilage, and microcartilage.

[0347] Columella: A piece of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0348] Columella angle: The angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfort horizontal, intersecting the subnasal point.

[0349] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left auricle. The auricle is the deepest point from the upper side of the notch to the tragus of the auricle.

[0350] Glabella: Located in soft tissue, it is the most prominent point in the midline sagittal plane of the forehead.

[0351] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper margin is attached to the nasal bone and the frontal process of the maxilla, and its lower margin is connected to the greater alar cartilage.

[0352] Lip, lower side (lower lip: labrale inferius):

[0353] Lip, upper side (upper lip: labrale superius):

[0354] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0355] Nostrils: Generally, ellipsoidal pterygoides form the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris). These nostrils are separated by the nasal septum.

[0356] Nasolabial fold or groove: A fold or groove in the skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0357] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0358] Inferior basement point: The lowest point where the auricle attaches to the skin of the face.

[0359] Superior basement point: The highest point where the auricle attaches to the skin of the face.

[0360] 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.

[0361] Philtrum: The midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0362] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0363] Nasal ridge: The nasal ridge is the midline elevation of the nose, extending from the therion to the nasal tip.

[0364] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides the plane into the right and left halves.

[0365] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0366] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0367] The lowest point of the nasal ala: This is a point on the lower periphery of the wing base, where the wing base joins the skin of the upper lip.

[0368] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal plane.

[0369] Supramenton: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion. 4.7.4.2 Anatomical structure of the skull

[0370] Frontal bone: The frontal bone includes the frontal squama, a large vertical portion that corresponds to the area known as the forehead.

[0371] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw and forms the jawbone.

[0372] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla protrudes upward from the side of the nose, forming its lateral boundary.

[0373] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are located side by side in the middle and upper parts of the face, and their joint forms the "bridge" of the nose.

[0374] Nasal root point: The intersection of the frontal bone and the two nasal bones, a concave region directly located between the eye and the upper part of the nasal ridge.

[0375] Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. It contains the foramen magnum, an oval opening through which the intracranial cavity communicates with the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0376] Orbit: A bony cavity within the skull that contains the eyeball.

[0377] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0378] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0379] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face, forming the cheekbones. 4.7.4.3 Anatomical structure of the respiratory system

[0380] The diaphragm is a sheet of muscle that extends over the bottom of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, drawing air into the lungs.

[0381] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0382] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, terminal bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0383] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located 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 nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0384] Pharynx: The part of the throat located directly below the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into the following three sections: nasopharynx (upper pharynx) (the nasal part of the pharynx), oropharynx (the oropharyngeal part) (the oral part of the pharynx), and pharynx (lower pharynx). 4.7.5 Patient Interface

[0385] Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0386] Elbow: An elbow is an example of a structure that directs the axis of airflow moving within it, changing its direction through an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a nearly circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a mating component. In certain embodiments, an elbow may be detachable from a mating component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a mating component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0387] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0388] Functional dead space: The portion of a plenum chamber from which CO2 can be collected (without being washed away).

[0389] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners configured to position and hold a patient interface in place on the patient's face for the delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0390] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0391] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed the ambient pressure when in use. The shell may form part of the wall of the mask plenum chamber.

[0392] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to the effect of sealing. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0393] Shell: The term "shell" is used to mean a curved, relatively thin-walled structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0394] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0395] Support: The term "support" is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0396] Swivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in the context of air delivery conduits, the subassembly of components preferably includes a pair of cylindrical conduits. During use, there is little to no leakage of airflow from the swivel.

[0397] Thai (noun): A structure designed to resist tension.

[0398] Ventilation section (noun): A structure that allows airflow into the surrounding air inside a mask or conduit, enabling clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve flow rates of approximately 10 liters / minute to 100 liters / minute, depending on the mask design and treatment pressure. 4.7.6 Structure Shape

[0399] Products based on this technology may include one or more three-dimensional mechanical structures (e.g., mask cushions or impellers). 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 any other characteristic of the associated surfaces. For example, a structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In yet another example, a structure may include a first surface and a second surface.

[0400] To facilitate the description of the shape and surface of the three-dimensional structure, we first consider the cross-section at point p through the surface of the structure. Please refer to Figures 27 to 31. Figures 27 to 31 show examples of cross-sections at point p on the surface and examples of the resulting planar curves. Figures 27 to 31 also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some examples, this surface will be described from the perspective of a hypothetical small person standing upright on the surface. 4.7.6.1 Curvature in one dimension

[0401] The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., 1 / radius of a circle tangent to the curve at p).

[0402] Positive curvature: If a curve at point p curves toward the outward normal, the curvature at that point is taken to have a positive value (if this hypothetical little person were to leave point p, they would need to walk uphill). See Figure 27 (relatively large positive curvature compared to Figure 28) and Figure 28 (relatively small positive curvature compared to Figure 3B). Such a curve is often called concave.

[0403] Zero curvature: If the curve at point p is a straight line, the curvature is taken as zero (if this hypothetical small person leaves point p, they can walk on a horizontal plane that is neither upward nor downward). See Figure 29.

[0404] Negative curvature: When a curve at point p curves away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this hypothetical little person were to walk away from point p, they would need to walk downhill). See Figure 30 (relatively small negative curvature compared to Figure 31) and Figure 31 (relatively large negative curvature compared to Figure 30). Such curves are often called convex. 4.7.6.2 Curvature of a two-dimensional surface

[0405] The description of the shape at a given point on a two-dimensional surface using this technique may include multiple perpendicular cross-sections. These cross-sections can cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section results in a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in Figures 27-31 may be examples of such multiple cross-sections at a particular point.

[0406] Major curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values ​​is called the major direction. In the example in Figures 27 to 31, the maximum curvature occurs in Figure 27 and the minimum occurs in Figure 31; therefore, Figures 27 and 31 are cross-sections in the major direction. The major curvature at p is the curvature in the major direction.

[0407] A region of a surface: A set of connected points on a surface. These points within a region may share similar properties (e.g., curvature or sign).

[0408] 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 walking uphill or downhill is facing.

[0409] Dome region: A region where the main curvatures at each point have the same sign (both are positive ("concave dome") or both are negative ("convex dome")).

[0410] Cylindrical region: A region where one major curvature is zero (or zero within a manufacturing tolerance, for example) and the other major curvature is non-zero.

[0411] Planar region: A region of a surface where both major curvatures are zero (or zero, for example, within a manufacturing tolerance).

[0412] Surface edge: The boundary or limit of a surface or area.

[0413] Path: In certain forms of this technology, “path” is taken to mean a path in a mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of this technology, “path” can be described, for example, as a route or course containing a set of points on a surface. (A hypothetical person’s path is the places they walk on the surface, similar to a path in a garden).

[0414] Path Length: In certain forms of this technology, "path length" refers to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance they walk along the path on the surface).

[0415] Straight-line distance: Straight-line distance is the distance between two points on a surface, but the surface itself is not considered. On a planar region, there exists a distance on the surface edge with the same path length as the straight-line distance between two points on the surface. On a non-planar surface, no path with the same path length as the straight-line distance between two points can exist. (For a hypothetical person, straight-line distance corresponds to the distance a crow "flies".) 4.7.6.3 Space curve

[0416] Spatial curves: Unlike plane curves, spatial curves do not necessarily exist within any given plane. Spatial curves can be closed; that is, they have no endpoints. Spatial curves can be considered as one-dimensional pieces of three-dimensional space. A hypothetical person walking along a DNA helix would be walking along a spatial curve. A typical human left ear contains a left-handed helix (see Figure 42). A typical human right ear contains a right-handed helix (see Figure 43). Figure 44 shows a right-handed helix. The edges of structures (e.g., the edges of a membrane or impeller) can follow spatial curves. In general, spatial curves can be described by their curvature and torsion at each point on the curve. Torsion is a measure of the nature of a curve originating from a plane. Torsion has a sign and magnitude. Torsion at a point on a spatial curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0417] 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 is flying along a curve and falls from their vehicle at a certain point, the direction of the tangent vector would be the direction in which the character would have been moving.

[0418] Unit Normal Vector: When a fictional character is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0419] 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 41) or the left-hand rule (Figure 40).

[0420] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 40 and 41.

[0421] Torsion of a spatial curve: Torsion of a spatial curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. Torsion of a spatial curve in a plane is zero. If the deviation of a spatial curve from the tangent plane is relatively small, the magnitude of the torsion of that spatial curve is relatively small (e.g., a gently sloping helical path). If the deviation of a spatial curve from the tangent plane is relatively large, the magnitude of the torsion of that spatial curve is relatively large (e.g., a steeply sloping helical path). Referring to Figure 44, since T2 > T1, the magnitude of the torsion in the neighborhood of the uppermost coil of the helix in Figure 44 is greater than the magnitude of the torsion of the lowermost coil of the helix in Figure 44.

[0422] Referring to the right-hand rule in Figure 41, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 44). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0423] Similarly, referring to the left-hand rule (see Figure 41), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 45. 4.7.6.4 Hole

[0424] A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). In the case of a thin-walled structure containing holes (e.g., a film), this structure can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the surface of the structure shown in Figure 34, bounded by planar curves.

[0425] 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 inner surface of the tire. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in Figure 37 and the exemplary cross-sectional views in Figures 38 and 39 showing its interior. The illustration shows how the two-dimensional hole is bounded by the inner surface. In yet another example, a conduit may contain a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole bounded by a surface through the structure shown in Figure 36, as illustrated. 4.8 Other Notes

[0426] Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office.

[0427] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0428] Furthermore, where values ​​(one or more) are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures as permitted or required by the practical technical implementation.

[0429] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0430] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0431] 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 indicates otherwise.

[0432] All published documents cited herein are used for disclosure and description of the methods and / or materials covered by those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as indicating that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited herein may differ from the actual dates of the published documents and may require individual verification.

[0433] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the listed elements, components, or steps may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0434] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0435] While the techniques described herein have been explained with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for the implementation of the techniques. For example, the terms “first” and “second” are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish distinct elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such modifications can be carried out simultaneously or even synchronously.

[0436] Therefore, it should be understood that numerous modifications are possible in the exemplary examples, and that other configurations may be devised, without deviating from the intent and scope of this technology. [Explanation of Symbols]

[0437] 4.9 List of reference codes 1000 patients 1100 Bedmate 3000 Patient Interfaces 3100 Seal-forming structure 3105 Foam cushion 3110 Undercushion 3115 Sealed surface 3120 Mounting surface 3125 holes 3126 Inner Self 3127 Peripheral surface 3130 First rim 3135 Second rim 3140 Upper central area 3142 Lower central area 3145 Wide area 3150 Wide area 3155 Bisector 3156 Lower corner area 3157 Upper area 3158 Intermediate area 3160 Support wall 3161 Horizontal axis 3162 Exterior 3165 Support flange 3170 Upper gusset 3175 Thick area 3180 Lower gusset 3185 Horizontal axis 3190 Rib 3195 Extension area 3196 Lower corner area 3197 Upper area 3198 Intermediate area 3199 Intermediate area 3200 Chassis 3205 Plenum Chamber 3210 Tendon 3211 Opening 3212 axis 3213 Frankfort horizontal plane 3215 Annular flange 3220 Top 3225 Lip Seal 3230 Lower point 3300 Frame Assembly 3305 Shroud 3310 Headgear Connector 3315 Opening 3320 Spring Arm 3325 Shroud connection part 3330 Upper headgear connector arm 3335 Lower headgear connector arm 3340 Middle part 3345 Upper headgear mounting point 3350 Magnetic Connector 3355 Flexible part 3400 stabilizing structure 3410 Upper side strap 3420 Lower side strap 3430 Circular head strap 3500 Ventilation section 3744 ISO 4000 RPT devices 4010 External Housing 4012 Top 4014 part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4200 Electrical components 4202 PCBA 4210 Power supply 4220 Input Devices 4230 Central Controller 4232 Clock 4240 Therapeutic Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed ​​Converter 4280 Data communication interface 4282 Remote External Communication Network 4284 Local external communication network 4286 Remote External Devices 4288 Local external device 4290 Output Device 4292 Display Driver 4294 displays 4300 Algorithms 4330 Treatment control module 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive part 5130 Humidifier Reservoir Dock 5135 Locking Lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Pressure transducer 5214 Flow Converter 5216 Temperature Sensor 5218 Humidity Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating element controller 5254 Air Circuit Controller

Claims

1. A patient interface configured to deliver a positive pressure flow of respiratory gas to the entrance of the patient's airway, including at least the entrance of the patient's nostrils, wherein the patient interface is configured to improve sleep-disordered breathing by approximately 4 cmH higher than the ambient pressure at the time of use during the patient's sleep throughout the patient's respiratory cycle. ２ O ~ approx. 30cmH ２ It is configured to maintain therapeutic pressure within a high range. The aforementioned patient interface is An elastomer support wall that forms at least a portion of a plenum chamber, configured to receive a positive pressure breathing gas flow, and having a central upper region and a central lower region opposite the central upper region, An elastomer support flange positioned at the end of the elastomer support wall, comprising an elastomer support flange extending radially inward from the elastomer support wall, A foam cushion attached to the elastomer support flange, configured to form a seal with the patient's face, In the central lower region, a first compressible rib is attached to the elastomer support wall and the elastomer support flange, A second compressible rib attached to the elastomer support wall and the elastomer support flange in the central lower region, Equipped with, The first and second compressible ribs are located opposite the bisecting plane that bisects the patient interface and intersects the central lower and central upper regions of the elastomer support wall. The central lower region of the elastomer support wall is provided with a lower gusset. The first and second compressible ribs are positioned adjacent to the lower gusset in a patient interface.

2. The patient interface according to claim 1, wherein at least a portion of the elastomer support wall is configured to pivot when the lower gusset is crushed.

3. The patient interface according to claim 1 or 2, wherein the lower gusset is bisected by the bisecting plane.

4. The patient interface according to any one of claims 1 to 3, wherein the central upper region of the elastomer support wall includes an upper gusset.

5. The patient interface according to claim 4, wherein at least a portion of the elastomer support wall is configured to pivot when the upper gusset is crushed.

6. The patient interface according to claim 4 or 5, wherein the elastomer support wall includes a pair of thickened regions located on the side surface of the upper gusset.

7. The patient interface according to any one of claims 4 to 6, wherein the upper gusset is bisected by the bisecting plane.

8. The patient interface according to any one of claims 1 to 7, wherein the elastomer support wall and the elastomer support flange are at an angle, and the first compressible rib and the second compressible rib are configured such that the angle between the elastomer support wall and the elastomer support flange decreases in response to the compressive force on the foam cushion.

9. The patient interface according to any one of claims 1 to 8, further comprising a shell having an inlet opening configured to receive the flow of positive-pressure respiratory gas, wherein the elastomer support wall is attached to the shell.

10. The patient interface according to claim 9, further comprising a positioning and stabilizing structure configured to support the shell, the elastomer support wall, and the foam cushion on the patient's head.

11. The positioning and stabilizing structure comprises a shroud and a plurality of headgear straps, according to claim 10, for the patient interface.

12. The patient interface according to claim 11, wherein the shroud is removablely attached to the shell at the entrance opening.

13. The patient interface according to claim 11 or 12, further comprising an air delivery tube connectable to the shroud and the shell.

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