Oro-nasal patient interface

Abstract

To provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases having one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.SOLUTION: A patient interface includes a positioning and stabilizing structure configured to maintain first and second seal-forming structures in a therapeutically effective position, the positioning and stabilizing structure including a frame coupled to a plenum chamber. The frame includes a central portion coupled to the plenum chamber outside the cavity, and a pair of arms extending in the aft direction from the central portion in the separation direction past the second seal-forming structure. The arms are more flexible than the central portion. The positioning and stabilizing structure also includes a headgear strap connected to the frame. The headgear strap is configured to apply tension to the first and second seal-forming structures via the frame to apply tension to the patient's face.SELECTED DRAWING: Figure 23

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of U.S. Provisional Application No. 63 / 058,001, filed on July 29, 2020, and Australian Provisional Application No. 2019903360, filed on September 10, 2019. The entire content of the same literature is incorporated herein by reference.

[0002] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and improving respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

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

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction 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, and this region is called the respiratory zone. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0005] There is a range of respiratory diseases. Certain diseases can be characterized by certain onset events (e.g., apnea, hypopnea, and hyperventilation).

[0006] Examples of respiratory diseases 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 disease.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as closure or obstruction of the upper airway during sleep. It is caused by an abnormally small upper airway during sleep and a normal lack of muscle tone in the tongue area, a combination of the soft palate and the posterior pharyngeal wall. Due to such a condition, the breathing stops of affected patients typically last for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients have no awareness of the symptoms. See Patent Document 1 (U.S. Patent No. 4,944,310: Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, and the alternating periodic continuation of the increase and decrease in ventilation, known as the CSR cycle, follows. CSR is characterized by the repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by repeated sleep awakenings, which can cause severe insomnia, increased sympathetic nerve activity, and increased afterload. See Patent Document 2 (U.S. Patent No. 6,532,959: Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory disorders, referring to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

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

[0011] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and waking chronic hypercapnia in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

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

[0013] Neuromuscular disease (NMD) is a broad term encompassing a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle impairment, which ultimately leads to inability to walk, confinement to a wheelchair, dysphagia, decreased respiratory muscle strength, and ultimately death due to respiratory insufficiency. Neuromuscular disorders can be classified into the following rapid - progressive and slow - progressive types: (i) Rapid - progressive disorders: characterized by muscle impairment that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers), (ii) Variable or slow - progressive disorders: characterized by muscle impairment that worsens over several years and only slightly reduces the average life expectancy (e.g., limb - girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory insufficiency symptoms in NMD include increased general debility, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thorax. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphosis may develop severe respiratory failure. The symptoms of respiratory failure are listed below: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking up, fatigue, decreased quality of sleep, and loss of appetite.

[0015] To treat or improve such conditions, a range of treatments are used. Additionally, in other respects, healthy individuals can also benefit from preventive treatment for respiratory diseases. However, there are multiple drawbacks in these.

[0016] 2.2.2 Therapy A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used for the treatment of one or more of the above respiratory diseases.

[0017] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of supplying air to the entrance of the airway at a controlled target pressure that is normally positive pressure with respect to the atmosphere over the entire respiratory cycle of the patient.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to advance or retract to the posterior oropharyngeal wall, CPAP therapy functions as an air sprint, thereby preventing the closure of the upper airway. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following about the device used for treatment provision, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, and lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilation assistance to a patient through the upper airway and performs part or all of the respiratory function to assist the patient's breathing and / or maintain an appropriate oxygen level in the body. The ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Invasive ventilation (IV) provides ventilation assistance to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] 2.2.2.2 Flow therapy In all respiratory therapies, the delivery of a defined therapeutic pressure is not necessarily intended. In some respiratory therapies, the delivery of a defined 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" (seal released), and respiratory therapy by the flow of conditioned or high-concentration gas can only be used as an adjunct to the patient's spontaneous breathing. In one embodiment, high flow therapy (HFT) is the provision of a continuous, heated, humidified air flow at a "therapy flow rate" that is maintained substantially constant throughout the respiratory cycle through a non-sealed or open patient interface. The therapy flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory disorders. As one mechanism of action, providing high flow air to the airway inlet improves ventilation efficiency because it enables the flushing or washout of CO2 exhaled from the patient's anatomic dead space. For this reason, HFT is sometimes referred to as dead space therapy (DST). Other benefits include improved warmth and humidification (possibly due to the benefit of secretion control) and the possibility of a gentle increase in airway pressure. As an alternative to a constant flow rate, the therapy flow rate can follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe that a continuous flow of oxygen-enriched gas be delivered to the patient's airway at a specified oxygen concentration (oxygen fraction in ambient air from 21% to 100%) and at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM).

[0023] 2.2.2.3 Supplemental Oxygen For certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is referred to as HFT with supplemental oxygen.

[0024] 2.2.3 Respiratory Therapy System 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.

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

[0026] Another form of therapy system is a mandibular repositioning device.

[0027] 2.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an air flow to an airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with, for example, an area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure with the ambient pressure for therapy 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 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.

[0028] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be possible 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.

[0029] Certain masks may be clinically unfavorable in the present technology (for example, when the mask blocks the airflow through the nose and only allows airflow through the mouth).

[0030] 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.

[0031] Certain masks may be impractical for use during sleep (for example, when sleeping on the side in bed with the head on the pillow).

[0032] There are multiple challenges in the design of a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. 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.

[0033] Due to these problems, in the case of some masks, especially when the wearing time is long or the patient is not used to the system, there may be one or more of the reasons such as being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in the case of such masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's commitment to treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0034] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's commitment.

[0035] In the case of masks for other uses (e.g., pilots), they may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0036] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0037] 2.2.3.1.1 Seal-forming structure 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.

[0038] The patient interface can be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure can 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 the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to be placed, for example, on the upper lip region and the nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces can be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0039] A seal-forming structure that may be effective in one area of a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variabilities, and sensitive areas of the patient's face. For example, the seal of a swimming goggle placed on a patient's forehead may be inappropriate for use on the patient's nose.

[0040] A particular seal-forming structure can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it may be necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0041] One type of seal-forming structure extends around 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 facing the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap may occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0042] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of sealing formation portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal, or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the shape of the patient, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0043] Another type of seal-forming structure may include friction fit elements inserted into the nostrils, for example, but there are also patients who find these seal-forming portions uncomfortable.

[0044] Another form of seal-forming structure may use an adhesive portion to achieve a seal. Among patients, there are also those who always feel it is inconvenient to attach or remove the adhesive portion to their own face.

[0045] Disclosures exist for a range of patient interface seal-forming structure technologies in the following patent applications assigned to ResMed Limited: WO1998 / 004,310, WO2006 / 074,513, WO2010 / 135,785.

[0046] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0047] 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 MIRAGE LIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describes the appearance of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (in particular, describes the appearance of ResMed Limited's SWIFT® LT nasal pillow), International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describe the appearance of ResMed Limited's MIRAGE LIBERTY® Full Face Mask), International Patent Application WO2009 / 052,560 (in particular, describes the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0048] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that impede sealing. Therefore, various techniques are used to position the seal-forming structure and maintain a seal against the appropriate part of the face.

[0049] In one technique, an adhesive part is used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0050] In another technique, one or more straps and / or stabilizing harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable and difficult to handle.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above treatments or as part of a system, for example by operating the device to generate an air delivery flow to the interface to the airway. The air flow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0052] 2.2.3.3 Air Circuit The air circuit is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components of a respiratory therapy system (for example, an RPT device and a patient interface). 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.

[0053] 2.2.3.4 Humidifier If the delivery of the air flow is carried out without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, a humidified gas is generated, thus minimizing drying of the nasal mucosa and increasing the comfort of the patient's airway. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air. Therefore, humidifiers often have the ability not only to heat the air flow but also to humidify the air flow.

[0054] 2.2.3.5 Oxygen Source Experts in this field have long recognized that when patients with respiratory failure exercise, they can obtain long-term benefits such as delaying disease progression, improving quality of life, and extending the patient's lifespan. However, stationary exercises such as treadmills and stationary bicycles are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, this mobility has been facilitated using small compressed oxygen tanks or cylinders mounted on carts. The drawbacks of these tanks are the limited amount of oxygen they can store and their weight of approximately 50 pounds when loaded.

[0055] Oxygen concentrators have been used for approximately 50 years for the supply of oxygen for respiratory therapy. In the case of conventional oxygen concentrators, due to their bulky and heavy nature, it is difficult and impractical to perform normal walking activities while wearing an oxygen concentrator. Recently, manufacturers of large stationary oxygen concentrators have started developing portable oxygen concentrators (POCs). The advantage of POCs is that theoretically, they can supply oxygen endlessly. To make these devices small for mobility, the various systems required for oxygen-enriched gas generation are made more compact. To minimize weight, size, and power consumption, POCs need to make the use of the generated oxygen as efficient as possible. This can be achieved by delivering oxygen as a series of pulses or "boluses", each bolus being set at a timing that coincides with the start of inhalation. This treatment mode is known as pulsed or demand (oxygen) delivery (POD) and is more suitable for stationary oxygen concentrators than conventional continuous flow delivery.

[0056] 2.2.3.6 Data Management For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) may obtain data describing the patient's treatment with the RPT device manually, calculate the usage rate over a given period, and compare this to the compliance rule. If a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0057] In a patient's treatment, there may be other ways to benefit from communication of treatment data to a third party or an external system.

[0058] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur.

[0059] 2.2.3.7 Mandibular Repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

[0060] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit over the teeth on the maxilla or maxilla bone and a lower splint intended to engage or fit over the teeth on the maxilla or mandible. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0061] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0062] There are also MRDs configured to push the mandible forward relative to the maxilla bone, and there are those designed to hold the mandible in a forward position, such as other MADs like the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temple and the mandible. Therefore, this device is configured to minimize or prevent any movement of one or more of the teeth.

[0063] 2.2.3.8 Ventilation technology Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section may enable gas 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] This ventilation section may include an orifice, and when using a mask, gas can flow through the orifice. In the case of a number of such ventilation sections, the sound is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation sections, for example, due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and co - sleeper 1100.

[0065] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: International Patent Application Publication No. WO1998 / 034,665, International Patent Application Publication No. WO2000 / 078,381, U.S. Patent No. 6,581,594, U.S. Patent Application Publication No. US2009 / 0050156, U.S. Patent Application Publication No. 2009 / 0044808.

[0066] Table of conventional mask noise (ISO17510 - 2:2007, at 1 m under 10 cmH2O pressure) [Table 1]

[0067] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0068] List the sound pressure values of various subjects as follows [Table 2]

[0069] 2.2.4 Screening, diagnostic systems and monitoring systems A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases and typically requires expert clinical staff for system application in many cases. In PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, patients had to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0070] Generally, screening and diagnosis are to identify a disease by its signs and symptoms. Usually, screening gives a true / false result indicating whether the patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can be continued indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0071] Clinical experts can appropriately perform patient screening, diagnosis, or monitoring based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may differ regarding a patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

[0072]

Patent Document 1

Patent Document 2

Summary of the Invention

Means for Solving the Problems

[0073] Brief Description of the Technology This technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] The first aspect of this technology relates to an apparatus used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases.

[0075] Another aspect of this technology relates to a method used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders.

[0076] One aspect of a specific form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0077] One form of this technology includes a patient interface. The patient interface is: A plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing, a plenum chamber, and A first seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's mouth, whereby the air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and A second seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding the patient's nasal inlet, whereby an air flow at said treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain said treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure, A ventilation structure that allows a continuous gas flow exhaled by the patient to escape from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation structure, The patient interface further comprises: A pair of support portions provided on opposite side portions of the interface between the second seal-forming structure and the front wall portion of the plenum chamber, the support portions being configured to prevent compression in the front-rear direction, the patient interface further comprising a pair of support portions.

[0078] In an embodiment:

[0079] a) The support portion is connected to a portion of the second seal-forming structure that seals the patient's upper lip during use,

[0080] b) The support portion is connected to a portion of the second seal-forming structure that seals the patient's upper lip directly below the lower side corners of the patient's nose during use,

[0081] c) The support portion is curved when viewed in a cross-section parallel to the sagittal plane,

[0082] d) The support portion is curved when viewed in a cross-section parallel to the frontal plane,

[0083] e) The plenum chamber includes an oral cavity portion and a nasal portion,

[0084] f) Each support portion is connected to the oral cavity portion of the plenum chamber adjacent to the boundary between the lateral side wall portion of the oral cavity portion and the lateral side wall portion of the nasal portion,

[0085] g) Each support portion is connected to the oral cavity portion of the shell adjacent to the boundary between the anterior wall portion of the oral cavity portion and the anterior wall portion of the nasal cavity portion,

[0086] h) The lateral side wall portion of the pre-nasal chamber is curved inwardly adjacent to the boundary with the nasal cavity, and each support portion is substantially adjacent to the adjacent lateral side wall portion,

[0087] i) The second seal-forming structure includes at least one nasal aperture configured to deliver the air flow at the treatment pressure to the inlet to the patient's nostrils, and in use, no part of any support portion is located directly below any of the nasal apertures,

[0088] j) The interface further includes a positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head,

[0089] k) The pre-nasal chamber is at least partially formed by the shell, and the ventilation structure is provided to the shell, and / or

[0090] l) The support portion is connected to the second seal-forming structure and is connected to the anterior wall of the pre-nasal chamber.

[0091] Another form of the present technology includes a patient interface. The patient interface is: A pre-nasal chamber pressurizable to a treatment pressure of at least 6 cmH2O above ambient air pressure, the pre-nasal chamber including a pre-nasal chamber inlet port sized and structured to receive the air flow at the treatment pressure for the patient's breathing, the pre-nasal chamber, A first seal-forming structure connected to the oral region of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the patient's oral inlet, whereby an air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure, A second seal-forming structure connected to the nasal region of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the patient's nasal inlet, whereby an air flow at the treatment pressure is delivered to the nose, and the second seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure, A ventilation structure that enables a continuous gas flow exhaled by the patient to escape from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation structure, Here: A first front wall portion of the nasal portion of the plenum chamber adjacent to the boundary with the oral portion of the plenum chamber is more flexible than the region immediately adjacent to the oral portion of the plenum chamber, and a second front wall portion of the nasal portion of the plenum chamber is directly adjacent to the first front wall portion and is on the opposite side of the first front wall portion with respect to the boundary with the oral portion of the plenum chamber and is less flexible than the directly adjacent portion of the front wall portion.

[0092] In an embodiment,

[0093] a) The first front wall portion is thinner than the directly adjacent portion of the plenum chamber wall,

[0094] b) The second front wall portion is thicker than the directly adjacent portion of the plenum chamber wall,

[0095] c) The first front wall portion and the second front wall portion are made of the same material,

[0096] d) The first front wall portion extends substantially across the entire width of the nose portion of the plenum chamber,

[0097] e) The second front wall portion extends across at least a majority of the width of the nose portion of the plenum chamber,

[0098] f) The first front wall portion extends upwardly around at least one lateral edge of the second front wall portion,

[0099] g) The second front wall portion extends substantially across the entire width of the nose portion of the plenum chamber,

[0100] h) The central portion of the first front wall portion extends further upwardly than the lateral portions of the first front wall portion,

[0101] I) The upper boundary of the first front wall portion is curved,

[0102] j) The lower boundary of the first front wall portion is curved,

[0103] k) The plenum chamber is at least partially formed by a shell, and the ventilation structure is provided to the shell,

[0104] l) The second front wall portion includes a band extending through the first front wall portion and is configured to extend to the patient through the plenum chamber,

[0105] m) The transition portion between the first front wall portion and the second front wall portion within the plenum chamber is substantially a stepped surface,

[0106] n) The transition portion between the first front wall portion and the second front wall portion outside the plenum chamber is substantially a smooth surface, and / or

[0107] o) The first front wall portion extends further upwardly than at least a part of the band during use.

[0108] Another form of the present technology includes a patient interface. The patient interface is: a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber, and a first seal-forming structure connected to the mouth portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's mouth, whereby the air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and a second seal-forming structure connected to the nose portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's nose, whereby the air flow at the treatment pressure is delivered to the nose, and the second seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and a ventilation structure that allows the continuous gas flow exhaled by the patient to escape from within the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, a ventilation structure, and where: The rear surface of the lateral portion of the second seal-forming structure slopes upward and forward from the boundary between the first seal-forming structure and the second seal-forming structure.

[0109] In an embodiment,

[0110] a) the inclination of each lateral portion forms an angle of 20 degrees to 90 degrees with the central contact surface of the mask,

[0111] b) In use, no part of the patient interface contacts the apex of the patient's nasal alae,

[0112] c) The interface is configured to avoid or at least reduce occlusion of the patient's nostrils relative to interfaces of related art, and / or

[0113] d) The plenum chamber is at least partially formed by the shell, and the ventilation structure is provided in the shell.

[0114] Another form of the present technology includes a patient interface. The patient interface is: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the treatment pressure for the patient's respiration, a plenum chamber, and A first seal-forming structure connected to the mouth portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against a patient's facial region surrounding the entrance to the patient's mouth, whereby the airflow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and A second seal-forming structure connected to the nasal portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against a patient's facial region surrounding the entrance to the patient's nose, whereby the airflow at the treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and A ventilation structure that enables the continuous gas flow exhaled by the patient to escape from inside the plenum chamber to the surroundings, the ventilation structure including a ventilation structure sized and shaped to maintain the treatment pressure within the plenum chamber during use. Here: The boundary between the first seal-forming structure and the second seal-forming structure includes a raised portion.

[0115] In an embodiment,

[0116] a) The radius of curvature of the raised portion is less than 2 mm.

[0117] b) The raised portion extends substantially across the entire boundary between the first seal-forming structure and the second seal-forming structure.

[0118] c) During use, the raised portion engages the patient's face in the vicinity of the entrance to the nostrils (where the wing meets the face above the upper lip).

[0119] d) The raised portion withstands the formation of wrinkles in the first seal-forming structure and / or the second seal-forming structure in the vicinity of the raised portion, and / or

[0120] e) During use, the plenum chamber is at least partially formed by a shell, and the ventilation structure is provided in the shell.

[0121] Another form of the present technology includes a patient interface. The patient interface is: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration. A first seal-forming structure connected to the oral region of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's mouth, whereby an air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A second seal-forming structure connected to the nasal region of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's nose, whereby an air flow at the treatment pressure is delivered to the nose, and the second seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A ventilation structure that enables a continuous gas flow exhaled by the patient to escape from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation structure, and comprising: Here: At least a part of the oral part of the plenum chamber includes a flexible shell, and the flexible shell is formed from a material having a Young's modulus of less than 0.4 GPa.

[0122] In an embodiment,

[0123] a) The flexible shell is formed from a material having a Young's modulus of less than 0.1 GPa (preferably 0.3 to 0.7 MPa).

[0124] b) At least one component is connected to the flexible shell, and at least one component is harder than the part of the flexible shell adjacent to the component.

[0125] c) At least one component includes one or more of the following: a ventilation module, a headgear connector, a headgear connector connected to a stiffening arm, a stiffening member, a less flexible shell portion,

[0126] d) At least one component is releasably connectable to a flexible shell,

[0127] e) At least one component is permanently connected to a flexible shell,

[0128] f) At least one component is overmolded onto a flexible shell,

[0129] g) The flexible shell includes a hardened portion that is thicker than the directly adjacent portion of the flexible shell,

[0130] h) At least one component is configured as a hardened rib or band,

[0131] i) The central portion of the oral cavity part of the plenum chamber has a higher rigidity than the rest of the plenum chamber, and / or

[0132] j) The plenum chamber is at least partially formed by a shell, and the ventilation structure is provided on the shell.

[0133] Another form of the present technology includes a patient interface. The patient interface is: A plenum chamber including a cavity that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for a patient's breathing, a plenum chamber, A first seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding the patient's oral inlet, whereby an airflow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A second seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding the patient's nasal inlet, whereby an airflow at the treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A ventilation structure that enables a continuous gas flow exhaled by the patient to escape from within the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation structure; A positioning and stabilization structure configured to maintain the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilization structure comprising: A frame connected to the plenum chamber, the frame comprising: A central portion connected to the plenum chamber outside the cavity, and A pair of arms extending rearwardly through the second seal-forming structure in a direction away from the central portion, the pair of arms being more flexible than the central portion, the frame comprising the pair of arms, and A headgear strap connected to the frame, the headgear strap being configured to apply tension through the frame to the first seal-forming structure and the second seal-forming structure and thereby apply it within the patient's face, the headgear strap.

[0134] In an embodiment,

[0135] a) Each of the pair of arms is more flexible than the frame,

[0136] b) The central portion is thicker than each of the pair of arms,

[0137] c) The central portion and each of the pair of arms are constructed from the same material,

[0138] d) Each of the pair of arms includes a first connection point, and the headgear strap is connected to the first connection point of each arm,

[0139] e) The first connection point is a loop, and by connecting the headgear strap to the loop, the strap is perpendicular to the edge of each loop and a force vector perpendicular to the edge is added from the strap,

[0140] f) The first connection point is a loop and includes a thin - thickness region, and the headgear strap can contact the thin - thickness region,

[0141] g) A first magnet is overmolded on the central portion of the frame, and the headgear strap includes a second magnet removably connected to the first magnet,

[0142] h) The first magnet includes an outer casing that at least partially encapsulates a magnetic material, and the outer casing includes a planar surface and a lip extending from the planar surface,

[0143] i) The overhang is spaced apart from the second magnet and is configured to engage the lip when the second magnet is connected to the magnetic material,

[0144] j) The plenum chamber includes a groove, and the central portion is positioned within the groove,

[0145] k) The central part can be removably positioned within the groove part.

[0146] l) The groove part includes a protrusion, and the central part includes a complementary slot configured to receive the protrusion.

[0147] m) The slot is tapered and includes a wider opening and a narrower opening, and the protrusion is configured to be received through the wider opening prior to the narrower opening.

[0148] n) The protrusion includes an overhang configured to extend onto the slot and hold the frame relative to the plenum chamber.

[0149] o) The plenum chamber includes a protrusion disposed adjacent to the groove part, and the protrusion is configured to hold the central part within the groove part.

[0150] p) The outer surface of the central part is in the same plane as the outer surface of the plenum chamber, and the outer surface of the central part and the outer surface of the plenum chamber are configured to face away from the patient during use.

[0151] q) The central part includes an annular shape, the plenum chamber inlet port is arranged radially within the central part, while the frame is connected to the plenum chamber.

[0152] r) The plenum chamber inlet port is configured to receive an elbow, and the elbow is configured to be spaced apart from the central part while being received within the plenum chamber inlet port.

[0153] s) Each arm is formed as a cantilever type structure relative to the central part.

[0154] t) The thickness of each arm decreases as it approaches the free end from the fixed end.

[0155] u) The arm includes on its inner surface a scalloped region configured to face the skin of the patient.

[0156] v) Each arm is pivotable relative to the central portion about a pivot point and / or

[0157] w) The pivot point is a living hinge.

[0158] Another form of the technology includes a patient interface. The patient interface: A plenum chamber including a cavity pressurizable to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the treatment pressure for the patient's breathing, the plenum chamber, A seal-forming structure constructed and arranged to form a seal against the patient's face region, whereby the airflow at the treatment pressure is delivered to the airway, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure, And a positioning and stabilization structure configured to hold the seal-forming structure in a therapeutically effective position.

[0159] Another aspect of one form of the technology is an oro-nasal patient interface that is more compact and less obtrusive to the patient.

[0160] Another aspect of one form of the technology is an oro-nasal patient interface having a nasal cushion portion that enables an improved fit to the lower corners of the nose.

[0161] Another aspect of one form of the technology is an oro-nasal patient interface that reduces occlusive contact on the nose.

[0162] Another aspect of one form of the present technology is an oro-nasal patient interface that is self-adjusting to accommodate patients with a variety of nasolabial angles.

[0163] Another aspect of one form of the present technology is an oro-nasal patient interface having a relatively flexible shell.

[0164] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0165] One aspect of one form of the present technology is a method of manufacturing the device.

[0166] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0167] One aspect of one form of the present technology is a portable RPT device that is portable by a human (e.g., around the home).

[0168] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning utensils are required. One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning utensils are required.

[0169] The described methods, systems, devices, and apparatuses may be embodied to improve functions in a processor (e.g., functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the described methods, systems, devices, and apparatuses enable improvements in the technical field of the automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0170] Of course, some of the above aspects may form sub-aspects of the present technology. In addition, various combinations of various ones of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0171] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0172] The present technology is illustrated by way of non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements:

Brief Description of the Drawings

[0173]

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DETAILED DESCRIPTION OF THE INVENTION

[0174] Detailed description of embodiments of the technology Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0175] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment can be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments can constitute a further embodiment.

[0176] In the description of aspects and examples of the present technology, anatomical direction terms are used (e.g., "front", "rear", "upper", etc.), and these directions are to be construed in the context of the present technology when used by the patient. For example, the front side of the patient interface refers to the side of the patient interface that is in front of the patient when the patient wears the patient interface in the intended manner.

[0177] When describing the orientation of a surface or site in any direction (e.g., "facing upward", "facing forward"), unless it is clear from the context, the surface or site shall be understood as being at least partially oriented in a specific direction. If a site is generally facing upward, the site can be said to "face upward" even if it is partially facing in another direction.

[0178] 5.1 Treatment In one form, the present technology includes a method for treating respiratory diseases. The method includes applying positive pressure to the entrance of the airway of patient 1000.

[0179] In certain embodiments of the present technology, the air supply at positive pressure is provided to the patient's nasal passage through one or both nostrils.

[0180] In certain embodiments of the present technology, mouth breathing is restricted, limited, or impeded.

[0181] 5.2 Respiratory Therapy System In one form, the present technology includes a respiratory therapy system for treating respiratory diseases. The respiratory therapy system can include an RPT device 4000 that supplies an air flow to patient 1000 through an air circuit 4170 and a patient interface 3000.

[0182] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities can be provided by one or more physical components. In some forms, one physical component can provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the patient's airway inlet(s) so as to maintain a positive pressure at the inlet(s) to the patient's airway 1000. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0183] In some examples of the present technology, the plenum chamber is at least partially formed by a shell 3250. In an example, the shell 3250 or a part of the shell 3250 can have a certain flexibility as further described below.

[0184] In some examples of the present technology, the patient interface is an oro-nasal patient interface. This patient interface is configured to seal around both the patient's nasal airway and oral airway. In some examples, the patient interface includes separate seals around each of the nasal airway and the oral airway.

[0185] In the examples shown in FIGS. 7 to 22, the seal-forming structure at the nasal site seals the lower surface of the patient's nose rather than being placed on the bridge or alar region of the patient's face.

[0186] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0187] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0188] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0189] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the surroundings.

[0190] 5.3.1 Seal formation structure In one embodiment of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0191] As described in more detail below, in a particular embodiment of the present invention, the seal formation structure 3100 includes a first seal formation structure 3101 and a second seal formation structure 3102. The first seal formation structure 3101 is connected to the oral portion 3201 of the plenum chamber and is constructed and arranged to form a seal with the area of the patient's face surrounding the entrance to the patient's mouth. The second seal formation structure 3102 is connected to the nasal portion 3202 of the plenum chamber 3200 that is constructed and arranged to form a seal with the area of the patient's face surrounding the entrance to the patient's nose. As used herein, the term "connected" refers to a site or component formed as a single piece as well as a site or component formed separately and joined together later. In some cases, the components may be connected by an intermediate component.

[0192] In a particular embodiment, the first seal formation structure 3101 seals the patient's face independently of the second seal formation structure 3102.

[0193] In certain forms, the first seal-forming structure 3101 and the second seal-forming structure 3102 cooperate to form a single common seal against the patient's face.

[0194] In one form, the target seal-forming region is disposed on the outer surface of the seal-forming structure 3100.

[0195] In certain forms of the present technology, the seal-forming structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0196] The seal-forming structure 3100 according to the present technology can be composed of a soft, flexible and elastic material (e.g., silicone).

[0197] In certain forms of the present technology, a system including more than one seal-forming structure 3100 is provided. Each seal-forming structure 3100 is configured to correspond to different size and / or shape ranges. For example, the system can include one form of the seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0198] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilization structure.

[0199] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral portion of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use. Limiting buckling can limit the formation of wrinkles in the seal forming structure 3100 that can lead to leakage and loss of therapeutic pressure.

[0200] In one form, the seal forming structure 3100 may include a compression sealing portion or a gasket sealing portion. In use, the compression sealing portion or the gasket sealing portion is constructed and arranged to be in a compressed state, for example, due to elastic tension in the positioning and stabilizing structure.

[0201] In one form, the seal forming structure 3100 includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0202] In one form, the seal forming structure 3100 includes a region having an adhesive surface or an adherent surface.

[0203] In certain forms of the present technology, the seal forming structure 3100 may include one or more of a pressure assist sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a site having an adhesive surface or an adherent surface.

[0204] 5.3.1.2 Nasal Region Next, referring to FIGS. 7 to 18, in some forms of the present technology, the second seal-forming structure 3102 includes a central portion 3110 configured to seal the surface of the patient's nose during use. The central portion may seal the lower peripheral portion of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In an example, a part of the seal-forming structure may engage with the patient's septum. The second seal-forming structure 3102 may further include side portions 3111 on the side of the central portion 3110. In an example, the seal-forming structure 3102 may be configured to contact the patient's face below the lower side of the nasal bridge or below the nasal tip point.

[0205] As can be seen from FIGS. 10 and 16 to 19, the rear surface 3112 of the side portion 3111 is inclined forward in the upper front direction from the boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102, inclining the outer shape at the rear side of the nasal portion of the mask forward.

[0206] In an embodiment using a raised portion 3120 (as further described below), the rear surface 3112 of the side portion 3111 may be inclined forward from the raised portion 3120.

[0207] In some forms of the present technology, the rear surface 3112 of the side portion 3111 forms an angle of 20° to 90° with the central contact surface of the mask. The central contact surface may be perpendicular to the sagittal plane and may extend substantially along the length of the raised portion 3120 and the chord portion 3210.

[0208] As shown in FIG. 19, in some embodiments, the side portion 3111 is configured not to contact any part of the patient interface 3000 with the apex point 1020 of the patient's nasal wing during use.

[0209] By tilting the side portion 3111 in this way, a smaller portion of the nose portion of the interface 3000 can be extended onto the side portion of the wing (compared to some similar interfaces of the related art). As a result, in some forms of the present technology, the portion of the wing that contacts the seal-forming structure 3100 is reduced relative to an interface with a side portion that is tilted rearwardly towards the patient's face, so that the wing that can be deformed and blocked due to the seal-forming structure 3100 (for example, when the patient is sleeping on their side with the interface in contact with the pillow) is correspondingly reduced.

[0210] 5.3.1.3 Boundary between the oral region and the nasal region Referring particularly to FIGS. 7, 8, 16 to 18, in one form of the present technology, the boundary between the first sealing-forming structure 3101 and the second sealing-forming structure 3102 forms or includes a corner or a ridge 3120. In use, the corner or ridge 3120 can engage with the patient's face above the upper lip and directly below the nose.

[0211] In an embodiment, the corner or ridge 3120 forms an angle that is more acute than the corresponding portion or region of some oro-nasal masks of the related art (for example, those described in PCT application No. PCT / AU2019 / 050278).

[0212] With such a more acute angle, when the mask is worn and treatment is applied, the possibility of wrinkles forming within the first seal-forming structure 3101 and / or the second seal-forming structure 3102 over or adjacent to the corner or ridge 3120 is reduced. In some oro-nasal patient interfaces that do not use such a structure, a very thin circular formation (which may have low fold resistance) may be required in this region. Symmetrically, the corner or ridge 3120 can be harder and better retain its shape than such an interface, and thus can better seal the recesses and wrinkles present around the patient's nose. This effect can be enhanced in embodiments with a support (such as support 3260 described herein) that resists or prevents compression in this region.

[0213] In some forms of the present technology, the radius of the corner or ridge 3120 can be less than 2 mm (e.g., about 1.75 mm). In one form of the present technology, the radius can vary from approximately 1.75 mm at the center of the ridge to approximately 0.75 mm at the side portion.

[0214] The angle formed by the first sealing structure and the second sealing structure can be from 20 degrees to 90 degrees (e.g., 36 degrees).

[0215] In some forms of the present technology, the corner or ridge 3120 can extend substantially across the entire boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102. In an embodiment, the corner or ridge 3120 can engage the patient's face at least in the vicinity of the entrance to the nostrils (e.g., where the ala meets the face above the upper lip) as shown by region 1010 in FIG. 20.

[0216] 5.3.1.4 Oral region As described above, in one form, the non-invasive patient interface 3000 includes a first seal-forming structure 3101. The first seal-forming structure 6101 forms a seal around the patient's mouth during use. The first seal-forming structure 3101 may form a seal on the jaw region of the patient's face.

[0217] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw region of the patient's face during use.

[0218] The seal-forming structure 3100 includes a lower lip portion 3130. The lower lip portion 3130 forms a seal against the patient's jaw region and / or the patient's lower lip and / or cheeks. As shown in FIG. 16, the lower lip portion 3130 may be connected (e.g., adjacent) to the upper lip portion 3131 via a perioral portion 3132.

[0219] The seal-forming structure 3100 has a relatively small wall thickness (e.g., less than 0.7 mm) disposed with respect to the perioral portion 3132, the lower lip portion 3130 of the seal-forming structure disposed against the jaw region, and at least the center of the lower lip portion 3130 (compared to other parts of the interface). By thinning the wall thickness at these locations, the achievement of an effective and comfortable seal is assisted. The seal-forming structure within these regions can be easily adapted to any complex geometry.

[0220] In some forms of the present technology, the oral cavity portion 3133 is substantially trapezoidal rather than oval or oblong, and corresponds more precisely to the shape of the patient's nose. By making the oral cavity portion such a shape, it may be possible to make the interface 3000 particularly compact and not substantially wider than the patient's nostril width.

[0221] 5.3.1.5 Nasal Pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal pillows or nasal cushions. Each nasal pillow or nasal cushion is configured and arranged to form a seal with each nostril of the patient's nose.

[0222] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement of both the displacement and angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem is connected.

[0223] 5.3.2 Plenum Chamber In some forms, the plenum chamber 3200 (or at least a portion of the plenum chamber 3200) and the seal-forming structure 3100 are formed from a single homogeneous piece of material (e.g., molded silicone). The combination of the seal-forming structure 3100 and the plenum chamber 3200 may be regarded as a cushion.

[0224] 5.3.2.1 Adjustability of Nasal Angle Referring particularly to FIGS. 9, 10, and 16-18-2, in one form of the present technology, the first front wall portion 3240 of the nose portion 3202 of the plenum chamber 3200 is more flexible than the region immediately adjacent to the oral cavity portion 3201. The first front wall portion 3240 may be provided adjacent to the boundary 3241 between the nose portion and the oral cavity portion of the plenum chamber 3200. In an embodiment, the first front wall portion 3240 may be symmetric about the mid-sagittal plane and may extend over at least 50% (e.g., at least 80%) of the width of the nose portion 3202 of the plenum chamber. In some embodiments, the first front wall portion 3240 may extend substantially over the entire width of the nose portion 3202 of the plenum chamber.

[0225] In some forms of the present technology, the second front wall portion 3242 is less flexible than the directly adjacent portion of the front wall portion. In some embodiments, the second front wall portion 3242 is directly adjacent to the first front wall portion 3240 on the side opposite the boundary 3241 between the nasal portion and the oral portion of the plenum chamber. In an embodiment, the second front wall portion 3242 may be symmetric about the mid-sagittal plane and may extend over at least 50% (e.g., at least 80%) of the width of the nasal portion 3202 of the plenum chamber. In some embodiments, the second front wall portion 3242 may extend substantially over the entire width of the nasal portion 3202 of the plenum chamber.

[0226] The flexible first front wall portion 3240 may enable the patient contact portion 3110 of the second seal forming structure 3102 to pivot or move in a hinged manner around the area on the rear side of the interface 3000. This may assist in enabling the interface to accommodate patients having various angles (i.e., nasolabial angles) between the lower nose and the upper lip.

[0227] For example, in an embodiment in which a corner or ridge 3120 is provided between the first seal forming structure 3101 and the second seal forming structure 3102 as described above, the patient contact portion 3110 may pivot or move in a hinged manner around the corner or ridge 3120 or the area in the vicinity thereof. In an embodiment having one or more support portions 3260 (further described below), the hinged motion area or the pivoting area may be provided directly above the support portion 3260.

[0228] As shown in FIG. 9, the first front wall portion 3240 may have an upper boundary 3243 and a lower boundary 3244. One or both of the upper boundary 3243 and the lower boundary 3244 may be curved, for example, as shown in the drawing, such that the central portion of the boundary is provided below the side portion. The first front wall portion 3240 may be substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across the width, for example, as shown in the embodiment in FIG. 9, where the height of the central portion of the first front wall portion 3240 is higher than the height of the side portions. If the curvature of one or both of the boundaries 3243 and 3244 and / or the height of the first front wall portion 3240 changes, the rigidity of the first front wall portion 3240 (i.e., the resistance to buckling or bending in response to the force on the patient contact portion 3110 of the second seal forming structure 3102) may also change.

[0229] Similarly, the second front wall portion 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of the present technology, the lower boundary 3248 of the second front wall portion 3242 is the same as the upper boundary 3243 of the first front wall portion 3240. Since both the upper boundary 3247 and the lower boundary 3248 of the second front wall portion 3242 may be curved, for example, the central portion of the boundary is provided below the side portion. The second front wall portion 3242 may be substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may be varied across the width, whereby, for example, the height of the central portion of the second front wall portion 3242 is less than the height of the side portions.

[0230] In some forms of the technology, other configuration methods for imparting the required rigidity to the first front wall portion 3240 can be used in addition to or instead of the curved boundary. For example, the thickness of the first front wall portion 3240 can be selected such that the required rigidity is obtained. In an example, the first front wall portion 3240 can be thinner than the directly adjacent portion of the plenum chamber wall. Further and / or alternatively, the first front wall portion 3240 can extend upward around the lateral edge of the second front wall portion 3242 as shown in FIG. 21, so that compared to embodiments in which the first front wall portion 3240 is not in such a shape, the rigidity / resistance to compression or buckling is reduced.

[0231] The second front wall portion 3242 (e.g., the band 3270) can assist in avoiding buckling of the nose portion 3202 and can provide support to the patient contact portion 3110 of the second seal-forming structure 3102 (which is typically relatively thin). If the support of the patient contact portion is insufficient, it can lead to a rupture of the sealing engagement with the patient's face. In one form, the second front wall portion 3242 is thicker than the directly adjacent portion of the plenum chamber wall. In a particular form, the second front wall portion 3242 is provided as a band of thick material 3270 as shown in FIGS. 16-19. The first front wall portion 3240 and the second front wall portion 3242 can be constructed from the same material (e.g., as part of an integrally formed shell 3250).

[0232] In some forms, the first front wall portion 3240 and the second front wall portion 3242 can include different thicknesses. For example, the thickness of the second front wall portion 3242 can be made greater than the thickness of the first front wall portion 3240, which can lead to an increase in the rigidity of the second front wall portion 3242 (e.g., when compared to the first front wall portion 3240). Specifically, the second front wall portion 3242 can be a band 3270 and can extend into the cavity 3272 of the plenum chamber 3200. For example, the band 3270 can extend through the first front wall portion 3240 and can extend towards a patient wearing the patient interface 3000. The outer surface of the nose portion 3202 can be substantially smooth, and the inner surface of the nose portion (e.g., within the cavity 3272) can be stepped (or can include discontinuities).

[0233] As shown in FIGS. 16-1 and 16-2, the first front wall portion 3240 can function as a hinge and can allow for flexion of the nose portion 3202. Since the first front wall portion 3240 can be the thinnest region of the nose portion 3202, it can be most susceptible to bending moments. Such an increase in the thickness of the band 3270 directs the bending moment in a direction away from the second front wall portion 3242 and towards the thinner first front wall portion 3240. An increase in the height of the band 3270 (i.e., an increase in the distance between the upper boundary 3247 and the lower boundary 3248) can also make the nose portion 3202 more rigid and can enable bending suppression around the first front wall portion 3240. The first front wall portion 3240 and the second front wall portion 3242 can move in the forward direction (e.g., away from the patient) with the occurrence of bending.

[0234] As shown in FIGS. 18-1 and 18-2, the upper boundary 3243 of the first front wall portion 3240 is not the same as the lower boundary 3248 of the second front wall portion 3242. Instead, the upper boundary 3243 is at least partially higher than the lower boundary 3248 and can be at least partially aligned with the upper boundary 3247 of the second front wall portion 3242. This enables the first front wall portion 3240 to be arranged at least partially along the band 3270 (e.g., surrounding the bands 3270 on two or more sides). In other words, the first front wall portion 3240 can be arranged on at least one of the ends of the band 3270. This can lead to an increase in the flexibility of the first front wall portion 3240 and enable further bending of the nose portion 3202 (e.g., in the forward direction).

[0235] As shown in FIG. 21-1, the nose portion 3202 may be formed without a hinge. In other words, the band may not be formed on the second front wall portion 3242, whereby the thicknesses of the first front wall portion 3240 and the second front wall portion 3242 are substantially equal. Since the nose portion 3202 can be made of silicone, it can be bendable even without a band, thereby obtaining a certain compliance in the nose portion 3202 and enabling accommodation for different nasolabial angles.

[0236] 5.3.2.2 Flexible Shell In some forms of the present technology, the shell 3250 can be composed of a rigid material such as polycarbonate. However, in other forms of the present technology, a certain flexibility may be imparted to the shell 3250 or a part of the shell 3250. For example, in an example, the shell 3250 can be formed from a material (e.g., foam) having a Young's modulus of 0.4 GPa or less. In some forms of the present technology, the shell 3250 can be composed of a material (e.g., rubber) having a Young's modulus of 0.1 GPa or less. In other forms of the present technology, the shell 3250 can be composed of a material (e.g., 0.7 MPa - 0.3 MPa) having a Young's modulus of 0.7 MPa or less. An example of such a material is silicone.

[0237] In an example, the shell 3250 and one or both of the first seal-forming structure 3101 and the second seal-forming structure 3102 can be formed from the same material (e.g., silicone, fabric, etc.).

[0238] In some forms of the present technology (e.g., see FIGS. 23 to 28-2), the shell 3250 can be substantially entirely constructed from a flexible material, whereby the degree of freedom of movement of the shell 3250 can be maximized (i.e., the rigidity restricting bending is substantially eliminated and / or the thick portions are substantially eliminated). Since the shell 3250 can have sufficient flexibility, one or more components can be added to provide the necessary rigidity in one or more ranges or regions of the shell 3250 (e.g., the region in contact with region 1010). For example, one or more of a ventilation module, a connection port, a headgear connector, a stiffening arm, and a headgear connector connected to a stiffening member can be connected to the shell 3250 so as to increase the rigidity of the plenum chamber 3200 in the region adjacent to the component as further described below. In some forms of the present technology, such components can be releasably connectable to the flexible shell 3250. Additionally or alternatively, one or more components can be permanently connected to the shell 3250, for example, by adhesion and / or overmolding. The rigidity-imparting member can also perform the function of increasing rigidity and / or shape support of the seal-forming structure 3100.

[0239] In some forms of the present technology, the shell 3250 can generally be flexible but can include a hardened portion that is thicker than the directly adjacent portion of the shell 3250. Such a hardened portion can be configured as a rib or a band and can extend laterally and / or vertically across the shell, for example, but many other configurations are possible. In some forms, the shell can include a substantially rigid portion manufactured from, for example, polycarbonate and a portion having a certain degree of flexibility.

[0240] In some forms of the present technology, it may be preferable to provide the central portion 3251 on the front side of the oral cavity portion 3201 of the plenum chamber 3200 with higher rigidity than the remaining portion of the plenum chamber 3200. In some forms of the present technology, the region having higher rigidity may be provided directly below the nasal portion 3202 and / or directly above the oral cavity portion 3201 as shown in FIG. 21 and further described below. In one form of the present technology, a part or all of the first front wall portion 3240 may be a region having higher rigidity rather than a region having higher flexibility. By providing higher rigidity to one or more of these regions, shape stability can be obtained, and the range in which the shell 3250 deforms due to the headgear force can be limited. If excessive deformation occurs, it may lead to a situation where the nostrils are blocked by the second seal formation structure 3102. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses, and may not be as important or may not be desirable in some cases for patients with narrow noses. In addition, the described region having higher rigidity can assist in reducing the torsional deformation of the interface. If torsional deformation of the interface occurs, the contact between one side of the second seal formation structure 3102 and the patient's nose may be lost, resulting in the occurrence of a leakage path.

[0241] As shown in FIGS. 21 and 21-1, in one form of the present technology, a rigid portion 3263 may be provided on the shell 3250, or higher rigidity may be imparted to at least a part of the shell 3250 than the remaining portion of the shell (e.g., the molded) shell provided with one or more connection ports 3600. In one form of the present technology, the rigid portion 3263 may be made of polycarbonate. Thereby, higher rigidity can be obtained than a shell composed only of silicone. In one form of the present technology, the holes forming the ventilation portion 3400 are formed within the rigid portion 3263. In some forms of the present technology, the connector 3310 for the positioning and stabilization structure is attached on an arm 3320 that imparts a certain rigidity to the shell.

[0242] In one aspect of the present technology, the rigid portion 3263 extends laterally across the front of the plenum chamber near the upper boundary of the first front wall portion 3240 (e.g., directly below the second front wall portion 3242). The rigid portion 3263 may extend continuously between the connection ports 3600 and may provide an air flow path that allows pressurized air to enter the plenum chamber 3200 through the connection ports 3600.

[0243] In some aspects of the present technology, the connection ports 3600 may have a substantially oval cross-section. The connection ports 3600 may be oriented such that the center line of each port is substantially parallel to the outer surface of the plenum chamber adjacent to the port.

[0244] In some aspects of the present technology, the rigid portion 3263 may project forward relative to the adjacent surface of the first front wall portion 3240 and may be shaped to enhance flexural resistance.

[0245] In some aspects of the present technology (e.g., see FIG. 21), the connector 3310 and the arm 3320 are provided at the lower side of the connection port 3600 to the lateral edge of the plenum chamber 3200. The connector 3310 may be provided at the lateral end of the arm 3320. The connector 3310 may provide additional rigidity to the plenum chamber 3200 and / or the seal forming structure 3100.

[0246] In some aspects of the present technology (e.g., see FIG. 21-1), the connector 3310 does not include the arm 3320 and is directly connected to the plenum chamber 3200. Thereby, the plenum chamber 3200 may be made more flexible than the plenum chamber 3200 of FIG. 21.

[0247] Figure 22 shows a plenum chamber 3200 including a vent attachment aperture 3410. A suitable vent or module may be inserted into the vent attachment aperture 3410. To increase the rigidity of the plenum chamber, the vent may be constructed from a relatively rigid material. In some forms of the present technology, the vent attachment aperture 3410 may be substantially oval, and the minor axis of the oval is substantially parallel to the sagittal plane.

[0248] In the embodiment shown in Figure 22, the vent attachment aperture is provided at the upper boundary of the mouth portion 3201 of the plenum chamber 3200.

[0249] In the embodiment shown in Figure 22, a connector 3310 for a positioning and stabilization structure is provided. The connector 3310 may be attached within a relatively thicker region of the shell 3250. In the illustrated embodiment, the connector 3310 is provided on the side of the plenum chamber 3200 below the vent attachment aperture 3410. In some forms of the present technology, the connector 3310 is a substantially circular magnetic head gear connector.

[0250] Although an inlet or connection port is not shown in the drawings of the plenum chamber shown in Figures 7 - 19, one of ordinary skill in the art will understand that one or more inlet ports are actually provided (e.g., inlet port 3600 as shown in Figures 21 and 22). The inlet port 3600 enables connection to the interface air circuit 4170 as further described herein. In some forms of the present technology, one or more components of the air circuit 4170 may also function as components of a positioning and stabilization structure.

[0251] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material may reduce the constriction of the patient interface and may assist in improving compliance with treatment. The use of a transparent material may assist the clinician in viewing the placement and function of the patient interface.

[0252] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material, such as translucent silicone. By using a translucent material, the pressing tightness of the patient interface can be reduced, and compliance with treatment can be assisted.

[0253] In certain forms of the present technology, a dedicated stiffening member or rigidity-imparting member (for example, one without other functions) can be provided on the plenum chamber 3200. These members can be formed from a material with higher rigidity than the plenum chamber 3200 (for example, higher rigidity than silicone). By overmolding a dedicated stiffening member onto the plenum chamber 3200, higher rigidity than the rigid portion 3263 or the arm 3320 of the shell 3250 can be obtained.

[0254] 5.3.3 Support Site As best shown in FIGS. 12 and 14 - 18, in one form of the present technology, the support portion 3260 is provided on the opposite side of the interface 3000 between the second seal-forming structure 3102 and the front wall portion of the plenum chamber 3200. As shown in FIG. 12, in the example, each support portion 3260 extends to the lateral edge of the interface.

[0255] The support portion 3260 is not configured to function as an under-cushion, but is configured to withstand compression in the front-rear direction or suppress compression in the front-rear direction. Thereby, the support portion 3260 supports and / or hardens the portion of the second seal-forming structure 3102 that engages with the patient's upper lip. Specifically, by the support portion 3260, as shown in FIG. 20, the region of the second seal-forming structure 3102 that can contact the region 1010 of the patient's face in the vicinity of the entrance to the nostril (where the nasal wing meets the region above the upper lip) can be supported and / or hardened. In other words, the region 1010 can be provided directly below each lower corner of the patient's nose.

[0256] These support portions 3260 assist in reliably preventing wrinkle formation in the seal formation structure 3100. Wrinkles in the seal formation structure can occur because the flexibility of the seal formation structure is extremely high and the radius of curvature is also large, so that it conforms to the patient's face. If the flexibility of the seal formation structure is too high, the seal formation structures can be folded or wrinkles can occur, resulting in leakage in the seal formation structure. A case where wrinkles can be of particular concern is when the seal formation structure is sealed against the region 1010 of the patient's face. The support portion 3260 can be particularly advantageous when the seal formation structure is configured to produce corners and / or ridges 3120 as described herein. The corners and / or ridges 3120 can be more acute curves (e.g., curves with a smaller radius of curvature) compared to a seal formation structure without the support portion 3260. The additional support and / or rigidity provided by the support portion 3260 reduces the ability of the second seal formation structure 3102 to conform to the patient's face. For the sake of maintaining patient comfort, the corners and / or ridges 3120 are selected and / or sized to substantially match the geometry (e.g., outer shape) of the patient's face. For example, the seal formation structure 3100 for a particular patient can be selected from a variety of sizes to substantially conform to the nasal wing region (i.e., in the vicinity of the region 1010). Such a more acute curvature enables the second seal formation structure 3102 to seal against various gaps around the patient's nose and also reduces the likelihood of wrinkle formation.

[0257] As can be seen particularly from FIGS. 14 to 16, in one embodiment of the present technology, the support portion 3260 is connected to the front side of the oral cavity portion 3201 of the premaxillary chamber adjacent to the boundary 3241 between the oral cavity portion 3201 and the nasal portion 3202. In some embodiments, the support portion 3260 can be curved when viewed from a cross-section parallel to the sagittal plane (as shown in FIGS. 16 to 18), and / or can be curved when viewed from a cross-section parallel to the frontal plane (as shown in FIGS. 14 and 15). The curvature can be positive or negative. In the illustrated example, the curvature can be negative (e.g., with respect to the patient's nose). In some examples, the lateral side wall portion 3245 of the premaxillary chamber 3200 can be curved inwardly adjacent to the boundary 3241 with the nasal portion 3202, and the support portion 3260 can be substantially adjacent to the adjacent lateral side wall portion 3245. As shown in FIG. 18, when viewed from a cross-section parallel to the sagittal plane, at least a part of the support portion 3260 can have a reduced thickness between a first end portion 3261 adjacent to the front wall portion of the premaxillary chamber 3200 and a second end portion 3262 adjacent to the seal forming structure 3100. For example, since the support portion 3260 can be thicker in the vicinity of the first end portion 3261, an increase in the support and / or rigidity provided to the second seal forming structure 3102 can be assisted. In some examples, the support portion 3260 can vary between a thickness of 0.1 mm (e.g., in the vicinity of the second end portion 3262) and a thickness of 3.5 mm (e.g., in the vicinity of the first end portion 3261). In some examples, the support portion 3260 can vary between a thickness of 0.3 mm (e.g., in the vicinity of the second end portion 3262) and a thickness of 3 mm (e.g., in the vicinity of the first end portion 3261). In some examples, the support portion 3260 can vary between a thickness of 1.3 mm (e.g., in the vicinity of the second end portion 3262) and a thickness of 2.5 mm (e.g., in the vicinity of the first end portion 3261).

[0258] Support portions 3260 with different geometries can be used for different patients. For example, if increased support and / or rigidity in the second seal-forming structure 3102 is required for a patient, the seal-forming structure 3100 can be used with a support portion 3260 that is thicker and / or more curved (e.g., a smaller radius of curvature), for example, in the vicinity of the first end 3261 and / or at any position along the length. For example, if a patient requires a more flexible second seal-forming structure 3102, the seal-forming structure 3100 can be used with a support portion 3260 that is thinner and / or less curved (e.g., a larger radius of curvature), for example, in the vicinity of the first end 3261 and / or at any position along the length.

[0259] As can be seen particularly from FIGS. 14 and 15, in one form of the present technique, the support portion 3260 is connected to the oral cavity portion 3201 of the prenasal chamber adjacent to the boundary between the lateral side wall portion 3245 of the oral cavity portion 3201 and the lateral side wall portion 3246 of the nasal portion 3202.

[0260] In some forms of the present technique, the shape of the support portion 3260 is such as to provide a substantially clean flow path from the oral cavity portion 3201 of the prenasal chamber to the nasal aperture(s) 3135. In some forms of the present technique, no portion of any support portion 3260 is provided directly below the nasal aperture(s) 3135.

[0261] 5.3.4 Positioning and Stabilization Structure The seal-forming structure 3100 of the patient interface 3000 of the present technique can be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0262] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure in the prenasal chamber 3200 to lift off the face.

[0263] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0264] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the potential for destructive effects (e.g., caused by tubing drag or accidental interference with the patient interface) on the patient interface 3000.

[0265] In one form of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure 3300 has a non - obtrusive outer shape or cross - sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0266] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky such that it would interfere with a patient sleeping in a supine sleep position with the patient's head resting on a pillow in the posterior region of the head.

[0267] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky such that it would interfere with a patient sleeping in a lateral sleep position with the patient's head resting on a pillow in the lateral region of the head.

[0268] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a decoupling site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This decoupling site is not resistant to compression and can be, for example, a flexible or flimsy strap. The decoupling portion is constructed and arranged so as to avoid a situation where, when the patient lies with their head on the pillow, the presence of the decoupling portion causes a force to the rear to be transmitted along the positioning and stabilization structure 3300 and interfere with the seal.

[0269] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one embodiment, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0270] In a particular embodiment of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut during use and direct a force to bring the seal-forming structure into close contact with a part of the patient's face. In one example, the strap can be configured as a tie.

[0271] In one embodiment of the present technology, the positioning and stabilization structure includes a first tie, and in use, at least a part of the lower edge of the first tie moves upward and passes over the upper ear base point of the patient's head and covers a part of the parietal bone without covering the occipital bone. It is constructed and arranged to do so.

[0272] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a part of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head.

[0273] In one form of the present technology suitable for a nose-only mask or a full-face mask, the positioning and stabilization structure includes a third tie constructed and arranged to interconnect a first tie and a second tie so as to reduce the tendency of the first tie and the second tie to move in a divergent direction.

[0274] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and for example non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0275] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable such that water vapor can pass through the interior.

[0276] In a particular form of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or shapes. For example, the system may include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0277] In the embodiments shown in FIGS. 21 and 22, a connector 3310 (e.g., a magnet connector) for connection to the positioning and stabilization structure is provided.

[0278] 5.3.4.1 Frame As shown in FIGS. 23-28-2, the frame 3350 is connected to the plenum chamber 3200 and assists in maintaining the therapeutically effective position of the seal-forming structure 3100. The plenum chamber 3200 shown in FIGS. 23-28-2 specifically shows an elbow 3500 connected in front of the patient's face, but the frame can be used with other types of plenum chambers 3200 (e.g., the plenum chamber 3200 of FIGS. 21-22 used with a conduit headgear).

[0279] In some forms, the frame 3350 is constructed from a rigid or semi-rigid material and provides support to the seal-forming structure 3100 and / or the plenum chamber 3200. For example, the frame 3350 can support the shape maintenance of the seal-forming structure 3100 and / or the plenum chamber 3200 to reduce the leakage of pressurized air due to bending and / or wrinkling when the seal-forming structure 3100 engages the patient's face.

[0280] In some forms, at least one connection point 3352 provided by the frame 3350 can assist in the indirect connection of the headgear strap 3354 to the plenum chamber 3200 and / or the seal-forming structure 3100. The connection point 3352 can be a loop (e.g., with a fully formed perimeter) and receive a portion of the headgear strap 3354. For example, the length of the left upper headgear strap 3356 can extend through the first loop 3352a and be pulled away from the plenum chamber 3200 to add tension through the left upper headgear strap 3356. The left upper headgear strap 3356 can be folded over itself and held at a selected length (e.g., by Velcro®, magnets, adhesives, etc.), thereby maintaining the added tension. Similar steps can be taken in the adjustment of the tension of the second loop 3352b of the right upper headgear strap 3358.

[0281] In some forms, the orientation of each loop 3352a and 3352b can be such that the force vectors applied from each upper headgear strap 3356 and 3358 are substantially perpendicular to the inner loop surface 3351 where they contact the upper headgear straps 3356 and 3358. As shown in FIG. 23, the upper right headgear strap 3358 engages loop 3352b substantially at the center of the inner loop surface 3351. When the upper right headgear strap 3358 is fastened, the force vector is applied in a substantially linear direction and not obliquely to the inner loop surface 3351. As a reason why the sealing of the seal formation structure 3100 can be improved thereby, the force directed along the arm 3362 is not oblique to the arm 3362, so in order to obtain the same sealing effect (e.g., sacrificing patient comfort) it is necessary to further fasten the upper headgear straps 3356 and 3358 and / or the proper engagement between the seal formation structure 3100 and the patient's face is hindered (e.g., leading to leakage).

[0282] As shown in FIG. 27-2, a particular form of loops 3352a and 3352b can include an eyelet cut 3353. The eyelet cut 3353 can be formed on the patient side of each loop 3352a and 3352b (e.g., in the vicinity of the patient's skin during use). The eyelet cut 3353 can create a region of reduced thickness along the perimeter of each loop 3352a and 3352b. The eyelet cut 3353 can extend around a portion of the perimeter of loops 3352a and 3352b (e.g., less than 360°). In the illustrated example, each headgear strap 3354 can contact the eyelet cut 3353 when received through loops 3352a and 3352b. The reduction in thickness of the eyelet cut 3353 can lead to a reduction in the material used in the manufacture of loops 3352a and 3352b, which can lead to a reduction in the number of manufacturing runs and / or manufacturing costs. The eyelet cut 3353 can additionally or alternatively provide a reduction in skin marks and an improvement in patient comfort.

[0283] In one form, at least one of loops 3352a and 3352b may not be formed completely around the outer perimeter. In other words, loops 3352a and 3352b can be C-shaped and / or U-shaped. The upper left headgear strap 3356 and / or the upper right headgear strap 3358 can be individually folded over themselves and then inserted through loops 3352a and 3352b. This enables a patient to maintain the same length adjustment in each of the upper headgear straps 3356 and 3358 (when the seal forming structure 3100 has been removed from the therapeutically effective position).

[0284] In some forms, the frame 3350 includes a central portion 3360 connected to the plenum chamber 3200. The central portion 3360 can have an annular shape and can have an outer shape corresponding to the shape of the plenum chamber 3200 (e.g., approximating a positive dome-shaped curvature).

[0285] In one form, a single size of the central portion 3360 can be used with plenum chambers 3200 and / or seal forming structures 3100 of various sizes. For example, the seal forming structure 3100 can be sized in multiple sizes (e.g., small, medium, large) and / or shapes (e.g., narrow, wide) for a better seal for patients with various face shapes. The engagement area of the central portion 3360 can remain substantially the same regardless of the size of the plenum chamber 3200 and / or the seal forming structure 3100. Thus, the central portion 3360 can be connected to cushions of various shapes and / or sizes and can provide substantially the same support.

[0286] In one form, the central portion 3360 can be removably connected to the plenum chamber 3200. A patient can use the same frame 3350 with multiple plenum chambers 3200. This can be useful when a patient first starts treatment to try different sized plenum chambers 3200 to find a proper fit. Removing the frame 3350 can also allow for separate cleaning of different elements of the patient interface 3000 and can be useful during cleaning of the patient interface 3000 as more thorough cleaning is reliably assisted.

[0287] In some forms, the frame 3350 includes arms 3362 that extend in a direction away from the central portion 3360. Loops 3352a and 3352b are formed at the ends of the arms 3362. In use, the arms 3362 can extend at least partially in a rearward direction such that the loops 3352a and 3352b can be positioned rearward of the plenum chamber 3200 and / or the seal forming structure 3100. The arms 3362 can extend laterally (e.g., to the left or right respectively) generally along the contour of the patient's face.

[0288] In some forms, while the patient interface 3000 is being worn by a patient, the arms 3362 engage a portion of the patient's face. For example, the arms 3362 can contact the patient's cheek. The arms 3362 can be shaped to conform to the curvature of the patient's face (e.g., extending rearwardly and laterally).

[0289] In some forms, the arms 3362 cannot substantially elongate due to the tension applied from each headgear strap 3356 and 3358 via the loops 3352a and 3352b (e.g., the arms 3362 can be rigidizers and / or non - extensible). For maintaining therapeutically effective pressure and preventing leakage, the tension can be transferred along the arms 3362 to the plenum chamber 3200 and / or the seal forming structure 3100.

[0290] In one form, the arm 3362 is constructed from a material that is more flexible than the material used in the construction of the central portion 3360. By molding these materials together, the frame 3350 is constructed as an integral one-piece structure. The arm 3362 may have a certain rigidity to assist in maintaining its shape. However, since the arm 3362 is bendable, the patient may be able to adjust the shape of the arm 3362 to conform to their facial structure. Since the patient is able to adjust the shape of the arm 3362, it can lead to an increase in the comfort experienced by the patient and can lead to an increase in patient treatment compliance. In this way, the arm 3362 can bend or flex relative to the central portion 3360 (e.g., due to a cantilever type configuration), but may be made unable to extend in the rearward direction (e.g., due to non-extensibility). Furthermore, since a relatively flexible material is used in the construction of each of the arms 3362, reduction of facial marks and increase in patient comfort can be assisted.

[0291] In one form, the arm 3362 and the central portion 3360 are constructed from the same material. This material provides sufficient flexibility to allow for shape adjustment and also sufficient rigidity to maintain the adjusted shape. Since the central portion 3360 is connected to the plenum chamber 3200, it can be more rigid than the arm 3362. Additionally or alternatively, the central portion 3360 can be made thicker than the arm 3362, which can also lead to an increase in the rigidity of the central portion 3360. Each arm 3362 is formed in a cantilever shape, so the ends adjacent to the loops 3352a and 3352b are not supported. Further, the thickness of the frame 3350 can be reduced along the length of each arm 3362 in the direction of the loops 3352a and 3352b (see, for example, FIG. 27-1). This can impart to each arm 3362 the flexibility necessary to bend and / or conform substantially to the shape of the patient's face (e.g., the cheek). Reduction of the width of each arm 3362 can also reduce the contact of the cheek between each arm 3362 and the patient's cheek, which can lead to an improvement in patient comfort. Reduction of the width along the length of each arm 3362 can also result in an increase in the flexibility adjacent to each of the loops 3352a and 3352b.

[0292] In some forms, the thickness of the fixed end of each arm 3362 can be from approximately 2 mm to approximately 7 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from approximately 2.5 mm to approximately 6 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from approximately 3 mm to approximately 5 mm. In some forms, the thickness of the fixed end of each arm 3362 can be approximately 4 mm.

[0293] In some forms, the thickness of the free end of each arm 3362 can be from approximately 0 mm to approximately 4 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from approximately 0.5 mm to approximately 3 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from approximately 1 mm to approximately 2.5 mm. In some forms, the thickness of the fixed end of each arm 3362 can be approximately 2 mm.

[0294] As shown in FIG. 27-3, some forms of the cross-section of each arm 3362 can be substantially rectangular. Substantially rectangular corners (e.g., one corner, two corners, four corners) can be curved. This reduces the acute surfaces that come into contact with the patient's skin, thus helping to improve patient comfort. Each arm 3362 can also have a height that is greater than its thickness. This height can be designed to distribute pressure comfortably across the patient's skin (e.g., by increasing the height) without obstructing the patient's peripheral vision or causing patient discomfort in other ways.

[0295] In some forms, the height of each arm 3362 can be from approximately 5 mm to approximately 15 mm. In some forms, the height of each arm 3362 can be from approximately 6.5 mm to approximately 13.5 mm. In some forms, the height of each arm 3362 can be from approximately 8 mm to approximately 12 mm. In some forms, the height of each arm 3362 can be from approximately 9.5 mm to approximately 10.5 mm. In some forms, the height of each arm 3362 can be approximately 10 mm.

[0296] As shown in FIGS. 26-4 and 26-5, a particular form of the frame 3350 can provide a swiveling movement between each arm 3362 and the central portion 3360. This swiveling movement can be different from the bending movement described above in that the pivot point 6012 can connect each arm 3362 to the central portion 3360 and enables the entire arm 3362 to move substantially by the same angular distance. As described above, each arm 3362 can also be capable of bending in addition to swiveling.

[0297] In one form, the pivot points 6012 are disposed at the same location on either side of the frame 3350. In other words, each arm 3362 can be connected to the central portion 3360, and each arm 3362 can extend by the same length passing through the pivot point 6012. This can enable a patient to perform a mirror-type adjustment of the arm 3362. Next, the patient can individually bend or flex each arm to perform an adjustment to a specific side.

[0298] In one form, each pivot point 6012 is a living hinge. In other words, the frame 3350 can be constructed from a substantially uniform material (or the transition between each arm 3362 and the central portion 3360 can be constructed from a substantially uniform material). The thickness at each hinge 6012 can be made significantly smaller than the thickness of the arm 3362 and the central portion 3360 that is directly adjacent to the hinge 6012. For example, the hinge 6012 can be formed as a groove on the surface of the frame 3350 and faces away from the patient during use. By constructing the hinge 6012 uniformly and integrally from substantially the same material as the arm 3362 and the central portion 3360, a reduction in manufacturing cost can be facilitated (compared to, for example, providing a hinge constructed from a different material).

[0299] Each arm 3362 can be pivotable around each hinge 6012 between a first position and a second position. The loops 3352a and 3352b can be arranged closely spaced together at the second position rather than at the first position.

[0300] In one form, the first position can be a relaxed position and the second position can be a biased position. The arm 3362 can move to the second position when an external force is applied and can return to the first position when the external force is removed.

[0301] In one form, the arm 3362 may be positioned at the first position or the second position without continuous application of an external force. When the arm 3362 is moved to the second position, the arms 3362 may overlap each other (for example, like glasses). This can assist in reducing the footprint for packaging and / or storage.

[0302] In other forms (not shown), each arm 3362 may be separated from the central portion 3360 and may be connected to the central portion 3360 by a rotational hinge (for example, a pin joint). In still other forms, each arm 3362 may be connected to the central portion 3360 by overmolding with flexibility therebetween, thereby enabling a certain amount of pivotal movement.

[0303] In some forms, the frame 3350 further includes at least one secondary connection point 3364 spaced apart from the loops 3352a and 3352b. The secondary connection point(s) 3364 provides additional connection locations, thereby further assisting in the indirect connection of the headgear strap 3354 to the plenum chamber 3200 and / or the seal forming structure 3100.

[0304] In certain forms, the frame 3350 includes two secondary connection points 3364 (for example, a left secondary connection point 3364a and a right secondary connection point 3364b). The secondary connection points 3364a and 3364b may be disposed below the loops 3352a and 3352b when the patient is wearing the patient interface 3000. The headgear strap 3354 may further include a lower left headgear strap 3366 and a lower right headgear strap 3368. The lower left headgear strap 3366 and the lower right headgear strap 3368 are each configured to connect to each secondary connection point 3364a and 3364b. Next, the entire headgear 3354 may be capable of providing forces to the upper and lower regions of the seal forming structure 3100 and / or the plenum chamber 3200.

[0305] In certain forms, the secondary connection points 3364a and 3364b are formed directly on the central portion 3360. In a state where the patient is wearing the patient interface 3000, the secondary connection points 3364a and 3364b may be provided forward of the loops 3352a and 3352b.

[0306] In certain forms, the secondary connection points 3364a and 3364b may be constructed from a single component, thereby assisting in reducing machining tool costs and / or manufacturing costs.

[0307] In certain forms, the left headgear strap 3366 and / or the lower right headgear strap 3368 are removably coupled to each of the secondary connection points 3364a and 3364b. The secondary connection points 3364a and 3364b may be magnetic, and the left headgear strap 3366 and / or the lower right headgear strap 3368 may be provided through magnets 3370 that are of the opposite polarity to the secondary connection points 3364a and 3364b. The lengths of the left headgear strap 3366 and / or the lower right headgear strap 3368 may be adjusted (e.g., similar to the left headgear strap 3356 and / or the upper right headgear strap 3358) by folding each of the straps 3366 and 3368 onto itself. Removal of each magnet 3370 from each of the secondary connection points 3364a and 3364b may be performed without changing the length adjustment of the left headgear strap 3366 and / or the lower right headgear strap 3368. The patient may don and doff the patient interface 3000 simply by removing the magnets 3370 from each of the secondary connection points 3364a and 3364b (e.g., without the need to remove the left headgear strap 3356 and / or the upper right headgear strap 3358 from each of the loops 3352a and 3352b).

[0308] As shown in FIGS. 28-1 and 28-2, each of the secondary connection points 3364a and 3364b can be constructed to improve the retention by each magnet 3370. The outer casing 3376 of each of the secondary connection points 3364a and 3364b can include a substantially planar (e.g., flat) surface 3378 and a lip 3380 extending from the planar surface 3378.

[0309] In the illustrated example, the outer casing 3376 can have a substantially elliptical shape, and the lip 3380 can extend near the apex of the planar surface 3378. The lip 3380 can extend around only a portion of the planar surface 3378 (e.g., less than 360°). In some examples, the lip 3380 can extend less than 180° around the planar surface 3378 (e.g., the lip 3380 need not extend to any of the co-apexes of the substantially elliptical planar surface 3378).

[0310] As shown in FIG. 28-2, each of the secondary connection points 3364a and 3364b can be coupled to the frame 3350 such that the lip 3380 is positioned near the center of the frame 3350. In other words, each of the secondary connection points 3364a and 3364b can be oriented such that (when the frame 3350 is coupled to the plenum chamber 3200) the lip 3380 is positioned near the elbow 3500.

[0311] Magnet 3370 includes a substantially planar surface that can engage with the substantially planar surface 3378 of the outer casing 3376. While engaged with the planar surface 3378, magnet 3370 can be magnetically coupled to the magnetic elements 3382 of the secondary connection points 3364a and 3364b. Overhang 3384 can be disposed at a distance from magnet 3370. As shown, overhang 3384 can be positioned on one side (e.g., the inner side) of lip 3380, and magnet 3370 can be positioned on the other side (e.g., the outer side) of lip 3380. In use, the patient can adjust the length of each lower headgear strap 3366 and 3368. When one of the lower headgear straps 3366 and 3368 is fastened, a force directed away from the center of the frame 3350 (e.g., laterally outward) can be applied. This force can be made higher than the magnetic force between magnet 3370 and magnetic element 3382, and due to this force, magnet 3370 can move relative to the planar surface 3378.

[0312] The overhang 3384 can prevent a situation where the magnet 3370 is disengaged from the magnetic material 3382 as a result of fastening each of the lower headgear straps 3366 and 3368. As the movement of the magnet 3370 starts, the overhang 3384 can contact the lip 3380, so that further movement in the direction away from the center of the frame 3350 can be restricted. Thus, the engagement between the lip 3380 and the overhang 3384 can assist in reducing the situation where the magnet 3370 is accidentally disconnected from each of the secondary connection points 3364a and 3364b (when fastening each of the lower headgear straps 3366 and 3368), but the patient's ability to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., to remove the positioning and stabilization structure 3300) is not restricted.

[0313] As shown in FIG. 24, the engagement region of the plenum chamber 3200 may include a groove portion 3280. In the illustrated example, the groove portion 3280 may be provided on the oral cavity portion 3201 of the plenum chamber 3200 and may be provided radially outside the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the groove portion 3280. Since the shape of the central portion 3360 may substantially correspond to the shape of the groove portion 3280, (for example, in an example where the frame 3350 is removably connected to the plenum chamber 3200) the patient may be assisted in properly orienting the frame 3350 with respect to the plenum chamber 3200.

[0314] In some forms, the groove portion 3280 may have a substantially annular shape with a fully formed perimeter. This perimeter may have substantially the same length in cushions of any size.

[0315] In some forms, the groove portion 3280 is recessed relative to the remainder of the outer surface of the plenum chamber 3200. The recessed groove portion 3280 may not substantially extend into the plenum chamber 3200 and does not interfere with the patient's face. The groove portion 3280 may have substantially the same depth throughout its perimeter.

[0316] In some forms, the length of the groove portion 3280 may be made smaller than the width of the central portion 3360 of the frame 3350. Due to the compliance of the cushion, it may be possible to receive a wider central portion 3360 within the groove portion 3280. This may enable the central portion 3360 to be connected to the groove portion 3280 (via press fit, friction fit and / or snap fit). The engagement between the groove portion 3280 and the central portion 3360 may assist in imparting rigidity to the plenum chamber 3200 and / or the seal forming structure 3100 because the rigidity of the frame 3350 may limit a certain flexibility of the plenum chamber 3200 alone (for example, as compared to the plenum chamber 3200).

[0317] In some forms, the cushion can be molded onto the frame 3350 such that the groove 3280 can be formed during the molding process. The material of the plenum chamber 3200 (e.g., silicone) can be molded at least partially around the central portion 3360 of the frame 3350 and can limit the situation where the central portion 3360 is removed from the groove 3280.

[0318] As shown in FIG. 25, the frame 3350 can be constructed from a plurality of pieces (e.g., each constructed from a different material). For example, the central portion can be constructed from a first material (e.g., rigid plastic). The arm 3362 can be connected to the central portion 3360 (e.g., by adhesive, molding, etc.) and can be constructed from a second material that is more flexible than the first material (e.g., flexible plastic, foam, etc.). The third material can be a magnetic material and can be connected to the central portion 3360 (e.g., via an adhesive). After being interconnected, the arm 3362 can be capable of moving in a manner similar to the integral one-piece structure as described above.

[0319] As shown in FIGS. 26 and 27, the frame 3350 can be constructed from a single piece of material. For example, the frame 3350 can be constructed from a TPE material such as Hytrel. As described above, both rigidity and flexibility can be imparted to the frame 3350 by the material used to construct the frame 3350. The magnet 3370 can be overmolded (or otherwise connected) to the central portion 3360.

[0320] In some forms, the central portion 3360 includes slots 3372. These slots 3372 can be formed on either side of the central portion 3360. The slots 3372 can generally have an elongated shape (e.g., rectangular, oval) and can be formed entirely within the boundaries of the central portion 3360.

[0321] As shown in FIG. 27, the central portion 3360 in some forms may include a tapered slot 3372. Specifically, the opening for the slot 3372 may be wider in the vicinity of the rear surface of the central portion 3360 (for example, the surface that contacts the plenum chamber 3200). The opening for the slot 3372 may be evenly reduced as it approaches the front surface of the central portion 3360.

[0322] FIG. 27 also shows that some forms of the arm 3362a (or arm 3362b) may include a recess or scallop 3373. The scallop 3373 may be formed on the inner surface of the arm 3362a and may be positioned so as to be provided in the vicinity of the patient's skin (when the patient is wearing the positioning and stabilization structure 3300). The scallop 3373 reduces the thickness along a part of the arm 3362a, and the possibility of sink marks occurring in the arm 3362a during the manufacturing process (for example, (for example, injection molding)) can be reduced. The scallop 3373 may also lead to a reduction in the material used for manufacturing the arm 3362a, which may lead to a reduction in the number of manufacturing times and / or a reduction in manufacturing costs.

[0323] Referring to FIGS. 26 to 26-2, the plenum chamber 3200 may include protrusions 3284 on the oral cavity portion 3201. These protrusions may be elongated and may have a shape similar to the slot 3372 (for example, may be tapered). The protrusions 3284 may be arranged in the groove 3280 so as to cooperate with the frame 3350 during assembly.

[0324] As shown in FIG. 26-2, some forms of the protrusions 3284 may include an overhang 6000 that at least partially extends over the groove 3280. The overhang 6000 may be formed asymmetrically around the protrusion 3284. In other words, the overhang 6000 may further extend over the groove 3280 on one side other than the other side.

[0325] In some forms, the groove 3280 can also be asymmetric. The groove 3280 can include an undercut 6004 on one side of the protrusion 3284 and an inclined surface 6008. The overhang 6000 can extend further on the undercut 6004 than on the inclined surface 6008. The length of the overhang 6000 extending on the undercut 6004 can limit the possibility that the frame 3350 is removed vertically from the plenum chamber 3200. The angle of the inclined surface 6008 can be directed toward the overhang 6000 and can limit the possibility that the frame 3350 is removed obliquely.

[0326] When the frame 3350 is assembled to the plenum chamber 3200 (e.g., via press fit, friction fit, snap fit, etc.), the patient can align the protrusion 3284 with the slot 3372 and receive the protrusion 3284 within the slot 3372 during use. The wider opening of the adjacent slot 3372 behind can assist in aligning the patient with each protrusion 3284 within each slot 3372. The protrusion 3284 can be slightly wider than the front opening of each slot 3372, but due to the flexibility of the plenum chamber 3200 (e.g., being constructed of an elastic material such as silicone), it can be received within the slot 3372. The protrusion 3284 can be slightly deformed when entering each slot 3372 (e.g., due to the slot 3372 narrowing).

[0327] After the protrusion 3284 passes through the slot 3372, the protrusion 3284 can substantially return to its original shape. For example, the overhang 6000 can be deformed (e.g., elastically deformed) when the slot 3372 receives the protrusion 3284 and can return to its initial position after the central portion 3360 is received within the groove 3280. The patient can experience this deformation as a tactile response to more easily observe the proper connection between the frame 3350 and the plenum chamber 3200. The overhang 6000 of the protrusion 3284 can be wider than the front opening of each slot 3372 in the relaxed or initial position.

[0328] Furthermore, since the width of the undercut 6004 can be substantially the same as that of the central portion 3360, the frame 3350 is snugly received within the groove portion 3280. Due to the flexible material of the plenum chamber 3200, the undercut 6004 can be made slightly smaller than the central portion 3360, so that the undercut 6004 can flex and receive the frame 3350 (e.g., via press fit, friction fit, snap fit, etc.).

[0329] Thus, the frame 3350 can be prevented from easily coming off the plenum chamber 3200. A patient may need to apply force to the frame 3350 to remove the frame 3350 from the groove portion 3280. This added force from the user can enable movement of the frame 3350 in a vertical or diagonal direction and overcome the retention provided by the overhang 6000. For example, a patient can lift the frame 3350 from the region of the central portion 3360 that contacts the inclined surface 6008 to provide a force for disengaging the frame 3350 from the plenum chamber 3200.

[0330] This force can exceed the forces generated due to normal movement of the plenum chamber 3200 and / or the seal forming structure 3100. In other words, the seal forming structure 3100 and / or the plenum chamber 3200 can move relative to the frame 3350 while the protrusions 3284 are received within the respective slots 3372. This can enable the seal forming structure 3100 and / or the plenum chamber 3200 to flex and conform to the patient's face (without loosening and coming off the frame 3350 and without the slots 3372 inadvertently disengaging from the protrusions 3284).

[0331] In other forms, the plenum chamber 3200 can be molded onto the frame 3350, and the protrusions 3284 can be obtained from a molding process for permanently holding the position of the frame 3350 relative to the plenum chamber 3200.

[0332] As shown in FIG. 26-3, some forms of the frame 3350 can be oriented to reduce contact with the cheeks while the connected frame 3350 and plenum chamber 3200 are being worn by the patient. For example, the arms 3362a and 3362b can be oriented (e.g., curved) to be substantially compliant in at least a portion (e.g., the cheeks) of the patient's face. However, in some instances, the entire length of each arm 3362 may not contact the patient's skin because the patient may find it uncomfortable for a foreign object to contact their cheek. Instead, a portion of each arm 3362 can be spaced from the patient's face, thereby reducing the surface of each arm 3362 that contacts the patient's face. By maintaining substantially the same curvature in each arm 3362 and moving the point of contact between each arm 3362 and the plenum chamber 3200 (e.g., via the manufacturing process), the overall length of each arm 3362 that contacts the patient's face can be varied. For example, when each arm 3362 contacts the plenum chamber 3200 closer to the elbow 3500, the maximum gap between each arm 3362 and the patient's face increases. That is, a larger portion of each arm 3362 is spaced from the patient's face (as contrasted with when each arm 3362 contacts the plenum chamber 3200 distal from the elbow 3500). Reducing the contact between each arm 3362 and the patient's face can lead to improved patient comfort.

[0333] Further, contact between each arm 3362 and the plenum chamber 3200 in the vicinity of the elbow (and thus distal from the rear surface 3112) can cause a reduction in support at the side portion 3111 of the plenum chamber 3200 (e.g., due to reduced engagement with the side portion 3111 of the rigid or semi-rigid arm). Thus, the side portion 3111 can have a higher level of flexibility, can better conform to the shape of the patient's nose, and can potentially create an effective seal.

[0334] As shown in FIGS. 26-4 and 26-5, some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the central portion 3360. The hinge 6012 may enable movement of the arm 3362 (e.g., pivotal movement) without affecting the connection between the frame 3350 and the plenum chamber 3200. In other words, even if any arm 3362 is pivoted around each hinge 6012, the protrusion 3284 is not disengaged from the slot 3372.

[0335] In some forms, the patient may move the arm 3362 to a second position to obtain a better fit. For example, the distance between the loops 3352a and 3352b in the first position may be made larger than the size of an average patient's head. Therefore, the patient may move the arm 3362 to a second position to obtain a proper sense of fit (e.g., contact between the arm 3362 and the patient's head). The arm 3362 may be held in the second position by adjustment of the upper headgear straps 3356 and 3358 (i.e., an external force may be obtained from the upper headgear straps 3356 and 3358).

[0336] Similar to the arm 3362, the plenum chamber 3200 and / or the seal forming structure 3100 may be made larger than the size of an average patient's face. For example, the seal forming structure 3100 may not fit snugly with the patient's mouth and / or nose. The plenum chamber 3200 and / or the seal forming structure 3100 may also be moved to a more compact position to improve engagement with an individual patient's face.

[0337] As shown in FIG. 26-5, when the arm 3362 is moved to the second position, the seal forming structure 3100 and / or the plenum chamber 3200 may move directly to a more compact position. The arm 3362 may contact the plenum chamber 3200 along the second front wall portion 3242. The arm 3362 may also contact the second front wall portion 3242 that is near the center of the plenum chamber 3200 and distal to the side portion 3111.

[0338] By moving each arm 3362 pivotally around the hinge 6012, an inwardly directed force can be provided to the plenum chamber 3200. Thereby, the distance between the side portions 3111 of the second seal forming structure 3102 can be reduced, and the second seal forming structure 3102 can be snugly positioned against the patient's nose. Compressing the seal forming structure 3100 and / or the plenum chamber 3200 can lead to an improved seal against the patient's face (e.g., due to limiting leakage). Further, adding an inwardly directed force in the vicinity of the center of the plenum chamber 3200 (e.g., as described for FIG. 26-3) can limit the total compression of the plenum chamber 3200, and thus limit the occurrence of wrinkles in the seal forming structure 3100.

[0339] As shown in FIG. 28, the frame 3350 can be shaped similarly to the frames in FIGS. 26 and 27. In other words, the frame 3350 can be constructed from a single material (e.g., semi-rigid). The frame 3350 can be thicker in the vicinity of the central portion 3360 and can become thinner as it approaches each loop 3352a and 3352b.

[0340] In some forms, the central portion 3360 of the frame 3350 can be generally substantially solid and may not include the slot 3372, and the plenum chamber 3200 may not include the protrusion 3284 within the groove 3280. Instead, the plenum chamber 3200 can include a protrusion 3288 disposed radially inward of the groove 3280. The protrusion 3288 can be raised from the remaining portion of the front face of the plenum chamber 3200. The protrusion 3288 can also extend at least partially radially outward. In other words, the protrusion 3288 can extend at least partially over the groove 3280 (e.g., the protrusion 3388 is spaced apart from the groove 3280).

[0341] While assembling the removable frame 3350 into the plenum chamber 3200, it may be necessary to position the frame 3350 such that the frame 3350 extends within the groove portion 3280 and below the protrusion 3288. After positioning the central portion 3260, retention of the central portion 3360 at a predetermined position may be assisted by the protrusion 3288. To disconnect the frame 3350 from the plenum chamber 3200, a patient may press at least one of the protrusions 3288 (e.g., in a lateral direction approaching the other protrusions 3288), whereby the protrusion may be made not to extend over the groove portion 3280. In other forms, the plenum chamber 3200 may be molded onto the frame 3350, and removal of the central portion 3360 may be avoided by the protrusion 3288.

[0342] In some forms, the frame 3350 of any of the above examples may be substantially flush with the outer surface of the plenum chamber 3200 when positioned within the groove portion 3280. The depth of the groove portion 3280 substantially corresponds to the thickness of the central portion 3360. Similarly, the shape of the central portion may be substantially approximated to the shape of the cushion as described above. The resulting assembly may have a substantially uniform surface. This helps to maintain the appearance of the patient interface 3000 unobtrusive as the frame 3350 does not protrude in front of the cushion (where the frame 3350 may obstruct the patient's line of sight).

[0343] 5.3.5 Ventilation In one form, the patient interface 3000 includes a ventilation portion 3400 configured and arranged to allow expulsion of exhaled gas (e.g., carbon dioxide).

[0344] In certain embodiments, the vent 3400 is configured to allow a continuous flow of air from the interior of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive relative to the atmosphere. The vent 3400 is configured such that, during use, it can reduce the rebreathing by the patient of exhaled CO2 by an amount sufficient to maintain the therapeutic pressure within the plenum chamber while maintaining the size of the ventilation flow rate.

[0345] One form of the vent 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0346] The vent 3400 can be disposed within the plenum chamber 3200. Alternatively, the vent 3400 is disposed within a disconnect structure (e.g., a swivel joint).

[0347] Although the ventilation structure is not illustrated in FIGS. 7 - 18, the embodiments of the present technology shown in FIGS. 7 - 18 can include a suitable ventilation structure, for example, in the plenum chamber (an example is shown in FIG. 21).

[0348] 5.3.6 Disconnect Structure(s) In one form, the patient interface 3000 includes at least one disconnect structure 3500 (e.g., a swivel or ball and socket). In some examples, the disconnect structure can be an elbow 3500 connected (e.g., removably connected, permanently connected) to the plenum chamber 3200 (e.g., the plenum chamber inlet port).

[0349] As shown in FIGS. 23-28, since the central portion 3360 of the frame 3350 has an annular shape, the central region of the oral cavity portion 3201 of the plenum chamber 3200 is not covered by the frame 3350. In some examples, the oral cavity portion 3201 includes an opening for receiving the elbow 3500. Since the opening for receiving the elbow 3500 can be significantly wider, the frame 3350 is disposed completely spaced apart from the opening. In other words, there is a length between the inner edge of the central portion 3360 and the opening for receiving the elbow 3500. Since the arm 3362a pressing 3362b and the secondary connection portions 3342a and 3342b are each disposed spaced apart from the opening and the elbow 3500, the headgear strap 3358 does not interfere with the movement (e.g., rotation) of the elbow.

[0350] Although not explicitly shown in the drawing of the plenum chamber shown in FIGS. 7-19, those skilled in the art will understand that, in fact, an elbow 3500 can be provided (as shown in FIG. 23, for example) and can enable connection to the air circuit 4170 of the interface.

[0351] 5.3.7 Connection Port The connection port 3600 enables connection to the air circuit 4170 (e.g., a removable connection via a snap fit, a permanent connection, etc.). The patient interface 3000 can include two connection ports 3600 on either side of the plenum chamber 3200. A conduit can be connected to the connection port 3600 to convey pressurized breathable gas to the patient. In some forms, these conduits can be conduit headgear and can contact the patient's head. These conduits can extend to the top of the patient's head (where the disconnection structure 3500 is disposed).

[0352] 5.3.8 Forehead Support In one form, the patient interface 3000 includes a forehead support 3700.

[0353] 5.3.9 Anti-Suffocation Valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0354] 5.3.10 Ports In one form of the technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the properties of the gas (e.g., pressure) within the plenum chamber 3200.

[0355] 5.4 RPT Device The RPT device 4000 according to one aspect of the technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an air flow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described, for example, anywhere in this document.

[0356] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O.

[0357] 5.4.1.1 RPT Device Algorithm As described above, in some forms of the technology, the central control device 4230 can be configured to embody one or more algorithms 4300 represented as a computer program recorded in a non-transitory computer-readable recording medium (e.g., the memory 4260). These algorithms 4300 are generally grouped into groups called modules.

[0358] In other forms of the present technology, some or all of algorithm 4300 can be implemented by a controller of an external device such as local external device 4288 or remote external device 4286. In such a form, data representing the input signals and / or intermediate algorithm outputs required for the portion of algorithm 4300 that is executed by the external device can be communicated to the external device via local external communication network 4284 or remote external communication network 4282. In such a form, the portion of algorithm 4300 that is executed by the external device can be represented as a computer program stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute a portion of algorithm 4300.

[0359] In such a form, treatment parameters generated by the external device via treatment engine module 4320 (in such a form, a portion of algorithm 4300 is executed by the external device) can be transmitted to central controller 4230 and passed to treatment control module 4330.

[0360] 5.5 Air Circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components (e.g., RPT device 4000 and patient interface 3000).

[0361] Specifically, air circuit 4170 can be in fluid connection with the outlet of air pressure block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0362] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., a temperature sensor). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., the 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. The entire disclosure of this document is incorporated herein by reference for all purposes.

[0363] 5.5.1 Supplemental Gas Delivery In one form of the technology, a supplemental gas, such as oxygen 4180, can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0364] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of the air or gas to be delivered to a patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and the temperature of the air stream before it is delivered to the patient airway.

[0365] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving the air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, such as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 can further include a humidifier base 5006. The humidifier base 5006 can be adapted to receive the humidifier reservoir 5110 and can include a heating element 5240.

[0366] 5.7 Respiratory waveform Figure 6 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time, and the vertical axis is respiratory flow rate. Since the parameter values can vary, typical respiration may have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 seconds, peak inspiratory flow rate, Q peak, 0.4 L / second, expiratory time, Te, 2.4 s, peak expiratory flow rate, Q peak, -0.5 L / second. The total duration of respiration Ttot is about 4 seconds. Humans typically breathe about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%.

[0367] 5.8 Respiratory therapy modes A variety of respiratory therapy modes can be implemented by the disclosed respiratory therapy system, including CPAP therapy and bilevel therapy.

[0368] 5.9 Glossary For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0369] 5.9.1 General Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0370] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) what directly surrounds the treatment system or the patient.

[0371] For example, the ambient humidity for a humidifier may be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0372] In another embodiment, the ambient pressure can be the pressure directly surrounding or external to the body.

[0373] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room other than noise generated, for example, from the RPT device or from the mask or patient interface. Ambient noise can be generated from sources outside the room.

[0374] Automatic positive airway pressure (APAP) therapy: A form of CPAP therapy in which the therapy pressure can be automatically adjusted, for example, between a minimum and a maximum limit during the breathing cycle, depending on the presence or absence of signs of SDB onset.

[0375] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., is increased in response to detection of signs of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0376] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to the instantaneous amount. In some cases, when referring to flow rate, a scalar quantity (i.e., a quantity having only magnitude) is meant. In other cases, when referring to flow rate, a vector quantity (i.e., a quantity having both magnitude and direction) is meant. Flow rate may be given the symbol Q. "Flow rate" may be abbreviated as "flow" in some cases.

[0377] In an example of patient breathing, the flow can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The device flow Qd is the flow of air exiting the RPT device. The total flow Qt is the flow of air and any supplemental gas reaching the patient interface via the air circuit. The vent flow Qv is the flow of air exiting the vent to allow the outflow of the exhaled gas. The leak flow Ql is the flow of leakage from the patient interface system or other locations. The breathing flow Qr is the flow of air received into the patient's respiratory system.

[0378] Flow therapy: A respiratory therapy that includes delivering an air flow to an airway inlet at a controlled flow rate, referred to as a therapeutic flow rate, that is typically positive pressure throughout the patient's breathing cycle.

[0379] Humidifier: The word "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve the patient's medical breathing condition.

[0380] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the ambient around elbow.

[0381] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient by an air pressure path (e.g., the air circuit and the patient interface and the air within). In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0382] Noise emission (acoustic): In this document, the emitted noise refers to the noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object according to ISO3744.

[0383] Noise ventilation (acoustic): In this document, the ventilation noise refers to the noise generated by the air flow through any ventilation (e.g., the ventilation holes in the patient interface).

[0384] Patient: A person with or without a respiratory disease.

[0385] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 , and approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar ~ 0.001 atm). In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0386] The symbol Pm is assigned to the pressure in the patient interface, and the symbol Pt is assigned to the treatment pressure representing the target value to be achieved by the interface pressure Pm at the current time.

[0387] Respiratory pressure therapy (RPT): The addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0388] Ventilator: A mechanical device that provides pressure assistance when the patient performs part or all of the breathing motion.

[0389] 5.9.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molding silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

[0390] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0391] 5.9.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0392] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0393] Hardness: The ability of a material to resist deformation itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). · "Soft" 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 cannot be easily deformed, for example, under finger pressure.

[0394] 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, tension, bending or torsion). The structure or component may provide different resistances in different directions. The antonym of stiffness is flexibility.

[0395] Flaccid structure or component: A structure or component that, when supported under its own weight, changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when subjected to its own weight.

[0396] Rigid structure or component: A structure or component that exhibits substantially no change in shape when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0397] As an example, an I - beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flaccid in a first direction and rigid in a second direction.

[0398] 5.9.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, e.g., 10 seconds. Obstructive apnea is said to occur when, despite the patient's efforts, air flow is not permitted due to some airway obstruction. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0399] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0400] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0401] Effort (respiratory): Respiratory effort is said to refer to the movement performed by the spontaneous breathing of a person attempting to breathe.

[0402] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0403] Flow limitation: Flow limitation is interpreted as a situation in a patient's breathing where an increase in the patient's effort does not cause a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0404] Types of waveforms of inspiratory flow limitation: (i) Flattening: After an increase, a relatively flat portion is followed by a decrease. (ii) M-shaped: Having one local peak at the rise and one local peak at the fall, with a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak that occurs in the rising portion, followed by a relatively flat portion. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs in the falling portion.

[0405] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a period of time, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as hypopnea: (i) A 30% decrease in patient breathing for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease (less than 50%) in patient breathing that continues for at least 10 seconds and is associated with at least 3% desaturation or arousal occurs.

[0406] Hyperpnea: The flow increases to a level higher than the normal flow rate.

[0407] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0408] Patency (airway): The degree to which the airway is open or the range over which the airway is open. Airway patency is an opening. Quantification of airway patency can be performed with a value indicating patency (1) and a value indicating closure (obstruction) (0).

[0409] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of expiration.

[0410] Peak flow (Qpeak): The maximum value of the flow rate in the inspiratory portion of the respiratory flow waveform.

[0411] Respiratory gas flow rate, air flow rate, patient's air flow rate, respiratory gas air flow rate (Qr): These terms can be understood to refer to the estimation of the respiratory air flow rate of the RPT device and are used in contrast to the "true respiratory flow rate" or "true respiratory gas flow rate", which is the actual respiratory flow rate of the patient, usually expressed in liters per minute.

[0412] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. In principle, the inspiratory volume V i (the amount of inhaled air) is equal to the expiratory volume V e (the amount of exhaled air), so a single tidal volume V t can be defined as equal to either amount. In practice, the tidal volume V t is estimated as some combination (e.g., the average of the inspiratory volume V i and the expiratory volume V e ).

[0413] Inspiratory time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0414] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0415] (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.

[0416] Typical recent ventilation: The ventilation value (i.e., the degree of tendency of the center of the most recent values of ventilation) to which the most recent values of ventilation Vent over a given time scale tend to cluster.

[0417] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation where the flow may slightly increase or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0418] Ventilation (Vent): The measurement of the gas exchange rate performed by the patient's respiratory system. The measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as volume and is understood as volume per minute.

[0419] 5.9.3 Ventilation Adaptive servo - ventilator (ASV): A servo - ventilator that does not have a fixed target ventilation but has a changeable target ventilation. The changeable target ventilation can be learned from some characteristics of the patient (e.g., the patient's respiratory characteristics).

[0420] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically, the number of breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0421] Cycle: The end of the inspiratory phase of the ventilator. When delivering breaths from the ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop the breath delivery.

[0422] Expiratory Positive Airway Pressure (EPAP): The base pressure to which a pressure varying within the respiratory cycle is added for the generation of a desired interface pressure that the ventilator attempts to achieve at a given time.

[0423] End Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. When the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., when Π(Φ) = 0 for Φ = 1), EEP is equal to EPAP.

[0424] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0425] Pressure support: A number indicating the pressure increase during ventilator inspiration compared to ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0426] Servo ventilator: A ventilator with patient ventilation and target ventilation, which adjusts the pressure support level to bring the patient ventilation closer to the target ventilation.

[0427] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period, the device automatically starts breath delivery.

[0428] Swing: A term corresponding to pressure support.

[0429] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to deliver a breath when the patient himself / herself starts the inspiratory portion of the breathing cycle.

[0430] 5.9.4 Anatomical Structure 5.9.4.1 Anatomical Structure of the Face Ala: The outer wall or "wing" of each nasal cavity (plural: alar)

[0431] Alare: The outermost point on the alar nose

[0432] Alar curvature (or alar apex) point: The rearmost point on the curved reference line of each alar, seen at the fold formed by the junction of the alar and the cheek

[0433] Auricle: The entire visible part of the ear

[0434] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone

[0435] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage

[0436] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip

[0437] Columella Angle: The angle between a line drawn through the midpoint of the nasal cavity and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point

[0438] Frankfurt Horizontal Plane: A line extending from the lowest point of the orbital margin to the left auricular point. The auricular point is the deepest point from the upper notch to the tragus of the auricle

[0439] Glabella: Located in the soft tissue, the most prominent point on the mid-sagittal plane of the forehead

[0440] Lateral Nasal Cartilage: A generally triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage

[0441] Lower Lip (Labrale-Inferius): A point on the face between the mouth and the chin, existing within the mid-sagittal plane

[0442] Upper lip (labrale superius): A point on the face between the mouth and the nose, present within the median sagittal plane.

[0443] Greater alar cartilage: A plate of cartilage, disposed inferior to the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0444] Nostril (nares): Generally an oval wing-shaped aperture that forms the entrance to the nasal cavity. The singular form of nostril is naris. These nares are separated by the nasal septum.

[0445] Nasolabial groove or nasolabial fold: A fold or groove in the skin that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0446] Nasolabial angle: The angle between the columella and the upper lip, intersecting with the subnasale point.

[0447] Lower ear attachment point: The lowest point of attachment of the auricle to the skin of the face.

[0448] Upper ear attachment point: The highest point of attachment of the auricle to the skin of the face.

[0449] Nasal tip point: The most prominent point or tip of the nose, which can be identified in the lateral view of the remaining part of the head portion.

[0450] Philtrum: A midline groove extending from the inferior border of the nasal septum to the upper part of the lip in the upper lip region.

[0451] Pogonion: The most anterior midpoint on the soft tissue of the jaw.

[0452] (Nasal) sill: The nasal sill is a median ridge of the nose that extends from the sellion to the nasal tip point.

[0453] Sagittal plane: A vertical plane extending from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into right and left halves.

[0454] Cellion: It is the most concave point on the area of the fronto-nasal suture, located on the soft tissue.

[0455] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0456] Lowest alar point: It is the point on the lower peripheral edge of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0457] Subnasale: It is located on the soft tissue and is the point where the columella joins the upper lip in the mid-sagittal plane.

[0458] Stomion: It is the most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0459] 5.9.4.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the area known as the forehead.

[0460] Mandible: The mandible forms the lower jaw. The gonion is a bony prominence of the jaw and forms the jaw.

[0461] Maxilla: The maxilla forms the upper jaw and is located below the lower jaw and below the eye socket. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0462] Nasal bone: The nasal bones are two small rectangular bones, which vary in size and shape among individuals. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0463] Nasion: It is the intersection of the frontal bone and the two nasal bones and is a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0464] Occipital bone: The occipital bone is located at the back and lower part of the skull. The occipital bone contains the foramen magnum, which is an oval hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0465] Orbit: A bony cavity in the skull that contains the eyeball.

[0466] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0467] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0468] Zygomatic bone: The two zygomatic bones in the face are located in the upper and outer parts of the face and form the cheek prominences.

[0469] 5.9.4.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet of muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0470] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0471] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0472] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. 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 or turbinate bones. In front of the nasal cavity is the nose, and behind it is connected to the nasopharynx through the posterior nares.

[0473] Pharynx: The portion of the throat located directly below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0474] 5.9.5 Patient Interface Anti-asphyxia 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.

[0475] Elbow: An elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a generally circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to an engaging component. In a particular form, the elbow can be removable from an engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to an engaging component via a one-time snap during manufacture while being non-removable by the patient.

[0476] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame may be airtight.

[0477] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear may include a collection of one or more struts, ties, and supplemental stiffeners configured to position and hold a patient interface in a predetermined position on a patient's face for delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and a fabric).

[0478] Membrane: A membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contracting.

[0479] Pneumatic chamber: A mask pneumatic chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. A shell may form part of the wall of the mask pneumatic chamber.

[0480] Seal: When used as a noun ("seal"), it may refer to a structure, and when used as a verb ("seal"), it may refer to its effect. Two elements may be constructed and / or arranged to "seal" or obtain a "sealing" effect between them without requiring a separate "seal" element itself.

[0481] Shell: A shell is taken to mean a curved, relatively thin structure having some bending, tensile, and compressive rigidity. For example, the curved structure wall of a mask may be a shell. In some forms, the shell or a part of the shell may be non-rigid. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0482] Supplemental stiffener: A supplemental stiffener is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0483] Strut: A strut is taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0484] Swivel (noun): A sub - assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel joint can be configured to rotate at an angle of at least 360 degrees. In another form, the swivel joint can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub - assembly of components preferably includes a pair of cylindrical conduits. In use, there is little air leakage from the swivel joint.

[0485] Tie (noun): A structure designed to resist tension.

[0486] Ventilation: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective wash - out of the exhaled gas. For example, in a clinically effective wash - out, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and the treatment pressure.

[0487] 5.9.6 Shape of the Structure The product according to the present technology can include one or more three - dimensional mechanical structures (e.g., a mask cushion or an impeller). The three - dimensional structure can be limited by two - dimensional surfaces. These surfaces can be distinguished using labels to describe the direction, position, function, or some other property of the associated surface. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal - forming structure can include a face - contacting (e.g., outer) surface and a separate non - face - contacting (e.g., lower or inner) surface. In another example, the structure can include a first surface and a second surface.

[0488] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0489] 5.9.6.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0490] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person leaves point p, they need to walk uphill). Refer to FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often referred to as concave.

[0491] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional small person leaves point p, they can walk on a horizontal plane that is neither uphill nor downhill). Refer to FIG. 3D.

[0492] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional small person leaves point p, they need to walk downhill). Refer to FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often referred to as convex.

[0493] 5.9.6.2 Curvature of a Two-Dimensional Surface The description of the shape at a given point on a two-dimensional surface according to the present technology may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B to 3F may be examples of such a plurality of cross-sections at a specific point.

[0494] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes its maximum and minimum values are called the principal directions. In the embodiments of FIGS. 3B to 3F, since the maximum curvature occurs in FIG. 3B and the minimum occurs in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0495] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0496] Saddle region: A region in which the principal curvatures at each point have opposite signs (i.e., one has a positive sign and the other has a negative sign), depending on the direction in which an imaginary person walking uphill or downhill would face.

[0497] Dome region: A region in which the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0498] Cylindrical region: A region in which one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0499] Planar region: A region of the surface in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0500] Edge of the surface: The boundary or limit of the surface or region.

[0501] Path: In a particular form of the present 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 a particular form of the present technology, "path" can be described, for example, as a route or course including a set of points on a surface. (The path of a fictional person is the place to walk on the surface and is similar to a garden path).

[0502] Path length: In a particular form of the present technology, "path length" is taken to refer 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 a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface).

[0503] Straight-line distance: The straight-line distance is the distance between two points on a surface without considering the surface. On a planar region, there is a distance on the edge of the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path having the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies").

[0504] 5.9.6.3 Space curve Space curve: Unlike a planar curve, a space curve does not necessarily lie in any particular plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one-dimensional piece of three-dimensional space. A fictional person walking along the strands of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edges of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the way a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point.

[0505] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is the unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0506] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0507] 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 (e.g., see Fig. 3P) or the left-hand rule (Fig. 3O).

[0508] Contact plane: The plane that contains the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0509] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (for example, a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (for example, a steeply sloping helical path). Referring to FIG. 3S, since T2 > T1, the magnitude of the torsion in the vicinity of the uppermost coil of the helix in FIG. 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in FIG. 3S.

[0510] Referring to the right - hand rule of FIG. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (for example, a right - hand helix as shown in FIG. 3S). A space curve that points in the direction away from the right - hand binormal can be regarded as having a negative torsion of the right - hand (for example, a left - hand helix).

[0511] Similarly, referring to the left - hand rule (see FIG. 3O), a space curve that points in the direction of the left - hand binormal can be regarded as having a positive torsion of the left - hand (for example, a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. Refer to FIG. 3T.

[0512] 5.9.6.4 Holes A surface can have one - dimensional holes (for example, holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (for example, a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in FIG. 3I are bounded by a planar curve.

[0513] The structure can 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 embodiment, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N where the inner surface bounding the two-dimensional hole is shown. In yet another embodiment, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole bounded by a surface as shown through the structure of FIG. 3K and as illustrated.

[0514] 5.10 Other Considerations Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided that it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0515] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of 1 / 10 of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the recited range, they are encompassed by the technology. If the recited range includes one or both of these limits, ranges exceeding either or both of these recited limits are also encompassed by the technology.

[0516] Furthermore, when a value(s) is executed as part of the technology herein, unless otherwise specified, it is understood that such value(s) can be approximated and such value(s) can be used to any appropriate significant digits to the extent permitted or required by the practical technical implementation.

[0517] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, only a limited number of exemplary methods and materials are described herein.

[0518] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can therefore be manufactured collectively or individually.

[0519] As used herein and in the appended claims, note that the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0520] All of the published documents described herein are hereby incorporated by reference for their disclosure and description of the methods and / or materials therein. The published documents described herein are provided only for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such published documents by virtue of prior invention. Further, the dates of the published documents may differ from the actual publication dates and may need to be individually verified.

[0521] The terms "comprises" and "comprising" are to be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0522] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0523] Although the techniques in this specification have been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, the terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, when describing or exemplifying the process steps in this method, they may be presented in an ordered manner, but such an order is not necessary. One skilled in the art will recognize that such an order can be changed and / or that the manner can be performed simultaneously or even synchronously.

[0524] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments without departing from the spirit and scope of the technology, and other arrangements can be devised.

Explanation of Reference Numerals

[0525] 1000 Patient 1010 Region near the alae nasi 1020 Apex of the ala 1100 Bedmate 3100 Seal formation structure 3101 First seal formation structure 3102 Second seal formation structure 3103 Boundary 3110 Central part 3111 Lateral part 3112 Rear surface of the lateral part 3120 Ridge 3130 Lower lip part 3131 Upper lip 3132 Peripheral part 3133 Oral orifice 3135 Nostril(s) 3200 Prenum chamber 3201 Oral part of the prenum chamber 3202 Nasal part of the prenum chamber 3210 Tendon 3220 Upper point 3230 Lower point 3240 First front wall part 3241 Boundary between the oral and nasal parts 3242 Second front wall part 3243 Upper boundary of the first front wall part 3244 Lower boundary of the first front wall part 3245 Lateral wall part 3246 Lateral wall part 3247 Upper boundary of the second front wall part 3248 Lower boundary of the second front wall part 3250 Shell 3251 Central part 3260 Support part 3261 First end of the support part 3262 Second end of the support part 3263 Rigid part 3270 Band 3272 Cavity 3280 Groove part 3284 Protrusion 3288 Protrusion 3300 Positioning and stabilization structure 3310 Connector 3320 Arm 3350 Frame 3351 Inner surface of the loop 3352 Connection point 3352a First loop 3352b Second loop 3353 Eyelet cut 3354 Headgear strap 3356 Upper left headgear strap 3358 Upper right headgear strap 3360 Central part 3362 Arm 3364 Second connection point 3364a Left secondary connection point 3364b Right secondary connection point 3366 Lower left strap 3368 Lower right strap 3370 Magnet 3372 Slot 3373 Scallop 3376 Outer casing 3378 Plane 3380 Lip 3382 Magnetic member 3384 Overhang 3400 Ventilation 3410 Aperture for ventilation part attachment 3600 Connection port 3700 Forehead support part 4000 RPT device 4010 External housing 4012 Upper part 4014 Lower part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic block 4110 Air filter 4112 Inlet air filter 4120 Muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Anti - spillback valve 4170 Air circuit 4180 Make - up gas 4200 Electrical component 4202 PCBA 4210 Power supply 4220 Input device 4270 Converter 5000 Humidifier 5002 Humidifier Inlet 5004 Humidifier Outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5120 Conductive Part 5130 Reservoir Dock 5135 Lock Lever 5150 Water Level Indicator 5240 Heating Element 6000 Overhang 6004 Undercut 6008 Inclined Plane 6012 Swivel Point

Claims

**Claim 1** A patient interface, comprising: Pressurable to a therapeutic pressure of at least 6 cmH above the ambient air pressure ２ A plenum chamber pressurable to a therapeutic pressure of at least 6 cmH above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for the patient's respiration, a plenum chamber, and A first seal-forming structure constructed and arranged to form a seal against a patient's facial region surrounding an inlet to the patient's mouth, whereby an air flow at said treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain said treatment pressure within a plenum chamber throughout a patient's respiratory cycle during use; a seal-forming structure; A second seal-forming structure constructed and arranged to form a seal against a patient's facial region surrounding an inlet to the patient's nose, whereby an air flow at said treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain said treatment pressure within a plenum chamber throughout a patient's respiratory cycle during use; a seal-forming structure; A ventilation structure that enables a continuous gas flow exhaled by the patient to escape from the interior of the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain said treatment pressure within the plenum chamber during use; a ventilation structure; The patient interface further comprises: A pair of support portions provided on opposite side portions of an interface between the second seal-forming structure and a front wall portion of the plenum chamber, the support portions being configured to prevent compression in the front-rear direction; a pair of support portions. **Claim 2** The patient interface according to claim 1, wherein the support portion is connected to a portion of the second seal-forming structure that seals the patient's upper lip during use. **Claim 3** The patient interface according to claim 1, wherein the support portion is connected to a portion of the second seal-forming structure that seals the patient's upper lip directly below the lower side corner of the patient's nose during use. **Claim 4** The patient interface according to claim 1, wherein the support portion is curved when viewed from a cross-section parallel to the sagittal plane. **Claim 5** The patient interface according to claim 1, wherein the support portion is curved when viewed from a cross-section parallel to the frontal plane. **Claim 6** The patient interface according to claim 1, wherein the plenum chamber includes an oral portion and a nasal portion. **Claim 7** The patient interface of claim 6, wherein each support portion is connected to the oral portion of the premaxillary chamber adjacent to the boundary between the lateral side wall portion of the oral portion and the lateral side wall portion of the nasal portion.

8. The patient interface according to claim 6, wherein each support portion is connected to the oral portion of the premaxillary chamber adjacent to the boundary between the front wall portion of the oral portion and the front wall portion of the nasal portion.

9. The patient interface according to claim 7, wherein the lateral side wall portion of the premaxillary chamber is curved inwardly adjacent to the boundary with the nasal portion, and each of the support portions is substantially adjacent to the adjacent lateral side wall portion.

10. The patient interface according to claim 1, wherein the second seal-forming structure includes at least one nasal aperture configured to deliver an air flow at the treatment pressure to an inlet to the patient's nostrils, and during use, no portion of any of the support portions is directly below any of the respective nasal apertures.

11. The patient interface according to claim 1, further comprising a positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

12. The patient interface according to claim 1, wherein the premaxillary chamber is at least partially formed by a shell, and the ventilation structure is provided in the shell.

13. The patient interface of claim 1, wherein the support portion is connected to the second seal-forming structure and to the front wall of the premaxillary chamber.

14. A patient interface comprising: Pressurable to a therapeutic pressure of at least 6 cmH exceeding the ambient air pressure ２ A plenum chamber pressurable to a therapeutic pressure of at least 6 cmH exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for a patient's respiration, the plenum chamber, and A first seal-forming structure connected to the oral portion of the premaxillary chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the inlet to the patient's mouth, whereby an air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure being constructed and arranged to maintain the treatment pressure within the premaxillary chamber throughout the patient's respiratory cycle during use. A second seal-forming structure connected to the nasal portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the patient's entrance to the nose, whereby an airflow at the treatment pressure is delivered to the nose, and the second seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle, a seal-forming structure, and A ventilation structure that allows a continuous gas flow exhaled by the patient to escape from the interior of the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, a ventilation structure, comprising, where: A first front wall portion of the nasal portion of the plenum chamber adjacent to the boundary with the oral portion of the plenum chamber is more flexible than the region immediately adjacent to the oral portion of the plenum chamber, and a second front wall portion of the nasal portion of the plenum chamber is directly adjacent to the first front wall portion and is on the opposite side of the first front wall portion with respect to the boundary with the oral portion of the plenum chamber and is less flexible than the directly adjacent portion of the front wall portion, a patient interface.

15. The patient interface according to claim 14, wherein the first front wall portion is thinner than the directly adjacent portion of the plenum chamber.

16. The patient interface according to claim 14, wherein the second front wall portion is thicker than the directly adjacent portion of the plenum chamber.

17. The patient interface according to claim 16, wherein the second front wall portion includes a band extending through the first front wall portion and configured to extend through the plenum chamber to the patient.

18. The patient interface according to claim 17, wherein the transition portion between the first front wall portion and the second front wall portion within the plenum chamber is substantially a stepped surface.

19. The patient interface according to claim 17, wherein the transition portion between the first front wall portion and the second front wall portion outside the plenum chamber is substantially a smooth surface.

20. The patient interface according to claim 17, wherein the first front wall portion extends at least further upward than at least a part of the band during use.

21. The patient interface according to claim 14, wherein the first front wall portion and the second front wall portion are made of the same material.

22. The patient interface according to claim 14, wherein the first front wall portion extends substantially across the entire width of the nose portion of the plenum chamber.

23. The patient interface according to claim 14, wherein the second front wall portion extends at least across a majority of the width of the nose portion of the plenum chamber.

24. The patient interface according to claim 14, wherein the first front wall portion extends upwardly around at least one lateral edge portion of the second front wall portion.

25. The patient interface according to claim 14, wherein the second front wall portion extends substantially across the entire width of the nose portion of the plenum chamber.

26. The patient interface according to claim 14, wherein a central portion of the first front wall portion extends further upwardly than lateral portions of the first front wall portion.

27. The patient interface according to claim 14, wherein an upper boundary of the first front wall portion is curved.

28. The patient interface according to claim 14, wherein a lower boundary of the first front wall portion is curved.

29. The patient interface according to claim 14, wherein the plenum chamber is at least partially formed by a shell, and the ventilation structure is provided in the shell.

30. A patient interface comprising: Pressurable to a therapeutic pressure of at least 6 cmH above the ambient air pressure ２ A plenum chamber pressurable to a therapeutic pressure of at least 6 cmH above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for the patient's respiration, a plenum chamber, and a first seal-forming structure connected to the mouth portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against a patient's facial region surrounding an entrance to the patient's mouth, whereby an air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout a patient's respiratory cycle during use; a second seal-forming structure connected to the nose portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against a patient's facial region surrounding an entrance to the patient's nose, whereby an air flow at the treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout a patient's respiratory cycle during use; A ventilation structure that enables the continuous gas flow exhaled by the patient to escape from the inside of the plenum chamber to the surroundings, the ventilation structure including a ventilation structure sized and shaped to maintain the treatment pressure within the plenum chamber during use. Here: A patient interface in which the rear surface of the side portion of the second seal-forming structure is inclined upward and forward from the boundary between the first seal-forming structure and the second seal-forming structure. **Claim 31** The patient interface according to claim 30, wherein an angle of 20 degrees to 90 degrees is formed with the central contact surface of the mask due to the inclination of each side portion. **Claim 32** The patient interface according to claim 30, wherein no part of the patient interface contacts the apex point of the patient's nasal wing during use. **Claim 33** The patient interface according to claim 30, wherein the patient interface is configured to avoid blocking the patient's nostrils. **Claim 34** The patient interface according to claim 30, wherein the plenum chamber is at least partially formed by a shell, and the ventilation structure is provided on the shell. **Claim 35** A patient interface comprising: Pressurizable to a therapeutic pressure of at least 6 cmH ２ O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for the patient's respiration, a plenum chamber, and A first seal-forming structure connected to the mouth portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's mouth, whereby the air flow at the treatment pressure is delivered to the mouth, and the first seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; a seal-forming structure A second seal-forming structure connected to the nose portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's nose, whereby the air flow at the treatment pressure is delivered to the nose, and the second seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; a seal-forming structure A ventilation structure that enables the continuous gas flow exhaled by the patient to escape from the inside of the plenum chamber to the surroundings, the ventilation structure including a ventilation structure sized and shaped to maintain the treatment pressure in the plenum chamber during use. Here: A patient interface in which the boundary between the first seal-forming structure and the second seal-forming structure includes a raised portion. **Claim 36** The patient interface according to claim 35, wherein the radius of curvature of the raised portion is less than 2 mm. **Claim 37** The patient interface according to claim 35, wherein the raised portion extends substantially across the entire boundary between the first seal-forming structure and the second seal-forming structure. **Claim 38** The patient interface according to claim 35, wherein during use, the raised portion engages the patient's face in the vicinity of the entrance to the nostrils, which is the location where the wing meets the face above the upper lip. **Claim 39** The patient interface according to claim 35, wherein the raised portion withstands the formation of wrinkles in the first seal-forming structure and / or the second seal-forming structure adjacent to the raised portion. **Claim 40** The patient interface according to claim 35, wherein during use, the plenum chamber is at least partially formed by a shell, and the ventilation structure is provided in the shell. **Claim 41** A patient interface comprising: At least 6 cmH above ambient air pressure ２ A plenum chamber capable of being pressurized to a therapeutic pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for a patient's respiration, the plenum chamber, A first seal-forming structure connected to the mouth portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's mouth, whereby the airflow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's breathing cycle during use. A seal-forming structure. A second seal-forming structure connected to the nose portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's nose, whereby the airflow at the treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's breathing cycle during use. A seal-forming structure. A ventilation structure that enables the continuous gas flow exhaled by the patient to escape from the inside of the plenum chamber to the surroundings, the ventilation structure including a ventilation structure sized and shaped to maintain the treatment pressure within the plenum chamber during use. Here: At least a part of the oral portion of the plenum chamber includes a flexible shell, and the flexible shell is formed of a material having a Young's modulus of less than 0.4 GPa, a patient interface.

42. The patient interface according to claim 41, wherein the Young's modulus is less than 0.1 GPa.

43. The patient interface according to claim 41, wherein the Young's modulus is 0.3 MPa to 0.7 MPa.

44. The patient interface according to claim 41, wherein at least one component is connected to the flexible shell, and at least one of the components is harder than a portion of the flexible shell adjacent to the component.

45. The patient interface according to claim 44, wherein at least one of the components includes one or more of the following: a ventilation module, a headgear connector, a headgear connector connected to a stiffening arm, a stiffening member, a less flexible shell portion.

46. The patient interface according to claim 44, wherein at least one of the components is releasably connectable to the flexible shell.

47. The patient interface according to claim 44, wherein at least one of the components is permanently connected to the flexible shell.

48. The patient interface according to claim 47, wherein at least one of the components is overmolded onto the flexible shell.

49. The patient interface according to claim 44, wherein at least one of the components is configured as a stiffening rib or band.

50. The patient interface according to claim 41, wherein the flexible shell includes a thickened hardened portion that is thicker than a directly adjacent portion of the flexible shell.

51. The patient interface according to claim 41, wherein the rigidity of the central portion of the oral portion of the plenum chamber is higher than that of the remaining portion of the plenum chamber.

52. The patient interface according to claim 41, wherein the plenum chamber is at least partially formed by a shell, and the ventilation structure is provided in the shell.

53. A patient interface comprising: It is pressurizable to a therapeutic pressure of at least 6 cmH ２ O above the ambient air pressure, the plenum chamber including a cavity, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for the patient's respiration, a plenum chamber, and A first seal-forming structure constructed and arranged to form a seal against a patient's facial region surrounding an inlet to the patient's mouth, whereby an airflow at the treatment pressure is delivered to the mouth, and the first seal-forming structure is constructed and arranged to maintain the treatment pressure within a plenum chamber throughout a patient's respiratory cycle during use; a seal-forming structure; A second seal-forming structure constructed and arranged to form a seal against a patient's facial region surrounding an inlet to the patient's nose, whereby an airflow at the treatment pressure is delivered to the nose, and the second seal-forming structure is constructed and arranged to maintain the treatment pressure within a plenum chamber throughout a patient's respiratory cycle during use; a seal-forming structure; A ventilation structure that enables a continuous gas flow exhaled by the patient to escape from within the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use; a ventilation structure; A positioning and stabilization structure configured to maintain the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilization structure comprising: A frame connected to the plenum chamber, the frame comprising: A central portion connected to the plenum chamber external to the cavity, and A pair of arms extending rearwardly from the central portion through the second seal-forming structure in a direction away from the central portion, the pair of arms being more flexible than the central portion; a frame comprising a pair of arms; and A headgear strap connected to the frame, the headgear strap being configured to apply tension through the frame to the first seal-forming structure and the second seal-forming structure and thereby apply it within the patient's face; a headgear strap. A patient interface.

54. The patient interface according to claim 53, wherein each arm of the pair of arms is more flexible than the frame.

55. The patient interface according to claim 54, wherein the central portion is thicker than each arm of the pair of arms.

56. The patient interface according to claim 55, wherein the central portion and each of the pair of arms are constructed from the same material.

57. The patient interface according to claim 53, wherein each of the pair of arms includes a first connection point, and the headgear strap is connected to the first connection point of each arm.

58. The patient interface according to claim 53, wherein a first magnet is overmolded onto the central portion of the frame, and the headgear strap includes a second magnet removably connected to the first magnet.

59. The patient interface according to claim 53, wherein the plenum chamber includes a groove portion, and the central portion is positioned within the groove portion.

60. The patient interface according to claim 59, wherein the central portion is removably positionable within the groove portion.

61. The patient interface according to claim 59, wherein the groove portion includes a protrusion, and the central portion includes a complementary slot configured to receive the protrusion.

62. The patient interface according to claim 61, wherein the slot is tapered and includes a wider opening and a narrower opening, and the protrusion is configured to be received through the wider opening prior to the narrower opening.

63. The patient interface according to claim 59, wherein the plenum chamber includes a protrusion disposed adjacent to the groove portion, and the protrusion is configured to hold the central portion within the groove portion.

64. The patient interface according to claim 59, wherein an outer surface of the central portion is in the same plane as an outer surface of the plenum chamber, and the outer surface of the central portion and the outer surface of the plenum chamber are configured to face away from the patient in use.

65. The patient interface according to claim 53, wherein the central portion includes an annular shape, and the plenum chamber inlet port is disposed radially within the central portion in a state where the frame is connected to the plenum chamber.

66. The plenum chamber inlet port is configured to receive an elbow, and the elbow is configured to be spaced apart from the central portion while being received within the plenum chamber inlet port, the patient interface according to claim 53.

67. Each arm of the pair of arms is pivotable relative to the central portion about a pivot point, the patient interface according to claim 53.

68. Each pivot point is a living hinge, the patient interface according to claim 67.

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