Patient Interface

Abstract

1. A patient interface comprising: a chassis portion at least partially forming a plenum chamber; a seal-forming structure; and a vent portion for permitting continuous flow of gases exhaled by the patient from an interior of the plenum chamber to the surroundings, said vent portion being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use, the chassis portion including a membrane portion formed at least in part from a textile material, the seal-forming structure being supported on the membrane portion, the membrane portion being constructed and arranged to be flexible to permit relative movement between the seal-forming structure and the chassis portion in use.

Description

Technical Field

[0001] [1 Cross - reference to Related Applications] This application claims priority to Australian Provisional Patent Application No. 2020904681, filed on December 16, 2020; Australian Provisional Patent Application No. 2021900782, filed on March 18, 2021; Australian Provisional Patent Application No. 2021901506, filed on May 20, 2021; Australian Provisional Patent Application No. 2021902571, filed on August 18, 2021; and Australian Provisional Patent Application No. 2021903730, filed on November 19, 2021, the entire contents of each of which are incorporated herein by reference.

Background Art

[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 disorders. This technology also relates to medical devices or apparatuses and their use.

[0003] [2.2 Description of Related Technologies] [2.2.1 The Human Respiratory System and Its Disorders] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0004] The airways consist of a series of branching canals that become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, which allows oxygen to be moved from inhaled air into the venous blood and carbon dioxide to be moved in the opposite direction. The trachea divides into the right and left main bronchi, which are further divided into terminal bronchioles. The bronchi constitute the guiding airways and are not involved in gas exchange. The airways further divide into respiratory bronchioles and eventually into alveoli. The splenic regions of the lungs are where gas exchange takes place and are called the respiratory regions. See "Respiratory Physiology" by John B. West, Lippincott Williams & Wilkins (9th edition, 2012).

[0005] There are various types of respiratory disorders. Certain disorders may be characterized by specific events (e.g., apnea, hypopnea, and hyperventilation).

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including obstruction or closure of the upper airway during sleep. This is a result of a combination of an abnormally small upper airway and a normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. When affected, a patient's breathing typically stops for periods of 30 to 120 seconds, sometimes as many as 200 to 300 times a night. This often results in excessive daytime sleepiness and can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although those affected may not be aware of the problem. See Patent Document 1.

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, which includes periods of rhythmic alternation of increasing and decreasing ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. CSR can be harmful because of the repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2.

[0009] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

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

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous disorders and illnesses that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to inability to walk, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over years but with only a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general weakness, difficulty swallowing, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause inefficient connections between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive disorders and share the potential for prolonged hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] Various therapies have been used to treat or improve such diseases. Furthermore, even otherwise healthy individuals can utilize such therapies to prevent the onset of respiratory problems. However, these therapies have numerous shortcomings.

[0016] [2.2.2 Therapy] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) have been used to treat one or more of the aforementioned respiratory disorders.

[0017] [2.2.2.1 Respiratory pressure therapy] Respiratory pressure therapy (as opposed to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves applying a controlled target pressure, nominally positive relative to the atmosphere, to the airway inlet throughout the patient's entire respiratory cycle.

[0018] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air pressure splint, preventing upper airway obstruction by pushing the soft palate and tongue forward and backward against the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and patients may choose not to follow the therapy if they notice one or more of the following about the devices used to deliver such therapy: discomfort, difficulty of use, high cost, and poor aesthetics.

[0019] [2.2.3 Respiratory Therapy System] These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them.

[0020] A respiratory therapy system may include respiratory pressure therapy devices (RPT devices), air circuits, humidifiers, patient interfaces, oxygen sources, and data management.

[0021] Another form of therapy system is the mandibular reduction device.

[0022] [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 inlet to the airway. The air flow can be provided via a mask to the nose and / or mouth, via a tube to the mouth, or via a tracheostomy tube to the trachea of the patient. Depending on the therapy applied, the patient interface can form a seal with the area of the patient's face, for example, to be sufficiently different from the ambient pressure and promote the delivery of gas at a pressure that results in the effect of the therapy, such as a positive pressure of about 10 cmH2O relative to the ambient pressure. In other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface blows into the nostrils but is configured to avoid a complete seal in particular. An example of such a patient interface is a nasal cannula.

[0023] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a purely decorative mask, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to prevent water ingress due to the higher external pressure while not maintaining the internal air at a pressure higher than the ambient.

[0024] Certain masks may be clinically unfavorable in the art, for example, if they block the air flow through the nose and only allow the air flow through the mouth.

[0025] In certain masks, it can be uncomfortable or impractical in the art if the patient has to insert a part of the mask structure into their mouth and create and maintain a seal via their lips.

[0026] Certain masks can be impractical in use during sleep, for example, when sleeping on a bed sideways with the head on a pillow.

[0027] There are numerous challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably among individuals. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during the course of respiratory therapy.

[0028] Due to these challenges, some masks, especially when worn for long periods or when the patient is unfamiliar with the system, have one or more of the following problems: obtrusive, undesirable aesthetics, expensive, poor fit, difficult to use, and uncomfortable. If a mask of incorrect size is used, it can lead to decreased compliance, comfort, and patient prognosis. Masks designed for pilots, masks designed as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable on first use, but in the case of such masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wear. Due to such discomfort, patient compliance with therapy can decrease. This is especially true when the mask needs to be worn during sleep.

[0029] CPAP therapy is very effective in the treatment of certain respiratory disorders when the patient adheres to the therapy. If the mask is uncomfortable or difficult to use, the patient may not follow the therapy. Since patients are often recommended to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which can affect patient compliance.

[0030] Masks for other uses (e.g., for pilots) may not be suitable for use in the treatment of sleep apnea, but masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0031] For these reasons, patient interfaces for CPAP delivery during sleep constitute a separate field.

[0032] [2.2.3.1.1 Seal-forming structure] The patient interface may include a seal-forming structure. Because this structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0033] Patient interfaces can be partially characterized according to the design intent of the position where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the bridge of the nose region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region during use by forming a seal, for example, on the lower lip region of the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces may be known by a variety of names depending on their manufacturer, including nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0034] A seal-forming structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles placed on a patient's forehead may be unsuitable for use on the patient's nose.

[0035] A specific seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. If there is a mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form the seal.

[0036] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. In this type of seal-forming structure, if the fit is insufficient, a gap will occur between the seal-forming structure and the face, requiring additional force to press the patient interface against the face and achieve a seal.

[0037] Another type of seal-forming structure incorporates a thin flap seal positioned around the periphery of the mask to provide a self-sealing effect, making contact with the patient's face when positive pressure is applied inside the mask. Similar to previous styles of seal-forming sections, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage from the mask may occur. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, this may result in wrinkles or buckling during use, leading to leakage.

[0038] Another type of seal-forming structure may include a friction-fitting element for insertion into the nostrils, for example, but some patients find this uncomfortable.

[0039] Another form of seal-forming structure may achieve the seal using an adhesive. Some patients may find it inconvenient to have adhesive constantly applied to their face or to remove it.

[0040] Various patient interface seal formation structures are disclosed in Patent Documents 3, 4, and 5.

[0041] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6, which was transferred to Puritan-Bennett Corporation.

[0042] ResMed Limited manufactures the following products incorporating a nasal pillow: 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. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: Patent Document 7 (in particular describing an aspect of ResMed Limited's SWIFT® Nasal Pillow), Patent Document 8 (in particular describing an aspect of ResMed Limited's SWIFT® LT Nasal Pillow); Patent Documents 9 and 10 (in particular describing an aspect of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); and Patent Document 11 (in particular describing an aspect of ResMed Limited's SWIFT® FX Nasal Pillow).

[0043] [2.2.3.1.2 Positioning and Stabilization] The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to a corresponding force from the air pressure that can break the seal. Therefore, various techniques have been employed to position the seal-forming structures and maintain a sealed relationship with the appropriate part of the face.

[0044] In one technique, an adhesive is used. See, for example, Patent Document 12. However, the use of adhesives can be unpleasant for some people.

[0045] In other techniques, one or more straps and / or stabilization harnesses are used. Many such harnesses have one or more of the following problems: poor fit, bulkiness, discomfort, and unnaturalness when used.

[0046] [2.2.3.1.3 Pressurized air conduit] In one type of treatment system, pressurized airflow is supplied to the patient interface through conduits in an air circuit that fluidize the patient interface, and as a result, when the patient interface is positioned over the patient's face during use, the conduits extend forward outward from the patient interface, away from the patient's face. This may sometimes be called a "tube down" configuration.

[0047] Some patients find such interfaces unsightly or claustrophobic, resulting in them discontinuing their use and decreased patient compliance. Furthermore, the conduits connecting to the interface in front of the patient's face can sometimes easily become entangled in bedding.

[0048] [2.2.3.1.4 Pressurized air conduits used for positioning / stabilizing seal-forming structures] An alternative type of treatment system that attempts to address such problems includes a patient interface in which a tube that delivers pressurized air to the patient's airway also functions as part of the headgear, positioning and stabilizing the sealing portion of the patient interface at an appropriate part of the patient's face. This type of patient interface may be called having a “conduit headgear” or “headgear piping”. Such a patient interface allows a conduit in an air circuit that provides pressurized airflow from a respiratory pressure therapy device to connect to the patient interface at a position other than in front of the patient's face. An example of such a treatment system is disclosed in Patent Document 13 (the contents of which are incorporated herein by reference), in which the conduit connects to a tube in the patient interface through a port positioned on the top of the patient's head when in use.

[0049] Patient interfaces incorporating headgear tubing can offer several advantages, such as preventing the conduits from connecting to the patient interface in front of the patient's face, which could be unsightly and visually unsightly. However, it is desirable that patient interfaces incorporating headgear tubing be comfortable for patients who wear them for extended periods while sleeping, and that they can fit a range of head shapes and sizes while forming an airtight and stable seal with the patient's face.

[0050] [2.2.3.2 Respiratory Pressure Therapy (RPT) Devices] Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the aforementioned therapies, for example, by operating the device to generate an airflow for delivery to an interface with the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0051] Device designers may be presented with countless options. Design criteria often conflict, meaning that certain design choices may deviate significantly from convention, or even be unavoidable. Furthermore, the comfort and effectiveness of a particular design may be highly sensitive to even minor changes in one or more parameters.

[0052] [2.2.3.3 Air Circuit] An air circuit is a conduit or tube constructed and positioned to allow airflow to move between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0053] [2.2.3.4 Humidifier] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, applying warm air to the facial area within and around the patient interface generally provides greater comfort than using cool air.

[0054] [2.2.3.5 Data Management] For clinical reasons, data may be collected to determine whether a patient prescribed respiratory therapy has “complied” (for example, whether the patient has used their RPT device in accordance with one or more “compliance rules”). An example of a compliance rule for CPAP therapy is that a patient must use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, the provider of the RPT device (e.g., the healthcare provider) may manually collect data describing the patient’s therapy using the RPT device, calculate the usage rate over a given period, and compare it to the compliance rules. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, they may notify third parties that the patient is compliant.

[0055] In patient therapy, there may be other ways in which patients benefit from the transmission of therapeutic data to a third party or external system.

[0056] Existing processes for transmitting and managing such data may be expensive, time-consuming, and prone to errors.

[0057] [2.2.3.6 Ventilation Technology] Some forms of treatment systems may include vents to flush out exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0058] [2.2.4 Screening, diagnostic, and monitoring systems] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, and typically requires specialized clinical staff to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient to record a variety of bodily signals, such as electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has traditionally involved observing the patient in the clinic over two nights (the first night being for pure diagnosis, and the second night for treatment parameter titration by the clinician). Therefore, PSG is expensive and inconvenient. In particular, it is unsuitable for screening / diagnosing / monitoring sleep-disordered breathing at home.

[0059] Generally, during screening and diagnosis, disease identification is explained by its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis can provide clinically actionable information. Screening and diagnosis tend to be one-time processes, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are suitable only for screening / diagnosis, while others can also be used for monitoring. Clinical professionals can adequately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Opinions on a patient's illness may differ among clinical professionals. Furthermore, certain clinical professionals may apply different criteria depending on the time period. [Prior art documents] [Patent Documents]

[0060] [Patent Document 1] U.S. Patent No. 4944310 [Patent Document 2] U.S. Patent No. 6532959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Patent No. 4782832 [Patent Document 7] International Application No. 2004 / 073778 [Patent Document 8] U.S. Patent Application No. 2009 / 0044808 [Patent Document 9] International Application No. 2006 / 130903 [Patent Document 10] International Application No. 2005 / 063328 [Patent Document 11] International Application No. 2009 / 052560 [Patent Document 12] U.S. Patent Application Publication No. 2010 / 0000534 [Patent Document 13] U.S. Patent Application Publication No. 2007 / 0246043 [Patent Document 14] U.S. Patent No. 6044844 [Patent Document 15] International Patent Application Publication No. 2019 / 183680 [Patent Document 16] U.S. Patent No. 7866944 [Patent Document 17] U.S. Patent No. 8638014 [Patent Document 18] U.S. Patent No. 8636479 [Patent Document 19] International Publication No. 2013 / 020167 [Patent Document 20] International Publication No. 2012 / 171072 [Overview of the project]

[0061] [3. Brief explanation of the technology] This technology relates to providing medical devices used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, and possesses one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability.

[0062] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0063] Another aspect of this technology relates to a method used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0064] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0065] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion that at least partially forms a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside it, so that as a result, airflow at the therapeutic pressure is delivered to at least the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A membrane portion that at least partially forms a plenum chamber, the membrane portion being connected to a chassis portion and at least partially formed from a textile material, the nasal pillow being supported on the membrane portion, and the membrane portion being constructed and positioned to be flexible in order to allow relative movement between the nasal pillow and the chassis portion during use, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe through their mouth from the surroundings if there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0066] For example: ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● The membrane portion is constructed and positioned to expand when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is stretchable; ● The membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The membrane portion is constructed and positioned to expand during use to fit one or more parts of the patient's nose; ● The membrane portion is constructed and positioned to expand during use, biasing each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is designed to engage with the patient's upper lip during use; ● The chassis is designed not to engage with the patient's sitac lips during use; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The plenum chamber includes a rear-upper facing side, configured to face the rear and upper sides during use, and the membrane portion and seal-forming structure form the majority of the rear-upper facing side; ● The membrane portion and seal-forming structure form substantially the entire side facing the rear upper side; ● The plenum chamber includes a front-upper facing side, configured to face the front and upper sides when in use, and the membrane portion forms the majority of the front-upper facing side; ● The plenum chamber includes a rear-lower facing side, configured to face the rear and lower sides when in use, and the membrane portion forms the majority of the rear-lower facing side; ● The chassis portion forms the majority of the front-lower side of the plenum chamber, which is configured to face both the front and lower sides during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis is designed not to engage with the patient's upper lip; ● Each nasal pillow is stalkless; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● Each nose pillow is made from elastomer material; ● Each nasal pillow is made from silicone or TPE; ● Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● The seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, thereby delivering the airflow to the patient's mouth under the therapeutic pressure; ● The membrane portion forms the oral cavity portion of the seal-forming structure; ● The patient interface includes a nasal cushion module and an oral cushion module; the chassis portion is a nasal chassis portion that forms part of the nasal cushion module, and the oral cushion module includes an oral chassis portion that supports the oral portion of the seal-forming structure; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection parts configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration; ● The patient interface further includes a ventilation module, which includes a ventilator, and the ventilation module is located on the front side of the chassis portion; ● The chassis portion includes a front opening for receiving the ventilation module; ● The ventilation module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass when flowing into the surroundings; and / or ● The ventilation module is configured to allow gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, passing by the side of the diffuser without flowing through it.

[0067] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion that at least partially forms a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure supported by a chassis portion, comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside, so that the airflow at the therapeutic pressure is delivered to at least the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A membrane portion that at least partially forms a plenum chamber, the membrane portion being connected to a chassis portion and at least partially formed from a textile material, the nasal pillow being supported on the membrane portion, the membrane portion being constructed and positioned to expand and conform to one or more parts of the patient's nose when in use, and the membrane portion A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe through their mouth from the surroundings if there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0068] For example: ● The membrane portion is constructed and positioned to be flexible to allow relative movement between the nasal pillow and the chassis portion during use; ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● The membrane portion is constructed and positioned to stretch and / or bend, allowing each nasal pillow to move and align with each of the patient's nostrils before pressure is applied; ● The membrane portion is constructed and positioned to expand when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is stretchable; ● The membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The membrane portion is constructed and positioned to expand during use, biasing each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is designed to engage with the patient's upper lip during use; ● The chassis is designed not to engage with the patient's sitac lips during use; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The plenum chamber includes a rear-upper facing side, configured to face the rear and upper sides during use, and the membrane portion and seal-forming structure form the majority of the rear-upper facing side; ● The membrane portion and seal-forming structure form substantially the entire side facing the rear upper side; ● The plenum chamber includes a front-upper facing side, configured to face the front and upper sides when in use, and the membrane portion forms the majority of the front-upper facing side; ● The plenum chamber includes a rear-lower facing side, configured to face the rear and lower sides when in use, and the membrane portion forms the majority of the rear-lower facing side; ● The chassis portion forms the majority of the front-lower side of the plenum chamber, which is configured to face both the front and lower sides during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis is designed not to engage with the patient's upper lip; ● Each nasal pillow does not have a stalk; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● Each nose pillow is made from elastomer material; ● Each nasal pillow is made from silicone or TPE; ● Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● The seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, thereby delivering the airflow to the patient's mouth under the therapeutic pressure; ● The membrane portion forms the oral cavity portion of the seal-forming structure; ● The patient interface includes a nasal cushion module and an oral cushion module; the chassis portion is a nasal chassis portion that forms part of the nasal cushion module, and the oral cushion module includes an oral chassis portion that supports the oral portion of the seal-forming structure; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection parts configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration; ● The patient interface further includes a ventilation module, which includes a ventilator, and the ventilation module is located on the front side of the chassis portion; ● The chassis portion includes a front opening for receiving the ventilation module; ● The ventilation module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass when flowing into the surroundings; and / or ● The ventilation module is configured to allow gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, passing by the side of the diffuser without flowing through it.

[0069] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion that at least partially forms a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside so that the airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use, and the seal-forming structure includes a nasal portion formed from an elastomer material, A membrane portion that forms at least partially a plenum chamber, the membrane portion being connected to a chassis portion and at least partially formed from a textile material, and the nose portion of the seal-forming structure being supported on the membrane portion, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe through their mouth from the surroundings if there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0070] For example: ● The membrane portion is constructed and positioned to be flexible in order to allow relative movement between the seal-forming structure and the chassis portion during use; ● The membrane portion is constructed and positioned to expand when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is stretchable; ● The membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The seal-forming structure includes a pair of nasal pillows, each constructed and positioned to form a seal with each nostril of the patient's nose, and each nasal pillow has holes inside to deliver airflow to the patient's nostrils at the therapeutic pressure; ● The membrane portion is constructed and positioned to be flexible to allow relative movement between the nasal pillow and the chassis portion during use; ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● Each nasal pillow does not have a stalk; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● Each nose pillow is made from elastomer material; ● Each nasal pillow is made from silicone or TPE; ● Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● The membrane portion is constructed and positioned to expand during use to fit one or more parts of the patient's nose; ● The membrane portion is constructed and positioned to expand during use, biasing each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is designed to engage with the patient's upper lip during use; ● The chassis is designed not to engage with the patient's sitac lips during use; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The plenum chamber includes a rear-upper facing side, configured to face the rear and upper sides during use, and the membrane portion and seal-forming structure form the majority of the rear-upper facing side; ● The membrane portion and seal-forming structure form substantially the entire side facing the rear upper side; ● The plenum chamber includes a front-upper facing side, configured to face the front and upper sides when in use, and the membrane portion forms the majority of the front-upper facing side; ● The plenum chamber includes a rear-lower facing side, configured to face the rear and lower sides when in use, and the membrane portion forms the majority of the rear-lower facing side; ● The chassis portion forms the majority of the front-lower side of the plenum chamber, which is configured to face both the front and lower sides during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis is designed not to engage with the patient's upper lip; ● The seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, thereby delivering the airflow to the patient's mouth under the therapeutic pressure; ● The membrane portion forms the oral cavity portion of the seal-forming structure; ● The patient interface includes a nasal cushion module and an oral cushion module; the chassis portion is a nasal chassis portion that forms part of the nasal cushion module, and the oral cushion module includes an oral chassis portion that supports the oral portion of the seal-forming structure; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection parts configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration; ● The patient interface further includes a ventilation module, which includes a ventilator, and the ventilation module is located on the front side of the chassis portion; ● The chassis portion includes a front opening for receiving the ventilation module; ● The ventilation module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass when flowing into the surroundings; and / or ● The ventilation module is configured to allow gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, passing by the side of the diffuser without flowing through it.

[0071] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion that at least partially forms a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure supported by a chassis portion, comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside, so that the airflow at the therapeutic pressure is delivered to at least the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A membrane portion that forms at least partially a plenum chamber, the membrane portion being connected to a chassis portion, the nasal pillow being supported on the membrane portion, and the membrane portion being formed from an elastic material that expands and contracts during expansion when the plenum chamber is pressurized to therapeutic pressure during use, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe through their mouth from the surroundings if there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0072] For example: ● The membrane portion is constructed and positioned to be flexible in order to allow the nose pillow to move relative to the chassis portion during use; ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The membrane portion is constructed and positioned so that when inflated during use, it biases each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is constructed and positioned to expand during use to fit one or more parts of the patient's nose; ● The membrane portion is designed to engage with the patient's upper lip during use; ● The chassis is designed not to engage with the patient's sitac lips during use; ● The membrane portion is formed at least partially from textile material; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The membrane portion is formed from silicone; ● The thickness of the membrane portion is less than 0.25 mm; ● The thickness of the membrane portion is 0.2 mm or less; ● The thickness of the membrane portion is within the range of 0.1 mm to 0.19 mm; ● The membrane portion is formed from silicone having a durometer hardness in the range of D20 to D40; ● The plenum chamber includes a rear-upper facing side, configured to face the rear and upper sides during use, and the membrane portion and seal-forming structure form the majority of the rear-upper facing side; ● The membrane portion and seal-forming structure form substantially the entire side facing the rear upper side; ● The plenum chamber includes a front-upper facing side, configured to face the front and upper sides when in use, and the membrane portion forms the majority of the front-upper facing side; ● The plenum chamber includes a rear-lower facing side, configured to face the rear and lower sides when in use, and the membrane portion forms the majority of the rear-lower facing side; ● The chassis portion forms the majority of the front-lower side of the plenum chamber, which is configured to face both the front and lower sides during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis is designed not to engage with the patient's upper lip; ● Each nasal pillow does not have a stalk; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● Each nose pillow is made from elastomer material; ● Each nasal pillow is made from silicone or TPE; ● Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● The seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, thereby delivering the airflow to the patient's mouth under the therapeutic pressure; ● The membrane portion forms the oral cavity portion of the seal-forming structure; ● The patient interface includes a nasal cushion module and an oral cushion module; the chassis portion is a nasal chassis portion that forms part of the nasal cushion module, and the oral cushion module includes an oral chassis portion that supports the oral portion of the seal-forming structure; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection parts configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration; ● The patient interface further includes a ventilation module, which includes a ventilator, and the ventilation module is located on the front side of the chassis portion; ● The chassis portion includes a front opening for receiving the ventilation module; ● The ventilation module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass when flowing into the surroundings; and / or ● The ventilation module is configured to allow gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, passing by the side of the diffuser without flowing through it.

[0073] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion comprising at least partially defining a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, which exceeds the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside so that the airflow at the therapeutic pressure is delivered to the patient's nostrils, and the seal-forming structure further comprises an oral portion configured to form a seal around the patient's mouth so that the airflow at the therapeutic pressure is delivered to the patient's mouth, and the seal-forming structure constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use, A membrane portion that at least partially defines the plenum chamber, the membrane portion being connected to the chassis portion and being more flexible than the chassis portion, the nasal pillow of the seal-forming structure being supported on the membrane portion, and the membrane portion forming the oral portion of the seal-forming structure, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe from the surroundings through their mouth if there is no pressurized airflow through the plenum chamber inlet port.

[0074] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion comprising at least partially defining a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, which exceeds the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside so that the airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use, and the seal-forming structure includes a nasal portion and an oral portion, A membrane portion that at least partially defines the plenum chamber, wherein the membrane portion is connected to the chassis portion and is more flexible than the chassis portion, the nasal portion of the seal-forming structure is connected to a substantially sheet-like nasal portion of the membrane portion, the nasal portion of the membrane portion surrounds the nasal portion of the seal-forming structure, creating a gap between the nasal portion of the seal-forming structure and the chassis portion, the membrane portion makes the nasal portion of the seal-forming structure movable relative to the chassis portion, and the oral portion of the membrane portion forms the oral portion of the seal-forming structure. A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe from the surroundings through their mouth if there is no pressurized airflow through the plenum chamber inlet port. For example: ● The membrane portion is flexible to allow relative movement between the nose portion and the chassis portion of the seal-forming structure during use; ● The nasal portion of the seal-forming structure includes a pair of nasal pillows supported on a membrane portion, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose; ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● The membrane portion is constructed and positioned to expand when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is stretchable; ● The membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The membrane portion is constructed and positioned to expand during use to fit one or more parts of the patient's nose; ● The membrane portion is constructed and positioned to expand during use, biasing each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is formed from textile material, at least partially; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The membrane portion is formed from an elastomer material; ● The membrane portion is formed from silicone; ● The thickness of the membrane portion is less than 0.25 mm; ● The thickness of the membrane portion is 0.2 mm or less; ● The chassis and membrane portions form the nasal and oral portions of the plenum chamber; ● The nasal portion of the plenum chamber includes a side facing posteriorly and superiorly, configured to face posteriorly and superiorly when in use; the membrane portion and seal-forming structure form the majority of the posteriorly and superiorly facing side; and the nasal pillow is positioned on the posteriorly and superiorly facing side; ● The membrane portion and seal-forming structure form substantially the entire posterior-superior side of the nasal portion of the plenum chamber; ● The nasal portion of the plenum chamber includes a front-upper facing side, configured to face forward and upward when in use, and the membrane portion forms the majority of the front-upper facing side; ● The chassis portion forms the majority of the front-facing side of the oral cavity portion of the plenum chamber; ● The chassis portion forms substantially the entire front-facing side of the oral portion of the plenum chamber; ● The chassis portion and oral portion of the seal-forming structure form substantially the entire rearward-facing side of the oral portion of the plenum chamber; ● The chassis portion is flexible to at least partially detach the membrane portion from destructive forces applied to the chassis portion during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis portion is curved to extend from one outer side of the patient's face to the other outer side of the patient's face when in use, and the chassis portion is substantially flush with the patient's cheek on each outer side; ● The chassis section is essentially shaped like a hyperbolic paraboloid or parabolic prism; ● The membrane portion is substantially shaped like a hyperbolic paraboloid or parabolic prism; ● The chassis and membrane sections are shaped like substantially hyperbolic parabolas, rotated 90 degrees relative to each other; ● The patient interface includes an undercushion that is attached to the chassis portion and configured to engage with the inner surface of the membrane portion to support the membrane portion during use; ● The under cushion is configured to engage with the chin area of ​​a membrane portion that is designed to come into contact with the chin area of ​​the patient's face during use; ● The undercushion is configured to engage with the cheek area of ​​a membrane portion that is designed to come into contact with the patient's cheek during use; ● The undercushion is configured to engage with the nasal area of ​​the membrane portion, which is designed to come into contact with the patient's nose during use; ● The under cushion is configured to engage with the membrane portion around the entire periphery of the membrane portion; ● The undercushion includes a pair of wing-like portions extending inward from the outer circumference of the undercushion, each wing-like portion being configured to bias the membrane portion and seal the patient's face in the area adjacent to each of the patient's nostrils; ● Each patient interface includes a pair of ribs extending between the chassis and each wing section to provide support to each wing section; ● The undercushion includes a rim provided along the outer circumference of the undercushion, the membrane portion is attached to the rim, and the rim is structured to leave a gap between the membrane portion and the undercushion, at least around the periphery of the undercushion; ● The rim of the undercushion provides a connecting surface to which the membrane portion connects to the undercushion, and this connecting surface is raised above the rest of the undercushion; ● Each nasal pillow does not have a stalk; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection parts configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration; ● The positioning and stabilization structure includes a pair of lower straps, each lower strap configured to be positioned on each side of the patient's head, below each lower earlobe point on the patient's head; ● The lower strap is elastically stretchable; ● The lower strap is configured to be releasably attached to the chassis; ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of openings configured to connect the gas delivery tubes to the chassis portion, the openings being sized and structured to receive an airflow from the gas delivery tubes at therapeutic pressure for breathing by the patient; ● The positioning and stabilizing structures include a pair of lower straps configured to be positioned on each side of the patient's head, below each lower earlobe point on the patient's head; ● The lower strap is elastically stretchable; ● The patient interface includes a pair of lower arms extending from the chassis, each lower arm configured to attach to a lower strap of the positioning and stabilization structure; ● On each outer side of the chassis section, each lower arm is connected to the chassis section directly adjacent to each gas delivery tube; ● The positioning and stabilization structure includes a pair of upper straps, each upper strap configured to be positioned on each side of the patient's head above each superior base point of the patient's head; ● The patient interface includes a pair of upper arms, each upper arm configured to attach to a separate upper strap; ● Each upper arm extends upward and backward relative to the chassis; ● Each upper arm extends from the chassis section; ● The patient interface includes a pair of lower arms extending from the chassis portion, each lower arm configured to attach to a pair of lower straps of a positioning and stabilizing structure configured to be positioned on each side of the patient's head below each lower earlobe point of the patient's head, and each upper arm extends from each of the lower arms; ● The patient interface further includes a ventilation module, which includes a ventilation section, and the ventilation module is located on the front side of the chassis portion; and / or ● The chassis section includes a front hole for receiving the ventilation module.

[0075] Another aspect of this technology includes a patient interface, the patient interface is A chassis portion that at least partially forms a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port that is sized and constructed to receive airflow at a therapeutic pressure for patient respiration, A seal-forming structure comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside it, so that as a result, airflow at the therapeutic pressure is delivered to at least the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A membrane portion connected to the chassis portion and forming at least partially the plenum chamber, the nasal pillow being supported on the membrane portion, the membrane portion being constructed and positioned to be flexible to allow relative movement between the nasal pillow and the chassis portion during use, and the membrane portion not having a predetermined three-dimensional shape when there is no positive pressure relative to the air pressure in the plenum chamber, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber during use, includes: The patient interface is configured to allow the patient to breathe through their mouth from the surroundings if there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0076] For example: ● The membrane portion is constructed and positioned to at least partially separate the movement of the nasal pillows from one another; ● The membrane portion is constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use; ● The membrane portion is constructed and positioned to expand when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is stretchable; ● The membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to therapeutic pressure during use; ● The membrane portion is constructed and positioned to be taut when there is no therapeutic pressure within the plenum chamber; ● The membrane portion is constructed and positioned to expand during use to fit one or more parts of the patient's nose; ● The membrane portion is constructed and positioned to expand during use, biasing each nasal pillow toward each of the patient's nostrils; ● The membrane portion is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion moves during use; ● The membrane portion is designed to engage with the patient's upper lip during use; ● The membrane portion is formed from textile material, at least partially; ● The membrane portion includes a textile layer and an air-impermeable layer; ● The textile layer provides the outer surface of the membrane portion; ● The membrane portion is formed from elastomer; ● The membrane portion is formed from silicone; ● The membrane portion takes the form of a sheet connected to the chassis portion at its edges; ● The plenum chamber includes a rear-upper facing side, configured to face the rear and upper sides during use, and the membrane portion and seal-forming structure form the majority of the rear-upper facing side; ● The membrane portion and seal-forming structure form substantially the entire side facing the rear upper side; ● The plenum chamber includes a front-upper facing side, configured to face the front and upper sides when in use, and the membrane portion forms the majority of the front-upper facing side; ● The plenum chamber includes a rear-lower facing side, configured to face the rear and lower sides when in use, and the membrane portion forms the majority of the rear-lower facing side; ● The chassis portion forms the majority of the front-lower side of the plenum chamber, which is configured to face both the front and lower sides during use; ● The chassis is formed from elastomer material; ● The chassis is formed from silicone or TPE; ● The chassis is designed not to engage with the patient's upper lip; ● Each nasal pillow does not have a stalk; ● Each nasal pillow includes a frustoconical portion with a tip and a base wider than the tip, the base being directly attached to the membrane portion; ● Each nasal pillow is made from a different material than the membrane portion; ● Each nose pillow is made from elastomer material; ● Each nasal pillow is made from silicone or TPE; ● The seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, thereby delivering the airflow to the patient's mouth under the therapeutic pressure; ● The membrane portion forms the oral cavity portion of the seal-forming structure; ● The patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie is constructed and positioned so that at least a portion of it lies over a region of the patient's head above the upper earlobe point when in use; ● The positioning and stabilization structure includes one or more gas delivery tubes configured to deliver airflow to the plenum chamber at therapeutic pressure; and / or ● The positioning and stabilization structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection portions configured to connect to the gas delivery tubes and sized and structured to receive an airflow at therapeutic pressure for patient respiration.

[0077] One form of this technology includes a patient interface for sealing and delivering an airflow at a continuous positive pressure relative to ambient air pressure to the entrances of the patient's airways, including the patient's nostrils and mouth, the patient interface being configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O above ambient air pressure throughout the patient's entire respiratory cycle during use, and to improve sleep-disordered breathing when the patient is sleeping; The patient interface is, A chassis portion formed from a textile material, wherein the chassis portion has a predetermined three-dimensional shape that is maintained throughout the patient's entire respiratory cycle. A seal-forming structure provided on the chassis portion, the seal-forming structure includes a foamed undercushion and a textile membrane portion connected to the foamed undercushion, configured to expand during use to form a seal around the entrance to the patient's nostrils and around the patient's mouth.

[0078] For example:

[0079] a) The textile membrane portion forms a seal around the anterior and lateral portions of the peripheral area of ​​the nasal ala base of the patient's nose, and from one side of the patient's nose to the opposite side of the patient's nose around the patient's mouth;

[0080] b) The textile membrane portion has an outer circumference and an inner circumference, and the width of the textile membrane portion between the inner and outer circumferences is greatest at the wing-shaped portion of the membrane portion, which is configured to seal at the corners of the nose;

[0081] c) The connecting portion is provided between the opposing wing-shaped portions of the textile membrane to prevent rupture;

[0082] d) The textile membrane portion forms a first seal around the entrance to the patient's nostrils and a separate second seal around the patient's mouth;

[0083] e) The textile membrane portion includes a first hole for delivering pressurized air to the patient's nostrils and a second hole for delivering pressurized air to the patient's mouth;

[0084] f) The textile membrane portion has only two holes;

[0085] g) The entire textile film portion is formed integrally from a single sheet of material;

[0086] h) The foam undercushion includes a pair of inwardly protruding portions configured to engage with the patient's face at the corners of the patient's nose;

[0087] i) The chassis section includes plastically deformable elements configured to allow adjustment of the frame width;

[0088] j) The patient interface includes an inlet port connector extending through the lower wall portion of the chassis, the inlet port connector having a central axis that extends substantially downward when in use;

[0089] k) The foam under cushion is in contact with the outer surface of the inlet port connector;

[0090] l) The front wall of the chassis section is in contact with the outer surface of the inlet port connector;

[0091] m) The inlet port connector protrudes through the front side wall of the chassis;

[0092] n) The chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's midline sagittal plane when in use;

[0093] o) The outer surface of the chassis portion directly adjacent to the inlet port connector has a radius substantially equal to the radius of the portion directly adjacent to the outside of the inlet port connector;

[0094] p) The patient interface includes a pair of upper headgear connectors and a pair of lower headgear connectors, with at least one of the headgear connectors being releasably connected to the chassis portion;

[0095] q) At least one headgear connector is connected to the chassis by a snap connector; and / or

[0096] r) The patient interface includes a ventilation module that is removably connected to the chassis portion.

[0097] Another form of this technology includes a patient interface for sealing and delivering an airflow at a continuous positive pressure relative to the ambient air pressure to the entrances to the patient's airways, including the patient's nostrils and mouth, the patient interface being configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure throughout the patient's entire respiratory cycle when in use, and to improve sleep-disordered breathing when the patient is sleeping; The above patient interface is, A chassis portion formed from a textile material, wherein the chassis portion has a predetermined three-dimensional shape that is maintained throughout the patient's entire respiratory cycle. A seal-forming structure provided on the chassis portion, the seal-forming structure comprising: a foamed undercushion; and a membrane portion connected to the foamed undercushion, configured to expand during use to form a seal around the entrance to the patient's nostrils and around the patient's mouth; The patient interface includes an inlet port connector extending through the lower wall portion of the chassis, the inlet port connector having a central axis that extends substantially downward when in use.

[0098] For example:

[0099] a) The foam under cushion is in contact with the outer surface of the inlet port connector;

[0100] b) The front wall of the chassis portion is in contact with the outer surface of the inlet port connector;

[0101] c) The inlet port connector protrudes through the front wall of the chassis section;

[0102] d) The chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's sagittal plane when in use;

[0103] e) The outer surface of the chassis portion directly adjacent to the inlet port connector has a radius substantially equal to the radius of the directly adjacent portion outside the connection port;

[0104] f) The patient interface includes a pair of upper headgear connectors and a pair of lower headgear connectors, with at least one of the headgear connectors being releasably connected to the chassis portion;

[0105] g) At least one headgear connector is connected to the chassis by a snap connector;

[0106] h) The patient interface includes a ventilation module that is releasably connected to the chassis portion; and / or

[0107] i) The membrane portion is formed from textile.

[0108] One form of this technology includes a patient interface, and the patient interface is

[0109] A chassis portion formed from a flexible material and partially forming a plenum chamber pressurized to a therapeutic pressure of at least 6 cmH2O exceeding ambient air pressure, wherein the chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's sagittal plane when in use,

[0110] An inlet port, sized and structured to receive airflow at therapeutic pressure for the patient's respiration,

[0111] A pair of upper headgear connectors connected to the chassis, and a pair of lower headgear connectors connected to the chassis,

[0112] A seal-forming structure provided in the chassis portion and partially forming a plenum chamber, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole inside it, thereby delivering airflow at therapeutic pressure to the entrance to the patient's nostrils and to the patient's mouth, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use;

[0113] The seal-forming structure includes an undercushion formed from foam, and a textile membrane portion connected to the undercushion, configured to expand during use to form a seal around the anterior and outer portions of the periphery of the nasal ala base of the patient's nose, and the seal-forming structure is further configured to form a seal around the patient's mouth.

[0114] The chassis is constructed to be flexible, and as a result, the magnitude of the first principal curvature may change when the patient interface is worn.

[0115] For example:

[0116] a) The chassis portion is curved such that the magnitude of the first principal curvature is greater when worn by a patient with a narrow face than when worn by a patient with a relatively wide face;

[0117] b) The chassis portion is formed from polymer;

[0118] c) The chassis portion is formed from biaxially oriented polyethylene terephthalate, such as Mylar®;

[0119] d) The thickness of the chassis portion is less than 0.5 mm, for example, substantially 0.25 mm;

[0120] e) The chassis portion is formed from a sheet of material;

[0121] f) The chassis section is punched out from a sheet of material;

[0122] g) The chassis portion is molded into shape;

[0123] h) The side of the undercushion facing the patient is configured to hold a substantially taut textile membrane portion when the patient interface is not in use;

[0124] i) The under cushion has a substantially "C" shaped cross-section;

[0125] j) The side of the undercushion not facing the patient includes a connection formation configured to connect the undercushion to the chassis portion;

[0126] k) The connection formation includes a channel configured to receive the edge of the chassis portion;

[0127] l) The channel extends around the entire peripheral portion of the undercushion on the side not facing the patient;

[0128] m) The engagement between the channel and the chassis portion forms a seal;

[0129] n) The under cushion includes a first part of the snap fastener, and the chassis includes a second part of the snap fastener;

[0130] o) The under cushion includes rigid clip formation;

[0131] p) The undercushion is formed from polyurethane, for example, thermoplastic polyurethane, or from a soft thermoplastic elastomer;

[0132] q) The textile membrane portion is attached to the undercushion around the outer edge of the textile membrane portion;

[0133] r) The textile membrane portion is bonded to the under cushion;

[0134] s) The textile membrane portion includes a first hole through which air can flow into both of the patient's nostrils during use;

[0135] t) The textile membrane portion includes a second hole through which air can flow into the patient's mouth during use, and the textile membrane portion extends between the first and second holes;

[0136] u) The textile membrane portion includes an air-impermeable coating on the side not facing the patient;

[0137] v) The air-impermeable coating includes a silicone layer;

[0138] w) The thickness of the silicone layer is substantially 0.05 mm;

[0139] x) The total thickness of the textile film portion is substantially 0.3 mm;

[0140] y) The textile film portion is formed from a single textile sheet;

[0141] z) Each upper headgear connector includes a curved arm;

[0142] aa) Each lower headgear connector includes a magnetic connector; and / or

[0143] ab) The chassis, seal forming structure, and head gear connector shall have a total weight of 45g or less;

[0144] Another form of this technology includes a patient interface, and the patient interface is

[0145] A chassis portion formed from a flexible material, partially forming a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O, exceeding the ambient air pressure.

[0146] An inlet port sized and constructed to receive airflow at therapeutic pressure for the patient's respiration;

[0147] A pair of upper headgear connectors connected to the chassis, and a pair of lower headgear connectors connected to the chassis;

[0148] A seal-forming structure that can be releasably connected to a chassis portion and partially forms a plenum chamber, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole inside it, thereby delivering airflow at therapeutic pressure to the entrance to the patient's nostrils and to the patient's mouth, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use, the seal-forming structure includes

[0149] The seal-forming structure includes an undercushion formed from foam, and a textile membrane portion connected to the undercushion, configured to expand during use to form a seal around the anterior and lateral portions of the peripheral area of ​​the nasal ala base of the patient's nose, and the seal-forming structure is further configured to form a seal around the patient's mouth.

[0150] For example:

[0151] a) The side of the undercushion not facing the patient includes a connection formation configured to connect the undercushion to the chassis portion;

[0152] b) The connection formation includes a channel configured to receive the edge of the chassis portion;

[0153] c) The channel extends around the entire peripheral portion of the undercushion on the side not facing the patient;

[0154] d) The engagement between the channel and the chassis portion forms a seal;

[0155] e) The under cushion includes a first part of the snap fastener, and the chassis includes a second part of the snap fastener;

[0156] f) The under cushion includes rigid clip formation;

[0157] g) The undercushion is formed from polyurethane, for example, thermoplastic polyurethane, or from a soft thermoplastic elastomer;

[0158] h) The side of the undercushion facing the patient is configured to hold a substantially taut textile membrane portion when the interface is not in use;

[0159] i) The under cushion has a substantially "C" shaped cross-section;

[0160] j) The textile membrane portion is attached to the undercushion around the outer edge of the textile membrane portion;

[0161] k) The textile membrane portion is bonded to the undercushion;

[0162] l) The textile membrane portion includes a first hole through which air can flow into both of the patient's nostrils during use;

[0163] m) The textile membrane portion includes a second hole through which air can flow into the patient's mouth during use, and the textile membrane portion extends between the first and second holes;

[0164] n) The textile membrane portion includes an air-impermeable coating on the side not facing the patient;

[0165] o) The air-impermeable coating includes a silicone layer;

[0166] p) The thickness of the silicone layer is substantially 0.05 mm;

[0167] q) The total thickness of the textile film portion is substantially 0.3 mm;

[0168] r) The textile film portion is formed from a single textile sheet; and / or

[0169] s) The chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's sagittal plane when in use.

[0170] Another aspect of one form of this technology is a patient interface that is molded together with a surrounding shape that is complementary to the shape of the wearer, or otherwise constructed.

[0171] One embodiment of this technology is a method for manufacturing an apparatus.

[0172] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has little experience using this type of medical device.

[0173] One embodiment of this technology is a portable RPT device that can be carried around by a person, for example, in the vicinity of their home.

[0174] One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, and does not require any special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home, for example with soapy water, and does not require any special cleaning equipment.

[0175] The methods, systems, devices, and apparatuses described can be implemented to improve the functionality of a processor (e.g., a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the methods, systems, devices, and apparatuses described enable improvements in the technical field of the automatic management, monitoring, and / or treatment of respiratory diseases, including, for example, sleep apnea.

[0176] Of course, some of the aspects can form sub - aspects of the present technology. Also, various ones of the sub - aspects and / or aspects can be combined in various ways to constitute further aspects or sub - aspects of the present technology.

[0177] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0178] [4 Brief Description of the Drawings] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to like elements including the following: [4.1 Respiratory Therapy System] [Figure 1A] A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow that receives positive - pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and sent to the patient 1000 along an air circuit 4170. A co - sleeper 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive - pressure air supplied from an RPT device. The air from the RPT device is humidified in a humidifier 5000 and sent to the patient 1000 along an air circuit 4170. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. [4.2 Respiratory System and Facial Anatomy] [Figure 2A] This diagram outlines the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] The diagram shows the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of a face exhibiting several features of identified surface anatomical structures, including the upper lip, upper lip red, lower lip red, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. Superior, inferior, radially medial, and radially lateral directions are also shown. [Figure 2D] This is a lateral view of the head, featuring several characteristics of identified surface anatomical structures, including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, outermost lateral point of the alae base, superior and inferior base points. Directions to the upper and lower, as well as the anterior and posterior, are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankfort horizontal and nasolabial angles are shown. The coronal plane is also shown. [Figure 2F] A pedicle view of the nose is shown, including several identified features such as the nasolabial folds, lower lips, upper lip red, nostrils, subnasal point, columella, nasal tip, and the long axis and midline sagittal plane of the nostrils. [Figure 2G] A lateral view of the superficial features of the nose is shown. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This image shows the nose after an incision made approximately a few millimeters medially from the sagittal midline, particularly highlighting the nasal septum cartilage and the medial crura of the greater alar cartilage. [Figure 2J] A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] A lateral view of the skull is shown, illustrating the external shape of the head surface and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is shown. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] An anterior-lateral view of the nose is shown. [4.3 Patient Interface] [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] A schematic diagram of a cross-section passing through the structure at a certain point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign and is relatively large compared to the magnitude of curvature shown in Figure 3C. [Figure 3C] A schematic diagram of a cross-section passing through the structure at a certain point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] A schematic diagram of a cross-section passing through a structure at a certain point is shown. The outward normal at the point is indicated. The curvature at the point has a value of zero. [Figure 3E] A schematic diagram of a cross-section passing through the structure at a certain point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] A schematic diagram of a cross-section passing through the structure at a certain point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and is relatively large compared to the magnitude of curvature shown in Figure 3E. [Figure 3G]A mask cushion including two pillows is shown. The outer surface of the cushion is shown. The edge of the surface is shown. The dome and saddle regions are shown. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is shown. The edge of the surface is shown. A path on the surface between points A and B is shown. The straight-line distance between points A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure having a one-dimensional hole within the surface is shown. The illustrated planar curve forms the boundary of the one-dimensional hole. [Figure 3J] A cross-section through the structure of FIG. 3I is shown. The illustrated surface bounds a two-dimensional hole within the structure of FIG. 3I. [Figure 3K] A perspective view of the structure of FIG. 3I including a two-dimensional hole and a one-dimensional hole is shown. The surface bounding the two-dimensional hole within the structure of FIG. 3I is also shown. [Figure 3L] A mask having an inflatable bladder as a cushion is shown. [Figure 3M] A cross-section through the mask of FIG. 3L is shown, showing the inner surface of the bladder. The inner surface bounds a two-dimensional hole within the mask. [Figure 3N] A further cross-section through the mask of FIG. 3L is shown. The inner surface is also shown. [Figure 3O] The left-hand rule is illustrated. [Figure 3P] The right-hand rule is illustrated. [Figure 3Q] A left ear including the helix of the left ear is shown. [Figure 3R] A right ear including the helix of the right ear is shown. [Figure 3S] A right-handed helix is shown. [Figure 3T] A view of a mask including the sign of the twist of a space curve defined by the edge of a sealing membrane within different regions of the mask is shown. [Figure 3U] A view of the phrenum chamber 3200 showing the sagittal plane and the intermediate contact surface is shown. [Figure 3V]Figure 3U shows a rear view of the plenum chamber. The orientation of the figure is perpendicular to the intermediate contact surface. The sagittal plane in Figure 3V bisects the plenum chamber to the left and right. [Figure 3W] Figure 3V shows a cross-section through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "intermediate contact" surface is shown. The intermediate contact surface is perpendicular to the sagittal plane. The orientation of the intermediate contact surface is on the sagittal plane and corresponds to the orientation of the chord 3201 that touches the cushion of the plenum chamber at two points on the sagittal plane (upper point 3221 and lower point 3230). Depending on the geometry of the cushion in this region, the intermediate contact surface can be tangential at both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in a position for use on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in a position for use. The intermediate contact surface generally corresponds to the “face plane” when the plenum chamber is in a position for use. In Figure 3X, the plenum chamber 3200 is the plenum chamber of the nasal mask, with the upper point 3221 approximately on the selion and the lower point 3230 on the upper lip. [Figure 3Y] This shows a patient interface in the form of a nasal cannula, which is one embodiment of this technology. [Figure 3Z] This shows a patient interface with a conduit headgear, which is one embodiment of this technology. [4.4 RPT Device] [Figure 4A] This shows an RPT device based on one form of this technology. [Figure 4B] This is a schematic diagram of the pneumatic passage of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic passage between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [4.5 Humidifier] [Figure 5A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 5B] This is an isometric view of a humidifier according to one embodiment of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [4.6 Respiratory waveform] [Figure 6A] A model of a typical respiratory waveform in a person during sleep is shown. [4.7 Further drawings of patient interfaces using examples of this technology] [Figure 7] This is a perspective view of a patient interface using an example of this technology. [Figure 8] Figure 7 is a front top view of the patient interface. [Figure 9] Figure 7 is a rear-top view of the patient interface. [Figure 10] Figure 7 shows a front view of the patient interface. [Figure 11] Figure 7 is a rear view of the patient interface. [Figure 12] Figure 7 shows the patient interface as it is worn by the patient before the plenum chamber of the patient interface is pressurized. [Figure 13] Figure 7 shows the patient interface when the device is worn by the patient and when the plenum chamber is inflated. [Figure 14] A top view of a patient interface, representing another example of this technology, is shown. [Figure 15] Figure 14 shows a posterior-top view of the patient interface. [Figure 16] Figure 14 shows a front-top view of the patient interface. [Figure 17] Figure 14 shows the patient interface when the device is worn by the patient and when the plenum chamber is inflated. [Figure 18] A posterior perspective view of the patient interface, representing another example of this technology, is shown. [Figure 19] Figure 18 shows a front perspective view of the patient interface. [Figure 20]Figure 18 shows an anterior-superior perspective view of the patient interface. [Figure 21] An anterior-superior perspective view of a patient interface, representing another example of this technology, is shown. [Figure 22] Figure 21 shows a posterior-superior perspective view of the patient interface. [Figure 23] Figure 21 shows an exploded view of the patient interface. [Figure 24] Figure 21 shows another exploded view of the patient interface. [Figure 25] This is a front-top perspective view of a patient interface, another example of this technology. [Figure 26] Figure 25 is a rear perspective view of the patient interface. [Figure 27] This is a front perspective view of the patient interface shown in Figure 25, which is used by patients. [Figure 28] This is a front-top perspective view of the patient interface shown in Figure 25, which is used by patients. [Figure 29] This is a top perspective view of the patient interface shown in Figure 25, which is used by patients. [Figure 30] Figure 25 is a rear-lower perspective view of the patient interface. [Figure 31] Figure 25 shows a rear perspective view of the patient interface with the membrane portion removed. [Figure 32] Figure 25 shows a rear-side perspective view of the patient interface with the membrane portion removed. [Figure 33] This is a front-top perspective view of a patient interface, another example of this technology. [Figure 34] Figure 33 is a rear perspective view of the patient interface. [Figure 35] Figure 33 is a front perspective view of the patient interface. [Figure 36] This is a front-top perspective view of the patient interface shown in Figure 33, which is used by patients. [Figure 37]This is a front side perspective view of the patient interface shown in Figure 33, which is used by patients. [Figure 38] This is a side view of a patient interface, another example of this technology being used on a patient. [Figure 39] This is a front-side perspective view of a patient interface, another example of this technology being used on a patient. [Figure 40] This is a front-side perspective view of a patient interface, another example of this technology. [Figure 41] Figure 40 is a front side perspective view of the patient interface cushion module. [Figure 42] Figure 40 is a top perspective view of the patient interface cushion module. [Figure 43] Figure 40 is a rear-top perspective view of the patient interface cushion module. [Figure 44] Figure 40 is a front side perspective view of the patient interface cushion module. [Figure 45] Figure 40 is a top perspective view of the patient interface cushion module. [Figure 46] This is a side perspective view of the patient interface shown in Figure 40, which is used by patients. [Figure 47] A frontal perspective view of a patient interface based on one embodiment of this technology is shown. [Figure 48] A frontal perspective view of a patient interface in another form of this technology is shown. [Figure 49] Figure 8 shows a rear view of the patient interface. [Figure 50] This shows a blank frame for a patient interface using one form of this technology. [Figure 51] Figure 50 shows the blanks folded and joined to form the frame. [Figure 52] This image shows a foamed undercushion of the patient interface before it is attached to the frame, representing one embodiment of this technology. [Figure 53]Figure 48 shows a rear perspective view of the patient interface with the textile membrane removed to reveal the undercushion. [Figure 54] This shows one form of textile film. [Figure 55] Figure 48 shows a view of the patient interface from below. [Figure 56] A perspective view of a patient interface based on one form of this technology is shown. [Figure 57] This is a schematic perspective view of a frame based on one form of this technology. [Figure 58] Figure 57 is a front view of the patient interface. [Figure 59] Figure 57 is a rear view of the patient interface. [Figure 60] Figure 57 is a rear view of the patient interface, which is bent into a narrow configuration. [Figure 61] This is a schematic partial cross-section passing through plane BB. [Figure 62] This is a schematic perspective view of the engagement portion and frame of an under cushion according to one embodiment of this technology. [Figure 63] Figure 62 is an enlarged view of the engagement portion of the under cushion and the frame. [Figure 64] This is an enlarged view of the connection between the under cushion engagement portion and the frame, according to one embodiment of this technology. [Figure 65] This is an enlarged view of the connection between the under cushion engagement portion and the frame, according to one embodiment of this technology. [Figure 66] This is a schematic cross-sectional view passing through plane AA. [Figure 67] Figure 7 is a rear perspective view of the patient interface. [Figure 68] This is a front view of a foamed undercushion, one embodiment of this technology. [Modes for carrying out the invention]

[0179] [5. Detailed explanation of the technology example] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and that these examples are subject to change. It should also be understood that the terminology used in this disclosure is intended solely to illustrate the specific examples discussed herein and is not limiting.

[0180] The following description is provided in relation to a variety of examples that may share one or more common properties and / or features. It should be understood that one or more features of any example may be combined with one or more features of another example or any other example. In addition, any single feature or combination of features in any of the examples may constitute further examples.

[0181] [5.1 Therapy] In one embodiment, the technology includes a method for treating respiratory distress, which involves applying positive pressure to the airway entrance of patient 1000.

[0182] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0183] In certain applications of this technology, mouth breathing is restricted, limited, or prevented.

[0184] [5.2 Respiratory Therapy Systems] In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0185] [5.3 Patient Interface] A non-invasive patient interface 3000 according to one aspect of this technology, as shown in Figure 3A, includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional aspects may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is positioned to surround the patient's airway inlet(s) to maintain positive pressure at the patient's airway inlet(s). Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0186] As shown in Figure 3Z, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit (e.g., an air circuit 4170 shown in Figures 1A-1C). The plenum chamber 3200 may be formed of one or more modular components, in the sense that one or more modular components can be replaced by different components (e.g., components of different sizes).

[0187] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0188] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0189] A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0190] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0191] [5.3.1 Seal-forming structure] The patient interface 3000 may include a seal-forming structure 3100. The seal-forming structure 3100 may be constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway. Furthermore, the seal-forming structure 3100 may have holes inside so that, as a result, the airflow at the therapeutic pressure described above is delivered at least to the entrance to the patient's nostrils during use. The seal-forming structure 3100 may be constructed and positioned to maintain therapeutic pressure within the plenum chamber 3200 throughout the patient's entire respiratory cycle during use.

[0192] In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a buffering function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient within a given treatment session depending on various factors (including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0193] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0194] In a particular embodiment of this technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber). In other embodiments, the seal-forming structure 3100 includes a foamed undercushion 3110 and a textile membrane portion 3220, as further described below.

[0195] The seal-forming structure 3100 produced by this technology can be constructed from a soft, flexible, and elastic material, such as silicone.

[0196] In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100, each configured to accommodate a range of different sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 suitable for larger heads rather than smaller heads, and another suitable for smaller heads rather than larger heads. However, since the examples of this technology may be suitable for a wide range of head sizes, they may be used by patients with relatively large and relatively small heads.

[0197] [5.3.1.1 Sealing mechanism] In one embodiment, the seal-forming structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure inside the plenum chamber 3200 (acting on its bottom surface) to bias it to form a tight, sealed engagement with the face. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0198] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member (thickness less than about 1 mm, e.g., about 0.25 mm to about 0.45 mm) extending around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends at least a portion around the periphery. The support flange is or contains a spring-like element and has the function of supporting the sealing flange so as not to buckle during use.

[0199] In one embodiment, the seal-forming structure may include a compression seal portion or a gasket seal portion. During use, the compression seal portion or gasket seal portion is constructed and positioned to be in a compressed state, for example, due to elastic tension in the positioning and stabilizing structure.

[0200] In one embodiment, the seal-forming structure includes a tensioned portion. During use, the tensioned portion is held under tension by, for example, an adjacent region of a sealing flange.

[0201] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0202] In a particular embodiment of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0203] [5.3.1.2 Nasal bridge or nasal ridge region] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0204] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0205] [5.3.1.3 Upper lip area] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region of the patient's face (i.e., the upper lip) when in use.

[0206] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use.

[0207] [5.3.1.4 Chin area] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the chin area of ​​the patient's face when in use.

[0208] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the chin area of ​​the patient's face when in use.

[0209] [5.3.1.5 Forehead area] In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when in use. In this embodiment, the plenum chamber may cover the eye when in use.

[0210] [5.3.1.6 Nasal pillow] In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose.

[0211] A nasal pillow according to one aspect of this technology includes a frustum of a cone (at least a portion of which forms a seal on the bottom surface of the patient's nose), a stalk, and a flexible region (located on the bottom surface of the frustum of the cone and connecting the frustum of the cone to the stalk). In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region works in conjunction to facilitate a universal joint structure that accommodates relative movement (both displacement and angular movement) between 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 stalk is connected.

[0212] In one example of a nasal pillow, at least a portion of the frustocone of each nasal pillow may be shaped and sized to fit into the patient's corresponding nostril. In another example of a nasal pillow, the frustocone of each nasal pillow may be shaped and sized not to fit into the patient's corresponding nostril. Each nasal pillow may be configured to seal the portion of the patient's nose that defines each nostril, including the patient's columella and each ala.

[0213] In some examples of nasal pillows, each nasal pillow may not have a stalk. The frustum of each nasal pillow may be directly attached to a part of the patient interface 3000 that defines the plenum chamber 3200.

[0214] [5.3.1.7 Nasal Mask] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal up to the upper lip region (e.g., the upper lip), up to the patient's nasal bridge or at least a portion of the nasal ridge above the nasal tip, and up to the patient's face above each outer part of the patient's nose, for example, adjacent to the patient's nasolabial folds. The patient interface 3000 shown in Figure 1B has this type of seal-forming structure 3100. This patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be called a “nasal cushion,” and the patient interface 3000 having such a seal-forming structure 3100 may be identified as a “nasal mask.”

[0215] [5.3.1.8 Full Face Mask] In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area immediately below the lower lip), up to at least a portion of the nasal bridge or the nasal ridge above the nasal tip, and up to the cheek area of ​​the patient's face. The patient interface 3000 shown in Figure 1C is of this type. This patient interface 3000 can deliver a supply of air or breathable gas to both nostrils and mouth of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be called a “full-face cushion,” and the patient interface 3000 may be identified as a “full-face mask.”

[0216] [5.3.1.9 Ultra-compact full-face mask] In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area immediately below the lower lip), up to the lower and / or anterior surface of the patient's nasal tip, and up to the patient's face over each outer side of the patient's nose, for example, adjacent to the nasolabial fold. The seal-forming structure 3100 may also form a seal in contact with the patient's upper lip. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver airflow or breathable gas to both of the patient's nostrils and mouth, or it may have an oral cavity opening configured to deliver air or breathable gas to the mouth and nostrils configured to deliver air or breathable gas to the nostrils, or it may have an oral cavity opening for delivering air to the patient's mouth and two nostrils for delivering air to each nostril. This type of patient interface 3000 may be known as a micro-full-face mask and may include a micro-full-face cushion.

[0217] [5.3.1.10 Nose Cradle Mask] In one embodiment, as shown, for example, in Figure 3Z, the seal-forming structure 3100 is configured to form a seal with the underside surface of the nose around the nostrils when in use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils in the underside peripheral area of ​​the patient's nose, including the underside and / or anterior surface of the patient's nasal tip and the patient's nasal wings. The seal-forming structure 3100 may seal the patient's upper lip. This type of seal-forming structure 3100 may be called, for example, a "cradle cushion," "nasal cradle cushion," or "subnasal cushion."

[0218] The shape of the seal-forming structure 3100 may be configured to conform to or closely follow the bottom surface of the patient's nose, and not to come into contact with the nasal bridge region or any part of the patient's nose above the nasal tip. In one embodiment of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides the opening into two orifices (each supplying air or breathable gas to each of the patient's nostrils during use). The bridge portion may be configured to come into contact with or seal the patient's nasal columella during use. Alternatively, the seal-forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nostrils.

[0219] [5.3.2 Plenum Chamber] The plenum chamber 3200 may be formed by a portion of the patient interface 3000 having a periphery whose shape is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the portion of the patient interface 3000 forming the plenum chamber 3200 is positioned very close to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the portion of the patient interface 3000 forming the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0220] In some forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less visually irritating and / or increase wearer comfort, which may improve compliance with therapy.

[0221] In certain forms of this technology, the plenum chamber 3200 is formed from one or more components constructed from a transparent material, such as transparent polycarbonate. The use of transparent materials can help make the patient interface less visually distracting and may improve compliance with therapy. The use of transparent materials may also help clinicians observe how the patient interface is positioned and functioning.

[0222] In a specific form of this technology, the plenum chamber 3200 is formed from one or more components constructed from a translucent material. The use of translucent materials can help to make the patient interface less visually distracting and may help improve compliance with therapy.

[0223] [5.3.3 Positioning and Stabilization Structures] The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by a positioning and stabilizing structure 3300 during use. The positioning and stabilizing structure 3300 may function as, or include, a "headgear" to engage with the patient's head to hold the patient interface 3000 in a sealed position.

[0224] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome at least the effect of positive pressure in the plenum chamber 3200 and lift the face away from it.

[0225] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000.

[0226] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of destructive forces on the patient interface 3000 (e.g., due to tube traction or accidental interference with the patient interface).

[0227] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided, configured to harmonize with what a patient wears while sleeping. In one example, the positioning and stabilizing structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0228] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is not too large or bulky, thereby preventing a patient from lying in a supine sleeping position with the posterior region of their head resting on a pillow.

[0229] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is not too large or bulky, thereby preventing a patient from lying in a lateral sleeping position with the side of their head resting on a pillow.

[0230] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. The release portion does not resist compression and may be, for example, a flexible or flimsy strap. The release portion is constructed and positioned such that, when a patient lies down with their head on a pillow, the force on the rear portion is transmitted along the positioning and stabilizing structure 3300, preventing the seal from being broken.

[0231] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a woven patient contact layer, a foam inner layer, and a woven outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the woven outer layer includes a loop material that engages with a hook material portion.

[0232] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap may be configured to be tensed during use and to direct a force that pulls the seal-forming structure closer to a portion of the patient's face. In one example, the strap may be configured as a tie.

[0233] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, when in use, at least a portion of its lower edge passes above the superior base of the patient's head and rests on a portion of the parietal bone without resting on the occipital bone.

[0234] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie, which is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the infraauricular point of the patient's head and rests below or above the occipital bone of the patient's head.

[0235] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect a first tie and a second tie, thereby reducing the tendency for the first tie and the second tie to move away from each other.

[0236] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a bendable (e.g., non-rigid) strap. An advantage of this embodiment is that when the patient is lying down and sleeping, the patient feels greater comfort from the strap.

[0237] In a particular form of this technology, the positioning and stabilizing structure 3300 includes a strap that is constructed to be breathable and allows water vapor to pass through.

[0238] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each configured to provide holding force and accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads rather than small-sized heads, and another form suitable for small-sized heads rather than large-sized heads.

[0239] [5.3.3.1 Conduit Headgear] [5.3.3.1.1 Conduit Headgear Tube] In some embodiments of this technology, the positioning and stabilization structure 3300 includes one or more headgear tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through a plenum chamber 3200 and a seal-forming structure 3100. In the embodiment of this technology illustrated in Figure 3Z, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate part of the patient's face (e.g., nose and / or mouth). Thus, the conduit of the air circuit 4170 that provides the pressurized airflow may be connected to the connection port 3600 of the patient interface at a location other than in front of the patient's face, for example, at the top of the patient's head. The patient interface 3000 shown in Figures 7 to 13 also includes gas delivery tubes 3350 that form a conduit headgear.

[0240] The positioning and stabilizing structure 3300 can be described as inflatable because air is contained in and can pass through the headgear piping in order to deliver pressurized air from the air circuit 4170 to the patient's airway. It is understood that not all components of the positioning and stabilizing structure 3300 must be inflatable. For example, in the example shown in Figure 3Z, the positioning and stabilizing structure 3300 includes an inflatable tube 3350 and a non-inflatable strap portion 3310.

[0241] In the embodiment of the technology illustrated in Figure 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 positioned on different sides of the patient's head during use, extending across each cheek region and over each ear (above the upper earlobe point on the patient's head) to an elbow 3612 at the top of the patient's head 1000. This embodiment of the technology may be advantageous because if the patient sleeps with their head turned to the side and one of the tubes is compressed, blocking or partially blocking the gas flow along the tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, e.g., one tube or three or more tubes. In one example where the patient interface has a single tube 3350, the single tube 3350 is positioned over one side of the patient's head (e.g., across one cheek area) during use, and a strap forms part of a positioning and stabilizing structure 3300, which is positioned over the other side of the patient's head (e.g., across another area) during use, and helps to secure the patient interface 3000 to the patient's head.

[0242] In the embodiment of the technology shown in Figure 3Z, the two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but connected in use and can be disconnected, for example, for cleaning or storage. When separate tubes are used, they can be indirectly connected to each other, for example, to a T-shaped connector having two arms / branchs to which each tube 3350 can be fluidly connected, and a third arm or opening that provides a connection port 3600 for fluid connection to an air circuit 4170 in use.

[0243] The tube 3350 may be formed from a flexible material such as an elastomer, for example, silicone or TPE, or from one or more textiles and / or foam materials. The tube 3350 may have a pre-formed shape and may be bent or changed to a different shape when force is applied, but may return to its original pre-formed shape when no such force is applied. The tube 3350 may generally have an arc-shaped or curved shape that approximates the contour of the patient's head between the top of the head and the nasal or oral cavity.

[0244] As described in Patent Document 14 (the contents of which are incorporated herein by reference), the tubes 3350 may be collapse-resistant so as not to obstruct the flow of breathable gas through the tubes if either tube is crushed during use, for example, if the space between the patient's head and the pillow is compressed. Collapse-resistant tubes are not always necessary, as the pressurized gas within the tubes can act as a splint to prevent, or at least limit, collapse of the tubes 3350 during use. Collapse-resistant tubes may be advantageous when only one tube 3350 is present, such as when a single tube is blocked during use, restricting gas flow and potentially halting therapy or reducing its effectiveness. In some examples, the tubes 3350 may be sized such that, if one of the tubes 3350 is blocked, each tube 3350 can independently provide sufficient gas flow to the plenum chamber 3200.

[0245] Each tube 3350 may be configured to receive airflow from a connecting port 3600 located at the top of the patient's head and deliver the airflow to a seal-forming structure 3100 located at the entrance to the patient's airway. In the example shown in Figure 3Z, when in use, each tube 3350 is on a path extending from the plenum chamber 3200 across the patient's cheek region to an elbow 3612 above the patient's ear. For example, a portion of each tube 3350 adjacent to the plenum chamber 3200 may lie over the maxillary region of the patient's head when in use. Another portion of each tube 3350 may lie over a region of the patient's head above the superior base of the ear. Each tube 3350 may also be over the patient's sphenoid bone and / or temporal bone, as well as one or both of the patient's frontal and parietal bones. The elbow 3612 may be located over the patient's parietal bone, over the frontal bone, and / or the point of contact between them (e.g., the coronal suture) when in use.

[0246] In certain embodiments of this technology, the patient interface 3000 may be positioned within a range of positions where the connection port 3600 crosses the top of the patient's head, and as a result, the patient interface 3000 may be positioned appropriately according to the comfort or fit of the individual patient. In some examples, the headgear tube 3350 is configured so that the upper part of the patient interface 3000 (e.g., the connection port 3600) can move relative to the lower part of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection port 3600 can be at least partially disconnected from the plenum chamber 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0247] As described above, in some examples of this technology, the patient interface 3000 generally includes a seal-forming structure 3100 that is located below the nose and takes the form of a cradle cushion that seals the lower periphery of the nose (e.g., a subnasal cushion). The positioning and stabilizing structure 3300, including a tube 3350, may be structured and positioned such that sealing force vectors in the posterior and superior directions (e.g., posterior-superior direction) pull the seal-forming structure 3100 into the patient's face below the nose. The posterior-superior sealing force vectors may facilitate the seal-forming structure 3100 forming a good seal on both sides of the patient's nose and upper lip, on both the lower periphery of the patient's nose and the anterior-facing surface of the patient's face.

[0248] [5.3.3.1.2 Stretchable and non-stretchable tube portions] In some examples of this technology, one or both of the tubes 3350 are not extendable in length. However, in some embodiments, the tube 3350 may include one or more extendable tube sections formed, for example, by an extendable bellows structure. In some embodiments, the patient interface 3000 may include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube having a tube wall having an extendable bellows structure. The patient interface 3000 shown in Figure 3Z includes a tube 3350, the upper portion of which each includes an extendable tube section taking the form of an extendable bellows structure 3362.

[0249] The cross-sectional shape of the non-stretchable tube section 3363 of tube 3350 may be circular, oval, oval, D-shaped, or rounded rectangle, as described, for example, in Patent Document 14. A cross-sectional shape that presents a flat surface of the tube on the side facing and in contact with the patient's face or other part of the head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0250] In some examples of this technology, the non-extendable tube section 3363 connects to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend along the side of the patient's head, downward, then curve forward and inward to connect to the plenum chamber 3200 in front of the patient's face. Before connecting to the plenum chamber 3200, the tube 3350 may extend to the same vertical position as the connection point with the plenum chamber 3200, or, in some examples, to a position below that connection point. That is, the tube 3350 may protrude at least partially upward before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the cushion module 3150 and / or the seal-forming structure 3100. The low position of the tube 3350 in front of the patient's face facilitates contact with the patient's face below the patient's chin, which may be more comfortable than contact at the patient's chin and may prevent excessive obstruction of the patient's peripheral vision.

[0251] [5.3.3.1.3 Conduit Headgear Connection Port] In certain embodiments of this technology, the patient interface 3000 may include a connection port 3600 located proximal to the upper, outer, or posterior portion of the patient's head. For example, in the embodiment of this technology illustrated in Figure 3Z, the connection port 3600 is located at the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3612 that forms the connection port 3600. The elbow 3612 may be configured to fluidly connect to a conduit in the air circuit 4170. The elbow 3612 may be configured to pivot relative to the positioning and stabilizing structure 3300 to at least partially disconnect the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3612 may be configured to pivot by rotating substantially around a vertical axis, and in some specific examples by rotating around two or more axes. In some examples, the elbow may include a tube 3350 or be connected to it by a ball joint. The connection port 3600 may be located in the sagittal plane of the patient's head when in use.

[0252] A patient interface with a connection port not positioned on the front of the patient's face may be advantageous because some patients may find conduits connecting to a patient interface on the front of their face unsightly and / or visually bothersome. For example, conduits connecting to a patient interface on the front of the patient's face may tend to interfere with bedding or bed linens, especially if the conduit extends downward from the patient interface during use. Embodiments of the technology including a patient interface with a connection port positioned above the patient's head during use may make it easier or more comfortable for the patient to lie down or sleep in one or more of the following positions: lateral sleeping position, supine position (e.g., lying on their back with their head generally facing upward), or prone position (e.g., lying face down with their head generally facing downward). Furthermore, connecting conduits to the front portion of the patient interface may exacerbate a problem known as tube traction, where the conduit applies undesirable force to the patient interface during movement of the patient's head or the conduit, thereby causing it to detach from the face. Tube traction may be less problematic if the force is applied to the upper part of the patient's head rather than the front of the patient's face, which is closer to the seal-forming structure (in which case the tube traction force is more likely to rupture the seal).

[0253] [5.3.3.1.4 Fluid connection of headgear tube] Two tubes 3350 are fluidly connected to a plenum chamber 3200 at their lower ends. In certain embodiments of this technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connecting two rigid connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow the patient to easily and reliably connect the two components to each other. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or audible feedback, such as a “reassuring click” or a sound that is easily usable by the patient to ensure that the patient knows that each tube 3350 is properly connected to the plenum chamber 3200. In one embodiment, the tubes 3350 are formed from silicone or textile material, and the lower end of each silicone tube 3350 is overmolded into a rigid connector made of, for example, polypropylene, polycarbonate, nylon. Each rigid connector on tube 3350 may include a female mating feature configured to connect to a male mating feature on the plenum chamber 3200. Alternatively, each rigid connector on tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples, each tube 3350 may include a male or female connector formed from a flexible material such as silicone or TPE, for example, the same material that forms the tube 3350.

[0254] In other examples, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, a resilient flexible (e.g., silicone) tube 3350 without a rigid connector may be configured to be compressed to reduce its diameter, and as a result may be compressed into a port in the plenum chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, sealing the tube 3350 into the port in an airtight manner. Alternatively, in a rigid-to-rigid type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure-operated seal, such as a periphery sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may be biased to contact the joint between the tube and the circumferential surface around the port or connector of the plenum chamber 3200, thereby forming or reinforcing a seal between the tube 3350 and the plenum chamber 3200.

[0255] [5.3.3.1.5 Conduit Headgear Strap] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes, in addition to the tube 3350, at least one headgear strap that functions to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in Figure 3Z, the patient interface 3000 includes a strap portion 3310 that forms part of the positioning and stabilizing structure 3300. The strap portion 3310 may be known, for example, as a back strap or rear headgear strap. In other examples of this technology, one or more additional straps may be provided. For example, the patient interface 3000 according to an example of this technology having a full-face cushion may have a second lower strap configured to rest against the patient's head, close to the patient's neck, and / or against the posterior surface of the patient's neck.

[0256] In the example shown in Figure 3Z, the strap portion 3310 of the positioning and stabilizing structure 3300 is positioned over each side of the patient's head and connects between two tubes 3350 that pass around the back of the patient's head (for example, lying on or below the occipital bone of the patient's head during use). The strap portion 3310 connects to each tube over the patient's ears. Referring to Figure 3Z, the positioning and stabilizing structure 3300 includes a pair of tabs 3355. During use, the strap portion 3310 may connect between the tabs 3355. The strap portion 3310 passes around the back of the patient's head and can be sufficiently flexible to be comfortable against the patient's head even when under tension during use.

[0257] [5.3.4 Ventilation] In one embodiment, the patient interface 3000 includes a vent 3400 constructed and positioned to allow for the flushing away of exhaled gases, such as carbon dioxide.

[0258] In a particular configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the surroundings while the pressure inside the plenum chamber is positive relative to the surroundings. The vent 3400 is configured such that the airflow is large enough to reduce rebreathing of CO2 exhaled by the patient, while maintaining therapeutic pressure inside the plenum chamber during use.

[0259] One form of the ventilation section 3400 according to this technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0260] The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a decoupling structure, such as a swivel.

[0261] [5.3.5 Cushion Modules and Exemplary Patient Interfaces] In the examples of the present technology shown in Figures 7-20 and 25-67, the patient interface 3000 includes a chassis portion 3210 that partially forms a plenum chamber 3200. The chassis portion 3210 and the membrane portion 3220 together (as shown below) can form a plenum chamber 3200 by enclosing a space of a certain volume that can be filled with air at a therapeutic pressure such as at least 4 cmH2O or at least 6 cmH2O, which is above the ambient air pressure. In some examples, a seal-forming structure 3100 may also partially form a plenum chamber 3200, depending on the type and / or shape of the seal-forming structure 3100.

[0262] The components forming the seal-forming structure 3100 and the plenum chamber 3200 form the cushion module 3150 of the patient interface 3000 in the examples shown in Figures 7 to 20 and 25 to 67. In the examples shown in Figures 7 to 13, Figures 7 to 11 show the cushion module 3150 alone, and Figures 12 to 13 show it connected to the headgear tube 3350. In these examples, the cushion module 3150 is separable from other components of the patient interface 3000, such as the positioning and stabilization structure 3300. The cushion module 3150 may be separable from the headgear tube 3350 of the positioning and stabilization structure 3300. Thus, in some examples of the art, the patient interface 3000 includes a removable cushion module 3150.

[0263] In some cases, the cushion module 3150 may be replaced in the patient interface 3000 with another cushion module 3150, for example, one of a different size (or at least one having a seal-forming structure 3100 of a different size or shape).

[0264] In other examples, the cushion module 3150 may not be separable from other components or parts of the patient interface 3000, such as the positioning and stabilization structure 3300. In some examples, the cushion module 3150 may include a chassis portion 3210, at least a part thereof, which is integrally formed with one or both of the headgear tubes 3350 or with a portion of the positioning and stabilization structure. The features of the patient interface 3000 disclosed herein should be understood to be appropriate whether the chassis portion 3210 is part of the removable cushion module 3150, unless otherwise clearly required in the context.

[0265] The plenum chamber 3200 may include one or more plenum chamber inlet ports that are sized and constructed to receive an airflow at therapeutic pressure for patient respiration.

[0266] In the examples shown in Figures 7 to 13, the plenum chamber 3200 of the patient interface 3000 has two plenum chamber inlet ports. In particular, the chassis portion 3210 defines two openings, one on each side of the chassis portion 3210. In the examples shown in Figures 14 to 17, the plenum chamber 3200 includes one plenum chamber inlet port. In particular, the chassis portion 3210 defines an opening at the connection point to the short tube 3610 that forms the plenum chamber inlet port.

[0267] In the example of the present technology shown in Figures 18 to 20, the patient interface 3000 includes a chassis portion 3210 and a membrane portion 3220 that form a plenum chamber 3200. In this example, the patient interface 3000 is configured to supply a pressurized airflow to the patient's mouth and nostrils. The plenum chamber 3200 is configured to be positioned in front of the patient's mouth, in addition to being below the patient's nose, when in use. Therefore, the plenum chamber 3200 is larger than the plenum chamber 3200 of the patient interface 3000 shown in Figures 7 to 13. Therefore, in the example shown in Figures 18 to 20, the plenum chamber 3200 is described as having a nasal portion configured to be positioned close to the user's nose when in use, and an oral portion configured to be positioned close to the user's mouth when in use. In this example, the chassis portion 3210 forms the majority of the front-facing side of the oral portion of the plenum chamber 3200. In some examples, the chassis portion 3210 forms substantially all of the front-facing side of the oral cavity portion of the plenum chamber 3200. In some examples, the chassis portion 3210 and the oral cavity portion of the seal-forming structure 3100 form substantially all of the rear-facing side of the oral cavity portion of the plenum chamber 3200. The components forming the seal-forming structure 3100 and the plenum chamber 3200 form the cushion module 3150 of the patient interface 3000 in this example. In this example, the cushion module 3150 is separable from other components of the patient interface, such as the positioning and stabilization structure 3300.

[0268] [5.3.5.1 Nasal cushion module and oral cushion module] In the example of the present technology shown in Figures 21 to 24, the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170 (each forming part of the plenum chamber 3200 of the patient interface 3000). In this example, the patient interface 3000 is configured to supply a pressurized airflow to the patient's mouth and nostrils. The nasal cushion module 3160 and the oral cushion module 3170 may be fluidly connected by an oral-nasal connector 3165, which may also form part of the plenum chamber 3200. The nasal cushion module 3160 may be described as forming the nasal portion of the plenum chamber 3200, and the oral cushion module 3170 may be described as forming the oral portion of the plenum chamber 3200. The nasal cushion module 3160 may be configured to be positioned below the patient's nose during use, and the oral cushion module 3170 may be configured to be positioned in front of the user's mouth during use.

[0269] In the examples shown in Figures 21 to 24, the nasal cushion module 3160 of the seal-forming structure 3100 may be formed by a nasal chassis portion 3216, a membrane portion 3220, and a nasal portion 3101. In this example, the nasal portion 3101 of the seal-forming structure 3100 includes a nasal pillow, but in other examples, it may include a different type of seal, such as a cradle cushion. The seal-forming structure 3100 in the form of a cradle cushion may be formed from, for example, silicone or TPE. The nasal chassis portion 3216 and the membrane portion 3220 may form the nasal portion of the plenum chamber 3200. The nasal portion 3101 of the seal-forming structure 3100 may be formed from an elastomer material.

[0270] The oral cushion module 3170 may be formed by an oral chassis portion 3217 and an oral portion 3102 of a seal-forming structure 3100, which together can form the oral portion of the plenum chamber 3200. The oral portion 3102 of the seal-forming structure 3100 may include a sealing flange configured to form a seal around the patient's mouth and to seal the patient's upper lip, lower lip, and cheek. The sealing flange is formed from silicone in the examples shown in Figures 21 to 24, but in other examples it may be formed from another elastomer material such as TPE, from a foam, or from a textile with an airtight membrane, such as a thin layer of silicone or another suitable material. The sealing flange forming the oral portion 3102 of the seal-forming structure 3100 may be formed integrally with the oral chassis portion 3217. The sealing flange may have a thickness in the range of, for example, 0.1 mm to 1 mm, or 0.2 mm to 0.8 mm, or 0.25 mm to 0.5 mm. The sealing flange may have a thickness of 0.25 mm in the lip region, which can provide a comfortable and effective seal in the patient's lip and adaptability to different patient geometries. In some examples, the sealing flange may have a thickness of 0.2 mm.

[0271] The oral cushion module 3170 may include a cavity 3218 (e.g., a recess) that can receive the nasal cushion module 3160. The cavity 3218 may open upward so that the nasal cushion module 3160 can be positioned above the oral cushion module 3170 when in use. The cavity 3218 may include a shape complementary to a portion of the nasal cushion module 3160 so that the nasal cushion module 3160 fits within the cavity 3218. The cavity 3218 may be defined by the oral chassis portion 3217 and / or oral portion 3102 of the seal-forming structure 3100. The cavity may be shaped so that, when the nasal cushion module 3160 is received within the cavity 3218, the nasal cushion module 3160 and the oral cushion module 3170 are correctly oriented relative to each other for use of the patient interface 3000.

[0272] The nasal cushion module 3160 of the patient interface 3000 shown in Figures 21-24 shares a variety of features with the cushion module 3150 of the patient interface shown in Figures 7-13, 14-17, and 18-20, including a chassis portion 3210, an outwardly protruding connection portion 3212, a membrane portion 3220, and a seal-forming structure 3100 or a part thereof. Unless otherwise specified in the context, the features of the cushion module 3150 described with reference to the patient interface 3000 shown in Figures 7-13, 14-17, and 18-20 should be understood to be applicable to the type of nasal cushion module 3160 shown in Figures 21-24. In some examples, the nasal cushion module 3160 of the modular patient interface 3000 (e.g., shown in Figures 21-24) is substantially identical to the cushion module 3150 shown in Figures 7-13. In some examples, the nasal cushion module 3160 of the modular patient interface 3000 is detachable from the oral cushion module 3170 and can be used independently, as it forms a nasal-only patient interface 3000 without covering the patient's mouth. The ventilation module 3410 may be provided instead of the oral-nasal connector 3165 (shown below).

[0273] Similarly, the features of the chassis portion 3210 described with reference to the patient interface 3000 shown in Figures 7-13, 14-17, and 18-20 should be understood to be applicable to the nasal chassis portion 3216 of the type shown in Figures 21-24. The features of the membrane portion 3220 described herein should be understood to be applicable to the membrane portion of the cushion module 3150 of the type shown in Figures 7-13, 14-17, and 18-20, and the nasal cushion module 3160 of the type shown in Figures 21-24, unless otherwise clearly required in the context.

[0274] [5.3.5.1.1 Oral-nasal connector] The oral-nasal connector 3165 of the patient interface 3000 shown in Figures 21-24 takes the form of a tubular portion that fluidly connects the inside of the nasal cushion module 3160 to the inside of the oral cushion module 3170. The tubular portion that forms the majority of the oral-nasal connector 3165 may be made of silicone or TPE, with one or both ends being made of a harder plastic material (e.g., polycarbonate or nylon). In some examples, the tubular portion that forms most of the oral-nasal connector 3165 may be made of the same material as the oral chassis portion 3217 and / or nasal chassis portion 3216. In the examples shown in Figures 21-24, the oral-nasal connector 3165 includes a rounded cross-section. The cross-section may be oval. In some examples, it may be rectangular and have rounded corners. In some examples, the entire oral-nasal connector 3165 may be made of an elastomer, such as silicone or TPE.

[0275] The oral-nasal connector 3165 may be detachably attached to one or both of the nasal cushion module 3160 and the oral cushion module 3170, but in some examples it may be permanently connected to one or both of the nasal cushion module 3160 and the oral cushion module 3170. Each of the nasal cushion module 3160 and the oral cushion module 3170 may include an opening for fluid connection to the oral-nasal connector 3165. The opening in the nasal cushion module 3160 may align with the oral-nasal connector 3165 when the nasal cushion module 3160 is received within the cavity 3218 in the oral cushion module 3170.

[0276] The oral-nasal connector 3165 may be configured to transmit a sealing force vector from the nasal cushion module 3160 to the oral cushion module 3170 to help hold the oral cushion module 3170 in the correct orientation for use with the patient interface 3000 (and vice versa). The oral-nasal connector 3165 may be configured to correctly orient the nasal cushion module 3160 and the oral cushion module 3170 relative to each other.

[0277] [5.3.5.2 Connection to positioning and stabilization structures] The patient interface 3000, illustrated in Figures 12–13 (its cushion module 3150 is illustrated in Figures 7–11), Figures 18–20, and Figures 21–24, each includes a positioning and stabilization structure 3300 comprising one or more gas delivery tubes 3350 configured to deliver airflow to the plenum chamber 3200 at therapeutic pressure. In particular, the positioning and stabilization structure 3300 comprises a pair of gas delivery tubes 3350. In these examples, the gas delivery tubes 3350 function as conduit headgear. Further descriptions of the gas delivery tubes 3350, conduit headgear, positioning and stabilization structure 3300, and their features are included elsewhere in this specification.

[0278] The chassis portion 3210 (or optionally the nasal chassis portion 3216) may include one or more outwardly projecting connector portions 3212, which are configured to connect to the gas delivery tubes 3350 and may be sized and constructed to receive an airflow at therapeutic pressure for patient respiration. The outwardly projecting connector portions 3212 may also, together with the chassis portion 3210 or the nasal chassis portion 3216 (optionally) and other parts of the membrane portion 3220, partially form the plenum chamber 3200. Each outwardly projecting connector portion 3212 may be configured to connect to each gas delivery tube 3350 and receive a gasflow from there, and may include an inlet to the interior of the chassis portion 3210. Each outwardly projecting connector portion 3212 may define a plenum chamber inlet port. The chassis portion 3210 may include a pair of connectors 3214 configured to connect to the gas delivery tubes 3350 of the positioning and stabilization structure 3300.

[0279] As shown in Figures 7 to 11, the connectors 3214 are provided on both outer sides of the chassis portion 3210, and in particular, in this example, each connector 3214 is provided on each of the connection portions 3212 that protrude outward from the chassis portion 3210. In this example, the connectors 3214 are provided at the entrance of the outwardly protruding connection portion 3212. Figures 12 to 13 show the gas delivery tube 3350 connected to the outwardly protruding connection portion 3212. The patient interface 3000 shown in Figures 18 to 20 includes the outwardly protruding connection portion 3212 and also has a chassis portion 3210 that can be connected to the gas delivery tube 3350 via the connectors 3214 (hidden inside the tube 3350 in Figures 18 to 20). In the examples shown in Figures 21 to 24, the nasal cushion module 3160 includes an outwardly protruding connecting portion 3212 and a nasal chassis portion 3216 that can be connected to the gas delivery tube 3350 via a connector 3214 (which is also hidden inside the gas delivery tube 3350 in Figures 21 to 24).

[0280] The angle at which the outwardly protruding connecting portion 3212 protrudes advantageously is such that the seal-forming structure 3100 (for example, in the case of the patient interface 3000 shown in Figures 21 to 24, its nasal portion 3101 and oral portion 3102) is oriented at an angle that allows the seal-forming structure 3100 to form a stable seal with the patient's face without blocking the patient's nose.

[0281] In other examples, the chassis portion 3210 does not have to include the outwardly protruding connecting portion 3212. In some examples, which will be described in more detail below, such as the example shown in Figures 14 to 17, the chassis portion 3210 includes, for example, a single opening on its front side (where the chassis portion 3210 can be fluidly connected to the air circuit 4170, for example, via a short pipe, to receive an airflow into the plenum chamber 3200 at therapeutic pressure). In such examples, the chassis portion 3210 may be configured to connect to the headgear strap of the positioning and stabilization structure 3300 of the patient interface 3000 (for example, via a rigidizer which may take the form of a substantially rigid arm covered with textile material or, for patient comfort, having at least textile material on the side facing the patient).

[0282] In the examples shown in Figures 18 to 20, the patient interface includes a cushion module 3150 that supplies air to both the patient's nose and mouth, and in the examples shown in Figures 21 to 24, the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170. As previously stated, in these examples, the patient positioning and stabilization structure 3300 includes a headgear tube 3350 that forms a conduit headgear. Furthermore, in these examples, the positioning and stabilization structure 3300 includes a pair of lower straps (not shown in the drawings, but the lower straps may be disclosed in Patent Document 15 (the entire contents of which are incorporated herein by reference)). Each lower strap may be configured to be positioned on each side of the patient's head, below each lower base point of the patient's head. The lower straps may optionally be configured to be releasably attached to the chassis portion 3210 or the oral chassis portion 3217. In some examples, the connection between the lower straps and the chassis portion may be a magnetic connection and / or a mechanical connection. The lower strap may be elastically stretchable, which may have the advantage that the positioning and stabilizing structure 3300 can withstand changes in the distance between the patient's chin and neck when the patient moves their own head.

[0283] [5.3.5.3 Ventilation] [5.3.5.3.1 Ventilation within the chassis] In some forms, the patient interface 3000 may include a vent 3400 that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber 3200 to the outside, for example, throughout the patient's entire respiratory cycle, and the vent 3400 is sized and shaped to maintain therapeutic pressure within the plenum chamber during use. In the examples illustrated in Figures 7 to 13, the patient interface 3000 includes a vent module 3410 containing the vent 3400. The vent module 3410 may be a component or assembly formed from a substantially rigid material and including a plurality of holes that form the vent 3400. The vent module 3410 may be located on the front side of the chassis portion 3210. In the example shown in Figures 7 to 13, the vent module 3410 is located on the front lower side of the chassis portion 3210. The chassis portion 3210 includes a hole for receiving the ventilation module 3410 (this is a front-lower hole in the illustrated example, and may be a front-facing or lower-facing hole in other examples). In some examples, the ventilation module 3410 is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows outwards. In some examples, the ventilation module 3410 is configured so that gas exhaled by the patient flows continuously from the inside of the plenum chamber 3200 outwards, passing beside the diffuser without flowing through it.

[0284] In the example shown in Figures 18 to 20, the patient interface 3000 includes a vent 3400 and a vent module 3410, which may be substantially as described above in relation to Figures 7 to 13. However, in this example, the vent 3400 is provided in a chassis portion 3210 adjacent to (e.g., on the front side of) the oral portion 3102 of the seal-forming structure 3100. The vent module 3410 may be provided on the front side of the chassis portion 3210. The chassis portion 3210 may include a front-facing hole that receives the vent module 3410.

[0285] Other patient interfaces in other examples of this technology (e.g., those described with reference to Figures 25 to 67) should be understood to have a gas flushing vent 3400 (e.g., a vent 3400 that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber 3200 to the surroundings, even if the vent 3400 is not depicted or identified in the drawings (the vent 3400 is sized and shaped to maintain therapeutic pressure within the plenum chamber during use)). The vent 3400 may be provided within a vent module 3410.

[0286] [5.3.5.3.2 Ventilation section within the oral-nasal connector] In the examples shown in Figures 21 to 24, the oral-nasal connector includes a vent 3400 of the patient interface 3000. In this example, the vent module 3410, which includes the vent 3400, is provided on the oral-nasal connector 3165. The vent module 3410 is received in a hole on the oral-nasal connector 3165. The vent module 3410 may be provided on the oral-nasal connector 3165 and the front portion of the patient interface 3000 to direct the gas flow discharged from the patient. The vent 3400 and the vent module 3410 may be as described in relation to the vent 3400 and the vent module 3410 in the examples shown in Figures 7 to 13.

[0287] [5.3.5.4 Anti-choking valve (AAV)] The patient interfaces 3000 shown in or described with reference to Figures 18-20 and 21-67 each further include an asphyxiation prevention valve (AAV), which is not visible in the drawings. The AAV may be located in the oral portion of the patient interface 3000. In some examples, the AAV is integrated into a ventilation module 3410. The ventilation module 3410 may include a gas flushing ventilation 3400 and the AAV. In some examples, the AAV is located within the chassis portion 3210 (or oral chassis portion 3217) of the patient interface 3000. In further examples, the AAV is located in the connection port 3600 of the patient interface 3000, or in the connection between the plenum chamber and the short tube 3610 (e.g., the inlet port connector 3605).

[0288] [5.3.5.5 Seal-forming structure] As described above, the patient interface 3000 includes a seal-forming structure 3100. The seal-forming structure 3100 may form part of the cushion module 3150. In an example where the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170, the seal-forming structure 3100 may form part of the nasal cushion module 3160 and the oral cushion module 3170.

[0289] In the examples shown in Figures 7–13, 14–17, 18–20, 21–24, and 25–46, the seal-forming structure 3100 includes a pair of nasal pillows. Each nasal pillow may be constructed and positioned to form a seal with each nostril of the patient's nose. Each nasal pillow may have a hole inside it, so that an airflow with therapeutic pressure can be delivered to at least the patient's nostrils.

[0290] In the examples shown in Figures 18-20, 21-24, and 25-46, the seal-forming structure 3100 includes a pair of nasal pillows forming the nasal portion 3101 of the seal-forming structure 3100, and further includes an oral portion 3102 of the seal-forming structure. The oral portion 3102 of the seal-forming structure 3100 shown in Figures 18-20 and 21-24 may be configured to form a seal around the patient's mouth, thereby delivering an airflow (e.g., at least a portion thereof) to the patient's mouth under therapeutic pressure.

[0291] A nasal pillow of the patient interface 3000, or more generally any seal-forming structure 3100, according to one example of this technology, may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use.

[0292] In each of the examples shown in Figures 7 to 46, the nasal pillows forming the seal-forming structure 3100 do not have a stalk. Each nasal pillow may include a conical portion (e.g., a frustoconical portion) having a tip and a base wider than the tip. The base may be directly attached to the membrane portion 3220 (described in detail below). That is, there can be no stalk or narrow connection between the frustoconical portion of each nasal pillow and the membrane portion 3220. The absence of a stalk may be advantageous in keeping the force applied by each pillow in the patient's nose small, thereby providing a comfortable patient interface 3000. Also, the absence of a stalk increases the stability of the nasal pillow, so that only a small force is required to hold it in place in the nostril, thereby making the patient feel more comfortable. In other examples, each nasal pillow includes a stalk connecting the frustoconical portion of the nasal pillow to the membrane portion 3220. However, the highly flexible membrane portion 3220 may allow sufficient movement of the nasal pillow to the extent that a stalk for the purpose of detachment may not be necessary.

[0293] The frustoconical portion of each nasal pillow can seal each nostril of the patient's nose. For example, the frustoconical portion of each nasal pillow can be constructed to seal the underside surface of the patient's nose, defining each nostril. For example, the frustoconical portion of each nasal pillow can seal the patient's nose at each nasal opening.

[0294] The nose pillow, which forms part of the seal-forming structure 3100, may be formed separately from the membrane portion 3220 and may be attached to the membrane portion 3220 by any means that creates a seal between the nose pillow and the membrane portion 3220 and fixes the nose pillow to the membrane portion 3220 for the entire desired lifespan of the cushion module 3150. In some examples, the nose pillow may be attached to the membrane portion 3220. In other examples, the nose pillow may be formed on the membrane portion 3220 by, for example, supporting the membrane portion 3220 or cushion module in a mold and molding the nose pillow in place on the membrane portion 3220.

[0295] In some examples, the nasal pillow is formed from a different material than the membrane portion 3220 (for example, the nasal pillow may be formed from a first material, and the membrane portion 3220 may be formed from a second material different from the first material). Each nasal pillow may be formed from an elastomer material. In the examples shown in Figures 7 to 46, the nasal pillow is formed from silicone. In other examples, the nasal pillow may be formed from, for example, thermoplastic elastomer (TPE), foam, textile, or a combination thereof. The nasal pillow may be formed from a single-wall or double-wall structure. In some examples, each nasal pillow is formed from a single wall. In other examples, the nasal pillow may be a double-wall nasal pillow (for example, formed from two walls).

[0296] In other examples, the seal-forming structure 3100 may take the form of a nasal cradle cushion (e.g., a seal-forming structure 3100 configured to seal the patient's nasal tip, alae, and upper lip). The nasal cradle seal-forming structure 3100 may be formed from an elastomer material such as silicone or TPE, or at least partially from a textile material, and optionally with an undercushion which may be formed from, for example, foam.

[0297] [5.3.5.6 Chassis and membrane sections] The patient interface 3000 may include a membrane portion 3220 connected to a chassis portion 3210 (or optionally a nasal chassis portion 3216). Together, the chassis portion 3210 and the membrane portion 3220 may form a plenum chamber 3200 that encloses a volume that can be filled with air, for example, at therapeutic pressure.

[0298] In some examples of this technology, the membrane portion 3220 supports the seal-forming structure 3100 or at least a part thereof (e.g., the nasal portion 3101 of the seal-forming structure 3100). For example, the seal-forming structure 3100 may be supported on the membrane portion 3220. In the examples shown in Figures 7 to 13 and Figures 14 to 17, the nasal pillow forming the seal-forming structure 3100 is supported on the membrane portion 3220. In the examples shown in Figures 18 to 20 and Figures 21 to 24, the nasal pillow supported on the membrane portion 3220 forms the nasal portion 3101 of the seal-forming structure 3100.

[0299] The chassis portion 3210 (or optionally the nasal chassis portion 3216 or the oral cavity chassis portion 3217) may be configured to support the membrane portion 3220 by being more rigid than the membrane portion 3220. The chassis portion 3210 may be formed from a material that is more rigid than the material forming the membrane portion 3220. Additionally or alternatively, the chassis portion 3210 may be thicker than the membrane portion (e.g., at least 5 times, at least 7 times, or at least 10 times thicker).

[0300] The chassis portion 3210 may be part of the cushion module 3150 (or possibly the nasal cushion module 3160 or oral cushion module 3170) having sufficient stiffness (e.g., as a result of material and / or shape / structure) to maintain the shape of the cushion module 3150 and support the membrane portion 3220. The chassis portion 3210 may hold the membrane portion 3220 substantially taut when the plenum chamber 3200 is not pressurized. For example, the chassis portion 3210 may hold the membrane portion 3220 substantially taut, so that the nasal pillow is held substantially in use position before the plenum chamber 3200 is pressurized. The membrane portion 3220 may be sufficiently taut to align the nasal pillow with the patient's nostrils if the patient wears the patient interface 3000 before the plenum chamber 3200 is pressurized. In particular, the chassis portion 3210 may hold the membrane portion 3220 taut but prevent it from expanding or contracting when at rest. Furthermore, the nose pillow, or more generally the seal-forming structure 3100, may provide some support for the resting shape of the membrane portion 3220. The resting membrane portion 3220 may be taut so as to be held substantially in a predetermined shape. In some examples, the resting membrane portion 3220 may be taut, but there may be no stress within the material forming the membrane portion 3220. The resting membrane portion 3220 may be held generally in a predetermined shape and taut so as to generally hold the seal-forming structure 3100 (e.g., the nose pillow) in a predetermined position relative to the chassis portion 3210, but it may be easily deformable by forces acting on the membrane portion 3220, such as finger pressure.

[0301] In some examples, the chassis portion 3210 may be formed from an elastomer material. In the examples shown in Figures 7 to 13, the chassis portion 3210 is formed from silicone. In other examples, the chassis portion 3210 may be formed from a thermoplastic elastomer (TPE). In further examples, the chassis portion 3210 may be formed from a substantially rigid material, such as a thermoplastic material, e.g., polycarbonate, nylon, etc. In the examples described with reference to Figures 47 to 67, the chassis portion 3210 may be formed from a textile material. In other examples, the chassis portion 3210 may be formed from a foam or a combination of materials, e.g., a combination of materials disclosed herein.

[0302] By constructing and positioning the membrane portion 3220 to be flexible, the seal-forming structure 3100 can move relative to one or more other parts of the patient interface 3000 during use. In particular, the seal-forming structure 3100 can move relative to the chassis portion 3210. For example, in the patient interface 3000 shown in Figures 7 to 24, the membrane portion 3220 is constructed and positioned to be flexible to allow relative movement between the nasal pillow and the chassis portion 3210 (e.g., the nasal chassis portion 3216 in the example shown in Figures 21 to 24). The membrane portion 3220 can allow relative movement between the nasal pillow and a part of the cushion module 3150 (or 3160), such as the chassis portion 3210, during use. The membrane portion 3220 can provide a trampoline function, allowing the chassis portion 3210 to move relative to the nasal pillow by deformation of the membrane portion 3220, while the seal-forming structure 3100, such as the nasal pillow, is held in place. The relative movement between the seal-forming structure 3100 and the chassis portion 3210 may include the stationary seal-forming structure 3100 being held in a fixed position so as to be in contact with the patient's face or within the patient's nostrils, while the chassis portion may move relative to the seal-forming structure 3100 and the user's face. Advantageously, this may at least partially decouple the seal-forming structure 3100 from the chassis portion 3210, thereby improving stability and sealing, particularly during head movement.

[0303] For example, the high flexibility of the membrane portion 3220 supporting the nasal pillow, generated by the thin thickness and material of the membrane portion 3220, can create a cushion that is highly resistant to the transmission of destructive forces from structural components / parts (such as the chassis portion 3210, as well as the positioning and stabilizing structure 3300) through the nasal pillow. Most or all of the destructive forces expected to be absorbed by the chassis portion 3210 during use of the patient interface 3000 can be absorbed by the membrane portion 3220, and the transfer of such forces to the nasal pillow can be prevented.

[0304] In some examples, the membrane portion 3220 may be constructed and positioned to at least partially decouple the movement of the nasal pillows from one another. In particular, the membrane portion 3220 may be constructed and positioned to allow each nasal pillow to move and align with each of the patient's nostrils during use. The membrane portion 3220 may be constructed and positioned to stretch and / or bend, allowing each nasal pillow to move and align with each of the patient's nostrils before pressure is applied. This allows the nasal pillows to easily fit a wide range of patient noses and / or withstand uneven mask setups. Furthermore, destructive forces, particularly during movement or lateral sleeping, can cause asymmetrical loading of the nasal pillows. The membrane portion 3220 may be configured to withstand uneven loading by decoupling the nasal pillows from each other and keeping each nasal pillow in a sealed position.

[0305] The membrane portion 3220 may be constructed and positioned to be flexible to provide the effects described herein, for example, by being thin and not held so tightly that it cannot move or deform. For example, the membrane portion 3220 may be formed from one or more thin layers of material and held so that it can be deformed to allow relative movement between the seal-forming structure 3100 and the chassis portion 3210. The chassis portion 3210, formed from a flexible material, such as an elastomer such as silicone or TPE, may also be advantageous in the deformation of the membrane portion 3220, and as a result the chassis portion 3210 may be movable relative to the nose pillow. In some examples, the chassis portion 3210 may be bendable, so that the boundary of the membrane portion 3220 moves when the chassis portion 3210 is bent, which may allow for further changes in the shape of the membrane portion 3220, in addition to the bending, stretching, and expanding capabilities of the membrane portion 3220 alone.

[0306] In some examples, the membrane portion 3220 may be constructed and positioned to expand when the plenum chamber 3200 is pressurized to a therapeutic pressure during use. The membrane portion 3220 may also be stretchable, and in some examples, it may be constructed and positioned to expand and contract during expansion when the plenum chamber 3200 is pressurized to a therapeutic pressure during use. In some examples, the membrane portion 3220 may be formed from a stretchable material (for example, a material that can expand and contract during expansion when the plenum chamber 3200 is pressurized to a therapeutic pressure during use).

[0307] In some examples, the membrane portion 3220 may be structured and arranged to be taut when there is no therapeutic pressure within the plenum chamber 3200. In such examples, the membrane portion 3220 may expand and contract during inflation (e.g., balloon-shaped) to have a larger surface area than when at rest when there is no pressure within the plenum chamber 3200. In other examples, the membrane portion 3220 may not be taut (e.g., loose / floppy), may be taut during inflation, and then expand and contract while further expanding.

[0308] As will be described in more detail below, the membrane portion 3220 does not have to be formed into a three-dimensional shape (for example, it may be formed as a sheet). Due to the lack of a predetermined three-dimensional shape, the membrane portion 3220 has little or no inherent bias to return to a predetermined shape, thus allowing for a large amount of movement of the nose pillow or other seal-forming structure 3100 for setup and disconnection purposes.

[0309] In an example of the present technology (for example, the example shown in Figures 18 to 20) in which the membrane portion 3220 partially forms both the nasal portion and the oral portion of the plenum chamber 3200, at least a portion of the membrane portion 3220 forming the nasal portion of the plenum chamber 3200 (which can be identified as the nasal portion of the membrane portion 3220) may be inflated in the manner described above. Alternatively or additionally, in an example in which the seal-forming structure 3100 includes a nasal portion 3101 and an oral portion 3102, a portion of the membrane portion 3220 supporting the nasal portion 3101 of the seal-forming structure 3100 may be inflated in the manner described above.

[0310] [5.3.5.6.1 Pressurizing the Plenum Chamber] Figures 7 to 11 show the patient interface 3000 before it is worn by the patient. As shown, the membrane portion 3220 is stretched taut to the extent that it is virtually wrinkle-free and fold-free. Figures 12 and 13 show the patient interface 3000 of Figures 7 to 11 when worn by the patient. In Figure 12, the plenum chamber 3200 is not pressurized, and in Figure 13, the plenum chamber 3200 is pressurized. Several aspects and behaviors of the patient interface 3000 shown in Figures 7 to 11 are described below with reference to Figures 12 to 13, but unless otherwise required by context, the described aspects and behaviors should be understood to be applicable to the patient interface 3000 shown in Figures 14 to 17, Figures 18 to 20, Figures 21 to 24, and Figures 25 to 46.

[0311] Figure 12 shows the patient interface 3000 worn by the patient but before the plenum chamber 3200 is pressurized. Before pressurization, the membrane portion 3220 may form on the bottom surface of the patient's nose and / or upper lip, for example, on the bottom surface of the patient's nasal tip as shown in Figure 12. Because the plenum chamber 3200 is not pressurized, the patient's nose, pressed against the membrane portion 3220, forms wrinkles in the membrane portion 3220 on the anterior-upper side of the plenum chamber 3200. At this point, the nasal pillow is held in place by the elastic force (e.g., spring return force) from the membrane portion 3220.

[0312] As shown in Figure 12, the membrane portion 3220 has an anterior edge (for example, the foremost boundary of the membrane portion 3220 to which the membrane portion 3220 is attached to the chassis portion 3210) that is spaced apart from the patient's nose. This space apart from the patient's nose or from the posterior superior side of the plenum chamber 3200 can be considered the "depth" of the anterior portion of the membrane portion 3220. The depth provides space for the patient's nose to be pressed into the membrane portion 3220 and causes compression of the anterior portion of the membrane portion 3220 during setup. The depth of the membrane portion 3220 in this region may be chosen so that the patient can tighten the headgear and their nose is pressed into this region, but not to the extent that their nose touches the chassis portion 3210.

[0313] Figure 13 shows the patient interface 3000 worn by the patient with the plenum chamber 3200 pressurized. As shown, the wrinkles within the membrane portion 3220, which were visible in Figure 12 before pressurization due to the membrane portion 3220 expanding and contracting (e.g., inflating like a balloon), are no longer directly below / in front of the patient's nose. This causes the frustoconical sealing portion (the part of the seal-forming structure) of the nasal pillow to embed / embed into the patient's nostrils. The pressure within the plenum chamber 3200 continues to press the pillow during use, providing a mask with a firm seal. The inflatable nature of the membrane portion 3220 can bias the nasal pillow toward each nostril for a good and stable seal during use, and as a result, the patient interface 3000 becomes virtually "self-adjusting".

[0314] The expansion of the membrane portion 3220 may favorably contribute to biasing the seal-forming structure 3100 toward the patient's face. In the examples shown in Figures 7 to 24, the membrane portion 3220 may be constructed and positioned to expand upon use, biasing each nasal pillow toward each of the patient's nostrils. This may favorably promote a good seal between each nasal pillow and each nostril.

[0315] In some examples, the membrane portion 3220 may be constructed and positioned to expand upon use to conform to one or more portions of the patient's nose. This allows for effective customization of the fit, resulting in patient comfort and a good seal by enveloping the patient's nose (e.g., the base of the nose) and distributing the sealing force. As previously mentioned, the membrane portion 3220 may conform to the patient's nasal tip. The membrane portion 3220 may conform to the downward-facing surface of the patient's nasal tip. In some examples, the membrane portion 3220 may be configured not to cover the anterior portion of the patient's nasal tip. This may advantageously provide an unobtrusive patient interface 3000. In some examples, the membrane portion 3220 may be configured to conform to the downward-facing surface of the patient's nasal ala. The effect of the membrane portion 3220 inflating like a balloon to seal the lower surface of the patient's nose and the patient's upper lip (described below), along with the ability of the thin membrane portion 3220 to conform to the patient's facial morphology, can favorably distribute force to the patient's nose and face over a wide area, thereby reducing the risk of areas of high contact pressure and potentially providing comfort during use.

[0316] The expansion of the membrane portion 3220 can also help maintain a good seal during use, for example, during movement of the patient's head, or when the patient interface 3000 is subjected to destructive forces such as tube traction or force due to contact between the patient interface 3000 and the patient's pillow or mattress. In particular, referring to the examples shown in Figures 7 to 24, the membrane portion 3220 is constructed and positioned to resist the nasal pillow separating from the patient's nostrils when the chassis portion 3210 moves during use. In some examples, the geometric orientation of the conical seal relative to the pressurized membrane ensures that the conical seal locks into the nostrils.

[0317] The membrane portion 3220 may be configured to engage with the patient's upper lip during use. In some examples, this may provide additional support, stability, and / or sealing to complement the seal-forming structure 3100. In some examples, this may provide a comfortable and stable fit (e.g., by distributing the load over a wide area). The chassis portion 3210 may be configured not to engage with the patient's lower lip during use, which may be uncomfortable. The chassis portion 3210 may have a sufficiently small and / or inconspicuous shape so that the membrane portion 3220 does not come into contact with the lower lip during use. A small and / or inconspicuous chassis portion 3210 may provide an unobtrusive patient interface 3000. Furthermore, the chassis portion 3210 may be configured not to engage with the patient's upper lip during use. In other words, in some cases, the membrane portion 3220 may come into contact with the patient's upper lip, but the chassis portion 3210 may not.

[0318] In some cases, the membrane portion 3220 does not come into contact with the patient's face other than the patient's nose and upper lip during use. The membrane portion 3220 cannot come into contact with the patient's cheek during use. In some cases, the membrane portion 3220 cannot come into contact with the patient's nasolabial fold during use. In some cases, the membrane portion 3220 cannot come into contact with the outward-facing side of the patient's nose during use. The membrane portion 3220 cannot come into contact with the patient's nasal bridge during use.

[0319] In some cases, the chassis portion 3210 does not come into contact with the patient's face during use. In some cases, the chassis portion does not come into contact with the patient's cheek during use. In some cases, the chassis portion does not come into contact with the patient's nasolabial fold during use.

[0320] [5.3.5.6.2 Textile membrane portion] In some examples of this technology, the membrane portion 3220 is formed at least partially from a textile material, such as a woven fabric. The textile material can advantageously provide a membrane portion 3220 having a surface that is comfortable when in contact with the patient's face. In the examples described with reference to Figures 7 to 67, the membrane portion 3220 includes a textile layer and an air-impermeable layer. The textile layer may include a woven fabric, and the air-impermeable layer may include, for example, a polymer film. In some examples, the air-impermeable layer may be formed from silicone. In some examples, the membrane portion 3220 may be formed from an air-impermeable film flocked with a textile material. Advantageously, the use of a textile material during the formation of the membrane portion 3220 allows the membrane portion 3220 to be sufficiently stretchable (at least during its usable life) while still being sufficiently tear-resistant, so as to be able to stretch and contract without tearing during expansion when the plenum chamber 3200 is pressurized. As illustrated in Figures 7 to 13, the textile layer provides the outer surface of the membrane portion 3220. That is, the textile layer may be outside the plenum chamber 3200, and in the example of Figures 7 to 13, it may be outside the cushion module 3150. In some examples, if the textile material of the membrane portion 3220 is sufficiently air-impermeable, an additional sealing layer may not be included.

[0321] In some examples, the knit stitch of the textile material of membrane portion 3220 may be a single jersey weft knit. In other examples, the textile material may include an alternative knit stitch (in some examples, a tricot knit).

[0322] The textile material may contain one or more synthetic fibers. In some examples, the textile material may contain 80% polyamide and 20% elastane. Elastane can advantageously provide high stretchability / elasticity. The elastane content may be in the range of 5% to 20%, 10% to 20%, or 5% to 15% in some examples. In some examples, the elastane content of the textile material is 15% or 10%. In some examples, the textile material contains polyester instead of polyamide. Other suitable materials that provide the effect of membrane portion 3220 described herein may also be used.

[0323] In some examples, the textile material is 0.27 mm thick. The membrane portion 3220 may include an airtight silicone lining with a thickness of approximately 0.03 mm, resulting in an overall thickness of 0.3 mm. In some examples, the weight of the textile material may be 105 gsm.

[0324] In some examples, the textile material is provided to a patient interface 3000 having a wale that generally runs vertically during use and a course that runs outward during use. The textile material may stretch considerably in the course direction, and the membrane portion 3220 may need to stretch more outward across the patient's face than vertically.

[0325] More generally, one aspect of the present technology is a patient interface 3000 having a chassis portion 3210 including a membrane portion 3220 at least partially formed from a textile material, as illustrated particularly in Figures 7 to 13, wherein a seal-forming structure 3100 of the patient interface 3000 is formed from an elastomer material and supported on the membrane portion 3220. In the example shown in Figures 7 to 13, the chassis portion 3210 includes a textile membrane portion 3220 supporting an elastomer seal-forming structure 3100 in the form of a nasal pillow. The textile surface of the membrane portion 3220 can provide comfortable contact with the face around the patient's airway, and the elastomer material forming the seal-forming structure 3100 can provide a good seal. The textile membrane portion 3220 may also have further advantages with respect to its ability to expand and contract without tearing, as described above.

[0326] Another advantage that may be provided by a configuration including a nasal pillow supported on the plenum chamber 3220, where the membrane portion 3220 is formed at least partially from a textile material and the seal-forming structure 3100 is formed from an elastomer material, is that the nasal pillow may be more rigid than the textile membrane portion 3220. Both nasal pillows may help to hold the membrane portion 3220 in a predetermined shape before it expands when the plenum chamber 3200 is pressurized. The nasal pillow may also transfer force to the more flexible membrane portion 3220 during use. The flexibility of the membrane portion 3220 allows the load to be distributed over a wide area on the patient's face (particularly the nose and the bottom of the upper lip), which may result in a comfortable patient interface 3000.

[0327] The textile membrane portion 3220 can be attached to the chassis portion 3210 by molding the chassis portion 3210 to the textile membrane portion 3220 while the textile membrane portion 3220 is supported in the mold. Alternatively, the chassis portion 3210 may be molded separately, and then the textile membrane portion 3220 may be attached to it (for example, by gluing, welding, taping, or other means). Similarly, the nose pillow (or other seal-forming structure) may be molded onto the textile membrane portion 3220, or molded separately and then attached (for example, by gluing or welding).

[0328] [5.3.5.6.3 Elastomer film portion] In other examples of this technology, the membrane portion 3220 may be formed from an elastomer such as silicone or TPE. The elastomer forming the membrane portion 3220 may be sufficiently thin and may have material properties that enable the membrane portion 3220 to function like the textile membrane portion 3220 described herein. Thus, the features of the membrane portion 3220 described with reference to the features provided by the textile membrane portion 3220 described herein should be understood to be applicable to the elastomer / silicone membrane portion 3220 unless otherwise specified in the context, and vice versa. In particular, the silicone membrane portion 3220 may be formed from a suitable silicone material, and may be sufficiently thin to expand while expanding when the plenum chamber 3200 is pressurized during use, while biasing the nasal pillow to engage with the patient's nostrils, and / or while providing relative movement between the nasal pillow and the chassis portion 3210, or between each of the nasal pillows. The silicone film portion 3220 may have a thickness of less than 0.25 mm, for example, 0.2 mm, or less than 0.2 mm, less than 0.15 mm, and in some examples, a thickness in the range of 0.05 mm to 0.2 mm or 0.1 mm to 0.15 mm. The silicone film portion 3220 may be formed from silicone having a durometer hardness in the range of D20 to D40. In some examples, other durometer values, such as durometer values ​​indicating softerness, may also be considered.

[0329] In an example where the membrane portion 3220 is formed from silicone, the membrane portion 3220 may be formed separately from the chassis portion 3210. For example, the membrane portion 3220 may be formed first and placed in a mold, and then the chassis portion 3210 may be injection molded and joined (e.g., bonded) to the membrane portion 3220. Alternatively, the chassis portion 3210 may be molded alone, and then the membrane portion 3220 may be attached to the chassis portion 3210 (e.g., by gluing or welding). In other examples, the membrane portion 3220 may be formed integrally with the chassis portion 3210, for example by molding the membrane portion 3220 and the chassis portion 3210 together in the same molding step, provided that the membrane portion 3220 has a moldable thickness. In some examples, the membrane portion 3220 is formed from silicone and includes a thickness of 0.2 mm. Advantageously, the silicone film portion 3220 having a thickness of 0.2 mm may have high elasticity, can be molded together with the chassis portion 3210, and may be sufficiently tear-resistant.

[0330] As described elsewhere in this specification, in some examples, the membrane portion 3220 is formed from an elastomer but not in a predetermined three-dimensional shape. The membrane portion 3220 does not need to have a bias toward a predetermined shape. This can provide a highly flexible membrane portion 3220 that can be advantageous for setup (allowing the nose pillow or other seal-forming structure 3100 to move and produce a good seal) and decoupling (allowing some destructive movement of the chassis portion 3210 relative to the nose pillow or other seal-forming structure 3100, instead of transmitting destructive movement to the nose pillow).

[0331] [5.3.5.6.4 Geometry and other aspects of the plenum chamber] As described above, the chassis portion 3210 and the membrane portion 3220 may form a plenum chamber 3200. The plenum chamber 3200 may include a rear-upper facing side, configured to face rearward and upward when in use. In examples of the art in which the patient interface 3000 includes an oral cavity portion, the rear-upper facing side described herein may be part of the nasal portion of the plenum chamber 3200. A seal-forming structure 3100 (or possibly the nasal portion of the seal-forming structure 3100), such as a nasal pillow of the patient interface 3000 shown in Figures 7 to 24, may be provided on the rear-upper facing side. The seal-forming structure 3100 may be provided on the rear-upper facing side such that it faces rearward and upward when in use, enabling it to engage with the anterior and posterior surfaces of the patient's nose when in use. The membrane portion 3220 and the seal-forming structure 3100 may form the majority of the rear-upper facing side of the plenum chamber 3200. As illustrated in Figures 7 to 24, the membrane portion 3220 and the seal-forming structure 3100 form substantially the entire side facing the rear upper side.

[0332] The plenum chamber 3200 may include an anterior-superfacing side, configured to face forward and upward when in use. In examples of the art in which the patient interface 3000 includes an oral portion, the posterior-superfacing side described herein may be part of the nasal portion of the plenum chamber 3200. As illustrated in Figures 7 to 24, the membrane portion 3220 may form a large portion of the plenum chamber 3200, or possibly the anterior-superfacing side of its nasal portion. The membrane portion 3220 may extend from the posterior-superfacing side to the anterior-superfacing side. The plenum chamber 3200 may include a curved boundary where the membrane portion 3220 intersects with the chassis portion 3210 on the anterior-superfacing side.

[0333] The plenum chamber 3200 may further include a rear-lower facing side, configured to face the rear and lower sides when in use. As illustrated in Figures 7–17 and 21–24, the membrane portion 3220 may form the majority of the rear-lower facing side of the plenum chamber 3200 (or possibly its nose portion). The membrane portion 3220 may extend from the rear-upper facing side to the rear-lower facing side. The plenum chamber 3200 may include a curved boundary where the membrane portion 3220 intersects with the chassis portion 3210 on the rear-lower facing side.

[0334] In the example of this technology shown in Figures 18 to 67, the plenum chamber 3200 may not include a side facing posteriorly downward within the nasal portion, as the side facing posteriorly upward of the plenum chamber 3200 that supports the nasal pillow may be adjacent to and above the oral cavity portion of the seal-forming structure 3100, which is also formed by the membrane portion 3220. A portion of the membrane portion 3220 that forms the oral cavity portion of the seal-forming structure 3100 may be identified as the oral cavity portion of the membrane portion 3220. Since the oral cavity portion of the seal-forming structure 3100 is configured to seal the patient's face around the patient's mouth, the oral cavity portion of the membrane portion 3220 may be configured to face substantially backward during use, and in this example, the oral cavity portion is an extension of the membrane portion 3220 that extends backward to the rear of the cushion module 3150.

[0335] In some examples of this technology, such as those illustrated in Figures 7 to 13, the chassis portion 3210 forms the majority of the front-lower side of the plenum chamber 3200, which is configured to face the front and bottom sides when in use. In this example, the chassis portion 3210 includes a hole configured to receive a ventilation module 3410, which includes a ventilation section 3400. The chassis portion 3210 may be stretch-fitted around the ventilation module 3410, thereby allowing the ventilation module 3410 to be inserted into the hole in the chassis portion 3210.

[0336] In some examples, the chassis portion 3210 and the membrane portion 3220 may each provide approximately half of the surface area of ​​the cushion module 3150.

[0337] In some cases, the front-upper side of the plenum chamber 3200, or at least a portion thereof, is substantially planar in the resting position. Similarly, the rear-down side of the plenum chamber 3200, or at least a portion thereof, may be substantially planar in the resting position. The front-upper side of the plenum chamber 3200, or at least a portion thereof, may be substantially parallel to the rear-down side of the plenum chamber 3200, or at least a portion thereof.

[0338] In some examples, the rearmost portion of the nasal pillow is positioned at a distance from the rearmost portion of the membrane portion 3220 when in use. Substantially all of the membrane portion 3220 may be located on the front lower side of the nasal pillow. The membrane portion 3220 does not have to extend rearward beyond the tip of the nasal pillow, and in some examples, it does not have to extend rearward beyond the base of the nasal pillow.

[0339] In some examples, the cushion module 3150 (or possibly the nasal cushion module 3160) of the patient interface 3000 does not include an outer upper portion of the nasal pillow that contacts the face. The cushion module 3150 may contact the nose and upper lip, but not, for example, the patient's cheek or nasolabial fold. The patient interface 3000 may be constructed and / or arranged such that the nasal pillow is positioned within the patient's nostril without the support portion of the cushion module 3150 that contacts the patient's cheek. In the examples illustrated herein, the membrane portion 3220 bends and / or expands to provide a reaction force that resists the separation of the nasal pillow from the patient's nostril after it has entered the nostril. Pressure within the plenum chamber 3200 also acts on the membrane portion 3220 to push the nasal pillow into the nostril. Furthermore, in examples where the patient interface 3000 includes a conduit headgear, the gas delivery tube 3350 can be bent to completely enclose the flexible cushion module 3150 toward the nose, which helps prevent the nasal pillow from separating from the nostrils.

[0340] In some embodiments of this technology, the membrane portion 3220 does not have to have a predetermined three-dimensional shape if there is no positive pressure relative to the air pressure inside the plenum chamber 3220. In some examples of this technology, the nose pillow is supported on a membrane portion 3220 that is not molded into a predetermined shape. In some examples, the membrane portion 3220 does not have to be formed into a predetermined shape by injection molding. In some examples, the membrane portion 3220 can be formed by a process other than molding (e.g., calendering). The membrane portion 3220 does not have to include a predetermined three-dimensional shape; that is, the membrane portion 3220 can be formed so as not to be biased into a predetermined shape. For example, the membrane portion 3220 can be manufactured in sheet form and thus can take the form of a sheet. In particular, the membrane portion 3220 can take the form of a sheet connected to the chassis portion 3210 at its edges (e.g., after the membrane portion 3220 has been cut to a shape and size that fits the edges of the chassis portion). The absence of a predetermined three-dimensional shape may reduce the restrictions on the movement of the nasal pillow in particular. As discussed elsewhere in this specification, the membrane portion 3220 may also be sheet-like and loose, and / or may be structured in a way that does not support itself in a predetermined three-dimensional shape.

[0341] The membrane portion 3220 is a thin sheet without other pre-formed geometric shapes (e.g., a thin silicone or textile membrane), which may allow the nasal pillow to freely conform to the geometric shape of the patient's nose. On the other hand, a membrane portion 3220 that is molded into a certain shape may resist deformation from that shape, which may limit the ability of the pillow to move to conform to the patient's nose. The nasal pillow may be able to move in a less restrictive manner when the membrane portion 3220 is not molded into a certain shape than when the membrane portion 3220 is molded into a certain shape. In particular, the nasal pillow may be able to dangle better around its base and move more significantly up and down along its axis. Furthermore, the lack of a molded shape in the membrane portion 3220 means that the nasal pillow is not molded to a certain orientation relative to the cushion module 3150. Moreover, a membrane portion 3220 that is not molded into a certain shape may allow the nasal pillow to have a larger range of motion. This allows the nose pillow to move very freely relative to the chassis portion 3210, which may help the nose pillow withstand destructive forces during use.

[0342] In some examples, the nasal pillows are not molded together. Each nasal pillow may be molded separately. Even if the nasal pillows are molded together, they may be separated from each other (e.g., by cutting) when attached to the membrane portion 3220. This is advantageous for uncoupling the nasal pillows from each other. In some examples, the nasal pillows are attached to the membrane portion 3220 such that they are not tilted toward each other in a resting state before the plenum chamber 3200 is pressurized.

[0343] In some cases, the membrane portion 3220 expands to a convex shape (for example, with a convex outer surface) when the plenum chamber 3200 is pressurized. This can help bias the nasal pillow toward the patient's nostrils and maintain continuous seal adjustment. Part or all of the membrane portion 3220 may become concave due to the presence of the patient's nose and face resisting this expansion, so that the nasal pillow is restrained and / or conforms to the patient's nose and upper lip.

[0344] In some cases, the cushion module 3150 (or possibly the nasal cushion module 3160) may not have a rigid frame. The absence of a rigid frame allows the sides of the cushion module 3150 to be at least partially disconnected from each other, thereby allowing the cushion module 3150 to adapt to a specific patient as needed and provide a good seal, and allowing the cushion module 3150 to withstand destructive forces.

[0345] [5.3.5.6.5 Membrane portion that forms seal-forming structure] In some cases, the membrane portion 3220 may form one or more parts of the seal-forming structure 3100. For example, the membrane portion 3220 may form the oral cavity portion of the seal-forming structure 3100.

[0346] In the examples shown in Figures 18 to 20, the seal-forming structure 3100 includes a nasal portion 3101 and an oral portion 3102. The nasal portion 3101 of the seal-forming structure 3100 includes a nasal pillow supported on a membrane portion 3220, and the oral portion 3102 of the seal-forming structure 3100 is formed by the membrane portion 3220. The patient interface 3000 shown in Figures 25 to 46 also has this configuration. The patient interface 3000 shown in Figures 47 to 67 also has a nasal portion and an oral portion, but in these examples, the patient interface 3000 does not include a nasal pillow; instead, the membrane portion 3220 provides both the nasal portion 3101 and the oral portion 3102 of the seal-forming structure 3100.

[0347] Referring to Figures 18 to 20, the membrane portion 3220 may include a nasal portion that forms part of the membrane portion 3220 supporting the nasal pillow (or another part of the seal-forming structure 3100 that forms a seal and provides airflow to the patient's nostrils, such as the cradle in some examples), and the membrane portion 3220 may further include an oral portion that forms the oral portion of the seal-forming structure 3100.

[0348] The membrane portion 3220 (for example, one or both of the nasal and oral portions of the membrane portion 3220) may be sheet-like. This can be by taking the form of a sheet of material. The sheet-like membrane portion 3220 may be substantially flat in some examples. In some examples, the membrane portion 3220 may not necessarily be perfectly flat, but may be sheet-like in the sense that it is generally flat and formed to resemble a sheet with a width and length much greater than its thickness. The membrane portion 3220 may have a uniform thickness. The sheet-like membrane portion 3220 may be formed by a sheet production process such as calendering, or by molding.

[0349] In some examples, when there is no positive pressure in the plenum chamber 3200, the membrane portion 3220 is loose. In some examples, the membrane portion 3220 may be constructed in a way that it cannot support itself in a predetermined three-dimensional shape. The membrane portion 3220 may be flimsy but can be held in place by its connection to the chassis portion 3200. In some examples, the membrane portion 3220 may not have a predetermined three-dimensional shape. The membrane portion 3220 may be constructed in a way that is not biased towards a predetermined three-dimensional shape. A membrane portion 3220 that lacks a predetermined shape and / or is so flexible that it cannot support itself in a predetermined shape may be particularly advantageous in disconnecting the nasal portion 3101 of the seal-forming structure 3100 from the chassis portion 3210 and / or fitting or conforming the nasal portion 3101 of the seal-forming structure 3100 to the patient's face.

[0350] The membrane portion 3220 may include a sealing flange that forms the oral portion 3102 of the seal-forming structure 3100. The upper portion of the sealing flange is formed integrally with the nasal portion of the membrane portion 3220 in the examples shown in Figures 18-20 and 25-46. More generally, a portion of the membrane portion 3220 that supports the nasal pillow is formed integrally with a portion of the membrane portion 3220 that forms the oral portion 3102 of the seal-forming structure 3100. The nasal portion of the membrane portion 3220 is formed integrally with the oral portion of the membrane portion 3220. The nasal portion of the membrane portion 3220 may also seal the patient's nose and / or the face adjacent to the nose, in addition to the nasal pillow, to form a seal.

[0351] The oral portion 3102 of the seal-forming structure 3100 may include a sealing flange configured to form a seal around the patient's mouth, sealing the patient's upper lip, lower lip, and cheek, and defining an oral opening to the plenum chamber 3200. The sealing flange is formed by a membrane portion 3220 in the examples shown in Figures 18-20 and 25-46. The membrane portion 3220 is connected to and supported by a chassis portion 3210. The periphery of the sealing flange formed by the membrane portion 3220 is supported by the chassis portion 3210 on the outside and underside of the sealing flange. The inner periphery of the sealing flange formed by the membrane portion 3220 is not constrained to conform well to the shape of the patient's face around the patient's mouth.

[0352] The sealing flange may include a curved cross-section at one or more positions around the oral opening, for example, on the upper lip and / or chin, so that the convex surface contacts the patient's face before conforming to the surface of the patient's face. In some examples, the cross-section of the sealing flange may be convex at the patient's cheek. In other examples, it may be substantially flat. The curved cross-section may provide a pressure-assisted seal to contact the patient's face, thereby helping the therapeutic pressure within the plenum chamber 3200 to hold the sealing flange in contact with the surface of the patient's face. The sealing flange formed by the membrane portion 3220 may be joined to the chassis portion 3210 so that the chassis portion 3210 does not come into contact with the patient's face during use. For example, the seam between the chassis portion 3210 and the membrane portion 3220 in the oral portion of the plenum chamber 3200 may be positioned at a distance from the patient's face during use.

[0353] In the examples shown in Figures 18 to 20, the membrane portion 3220 may be formed from a textile material (e.g., by an airtight silicone layer) as described elsewhere in this specification, or from a thin silicone (e.g., about 0.2 mm in some examples), or from another elastomer such as TPE.

[0354] Figures 25 to 46 show further examples of the patient interface 3000, including a cushion module 3150 having a membrane portion 3220 that forms the oral portion 3102 of the seal-forming structure 3100. These examples are described in more detail below.

[0355] In several examples, including those shown in Figures 25 to 46, the chassis portion 3210 may be flexible to at least partially disengage the membrane portion 3220 from destructive forces applied to the chassis portion 3210 during use. These destructive forces may include forces that could adversely affect the seal formed between the seal-forming structure 3100 and the patient's face, such as tube traction or force applied to the patient interface 3000 by the patient's pillow / bed during lateral sleep. Despite some flexibility providing this disengagement effect, the chassis portion 3210 possesses sufficient stiffness to support the membrane portion 3220.

[0356] In some examples, the chassis portion 3210 may be formed at least partially from a textile material, and may be a thick, somewhat rigid textile material capable of supporting its own shape, such as breathoprene. For example, the chassis portion 3210 may be formed from breathoprene with a thickness of 2.5 mm. In other examples, the chassis portion 3210 may be formed from a polymer material (flexible by its thinness and geometry). Such a polymer material may be substantially rigid in thicker portions, but the chassis portion 3210 is thin enough so that the material can at least partially absorb destructive forces by deformation. The chassis portion 3210 may be flexible to absorb destructive forces, but it has sufficient stiffness to support its own shape and support the membrane portion 3220 during use.

[0357] In the examples illustrated in Figures 25 to 46, the chassis portion 3210 is formed from Mylar. The Mylar material may have a thickness in the range of 0.2 mm to 0.5 mm, for example, 0.25 mm. In other examples, the chassis portion 3210 may be formed from polycarbonate having a thickness in the range of 0.4 to 1 mm (for example, in the range of 0.5 to 0.75 mm). The chassis portion 3210 may include a molded shell or a vacuum-formed (and cut to size as needed) sheet. In other examples, the chassis portion 3210 may be formed from an elastomer material such as silicone or TPE.

[0358] In the examples shown in Figures 25 to 46, the chassis portion 3210 is shaped to curve from one outer side of the patient's face to the other outer side of the patient's face when in use. The chassis portion 3210 may be substantially flush with the patient's cheek on each outer side. For example, as shown in Figure 29, on both outer sides of the patient's face, the chassis portion 3210 is substantially flush with the patient's cheek, and for example, a line along the curvature of the chassis portion 3210 is substantially aligned with the surface of the patient's cheek. This flush relationship helps the patient interface 3000 maintain an inconspicuous appearance and / or may provide better lateral sleeping compared to when the sides of the chassis portion 3210 protrude above the patient's cheek. The patient interface 3000 shown in Figures 40 to 46 (described in further detail below) also has this structure and curvature of the cushion module 3150, which helps prevent destructive forces, especially during lateral sleeping.

[0359] The chassis portion 3210 can be substantially hyperbolic paraboloid in shape. The membrane portion 3220 can also be substantially hyperbolic paraboloid in shape. In the examples shown in Figures 25 to 46, the chassis portion 3210 and the membrane portion 3220 are each hyperbolic paraboloid in shape. It should be understood that the chassis portion 3210 and the membrane portion 3220 can each be hyperbolic paraboloid in shape despite the presence of one or more parts or features that do not form part of the hyperbolic paraboloid shape. The chassis portion 3210 and the membrane portion 3220 can be substantially hyperbolic paraboloid in shape, rotated 90 degrees relative to each other, and joined together around their edges. In some examples, one or both of the chassis portion 3210 and the membrane portion 3220 can be substantially parabolic in shape. That is, in some examples, the chassis portion 3210 and / or the membrane portion 3220 may have a parabolic shape in their undeformed state before being worn by a patient, although they may be as described elsewhere in this specification. In further examples, the chassis portion 3210 and / or membrane portion 3220 may have shapes other than hyperbolic parabolas or parabolic columns.

[0360] For example, the membrane portion 3220 may have a curvature in the sagittal plane that curves upward from the chin region of the patient's face toward the patient's nose, and then forward, in orientation during use and before engaging with the patient's face. After the patient interface 3000 is worn and the membrane portion 3220 engages with the patient's face, its shape has a more complex curvature to conform to the contours on the surface of the patient's face.

[0361] In a plane perpendicular to the sagittal plane (e.g., a horizontal plane, or a plane oriented from the rear-upper to the front-downper), in the orientation for use, the membrane portion 3220 does not need to have curvature before engaging with the patient's face because it is held sufficiently taut by the chassis portion 3210. After the patient wears the patient interface 3000 and the membrane portion 3220 engages with the patient's face, the membrane portion 3220 may conform to the geometry of the patient's face, curving forward from one outside of the patient's face along one of the patient's cheeks, then inward toward the sagittal plane of the user's head, then outward along the other of the patient's cheeks to the other outside of the patient's face, and then backward. In the same plane, the chassis portion 3210 may also curve forward from one outside of the patient's face along one of the user's cheeks, then inward toward the sagittal plane, and then outward and backward along the other of the user's cheeks to the other outside of the patient's face.

[0362] [5.3.5.6.6 Connecting the cushion module to the positioning and stabilization structure] Figures 25 to 46 show patient interfaces 3000 according to further examples of the present technology. In these examples, the patient interface 3000 has various forms of the positioning and stabilization structure 3300. All patient interfaces 3000 shown in Figures 25 to 46 not only have a membrane portion 3220 that forms the oral portion 3102 of the seal-forming structure 3100, but also include a cushion module 3150 that supports a nasal pillow that forms the nasal portion 3101 of the seal-forming structure 3100. The membrane portion 3220 may be as previously described with reference to Figures 18 to 20. The positioning and stabilization structure 3300 described with reference to Figures 25 to 46, and the manner in which the cushion module 3150 connects to the positioning and stabilization structure 3300, should be understood to be applicable to other examples of the present technology, such as patient interfaces 3000 having separate nasal cushion modules 3160 and oral cushion modules 3170, unless otherwise required in context. Similarly, any feature of the cushion module 3150 described with reference to Figures 25 to 46 should be understood to be applicable to the patient interface 3000 having an alternative positioning and stabilizing structure 3300.

[0363] The patient interface 3000 shown in Figures 47 to 67 has several similarities and differences to the positioning and stabilization structure 3300 shown in Figures 25 to 46. It should be understood that the aspects of the positioning and stabilization structure 3300 described with reference to Figures 25 to 46 can be applied to the aspects shown in Figures 47 to 67, and vice versa, unless otherwise clearly required in the context.

[0364] Figures 25 to 30 show a patient interface 3000 according to an example of this technology. Figures 27 to 29 show the patient interface 3000 in use with a patient, along with a positioning and stabilization structure 3300.

[0365] In this example, the positioning and stabilization structure 3300 includes a pair of upper straps 3316. Each upper strap 3316 is configured to be positioned on each side of the patient's head, above each superior base point of the patient's head. In this example, the patient interface 3000 includes a pair of upper arms 3311 connected to the chassis portion 3210. Each upper arm 3311 is configured to be attached to each of the upper straps 3316 as shown in Figures 27 to 29. In this example, each upper arm 3311 extends upward and backward relative to the chassis portion 3210. The upper arms 3311 may also extend outward relative to the chassis portion 3210. The upper arms 3311 may be flexible in one or more directions but rigid to bend in one or more other directions. For example, the upper arms 3311 can be bent inward and outward to accommodate variations in the patient's head size. However, the upper arm 3311 may be constructed to resist bending in the vertical direction, which may help translate the force vector from the upper strap 3316 to the seal-forming structure 3100. In some examples, the upper arm 3311 is overmolded onto the chassis portion 3210. In other examples, the upper arm 3311 may be formed separately and then mechanically connected to the chassis portion 3210 (e.g., by a snap-fit ​​connection).

[0366] Each upper arm 3311 provides an upper headgear connection point to which the strap portion of the positioning and stabilizing structure 3300 can be connected. Each upper arm 3311 may include an upper headgear connection point at its end in the form of an opening (e.g., an eyelet or slot). In the example shown in Figures 25 to 30, each upper strap 3316 of the positioning and stabilizing structure 3300 passes through an opening in each upper arm 3311, wraps around to the rear, and is secured to itself, for example, by a hook-and-loop connection.

[0367] In the examples shown in Figures 25 to 30, the chassis portion 3210 is flexible (but has sufficient rigidity to support the membrane portion 3220 and effectively transmit the sealing force vector). In this example, the chassis portion 3210 may be formed from Mylar. More specifically, the chassis portion 3210 may be flexible enough to bend in the horizontal plane (for example, the chassis portion 3210 can be deformed so that its outer surfaces move closer together or further apart from each other), but its geometry may prevent it from bending in the vertical plane.

[0368] The chassis portion 3210 may include one or more wires extending from one outer side to the other outer side of the chassis portion 3210, and by adjusting the shape of the wires, the shape of the chassis portion 3210 (such as curvature or width) can be selectively adjusted. In particular, as shown in Figure 25, the chassis portion 3210 includes a pair of wires extending from one outer side to the other outer side of the chassis portion 3210. In this example, the wires connect the positions where the upper arm 3311 connects to the chassis portion 3210. In other examples, the wires may be positioned so that their ends do not coincide with the ends of the upper arm 3311. More generally, the wires may be plastically deformable elements 3266, as described with reference to, for example, Figure 48.

[0369] In further examples, the wire may be omitted. The chassis portion 3210 may be flexible enough to adjust its shape during use without the user selectively adjusting its shape using the wire. In some examples, the upper arm 3311 and the wire may be constructed together as an assembly and then attached to the chassis portion 3210. The patient or their clinician may selectively adjust the shape of the chassis portion 3210 by plastically deforming the wire to achieve a good fit of the patient interface 3000 to the patient's specific anatomical structure. The flexibility of the chassis portion 3210 may also allow for at least partial isolation of lateral forces from the seal-forming structure 3100, such as destructive forces that may occur during lateral sleep, when the chassis portion 3210 is pressed against a pillow.

[0370] The upper arm 3311 of the patient interface 3000, shown in Figures 25 to 30, has an inconspicuous shape relative to the chassis portion 3210, for example, being nearly flush with the external surface of the chassis portion 3210. As previously mentioned, in this example, the chassis portion 3210 is constructed to be flush with the surface of the user's cheek when in use in order to maintain an inconspicuous shape. The upper arm 3311 is also nearly flush with the external surface of the chassis portion 3210, and as a result, the cushion module 3150 as a whole maintains an inconspicuous shape relative to the patient's face. The upper arm 3311 and the chassis portion 3210 are designed so that, when worn, the patient interface 3000 fits flush with the cheek and then follows the triangular shape of the nose. The final shape produces a smooth, rounded, compact mask volume below the nose and in front of the mouth. This shape can advantageously facilitate lateral sleeping during use. Advantageously, the cushion module 3150 does not have the shoulder feature adjacent to the side of the nose, which would normally cause the cushion module 3150 to tilt sideways during lateral sleeping.

[0371] The positioning and stabilization structure 3300 of the patient interface 3000 shown in Figures 25 to 30 also includes a pair of lower straps 3317, each lower strap 3317 configured to be positioned on each side of the patient's head, below each lower earlobe point on the patient's head. The patient interface 3000 also includes a pair of lower arms 3313 extending from the chassis portion 3210, each lower arm 3313 configured to attach to each of the lower straps 3317. Each lower strap 3317 may be attached to a headgear clip 3315 configured to be releasably attached to each lower arm 3313, for example, via a magnetic connection. As shown in Figure 25, each lower arm 3313 includes a lower headgear connection point 3314, which in this example includes a magnet. Each lower arm 3313 may include a magnet attached to the end portion of the lower arm 3313, for example, by an overmolding and being snugly wrapped around it. The headgear clip 3315 may also include a magnet or a magnetic material. In other examples, each lower headgear connection point 3314 may include magnetic material, and the headgear clip 3315 may include a magnet. In some examples, the lower arm 3313 is overmolded onto the chassis portion 3210. In other examples, the lower arm 3313 may be formed separately and then mechanically connected to the chassis portion 3210 (e.g., by a snap-fit ​​connection).

[0372] In the example shown in Figures 25 to 30, the patient interface 3000 includes a short tube 3610 that is fluidly connected to the chassis portion 3210 at its proximal end. The short tube 3610 includes a connection port 3600 at its distal end that receives airflow or other breathable gases from a conduit of an air circuit 4170 connected to the RPT device 4000 when in use. The patient interface 3000 includes a vent 3400 provided at the connection of the short tube 3610 to the chassis portion 3210 in this example. The connection between the short tube 3610 and the chassis portion 3210 may be a swivel connection that allows the short tube 3610 to rotate relative to the chassis portion 3210, helping to prevent tube traction, and may take the form of an elbow. The short tube 3610 may extend forward and / or downward from the cushion module 3150. The patient interface 3000 also includes an AAV (not shown), which may also be present at the swivel connection.

[0373] Figures 33 to 37 show a patient interface 3000 according to another example of the present technology. In this example, the patient interface 3000 includes a seal-forming structure 3100 of the type described with reference to Figures 18 to 20 and Figures 25 to 30, for example, a nasal portion 3101 of the seal-forming structure 3100 in the form of a nasal pillow, and a membrane portion 3220 that forms an oral portion 3102 of the seal-forming structure 3100. The chassis portion 3210, the membrane portion 3220, and the seal-forming structure 3100 may be as described with reference to the patient interface 3000 shown in Figures 18 to 20. The patient interface 3000 includes a positioning and stabilizing structure 3300 including a pair of upper straps 3316 and a pair of lower straps 3317. In this example, the patient interface 3000 includes a pair of upper arms 3311, each upper arm 3311 configured to attach to each of the upper straps 3316. Each upper arm 3311 may extend upward and rearward relative to the chassis portion 3210.

[0374] In the example shown in Figures 33 to 37, the patient interface 3000 also includes a pair of lower arms 3313 extending from the chassis portion 3210. Each lower arm 3313 is configured to attach to each of the lower straps 3317 of the positioning and stabilization structure 3300. In this particular example, each upper arm 3311 extends from each of the lower arms 3313. The lower arms 3313 extend rearward from the chassis portion 3210, and the upper arms 3311 extend partially upward from the lower arms 3313. Thus, the upper arms 3311 are not directly attached to the chassis portion 3210. This provides a single connection point on each outside of the patient interface 3000 between the positioning and stabilization structure 3300 and the cushion module 3150. In other examples, each lower arm 3313 may extend from each of the upper arms 3311, and on each outer side of the patient interface 3000 there may be a single mounting point between the arms 3311 and 3313 and the chassis portion 3210 (made by the connection of the lower arm 3313 to the chassis portion 3210).

[0375] In the examples shown in Figures 33 to 37, the upper arm 3311 and the lower arm 3313 each include eyelets at their ends, and through these eyelets, the upper strap 3316 or the lower strap 3317 each is wrapped around and secured to itself again, for example, using a hook-and-loop connection. This is the same method of connection between the headgear straps and the arms as previously described with reference to Figures 25 to 30. The upper strap 3316 and the lower strap 3317 each lie on the upper surface of the patient's head when in use, extending downward over both outer sides of the patient's head, across at least the posteriorly facing surface of the patient's head, and connecting to and extending from a crown strap 3318 that connects to the upper strap 3316 and the lower strap 3317. The crown strap 3318 engages with the upper and posterior surfaces of the patient's head, providing anchors to the upper strap 3316 and lower strap 3317, thereby causing the upper strap 3316 and lower strap 3317 to be taut between the cushion module 3150 and the crown strap 3318.

[0376] Figure 38 shows a patient interface 3000 similar to those shown in Figures 33-37, but with a positioning and stabilizing structure 3300 providing an alternative type of connection between the lower strap 3317 and the lower arm 3313. In this example, in the same manner as shown in Figures 33-37, the lower arm 3313 extends from the chassis portion 3210, and the upper arm 3311 extends from the lower arm 3313. However, in Figure 38, the lower strap 3317 includes a headgear clip 3315 configured to be releasably attached to a headgear connection point on the lower arm 3313. The headgear clip 3315 can be magnetically attached to the lower arm 3313 (in the same manner as the lower headgear connection point 3314 illustrated and described above with reference to Figure 25, for example). This may allow for rapid connection and disconnection between the lower strap 3317 and the lower arm 3313, so that when removing the patient interface 3000, the lower strap 3317 can be rapidly disconnected from the lower arm 3313, and when putting it on, it can be rapidly connected. In this example, the patient interface 3000 also includes a crown strap 3318 (from which the upper strap 3316 and the lower strap 3317 extend).

[0377] Figure 39 shows a patient interface 3000 according to another example of the present technology, where the cushion module 3150 includes two headgear connectors on each of its outer sides. In this example, the patient interface 3000 does not include an upper arm 3311. In this example, the cushion module 3150 includes eyelets on each of its outer sides. The eyelets may, in this example, be formed by a portion of the chassis portion 3210 or by a component attached to the chassis portion 3210. Each upper strap 3316 can be wrapped around each of the eyelets provided on the cushion module 3150 and then secured to itself again, for example, using a hook-and-loop connection. The cushion module 3150 also includes a lower arm 3313 to which the lower strap 3317 of the positioning and stabilization structure 3300 can be connected. In this example, the lower strap 3317 includes a headgear clip 3315 configured to be releasably attached to a lower headgear connection point on the lower arm 3313 (which may take the same form as the lower headgear connection point 3314 illustrated and described with respect to Figure 25). In this example, the patient interface 3000 also includes a crown strap 3318 (from which the upper strap 3316 and the lower strap 3317 extend).

[0378] Figures 40–46 show a patient interface 3000 according to another example of the present technology. In this example, the patient interface 3000 includes a cushion module 3150 similar to that described with reference to Figures 33–39. Many features and characteristics of the membrane portion 3220, chassis portion 3210, and undercushion 3225 (described below) are the same as those described with reference to Figures 33–39. However, in this example, the patient interface 3000 includes a positioning and stabilization structure 3300 including a conduit headgear. As shown, the positioning and stabilization structure 3300 includes a pair of gas delivery tubes 3350. The chassis portion 3210 includes a pair of openings configured to connect the gas delivery tubes 3350 to the chassis portion, the openings being sized and constructed to receive an airflow from the gas delivery tubes 3350 at therapeutic pressure for breathing by the patient. The gas delivery tube 3350 is configured to deliver an air supply from a connection port 3600 on the top of the patient's head to a plenum chamber 3200 in a cushion module 3150 defined by a chassis portion 3210 and a membrane portion 3220. The gas delivery tube 3350 may be configured to be disconnected from the chassis portion 3210, for example, for cleaning. Features of the positioning and stabilization structure 3300, which takes the form of a conduit headgear, are described elsewhere in this specification, with reference to, for example, Figures 7 to 13 and Figures 18 to 24.

[0379] In this particular example, the gas delivery tube 3350 includes a textile outer layer. The textile material may be very comfortable for the user, and the appearance of the patient interface 3000 may resemble pajamas rather than a medical device. The gas delivery tube 3350 may be thermoformed into a certain shape, may include a foam inner layer, and may include a sealing layer in the form of a film attached to the inner surface of each gas delivery tube 3350. The outer surface of each gas delivery tube 3350 facing the patient may be substantially flat and wide, which may distribute the force on the patient's head and face over a wide area, providing a comfortable fit.

[0380] In the example shown in Figures 40 to 46, each gas delivery tube 3350 connects to the outside of each cushion module 3150, and in particular to the chassis portion 3210. The chassis portion 3210 defines a pair of plenum chamber inlet ports that allow the plenum chamber 3200 to receive a supply of air at therapeutic pressure for patient respiration. The attachment of the gas delivery tubes 3350 to the chassis portion 3210 contributes to the stability of the patient interface 3000. The gas delivery tubes 3350 function both as conduits for supplying air and as part of the positioning and stabilizing structure 3300, helping to hold the cushion module 3150 in place with good sealing and good stability. In this example, the cushion module 3150 also includes a tight curvature in the chassis portion 3210, which allows the chassis portion 3210 to be highly flexible enough to bend around its vertical centerline, and to easily absorb potentially destructive forces that may be experienced during use, for example, during lateral sleeping.

[0381] As shown in Figure 46, the positioning and stabilizing structure 3300 includes a pair of lower straps 3317 configured to be positioned on each side of the patient's head, below each lower earlobe point of the patient's head; in this example, each lower strap 3317 includes a headgear clip 3315 configured to be releasably attached to the cushion module 3150. The headgear clips 3315 can be attached to the chassis portion 3210 by magnetic connection. As shown in Figures 40, 41, 44, and 45, the cushion module includes a lower arm 3313 having a lower headgear connection point 3314 to which the headgear clips 3315 on the lower straps 3317 are releasably attached. The lower headgear connection point 3314 may be identical to that illustrated and described with reference to Figure 25. In this example, the lower strap 3317 is elastically stretchable so that the positioning and stabilizing structure 3300 can withstand changes in the orientation of the patient's head, and in particular changes in the distance between the patient's chin and the posterior surface of the patient's neck that is close to the base of the user's head.

[0382] In this example, the patient interface 3000 includes a pair of lower arms 3313 extending from the chassis portion 3210, each lower arm 3313 configured to attach to each of the lower straps 3317 of the positioning and stabilization structure 3300. Each lower arm 3313 may include a lower headgear attachment point, each of which can be connected to, for example, a magnetic attachment point (e.g., a magnet or magnetic material). In this example of the technology, on each outside of the chassis portion 3210, each lower arm 3313 connects to the chassis portion 3210 directly adjacent to each gas delivery tube 3350. This arrangement configuration has the appearance of a single headgear attachment point on each outside of the cushion module 3150, thereby making the patient interface 3000 appear smaller and easier to fit.

[0383] The positioning and stabilization structure 3300 further includes a back strap 3319 configured to connect gas delivery tubes 3350 together and to lie over or beneath the occipital bone of the patient's head during use. The back strap 3319 may be connected to a lower strap 3317 behind the patient's head and / or neck. As shown in the figure, the back strap 3319 is positioned over each side of the patient's head, and at least a portion of the back strap 3319 is positioned above the superior base of the ear. The back strap 3319 may be connected to a gas delivery tube 3350 above the superior base of the ear.

[0384] [5.3.5.6.7 Undercushion] In some examples of this technology, the patient interface 3000 includes an undercushion. The patient interface 3000 shown in Figures 25–30 includes an undercushion 3225 behind the membrane portion 3220 visible in Figure 26. The undercushion 3225 may be attached to the chassis portion 3210 and may be configured to engage with the inner surface of the membrane portion 3220 to support the membrane portion 3220 during use. The undercushion 3225 may be configured to engage with any one or more of the following: the chin region of the membrane portion 3220 configured to contact the chin region of the patient's face during use; the cheek region of the membrane portion 3220 configured to contact the patient's cheek during use; and the nose region of the membrane portion 3220 configured to contact the patient's nose during use. In some examples, the undercushion 3225 may be located behind the cheek region of the membrane portion 3220 and behind the chin region of the membrane portion 3220. In some examples, the undercushion may be located behind only the chin region of the membrane portion 3220. In some examples of this technology, it should be understood that the patient interface 3000 does not have an undercushion.

[0385] Figures 31 and 32 show a diagram of the patient interface 3000 shown in Figures 25 to 30, but with the portion including the membrane portion 3220 removed to expose the undercushion 3225. In this example, the undercushion 3225 engages with the chin region, the cheek region, and the nasal region of the membrane portion 3220. In this example, the undercushion 3225 is configured to engage with the membrane portion 3220 around the entire periphery of the membrane portion 3220.

[0386] The undercushion 3225 may be formed from a flexible and resilient material, such as an elastomer (e.g., silicone or TPE). The undercushion 3225 may be molded onto the chassis portion 3210, for example, if the undercushion 3225 is formed from an elastomer and the chassis portion 3210 is formed from Mylar, polycarbonate, or a rigid textile material. The undercushion 3225 may take the form of a flange and extend inward from the periphery of the chassis portion 3210. The undercushion 3225 may be structured to act as a cantilever support, holding the membrane portion 3220 in contact with the patient's face during use. In some examples, the undercushion 3225 may be formed from the same material as the chassis portion 3210 and may be formed integrally with the chassis portion 3210. In further examples, the undercushion 3225 may be attached to the chassis portion 3210.

[0387] The undercushion 3225, when engaged with the patient's face, may deform together with the membrane portion 3220 to conform to the shape of the patient's face. The upper portion of the undercushion 3225, shown in Figures 31-32, is configured to bend to conform to the patient's nose and cheeks when the patient wears the patient interface 3000. The upper portion of the undercushion 3225 may have a thickness in the range of 0.5-1.5 mm, 0.75-1.25 mm, or, for example, 1 mm. The lower portion of the undercushion 3225 is configured to bend to conform to the chin area (e.g., adjacent to the patient's supramentum and sitacus, and above the mental prominence). The thickness of the lower portion of the undercushion 3225 may vary. For example, the inner portion of the lower portion of the undercushion 3225 may be thinner than the outer portion of the lower portion of the undercushion 3225. This may provide comfort to the patient during use.

[0388] In the examples shown in Figures 31 and 32, the undercushion 3225 includes a pair of wing-like portions 3227. The wing-like portions 3227 extend inward relative to the outer circumference of the undercushion 3225. Each wing-like portion 3227 is configured to bias a membrane portion 3220 to seal the patient's face in areas adjacent to each of the patient's nostrils, such as the area between the patient's nasolabial fold and upper lip. The wing-like portions 3227 may bias the membrane portion 3220 to contact areas of the patient's face below and / or outside the patient's nostrils (e.g., the corners of the nose). In examples where the undercushion 3225 takes the form of a flange, the wing-like portions 3227 may be extensions of the flange (e.g., flange portions that extend inward to a greater extent than other flange portions). In some examples, the wing-like portions 3227 are formed integrally with the other parts of the undercushion 3225. In other examples, the wing-shaped portions 3227 may be formed separately from the rest of the undercushion 3225. In some examples, the undercushion 3225 may be formed from multiple separate pieces. In the examples shown in Figures 31-32, the undercushion 3225 has a one-piece construction. Each wing-shaped portion 3227 may extend inward in the orientation of the patient interface 3000 during use. As shown in Figures 31-32, the undercushion 3225 may define an opening from which air can flow from the plenum chamber 3200 into the patient's airway. The wing-shaped portions 3227 may divide this opening into a nasal portion of the opening and an oral portion of the opening.

[0389] In the examples shown in Figures 25 to 32, the patient interface 3000 also includes a pair of ribs 3226 extending between the chassis portion 3210 and each of the wing portions 3227 to provide support to each wing portion 3227. The ribs 3226 may provide support to the wing portions 3227 by resisting compression and / or buckling. The ribs 3226 may function as supports, resisting movement of the wing portions 3227 toward the inner surface of the chassis portion 3210. The ribs 3226 may be formed from the same material as the undercushion 3225, such as silicone, and may be formed integrally with the undercushion 3225. In other examples, the ribs 3226 may be formed from the same material as the chassis portion 3210 and may be formed integrally with the chassis portion 3210. The ribs 3226 may be 1 mm thick in one example. In some cases, the patient interface 3000 does not include the rib 3226, and only the under cushion 3225 supports the membrane portion 3220.

[0390] The undercushion 3225 of the patient interface 3000 shown in Figures 25 to 32 also includes a rim 3228. The rim 3228 may separate a portion of the membrane portion 3220 from the undercushion 3225. In this example, the membrane portion 3220 is attached to the rim 3228, and the rim 3228 is constructed to create a gap between the membrane portion 3220 and the undercushion 3225, at least around the periphery of the undercushion 3225. The rim 3228 of the undercushion 3225 may provide a connecting surface to which the membrane portion 3220 connects to the undercushion 3225, and the connecting surface is raised above the rest of the undercushion 3225 (the rest of the undercushion 3225 is the flange in the example shown in Figures 31 to 32). The connecting surface may be raised 2 mm above the rest of the undercushion 3225. The width of the connecting surface may be, for example, 2 mm. The rim 3228 may have a square or rectangular cross-section. In some cases, the connecting surface may be more (or less) than 2 mm in width and may protrude more than (or less) than the rest of the undercushion by more than 2 mm. The membrane portion 3220 may be attached to the connecting surface.

[0391] The patient interface 3000 shown in Figures 33 to 37 also includes an undercushion 3225. Figure 35 shows the undercushion 3225 as a detail hidden behind the chassis portion 3210. In this figure, the nasal pillow forming the nasal portion 3101 of the seal-forming structure 3100, along with the outer edge of the oral opening within the membrane portion 3220, can also be seen as a hidden detail. In this example of the art, the undercushion 3225 does not extend around the entire periphery of the chassis portion 3210. The undercushion 3225 extends downward and inward from a position close to one of the patient's cheeks when in use, intersecting the sagittal plane, and then extending outward and upward to a position close to the other of the patient's cheeks. The undercushion 3225 may be configured to engage with the chin region of the membrane portion 3220 configured to contact the patient's chin region, and may be configured to engage with the cheek region of the membrane portion 3220 configured to contact the patient's cheek when in use. However, the undercushion 3225 does not extend to the nasal portion of the cushion module 3150. That is, in this example, there is no undercushion 3225 behind the nasal portion of the membrane portion 3220 configured to contact the patient's nose. The undercushion 3225 may include ends located behind the membrane portion 3220 at the user's cheeks above the patient's upper lip and / or nose. If there is no undercushion 3225 behind the membrane portion 3220 at the patient's nose, a cushion module 3150 can be obtained that has an undercushion supporting the membrane portion 3220 so as to contact at least the patient's cheeks and chin, while being easier or more cost-effective to manufacture. The absence of the undercushion 3225 in the nasal region of the cushion module 3150 may also provide good comfort, as the patient's nose is not pressed against the undercushion 3225, and may also provide a good seal, as the thin membrane portion 3220 is freely deformable so that the nasal pillow can completely enclose the nose and can move to the correct orientation to seal to the extent required for the patient's specific facial geometry. Furthermore, the tension within the membrane portion 3220 alone may be sufficient to hold the nasal pillow in place for setup and use.

[0392] The patient interfaces shown in Figures 40 to 46 also include the undercushion 3225. The undercushion 3225 is shown as a hidden detail in Figure 44. As illustrated, this is substantially identical to the undercushion 3225 of the patient interface 3000 shown in Figures 33 to 37.

[0393] [5.3.5.7 Plenum chamber connected to the frame] Figures 14-17 show an example of the patient interface 3000, in which the seal-forming structure 3100 and membrane portion 3220 are substantially identical to those shown in Figures 7-13, with some differences. All disclosures made herein with respect to the plenum chamber 3200, chassis portion 3210, membrane portion 3220, and seal-forming structure 3100 should be understood to be applicable to the example shown in Figures 14-17 unless otherwise stated or clearly required in the context. In this example, the patient interface 3000 does not have a conduit headgear. Instead, the patient interface 3000 includes a positioning and stabilization structure 3300 which includes a pair of headgear strap portions 3310 (which may be rigid in some examples). The positioning and stabilization structure 3300 holds the plenum chamber 3200 and seal-forming structure 3100 in place when in use. The patient interface 3000 also includes a frame 3320 and a short tube 3610. In this example, the plenum chamber 3200 and the seal-forming structure 3100 form a cushion module 3150.

[0394] [5.3.5.7.1 Strap section] Each strap portion 3310 is positioned on each side of the patient's head when in use. In some examples, the strap portions 3310 are connected to each other at the back of the patient's head, for example by a buckle. In other examples, the strap portions 3310 are formed integrally with each other; that is, they may be part of the length of a single headgear strap. Each strap portion 3310 may be positioned above each superior base of the patient's head. The strap portions 3310 may be configured to lie on the parietal bone of the patient's head when in use. In some examples, the strap portions 3310 may be connected to or formed by a bifurcated strap portion between two strap portions 3310 configured to rest on the posterior and / or posterior superior surface of the patient's head.

[0395] The overall length of the strap portion 3310 may be selectively adjustable by the user, for example, using a buckle between two strap portions 3310. In some examples, the strap portion 3310 may be elastically stretchable so as to resist forces that, when worn by a patient, generate tension within the strap portion 3310, pulling the seal-forming structure 3100 toward the patient's airway and tending to separate the seal-forming structure 3100 from the patient's face.

[0396] [5.3.5.7.2 Frame] The patient interface 3000 also includes a frame 3320 in the example shown in Figures 14-17. In this example, the plenum chamber 3200 of the patient interface 3000 is connected to the frame 3320. The chassis portion 3210 may be configured to connect to the frame 3320. Each of the strap portions 3310 is also connected to the frame 3320. The frame 3320 may be substantially rigid (e.g., not easily deformed by finger pressure alone) and may be formed from polycarbonate as an example. In other examples, the frame 3320 may be semi-rigid (e.g., at least to some extent flexible by finger pressure and / or when tension is present in the headgear strap portion 3310). The frame 3320 may curve from left to right and may include curvature corresponding to the curvature of the front side of the chassis portion 3210. In some examples, the curvature of the frame 3320 may follow the curvature of the front boundary of the membrane portion 3220.

[0397] The plenum chamber 3200 may be larger than the frame 3320, and as a result, the chassis section 3210 extends approximately 2-3 mm beyond the frame 3320 on each side of the frame.

[0398] [5.3.5.7.3 Short pipe] The patient interface 3000 shown in Figures 7 to 13 includes a conduit headgear, and the plenum chamber 3200 receives airflow at therapeutic pressure via a gas delivery tube 3350, whereas the patient interface 3000 shown in Figures 14 to 17 includes a short tube 3610 through which the plenum chamber 3200 receives airflow. The plenum chamber 3200 includes a central opening that receives airflow from the short tube 3610. The central opening of the plenum chamber 3200 may form a plenum chamber inlet port.

[0399] The short pipe 3610 may be a short length of tubing having a connection port 3600 at its end distal to the patient. A longer conduit forming part of the air circuit 4170 between the RPT device 4000 and the patient interface 3000 may be fluidly connected to the short pipe 3610 at the connection port 3600. The short pipe 3610 may include a swivel connector that forms the connection port 3600. The short pipe 3610 may, advantageously, function to at least partially decouple the conduit connected from the seal-forming structure 3100 to the connection port 3600. The short pipe 3610 may be considered to form part of the patient interface 3000.

[0400] The frame 3320 may also include a central opening through which the airflow entering the plenum chamber 3200 passes. The central opening in the frame 3320 may be aligned with the central opening in the plenum chamber 3200 and may be aligned with the short pipe 3610. In this particular example, the plenum chamber 3200 connects to the frame 3320 around the periphery of the central opening in the frame 3320. In this example, the frame 3320 includes a flange around the periphery of the central opening to which the plenum chamber 3200 can be connected.

[0401] The plenum chamber 3200 also includes a chassis portion 3210 and a membrane portion 3220, as shown in the examples in Figures 7 to 13. The central opening within the plenum chamber 3200 may be formed within the chassis portion 3210. The chassis portion 3210 may be formed from silicone and may be connected to the frame 3320 around the central opening of the frame 3320 using stretch-fit connections.

[0402] [5.3.5.7.4 Connection between the frame and the strap] In the examples shown in Figures 14 to 17, the plenum chamber 3200 includes two outer openings through which air can be discharged, for example, for gas flushing. Each outer opening in the plenum chamber 3200 may be located on the outside of each central opening and may be formed by holes in the chassis portion 3210. Each outer opening may be aligned with a corresponding vent 3400 in the frame 3320 when in use. Air from the plenum chamber 3200 may pass through the outer openings in the chassis portion 3210 and then through the corresponding vents 3400 in the frame 3320. Each vent 3400 may be formed by one or more openings in the frame 3320 through which air can pass.

[0403] The frame 3320 may include outer openings corresponding to outer openings in the chassis portion 3210. The frame 3320 may include flanges around the outer openings, and the outer openings in the chassis portion 3210 may stretch-fit to the flanges around the outer openings in the frame 3320. The chassis portion 3210 may be connected to the frame 3320 at each of the outer openings and the central opening of the frame 3320. In the examples shown in Figures 14 to 17, each outer opening in the frame 3320 includes a plurality of holes that form a ventilation portion 3400.

[0404] In this example, the headgear strap portion 3310 is configured to connect to the frame 3320 on the opposite side of the frame 3320 to the plenum chamber 3200. Each headgear strap portion 3310 includes a connector 3312 configured to attach to a corresponding connection point on the frame 3320. Each connector 3312 can be attached to each connection point at a position corresponding to each vent 3400 within the frame. For example, the vents 3400 may be provided around or formed together with the headgear strap connection points. Thus, in this example, the patient interface 3000 includes a configuration of dividing vents.

[0405] [5.3.5.8 Textile Chassis Section] Referring to Figures 47 to 55, in some examples, the patient interface 3000 may include a chassis portion 3210 constructed at least partially from a textile material. In some examples, the textile is coated with an air-impermeable coating, such as a silicone coating. In some examples, the chassis portion 3210 is formed from bresoprene. In some examples, the chassis portion 3210 may be formed from a foam. The chassis portion 3210 may form part of the cushion module 3150 of the patient interface 3000.

[0406] The chassis portion 3210 may be constructed to have sufficient rigidity to maintain a predetermined three-dimensional shape throughout the patient's respiratory cycle. The stiffness may be due to the geometry of the chassis portion 3210, and / or the chassis portion 3210 may be thermoformed so that the material forming the chassis portion 3210 (e.g., textile material) is inherently rigid. In some examples, the chassis portion 3210 may include folding portions that contribute to its stiffness. For example, a textile portion may be folded and joined to other portions, thereby creating a structure that can maintain its three-dimensional shape throughout the patient's respiratory cycle.

[0407] Referring next to Figure 50, an example of a blank 3250 for the textile chassis portion 3210 is shown. Figure 51 shows a blank 3250 having two lower edges 3252 of the blank 3250 joined together so that the blank 3250 generally adopts a conical or frustoconical shape, with a joint 3254 between the two edges 3252 located on the lower portion of the chassis portion 3210. In the example shown, the chassis portion 3210 has no seams or joints above the opening 3256 from which the inlet port connector 3605 of the patient interface 3000 extends when in use. In some examples, the chassis portion 3210 may appear substantially circular or oval when viewed from the front.

[0408] As shown in Figure 51, the lower portion of the blank 3250 is folded inward along an outward-extending fold 3258, and the outer edge 3260 of the flap 3262 formed by this fold 3258 connects to the inner surface 3264 of the chassis portion 3210. In this way, the chassis portion 3210 is made to have sufficient rigidity or stiffness to maintain its three-dimensional shape throughout the patient's respiratory cycle.

[0409] In the example where the textile chassis portion 3210 is thermoformed, it may not be necessary to include the flap 3262 shown in Figure 51, and the shape of the blank 3250 can be changed accordingly.

[0410] In the example, a plastically deformable element 3266, such as a thin steel wire or ribbon, may extend outward across the chassis portion 3210, as best shown in Figure 48. The plastically deformable element 3266 may be deformed by the patient to make the chassis portion 3210 wider or narrower as needed.

[0411] In particular, referring to Figure 47, in some examples, the chassis portion 3210 has a non-zero negative first principal curvature PC1 and a substantially zero second principal curvature PC2, the second principal curvature PC2 being substantially parallel to the patient's sagittal plane when in use.

[0412] In the example, the patient interface 3000 includes an inlet port connector 3605 extending through the lower wall 3268 of the chassis portion 3210, as best shown in Figure 55. In the example, the inlet port connector 3605 has a central axis AA that extends substantially downward when in use, as shown, for example, in Figure 48.

[0413] The inlet port connector 3605 may be configured to fluidize to a short tube 3610, for example, as shown in Figures 47–49, or as described in any other examples elsewhere in this specification. The short tube 3610 may be connected to the inlet port connector 3605 at its proximal end and may include a connection port 3600 for connection to the RPT device 4000, for example, via a long conduit of the air circuit 4170. In other examples, the short tube 3610 is not provided, and the inlet port connector 3605 provides a connection port 3600 of the patient interface 3000 for connection to the RPT device 4000 via a conduit of the air circuit 4170.

[0414] In some examples, the patient interface 3000 may be very compact, and as a result, the outside of the inlet port connector 3605 may be in contact with or very close to the foam undercushion 3225 and in contact with the front wall of the chassis portion 3210. In some examples, as shown in Figure 48, for example, the front wall 3270 of the chassis portion 3210 may have a cutout 3272 that allows the inlet port connector 3605 to protrude through it. In the example, the depth of the lowest portion of the cushion module 3150 (e.g., the distance from the textile membrane portion 3220 to the front wall 3270 of the chassis portion 3210) may be substantially equal to the diameter of the inlet port connector 3605 plus the thickness of the foam undercushion 3225. The depth of the uppermost portion of the cushion module 3150 may be substantially equal to the thickness of the foam undercushion 3225 plus the thickness of the textile chassis portion 3210.

[0415] In some examples, the outer surface of chassis portion 3210 has a radius substantially equal to the radius of the immediately adjacent outer portion of the inlet port connector 3605 at position 3274, which is directly adjacent to the inlet port connector 3605. In an example, the central front portion 3276 of chassis portion 3210 (shown in Figure 47), which extends from the top to the bottom of chassis portion 3210, may have a radius substantially equal to the radius of the inlet port connector 3605.

[0416] The patient interface 3000 shown in Figures 47 and 48 includes a vent 3400, which may be as described elsewhere in this specification. In one embodiment, the patient interface 3000 may include a vent module 3410 containing the vent 3400, the vent module 3410 being removably connectable by the patient to the chassis portion 3210, so that the vent 3400 may be disconnected from and reconnected from the chassis portion 3210, for example, for cleaning or replacement. The vent may take any form as described herein.

[0417] [5.3.5.8.1 Headgear Connector] In the example, the patient interface 3000 includes a pair of upper headgear connectors 3301 and a pair of lower headgear connectors 3302. For example, in the example shown in Figures 47 and 48, the upper headgear connector 3301 includes an upper arm 3311 that is elastically deformable but can be rigidized to resist bending in one or more directions. Each upper arm 3311 may have a strap connector portion 3340 at its distal end. The strap connector portion 3340 may include loops, slots, etc.

[0418] The lower headgear connector 3302 in the example shown in Figure 47 includes a lower arm 3313 that can be rigidized as described with respect to the upper arm 3311. Any suitable type of headgear connector can be used for the lower headgear connector 3302, for example, a magnetic connector provided at the end of the lower arm 3313.

[0419] In some examples, one or more of the headgear connectors 3301, 3302 may be removably connected to the chassis portion 3210. That is, the connector itself may be repeatedly connected to and disconnected from the chassis portion 3210 (rather than the connector simply being repeatedly connected to and disconnected from the headgear). In some examples, the headgear connector may be connected to the chassis portion 3210 by a snap fastener.

[0420] This method of connection between the headgear connector and the chassis portion 3210 means that the chassis portion 3210 is replaceable, and the headgear connectors 3301 and 3302 can be removed and reused with a new chassis portion 3210. For example, the headgear connectors 3301 and 3302 can be removed so that the chassis portion 3210 and the seal forming structure 3100 can be replaced together.

[0421] [5.3.5.8.2 Foamed under cushion] In particular, referring to Figure 52, the seal-forming structure 3100 includes a foamed undercushion 3225. In one embodiment of the art, when connected to the chassis portion 3210, the foamed undercushion 3225 is shaped to extend around the patient's mouth and beneath the anterior and lateral portions of the periphery of the base of the nasal wings of the patient's nose. When in use, the foamed undercushion 3225 supports the textile membrane portion 3220. The undercushion 3225 has at least one opening 3112 that allows air to flow into the patient's airway.

[0422] In the example, the foamed undercushion 3225 is made of polyurethane, such as thermoplastic polyurethane, or a soft thermoplastic elastomer. In the example, the undercushion material is soft enough not to cause substantial discomfort when in contact with the face.

[0423] In the example, the foam constituting the undercushion 3225 is substantially air-impermeable, and for example, the foam may be a skinned foam.

[0424] As shown in Figure 53, the under cushion 3225 may have a substantially triangular shape (for example, before being attached to the chassis portion 3210), and one side 3114 of the triangle may have a slightly convex shape (for example, corresponding to the lower portion of the opening to the seal forming structure).

[0425] For example, as shown in Figure 53, in other examples, a substantially triangular foam undercushion 3225 may include a support portion 3116 that, when in use, extends outward and inward to engage with the corner of the patient's nose where the nose and mouth meet, and / or ensures that the textile membrane portion 3220 is adequately supported in the area where the patient's nose meets the patient's face (e.g., engaging with the patient's face at the corner of the patient's nose). In the example, the support portion 3116 may be compressed to contact the corner of the patient's nose when in use, or to contact the patient's face at or near the corner of the nose, such as between the alae and nasolabial folds.

[0426] [5.3.5.8.3 Textile film] As described elsewhere in this specification, the seal-forming structure 3100 may include a sealing flange utilizing a pressure-assisted sealing mechanism. The sealing flange may include a textile membrane portion 3220, but in other examples, alternative materials such as silicone may also be used. When in use, the sealing flange can readily respond to the positive system pressure inside the plenum chamber 3200 (acting on its bottom surface) to bias it to form a tight, sealed engagement with the face. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0427] In the example shown in Figure 55, for example, the patient interface 3000 includes a textile membrane portion 3220 connected to the patient-facing side of the foam undercushion 3225 around its outer circumference 3140 (e.g., around the entire periphery). In the example, the only connection between the textile membrane portion 3220 and the foam undercushion 3225 is at the outer circumference 3140 of the textile membrane portion 3220. When subjected to therapeutic pressure inside the plenum chamber 3200, the textile membrane portion 3220 may "inflate like a balloon" under pressure and move away from the undercushion 3225 toward the patient's face. This allows the textile membrane portion 3220 to conform closely to the shape of the patient's face.

[0428] In some examples, the textile membrane portion 3220 is configured to form a seal around at least the anterior and lateral portions of the peripheral area of ​​the alae base of the patient's nose, and / or the lateral portions of the nasal portion directly adjacent to the lower peripheral area. In some examples, the membrane portion 3220 may engage with the nasal tip region, alae, and upper lip of the user's nose. In some examples, the membrane portion 3220 may engage with the area of ​​the patient's face between the alae and the nasolabial folds.

[0429] In this example, the entire textile film portion 3220 is integrally formed from a single textile sheet. For example, the textile film portion 3220 does not have to include seams.

[0430] In particular, referring to Figure 54, in one embodiment, the textile membrane portion 3220 may include an outer circumference 3140 and an inner circumference 3142 defining the edge of the hole. In one example, the width W of the textile membrane portion 3220, measured between the outer circumference 3140 and the inner circumference 3142, may be greatest in the portion of the membrane intended to seal the corner of the patient's nose where it meets the face. In some examples, the membrane portion 3220 may form a "wing-like" portion 3144 extending inward in this region.

[0431] In some cases, connecting parts or "bridges" may be provided between these parts to prevent the textile membrane parts 3220 from bursting.

[0432] For example, in another example as shown in Figure 49, the textile membrane portion 3220 may include a first hole 3146 through which air can flow from the plenum chamber 3200 into both nostrils of the patient, and a second hole 3148 through which air can flow from the plenum chamber 3200 into the patient's mouth. The membrane portion 3220 may extend between the first and second holes 3146, 3148. In this example, only two holes 3146, 3148 are provided.

[0433] In an example with two holes, as shown in Figure 49, the textile membrane portion 3220 can form a seal around the entrance to the patient's nostrils and a separate seal around the patient's mouth.

[0434] The textile membrane portion 3220 may be coated with an air-impermeable coating, such as a silicone coating. In one example, the thickness of the silicone coating is substantially 0.05 mm, and the thickness of the textile membrane portion 3220 including the coating is substantially 0.3 mm. The coating may be on the side of the textile membrane portion 3220 that does not come into contact with the patient.

[0435] In the examples shown in Figures 49 and 55, the textile membrane portion may include a knitted fabric. The membrane portion 3220 may be highly flexible to easily conform to the shape of the patient's face.

[0436] The highly compliant, pressure-activated textile membrane portion 3220 enables a robust seal. The compliant textile membrane portion 3220 can conform to various facial shapes when subjected to therapeutic pressure.

[0437] In other examples of this technology, the membrane portion 3220 may be as described elsewhere in this specification. In some examples, the membrane portion 3220 may be formed from silicone. In some examples, the membrane portion 3220 may be formed from a silicone sheet. In some examples, the membrane portion 3220 may be formed from silicone that is not molded to have a predetermined three-dimensional shape. More generally, the membrane portion 3220 may be formed by processes other than molding and may be formed as a sheet.

[0438] Any feature of the textile membrane portion 3220 described with reference to Figures 47 to 55 may be applied to the patient interface 3000 according to another example of the Art, such as any example disclosed herein. Similarly, any feature of the membrane portion 3220 of any other patient interface 3000 described herein may be applied to the patient interface 3000 of Figures 47 to 55.

[0439] [5.3.5.9 Frames formed from elastic and flexible materials] An example of the patient interface 3000 of this technology may be particularly lightweight compared to several other patient interfaces of the prior art. For example, the weight of the patient interface of this technology may be less than 50 grams, more preferably less than 45 grams. For example, the patient interface 3000 shown in Figures 56-58, which includes a chassis portion 3210, a foamed undercushion 3225, a textile membrane portion 3220, an upper arm 3311, a lower headgear connection point 3314, and an integrated short tube 3610, may weigh substantially 44.6 grams.

[0440] In one embodiment of this technology, the chassis portion 3210 is formed from an elastic, flexible material. For example, the chassis portion 3210 is formed from a polymer, such as biaxially oriented polyethylene terephthalate, such as Mylar®. The material may be less than 0.5 mm thick, for example, 0.25 mm thick. In other examples, the chassis portion 3210 may be formed from silicone. Alternatively, the chassis portion 3210 may be as described elsewhere in this specification by other examples of this technology.

[0441] In the example, the chassis portion 3210 is curved to have a non-zero first principal curvature PC1 and a substantially zero second principal curvature PC2, as schematically shown in Figure 48.

[0442] In the example, the patient interface 3000 is configured such that the second principal curvature PC2 is substantially parallel to the patient's sagittal plane when in use (for example, in the sagittal plane of the patient's head when in use).

[0443] The chassis portion 3210 may be formed from a flat material sheet held in a curved configuration by the seal-forming structure 3100, or the chassis portion 3210 may be inherently curved, for example, by thermoforming, molding, or otherwise manufactured to have a specific curve. In the example, the chassis portion 3210 may be punched out from a material sheet, but other methods of forming the chassis portion 3210 are also possible, such as any other method or scheme described herein.

[0444] As shown in Figures 58 and 59, in some embodiments of this technology, the chassis portion 3210 comprises a pair of upper headgear connectors 3301 and a pair of lower headgear connectors 3302. In one example, the chassis portion 3210 also comprises an inlet port connector 3605 for connection to an air delivery tube during use (e.g., a releasable connection). In one example, the frame 3240 comprises at least one vent 3400 for gas flushing, which may be as described elsewhere in this specification. The patient interface 3000 may also include an AAV integrated into, for example, the inlet port connector 3605.

[0445] In an example where the chassis portion 3210 is relatively thin and flexible and has substantially zero principal curvature substantially aligned with the sagittal plane, the chassis portion 3210 can bend relatively easily, and as a result, the magnitude of the first principal curvature PC1 can change when the patient interface 3000 is worn. For example, the magnitude of the first principal curvature PC1 may be relatively large when the patient interface 3000 is worn by a patient with a relatively narrow face (e.g., the chassis portion 3210 may be curved more significantly, as shown in the exaggerated form in Figure 60 (this figure shows the patient interface 3000 compressed into a narrow configuration by a patient)), but may be smaller when the patient interface 3000 is worn by a person with a relatively wide face (e.g., the chassis portion 3210 may be relatively "flat," as shown, for example, in Figure 59). Thus, the patient interface 3000 may be adaptable to fit patients with faces of various different sizes.

[0446] [5.3.5.9.1 Foamed under cushion] Referring next to Figures 59 and 61, the seal-forming structure 3100 includes an undercushion 3225 formed from foam. The foam undercushion 3225 is shaped to extend around the patient's mouth, as well as around the anterior and lateral portions of the periphery of the base of the nostrils of the patient's nose. An example of a patient interface 3000 made by this technique may be called a miniature full-face mask.

[0447] The foamed undercushion 3225 is preferably removably connected to the chassis portion 3210. In one example, the foamed undercushion 3225 includes a channel 3130, shown in Figures 61, 62, and 63, configured to engage with the outer edge of the chassis portion 3210. In this example, the channel 3130 is configured to engage with the entire outer circumference 3241 of the chassis portion 3210. If the patient wishes to separate the seal-forming structure 3100 from the chassis portion 3210 (for example, to clean or replace the seal-forming structure 3100), the foamed undercushion 3225 can be peeled off from the chassis portion 3210.

[0448] The connection between the foamed undercushion 3225 and the chassis portion 3210 is substantially airtight. That is, a seal is formed between the foamed undercushion 3225 and the chassis portion 3210. In one example, the channel 3130 extends across the chassis portion 3210 and is partially defined by a flexible lip 3131 at the edge of the undercushion 3225 that seals the chassis portion 3210. In this example, the lip 3131 is molded into the undercushion 3225 using the undercushion material (e.g., foam). This allows the connection between the chassis portion 3210 and the undercushion 3225 to maintain flexibility.

[0449] In some examples, other connector mechanisms may be provided in addition to, or as an alternative to, the channel 3130 engaging portion described above. For example, in one embodiment, one or more snap fasteners 3132 are provided to connect the foam undercushion 3225 to the chassis portion 3210, as schematically shown in Figure 64. In another example, the foam undercushion 3225 may include one or more substantially rigid clipping portions 3133 that engage with the frame 3240, as schematically shown in Figure 65.

[0450] In the example, the foam undercushion 3225 has a shape and configuration that reduces its resistance to compression by the patient's face in at least some areas (e.g., less resistance to compression than other areas). For example, as shown in Figure 61, the foam undercushion 3225 may have a substantially "C" shaped cross-section, which is relatively easily compressed, although other suitable cross-sectional shapes may also be used. In the example, the cross-sectional shape may vary around the periphery of the foam undercushion 3225, so that some parts of the foam undercushion 3225 (e.g., the part around the nose) are more easily compressed than other parts (e.g., the part around the mouth).

[0451] Referring next to Figure 66, in one example, the area of ​​the foam undercushion 3225 that receives the tip of the patient's nose has a depth d1 of 14 mm and a height h1 of 12 mm. In this particular example, the undercushion 3225 has a maximum depth d2 of 21 mm in the portion that engages with the patient's cheek at the side of the patient's mouth. The width of this area may be 13 mm. The undercushion 3225 may have a depth d3 of 15 mm and a height h3 of 15 mm in the portion below the patient's mouth. In this example, the height, width, and / or depth of the undercushion 3225 may vary between the chassis portion 3210 and the textile membrane portion 3220. That is, the undercushion 3225 does not have to have a constant cross-section.

[0452] Referring to Figure 68, which shows an example of a foamed undercushion 3225 alone, the upper portion 3280 of the undercushion 3225, configured to engage with the bottom surface of the patient's nose, includes a vertical portion 3281, a horizontal portion 3282, and a chamfered or angled portion 3283 between the vertical and horizontal portions, and is formed as a plane of rotation about a vertical axis A.

[0453] In the example, the foamed undercushion 3225 is made from polyurethane, such as thermoplastic polyurethane, or from a soft thermoplastic elastomer. A foam having the following properties may be suitable: ● Deflection due to force: 95 ± 20 N @ 40% (Test specification: AS 2282.8 Method A) ● Density: 54.5 + / - 2.5 kg / m³ (Test specification: AS 2282.3) ● Air permeability: <1.5 l / min @ 20 cmH2O (R630-602 permeability test (cyclic) procedure).

[0454] Foam materials having properties different from those described above may be used in other examples of this technology. In one embodiment of this technology, polyethylene foam may be used.

[0455] In this example, the foam may be substantially impermeable to water, and as a result, the mask can be thoroughly dried before use at night if washed early that day.

[0456] In this example, the undercushion material is soft enough to cause virtually no discomfort when engaging with the face, but hard enough to maintain and seal the frame when the patient interface is worn.

[0457] In the example, the foam constituting the undercushion is substantially air-impermeable, and for example, the foam may be a hulled foam.

[0458] During use, the foamed undercushion 3225 supports the textile membrane portion 3220.

[0459] [5.3.5.9.2 Textile film] In particular, referring to Figures 59 and 61, in one embodiment, the seal-forming structure 3100 includes a textile membrane portion 3220 that functions as a pressure-assisted sealing mechanism. During use, the textile membrane portion 3220 can readily respond to the positive system pressure inside the plenum chamber 3200 (acting on its bottom surface) and bias it to form a tight, sealed engagement with the face. The pressure-assisted mechanism may work in conjunction with the elastic tension in the positioning and stabilizing structure 3300.

[0460] In the example, the textile membrane portion 3220 is connected at its outer circumference 3140 to the patient-facing side of the foam undercushion 3225, so that the membrane is substantially taut when not in use. In the example, the only connection between the textile membrane portion 3220 and the foam undercushion 3225 is at the outer circumference 3140 of the textile membrane portion 3220. When subjected to therapeutic pressure inside the plenum chamber 3200, the textile membrane portion 3220 may be compressed and "inflated like a balloon," as shown in 3220a. This allows the textile membrane to conform closely to the shape of the patient's face.

[0461] In the example, the textile membrane portion 3220 is formed from a single textile sheet. The textile membrane portion 3220 may include a first opening 3146 through which air can flow from the plenum chamber 3200 to both nostrils of the patient, and a second opening 3148 through which air can flow from the plenum chamber 3200 to the patient's mouth. The membrane portion 3220 may extend between the first and second openings 3146, 3148. In other examples (not shown), the membrane portion 3220 may have a single opening for both the patient's mouth and nostrils. In the example, the membrane portion 3220 may effectively have only a single opening, but the opposing outer surfaces of the membrane portion 3220 at the edges of the opening may be connected by a bridging portion, such as a textile bridging portion. In other examples, the membrane portion 3220 may include an oral opening and two nostrils, each nostril configured to fluidly communicate with each nostril of the patient's nose during use.

[0462] The textile film portion 3220 may have coatings and thicknesses as described elsewhere in this specification, for example, as described with reference to the examples shown in Figures 47 to 55, or as described with reference to any other examples herein.

[0463] The textile membrane portion 3220 may include a knitted fabric. The membrane portion 3220 may be highly flexible to easily conform to the shape of the patient's face. In example, the textile may include polyamide (e.g., nylon), polyester, and / or elastane (e.g., spandex).

[0464] In one example, a textile having the following characteristics may be used: ● Single jersey knit; ● Content: Polyamide 80%, Elastane 20%; ● Density: 136 courses per inch, 75 wales per inch; ● Weight: 105g / m2; and ● Stretching at 1.5kg: Length 80-108%, width 93-126%.

[0465] In other examples, textile materials may have properties different from those described above.

[0466] In this example, the chassis portion 3210 and the foamed undercushion 3225 are shaped such that, when viewed in a cross-section passing through the sagittal plane (e.g., the central sagittal plane), the side 3121 of the textile membrane portion 3220 facing the patient lies on a continuous convex curve 3235, as shown in Figure 67.

[0467] For example, the textile membrane portion 3220 does not need to have secondary geometric features that could generate wrinkles. This allows the membrane to be maintained in a configuration that does not generate wrinkles when the patient interface 3000 is not in use. When the patient interface 3000 is applied to the face, the membrane portion 3220 bends around the periphery of the nose and mouth openings, as these may be the first points of engagement, thus conforming to the shape of the face.

[0468] A highly compliant textile membrane portion 3220, which is activated by pressure, can enable a robust seal. The compliant textile membrane portion 3220 can conform to various facial shapes when subjected to therapeutic pressure. Because conventional seal-forming structures may have low compliance, a compliant textile membrane, and / or a membrane with a large surface area in contact with the patient's face, can help reduce the pressure-increasing area between the seal-forming structure 3100 and the patient's face. In some examples, the textile may be a fine knit. The surface of the textile may be low-friction so that the patient can easily position the cushion module 3150 when wearing the patient interf...

Claims

1. It is a patient interface, At least 4 cmH above ambient air pressure ２ A chassis portion that at least partially forms a plenum chamber pressurized to a therapeutic pressure of O, the plenum chamber including a plenum chamber inlet port which is sized and constructed to receive airflow at the therapeutic pressure for patient respiration, A seal-forming structure comprising a pair of nasal pillows, each nasal pillow constructed and positioned to form a seal with each nostril of the patient's nose, each nasal pillow having a hole inside so that the airflow at the therapeutic pressure is delivered to at least the patient's nostrils, and the seal-forming structure constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use, A membrane portion connected to the chassis portion and forming at least partially the plenum chamber, wherein the nasal pillow is supported on the membrane portion, the membrane portion is constructed and positioned to be flexible to allow relative movement between the nasal pillow and the chassis portion during use, the membrane portion does not have a predetermined three-dimensional shape when there is no positive pressure relative to the air pressure in the plenum chamber, and takes the form of a sheet connected to the chassis portion at its edge, A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain the therapeutic pressure within the plenum chamber during use, The patient interface is configured to allow the patient to breathe through their mouth from the surroundings when there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

2. The membrane portion is stretchable, according to claim 1, patient interface.

3. The patient interface of claim 2, wherein the membrane portion is constructed and positioned to expand and contract during expansion when the plenum chamber is pressurized to the therapeutic pressure during use.

4. The patient interface according to any one of claims 1 to 3, wherein the membrane portion is constructed and positioned to expand during use to fit one or more portions of the patient's nose.

5. The patient interface according to any one of claims 1 to 4, wherein the membrane portion is constructed and positioned to expand during use and bias each of the nasal pillows toward each of the patient's nostrils.

6. The patient interface according to any one of claims 1 to 5, wherein the membrane portion is configured to engage with the patient's upper lip when in use.

7. The patient interface according to any one of claims 1 to 6, wherein the membrane portion is formed at least partially from a textile material.

8. The patient interface according to claim 7, wherein the membrane portion includes a textile layer and an air-impermeable layer.

9. Each of the nasal pillows is formed from an elastomer material, the patient interface according to claim 7.

10. The aforementioned membrane portion is formed from an elastomer, according to any one of claims 1 to 7.

11. The aforementioned membrane portion is formed from silicone, the patient interface according to claim 10.

12. The patient interface according to claim 10 or 11, wherein the membrane portion takes the form of a sheet connected to the chassis portion at the edge of the membrane portion.

13. The chassis portion is formed from an elastomer material, according to any one of claims 1 to 12.

14. The patient interface according to any one of claims 1 to 13, wherein the nasal pillow is formed separately from the membrane portion and attached to the membrane portion.

15. The patient interface according to any one of claims 1 to 14, wherein each of the nasal pillows is free of a stalk.

16. Each of the nasal pillows comprises a frustoconical portion having a tip and a base wider than the tip, the base being directly attached to the membrane portion, the patient interface according to any one of claims 1 to 15.

17. Each nasal pillow is formed from a material different from the membrane portion, the patient interface according to any one of claims 1 to 16.

18. Each of the nasal pillows is formed from an elastomer material, a patient interface according to any one of claims 1 to 16.

19. Each of the nasal pillows is formed from silicone, the patient interface of claim 18.

20. Each of the nasal pillows is formed at least partially from a textile material, the patient interface according to any one of claims 1 to 16.

21. Each of the nasal pillows is formed from a single wall, a patient interface according to any one of claims 1 to 20.

22. Each of the nasal pillows is formed from a double-wall structure, a patient interface according to any one of claims 1 to 20.

23. The patient interface according to any one of claims 1 to 22, wherein the seal-forming structure further includes an oral portion configured to form a seal around the patient's mouth, so that the airflow is delivered to the patient's mouth at the therapeutic pressure.

24. The membrane portion forms the oral cavity portion of the seal-forming structure, according to claim 23.

25. The patient interface according to any one of claims 1 to 24, wherein the patient interface includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure includes a tie, the tie being constructed and positioned such that at least a portion of it lies over a region of the patient's head above the upper earlobe point of the patient's head when in use.

26. The patient interface of claim 25, wherein the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection portions configured to connect to the gas delivery tubes and sized and constructed to receive an airflow at the therapeutic pressure for breathing by the patient.

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