Patient interface

Abstract

A cushion module comprising an inflation chamber pressurizable to a treatment pressure, a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to an airway of the patient, a facing portion at least partially forming a front side of the cushion module, the seal-forming structure attached to the facing portion, wherein the facing portion comprises a curved shape and, in use, is curved at least partially toward a rearward direction on an outer side of the facing portion, and wherein the facing portion is biased away from the curved shape toward a shape that is more flat than the curved shape to provide, in use, a taut feeling to the seal-forming structure.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of Australian Provisional Patent Application No. 2022903105, filed on October 20, 2022, Australian Provisional Patent Application No. 2023902063, filed on June 29, 2023, and Australian Provisional Patent Application No. 2023902625, filed on August 18, 2023, each of which is hereby incorporated by reference in its entirety. Technical field

[0003] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related disorders. The present technology also relates to medical devices or equipment and their uses. Background art

[0004] The human respiratory system and its disorders

[0005] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0006] The airway includes a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which ultimately divide further into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airway leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is where gas exchange occurs and is referred to as the respiratory zone. See "Respiratory Physiology" 9th Edition by John B. West, published by Lippincott Williams & Wilkins in 2012.

[0007] There is a range of respiratory disorders. Some disorders can be characterized by specific events such as apnea, hypopnea, and hyperventilation.

[0008] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne - Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.

[0009] Therapies

[0010] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0011] Respiratory pressure therapy

[0012] Respiratory pressure therapy is the application of supplying air to the entrance of the airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapies such as tank ventilators or cuirass ventilators).

[0013] 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 a pneumatic splint and can prevent upper airway occlusion, for example, by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and thus if patients find that the device used to provide such therapy is uncomfortable, difficult to use, expensive, and / or unaesthetic in one or more ways, they may choose not to comply with the therapy.

[0014] Respiratory therapy system

[0015] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring a condition without treating it.

[0016] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0017] Another form of therapy system is a mandibular repositioning device.

[0018] Patient interface

[0019] A patient interface can be used to engage a respiratory device with its wearer, for example, by providing an air stream to the entrance of the airway. The air stream can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can form a seal with, for example, an area of the patient's face to facilitate delivery of gas at a pressure that has a sufficient difference from the ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve the therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0020] Certain other facemask systems may not be functionally suitable for the present field. For example, purely decorative facemasks may not maintain proper pressure. Facemask systems for underwater swimming or diving can be configured to prevent water from a higher external pressure from entering, but do not maintain the internal air at a pressure above ambient pressure.

[0021] Certain facemasks may be clinically disadvantageous for the present technology, for example if they block the airflow through the nose and only allow airflow through the mouth.

[0022] If certain facemasks require the patient to insert a part of the facemask structure into their mouth to form and maintain a seal around their lips, these facemasks may be uncomfortable or impractical for the present technology.

[0023] Certain facemasks may be less practical to use while sleeping, for example when lying on one's side in bed with the head on a pillow.

[0024] Certain facemasks may cause claustrophobia, restlessness, and / or a feeling of being too obtrusive in some patients.

[0025] The design of the patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move over the course of a respiratory therapy session.

[0026] Due to these challenges, some facemasks have one or more problems of being obtrusive, unaesthetic, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for long periods of time, or when the patient is not familiar with a particular system. A facemask of the wrong size can lead to reduced compliance, reduced comfort, and poorer patient outcomes. Facemasks designed only for pilots, facemasks designed as part of personal protective equipment (such as filter masks), SCUBA masks, or facemasks designed for the administration of anesthetics are acceptable for their original applications, but are not as comfortable as would be ideal for wearing over long periods (such as several hours). This discomfort can lead to reduced patient compliance with the therapy, especially if the facemask is worn during sleep.

[0027] Assuming the patient adheres to the therapy, CPAP therapy is very effective in treating certain respiratory disorders. If the facemask is uncomfortable or difficult to use, the patient may not adhere to the therapy. Since patients are generally advised to clean their facemasks regularly, if the facemask is difficult to clean (such as difficult to assemble or disassemble), the patient may not be able to clean their facemask, which can affect patient compliance.

[0028] While masks used for other applications (such as for pilots) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

[0029] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0030] Some patient interfaces of the prior art include a cushion module having a rigid shell with a predefined shape based on the anthropometrics of an envisioned person in the middle of a selected size range. Thus, the success of the seal and comfort of a given-size cushion module may be closely related to the correlation between the patient's anthropometrics and the anthropometrics of the envisioned person on which the design is based. This may lead to the need to "fit" the patient (possibly with the help of a suitably qualified professional) to a particular-size cushion module and / or a particular type of interface. This may also lead to the need to manufacture a range of differently sized cushion modules to ensure that a wide range of patients can find a size that fits them.

[0031] Seal-forming structure

[0032] A patient interface may include a seal-forming structure. Since the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0033] A patient interface may be characterized in part by the design intent of the seal-forming structure to engage the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-part that forms a seal around the left nostril and a second sub-part that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils in use. Such a single element may be designed to cover, for example, the upper lip region and the bridge of the nose of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region in use, such as by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oro-nasal masks.

[0034] For example, due to the different shapes, structures, variable regions, and sensitive regions of the patient's face, a seal-forming structure that may be effective in one region of the patient's face may not be suitable in another region. For example, a seal on a swimming goggle that covers the patient's forehead may not be suitable for use on the patient's nose.

[0035] Certain seal-forming structures can be designed for mass manufacturing such that a single design can conform and be comfortable and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0036] One type of seal-forming structure extends around the periphery of a patient interface and is intended to seal against a patient's face when force is applied to the patient interface, where the seal-forming structure engages the patient's face in a face-to-face manner. The seal-forming structure can include an air- or fluid-filled cushion, or a molded or formed surface of an elastomeric sealing element made of an elastomer such as rubber. For this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0037] Another type of seal-forming structure incorporates a flap seal of a thin material (e.g., silicone) positioned around the periphery of a face mask to provide a self-sealing action against a patient's face when positive pressure is applied within the face mask. Similar to the previously styled seal-forming portions, if the match between the face and the face mask is poor, additional force may be required to achieve a seal, otherwise the face mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leakage.

[0038] Another type of seal-forming structure can include friction-fit elements, such as for insertion into the nostrils, although some patients find these uncomfortable.

[0039] Another form of seal-forming structure can use an adhesive to achieve a seal. Some patients may find it inconvenient to regularly apply and remove the adhesive on their face.

[0040] A series of patient interface seal-forming structure techniques are disclosed in the following patent applications: WO 1998 / 004,310; WO2006 / 074,513; WO 2010 / 135,785.

[0041] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett of the United States. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Corporation.

[0042] ResMed Inc. or one or more of its related companies has manufactured the following products incorporating nasal pillows: SWIFTTM Nasal Pillow Mask, SWIFT TM II Nasal Pillow Mask, SWIFT TM LT Nasal Pillow Mask, SWIFT TM FX Nasal Pillow Mask and MIRAGELIBERTY TM Full face mask. The following patent applications describe examples of nasal pillow masks: International Patent Application WO 2004 / 073778 (which particularly describes aspects of the SWIFT TM nasal pillow mask), U.S. Patent Application 2009 / 0044808 (which particularly describes aspects of the SWIFT TM LT nasal pillow mask); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which particularly describe aspects of the MIRAGELIBERTY TM full face mask); International Patent Application WO 2009 / 052560 (which particularly describes aspects of the SWIFT TM FX nasal pillow mask).

[0043] Many seal - forming structures of the prior art include an element made of silicone (or another similar polymer) that creates a seal against the patient's face. However, some patients may not like the surface texture of silicone and / or its lack of breathability.

[0044] Positioning and Stabilization

[0045] The seal - forming structure of a patient interface for positive airway pressure therapy is subject to stresses from the air pressure that breaks the seal. Accordingly, a variety of techniques have been used to position the seal - forming structure and maintain a sealing relationship with the appropriate portion of the face. When comparing different positioning and stabilization techniques, several factors can be considered. These factors include: how effective the technique is at maintaining the seal - forming structure in the desired position and in sealing engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels invasive and / or claustrophobic when wearing the patient interface; and aesthetic appeal.

[0046] One technique is to use an adhesive - see, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using an adhesive can be uncomfortable for some people.

[0047] Another technique is to use one or more straps and / or stabilizing bands. Many such bands have one or more problems, namely poor fit, bulkiness, discomfort, and inconvenience in use.

[0048] Pressurized Air Conduit

[0049] In one type of therapy system, a pressurized air stream is provided to a patient interface through a conduit in an air circuit that is fluidly connected to the patient interface at a location in front of the patient's face when the patient interface is positioned on the patient's face during use. The conduit can extend forwardly away from the patient's face from the patient interface.

[0050] Pressurized air conduit for positioning / stabilizing a seal-forming structure

[0051] Another type of therapy system includes a patient interface where a tube that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize a seal-forming portion of the patient interface at an appropriate portion of the patient's face. This type of patient interface can be referred to as having a "conduit headgear" or "headgear tube". Such patient interfaces allow a conduit in an air circuit that provides a pressurized air stream from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a therapy system is disclosed in U.S. Patent Publication No. US 2007 / 0246043, the content of which is incorporated herein by reference, where the conduit is connected to a tube in the patient interface through a port that is positioned on top of the patient's head during use.

[0052] It is desirable that a patient interface incorporating a headgear tube be comfortable for a patient to wear over a long period while the patient is asleep, form an airtight and stable seal with the patient's face, and also conform to a range of patient head shapes and sizes.

[0053] Respiratory pressure therapy (RPT) device

[0054] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the many therapies described above, such as by operating the device to generate an air stream for delivery to an airway interface. The air stream can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also serve as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0055] Device designers may be faced with making countless choices. Design criteria often conflict, meaning that certain design choices are outside the norm or inevitable. In addition, comfort and efficacy in certain aspects may be highly sensitive to minor nuances in one or more parameters.

[0056] Air circuit

[0057] An air circuit is a conduit or tube that is constructed and arranged to allow air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0058] Humidifier

[0059] Delivering an air flow without humidification can cause airway dryness. Using a humidifier with an RPT device and a patient interface produces a humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air typically applied to the facial area inside and around the patient interface is more comfortable than cold air. Thus, humidifiers generally have the ability to heat and humidify an air flow.

[0060] Ventilation techniques

[0061] Some forms of treatment systems can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow gas to flow from the interior space of the patient interface (e.g., an inflation chamber) to the exterior of the patient interface (e.g., to the environment).

[0062] The vent can include an orifice, and in the use of a face mask, gas can flow through the orifice. Many such vents are noisy. Other vents may become blocked during use and thus provide inadequate flushing. Some vents can, for example, disturb the sleep of the patient 1000's bed partner 1100 through noise or a concentrated air flow. Summary of the invention

[0063] The present technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0064] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing a respiratory disorder.

[0065] Another aspect of the present technology relates to a method for screening, diagnosing, monitoring, improving, treating, or preventing a respiratory disorder.

[0066] One aspect of certain forms of the present technology is to provide a method and / or device for improving a patient's compliance with respiratory therapy.

[0067] One form of the present technology includes a positioning and stabilizing structure that is configured to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one strap.

[0068] One form of the present technology includes a patient interface that includes an inflatable chamber, a seal-forming structure, and a positioning and stabilization structure.

[0069] One form of the present technology includes a patient interface that includes an inflatable chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port that is sized and configured to receive an airflow at the treatment pressure for the patient to breathe. The patient interface further includes a seal-forming structure that is constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway. The seal-forming structure has a hole therein such that the airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber during the entire breathing cycle of the patient in use. The patient interface further includes a positioning and stabilization structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0070] Another aspect of one form of the present technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0071] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably with one another to form different modular components.

[0072] One aspect of one form of the present technology includes a patient interface that includes:

[0073] A gasket module that forms an inflatable chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port that is sized and configured to receive an airflow at the treatment pressure for the patient to breathe;

[0074] A seal-forming structure that partially forms the gasket module, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having a hole therein such that the airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflatable chamber during the entire breathing cycle of the patient in use;

[0075] A vent that allows the gas exhaled by the patient to continuously flow from the interior of the inflatable chamber to the environment, the vent being sized and shaped to maintain the treatment pressure in the inflatable chamber in use;

[0076] A face lining portion, the face lining portion at least partially forming a front side of the cushion module, a seal forming structure being attached to the face lining portion;

[0077] wherein the face lining portion includes a curved shape and is at least partially curved in a rearward direction on an outer side of the face lining portion in use, and wherein a shape that is flatter than the curved shape biases the face lining portion away from the curved shape to provide a tensioning sensation for the seal forming structure in use;

[0078] wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered in use.

[0079] Another aspect of the technology includes a cushion module for a patient interface, the cushion module comprising:

[0080] An inflation chamber, the inflation chamber being pressurizable to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port, the inflation chamber inlet port being sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0081] A seal forming structure, the seal forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds an inlet of the patient's airway, the seal forming structure having holes therein such that an air flow at the therapeutic pressure is delivered at least to an inlet of the patient's nostrils, the seal forming structure being constructed and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's breathing cycle in use;

[0082] A face lining portion, the face lining portion at least partially forming a front side of the cushion module, a seal forming structure being attached to the face lining portion;

[0083] wherein the face lining portion includes a curved shape and is at least partially curved in a rearward direction on an outer side of the face lining portion in use, and wherein a shape that is flatter than the curved shape biases the face lining portion away from the curved shape to provide a tensioning sensation for the seal forming structure in use.

[0084] In an example:

[0085] · The face lining portion is first formed into a formed shape having a curvature less than the curved shape, and wherein after the seal forming structure is attached to the face lining portion, the seal forming structure holds the face lining portion in the curved shape, and the face lining portion is biased away from the curved shape due to a tendency to return to the formed shape;

[0086] · The face lining portion is thermoformed into the formed shape;

[0087] · The cushion module includes an elastic member that biases the face cushion portion away from a curved shape;

[0088] · The elastic member is disposed inside the inflatable chamber;

[0089] · The elastic member engages the face cushion portion along the connection between the face cushion portion and the seal-forming structure;

[0090] · Bias the elastic member towards an annular shape;

[0091] · The elastic member is formed in an annular shape and deforms during being disposed inside the inflatable chamber, and the elastic member is biased towards an annular shape during use to bias the face cushion portion away from a curved shape during use;

[0092] · The elastic member is formed of a polymeric material; and / or

[0093] · The elastic member is molded.

[0094] In another example:

[0095] · The face cushion portion at least partially forms the inflatable chamber;

[0096] · The face cushion portion is at least partially formed of one or more foam and / or fabric materials;

[0097] · The face cushion portion is formed of foam covered with a fabric material at least on its non-patient-facing side;

[0098] · The face cushion portion has a non-zero negative first principal curvature and a second principal curvature smaller than the first principal curvature;

[0099] · The seal-forming structure includes a membrane portion configured to engage the patient's face;

[0100] · The membrane portion is configured to form a seal with at least the nasal apex region and the alae nasi of the patient's nose;

[0101] · The membrane portion includes a nasal cavity hole through which air can flow to the patient's two nostrils during use;

[0102] · The membrane portion includes an oral cavity hole through which air can flow to the patient's mouth during use;

[0103] · The membrane portion is at least partially formed of a fabric material and is airtight;

[0104] · The cushion module includes at least a pair of headgear connection portions that are connected to the face cushion portion and are configured to be connected to the positioning and stabilizing structure;

[0105] · The at least one pair of headgear connection portions includes a pair of upper headgear connection portions connected to the face cushion portion and a pair of lower headgear connection portions connected to the face cushion portion;

[0106] · Each of the upper headgear connection portions includes a curved arm; and / or

[0107] · Each of the lower headgear connection portions includes a magnetic connector.

[0108] Another aspect of one form of the present technology is a patient interface that includes:

[0109] A cushion module that forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0110] A seal-forming structure that partially forms the cushion module, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having holes therein such that an air flow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use;

[0111] A vent that allows the patient's exhaled gas to continuously flow from the interior of the inflatable chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the inflatable chamber during use;

[0112] A face cushion portion that at least partially forms the front side of the cushion module, the seal-forming structure being attached to the face cushion portion;

[0113] Wherein the seal-forming structure includes:

[0114] A membrane portion that is configured to contact the patient's face during use, the membrane portion being attached to the periphery of the face cushion portion;

[0115] A pair of seal support portions, each seal support portion being provided on a respective outer side of the face cushion portion and protruding from the face cushion portion in at least a partial inward direction, each seal support portion being configured to push the membrane portion against the patient's face during use;

[0116] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized air flow through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0117] Another aspect of the present technology includes a cushion module for a patient interface, the cushion module comprising:

[0118] An inflatable chamber that can be pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for patient breathing;

[0119] A seal-forming structure configured and arranged to form a seal with an area of the patient's face surrounding the inlet of the patient's airway, the seal-forming structure having apertures therein such that an air flow at the therapeutic pressure is delivered at least to the inlets of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use;

[0120] A face cushion portion that at least partially forms the front side of the cushion module, the seal-forming structure being attached to the face cushion portion;

[0121] Wherein the seal-forming structure includes:

[0122] A membrane portion configured to contact the patient's face during use, the membrane portion being attached to the periphery of the face cushion portion; and

[0123] A pair of seal support portions, each seal support portion being provided on a respective outer side of the face cushion portion and protruding from the face cushion portion in at least a partial inward direction, each seal support portion configured to push the membrane portion against the patient's face during use.

[0124] In an example:

[0125] · Each of the pair of seal support portions protrudes from or near the periphery of the face cushion portion;

[0126] · Each of the pair of seal support portions protrudes near the peripheral edge of the face cushion portion but is spaced from the peripheral edge by a spacing;

[0127] · The spacing is in the range of 0.5 mm to 5 mm;

[0128] · The spacing is in the range of 1 mm to 3 mm;

[0129] · The membrane portion includes nasal apertures through which air can flow to the patient's two nostrils during use;

[0130] · The membrane portion includes oral apertures through which air can flow to the patient's mouth during use;

[0131] · Each of the pair of seal support portions is designed to press the membrane portion against a respective one of the patient's cheeks;

[0132] · The membrane portion is configured to form a seal against at least the nasal prominence area and the alae nasi of the patient's nose;

[0133] · Each of the pair of seal support portions is designed and arranged to urge the membrane portion to seal at or near a respective one of the alar crestal points on the patient's face;

[0134] · Each of the pair of seal support portions includes an inner projection that is designed and arranged to push the membrane portion toward the user's face near a respective one of the alar crestal points;

[0135] · Each of the pair of seal support portions includes a lower portion having a concave inner edge;

[0136] · Each of the pair of seal support portions includes an upper portion having a convex inner edge;

[0137] · Each seal support portion is stiffer in the lower portion than in the upper portion;

[0138] · Each of the pair of seal support portions includes an upper portion having a concave inner edge that is designed and arranged to be near the patient's alae nasi and conform to the shape of the patient's alae nasi;

[0139] · Each of the pair of seal support portions includes an upper portion and a lower portion, and each seal support portion is stiffer in the lower portion than in the upper portion;

[0140] · The membrane portion is suspended above each seal support portion;

[0141] · The face lining portion at least partially forms an inflatable chamber;

[0142] · The face lining portion is at least partially formed of one or more foam and / or fabric materials;

[0143] · The face lining portion is formed of foam covered with fabric material at least on its non-patient-facing side;

[0144] · The seal support portion is at least partially formed of foam;

[0145] · The seal support portion is formed of the same material as the face lining portion;

[0146] · The face lining portion includes a curved shape and is at least partially curved rearwardly on the outer side of the face lining portion in use;

[0147] · wherein the face lining portion is thermoformed to shape; and / or

[0148] · wherein the sealing support portion is not thermoformed to shape.

[0149] In a further example:

[0150] · the face cushion portion has a non-zero negative first principal curvature and a second principal curvature less than the first principal curvature;

[0151] · the membrane portion is at least partially formed of a fabric material and is airtight;

[0152] · the cushion module includes at least a pair of headgear connection portions that are connected to the face cushion portion and are configured to be connected to a positioning and stabilizing structure;

[0153] · the at least a pair of headgear connection portions includes a pair of upper headgear connection portions connected to the face cushion portion and a pair of lower headgear connection portions connected to the face cushion portion;

[0154] · each of the upper headgear connection portions includes a curved arm; and / or

[0155] · each of the lower headgear connection portions includes a magnetic connector.

[0156] Another aspect of one form of the present technology is a patient interface that includes:

[0157] a cushion module that forms an inflatable chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O higher than the ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the treatment pressure for a patient to breathe;

[0158] a seal-forming structure that at least partially forms the cushion module, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having holes therein such that an air flow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle during use;

[0159] a vent that allows the gas exhaled by the patient to continuously flow from the interior of the inflatable chamber to the environment, the vent being sized and shaped to maintain the treatment pressure in the inflatable chamber during use;

[0160] a face cushion portion formed of a flexible material and at least partially forming the front side of the cushion module, the seal-forming structure being attached to the face cushion portion;

[0161] a pair of first headgear connection portions configured to connect to the first strap portion of the positioning and stabilizing structure, the first headgear connection portions each formed of a flexible material and each attached to a non-patient-facing side of the face lining portion proximate an outer side of the face lining portion;

[0162] wherein the face lining portion includes a peripheral edge formed by an upper edge portion and a lower edge portion, the upper edge portion and the lower edge portion being connected to each other by a pair of outer edge portions at respective outer sides of the face lining portion, each outer edge portion including an outermost point, wherein each of the first headgear connecting portions is attached to the face lining portion inboard of the outer edge portions;

[0163] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the inflation chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0164] Another aspect of the present technology includes a cushion module for a patient interface, the cushion module comprising:

[0165] a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0166] a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at said treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain said treatment pressure in the plenum throughout a breathing cycle of the patient;

[0167] a facing portion formed of a flexible material and forming at least in part a front side of the cushion module, the seal-forming structure being attached to the facing portion;

[0168] a pair of first headgear connecting portions configured to connect to the first strap portion of the positioning and stabilizing structure, the first headgear connecting portions each formed of a flexible material and each attached to a non-patient-facing side of the face lining portion proximate an outer side of the face lining portion; and

[0169] The face lining portion includes a peripheral edge formed by an upper edge portion and a lower edge portion, the upper edge portion and the lower edge portion being connected to each other by a pair of outer edge portions at respective outer sides of the face lining portion, each outer edge portion including an outermost point, wherein each of the first headgear connection portions is attached to the face lining portion inside the outer edge portion.

[0170] In an example:

[0171] · The first headgear connection portions are designed and arranged to push the face lining portion near the outermost points towards the patient's face during use;

[0172] · Each of the first headgear connection portions is attached to the face lining portion near both the upper edge portion and the lower edge portion of the peripheral edge of the face lining portion;

[0173] · Each of the first headgear connection portions is attached to the face lining portion at a joint portion that is located on the non-patient-facing side of the face lining portion, from or near the upper edge portion of the peripheral edge of the face lining portion to or near the lower edge portion;

[0174] · Each of the first headgear connection portions is pivotable relative to the face lining portion along the joint portion;

[0175] · Each of the first headgear connection portions includes an upper edge, a lower edge, and a first strap connection point configured to be attached to a first strap portion of the positioning and stabilizing structure, and the upper edge and the lower edge of each of the first headgear connection portions converge towards each other towards the first strap connection point;

[0176] · The upper edge of each of the first headgear connection portions is substantially tangent to the upper edge portion of the peripheral edge of the face lining portion during use;

[0177] · The lower edge of each of the first headgear connection portions is substantially tangent to the lower edge portion of the peripheral edge of the face lining portion during use;

[0178] · Each of the first headgear connection portions is formed of a fabric material;

[0179] · At least a central portion of each of the first headgear connection portions is formed of a webbing;

[0180] · The first headgear connection portions are upper headgear connection portions, the first strap connection points are upper strap connection points, and the first strap portions of the positioning and stabilizing structure are upper strap portions, and the cushion module further includes a pair of lower headgear connection portions configured to be connected to lower strap portions of the positioning and stabilizing structure;

[0181] · Each lower headgear connection portion includes a magnetic headgear connection point provided to the face cushion portion, and the corresponding lower strip portion can be magnetically attached to the face cushion portion;

[0182] · The face cushion portion is at least partially formed of foam and / or fabric material;

[0183] · The face cushion portion is formed of foam covered with fabric material at least on its side facing away from the patient;

[0184] · The cushion module includes a deformable adjustment member attached to the face cushion portion, and the deformable adjustment member is designed and arranged to be selectively adjusted by the patient to adjust the curvature of the face cushion portion;

[0185] · The deformable adjustment member includes a deformable metal strip that spans from one outer side of the face cushion portion to the other outer side; and / or

[0186] · The deformable metal strip spans between positions at or near the junction between the first headgear connection portion and the face cushion portion.

[0187] In a further example:

[0188] · The face cushion portion has a non-zero negative first principal curvature and a second principal curvature that is less than the first principal curvature;

[0189] · The seal-forming structure includes a membrane portion that is configured to engage the patient's face;

[0190] · The membrane portion is configured to form a seal with at least the nasal prominence area and the alae nasi of the patient's nose;

[0191] · The membrane portion includes nasal apertures through which air can flow to the patient's two nostrils during use;

[0192] · The membrane portion includes oral apertures through which air can flow to the patient's mouth during use; and / or

[0193] · The membrane portion is at least partially formed of fabric material and is airtight.

[0194] Another aspect of one form of the present technology is a patient interface that includes:

[0195] A cushion module that forms an inflatable chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O higher than the ambient air pressure, and the inflatable chamber includes an inflatable chamber inlet port that is sized and structured to receive an air flow at the treatment pressure for the patient to breathe;

[0196] At least partially form a seal-forming structure of the cushion module, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the entrance of the patient's airway, the seal-forming structure having holes therein such that an air flow at the treatment pressure is delivered at least to the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflation chamber during the entire respiratory cycle of the patient in use, the seal-forming structure including at least one nasal aperture and at least one oral aperture through which air can flow to the patient's nasal airway and through which air can flow to the patient's mouth;

[0197] A vent that allows the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the environment, the size and shape of the vent being designed to maintain the treatment pressure in the inflation chamber during use;

[0198] A face cushion portion formed of a flexible material and at least partially forming the front side of the cushion module, to which the seal-forming structure is attached;

[0199] A pair of outer headgear connection portions extending from the rear of the seal-forming structure at the outer side of the cushion module, the outer headgear connection portions being configured to be connected to the outer strip portions of the positioning and stabilization structure, each of the outer headgear connection portions being formed of a flexible material;

[0200] Wherein the cushion module is configured to be supported in place on the patient's face by the outer strip portions of the positioning and stabilization structure during use in the absence of any other strip portions of the positioning and stabilization structure;

[0201] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port.

[0202] Another aspect of the present technology includes a cushion module for a patient interface, the cushion module including:

[0203] An inflation chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O higher than the ambient air pressure, the inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air flow at the treatment pressure for the patient to breathe;

[0204] A seal-forming structure that is constructed and arranged to form a seal with an area of the patient's face surrounding the entrance of the patient's airway, the seal-forming structure having holes therein such that an air flow at the treatment pressure is delivered at least to the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflation chamber during the entire respiratory cycle of the patient in use;

[0205] A face lining portion, which is formed of a flexible material and at least partially forms the front side of the cushion module, and a sealing formation structure is attached to the face lining portion; and

[0206] A pair of outer headgear connection portions, which extend from the rear of the sealing formation structure at the outer side of the cushion module, and the outer headgear connection portions are configured to be connected to the outer strip portions of the positioning and stabilizing structure, and each of the outer headgear connection portions is formed of a flexible material;

[0207] wherein the cushion module is configured to be supported in place on a patient's face by the outer strip portions of the positioning and stabilizing structure in use in the absence of any other strip portions of the positioning and stabilizing structure.

[0208] In an example:

[0209] · The face lining portion includes an upper edge portion and a lower edge portion that define the height of the face lining portion, and each of the outer headgear connection portions includes an upper edge and a lower edge that define the height of the corresponding outer headgear connection portion;

[0210] · Each of the outer headgear connection portions is attached to the face lining portion near both the upper edge portion and the lower edge portion of the peripheral edge of the face lining portion;

[0211] · The height of each outer headgear connection portion is at least half of the height of the face lining portion;

[0212] · The height of each outer headgear connection portion is at least two-thirds of the height of the face lining portion;

[0213] · The upper edge of the corresponding outer headgear connection portion is located near the upper edge portion of the face lining portion;

[0214] · The lower edge of the corresponding outer headgear connection portion is located near the lower edge portion of the face lining portion;

[0215] · The height of each outer headgear connection portion is substantially the same as the height of the face lining portion;

[0216] · Each of the outer headgear connection portions is connected to the face lining portion substantially continuously along the height of the corresponding outer headgear connection portion;

[0217] · Each of the outer headgear connection portions is pivotable relative to the face lining portion both outwardly and inwardly;

[0218] · Each of the outer headgear connection portions includes a slot to which the corresponding outer strip portion of the positioning and stabilizing structure can be connected in use;

[0219] · The outer headgear connection portion is integrally formed with the face cushion portion;

[0220] · The face cushion portion is formed of foam and / or fabric material;

[0221] · Each of the outer headgear connection portions is formed of foam and / or fabric material; and / or

[0222] · The face cushion portion is formed of foam covered with fabric material at least on its non-patient-facing side.

[0223] In another example:

[0224] · The face cushion portion has a non-zero negative first principal curvature and a second principal curvature less than the first principal curvature;

[0225] · The seal-forming structure includes a membrane portion configured to engage the patient's face;

[0226] · The membrane portion is configured to form a seal with at least the nasal apex region and the alae nasi of the patient's nose; and / or

[0227] · The membrane portion is at least partially formed of fabric material and is airtight.

[0228] Another aspect of one form of the present technology is a patient interface that includes:

[0229] A cushion module that forms an inflatable chamber that can be pressurized to a treatment pressure of at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient to breathe;

[0230] At least partially forming a seal-forming structure of the cushion module, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the inlet of the patient's airway, the seal-forming structure having holes therein such that an air flow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle;

[0231] A vent that allows the patient's exhaled gas to continuously flow from the interior of the inflatable chamber to the environment, the vent being sized and shaped to maintain the treatment pressure in the inflatable chamber during use;

[0232] A face cushion portion formed of a flexible material and at least partially forming the front side of the cushion module, the seal-forming structure being attached to the face cushion portion;

[0233] A frame attached to the face lining portion, the frame being constructed and arranged to reinforce the face lining portion, the frame having a pair of outer headgear connection portions located on respective outer sides of the cushion module, the outer headgear connection portions being configured to connect to outer strip portions of a positioning and stabilizing structure;

[0234] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0235] Another aspect of the present technology includes a cushion module for a patient interface, the cushion module comprising:

[0236] An inflation chamber, the inflation chamber being pressurizable to a treatment pressure of at least 4 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port, the inflation chamber inlet port being sized and configured to receive an air flow at the treatment pressure for the patient to breathe;

[0237] A seal-forming structure, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the seal-forming structure having holes therein such that an air flow at the treatment pressure is delivered at least to the inlets of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use;

[0238] A face lining portion, the face lining portion being formed of a flexible material and at least partially forming the front side of the cushion module, the seal-forming structure being attached to the face lining portion; and

[0239] A frame attached to the face lining portion, the frame being constructed and arranged to reinforce the face lining portion, the frame having a pair of outer headgear connection portions located on respective outer sides of the cushion module, the outer headgear connection portions being configured to connect to outer strip portions of a positioning and stabilizing structure.

[0240] In an example:

[0241] · The cushion module is configured to be supported in a proper position on the patient's face by the outer strip portions of the positioning and stabilizing structure during use in the absence of any other strip portions of the positioning and stabilizing structure;

[0242] · The frame is in the form of a skeleton;

[0243] · The frame is formed of a plurality of elongate portions connected to each other;

[0244] · The frame is constructed and arranged to impart a shape to the face lining portion during use;

[0245] · The face lining portion includes a peripheral edge formed by an upper edge portion and a lower edge portion, the upper edge portion and the lower edge portion being connected to each other by a pair of outer edge portions at respective outer sides of the face lining portion, and the frame includes a peripheral portion having a shape corresponding to the peripheral edge of the face lining portion;

[0246] · The shape of the peripheral portion of the frame substantially conforms to the peripheral edge of the face lining portion;

[0247] · Each outer strip connection portion of the frame is connected between the upper portion of the frame and the lower portion of the frame;

[0248] · The upper edge portion of the face lining portion bends backward away from the mid-sagittal plane of either outer side of the patient's face during use, the outer edge portion bends backward and downward away from the upper edge portion and then bends downward and forward toward the lower edge portion, and the lower edge portion bends inward and back toward the mid-sagittal plane;

[0249] · Each outer strip connection portion is connected to the upper portion of the frame near the junction between the upper edge portion of the peripheral edge of the face lining portion and the corresponding outer edge portion;

[0250] · Each outer strip connection portion is connected to the lower portion of the frame near the junction between the lower edge portion of the peripheral edge of the face lining portion and the corresponding outer edge portion;

[0251] · Each outer strip connection portion includes an elongate portion around which the corresponding outer strip portion of the positioning and stabilizing structure can be wound and secured back to itself;

[0252] · The face lining portion is formed of foam and / or fabric material;

[0253] · The face lining portion is formed of foam covered with fabric material at least on its side facing away from the patient;

[0254] · The face lining portion includes an outer pocket designed and arranged to receive and hold the frame during use;

[0255] · The outer pocket is formed of fabric material;

[0256] · The frame includes a pair of outer portions, each outer portion being outside a respective one of the outer strip connection portions of the outer strip connection portions, and each outer portion is received in a respective one of the outer pockets in the outer pocket during use.

[0257] In a further example:

[0258] · The face lining portion has a non-zero negative first principal curvature and a second principal curvature less than the first principal curvature;

[0259] · The seal-forming structure includes a membrane portion configured to engage the patient's face;

[0260] · The membrane portion is configured to form a seal with at least the nasal prominence area and the alae nasi of the patient's nose;

[0261] · The membrane portion includes nasal cavities through which air can flow to the patient's two nostrils during use;

[0262] · The membrane portion includes oral cavities through which air can flow to the patient's mouth during use; and / or

[0263] · The membrane portion is at least partially formed of a fabric material and is airtight.

[0264] Another aspect of one form of the present technology is to provide a patient interface that can be flexed to accommodate patients with faces of different widths.

[0265] Another aspect of one form of the present technology is to provide a lightweight oro-nasal patient interface.

[0266] Another aspect of one form of the present technology is to provide a comfortable and low-cost oro-nasal patient interface.

[0267] Another form of the present technology includes a patient interface that includes:

[0268] An inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the inflatable chamber having at least one inflatable chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient to breathe;

[0269] At least a pair of headgear connection portions that are connected to a face cushion portion and are configured to be connected to a positioning and stabilizing structure;

[0270] A seal-forming structure that partially forms the inflatable chamber, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having at least one hole therein such that an air flow at the treatment pressure is delivered to the patient's nostrils and the inlet of the patient's mouth, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflatable chamber during the entire breathing cycle of the patient during use,

[0271] A face cushion portion that at least partially forms the front side of the patient interface, to which the seal-forming structure is attached;

[0272] The seal-forming structure includes a base pad and a membrane portion configured to form a seal in use against at least the nasal prominence area and the alae nasi of the patient's nose, and the seal-forming structure is further configured to form a seal around the patient's mouth;

[0273] Wherein the face-liner portion is at least partially formed of foam and / or fabric material, the base pad is attached to the patient-facing surface of the face-liner portion, and the membrane portion substantially covers the patient-facing side of the base pad, and the membrane portion is attached to the base pad and / or the face-liner portion.

[0274] In an example:

[0275] · Wherein the face-liner portion at least partially forms an inflatable chamber;

[0276] · The base pad and the membrane portion substantially form the entirety of the inflatable chamber;

[0277] · The face-liner portion is formed of foam covered with fabric material on the non-patient-facing surface of the face-liner portion;

[0278] · The face-liner portion includes a fabric layer on the patient-facing surface;

[0279] · The face-liner portion is formed of fabric material and one or more air-impermeable layers;

[0280] · The base pad is formed of foam;

[0281] · The base pad is formed of polyurethane foam (such as thermoplastic polyurethane);

[0282] · The base pad is air-impermeable;

[0283] · The face-liner portion includes a curved three-dimensional shape in use;

[0284] · The face-liner portion is thermoformed into a curved three-dimensional shape so as to support itself in the curved three-dimensional shape;

[0285] · The base pad is formed of compression-cut foam;

[0286] · The base pad is formed of molded foam;

[0287] · The face-liner portion cannot support itself in a curved three-dimensional shape; and / or

[0288] · The base pad is formed of molded foam and supports the face-liner portion in a curved three-dimensional shape.

[0289] In a further example:

[0290] · The base pad is configured to keep the membrane portion substantially taut when the patient interface is not in use;

[0291] · The membrane portion is bonded to the base pad and / or the face-liner portion;

[0292] · The membrane portion includes a first aperture through which air can flow to the patient's two nostrils during use;

[0293] · The membrane portion includes a second aperture through which air can flow to the patient's mouth during use;

[0294] · The membrane portion is at least partially formed of a fabric material and is airtight;

[0295] · The base pad includes a nasal portion configured to be positioned adjacent to the lower periphery of the patient's nose during use, the base pad forming a nasal recess in the nasal portion, the nasal recess including a shape corresponding to the lower periphery of the patient's nose; and / or

[0296] · The membrane portion is attached to the base pad surrounding the periphery of the nasal recess.

[0297] In a further example:

[0298] · The face lining portion has a first principal curvature that is non-zero and negative and a second principal curvature that is less than the first principal curvature;

[0299] · The second principal curvature is substantially zero and is substantially parallel to the sagittal plane of the patient during use;

[0300] · The face lining portion is configured to flex such that when worn by a patient with a narrow face, the first principal curvature has a greater magnitude than when worn by a patient with a relatively wide face;

[0301] · The at least one pair of headgear connector portions includes a pair of upper headgear connector portions connected to the chassis portion and a pair of lower headgear connector portions connected to the chassis portion;

[0302] · Each of the upper headgear connectors includes a buckle disposed at a respective end of the strap; and / or

[0303] · Each of the lower headgear connector portions includes a magnetic connector.

[0304] Another form of the technology includes a patient interface that includes:

[0305] An inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure, the inflatable chamber having at least one inflatable chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0306] At least one pair of headgear connector portions configured to connect to a positioning and stabilizing structure;

[0307] A seal-forming structure that partially forms an inflation chamber, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having at least one aperture therein such that an air flow at the treatment pressure is delivered to the patient's nostrils and the inlet of the patient's mouth, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0308] Wherein the seal-forming structure includes a base pad and a membrane portion connected to the base pad, the membrane portion being configured to form a seal with at least the nasal prominence area and the alae nasi of the patient's nose, the seal-forming structure also being configured to form a seal around the patient's mouth;

[0309] Wherein the base pad includes a nasal cavity portion that is configured to be positioned adjacent to the lower periphery of the patient's nose during use, the base pad forming a nasal recess in the nasal cavity portion, the nasal recess being configured to at least partially surround the lower periphery of the patient's nose during use, the membrane portion being supported by the base pad at the periphery of the nasal recess, wherein the nasal cavity portion of the base pad includes:

[0310] An inner peripheral portion that partially defines the periphery of the nasal recess and is designed to support the membrane portion at an inner position adjacent to the patient's nasal prominence;

[0311] A pair of outer peripheral portions that partially define the periphery of the nasal recess and are located on the respective outer sides of the inner peripheral portion, the outer peripheral portions being designed to support the membrane portion above the patient's alae nasi on the respective outer sides of the patient's nose and above the inner position where the inner peripheral portion supports the membrane portion.

[0312] In an example:

[0313] · The outer peripheral portion curves upward away from the inner peripheral portion along the periphery of the nasal recess to the respective uppermost points of each outer peripheral portion;

[0314] · The outer peripheral portion curves downward in a rearward direction away from the respective uppermost points along the periphery of the nasal recess;

[0315] · The inner peripheral portion curves upward on either of its outer sides into the outer peripheral portion;

[0316] · Each outer peripheral portion includes a vault shape at the respective uppermost point;

[0317] · The inner peripheral portion includes a saddle shape;

[0318] · The patient interface includes a face-lining portion that at least partially defines the inflation chamber, the base pad being attached to the patient-facing side of the face-lining portion;

[0319] · Each of the outer peripheral portions extends above the upper edge of the face lining portion;

[0320] · The outer peripheral portions are flexible and are designed to deform medially towards the patient's nose in use; and / or

[0321] · The outer peripheral portions are designed to bend medially towards the patient's nose in use.

[0322] In a further example:

[0323] · The nasal recess is configured to avoid simultaneously engaging both laterals of the patient's nose;

[0324] · When the patient's nose is centered within the nasal recess, the nasal recess substantially does not engage either lateral of the patient's nose;

[0325] · The nasal recess includes a shape corresponding to the lower periphery of the patient's nose in a plane parallel to the Frankfurt horizontal plane of the patient's head;

[0326] · The nasal recess substantially surrounds, in use, all the laterally-facing and forward-facing portions of the lower periphery of the patient's nose;

[0327] · The nasal recess includes an inward-facing wall that at least partially surrounds the lower periphery of the patient's nose in use;

[0328] · The inward-facing wall slopes inwardly and upwardly in part;

[0329] · The inward-facing wall extends from one cheek of the patient adjacent to or at the patient's cheek around the patient's nose to the other cheek of the patient adjacent to or at the patient's cheek;

[0330] · The membrane portion is attached to a bottom pad surrounding the periphery of the nasal recess;

[0331] · The inward-facing wall has a concave cross-section in a plane parallel to the Frankfurt horizontal plane of the patient's head;

[0332] · The inward-facing wall has a concave cross-section in the median sagittal plane of the patient's head and / or in a plane parallel to the median coronal plane of the patient's head;

[0333] · The bottom pad includes a pair of rear support portions, each positioned on a respective lateral of the nasal recess and configured to engage the patient's face medial to and adjacent to the nasolabial fold of the patient's face;

[0334] · The rear support portions engage the patient's face at a location below the ala of the nose on either lateral of the upper lip of the patient and / or at a location vertically aligned with the ala of the nose between the ala of the nose and the nasolabial fold;

[0335] · The rear support portion is shaped to project at least partially inwardly into a concave surface formed on the patient's face on either side of the patient's nasal alae; and / or

[0336] · The inward-facing wall extends from a first rear support portion among the rear support portions surrounding the patient's nose to another rear support portion among the rear support portions.

[0337] In a further example:

[0338] · The base pad is configured to keep the membrane portion substantially taut when the patient interface is not in use;

[0339] · The membrane portion is attached to a base pad surrounding an outer periphery of the membrane portion;

[0340] · The membrane portion is bonded to the base pad and / or the face lining portion;

[0341] · The membrane portion includes a first aperture through which air can flow to the patient's two nostrils in use;

[0342] · The membrane portion includes a second aperture through which air can flow to the patient's mouth in use;

[0343] · The membrane portion is at least partially formed of a fabric material;

[0344] · The base pad is formed of foam;

[0345] · The base pad is formed of molded foam;

[0346] · The base pad is formed of compression cut foam;

[0347] · The base pad is formed of polyurethane (such as thermoplastic polyurethane);

[0348] · The face lining portion has a first principal curvature that is non-zero and negative and a second principal curvature that is less than the first principal curvature;

[0349] · The second principal curvature is substantially zero and is substantially parallel to the sagittal plane of the patient in use;

[0350] · The face lining portion is configured to flex such that when worn by a patient with a narrow face, the first principal curvature has a greater magnitude than when worn by a patient with a relatively wider face;

[0351] · The at least one pair of headgear connectors includes a pair of upper headgear connectors connected to the chassis portion and a pair of lower headgear connectors connected to the chassis portion;

[0352] · Each of the upper headgear connectors is formed by a buckle provided to a fabric strap; and / or

[0353] · Each of the headgear connectors includes a magnetic connector.

[0354] Another form of the technology includes a patient interface that includes:

[0355] An inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure, the inflatable chamber having at least one inflatable chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0356] At least a pair of headgear connector portions configured to be connected to a positioning and stabilizing structure;

[0357] A seal-forming structure that partially forms the inflatable chamber, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure having at least one aperture therein such that an air flow at the therapeutic pressure is delivered to the patient's nostrils and the inlet of the patient's mouth, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use,

[0358] Wherein the seal-forming structure includes a bottom pad and a membrane portion connected to the bottom pad;

[0359] Wherein the bottom pad is designed to bend at one or more locations when the patient wears the patient interface.

[0360] In an example:

[0361] · The bottom pad is designed to bend in such a way that a first portion of a cross-section through the bottom pad bends relative to a second portion of the cross-section through the bottom pad;

[0362] · A first portion of the cross-section through the bottom pad forms the patient-facing side of the bottom pad and in use pushes the membrane portion of the seal-forming structure against the patient's face, and a second portion of the cross-section through the bottom pad forms the non-patient-facing side of the bottom pad in use;

[0363] · The bottom pad is designed to bend near the user's nose when the patient wears the patient interface;

[0364] · The bottom pad is designed to bend near the user's mouth when the patient wears the patient interface;

[0365] · The bottom pad is designed to bend near the lower lip of the user when the patient wears the patient interface;

[0366] · The bottom pad is designed to bend near the user's cheek when the patient wears the patient interface;

[0367] · The membrane portion is configured to form a seal against at least the nasal prominence area and the alae nasi of the patient's nose, and the seal-forming structure is further configured to form a seal around the patient's mouth;

[0368] Wherein the base pad includes a nasal cavity portion configured to be positioned adjacent to the lower periphery of the patient's nose in use, the base pad forms a nasal recess in the nasal cavity portion, the nasal recess is configured to at least partially surround the lower periphery of the patient's nose in use, and the membrane portion is supported by the base pad at the periphery of the nasal recess;

[0369] · Wherein the nasal cavity portion of the base pad includes a pair of outer peripheral portions that partially define the periphery of the nasal recess and are located on the respective outer sides of the patient's nose in use, and the outer peripheral portions are designed to support the membrane portion above the patient's alae nasi on the respective outer sides of the patient's nose;

[0370] · The outer peripheral portions are flexible and are designed to deform medially towards the patient's nose in use;

[0371] · The outer peripheral portions are designed to bend medially towards the patient's nose in use;

[0372] · The base pad includes one or more hinge regions at which the base pad is designed to bend when the patient dons the patient interface;

[0373] · Each of the one or more hinge regions is formed by a channel formed in the base pad, and the channel forms a region of reduced thickness;

[0374] · The oral cavity channel forming one of the one or more hinge regions is provided in the lower lip region of the base pad;

[0375] · The oral cavity channel is provided in the cheek region of the base pad;

[0376] · The oral cavity channel extends along a first cheek region, along the lower lip region and along a second cheek region;

[0377] · The nasal cavity channel is provided in the nasal recess;

[0378] · The nasal cavity channel extends laterally around the nasal recess;

[0379] · The base pad includes a pair of rear support portions, each of the pair of rear support portions being positioned on the respective outer side of the nasal recess and configured to engage the patient's face medial to and adjacent to the nasolabial fold of the patient's face, and wherein the nasal cavity channel is provided near the rear support portions; and / or

[0380] · The nasal cavity channel and the oral cavity channel converge at the respective outer sides of the base pad to form a single continuous channel.

[0381] In a further example:

[0382] · The nasal recess is configured to avoid simultaneously engaging both outer sides of the patient's nose;

[0383] · The nasal recess includes a shape corresponding to the lower periphery of the patient's nose in a plane parallel to the Frankfurt horizontal plane of the patient's head;

[0384] · The nasal recess substantially encloses in use all outward-facing and forward-facing portions of the lower periphery of the patient's nose;

[0385] · The nasal recess includes an inward-facing wall that at least partially encloses the lower periphery of the patient's nose in use;

[0386] · The inward-facing wall is partially inward and partially upward;

[0387] · The inward-facing wall extends from one cheek of the patient adjacent to or near the patient's nose around the patient's nose to the other cheek of the patient adjacent to or near the patient's nose; and / or

[0388] · The membrane portion is attached to a bottom pad surrounding the periphery of the nasal recess.

[0389] In another example:

[0390] · The patient interface includes a face cushion portion that partially forms an inflatable chamber, to which the bottom pad is attached;

[0391] · The face cushion portion is formed of foam covered with a fabric material on the non-patient-facing surface of the face cushion portion;

[0392] · The face cushion portion includes a fabric layer on the patient-facing surface;

[0393] · The bottom pad is formed of foam;

[0394] · The bottom pad includes a skinned surface;

[0395] · The bottom pad is formed of polyurethane (such as thermoplastic polyurethane);

[0396] · The face cushion portion includes a curved three-dimensional shape in use;

[0397] · The face cushion portion is thermoformed into a curved three-dimensional shape so as to support itself in that curved three-dimensional shape;

[0398] · The bottom pad is formed of compression cut foam;

[0399] · The bottom pad is formed of molded foam;

[0400] · The face cushion portion cannot support itself in a curved three-dimensional shape;

[0401] · The base pad is formed of molded foam and supports the face cushion portion in a curved three-dimensional shape;

[0402] · The base pad is configured to keep the membrane portion substantially taut when the patient interface is not in use;

[0403] · The membrane portion is coupled to the base pad and / or the face cushion portion;

[0404] · The membrane portion includes a first aperture through which, in use, air can flow to the patient's two nostrils;

[0405] · The membrane portion includes a second aperture through which, in use, air can flow to the patient's mouth; and / or

[0406] · The membrane portion is at least partially formed of a fabric material.

[0407] Another aspect is a patient interface that includes a cushion module according to any one of the above aspects or examples, wherein the patient interface includes a positioning and stabilization structure configured to apply a force to the cushion module to hold the cushion module in a sealed position during use. The positioning and stabilization structure can include a pair of first strap portions configured to be coupled to the cushion module. In some examples, the positioning and stabilization structure can include a pair of upper strap portions and a pair of lower strap portions configured to be coupled to the cushion module.

[0408] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape complementary to the peripheral shape of an intended wearer.

[0409] One aspect of one form of the present technology is a method of manufacturing a device.

[0410] Another aspect of one form of the present technology is a method of assembling a modular system, including selecting a positioning and stabilization structure and coupling the positioning and stabilization structure to a first cushion or a second cushion.

[0411] One aspect of certain forms of the present technology is an easy-to-use medical device, such as being easy to use by a person who has not received medical training, by a person with limited flexibility and vision, or by a person with limited experience in using this type of medical device.

[0412] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around a person's home).

[0413] One aspect of one form of the present technology is a patient interface that can be cleaned at a patient's home, for example, in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be cleaned at a patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0414] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of processors such as those of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Additionally, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions such as, for example, sleep-disordered breathing.

[0415] Of course, parts of these aspects can form sub-aspects of the present technology. Additionally, the various sub-aspects and / or aspects in the sub-aspects and / or aspects can be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0416] Other features of the present technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. Description of the Drawings

[0417] The present technology is illustrated by way of example and not limitation in the figures of the drawings, in which like reference numerals refer to similar elements, including:

[0418] Respiratory therapy system

[0419] Figure 1A A system including a patient 1000 is shown, where the patient 1000 wears a patient interface 3000 in the form of nasal pillows, and the patient interface 3000 receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0420] Figure 1B A system including a patient 1000 is shown, where the patient 1000 wears a patient interface 3000 in the form of a nasal mask, and the patient interface 3000 receives a positive pressure air supply 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.

[0421] Figure 1CShows a system including patient 1000, who wears a patient interface 3000 in the form of a full-face mask, and the patient interface 3000 receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and is transmitted along an air circuit 4170 to patient 1000. The patient is sleeping in a lateral recumbent sleeping position.

[0422] Respiratory System and Facial Anatomy

[0423] Figure 2A Shows a schematic diagram of the human respiratory system including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0424] Figure 2B Shows a view of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, major alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0425] Figure 2C Is a front view of a face with several identified surface anatomical features, including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial fold, and oral commissure points. The upper, lower, radially inward, and radially outward directions are also indicated.

[0426] Figure 2D Is a side view of a head with several identified surface anatomical features, including the glabella, nasion, nasal prominence, subnasale, upper lip, lower lip, supramental point, nasal ridge, alar crest point, superior auricular point, and inferior auricular point. The up-down direction and the front-back direction are also indicated.

[0427] Figure 2E Is another side view of the head. The approximate positions of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0428] Figure 2F Shows a bottom view of the nose with several identified features, including the nasolabial fold, lower lip, vermilion border of the upper lip, nostrils, subnasale, columella, nasal prominence, long axis of the nostril, and median sagittal plane.

[0429] Figure 2G Shows a side view of the surface features of the nose.

[0430] Figure 2H Shows the subcutaneous structure of the nose, including the lateral cartilage, septal cartilage, major alar cartilage, minor alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0431] Figure 2I Shows a medial anatomical view of the nose approximately a few millimeters from the mid-sagittal plane, particularly showing the septal cartilage and the medial crura of the greater alar cartilages.

[0432] Figure 2J Shows a front view of the skull including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0433] Figure 2K Shows a lateral view of the skull with the outline of the surface of the head 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0434] Figure 2L Shows an anterolateral view of the nose.

[0435] Patient interface

[0436] Figure 3A Shows a nasal mask form of the patient interface according to one form of the present technology.

[0437] Figure 3A-1 Shows the forces acting on the Figure 3A patient interface during use.

[0438] Figure 3B Shows a schematic diagram of a cross-section through the structure at a point. The outward normal at that point is indicated. The curvature at that point has a positive sign and is relatively large in magnitude when compared to the Figure 3C magnitude of the curvature shown.

[0439] Figure 3C Shows a schematic diagram of a cross-section through the structure at a point. The outward normal at that point is indicated. The curvature at that point has a positive sign and is relatively small in magnitude when compared to the Figure 3B magnitude of the curvature shown.

[0440] Figure 3D Shows a schematic diagram of a cross-section through the structure at a point. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0441] Figure 3E Shows a schematic diagram of a cross-section through the structure at a point. The outward normal at that point is indicated. The curvature at that point has a negative sign and is relatively small in magnitude when compared to the Figure 3F magnitude of the curvature shown.

[0442] Figure 3FA schematic diagram showing a cross-section through a structure at a point is presented. The outward normal at that point is indicated. The curvature at that point has a negative sign and is relatively large in magnitude when compared with Figure 3E the magnitude of the curvature shown.

[0443] Figure 3G A cushion for a face mask including two pillows is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The vault region and the saddle region are indicated.

[0444] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. A path on the surface between point A and point B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and one vault region are indicated.

[0445] Figure 3I The surface of a structure having a one-dimensional hole in the surface is shown. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0446] Figure 3J A cross-section through the Figure 3I structure is shown. The illustrated surface bounds a two-dimensional hole in the Figure 3I structure.

[0447] Figure 3K A Figure 3I perspective view of the structure, including a two-dimensional hole and a one-dimensional hole, is shown. Also shown is the surface that bounds the two-dimensional hole in the Figure 3I structure.

[0448] Figure 3L A face mask having an inflatable bladder as a cushion is shown.

[0449] Figure 3M A cross-section through the Figure 3L face mask is shown, and the inner surface of the bladder is shown. The inner surface bounds a two-dimensional hole in the face mask.

[0450] Figure 3N A further cross-section through the Figure 3L face mask is shown. The inner surface is also indicated.

[0451] Figure 3O The left-hand rule is illustrated.

[0452] Figure 3P The right-hand rule is illustrated.

[0453] Figure 3Q The left ear, including the left ear helix, is shown.

[0454] Figure 3R The right ear, including the right ear helix, is shown.

[0455] Figure 3S shows a right-handed helix.

[0456] Figure 3T shows a view of the face mask, including the sign of the twist of the space curve defined by the edge of the sealing membrane in different regions of the face mask.

[0457] Figure 3U shows a view of the inflatable chamber 3200, showing the sagittal plane and the intermediate contact plane.

[0458] Figure 3V shows Figure 3U a view of the rear portion of the inflatable chamber. The direction of this view is orthogonal to the intermediate contact plane. Figure 3V The sagittal plane in [reference] bisects the inflatable chamber into a left-hand side and a right-hand side.

[0459] Figure 3W shows a cross-section through the Figure 3V inflatable chamber, which cross-section is taken at the sagittal plane shown in Figure 3V The "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of the chord 3210, which lies in the sagittal plane and contacts the gasket of the inflatable chamber only at two points (upper point 3215 and lower point 3230) on the sagittal plane. Depending on the geometry of the gasket in this region, the intermediate contact plane can be the tangent plane at the upper and lower points.

[0460] Figure 3X shows the Figure 3U inflatable chamber 3200 in a position for use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the median sagittal plane of the face. When the inflatable chamber is in the use position, the intermediate contact plane generally corresponds to the "plane of the face". In Figure 3X [reference], the inflatable chamber 3200 is the inflatable chamber of a nasal mask, and the upper point 3215 is approximately located on the nasal bridge point, while the lower point 3230 is located on the upper lip.

[0461] Figure 3Y shows a patient interface in the form of a nasal cannula according to one form of the present technology.

[0462] Figure 3Z shows a patient interface with a catheter headgear according to one form of the present technology.

[0463] Figure 3Z-1 shows the forces acting on the Figure 3Z patient interface during use.

[0464] RPT device

[0465] Figure 4AShows an RPT device according to one form of the present technology.

[0466] Figure 4B Is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined upstream of the patient interface, and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0467] Humidifier

[0468] Figure 5A Shows an isometric view of a humidifier according to one form of the present technology.

[0469] Figure 5B Shows an isometric view of a humidifier according to one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0470] Respiratory waveform

[0471] Figure 6 Shows a typical respiratory waveform of a human model while sleeping.

[0472] Modular

[0473] Figure 7A Shows a perspective view of a gasket of a patient interface configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0474] Figure 7B Shows a perspective view of a gasket of a patient interface configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0475] Figure 7C Shows a perspective view of a tube that can be used with Figure 7A the gasket or Figure 7B the gasket.

[0476] Figure 7D Shows a perspective view of a tube that can be used with Figure 7A the gasket or Figure 7B the gasket.

[0477] Figure 7E Shows a perspective view of a reinforcing arm that can be used with Figure 7A the gasket.

[0478] Figure 7F Shows a perspective view of a headgear strap that can be used with Figure 7B the gasket.

[0479] Figure 7G shows a front view of a pair of sleeves removably assembled to a tube or Figure 7C a reinforcing arm. Figure 7D of

[0480] Figure 7H shows a front view of a complete sleeve removably assembled to a Figure 7D reinforcing arm.

[0481] Figure 7I shows a front perspective view of yet another alternative form of a complete sleeve removably assembled to a Figure 7D reinforcing arm.

[0482] Figure 7J is a front view of a patient wearing a tube connected to Figure 7C a headgear strip and Figure 7E a sleeve of Figure 7G a gasket. Figure 7A of

[0483] Figure 7K is a front view of a patient wearing a reinforcing arm connected to Figure 7D a headgear strip and Figure 7E a sleeve of Figure 7H a gasket. Figure 7A of

[0484] Figure 7L is a front view of a patient wearing a catheter headgear and Figure 7C a headgear strip of Figure 7F a gasket. Figure 7B of

[0485] Figure 7M is a front view of a patient wearing a reinforcing arm connected to Figure 7D a headgear strip and Figure 7F a sleeve of Figure 7I a gasket. Figure 7B of

[0486] Figure 7N is Figure 7L an isolated perspective view of a vent.

[0487] Figure 7O is Figure 7M an isolated perspective view of a part of an air circuit.

[0488] Figure 7P is a schematic diagram illustrating possible combinations of a patient interface.

[0489] Additional examples of the present technology

[0490] Figure 8A perspective view illustration of a patient interface when used by a patient according to an example of the present technology.

[0491] Figure 9 is Figure 8 An outside view illustration of the patient interface when used by a patient as shown.

[0492] Figure 10 is Figure 8 A front perspective view illustration of a cushion module of the patient interface.

[0493] Figure 11 is Figure 10 A rear perspective view illustration of the cushion module.

[0494] Figure 12 is Figure 8 A perspective view illustration of the patient interface as shown.

[0495] Figure 13 is Figure 8 A rear perspective view illustration of the patient interface in a wide configuration as shown.

[0496] Figure 14 is Figure 8 A rear perspective view illustration of the patient interface in a narrow configuration as shown.

[0497] Figure 15 is Figure 8 A front perspective view illustration of a face cushion portion of the patient interface as shown.

[0498] Figure 16 is Figure 15 An upper outside perspective view illustration of the face cushion portion as shown.

[0499] Figure 17 A rear outside perspective view illustration of a face cushion portion of a patient interface according to another example of the present technology.

[0500] Figure 18 is Figure 17 A rear lower perspective view illustration of the face cushion portion as shown.

[0501] Figure 19 is Figure 17 A rear view illustration of the face cushion portion as shown.

[0502] Figure 20 is including Figure 17 A rear perspective view illustration of a cushion module of the face cushion portion as shown.

[0503] Figure 21 is Figure 20 Another rear perspective view illustration of the cushion module as shown.

[0504] Figure 22 isFigure 20 Perspective view illustration of the lower side of the cushion module shown.

[0505] Figure 23 is Figure 20 Rear upper perspective view illustration of the cushion module shown.

[0506] Figure 24 Rear upper perspective view illustration of a cushion module according to another example of the present technology.

[0507] Figure 25 Perspective view of a cushion module according to another example of the present technology and an elastic member of the cushion module in an unassembled configuration.

[0508] Figure 26 is Figure 25 Outer side perspective view illustration of the cushion module in an unassembled configuration shown, where the elastic member is visible through the oral cavity hole of the cushion module.

[0509] Figure 27 is Figure 26 Outer side rear lower perspective view of the cushion module shown, where the elastic member is visible through the oral cavity hole of the cushion module.

[0510] Figure 28 is Figure 26 Rear upper perspective view illustration of the cushion module shown, where the elastic member is visible through the oral cavity hole of the cushion module.

[0511] Figure 29 Perspective view illustration of a patient interface when being used by a patient according to another example of the present technology.

[0512] Figure 30 is Figure 29 Perspective view illustration of the patient interface in an isolated state shown.

[0513] Figure 31 is Figure 29 Rear perspective view illustration of the cushion module of the patient interface shown.

[0514] Figure 32 is Figure 31 Rear upper perspective view illustration of the cushion module shown.

[0515] Figure 33 is Figure 31 Front outer side perspective view illustration of the cushion module shown.

[0516] Figure 34 is Figure 31 Front view illustration of the cushion module shown.

[0517] Figure 35 is Figure 31An external view illustration of the cushion module shown, where the upper headgear connection part is pulled in the forward direction.

[0518] Figure 36 is Figure 31 An upper external perspective view illustration of the cushion module shown, where the upper headgear connection part is pulled in the forward direction.

[0519] Figure 37 is a perspective view of a patient interface according to another example of the present technology.

[0520] Figure 38 is Figure 37 A detailed perspective view of the cushion module of the patient interface shown.

[0521] Figure 39 is a perspective view of a cushion module according to another example of the present technology.

[0522] Figure 40 is for Figure 39 A perspective view of the frame of the cushion module shown.

[0523] Figure 41 is Figure 39 shown with Figure 40 the frame and Figure 42 A perspective view of the cushion module assembled with the ventilation module shown.

[0524] Figure 42 is for Figure 39 The ventilation module of the cushion module shown.

[0525] Figures 43 to 48 Shows an illustration of a patient interface and its components according to another example of the present technology.

[0526] Figure 49 Shows an upper view illustration of the bottom cushion for a patient interface according to another example of the present technology.

[0527] Figure 50 Shows Figure 49 A rear view illustration of the bottom cushion shown.

[0528] Figure 51 Shows a rear perspective view illustration of a patient interface according to another example of the present technology.

[0529] Figure 52 is a schematic diagram showing Figure 51 The seal between the patient interface shown and the patient's nose.

[0530] Figures 53 to 54 Shows Figure 51 A front perspective view illustration of the patient interface in use shown.

[0531] Figures 55 to 60 A diagram showing a patient interface and its components according to another example of the present technology.

[0532] Figures 61 to 62 A diagram showing the base pad and face cushion portion of a patient interface according to another example of the present technology.

[0533] Figures 63 to 65 A diagram showing a patient interface and its components according to another example of the present technology.

[0534] Figure 66 Shows Figures 63 to 65 A front perspective view diagram of the patient interface in use as shown.

[0535] Figure 67 A diagram showing a part of a patient interface according to another example of the present technology.

[0536] Figure 68 And Figure 69 A diagram showing a partial cross-section through a patient interface according to another example of the present technology.

[0537] Figure 70 And Figure 71 A view of the base pad according to another example of the present technology.

[0538] Figure 72 Shows a front view of a cushion module including Figure 70 the base pad, with the membrane portion omitted.

[0539] Figure 73 Shows Figure 72 a rear view of the cushion module, with the membrane portion omitted.

[0540] Figure 74 Shows a front view of a cushion module including Figure 72 the membrane portion.

[0541] Figure 75 Shows a rear view of a cushion module including Figure 72 the membrane portion.

[0542] Figure 76 Shows Figure 72 a partial exploded view of the cushion module, with the membrane portion omitted.

[0543] Figure 77 Shows a front upper view of a patient interface including Figure 72 the cushion module when worn by a patient. Detailed Description

[0544] Before further describing the technology in detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terms used in this disclosure are for the purpose of describing only the specific examples discussed herein and are not intended to be limiting.

[0545] The following description is provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any one example may constitute another example.

[0546] Therapy

[0547] In one form, the technology includes a method for treating a respiratory disorder, the method including applying positive pressure to the entrance of the airway of a patient 1000.

[0548] In certain examples of the technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

[0549] In certain examples of the technology, mouth breathing is restricted, constrained, or prevented.

[0550] Respiratory therapy system

[0551] In one form, the technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air stream to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0552] Patient interface

[0553] According to one aspect of the technology, as Figure 3A shown, the non-invasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 in one form for connecting to the air circuit 4170, and (in some specific examples) a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the airway of the patient so as to maintain positive pressure at the entrance of the airway of the patient 1000. Accordingly, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0554] As Figure 3ZAs shown, the non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilization structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit (such as the air circuit 4170 shown in Figures 1A to 1C ). The inflatable chamber 3200 can be formed by one or more modular components (e.g., the gasket module 3150 together with the seal-forming structure 3100), in the sense that it or they can be replaced with different components (e.g., components having different sizes). The gasket module 3150 can be part of the mask forming the inflatable chamber 3200 and the seal-forming structure 3100. The gasket module 3150 can be separated from other components of the patient interface 3000, or it may not be separated from one or more other components (such as parts of the positioning and stabilization structure 3300, the ventilation module, the short tube 3610, and / or the disconnect structure).

[0555] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal prongs 3810a, 3810b that can deliver air to the respective nostrils of the patient 1000 via corresponding orifices in their tips. Such nasal prongs generally do not form a seal with the inner or outer skin surface of the nostrils. This type of interface creates one or more gaps that are present by design (intentional) during use, but they are generally not fixed in size such that they may vary unpredictably due to movement during use. Different from other types of mask-based respiratory therapy systems, this can provide complex pneumatic variables for the respiratory therapy system when control and / or assessment are implemented. The air to the nasal prongs can be delivered through one or more air supply lumens 3820a, 3820b connected to the unsealed nasal cannula-type patient interface 3800. The lumens 3820a, 3820b lead from the unsealed nasal cannula-type patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an air flow at a controlled flow rate rather than a controlled pressure. The "vent" or gap at the unsealed patient interface 3800 is a passage between the ends of the prongs 3810a and 3810b of the unsealed nasal cannula-type patient interface 3800 that leads to the atmosphere through the patient's nostrils, and excess air flow escapes to the environment through this "vent" or gap.

[0556] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0557] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to provide an air supply at a positive pressure of at least 2, 4, 6, 8, or at least 10 cmH2O relative to the environment.

[0558] A patient interface 3000 according to one form of the present technology is constructed and arranged to be able to provide an air supply at a positive pressure of at least 20 cmH2O relative to the environment, such as up to 30 cmH2O or up to 40 cmH2O.

[0559] Figures 43 to 77 Various views of a patient interface 3000 and its components or parts according to examples of the present technology are shown. In these examples, the patient interface 3000 includes an inflatable chamber 3200 that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The inflatable chamber 3200 has at least one inflatable chamber inlet port 3202 that is sized and configured to receive an air flow at the treatment pressure for a patient to breathe. In these examples, the inflatable chamber 3200 of each patient interface is partially formed by a face seal portion 3240 of the patient interface 3000. The inflatable chamber inlet port 3202 can be formed in the face seal portion 3240, such as as Figure 51 , Figure 53 , Figure 54 , Figure 63 , Figure 64 , Figure 66 and Figures 72 to 77 shown. In many other figures of the face seal portion 3240, the inflatable chamber inlet port 3202 is not shown or not labeled. The face seal portion 3240 can at least partially form the front side of the patient interface 3000, such as as Figure 53 , Figure 54 , Figure 66 and Figures 72 to 77 shown.

[0560] The patient interface 3000 can also include at least a pair of headgear connectors that are configured to connect to a positioning and stabilizing structure 3300 of the patient interface 3000 (see Figure 52 , Figure 53 , Figure 66 and Figure 77 ). The headgear connectors can be connected to the face seal portion 3240. In the illustrated example, the patient interface 3000 includes a pair of upper headgear connector portions 3310 and a pair of lower headgear connector portions 3320. In other examples, there can be only a pair of headgear connectors (e.g., two-point headgear connection).

[0561] In Figures 70 to 77 the example shown, the headgear connectors are substantially as described below with reference to Figures 29 to 36 separately.

[0562] Also refer to Figures 43 to 77, each patient interface 3000 further includes a seal-forming structure 3100 that partially forms an inflation chamber 3200. The seal-forming structure 3100 may be attached to the face cushion portion 3240. The seal-forming structure 3100 is configured and arranged to form a seal with an area of the patient's face that surrounds the entrance of the patient's airway during use. The seal-forming structure 3100 has at least one aperture therein such that an air flow at a treatment pressure is delivered to the patient's nostrils and the entrance of the patient's mouth. The seal-forming structure 3100 is configured and arranged to maintain the treatment pressure in the inflation chamber during the patient's entire respiratory cycle during use.

[0563] In some examples of the present technology, the seal-forming structure 3100 includes a base pad 3225. The seal-forming structure 3100 may further include a membrane portion 3220 that is connected to the base pad 3225 and / or the face cushion portion 3240, and the membrane portion 3220 is configured to form a seal with at least the nasal prominence area and the alae nasi of the patient's nose. In this example, the seal-forming structure 3100 is further configured to form a seal around the patient's mouth. The seal-forming structure 3100 may be configured to be inflated to form a partial or complete seal. The seal-forming structure 3100 may additionally or alternatively be pressed against the patient's face to form a seal in one or more areas.

[0564] Gasket module

[0565] In Figures 43 to 77 the illustrated example, the face cushion portion 3240, the base pad 3225, and the membrane portion 3220 may together form a gasket module 3150. The gasket module 3150 may be combined with other components (such as a positioning and stabilization structure 3300 (e.g., a headgear) and a connector 3620 and / or a short tube 3610 for fluid connection to an air circuit) to form the patient interface 3000. By way of example, in Figure 53 , Figure 54 , Figure 66 and Figure 76 these components are shown. The gasket module 3150 and thus the face cushion portion 3240, the base pad 3225, and the membrane portion 3220 may be provided in a variety of shape / size options to conform to a range of patient face shapes and sizes. Further details of the gasket module 3150 will be described below with reference to Figures 8 to 42 .

[0566] Figure 8 and Figure 9 show a patient interface 3000 according to another example of the present technology. Figures 10 to 16 Shows a view of the components of the patient interface 3000. Figures 17 to 42 Shows additional patient interface components or the patient interface 3000. The example shown in Figures 8 to 42 will be described in detail below. It should be understood thatFigures 8 to 42 shown or referenced Figures 8 to 42 Any feature of the example described may be combined with Figures 43 to 77 shown or referenced Figures 43 to 77 any feature described.

[0567] The patient interface 3000 includes a cushion module 3150 that forms an inflation chamber 3200 that can be pressurized to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure. The inflation chamber 3200 includes Figure 10 the inflation chamber inlet port 3244 shown, the size and structure of which are designed to receive an air flow at the therapeutic pressure for the patient to breathe.

[0568] The patient interface 3000 further includes a seal-forming structure 3100 that partially forms the cushion module 3150. The seal-forming structure 3100 may be constructed and arranged to form a seal with an area of the patient's face that surrounds the entrance to the patient's airway. The seal-forming structure 3100 may have holes therein such that an air flow at the therapeutic pressure is delivered at least to the entrances of the patient's nostrils. In Figures 8 to 77 the example shown, the seal-forming structure includes a nasal cavity aperture 3171 that provides an air flow to the patient's nasal airway and an oral aperture 3172 that provides an air flow to the patient's mouth. The seal-forming structure 3100 may be constructed and arranged to maintain the therapeutic pressure in the inflation chamber 3200 throughout the patient's respiratory cycle during use.

[0569] The patient interface 3000 further includes a vent 3400. The vent 3400 may allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber 3200 to the environment. The size and shape of the vent 3400 may be designed to maintain the therapeutic pressure in the inflation chamber 3200 during use.

[0570] In this example, the patient interface 3000 may be configured to allow the patient to breathe from the environment through their mouth without a pressurized air flow passing through the inflation chamber inlet port 3244. For example, the patient interface 3000 may include an anti-asphyxia valve (AAV).

[0571] The cushion module 3150 may include the seal-forming structure 3100 and the face cushion portion 3240 described below, and may also include additional components or parts, such as Figures 43 to 77 a bottom cushion 3225 in the case of the example shown.

[0572] referenced Figures 8 to 42In the illustrated or described examples, the seal-forming structure 3100 may include a membrane portion 3220 configured to engage the patient's face in use. The membrane portion 3220 may be attached to the face-liner portion 3240. For example, the membrane portion 3220 may be attached to the periphery of the face-liner portion 3240.

[0573] The membrane portion 3220 may be configured to form a seal around at least the nasal bridge point region and the nasal wings of the patient's nose. The patient interface 3000 having this configuration may be referred to as an ultra-compact full-face (UCFF) mask. As Figure 11 marked in and shown in other figures, the membrane portion 3220 may include nasal apertures 3171 through which air may flow to the patient's two nostrils in use. In other examples, the membrane portion 3220 or other seal-forming structure 3100 may include a pair of nasal apertures 3171, each nasal aperture 3171 shaped and positioned to provide an air flow to a respective one of the patient's nostrils. As particularly shown in Figure 11 the membrane portion 3220 may include an oral aperture 3172 through which air may flow to the patient's mouth in use. In some examples, the membrane portion 3220 may include a single aperture shaped and sized to seal around the nasal airway and the mouth.

[0574] In some examples, the nasal apertures 3171 and the oral aperture 3172 are oriented at approximately 90 degrees relative to each other. In other examples, for instance, they may be oriented at between 70 and 90 degrees to each other.

[0575] The membrane portion 3220 may be formed at least in part from a fabric material and may be airtight. The membrane portion 3220 may include a fabric layer and an airtight layer, such as a silicone or TPU film layer. In other examples, the membrane portion 3220 may be formed from an elastomeric material such as silicone or thermoplastic elastomer. In some examples, the membrane portion 3220 may include a total thickness of 0.3 mm. For example, the membrane portion 3220 may include a fabric layer having a thickness of 0.27 mm and a silicone layer of 0.03 mm applied to its underside (the inside of the inflation chamber 3200). The fabric may be knitted, for example made of synthetic fibers. The membrane portion 3220 may be knitted to allow it to stretch in use to easily conform to the patient's face. In other examples, the membrane portion 3220 may be thicker, for example 0.5 mm overall.

[0576] The cushion module 3150 may include at least a pair of headgear connection portions that are connected to the face-liner portion 3240 and are configured to be connected to the positioning and stabilization structure 3300 of the patient interface 3000. In reference Figures 8 to 36In the illustrated or described examples, for instance, the patient interface 3000 or its cushion module 3150 can include a pair of upper headgear connection portions 3310 connected to the face cushion portion 3240 and a pair of lower headgear connection portions 3320 connected to the face cushion portion 3240. In Figures 8 to 28 the illustrated example, each of the upper headgear connection portions 3310 includes a curved arm. Each of the lower headgear connection portions 3320 includes a magnetic connector. As Figure 8 and Figure 9 shown, the upper strip portion 3311 of the positioning and stabilizing structure 3300 can be attached to each upper headgear connection portion 3310, and the lower strip portion 3321 of the positioning and stabilizing structure 3300 can be attached to each of the lower headgear connection portions 3320. The upper strip portion 3311 and the lower strip portion 3321 of the positioning and stabilizing structure 3300 can be connected to the crown strip portion 3360, such as as Figure 9 shown. The crown strip portion 3360 can engage the rear portion of the patient's head, hold it in a stable position and provide an anchor to which the upper strip portion 3311 and the lower strip portion 3321 are connected in use and to which tension is transferred.

[0577] For clarity, the upper headgear connection portions 3310 are not shown in many of the figures showing the face cushion portion 3240.

[0578] Face cushion portion

[0579] Referring Figures 8 to 16 to, the patient interface 3000 in this example includes a face cushion portion 3240. The face cushion portion 3240 can partially form the inflation chamber 3200. The face cushion portion 3240 can form the front portion of the cushion module 3150 and, in some examples, can include an inflation chamber inlet port 3244 and / or a connection to the positioning and stabilizing structure 3300. The face cushion portion 3240 can at least partially form the front side of the cushion module 3150. For example, the face cushion portion 3240 can form most of the side of the cushion module 3150 facing away from the patient. The seal-forming structure 3100 can be attached to the face cushion portion 3240. For example, the seal-forming structure 3100 can be attached to the side of the face cushion portion 3240 facing the patient. In particular, as Figure 15 and Figure 16 shown, the face cushion portion 3240 can include a curved shape and can be curved at least partially in a rearward direction on the outer side of the face cushion portion 3240 in use. The face cushion portion 3240 can be curved to conform to the shape of the patient's face. For example, the face cushion portion 3240 can be curved to wrap around the patient's face on either side of the midsagittal plane of the user's head.

[0580] As Figure 15As shown, the face cushion portion 3240 may have a non-zero negative first principal curvature P1 and a second principal curvature P2 that is less than the first principal curvature P1. In some instances, the second principal curvature P2 may be less than the first principal curvature P1 in the sense that the second principal curvature P2 may be zero. In some instances, the periphery of the face cushion portion 3240 may be reminiscent of a hyperbolic paraboloid. In some instances, the face cushion portion 3240 includes a single curved surface to provide a structure that is slightly rigid in the vertical direction but more flexible in the horizontal direction to allow the structure to conform to the patient's face. The curved shape may provide a low-profile face mask that closely conforms to the shape of the patient's face from left to right. For example, in use, the face cushion portion 3240 may be substantially tangent to the patient's face.

[0581] The face cushion portion 3240 may be formed of a flexible material. In some instances, the face cushion portion is at least partially formed of one or more foam and / or fabric materials. In some instances, the face cushion portion 3240 is formed of foam covered with a fabric material at least on its non-patient-facing side. In some instances, the face cushion portion 3240 includes a foam layer covered with a fabric material layer on both of its sides (such as the patient-facing side and the non-patient-facing side). The face cushion portion 3240 may be airtight, for example, by having one or more airtight layers, such as an airtight foam or an airtight coating or film layer. In other instances, the face cushion portion 3240 may be formed of spacer fabric. In an instance, the face cushion portion 3240 may be formed of other synthetic materials that can be thermoformed into a shape.

[0582] Figures 17 to 28 Views showing additional instances of the cushion module 3150 and the face cushion portion 3240 are shown. In each of these instances, the face cushion portion 3240 also includes the curved shape as described above.

[0583] In Figure 8 、 Figure 9 、 Figures 12 to 14 and Figures 29 to 36 In the instances shown, the cushion module 3150 includes a deformable adjustment member 3242 attached to the face cushion portion 3240. The deformable adjustment member 3242 may be designed and arranged to be selectively adjusted by the patient to adjust the curvature of the face cushion portion 3240. In these particular instances, the deformable adjustment member 3242 includes a deformable metal (such as aluminum) bar that spans from one outer side of the face cushion portion 3240 to the other outer side. The deformable metal bar may span between positions at or near the junction between the first headgear connection portion 3310 and the face cushion portion 3240. In Figure 8 and Figure 9 In the instances shown, there is one deformable adjustment member 3242, and in Figures 29 to 36In the illustrated example, there are two deformable adjustment members 3242. The deformable adjustment member 3242 can alternatively be a plastically deformable polymer instead of a metal strip. As Figure 13 and Figure 14 shown, the deformable adjustment member 3242 allows the patient to adjust the width of the cushion module 3150 between a wider configuration ( Figure 13 shown) and a narrower configuration ( Figure 14 shown) by adjusting the curvature of the face lining portion 3240. This can advantageously allow the patient to customize the shape of the cushion module 3150 according to their face to help achieve a good fit. The deformable adjustment member 3242 can be provided to the upper portion of the face lining portion 3240 so that it can mainly adjust the curvature of the face lining portion 3240 near the patient's nose. The deformable adjustment member 3242 can be provided together with or separately from the biasing mechanism discussed below. For example, the face lining portion 3240 can be biased outward to cause the seal forming structure 3100 to expand outward, but the deformable adjustment member 3242 can set a limit on the width of the upper portion of the face lining portion 3240 to help solve leakage near the nose.

[0584] Biasing of the face lining portion

[0585] In Figures 8 to 28 each of the illustrated examples, the face lining portion 3240 can be biased away from the curved shape towards a flatter shape than the curved shape to provide a tight feeling for the seal forming structure 3100 during use. This can advantageously provide a good seal with a low risk of leakage and can be comfortable for the patient, or at least more comfortable than the seal forming structure 3100 that is not required to be tight.

[0586] In some examples, such as Figures 8 to 24In the illustrated example, the face liner portion 3240 can first be formed into a formed shape having a curvature smaller than the curved shape. However, after the seal-forming structure 3100 is attached to the face liner portion 3240, the seal-forming structure 3100 can hold the face liner portion 3240 in the curved shape, and the face liner portion 3240 may be biased away from the curved shape due to a tendency to return to the formed shape. That is, the face liner portion 3240 is formed during manufacturing such that the degree of curvature of the face liner portion 3240 is less than the degree of curvature it is expected to have during use. The seal-forming structure 3100 can be attached to the face liner portion 3240 during a subsequent manufacturing step. The dimensions of the seal-forming structure 3100 can be designed to pull the sides of the face liner portion 3240 inwardly after the seal-forming structure 3100 is attached to the face liner portion 3240, thereby pulling the face liner portion 3240 into a shape that is more curved than the original formed shape of the face liner portion 3240. The face liner portion 3240 can be biased back to the less curved formed shape, after which the sides of the face liner portion 3240 may tend to pull the seal-forming structure 3100 outwardly. This may tend to cause the seal-forming structure 3100 to expand outwardly in the direction indicated by the axis S in Figure 21 which can advantageously provide a tight seal-forming structure 3100 that may be less likely to leak than a loose seal-forming structure 3100.

[0587] For example, the face liner portion 3240 can be thermoformed into the formed shape.

[0588] In another form of the technology, for example as Figures 25 to shown, the gasket module 3150 can include an elastic member 3260 that biases the face liner portion 3240 away from the curved shape. In this example, the face liner portion 3240 can be formed into the curved shape and biased by the elastic member 3260 toward the less curved / flatter shape. ​ The gasket module 3150 formed by the membrane portion 3220 and the face liner portion 3240 is shown. In this example, the membrane portion 3220 forms the seal-forming structure 3100. ​ The elastic member 3260 is also shown separately.

[0589] As ​ shown, in this example, the elastic member 3260 is disposed inside the inflatable chamber 3200. The elastic member 3240 can engage the face liner portion along the connection interface between the face liner portion and the seal-forming structure 3100.

[0590] In this example, the elastic member 3260 is biased toward an annular shape, as ​As shown. The elastic member 3260 can be formed into an annular shape and deformed during being set inside the inflatable chamber 3200. The elastic member 3260 can be biased towards the annular shape during use to bias the face lining portion away from the curved shape during use. That is, the elastic member 3260 can be formed to have a ring shape / annular shape as ​ shown, and can be elastic to tend to return to that annular shape after deformation.

[0591] The elastic member 3260 can engage the face lining portion 3240 along the connection joint surface between the face lining portion 3240 and the seal forming structure 3100, as ​ shown. The elastic member 3260 can be assembled inside the gasket module 3150 at the connection between the face lining portion 3240 and the seal forming structure 3100, and this connection may not be located on a circular curve. For example, the face lining portion 3240 can have the shape of a hyperbolic paraboloid or a parabolic cylinder. Similarly, in some instances, the seal forming structure 3100 or the membrane portion 3220 forming the seal forming structure 3100 can also have the shape of a hyperbolic paraboloid or a parabolic cylinder. Additionally or alternatively, the connection, boundary, joint or seam (as the case may be) between the face lining portion 3240 and the seal forming structure 3100 can be a curve having the shape of a boundary of a hyperbolic paraboloid or a parabolic cylinder. The deformation of the elastic member 3260 into this non-circular shape may cause the elastic member 3260 to return a restoring force onto the gasket module 3150 or at least its face lining portion 3240 or the seal forming structure 3100. Therefore, the elastic member 3260 can bias the face lining portion 3240 away from its curved in-use shape towards a flatter shape than the curved shape to provide a tight feeling for the seal forming structure during use.

[0592] A seal forming structure 3100 presented to the patient without creases may have a higher chance of obtaining a good seal because creases can generally result in leakage paths. Having a component that can apply tension to the seal forming structure 3100 can help maintain the seal during dynamic sleep because the applied tension will continuously act on any loose / wrinkled areas that may form.

[0593] In some instances, the elastic member 3260 can cause the seal forming structure 3100 to expand outwards and also cause the seal forming structure 3100 to expand in the up and down directions, as ​ indicated by the four arrows shown.

[0594] The elastic member 3260 can be formed of a polymeric material such as nylon, ABS, TPU, silicone, or of stainless steel or any other suitable material. The elastic member 3260 can be molded, for example. Alternatively, the elastic member can be stretched or extruded, cut, and its ends joined to form a loop shape. In some instances, the elastic member 3260 can be elongate (e.g., having unjoined ends). In some instances, the elastic member 3260 can be biased toward a straight shape (or at least a shape that is straighter than the shape it can assume when assembled in the gasket module 3150). The elastic member 3260 may be inherently spring-loaded.

[0595] In one instance, the elastic member 3260 can have a diameter of 90 mm and, when formed of a relatively stiff polymer such as nylon or ABS, can form a circular cross-section with a diameter of 1.5 mm.

[0596] In some instances, the face liner portion 3240 can be biased to then tension the seal-forming structure 3100 or the membrane portion 3220 with a plurality of mechanisms. For example, the face liner portion 3240 can have an inherent bias toward a formed shape and can also have a separate elastic member 3260 that provides additional bias.

[0597] In other instances, the elastic member 3260 can be applied externally to the face liner portion 3240 rather than internally within the inflatable chamber 3200. That is, providing the elastic member 3260 internally can enable it to act directly on the seal-forming structure 3100 and can also make it more discrete.

[0598] Seal support portion

[0599] In ​ the illustrated instance, in addition to the membrane portion 3220, the seal-forming structure 3100 includes a pair of seal support portions 3250. Each seal support portion can be disposed to a respective outer side of the face liner portion 3240 and can project from the face liner portion 3240 in at least a partial medial direction. Each seal support portion 3250 can be configured to push the membrane portion 3220 against the patient's face in use. The seal support portion 3250 can serve as a bottom gasket.

[0600] ​ The face liner portion 3240 and the seal support portions 3250 are shown isolated from the membrane portion 3220 and other components not shown. ​ 、 ​ 、 ​ and ​ The gasket module 3150 is shown, which includes the membrane portion 3220, and the seal support portions 3250 are depicted by hiding details. ​Illustrates a sealing support portion 3250 through the oral aperture 3172 of the gasket module 3150.

[0601] As illustrated, each of a pair of sealing support portions 3250 may project from or near the periphery of the face-lining portion 3240. In these particular examples, each of the pair of sealing support portions 3250 may project from near the peripheral edge of the face-lining portion 3240, but may be spaced from the peripheral edge by a spacing. This may advantageously assist in manufacturing the gasket module 3150 and may allow air to flow between the membrane portion 3220 and each sealing support portion 3250, which may assist in inflating the membrane portion 3220 in any local location or circumstance (transient or otherwise) where the sealing support portion 3250 is not in engagement with the patient's face. The spacing may be in the range of 0.5 mm to 5 mm, such as in the range of 1 mm to 3 mm. In other examples, there is no spacing between the sealing support portion 3250 and the peripheral edge of the face-lining portion 3240. In such examples, when the inflation chamber 3200 is pressurized, air within the inflation chamber 3200 may still tend to flow between the sealing support portion 3250 and the membrane portion 3220, after which the membrane portion 3220 may still inflate above the sealing support portion 3250.

[0602] Each of a pair of sealing support portions 3250 may be designed to push the membrane portion 3220 against a respective one of the patient's cheeks in use. Additionally, in the illustrated example, each of the pair of sealing support portions 3250 is designed and arranged to urge the membrane portion 3220 to seal at or near a respective one of the alar crestal points on the patient's face. This may be a difficult area to seal, and the sealing support portion 3250 may advantageously assist in achieving a good seal at these locations and / or more generally around the lower periphery of the user's nose. In ​ the illustrated example, each of the pair of sealing support portions 3250 includes an inner projection 3253 that is designed and arranged to push the membrane portion 3220 towards the patient's face near a respective one of the alar crestal points. In other examples, such as Figures 17 to 23 the illustrated example, the sealing support portion 3250 may project more generally towards the alar crestal points. In these examples, each of the pair of sealing support portions 3250 includes a lower portion 3251 having a concave inner edge. The lower portion 3251 may push the membrane portion 3220 against the patient's cheek. Each of the pair of sealing support portions 3250 may additionally or alternatively include an upper portion 3252 having a convex inner edge. The upper portion 3252 may urge the membrane portion 3220 to seal at or near the lower periphery of the patient's nose. Figure 24An alternative example is shown, where the upper portion 3252 has a concave inner edge that is designed and arranged to be close to and conform to the shape of the patient's nasal wings. As compared with Figures 17 to 23 the example shown, this arrangement can provide a smaller inwardly directed force on the patient's nasal wings, which may perform better or be more preferred for some patients.

[0603] The sealing support portion 3250 can be formed at least in part of foam. In some examples, one or both sides of the sealing support portion 3250 can be covered with a fabric layer. In the illustrated example, the sealing support portion 3250 is formed of the same material as the face lining portion 3240. In some examples, the face lining portion 3240 is thermoformed to shape (e.g., formed into a curved shape). In some examples, the sealing support portion 3250 may not be thermoformed to shape. This can make them more comfortable on the patient's face and / or more conform to the shape of the patient's face. In other examples, the sealing support portion 3250 can be thermoformed to shape.

[0604] In an example, the sealing support portion 3250 can be integrally formed with the face lining portion 3240, or can be formed separately and then adhered, welded, otherwise joined, or stitched to the face lining portion 3240 in an example.

[0605] In some examples, the sealing support portion 3250 can be formed of a 4 mm thick foam layer covered with a fabric material on one or both sides. In other examples, the sealing support portion 3250 can be formed of foam having a thickness in the range of 3.5 mm to 4.5 mm or in the range of 3 mm to 5 mm.

[0606] The sealing support portion 3250 can project inwardly and rearwardly in use. In some examples, even when the patient interface 3000 is not in use, the edges of the sealing support portion 3250 (e.g., the concave and / or convex edges of the lower portion 3251 and the upper portion 3252 of the sealing support portion 3250) can be pushed against the membrane portion 3220. This can help keep the membrane portion 3220 taut and thus can advantageously help maintain a good seal during use.

[0607] In some instances, the seal support portion 3250 may be stiffer in the lower portion 3251 than in the upper portion 3252, for example, due to a longer cantilever length in the upper portion 3252 than in the lower portion 3251. The seal support portion 3250 may effectively form cantilever structures of different lengths that are relatively flexible and compliant in some regions and rigid in other regions. This variability in stiffness corresponds to the different regions of the face and their ability to withstand loading. The seal support portion 3250 reacts to the face upon donning of the headgear and remains comfortable over its entire length while allowing the seal to perform its pressure sealing function.

[0608] The membrane portion 3220 may be suspended over each seal support portion 3250, as Figure 20 , Figure 21 , Figure 23 and Figure 24 illustrated. This may assist the membrane portion 3220 in sealing near the nasal and oral apertures of the membrane portion 3220 as the treatment pressure in the inflation chamber 3200 acts unimpeded on the inner surface of the membrane portion 3220.

[0609] Flexible headgear connection portion

[0610] Figures 29 to 36 illustrates a patient interface 3000 and its cushion module 3150 of another example of the present technology. In this example, the face cushion portion 3240 is formed of a flexible material and may be as described above with reference to other examples. The membrane portion 3220 may also be as described above with reference to other examples.

[0611] The patient interface 3000 in this example includes a pair of upper headgear connection portions 3310 (which may be identified as first or outer headgear connection portions in an example where only one headgear strap is connected to each outer side of the cushion module 3150), the pair of upper headgear connection portions 3310 being configured to connect to an upper strap portion 3311 of a positioning and stabilization structure 3300 of the patient interface 3000 (the upper strap portion 3311 may be identified as a first or outer strap portion in a two-point headgear connection example). The upper headgear connection portions 3311 may each be formed of a flexible material and may each be attached to the face cushion portion 3240 on the non-patient facing side near the outer side of the face cushion portion 3240.

[0612] In this example and in other examples disclosed herein, the face cushion portion 3240 includes a peripheral edge formed by an upper edge portion 3245 and a lower edge portion 3246, the upper edge portion 3245 and the lower edge portion 3246 being connected to each other by a pair of outer edge portions 3247 at respective outer sides of the face cushion portion 3240. Each outer edge portion 3247 includes an outermost point.

[0613] In Figures 29 to 36 the specific example shown, each of the upper headgear connection portions 3311 is attached to the face-liner portion 3240 inside the outer edge portion 3247. In this example, the upper headgear connection portion 3310 is designed and arranged to push the face-liner portion 3240 near the outermost point toward the patient's face during use. Referring to Figure 35 and Figure 36 , the face-liner portion 3240 includes an outer portion 3248 on each of its outer sides, and the upper strip portion 3310 pushes the outer portion 3248 toward the patient's face. Advantageously, this can allow the seal-forming structure 3100 to engage well with the patient's face. Most of the backward-directed tension in the upper strip portions 3311 of the positioning and stabilizing structure 3300 can be converted into an inward-directed force applied to the face-liner portion 3240 and then in turn applied to the seal-forming structure 3100. The upper headgear connection portion 3310 can also be identified as a "wing". These wings can extend generally tangentially from the non-patient-facing surface of the face-liner portion 3240 in a partially rearward direction and a partially outward direction. They can be attached to the face-liner portion 3240 and extend generally tangentially from the surface of the face-liner portion 3240 such that they are substantially flush with the non-patient-facing surface of the face-liner portion 3240.

[0614] Each of the upper headgear connection portions 3310 can be attached to the face-liner portion 3240 near both the upper edge portion 3245 and the lower edge portion 3246 of the peripheral edge of the face-liner portion 3240. In particular, in the illustrated example, each of the upper headgear connection portions 3310 is attached to the face-liner portion 3240 at a junction 3315 that is located on the non-patient-facing side of the face-liner portion 3240, from or near the upper edge portion 3245 of the peripheral edge of the face-liner portion 3240 to or near the lower edge portion 3246. This can allow the upper headgear connection portions 3310 to pull the face-liner portion 3240 into contact with the user's face across the entire height of the cushion module 3150, thus facilitating a good seal and also being aesthetically pleasing and increasing the perceived comfort, which can promote greater patient compliance.

[0615] Each of the upper headgear connection portions 3310 is capable of pivoting relative to the face cushion portion 3240 along the joint 3315. This flexibility in the headgear connection can advantageously help avoid unwanted headgear force transmission back to the cushion module 3150, such as may occur during side sleeping. The wings can act in concert with the headgear straps such that the patient interface 3000 as a whole is close to the face / cheek. This can provide a low-profile patient interface 3000, which can maintain any low risk of lateral leakage during side sleeping. In particular, the flexible fabric construction of the headgear connection can help prevent mask leakage. For example, the flexible fabric reduces the ability of the connection portion to transmit force back to the face cushion portion 3240 to cause the mask to leak forward. Additionally, the lateral flexibility of the headgear straps can advantageously reduce the ability of their connection portions to cause the mask to leak laterally.

[0616] The upper headgear connection portions 3310 can contact the face only at the narrower distal end to which the headgear straps 3311 are attached. They effectively bridge the gap between the cushion module 3150 and the cheek.

[0617] With particular reference to Figure 33 and Figure 34 , each of the upper headgear connection portions 3310 includes an upper edge 3312, a lower edge 3313, and an upper strap attachment point 3314 (which can be identified as the first or outer strap attachment point in the case of a cushion module 3150 having only two headgear connections). Each upper strap attachment point 3314 can be configured to attach to a corresponding upper strap portion 3311 of the positioning and stabilization structure 3300. In this instance, the upper edge 3312 and the lower edge 3313 of each of the upper headgear connection portions 3310 converge towards each other towards the upper strap attachment point 3314.

[0618] The upper edge 3312 of each of the upper headgear connection portions 3310 can be substantially tangent to the upper edge portion 3245 of the peripheral edge of the face cushion portion 3240 in use. Additionally or alternatively, the lower edge of each of the upper headgear connection portions 3310 can be substantially tangent to the lower edge portion 3246 of the peripheral edge of the face cushion portion 3240 in use. Thus, the outer shape (e.g., the upper edge 3312 and the lower edge 3313) of each upper headgear connection portion 3310 conforms to the outer peripheral shape (e.g., the upper edge portion 3245 and the lower edge portion 3246) of the face cushion portion 3240, for example, in a tangential manner. This can allow the upper headgear connection portions 3310 to pull the face cushion portion 3240 into contact with the user's face across the entire height of the cushion module 3150, thereby facilitating a good seal and also being aesthetically pleasing, which can increase the perceived comfort and / or greater patient compliance.

[0619] As Figures 29 to 36As shown, the cushion module 3150 also includes a pair of lower headgear connection portions 3320 configured to connect to the lower strip portion 3321 of the positioning and stabilization structure 3300. In this example, each lower headgear connection portion 3320 includes a magnetic headgear connection point provided to the face cushion portion 3240, and the corresponding lower strip portion 3321 can be magnetically attached to the face cushion portion 3240.

[0620] Figure 37 and Figure 38 FIG. shows a patient interface 3000 according to another example of the present technology. In this example, the headgear is connected to the cushion module 3150 at only two points. The cushion module 3150 includes a pair of outer headgear connection portions 3330 that extend at the rear of the seal-forming structure 3100 on the outer side of the cushion module 3150. The outer headgear connection portions 3330 can be configured to connect to the outer strip portions 3331 of the positioning and stabilization structure 3300. In this example, each of the outer headgear connection portions 3330 is formed of a flexible material. The cushion module 3150 is configured to be supported in place on the patient's face by the outer strip portions 3330 of the positioning and stabilization structure 3300 in use in the absence of any other strip portions of the positioning and stabilization structure 3300. The outer headgear connection portions 3330 can also be more generally identified as headgear connection portions. In this example, each of the outer headgear connection portions 3330 includes a slot to which the corresponding outer strip portion 3331 of the positioning and stabilization structure 3300 can be connected in use.

[0621] The face cushion portion 3240 includes an upper edge portion 3245 and a lower edge portion 3246 that define the height of the face cushion portion 3240, and each of the outer headgear connection portions 3330 includes an upper edge 3332 and a lower edge 3333 that define the height of the corresponding outer headgear connection portion 3330.

[0622] As shown in the figure, each of the outer headgear connection portions 3330 is attached to the face cushion portion 3240 near both the upper edge portion 3245 and the lower edge portion 3246 of the peripheral edge of the face cushion portion 3240. The height of each outer headgear connection portion 3330 can be at least half of the height of the face cushion portion 3240. In some examples, the height of each outer headgear connection portion 3330 can be at least two-thirds of the height of the face cushion portion 3240. In the illustrated example, the upper edge 3332 of the corresponding outer headgear connection portion 3330 is located near the upper edge portion 3245 of the face cushion portion 3240. Similarly, the lower edge 3333 of the corresponding outer headgear connection portion 3330 is located near the lower edge portion 3246 of the face cushion portion 3240. In this example, the height of each outer headgear connection portion 3330 is substantially the same as the height of the face cushion portion 3240. Each of the outer headgear connection portions 3330 is connected to the face cushion portion 3240 substantially continuously along the height of the corresponding outer headgear connection portion 3330. This arrangement can advantageously provide for the uniform transfer of force from the outer strip portion 3331 of the positioning and stabilization structure 3300 to the cushion module 3150, facilitating a full and stable seal.

[0623] The flexibility in the outer headgear connection portions 3330 can provide advantages similar to those described above with respect to Figures 29 to 36 the upper headgear connection portion 3310 shown, such as the ability to transfer the tension in the headgear strap to a backward and / or upwardly directed force on the cushion module 3150 without transferring an unwanted forwardly directed force from the headgear strap to the cushion module 3150, such as may occur during movement or side sleeping. Each of the outer headgear connection portions 3330 is capable of pivoting laterally and medially relative to the face cushion portion 3240. This can further decouple the cushion module 3150 from unwanted forces received by the headgear strap. The flexible outer headgear connection 3330 can also advantageously provide a two-point connection to the cushion module 3150, which inherently allows a certain degree of pivoting freedom of the cushion module 3150 relative to the positioning and stabilization structure 3300. This can advantageously allow the patient interface 3000 to accommodate variations in facial shape and size and thus fit a large number of patients.

[0624] In some examples, the outer headgear connection portions 3330 can be integrally formed with the face cushion portion 3240. The face cushion portion 3240 can be constructed as described elsewhere herein, for example, formed from foam and / or fabric materials. In other examples, the outer headgear connection portions 3330 can be bonded, welded, stitched, or otherwise attached to the face cushion portion 3240.

[0625] Frame provided to the face cushion portion

[0626] Figures 39 to 42 Shown is a gasket module 3150 and its components according to another example of the present technology. The patient interface 3000 includes a face cushion portion 3240 formed of a flexible material and at least partially forming the front side of the gasket module 3150. A seal forming structure 3100 is attached to the face cushion portion 3240. The seal forming structure 3100 may include a membrane portion 3220 as described elsewhere herein. Except for some differences described below, the face cushion portion 3240 may be as described elsewhere herein.

[0627] In this example, the patient interface 3000 includes a frame 3290 attached to the face cushion portion 3240. The frame 3290 may be constructed and arranged to reinforce the face cushion portion 3240. The frame 3290 may be in the form of a skeleton. As Figure 40 shown, the frame is formed of a plurality of elongated portions connected to each other. The frame 3290 may also be identified as an exoskeleton.

[0628] As illustrated, the frame 3290 in this example includes a pair of outer headgear connection portions 3294 located on respective outer sides of the gasket module 3150. The outer headgear connection portions 3294 may be configured to connect to an outer strip portion 3331 of a positioning and stabilizing structure 3300, which may be the positioning and stabilizing structure 3300 as Figure 37 and Figure 38 shown, by way of example only. In Figures 39 to 42 the example shown, the gasket module 3150 is configured to be supported in a proper position on a patient's face by the outer strip portion 3331 of the positioning and stabilizing structure 3300 in use in the absence of any other strip portions of the positioning and stabilizing structure 3300.

[0629] The frame 3290 may be constructed and arranged to impart a shape to the face cushion portion 3240 in use. The frame 3290 may, for example, hold the shape of the face cushion portion 3240 in use in a splint-like manner. The frame 3290 may be flexible and elastic, but may be harder than the face cushion portion 3240. In an example, the frame 3290 may be formed of nylon, Hytrel, polypropylene, polyurethane (e.g., TPU), polycarbonate, bamboo, silicone, thermoplastic elastomer, or another suitable material (including, for example, any suitable thermoplastic resin, elastomer, or fabric). In other examples, the frame 3290 may be flexible and elastic and act as a spring.

[0630] Reference Figure 39, the face liner portion 3240 includes a peripheral edge formed by an upper edge portion 3245 and a lower edge portion 3245, and the upper edge portion 3245 and the lower edge portion 3245 are connected to each other by a pair of outer edge portions 3247 at corresponding outer sides of the face liner portion 3240. Refer to Figure 40 and Figure 41 , the frame 3290 in this example includes a peripheral portion having a shape corresponding to the peripheral edge of the face liner portion 3240.

[0631] Similar to some other face liner portions 3240 illustrated herein, the upper edge portion 3245 of the face liner portion 3240 is bent backward away from the mid-sagittal plane on either outer side of the patient's face during use, the outer edge portion 3247 is bent backward and downward away from the upper edge portion 3245, then bent downward and forward toward the lower edge portion 3246, and the lower edge portion 3246 is bent inward back toward the mid-sagittal plane.

[0632] As Figure 41 illustrated Figure 41 , a pad module 3150 and a frame 3290 in an assembled configuration are shown. The peripheral portion of the frame 3290 (e.g., the upper portion, lower portion, and outer portions of the frame 3290) has a shape substantially conforming to the peripheral edge of the face liner portion 3240. Each outer strip connection portion 3294 of the frame 3290 is connected between the upper portion 3291 of the frame 3290 and the lower portion 3292 of the frame 3290. When the frame 3290 is attached to the face liner portion 3240, each outer strip connection portion 3294 is connected to the upper portion 3291 of the frame 3290 near the confluence between the upper edge portion 3245 of the peripheral edge of the face liner portion 3240 and the corresponding outer edge portion 3247. Similarly, each outer strip connection portion 3294 is connected to the lower portion 3292 of the frame 3290 near the confluence between the lower edge portion 3246 of the peripheral edge of the face liner portion 3240 and the corresponding outer edge portion 3247. As Figure 40 and Figure 41 illustrated, in this example, each outer strip connection portion 3330 includes an elongated portion around which the corresponding outer strip portion 3331 of the positioning and stabilizing structure 3300 can be wound and secured back to itself (e.g., using a hook-and-loop connection).

[0633] The face liner portion 3240 can be formed of foam and / or fabric material. And in Figures 39 to 42In the illustrated example, the face-liner portion 3240 is formed of foam covered with a fabric material at least on its non-patient-facing side. In this example, the face-liner portion 3240 includes an outer pocket 3280 that is designed and arranged to receive and hold a frame 3290 in use. The pocket 3280 may be formed of a fabric material (such as the same fabric material that covers the non-patient-facing surface of the face-liner portion 3240 and / or the same fabric material that forms the membrane portion 3220). As Figure 40 shown, the frame 3290 may include a pair of outer portions 3293, each outer portion being outside of a respective one of the outer strip connection portions 3294. In use, each outer portion 3293 may be received in a respective one of the outer pockets 3280.

[0634] The pockets 3280 may each be formed of an additional material layer attached to the non-patient-facing side of the face-liner portion 3240. The additional material layer may have an outer peripheral shape that is substantially the same as the outer portion of the face-liner portion 3240. Each additional material layer may include a respective outer edge portion 3247 along the peripheral edge of the face-liner portion that is joined to the outer edge of the face-liner portion 3240. Additionally, each additional material layer may include an inner edge that is not joined to the face-liner portion 3240. In Figure 41 the illustrated example, this forms the pockets 3280 that are open inwardly to receive the respective outer portions 3293 of the frame 3290. The pockets 3280 may be formed of any material suitable for holding the frame 3290 (such as nylon, polyester, or silicone). The material may be stretchable so as to hold the frame 3290 tightly. The material may be attached to the face-liner portion 3280 in any suitable manner (such as by gluing, welding, or otherwise bonding or stitching).

[0635] Referring Figure 41 and Figure 42 , the cushion module 3150 in this example includes a ventilation module 3402. The ventilation module 3402 is designed to be received in a front hole 3271 in the face-liner portion 3240. In this example, the ventilation module 3402 defines an inflation chamber inlet port 3244 and also provides a ventilation port 3400. The ventilation port 3400 may be formed by a plurality of holes circumferentially disposed around the inflation chamber inlet port 3244. The ventilation module 3402 may be in the form of a ring. In some examples, the ventilation module 3402 includes diffuser material through which the ventilation air flow passes before or during ventilation from the ventilation port 3400. The ventilation module 3402 may be configured to be attached at the inflation chamber inlet port 3244 to a connector, such as Figure 8 and Figure 9 shown by the rotary connector 3620. The ventilation module 3402 may be provided to any example of the cushion module 3150 described herein.

[0636] Sealing formation structure

[0637] In one form of the present technology, the sealing formation structure 3100 provides a target sealing formation area and may additionally provide a cushioning function. The target sealing formation area is the area on the sealing formation structure 3100 where a seal may occur. The area where the actual seal occurs - the actual sealing surface - may vary over time and from patient to patient within a given treatment session, depending on a range of factors, including for example the position on the face where the patient interface is placed, the tension in the positioning and stabilization structure, and the shape of the patient's face.

[0638] In one form, the target sealing formation area is located on the outer surface of the sealing formation structure 3100.

[0639] In certain forms of the present technology, the sealing formation structure 3100 is composed of a biocompatible material (such as silicone rubber).

[0640] The sealing formation structure 3100 according to some examples of the present technology may be composed of or at least include a soft, flexible, elastic material (such as silicone resin).

[0641] In some forms, the sealing formation structure 3100 includes a bottom pad 3225 that may be formed of foam and a membrane portion 3220 that may be formed at least in part of a fabric material, as further described below. The sealing formation structure 3100 may be connected to the face-liner portion 3240 and may partially form an inflation chamber 3200. It should be understood that when the membrane portion 3220 is described as being formed of a fabric material, it may include non-fabric layers (such as other layers or films of silicone resin, polyurethane, or other suitable materials) to provide airtightness / impermeability.

[0642] In certain forms of the present technology, a system including more than one sealing formation structure 3100 is provided, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. Different sealing formation structures 3100 may be provided for different liner module options. For example, the system may include one form of the sealing formation structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another sealing formation structure that is suitable for small-sized heads but not for large-sized heads. However, examples of the technology may be suitable for a wide range of heads and may therefore be used by patients with relatively large heads and relatively small heads.

[0643] Bottom pad

[0644] In Figures 43 to 77In the illustrated example, the seal-forming structure 3100 includes a base gasket 3225. In the illustrated example, the base gasket 3225 is formed of foam, but it should be understood that other materials and structures (such as elastomeric structures, inflatable base gaskets, gels, solid semi-rigid materials (e.g., silicone or TPE)) can also be used to form the base gasket. The base gasket 3225 can be formed, for example, of a soft foam material that can be easily compressed and shaped to the portion of the face where it engages below the membrane portion 3220. The base gasket 3225 is shaped to extend around the patient's mouth and be positioned adjacent to the lower periphery of the patient's nose in use. The base gasket 3225 can engage the patient's face around the mouth and, in some instances, engage the patient's face around the nose periphery. The base gasket 3225 can be airtight. An example of the patient interface 3000 made according to the present invention can be referred to as an ultra-compact full-face mask.

[0645] Attached to the base gasket 3225 is a membrane portion 3220 that is configured to contact the patient's face in use to form a seal around the nose and / or mouth, as will be described below. The base gasket 3225 can hold the membrane portion 3220 in place and shape to form a seal against the patient's face. In some instances, the base gasket 3225 can press the membrane portion 3220 against the user's face around the user's mouth in use. In some instances, the base gasket 3225 can support the membrane portion 3220 around the patient's nose such that the membrane portion 3220 engages the patient's nose, but the base gasket 3225 remains substantially away from the patient's nose, for example, sufficiently avoiding nasal occlusion, except for a small amount of contact that may inevitably occur during use. The base gasket 3225 can be attached to the patient-facing side of the face lining portion 3240.

[0646] In Figures 43 to 77 In the illustrated example, the base gasket 3225 is formed of foam. In some instances, the base gasket 3225 can be formed of foam and can include a skin surface. The skin surface can help prevent the penetration of air and / or water and also help with cleaning. In some instances, the base gasket 3225 is formed of polyurethane foam or polypropylene foam. In other instances, the base gasket 3225 is formed of another suitable foam material. In an example, the base gasket 3225 can be formed of open-cell foam or closed-cell foam. The base gasket 3225 can be airtight, for example, due to the skin surface or an airtight coating.

[0647] In Figures 43 to 53In the illustrated example, the base pad 3225 is formed of molded foam. Compared to forming the base pad 3225 by some other method (such as cutting from a foam sheet), the molded base pad 3225 can allow for a more complex three-dimensional shape and / or allow for the provision of finer details. As described above, the face-liner portion 3240 to which the base pad 3225 is attached can include a curved three-dimensional shape in use. In some instances where the base pad 3225 is formed of molded foam, the face-liner portion 3240 cannot support itself in a curved three-dimensional shape in use (e.g., it may not be thermoformed or otherwise designed to assume a particular shape). In such instances, the base pad 3225 can support the face-liner portion 3240 in a curved three-dimensional shape. The molded base pad 3225 can have sufficient stiffness such that the face-liner portion 3240 assumes a curved three-dimensional shape in use when attached to the base pad 3225. The face-liner portion 3240 can be attached to the non-patient-facing side of the base pad. The non-patient-facing side of the base pad can include a surface corresponding to the curved three-dimensional shape of the face-liner portion 3240 in use. Using a molded base pad 3225 that can hold the face-liner portion 3240 in its shape in use can avoid the need for steps to form the face-liner portion 3240 into a particular shape (such as thermoforming), or avoid the need for additional reinforcement / shaping components, thereby reducing the cost and / or weight of the patient interface 3000.

[0648] Figure 45 and Figures 47 to 50 A molded foam base pad 3225 is shown. The molded base pad 3225 is capable of supporting itself in the illustrated shape, including having a curvature from one outer side to the other outer side on the front and back sides of the base pad 3225. Figure 45 A face-liner portion 3240 is shown that is thermoformed into a three-dimensional shape corresponding to the shape of the front side of the base pad 3225. Figure 46 Two attached components are shown. In this and other instances, the face-liner portion 3240 can be attached to the base pad 3225 by any suitable process (including gluing, welding, or otherwise bonding, etc.). In some instances, the base pad 3225 can be incorporated into the face-liner portion 3240 during the molding process. It should be understood that although Figure 45 A face-liner portion 3240 is shown formed into a curved three-dimensional shape, but in other instances, the face-liner portion 3240 can be formed in a generally flat sheet configuration and then can assume the curved shape of the front side of the base pad 3225 when attached to the base pad 3225.

[0649] In Figures 54 to 76In the illustrated example, the base cushion 3225 is formed of compression cut foam. Compression cut foam can have three-dimensional features, but may not have sufficient structural stiffness to support itself in a shape that curves from one outer side to another outer side. For example, the base cushion 3225 formed of compression cut foam cannot be shaped to have a curved front surface / a surface facing away from the patient, while also including a curvature on the side facing the patient to match the curvature of the patient's face. In contrast, the compression cut foam base cushion 3225 can generally be flatter and may require another component to hold it in the in-use shape. In such instances, the face liner portion 3240 can be thermoformed (or otherwise shaped) into a curved three-dimensional shape so as to support itself in a three-dimensional shape in use. Then, the base cushion 3225 formed of compression cut foam can be attached to the face liner portion 3240, which can support itself and the base cushion 3225 in a predetermined in-use shape. The final shape of both the face liner portion 3240 and the base cushion 3225 can be a shape that generally curves from one outer side to another outer side to closely conform to the patient's face in use, thereby providing the low-profile patient interface 3000.

[0650] Figures 57 to 62 Views of the face liner portion 3240 and the compression cut foam base cushion 3225 are shown. As Figure 57 shown, the base cushion 3225 has a generally flat configuration except for local three-dimensional features. For example, the front surface of the base cushion 3225 is generally planar. Figure 58 Shown is that the face liner portion 3240 is shaped to curve from one outer side to another outer side as compared to the generally uncurved base cushion 3225. The face liner portion 3240 has a curved three-dimensional shape that is substantially the same as the in-use shape (such as Figure 66 the shape shown). Figure 59 and Figure 60 Shown is Figure 57 and Figure 58 the compression cut base cushion 3225 attached to the face liner portion 3240 as shown. As is clearly visible from Figure 59 and Figure 60 after the base cushion 3225 is attached to the face liner portion 3240, the base cushion 3225 is held in a curved shape corresponding to the curvature of the face liner portion 3240. The face liner portion 3240 holds the base cushion 3225 in the in-use shape, which in the illustrated example is a curved three-dimensional shape.

[0651] Similarly, Figures 70 to 71 shown is a base cushion 3225 formed by compression cutting in a relatively flat shape according to another example of the present technology, and Figure 73The backing pad 3225 attached to the face lining portion 3240 is shown. After that, the backing pad 3225 assumes a relatively more curved shape (compared to the relatively flat shape it forms). The face lining portion 3240 is shaped to bend backward in the outer direction away from the inner region of the face lining portion 3240, and the face lining portion 3240 can impart a corresponding shape to the backing pad 3225. In some examples, the face lining portion 3240 can be in the shape of a hyperbolic paraboloid or a parabolic cylinder. As particularly shown in Figure 73 as shown, compared to being in Figure 70 and Figure 71 the flat configuration shown, once attached to the face lining portion 3240, the backing pad 3225 is more curved at the inner position. Figure 76 The backing pad 3225 and the face lining portion 3240 in the formed shape are shown side by side. The face lining portion 3240 has a rear side with a greater curvature than the formed shape of the backing pad 3225. The face lining portion 3240 can impart a predefined three-dimensional shape to the backing pad 3225. In some examples, compared to the relatively flatter formed shape of the backing pad 3225 formed, for example, by compression cutting, the backing pad 3225 can be more curved about either or both of the horizontal axis and the vertical axis after being attached to the face lining portion 3240. The face lining portion 3240 can be harder than the backing pad 3225 to impart a shape to the backing pad 3225. After being attached to the face lining portion 3240, the three-dimensional shape of the backing pad 3225 is a predefined shape configured to provide a comfortable, effective, and stable seal in use.

[0652] In Figure 70 and Figure 71 the examples shown, the backing pad 3225 can include a substantially flat front (e.g., facing away from the patient) side and a rear (e.g., facing the patient) side. The rear (e.g., facing the patient) side includes a curved surface configured to engage the patient's face to achieve a seal. The front surface of the backing pad 3225 can assume the shape of the rearward-facing surface of the face lining portion 3240, which can be in the shape of a hyperbolic paraboloid or a parabolic cylinder in some examples, or can be the shape described elsewhere herein with reference to the face lining portion 3240 of another example of the present technology.

[0653] The backing pad 3225 can include a curvature on its patient-facing side to form one or more features such as a nasal recess 3228, an inward-facing wall 3226, and a rear support portion 3227, which will be described in detail below. These features are shown in Figure 70 and Figure 71are identified and, once the base pad 3225 is attached to the face-liner portion 3240 and deformed, bent, and / or folded during the process, can each assume a final shape and position. Unless the context otherwise requires, the following description of the nasal recess 3228, the inward-facing wall 3226, and the rear support portion 3227, and any associated features or portions, is to be understood as applying to Figures 70 to 77 the illustrated example.

[0654] In particular, as Figure 70 , Figure 71 , Figure 73 and Figure 76 visibly shown, the base pad 3225 includes a circular patient-facing surface. At least compared to some other shapes that may have sharp corners, this circular surface can advantageously provide a comfortable engagement with the patient's face when the base pad 3225 is pressed against the patient's face.

[0655] As Figure 75 shown, the base pad 3225 is shaped such that when the membrane portion 3220 is attached (to the base pad 3225 and / or the face-liner portion 3240), the membrane portion 3220 has a curvature (indicated by the dashed line) in the midsagittal plane from the upper part to the lower part of the cushion module 3150 during use, the curvature being substantially smooth, e.g., without corners, tight creases, or sharp changes in geometry. Figure 75 The nasal orifice 3171 and the oral orifice 3172 are also shown. In this example, the nasal orifice 3171 and the oral orifice 3172 are aligned relative to the shape of the base pad 3225, e.g., at a predetermined position. Both orifices are spaced apart from the base pad 3225. The membrane portion 3220 at the periphery of each orifice 3171, 3172 does not contact the base pad 3225. Advantageously, this allows the pressure in the inflation chamber 3200 to act on the membrane portion 3220 to form a pressure-assisted seal. As Figure 74 shown, the membrane portion 3220 is attached to the base pad 3225 substantially at and along the outer periphery of the base pad 3220.

[0656] Nasal recess

[0657] In some forms of this technique, e.g., particularly in Figures 45 to 52 , Figures 59 to 65 and Figures 70 to 77As shown in, the bottom cushion 3225 can include a nasal portion configured to be positioned adjacent to the lower periphery of the patient's nose during use. The bottom cushion 3225 can include a nasal recess 3228 in the nasal portion, and the nasal recess 3228 can be shaped to receive the patient's nose during use. In some forms of the technique, the nasal recess 3228 can be shaped to receive the patient's nose without engaging the patient's nose or at least without applying an occlusive force to the patient's nose. The nasal recess 3228 can be configured to at least partially surround the lower periphery of the patient's nose during use. In some instances, the nasal recess 3228 provides a gap between the bottom cushion 3225 and the lower periphery of the patient's nose (e.g., the lower portions of the alae nasi and the nasion). The nasal recess 3228 can be configured to prevent the seal-forming structure 3100 from occluding the patient's nose, such as when the headgear is tightened. The membrane portion 3220 can be supported by the bottom cushion 3225 at the periphery of the nasal recess 3228. For example, the membrane portion 3220 can be attached to the bottom cushion 3225 at or near the periphery of the nasal recess 3228. The membrane portion 3220 can contact and / or be supported by the bottom cushion 3225 at the periphery of the nasal recess 3228, but can be non-contact with the bottom cushion 3225 in the medial region inside the periphery of the nasal recess 3228 (such as the medial region below and horizontally aligned with the patient's nose), e.g., cannot contact the bottom cushion 3225 during use. In the region of the downward-facing surface of the membrane portion 3220 that contacts the patient's nose, the membrane portion 3220 cannot contact the bottom cushion 3225.

[0658] In some instances, the nasal recess 3228 can space the base pad 3225 from the patient's nose at least when the patient initially dons the patient interface 3000 before sleep, so as not to press the membrane portion 3220 against the patient's nose, or at least not to press the membrane portion 3220 against the nasal alae. The nasal recess 3228 can prevent the base pad 3225 from engaging the patient's nose or at least prevent the base pad 3225 from occluding the patient's nose (e.g., by not engaging the base pad 3225 with sufficient force to close or partially close the nostrils). The nasal recess 3228 can prevent accidental occlusion of the patient's nose, which might otherwise occur if the base pad 3225 were shaped to engage the nose with the membrane portion 3220 (e.g., by pressing the membrane portion 3220 against the nasal alae). It should be understood that in some patients with large noses, the base pad 3225 can still have a small amount of engagement with a portion of the user's nose, but due to the nasal recess 3228, the user's nose can be unoccluded. For example, the nasal recess 3228 can be configured to avoid engaging both outer sides of the patient's nose simultaneously. In some instances, when the patient's nose is centered within the nasal recess 3228, the nasal recess 3228 essentially does not engage either outer side of the patient's nose. In some instances, the nasal recess 3228 can be designed to essentially not provide an inwardly directed force on the patient's nasal alae during use. In some forms, the nasal recess 3228 is designed and arranged such that the base pad 3225 essentially does not exert a force on the patient's nose during use. In some forms, the nasal recess 3228 is designed and arranged such that there can be some contact with the patient's nose, but not enough force to occlude the patient's nostrils, and possibly with minimal force for long-term comfort.

[0659] The base pad 3225 and the face seal portion 3240 can be configured such that they are positioned very close to the patient's face during use to allow engagement between the base pad 3225 and the patient's cheek and mouth regions. The nasal recess 3228 can allow the base pad 3225 to be pushed against the patient's cheek and mouth regions without overly pushing the patient's nasal alae closed, which could occlude the patient's nasal airway.

[0660] In Figures 43 to 77 the illustrated instance, the nasal recess 3228 (e.g., the portion of the base pad 3225 forming the nasal recess 3228) includes a shape corresponding to the lower periphery of the nose (e.g., the nasal tip portion and the lower shape of the nasal alae). The corresponding shape, combined with only a small spacing between the nasal recess 3228 and the patient's nose during use, can provide a low-profile patient interface 3000.

[0661] In some forms, such as Figures 49 to 52 、 Figures 63 to 64 and Figures 70 to 77As shown, the nasal recess 3228 may include an inward-facing wall 3226. The inward-facing wall 3226 may face the patient's nose and may also be described as a nose-facing wall. The inward-facing wall 3226 may face inwardly in part and upwardly in part. For example, the inward-facing wall 3226 may be designed to face and at least partially surround the lower periphery of the patient's nose in use. In these instances, the inward-facing wall 3226 may be one or more of substantially chamfered, frustoconical, bowl-shaped, frustospherical, parabolic, and other possible shapes. The inward-facing wall 3226 may be concave and, in some instances, concave in two orthogonal planes. For example, when viewed in a vertical cross-section (e.g., a cross-section parallel to the sagittal or coronal plane) and when viewed in a horizontal cross-section (e.g., a cross-section parallel to the Frankfurt horizontal plane), the inward-facing wall 3226 may include a concave shape. In other instances, the inward-facing wall 3226 may not be concave in the vertical cross-section, such as if the inward-facing wall 3226 is chamfered or otherwise appears as a straight line in the vertical cross-section. In some instances, the inward-facing wall 3226 may appear as a straight line at one location (e.g., near the nasion) in the vertical cross-section but may appear as a curve at another location (e.g., outside the patient's alae nasi) in the vertical cross-section, or vice versa.

[0662] The inward-facing wall 3226 may include a pair of outer portions on either outer side of the nasal recess 3228. The outer portions may face inward and may be positioned on either outer side of the user's nose in use. The inward-facing wall 3226 may be concave. The outer portions of the inward-facing wall 3226 may face inwardly in part and upwardly in part. The inward-facing wall 3226 may include the same or a similar shape at the front portion of the inward-facing wall 3226 (e.g., at a location near the patient's nasion). The front portion of the inward-facing wall 3226 may face rearward and may be positioned in front of and / or below the patient's nasion. The front portion of the inward-facing wall 3226 may face rearwardly in part and upwardly in part. Similar to the outer portions of the inward-facing wall 3226, the front portion of the inward-facing wall 3226 may be concave.

[0663] In Figures 49 to 52 、 Figures 63 to 64 and Figures 70 to 77In the illustrated example, the inward-facing wall 3226 is concave in a horizontal plane. The concave surface in the horizontal plane creates a nasal recess 3228 that surrounds the lower periphery of the patient's nose. The shape of the nasal recess 3228 and its inward-facing wall 3226 in the horizontal plane can be semi-circular or can be a non-circular concave shape, such as a shape that is closer to a triangle with rounded front corners, outer sides, and no base. In some examples, the nasal recess 3228 can generally have a shape in the horizontal plane that conforms to the general shape of the patient's nose (e.g., the lower periphery of the patient's nose). In some forms, when viewed in a horizontal cross-section, the inward-facing wall 3226 includes a rearward-facing concave front portion and two outer portions. The outer portions can face mainly inward and, to a lesser extent, rearward. Such a shape can more closely conform to the shape of a narrow and long nose. In some examples, the base pad 3225 (or the pad module including the base pad 3225) is provided in a range of sizes and / or shapes, and the shape of the nasal recess 3228 and its inward-facing wall 3226 is different from the options of this range of pad modules, such that each patient can select a pad module having the base pad 3225 with the best fit for their nose and face.

[0664] In some examples, the nasal recess 3228 substantially surrounds all of the outer and forward-facing portions of the lower periphery of the patient's nose in use. The inward-facing wall 3226 can extend from one cheek of the patient adjacent to or near the patient's nose around to the other cheek of the patient adjacent to or near the patient's nose.

[0665] Specific reference Figures 46 to 51 、 Figures 57 to 64 and Figures 70 to 77 In these specific examples, each of the base pads 3225 also includes a pair of rear support portions 3227, each rear support portion 3227 being located on a respective outer side of the nasal recess 3228 and being configured to engage the patient's face medial to and adjacent to the nasolabial fold of the patient's face. For example, these rear support portions 3227 can engage the patient's face at a location below the alar cartilage on either outer side of the upper lip of the patient, or can engage the patient's face at a location vertically aligned with the alar cartilage of the patient between the alar cartilage and the nasolabial fold. In some examples, the rear support portions 3227 can engage the patient's face in a region extending vertically from beside the alar cartilage to beside the upper lip of the patient. The rear support portions 3227 can engage the face to support the patient interface 3000 in place and can also advantageously cause the membrane portion 3220 to form a good seal near the lower corners of the patient's nose, which may be more difficult to seal in a wide range of patients compared to other locations such as the cheeks. For example, as Figure 49 、 Figure 50 、 Figure 51 and Figure 73As shown, the inward-facing wall 3226 can extend from a first of the rear support portions 3227 surrounding the patient's nose to another of the rear support portions 3227.

[0666] Figure 49 , Figure 50 , Figure 51 and Figure 73 Each of the rear support portions 3227 in the examples shown also includes a region of the inward-facing wall 3226, although this may be a relatively small region compared to the overall dimensions of the inward-facing wall 3226. In these examples, each of the rear support portions 3227 is shaped to at least partially project medially into a concave surface formed on the patient's face on either outer side of the alae nasi, e.g., between the alae nasi and an adjacent portion of the patient's face. For example, the rearward-facing surface or portion of each rear support portion 3227 can engage the patient's face in the region between the nasolabial fold and the alae nasi. At the same time, the inward-facing surface 3226 that forms part of or is located near each rear support portion 3227 can engage a respective one of the patient's alae nasi. The rear support portions 3227 can "dig into" the concave surfaces on either side of the patient's nose to help achieve a good seal in these regions. The rear support portions 3227 can engage only the last portions of the alae nasi. The rear support portions 3227 can contact the alae nasi to facilitate sealing of the concave surfaces at either outer side of the lower periphery of the patient's nose. The bottom pad 3225 is still configured to avoid applying a medially-directed force on the patient's nose that may tend to occlude the nasal airway.

[0667] For example, as Figure 49 , Figure 50 , Figure 51 and Figure 73 each show, the rear support portions 3227 are shaped to closely correspond to the geometry of the surface of the patient's face at and near the alar crest points (e.g., where each of the alae nasi meets the patient's cheek). In these examples, each of the rear support portions 3227 includes a rearward-facing surface 3227a and an inward-facing surface 3227b. It should be understood that the inward-facing surface 3227b can face partially forward as well as inward. Similarly, the rearward-facing surface 3227a can face partially inward as well as rearward. The rearward-facing surface 3227a of each rear support portion 3227 can be, for example, convex to complement the concave surface in the patient's face in the region between the nasolabial fold and the lower periphery of the patient's nose. The inward-facing surface 3227b of each rear support portion 3227 can be, for example, concave to match the convex shape of each of the patient's alae nasi.

[0668] In Figures 43 to 77In the illustrated examples, the membrane portion 3220 is attached to a base pad 3225 that surrounds the periphery of the nasal recess 3228. In these examples, the base pad 3225 includes an upward-facing surface 3229 that is positioned adjacent to and surrounds the periphery of the nasal recess 3228, and the membrane portion 3220 is attached to the upward-facing surface 3229 of the base pad 3225. The membrane portion 3220 can be glued, bonded, welded, or otherwise attached to the upward-facing surface 3229. In some examples, the upward-facing surface 3229 can be flat. In other examples, the upward-facing surface 3229 can have a small curvature in cross-section, but not to the extent that the membrane portion 3220 cannot be firmly attached to the upward-facing surface 3229. In other examples, the membrane portion 3220 is attached to an attachment surface of the nasal cavity portion, which can be upward-facing or not. In some examples, the portion that defines the nasal recess 3228 can have a consistent wall cross-section around the nasal recess 3228 to avoid weak points. That is, in some examples, the nasal cavity portion of the base pad 3225 can include an inner recess 3229a in the upward-facing surface 3229, such as most clearly shown in Figure 47 , Figure 48 , Figure 49 and Figure 50 . The inner recess 3229a can be configured to provide clearance and / or reduce pressure on the nasal prominence in the event of an inadvertent engagement between the base pad 3225 and the nasal prominence. While the nasal recess 3228 and the inner recess 3229a are intended to provide clearance for the nose and its nasal prominence, respectively, it should be understood that for some patients, there may be some engagement between the base pad 3225 and the nose at one or more locations. However, the nasal recess 3228 and the inner recess 3229a should still be understood to be configured (e.g., designed, shaped, arranged, and / or positioned) to provide clearance because they are generally shaped to avoid contact with the nose and the nasal prominence, respectively, and result in less contact than would otherwise occur.

[0669] Specifically referring to Figure 51 and Figure 52 , in some forms of the present technology, the nasal cavity portion of the base pad 3225 includes an inner peripheral portion 3231 that partially defines the periphery of the nasal recess 3228. The inner peripheral portion 3231 is designed to support the membrane portion 3220 at an inner location near the patient's nasal prominence. The nasal cavity portion can also include a pair of outer peripheral portions 3232 that also partially define the periphery of the nasal recess 3228. The outer peripheral portions 3232 are located on the respective outer sides of the inner peripheral portion 3231. The outer peripheral portions 3232 are designed to support the membrane portion 3220 above the patient's alae on the respective outer sides of the patient's nose (e.g., as in Figure 52As shown). The outer peripheral portion 3232 can be designed to support the membrane portion 3220 above the inner position of the membrane portion 3220 supported by the inner peripheral portion 3231.

[0670] As Figure 51 shown, the outer peripheral portion 3232 can be bent upward along the periphery of the nasal recess away from the inner peripheral portion 3231 to the respective uppermost points of each outer peripheral portion 3232. Behind the uppermost points, the outer peripheral portion 3232 is bent downward along the periphery of the nasal recess 3228 in a rearward direction away from the respective uppermost points. On the inner side, the inner peripheral portion 3231 bends upward on either of its outer sides into the outer peripheral portion 3232. As Figure 51 shown, each outer peripheral portion 3232 includes a vault shape at the respective uppermost points. The outer peripheral portion 3232 can be convex on two orthogonal axes at the uppermost points. Also as Figure 51 shown, the inner peripheral portion 3231 includes a saddle shape. The inner peripheral portion 3231 can be convex on the anterior-posterior axis, but can be concave in the medial-lateral direction along the periphery of the nasal recess.

[0671] Referring Figure 52 , the outer peripheral portion 3232 is advantageously positioned relatively high (e.g., quite upward) relative to the lower periphery of the patient's nose and relative to the patient's alae nasi. This provides a large presentation angle P, as indicated in Figure 52 . The presentation angle P is the angle on each side of the membrane portion 3220 in use. The large presentation angle P urges the membrane portion 3220 to wrap upward / upward around each outer alae nasi of the user's nose. This tendency can help provide a stable / robust seal in use and can facilitate the patient interface 3000 to accommodate a wide range of patient nose shapes and sizes.

[0672] Additionally, the high side of the nasal cavity portion and the deep positioning of the patient's nose in use can provide easier patient installation / fitting, as the patient interface 3000 can be more adaptable to a range of patient anatomies. Further, since after the application of therapy pressure, headgear tension, and some jitter, the patient's nose will effectively float within the nasal recess 3228, when the membrane portion 3220 firmly engages the lower periphery of its nose and partially wraps around the lower periphery of its nose, the patient's nose may tend to be correctly positioned, as the patient's nose naturally tends to occupy the low, floating position within the nasal recess 3228.

[0673] As described in more detail elsewhere, Figures 43 to 77 the patient interface 3000 in the example shown includes a face-liner portion 3240 that at least partially defines an inflatable chamber 3200, and a bottom cushion 3225 is attached to the patient-facing side of the face-liner portion 3240. In Figure 51 andFigure 52 and Figures 70 to 77 In the specific examples shown, each of the outer peripheral portions 3232 extends above the upper edge / boundary of the face lining portion 3240. The outer peripheral portions 3232 are not attached to the face lining portion 3240 above / on top of the face lining portion 3240. The partial or complete non - attachment of each outer peripheral portion 3232 to the face lining portion 3240 can advantageously facilitate the flexure / bending of the outer peripheral portions 3232, which will be described below.

[0674] In some examples, such as in Figure 72 the example shown, the portion of the base pad 3225 positioned adjacent to the nasal wing (e.g., the outer peripheral portion 3232) is the only portion of the base pad 3225 that protrudes beyond the peripheral edge of the face lining portion 3240. Due to the lack of support on the non - patient - facing side, these regions may actually be less rigid than other regions.

[0675] Flexure

[0676] Although most of the base pad 3225 that directly engages around the nose and mouth is configured to deform by compression in use, one or more portions of the base pad 3225 can be configured to deform in another way. In some forms of the technology, the base pad 3225 can be configured to flex in response to a force applied to the base pad 3225 in use.

[0677] In particular, in some forms of the technology, the patient interface 3000 includes a seal - forming structure 3100 that includes the base pad 3225 and a membrane portion 3220 connected to the base pad 3225. The base pad 3225 can be designed to bend at one or more locations when the patient dons the patient interface. Figure 68 and Figure 69 respectively show cross - sectional views of such a base pad 3225 through the outer peripheral portion 3232 (in Figure 68 ) and through the sub - labial portion (in Figure 69 ).

[0678] The base pad 3225 can be configured to bend in cross - section. In some examples, the base pad 3225 includes a bent portion of the base pad near the periphery of the base pad 3225. This can be distinguished from the bending of the entire base pad 3225. In some examples, the base pad 3225 is designed to bend in such a way that a first portion of the cross - section through the base pad 3225 bends relative to a second portion of the cross - section through the base pad 3225. For example, referring to Figure 68, the upper portion of the base pad 3225 near the nasal wing can be bent relative to the lower portion connected to the face lining portion 3240. In some instances, the first portion of the cross-section through the base pad 3225 forms the side of the base pad 3225 facing the patient in use and pushes the membrane portion 3220 of the sealing formation structure 3100 against the patient's face, and the second portion of the cross-section through the base pad 3225 forms the side of the base pad 3225 facing away from the patient in use. For example, referring to Figure 69 , when observed in the cross-section shown in Figure 69 , the left side of the base pad 3225 pushes the membrane portion 3220 against the patient's face and can form a first portion that bends relative to a second portion of the base pad 3225 that does not engage the user's face (e.g., Figure 69 , the right hand side of the cross-section in

[0679] In an example, the base pad 3225 can be designed to bend when the patient wears the patient interface 3000 in any one or more of the following positions: near the user's nose, near the user's mouth, near the lower lip of the user, and / or near the user's cheek.

[0680] In some patient interfaces 3000 according to examples of the present technology that include a base pad 3225 having a nasal cavity portion forming a nasal recess 3228 (such as the type of base pad 3225 of the patient interface 3000 shown in Figure 51 ), the base pad 3225 can include an outer peripheral portion 3232, as described elsewhere herein. In some forms of the present technology, the outer peripheral portion 3232 of the base pad 3225 is flexible and is designed to deform medially towards the patient's nose in use. In some instances, the outer peripheral portion 3232 is designed to bend medially towards the patient's nose in use. In some instances, such as the examples shown in Figure 51 , Figure 52 and Figure 68 , the outer peripheral portion 3232 is supported at the lower end and not supported at the upper end (except for their connection to the membrane portion 3220), and thus acts in a cantilever beam manner. In use, the patient's nose exerts a downward force on the membrane portion 3220, which will tend to pull the upper (free) end of the outer peripheral portion 3232 medially. This can advantageously facilitate the membrane portion 3220 to wrap around the lower periphery of the patient's nose and / or the outer edge of the nasal wing, which can provide a stable seal for a wide range of patient nose shapes and sizes and / or can facilitate easy installation.

[0681] Referring to Figure 68 and Figure 69Examples depicted by partial cross - sections. In some forms, the base pad 3225 can include one or more hinge regions 3234, and the base pad 3225 is designed to bend at the one or more hinge regions 3234 when the patient wears the patient interface 3000. In some forms, each of the hinge regions 3234 can be formed by a channel 3233 (such as the channels depicted in Figure 68 and Figure 69 ) formed in the base pad 3225, and the channel 3233 forms a region of reduced thickness.

[0682] Figure 69 An oral cavity channel 3233 forming a hinge region 3234 in the lower lip region of the base pad 3225 is shown. This can facilitate bending in the lower lip region of the base pad 3225 to complement the compressibility of the material forming the base pad 3225. The oral cavity channel 3233 can additionally or alternatively be provided in the cheek region of the base pad 3225. In some instances, the oral cavity channel 3233 extends along a first cheek region, along the lower lip region, and along a second cheek region.

[0683] Figure 68 A nasal cavity channel 3233 provided in the nasal recess 3228 of the base pad 3225 is shown. The nasal cavity channel 3233 can extend laterally around the nasal recess, for example following the inward - facing wall 3226 below the inward - facing wall 3226. The base pad 3225 can also include a pair of rear support portions 3227, each rear support portion 3227 being positioned on the respective outer side of the nasal recess 3228 and configured to engage the patient's face medial to and adjacent to the nasolabial groove of the patient's face. For example, the nasal cavity channel 3233 can be provided near the rear support portion 3227. In some forms, the nasal cavity channel 3233 and the oral cavity channel 3233 converge at the respective outer sides of the base pad 3225 to form a single continuous channel 3233.

[0684] Base pad material

[0685] In an example, the base pad 3225 formed of a foam material is made of polyurethane (thermoplastic or thermosetting polyurethane), or a thermoplastic elastomer (e.g., a soft TPE having behavior similar to foam). Foams having the following properties may be suitable:

[0686] · Force deflection: at 40%, 95 + / − 20 N (test specification: AS 2282.8 method A)

[0687] · Density: 54.5 + / − 2.5 kg / m3 (test specification: AS 2282.3)

[0688] · Air permeability: at 20 cm H2O, < 1.5 liters / minute.

[0689] In some instances, a foam having a density lower than the above density can be used to form the base pad 3225. In some instances, the base pad 3225 can be formed of a low density foam, but can have a sufficiently thick base or body such that it can adequately support the membrane 3221 and support itself, particularly in the nasal region. In some forms, the base pad 3225 can be formed of a low density foam, but can have a sufficiently thick skin. The base pad 3225 can be provided with a sufficiently thick skin to provide sufficient airtightness, watertightness, stiffness, and / or comfort.

[0690] In other instances, in addition to other instances, any one of polypropylene foam, polyethylene foam, silicone foam, or EVA foam can be used.

[0691] In some instances, the foam base pad 3225 can be formed by molding (e.g., injection molding).

[0692] In an instance, the foam can be substantially waterproof such that the face mask can dry sufficiently before use at night when washed earlier in the day.

[0693] In an instance, the base pad material is soft enough to cause substantially no discomfort when engaging the face, but is sturdy enough to hold the face lining portion 3240 and hold the membrane portion 3220 in a sealed manner when the patient interface is worn.

[0694] In an instance, the foam forming the base pad 3225 is substantially airtight. For example, the foam can be a skinned foam.

[0695] Sealing mechanism

[0696] In one form, the seal forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on the underside of the sealing flange within the interior of the inflatable chamber 3200 to urge it into a tight sealing engagement with the face. The pressure assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0697] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm) that extends around the perimeter of the inflatable chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflatable chamber 3200 and extends around at least a portion of the perimeter path. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange against bending during use.

[0698] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is configured and arranged to be in a compressed state, such as as a result of elastic tension in a positioning and stabilizing structure.

[0699] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is maintained in a tensioned state, for example, by a proximity region of a seal flange.

[0700] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0701] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tension portion, and a portion having a sticky or adhesive surface.

[0702] Bridge of nose or nasal ridge region

[0703] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the bridge of nose region or nasal ridge region of the patient's face in use.

[0704] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the bridge of nose region or nasal ridge region of the patient's face in use.

[0705] Upper lip region

[0706] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e., the upper part of the lip) of the patient's face in use.

[0707] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the upper lip region of the patient's face in use.

[0708] Chin region

[0709] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the chin region of the patient's face in use.

[0710] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the chin region of the patient's face in use.

[0711] Forehead region

[0712] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face in use. In this form, the inflatable chamber can cover the eyes in use.

[0713] Nasal pillow

[0714] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal pillows, each nasal pillow being configured and arranged to form a seal with a respective nostril of the patient's nose.

[0715] The nasal pillow according to one aspect of the present technology includes: a frustum of a cone, at least a portion of which forms a seal on the underside of the patient's nose; a stem; and a flexible region located on the underside of the frustum of the cone and connecting the frustum of the cone to the stem. Additionally, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. These flexible regions can cooperate to contribute to a gimbal structure that accommodates displacement and relative 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 can be axially displaced towards the structure to which the stem is connected.

[0716] Nasal mask only

[0717] In one form, the patient interface 3000 includes a seal-forming structure 3100 that is configured to seal around the entrance of the patient's nasal airway but not around the patient's mouth. The seal-forming structure 3100 can be configured to seal to the upper lip region of the patient. The patient interface 3000 can leave the patient's mouth uncovered. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 rather than the mouth. This type of patient interface can be identified as a full nasal mask.

[0718] One form of the full nasal mask according to the present technology is a face mask that is conventionally identified as a "nasal mask" and has a seal-forming structure 3100 that is configured to seal around the nose on the patient's face and above the nasal bridge. The shape of the nasal mask can be generally triangular. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that forms a seal in use on the upper lip region (e.g., upper lip), on at least a portion of the patient's nasal bridge or nasal ridge above the nasion, and on the patient's face on each outer side of the patient's nose (e.g., near the patient's nasolabial fold). Figure 1B The illustrated patient interface 3000 has a seal-forming structure 3100 of this type. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 through a single orifice.

[0719] Another form of the full nasal mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nasal cradle" mask, and the seal-forming structure 3100 can be identified as a "nasal cradle gasket". In one form, for example, asFigure 3Z As shown, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils in use. The seal-forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower surface and / or the front surface of the nasal tubercle region of the patient's nose and the alae nasi of the patient. The seal-forming structure 3100 can seal to the upper lip of the patient. The shape of the seal-forming structure 3100 can be configured to match or closely conform to the lower side of the patient's nose and can not contact the bridge region of the patient's nose or any part of the patient's nose above the nasal tubercle. In one form of the nose pad, the seal-forming structure 3100 includes a bridging portion that divides the opening into two orifices, and in use, each of the two orifices supplies air or breathable gas to a corresponding one of the patient's nostrils. The bridging portion can be configured to contact or seal against the columella of the patient's nose in use. Alternatively, the seal-forming structure 3100 can include a single opening to provide an air flow or breathable gas to both nostrils of the patient.

[0720] In some forms, only the nasal mask can include the nasal pillow as described above.

[0721] Nasal and mouth mask

[0722] In one form, the patient interface 3000 includes a seal-forming structure 3100 that is configured to surround the entrance of the patient's nasal airway and also seal around the patient's mouth. The seal-forming structure 3100 can be configured to seal to the patient's face near the chin region. The patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000. This type of patient interface can be identified as a nasal and mouth mask.

[0723] The nasal and mouth mask according to one form of the present technology is a mask that is traditionally identified as a "full-face mask" and has a seal-forming structure 3100 that is configured to seal on the patient's face around the nose, under the mouth, and above the bridge of the nose. The shape of the nasal and mouth mask can be generally triangular. In one form, the patient interface 3000 includes a seal-forming structure 3100 that forms a seal in use with the patient's chin region (which can include the lower lip of the patient and / or the region directly below the lower lip), at least a portion of the patient's nasal bridge or nasal ridge above the nasal tubercle, and the cheek region of the patient's face. Figure 1C The illustrated patient interface 3000 is of this type. The patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of seal-forming structure 3100 can be referred to as a "nasal and mouth gasket".

[0724] In another form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the lower surface and / or the front surface of the nasal tip portion of the patient's nose, on the alae nasi of the patient's nose, and on the patient's face on each lateral side of the patient's nose (e.g., near the nasolabial fold) in the patient's chin region, which may include the lower lip of the patient and / or the region directly below the lower lip. The seal-forming structure 3100 may also form a seal against the upper lip of the patient. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver an air stream or breathable gas to the patient's nostrils and mouth, may have an oral aperture configured to supply air or breathable gas to the mouth and a nasal aperture configured to supply air or breathable gas to the nostrils, or may have an oral aperture for delivering air to the patient's mouth and two nasal apertures for delivering air to the respective nostrils. This type of patient interface 3000 may have a nasal portion and an oral portion that seals to the patient's face at a location similar to a nasal pillow.

[0725] In a further form of the nasal and mouth mask, the patient interface 3000 may include a seal-forming structure 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal around the patient's mouth against the patient's face.

[0726] In some forms, the seal-forming structure 3100 may have a nasal portion that is separate and distinct from the oral portion. In other forms, the seal-forming structure 3100 may form a continuous seal around the patient's nose and mouth.

[0727] It should be understood that the above examples of different forms of the patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, the patient interface 3000 may include a combination of different features of the above examples of only the nasal mask and the nasal and mouth mask.

[0728] Membrane portion

[0729] As described above, in an example, the patient interface 3000 may include a membrane portion 3220 that engages the patient's face. In use, the base pad 3225 supports the membrane portion 3220. In various examples, the membrane portion 3220 may be formed at least in part of a fabric material, an elastomer such as silicone or TPE, or another suitable material. The membrane portion 3220 may be airtight. In particular, in one form, such as Figures 43 to 77As shown in the example of, the seal forming structure includes a fabric membrane portion 3220 that serves as a pressure assisted sealing mechanism. In use, the fabric membrane portion 3220 can easily respond to the system positive pressure acting on its inner side inside the inflatable chamber 3200 to urge it to form a tight sealing engagement with the face. The pressure assisted mechanism can act together with the elastic tension in the positioning and stabilizing structure 3300. In other examples, the membrane portion 3220 can be formed of silicone (such as a silicone membrane having a thickness of 0.2 mm to 0.4 mm or 0.25 mm to 0.3 mm).

[0730] Inflatable chamber

[0731] The inflatable chamber 3200 has a perimeter that is shaped to be complementary to the surface profile in the area of the average person's face that will form a seal in use. In use, the boundary edge of the inflatable chamber 3200 is positioned against the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 can extend around the entire perimeter of the inflatable chamber 3200 in use. In some forms, the inflatable chamber 3200 and the seal forming structure 3100 are formed from a single homogeneous sheet of material.

[0732] In certain forms of the present technology, the inflatable chamber 3200 does not cover the patient's eyes in use. In other words, the eyes are outside the pressurized volume defined by the inflatable chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with the therapy.

[0733] In certain forms of the present technology, the inflatable chamber 3200 is constructed of a transparent material (such as transparent polycarbonate). Using a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with the therapy. Using a transparent material can help the clinician observe how the patient interface is positioned and functions.

[0734] In certain forms of the present technology, the inflatable chamber 3200 is constructed of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with the therapy.

[0735] In some forms, the inflatable chamber 3200 is constructed of a rigid material such as polycarbonate. The rigid material can provide support for the seal forming structure.

[0736] In some forms, the inflatable chamber 3200 is made of a flexible material (e.g., made of a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in an instance, it can then be formed of a material having a Young's modulus of 0.4 GPa or less (such as foam). In some forms of the technology, the inflatable chamber 3200 can be made of a material having a Young's modulus of 0.1 GPa or less (such as rubber). In other forms of the technology, the inflatable chamber 3200 can be made of a material having a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0737] Multiple openings

[0738] Such as Figure 7A And Figure 7B As shown, different inflatable chambers 3200-1, 3200-2 can be formed as part of multi-opening gaskets 3050-1, 3050-2. In the illustrated instance, the gaskets 3050-1, 3050-2 each include three openings, but alternative gaskets can be formed with more or fewer openings.

[0739] In some forms, the different openings can serve different functions. For example, some openings can be only inlet openings, while other openings can be only outlet openings.

[0740] In other forms, at least one opening can provide two different functions. For example, during the same breathing cycle, one opening can be used as both an inlet and an outlet.

[0741] The multiple openings can allow for various configurations of delivering air to the inflatable chambers 3200-1, 3200-2. For example, depending on patient needs and / or patient comfort, the patient can use a given gasket 3050-1, 3050-2 in a "tube up" configuration (e.g., using a catheter headgear described below) or a "tube down" configuration (e.g., using a single catheter in front of the patient's face).

[0742] Nose and mouth masks

[0743] Such as Figure 7A As shown, the inflatable chamber 3200-1 includes a pair of inflatable chamber inlet ports 3254-1, which can be used to deliver gas into and / or out of the inflatable chamber 3200-1. The inflatable chamber inlet ports 3254-1 can be disposed on opposite sides of the inflatable chamber 3200-1 (e.g., left and right sides).

[0744] In some forms, the inflatable chamber 3200-1 can further include at least one ventilation opening 3402-1 (see, for example Figure 7A). The ventilation opening 3402-1 can be provided at the center of the inflation chamber 3200-1. For example, the ventilation opening 3402-1 can be provided between the inflation chamber inlet ports 3254-1.

[0745] In some forms, the inflation chamber 3200-1 can include a pair of grooves 3266-1. Each groove 3266-1 can be provided close to one of the inflation chamber inlet ports 3254-1. Each groove 3266-1 can form a partially recessed surface.

[0746] Only the nasal mask

[0747] The inflation chamber 3200-2 of only the nasal cushion 3050-2 can be similar to the inflation chamber 3200-1 of the mouth and nasal cushion 3050-1. Some similarities and differences between the inflation chambers 3200-1 and 3200-2 will be described below only.

[0748] As Figure 7B shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 can be provided on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0749] In some forms, the inflation chamber 3200-2 can also include at least one ventilation opening 3402-2 (see, for example Figure 7B ). The ventilation opening 3402-2 can be provided at the center of the inflation chamber 3200-2. For example, the ventilation opening 3402-2 can be provided between the inflation chamber inlet ports 3254-2.

[0750] In some forms, the inflation chamber 3200-2 can include a pair of grooves 3266-2. Each groove 3266-2 can be provided close to one of the inflation chamber inlet ports 3254-2. Each groove 3266-2 can form a partially recessed surface.

[0751] Inflation chamber with a face-liner portion

[0752] In Figures 43 to 66 the illustrated example, the inflation chamber 3200 is partially formed by the seal-forming structure 3100 and partially by the face-liner portion 3240. In this example, the inflation chamber inlet port 3202 is a single opening provided in the face-liner portion 3240. In particular, the short tube 3610 is connected to the face-liner portion 3240 and fluidly connected to the inflation chamber inlet port 3202 to deliver an air flow to the inflation chamber 3200. In these examples, the patient interface 3000 includes a connector 3620 that connects the short tube 3610 to the face-liner portion 3240. As Figure 53 、Figure 54 and Figure 66 As shown in Figure 54 and Figure 66 , the connector 3620 is an elbow tube in these instances. In other instances, it may be another type of connector, such as a straight connector. In some instances, the connector 3620 may be rotatable relative to the plenum chamber 3200. At the distal end of the stub tube 3610, the patient interface 3000 may include a connection port 3600 that may be connected to an air circuit 4170 that is connected to the RPT device 4000.

[0753] As will be described below, in some instances, the face cushion portion 3240 may at least partially form the plenum chamber 3200, for example, together with the base pad 3225 and / or the membrane portion 3220. In other instances, for example, if the base pad 3225 does not include any openings on its front side other than for other connectors for connecting to the stub tube 3610 or to the air circuit 4170, the base pad 3225 and the membrane portion 3220 may form substantially all of the plenum chamber 3200. In such instances, the face cushion portion 3240 may form a structural member that provides structural rigidity to the cushion module or holds the base pad 3225 in a predetermined shape.

[0754] face cushion portion

[0755] As described above, Figures 43 to 66 the patient interfaces 3000 shown each include a face cushion portion 3240 that may partially form the plenum chamber 3200. The face cushion portion 3240 may form the front side of the patient interface 3000 or at least its cushion module. The face cushion portion 3240 may include a patient-facing surface, for example, on the side facing the patient, and the base pad 3225 may be attached to the patient-facing surface of the face cushion portion 3240. The membrane portion 3220 may substantially cover the patient-facing side of the base pad 3225 and may be attached to the base pad 3225 and / or the face cushion portion 3240.

[0756] The face cushion portion 3240 may be partially formed of foam and / or fabric material. In Figures 43 to 66In the illustrated example, the face cushion portion 3240 is formed of foam covered with a fabric material / fabric layer on its non-patient-facing surface. The fabric material on the non-patient-facing / front-facing surface can advantageously provide a comfortable feel when manipulating the patient interface 3000 and an appearance consistent with bedding and comfort, which may make the patient more compliant with the therapy than if the patient interface 3000 looked more like a pure medical device. In some examples, the face cushion portion 3240 also includes a fabric layer on its patient-facing surface. In some examples, the foam material that partially forms the face cushion portion 3240 can be polyurethane foam. In some examples, the foam material can be a closed-cell foam, which can advantageously provide air impermeability. In some examples, the fabric material formed on both sides of the face cushion portion 3240 can be formed of nylon or polyester and can be woven, such as knitted. In some examples, the face cushion portion 3240 can include an air-impermeable film disposed between the fabric layer and the foam layer, which can provide air and / or moisture impermeability and can allow the use of open-cell foam in the face cushion portion 3240.

[0757] In some examples, the face cushion portion 3240 is formed of foam (without fabric). In such examples, the foam can be air-impermeable in nature, for example, it can be a closed-cell foam. In other examples, the foam can be coated with an air-impermeable layer (such as silicone, polyurethane, or other air-impermeable film / sheet). The foam material is not essential in the face cushion portion 3240 and can be replaced by another material (such as a thick synthetic material capable of being formed by thermoforming) in some examples. In some examples, the face cushion portion 3240 is formed of a fabric material (e.g., without foam), and its thickness can be, for example, 2 mm to 5 mm. The fabric material can be covered / coated with one or more air-impermeable layers to provide air impermeability. In some examples, the face cushion portion 3240 can include a synthetic felt material. In some examples where the base pad 3225 and the membrane portion 3220 define an inflatable chamber 3200 while the face cushion portion 3240 does not define an inflatable chamber 3200, it may not be necessary to make the face cushion portion 3240 air-impermeable.

[0758] The face gasket portion 3240 can include a curved three-dimensional shape in use. In the illustrated example, the face gasket portion 3240 is thermoformed into a curved three-dimensional shape so as to support itself in the curved three-dimensional shape. The face gasket portion 3240 can be semi-rigid to provide shape and / or structure to the cushion module of the patient interface 3000. In some examples, the face gasket portion 3240 is designed to support the base gasket 3225. As described elsewhere herein, the base gasket 3225 can be formed of foam and cannot support itself in the shape in use (e.g., if the base gasket 3225 is formed of compression cut foam). However, in some examples, the face gasket portion 3240 is capable of supporting itself in the shape in use and also supporting the base gasket 3225 in the shape in use. In other examples, the face gasket portion 3240 cannot support itself in the curved three-dimensional shape. In such examples, the base gasket 3225 can be designed to support itself in a predetermined shape and be capable of supporting the face gasket portion 3240 in the curved three-dimensional shape corresponding to the shape in use. For example, the base gasket 3225 can be formed of molded foam and can support the face gasket portion 3240 in the curved three-dimensional shape. In additional examples, neither the face gasket portion 3240 nor the base gasket 3225 can fully support themselves in a predetermined shape, but when attached to each other, such as when bonded together or otherwise attached, they can each assume a predetermined shape. The assembly can support itself in a predetermined shape. For example, once attached, each of the face gasket portion 3240 and the base gasket 3225 can support the other in a predetermined shape. In various examples, each of the face gasket portion 3240 and the base gasket 3225 cannot support itself (e.g., completely flaccid) or can only partially support itself (e.g., somewhat wobbly) before being attached to the other.

[0759] In some examples, the face gasket portion 3240 includes a first principal curvature that is non-zero and negative and a second principal curvature that is less than the first principal curvature. In the example, the face gasket portion 3240 is curved such that it has a first principal curvature P1 that is non-zero and negative and a second principal curvature P2 that is substantially zero, as Figure 45 shown.

[0760] In the example, the patient interface 3000 is configured such that the second principal curvature P2 is substantially parallel to the patient's midsagittal plane in use and can be located in the midsagittal plane in use.

[0761] In some instances, the face cushion portion 3240 is formed to be substantially flat, but is held in a curved configuration by the base pad 3225. In other instances, the face cushion portion 3240 can be inherently curved, for example it can be thermoformed, molded or otherwise manufactured to have an inherent curvature. In some instances, the face cushion portion 3240 can be flexible enough such that, although held in a curved configuration by the base pad 3225, the face cushion portion 3240 substantially does not deform the base pad 3225 (e.g., by a reaction force). In some instances, the base pad 3225 holds the face cushion portion 3240 in a curved shape across the user's face in the lateral-medial direction and allows the curved shape to flex, but substantially prevents cross-section flexure of the face cushion portion 3240 in the sagittal plane. In some instances, the face cushion portion 3240 is formed as a hyperbolic paraboloid or a parabolic cylinder. The confluence of the base pad 3225 and / or the membrane portion 3220 with the face cushion portion 3240 can form a path located on the hyperbolic paraboloid or the parabolic cylinder.

[0762] The patient interface 3000 can include at least a pair of headgear connectors connected to the face cushion portion 3240. The headgear connectors can be configured to connect to headgear straps of the positioning and stabilization structure 3300 of the patient interface 3000. In particular, as Figure 53 , Figure 54 and Figure 66 shown, in some forms of the technology, the face cushion portion 3240 is provided with a pair of upper headgear connector portions 3310 and a pair of lower headgear connector portions 3320. In an instance, the face cushion portion 3240 is also provided with an opening for connecting (e.g., releasably connecting) to an air delivery tube in use. In an instance, the face cushion portion 3240 is provided with at least one vent 3400 for gas flushing (e.g., to provide a continuous airflow from the inflation chamber 3200 to the environment throughout the patient's breathing cycle in use). In the instance shown in Figures 43 to 66 , the frame 3240 includes a connector 3620 that provides a connection to a short tube 3610 that has a connection port 3600 at its end. The connector 3620 can be in the form of a bent tube and / or can be configured to rotate relative to the frame 3240. In this instance, the vent 3400 is provided to the connector 3620. The vent 3400 can be formed by a plurality of holes. As depicted in Figure 53 , Figure 54 and Figure 66 (most obvious on only one side), the upper headgear connector portion 3310 is connected to the upper headgear strap 3311, and the lower headgear connector portion 3320 is connected to the lower headgear strap 3321.

[0763] In some instances where the face seal portion 3240 is relatively flexible and has a substantially zero principal curvature that is substantially aligned with the sagittal plane, the face seal portion 3240 can be flexed relatively easily such that the magnitude of the first principal curvature P1 can vary when the patient interface 3000 is donned. For example, when the patient interface 3000 is donned by a person with a relatively narrow face, the magnitude of the first principal curvature can be relatively large (e.g., the frame 3240 can be more curved), but when the patient interface 3000 is donned by a person with a relatively wide face, the magnitude of the first principal curvature can be smaller (e.g., the frame 3240 can be relatively "flatter"). In such instances, the face seal portion 3240 is configured to flex such that when donned by a patient with a relatively narrow face, the first principal curvature has a greater magnitude than when donned by a patient with a relatively wide face. In this manner, the patient interface 3000 can be adapted to fit patients with a range of different face sizes.

[0764] In instances where the face seal portion 3240 does not have a preformed curvature in the sagittal plane (e.g., the above-described principal curvature P2), the face seal portion 3240 can be configured to be less flexible in the sagittal plane (e.g., changing the second principal curvature P2) than in the horizontal plane (e.g., changing the first principal curvature P1). Additionally, the face seal portion 3240 can be shorter in the up-down direction than in the medial-lateral direction, which further makes it less likely for the face seal portion 3240 to flex in the sagittal plane. In some instances, the face seal portion 3240 can include a small curvature in the sagittal plane (e.g., principal curvature P2), either by being formed to have the small curvature or by being held in a curved shape by the base pad 3225.

[0765] Figure 67 Illustrated in one instance, the outer sides of the face seal portion 3240 can be angled relative to each other at an angle A of 90 degrees. In other instances, by way of example only, the outer sides of the face seal portion 3240 can form an included angle between 70 degrees and 120 degrees, between 75 degrees and 110 degrees, between 80 degrees and 100 degrees, or between 85 degrees and 95 degrees. Additionally, in one instance, the inner portion of the face seal can be curved with a radius of curvature D of substantially 30 mm. In other instances, the radius D can be in the range of 20 mm to 40 mm or 25 mm to 35 mm.

[0766] Positioning and stabilization structure

[0767] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position in use by a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 can include and act as a "headgear" in that it engages the patient's head to hold the patient interface 3000 in the sealed position. Examples of positioning and stabilization structures can be found in Figure 3A andFigure 3A-1 is shown in

[0768] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift away from the face (i.e., F 充气 ).

[0769] In one form, the positioning and stabilizing structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0770] Continuing to refer to Figure 3A-1 , the positioning and stabilizing structure 3300 provides a force F PSS that helps to maintain the inflation chamber 3200 in a sealed position on the patient's face. The positioning and stabilizing force F PSS can be the resultant of various forces from different elements of the positioning and stabilizing structure 3300. For example, the headgear straps can individually provide a strap force F 条带 to hold the seal-forming structure 3100 on the patient's face. The force F 条带 can also be directed at least partially in an upward direction to overcome the force of gravity F g . The force of gravity F g can be specifically shown for the seal-forming structure 3100 and the inflation chamber 3200, but the force of gravity will act on the entire patient interface 3000 (i.e., in the same direction as the illustrated force of gravity F g ).

[0771] The force of gravity F g can be opposed by a frictional force F f that can act in a direction directly opposite to the force of gravity F g . When the force of gravity pulls the seal-forming structure 3100 and the inflation chamber 3200 in a downward direction (as observed in Figure 3A-1 ), the frictional force F f will act in an upward direction (e.g., against the patient's face). For example, the patient can experience the frictional force F f at the upper lip (and / or other surfaces of the patient's face that contact the seal-forming structure 3100) to oppose movement in a downward direction (which can help to stabilize the gasket in place). Although the frictional force F f is specifically shown as being opposite to the force of gravity F g of the seal-forming structure 3100 and the inflation chamber 3200, components of the total frictional force (not shown) will also be opposite to the force of gravity F g associated with the positioning and stabilizing structure 3300 and any other parts of the patient interface 3000. The frictional force can act along any location where the patient interface 3000 contacts the patient's skin (or hair). The frictional force F f acts in a direction opposite to the force of gravity Fg in the opposite direction and extending along the patient's skin (or hair). In some forms, the gravitational force F g can also be counteracted by the vertical component of the reaction force from the patient's face acting on the seal-forming structure 3100, such as at the nasal ridge area and the chin area of the patient's face.

[0772] In some forms, the sum of the various forces can be equal to zero, such that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, the gravitational force F g and the blowing force F 充气 tend to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F PSS is applied to counteract the gravitational force F g and the blowing force F 充气 (as well as any frictional force F f ) and keep the seal-forming structure 3100 properly positioned. Although the positioning and stabilizing force FPSS may exceed the sum of the gravitational force F g and the blowing force F 充气 (where any additional positioning and stabilizing force F PSS is balanced by the reaction force from the patient's head acting on the various parts of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force F PSS is exactly strong enough to achieve this. In some instances, the positioning and stabilizing structure 3300 can be adjustable such that when assembled, the positioning and stabilizing force F PSS is greater than the force required to precisely balance the gravitational force F g and the blowing force F 充气 to hold the patient interface 3000 against the patient's head tightly enough such that the disruptive forces (such as tube resistance or lateral shunting of the inflation chamber 3200 during side lying) that may be experienced during use do not break the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can determine the positioning and stabilizing force F PSS required to achieve balance.

[0773] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of disruptive forces (such as from tube resistance or accidental interference with the patient interface) on the patient interface 3000.

[0774] In one form of the present technology, a positioning and stabilizing structure 3300 is provided and configured in a manner consistent with the way a patient wears it while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0775] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying in a supine sleeping position, where the back region of the patient's head is on the pillow.

[0776] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying in a lateral sleeping position, where the side region of the patient's head is on the pillow.

[0777] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a disconnect portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. The disconnect portion does not resist compression and can be, for example, a flexible or floppy strip. The disconnect portion is constructed and arranged such that when the patient lies their head on the pillow, the presence of the disconnect portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0778] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strip formed by a laminate of a fabric layer that contacts the patient, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes loop material to engage with a hook material portion.

[0779] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strip. For example, the strip can be configured to be in a tensioned state during use and direct forces to pull a seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strip can be configured as a tie.

[0780] In one form of the present technology, the positioning and stabilizing structure includes a first tie that is constructed and arranged such that in use, at least a portion of its lower edge passes above the supra-aural base point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0781] In one form of the present technology applicable to a nasal mask only or to a full-face mask, the positioning and stabilizing structure includes a second strap that is configured and arranged such that at least a portion of its upper edge passes under the subauricular base point of the patient's head and covers or is located below the occipital bone of the patient's head during use.

[0782] In one form of the present technology applicable to a nasal mask only or to a full-face mask, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to move apart from each other.

[0783] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a bendable and, for example, non-rigid strip. The advantage of this aspect is that the strip is more comfortable for the patient when the patient is sleeping.

[0784] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strip configured to be breathable to allow moisture to pass through the strip.

[0785] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure 3300 being configured to provide a holding force corresponding to a different range of sizes and / or shapes. For example, the system can include one form of the positioning and stabilizing structure 3300 suitable for a large-sized head but not for a small-sized head, and another form of the positioning and stabilizing structure 3300 suitable for a small-sized head but not for a large-sized head.

[0786] Catheter headgear

[0787] Catheter head sleeve

[0788] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head sleeves 3350 that deliver pressurized air received from a catheter forming part of an air circuit 4170 from an RPT device to the patient's airway, for example, through an inflation chamber 3200 and a seal-forming structure 3100. In Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion (e.g., the nose and / or mouth) of the patient's face during use. This allows the catheter of the air circuit 4170 that provides the pressurized air flow to be connected to a connection port 3600 of the patient interface at a location other than in front of the patient's face (e.g., on top of the patient's head).

[0789] InFigure 3Z In the illustrated form of the present technology, the positioning and stabilization structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head in use and extending across a respective cheek region above the corresponding ear (above the supra-auricular reference point on the patient's head) to a elbow tube 3615 on top of the patient 1000's head. This form of technology may be advantageous because if the patient sleeps on their side and one of the tubes 3350 is compressed to block or partially block the airflow along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other instances of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0790] In one instance where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek region), and a strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another region) to assist in securing the patient interface 3000 to the patient's head. For example, the tube 3350 and the strap may each be in a tensioned state in use to assist in maintaining the seal-forming structure 3100 in the sealed position.

[0791] In one form, the tube 3350 may be at least partially extensible such that the tube 3350 and the strap can be adjusted to be substantially equal in length when worn by the patient. This may allow for substantially symmetric adjustment between the tube 3350 and the strap such that the seal-forming structure remains substantially centered.

[0792] In Figure 3Z In the illustrated form of the technology, the two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to the connection port 3600. In some instances, the two tubes 3350 are integrally formed, while in other instances, the tubes 3350 are formed separately but are connected and disconnectable in use, e.g., for cleaning or storage. In the case of using separate tubes, they may be indirectly connected together, such as each tube being connected to a T-shaped connector. The T-shaped connector may have two arms / branches, each arm / branch being fluidly connectable to a respective one of the tubes 3350. Additionally, the T-shaped connector may have a third arm or opening that provides the connection port 3600 for fluid connection to the air circuit 4170 in use. The opening may be an inlet 3332 for receiving a pressurized air flow (see, e.g., 7C).

[0793] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0794] In some forms, the third arm of the T-shaped connector can be formed at an angle relative to each of the first two arms.

[0795] In some forms, a Y-shaped connector can be used instead of the T-shaped connector. The first two arms can be angled relative to each other, and the third arm can be angled relative to the first two arms. The angled formation of the first two arms can be similar to the shape of the patient's head so as to conform to that shape.

[0796] In some forms, at least one of the arms of the T-shaped connector (or Y-shaped connector) can be flexible. This can allow the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0797] In some forms, at least one of the arms of the T-shaped connector (or Y-shaped connector) can be at least partially reinforced. This can help maintain the shape of the connector such that bending of the connector does not block the air flow path.

[0798] The tube 3350 can be formed of a flexible material such as an elastomer (e.g., silicone or TPE), and / or formed of one or more fabric and / or foam materials. The tube 3350 can have a preformed shape and be capable of bending or moving into another shape after a force is applied, but may return to the original preformed shape when the force is absent. The tube 3350 can be generally arcuate or curved, with a shape approximating the contour of the head between the top of the patient's head and the nasal or oral region.

[0799] In some instances, the one or more tubes 3350 are crush-resistant to resist being blocked if squeezed during use (e.g., if pressed between the patient's head and a pillow, especially if there is only one tube 3350). The tube 3350 can be formed to have sufficient structural stiffness to resist crushing, or can be as described in U.S. Patent No. 6,044,844, the content of which is incorporated herein by reference.

[0800] Each tube 3350 can be configured to receive an air flow from a connection port 3600 on the top of the patient's head and deliver the air flow to a seal-forming structure 3100 at the entrance to the patient's airway. Figure 3ZIn the illustrated example, each tube 3350 is positioned, in use, on a path extending from the inflation chamber 3200 across the patient's cheek area and above the patient's ear to the elbow tube 3615. For example, a portion of each tube 3350 near the inflation chamber 3200 may, in use, cover the maxillary region of the patient's head. Another portion of each tube 3350 may cover an area of the patient's head above the supra-auricular base point of the patient's head. Each tube 3350 may also be positioned over either or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The elbow tube 3615 may, in use, be positioned over the patient's parietal bone, over the frontal bone, and / or over the junction therebetween (e.g., the coronal suture).

[0801] In some forms of the technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range of positions across the top of the patient's head such that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some examples, the head harness 3350 is configured to allow the upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially decoupled from the inflation 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).

[0802] As described above, in some examples of the technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a pad that is generally positioned under the nose and sealed to the lower periphery of the nose (e.g., an under-nose gasket). The positioning and stabilization structure 3300, including the tubes 3350, can be designed and arranged to pull the seal-forming structure 3100 into the patient's face under the nose with a sealing force in the posterior and upward directions (e.g., a posterior-upward direction). A sealing force having a posterior-upward direction can cause the seal-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surface of the patient's face, such as on either side of the patient's nose and the upper lip region of the patient.

[0803] A conduit forming part of the positioning and stabilization structure 3300, such as a head strap, can provide a force contributing to the positioning and stabilization force F PSS as Figure 3Z-1 illustrated, the positioning and stabilization force F PSSIt can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, each conduit can provide a force F_conduit that guides along the rearward and corresponding lateral directions to hold the seal-forming structure 3100 against the patient's face (entering the upper lip and sealing under the nose), and counteract the effect of the positive pressure in the inflation chamber 3200 to lift away from the face (i.e., F 充气 ). The force F 导管 can also be guided at least partially in the upward direction to overcome the gravitational force F g .

[0804] In some forms, when the conduit is filled with pressurized air, the conduit can provide a force that guides to the patient's head. This force can help clamp the patient's head. This force can be caused by the inflation of the conduit during normal use. In some forms, this force can provide a buffering effect on the patient's head. The conduit can be designed to limit expansion to prevent over-clamping of the patient's head.

[0805] The position of the patient's head can also change the clamping force of the conduit. For example, if the patient lies on their side, the weight of the patient's head may compress one conduit, and the other conduit (e.g., the outer part not between the patient's head and the sleep surface, such as a pillow) may additionally expand to maintain substantially the same pressurized air flow.

[0806] The gravitational force F g can be opposite to the frictional force F f , and this frictional force can act in a direction directly opposite to the gravitational force F g . When the gravitational force pulls the seal-forming structure 3100 and the inflation chamber 3200 downward (as observed in Figure 3A-1 ), the frictional force F f will act in the upward direction (e.g., against the patient's face). For example, the patient can experience the frictional force F f on the upper part of their lip (and / or other surfaces of the patient's face in contact with the seal-forming structure 3100) to counteract the downward movement (which can help stabilize the gasket in place). Although the frictional force F f is specifically shown as being relative to the gravitational force F g of the seal-forming structure 3100 and the inflation chamber 3200, the components of the total frictional force (not shown) will also be relative to the gravitational force F g associated with the positioning and stabilizing structure 3300 and any other parts of the patient interface 3000. The frictional force can act along any position where the patient interface 3000 contacts the patient's skin (or hair). The frictional force F f acts in a direction opposite to the gravitational force F g and extends along the patient's skin (or hair).

[0807] In some forms, the sum of the various forces can be equal to zero such that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, the gravitational force F g and the blowing force F 充气 tend to move the seal-forming structure 3100 away from the desired seal position. A positioning and stabilizing force F PSS is applied to counteract the gravitational force F g and the blowing force F 充气 (as well as any frictional force F f ) and keep the seal-forming structure 3100 properly positioned. Although the positioning and stabilizing force F PSS may exceed the sum of the gravitational force F g and the blowing force F 充气 (where any additional positioning and stabilizing force F PSS is balanced by the reaction force from the patient's head acting on the various parts of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper seal position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force F PSS is just strong enough to achieve this. In some instances, the positioning and stabilizing structure 3300 can be adjustable such that when assembled, the positioning and stabilizing force F PSS is greater than the force required to precisely balance the gravitational force F g and the blowing force F 充气 to hold the patient interface 3000 against the patient's head tightly enough such that the disruptive forces (such as tube resistance or lateral shunting of the inflation chamber 3200 during side lying) that may be experienced during use do not break the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can determine the positioning and stabilizing force F PSS required to achieve balance.

[0808] Extensible tube portions and non-extensible tube portions

[0809] In some examples of the present technology, one or both of the tubes 3350 are non-extensible in length. However, in some forms, the tube 3350 can include one or more extensible tube segments, such as formed by an extensible accordion-like structure. In some forms, the patient interface 3000 can include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube, the gas delivery tube including a tube wall having an extensible accordion-like structure. Figure 3Z The illustrated patient interface 3000 includes a tube 3350, the upper portion of which includes extensible tube segments each in the form of an extensible accordion-like structure 3362.

[0810] In some forms, the extensible accordion structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion structure 3328 can be biased towards a retracted position and can move to an extended position when the patient dons the positioning and stabilization structure 3300. Since portions of the tube 3350 may be substantially inextensible (e.g., the inextensible tube section 3363), the accordion structure 3328 allows the positioning and stabilization structure 3300 to stretch to conform to different sized heads. This can allow a single sized tube 3350 to be used with multiple sized heads. For example, due to the accordion structure 3328, the positioning and stabilization structure 3300 can be "one size fits all". Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can select the length that most closely conforms to their head, and the accordion structure 3328 can make minor adjustments to customize the fit to the individual patient.

[0811] In some forms, the inlet 3332 can be disposed in the middle of the conduit 6320. For example, the tube 3350 can be symmetric about the inlet 3332 by at least one axis.

[0812] The cross-sectional shape of the inextensible tube section 3363 of the tube 3350 can be circular, oval, ovoid, D-shaped, or rounded rectangular, e.g., as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface of the tube on the side facing and contacting other parts of the patient's face or head can be more comfortably worn compared to, for example, a tube having a circular cross-section.

[0813] In some examples of the present technology, the inextensible tube section 3363 is connected to the inflatable chamber 3200 at a low angle. The head sleeve 3350 can extend downward along the side of the patient's head and then bend forward and medially to connect to the inflatable chamber 3200 in front of the patient's face. Before connecting to the inflatable chamber 3200, the tube 3350 can extend to a position at the same vertical position (or in some instances, below it) as the connection to the inflatable chamber 3200. That is, before connecting to the inflatable chamber 3200, the tube 3350 can project in at least a partially upward direction. A portion of the tube 3350 can be located below the inflatable chamber 3200 and / or the seal forming structure 3100. The tube 3350 can contact the patient's face below the patient's cheekbone, which can be more comfortable than contacting on the patient's cheekbone and can avoid overly obscuring the patient's peripheral vision.

[0814] Catheter headgear connection port

[0815] In certain forms of the present technology, the patient interface 3000 can include a connection port 3600 located near the upper, outer, or posterior portion of the patient's head. For example, inFigure 3Z In the illustrated form of the present technology, the connection port 3600 is located on top of the patient's head (e.g., at a position above the patient's head). In this instance, the patient interface 3000 includes an elbow 3615 that forms the connection port 3600. The elbow 3615 may be configured to be in fluid communication with a conduit of the air circuit 4170. The elbow 3615 may be configured to rotate relative to the positioning and stabilization structure 3300 to at least partially decouple the conduit from the positioning and stabilization structure 3300. In some instances, the elbow 3615 may be configured to rotate by rotating about a substantially vertical axis and, in some particular instances, by rotating about two or more axes. In some instances, the elbow may include a tube 3350 or be connected to the tube 3350 by a ball and socket joint. The connection portion 3600 may be in the sagittal plane of the patient's head during use.

[0816] A patient interface in which the connection port is not located in front of the patient's face may be advantageous because some patients may find the conduit connected to a patient interface in front of the patient's face to be unaesthetic and / or obtrusive. For example, a conduit connected to a patient interface in front of the patient's face may be prone to interfering with bedding or sheets and pillowcases, especially if the conduit extends downward from the patient interface during use. Forms of the present technology that include a patient interface having a connection port that is positioned above the patient's head during use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., on their back, generally facing upward), or a prone position (e.g., on their front, generally facing downward). Additionally, connecting the conduit to the front portion of the patient interface may exacerbate a problem known as tube drag, where, during movement of the patient's head or the conduit, the conduit exerts an undesirable force on the patient interface, causing displacement away from the face. Tube drag may be less of a problem when the force is received at a position above the patient's head rather than in front of the patient's face near the seal-forming structure, where tube drag is more likely to break the seal.

[0817] Head cannula fluid connection

[0818] Two tubes 3350 are fluidly connected to the inflation chamber 3200 at their lower ends. In some forms of the technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured such that a patient can easily connect the two components together in a reliable manner. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or audible feedback in the form of a "satisfying click" or similar sound, such that a patient can easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or fabric material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connectors on each tube 3350 can include concave mating features that are configured to connect to convex mating features on the inflation chamber 3200. Alternatively, the rigid connectors on each tube 3350 can include convex mating features that are configured to connect to concave mating features on the inflation chamber 3200. In other instances, the tubes 3350 can each include a convex connector or a concave connector formed of a flexible material such as silicone or TPE (e.g., the same material as that forming the tubes 3350).

[0819] In other instances, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, an elastomeric flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be squeezed to reduce its diameter such that it can be compressed into a port in the inflation chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 airtight in the port. Alternatively, in a hard-to-hard type of engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or the inflation chamber 3200 can include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the inflation chamber 3200 to form or enhance the seal between the tube 3350 and the inflation chamber 3200.

[0820] Headstrap

[0821] In some forms, the positioning and stabilizing structure 3300 can include a headgear 3302 having at least one strap that can be worn by a patient to help correctly orient the seal-forming structure 3100 against the patient's face (e.g., to limit or prevent leakage).

[0822] As described above, some forms of the headgear 3302 can be constructed of a fabric material that can comfortably conform to the patient's skin. The fabric can be flexible to conform to a variety of facial contours. Although the fabric can include reinforcements along a selected length, it can limit the bending, flexing, and / or stretching of the headgear 3302.

[0823] In some forms, the headgear 3302 can be at least partially extensible. For example, the headgear 3302 can include an elastic material or a similar extensible material. For example, the entire headgear 3302 can be extensible, or selected portions can be extensible (or more extensible than the surrounding portions). This can allow the headgear 3302 to stretch in a tensioned state, which can help provide a sealing force for the seal-forming structure 3100.

[0824] Two forms of the headgear, the four-point headgear 3302-1 and the two-point headgear 3302-2, are discussed in more detail below as illustrative examples.

[0825] Four-point connection

[0826] As Figure 7E shown, some forms of the headgear 3302-1 can be four-point connection headgears. This means that the headgear 3302-1 can be connected to the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to four separate locations on the arms of the inflation chamber 3200. The headgear 3302-1 can include four different straps that provide tension to help maintain the seal-forming structure 3100 in a sealed position. Figure 3A The positioning and stabilizing structure 3300 can also be considered a four-point connection headgear.

[0827] In some forms, the headgear 3302-1 can include a lower strap 3304-1 that can be connected to the lower portion of the gasket 3050-1. The lower strap 3304-1 can extend along the patient's cheek toward the posterior region of the patient's head. For example, the lower strap 3304-1 can cover the masseter muscle on either side of the patient's face. Thus, the lower strap 3304-1 can contact the patient's head below the patient's ear. The lower strap 3304-1 can converge at the back of the patient's head and can cover the occipital bone and / or the trapezius muscle.

[0828] The headgear 3302-1 can also include an upper strap 3305-1 that can cover the temporal bone, the parietal bone, and / or the occipital bone. The upper strap 3305-1 can also be connected to the tube 3350 (e.g., by docking with the tab 3318).

[0829] The rear strip 3307-1 can extend between the upper strips 3305-1 and between the lower strips 3304-1. The lower strip 3304-1 and the upper strip 3305-1 on a given side (e.g., left or right) can also be connected to the rear strip 3307-1 adjacent to each other. Thus, the height of the rear strip 3307-1 can be approximately the combined height of the lower strip 3304-1 and the upper strip 3305-1. In use, the rear strip 3307-1 can cover the occipital bone and / or the parietal bone. This can allow the rear strip 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0830] In the illustrated example, the headgear 3302-1 can be formed in a generally X shape. The lower strip 3304-1 and the upper strip 3305-1 can be connected to the rear strip 3307-1 using stitching, ultrasonic welding, or any similar process.

[0831] In some forms, the lower strip 3304-1 is connected to the magnetic member 3306-1. For example, each lower strip 3304-1 can pass through the magnetic member 3306-1 such that the length of each lower strip 3304-1 can be adjusted. The magnetic member 3306-1 can be removably connected to the magnet 3370-1 (described below) such that the lower strip 3304-1 can be disconnected from the inflatable chamber 3200, but the length of the lower strip 3304-1 can be unaffected.

[0832] In some forms, the upper strip 3305-1 can be directly connected to the tab 3318 of the tube 3350. The upper strip 3305-1 can pass through the tab 3318 in order to adjust the length and control the tension of each upper strip 3305-1.

[0833] In some forms, the headgear 3302-1 can be used only with the nose and mouth pad 3050-1 (e.g., because only the nose pad 3050-1 does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the reinforcement arm 3340.

[0834] Two-point connection

[0835] As Figure 7F shown, some forms of the headgear 3302-2 can be a two-point connection headgear. This means that the headgear 3302-2 can be connected to two separate places.

[0836] In some forms, the headgear 3302-2 can be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple strips that are joined (e.g., stitched) together. This can be comfortable for patients as they do not come into contact with any seams or junctions that join different strips. In other forms, the headgear 3302-2 can be formed from multiple strips (e.g., two upper strips, a rear strip, etc.) that are joined together (e.g., using stitching, ultrasonic welding, etc.).

[0837] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strip that, in addition to the tube 3350, acts to position and stabilize the seal-forming structure 3100 at the entrance of the patient's airway. As Figure 3Z shown, the patient interface 3000 includes a strip 3307-2 that forms part of the positioning and stabilizing structure 3300. For example, this strip 3307-2 can be referred to as a back strap or a rear headgear strip. The rear strip 3307-2 can cover the temporal, parietal, and / or occipital bones. In other instances of the present technology, one or more additional strips can be provided. For example, a patient interface 3000 having a nasal and oral cushion according to an example of the present technology can have a second lower strip that is configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0838] In Figure 3Z the example shown, a strip 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350 that are positioned on each side of the patient's head and that wrap around the back of the patient's head, e.g., covering the occipital bone of the patient's head or being located below the occipital bone of the patient's head in use. The strip 3310 is connected to each tube above the patient's ear. Referring Figure 3Z to, the positioning and stabilizing structure 3300 includes a pair of tabs 3318. In use, the strip 3310 can be connected between the tabs 3318. Even when in a tensioned state in use, the strip 3310 can be flexible enough to wrap around the back of the patient's head and comfortably abut against the patient's head.

[0839] As Figure 7FAs shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear strip 3307-2 of the headgear 3302-2 (e.g., configured to contact the posterior portion of the patient's head) can be wider than the peripheral portion of the headgear 3302-2. The middle section 3308-2 of the rear strip 3307-2 can include a slit 3309-2. Thus, due to this slit 3309-2, the upper section of the rear strip 3307-2 can move relative to the lower section. This can allow the patient to have greater strip coverage over the posterior region of their head, which can help to better anchor the headgear 3302-2 to the patient's head since there is no lower strip (e.g., 3304-1).

[0840] In some forms, the headgear 3302-2 can be used only with the nasal cushion 3050-2 (e.g., because the nasal and mouth cushion 3050-1 does not have four attachment points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the reinforcement arm 3340.

[0841] Reinforcement arm

[0842] As Figure 7D shown, the reinforcement arm 3340 can be an elongated, rigid member that helps to maintain the cushion (e.g., the nasal and mouth cushion 3050-1 or the nasal cushion 3050-2) in an operative position. The reinforcement arm 3340 can contact one side of the patient's head and provide a force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0843] In some forms, the reinforcement arm 3340 is constructed of a rigid material (such as plastic). This rigid material may not allow the reinforcement arm 3340 to stretch. Additionally, the reinforcement arm 3340 can be substantially non-flexible and may not be bendable. The reinforcement arm 3340 can be pre-molded into a desired shape to conform to the patient's head. For example, the reinforcement arm 3340 can be molded into a curved shape to substantially correspond to the shape of one side of the patient's head (e.g., covering the masseter muscle and / or the temporal bone).

[0844] In certain forms, the reinforcement arm 3340 can be molded to conform to a particular patient's head (e.g., customizing the reinforcement arm 3340).

[0845] In some forms, the reinforcement arm 3340 can be flexible along at least one direction. For example, the reinforcement arm 3340 can be flexible about its width and can be non-flexible along its length. In other words, the reinforcement arm 3340 can bend about an axis along the width of the reinforcement arm 3340, but cannot bend about an axis perpendicular to the reinforcement arm 3340. This can allow an individual patient to adjust the reinforcement arm 3340 to better conform to their individual head.

[0846] In certain forms, the reinforcement arm 3340 can remain in the new position after being bent. This can allow the patient to adjust the shape of the reinforcement arm 3340 for their specific head, and then the reinforcement arm 3340 will maintain the desired shape during use to improve patient comfort.

[0847] In some forms, the first end 3342 of the reinforcement arm 3340 can be a free end, and the second end 3344 of the reinforcement arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved to minimize sharp edges that may cause patient discomfort. In use, the first end 3342 can also cover the patient's head near the temporal bone. The second end 3344 can be fixed to the arm connection structure 3504.

[0848] In some forms, the arm connection structure 3504 can be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 can have substantially the same shape. This can allow the conduit connection structure 3500 or the arm connection structure 3504 to be fitted into a groove (e.g., 3266-1 or 3266-2) and connected to the inflation chamber inlet port 3254. The arm connection structure 3504 can be connected to the nose and mouth gasket 3050-1 or only the nose gasket 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap fit, press fit, friction fit, etc.).

[0849] In some forms, the arm connection structure 3504 can be used as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Different from the tube 3350, the reinforcement arm 3340 does not deliver pressurized air to the inflation chamber 3200. The reinforcement arm 3340 can be used with a "tube down" configuration in which the hose is connected to the ventilation opening 3402 (e.g., 3402-1 and / or 3402-2), and air is delivered into the inflation chamber 3200 through the ventilation opening 3402. In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Thus, the arm connection structure 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict air flow into or out of the inflation chamber 3200.

[0850] Connector for positioning and stabilizing structure

[0851] As best seen in Figure 53 、 Figure 54 and Figure 66 In the example, the connector for connecting the positioning and stabilizing structure 3300 to the patient interface 3000 is provided to the face cushion portion 3240. In the example, the face cushion portion 3240 is provided with a pair of upper headgear connector portions 3310 and a pair of lower headgear connector portions 3320.

[0852] Each of the upper headgear connector portions 3310 includes a buckle provided to the respective end of a strap, which can be formed of fabric. In other examples, the upper headgear connector portions 3310 take the form of partially reinforced arms, each arm provided with a strap engaging means / component (e.g., a loop or slot) for engaging the headgear strap at or near its end.

[0853] In the illustrated example, the lower headgear connector portion 3320 includes a magnetic connector that can engage a complementary connector attached to the lower headgear strap.

[0854] As Figure 53 、 Figure 54 and Figure 66 depicted in, the upper headgear connector portion 3310 is connected to the upper headgear strap 3311, and the lower headgear connector portion 3320 is connected to the lower headgear strap 3321.

[0855] It should be understood that according to examples of the present technology, any suitable positioning and stabilizing structure 3300 can be provided to the patient interface 3000, and any suitable corresponding headgear connector can be provided to the frame 3240 or the cushion module.

[0856] Ventilation port

[0857] In one form, the patient interface 3000 includes a vent 3400 that is configured and arranged to permit flushing of exhaled gas (e.g., carbon dioxide).

[0858] In certain forms, the vent 3400 is configured to permit a continuous flow of air from the interior of the plenum 3200 to the environment while the pressure within the plenum is positive relative to the environment. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure within the plenum during use.

[0859] One form of the vent 3400 according to the present technology includes a plurality of holes, e.g., from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0860] The vent 3400 may be located within the plenum 3200. Alternatively, the vent 3400 is located in a disconnect structure, such as a swivel shaft. In other instances, the vent 3400 may be located in the face cushion portion 3240 or the base gasket 3225.

[0861] As Figure 7N shown, a vent 3450 may be used with the patient interface 3000. The vent 3450 may have a shape that is substantially similar to the vent opening 3402-1 (e.g., a generally circular shape).

[0862] The vent 3450 may be used with a mouth and nose plenum 3200-1 (e.g., as illustrated in Figure 7A ), or a nose-only plenum 3200-2 (e.g., as illustrated in Figure 7B ).

[0863] Continuing to refer to Figure 7A the vent 3450 may include a vent housing 3404 that may be configured to engage the vent opening 3402. The vent housing 3404 may be constructed of a rigid or semi-rigid material. For example, the vent housing 3404 may be constructed of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit unwanted flexure that may affect the position of the seal forming structure 3100 on the patient's face).

[0864] The venting housing 3404 can include a front surface 3408, a rear surface 3412, and a recess 3416. The front surface 3408 faces away from the patient's face in use and can be positioned outside of the pressurized volume of the inflatable chamber 3200. The rear surface 3412 is disposed opposite the front surface 3408. In use, the rear surface 3412 can face the patient and can be disposed within the pressurized volume of the inflatable chamber 3200. The recess 3416 can be formed between the front surface 3408 and the rear surface 3412. A portion of the inflatable chamber 3200 can be received within the recess 3416 to hold the vent 3400 in place.

[0865] In some forms, a diffuser 3448 can be used with the venting housing 3404. The diffuser 3448 can help limit the decibel output from either patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 can help limit the decibel level associated with the air output (e.g., exhaled air) from the patient interface 3000, but the diffuser 3448 can limit the decibel level at any point in the patient interface.

[0866] In certain forms, the diffuser 3448 can diffuse and thus slow the exhaust as it exits the inflatable chamber 3200 and passes through the venting housing 3404. The diffuser 3448 can help avoid jetting and discomfort associated with the patient and / or bed partner (e.g., noise caused by jetting onto pillows, sheets, bedding, etc.).

[0867] In some forms, the diffuser can include a front surface 3456 that faces away from the patient in use. The outer diameter of the front surface 3456 can be less than the inner diameter of the venting housing 3404 near the front surface 3408. This can form a gap 3464 through which air can travel.

[0868] Disconnect structure

[0869] In one form, the patient interface 3000 includes at least one disconnect structure, such as a swivel shaft or ball and socket. As Figure 8 , Figure 9 , Figure 12 , Figure 29 , Figure 30 , Figure 37 and Figure 38As shown, for example, the patient interface 3000 includes a connector 3620 designed to connect to a short tube 3610. In other instances, the connector 3620 can form a connection port 3600 for direct attachment to an air circuit 4170 (e.g., attached to a conduit connected to the RPT device 4000). The connector 3620 is capable of moving about at least one or two axes to at least partially decouple the short tube 3610 or the air circuit 4170 from the gasket module 3150. In some instances, the connector 3620 forms a vent port 3400, for example, by having a plurality of vent holes.

[0870] As described above, in some instances, the face gasket portion 3240 is connected to the short tube 3610 via the connector 3620, for example, as in the Figure 53 , Figure 54 and Figure 66 illustrated instances. In this instance, the connector 3620 is in the form of a bent tube. In other instances, the connector 3620 can be a straight connector. In this instance, the connector 3620 provides a ball-and-socket joint connection with the face gasket portion 3240 to provide multiple axes of rotation, and in other instances, the connector 3620 can be connected to the face gasket portion to rotate about only a single axis (e.g., an axis coaxial with a hole in the face gasket portion 3240). In such an instance, the connector 3620 can include an additional portion that rotates independently of the portion that rotates within the face gasket portion 3240 to provide an additional axis of rotation that can be used for the connection between the short tube 3610 and the face gasket portion 3240. The connector 3620 can be removably attached to the face gasket portion 3240. The connector 3620 forms a decoupling structure by being able to rotate about one or more axes relative to the face gasket portion 3240.

[0871] In Figure 53 , Figure 54 and Figure 66 illustrated instances, the short tube 3610 also forms a decoupling structure because the short tube 3610 decouples the movement of the air circuit 4170 to which it is attached from the face gasket portion 3240, thereby at least partially reducing the effect of tube resistance during use. Additionally, in some instances, the connection port 3600 can include a rotational connection to the air circuit, thereby providing additional or alternative decoupling of the air circuit 4170 from the face gasket portion 3240.

[0872] Connection port

[0873] The connection port 3600 allows connection to the air circuit 4170. In Figure 8 , Figure 9 , Figure 12 , Figure 29 , Figure 30 , Figure 37 and Figure 38In the illustrated example, for instance, the connection port 3600 is disposed at the distal end of the stub tube 3610. In other examples, the connection port 3600 can be disposed more directly on the gasket module 3150, such as to a connector that is directly connected to the gasket module 3150.

[0874] In Figure 53 、 Figure 54 and Figure 66 the illustrated example, the connection port 3600 is at the distal end of the stub tube 3612. In other examples, the connection port 3600 can be attached to the face gasket portion 3240 without the stub tube 3612. In such an example, the connection port 3600 can be provided by an elbow that is fluidly connected to the face gasket portion 3240 and configured to be fluidly connected to the air circuit 4170.

[0875] Frontal support

[0876] In one form, the patient interface 3000 includes a frontal support 3700.

[0877] Anti-asphyxiation valve

[0878] In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0879] Port

[0880] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one form, this allows a clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the inflation chamber 3200, such as pressure.

[0881] Modular

[0882] As described above, the gasket, headgear, and sleeve can have different styles, which can correspond to different uses (e.g., mouth breathing, nose breathing, etc.). A patient or clinician can select certain combinations of the gasket, headgear, and sleeve in order to optimize the effectiveness of the therapy and / or the comfort of the individual patient. Examples of this type of modular design are described in PCT / SG2022 / 050777, filed on October 28, 2022, which is incorporated herein by reference in its entirety.

[0883] In some forms, different styles of gaskets, headgears, and sleeves can be interchangeably used with one another in order to form different combinations of patient interfaces. From a manufacturing perspective, this can be beneficial because fewer parts can be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations can allow a patient to change the style of the patient interface without changing each individual part.

[0884] Air can be delivered to a patient in one of two main ways. In one example, a patient can receive a pressurized air stream through a head cannula 3350 (see, for example, Figure 3Z ). This can be referred to as a "tube up" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, a patient can receive a pressurized air stream through a catheter connected to an inflatable chamber 3200 (e.g., through connection port 3600 (see, for example, Figure 3A ). This can be referred to as a "tube down" configuration, where the air flow conduit is positioned in front of the patient's face. Different patients find one style of air delivery more comfortable than the other (e.g., due to the patient's sleep pattern). Thus, it may be beneficial to allow a single style of patient interface to be used in either a "tube up" or "tube down" configuration.

[0885] The patient interface can be part of a modular assembly with various interchangeable components that can be replaced by the patient and / or clinician with one or more components of a different style. The following description describes the various combinations that can result from assembling different components together.

[0886] Sleeve

[0887] In some forms, to allow modularity, the sleeve can be used with tube 3350 and / or reinforcement arm 3340. The sleeve can at least partially surround tube 3350 and / or reinforcement arm 3340. As Figures 7G to 7I shown, sleeves of different shapes can be used, which can correspond to different styles of positioning and stabilization structures 3300. In some forms, the configuration of the sleeve can be customized to fit a particular user's face. For example, the sleeve can be configured in a relatively more posterior region of the patient's head.

[0888] In some forms, the sleeve can be constructed of a comfort material. For example, the sleeve can be constructed of a fabric material, a foam material, or a combination of both. The comfort material can contact the patient during use and can feel soft on the patient's skin to improve patient compliance.

[0889] The material can also be flexible to help put on the sleeve or remove it from tube 3350 or reinforcement arm 3340. For example, the material can allow the sleeve to bend to conform to the shape of tube or catheter headgear 3350 or reinforcement arm 3340, which can vary according to the shape of an individual patient's head.

[0890] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around tube 3350 or reinforcement arm 3340. The elastic material can then return to its initial position, which is snug against tube 3350 or reinforcement arm 3340, to limit sleeve slippage during use.

[0891] As described in more detail below, some forms of the sleeve can be dedicated to the reinforcement elements (e.g., tube 3350 and / or reinforcement arm 3340). However, the sleeve can help the reinforcement elements connect interchangeably with the gasket of this version or style (e.g., mouth and nose gasket 3050-1, nose-only gasket 3050-2, etc.).

[0892] Catheter sleeve

[0893] As Figure 7G shown, an example of the sleeve is catheter sleeve 3351, which can be used with tube 3350 described above.

[0894] As Figure 7G shown, catheter sleeve 3351 can include a curved shape similar to that of tube 3350 as Figure 7C shown. The flexible material used to construct catheter sleeve 3351 can allow catheter sleeve 3351 to bend further to correspond to the shape of tube 3350 (e.g., when worn by a patient).

[0895] In some forms, catheter sleeve 3351 can include a first or upper opening 3352. The upper opening 3352 can be provided at one end of catheter sleeve 3351. The upper opening 3352 can be an opening leading to a channel extending along at least a portion of catheter sleeve 3351.

[0896] As Figure 7G shown, some forms of catheter sleeve 3351 can also include a lower extension 3354. The lower extension 3354 can be positioned on the end of catheter sleeve 3351 opposite the upper opening 3352. Catheter sleeve 3351 can be customized to fit a particular user's face. For example, the lower extension 3354 of catheter sleeve 3351 can be configured in a relatively more posterior or anterior region of the patient's head.

[0897] Some forms of the lower extension 3354 can include a rigid or semi-rigid member (e.g., within sleeve 3351). The rigid or semi-rigid member can be made of a plastic material or a similar material. Alternatively, a manufacturing process (e.g., stitched reinforcement threads, flat knitting, using a thicker material) can be used to strengthen the lower extension 3354.

[0898] As Figure 7GAs shown, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated example, the connecting member 3356 may be a magnet, but in other examples, the connecting member 3356 may be a different type of connector (e.g., mechanical fastener, adhesive, hook and loop material, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, but the connecting member 3356 may alternatively be positioned anywhere along the lower extension 3354.

[0899] In some forms, the connecting member 3356 (e.g., a magnet) may removably connect to the magnet 3370-1 of the headgear 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (e.g., see Figure 7J ), the magnet 3370-1 connected to the lower strip 3304-1 may removably connect to the connecting member 3356 to provide tension.

[0900] Four-point arm sleeve

[0901] As Figure 7H shown, another example of a sleeve is the four-point arm sleeve 3380, which may be used with the reinforcement arm 3340 described above.

[0902] As Figure 7H shown, the four-point arm sleeve 3380 may include a curved shape that may be similar to the shape of the reinforcement arm 3340 Figure 7D shown. The flexible material used to construct the four-point arm sleeve 3380 may allow the four-point arm sleeve 3380 to further bend to correspond to the shape of the reinforcement arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0903] As Figure 7H shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be positioned at one end of the four-point arm sleeve 3380.

[0904] In the illustrated example, the shape and / or structure of the lower extension 3384 is substantially the same as the shape of the lower extension 3354. For example, the lower extension 3384 ma...

Claims

1. A cushion module for a patient interface, the cushion module comprising: An inflatable chamber that can be pressurized to a therapeutic pressure that is at least 4 cmH2O higher than the ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for a patient to breathe; A seal-forming structure configured and arranged to form a seal with an area of the patient's face surrounding an inlet of the patient's airway, the seal-forming structure having holes therein such that the air flow at the therapeutic pressure is delivered at least to an inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; A face-liner portion that at least partially forms a front side of the cushion module, the seal-forming structure being attached to the face-liner portion; Wherein the face-liner portion includes a curved shape and at least partially curves rearwardly on an outer side of the face-liner portion during use, and wherein biasing the face-liner portion away from the curved shape toward a flatter shape than the curved shape provides a tensioning sensation for the seal-forming structure during use.

2. The cushion module according to claim 1, wherein the face-liner portion is first formed into a formed shape having a smaller curvature than the curved shape, and wherein after the seal-forming structure is attached to the face-liner portion, the seal-forming structure holds the face-liner portion in the curved shape, and the face-liner portion is biased away from the curved shape due to a tendency to return to the formed shape.

3. The cushion module according to claim 2, wherein the face-liner portion is thermoformed into the formed shape.

4. The cushion module according to claim 1, wherein the cushion module includes an elastic member that biases the face-liner portion away from the curved shape.

5. The cushion module according to claim 4, wherein the elastic member is disposed inside the inflatable chamber.

6. The cushion module according to claim 5, wherein the elastic member engages the face-liner portion along a connection between the face-liner portion and the seal-forming structure.

7. The cushion module according to any one of claims 4 to 6, wherein the elastic member is biased toward an annular shape.

8. The cushion module according to claim 7, wherein the elastic member is formed into the annular shape and deforms during being disposed inside the inflatable chamber, biasing the elastic member toward the annular shape during use to bias the face-liner portion away from the curved shape during use.

9. The cushion module according to any one of claims 4 to 8, wherein the elastic member is formed of a polymeric material.

10. The cushion module according to any one of claims 4 to 9, wherein the elastic member is molded.

11. The cushion module according to any one of claims 1 to 10, wherein the face-liner portion at least partially forms the inflatable chamber.

12. The cushion module according to any one of claims 1 to 11, wherein the face cushion portion is at least partially formed of one or more foam and / or fabric materials.

13. The cushion module according to claim 12, wherein the face cushion portion is formed of foam covered with a fabric material at least on its non-patient-facing side.

14. The cushion module according to any one of claims 1 to 13, wherein the seal-forming structure includes a membrane portion configured to engage the patient's face.

15. The cushion module according to any one of claims 1 to 14, wherein the membrane portion includes nasal apertures through which air can flow to the patient's two nostrils in use.

16. The cushion module according to any one of claims 1 to 15, wherein the membrane portion includes oral apertures through which air can flow to the patient's mouth in use.

17. The cushion module according to any one of claims 1 to 16, wherein the membrane portion is at least partially formed of a fabric material and is airtight.

18. The cushion module according to any one of claims 1 to 17, wherein the cushion module includes at least a pair of headgear connection portions that are connected to the face cushion portion and are configured to be connected to a positioning and stabilizing structure.

19. The cushion module according to claim 18, wherein the at least a pair of headgear connection portions includes a pair of upper headgear connection portions connected to the face cushion portion and a pair of lower headgear connection portions connected to the face cushion portion.

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