Patient interface with support assembly or frame

Abstract

A patient interface may include an inflation chamber that can be pressurized to a treatment pressure; a seal-forming structure constructed and arranged to seal with an area of the patient's face, the seal-forming structure having a plurality of connecting structures and at least one aperture; a support assembly configured to support the seal forming structure and including: a plurality of couplers movably connected to corresponding ones of the connection structures; a plurality of links; and a plurality of arms, each of the arms connecting one of the links to a corresponding one of the couplings; a positioning and stabilizing structure, the positioning and stabilizing structure comprising at least one strap connected to the support assembly; wherein the support assembly is configured to expand in a first dimension and a second dimension substantially orthogonal to the first dimension when tension from the positioning and stabilizing structure increases.

Description

[0001] Part of the disclosure of this patent document contains copyrighted material. The copyright owner does not object to the reproduction by anyone of the patent documents or patent disclosures in the form in which they appear in the patent office file or records, but reserves all copyright rights whatsoever.

[0002] Cross - reference to related applications

[0003] This application claims priority to Australian Provisional Application No. 2022903741, filed on December 7, 2022, the entire content of which is incorporated herein by reference. Background art 2.1 Technical field

[0004] This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of breathing - related disorders. This technology also relates to medical devices or equipment and their uses.

[0005] 2.2 Description of related technologies

[0006] 2.2.1 The human respiratory system and its disorders

[0007] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0008] 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 the region where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th Edition, by John B. West, published by Lippincott Williams & Wilkins in 2012.

[0009] There is a series of breathing disorders. Some disorders can be characterized by specific events, such as apnea, hypopnea, and hyperventilation.

[0010] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne - Stokes respiration (CSR), respiratory insufficiency, obesity - hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by events that include the occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway during sleep and the normal loss of muscle tone in the regions of the tongue, soft palate, and posterior pharyngeal wall. The condition causes affected patients to stop breathing, typically for periods of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can result in cardiovascular disease and brain damage. The syndrome is a common disorder, especially in middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repetitive deoxygenation and reoxygenation of arterial blood. CSR can be harmful due to the repetitive oxygen lack. In some patients, CSR is associated with repetitive microarousals from sleep, which cause severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs are unable to inhale sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0014] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0015] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These common characteristics include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (the major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular diseases (NMDs) are a broad term encompassing many diseases and afflictions that directly or indirectly impair muscle function through intrinsic muscle pathology or neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of the ability to walk, wheelchair dependence, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Symptoms of respiratory failure in NMDs include: increasing general weakness, difficulty swallowing, dyspnea during exercise and at rest, fatigue, lethargy, morning headache, and difficulty concentrating and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that result in an inefficient coupling between the respiratory muscles and the thoracic cage. These disorders are typically characterized by restrictive defects and have the potential for chronic hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of therapies have been used to treat or improve such conditions. In addition, these therapies can be utilized by other healthy individuals to prevent the onset of respiratory disorders. However, these therapies have many drawbacks.

[0020] 2.2.2 Therapies

[0021] 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 respiratory disorders.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the application of 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).

[0024] 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 obstruction, for example, by pushing the soft palate and tongue forward and away from the posterior wall of the oropharynx. 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, or unaesthetic in one or more respects, they may choose not to comply with the therapy.

[0025] 2.2.3 Respiratory therapy system

[0026] 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.

[0027] 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.

[0028] 2.2.3.1 Patient interface

[0029] The patient interface can be used to engage respiratory equipment with its wearer, for example, by providing an air flow to the entrance of the airway. The air flow can be provided to the nose and / or mouth via a mask, to the 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 an area of the patient's face, for example, to facilitate delivery of gas at a pressure with 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 a gas supply to the airway at a positive pressure of about 10 cmH2O. For a flow therapy 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.

[0030] Some other mask systems may not be functionally suitable for the present field. For example, a purely decorative mask may not be able to maintain an appropriate pressure. A mask system for underwater swimming or diving can be configured to prevent water from entering due to the higher external pressure but will not maintain the internal air at a pressure higher than the ambient pressure.

[0031] Some masks may be clinically disadvantageous for the present technology, for example, if they block the air flow through the nose and only allow air flow through the mouth.

[0032] If some masks require the patient to insert a part of the mask structure into their mouth to form and maintain a seal through their lips, these masks may be uncomfortable or impractical for the present technology.

[0033] Some face masks may be impractical to use while sleeping, such as when lying on one's side in bed with the head on a pillow.

[0034] 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 mandible or jawbone can move relative to the other bones of the skull. The entire head can move during respiratory therapy.

[0035] Due to these challenges, some face masks have one or more problems, namely being obtrusive, unaesthetic, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for long periods or when the patient is not familiar with a system. A face mask of the wrong size can lead to reduced compliance, reduced comfort, and poor patient outcomes. Face masks designed only for pilots, face masks designed as part of personal protective equipment (such as filter masks), SCUBA masks, or masks for the administration of anesthetics are tolerable for their original applications, but nonetheless, such masks may be undesirably uncomfortable when worn for long periods (e.g., several hours). This discomfort can lead to reduced patient compliance with the therapy. This is especially true if the mask is worn during sleep.

[0036] Assuming the patient adheres to the therapy, CPAP therapy is very effective in treating certain respiratory disorders. If the face mask is uncomfortable or difficult to use, the patient may not adhere to the therapy. Since patients are typically advised to clean their face masks regularly, if the face mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their face mask, and this can affect patient compliance.

[0037] While face masks for other applications (such as pilots) may not be suitable for treating sleep apnea, face masks designed for treating sleep apnea may be suitable for other applications.

[0038] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0039] 2.2.3.1.1 Seal-forming structure

[0040] The 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.

[0041] The patient interface can be characterized in part by the design intent of the seal-forming structure to engage with the face in use. In one form of the patient interface, the seal-forming structure can 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 can include a single element that surrounds both nostrils in use. Such a single element can be designed to cover, for example, the upper lip area and the bridge of the nose of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the mouth area in use, such as by forming a seal over the lower lip area of the face. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth area in use. These different types of patient interfaces can be known by various names to their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oro-nasal masks.

[0042] 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.

[0043] Certain seal-forming structures can be designed for mass production such that one design fits and is 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 the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted in order to form a seal.

[0044] One type of seal-forming structure extends around the periphery of the patient interface and is designed to seal against the patient's face when a force is applied to the patient interface, where the seal-forming structure engages the patient's face face-to-face. The seal-forming structure can include an air- or fluid-filled pad, or a molded or formed surface of an elastomeric seal element made of a material such as rubber. For this type of seal-forming structure, if the fit is insufficient, 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 in order to achieve a seal.

[0045] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the face mask to provide a self-sealing action against the patient's face when positive pressure is applied within the face mask. Similar to the previously styled seal-forming portion, 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.

[0046] Another type of seal-forming structure may include friction fit elements, such as for insertion into the nostrils, however some patients find these seal-forming structures uncomfortable.

[0047] Another form of seal-forming structure may use an adhesive to effect the seal. Some patients may find it inconvenient to apply and remove the adhesive to and from their face frequently.

[0048] A series of patient interface seal-forming structure techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0049] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0050] ResMed Limited manufactures the following products incorporating nasal pillows: SWIFT™ Nasal Pillow Mask, SWIFT™ II Nasal Pillow Mask, SWIFT™ LT Nasal Pillow Mask, SWIFT™ FX Nasal Pillow Mask, and MIRAGE LIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073778 (describing other aspects of the ResMed Limited SWIFT™ Nasal Pillow), U.S. Patent Application 2009 / 0044808 (describing other aspects of the ResMed Limited SWIFT™ LT Nasal Pillow); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing other aspects of the ResMed Limited MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO 2009 / 052560 (describing other aspects of the ResMed Limited SWIFT™ FX Nasal Pillow).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] A seal-forming structure for a patient interface for positive airway pressure therapy is subject to stresses from the air pressure that would break the seal. Accordingly, a variety of techniques have been used to position the seal-forming structure and maintain a sealed relationship with the appropriate portion of the face.

[0053] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0054] Another technique is to use one or more straps and / or stabilizing bands. Many such bands suffer from one or more of poor fit, bulkiness, discomfort, and inconvenience of use.

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0056] A Respiratory Pressure Therapy (RPT) device can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an interface of the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0057] 2.2.3.3 Air Circuit

[0058] An air circuit is a conduit or tube that is constructed and arranged to allow an 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.

[0059] 2.2.3.4 Humidifier

[0060] 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 nasal mucosa dryness and increases the comfort of the patient's airway. Additionally, in colder climates, warm air that is typically applied to the facial area inside and around the patient interface is more comfortable than cold air.

[0061] 2.2.3.5 Data Management

[0062] There may be clinical reasons for obtaining data to determine whether a patient who has received respiratory therapy has been "compliant", such as the patient having used their RPT device in accordance with one or more "compliance rules". An example of a compliance rule for CPAP therapy is that, in order for a patient to be considered compliant, the patient is required to use the RPT device for at least four hours per night for at least 21 or 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (such as a healthcare provider) may manually obtain data describing the patient's therapy using the RPT device, calculate the usage rate over a predetermined period of time, and compare it to the compliance rule. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0063] There may be other aspects of a patient's therapy that would benefit from communicating the therapy data to a third party or an external system.

[0064] Existing processes for communicating and managing such data may suffer from one or more of the following problems: high cost, time-consuming, error-prone.

[0065] 2.2.3.6 Ventilation techniques

[0066] Some forms of treatment systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from the interior space of the patient interface (e.g., the inflation chamber) to the exterior of the patient interface (e.g., to the environment).

[0067] The vent may include an aperture, and in the use of a mask, gas may flow through the aperture. Many such vents are noisy. Other vents may become blocked during use and thus provide inadequate flushing. Some vents may disrupt the sleep of the patient 1000's bed partner 1100, for example, through noise or a concentrated airflow.

[0068] ResMed Limited has developed many improved mask ventilation techniques. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0069] Noise table of existing masks (ISO 17510-2:2007, 10 cmH2O pressure 1 m)

[0070]

[0071] (*Only one sample, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744*)

[0072] The sound pressure values of each object are listed below

[0073] Summary of the Invention

[0074] 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.

[0075] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0076] Another aspect of the present technology relates to a method for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0077] 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.

[0078] One aspect of the present technology relates to a patient interface that includes: an inflatable chamber; a seal-forming structure having a plurality of connection structures; a support assembly configured to support the seal-forming structure and including: a plurality of couplers movably connected to corresponding ones of the connection structures; a plurality of linkages; and a plurality of arms, each of the arms connecting one of the linkages to a corresponding one of the couplers; a positioning and stabilizing structure including at least one strap connected to the support assembly; and a vent configured to allow a flow of ventilation air to be continuously transferred to the atmosphere throughout the patient's respiratory cycle during use, wherein the support assembly is configured to expand in a first dimension and a second dimension generally orthogonal to the first dimension when the tension from the positioning and stabilizing structure increases.

[0079] Another aspect of the present technology relates to a patient interface that includes: an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 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 a patient to breathe; a seal-forming structure connected to the inflatable chamber, the seal-forming structure being constructed and arranged to seal with an area of the patient's face that surrounds an inlet of the patient's airway, 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, the seal-forming structure having a plurality of connection structures, and the seal-forming structure having at least one aperture configured to direct the air flow at least to the patient's nostrils; a support assembly configured to support the seal-forming structure and including: a plurality of couplers movably connected to corresponding ones of the connection structures; a plurality of linkages; and a plurality of arms, each of the arms connecting one of the linkages to a corresponding one of the couplers; a positioning and stabilizing structure including at least one strap connected to the support assembly to hold the seal-forming structure in a therapeutically effective position on the patient's head during use; and a vent configured to allow a ventilation air flow to continuously pass to the atmosphere throughout the patient's respiratory cycle during use, 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; and wherein the support assembly is configured to expand in a first dimension and in a second dimension that is generally orthogonal to the first dimension when the tension from the positioning and stabilizing structure increases.

[0080] In the examples of each aspect of the first two paragraphs: (a) each arm in the arms can be more flexible than each link in the linkages; (b) the plurality of linkages can include a pair of side linkages, each side linkage positioned on a corresponding side of the support assembly; (c) each side linkage of the side linkages can include a strap connector, and the positioning and stabilizing structure can include a pair of side straps, each side strap of the side straps being configured to pass over a corresponding side of the patient's head and each side strap of the side straps being connected to the corresponding strap connector; (d) each strap connector of the strap connectors can include a slot to allow the corresponding side strap to pass through the slot and be connected to the corresponding strap connector; (e) the support assembly can be configured such that the tension from each side strap pulls the corresponding strap connector to deform the arm connected to the side linkage; (f) the plurality of connection structures can include a first connection structure protruding from the seal-forming structure and a second connection structure protruding from the seal-forming structure; (g) the plurality of couplers can include a first coupler connected to the first connection structure and a second coupler connected to the second connection structure; (h) the plurality of arms can include a first arm connected to the first coupler and a second arm connected to the second coupler; (i) the plurality of linkages can include a first linkage connected to each of the first arm and the second arm; (j) the support assembly can include a plurality of joints, each arm of the arms being connected to a corresponding one of the linkages at one of the joints; (k) each of the first connection structure and the second connection structure can be a lug having a circular cross-section; (l) each of the first coupler and the second coupler can be configured to rotate around a corresponding one of the first connection structure and the second connection structure; (m) the seal-forming structure and the inflation chamber can be constructed of a single piece of flexible material; (n) the flexible material can be silicone; (o) each arm of the arms can be constructed of a first material, and each link of the linkages is constructed of a second material that is more rigid than the first material; (p) the second material can be plastic; (q) the first material can be plastic, elastomer, or rubber; (r) each arm of the arms can include a notched portion that is more flexible than the remainder of the arm; (s) the support assembly can be configured such that when deformed due to the tension from the positioning and stabilizing structure, the support assembly deforms the seal-forming structure; (t) the at least one hole can include: a nasal hole configured to direct the air flow to the patient's nostrils; and a mouth hole configured to direct the air flow to the patient's mouth; (u) the support assembly can include two strap connectors, and the positioning and stabilizing structure can include two side straps connected to a corresponding one of the strap connectors, each side strap of the side straps being configured to pass over a corresponding side of the patient's head;(v) Each side strap of the side straps can be configured to pass over the corresponding side of the patient's head above the patient's ear and below the patient's eye; (w) Each side strap of the side straps can include a stiffening arm attached thereto; (x) The connection structure and the seal forming structure can be integrally molded as a single unit; (y) The support assembly can be configured to allow the seal forming structure to return to an undeformed state when the tension from the positioning and stabilizing structure is released; (z) The support assembly can be elastically deformable in response to an increase in the tension from the positioning and stabilizing structure; (aa) Each coupler in the couplers can be removably or permanently connected to a corresponding one of the connection structures in the connection structure; (bb) The elbow can be rotatably and removably connected to the inflation chamber inlet port; (cc) The plurality of couplers, the plurality of arms, and the plurality of links can be connected to form an opening through which the elbow is rotatably and removably connected to the inflation chamber inlet port such that the support assembly surrounds the elbow; and / or (dd) The support assembly can have a negative Poisson's ratio.;

[0081] One aspect of the present technology relates to a patient interface that includes: an inflation chamber; a seal forming structure constructed of a first elastic material; a frame constructed of a second elastic material having a greater elastic modulus than the first elastic material; a positioning and stabilizing structure including a pair of side straps connected to the frame; and a vent configured to allow a ventilation air flow to be continuously transferred to the atmosphere throughout the patient's respiratory cycle during use, wherein the frame is configured to elastically expand in a first dimension and a second dimension generally orthogonal to the first dimension when the tension from the positioning and stabilizing structure increases.

[0082] Another aspect of the present technology relates to a patient interface that includes: an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 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; a seal-forming structure connected to the inflatable chamber, the seal-forming structure being constructed and arranged to seal with a region of the patient's face that surrounds an entrance to the patient's airway, 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, the seal-forming structure having at least one aperture configured to direct the air flow at least to the patient's nostrils, and the seal-forming structure being constructed of a first elastic material; a frame connected to the seal-forming structure and constructed of a second elastic material having a greater modulus of elasticity than the first elastic material; a positioning and stabilization structure including a pair of side straps connected to the frame, each of the side straps being configured to pass over a corresponding side of the patient's head to hold the seal-forming structure in a therapeutically effective position on the patient's head during use; and a vent configured to allow a ventilation air flow to continuously pass to the atmosphere throughout the patient's respiratory cycle during use, 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; and wherein the frame is configured to elastically expand in a first dimension and in a second dimension that is generally orthogonal to the first dimension when the tension from the positioning and stabilization structure increases.

[0083] In the examples of each aspect of the first two paragraphs: (a) the frame may be constructed of a single piece of homogeneous second elastic material; (b) the seal-forming structure may be constructed of a single piece of homogeneous first elastic material; (c) the frame may be movably connected to the seal-forming structure; (d) the frame may include a pair of strap connectors, and each of the side straps may be connected to a corresponding strap connector; (e) each of the strap connectors may include a slot to allow the corresponding side strap to pass through the slot and be connected to the corresponding strap connector; (f) the frame may be configured such that the tension from each side strap pulls the corresponding strap connector to deform the frame; (g) the seal-forming structure may include a plurality of connecting structures that protrude from the seal-forming structure and are configured to connect to the frame; (h) the first elastic material may be silicone; (i) the second elastic material may be plastic; (j) the first elastic material may be plastic, elastomer, or rubber; (k) the frame may include a notch portion that is more flexible than the rest of the frame; (l) the frame may be configured such that when deformed due to the tension from the positioning and stabilizing structure, the frame deforms the seal-forming structure; (m) the at least one hole may include: a nasal hole configured to direct the air flow to the patient's nostrils; and a mouth hole configured to direct the air flow to the patient's mouth; (n) the frame may include two strap connectors; (o) each of the side straps may be connected to a corresponding strap connector; (p) each of the side straps may be configured to pass over the patient's ear and under the patient's eye on the corresponding side of the patient's head; (q) each of the side straps may include a stiffening arm attached thereto; (r) the connecting structure may be integrally molded with the seal-forming structure as a single unit; (s) the frame may be configured to allow the seal-forming structure to return to an undeformed state when the tension from the positioning and stabilizing structure is released; (t) the frame may be elastically deformable in response to an increase in the tension from the positioning and stabilizing structure; (u) the frame may be movably or permanently connected to the seal-forming structure; (v) the elbow may be rotatably and removably connected to the inflation chamber inlet port; (w) the frame may form an opening through which the elbow is rotatably and removably connected to the inflation chamber inlet port such that the frame surrounds the elbow; (x) the frame has a negative Poisson's ratio; and / or (y) the frame may include two pairs of strap connectors on each side, and the positioning and stabilizing structure may include two pairs of side straps, each pair of side straps being configured to connect to a corresponding one of the two pairs of strap connectors on the corresponding side of the patient's head.

[0084] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0085] One aspect of one form of the present technology is a method of manufacturing a device.

[0086] One aspect of certain forms of the present technology is an easy-to-use medical device, for example, used by a person without medical training, by a person with limited dexterity or vision, or by a person with limited experience in using this type of medical device.

[0087] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., in a person's home).

[0088] One aspect of one form of the present technology is a patient interface that can be cleaned in 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 in a patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0089] The described methods, systems, devices, and equipment can be implemented to improve the functionality of processors (such as those of dedicated computers, respiratory monitors, and / or respiratory therapy devices). Additionally, the described methods, systems, devices, and equipment can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep apnea.

[0090] Of course, portions of these aspects can form sub-aspects of the present technology. Additionally, the sub-aspects and / or individual aspects within the aspects can be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0091] Other features of the technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0092] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to similar elements and include:

[0093] 4.1 Respiratory Therapy System

[0094] Figure 1A A system including patient 1000 is shown, where the patient wears a patient interface 3000 in the form of a nasal pillow that receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified 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 position.

[0095] Figure 1B A system including patient 1000 is shown, where the patient wears a patient interface 3000 in the form of a nasal mask, and the patient interface 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.

[0096] Figure 1C A system including patient 1000 is shown, where the patient wears a patient interface 3000 in the form of a full face mask, and the patient interface 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 sleeping position.

[0097] 4.2 Respiratory System and Facial Anatomy

[0098] Figure 2A 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 is shown.

[0099] Figure 2B A view of the human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, major alar cartilage, nostril, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0100] Figure 2C A front view of a face with several identified surface anatomical features is shown. The several identified surface anatomical features include the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial groove, and oral commissure point. The upper, lower, radially inward, and radially outward directions are also indicated.

[0101] Figure 2D A side view of a head with several identified surface anatomical features is shown, including the glabella point, nasion point, nasal prominence point, subnasale point, upper lip, lower lip, supramental point, nasal ridge, alar ridge point, superior auricular point, and inferior auricular point. The up-down direction and the front-back direction are also indicated.

[0102] Figure 2E A side view of the other side of the head is shown. The approximate positions of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0103] Figure 2F A bottom view of the nose with several identified features is shown. The several identified features include the nasolabial groove, lower lip, vermilion border of the upper lip, nostril, subnasale point, columella nasi, nasal prominence point, long axis of the nostril, and median sagittal plane.

[0104] Figure 2GA side view showing the surface features of the nose.

[0105] 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.

[0106] Figure 2I Shows a medial anatomical view of the nose approximately several millimeters from the median sagittal plane, particularly showing the medial crura of the septal cartilage and the major alar cartilage.

[0107] 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.

[0108] Figure 2K Shows a side view of the skull with the contour 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.

[0109] Figure 2L Shows an anterolateral view of the nose.

[0110] 4.3 Patient Interface

[0111] Figure 3A Shows a nasal mask - type patient interface according to one form of the present technology.

[0112] Figure 3B Shows a schematic 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 has a relatively large magnitude when compared with Figure 3C the curvature magnitude shown.

[0113] Figure 3C Shows a schematic 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 has a relatively small magnitude when compared with Figure 3B the curvature magnitude shown.

[0114] Figure 3D Shows a schematic 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.

[0115] Figure 3E Shows a schematic 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 when compared with Figure 3Fhas a relatively small magnitude when compared to the curvature magnitude shown.

[0116] Figure 3F A schematic cross-section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and has a relatively large magnitude when compared to Figure 3E the curvature magnitude shown.

[0117] 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.

[0118] 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.

[0119] 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.

[0120] Figure 3J A cross-section through a Figure 3I structure is shown. The illustrated surface bounds a Figure 3I two-dimensional hole in the structure.

[0121] Figure 3K A Figure 3I perspective view of a structure including a two-dimensional hole and a one-dimensional hole is shown. Also shown is the surface that bounds the Figure 3I two-dimensional hole in the structure.

[0122] Figure 3L A face mask having an inflatable bladder as a cushion is shown.

[0123] Figure 3M A cross-section through a 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.

[0124] Figure 3N A further cross-section through a Figure 3L face mask is shown. The inner surface is also indicated.

[0125] Figure 3O The left-hand rule is illustrated.

[0126] Figure 3P The right-hand rule is illustrated.

[0127] Figure 3Q The left ear is shown, including the left ear helix.

[0128] Figure 3R Shows the right ear, including the right ear helix.

[0129] Figure 3S Shows the right hand helix.

[0130] 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 film in different regions of the face mask.

[0131] Figure 3U Shows a view of the inflatable chamber 3200, showing the sagittal plane and the intermediate contact plane.

[0132] Figure 3V Shows Figure 3U A view of the rear part of the inflatable chamber. The direction of this view is orthogonal to the intermediate contact plane. Figure 3V The sagittal plane in bisects the inflatable chamber into a left hand side and a right hand side.

[0133] Figure 3W Shows a cross section through Figure 3V the inflatable chamber, which cross section is taken at the Figure 3V sagittal plane shown. 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 on the sagittal plane and touches the gasket of the inflatable chamber only at two points (upper point 3220 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.

[0134] 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 the inflatable chamber 3200 is the inflatable chamber of a nasal mask, and the upper point 3220 is generally located on the nasal bridge point, and the lower point 3230 is located on the upper lip.

[0135] 4.4 RPT device

[0136] Figure 4A Shows an RPT device according to one form of the present technology.

[0137] Figure 4BSchematic 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. Articles within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0138] 4.5 Humidifier

[0139] Figure 5A An isometric view of a humidifier according to one form of the present technology is shown.

[0140] Figure 5B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0141] 4.6 Respiratory waveform

[0142] Figure 6 A typical respiratory waveform of a human model during sleep is shown.

[0143] 4.7 Patient interface with support assembly or frame

[0144] Figure 7A A perspective view of a seal-forming structure with a partial support assembly according to an example of the present technology is shown.

[0145] Figure 7B Another perspective view of a seal-forming structure with a partial support assembly according to an example of the present technology is shown.

[0146] Figure 7C Another perspective view of a seal-forming structure with a partial support assembly according to an example of the present technology is shown.

[0147] Figure 7D Another perspective view of a seal-forming structure with a partial support assembly according to an example of the present technology is shown.

[0148] Figure 7E A front view of a seal-forming structure with a partial support assembly according to an example of the present technology is shown.

[0149] Figure 8A A perspective view of a seal-forming structure with a support assembly according to an example of the present technology is shown.

[0150] Figure 8B Another perspective view of a seal-forming structure with a support assembly according to an example of the present technology is shown.

[0151] Figure 8CShows another perspective view of a seal-forming structure with a support assembly according to an example of the present technology.

[0152] Figure 8D Shows a rear view of a seal-forming structure with a support assembly according to an example of the present technology.

[0153] Figure 8E Shows a front view of a seal-forming structure with a support assembly according to an example of the present technology.

[0154] Figure 9 Shows a side view of a patient-worn patient interface according to an example of the present technology.

[0155] Figure 10 Shows a side view of a patient-worn patient interface according to an example of the present technology.

[0156] Figure 11 Shows a side view of a patient-worn patient interface according to an example of the present technology.

[0157] Figure 12 Shows a side view of a patient-worn patient interface according to an example of the present technology.

[0158] Figure 13 Shows a side view of a patient-worn patient interface according to an example of the present technology.

[0159] Figure 14 Shows a side view of a patient-worn patient interface according to an example of the present technology. Detailed Description

[0160] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, 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 the specific examples described herein only and are not intended to be limiting.

[0161] The following description is provided with respect to 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 of the examples may constitute another example.

[0162] 5.1 Therapy

[0163] In one form, the present technology includes a method for treating a respiratory disorder, the method including applying positive pressure to an inlet of an airway of a patient 1000.

[0164] In certain examples of the present technology, a positive pressure air supply is provided to a nasal passage of the patient via one or both nostrils.

[0165] In certain examples of the present technology, mouth breathing is restricted, constrained, or prevented.

[0166] 5.2 Respiratory Therapy System

[0167] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. 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.

[0168] 5.3 Patient Interface

[0169] The non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connecting to the air circuit 4170, and 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 patient's airway so as to maintain a positive pressure at the entrance of the patient 1000's airway. Accordingly, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0170] 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.

[0171] 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 6 cmH2O relative to the environment.

[0172] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0173] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0174] 5.3.1 Seal-Forming Structure

[0175] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and can additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal can occur. The area where the actual seal occurs (the actual seal surface) can vary over time and among patients during 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.

[0176] In one form, the target seal-forming area is located on the outer surface of the seal-forming structure 3100.

[0177] In certain forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material (such as silicone rubber).

[0178] The seal-forming structure 3100 according to the present technology can be constructed of a soft, flexible, elastic material (such as silicone resin).

[0179] In certain forms of the present technology, a system including more than one seal-forming structure 3100 is provided, each seal-forming structure being configured to correspond to a different range of sizes and / or shapes. For example, the system can include one form of the seal-forming structure 3100 that is suitable for a large-sized head but not for a small-sized head, and another such seal-forming structure that is suitable for a small-sized head but not for a large-sized head.

[0180] 5.3.1.1 Sealing mechanism

[0181] In one form, the seal-forming structure includes a seal flange utilizing a pressure-assisted sealing mechanism. In use, the seal flange can readily respond to the system positive pressure acting on the underside of the seal flange within the interior of the inflation 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 stabilization structure.

[0182] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness less than about 1 mm (such as from about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the edge of the inflation chamber 3200 and extends around at least a portion of the path of the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the seal flange against bending during use.

[0183] In one form, the seal-forming structure may 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.

[0184] 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 an adjacent region of a seal flange.

[0185] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0186] In certain forms of the present technology, the seal-forming structure may include one or more of the following: 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.

[0187] 5.3.1.2 Nasal bridge or nasal ridge region

[0188] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face in use.

[0189] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the nasal bridge region or nasal ridge region of the patient's face in use.

[0190] 5.3.1.3 Upper lip region

[0191] 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.

[0192] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of the patient's face in use.

[0193] 5.3.1.4 Chin region

[0194] 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.

[0195] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin region of the patient's face in use.

[0196] 5.3.1.5 Forehead region

[0197] 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.

[0198] 5.3.1.6 Nasal pillows

[0199] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal jets or nasal pillows, each nasal jet or nasal pillow being configured and arranged to form a seal with a respective nostril of the patient's nose.

[0200] 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 lower side of the patient's nose; a stem; a flexible region located on the lower side 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 relative movement of displacement and angle 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.

[0201] 5.3.2 Inflatable chamber

[0202] The inflatable chamber 3200 has a perimeter that is shaped to be complementary to the surface profile of an average person's face in the region 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.

[0203] 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.

[0204] In certain forms of the present technology, the inflatable chamber 3200 is made 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.

[0205] In certain forms of the present technology, the inflatable chamber 3200 is made of a translucent material. Using a translucent material can reduce the prominence of the patient interface and help improve compliance with the therapy.

[0206] 5.3.3 Support assembly

[0207] Figures 7A to 8E An example of the present technology is shown, where the patient interface 3000 includes a support assembly or structure 3129 configured to support a seal-forming structure 3100. The support assembly 3129 may include a number of interconnecting members that support the seal-forming structure 3100, as described below.

[0208] In these examples, the seal-forming structure 3100 may be composed of a first elastic material, which may be silicone, plastic, elastomer, or rubber. The seal-forming structure 3100 may be constructed from a single-piece homogeneous first elastic material. The seal-forming structure 3100 may have at least one hole configured to direct an air flow at least to the patient's nostrils. The at least one hole may include one or two nasal holes 3102 configured to direct an air flow to the patient's nostrils, and may also include a mouth hole 3104 configured to direct an air flow to the patient's mouth. The seal-forming structure 3100 may include a nose portion 3101 configured to engage the patient's face around the nose. The seal-forming structure 3100 may include a mouth portion 3103 configured to engage the patient's face around the mouth. The seal-forming structure 3100 has a plurality of connection structures, which may be in the form of lugs 3105 having a circular cross-section. The connection structures (e.g., lugs 3105) may project from the seal-forming structure 3100. The connection structures (e.g., lugs 3105) may be integrally molded with the seal-forming structure 3100 as a single unit.

[0209] The support assembly 3129 may include a plurality of couplers 3130 movably connected to corresponding connection structures in the connection structures (e.g., lugs 3105). The couplers 3130 may be configured to rotate around the corresponding connection structures in the connection structures (e.g., lugs 3105). The couplers 3130 may also be removably or permanently connected to the corresponding connection structures in the connection structures (e.g., lugs 3105).

[0210] The support assembly 3129 may include a plurality of linkages (e.g., an upper horizontal linkage 3133, a lower horizontal linkage 3134, and / or a side linkage 3135). Each side linkage 3135 may be positioned on a corresponding side of the support assembly 3129. Each side linkage among the side linkages 3135 may include a strap connector 3138, and the positioning and stabilizing structure 3300 may include a pair of side straps 3303, each of the side straps 3303 being configured to pass over a corresponding side of a patient's head and connect to a corresponding strap connector 3138. Each strap connector 3138 among the strap connectors 3138 may include a slot 3137 to allow the corresponding side strap 3303 to pass through the slot and connect to the corresponding strap connector 3138. As shown, the support assembly 3129 may include two strap connectors 3138.

[0211] The support assembly 3129 may include a plurality of arms (e.g., one or more horizontal arms 3131 and / or one or more vertical arms 3132). These arms (horizontal arms 3131 and vertical arms 3132) may be more flexible than the linkages (upper horizontal linkage 3133, lower horizontal linkage 3134, and side linkage 3135). These arms (horizontal arms 3131 and vertical arms 3132) may interconnect the linkages (upper horizontal linkage 3133, lower horizontal linkage 3134, and side linkage 3135) and the coupler 3130. Figure 8A For example, one of the horizontal arms 3131 is shown, which is connected to the upper horizontal linkage 3133 at one end and to one of the couplers in the coupler 3130 at the other end. The same coupler 3130 is also connected to one of the vertical arms 3132, which is also connected to one of the side linkages 3135. Figure 8A For example, one of the horizontal arms 3131 is also shown, which is connected to the lower horizontal linkage 3134 at one end and to one of the couplers in the coupler 3130 at the other end. The same coupler 3130 is also connected to one of the vertical arms 3132, which is also connected to one of the side linkages 3135.

[0212] The support assembly 3129 may include a plurality of joints 3136, where any one of these arms (horizontal arms 3131 and vertical arms 3132) is connected to a corresponding one of the linkages (upper horizontal linkage 3133, lower horizontal linkage 3134, and side linkage 3135) or the coupler 3130.

[0213] Each of these arms (the horizontal arm 3131 and the vertical arm 3132) may be constructed of a first material, and each of the linkages (the upper horizontal linkage 3133, the lower horizontal linkage 3134, and the side linkage 3135) may be constructed of a second material that is more rigid than the first material. Additionally, the coupler 3130 may be constructed of another material that is more rigid than the first material and may be the same as or different from the first material. The second material may be plastic. The first material may be plastic, elastomer, or rubber. Each of these arms (the horizontal arm 3131 and the vertical arm 3132) may include one or more notch portions to be more flexible than the remainder of these arms (the horizontal arm 3131 and the vertical arm 3132).

[0214] When the tension from the positioning and stabilization structure 3300 increases, the support assembly 3129 may elastically expand in a first dimension and a second dimension that is generally orthogonal to the first dimension. Thus, when each of the side straps 3303 in the side straps is pulled, in the case of being connected to the corresponding strap connector 3138, the support assembly 3129 widens in the lateral direction. For example, the side linkages 3135 are pulled away from each other and away from the sagittal plane of the patient in a direction generally perpendicular to the sagittal plane of the patient. The support assembly 3129 also widens in the upward and downward directions. For example, the upper horizontal linkage 3133 and the lower horizontal linkage 3134 are pulled away from each other in corresponding directions generally parallel to the sagittal plane of the patient. This may allow the support assembly 3129 to deform and change the shape of the seal-forming structure 3100 to which the support assembly is connected when deformed due to the tension from the side straps 3303, so as to adapt to the patient's face and maintain an effective seal, such as at the nasal corner near the nasolabial fold and / or at the gnathion near the chin. The deformability of the support assembly 3129 and thus the deformability of the seal-forming structure 3100 may allow a balanced sealing force to be obtained at such areas of the patient, which may be difficult to seal due to complex geometries. The support assembly 3129 may be configured to deform without manual adjustment.

[0215] The support assembly 3129 can be configured such that the tension from each side strap 3303 pulls on the corresponding strap connector 3138 to deform the arms (horizontal arm 3131 and vertical arm 3132) directly or indirectly connected to the corresponding side link 3135. The support assembly 3129 can be configured such that when deformed due to the tension from the positioning and stabilization structure 3300, the support assembly 3129 deforms the seal-forming structure 3100. The support assembly 3129 can be configured to allow the seal-forming structure 3100 to return to its undeformed state when the tension from the positioning and stabilization structure 3300 is released. The support assembly 3129 can be elastically deformable in response to an increase in the tension from the positioning and stabilization structure 3300. The overall support assembly 3129 (i.e., the combination of its components, their interconnections, and their respective materials) can have a negative Poisson's ratio.

[0216] Each side strap of the side straps 3303 can be configured to pass over the ear and under the eye of the patient on the corresponding side of the patient's head. Each side strap of the side straps 3303 can include a stiffening arm attached thereto.

[0217] The coupler 3130, the arms (horizontal arm 3131 and vertical arm 3132), and the links (upper horizontal link 3133, lower horizontal link 3134, and side link 3135) can be connected to form an opening through which the elbow is rotatably and removably connected to the inflation chamber inlet port 3600 such that the support assembly 3129 surrounds the elbow. The elbow can be removably and rotatably connected to the inflation chamber inlet port 3600.

[0218] 5.3.4 Frame

[0219] Figures 9 to 14 An example of the present technology is shown where the patient interface 3000 includes a frame 3201. The frame 3201 can support the seal-forming structure 3100 and deform under the tension from the positioning and stabilization structure 3300, thereby deforming the seal-forming structure 3100.

[0220] In these examples, the seal-forming structure 3100 may be constructed of a first elastic material, which may be silicone, plastic, elastomer, or rubber. The seal-forming structure 3100 may be constructed of a single piece of homogeneous first elastic material. The seal-forming structure 3100 may have at least one hole configured to direct an air flow at least to a patient's nostrils. The at least one hole may include one or two nasal holes 3102 configured to direct the air flow to the patient's nostrils and may further include an oral hole 3104 configured to direct the air flow to the patient's mouth. The seal-forming structure 3100 may include a nose portion 3101 configured to engage the patient's face around the nose. The seal-forming structure 3100 may include a mouth portion 3103 configured to engage the patient's face around the mouth.

[0221] In these examples, the frame 3201 may be connected to the seal-forming structure 3100. The frame 3201 may be constructed of a second elastic material. The second elastic material may have a greater modulus of elasticity than the first elastic material. The frame 3201 may be flexible but less flexible than the seal-forming structure 3100. The second elastic material may be plastic or elastomer. The frame 3201 may be constructed of a single piece of homogeneous second elastic material. The frame 3201 may include one or more notch portions that are more flexible than the remainder of the frame 3201. The frame 3201 may be movably connected to the seal-forming structure 3100. The frame 3201 may be removably or permanently connected to the seal-forming structure 3100. The seal-forming structure 3100 may include a plurality of connection structures that project from the seal-forming structure and are configured to connect to the frame 3201. These connection structures may be integrally molded with the seal-forming structure 3100 as a single unit. The frame 3201 may not have a forehead support.

[0222] The positioning and stabilization structure 3300 includes a pair of side straps 3303 connected to the frame 3201, and each of the side straps 3303 in the pair of side straps is configured to pass over a corresponding side of the patient's head. The frame 3201 may include a pair of strap connectors 3138, and each of the side straps 3303 in the pair of side straps may be connected to a corresponding strap connector 3138. The frame 3201 may include two strap connectors 3138. Each of the strap connectors 3138 may include a slot 3137 to allow the corresponding side strap 3303 to pass through the slot and be connected to the corresponding strap connector 3138. The frame 3201 may include two pairs of strap connectors 3138 on each side. The positioning and stabilization structure 3300 may include two pairs of side straps 3303, and each pair of side straps 3303 is configured to be connected to a corresponding one of the strap connectors 3138 in each pair of strap connectors 3138 on the corresponding side of the patient's head. Each side strap 3303 may be connected to a corresponding strap connector 3138. Each of the side straps 3303 in the pair of side straps is configured to pass over the corresponding side of the patient's head above the patient's ear and below the patient's eye. Each of the side straps 3303 in the pair of side straps may include a stiffening arm attached thereto.

[0223] The frame 3201 is configured to elastically expand in a first dimension and a second dimension generally orthogonal to the first dimension when the tension from the positioning and stabilization structure 3300 increases. Thus, when each of the side straps 3303 is pulled while being connected to the corresponding strap connector 3138, the frame 3201 widens in the lateral direction, e.g., each side is pulled away from the patient's sagittal plane in a direction generally perpendicular to the patient's sagittal plane, and the frame 3201 also widens in the upward and downward directions, e.g., the top portion and the bottom portion of the frame 3201 are pulled away from each other in corresponding directions generally parallel to the patient's sagittal plane. This may allow the frame 3201 to deform and change the shape of the seal-forming structure 3100 to which the frame is connected when deformed due to the tension from the side straps 3303 to adapt to the patient's face and maintain an effective seal, e.g., at the nasal corner near the nasolabial fold and / or at the supramental point near the chin. The deformability of the frame 3201 and thus the deformability of the seal-forming structure 3100 may allow a balanced sealing force to be obtained at such regions of the patient, which may be difficult to seal due to complex geometries. The frame 3201 may be configured to deform without manual adjustment.

[0224] The frame 3201 can be configured such that the tension from each side strap 3303 pulls on the corresponding strap connector 3138 to deform the frame 3201. The frame 3201 can be configured such that when deformed due to the tension from the positioning and stabilization structure 3300, the frame 3201 deforms the seal-forming structure 3100. The frame 3201 can be configured to allow the seal-forming structure 3100 to return to its undeformed state when the tension from the positioning and stabilization structure 3300 is released. The frame 3201 can be elastically deformable in response to an increase in the tension from the positioning and stabilization structure 3300. The frame 3201 can have a negative Poisson's ratio.

[0225] When the tension in the straps 3303 increases (e.g., due to being tightened by the patient), the increased tension causes deformation of the frame 3201. Accordingly, the frame 3201 can elastically expand in a first dimension and in a second dimension that is generally orthogonal to the first dimension, elastically expand in a first dimension and in a second dimension that is generally orthogonal to the first dimension.

[0226] The frame 3201 can form an opening. The elbow can be removably and rotatably connected to the inflation chamber inlet port 3600. The elbow 3500 can also extend through the opening such that the frame 3201 surrounds the elbow.

[0227] The various examples discussed in more detail below include different arrangements of the positioning and stabilization structure 3300, but in each of these examples, the frame 3201 and its structure, operation, and function are generally similar, as described above.

[0228] In Figure 9 the example, the positioning and stabilization structure 3300 includes an upper strap 3301 that passes over the top of the patient's head and a rear strap 3302 that passes behind the patient's head. The upper strap 3301 and the rear strap 3302 are connected to a stiffening arm assembly 3304 at upper stiffening arms 3305 and rear stiffening arms 3306, respectively, on each side of the patient's head. The stiffening arm assembly 3304 can be seen to be located above the patient's ears. The stiffening arm assembly 3304 also includes side stiffening arms 3307 that are connected to side straps 3303 on each side of the patient's head. The lengths of the upper strap 3301, the rear strap 3302, and the side straps 3303 can be adjustable. The length adjustment can be provided by elasticity or by hook-and-loop connections or both.

[0229] The side stiffening arms 3307 extend downward such that the connection to the side straps is located at or below the lower portion of the patient's ears. Further, this can allow the tension vector from the side straps 3303 to be directed in a direction generally perpendicular to the patient's coronal plane and parallel to the patient's sagittal plane. By pulling the seal-forming structure 3100 more directly rearward against the patient's face, the seal can be more secure.

[0230] Figure 10 shows another view of an example from Figure 9 to show the slot 3137 of the strap connector 3138 to which the side strap 3303 is connected. Figure 10 Also shown are the upper horizontal link 3133 and the lower horizontal link 3134 of the frame 3201.

[0231] Figure 11 Shows another example where the positioning and stabilizing structure 3300 includes an upper side strap 3314 and a lower side strap 3315 on each side of the patient's head. The upper side strap 3314 passes above the patient's ears and the lower side strap 3315 passes below the patient's ears. The positioning and stabilizing structure 3300 also includes a rear portion 3316 that engages the back of the patient's head. The positioning and stabilizing structure 3300 also includes a stiffening arm assembly 3310 that includes an upper stiffening arm 3312 connected to the upper side strap 3314 and a lower stiffening arm 3311 connected to the lower side strap 3315. The stiffening arm assembly 3310 is also connected to the frame 3201. The connection of the stiffening arm assembly 3310 to the frame 3201 may allow the tension vectors from the upper side strap 3314 and the lower side strap 3315 to be directed in a direction generally perpendicular to the patient's coronal plane and parallel to the patient's sagittal plane. By pulling the seal forming structure 3100 more directly rearward against the patient's face, the seal may be more secure.

[0232] Figure 12 Shows another example of the patient interface 3000 where the positioning and stabilizing structure 3300 includes a stiffening arm 3320 that is connected to a side strap 3322 and has an inflatable cuff 3321 on the stiffening arm 3320. The stiffening arm 3320 may be fixed to the side strap 3322 by suturing. The positioning and stabilizing structure 3300 also includes an adjustable length upper strap 3323 and an adjustable length rear strap 3324.

[0233] Figure 13 Shows another example of the patient interface 3000 where the positioning and stabilizing structure 3300 includes an adjustable length rear strap 3340 and an adjustable length upper strap 3341. On each side of the patient's head, the positioning and stabilizing structure 3300 includes an adjustable length upper side strap 3342 and an adjustable length lower side strap 3343, which are connected to the upper strap connector 3202 and the lower strap connector 3203 of the frame 3201, respectively. On each side of the patient's head, the positioning and stabilizing structure 3300 also includes an upper stiffening arm 3345 that supports the upper side strap 3342 and a lower stiffening arm 3347 that supports the lower side strap 3343. Two different side straps in this arrangement may allow straps of different directions and magnitudes to adjust the sealing force of the seal forming structure 3100 against the patient's face.

[0234] Figure 14 Illustrates an example in which the patient interface 3000 includes a positioning and stabilization structure 3300 having an adjustable upper strap 3360 that passes through the top of the patient's head and a stiffened strap 3361 that passes behind the patient's head and along the side of the patient's head. The stiffened strap 3361 may include a stiffened arm positioned internally, which is not visible in this view as it is covered by the strap material. Additionally, the stiffened strap 3361 is bendable to pass over the side of the patient's head and above the ear. The stiffened strap 3361 also includes a slot 3362 through which the upper strap 3360 is attached. The positioning and stabilization structure 3300 also includes a side strap 3363 that passes along the side of the patient's face, connects to the frame 3201, and is adjustable in length.

[0235] 5.3.5 Positioning and stabilization structure

[0236] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by the positioning and stabilization structure 3300 during use.

[0237] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome at least the positive pressure effect in the inflation chamber 3200 to lift away from the face.

[0238] In one form, the positioning and stabilization structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0239] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to overcome the potential effect of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0240] In one form of the present technology, a positioning and stabilization structure 3300 is provided and is configured in a manner consistent with the way the patient wears it while sleeping. In one example, the positioning and stabilization 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 stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0241] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying on their back with the back region of the patient's head on a pillow.

[0242] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to not be so large and cumbersome as to prevent a patient from lying in a side sleeping position, where a lateral region of the patient's head is on a pillow.

[0243] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a disconnect portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The disconnect portion does not resist compression and can be, for example, a flexible or floppy strap. 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.

[0244] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap formed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material to engage with a hook material portion.

[0245] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be in a tensioned state in use and to direct forces to cause a seal-forming structure to make sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.

[0246] 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 the lower edge of the first tie 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.

[0247] In one form of the present technology applicable to a pure nasal mask or a full face mask, the positioning and stabilizing structure includes a second tie that is constructed and arranged such that in use, at least a portion of the upper edge of the second tie passes below the infra-aural base point of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0248] In one form of the present technology suitable for a pure nasal mask or a full face mask, the positioning and stabilizing structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce the tendency for the first tie and the second tie to move apart from each other.

[0249] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a bendable and, for example, non-rigid strap. An advantage of this aspect is that the strap is more comfortable for the patient lying on it when the patient is sleeping.

[0250] In some forms of the technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable to allow moisture transfer through the strap.

[0251] In some forms of the technology, a system is provided that includes more than one positioning and stabilization structure 3300, each positioning and stabilization structure 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 stabilization structure 3300 that is suitable for a large-sized head but not for a small-sized head, while another positioning and stabilization structure is suitable for a small-sized head but not for a large-sized head.

[0252] 5.3.6 Ventilation Port

[0253] In one form, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow the flushing of exhaled gas (e.g., carbon dioxide).

[0254] In some forms, the ventilation port 3400 is configured to allow a continuous airflow from the interior of the inflation chamber 3200 to the environment while the pressure in the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the magnitude of the ventilation port flow is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure in the inflation chamber during use.

[0255] One form of the ventilation port 3400 according to the 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.

[0256] The ventilation port 3400 can be located in the inflation chamber 3200. Alternatively, the ventilation port 3400 is located in a decoupling structure (e.g., a swivel axis).

[0257] 5.3.7 Decoupling Structure

[0258] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel axis or a ball and socket.

[0259] 5.3.8 Connection Port

[0260] The connection port 3600 allows connection to the air circuit 4170.

[0261] 5.3.9 Forehead Support

[0262] In one form, the patient interface 3000 includes a forehead support 3700.

[0263] 5.3.10 Anti-Suffocation Valve

[0264] In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0265] 5.3.11 Ports

[0266] 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.

[0267] 5.4 RPT Device

[0268] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described in whole or in part herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0269] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0270] The RPT device may have an external housing 4010 that is formed of two parts: an upper part 4012 and a lower part 4014. Additionally, the external housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0271] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as pressure sensors and flow sensors.

[0272] One or more air path items can be located within a removable monolithic structure that will be referred to as the pneumatic block 4020. The pneumatic block 4020 can be located within the external housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0273] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0274] 5.4.1 Mechanical and pneumatic components of the RPT device

[0275] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as corresponding separate units.

[0276] 5.4.1.1 Air filter

[0277] The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0278] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0279] In one form, the outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0280] 5.4.1.2 Silencer

[0281] The RPT device according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120.

[0282] In one form of the present technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0283] In one form of the present technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0284] 5.4.1.3 Pressure generator

[0285] In one form of the technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 can include a brushless DC motor 4144 having one or more impellers. These impellers can be located in a volute. The blower may be capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when performing respiratory pressure therapy. The blower can be as described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0286] 5.4.1.4 Anti-backflow valve

[0287] In one form of the technology, the anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0288] 5.5 Air circuit

[0289] The air circuit 4170 according to one aspect of the technology is a conduit or tube that is constructed and arranged to allow an air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000, in use.

[0290] In particular, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. This air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for inhalation and exhalation of the circuit. In other cases, a single branch is used.

[0291] In some forms, the air circuit 4170 can include one or more heating elements that are configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element can be in the form of a heating wire loop and can include one or more transducers, such as temperature sensors. In one form, the heating wire loop can be helically wound around the axis of the air circuit 4170. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0292] 5.5.1 Supplemental gas delivery

[0293] In one form of the technology, a supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170, and / or to the patient interface 3000.

[0294] 5.6 Humidifier

[0295] 5.6.1 Humidifier Overview

[0296] In one form of the technology, a humidifier 5000 is provided (e.g., as Figure 5A shown) to vary the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Generally, the humidifier 5000 is used to increase the absolute humidity of the air stream and increase the temperature of the air stream (relative to the ambient air) before delivery to the patient's airway.

[0297] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, as Figure 5A and Figure 5B shown, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006 that is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0298] 5.6.2 Humidifier Components

[0299] 5.6.2.1 Water Reservoir

[0300] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 that is configured to hold or retain a volume of liquid (e.g., water) to be evaporated to humidify the air stream. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide sufficient humidification at least for the duration of a respiratory therapy session, such as an overnight sleep period. Generally, the reservoir 5110 is configured to hold several hundred milliliters of water, e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (such as a building's water supply system).

[0301] According to one aspect, the water reservoir 5110 is configured to add humidity to the air stream from the RPT device 4000 as the air stream travels through it. In one form, the water reservoir 5110 may be configured to facilitate the air stream traveling in a curved path through the reservoir 5110 while in contact with the volume of water therein.

[0302] According to one form, the reservoir 5110 can be removed from the humidifier 5000, for example, along a lateral direction as shown in Figure 5A and Figure 5B the illustration.

[0303] The reservoir 5110 can also be configured such that when the reservoir 5110 is displaced and / or rotated from its normal operating orientation, it prevents liquid from flowing out of it, such as through any of the orifices and / or between its sub-components. Since the air flow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 can also be configured to prevent loss of pneumatic pressure due to leakage and / or flow impedance.

[0304] 5.6.2.2 Conductive portion

[0305] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive portion 5120 can be arranged as a plate, but other shapes are also applicable. All or a portion of the conductive portion 5120 can be made of a thermally conductive material (such as aluminum (e.g., having a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics). In some cases, an appropriate thermal conductivity can be achieved with a material having a lower conductivity and an appropriate geometry.

[0306] 5.6.2.3 Humidifier reservoir base

[0307] In one form, the humidifier 5000 can include a humidifier reservoir base 5130 (as shown in Figure 5B the illustration) that is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 can include locking features, such as a locking lever 5135 that is configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0308] 5.6.2.4 Water level indicator

[0309] The humidifier reservoir 5110 can include a water level indicator 5150 as shown in Figures 5A to 5B the illustration. In some forms, the water level indicator 5150 can provide one or more indications to a user (such as the patient 1000 or a caregiver) regarding the volume of water in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 can include an indication of a maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200 ml, 300 ml, or 400 ml.

[0310] 5.7 Respiratory waveform

[0311] Figure 6 Shows a typical breathing waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is breathing flow. Although the parameter values can vary, typical breathing may have the following approximate values: tidal volume Vt of 0.5 L, inhalation time Ti of 1.6 s, peak inspiratory flow Qpeak of 0.4 L / s, exhalation time Te of 2.4 s, peak expiratory flow Qpeak of -0.5 L / s. The total duration of a breath Ttotal is approximately 4 s. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), and the ventilation volume Vent is approximately 7.5 L / min. The typical duty cycle (the ratio of Ti to Ttot) is approximately 40%.

[0312] 5.8 Glossary

[0313] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may be applied. In other forms of the present technology, alternative definitions may be applied.

[0314] 5.8.1 General Terms

[0315] Air: In certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich air.

[0316] Environment: In certain forms of the present technology, the term environment is considered to mean (i) the exterior of the treatment system or the patient, and (ii) the area directly surrounding the treatment system or the patient.

[0317] For example, the environment with respect to a humidifier Humidity can be the humidity of the air directly surrounding the humidifier, such as the humidity in the room where the patient is sleeping. This environmental humidity can be different from the humidity outside the room where the patient is sleeping.

[0318] In another example, the ambient pressure can be the pressure adjacent to or outside the body.

[0319] In certain forms, environmental (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, in addition to noise generated, for example, by an RPT device or from a mask or patient interface. Environmental noise may be generated by sources outside the room.

[0320] Auto Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy in which the treatment pressure can be automatically adjusted between a minimum and a maximum (e.g., different with each breath), depending on whether there is an indication of an SDB event.

[0321] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapeutic pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the inlet of the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, this pressure will vary between different respiratory cycles of the patient, e.g., increasing in response to detection of an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0322] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow will be a reference to a scalar, i.e., a quantity having only magnitude. In other cases, a reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow" or "airflow".

[0323] In an example of patient breathing, the flow rate may nominally be positive for the inspiratory portion of the patient's respiratory cycle and thus negative for the expiratory portion of the patient's respiratory cycle. The device flow rate Qd is the flow rate of air leaving the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. The ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gas. The leak flow rate Ql is the flow rate of air leaking from the patient interface system or elsewhere. The respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0324] Flow therapy: A respiratory therapy that includes delivering an air stream to the airway inlet at a controlled flow rate, called the therapeutic flow rate, which is typically positive throughout the patient's respiratory cycle.

[0325] Humidifier: The term humidifier will be taken to mean a humidifying device that is constructed and arranged or constructed with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve a patient's medical respiratory condition.

[0326] Leak: The term leak will be taken to mean an unintended air flow. In one example, a leak may occur due to an imperfect seal between the mask and the patient's face. In another example, a leak may occur in a swivel elbow leading to the environment.

[0327] Conduction noise (acoustic): Conduction noise in this document refers to noise transmitted to the patient through a pneumatic path such as an air circuit and patient interface and the air therein. In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0328] Radiated noise (acoustics): The radiated noise in this document refers to the noise transmitted from the ambient air to the patient. In one form, the radiated noise can be quantified by measuring the sound power / sound pressure level of the object under discussion according to ISO 3744.

[0329] Vent noise (acoustics): The vent noise in this document refers to the noise generated by the air flow through any vent (such as the vent hole of the patient interface).

[0330] Oxygen-rich air: Air with an oxygen concentration greater than that of ambient air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-rich air" is sometimes abbreviated as "oxygen".

[0331] Medical oxygen: Medical oxygen is defined as oxygen-rich air with an oxygen concentration of 80% or higher.

[0332] Patient: A person, whether or not they have a respiratory disorder.

[0333] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, g-f / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmH2O.

[0334] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the interface pressure Pm.

[0335] Respiratory pressure therapy: Applying an air supply to the inlet of the airway at a treatment pressure that is usually positive relative to the atmosphere.

[0336] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0337] 5.8.1.1 Materials

[0338] Silicone or silicone elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is the Wacker Group. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0339] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0340] 5.8.1.2 Mechanical Properties

[0341] Resilience: The ability of a material to absorb energy when elastically deformed and release the energy when unloaded.

[0342] Elasticity: Substantially all of the energy will be released when unloaded. This includes, for example, certain silicones and thermoplastic elastomers.

[0343] Hardness: The ability of a material to resist deformation itself (described, for example, by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0344] · "Soft" materials can include silicones or thermoplastic elastomers (TPE), and can be easily deformed, for example, under finger pressure.

[0345] · "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0346] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torque. The structure or component can provide different resistances in different directions. The opposite of stiffness is flexibility.

[0347] Soft structure or component: A structure or component that will change shape (e.g., bend) when made to support its own weight for a relatively short period of time such as 1 second.

[0348] Rigid structure or component: A structure or component that will essentially not change shape when subjected to the loads typically encountered in use. An example of such use can be to establish and maintain a sealing relationship between a patient interface and the inlet of a patient's airway, for example, under a load of approximately 20 cmH2O to 30 cmH2O pressure.

[0349] As an example, an I-beam can include a bending stiffness (resistance to bending loads) that is different in a first direction compared to a second orthogonal direction. In another example, a structure or component can be flexible in a first direction and rigid in a second direction.

[0350] 5.8.2 Respiratory Cycle

[0351] Apnea: According to some definitions, apnea is considered to have occurred when the flow drops below a predetermined threshold for a period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected despite a patent airway due to a decrease or absence of respiratory effort. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0352] Respiratory rate: The frequency of a patient's spontaneous breathing, which is typically measured as the number of breaths per minute.

[0353] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0354] Effort (respiratory): The work done by a person making a spontaneous effort to breathe.

[0355] Expiratory portion of the respiratory cycle: The time period from the start of expiratory flow to the start of inspiratory flow.

[0356] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than an interruption of flow. In one form, hypopnea can be considered to have occurred when the flow drops below a threshold rate for a period of time. Central hypopnea will be considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following can be considered hypopnea:

[0357] (i) The patient's breathing is reduced by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0358] (ii) The patient's breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0359] Hyperpnea: The flow increases to a level above normal.

[0360] Inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow will be considered the inspiratory portion of the respiratory cycle.

[0361] Patency (airway): The degree or extent of airway opening. A patent airway is open. Airway patency can be quantified, e.g., a value of (1) is open and a value of zero (0) is closed (obstructed).

[0362] Peak flow (Qpeak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0363] Respiratory flow, patient gas flow, respiratory gas flow (Qr): These terms can be understood to refer to an estimate of the respiratory flow of an RPT device, as opposed to the "true respiratory flow," which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0364] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is applied. In principle, the inspiratory volume Vi (the volume of inhaled air) is equal to the expiratory volume Ve (the volume of exhaled air), and thus a single tidal volume Vt can be defined as equal to either quantity. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, e.g., the average.

[0365] Inspiratory time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0366] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0367] (Total) time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0368] Typical recent ventilation volume: The ventilation value around which the recent ventilation values Vent tend to cluster within some predetermined time range, i.e., a measure of the central tendency of the recent ventilation values.

[0369] Upper airway obstruction (UAO): Includes partial and complete upper airway obstruction. This may be associated with a state of flow limitation where flow only increases slightly or may even decrease as the pressure difference across the upper airway increases (Starling impedance behavior).

[0370] Ventilation volume (Vent): A measurement of the total amount of gas exchanged by the patient's respiratory system. The measure of ventilation volume can include one or both of the inspiratory flow and the expiratory flow (per unit time). When expressed as a volume per minute, this quantity is typically referred to as "minute ventilation." Ventilation volume (Vent): A measurement of the rate of gas exchanged by the patient's respiratory system.

[0371] 5.8.3 Anatomy

[0372] 5.8.3.1 Facial Anatomy

[0373] Ala: The outer wall or "wing" of each nostril (plural: alae).

[0374] Ala tip: The outermost point on the ala.

[0375] Ala curvature (or ala crest) point: The final point in the curved baseline of each ala, found in the fold where the ala meets the cheek.

[0376] Auricle: The entire outer visible part of the ear.

[0377] (Nasal) bony framework: The bony framework of the nose includes the nasal bones, the frontal processes of the maxillae, and the nasal part of the frontal bone.

[0378] (Nasal) cartilaginous framework: The cartilaginous framework of the nose includes the septal cartilage, the lateral cartilages, the major cartilages, and the minor cartilages.

[0379] Columella: The strip of skin that separates the nostrils and extends from the nasal tip point to the upper lip.

[0380] Columella angle: The angle between a line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfurt horizontal plane and intersecting the subnasale point.

[0381] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the tragion point of the left ear. The tragion point is the deepest point in the notch above the tragus of the auricle.

[0382] Glabella: Located on the soft tissue, the most prominent point in the median sagittal plane of the forehead.

[0383] Lateral nasal cartilage: A roughly triangular cartilaginous plate. Its upper edge is attached to the nasal bones and the frontal processes of the maxillae, and its lower edge is connected to the major alar cartilage.

[0384] Major alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four small cartilages of the ala.

[0385] Nares / nostrils: The roughly oval-shaped orifices that form the entrance to the nasal cavity. The singular form of nares is naris / nostril. The nares are separated by the nasal septum.

[0386] Nasolabial sulcus or nasolabial fold: The skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0387] Nasolabial angle: The angle between the columella and the upper lip (meeting at the subnasale point).

[0388] Infraauricular basal point: The lowest point where the auricle attaches to the facial skin.

[0389] Supraauricular basal point: The highest point where the auricle attaches to the facial skin.

[0390] Nasal prominence point: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0391] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the upper lip area.

[0392] Gnathion: Located on the soft tissue, the most anterior midpoint of the chin.

[0393] Ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the nasion to the nasal prominence point.

[0394] Sagittal plane: The vertical plane from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0395] Nasion: Located on the soft tissue, the most concave point covering the fronto-nasal suture area.

[0396] Septal cartilage (nose): The septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0397] Lower margin of alae nasi: The point at the lower margin of the alar base where the alar base joins the skin of the upper (superior) lip.

[0398] Subnasale: Located on the soft tissue, the point at the intersection of the columella and the upper lip in the median sagittal plane.

[0399] Submentale: The point with the greatest concavity in the midline of the lower lip, located between the midpoint of the lower lip and the soft tissue gnathion.

[0400] 5.8.3.2 Skull anatomy

[0401] Frontal bone: The frontal bone includes a large vertical part (frontal squama), which corresponds to the area called the forehead.

[0402] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0403] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0404] Nasal bones: The nasal bones are two small oval bones, the size and form of which vary among different individuals; they are located side by side in the middle and upper part of the face and form the "beam" of the nose through their junction points.

[0405] Nasion: The intersection of the frontal bone and the two nasal bones, directly located between the eyes and in the depressed area above the bridge of the nose.

[0406] Occipital bone: The occipital bone is located in the posterior and inferior parts of the skull. It includes an oval cavity, namely the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0407] Orbit: The bony cavity in the skull that houses the eyeball.

[0408] Parietal bone: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0409] Temporal bone: The temporal bones are located at the base and on the sides of the skull and support the part of the face called the temple.

[0410] Zygomatic bone: The face includes two zygomatic bones, which are located in the upper and lateral parts of the face and form the prominences of the cheeks.

[0411] 5.8.3.3 Respiratory System Anatomy

[0412] Diaphragm: A muscular sheet that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0413] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0414] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains respiratory bronchioles, alveolar ducts, and alveoli.

[0415] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or turbinate bones. The front part of the nasal cavity is the nose, and the back part joins the nasopharynx via the posterior nasal aperture.

[0416] Pharynx: The part of the throat located just below the nasal cavity (beneath) and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0417] 5.8.4 Patient Interface

[0418] Anti-asphyxia valve (AAV): A component or sub-component of a mask system that reduces the risk of a patient rebreatheing excessive CO2 by opening to the atmosphere in a safe and secure manner.

[0419] Elbow: An elbow is an example of a structure that guides the axis of an air flow passing through it to change direction by a certain angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a generally circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to a mating component, such as approximately 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap connection. In some forms, the elbow can be assembled to the mating component via a one-time snap during manufacturing but cannot be removed by the patient.

[0420] Frame: A frame will be considered to mean a mask structure that bears the tension load between two or more connection points to the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames can also be airtight.

[0421] Headgear: Headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear can include a collection of one or more supports, straps, and reinforcements that are configured to position and retain the patient interface in place on the patient's face for respiratory therapy. Some straps are formed from a soft, flexible, elastic material, such as a laminated composite of foam and fabric.

[0422] Membrane: A membrane will be considered to mean a typically thin element that preferably has substantially no resistance to bending but has resistance to stretching.

[0423] Inflatable chamber: A mask inflatable chamber will be considered to mean a part of the patient interface that has a wall enclosing at least partially a volume space that has air pressurized above atmospheric pressure therein during use. The housing can form part of the wall of the mask inflatable chamber.

[0424] Seal: It can refer to the noun form of a structure ("seal") or the verb form of an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve a "seal" therebetween without the need for a separate "seal" element itself.

[0425] Housing: A housing will be considered to mean a curved, relatively thin structure having bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask can be a housing. In some forms, the housing can be polyhedral. In some forms, the housing can be airtight. In some forms, the housing can not be airtight.

[0426] Reinforcement: A reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0427] Strut: A strut will be considered to be a structural member designed to increase the compressive resistance of another component in at least one direction.

[0428] Swivel (noun): A sub - assembly of components configured to rotate preferably at low torque and preferably independently about a common axis. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel can be configured to rotate through an angle less than 360 degrees. When used in the case of an air delivery conduit, the sub - assembly of components preferably includes a pair of mating cylindrical conduits. In use, there may be little or no air flow leakage from the swivel.

[0429] Tie (noun): A structure designed to resist tension.

[0430] Vent: (noun): A structure that allows air to flow from the interior of a face mask or a conduit to the ambient air for the purpose of clinically effectively flushing exhaled gas. For example, depending on the face mask design and treatment pressure, clinically effective flushing can involve a flow rate of from about 10 liters per minute to about 100 liters per minute.

[0431] 5.8.5 Structural Shape

[0432] Products according to the present technology may include one or more three - dimensional mechanical structures, such as a face mask cushion or an impeller. The three - dimensional structure can be bounded by two - dimensional surfaces. These surfaces can be distinguished using labels to describe the associated surface orientation, position, function, or some other characteristic. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a sealing - forming structure can include a face - contacting (e.g., external) surface and a separate non - face - contacting (e.g., underside or inner) surface. In another example, the structure can include a first surface and a second surface.

[0433] To facilitate the description of the shape of three - dimensional structures and surfaces, we first consider a cross - section through the surface of the structure at a point p. See Figures 3B to 3F , which illustrate examples of cross - sections at a point p on the surface and the resulting planar curves. Figures 3B to 3F Also illustrated is the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the perspective of a hypothetical little person standing upright on the surface.

[0434] 5.8.5.1 One - Dimensional Curvature

[0435] The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / the radius of the circle that just touches the curve at p).

[0436] Positive curvature: If the curve at p turns towards the outer normal, the curvature at that point is taken as positive (if the imaginary little people leave point p, they must go uphill). See Figure 3B (compared to Figure 3C relatively large positive curvature) and Figure 3C (compared to Figure 3B relatively small positive curvature). Such curves are usually called concave curves.

[0437] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if the imaginary little people leave point p, they can walk horizontally, neither uphill nor downhill). See Figure 3D .

[0438] Negative curvature: If the curve at p turns away from the outer normal, the curvature in that direction at that point is taken as negative (if the imaginary little people leave point p, they must go downhill). See Figure 3E (compared to Figure 3F relatively small negative curvature) and Figure 3F (compared to Figure 3E relatively large negative curvature). Such curves are usually called convex curves.

[0439] 5.8.5.2 Curvature of a two-dimensional surface

[0440] The description of the shape at a given point on a two-dimensional surface according to the present technology may include a plurality of normal cross-sections. The plurality of cross-sections may cut the surface in a plane ("normal plane") including the outer normal, and each cross-section may be taken in a different direction. Each cross-section produces a plane curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small magnitude. Figures 3B to 3F The plane curves in

[0441] Principal curvature and principal direction: The directions of the normal planes in which the curve curvature takes its maximum and minimum values are called principal directions. In Figures 3B to 3F the example of Figure 3B the maximum curvature occurs in Figure 3F and the minimum curvature occurs in Figure 3B and Figure 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0442] Surface area: A set of connected points on the surface. The set of points in the area may have similar characteristics, such as curvature or sign.

[0443] Saddle region: A region where the principal curvatures have opposite signs at each point, i.e., one is positive and the other is negative (depending on the direction in which the imaginary person turns, they can go uphill or downhill).

[0444] Vault region: A region where the principal curvatures have the same sign at each point, e.g., both are positive ("concave vault") or both are negative ("convex vault").

[0445] Cylindrical region: A region where one of the principal curvatures is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non - zero.

[0446] Plane region: A surface region where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0447] Edge of a surface: The boundary or limit of a surface or region.

[0448] Path: In some forms of the present technology, "path" will be considered to mean a path in the mathematical - topological sense, e.g., a continuous space curve on a surface from f(0) to f(1). In some forms of the present technology, a 'path' can be described as a route or course, including, for example, a set of points on a surface. (The path of the imaginary person is where they walk on the surface and is similar to a garden path).

[0449] Path length: In some forms of the present technology, "path length" will be considered to mean the distance along a surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of the imaginary person will be the distance they have to walk along the path on the surface).

[0450] Straight - line distance: The straight - line distance is the distance between two points on a surface, but is independent of the surface. On a plane region, there will be a path on the surface that has the same path length as the straight - line distance between two points on the surface. On a non - planar surface, there may not be a path that has the same path length as the straight - line distance between two points. (For the imaginary person, the straight - line distance will correspond to the "as - the - crow - flies" distance).

[0451] 5.8.5.3 Space curve

[0452] Space curve: Different from a plane curve, a space curve does not have to lie in any particular plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one - dimensional segment of three - dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left - handed helix, see Figure 3Q。A typical human right ear includes a helix, which is a right-handed helix, see Figure 3R 。 Figure 3S shows a right-handed helix. The edges of a structure, such as the edge of a membrane or an impeller, can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to the tangent vector, the normal vector, and the binormal vector at that point.

[0453] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude starting from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person is flying along the curve and drops from her vehicle at a particular point, the direction of the tangent vector is the direction in which she will travel.

[0454] Unit normal vector: As the imaginary person moves along the curve, the tangent vector itself also changes. The unit vector in the same direction as the change in the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0455] Binormal unit vector: The binormal unit vector is perpendicular to both the tangential vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P ) or alternatively by the left-hand rule ( Figure 3O ).

[0456] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figure 3O and Figure 3P 。

[0457] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve lying in a plane has zero torsion. A space curve that deviates by a relatively small amount from the osculating plane will have a relatively small torsion magnitude (e.g., a gently sloping helical path). A space curve that deviates by a relatively large amount from the osculating plane will have a relatively large torsion magnitude (e.g., a steeply sloping helical path). See Figure 3S , since T2 > T1, thus Figure 3S the torsion magnitude near the top coil of the Figure 3S helix is greater than the torsion magnitude of the bottom coil of the

[0458] Referring to Figure 3P the right-hand rule, a space curve that turns towards the right-handed binormal direction can be considered to have a right-handed positive torsion (e.g., Figure 3SThe right-handed helix shown in []. A space curve that turns away from the right-handed binormal direction can be considered to have a right-handed negative twist (e.g., a left-handed helix).

[0459] Similarly, referring to the left-hand rule (see Figure 3O ), a space curve that turns towards the left-handed binormal direction can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus, left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0460] 5.8.5.4 Holes

[0461] A surface can have one-dimensional holes, such as holes bounded by a planar curve or by a space curve. A thin structure (e.g., a membrane) with holes can be described as having one-dimensional holes. See, for example, Figure 3I the one-dimensional holes bounded by a planar curve in the structural surface shown.

[0462] A structure can have two-dimensional holes, such as holes bounded by a surface. For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, Figure 3L the gasket of [] and Figure 3M and Figure 3N the example cross-section through the gasket in [], where the inner surface bounding the two-dimensional hole is indicated. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole bounded by the inner surface of the conduit. Also see the two-dimensional hole bounded by the shown surface in the structure shown in Figure 3K .

[0463] 5.9 Other Remarks

[0464] Unless explicitly stated in the context and a numerical range is provided, it should be understood that each intermediate value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated value or intermediate value within the said range are broadly encompassed in the present technology. The upper and lower limits of these intermediate ranges can be independently included in the intermediate range and are also encompassed in the technology, subject to any explicit exclusionary limitations in the range. In cases where the range includes one or both of the limitations, ranges excluding either or both of the included limitations are also included in the present technology.

[0465] Furthermore, in cases where one or more values are stated herein as being achieved as part of the present technology, it should be understood that, unless otherwise stated, such values can be approximate and such values can be used to any appropriate significant figures to the extent that the actual technical implementation permits or requires them.

[0466] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0467] When a particular material is identified for constructing a component, obvious alternative materials with similar properties can be used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0468] It must be noted that, as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0469] All publications mentioned herein are hereby incorporated by reference in their entirety to disclose and describe the methods and / or materials as the subject matter of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that this technology is not entitled to antedate such disclosure by virtue of prior invention. In addition, the publication dates provided may be different from the actual publication dates, which may require independent verification.

[0470] The term "comprises / comprising" should be understood to mean that the element, component, or step in a non-exclusive manner, indicating that the recited element, component, or step may be present or utilized, or a combination with other elements, components, or steps not expressly recited.

[0471] The subject headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found throughout the disclosure or the claims. Subject headings should not be used to interpret the scope of the claims or claim limitations.

[0472] Although the technologies herein have been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of this technology. In some cases, the terms and symbols may imply specific details that are not required to practice this technology. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order but may be used to distinguish different elements. In addition, although the process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence can be modified and / or various aspects of it can be carried out simultaneously or even synchronously.

[0473] Accordingly, it should be understood that numerous modifications may be made to the illustrative examples, and it should be understood that other arrangements may be designed without departing from the spirit and scope of the present technology.

[0474] 5.10 List of Reference Numerals

[0475]

[0476]

[0477]

[0478]

Claims

1. A patient interface, the patient interface comprising: An inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 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 a patient to breathe; A seal-forming structure connected to the inflatable chamber, the seal-forming structure being constructed and arranged to seal with an area of the patient's face surrounding an inlet of the patient's airway, 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, the seal-forming structure having a plurality of connection structures, and the seal-forming structure having at least one hole configured to direct the air flow at least to the patient's nostrils; A support assembly configured to support the seal-forming structure and including: A plurality of connectors movably connected to corresponding ones of the connection structures; A plurality of linkages; and A plurality of arms, each of the arms connecting one of the linkages to a corresponding one of the connectors; A positioning and stabilizing structure including at least one strap connected to the support assembly to hold the seal-forming structure in a therapeutically effective position on the patient's head during use; and A vent configured to allow a ventilation air flow to continuously pass to the atmosphere throughout the patient's respiratory cycle during use, wherein the patient interface is configured to allow the patient to breathe from the surroundings through their mouth without a pressurized air flow through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered; and wherein the support assembly is configured to expand in a first dimension and a second dimension that is generally orthogonal to the first dimension when the tension from the positioning and stabilizing structure increases.

2. The patient interface according to claim 1, wherein each of the arms is more flexible than each of the linkages.

3. The patient interface according to claim 1 or 2, wherein the plurality of linkages includes a pair of side linkages, each side linkage positioned on a corresponding side of the support assembly.

4. The patient interface according to any one of claims 1 to 3, wherein each of the side linkages includes a strap connector, and wherein the positioning and stabilizing structure includes a pair of side straps, each of the side straps being configured to pass over a corresponding side of the patient's head and each of the side straps being connected to a corresponding strap connector.

5. The patient interface according to any one of claims 1 to 4, wherein each of the strap connectors includes a slot to allow the corresponding side strap to pass through the slot and be connected to the corresponding strap connector.

6. The patient interface according to one of claims 1 to 5, wherein the support assembly is configured such that the tension from each side strap pulls the corresponding strap connector to deform the arm connected to the side link.

7. The patient interface according to one of claims 1 to 6, wherein the plurality of connection structures include a first connection structure protruding from the seal-forming structure and a second connection structure protruding from the seal-forming structure.

8. The patient interface according to one of claims 1 to 7, wherein the plurality of couplers include a first coupler connected to the first connection structure and a second coupler connected to the second connection structure.

9. The patient interface according to one of claims 1 to 8, wherein the plurality of arms include a first arm connected to the first coupler and a second arm connected to the second coupler.

10. The patient interface according to one of claims 1 to 9, wherein the plurality of links include a first link connected to each of the first arm and the second arm.

11. The patient interface according to one of claims 1 to 10, wherein the support assembly further includes a plurality of joints, and each arm of the arms is connected to a corresponding one of the links at one of the joints.

12. The patient interface according to one of claims 1 to 11, wherein each of the first connection structure and the second connection structure is a lug having a circular cross-section.

13. The patient interface according to one of claims 1 to 12, wherein each of the first coupler and the second coupler is configured to rotate around a corresponding one of the first connection structure and the second connection structure.

14. The patient interface according to one of claims 1 to 13, wherein the seal-forming structure and the inflation chamber are constructed of a single piece of flexible material.

15. The patient interface according to one of claims 1 to 14, wherein the flexible material is silicone.

16. The patient interface according to one of claims 1 to 15, wherein each arm of the arms is constructed of a first material, and each link of the links is constructed of a second material that is more rigid than the first material.

17. The patient interface according to one of claims 1 to 16, wherein the second material is plastic.

18. The patient interface according to one of claims 1 to 17, wherein the first material is plastic, elastomer or rubber.

19. The patient interface according to one of claims 1 to 18, wherein each arm of the arms includes a notch portion that is more flexible than the rest of the arm.

20. The patient interface according to one of claims 1 to 19, wherein the support assembly is configured such that when deformed due to the tension from the positioning and stabilizing structure, the support assembly deforms the seal-forming structure.

21. The patient interface according to one of claims 1 to 20, wherein the at least one aperture comprises: A nasal orifice configured to direct the air flow to the nostrils of the patient; and an oral aperture configured to direct the air flow to the patient's mouth.

22. The patient interface according to one of claims 1 to 21, wherein the support assembly includes two strap connectors, and wherein the positioning and stabilization structure includes two side straps connected to a respective one of the strap connectors, each of the side straps being configured to pass over a respective side of the patient's head.

23. The patient interface according to one of claims 1 to 22, wherein each of the side straps is configured to pass over the respective side of the patient's head above the patient's ear and below the patient's eye.

24. The patient interface according to one of claims 1 to 23, wherein each of the side straps includes a stiffening arm attached thereto.

25. The patient interface according to one of claims 1 to 24, wherein the connection structure and the seal-forming structure are integrally molded as a single unit.

26. The patient interface according to one of claims 1 to 25, wherein the support assembly is configured to allow the seal-forming structure to return to an undeformed state when the tension from the positioning and stabilization structure is released.

27. The patient interface according to one of claims 1 to 26, wherein the support assembly is elastically deformable in response to an increase in the tension from the positioning and stabilization structure.

28. The patient interface according to one of claims 1 to 27, wherein each of the connectors is removably or permanently connected to a respective one of the connection structures.

29. The patient interface according to one of claims 1 to 28, the patient interface further including an elbow rotatably and removably connected to the inflation chamber inlet port, and wherein the plurality of connectors, the plurality of arms, and the plurality of linkages are connected to form an opening through which the elbow is rotatably and removably connected to the inflation chamber inlet port such that the support assembly surrounds the elbow.

30. The patient interface according to one of claims 1 to 29, wherein the support assembly has a negative Poisson's ratio.

31. A patient interface, the patient interface comprising: an inflation chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port sized and configured to receive an air flow at the treatment pressure for patient breathing; A seal-forming structure that is connected to the plenum chamber, the seal-forming structure being configured and arranged to seal against an area of the patient's face that surrounds the inlet of the patient's airway, the seal-forming structure being configured and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure having at least one aperture that is configured to direct the air flow to at least one nostril of the patient, and the seal-forming structure being constructed from a first elastomeric material; A frame that is connected to the seal-forming structure and is constructed from a second elastomeric material having a greater modulus of elasticity than the first elastomeric material; A positioning and stabilizing structure that includes a pair of side straps connected to the frame, each of the side straps being configured to pass around a respective side of the patient's head to hold the seal-forming structure in a therapeutically effective position on the patient's head during use; and A vent that is configured to allow a ventilation air flow to be continuously transferred to the atmosphere throughout the patient's respiratory cycle during use, wherein the patient interface is configured to allow the patient to breathe from the surroundings through their mouth in the absence of a pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered; and wherein the frame is configured to elastically expand in a first dimension and in a second dimension that is generally orthogonal to the first dimension when the tension from the positioning and stabilizing structure increases.

32. The patient interface according to claim 31, wherein the frame is constructed from a single piece of homogeneous second elastomeric material.

33. The patient interface according to claim 31 or 32, wherein the seal-forming structure is constructed from a single piece of homogeneous first elastomeric material.

34. The patient interface according to any one of claims 31 to 33, wherein the frame is movably connected to the seal-forming structure.

35. The patient interface according to any one of claims 31 to 34, wherein the frame includes a pair of strap connectors, and wherein each of the side straps is connected to a respective strap connector.

36. The patient interface according to any one of claims 31 to 35, wherein each of the strap connectors includes a slot to allow the respective side strap to pass through the slot and be connected to the respective strap connector.

37. The patient interface according to any one of claims 31 to 36, wherein the frame is configured such that the tension from each side strap pulls on the respective strap connector to deform the frame.

38. The patient interface according to any one of claims 31 to 37, wherein the seal-forming structure includes a plurality of connection structures that project from the seal-forming structure and are configured to connect to the frame.

39. The patient interface according to one of claims 31 to 38, wherein the first elastic material is silicone.

40. The patient interface according to one of claims 31 to 39, wherein the second elastic material is plastic.

41. The patient interface according to one of claims 31 to 40, wherein the first elastic material is plastic, elastomer or rubber.

42. The patient interface according to one of claims 31 to 41, wherein the frame includes a notch portion that is more flexible than the rest of the frame.

43. The patient interface according to one of claims 31 to 42, wherein the frame is configured such that when deformed due to the tension from the positioning and stabilizing structure, the frame deforms the seal forming structure.

44. The patient interface according to one of claims 31 to 43, wherein the at least one aperture comprises: A nasal aperture configured to direct the air flow to the nostrils of the patient; and an oral aperture configured to direct the air flow to the mouth of the patient.

45. The patient interface according to one of claims 31 to 44, wherein the frame includes two strap connectors, and wherein each of the side straps is connected to a corresponding strap connector.

46. The patient interface according to one of claims 31 to 45, wherein each of the side straps is configured to pass over the ear and under the eye of the patient on a corresponding side of the patient's head.

47. The patient interface according to one of claims 31 to 46, wherein each of the side straps includes a stiffening arm attached thereto.

48. The patient interface according to one of claims 31 to 47, wherein the connection structure and the seal forming structure are integrally molded as a single unit.

49. The patient interface according to one of claims 31 to 48, wherein the frame is configured to allow the seal forming structure to return to an undeformed state when the tension from the positioning and stabilizing structure is released.

50. The patient interface according to one of claims 31 to 49, wherein the frame is elastically deformable in response to an increase in the tension from the positioning and stabilizing structure.

51. The patient interface according to one of claims 31 to 50, wherein the frame is removably or permanently connected to the seal forming structure.

52. The patient interface according to one of claims 31 to 51, the patient interface further includes an elbow rotatably and removably connected to the inflation chamber inlet port, and wherein the frame forms an opening through which the elbow is rotatably and removably connected to the inflation chamber inlet port such that the frame surrounds the elbow.

53. The patient interface according to one of claims 31 to 52, wherein the frame has a negative Poisson's ratio.

54. The patient interface according to one of claims 31 to 53, wherein the frame includes two pairs of strap connectors on each side, and the positioning and stabilization structure includes two pairs of side straps, each pair of side straps being configured to connect to a corresponding one of the two pairs of strap connectors on the corresponding side of the patient's head.

Images