Patient interface and its location and stabilization structure

Abstract

This invention relates to patient interfaces and their positioning and stabilization structures. A patient interface system for delivering respiratory therapy to a patient includes: a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal around a patient's nostril opening with respect to the patient's face; the nasal chamber including an opening; an inlet conduit connected to the nasal portion to deliver pressurized breathable gas to the nasal chamber; and a nasal chamber coupling member adapted to form a releasable fluid coupling portion to allow the nasal portion to be fluidly coupled to a mouth portion, thereby transferring a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims the benefit of Australian Provisional Application No. 2019903367, filed on 10 September 2019; Australian Provisional Application No. 2020901773, filed on 29 May 2020; and Australian Provisional Application No. 2020900590, filed on 28 February 2020, each of which is incorporated herein by reference in its entirety. Background Technology 2.1 Technical Field

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

[0005] 2.2 Description of relevant technologies

[0006] 2.2.1 The Human Respiratory System and Its Disorders

[0007] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0008] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0009] A range of breathing disorders exist. Some conditions may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes the affected patient to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected 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 dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough 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 unusual shortness of breath during exercise.

[0015] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without 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 diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and 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 type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0018] The chest wall is a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause 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 treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0020] 2.2.2 Treatment

[0021] Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory disorders.

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, or if so, in any of these ways.

[0023] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0024] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] 2.2.3 Treatment System

[0026] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0027] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0028] Another form of treatment system is the mandibular repositioning device.

[0029] 2.2.3.1 Patient Interface

[0030] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's 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 treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0031] Some other patient interface systems may not be functionally suitable for this field. For example, a purely decorative patient interface may not be able to maintain suitable pressure. A patient interface system for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0032] Some patient interfaces may be clinically disadvantageous to this technology, such as when they block airflow through the nose and only allow it through the mouth.

[0033] If some patient interfaces require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0034] Some patient interfaces may not be available for use while sleeping, such as when sleeping on one's side with one's head on a pillow.

[0035] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas 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 the duration of respiratory therapy.

[0036] Due to these challenges, some patient interfaces suffer from one or more of the following problems: obtrusive, unsightly, expensive, incongruous, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Patient interfaces designed solely for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the patient interface is to be worn during sleep.

[0037] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing disorders. However, if the patient interface is uncomfortable or difficult to use, patient adherence may be compromised. Since patients are often advised to clean their patient interfaces regularly, if the interface is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean it, which could affect adherence.

[0038] While a patient interface designed for other applications (such as pilots) may not be suitable for treating sleep-disordered breathing, a patient interface designed for treating sleep-disordered breathing may be suitable for other applications.

[0039] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0040] 2.2.3.1.1 Sealing Formation Structure

[0041] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0042] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal patient interfaces, full-face patient interfaces, nasal pillows, nasal sprays, and oronasal patient interfaces.

[0043] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0044] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of 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 to form a seal.

[0045] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0046] Another type of seal-forming structure incorporates a valve seal made of a thin material positioned around the periphery of the patient interface to provide a self-sealing effect against the patient's face when positive pressure is applied within the patient interface. Similar to the previous type of seal-forming section, if the fit between the face and the patient interface is poor, additional force may be required to achieve a seal, or the patient interface may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leakage.

[0047] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0048] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0049] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0050] 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 Puritan-Bennett Corporation.

[0051] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and 0043 MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes ResMed's SWIFT...) TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY) TM (Regarding full-face masks); International Patent Application WO 2009 / 052,560 (which describes ResMed's SWIFT...) TM Other aspects of the FX nose pillow).

[0052] 2.2.3.1.2 Positioning and Stability

[0053] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0054] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0055] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use.

[0056] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0057] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0058] 2.2.3.3 Humidifier

[0059] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0060] 2.2.3.4 Data Management

[0061] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is requiring the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0062] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0063] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0064] 2.2.3.5 Ventilation port technology

[0065] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0066] The vent may include an orifice through which gas can flow when the patient interface is used. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disturb the sleep of the patient's bedside companions by causing noise or congested airflow.

[0067] ResMed has developed numerous improved patient interface ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; and International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808. Summary of the Invention

[0068] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0069] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0070] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0071] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0072] One aspect of this technology relates to a patient interface system that can be used as a nasal-only patient interface or an oronasal patient interface.

[0073] Another aspect of this technology relates to a mouth-nose patient interface that is essentially composed of flexible components.

[0074] Another aspect of this technology relates to a stable oronasal patient interface at a nasal seal portion that is separate from the mouth seal portion.

[0075] Another aspect of this technology relates to a mouth-nose patient interface having at least a first headband connection on the nose portion of the patient interface and at least a second headband connection on the mouth portion of the patient interface.

[0076] Another aspect of this technology relates to a modular patient interface system suitable for use in a nostril-only configuration or in a nostril and mouth configuration.

[0077] Another aspect of this technology relates to a modular patient interface system suitable for use in a nostril-only configuration, a mouth-only configuration, or a nostril and mouth configuration.

[0078] One aspect of this technology relates to a patient interface comprising: at least one inflatable chamber for the patient interface, the inflatable chamber being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle in use.

[0079] In one form of this technology, the patient interface system includes a nose portion and a mouth portion, which can be used together with the nose portion or only with the nose portion, depending on the patient's choice. When used with the nose portion, the mouth portion can be used to deliver respiratory therapy to the patient's mouth or can be used as a mouth seal.

[0080] In one form of this technology, the patient interface system is provided with a nose portion and a mouth portion, which can be used with both the nose portion and the mouth portion, or only with the nose portion, or only with the mouth portion, when selected by the patient.

[0081] In one form of this technology, the patient interface system is provided with a nose portion and a mouth portion, wherein the nose portion includes a nostril sealing portion adapted to form a seal with the patient's nostrils, wherein the nostril sealing portion is configured to extend or bend outward from a support wall defining an air path into the nostril sealing portion.

[0082] Another aspect of this technology relates to a patient interface system comprising a nose portion and a mouth portion, wherein the mouth portion is adapted for use in a first configuration and a second configuration, wherein in the first configuration at least a portion of pressurized breathable gas is delivered to the patient's mouth, and in the second configuration the mouth portion serves as a mouth seal to prevent any pressurized breathable gas from being delivered to the patient's mouth.

[0083] Another aspect of this technology relates to a method for providing a patient interface kit for delivering respiratory therapy to a patient, wherein the nasal portion and the mouth portion can be used together, used only with the nasal portion, or used only with the mouth portion, depending on the patient's choice.

[0084] Another aspect of this technology relates to a method of providing a patient interface kit for delivering respiratory therapy to a patient, wherein the nasal portion and the mouth portion can be used together, used only with the nasal portion, or used only with the mouth portion when selected by the patient, wherein when both the nasal portion and the mouth portion are used together, both the nasal portion and the mouth portion can be used separately to deliver pressurized air to the patient's nostrils and mouth, or one of the nasal portion and the mouth portion can be used to deliver pressurized air to the patient's nostrils or mouth, while the other of the nasal portion and the mouth portion acts as a nasal or mouth seal.

[0085] Another aspect of this technology relates to a method for switching a patient interface system having a nose portion and a mouth portion between a first and a second mode, wherein in the first mode, the patient interface system can be used with both the nose portion and the mouth portion, and in the second mode, the patient interface system can be used with only the nose portion.

[0086] Another aspect of this technology relates to a kit that provides a nasal portion for delivering respiratory therapy into a patient's nostrils, the nasal portion being adapted to work in conjunction with a mouth portion.

[0087] Another aspect of this technology relates to a kit that provides a mouth part for delivering respiratory therapy to a patient's mouth, the mouth part being adapted to work in conjunction with a nasal part.

[0088] Another aspect of this technology relates to a method of providing respiratory therapy only to a patient's nostrils, only to one of the patient's mouths, or both of the patient's nostrils and mouths, and periodically changing the respiratory therapy to only to the patient's nostrils, only to the other of the patient's mouths, or both of the patient's nostrils and mouths.

[0089] Another aspect of this technology relates to a method of respiratory therapy, wherein a first patient interface having a first cover is applied to a patient for a period of time, then the first patient interface is removed, and a second patient interface having a second cover different from the first cover is applied to the patient for a period of time.

[0090] Another aspect of this technology relates to a mouth portion for delivering respiratory therapy to a patient, the mouth portion including a docking station adapted to receive a nasal portion, wherein the nasal portion can be used as a nostril-only device for delivering pressurized gas to the patient's nostrils.

[0091] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion adapted to form a seal with a patient's nostrils; a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas; and an inlet conduit connected to at least one of the nasal portion and the mouth portion to deliver pressurized breathable gas, wherein the patient interface system is adapted to selectively use the nasal portion and / or the mouth portion in a first mode utilizing both the nasal portion and the mouth portion and in a second mode utilizing the nasal portion but not the mouth portion.

[0092] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion adapted to form a seal with a patient's nostrils; a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth; and an inlet conduit connected to at least one of the nasal portion and the mouth portion to deliver pressurized breathable gas to the patient, wherein the nasal portion and the mouth portion are adapted to connect to each other, and the mouth portion is adapted to selectively operate in a first configuration and a second configuration, wherein in the first configuration at least a portion of the pressurized breathable gas is delivered to the patient's mouth, and in the second configuration the mouth portion serves as a mouth seal to prevent any pressurized breathable gas from being delivered into the patient's mouth.

[0093] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface including a sealing portion comprising a nasal sealing portion and a mouth sealing portion, the nasal sealing portion being adapted to form a seal with the patient's nostrils, the nasal sealing portion being configured to extend or bend outward from a support wall defining an air path into the nasal sealing portion, the mouth sealing portion being adapted to form a seal with the patient's mouth, the sealing portion being adapted to connect to at least one inlet conduit for receiving a supply of pressurized breathable gas; and a headband for holding the sealing assembly in an appropriate position on the patient's head.

[0094] Another aspect of this technology relates to a method of providing a patient interface system kit for delivering respiratory therapy to a patient, the method comprising providing a nasal portion adapted to form a seal with a patient's nostrils; providing a portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas; and providing an inlet conduit connectable to at least one of the nasal portion and the mouth inflation chamber for delivering pressurized breathable gas, wherein, according to the patient's selection, the patient interface system is adapted to selectively utilize the nasal portion and / or the mouth portion in at least a first and a second mode, the first mode utilizing the nasal portion and the mouth portion to deliver respiratory therapy to the patient's nostrils, wherein the mouth portion is configured to deliver respiratory therapy to the patient's mouth or seal the mouth portion, and in a second mode, utilizing the nasal portion to deliver respiratory therapy to the patient's nostrils without utilizing the mouth portion as a seal or for delivering respiratory therapy.

[0095] Another aspect of this technology relates to a method for switching a patient interface system between a first mode and a second mode for delivering respiratory therapy to a patient, the method comprising: providing a nasal portion adapted to form a seal with a patient's nostrils; providing a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas; assembling the patient interface system in a first mode utilizing the nasal portion and the mouth portion to deliver respiratory therapy to the patient's nostrils; utilizing the mouth portion to deliver respiratory therapy to the patient's mouth or using the mouth portion as a mouth seal; and switching the patient interface system in a second mode utilizing the nasal portion to deliver respiratory therapy to the patient's nostrils without utilizing the mouth portion. The nasal portion may include an upper lip portion configured to seal against the patient's upper lip in use; the upper lip portion having a stiffness similar to that of the central portion; the upper lip portion having a wall thickness substantially equal to that of the central portion; and the upper lip portion including a wall thickness less than that of these intermediate portions.

[0096] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with the mouth of a patient, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas; and a nasal portion docking station formed on the mouth portion, the nasal portion docking station adapted to receive the nasal portion, wherein the nasal portion is capable of being used as a nostril-only device for delivering pressurized gas to the patient's nostrils.

[0097] Another aspect of this technology relates to a medical package comprising a kit for converting a CPAP device containing only a nasal portion into a CPAP device having both a nasal and a mouth portion, the medical package comprising: a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas; an airway plug adapted to block the opening in the nasal portion only; and a headband adapted to secure at least the mouth portion to the patient's head.

[0098] Another aspect of this technology relates to a system kit adapted to convert a nasal-only device for delivering respiratory therapy to a patient into a nasal and mouth device for delivering respiratory therapy to a patient, the system kit comprising: a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth inflation chamber including an opening adapted to selectively receive pressurized breathable gas, the mouth portion adapted to be used together with the nasal-only device as a nasal and mouth device; a plug connected to the opening in the mouth inflation chamber or the opening in the nasal-only device; and a headband adapted to secure at least the mouth portion to the patient's head.

[0099] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion adapted to form a seal with the patient's nostrils; a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with the patient's mouth; and a double-branch elbow, for example having one branch connected to the nasal portion and another branch connected to the mouth portion, for delivering pressurized breathable gas to the nasal portion and the mouth portion.

[0100] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion adapted to form a seal with a patient's nostrils; a mouth portion including a mouth inflation chamber and a mouth sealing portion adapted to form a seal with a patient's mouth; and a covering valve extending from the mouth portion to cover the nasal portion and / or the patient's nostrils in use.

[0101] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion adapted to form a seal with the patient's nostrils; and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth sealing portion being generally horizontally oriented and the nasal sealing portion being generally vertically oriented.

[0102] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with the patient's nostrils; and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the nasal support portion being a semi-rigid material and the nasal sealing portion being a flexible material.

[0103] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with the patient's nasal cavity; a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth portion and / or the nasal portion including a magnet for holding the mouth portion and / or the nasal portion in place.

[0104] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion adapted to form a seal with the patient's nostrils; a mouth portion adapted to form a seal with the patient's mouth; and a foam portion adapted to clamp onto at least one of the nasal portion and the mouth portion to form a seal between the patient interface system and the patient.

[0105] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with a patient's nasal cavity; a mouth portion including a mouth sealing portion adapted to form a seal with a patient's mouth; and a connecting ring adapted to connect the mouth portion to the nasal portion, the connecting ring having a first channel adapted to receive the mouth portion and a second channel adapted to receive the nasal portion.

[0106] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with the patient's nasal cavity; and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, wherein the nasal sealing portion has a recess adapted to form an interference fit with the mouth portion.

[0107] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nose portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with the patient's nostrils; a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth; an upper headband adapted to be connected to the nose portion, the upper headband including a back strap adapted to be wrapped around the back of the patient's head; and a lower headband adapted to be connected to the mouth portion, the lower headband having loops adapted to receive the back strap of the upper headband.

[0108] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion adapted to form a seal with the patient's nostrils; an elbow connected to the nasal portion for delivering pressurized gas, the elbow including a lug portion; and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth portion including a lug portion selectively connected to the elbow to connect the mouth portion to an opening of the nasal portion.

[0109] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion adapted to form a seal with the patient's nostrils; and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth sealing portion including a pad having a notch or a lower hardness area and shaped to accommodate the nasal portion.

[0110] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: a nasal portion including a nasal sealing portion and a nasal support portion, the nasal sealing portion being adapted to form a seal with a patient's nasal cavity; and a mouth portion including a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth portion including a pad and a pad fascia portion, the pad fascia portion being adapted to connect to the pad, the pad having a connection portion with an orifice adapted to receive a ring for connecting the nasal portion to the mouth portion.

[0111] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a mouth portion, the mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth sealing portion not including a notch.

[0112] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal around a patient's nostril opening with respect to the patient's face, the nasal chamber including an opening; an inlet conduit connected to the nasal portion to deliver pressurized breathable gas to the nasal chamber; and a nasal chamber coupling member adapted to form a releasable fluid coupling portion to allow the nasal portion to be fluidly coupled to a mouth portion, thereby transferring a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

[0113] In some forms: (a) the nasal portion includes a nasal pad forming at least a portion of the nasal chamber, and wherein the nasal chamber opening and the connecting member are formed in the nasal pad; the nasal pad is a bolster pad; (b) the nasal pad is a support pad; (c) the connecting member includes a clip mechanism extending around the nasal chamber opening and arranged to form part of a resilient clip connection; (d) the clip mechanism includes a resilient hinge; (e) the connecting member includes at least a portion of a periphery extending around the nasal chamber opening; (f) the periphery includes at least one of a protrusion or a recess that allows interlocking connection; (g) the periphery includes an inclined surface to provide an introduction surface to the resilient connection; and / or (g) the connecting member forms part of a latching connection.

[0114] In some forms, the patient interface further includes a removable ventilation module adapted to attach to the nasal chamber to expel air exhaled by the patient; the ventilation module is arranged to be releasably connected to the nasal chamber coupling member, such that the patient interface system can be configured in a first mode and a second mode, in the first mode, the ventilation module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal-only patient interface, and in the second mode, the ventilation module is removed to allow the nasal portion to be fluidly coupled to the mouth portion to deliver a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

[0115] In some forms: (a) the patient interface further includes at least one guide vane that provides a barrier to the fluid connection to guide gas from the nasal chamber through the ventilation module; (b) the at least one guide vane forms part of the ventilation module; (c) the ventilation module is an anti-asphyxiation ventilator (AAV); and / or (d) the AAV includes a valve flap, and the at least one guide vane is arranged to guide gas from the nasal chamber to the valve flap.

[0116] In some forms, the patient interface further includes a mouth portion comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including an opening adapted to receive pressurized breathable gas, and wherein, when fluidly connected, the nasal portion is adapted to transmit the pressurized breathable gas to the mouth portion through the nasal chamber opening and the mouth chamber opening.

[0117] In some forms: (a) the mouth chamber includes a ventilation opening adapted to receive a ventilation port adapted to expel gas exhaled by the patient; (b) the ventilation opening is configured to receive the removable ventilation module; (c) the mouth portion includes a mouth liner forming at least a portion of the mouth chamber, wherein the opening is formed in the mouth liner; (d) the mouth portion further includes a coupling member arranged to form part of the fluid connection for connecting the nose portion and the mouth portion; (e) the mouth portion coupling member extends around the mouth chamber opening; (f) the mouth portion coupling member includes a clamping mechanism extending around the mouth chamber opening and (g) The clip mechanism includes a resilient hinge; (h) The mouth portion connection includes at least a portion of a periphery extending around the mouth chamber opening; (i) The periphery includes at least one of a protrusion or recess that allows interlocking connection; (j) The periphery includes an inclined surface to provide an introduction surface to the resilient connection; (k) The mouth portion connection forms part of a latching connection; (i) The mouth portion connection is formed as an overmolded part combining a silicone overlay and a rigid backing; (m) The mouth chamber connection is adapted to be directly connected to the nasal chamber connection to form the fluid connection; (n) The patient interface further includes a connector adapted to form the A fluid coupling is a portion thereof and includes: a nasal end adapted for attachment to the nasal chamber coupling member, an opposite mouth end attachable to the mouth coupling member, and a passage extending between the nasal end and the mouth end; (o) the connector further includes at least one blade disposed in the connector passage; (p) at least one of the nasal end or the mouth end includes a clamping mechanism for engaging with the coupling member of the mouth portion; (q) at least one of the nasal end or the mouth end is elastically deformable for connecting with the coupling member of the nasal portion or the mouth portion; (r) at least one of the nasal end or the mouth end includes a mechanism allowing connection with the nasal portion or the mouth portion. (s) At least one of the interlocking protrusions or recesses of the connecting components; (s) at least one of the nose portion or the mouth portion includes a component latching formation that allows latching connection with the connecting portion of the nose portion or mouth portion; (t) the connector incorporates a connector chamber between these nose and mouth portions; (u) the connector is formed as a single unit; (v) the connector is formed from multiple components; (w) an anti-asphyxiation vent (AAV) is integrally formed with the mouth portion connecting component; (x) the connector incorporates an anti-asphyxiation vent (AAV) disposed between the nose and mouth portions; (y) the AAV includes a valve flap extending through the interior of the connector passage.(z) The connector includes one or more guide vanes extending across at least a portion of the interior of the connector to guide airflow in the connector passage; (aa) The one or more guide vanes are arranged to guide gas from the nasal cavity to the valve; and / or (ab) The patient interface further includes a locking member forming part of the connection, the connection forming at least one of the nasal portion or mouth portion coupling members to fluidly couple the nasal portion to the mouth portion;

[0118] In some forms, the mouth portion further includes a coupling member arranged to form part of the fluid connection for connecting the nose portion and the mouth portion.

[0119] In some forms, the oral cavity connection component is adapted to be directly connected to the nasal cavity connection component to form the fluid connection.

[0120] In some forms, the patient interface further includes a connector adapted to form part of the fluid connection and having: a nasal end adapted to be attached to the nasal chamber connection member, an opposite mouth end attachable to the mouth connection member, and a passage extending between the nasal end and the mouth end.

[0121] In some forms, the connector incorporates an anti-asphyxiation airway (AAV) disposed between the nasal end and the mouth end.

[0122] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal around a patient's nostril opening with respect to the patient's face, the nasal chamber including an opening; an inlet conduit connected to the nasal portion to deliver pressurized breathable gas to the nasal chamber; a vent fluidly connected to the opening in the nasal chamber to expel gas exhaled by the patient; and at least one guide vane providing obstruction to the fluid connection to guide gas from the nasal chamber through the vent.

[0123] In some forms: (a) the nasal portion includes a nasal pad forming at least a portion of the nasal chamber, and wherein the nasal chamber opening is formed in the nasal pad; (b) the nasal pad is a pillow pad; (c) the nasal pad is a support pad; (d) the airway forms part of an airway module adapted to the nasal portion and engaging the at least one guide vane; (e) the patient interface further includes a connector adapted to form part of a fluid connection between the nasal chamber and the airway, the connector having: a nasal portion end adapted to be adapted to be adapted to the nasal chamber, an opposite airway end adapted to be adapted to be adapted to the airway, and a passage extending between the nasal portion end and the airway end; (f) the connector further includes at least one guide vane disposed in the connector passage; (g) the airway is an anti-asphyxiation vent (AAV); and / or (h) the AAV includes a valve, and the at least one guide vane is arranged to guide gas from the nasal chamber to the valve.

[0124] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, comprising: a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including: an opening adapted to receive pressurized breathable gas; and a mouth chamber coupling member adapted to form a releasable fluid coupling portion to enable the mouth portion to be fluidly coupled to a nasal portion to receive a portion of pressurized breathable gas from the nasal portion through the mouth portion opening.

[0125] In some forms: (a) the mouth portion includes a mouth liner forming at least a portion of the mouth chamber, and wherein the opening is formed in the mouth liner; (b) the mouth portion coupling member extends around the mouth chamber opening; (c) the mouth portion coupling member includes a clamping mechanism extending around the mouth chamber opening and arranged to form part of a resilient clamp connection; (d) the clamping mechanism includes a resilient hinge; (e) the mouth portion coupling member includes at least a portion of a periphery extending around the mouth chamber opening; (f) the periphery includes at least one of a protrusion or recess that allows interlocking connection; (g) the periphery includes an inclined surface to provide an introduction surface to the resilient connection; (h) the mouth portion coupling member forms part of a latching connection; (i) the coupling member is an overmolded part combining a silicone coating and a rigid backing; and / or (j) an anti-asphyxiation vent (AAV) is integrally formed with the mouth portion coupling member.

[0126] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, comprising: a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including a coupling member adapted to receive pressurized breathable gas; and an anti-asphyxiation vent (AAV) forming part of the mouth chamber coupling member.

[0127] In some forms: (a) the connecting member is formed as an overmolded component combining a silicone coating and a rigid backing; (b) the patient interface further includes at least one guide vane to direct gas to the AAV; and / or (c) the AAV includes a valve flap, and the at least one guide vane is arranged to direct gas from the nasal chamber to the valve flap.

[0128] Another aspect of this technology relates to a patient interface system for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with a patient's nostrils, the nasal chamber including an opening; a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth chamber including an opening adapted to receive pressurized breathable gas; and an inlet conduit connected to at least one of the nasal portion or the mouth portion to deliver pressurized breathable gas, such that the mouth portion can be coupled to the nasal portion to provide a sealing connection between the opening in the nasal chamber and the opening in the mouth chamber, the connector including an anti-asphyxiation ventilation port (AAV); the patient interface system is configurable such that the nasal portion is coupled to the mouth portion via the connector to transmit a portion of the pressurized breathable gas between the nasal chamber and the mouth chamber, wherein the AAV is disposed between the nasal portion and the mouth portion.

[0129] In some forms: (a) the AAV includes a valve flap extending through an internal passage of the connector; (b) the connector includes one or more blades extending across at least a portion of the internal passage to direct the gas flow to the valve flap; (c) at least one of the nose portion and the mouth portion includes a headband connector adapted to be connected to the headband; (d) both the nose portion and the mouth portion include headband connectors for connection to the headband; and / or (e) the headband further includes complementary patient interface connectors adapted to connect the headband to any one or both of the nose portion and the mouth portion.

[0130] According to another aspect of the present technology, a method is provided for providing a patient interface system kit for delivering respiratory therapy to a patient. The method includes: providing a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostril, the nasal chamber including an opening; providing an inlet catheter connected to the nasal portion to deliver pressurized breathable gas to the nasal chamber; providing a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including an opening adapted to receive pressurized breathable gas; providing a fluid coupling to enable a sealable connection between the opening in the nasal chamber and the opening in the mouth chamber; and providing a detachable [device / partition] adapted to mate with the opening in the nasal chamber. A detachable nasal cavity ventilation module, wherein, depending on the patient's selection, the patient system is adapted to selectively use the patient interface in at least a first and a second mode, the first mode connecting the nasal portion to the mouth portion via the fluid coupling to transfer a portion of pressurized breathable gas between the nasal cavity and the mouth cavity, thereby delivering respiratory therapy through both the nasal portion and the mouth portion; and in the second mode, the mouth portion is not connected to the nasal portion via the fluid coupling, and the nasal ventilation module is adapted to an opening in the nasal cavity to enable the patient interface system to deliver respiratory therapy as a nasal-only patient interface.

[0131] According to another aspect of the present technology, a method is provided for providing a patient interface system kit for delivering respiratory therapy to a patient. The method includes: providing a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostril, the nasal chamber including an opening; providing an inlet catheter connected to at least one of the nasal portion or the mouth portion to deliver the pressurized breathable gas into the nasal chamber; providing a mouth portion comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including an opening adapted to receive the pressurized breathable gas; and providing a connector enabling the mouth portion to be coupled to the nasal portion to provide a sealing connection between the opening in the nasal chamber and the opening in the mouth chamber, the connector including an anti-asphyxiation ventilation port (AAV); wherein the patient interface system is configurable such that the nasal portion is coupled to the mouth portion via the connector to transmit a portion of the pressurized breathable gas between the nasal chamber and the mouth chamber, wherein the AAV is disposed between the nasal portion and the mouth portion.

[0132] According to another aspect of the present technology, a method is provided for switching a patient interface system between a first mode and a second mode, the mask system being used to deliver respiratory therapy to a patient. The method includes: providing a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils, the nasal chamber including an opening; providing a mouth portion comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including an opening adapted to selectively receive pressurized breathable gas; assembling the mask system in the first mode using the nasal portion and the mouth portion to provide the respiratory therapy to the patient's nostrils, and using the mouth portion to provide the respiratory therapy to the patient's mouth; and converting the mask system to the second mode using the nasal portion to provide the respiratory therapy to the patient's nostrils by partially disconnecting the mouth portion from the nasal portion and incorporating a ventilation device in the nasal chamber opening.

[0133] According to another aspect of the present technology, a positioning and stabilizing structure is provided for holding a sealing-forming structure in a therapeutically effective position on a patient's head, the sealing-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilizing structure comprising: a first strap configured to pass around the back of the patient's head during use; and an attachment arrangement disposed on the first strap and forming part of a coupling for releasably attaching a second strap to the first strap, the second strap being connectable to an additional component of the sealing-forming structure, the additional component being selectively combined with the sealing-forming structure at the patient's selection.

[0134] According to another aspect of the present technology, a positioning and stabilizing structure is provided for holding a patient interface in a therapeutically effective position on a patient's head, the patient interface including a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils for sealingly delivering an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilizing structure comprising: a first strap configured to bypass the back of the patient's head during use; and an attachment arrangement disposed on the first strap and forming part of a coupling for releasably attaching a second strap to the first strap, the second strap being connectable to a mouth portion, the mouth portion selectively combined with the nasal portion at the patient's selection to allow the patient interface to deliver respiratory therapy through both the nasal portion and the mouth portion.

[0135] In some forms: (a) the attachment arrangement includes an attachment area that allows the attachment position of the second strap to vary within the attachment area; (b) the attachment arrangement is formed by a plurality of components; (c) the connection includes one or more hook or loop fastening mechanisms; (d) the connection includes at least one snap fastener; (e) the attachment arrangement includes a guide portion to facilitate proper positioning of the second strap with the first strap; (f) the guide portion is in the form of a mark provided on the first strap; (g) the guide portion includes at least one of a protrusion or recess that allows interlocking connection with a corresponding at least one protrusion or recess of the second strap; (h) the attachment arrangement includes two or more guide portions positioned spaced apart along the first strap; (i) the attachment arrangement includes a portion along a portion of the first strap. (j) The positioning and stabilizing structure further includes a second strap, the second strap including a complementary attachment device for forming a connection with the attachment arrangement of the first strap; (k) The complementary attachment arrangement includes a valve extending laterally from the second strap, the valve being capable of passing through the slit in use to releasably attach the second strap to the first strap; (i) Once the valve passes through the slit in use, it is releasably attached to the first strap to form at least a portion of the connection; (m) Once the valve passes through the slit in use, it is releasably attached to the second strap, thereby releasably attaching the second strap to the first strap to form at least a portion of the connection; and / or (n) The connection contributes to the dynamic stability of the positioning and stabilizing structure to maintain the sealing structure in a therapeutically effective position on the patient's head.

[0136] According to another aspect of the present technology, a patient interface system for delivering respiratory therapy to a patient is provided, the patient interface system comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with respect to the patient's face to an inlet surrounding the patient's nostrils, the nasal chamber including an opening; an inlet conduit connected to the nasal portion to deliver pressurized breathable gas to the nasal chamber; and a positioning and stabilizing structure for holding the patient interface in a therapeutically effective position on the patient's head, the structure comprising: a first strap configured to pass around the back of the patient's head in use; and an attachment arrangement disposed on the first strap and forming part of a coupling for releasably attaching a second strap to the first strap, the second strap being connectable to a mouth portion, the mouth portion selectively combined with the nasal portion at the patient's choice to allow the patient interface to deliver respiratory therapy through both the nasal portion and the mouth portion.

[0137] In some forms: (a) the patient interface system further includes: a mouth portion that is selectively combined with a nose portion according to the patient's choice; and a second strap that includes a complementary attachment arrangement for forming a connection with the attachment arrangement of the first strap; (b) the patient interface system further includes: a nasal chamber connection member adapted to form a portion of a releasable fluid connection to enable the nose portion to be fluidly connected to the mouth portion so that a portion of the pressurized breathable gas is transmitted to the mouth portion through the nasal chamber opening; and / or (c) the connection contributes to the dynamic stability of the positioning and stabilizing structure to maintain the sealing structure in a therapeutically effective position on the patient's head.

[0138] According to another aspect of the present technology, an inflatable chamber for a patient interface is provided, the inflatable chamber being pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber comprising: one or more inflatable chamber inlet ports, the inflatable chamber inlet ports being sized and structured to receive an airflow at the therapeutic pressure for patient breathing; and a sealing formation structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing formation structure having one or more orifices therein such that an airflow at the therapeutic pressure is delivered through the one or more orifices to at least the inlet of the patient's nostrils and the patient's mouth, the sealing formation structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The sealing formation structure comprises: a nasal portion configured to form a seal on or near the patient's nose for sealing the patient's face; and a mouth portion configured to form a seal around the patient's mouth for sealing the patient's face, the sealing formation structure having a first surface finish in the nasal portion and a second surface finish different from the first surface finish in the mouth portion.

[0139] In the example: the difference between the first surface finish and the second surface finish is that the coefficient of friction between the sealing structure and the patient's face is greater in the mouth portion than in the nose portion; the first surface finish is configured to provide a smooth feel on the patient's face to the nose portion (e.g., for comfort); the second surface finish is configured to provide a gripping contact on the patient's face to the mouth portion (e.g., for a stronger seal); the first surface finish may be a frosted surface finish; the second surface finish may be a polished surface finish; the boundary between the first surface finish and the second surface finish may be located on the portion of the sealing structure that contacts the patient's cheek during use; the nose portion may include an upper lip portion having the first surface finish; the non-patient contact surface of the nose portion may have a surface finish different from the first surface finish; and / or the non-patient contact surface of the nose portion may have a second surface finish.

[0140] According to another aspect of the present technology, a patient interface is provided, comprising: an inflatable chamber according to one aspect of the present technology described above; a positioning and stabilizing structure that provides a force for holding the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that, in use, at least a portion covers an area of ​​the patient's head above an ear-based point; a ventilation structure configured to allow continuous flow of exhaled air from the interior of the inflatable chamber to the surrounding environment, the size and shape of the ventilation structure being configured to maintain therapeutic pressure within the inflatable chamber in use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without pressurized air being transmitted through the inlet port of the inflatable chamber.

[0141] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0142] One aspect of this technology is a method for manufacturing equipment.

[0143] One aspect of certain forms of this technology is an easy-to-use medical device, for example, that can be easily used by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0144] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0145] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing with soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be used in a patient's home, for example, by washing with soapy water, without requiring specialized cleaning equipment.

[0146] In one aspect of this technology, a positioning and stabilizing structure is disclosed that holds a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes a first strap and an attachment arrangement. The first strap is configured to pass around the back of the patient's head during use. The attachment arrangement is disposed on the first strap and forms part of a connection for releasably attaching a second strap to the first strap. The second strap can be connected to an additional component of the sealing-forming structure, which selectively engages with the sealing-forming structure at the patient's choice.

[0147] In another aspect of this technology, a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head is disclosed. The patient interface includes a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils to deliver a therapeutic airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle in use. The positioning and stabilizing structure includes a first strap and an attachment arrangement. The first strap is configured to bypass the back of the patient's head in use. The attachment arrangement is disposed on the first strap and forms part of a connection for releasably attaching a second strap to the first strap. The second strap can be connected to a mouth portion, which, at the patient's selection, is selectively combined with the nasal portion to allow the patient interface to deliver respiratory therapy through both the nasal and mouth portions.

[0148] In some forms, the attachment arrangement may include an attachment area that allows the attachment position of the second strap to vary within the attachment area.

[0149] In some forms, the attachment arrangement may be formed by multiple components.

[0150] In some forms, the connection may include one or more hook or loop fastening mechanisms.

[0151] In some forms, the connection may include at least one snap.

[0152] In some forms, the attachment arrangement may include guide portions to facilitate proper positioning of the second strap with the first strap. In some forms, the guide portions may be in the form of markings arranged on the first strap. In some forms, the guide portions may include at least one protrusion or recess that allows interlocking with a corresponding at least one protrusion or recess of the second strap. In some forms, the attachment arrangement may include two or more guide portions positioned at intervals along the first strap.

[0153] In some forms, the attachment arrangement may include at least one slit along a portion of the first strap.

[0154] In some forms, the positioning and stabilizing structure may further include a second strap. The second strap may include a complementary attachment arrangement for engaging with the attachment arrangement of the first strap.

[0155] In some forms, the complementary attachment arrangement includes a valve extending laterally from the second strap, the valve being capable of passing through the slit in use to releasably attach the second strap to the first strap. In some forms, the valve, once passing through the slit in use, is releasably attached to the first strap to form at least a portion of the connection. In some forms, the valve, once passing through the slit in use, is releasably attached to the second strap, thereby allowing the second strap to be releasably attached to the first strap to form at least a portion of the connection.

[0156] In some forms, the connection contributes to the dynamic stability of the positioning and stabilizing structure to maintain the sealing structure in a therapeutically effective position on the patient's head.

[0157] In another aspect of this technology, a patient interface system for delivering respiratory therapy to a patient is disclosed. The patient interface system includes a nasal portion, an inlet catheter, and positioning and stabilizing structures. The nasal portion includes a nasal chamber and a nasal seal portion adapted to form a seal with the patient's face around an inlet to the patient's nostrils. The nasal chamber includes an opening. The inlet catheter is connected to the nasal portion to deliver pressurized breathable gas into the nasal chamber. The positioning and stabilizing structures hold the patient interface in a therapeutically effective position on the patient's head. The positioning and stabilizing structures include a first strap and an attachment arrangement. The first strap is configured to bypass the back of the patient's head in use. The attachment arrangement is disposed on the first strap and forms part of a connection for releasably attaching a second strap to the first strap. The second strap can be connected to a mouth portion, which, at the patient's selection, is selectively combined with the nasal portion to allow the patient interface to deliver respiratory therapy through both the nasal and mouth portions.

[0158] In some forms, the patient interface system may further include a mouth portion and a second strap connected to the mouth portion, the mouth portion being selectively combined with the nose portion at the patient's choice. The second strap includes a complementary attachment arrangement for engaging with an attachment arrangement of the first strap.

[0159] In some forms, the patient interface system may further include a nasal chamber connection component adapted to form part of a releasable fluid connection, enabling the nasal chamber portion to be fluidly connected to the mouth portion so that a portion of pressurized breathable gas is delivered to the mouth portion through the nasal chamber opening.

[0160] In some forms, the connection can contribute to the dynamic stability of the positioning and stabilizing structure to maintain the sealing structure in a therapeutically effective position on the patient's head.

[0161] In another aspect of this technology, a holding component for connecting a patient interface to a positioning and stabilizing structure is disclosed, the positioning and stabilizing structure being configured to generate a force that holds the patient interface in a therapeutically effective position on the patient's head. The patient interface includes: an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use; one or more inflation chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle during use; a sealing formation defining at least a portion of the inflation chamber, the sealing formation being configured and arranged to seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing formation being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; and a housing defining at least a portion of the inflation chamber, the housing supporting the sealing formation; the retaining assembly includes a connector and a patient interface engagement portion, the connector including: a connecting portion and a retaining portion, the connecting portion being configured to engage the positioning and stabilizing structure, and the retaining portion being configured to retain the connector relative to the patient interface. The patient interface engagement portion is located on the patient interface, and the patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a first retaining arrangement and a second retaining arrangement.

[0162] In some forms, the first holding arrangement is a mechanical arrangement.

[0163] In some forms, the first retaining arrangement includes complementary protrusions adapted to retain the retaining portion relative to the patient interface engagement portion in a direction along the surface of the patient interface.

[0164] In some forms, the second retaining arrangement is magnetic.

[0165] In some forms, the second retaining arrangement is adapted to retain the retaining portion in a direction remote from the patient interface. In some forms, the patient interface engagement portion protrudes from the surface of the patient interface. In some forms, the engagement portion protrudes from the housing. In some forms, the positioning and stabilizing structure includes a strap configured to extend around the patient's head and retain the sealing structure in a therapeutically effective position on the patient's head.

[0166] In some forms, the retaining assembly further includes a hinge element between the connecting portion and the retaining portion and configured such that the connecting portion and the retaining portion are hinged relative to each other.

[0167] In some forms, hinges include movable hinges.

[0168] In another aspect of this technology, a holding component for connecting a patient interface to a positioning and stabilizing structure is disclosed, the positioning and stabilizing structure being configured to generate a force that holds the patient interface in a therapeutically effective position on the patient's head. The patient interface includes: an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use; one or more inflation chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle during use; a sealing structure defining at least a portion of the inflation chamber, the sealing structure being configured and arranged to seal with a region of the patient's face surrounding an inlet to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; and a housing defining at least a portion of the inflation chamber, the housing supporting the sealing structure; the retaining assembly includes a connector and a patient interface engagement portion, the connector including: a connecting portion configured to engage the positioning and stabilizing structure; a retaining portion configured to retain the connector relative to the patient interface; and a hinge element between the connecting portion and the retaining portion and configured such that the connecting portion and the retaining portion are hinged relative to each other. The patient interface engagement portion is supported on the patient interface. The patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a magnetic retaining arrangement.

[0169] In another aspect of this technology, a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle is disclosed; one or more inflatable chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle during use; a sealing structure defining at least a portion of the inflatable chamber, the sealing structure being configured and arranged to seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; a housing defining at least a portion of the inflatable chamber, the housing supporting the sealing structure; and a patient interface engagement portion extending from the housing and configured to attach to a connector for a positioning and stabilizing structure configured to generate a force holding the patient interface in a therapeutically effective position on the patient's head, such that the connector and the patient interface engagement portion are engaged by a first mechanical holding arrangement and a second magnetic holding arrangement.

[0170] In some forms, the patient interface engagement portion includes a protrusion that extends from the housing and includes a magnet configured to magnetically engage the connector and a shoulder configured to mechanically engage the connector.

[0171] In some forms, the magnet is configured to resist movement of the connector away from the patient interface, and the shoulder is configured to resist movement of the connector in a direction along the surface of the patient interface.

[0172] In another aspect of this technology, a patient interface system comprising an inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle is disclosed; one or more inflatable chamber inlet ports, sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle during use; and a sealing structure defining at least a portion of the inflatable chamber, the sealing structure being configured and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the sealing structure being configured and arranged to seal during the patient's respiratory cycle. The ring maintains the treatment pressure in the inflation chamber; a housing defining at least a portion of the inflation chamber, the housing supporting the sealing structure; a positioning and stabilizing structure configured to generate a force that holds the sealing structure in a therapeutically effective position on the patient's head; and a retaining assembly including a connector and a patient interface engagement portion, the connector including: a connecting portion configured to engage the positioning and stabilizing structure; a retaining portion configured to retain the connector relative to the patient interface; and a hinge element configured between the connecting portion and the retaining portion such that the connecting portion and the retaining portion are hinged relative to each other. The patient interface engagement portion is located on the patient interface. The patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a first retaining arrangement and a second retaining arrangement.

[0173] In some forms, (a) the first retaining arrangement is a mechanical arrangement; (b) the first retaining arrangement includes complementary protrusions adapted to retain the retaining portion relative to the patient interface engagement portion in a direction along the surface of the patient interface; (c) the second retaining arrangement is magnetic; (d) the second retaining arrangement is adapted to retain the retaining portion relative to the patient interface in a direction away from the patient interface; (e) the patient interface engagement portion protrudes from the surface of the patient interface; (f) the engagement portion protrudes from the housing; (g) the positioning and stabilizing structure includes a strap configured to extend around the patient's head and retain the sealing structure in a therapeutically effective position on the patient's head; and / or (h) the hinge includes a movable hinge.

[0174] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0175] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0176] The following is a brief description of embodiments according to the present invention.

[0177] Implementation 1. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0178] The nasal portion includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with respect to the patient's face around an entrance to the patient's nostrils, the nasal chamber including an opening;

[0179] An inlet cannula, which is connected to the nasal portion to deliver pressurized breathable gas into the nasal chamber; and

[0180] A nasal chamber connection component adapted to form part of a releasable fluid connection to enable the nasal portion to be fluidly connected to the mouth portion to deliver a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

[0181] Embodiment 2. The patient interface system as described in Embodiment 1, wherein the nasal portion includes a nasal pad forming at least a portion of the nasal chamber, and wherein the nasal chamber opening and the connecting member are formed in the nasal pad.

[0182] Implementation method 3. The patient interface system as described in implementation method 2, wherein the nasal pad is a pillow pad.

[0183] Implementation 4. The patient interface system as described in Implementation 2, wherein the nasal pad is a support pad.

[0184] Implementation 5. The patient interface system as described in any of the preceding embodiments, wherein the connecting component includes a clip mechanism that extends around the nasal cavity opening and is arranged to form part of a resilient clip connection.

[0185] Implementation 6. The patient interface system as described in Implementation 5, wherein the clamp mechanism includes a resilient hinge.

[0186] Embodiment 7. The patient interface system as described in any one of Embodiments 1 to 4, wherein the connecting member includes at least a portion of its periphery extending around the nasal chamber opening.

[0187] Implementation 8. The patient interface system as described in Implementation 7, wherein the periphery includes at least one of a protrusion or a recess that allows interlocking connections.

[0188] Implementation 9. The patient interface system as described in Implementation 7 or 8, wherein the periphery includes a sloped surface to provide an insertion surface to the resilient connection.

[0189] Embodiment 10. The patient interface system as described in any one of Embodiments 1 to 4, wherein the connecting component forms part of a latching connection.

[0190] Implementation 11. The patient interface system as described in any of the preceding embodiments further includes a removable ventilation module adapted to attach to the nasal chamber to expel gas exhaled by the patient; the ventilation module is arranged to be releasably connected to the nasal chamber coupling member such that the patient interface system can be configured in a first mode and a second mode, in the first mode, the ventilation module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal-only patient interface, and in the second mode, the ventilation module is removed to allow the nasal portion to be fluidly coupled to the mouth portion to deliver a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

[0191] Embodiment 12. The patient interface system of Embodiment 11 further includes at least one guide vane that provides an obstruction to the fluid connection to guide gas from the nasal chamber through the ventilation module.

[0192] Embodiment 13. The patient interface system as described in Embodiment 12, wherein at least one guide vane forms part of the ventilation module.

[0193] Implementation 14. The patient interface system as described in any one of Implementations 11 to 13, wherein the ventilation module is an anti-asphyxia ventilation (AAV).

[0194] Implementation 15. The patient interface system as described in Implementation 14, wherein the AAV includes a valve flap, and the at least one guide vane is arranged to guide gas from the nasal chamber to the valve flap.

[0195] Embodiment 16. The patient interface system as described in any of the preceding embodiments further includes a mouth portion, the mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with the mouth of the patient, the mouth chamber including an opening adapted to receive pressurized breathable gas, and wherein, when fluidly connected, the nasal portion is adapted to transmit the pressurized breathable gas to the mouth portion through the nasal chamber opening and the mouth chamber opening.

[0196] Embodiment 17. The patient interface system as described in Embodiment 16, wherein the mouth chamber includes a ventilation opening adapted to receive a ventilation port and adapted to discharge gas exhaled by the patient.

[0197] Implementation 18. The patient interface system as described in Implementation 17 when subordinate to Implementation 11, wherein the ventilation opening is configured to receive the removable ventilation port module.

[0198] Embodiment 19. The patient interface system as described in Embodiments 16 to 18, wherein the mouth portion includes a mouth liner forming at least a portion of the mouth cavity, and wherein the opening is formed in the mouth liner.

[0199] Embodiment 20. A patient interface system as described in any one of Embodiments 16 to 19, wherein the mouth portion further includes a coupling member arranged to form part of the fluid connection for connecting the nose portion and the mouth portion.

[0200] Implementation 21. The patient interface system as described in Implementation 20, wherein the mouth portion connecting member extends around the mouth cavity opening.

[0201] Implementation 22. The patient interface system as described in Implementation 20 or 21, wherein the mouth portion connection component includes a clip mechanism that extends around the mouth cavity opening and is arranged to form part of a resilient clip connection.

[0202] Implementation 23. The patient interface system as described in Implementation 22, wherein the clamp mechanism includes a resilient hinge.

[0203] Embodiment 24. The patient interface system as described in Embodiment 20 or 21, wherein the mouth portion connection member includes at least a portion of its periphery extending around the mouth cavity opening.

[0204] Implementation 25. The patient interface system as described in Implementation 24, wherein the periphery includes at least one of a protrusion or a recess that allows interlocking connections.

[0205] Implementation 26. The patient interface system as described in Implementation 24 or 25, wherein the periphery includes a sloped surface to provide an insertion surface to the resilient connection.

[0206] Implementation 27. The patient interface system as described in Implementation 20 or 21, wherein the mouth portion connecting member forms part of a latching connection.

[0207] Embodiment 28. The patient interface system as described in any one of Embodiments 20 to 27, wherein the mouth portion connecting member is formed as a covered molding combining a silicone coating and a rigid backing.

[0208] Embodiment 29. The patient interface system of any one of Embodiments 20 to 28, wherein the oral cavity connection member is adapted to be directly connected to the nasal cavity connection member to form the fluid connection.

[0209] Embodiment 30. The patient interface system of any one of Embodiments 20 to 28 further includes a connector adapted to form part of the fluid connection and having: a nasal portion adapted to be attached to the nasal chamber connection member, an opposite mouth portion adapted to be attached to the mouth portion connection member, and a passage extending between the nasal portion and the mouth portion.

[0210] Embodiment 31. The patient interface system as described in Embodiment 30, wherein the connector further comprises at least one blade disposed in the connector passage.

[0211] Embodiment 32. The patient interface system as described in Embodiment 30 or 31, wherein at least one of the nose portion or the mouth portion includes a clamping mechanism for engaging with the connecting member of the mouth portion.

[0212] Embodiment 33. The patient interface system of any one of Embodiments 30 to 32, wherein at least one of the nose portion or the mouth portion is elastically deformable to connect with a connecting member of the nose portion or the mouth portion.

[0213] Embodiment 34. The patient interface system of any one of Embodiments 30 to 33, wherein at least one of the nose portion end or the mouth portion end includes at least one of a protrusion or recess that allows interlocking connection with the connecting member of the nose portion or the mouth portion.

[0214] Embodiment 35. The patient interface system of any one of Embodiments 30 to 34, wherein at least one of the nose portion end or the mouth portion end includes a component latch formation that allows a latching connection with a connecting portion of the nose portion or the mouth portion.

[0215] Embodiment 36. The patient interface system as described in any one of Embodiments 30 to 35, wherein the connector is coupled to a connector chamber between the nasal portion and the mouth portion.

[0216] Implementation 37. The patient interface system as described in any one of Implementations 30 to 36, wherein the connector is formed as an integral structure.

[0217] Implementation 38. The patient interface system as described in any one of Implementations 30 to 36, wherein the connector is formed of a plurality of components.

[0218] Embodiment 39. The patient interface system as described in any one of Embodiments 20 to 38, wherein the anti-asphyxiation ventilation port (AAV) is integrally formed with the mouth portion connecting component.

[0219] Embodiment 40. The patient interface as described in any one of Embodiments 30 to 38, wherein the connector is coupled to an anti-asphyxiation ventilation (AAV) disposed between the nasal portion end and the mouth portion end.

[0220] Implementation 41. The patient interface system as described in Implementation 40, wherein the AAV includes a valve flap extending through the interior of the connector passage.

[0221] Implementation 42. The patient interface system as described in Implementation 41, wherein the connector includes one or more guide vanes that extend across at least a portion of the interior of the connector to guide airflow in the connector passage.

[0222] Implementation 43. The patient interface as described in Implementation 42, wherein the one or more guide vanes are arranged to guide gas from the nasal chamber to the valve.

[0223] Embodiment 44. The patient interface of any one of Embodiments 20 to 43 further includes a locking member forming part of the connection, the connection forming at least one of the nose portion or mouth portion coupling members to fluidly connect the nose portion to the mouth portion.

[0224] Implementation 45. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0225] The nasal portion includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with respect to the patient's face around an entrance to the patient's nostrils, the nasal chamber including an opening;

[0226] An inlet cannula is connected to the nasal portion to deliver pressurized breathable gas into the nasal cavity;

[0227] A ventilation port, fluidly connected to an opening in the nasal cavity to expel air exhaled by the patient; and

[0228] At least one guide vane provides an obstruction to the fluid connection to guide gas from the nasal chamber through the vent.

[0229] Embodiment 46. The patient interface system of Embodiment 45, wherein the nasal portion includes a nasal pad forming at least a portion of the nasal chamber, and wherein the nasal chamber opening is formed in the nasal pad.

[0230] Implementation 47. The patient interface system as described in Implementation 46, wherein the nasal pad is a pillow pad.

[0231] Implementation 48. The patient interface system as described in Implementation 46, wherein the nasal pad is a support pad.

[0232] Implementation 49. A patient interface system as described in any one of Implementations 45 to 48, wherein the airway forms part of an airway module that is adapted to the nasal portion and incorporates the at least one guide vane.

[0233] Embodiment 50. The patient interface system of any one of Embodiments 45 to 49 further includes a connector adapted to form part of a fluid connection between the nasal chamber and the airway, the connector having: a nasal end adapted to mate with the nasal chamber, an opposite airway end adapted to mate with the airway, and a passage extending between the nasal end and the airway end.

[0234] Embodiment 51. The patient interface system as described in Embodiment 50, wherein the connector further includes the at least one guide blade disposed in the connector passage.

[0235] Implementation 52. The patient interface system as described in any one of Implementations 45 to 51, wherein the ventilation port is an anti-asphyxiation ventilation port (AAV).

[0236] Implementation 53. The patient interface system as described in Implementation 52, wherein the AAV includes a valve flap, and the at least one guide vane is arranged to guide gas from the nasal chamber to the valve flap.

[0237] Implementation 54. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0238] The mouth portion includes a mouth chamber and a mouth sealing portion, the mouth sealing portion being adapted to form a seal with the patient's mouth, and the mouth chamber including an opening adapted to receive pressurized breathable gas;

[0239] A mouth chamber connection component adapted to form part of a releasable fluid connection so that the mouth portion can be fluidly connected to the nose portion, thereby receiving a portion of the pressurized breathable gas from the nose portion through an opening in the mouth portion.

[0240] Embodiment 55. The patient interface system as described in Embodiment 54, wherein the mouth portion includes a mouth liner forming at least a portion of the mouth cavity, and wherein the opening is formed in the mouth liner.

[0241] Embodiment 56. The patient interface system as described in Embodiment 54 or 55, wherein the mouth portion connecting member extends around the mouth cavity opening.

[0242] Embodiment 57. A patient interface system as described in any one of Embodiments 54 or 56, wherein the mouth portion connection component includes a clip mechanism that extends around the mouth cavity opening and is arranged to form part of a resilient clip connection.

[0243] Implementation 58. The patient interface system as described in Implementation 57, wherein the clamp mechanism includes a resilient hinge.

[0244] Embodiment 59. A patient interface system as described in any one of Embodiments 54 to 56, wherein the mouth portion connection member includes at least a portion of its periphery extending around the mouth chamber opening.

[0245] Embodiment 60. The patient interface system as described in Embodiment 59, wherein the periphery includes at least one of a protrusion or a recess that allows interlocking connections.

[0246] Embodiment 61. A patient interface system as described in any one of Embodiments 54 to 56, wherein the periphery includes a sloped surface to provide an insertion surface to the resilient connection.

[0247] Embodiment 62. The patient interface system as described in any one of Embodiments 54 to 56, wherein the mouth portion connecting member forms part of a latching connection.

[0248] Embodiment 63. The patient interface system as described in any one of Embodiments 54 to 62, wherein the connecting component is formed as an overmolded part combining a silicone coating and a rigid backing.

[0249] Embodiment 64. The patient interface system as described in any one of Embodiments 54 to 63, wherein the anti-asphyxiation ventilation port (AAV) is integrally formed with the mouth portion connecting component.

[0250] Implementation 65. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0251] The mouth portion includes a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including a connecting member adapted to receive pressurized breathable gas; and

[0252] An anti-asphyxiation vent (AAV) that forms part of the mouth chamber connection component.

[0253] Embodiment 66. The patient interface system as described in Embodiment 65, wherein the connecting component is formed as an overmolded part combining a silicone coating and a rigid backing.

[0254] Implementation 67. The patient interface system as described in Implementation 65 or 66 further includes at least one guide vane to direct gas to the AAV.

[0255] Implementation 68. The patient interface system as described in Implementation 67, wherein the AAV includes a valve flap, and the at least one guide vane is arranged to direct the airflow onto the valve flap.

[0256] Implementation 69. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0257] The nasal portion includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with the patient's nostril, the nasal chamber including an opening;

[0258] A mouth portion, comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth chamber including an opening adapted to receive pressurized breathable gas; and

[0259] An inlet cannula, connected to at least one of the nasal portion or the mouth portion, to deliver the pressurized breathable gas; and

[0260] A connector that allows the mouth portion to engage with the nose portion to provide a sealing connection between an opening in the nasal chamber and an opening in the mouth chamber, the connector including an anti-asphyxiation airway (AAV); and

[0261] The patient interface system is configured such that the nasal portion is connected to the mouth portion via the connector to transmit a portion of the pressurized breathable gas between the nasal chamber and the mouth chamber, wherein the AAV is disposed between the nasal portion and the mouth portion.

[0262] Implementation 70. The patient interface system as described in Implementation 69, wherein the AAV includes a valve flap extending through an internal passageway of the connector.

[0263] Implementation 71. The patient interface system as described in Implementation 70, wherein the connector includes one or more blades extending through at least a portion of the internal passage to direct the airflow to the valve disc.

[0264] Embodiment 72. The patient interface system according to any one of the foregoing embodiments, wherein at least one of the nose portion and the mouth portion includes a headband connector adapted to be connected to the headband.

[0265] Embodiment 73. The patient interface system as described in Embodiment 72, wherein both the nose portion and the mouth portion include headband connectors for connection to the headband.

[0266] Embodiment 74. The patient interface system as described in Embodiment 73, wherein the headband further includes a complementary patient interface connector adapted to connect the headband to either or both of the nose portion and the mouth portion.

[0267] Implementation 75. A method for providing a patient interface system kit for delivering respiratory therapy to a patient, the method comprising:

[0268] A nasal portion is provided that includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with the patient's nostril, the nasal chamber including an opening;

[0269] An inlet catheter is provided, which is connected to the nasal portion to deliver the pressurized breathable gas into the nasal chamber;

[0270] A mouth portion is provided, comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the mouth of the patient, the mouth chamber including an opening adapted to receive pressurized breathable gas;

[0271] Provide a fluid connection to enable a sealing connection between the opening in the nasal chamber and the opening in the oral chamber; and

[0272] A detachable nasal cavity ventilation module is provided to be adapted to fit an opening in the nasal cavity;

[0273] Depending on the patient's choice, the patient system is adapted to selectively use the patient interface in at least a first and a second mode. In the first mode, the nasal portion is connected to the mouth portion via the fluid coupling to transfer a portion of pressurized breathable gas between the nasal and mouth chambers, thereby delivering respiratory therapy through both the nasal and mouth portions. In the second mode, the mouth portion is not connected to the nasal portion via the fluid coupling, and the nasal ventilation module is adapted to an opening in the nasal chamber, enabling the patient interface system to deliver respiratory therapy as a nasal-only patient interface.

[0274] Implementation 76. A method for providing a patient interface system kit for delivering respiratory therapy to a patient, the method comprising:

[0275] A nasal portion is provided that includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with the patient's nostril, the nasal chamber including an opening;

[0276] An inlet catheter is provided, which is connected to at least one of the nasal portion or the mouth portion to deliver the pressurized breathable gas into the nasal chamber;

[0277] A mouth portion is provided, comprising a mouth chamber and a mouth sealing portion adapted to form a seal with the mouth of the patient, the mouth chamber including an opening adapted to receive pressurized breathable gas; and

[0278] A connector is provided that enables the mouth portion to engage with the nose portion to provide a sealing connection between an opening in the nasal chamber and an opening in the mouth chamber, the connector including an anti-asphyxiation airway (AAV);

[0279] The patient interface system is configured such that the nasal portion is connected to the mouth portion via the connector to transmit a portion of the pressurized breathable gas between the nasal chamber and the mouth chamber, wherein the AAV is disposed between the nasal portion and the mouth portion.

[0280] Implementation 77. A method for switching a patient interface system between a first mode and a second mode, the mask system being used to deliver respiratory therapy to a patient, the method comprising:

[0281] A nasal portion is provided that includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with the patient's nostril, the nasal chamber including an opening;

[0282] A mouth portion is provided, comprising a mouth chamber and a mouth sealing portion adapted to form a seal with a patient's mouth, the mouth chamber including an opening adapted to selectively receive pressurized breathable gas;

[0283] The mask system is assembled in the first configuration using the nose portion and the mouth portion to provide the breathing therapy to the patient's nostrils, and the mouth portion is used to provide the breathing therapy to the patient's mouth; and

[0284] By disconnecting the mouth portion from the nose portion and integrating a ventilation device into the nasal cavity opening, the mask system is converted to the second mode using the nose portion to provide the respiratory therapy to the patient's nostrils.

[0285] Embodiment 78. A positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head, said sealing-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising:

[0286] A first bandage, configured to wrap around the back of the patient's head during use; and

[0287] An attachment arrangement is provided on the first bandage and forms part of a connection for releasably attaching a second bandage to the first bandage, the second bandage being connectable to an additional component of the sealing structure, the additional component being selectively combined with the sealing structure at the patient's choice.

[0288] Embodiment 79. A positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head, the patient interface including a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils, for sealingly delivering an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilizing structure comprising:

[0289] A first bandage, configured to wrap around the back of the patient's head during use; and

[0290] An attachment arrangement is provided on the first strap and forms part of a connection for releasably attaching a second strap to the first strap, the second strap being connectable to a mouth portion, wherein, at the patient's choice, the mouth portion is selectively combined with the nasal portion to allow the patient interface to deliver respiratory therapy through both the nasal portion and the mouth portion.

[0291] Implementation 80. The positioning and stabilizing structure as described in Implementation 78 or 79, wherein the attachment arrangement includes an attachment region that allows the attachment position of the second strap to vary within the attachment region.

[0292] Embodiment 81. The positioning and stabilizing structure as described in any one of Embodiments 78 to 80, wherein the attachment arrangement is formed by a plurality of components.

[0293] Embodiment 82. The positioning and stabilizing structure as described in any one of Embodiments 78 to 81, wherein the connection includes one or more hook or loop fastening mechanisms.

[0294] Embodiment 83. The positioning and stabilizing structure as described in any one of Embodiments 78 to 82, wherein the connection includes at least one snap.

[0295] Embodiment 84. The positioning and stabilizing structure as described in any one of Embodiments 78 to 83, wherein the attachment arrangement includes a guide to facilitate the correct positioning of the second strap and the first strap.

[0296] Implementation method 85. The positioning and stabilizing structure as described in implementation method 84, wherein the guide portion is in the form of a mark provided on the first strap.

[0297] Embodiment 86. The positioning and stabilizing structure as described in any one of Embodiments 84 or 85, wherein the guide portion includes at least one of a protrusion or a recess, the at least one protrusion or recess allowing interlocking connection with a corresponding at least one protrusion or recess of the second strap.

[0298] Embodiment 87. The positioning and stabilizing structure as described in any one of Embodiments 78 to 84, wherein the attachment arrangement includes two or more guide portions positioned at intervals along the first strap.

[0299] Embodiment 88. The positioning and stabilizing structure as described in any one of Embodiments 78 to 87, wherein the attachment arrangement includes at least one slit along a portion of the first strap.

[0300] Embodiment 89. The positioning and stabilizing structure as described in any one of Embodiments 78 to 88 further includes a second strap, the second strap including a complementary attachment device for engaging with the attachment arrangement of the first strap.

[0301] Implementation 90. The positioning and stabilizing structure as described in Implementation 89 when subordinate to Implementation 88, wherein the complementary attachment arrangement includes a valve extending laterally from the second strap, the valve being capable of passing through the slit in use to releasably attach the second strap to the first strap.

[0302] Implementation 91. The positioning and stabilizing structure as described in Implementation 90, wherein the valve disc, once it passes through the slit in use, can be releasably attached to the first strap to form at least a portion of the connection.

[0303] Implementation 92. The positioning and stabilizing structure as described in Implementation 90, wherein the valve flap, once passing through the slit in use, can be releasably attached to the second strap, thereby allowing the second strap to be releasably attached to the first strap to form at least a portion of the connection.

[0304] Implementation 93. The positioning and stabilizing structure as described in any one of Implementations 89 to 92, wherein the connection contributes to the dynamic stability of the positioning and stabilizing structure to maintain the sealing structure in a therapeutically effective position on the patient's head.

[0305] Implementation 94. A patient interface system for delivering respiratory therapy to a patient, comprising:

[0306] The nasal portion includes a nasal chamber and a nasal sealing portion, the nasal sealing portion being adapted to form a seal with respect to the patient's face around an entrance to the patient's nostrils, the nasal chamber including an opening;

[0307] An inlet cannula, which is connected to the nasal portion to deliver pressurized breathable gas into the nasal chamber; and

[0308] A positioning and stabilizing structure that holds the patient interface in a therapeutically effective position on the patient's head, the structure comprising:

[0309] A first bandage, configured to wrap around the back of the patient's head during use; and

[0310] An attachment arrangement is disposed on the first strap and forms part of a connection for releasably attaching a second strap to the first strap, the second strap being connectable to a mouth portion, wherein, at the patient's selection, the mouth portion is selectively combined with the nasal portion to allow the patient interface to deliver respiratory therapy through both the nasal portion and the mouth portion.

[0311] Embodiment 95. The patient interface system as described in Embodiment 94 further includes the mouth portion, which, when the patient can choose, is selectively combined with the nose portion, and

[0312] The second strap, which is connected to the mouth portion, includes a complementary attachment arrangement for engaging with the attachment arrangement of the first strap.

[0313] Embodiment 96. The patient interface system of Embodiment 94 or 95 further includes a nasal chamber connection component adapted to form part of a releasable fluid connection so that the nasal portion can be fluidly connected to the mouth portion, thereby transmitting a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

[0314] Implementation 97. The patient interface system as described in any one of Implementations 94 to 96, wherein the connection contributes to the dynamic stability of the positioning and stabilizing structure to maintain the sealing-forming structure in a therapeutically effective position on the patient's head.

[0315] Implementation 98. A patient interface system as described in any one of Implementations 94 to 97, wherein the features of the positioning and stabilizing structure are otherwise defined as in any one of Implementations 80 to 93.

[0316] Embodiment 99. A holding assembly for connecting a patient interface to a positioning and stabilizing structure, the positioning and stabilizing structure being configured to generate a force holding the patient interface in a therapeutically effective position on the patient's head, the patient interface comprising:

[0317] An inflation chamber, which, during use, can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle;

[0318] One or more air chamber inlet ports, the size and configuration of which are determined to receive an airflow at the treatment pressure so that the patient can breathe during the patient’s entire respiratory cycle in use;

[0319] A sealing structure defining at least a portion of the inflation chamber, the sealing structure being configured and arranged to seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber during use throughout the patient's respiratory cycle; and

[0320] A housing that defines at least a portion of the inflation chamber, the housing supporting the sealing structure;

[0321] The retaining component includes a connector and a patient interface engagement portion.

[0322] The connector includes:

[0323] A connecting portion and a retaining portion, the connecting portion being configured to engage the positioning and stabilizing structure, and the retaining portion being configured to retain the connector relative to the patient interface;

[0324] The patient interface engagement portion is located on the patient interface, and

[0325] The patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a first retaining arrangement and a second retaining arrangement.

[0326] Implementation 100. The retaining assembly as described in Implementation 99, wherein the first retaining arrangement is a mechanical arrangement.

[0327] Embodiment 101. The retaining assembly as described in Embodiment 99, wherein the first retaining arrangement includes complementary protrusions adapted to retain the retaining portion relative to the patient interface engagement portion in a direction along the surface of the patient interface.

[0328] Embodiment 102. The retaining assembly as described in any one of Embodiments 99 to 101, wherein the second retaining arrangement is magnetic.

[0329] Embodiment 103. The retaining assembly as described in any one of Embodiments 99 to 102, wherein the second retaining arrangement is adapted to retain the retaining portion in a direction away from the patient interface relative to the patient interface.

[0330] Embodiment 104. The retaining assembly as described in any one of Embodiments 99 to 103, wherein the patient interface engagement portion protrudes from the surface of the patient interface.

[0331] Embodiment 105. The retaining assembly as described in Embodiment 104, wherein the engaging portion protrudes from the housing.

[0332] Embodiment 106. The retention assembly as described in any one of Embodiments 99 to 105, wherein the positioning and stabilizing structure includes a strap configured to extend around the patient’s head and retain the sealing structure in a therapeutically effective position on the patient’s head.

[0333] Embodiment 107. The retaining assembly as described in any one of Embodiments 99 to 106 further includes a hinge element between the connecting portion and the retaining portion and configured such that the connecting portion and the retaining portion are hinged relative to each other.

[0334] Embodiment 108. The retaining assembly as described in Embodiment 107, wherein the hinge includes a movable hinge.

[0335] Embodiment 109. A holding assembly for connecting a patient interface to a positioning and stabilizing structure, the positioning and stabilizing structure being configured to generate a force holding the patient interface in a therapeutically effective position on the patient's head, the patient interface comprising:

[0336] An inflation chamber, which, during use, can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle;

[0337] One or more air chamber inlet ports, the size and configuration of which are determined to receive an airflow at the treatment pressure so that the patient can breathe during the patient’s entire respiratory cycle in use;

[0338] A sealing structure defining at least a portion of the inflation chamber, the sealing structure being configured and arranged to seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber during use throughout the patient's respiratory cycle; and

[0339] A housing that defines at least a portion of the inflation chamber, the housing supporting the sealing structure;

[0340] The retaining component includes a connector and a patient interface engagement portion.

[0341] The connector includes:

[0342] A connecting portion configured to engage the positioning and stabilizing structure; a retaining portion configured to retain the connector relative to the patient interface; and a hinge element between the connecting portion and the retaining portion and configured such that the connecting portion and the retaining portion are hinged relative to each other.

[0343] The patient interface engagement portion is located on the patient interface, and

[0344] The patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a magnetic retaining arrangement.

[0345] Implementation method 110. A patient interface comprising:

[0346] An inflation chamber, which, during use, can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle;

[0347] One or more air chamber inlet ports, the size and configuration of which are determined to receive an airflow at the treatment pressure so that the patient can breathe during the patient’s entire respiratory cycle in use;

[0348] A sealing structure defining at least a portion of the inflation chamber, the sealing structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber during use throughout the patient's respiratory cycle;

[0349] A housing defining at least a portion of the inflation chamber, the housing supporting the sealing structure; and

[0350] A patient interface engagement portion extends from the housing and is configured to attach to a connector for a positioning and stabilizing structure configured to generate a force that holds the patient interface in a therapeutically effective position on the patient's head, such that the connector and the patient interface engagement portion are engaged by a first mechanical holding arrangement and a second magnetic holding arrangement.

[0351] Embodiment 111. The patient interface as described in Embodiment 110, wherein the patient interface engagement portion includes a protrusion that protrudes from the housing and includes a magnet configured to magnetically engage the connector and a shoulder configured to mechanically engage the connector.

[0352] Embodiment 112. The patient interface as described in Embodiment 111, wherein the magnet is configured to resist movement of the connector away from the patient interface, and the shoulder is configured to resist movement of the connector in a direction along the surface of the patient interface.

[0353] Implementation method 113. A patient interface comprising:

[0354] An inflation chamber, which, during use, can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle;

[0355] One or more air chamber inlet ports, the size and configuration of which are determined to receive an airflow at the treatment pressure so that the patient can breathe during the patient’s entire respiratory cycle in use;

[0356] A sealing structure defining at least a portion of the inflation chamber, the sealing structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber during use throughout the patient's respiratory cycle;

[0357] A housing that defines at least a portion of the inflation chamber, the housing supporting the sealing structure;

[0358] A positioning and stabilizing structure configured to generate a force that holds the sealing structure in a therapeutically effective position on the patient's head; and

[0359] The retaining component includes a connector and a patient interface engagement portion.

[0360] The connector includes:

[0361] A connecting portion configured to engage the positioning and stabilizing structure; a retaining portion configured to retain the connector relative to the patient interface; and a hinge element configured between the connecting portion and the retaining portion such that the connecting portion and the retaining portion are hinged relative to each other.

[0362] The patient interface engagement portion is supported on the patient interface, and

[0363] The patient interface engagement portion and the retaining portion are configured to be removably engaged with each other via a first retaining arrangement and a second retaining arrangement.

[0364] Implementation 114. The patient interface system as described in Implementation 113, wherein the first holding arrangement is a mechanical arrangement.

[0365] Embodiment 115. A patient interface system as described in Embodiment 113 or 114, wherein the first retaining arrangement includes complementary protrusions adapted to retain the retaining portion relative to the patient interface engagement portion in a direction along the surface of the patient interface.

[0366] Implementation 116. The patient interface system as described in any one of Implementations 113 to 115, wherein the second retaining arrangement is magnetic.

[0367] Embodiment 117. A patient interface system as described in any one of Embodiments 113 to 116, wherein the second holding arrangement is adapted to hold the holding portion relative to the patient interface in a direction away from the patient interface.

[0368] Embodiment 118. The patient interface system as described in any one of Embodiments 113 to 117, wherein the patient interface engagement portion protrudes from the surface of the patient interface.

[0369] Embodiment 119. The patient interface system as described in Embodiment 118, wherein the engagement portion protrudes from the housing.

[0370] Embodiment 120. A patient interface system as described in any one of Embodiments 113 to 119, wherein the positioning and stabilizing structure includes a strap configured to extend around the patient’s head and hold the sealing structure in a therapeutically effective position on the patient’s head.

[0371] Implementation 121. The patient interface system as described in any one of Implementations 113 to 120, wherein the hinge includes a movable hinge.

[0372] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0373] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0374] 4.1 Treatment System

[0375] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow 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 is also shown. The patient is sleeping in a supine position.

[0376] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 via a nasal 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 delivered to the patient 1000 along an air circuit 4170.

[0377] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face patient interface manner receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0378] 4.2 Respiratory System and Facial Anatomy

[0379] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0380] Figure 2B This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0381] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0382] Figure 2DIt is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0383] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0384] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0385] Figure 2G A side view showing the surface features of the nose.

[0386] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0387] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0388] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also labeled.

[0389] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. 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 also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0390] Figure 2L The frontal lateral view of the nose is shown.

[0391] 4.3 Patient Interface

[0392] Figure 3A A patient interface in the form of a nasal patient interface according to the present technology is shown.

[0393] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0394] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0395] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0396] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0397] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0398] Figure 3G A liner for a patient interface comprising two pillows is shown. The outer surface of the liner is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0399] Figure 3H The padding for the patient interface is shown. The outer surface of the pad is indicated. The edges of the surface are indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0400] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0401] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0402] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0403] Figure 3L A patient interface with an inflatable airbag as a pad is shown.

[0404] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the patient interface and the inner surface of the airbag. The inner surface defines a two-dimensional aperture in the mask.

[0405] Figure 3N Showing through Figure 3L Another cross-section of the patient interface. The inner surface is also marked.

[0406] Figure 3O The left-hand rule is shown.

[0407] Figure 3P The right-hand rule is shown.

[0408] Figure 3Q The left ear is shown, including the left ear spiral.

[0409] Figure 3R The right ear is shown, including the right ear spiral.

[0410] Figure 3S A right-handed spiral is shown.

[0411] Figure 3T A view of the patient interface is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the patient interface.

[0412] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0413] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0414] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, said cross-section is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3209, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3229). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0415] Figure 3X It shows Figure 3UThe position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, this intermediate contact plane generally corresponds to the 'plane of the face'. Figure 3X In the middle, the air chamber 3200 is the air chamber of the nasal patient interface, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3229 is located on the upper lip.

[0416] 4.4RPT device

[0417] Figure 4 An RPT device of one form according to the present technology is shown.

[0418] Figure 5 This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as 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 located downstream of the blower and upstream of the patient interface.

[0419] 4.5 Respiratory waveform

[0420] Figure 6 The diagram shows a typical breathing waveform of a person during sleep.

[0421] 4.6 Patient Interface Embodiments of this Technology

[0422] Figure 7-1 A front view of a patient interface system on the head of a model patient in nostril-only mode, according to an embodiment of the present technology, is depicted.

[0423] Figure 7-2 A front view of a patient interface system on the head of a model patient in a nostril and mouth pattern, according to an embodiment of the present technology, is depicted.

[0424] Figure 7-3 A front view of a patient interface system on the head of a model patient in a nostril and mouth mode, according to an embodiment of the present technology, is depicted.

[0425] Figure 7-4 A front view of a patient interface system on the head of a model patient in mouth-only mode, according to an embodiment of the present technology, is depicted.

[0426] Figure 7-5 A front view exploded view of a patient interface system according to an embodiment of the present technology is depicted, showing how the nose portion can be connected to the mouth portion.

[0427] Figure 8 A bendless connector according to an embodiment of the present technology is depicted. Figures 7-1 to 7-5 The front view of the patient interface system.

[0428] Figure 9 The embodiments according to this technology are described. Figures 7-1 to 7-5 The rear view of the patient interface system.

[0429] Figure 10 The embodiments according to this technology are described. Figures 7-1 to 7-5 The rear isometric view of the patient interface system.

[0430] Figure 11-1 A front isometric view of a patient interface system on the head of a model patient, according to another embodiment of the present technology, is depicted.

[0431] Figure 11-2 Depicting Figure 11-1 The patient interface system on the head of the model patient is in a front isometric view in nostril-only mode.

[0432] Figure 12 A side view of the patient interface system of Figure 11 in use according to an embodiment of the present technology is depicted.

[0433] Figure 13 The embodiments according to this technology are described. Figure 11-1 Rear isometric view of the headband used with the patient interface system.

[0434] Figure 14 A bendless connector according to an embodiment of the present technology is depicted. Figure 11-1 The front isometric view of the patient interface system.

[0435] Figure 15 A bendless connector according to an embodiment of the present technology is depicted. Figure 11-1 The front view of the patient interface system.

[0436] Figure 16 A noseless portion is depicted according to an embodiment of the present technology. Figure 11-1 A top view of the patient interface system.

[0437] Figure 17 The embodiments according to this technology are described. Figure 11-1 The rear isometric view of the patient interface system.

[0438] Figure 18 The embodiments according to this technology are described. Figure 11-1 The rear view of the patient interface system.

[0439] Figure 19The embodiments according to this technology are described. Figure 11-1 A front view of a portion of a patient interface system, which does not have a nose section, does not have a bend connector, and includes a headband.

[0440] Figure 20 A front view of a patient interface system on the head of a model patient according to another embodiment of the present technology is depicted.

[0441] Figure 21 The image depicts an embodiment of the present technology on the head of a model patient. Figure 20 A side view of the patient interface system.

[0442] Figure 22 A rear view of a patient interface system according to another embodiment of the present technology is depicted, wherein the decoupling and connection portions have been removed.

[0443] Figure 23 The embodiments according to this technology are described. Figure 22 The front isometric view of the patient interface system.

[0444] Figure 24 The embodiments according to this technology are described. Figure 22 The front isometric view of the patient interface system.

[0445] Figure 25 A rear isometric view of the nasal portion, which can be used with a patient interface system according to an embodiment of the present technology, is depicted.

[0446] Figure 26 The embodiments according to this technology are described. Figure 25 The front isometric view of the nose portion.

[0447] Figure 27 A front isometric view of a patient interface system on the head of a model patient in a nostril-only mode, according to another embodiment of the present technology, is depicted.

[0448] Figure 28 The image depicts an embodiment of the present technology on the head of a model patient. Figure 27 The patient interface system is positioned in a front isometric view with the nostrils and mouth configured.

[0449] Figure 29 A front isometric view of a patient interface system on the head of a model patient, according to another embodiment of the present technology, is depicted.

[0450] Figure 30 A side view of a patient interface system on the head of a model patient according to another embodiment of the present technology is depicted.

[0451] Figure 31 A side view of a patient interface system on the head of a model patient according to another embodiment of the present technology is depicted.

[0452] Figure 32 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0453] Figure 33 A schematic cross-sectional view of an integrated patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0454] Figure 34 A schematic cross-sectional view of an integrated patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0455] Figure 35-1 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0456] Figure 35-2 The embodiments according to this technology are described. Figure 35-1 A schematic top view of the mouth seal portion of the patient interface system.

[0457] Figure 35-3 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0458] Figure 36-1 A schematic cross-sectional view of a modular patient interface on the head of a model patient according to an embodiment of the present technology is depicted.

[0459] Figure 36-2 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0460] Figure 37 A cross-sectional view of an integrated patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0461] Figures 38(a)-(k) are schematic diagrams of the flow of pressurized gas through various configurations of the patient interface system according to embodiments of the present technology.

[0462] Figure 39 A schematic diagram of a nostril and mouth kit according to an embodiment of the present technology is depicted.

[0463] Figure 40 A schematic diagram of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0464] Figure 41 A front view of a nostril sealing portion according to an embodiment of the present technology is depicted.

[0465] Figure 42 The embodiments according to this technology are described. Figure 41 A front perspective view of the nostril sealing section.

[0466] Figure 43 depicts a nasal-only CPAP device on a model patient's head using existing technology.

[0467] Figure 44 A modification kit for converting the nostril-only CPAP device of FIG43 into a nostril and mouth CPAP device according to an embodiment of the present technology is depicted.

[0468] Figure 45 A modification kit for converting the nostril-only CPAP device of FIG43 into a nostril and mouth CPAP device according to an embodiment of the present technology is depicted.

[0469] Figure 46 depicts a prior art nostril-only CPAP device.

[0470] Figure 47 A modification kit is depicted according to an embodiment of the present technology for converting the nostril-only CPAP device of FIG46 into a nostril and mouth CPAP device illustrated on the head of a model patient.

[0471] Figure 48 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0472] Figure 49 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0473] Figure 50 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0474] Figure 50A This is a cross-sectional view of the nose portion according to an embodiment of this technology.

[0475] Figure 50B This is a cross-sectional view of the nose portion according to an embodiment of this technology.

[0476] Figure 51 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0477] Figure 52A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0478] Figure 53 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0479] Figure 54 A schematic partial cross-sectional view of a modular patient interface system according to an embodiment of the present technology is depicted.

[0480] Figure 55 This is an exploded diagram of a modular patient interface system on the head of a model patient according to an implementation scheme of this technology.

[0481] Figure 56 A schematic cross-sectional view of an integrated (or modular) patient interface system on a patient's head according to an embodiment of the present technology is depicted.

[0482] Figure 57 Depicting on the head of a model patient Figure 56 A perspective view of an integrated (or modular) patient interface system.

[0483] Figure 58 Depicting Figure 57 A side view of an integrated (or modular) patient interface system.

[0484] Figure 59 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0485] Figure 60 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0486] Figure 61 A rear view of the nasal portion of a patient interface system according to an embodiment of the present technology is depicted.

[0487] Figure 61A Is it through Figure 61 The cross-sectional view of line 61A-61A.

[0488] Figure 62 A rear view of the nasal portion of a patient interface system according to an embodiment of the present technology is depicted.

[0489] Figure 62A Is it through Figure 62 The cross-sectional view of line 62A-62A.

[0490] Figure 63A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0491] Figure 64 A side view depicts an integrated or modular patient interface system on the head of a model patient according to an embodiment of the present technology.

[0492] Figure 65 A perspective view depicting an integrated or modular patient interface system on the head of a model patient according to an embodiment of the present technology is shown.

[0493] Figure 66 A rear view of a modular patient interface system according to an embodiment of the present technology is depicted.

[0494] Figure 67 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0495] Figure 68 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0496] Figure 69 An exploded diagram of a modular patient interface system according to an embodiment of the present technology is depicted.

[0497] Figure 70 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0498] Figure 71 A schematic cross-sectional view of a modular patient interface system on the head of a model patient according to an embodiment of the present technology is depicted.

[0499] Figure 72 An exploded diagram of a modular patient interface system according to an embodiment of the present technology is depicted.

[0500] Figure 73 An exploded diagram of a modular patient interface system according to an embodiment of the present technology is depicted.

[0501] Figure 74 A perspective view of a modular patient interface system according to an embodiment of the present technology is depicted.

[0502] Figure 75 Depicting Figure 74 Front view of the modular patient interface system.

[0503] Figure 76 Depicting Figure 74 A top view of the modular patient interface system.

[0504] Figure 77 Depicting Figure 74 A top view of the modular patient interface system.

[0505] Figure 78 Depicting Figure 74 A side view of the modular patient interface system.

[0506] Figure 79 Depicting along Figure 75 The cross-sectional view of line 75-75.

[0507] Figure 80 Depicting Figure 74 A perspective view of the nasal portion of the patient interface system.

[0508] Figure 81 Depicting Figure 74 A perspective view of the mouth portion of the patient interface system.

[0509] Figure 82 Depicting Figure 74 A perspective view of the padding portion of the patient interface system.

[0510] Figure 83 Depicting Figure 74 Front view of the padding portion of the patient interface system.

[0511] Figure 84 Depicting Figure 74 A top view of the padding portion of the patient interface system.

[0512] Figure 85 Depicting Figure 74 A bottom view of the padding portion of the patient interface system.

[0513] Figure 86 Depicting along Figure 83 A cross-sectional view of line 80-80.

[0514] Figure 87 Depicting along Figure 83 The cross-sectional view of line 81-81.

[0515] Figure 88 Depicting along Figure 83 The cross-sectional view of line 82-82.

[0516] Figure 89 Depicting along Figure 83 The cross-sectional view of line 83-83.

[0517] Figure 90 Depicting along Figure 83 The cross-sectional view of line 84-84.

[0518] Figure 91 Depicting along Figure 77 The cross-sectional view of line 85-85.

[0519] Figure 92 Depicting Figure 74 Rear view of the padding portion of the patient interface system.

[0520] Figure 93 Depicting Figure 74 Right side view of the padding portion of the patient interface system.

[0521] Figure 94 Depicting Figure 74 Left view of the padding portion of the patient interface system.

[0522] Figure 95 Depicting Figure 74 A perspective view of the padding portion of the patient interface system.

[0523] Figure 96 , 97A 97B shows a headband system that can be switched between two-point and four-point support according to current technology.

[0524] Figures 98A to 98E A modified mouth liner according to the prior art is shown.

[0525] Figures 99A to 99I A modified mouth liner according to the prior art is shown.

[0526] Figure 100-108 An example of a liner-fascia connection according to this technology is shown.

[0527] Figure 109 An example of a lip seal according to this technology is shown.

[0528] Figure 110 This is an exploded assembly diagram of a patient interface system based on an implementation scheme of this technology.

[0529] Figure 111 It is in the assembly state. Figure 110 The rear view of the patient interface system.

[0530] Figure 112 It is in the assembly state. Figure 110 A top view of the patient interface system.

[0531] Figure 113 It is in the assembly state. Figure 110 A bottom view of the patient interface system.

[0532] Figure 114 It is in the assembly state. Figure 110The left-hand view of the patient interface system.

[0533] Figure 115 It is along Figure 111 The cross-sectional view of line 109-109 in the diagram.

[0534] Figure 116 It is along Figure 111 The cross-sectional view of line 110-110 in the diagram.

[0535] Figure 117 yes Figure 116 A detailed view of a portion of the content.

[0536] Figure 118 yes Figure 110 Isometric view of the mouth pad of the patient interface system.

[0537] Figure 119 yes Figure 110 A front isometric view of the mouth pad of the patient interface system.

[0538] Figure 120 yes Figure 110 Front view of the mouth liner of the patient interface system.

[0539] Figure 121 yes Figure 110 A top view of the mouth liner of the patient interface system.

[0540] Figure 122 yes Figure 110 A bottom view of the mouth pad of the patient interface.

[0541] Figure 123 yes Figure 110 The right-side view of the mouth liner of the patient interface system.

[0542] Figure 124 yes Figure 110 Front view of the mouth liner of the patient interface system.

[0543] Figure 125 It is the mouth pad along Figure 124 The cross-sectional view of line 119-119 in the diagram.

[0544] Figure 126 It is the mouth pad along Figure 124 The cross-sectional view of line 120-120 in the middle.

[0545] Figure 127 It is the mouth pad along Figure 124 The cross-sectional view of line 121-121 in the diagram.

[0546] Figure 128 It is the mouth pad along Figure 124 The cross-sectional view of line 122-122 in the diagram.

[0547] Figure 129 It is the mouth pad along Figure 124 The cross-sectional view of line 123-123 in the diagram.

[0548] Figure 130 It is the mouth pad along Figure 124 The cross-sectional view of line 124-120 in the diagram.

[0549] Figure 131 yes Figure 110 Rear isometric view of the liner clip of the patient interface system.

[0550] Figure 132 yes Figure 131 Front isometric view of the pad clip.

[0551] Figure 133 yes Figure 131 A top view of the padding clip.

[0552] Figure 134 yes Figure 131 A bottom view of the padding clip.

[0553] Figure 135 yes Figure 131 Left side view of the padding clip.

[0554] Figure 136 yes Figure 131 Rear view of the pad clip.

[0555] Figure 137 It is along Figure 136 The cross-sectional view of line 131-131 in the diagram.

[0556] Figure 138 yes Figure 110 An isometric view of the fascia of the patient interface system.

[0557] Figure 139 yes Figure 138 Anterior view of the fascia.

[0558] Figure 140 yes Figure 138 The posterior view of the fascia.

[0559] Figure 141 yes Figure 138 A top view of the fascia.

[0560] Figure 142 yes Figure 138 A top view of the fascia.

[0561] Figure 143 yes Figure 138 Right-side view of the fascia.

[0562] Figure 144 It is along Figure 139 The cross-sectional view of line 138-138 in the diagram.

[0563] Figure 145 This is a front isometric view of a liner clip according to an embodiment of the present technology.

[0564] Figure 146 yes Figure 145 Rear isometric view of the pad clip.

[0565] Figure 147 yes Figure 145 Front view of the pad clip.

[0566] Figure 148 yes Figure 145 A top view of the padding clip.

[0567] Figure 149 yes Figure 145 A bottom view of the padding clip.

[0568] Figure 150 yes Figure 145 Left side view of the padding clip.

[0569] Figure 151 It is along Figure 147 The cross-sectional view of line 145-145 in the middle.

[0570] Figure 152 A perspective view of a modular patient interface system according to an embodiment of the present technology is depicted.

[0571] Figure 153 yes Figure 152 A decomposed side view of the modular patient interface system.

[0572] Figure 154 It is in nostril-only mode. Figure 152 A perspective view of a modular patient interface system.

[0573] Figure 155A yes Figure 152 A perspective view of the mouth section of a modular patient interface system;

[0574] Figure 155B yes Figure 155A Left side view of the mouth portion.

[0575] Figure 155C yes Figure 155A Rear view of the mouth section.

[0576] Figure 155D It is connected to the nose part. Figure 155A Rear perspective view of the mouth section.

[0577] Figure 155E It is connected to the nose part. Figure 155A A front perspective view of the mouth section.

[0578] Figure 155F It is a top view including the nasal portion of the pillow pad.

[0579] Figure 155G It is a top view including the nose portion of the nose fork.

[0580] Figure 156A It shows the use of Figure 152 An implementation scheme for the connection and arrangement of components of a modular patient interface system.

[0581] Figure 156B It is used for Figure 152 A schematic diagram of an implementation scheme for the connection arrangement of the vents or covers of a modular patient interface system.

[0582] Figure 156C It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of the mouth part of the modular patient interface system.

[0583] Figure 157 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0584] Figure 158A It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0585] Figure 158B It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system; Figure 159 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0586] Figure 160 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0587] Figure 161 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0588] Figure 162 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0589] Figure 163 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0590] Figure 164 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0591] Figure 165 It is used for Figure 152 A schematic diagram of the implementation scheme for the connection arrangement of components of a modular patient interface system.

[0592] Figure 166 It is combined with the intermediate chamber Figure 152 A schematic diagram of a variant implementation scheme of the modular patient interface system.

[0593] Figure 167 yes Figure 152 A schematic diagram of a variant implementation scheme for the connector of a modular patient interface system.

[0594] Figure 168A This is a cross-sectional left-side view of a nasal patient interface with AAV according to an embodiment of the present technology.

[0595] Figure 168B It is with Figure 168A Top perspective view of the AAV nasal patient interface.

[0596] Figure 169 It is used for Figure 168A Rear view of the AAV connector module for the patient interface.

[0597] Figure 170 yes Figure 168A A cross-sectional side view of the AAV patient interface.

[0598] Figure 171A yes Figure 152 Front perspective view of the connector for the patient interface.

[0599] Figure 171B yes Figure 171A Top perspective view of the connector for the patient interface.

[0600] Figure 172A-C This is a close-up view of the cross-section of the nose headband and mouth headband when connected by various embodiments of a connector comprising one or more portions of Velcro, wherein the mouth headband is: V-shaped and having two Velcro portions, U-shaped and having two Velcro portions, or a one-piece design with two Velcro portions that can be separately connected to the nose headband.

[0601] Figure 173A-CThis is a close-up view of the cross-section of the nose section headband and the mouth section headband, which are configured to be connected via various embodiments of a connector comprising multiple snap-fit ​​connectors, the nose section headband comprising two convex snap-fit ​​connectors or alternating convex / concave snap-fit ​​connectors.

[0602] Figure 174 This is a close-up view of the cross-section of the nose section headband and the mouth section headband, the headbands being configured to be connected via an embodiment of a connector comprising multiple tabs and latches.

[0603] Figure 175A and 175B This is a close-up view of the cross-section of the nose and mouth portion headbands, which are configured to be connected via various embodiments of connectors, wherein the nose and mouth portion headbands also include embodiments of alignment guides comprising one or more markings, shapes, or patterns.

[0604] Figure 176A , 176B Figures 176C and 176C are close-up cross-sectional views of the nose and mouth portion headbands, which are configured to be connected via various embodiments of connectors, wherein the nose and mouth portion headbands also include embodiments of alignment guides, wherein the nose portion correspondingly includes a single recessed groove, multiple recesses, or recessed rings to engage correspondingly shaped protrusions of the mouth portion headband.

[0605] Figure 177 This is a close-up view of the cross-section of the nose section headband and the mouth section headband, the headbands being configured to be connected via an embodiment of a connector having a hook tab and a corresponding latch, wherein the nose section headband also includes a recessed portion surrounding the hook tab and the corresponding latch of the connector.

[0606] Figure 178A-C This is a close-up view of the cross-section of the nose headband and the mouth headband, the headbands being configured to engage via a connector in one embodiment, the connector being configured on a valve flap of the mouth headband, the valve flap passing through a slit in the nose headband, wherein the valve flap is narrower than the slit, the valve flap being sized to correspond to the slit, or multiple valve flaps passing through a single slit respectively.

[0607] Figure 179 An example of a connector for attaching a headband to a patient interface is shown according to the present technology.

[0608] Figure 180 An example of a chassis including a chassis connector according to the present technology is shown.

[0609] Figure 181 Examples of connections based on this technology are shown. Figure 180 The base frame shown in the image Figure 179 The connector.

[0610] Figure 182 This is a front view of an air chamber 3200 according to one form of the present technology.

[0611] Figure 183 yes Figure 182 Rear view of the 3200 air chamber.

[0612] Figure 184 yes Figure 182 Side view of the 3200 air chamber.

[0613] Figure 185 yes Figure 182 A top view of the 3200 air chamber.

[0614] Figure 186 yes Figure 182 A bottom view of the 3200 air chamber.

[0615] Figure 187 yes Figure 182 A perspective view of the 3200 air chamber.

[0616] Figure 188 yes Figure 182 Another perspective view of the 3200 air chamber.

[0617] Figure 189 yes Figure 182 Another perspective view of the 3200 air chamber. Detailed Implementation

[0618] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this invention is for the purpose of describing the specific instances described herein only and is not intended to be limiting.

[0619] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may constitute another instance.

[0620] Anatomical directional terms are used to describe aspects and instances of this technology, such as “anterior,” “posterior,” “superior,” “inferior,” “lateral,” “middle,” etc., which are applied in the context of this technology when used by a patient. For example, the anterior side of the patient interface refers to the side of the patient interface relative to the patient in front of the patient when the patient wears the patient interface in the intended manner.

[0621] A surface or part is described as facing a direction, such as "facing upwards," "facing forwards," etc. Unless the context clearly requires it, a surface or part should be understood as at least partially facing a particular direction. If a part is generally facing upwards, it may be "facing upwards" even if the part is also partially facing another direction.

[0622] 5.1 Treatment

[0623] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0624] In some instances of this technique, positive pressure air is supplied to the patient’s nasal passages through one or both nostrils.

[0625] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0626] 5.2 Treatment System

[0627] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0628] 5.3 Patient Interface

[0629] This patient interface system delivers pressurized breathable gas to a patient and includes a nasal portion, a mouth portion, positioning and stabilizing structures, and an air delivery system. Sealing portions may be included in the nasal and / or mouth portions to form a seal or substantially a seal with the patient's nose and / or mouth. One or more air vents may also be included to expel gas exhaled by the patient through the nasal and / or mouth portions. However, the patient interface may be non-ventilated and used in hospital / ventilated settings. The patient interface system may also be equipped with an anti-asphyxiation valve (AAV).

[0630] The sealing portion is arranged to form a seal or substantially a seal with the patient's nose and / or mouth to deliver pressurized gas to the patient. Preferably, the sealing portion has a nasal sealing portion and a mouth sealing portion. These nasal and mouth sealing portions may be integrally formed, or they may be in the form of separate elements. These nasal and mouth sealing portions may be connected or otherwise positioned to seal independently or discretely with the patient's nose and mouth, respectively.

[0631] A positioning and stabilizing structure may be connected to a sealing portion and adapted to engage the sealing portion with a patient. The positioning and stabilizing structure may have upper and lower portions configured and arranged to avoid the patient's eyes and ears during use. The upper and lower portions may be integral, in separate, unconnected parts, or in separate, connected parts. The positioning and stabilizing structure may have a rear portion adapted to engage with the back of the patient's head during use. The rear portion may interconnect these upper and lower portions.

[0632] The air delivery system can connect the sealed portion to the airflow generator. The air delivery system may include elbows and / or pipes.

[0633] The patient interface system provides patients with options for treatment (nose only, mouth only, or both nose and mouth treatment) without becoming too expensive and also improves the intuitive usability of the patient interface system. This allows patients to use the patient interface system without much or any instructions.

[0634] The patient interface system can be a modular patient interface system having a nose portion and a mouth portion, wherein the nose portion is adapted to provide respiratory therapy to the patient's nostrils in the absence of the mouth portion, or the nose portion can be adapted to be used in conjunction with the mouth portion to provide respiratory therapy to the patient's nostrils and mouth, or to provide respiratory therapy to the patient's nostrils and use the mouth portion as a mouth seal.

[0635] The patient interface system may be a modular patient interface system having a nose portion and a mouth portion, wherein the mouth portion is adapted to provide breathing therapy to the patient's mouth in the absence of the nose portion, or the mouth portion is adapted to be used in conjunction with the nose portion to provide breathing therapy to the patient's nostrils and mouth, or to provide breathing therapy to the patient's mouth and use the nose portion as a nostril seal.

[0636] The patient interface system may be an integrated patient interface system having a nose portion and a mouth portion, wherein the nose portion and mouth portion are integrated and formed as a single piece. Pressurized gas may be supplied to the nostril and mouth portions for delivery to the nose and mouth, or pressurized gas may be delivered only to the nostril or mouth portion, while the other portions are isolated from the pressurized gas.

[0637] For example, such as Figures 7-1 to 10 As shown, the patient interface system 1 may include a nose portion 20, a mouth portion 40, and a positioning and stabilizing structure, which may include a headband 60. An air delivery system may deliver air to the patient interface system 1, for example, through a flexible tube 5. Figures 7-1 to 10The patient interface system is one in which the nose portion 20 and the mouth portion 40 are adapted to be used independently of each other (in a nostril-only mode or a mouth-only mode), or the nose portion 20 and the mouth portion 40 can be used together (in a nostril and mouth mode). When used in the nostril and mouth mode, one of the nose portion 20 and the mouth portion 40 can be used to deliver pressurized gas, while the other of the nose portion 20 and the mouth portion 40 can be used as a nostril or mouth seal. In another form, when used in the nostril and mouth mode, both the nose portion 20 and the mouth portion 40 can be used to deliver pressurized gas to the patient's airway. Alternatively, the patient interface system 1 can be configured as an integrated patient interface system in which the nose portion 20 and the mouth portion 40 are formed as a single element.

[0638] Figures 11-1 to 19 Another patient interface system 1 is shown, which can be in the form of a modular patient interface, wherein the nose portion 20 and the mouth portion 40 can be adapted to be used independently of each other, or the nose portion 20 and the mouth portion 40 can be adapted to work together to deliver breathable pressurized gas to the patient's nostrils and mouth. Figure 11-1 and 12 In -19, the flexible tube 5 is connected to the rotating ring 4 via the elbow 2 to guide pressurized breathable gas into the chamber of the mouth portion 40 and the nose portion 20. Figure 11-1 and Figure 12-18 A modular patient interface system in nasal and mouth modes is shown, in which both nasal portion 20 and mouth portion 40 are used. Figure 5 -2 illustrates a nostril-only patient interface system 1, in which a nasal portion 20 is used without a mouth portion 40. In the nostril-only mode, a bend 2, a flexible tube 5, and a rotating ring 4 are connected to an opening in the nasal portion 20.

[0639] Figure 20 and 21 An integrated patient interface system 101 is shown, comprising a nose portion 120, a mouth portion 140, and a positioning and stabilization structure, which may include a headband 160. In the integrated patient interface system, the nose portion 120 and the mouth portion 140 are inseparable and are typically formed together as a single unit. An air delivery system may deliver air to the patient interface system 101, such as via a flexible tube 105 connected to the mouth portion 140 via an elbow 102.

[0640] Figure 22-24 Another patient interface system 201 is shown, which may be an integrated patient interface system, and includes a nose portion 220 and a mouth portion 240. An air delivery system may deliver air to the patient interface system 201.

[0641] Figure 27 and 29A modular patient interface system 301 according to an embodiment of the present technology is illustrated. The patient interface system 301 includes a nose portion 320, a mouth portion 340, and a headband 360. An air delivery system may deliver air to the patient interface system 301, for example, via a flexible tube 305 connected to the mouth portion 340 or the nose portion 320 via a connector 306 and optionally a swivel connector 308. The connector 306 may be in the form of an elbow or other type of connector. The connector 306 may be a flexible portion capable of absorbing external forces that could otherwise cause the nose portion 320 and / or the mouth portion 340 to lose its seal from the patient, such as forces that might be caused by tube drag. Figure 27 A patient interface system 301 in nasal mode is shown. Figure 28 A patient interface system 301 in nostril and mouth mode is shown.

[0642] Figure 29 A modular patient interface system 370 according to an embodiment of the present technology is shown. The patient interface 370 includes a nose portion 372, a mouth portion 380, and a headband 360. An air delivery system including an air delivery tube or conduit 379 can deliver air to the patient interface system 370. In addition, the tube 379 can also be used as a headband in addition to serving as an air delivery tube or conduit.

[0643] Figure 30 A modular patient interface 401 according to an embodiment of the present technology is shown. The patient interface 401 includes a nose portion 420, a mouth portion 440, and a headband 460. An air delivery system may deliver air to the patient interface system 401, for example, via a flexible tube 405, which is connected to the mouth portion 440 via connectors such as an elbow 402 and an optional rotary connector 444.

[0644] Figure 31 An integrated patient interface 501 according to an embodiment of the present technology is shown. The patient interface 501 includes a nose portion 520, a mouth portion 540, and a headband 560. An air delivery system may deliver air to the patient interface system 501, for example, via a flexible tube 505, which is connected to the mouth portion 540 via connectors such as an elbow 502 and an optional rotary connector 544.

[0645] Figure 40 A patient interface 701 is shown, which may be in the form of a modular patient interface, wherein the nose portion 720 and the mouth portion 740 may be adapted to not be used by each other, or the nose portion 720 and the mouth portion 740 may work together to deliver breathable pressurized gas to the patient's nostrils and mouth. Figure 40A patient interface system 701 using a nostril and mouth mode is shown, wherein a flexible tube 705 is connected via a double elbow 712 to rotating rings 710 and 744 to direct pressurized breathable gas into the chamber of the mouth portion 740 and the nasal portion 720.

[0646] In the nostril-only mode, only the nasal portion 720 is used, and the mouth portion 740 is not used. In this mode, the double elbow 712 and the mouth portion 740 are removed. The patient uses only the nasal portion 720 and connects the tube 705 to the rotating ring or other connector 710. An elbow, such as elbow 2, can be used to connect the tube 705 to the rotating ring or other connector 710.

[0647] In the mouth-only mode, only the mouth portion 740 is used, without the nose portion 720. In this mode, the double elbow 712 and the nose portion 720 are removed. The patient uses only the mouth portion 740 and the tube 705 is connected to the swivel ring or other connector 744. An elbow, such as elbow 2, can be used to connect the tube 705 to the swivel ring or other connector 744.

[0648] 5.3.1 Nasal section

[0649] The nasal portion is designed to form a seal with the patient's nasal airway during use. The nasal portion can be a seal positioned on the outside of the patient's nose, such as a support-type patient interface or a typical nasal patient interface. Alternatively, it can be a nostril-type seal around the nose, like a pillow-type patient interface, or it can be a mid-nasal seal, like a nasal plug. A nostril seal may be a suitable option for patients with upper airway obstruction. Breathing through the nose can also have other benefits, such as natural filtration of inhaled air.

[0650] like Figures 7-1 to 10 As shown, the modular patient interface system 1 may include a nasal portion 20. The nasal portion 20 may include a nostril sealing portion 22, a decoupling portion 25, a headband connector 21, a rotating ring 4, and a plug 3. The headband connector 21 may include a headband tab 31 adapted to be attached to a headband.

[0651] The decoupling portion 25 can be used to decouple the force applied to the nose portion 20 from the nostril sealing portion 22, for example, the tube drag force applied to the rotating ring 4 by the movement of the flexible tube 5. The rotating ring 4 is fitted into an opening in the decoupling portion 25 on the front of the nose portion 20. The decoupling portion 25 may include a thin-walled portion, for example less than 1 mm, so that the portion can be flexible.

[0652] The plug 3 is adapted to fit into a rotating ring. The plug 3 may include a plurality of optional vents 6 that allow air exhaled from the patient's nose to escape from the nasal portion 20. Preferably, the vents 6 are arranged in a diffuser array to prevent air from being ejected from the vents. In some embodiments, the plug 3 may be removed and replaced with a connection to the tube 5.

[0653] Figure 7-1 The nasal portion 20 of the patient interface system 1 for use in nostril-only mode is shown. Using the nasal portion 20, without using the mouth portion 40, a bend 2 and a flexible tube 5 are connected to a rotating ring 4 on the nasal portion 20.

[0654] exist Figures 7-1 to 10 The nose portion 20 shown in the image may be a Swift product commercially available from ResMed Ltd. TM Modified versions of FX (e.g., as described in 2009 / 052560A1 and WO 2010 / 139014A1, both of which are incorporated herein by reference in their entirety) may be used, but other nasal parts may be used, for example. Nasal part 20 may be a Swift product commercially available from ResMed Ltd. TM FX has been modified to include connector 30, such as Figure 7-1 , 7-5 As shown in Figure 9, connector 30 is adapted to connect to chamber 49 of nose portion 20 at opening 46 in mouth portion 40, such that air is pneumatically allowed to flow between nose portion 20 and mouth portion 40. When in... Figure 7-1 When used only in the nostril configuration shown, connector 30 is removed from opening 46, as... Figure 7-5 As shown in the exploded view, connector 30 engages with plug 35. Plug 35 is shaped to fit into opening 46 or connector 30 as needed. Plug 3 is removed from nose portion 20, and elbow 2 and flexible tube 5 can be connected to nose portion 20 via rotating ring 4 to deliver pressurized breathable gas to nose portion 20.

[0655] Figures 11-1 to 19 A patient interface system 1 including a nasal portion 20 is shown. The nasal portion 20 may include a nostril sealing portion 22, a decoupling portion 25, a headband connector 21, and a rotating ring 4. The headband connector 21 may include a headband tab 31 adapted to be connected to a headband 60.

[0656] For example, the nose portion 20 shown in Figures 11 to 19 can be a Swift product commercially available from ResMed Ltd. TM FX, but other nasal parts may be used, for example. Further details of this nasal part 20 are disclosed in WO 2009 / 05256A1, the disclosure of which is incorporated herein by reference in its entirety.

[0657] Figure 25 and26 Another nose portion 220 is shown, which can be used with any of the embodiments disclosed herein. The nose portion 220 may include a nostril sealing portion 222, a support membrane 252, a support portion 253, and a headband connector 230 having headband tabs 231 for attachment to a headband. The support membrane 252 may be adapted to attach to a rotating ring or to other connectors for attachment to a pressurized breathable gas source. Further details of the nose portion 220 are disclosed in WO 2010 / 139014 A1, the entire contents of which are incorporated herein by reference.

[0658] Figure 20 and 21 An integrated patient interface system 1 is shown, which includes a nasal portion 120. The nasal portion 120 may include a nostril sealing portion 122, a decoupling portion 125, and a headband connector 121 adapted for connection to a headband 160. The nasal portion, such as the commercially available Swift, can be used. TM For the FX nose part, the commercially available Swift TM A modified version of the FX nose section, or Figure 25 and 26 The nasal part, and with Figure 20 and 21 The implementation plan is integrated.

[0659] Figure 22-24 A patient interface system 201 is shown that may include a nasal portion 220. The nasal portion 220 may include a nostril sealing portion 222 and an opening 226 for receiving pressurized breathable gas. The patient interface system 201 is shown having features such as Figure 25 and 26 The nose portion 220 shown is acceptable, although other nose portions, such as the commercially available Swift, can be used. TM FX nose part or commercially available Swift TM A modified version of the FX nose section.

[0660] Figure 27 and 28 A modular patient interface system 301 is shown, which includes a nose portion 320. The nose portion 320 may include a nostril sealing portion 322, a decoupling portion 325, and a headband connector 321 for connection to a headband 360. The nose portion 320 may be adapted to connect to a connector 306 via an opening 326 adapted to receive a connector 306.

[0661] Figure 29 The illustration shows an integrated patient interface system including a nose portion 372 connected to a mouth portion 380 and a headband 360. The nose portion 372 includes a nostril sealing portion 374 adapted to form a seal with the patient's nostrils.

[0662] Figure 30An integrated patient interface system 401 is illustrated, including a nose portion 420 connected to a mouth portion 440 and a headband 460. The nose portion 420 includes a nostril-sealing portion 422 adapted to form a seal with a patient's nostrils, a decoupling portion 425, and a headband connector 421 adapted to connect to the headband 460. The nose portion 420 is illustrated as... Figure 25 and 26 The membrane type shown can be used, although other nasal parts, such as the commercially available Swift, may also be used. TM FX nose part or commercially available Swift TM A modified version of the FX nose section.

[0663] Figure 31 An integrated patient interface system 501 is illustrated, including a nose portion 520 connected to a mouth portion 540 and a headband 560. The nose portion 520 includes a nostril-sealing portion 522 adapted to form a seal with the patient's nostrils, a decoupling portion 525, and a headband connector 521 adapted to connect to the headband 560. The nose portion 520 is illustrated as... Figure 25 and 26 The membrane type shown can be used, although other nasal parts, such as the commercially available Swift, may also be used. TM FX nose part or commercially available Swift TM A modified version of the FX nose section.

[0664] Figure 40 A modular patient interface system 701 is shown, comprising a nose portion 720 connected to a mouth portion 740 and a headband 760. The nose portion 720 includes a nostril-sealing portion 722 adapted to form a seal with the patient's nostrils, a decoupling portion 725, and a headband connector 721 adapted to connect to the headband 760. The nose portion 720 may be a commercially available Swift... TM The FX nose part, although other nose parts, such as the commercially available Swift, can also be used. TM FX nose part or Figure 25 and 26 The nose portion shown.

[0665] Figure 61 , 61A Figures 62 and 62A show nose portions 1380 and 1390, each nose portion including foam portions 1382 and 1392. Foam portions 1382 and 1392 have holes 1384 and 1394 that allow air to pass through. Figure 61A As shown, foam portion 1382 is compliant and will reveal the nose fork once compressed. Figure 62A As shown, the nose fork retracts to hold the foam portion 1392 in place and provide a relatively flat surface for contact with the nose.

[0666] 5.3.2 Mouth section

[0667] The mouthpiece can be adapted to surround the patient's mouth and form a seal with the patient's airway at the mouthpiece. The seal of the mouthpiece can be a valve-type seal like a membrane seal, or a compression seal using materials such as foam, gel, or fabric.

[0668] like Figures 7-2 to 10 The mouth portion 40 shown may include a mouth sealing portion 42, a decoupling portion 45 that decouples the force applied to the mouth portion 40 from the mouth sealing portion 42, a lower headband connector 41, and a rotating connector 44. The mouth portion 40 forms a chamber 49 into which air can be delivered and guided into the patient's mouth.

[0669] A rotary connector 44 may be disposed in the front opening 52 of the mouthpiece 40. The rotary connector 44 may be a rotating ring adapted to connect to a tube connector (such as an elbow 2) for connecting to a flexible tube 5, which delivers breathable gas to the mouthpiece 40. The rotary connector 44 may be removed from the front opening of the mouthpiece 40. Alternatively, the tube 5 may be directly connected to the mouthpiece 40.

[0670] Figures 7-1 to 10 The mouth portion 40 shown is also adapted to connect to the nose portion 20. Specifically, as... Figure 7-4 and 7-5 As shown, the mouth portion 40 may include an aperture or opening 46 adapted to receive and seal the connector 30 of the nose portion 20 to pneumatically connect the nose portion 20 to the chamber 49 of the mouth portion 40. The patient interface system 1 may include a plug 35 adapted to fit into and be inserted into the connector 30 or aperture 46. Furthermore, the nose portion 20 may function in a nostril-only mode without the mouth portion 40.

[0671] The mouth portion 40 can be used as a docking station, wherein the mouth portion 40 is adapted to provide docking relative to the nose portion 20 (the mouth portion is adapted to removably receive the nose portion). Figure 7-5 As shown, the mouth portion may include a nose portion docking station 56 formed on the mouth portion 40, wherein the nose portion docking station 56 is adapted to receive the nose portion 20. The received nose portion 20 can be used as a nostril-only device for delivering pressurized breathable gas into the patient's nostrils.

[0672] The nasal docking station 56 can be adapted to receive the nasal portion 20 by having a shape selectively adapted to fit the shape of the nasal portion. For example, as Figure 7-5As shown, the nose portion docking station 56 may have a curved upper surface to match the curved lower portion of the mouth portion 40. The nose portion docking station 56 may be adapted to receive the nose portion 20 by having an opening or aperture (such as aperture 46) adapted to receive a protrusion or connector, such as connector 30, in the nose portion 20. Optional connection between the docking station 56 and the nose portion 20 is possible, such as holding the nose portion 20 in place using undercuts or grooves. A plug 35 may be provided, adapted to be inserted into connector 30 or opening 46.

[0673] When the connector 30 of the nose portion 20 is connected to the opening 46 of the mouth portion, the plug 35 can be placed in the connector 30 to prevent air from flowing pneumatically between the nose portion 20 and the mouth portion 40. Alternatively, by including as Figure 9 The valve 55 shown selectively opens and closes the opening 46, and the mouth portion 40 is adapted to prevent airflow between the nose portion 20 and the mouth portion 40. The patient can, for example, by rotating... Figure 8 and 9 The knob 54 shown is used to selectively operate valve 55.

[0674] In some embodiments, for example Figure 7-3 As shown, the elbow 2 and flexible tube 5 may not be connected to the rotary connector 44, but may be replaced by a plug 3, which may or may not include an optional vent 6.

[0675] Figures 11-1 to 19 A modular patient interface system 1 is shown, which includes a mouth portion 40, said mouth portion having an optional connection to a nose portion 20. Specifically, in Figures 11-1 to 19 In this embodiment, the nose connector 43 is used to connect the mouth portion 40 to the nose portion 20. The nose connector 43 is adapted to fit onto and seal the nose portion 20, such that air from the flexible tube 5 can be delivered into the mouth portion 40 and through the nose connector 43 to the nose portion. The decoupling portion 45 can decouple the force (e.g., tube drag force) at the rotating ring 4 from both the sealing portion 22 of the nose portion 20 and the sealing portion 42 of the mouth portion 40.

[0676] The sealing portion 42 of the mouth portion 40 may include a bottom portion 79, a side portion 81, a top portion 85, and a neck portion 87. The bottom portion 79 may be adapted to form a seal with the patient's lower lip or chin area. The top portion 85 may be adapted to form a seal with the patient's upper lip area. These side portions may be adapted to form a seal with the patient's face on multiple side areas of the patient's mouth. The side portion 81 extends between the bottom portion 79 and the top portion 85. The neck portion 87 connects the top portion 85 to the nose portion connector 43. The sealing portion 42 transitions from the top portion 85 to the neck portion 87, which is narrower than the top portion 85 to conform to the size and shape of the nose portion connector 43. By having a narrower neck portion 87, the pressure and flow rate of air entering the sealing portion 42 can be increased. Figure 20 and 21 A patient interface system 101 including a mouth portion 140 is shown. The mouth portion 140 may include a structural portion 147, a mouth sealing portion 142, a decoupling portion 145, a headband connector 141 for connection to a headband, and a vent 103, which may include one or more vents or slots for venting exhaled air from the patient. When the nose portion 120 and mouth portion 140 are not formed as an integral element, a nose portion connector 143 for connection to the nose portion 120 may be used. A flexible tube 105 may be connected to the mouth portion 140 via an elbow 102. The structural portion 147 may be configured and arranged to harden the periphery of the sealing portion to maintain the shape of the sealing portion and to apply sufficient sealing force to the patient's face.

[0677] Figures 22 to 24 A patient interface system 201 including a mouth portion 240 is shown. The mouth portion 240 includes: a mouth sealing portion 242, which may be in the form of a pad for sealing with the patient's mouth; a frame 247; a mouth opening 246 for receiving pressurized breathable air; a decoupling portion 245; and a nostril connection portion 243 for connecting with a nasal portion. Figure 16 The frame 247 is shown, with the decoupling portion 245 and the connecting portion 243 removed. Although not shown, the mouth portion may include a connection to a flexible tube for delivering pressurized breathable gas, such as a rotary connector, elbow, and flexible tube as shown in other embodiments.

[0678] Figure 27 and 28 A modular patient interface system 301 including a mouth portion 340 is shown. The mouth portion 340 includes a decoupling portion 345, an opening 348, and a connector 349. The connector 309 is adapted to connect to, for example, Figure 27 The opening 326 in the nose portion 320 shown or as Figure 28The mouth portion 340 is shown with an opening 348. When the patient interface 301 is used in both nose and mouth mode, the connector 349 of the mouth portion is adapted to connect to the opening 326 in the nose portion 320. When the patient interface 301 is used in mouth-only mode, a plug can be provided to insert into the connector 349.

[0679] Figure 29 The patient interface system shown may include a mouth portion 380. The mouth portion 380 may include a mouth sealing portion 375 and may be adapted to connect to a headband 360 and to a nose portion 372. The patient interface system may include an air delivery conduit or tube 379 that can be integrated into the headband. The air delivery tube 379 thus eliminates the need for an elbow connected to the mouth portion 380, thereby providing "ducted" air delivery and giving the patient interface system 375 a more streamlined appearance.

[0680] Figure 30 The patient interface system 401 shown includes a mouth portion 440. The mouth portion 440 includes a mouth sealing portion 442, a headband connector 441 for connection to a headband 460, and a decoupling portion 445. A swivel connector 444 can connect the mouth portion 440 to an elbow 402 and a flexible hose 405, which delivers pressurized breathable gas to the patient interface system 401.

[0681] Figure 31 The patient interface system 501 shown includes a mouth portion 540. The mouth portion 540 includes a mouth sealing portion 542, a headband connector 541 for connection to a headband 560, a swivel connector 544, and a foam patient contact portion 569. Foam may be placed around the periphery of the mouth sealing portion 542, but for comfort, it may optionally be placed only in selected areas, such as only in the upper lip area. Silicone or other sealing devices may be placed in the area surrounding the periphery of the mouth sealing portion 542 without foam. The mouth portion 540 may also include an optional decoupling portion 545. The swivel connector 544 may connect to an elbow 502 and a flexible hose 505 that delivers pressurized breathable gas to the patient interface system 501. The foam patient contact portion 569 may contact and form a seal with the patient's upper lip area, thus forming part of the mouth seal.

[0682] Figure 40 The patient interface system 701 shown includes a mouth portion 740. The mouth portion 740 may include a mouth sealing portion 742, a decoupling portion 745, and a headband connector 741 for connection to a headband 760. A swivel ring or other connector 744 may also be used for connection to a flexible hose 705 via a double elbow 712.

[0683] 5.3.3 Sealing Part

[0684] The sealing portion may consist of at least two parts: a nasal sealing portion and a mouth sealing portion. By providing at least a nasal sealing portion and a mouth sealing portion, patients can selectively receive pressurized breathable gas through their nose and / or mouth.

[0685] These nasal sealing portions can function independently of the mouth sealing portions. Therefore, in some embodiments, if desired, the patient can remove the mouth sealing portions by removing the mouth portion and use only the nose portion with the nasal sealing portions. The mouth sealing portions can function independently of these nasal sealing portions. Therefore, in some embodiments, the patient can remove both the nose portion and the nasal sealing portions and use only the mouth portion and the mouth sealing portions.

[0686] Both the nasal and oral sealing portions may need to form a seal with the patient's upper lip. However, due to the limited surface area for positioning the nasal and oral sealing portions in the upper lip region, various implementations utilize structural elements to achieve a seal for both the nasal and oral sealing portions in the patient's upper lip region.

[0687] The mouth seal can be suitable for a wide range of people. The mouth seal can have a single size suitable for most people. However, the mouth seal can be offered in various sizes to accommodate a wide range of people. The mouth seal can be longitudinally adjustable to accommodate varying anthropometry within the population.

[0688] The nasal sealing portion can be suitable for a wide range of people. Preferably, the nasal sealing portion can be provided in one or two sizes to accommodate a wide range of people.

[0689] 5.3.3.1 Nostril sealing section

[0690] The nasal sealing portion is adapted to provide a comfortable and effective seal with the patient's nostrils.

[0691] The nasal sealing component can be in the form of a pillow, nasal fork, or membrane seal, such as a nasal support and / or nasal chamber.

[0692] The nostril seal may be a pillow seal such as that disclosed in PCT application No. WO 2009 / 052560 A1, which is incorporated herein by reference in its entirety.

[0693] Preferably, the nasal seal portion can be flexible and compliant so as to conform to the shape of the patient's nose and / or nostrils during use.

[0694] Preferably, the nostril seal may be made of polymers such as silicone, thermoplastic elastomers, or thermoplastic urethanes. Optionally, the nostril seal may be made of foam, gel, fabric, or other compliant materials. Alternatively, the nostril seal may be constructed from a combination of materials, such as a foam and fabric laminate, a fabric and polymer combination, or any other combination of the foregoing materials.

[0695] like Figures 7-1 to 10 As shown, embodiments of this technology may include a nasal sealing portion 22 in the form of a pillow or nasal fork type nasal seal. Optionally, the nasal sealing portion 22 may be a membrane-type nasal seal or a nasal chamber. The nasal sealing portion 22 is adapted to form a seal with the patient's nostrils during use. The nasal sealing portion 22 may be positioned below the patient's nose and shaped to form an effective seal.

[0696] like Figure 25 and 26 As shown, the nose portion 220 may include a nostril sealing portion 222, a support membrane 252, a support portion 253, and a headband connector 230, the headband connector having a headband tab 231 for attachment to a headband. When used with a membrane-type nose portion, all embodiments disclosed herein may use a nostril sealing portion in the form of the nostril sealing portion 222.

[0697] These nasal sealing portions 222 may include a nasal tip engagement portion 254, an upper lip engagement portion 256, and a thickened corner region 258. Support portions 253 may include a rear thickened portion 262 and a front thickened portion 260. Higher stiffness materials may be used in portions of the support portion 253 instead of the thickened portions 260 and 262, or in addition to the thickened portions 260 and 262, to provide additional support in these areas. These front thickened portions 260 are positioned adjacent to the areas of the sealing portions that come into contact with the sides of the patient's nose during use and transfer the headband load to the clamping force on the sides of the patient's nose to provide an effective seal. The front thickened portion 260 may have a thickness that increases from top to bottom. The rear thickened portion 262 may include a lower portion 266 having a first thickness and an upper portion 264 having a second thickness greater than the first thickness.

[0698] The nasal tip engagement portion 254 is formed as a suspended flexible membrane. The sides of the sealing portion 222 are connected to or joined to the support portion 253, and an anterior gap exists between the central portion of the sealing portion 222 and the support portion 253 at the anterior anchor point 257. By utilizing this suspended flexible membrane, the nasal tip engagement portion 254 provides a flexible surface that maintains tensile contact with the nose during patient interface movement and better adapts to changing nasal geometry. The nasal tip engagement portion 254 engages with and seals the patient's nose and extends toward the support portion 253. The sides of the sealing portion 222 engage with and seal the sides of the patient's nose.

[0699] The sealing portion 222 includes an upper lip engagement portion 256 that engages with the patient's upper lip during use. The upper lip engagement portion 256 is formed as a suspended flexible membrane with a rear gap between the upper lip engagement portion 256 of the sealing portion 222 and a support portion 253. The rear gap is located between rear anchoring points 259 that anchor the sealing portion 222 to the support portion 253. The flexible suspended membrane provides a flexible surface that maintains stretch contact with the patient's upper lip during patient interface movement and can be stretched to adapt to changing facial geometry by allowing movement of the upper lip engagement portion 256.

[0700] The post-thickening portion 262 may have a curved portion 268. These post-thickening portions 262 may include a hollowed-out portion 270 to reduce the volume of the silicone and reduce curing time. The post-thickening portion 262 is located directly below the thickened corner region 258 of the sealing portion 222, such as... Figure 20 What I saw in [the text]. When with, as Figure 24 and 25 When used together with the headband connector shown, the rear thickened portion 262 transfers the load from the headband connector to the thickened corner area 258 and the lower corner of the patient's nose to help provide an effective seal, and the load transfer to the lower corner of the patient's nose increases when the headband is tensioned. Bending forces from the headband connector are transferred during use by the rear thickened portion 262 to the thickened corner area 258 of the sealing portion 222 to apply the sealing force as an anchoring force to the area adjacent to the nasolabial fold of the patient's nose.

[0701] The nostril sealing portion 222 is configured to extend or bend outward from the support wall 221 formed in the orifice 226, which defines the air path through the nose portion 220.

[0702] Further details of the nostril seal portion 222 are disclosed in WO 2010 / 139014 A1, which is incorporated herein by reference in its entirety.

[0703] All embodiments disclosed herein can use a pillow or fork-shaped nasal seal, for example Figure 25 and26 The membrane-type nasal seal shown, or the nasal seal portion in the form of a nasal chamber.

[0704] Figure 41 and 42 A nasal seal portion 820 is shown, which can be used to form a seal with a patient's nostrils to deliver pressurized breathable gas into the patient's nostrils via an opening 826 and an inlet tube 830 in the patient interface system. The nasal seal portion 820 can be a membrane-type nasal seal, such as... Figure 25 and 26 The sealing part 222 is shown.

[0705] A dial 822 and rigid elements 823 are disposed on the bottom surface of the nostril sealing portion 820. There may be four such rigid elements 823, but any number can be used. These rigid elements 823 may be arranged to extend radially from the dial 822, and the dial 822 may be arranged to surround the opening 826. Rotating the dial 822 causes the helical gear to rotate, moving the rigid elements 823 up or down, thereby moving the sides of the nostril sealing portion 820 up or down, increasing or decreasing the pressure on the sides of the patient's nostrils during use.

[0706] 5.3.3.2 Nose sealing part

[0707] The mouth seal portion is adaptable to seal with the patient's mouth. Preferably, the mouth seal portion can be flexible and compliant to conform to the shape of the patient's nose and / or nostrils during use. The mouth seal portion may include a membrane that extends over the patient's upper lip and chin areas, i.e., is more flexible than the lateral areas of the membrane that meet the patient's cheeks. The cheek or lateral mouth areas are less sensitive to pressure from forces from the patient's interface system, thus allowing greater force to be applied in the cheek or lateral areas to anchor the mouth portion to the patient's mouth. Furthermore, the flexibility of the upper lip and chin areas means that the mouth seal portion can bend from a generally planar position to fit a flat / flat face, and can also fit a sharp / angled face by bending into a concave position.

[0708] Preferably, the mouth seal portion may be composed of polymers such as silicone, thermoplastic elastomers, or thermoplastic urethanes. Optionally, the mouth seal portion may be composed of foam, gel, fabric, or other compliant materials. Alternatively, the mouth seal portion may be constructed from combinations of materials, such as foam and fabric laminations, fabric and polymer combinations, or any other combination of the foregoing materials.

[0709] like Figures 7-1 to 10As shown, embodiments of the present technology may include a mouth-sealing portion 42. The mouth-sealing portion 42 is adapted to form a seal with a patient's mouth during use. The mouth-sealing portion 42 may be positioned around the patient's mouth and shaped to form an effective seal. The mouth-sealing portion 42 may be in the form of a pad forming a rear opening 50 for insertion into the patient's mouth. The pad may be a soft silicone pad that contacts the patient's mouth area and forms a seal. All embodiments disclosed herein may include the mouth-sealing portion as described above.

[0710] like Figure 32 As shown in the schematic cross-sectional view, the mouth-sealing portion 42 can seal around the patient's mouth in the area of ​​the patient's upper lip and in the area between the patient's lower lip and chin. Figure 32 As further shown, the mouth seal 42 may be disposed between the decoupling portion 25 and the patient's upper lip.

[0711] 5.3.3.3 Decoupling

[0712] A decoupling or force-absorbing element may be present, positioned as part of the nose portion or mouth portion. The decoupling element may be positioned between a first portion and a second portion of the nose portion, and / or between a first portion and a second portion of the mouth portion, to prevent movement or force acting on the nostrils or mouth portion from damaging the seal of the corresponding sealing portion.

[0713] In one implementation, the decoupling element may be a spring.

[0714] In another embodiment, the decoupling element may be a gusset or a flexible chamber.

[0715] like Figure 7-4 As shown, the decoupling portion 25 can be disposed between the nostril sealing portion 22 and the rotating ring 4. The decoupling portion 25 can be a thin, flexible region of elastic material, adapted to absorb force and / or motion by bending and / or changing its shape. For example, the decoupling portion 25 decouples the force or motion acting on the rotating ring 4 from transmission to the nostril sealing portion 22.

[0716] The mouth sealing portion 40 may also include a decoupling portion 45 that can be disposed between the frame 47 and the rotary connector 44. The decoupling portion 45 may be a thin, flexible region adapted to absorb forces and / or motion by bending and / or changing its shape. For example, the decoupling portion 45 decouples forces or motions (e.g., tube drag forces) acting on the flexible tube 5, the rotary connector 44, and / or the elbow 2 from being transmitted to the mouth sealing portion 42, thereby providing a more effective seal for the patient. All embodiments disclosed herein may include one or more decoupling portions as described, which may be part of the nasal portion and / or the mouth portion.

[0717] exist Figure 52 In the patient interface system 1180, the nasal portion 1190 is decoupled from the movement in the mouth portion 1182 via a decoupling portion 1181. If the air hose 1185 and / or the mouth portion 1182 moves, the decoupling portion 1181 allows the nasal portion 1190 to maintain a sealed engagement with the patient's nostrils. The nasal portion 1190 can rotate relative to the mouth portion 1182. A valve 1183 will move together with the air hose 1185 and / or the mouth portion 1182.

[0718] 5.3.3.4 Relationship between the nostrils and the mouth seal

[0719] The sealing components can be constructed as a single unit, which includes a nostril sealing component and a mouth sealing component.

[0720] The sealing components can be constructed in more than one piece and then connected together to operate as a patient interface for the nose and mouth. For example, the nasal sealing component can be configured as a first component, and the mouth sealing component can be configured as a second component, and then the first and second components can be connected together.

[0721] In a further preferred embodiment, the sealing portion can be configured as more than one component, wherein each component can be used independently of or attached to other components, and each arrangement still provides treatment to the patient. For example, the nasal portion including the nostril sealing portion can be separated from the mouth portion including the mouth sealing portion, and the nasal portion including the nostril sealing portion can be used without the mouth portion including the mouth sealing portion attached, still enabling treatment delivery to the patient's nostrils.

[0722] 5.3.3.5 Connection between the nostrils and mouth section and the headband

[0723] The headband 60 can be connected to each of the nose portion 20 and the mouth portion 40. This differs from many prior art arrangements in which the headband is only connected to the mouth portion, and the mouth portion is constructed and arranged to allow the nose portion to be fitted into a sealed connection with the patient's nose.

[0724] like Figures 7-1 to 19 As shown, the nose portion 20 may include a headband connector 21. The headband connector 21 may include a headband tab 31 that may intersect with or connect to an opening 70, which may be in the form of a slot or loop on the headband strap 61.

[0725] The mouth portion 40 may include a lower headband connector 41 for receiving a locking device 64 from the lower headband strap 63.

[0726] For the nose portion 20 and the mouth portion 40, optional connecting devices are possible. For example, hook-and-loop connections, push-in fit connections, interference fits, ball joints, etc., can be used.

[0727] 5.3.4 Positioning and Stabilizing Structure

[0728] The positioning and stabilizing structure in the form of headband 60 is adapted to maintain a sealed engagement between the patient interface system and the patient's nostrils and mouth. Headband 60 may include straps adapted to secure its position on the patient's head. The straps may include side headband straps 61, lower headband straps 63, rear headband straps 65, and a top headband portion 66. The straps may also direct tension onto the patient interface adapted to seal the patient interface to the patient's face.

[0729] 5.3.4.1 Headband side section

[0730] Figures 7-1 to 7-3 Figures 11-1 to 13 show a headband 60 in use. Side headband straps 61 are adaptable for positioning above the cheek, below the eyes, and above the patient's ears. Side headband straps 61 can be connected to headband connector 21 of the nose portion 20.

[0731] The side headband strap 61 may include a side headband strap connector 62 for connection to the headband strap connector 21 of the nose portion 20. The side headband connector 62 may be used to capture a loop on the headband tab 31 on the nose portion 20. Any connection method is possible, such as hook and loop connection, clip, push-fit tab. Alternatively, the side headband strap 61 may be integrally formed with the nose portion 20.

[0732] The side head strap 61 is preferably made of a longitudinally stretchable flexible material. The side strap 61 may be made of fabric, foam, foam and fabric composite, silicone, nylon, elastic material or any other flexible material.

[0733] The side headband strap 61 can provide an upward vector to the patient interface system 1 to help hold the patient interface system 1 in the desired position. The upward vector can be tilted upward relative to the vector applied by the lower headband strap 63.

[0734] 5.3.4.2 Crown portion

[0735] The headband 60 may also include a crown strap portion or a top strap 66, which can be adapted to be positioned on the top of the patient's head or on the crown during use. The crown strap portion 66 can provide an upward vector to the patient interface system to help hold the patient interface system in the desired position.

[0736] The crown band portion 66 may be continuous with or otherwise connected to the side headband band 61. The crown band portion 66 and / or the side headband band 61 may also include a band loop 68. The band loop 68 may be configured to receive the rear portion 65.

[0737] The crown strap portion 66 may further include an adjustment mechanism 69. The adjustment mechanism 69 may be the adjustment mechanism described in WO 2009 / 052560A1, which is incorporated herein by reference in its entirety.

[0738] The crown bandage portion 66 may preferably be made of a longitudinally stretchable flexible material. The crown bandage portion 66 may be made of fabric, foam, foam and fabric composite, silicone, nylon, elastic material or any other flexible material.

[0739] 5.3.4.3 Lower part of the headband

[0740] The headband 60 may also include a lower headband strap 63, which can be connected to the mouth portion 40 of the patient interface system 1. The lower headband strap 63 can guide tension on the mouth portion 40 to provide a vector force perpendicular to the patient's face, and thus seal the mouth portion 40 on the patient's face.

[0741] The lower headband 63 can be a bandage that is basically pointed below the patient's ears.

[0742] The lower headband strap 63 may be connected to the rear portion 65 of the headband or otherwise formed therefrom.

[0743] 5.3.4.4 Rear part of the headband

[0744] The headband 60 may further include a rear portion or strap 65. The rear portion 65 may be continuous with or otherwise connected to the side headband strap 61 or crown strap portion 66. The rear portion 65 may pass through a strap loop 68 and be positioned above the patient's ear. The rear portion 65 may travel down the side of the patient's head during use and capture the occipital bone to anchor the headband 60 in place. The rear portion 65 may also be connected to the lower headband strap 63 at a connection area 67.

[0745] The rear portion 65 provides downward and backward (i.e., away from the patient's face) vectors to balance the upward vector of the crown ligature portion 66 and help pull the patient interface system 1 into a sealed engagement with the patient's face.

[0746] The posterior portion 65 can be fixed in an appropriate position below the patient's occipital bone by attaching it to the lower strap 63 (see...). Figure 13 The attachment may be located at the connection area 67. The connection area 67 may include a sewn connection, a hook and loop connection, or any other connection. The connection area 67 may also be a permanent connection, such that the rear portion 65 and the lower binding strap 63 are integrated.

[0747] The rear portion 65 may preferably be made of a longitudinally stretchable flexible material. The rear portion 65 may be made of fabric, foam, foam and fabric composite, silicone, nylon, elastic material or any other flexible material.

[0748] 5.3.4.5 Headband Options

[0749] Various patient interface systems and kit implementations may include, for example Figure 39 Various headband options are shown. For example, when used in nostril-only mode, a nose headband 812 suitable for securing the nose portion to the patient's head can be used. When used in mouth-only mode, a mouth headband 850 suitable for securing the mouth portion to the patient's head can be used.

[0750] The nasal headband 812 uses an upward-angled headband vector to align the nasal seal with the patient's nostrils. The mouth headband 850 uses a headband vector typically oriented in the horizontal plane to align the mouth seal with the patient's mouth. Figure 39 In the examples shown in Figures 43-44, the headband vectors are at an angle relative to each other. However, in Figures 40-41 In the example, due to the nature of the padding and the sealing forces involved, the headband vectors are usually parallel to each other.

[0751] When used in the nostril and mouth configuration, the nose headband 812 and mouth headband 850 can be used together to secure the nose and mouth sections to the patient's head. Alternatively, a nostril and mouth headband 860 can be used, which includes a connection area in the back, such as... Figure 13 The connection area 67 is shown. The headband 860 of the nostril and mouth portions generates a headband vector that returns along the patient's head and upwards to secure the nose portion 820 to the patient's nostrils, and returns along the patient's head to secure the mouth portion 840 to the patient's head.

[0752] Each of the nose headband 812 and the mouth headband 850 can be connected at two points to a corresponding one of the nose or mouth portions of the patient interface system of this technology. In some forms, when the nose and mouth portions of the patient interface system are used together as a single system, both the nose headband 812 and the mouth headband 850 can be used to provide a positioning and stabilizing structure with four connection points. The conversion from a two-point to a four-point positioning and stabilizing structure allows the user to optimize or at least improve the force vector of the reconfigured patient interface system. Therefore, the improved vector of the reconfigured four-point positioning and stabilizing structure can improve the effectiveness of the seal-forming structure and, in some embodiments, also improve the overall user comfort. In some forms, the addition of the mouth headband 850 can provide improved stability to the patient interface system. This can be particularly useful in forms that incorporate a patient interface system having an integral seal-forming structure that engages both the patient's oral and nasal air passages.

[0753] For example, when the nasal interface portion is reconfigured to become a bi-nose and mouth interface (i.e., oronasal), or similarly, by providing the patient interface system with separable nasal and mouth portions, and reconfiguring the mouth interface portion into a bi-nose and mouth interface with a corresponding removable and adjustable accompanying headband system, the patient interface system can be modularly configured by the user to suit their individual treatment requirements and desired level of comfort. Modularly configurable patient interface systems also improve the cost efficiency of manufacturing patient interface systems.

[0754] In some forms, the nose and mouth headbands of the disclosed patient interface system can be configured to be independent of each other (e.g., Figure 44 In some forms, connector 856 can be used to facilitate the connection of the headband 870 to the nostrils and mouth sections. For example, as... Figure 39 As shown. Connector 856 can be used to facilitate the connection of the nose section headband and the mouth section headband at one or more locations along the respective headbands. For example, connector 856 can be positioned towards the central posterior portion of the user's head, adjacent to the occipital bone.

[0755] As those skilled in the art will understand, the connectors or multiple connectors used to connect the nose and mouth headbands can take many forms. Functionally, the combined nose and mouth headbands together provide a positioning and stabilizing structure having four connection points with the facial interface structure providing treatment.

[0756] In some forms, each of the nose headband and mouth headband may include one or more connectors, with the one or more connectors of the nose headband engaging in opposite directions with the one or more connectors of the mouth headband. Connector 856 may be a Verco connector, a hook or loop material connector, etc. Any of the above headband options can be used in various implementations.

[0757] For example, in some forms, the nose headband 8812 may be formed of a material capable of removably engaging a connector 8856 comprising a Velcro fastener adapted to the mouth headband 8850 (e.g. Figure 172A and 172B Alternatively, in some forms, the nose portion headband 8812 may include one or more connectors 8856 that contain a Velcro (or similar material) layer adapted to removably engage the material of the mouth portion headband 8850 (e.g., Figure 172C ).

[0758] In another example, in some forms, connector 8856 may include one or more snap-fit ​​connections, wherein one or more convex snap-fit ​​connectors 8856' are adapted to the nose portion headband 8812 and one or more concave snap-fit ​​connectors 8856" are adapted to the mouth portion headband 8850, or vice versa (e.g., Figure 173A and 173B The plurality of convex snap connectors 8856' may be spaced apart along the nose portion headband 8812 to correspond to and removably engage with a plurality of similarly spaced concave snap connectors 8856" on the mouth portion headband 8850. In some forms, the convex and concave snap connectors 8856', 8856" may be thermoformed into the material of each respective headband portion 8812, 8850. In some alternative forms, the inserted and recessed snap connectors 8856', 8856" may be countersunk into the material of each respective headband portion 8812, 8850 by a riveting process. Reducing the profile of connector 8856 may be advantageous. For example, by reducing the profile of connector 8856, user comfort may be improved in some forms.

[0759] In another instance, in some forms, connector 8856 may include one or more tabs 8857 that extend laterally from the mouth portion headband 8850 to hook into one or more latches 8858 and thus removably engage with these latches, which are adapted to the nasal cannula system headband strap to receive one or more of the tabs 8857, or vice versa (e.g. Figure 174 In some forms, each of the one or more tabs 8857 may be formed as a fixed portion of the material. In some forms, each of the one or more tabs 8857 may be formed of an elastically stretchable material, thereby allowing the one or more tabs 8857 to be stretched to reach a corresponding latch in one or more latches 8858.

[0760] In a configuration including a corresponding pair of connectors 856, the position of one or more connectors on a headband portion 8812, 8850 can limit the variation in the relative spatial positioning of the corresponding connector 856 and another of the headband portions 8812, 8850. This improves the ease of conversion from two-point to four-point positioning and stabilization structures, as one or more connectors 856 can guide the user and allow for a more intuitive connection.

[0761] For example, in some forms, multiple spaced connectors 856 may be positioned along the nose portion headband 8812. This is achieved by limiting the engagement positions of the corresponding connectors 856 on the mouth portion headband 8850 (e.g., Figures 172A-173CThe permissible variations of the spaced connector 856 mean that it can therefore be used as a guide for the user.

[0762] In another example, see Figure 172A The mouth section headband 8850 includes a U-shaped segment 8852, with a flange at each distal end of the U-shape comprising a Velcro layer. In some forms, the entire nose section headband 8812 may be formed of a material that engages with Velcro; in other forms, the material of the nose section headband 8812 may be formed of a material that does not engage with Velcro, instead, two sections of Velcro-engaged material may be adapted as layers on the nose section headband 8812 to guide the user when the Velcro at each distal end of the U-shaped segment of the mouth section headband 8850 is positioned.

[0763] See another example. Figure 173A Different convex and concave snap connectors 8856', 8856" can be spaced apart along each corresponding headband portion 8812, 8850, thus limiting the permissible range of variation when connecting the nose portion headband 8812 and the mouth portion headband 8850. In some forms, see [reference needed]. Figure 173C The convex snap connector 8856' and the concave snap connector 8856" can be alternated, such that the convex snap connector 8856' is spaced apart from the concave snap connector 8856" on the same headband portion. This helps guide the user to correctly connect the headband portions 8812, 8850 relative to each other.

[0764] In some other forms, at least one of the nose headband 8812 and the mouth headband 8850 may include an alignment guide 8860 to provide guidance to the user when engaging the connector 856. The alignment guide 8860 can help position and / or orient at least one of the connectors 856, thereby improving the vectoring of the reconfigured four-point positioning and stabilization structure.

[0765] For example, see Figure 175A and 175B Connector 8856 and alignment guide 8860 may contain the same pattern, multiple visible lines (e.g. Figure 175A ) or shape (e.g. Figure 175B The alignment guides 8860 thus indicate the position and / or orientation on the headband portion. The user can be instructed to simply place the connector 8856 onto the matching patterns, lines, or shapes of these alignment guides 8860. This can be intuitive for the user to understand where and at what angle the connector should engage.

[0766] In another instance, see Figures 176A to 176CThe alignment guide 8860 may take the form of one or more protrusions and / or one or more recesses of at least one of the nose portion headband 8812 and the mouth portion headband 8850. In some forms, one or more protrusions and / or recesses of the alignment guide 8860 may be thermoformed onto each headband strap. One or more protrusions and / or recesses of the alignment guide 8860 may be formed as a single protrusion or recess (e.g., Figure 176A As shown), it is formed as multiple protrusions or recesses (e.g. Figure 176B As shown), or a protrusion or recess formed as a loop (e.g. Figure 176C (as shown in the figure) to correspond to the number and shape of one or more corresponding protrusions or recesses of connector 8856, which are adapted to fit within these alignment guides 8860 for engagement there.

[0767] In some forms, the nose headband 8812 and mouth headband 8850 may include combinations of various types of connectors 8856 and alignment guides 8860. See, for example. Figure 177 The connector 8856 may include multiple corresponding hooks and tabs that protrude on island-shaped protrusions in the other recessed alignment guide 8860 area of ​​the nose section headband 8812.

[0768] In some forms, the mouth headband 8850 may include a connector 8856 for one or more valve flaps 8862 extending laterally therefrom, and is adapted to pass through a corresponding configuration at or through the nose headband 8812. The one or more valve flaps 8862 can be folded and secured once through the slit 8814 to hold the nose headband 8812 and mouth headband 8850 together (e.g., Figure 178A In some forms, the folding valve flap 8862 can be secured to itself via connector 8856 or to the nose section headband 8812. The one or more valve flaps 8862 may include a Velcro connector layer 8856, a snap-fit ​​connector, or other similar corresponding fastening devices (e.g., Figure 178B In some forms, valve disc 8862 may have a width that extends partially along the width of slit 8814 (e.g., Figure 178A In other forms, the valve disc 8862 and the slit 8814 can have corresponding dimensions (e.g., Figure 178B In some other forms, multiple valve discs 8862 can pass through a single slit 8814 (e.g.) Figure 178C ).

[0769] Similarly, a headband 870 with connected nostril and mouth sections can be used, which includes a connector 856 for connecting the nostril-only headband and the mouth-only headband at the back section. Connector 856 can be a Verco connector, a hook or loop material connector, etc. Any of the above headband options can be used in various implementations.

[0770] Other alternatives for allowing selective attachment and disengagement are possible, see, for example, those described below. Figure 73 It includes a back strap 1619 extending through a back loop 1622.

[0771] exist Figure 96 Another variation is shown in 97, which illustrates another option for converting a two-point headband to a four-point headband. Headband 2000 includes a two-point headband 2001, such as... Figure 39 and Figure 73 As shown, it includes a pair of front straps to support the patient interface. Additionally, the rear of the headband 2000 includes a first rear strap 2002 connected to the pair of front straps and a second rear strap 2006 that can be attached to the first rear strap via a snap or buckle.

[0772] Specifically, the first rear strap 2002 may have a convex member 2002.1, and the second rear strap 2006 may have a complementary / concave member 2006.2 to allow selected attachment and disengagement.

[0773] 5.3.5 Vent

[0774] Implementations of this technology can utilize one or more air vents in the patient interface system to expel the patient's exhaled air. These air vents can be arranged to expel exhaled air from the nasal portion 20, the mouth portion 40, or both the nasal portion 20 and the mouth portion 40.

[0775] For example, the plug 3 is included on the nasal portion 20 and may include an air vent 6 to expel exhaled air from the patient's nostrils. Optionally, another air vent 6 may be included on the elbow 2 connected to the mouth portion 40 to expel exhaled air from the patient's mouth. Neither of the air vents 6 may be omitted, particularly if one of the nasal portion 20 or the mouth portion 40 is used as a sealing portion, for example, a portion that does not deliver breathable gas to the patient.

[0776] These vents 6 can be in the form of a series or an array of individual vents. Alternatively, the vent 6 can be in the form of a single or series of slots, as shown in Figures 11 and 12, or in the form of another orifice or multiple orifices.

[0777] 5.3.6 Air Delivery System

[0778] Air delivered in the form of pressurized breathable gas is delivered to the patient interface system 1 through a flexible tube 5. The flexible tube 5 is coupled to a blower / humidifier or other air delivery device adapted to deliver pressurized breathable gas to the patient for treatment.

[0779] 5.3.7 Modular Patient Interface System

[0780] The patient interface system implementation disclosed herein can be a modular patient interface system, including a nose portion, a mouth portion, and a headband. The modular patient interface system can be adapted to allow patients to selectively use the nose portion and / or the mouth portion in a first mode and a second mode. In the first mode, the patient can use both the nose portion and the mouth portion. In the second mode, the patient can use only the nose portion without using the mouth portion.

[0781] Some implementations may also allow the modular patient interface system to be used in a third mode, where the mouth portion is used instead of the nose portion. In implementations providing a third mode, the mouth portion is used to supply air to the patient's mouth, while the nose portion is not used and is not worn by the user. Additionally, in some implementations, the nose and mouth portions may be adapted to allow free airflow between the chambers of the nose and mouth portions, such as openings and / or connectors between the chambers. Some implementations may include plugs or selectively operated valves that can be used to block openings or connectors to prevent airflow between the nose and mouth portions. Plugs may also be used to block openings or connectors when the nose or mouth portion is used alone. All modular patient interface systems can be alternatively configured as integrated patient interface systems where the nose portion cannot be separated from the mouth portion and used independently.

[0782] Figures 38(a) to 38(k) This is a schematic diagram illustrating the use of the nose portion 20 and mouth portion 40 in various modes. In the first mode, the patient can use both the nose portion and the mouth portion, such as... Figure 38(e) , 38(f) As shown in Figures 38(g), 38(h), and 38(k), air is delivered to the patient's nostrils via the nasal portion 20, while air is delivered to the patient's mouth via the mouth portion 40. In Figure 38(e), the nasal portion 20 and mouth portion 40 do not have a connection between their chambers, and pressurized air is applied to both the nasal portion 20 and mouth portion 40, with the nasal portion delivering air to the patient's nostrils and the mouth portion delivering air to the patient's mouth. In Figure 38(f), a connection exists between the chambers of the nasal portion 20 and mouth portion 40. Pressurized air is applied to the chamber of mouth portion 40 and flows through mouth portion 40 to the patient's mouth, and flows from mouth portion 40 to the patient's nostrils via the connection with nasal portion 20.

[0783] In Figure 38(g), a connection exists between the chambers of the nose portion 20 and the mouth portion 40. Pressurized air is applied to the chamber of the nose portion 20 and flows through the nose portion 20 to the patient's nostrils, and then flows from the nose portion 20 to the patient's mouth through the connection with the mouth portion 40 and the patient's mouth. In Figure 38(h), a connection exists between the chambers of the nose portion 20 and the mouth portion 40. Pressurized air is applied to the chambers of the nose portion 20 and the mouth portion 40, and can flow through the connection between the nose portion 20 and the mouth portion 40. In Figure 38, a connection exists between the chambers of the nose portion 20 and the mouth portion 40, but this connection is blocked by a plug, valve, etc. Pressurized air is applied to the chambers of the nose portion 20 and the mouth portion 40, and flows through the nose portion 20 to the patient's nostrils and then through the mouth portion 40 to the patient's mouth.

[0784] In the first mode, the patient can also use the nose section 20 and the mouth section 40, such as Figure 38(c) and 38(i) As shown, the nose portion 20 serves as a nasal seal, while the mouth portion 40 delivers air to the patient's mouth. In Figure 38(c), there is no connection between the nose portion 20 and the mouth portion 40, and pressurized air is delivered to the patient's mouth through the mouth portion 40, while the nose portion acts as a nasal seal. In Figure 38(i), there is a connection between the nose portion 20 and the mouth portion 40, but this connection is blocked by a plug, valve, etc. Pressurized air is delivered to the patient's mouth through the mouth portion 40, and the nose portion 20 acts as a nasal seal.

[0785] In the first mode, the patient can use the nose part 20 and the mouth part 40, such as Figure 38(d) and 38(j) As shown, air is delivered to the patient's nostrils using the nose portion 20, while the mouth portion 40 serves as a mouth seal. In Figure 38(d), there is no connection between the nose portion 20 and the mouth portion 40, and pressurized air is delivered to the patient's mouth through the nose portion 20, while the mouth portion 40 serves as a mouth seal.

[0786] In the second mode, as shown in Figure 38(a), the nose portion 20 is used alone to deliver air into the patient's nostrils, while the mouth portion is not used and is not worn by the patient. In embodiments utilizing a connection that allows air to flow between the nose and mouth portions, when the nose portion 20 is used alone, the opening can be blocked using a plug, valve, or the like.

[0787] In the third mode, as shown in Figure 38(b), the mouth portion 40 is used solely to deliver air to the patient's mouth, while the nose portion 20 is not used and is not worn by the patient. In embodiments utilizing a connection that allows air to flow between the nose portion 20 and the mouth portion 40, when the mouth portion 40 is used alone, the opening can be blocked using a plug, valve, or the like.

[0788] Figures 7-1 to 10 The implementation scheme is a modular patient interface system 1, wherein the nose part 20 can be used by the patient in a nostril-only mode without the mouth part 40, the mouth part 40 can be used by the patient in a mouth-only mode without the nose part 20, and the nose part 20 can be used together with the mouth part 40 in a nostril and mouth mode. Figure 7-2 and Figure 8-10 A patient interface system 1 in a nostril and mouth mode is shown, wherein a nose portion 20 is used in conjunction with a mouth portion 40. When used in the nostril and mouth mode, the patient interface system 1 can deliver air to the patient's nostrils using the nose portion 20 and deliver air to the patient's mouth using the mouth portion 40. Alternatively, the patient interface system 1 can deliver air to the patient's nostrils using the nose portion 20 while the mouth portion 40 can be used as a mouth seal without delivering air to the patient's mouth, or the patient interface system 1 can deliver air to the patient's mouth using the mouth portion 40 while the nose portion 20 can be used as a nostril seal without delivering air to the patient's nostrils.

[0789] Both the nose portion 20 and the mouth portion 40 are adapted to connect to a pressurized source of breathable gas. Specifically, in Figures 7-2 to 10 In this embodiment, both the nose portion 20 and the mouth portion 40 are adapted to be connected via the elbow 2 to a pressurized breathable gas source, such as a flexible tube 5, although only one of these portions may be connected. The flexible tube 5 may be connected to one or both of the nose portion 20 and the mouth portion 40. The connection to the nose portion 20 and the mouth portion 40 can be made by using, for example... Figure 40 The connector shown is used to implement the double elbow 712.

[0790] exist Figure 7-2 and Figures 8 to 10 In one embodiment, the nose portion 20 and the mouth portion 40 are internally connected, allowing air to flow between them, for example, by using a connector 30 in the nose portion to connect to an opening 46 in the mouth portion 40, although other connections may be used. If it is desired to prevent air from flowing between the nose portion 20 and the mouth portion 40, the connection can be blocked by using a plug 35 or a valve 55 actuated by a knob 54.

[0791] The patient interface system 1 can be used in which pressurized breathable gas is received by the patient's nostrils and mouth by connecting the elbow 2 and flexible tube 5 to either the rotary connector 4 of the nose portion 20 or the rotary connector 44 of the mouth portion 40, and the breathable gas can flow through the connector 30 and the opening 46. The patient interface system 1 can also be used as a mouth seal or a nostril seal, wherein the connector 30 and / or the opening 46 will be blocked by utilizing the plug 35 or by actuating the valve with the knob 54, and only one of the nose portion 20 or the mouth portion 40 is connected to the elbow 2 and flexible tube 5. For example, if the elbow 2 and flexible tube 5 are connected to the nose portion 20, and the connector 30 and / or the opening 46 are blocked by utilizing the plug 35 or by actuating the valve 55 with the knob 54, pressurized air is delivered to the nose portion 20 and the mouth portion 40 acts as a mouth seal that does not deliver pressurized air to the patient's mouth. Alternatively, if the elbow 2 and flexible tube 5 are connected to the mouth portion 40, and the connector 30 and / or opening 46 are blocked by using the plug 35 or by actuating the valve 55 with the knob 54, pressurized air is delivered to the mouth portion 40, and the nose portion 20 acts as a nasal seal that does not deliver pressurized air to the patient's nostrils.

[0792] like Figure 7-1 As shown, the patient interface system 1 is also adapted to operate in a nostril-only mode using the nasal portion 20 without the mouth portion 40. In this mode, the mouth portion 40 and the lower headband strap 63 are not used; the plug 3 is removed from the nasal portion 20, and the elbow 2 and flexible tube 5 are connected to the nasal portion 20 to deliver pressurized breathable gas to the patient's nostrils. The connector 30 is inserted with a plug 35.

[0793] Patient interface system 1 is also suitable for operation in mouth-only mode using mouth portion 40 but not nose portion 20, such as Figure 7-4 As shown. In this mode, the nose section 20 and headband strap 61 are not used, and the elbow 2 and flexible tube 5 are connected to the mouth section 40 via a rotary connector 44 to deliver pressurized breathable gas to the patient's mouth. The mouth opening 46 is plugged with a plug 35.

[0794] Figures 11-1 to 19 Another embodiment of patient interface system 1, which can be a modular patient interface system, is shown. Figure 11-1 and 12 -19 illustrates a modular patient interface system 1 in both nostril and mouth configuration. A flexible tube 5 is connected to an elbow 2 via a swivel ring 4 to direct pressurized breathable gas into the chamber of the mouth portion 40 and into the nose portion 20 via a nose portion connector 43.

[0795] The decoupling portion 45 is connected between the rotating ring 4 and the nose portion 20 and the mouth portion 40. Additionally, the nose portion 20 may also include the decoupling portion 25, such that the nose portion benefits from both decoupling portions to decouple the force or movement applied to the flexible tube 5, the elbow 2 and / or the rotating ring 4 from the sealing portion 22 transmitted to the nose portion 20.

[0796] exist Figures 11-1 to 19 In one embodiment, the nostril sealing portion 22 can be as follows: Figure 14 , 15 The nasal bolster shown in Figures 17 and 18 can be in the form of a nasal fork, a membrane seal such as a nasal brace, and / or a nasal chamber. For example, the nasal portion in Figures 11-19 can be... Figure 25 and 26 The nose portion 220 is shown in the form of the nose portion 220. The support portion 252 may or may not be included. When the nose portion 220 is used, the sealing portion 222, which seals with the patient's nostrils, is configured to extend outward or bend from the support wall 221 that defines the air path through the sealing portion 222 and form a seal with the patient's nasal tip, upper lip, and nostrils.

[0797] like Figure 11-2 As shown, the patient interface system can be used only in a nostril mode. In this mode, the patient interface system is used with the nose portion 20, and the mouth portion 40 is not used by the patient. To convert the patient interface system from a nostril and mouth mode to a nostril-only mode, the rotating ring 4, elbow 2, and flexible tube 5 are removed from the mouth portion 40. The mouth portion 40 is removed from its connection to the nose portion 20 by disconnecting the nose portion connector 43 from the nose portion 20 and the rotating ring 4. The elbow 2 and flexible tube 5 are connected to the nose portion. Although the headband 60 shown is illustrated with a connection area 67, the connection area 67 can be omitted to allow the use of the patient interface system 1 in a nostril-only configuration without the lower headband strap 63.

[0798] Figure 27 and 28 A patient interface system 301 according to an embodiment of the present technology is illustrated. The patient interface system 301 is adapted for use in a nostril-only mode, a mouth-only mode, or a nostril and mouth mode. The patient interface system 301 includes a nose portion 320, a mouth portion 340, a headband 360, a connector 306, an optional rotary connector 308, and a flexible tube 305. The connector 306 may be in the form of an elbow or other type of connector.

[0799] The nose portion 320 includes a nostril sealing portion 322, a headband connector 321 for connection to the headband 360, a decoupling portion 325, and an opening 326. The nostril sealing portion 322 may be in the form of a occipital, nose fork, nasal chamber, or membrane seal, and may be... Figure 25 and 26The nose sealing portion 222 is shown in the form of the mouth portion 340. The mouth portion 340 includes a decoupling portion 345, an opening 348, and a connector 349. The connector 306 is adapted to connect to the opening 326 in the nose portion 320 or the opening 348 in the mouth portion 340.

[0800] like Figure 33 As shown, the patient interface system 301 is adapted for use by a patient in a nostril-only mode without the mouth portion 340. A connector 306 connects to an opening 326 in the nose portion 320. An optional rotary connector 308 can be used between the connector 306 and a flexible tube 305 that delivers pressurized breathable gas to the nose portion 320.

[0801] like Figure 28 As shown, by removing connector 306 from opening 326 in nose portion 320, connecting connector 349 of mouth portion to opening 326, and connecting connector 306 to opening 348 in mouth portion 340, it is possible to... Figure 27 The nostril-only configuration is converted to a nostril and mouth configuration. In the nostril and mouth configuration, the nose portion can receive pressurized breathable air via connector 349 and opening 326. Alternatively, by placing a plug in connector 349, the nose portion 320 can be used as a nostril seal, preventing pressurized breathable air from being delivered to the nose portion 320.

[0802] In the absence of the nose portion 320, the mouth portion 340 can also be used in the mouth-only configuration. In the mouth-only configuration, the nose portion 320 is not used, and a plug is placed in the connector 349 to provide a seal.

[0803] Figure 30 A modular patient interface system 401 according to an embodiment of the present technology is shown. The patient interface system 401 includes a nose portion 420, a mouth portion 440, and a headband 460.

[0804] The nose portion 420 includes a nostril sealing portion 422 for forming a seal with the patient's nostrils, and a headband connector 421 adapted for connection to a headband 460. The nose portion 420 is shown having the nostril sealing portion 422, such as... Figure 25 and 26 The type shown is acceptable, but other nostril sealing components, such as the nasal pillow, nasal tip, or nasal chamber, can also be used. An optional decoupling portion 425 may be included to decouple any forces applied to the nasal portion 420. The headband 460 can be used with... Figures 7-1 to 10 The headband shown is the same as 60.

[0805] Mouth portion 440 includes a mouth sealing portion 442, a headband connector 441 for connection to a headband 460, and a swivel connector 444. The mouth portion may also include an optional decoupling portion 445. The swivel connector 444 can connect to an elbow 402 and a flexible hose 405 that delivers pressurized breathable gas to the patient interface system 401. The patient interface system 401 may alternatively be configured as a modular patient interface system in which the mouth portion 440 is separable from the nose portion 420 and both portions can be used independently, and the flexible hose 405 can be connected to the nose portion 420 via the swivel connector 444, etc. A flexible portion 443 may be disposed between the decoupling portions 425 and 445. The flexible portion 443 may be a gusset or retractable portion between the mouth portion 440 and the nose portion 420, allowing the nose portion 420 to adopt a nasolabial angle (the angle between the nasal septum and the patient's upper lip).

[0806] Figure 31 A modular patient interface system 501 according to an embodiment of the present technology is shown. The patient interface system 501 includes a nose portion 520, a mouth portion 540, and a headband 560.

[0807] The nose portion 520 includes a nostril-sealing portion 522 adapted to form a seal with the patient's nostrils, and a headband connector 521 for connection to the headband 560. The nose portion 520 is shown having the nostril-sealing portion 522, such as... Figure 25 and 26 The type shown is acceptable, but other nostril sealing components, such as the nasal pillow, nasal tip, or nasal chamber, can also be used. An optional decoupling portion 525 may be included to decouple any forces applied to the nasal portion 520. The headband 560 can be used with... Figure 7-1 The headband shown in Figure 11 is the same as that shown in Figure 60.

[0808] Mouth portion 540 includes a mouth seal portion 542, a headband connector 541 for connection to a headband 560, a rotary connector 544, and a foam seal or patient contact portion 569. The foam patient contact portion 569 may be a wedge that serves as at least a part of the mouth seal. Mouth portion 540 may also include an optional decoupling portion 545. Rotary connector 544 may connect to elbow 502 and flexible hose 505, which delivers pressurized breathable gas to patient interface system 501. Patient interface system 501 may alternatively be configured as an integrated patient interface system in which mouth portion 540 is separable from nose portion 520 and both portions can be used independently, and flexible hose 505 may be connected to nose portion 520 via rotary connector 544, etc.

[0809] Figure 40Another modular patient interface system 701 is shown. The patient interface system 701 includes a nose portion 720, a mouth portion 740, and a headband 760. In this embodiment, the nose portion 720 is modularly connected to the mouth portion 740, such that the nose portion 720 can be used in a first nostril-only mode without the mouth portion 740, the mouth portion 740 can be used in a second mouth-only mode without the nose portion, or the nose portion 720 can be used together with the mouth portion 740 in a third nostril and mouth mode.

[0810] The nasal portion 720 may include a sealing portion 722 adapted to form a seal with the patient's nostril, an optional decoupling portion 725, and a headband connector 721 for connection to a headband 760. A swivel ring or other connector 710 may also be used. The sealing portion 722 may be in the form of a occipital, nasal fork, nasal chamber, or nostril sealing portion, such as... Figure 25 and 26 The membrane type shown.

[0811] The mouth portion 740 may include a mouth sealing portion 742, a decoupling portion 745, and a headband connector 741 for connection to the headband 760. A swivel ring or other connector 744 may also be used.

[0812] In such Figure 40 In the mouth and nostril configuration shown, both the nose portion 720 and the mouth portion 740 are used and connected to the flexible tube 705 via a double elbow 712. The double elbow 712 includes two elbow fittings that allow it to connect to both the nose portion 720 and the mouth portion 740 to deliver pressurized breathable air to the patient's nostrils and mouth. The nose portion 720 and the mouth portion 740 may be pneumatically connected or not.

[0813] In the nostril-only mode, only the nasal portion 720 is used, and the mouth portion 740 is not used. In this mode, the double elbow 712 and the mouth portion 740 are removed. The patient uses only the nasal portion 720 and connects the tube 705 to the rotating ring or other connector 710. An elbow, such as elbow 2, can be used to connect the tube 705 to the rotating ring or other connector 710.

[0814] In the mouth-only mode, only the mouth portion 740 is used, without the nose portion 720. In this mode, the double elbow 712 and the nose portion 720 are removed. The patient uses only the mouth portion 740 and the tube 705 is connected to the swivel ring or other connector 744. An elbow, such as elbow 2, can be used to connect the tube 705 to the swivel ring or other connector 744.

[0815] Figure 32A schematic cross-sectional view of a patient interface system 1 used in a nostril and mouth configuration is shown. In this embodiment, the mouth portion 40 may include a sealing ring 51 adapted to connect and seal the mouth portion 40 to the nose portion 20. Alternatively, the sealing ring 51 may be formed as part of the nose portion 20 and connected and sealed to the mouth portion 40. Furthermore, other types of connectors may be used, or the nose portion 20 and the mouth portion 40 may be formed as an integral element, thus eliminating the need for a sealing ring or other types of connectors.

[0816] exist Figure 32 In this embodiment, the flexible tube 5 is connected to the mouth portion 40 via a brace 8 and an optional inline AAV (anti-asphyxia valve) adapter 10, without utilizing the elbow 2 and the rotary connector 4. By moving the flexible tube 5 away from the front of the patient's face, the embodiment presents a very streamlined appearance.

[0817] Figure 35-1 A schematic cross-sectional view of a patient interface system 401 used in a nostril and mouth configuration is shown. The nose portion 420 may include a support portion 458 and a sealing portion 422. The sealing portion 422 includes a nose tip engagement portion 454 that engages and seals with the patient's nose tip, an upper lip engagement portion 456 that engages and seals with the patient's upper lip region, and a sealing ring 472 that engages and seals with the mouth portion 440. The sealing ring 472 may optionally be part of the mouth portion 440, rather than part of the nose portion 420.

[0818] Mouth portion 440 may include a swivel ring 444 connected to a flexible tube 405. The flexible tube 405 may be directly connected to the swivel ring 444, or it may be connected via an elbow, such as an elbow 402. Mouth sealing portion 442 forms a seal around the patient's mouth and includes an upper lip engagement portion 448 that forms a seal with the patient's upper lip region.

[0819] For the upper lip engagement portion 456 of the nose portion 420 and the upper lip engagement portion 448 of the mouth portion, there is a limited amount of space on the patient's upper lip. Therefore, the upper lip engagement portion 448 can be disposed between the support portion 458 of the nose portion 420 and the patient's upper lip. Figure 35-2 A mouth-sealing portion 442 with an upper lip engagement portion 448 is shown. The upper lip engagement portion 448 may be an ultrathin flat film having a thickness of about 0.1 mm to 0.3 mm, preferably about 0.2 mm, compared to the rest of the mouth-sealing portion 442, which may have a thickness of about 0.3 mm to 2 mm, preferably about 0.5 mm. However, portions of the mouth-sealing portion 442 may include thickened portions 409 around the sides of the mouth region corresponding to the patient's cheek region for added support. These thickened regions 409 may have a thickness of, for example, about 1.5 mm.

[0820] Figure 35-3 This is a schematic cross-sectional view showing further details of the patient interface system 401. Specifically, Figure 35-3 The diagram illustrates how the mouth-sealing portion 442 extends around the patient's mouth and how the nostril-widening engagement portion 427 engages with the widened nostrils of the patient. Additionally, the rear edge of the nasal-sealing region 470 is shown together with the edge of the nostril-sealing portion 422.

[0821] Figure 36-1 A schematic cross-sectional view of a patient interface system 501 used in a nostril and mouth mode is shown. The nose portion 520 may include a support portion 558, a sealing portion 522, and an optional decoupling portion 525. The sealing portion 522 includes a nasal tip engagement portion 554 that engages and seals with the patient's nasal tip and an upper lip engagement portion 556 that engages and seals with the patient's upper lip region. A sealing ring 572 that engages and seals with the mouth portion 540 may be attached to the decoupling portion. The sealing ring 572 may optionally be part of the mouth portion 540, rather than part of the nose portion 520.

[0822] The mouth portion 540 may include an optional cushioning rigidity 573 to increase the rigidity of the sealing portion 522. The cushioning rigidity 573 may be made of a polymer, such as polycarbonate, nylon, polypropylene, high-density foam, fabric with low tensile properties (e.g., 3D braided fabric), or silicone or gel with a higher Shore hardness (e.g., 70 Shore A). There is a limited amount of space on the patient's upper lip for an upper lip engagement portion 556 for the nose portion and an upper lip engagement portion for the mouth portion. Therefore, a foam patient contact portion 569 may be disposed in the gap between the padding on the mouth portion 540 and the upper lip engagement portion 556. The foam patient contact portion 569 may contact the patient's upper lip area and form a seal, thereby forming part of the mouth seal.

[0823] Figure 36-2 A schematic cross-sectional view of a patient interface system 501 used in a second nostril and mouth configuration is shown. A sealing ring 572 is formed as part of the mouth portion 540 and is adapted to engage and seal with the decoupling portion 525 of the nose portion 520. There is a limited amount of space on the patient's upper lip for an upper lip engagement portion 556 for the nose portion and an upper lip engagement portion for the mouth portion. In this embodiment, a foam patient contact portion 569 is configured to abut against the decoupling portion 525 and a pad on the mouth portion 540, and to contact and form a seal with the patient's upper lip region. The foam patient contact portion 569 can form part of the mouth seal. Figure 36-1 The 573 buffer rigid component can also be used Figure 36-2 The implementation scheme and any other implementation scheme disclosed herein.

[0824] Figure 48A schematic cross-sectional view of a patient interface system 1100 used in a nostril and mouth mode is shown. The patient interface system 1100 may be... Figure 40 A variation of the patient interface system 701 is shown. The patient interface system 1100 includes a nose portion 1120, a mouth portion 1130, and a double elbow 1140. The lower end 1141 of the double elbow 1140 is adapted to connect to a rotary joint 1105, which can be connected to a flexible tube to deliver air to the patient interface system 1100. The lower end 1141 can be connected to the rotary joint 1105 via a ball-and-socket arrangement (as shown), the ball-and-socket arrangement being adapted to provide a greater degree of mobility for both the rotary joint and the air delivery tube. Alternatively, the lower end 1141 can be connected to the rotary joint 1105 in any arrangement, such as interference fit, overmolding, etc.

[0825] The first air passage or branch 1146 of the double elbow 1140 is adapted to communicate with an opening in the mouth portion 1130, and the second air passage or branch 1148 of the double elbow 1140 is adapted to communicate with an opening in the nose portion 1120. A first elbow ring 1142 and a second elbow ring 1144 are used to connect the double elbow 1140 to the nose portion 1120 and the mouth portion 1130, respectively, although other types of connectors may also be used. The double elbow may include barbed end portions 1143 at the ends of the first branch 1146 and the second branch 1148 for engagement with the mouth portion 1130 and the nose portion 1120.

[0826] The mouth portion 1130 includes a lower lip engagement portion 1134 adapted to form a seal below the patient's lower lip, and an upper lip engagement portion 1132 adapted to form a seal directly above the patient's upper lip. The nose portion 1120 includes a nozzle 1122 adapted to position the nose portion 1120 near the patient's nostrils and ensure that the foam portion 1154 is in a position to seal with the patient's nostrils, although a bolus, nasal chamber, nasal support (nostril seal), or membrane seal may also be used to form a seal with the patient's nostrils.

[0827] The mouth portion 1130 may be a single-walled or fabric / foam composite mouth portion with a relatively low Shore hardness. The nose portion 1120 may have a hardness of, for example, about 40 Shore A.

[0828] Figure 49 A schematic cross-sectional view of a patient interface system 1100 used in a nostril and mouth mode is shown, and it is compared with a system having a different nasal portion 1150. Figure 48The patient interface system 1100 is identical to this one. The nasal portion 1150 includes a support portion 1153 supporting a nozzle 1152 and a foam portion 1154. The nozzle 1152 and the foam portion 1154 together form a sealing portion adapted to form a seal with the patient's nostrils. The nozzle 1152 may have an air passage whose size gradually decreases as air approaches the patient's nostrils. The support portion 1153 may have a hardness of, for example, 40 Shore A. The nozzle 1152 helps support the foam portion 1154 in a position close to the patient's nostrils. The foam portion 1154 allows for a wider range of fit because the foam, due to its compressibility, can adapt to various nostril sizes. The foam portion 1154 also provides patient comfort.

[0829] Figure 50 A schematic cross-sectional view of a patient interface system 1100 with a nose portion 1160 for use in a nostril and mouth configuration is shown. The nose portion 1160 includes a support portion 1162 and a sealing portion 1164. The support portion 1162 may be made of silicone and serves as an intermediate or connecting portion between the double elbow 1140 and the sealing portion 1164.

[0830] The support portion 1162 positions the sealing portion 1164 below the user's nostrils and holds the sealing portion 1164 in that position. The support portion 1162 may include substantially parallel side portions and an end portion 1165 formed substantially perpendicular to the side portions. The end portion 1165 provides an interface for the sealing portion 1164. The sealing portion 1164 may be made of foam, gel, or other suitable material. Preferably, the sealing portion 1164 is more flexible than the support portion 1162, thereby contributing to a comfortable seal and range of fit. The sealing portion 1164 may be a porous foam that forms a seal with the patient's nasal tip, upper lip, and nostrils. In one example, such as... Figure 50A As shown, the support portion may include a support wall 1162-1 (e.g., made of silicone or a material with a higher rigidity than the foam sealing portion) to prevent the foam from compressing and clogging the nostrils. In another example, as... Figure 50B As shown, the foam sealing portion 1164 may have a flared shape (e.g., an outward flare) with a silicone support wall underneath to ensure the structural stability of the foam and also to ensure a seal with the patient.

[0831] Figure 51 A schematic cross-sectional view of a patient interface system 1100 having a nose portion 1170 for use in a nostril and mouth configuration is shown. The nose portion 1170 includes a support portion 1172 and a sealing portion 1174. The sealing portion 1174 includes a nasal tip engagement portion 1176 and an upper lip engagement portion 1178. The support portion 1172 can form a seal directly above the patient's upper lip and can be positioned between the patient's upper lip and the upper lip engagement portion 1132 of the mouth portion 1130.

[0832] The support portion 1172 may have a higher Shore hardness than the sealing portion 1174. For example, the support portion may have a Shore hardness A of, for example, about 20-80, preferably 30-60, or about 40, while the sealing portion 1174 has a Shore hardness A of about 5-40 or about 20. The hardness of the sealing portion is generally lower than that of the support portion.

[0833] Figure 52 A schematic cross-sectional view of a patient interface system 1180 for use in both nostril and mouth mode is shown. The patient interface system has a mouth portion 1182 and a nose portion 1190. The nose portion 1190 can be removed from the patient interface system 1180 and can be replaced with a plug, so that the patient interface system 1180 can be used in mouth-only mode.

[0834] The nozzle portion 1182 includes an orifice for connecting an air supply to deliver air to the patient interface system 1180. An elbow 1188 is connected to the orifice via a sealing ring 1189. A rotary joint 1187 can be connected between the elbow 1188 and the air hose 1185. A rotating cuff (not shown) can be connected between the rotary joint 1187 and the air hose 1185.

[0835] The mouth portion 1182 includes a lower lip engagement portion 1184 adapted to form a seal below the patient's lower lip, an upper lip engagement portion 1186 adapted to form a seal directly above the patient's upper lip, and a decorative valve or covering valve 1183 for covering the nostrils and / or the tip of the nose (primarily for covering the tip of the nose), adapted to cover the patient's nostrils and nasal portion 1190, making the patient interface system 1180 more visually appealing. The covering valve 1183 extends upward to a sufficient height to cover the patient's nostrils and nasal portion 1190.

[0836] The nose portion 1190 may include a support portion 1192 and a sealing portion 1193. The sealing portion includes a nose tip engagement portion 1194 and an upper lip engagement portion 1196. The nose portion 1190 may be connected to an upper opening in the mouth portion 1182 via a mouth clip 1198 and a nostril clip 1198.1, and the nose portion 1190 may be placed within the mouth clip and nostril clip. When the nose portion 1190 is not used with the patient interface system 1180, the nose portion 1190 is removed from the mouth clip 1198, and a plug may be inserted into the mouth clip 1198 or the opening to provide a seal. The mouth clip 1198 may be made of silicone or other materials, such as nylon, polypropylene, etc.

[0837] Figure 53A schematic cross-sectional view of a patient interface system 1200 for use in both nostril and mouth modes is shown. The patient interface system has a mouth portion 1202 and a nose portion 1220. The nose portion 1220 can be removed from the patient interface system 1200 and can be replaced with a plug, such that the patient interface system 1200 can be used in a mouth-only mode and the nose portion can be used in a nostril-only mode.

[0838] The mouth portion 1202 includes an anterior portion 1204 or fascia, a lower lip engagement portion 1206, an upper lip engagement portion 1208, a nasal portion flap 1210, a decorative valve or covering valve 1212, and a decoupling portion 1214. The anterior portion or fascia 1204 may be a large, transparent window allowing the patient's mouth area to be visible. The nasal portion flap 1210 may be adapted to receive the nasal portion 1220 and engage it in a sealing manner with the nasal portion.

[0839] The nasal portion 1220 includes an attachment ring 1229 adapted to seal with the mouth portion 1202, a support portion 1222, and a sealing portion 1224. The attachment ring 1229 may be co-molded, welded, permanently snapped, or removably attached to the rest of the nasal portion 1220. The sealing portion 1224 includes a nasal tip engagement portion 1228 adapted to form a seal with the tip of the patient's nose, and an upper lip engagement portion 1226 adapted to form a seal just above the patient's upper lip.

[0840] The cover valve 1212 is located near the nose tip engagement portion 1228 of the nose portion 1220. Therefore, if the cover valve 1212 moves, the nose tip engagement portion 1228 also moves. Thus, a decoupling portion 1214 is included on the mouth portion 1202 at a location below the cover valve 1212. The decoupling portion 1214 is used to decouple forces applied to the mouth portion 1202 (such as forces that can be applied by movement of the air hose 1232) from those transmitted to the nose portion 1220.

[0841] The mouth portion 1202 includes a lower opening adapted to receive an elbow 1230, such as a gusseted elbow connected to the air delivery tube 1232. The gusseted elbow 1230 may include an anti-asphyxiation valve and / or one or more vents for expelling exhaled air. In nasal-only mode, the tube may be connected to a nasal pad or pillow.

[0842] Figure 54 and 55 A modular patient interface system 1260 is shown, which includes a mouth portion 1262 and a nose portion 1280. The patient interface system 1260 is adapted for use in a mouth-only mode, a nostril-only mode, or a mouth-nostril mode.

[0843] Mouth portion 1262 includes a lower lip engagement portion 1264, an upper lip engagement portion 1266 adapted to actuate the nose seal to engage with the face, a decoupling (accordion-style) portion 1270, and an orifice 1272. An orifice (not shown) may be provided on the front or bottom of the mouth portion for connecting an air source, such as an air hose connected via an elbow. The flexible portion 1270 may be air-actuated, or it may be a thinner wall section, for example, less rigid, forming a decoupling portion that decouples the force applied to the mouth portion 1262 from the force applied to the nose portion 1280. When used in mouth-only mode, the orifice 1272 may be plugged to provide an airtight seal.

[0844] The nose portion 1280 includes a support portion 1282, a sealing portion 1284, and a headband connector 1290. The sealing portion 1284 is adapted to seal against the patient's upper lip and nasal tip. When used in nostril-only mode, the opening 1274 can be connected to an air source, or blocked if air is supplied alternatively. When used in nostril and mouth mode, a nostril clip 1286 can be attached, preferably permanently attached, or otherwise formed into the support portion 1282, and a mouth clip 1268 can be attached, preferably permanently attached, or otherwise formed into the padding of the mouth portion 1262. The nostril clip 1286 and mouth clip 1268 are adapted to be sealed together, for example, by notches formed on the clips, such that the mouth portion 1262 can be connected to the nose portion 1280 in a nostril and mouth manner.

[0845] Figure 60 A cross-sectional view of a modular patient interface system 1350 is shown, which includes a mouth portion 1352 and a nose portion 1360. The nose portion 1360 can be removed from the patient interface system 1350 and can be replaced with a plug, such that the patient interface system 1350 can be used in a mouth-only mode, or the nose portion 1360 can be used in a nostril-only mode.

[0846] The mouth portion includes a frame 1354 and a mouth seal 1355. A first opening 1351 is positioned in the frame 1354, which is adapted to receive an elbow 1374 for delivery from an air hose via a swivel joint 1376. A second opening 1357 is formed in the frame 1354 and can be plugged when the patient interface system is used in mouth-only mode; when the patient interface system 1350 is used in nostril and mouth mode, the second opening connects to the nose portion 1360.

[0847] The frame 1354 can be a rigid or semi-rigid material, such as polycarbonate. The mouth seal 1355 can be a flexible material, such as silicone. The mouth seal 1355 includes a lower lip engagement portion 1356 and an upper lip engagement portion 1358, the lower lip engagement portion being adapted to form a seal below the patient's lower lip, and the upper lip engagement portion being adapted to form a seal directly above the patient's upper lip (when used in mouth-only mode).

[0848] The nasal portion 1360 includes a support portion 1362 and a sealing portion 1364. The sealing portion 1364 includes a nasal tip engagement portion 1368 adapted to form a seal with the patient's nasal tip, and an upper lip engagement portion 1370 adapted to form a seal directly above the patient's upper lip. The support portion 1362 can also form a seal directly above the patient's upper lip. A ring 1359 can be used to connect the nasal portion 1360 to the mouth portion 1352.

[0849] Figure 66 A modular patient interface system 1430 is shown, which includes a mouth portion 1432 and a nose portion 1440. The mouth portion 1432 includes a pad portion 1434 adapted to form a seal around the patient's mouth.

[0850] The nasal portion 1440 includes a support portion 1446 and a sealing portion 1442. The sealing portion is adapted to form a seal with the patient's nostrils and includes a corner of the nasal region 1447 and an upper lip engagement portion 1443.

[0851] Magnets 1436 and 1448 can be placed on the mouth portion 1432 and the nose portion 1440 to ensure that the nose portion 1440 is correctly oriented relative to the mouth portion 1432. Either pair of magnets 1436 and 1448 can be replaced by a metal portion. Magnet 1448 in the nose portion 1440 can be placed in the corner of the nasal region 1447 to ensure sufficient tension in the nostril seal on the patient's upper lip and the corner of the nose.

[0852] Figure 67 A cross-sectional view of a modular patient interface system 1480 is shown, which includes a mouth portion 1482 and a nose portion 1490. The nose portion 1490 can be removed from the patient interface system 1480 and can be replaced with a plug, such that the patient interface system 1480 can be used in a mouth-only mode, or the nose portion 1490 can be used in a nostril-only mode. Alternatively, the system can be used in both nostril and mouth modes. In one example, separate foam components may be provided for the mouth and nose sealing portions, allowing the patient interface system to be used in either a mouth-only or nostril-only mode.

[0853] The mouthpiece portion 1482 includes a frame 1484 and a decorative valve flap or cover valve flap 1486, a lower orifice 1485 for connecting a rotating ring or bladder 1498 and an air hose 1499, and an upper orifice 1487 for connecting a nose portion 1490. The frame 1484 may be a rigid material, such as polycarbonate, or a semi-rigid material, such as semi-rigid nylon. The foam portion 1492 may have clips 1493 for attaching to the frame 1484.

[0854] The nose portion 1490 may include a flexible portion 1496, a foam portion 1492 that can be attached to the flexible portion 1496 by one or more clips 1493, and a nozzle portion 1494. A cover portion 1486 of the mouth portion 1482 may support the nose portion 1490. Alternatively, a permanent connection may be used, for example, by directly attaching the foam portion to the flexible portion.

[0855] Figure 67 , 68 Figures 69 and 69 illustrate a modular patient interface system 1500, which includes a mouth portion 1502 and a nose portion 1510. The nose portion 1510 can be removed from the patient interface system 1500 and can be replaced with a plug, such that the patient interface system 1500 can be used in a mouth-only mode, or the nose portion 1510 can be used in a nostril-only mode.

[0856] The nozzle portion 1502 includes a frame 1504 and a decorative or cover valve flap 1509, a lower orifice 1505 for connecting to an elbow 1507, and an upper orifice 1503 for connecting to a nose portion 1510. The frame 1504 may be a rigid material such as polycarbonate, or a semi-rigid or flexible material such as nylon or silicone. The foam portion 1506 may have clips 1508 for attaching to the frame 1504.

[0857] The nose portion 1510 may include a flexible portion 1512 (e.g., silicone) and a foam portion 1516, the foam portion being attached to the flexible portion 1512 via one or more clips 1514. A covering portion 1509 of the mouth portion 1502 may be spaced apart from the nose portion 1510. Clips 1508, 1514 may have surfaces facing the foam portion, said surfaces being angled to bias or facilitate the application of force to the foam in certain directions (e.g., toward the patient's lips).

[0858] Figure 70 A modular patient interface system 1520 is shown, comprising a mouth portion 1522 and a nose portion 1540. The nose portion 1540 can be removed from the patient interface system 1520 and can be replaced with a plug, such that the patient interface system 1520 can be used in a mouth-only mode, or the nose portion 1540 can be used in a nostril-only mode. Alternatively, the system can be used in both mouth and nose modes.

[0859] Mouth portion 1522 includes a frame 1523, a lower opening 1527 for connecting an elbow 1560 (which may include a vent 1562) and an air hose 1566, and an upper opening 1528 for connecting a nose portion 1540. The frame 1523 may be a rigid material such as polycarbonate, or a more flexible material such as silicone. The lower lip engagement portion 1524 is adapted to form a seal with the patient's lower lip, while the upper lip engagement portion 1526 is adapted to form a seal with the patient's upper lip.

[0860] The nasal portion 1540 includes a support portion 1542 and a sealing portion 1544. The sealing portion 1544 includes an upper lip engagement portion 1548 and a nasal tip engagement portion 1546. The upper lip engagement portion is adapted to seal directly above the patient's upper lip, and the nasal tip engagement portion is adapted to form a seal with or near the patient's nasal tip. In the upper lip region, the support portion 1542 may contact the upper lip engagement portion 1526 of the mouth portion 1522. When used in nostril-only mode, the orifice 1528 may be connected to an air source, or blocked if air is alternatively supplied.

[0861] When used in nostril and mouth mode, a connecting ring 1550 can be used. The connecting ring 1550 has a first channel 1552 and a second channel 1554. The first channel 1552 is adapted to receive the mouth portion 1522 and the second channel 1554 is adapted to receive the nose portion 1540.

[0862] Figure 71 A modular patient interface system 1580 is shown, which includes a mouth portion 1582 and a nose portion 1590, the mouth portion and nose portion providing a soft connection between the nose portion and the mouth portion. The nose portion 1590 can be removed from the patient interface system 1580 and can be replaced with a plug, such that the patient interface system 1580 can be used in a mouth-only mode, or the nose portion 1590 can be used in a nostril-only mode.

[0863] Mouth portion 1582 includes a frame 1589, a lower orifice 1579 for connecting to an elbow 1581, an air hose 1587, and an upper orifice 1577 for connecting to a nose portion 1590. In one example, the elbow may include a button adapted to allow for quick release of the elbow. A vent 1585 may be formed in the elbow 1581, for example, via a vent ring interconnecting the elbow and the frame, or alternatively, the vent may be formed in the mouth portion 1582. A lower lip engagement portion 1584 is adapted to form a seal with the patient's lower lip, while an upper lip engagement portion 1586 is adapted to form a seal with the patient's upper lip.

[0864] The nasal portion 1590 includes a supporting portion 1592 and a sealing portion 1594. The sealing portion 1594 includes an upper lip engagement portion 1598 adapted to form a seal with the patient's upper lip and a nasal tip engagement portion 1596 adapted to form a seal with the patient's nasal tip.

[0865] The nose portion 1590 may have a recess 1595 adapted to form an interference fit with the mouth portion 1582. The nose portion 1590 may be elastic and can be pressed inward to receive the mouth portion in the recess and then spring back to its original shape. The "trumpet" shape on the mouth portion provides an inlet to guide the nose portion into place. In addition, a thin silicone wall may be provided to seal around the nose portion.

[0866] Figure 72 A modular patient interface system 1600 is shown, which includes a mouth portion 1602, a nose portion 1610, an elbow and swivel joint 1612, an upper headband 1618 with a back strap 1619, and a lower headband 1620 with a back loop 1622.

[0867] The upper headband 1618 is adapted to be connected to the nose portion 1610 via connector 1617, and the lower headband 1620 is adapted to be connected to the mouth portion 1602 via connector 1615. The back strap 1619 of the upper headband 1618 can be inserted through the back loop 1622 of the lower headband 1620. Alternatively, another strap can be connected from the back strap 1619 to the back loop 1622.

[0868] Figure 73 A modular patient interface system 1630 is shown, comprising a mouth portion 1632, a nose portion 1640, an elbow 1644, and an air hose 1646. The mouth portion 1632 may have an opening 1634 adapted to receive a lug provided on the back of the elbow 1644. Thus, the nose portion 1640 can operate independently of the mouth portion 1632, or it can be connected to the mouth portion 1632. In the example shown, the mouth portion can be connected to the nose portion without disconnecting the elbow.

[0869] Example Gasket 1:

[0870] Figures 74-79 A patient interface system 1650 is shown, which has a mouth portion 1652 and a nose portion 1660. Figure 80 The nose portion 1660 is shown. Figure 81 The mouth portion, fascia, or supporting structure is shown 1652. Figures 82 to 95 The pad 1654 of the mouth portion 1652 is shown.

[0871] The mouth portion 1652 is removably detachable from the nose portion 1660, although the two portions can be molded together. Sealing ring 1665 ( Figure 79 This can be used to connect the mouth portion 1652 to the nose portion 1660. The orifice 1656 is adapted to connect to an air source to deliver air to the patient interface system 1650. The mouth portion includes: a lining fascia portion 1657 (which may be transparent or translucent); and a decoupling portion 1659, which may be a thinner portion compared to the rest of the front portion of the mouth portion, to decouple the force exerted by the movement of the elbow / air hose connected to the orifice 1656 from the rest of the patient interface system 1650.

[0872] A decorative or covering valve 1658 covers / supports the patient's nostril area. Preferably, the decorative valve covers all or part of the nostril seal portion 1660. Such an arrangement is less visually noticeable to the patient and can help stabilize the nostril seal portion 1660.

[0873] The liner 1654 is connected to the liner fascia portion 1657 and is adapted to form a seal around the patient's mouth. The connection between the liner 1654 and the liner fascia portion 1658 can be achieved by an interference fit, such as a tongue and groove.

[0874] The lower headband connector (not shown) can be as follows Figure 30 The padding is positioned in front of the mouth portion 1652 as shown. Both the padding 1654 and the padding fascia portion 1657 can have a Shore A hardness of 40 or similar. Alternatively, the padding fascia portion 1657 can have a relatively higher hardness compared to the padding 1654. The padding fascia portion 1657 can be constructed from a semi-rigid polymer, such as nylon, polycarbonate, or polypropylene. The padding fascia portion 1657 can have a Shore A hardness of 40-80. The padding 1654 can be constructed from a suitable material, such as silicone, foam, gel, or TPE. The padding 1654 can be constructed from a material having a Shore A hardness of 5-40, for example, 5-25 Shore A.

[0875] The pad 1654 can be constructed from a combination of various materials, such as a first portion with a first hardness near the fascia portion of the pad and a second portion with a second hardness near the patient contact portion. Preferably, the first hardness is greater than the second hardness to provide structural support to the patient contact portion. For example, the first portion may have a hardness of 25-60 Shore A or 35-50 Shore A. The second portion may have a hardness of 5-25 Shore A or 5-15 Shore A. The first portion may be thicker than the second portion; for example, the first portion may be 1-3 mm or 1-2 mm, and the second portion may be 0.1-2 mm, 0.1-1 mm, or approximately 0.8 mm. The combination of the thin-walled segment and the soft material at the second portion allows the pad to be more compliant and flexible, thereby shaping it to fit the patient's face. The thicker first portion provides structure to provide stability. Together, they allow for a single-walled pad that essentially mimics a double-walled pad.

[0876] Preferably, the pad 1654 in the chin region 1693 can be flexible and / or can have low stiffness (e.g., 5-15 Shore A), such that when the pad is placed on the user's face, the pad stretches on the patient's chin. This stretching of the pad in the chin region 1693 allows the pad to be in a taut state on the patient's chin, which can form a strong seal with the patient's chin and ensure that the pad can accommodate a wider range of chin geometries.

[0877] Pad 1654 includes a pad fascia connection portion 1655 adapted to connect to pad fascia 1657. Figure 82 The ring connection portion 1680 and the notch 1684 are present. In one alternative, the padding fascia and the padding can be formed as a single piece. The ring connection portion 1680 includes an aperture 1682 adapted to receive a connecting ring (for connecting the mouth portion 1652 to the nose portion 1660). In one alternative, the ring connection portion and the connecting ring can be formed as a single piece. In another alternative, the padding can be formed with a first connecting ring and the nose portion can be formed with a second connecting ring, the first connecting ring being received by the second connecting ring (or vice versa).

[0878] The notch 1684 is adapted to receive the nose portion 1660 or other portions of the nose portion 1660 (e.g., the headband connector portion of the nose portion 1660) of the gusset 1671. Figure 80 Different shaped notches can be used if different nose portions are used. The notch 1684 is recessed in the liner 1654 so as not to interfere with the seal of the liner 1654 when the nose portion 1660 is in the notch 1684. That is, the notch 1684 can be located below or offset below the uppermost surface of the mouth liner 1654.

[0879] The notch 1684 can also be a recess, groove, channel, hollow, small notch, recess, dimple, dent, depression, pit, pit, valley, or sinkhole—that is, an area of ​​the liner adapted to receive the nasal portion, which has an alternative or abstract geometry when compared to the rest of the mouth liner. The notch may not be a hole, cut, or orifice. The notch can be airtight. The notch can be formed of a soft, comfortable material, such as the mouth liner, rather than a frame. This arrangement is preferred because a comfortable notch allows for adjustment of the nasal portion's position to fit more patients. The notch allows the nasal portion to move in the up-down direction to accommodate different patient nasal heights. For example, the notch can increase rigidity when air pressure is applied to the mouth liner. The notch can stabilize the nostril portion in the medial-lateral direction. This can be achieved by the shape of the notch adapted to match the shape of the nasal portion. This arrangement ensures that the nasal portion maintains a sealed engagement with the patient's nostrils during use when tube resistance or other forces are applied to the sides of the patient interface.

[0880] The nasal seal portion may reside or rest within the notch. The patient contact portion of the nasal seal portion may be positioned outside, above, or above the notch. This arrangement ensures that the patient can see the nasal seal portion contacting their nose to ensure alignment and a seal.

[0881] In one configuration, the nasal seal may be in airflow communication with the mouth portion without passing through a notch.

[0882] The notch may have lower stiffness than the surrounding portion of the mouth liner. The notch may have a relatively thinner wall section than other areas of the mouth liner. The notch may be formed of a different material than the rest of the mouth liner.

[0883] The notch may be continuous with or integral with the upper lip contact area of ​​the lip pad and thus form a seal with the patient's upper lip.

[0884] The mouth pad may include an upper lip region adapted to engage with the patient's upper lip. The mouth pad may further include a cheek region adapted to connect with the patient's cheek and / or lateral lip interface. The mouth pad defines a wall between the patient contact portion of the mouth pad and the frame contact portion of the mouth pad. The wall may include different portions, such as an upper lip wall portion, a chin wall portion, and two cheek wall portions, each corresponding to a corresponding upper lip, chin, and cheek region of the patient's face. In one form, the cheek wall portions may be harder than the upper lip wall portions. In another form, the chin wall portions may be harder than the upper lip wall portions. In some forms, the upper lip portions may be less rigid than the cheek wall portions. In such arrangements, the cheek contact portions can compressively act on the patient's cheek, allowing the upper lip and chin regions to be un...

Claims

1. A patient interface system for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal seal portion adapted to form a seal with a patient's face around an entrance to the patient's nares, the nasal chamber including a nasal chamber opening; an entrance conduit connected to the entrance opening in the nasal portion to deliver pressurized breathable gas to the nasal chamber and configured to contact at least an area of the patient's head superior to the patient's head's otobasion superior; a nasal chamber coupling component adapted to form part of a releasable fluid coupling to enable the nasal portion to be fluidly coupled to a mouth portion to transmit a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion; and a removable vent module adapted to be attached to the nasal chamber to exhaust gases exhaled by the patient; the vent module being arranged to be releasably connected with the nasal chamber coupling component such that the patient interface system is configurable in a first mode in which the vent module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal only patient interface and a second mode in which the vent module is removed from the nasal chamber to enable the nasal portion to be fluidly coupled to the mouth portion to transmit a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion.

2. The patient interface system of claim 1, wherein the nasal portion includes a nasal cushion forming at least a portion of the nasal chamber, and wherein the nasal chamber opening and the coupling component are formed in the nasal cushion. the nasal cushion is a pillow cushion.

3. The patient interface system of claim 2, wherein, the nasal cushion is a cradle cushion.

4. The patient interface system of claim 2, wherein, the coupling component includes a clip mechanism extending around the nasal chamber opening and arranged to form part of a resilient clip connection.

5. The patient interface system of claim 1, wherein, the clip mechanism includes a resilient hinge.

6. The patient interface system of claim 5, wherein, the coupling component includes at least a partial perimeter extending around the nasal chamber opening.

7. The patient interface system of claim 1, wherein, the perimeter includes at least one of a protrusion or a recess to allow an interlocking connection.

8. The patient interface system of claim 7, wherein, the perimeter includes a ramped surface to provide a lead-in surface to a resilient connection.

9. The patient interface system of claim 7, wherein, the coupling component forms part of a latching connection.

10. The patient interface system of claim 1, wherein, in the second mode, the removable vent module is adapted to be attached to an opening in the mouth portion.

11. The patient interface system of claim 1, wherein, 12. The patient interface system of claim 1, further including at least one guide vane to provide an obstruction to the fluid coupling in the first mode to direct airflow from the nasal chamber through the vent module.

13. The patient interface system of claim 12, wherein the at least one guide vane forms part of the vent module. the vent module is an anti-asphyxia vent, and wherein the anti-asphyxia vent includes a valve flap and the at least one guide vane is arranged to direct gas from the nasal chamber onto the valve flap.

14. The patient interface system of claim 12, wherein, 15. The patient interface system of claim 1, further including the mouth portion. ​ 16. The patient interface system of claim 15, wherein, The mouth portion includes a mouth chamber and a mouth seal portion adapted to form a seal with the patient's mouth, the mouth chamber including a mouth chamber opening adapted to receive pressurized breathable gas from the nasal chamber when the mouth portion has a fluid coupling to the nasal portion, such that the nasal portion is adapted to transmit the pressurized breathable gas to the mouth portion through the nasal chamber opening and the mouth chamber opening.

17. The patient interface system of claim 16, wherein, The mouth chamber includes a vent opening adapted to receive a vent, the vent opening being adapted to exhaust gases exhaled by the patient.

18. The patient interface system of claim 17, wherein the vent opening is configured to receive the removable vent module.

19. The patient interface system of claim 16, wherein, The mouth portion includes a mouth cushion forming at least a portion of the mouth chamber, and wherein the mouth chamber opening is formed in the mouth cushion.

20. The patient interface system of claim 16, wherein, The mouth portion further includes a mouth portion coupling component arranged to form a portion of the fluid coupling to connect the nasal portion and the mouth portion.

21. The patient interface system of claim 20, wherein, The mouth portion coupling component extends around the mouth chamber opening.

22. The patient interface system of claim 20, wherein, The mouth portion coupling component includes a clip mechanism extending around the mouth chamber opening and arranged to form a portion of a resilient clip connection.

23. The patient interface system of claim 22, wherein the clip mechanism includes a resilient hinge.

24. The patient interface system of claim 20, wherein, The mouth portion coupling component includes at least a partial circumference extending around the mouth chamber opening.

25. The patient interface system of claim 24, wherein, The at least partial circumference includes at least one of a protrusion or a recess allowing an interlocking connection.

26. The patient interface system of claim 24, wherein, The at least partial circumference includes a ramped surface to provide a lead-in surface to a resilient connection.

27. The patient interface system of claim 20, wherein, The mouth portion coupling component forms a portion of a latching connection.

28. The patient interface system of claim 20, wherein, The mouth portion coupling component is formed as an overmold incorporating a silicone cover layer and a rigid backing.

29. The patient interface system of claim 20, wherein, The mouth portion coupling component is adapted to directly connect with the nasal chamber coupling component to form the fluid coupling.

30. The patient interface system of claim 20, further including a connector adapted to form a portion of the fluid coupling and having a nasal portion end adapted to be attachable to the nasal chamber coupling component, an opposite mouth portion end attachable to the mouth portion coupling component, and a passageway extending between the nasal portion end and the mouth portion end.

31. The patient interface system of claim 30, wherein, The connector further includes at least one tab disposed in the passageway of the connector.

32. The patient interface system of claim 30, wherein, At least one of the nasal portion end or the mouth portion end includes a clamping mechanism to engage with the coupling component of the mouth portion.

33. The patient interface system of claim 30, wherein at least one of the nasal portion end or the mouth portion end is resiliently deformable to connect with the coupling component of the nasal portion or mouth portion.

34. The patient interface system of claim 30, wherein, At least one of the nasal portion end or the mouth portion end includes at least one of a protrusion or a recess allowing an interlocking connection with the coupling component of the nasal portion or mouth portion.

35. The patient interface system of claim 30, wherein, At least one of the nasal portion end or the mouth portion end includes a zero-part latch formation that allows for a latched connection with a nasal chamber coupling component of the nasal portion or a mouth portion coupling component of the mouth portion.

36. The patient interface system of claim 30, wherein, The connector incorporates a connector chamber between the nasal portion end and the mouth portion end.

37. The patient interface system of claim 30, wherein, The connector is formed as a unitary structure.

38. The patient interface system of claim 30, wherein, The connector is formed from multiple parts.

39. The patient interface system of claim 20, wherein, The anti-asphyxiation vent is integrally formed with the mouth portion coupling component.

40. The patient interface system of claim 30, wherein, The connector incorporates an anti-asphyxiation vent disposed between the nasal portion end and the mouth portion end.

41. The patient interface system of claim 40, wherein, The anti-asphyxiation vent includes a valve flap that extends across the interior of the passageway of the connector.

42. A patient interface system for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with a patient's face around an entrance to the patient's nares, the nasal chamber including a nasal chamber opening; an entrance conduit connected to an entrance opening in the nasal portion to deliver pressurized breathable gas to the nasal chamber and configured to contact at least an area of the patient's head superior to the patient's head's otobasion superior; a removable vent adapted to couple to a nasal chamber coupling component to exhaust gases exhaled by the patient, wherein the removable vent is arranged to releasably connect with the nasal chamber opening in a first mode in which the removable vent forms a first fluid coupling to the nasal chamber to enable the patient interface system to operate as a nasal only patient interface and a second mode in which the removable vent is removed from the nasal chamber to enable the nasal portion to form a second fluid coupling to a mouth portion to transmit a portion of the pressurized breathable gas through the nasal chamber opening to the mouth portion; and at least one guide vane that provides an obstruction to the first fluid coupling to direct airflow from the nasal chamber through the removable vent.

43. The patient interface system of claim 42, wherein the nasal portion includes a nasal cushion that forms at least a portion of the nasal chamber, and wherein the nasal chamber opening is formed in the nasal cushion.

44. The patient interface system of claim 43, wherein, The nasal cushion is a pillow cushion.

45. The patient interface system of claim 43, wherein, The nasal cushion is a cradle cushion.

46. The patient interface system of claim 42, wherein, The removable vent forms part of a vent module that is adapted with the nasal portion and incorporates the at least one guide vane.

47. The patient interface system of claim 42, further comprising a connector adapted to form part of the first fluid coupling, the connector having a nasal portion end adapted to fit with the nasal chamber, an opposite vent end adapted to fit with the removable vent, and a passageway extending between the nasal portion end and the vent end.

48. The patient interface system of claim 47, wherein, The connector further comprises the at least one guide vane disposed in the passageway of the connector.

49. The patient interface system of claim 42, wherein, The vent is an anti-asphyxiation vent.

50. The patient interface system of claim 49, wherein, The anti-asphyxia vent includes a valve flap, and the at least one guide vane is arranged to direct gas from the nasal chamber onto the valve flap.

51. The patient interface system of claim 42, further comprising the mouth portion.

52. The patient interface system of claim 51, wherein the mouth portion includes a mouth chamber and a mouth seal portion adapted to form a seal with the patient's mouth, the mouth chamber including a mouth chamber opening adapted to receive the pressurized breathable gas; and wherein the mouth portion includes a mouth chamber coupling component adapted to form part of a releasable fluid coupling to enable the mouth portion to be fluidly coupled to the nasal portion to receive the portion of the pressurized breathable gas from the nasal portion through the mouth chamber opening of the mouth chamber.

53. The patient interface system of claim 52, wherein, The mouth portion includes a mouth cushion forming at least a portion of the mouth chamber, and wherein the mouth chamber opening is formed in the mouth cushion.

54. The patient interface system of claim 52, wherein, The mouth chamber coupling component extends around the mouth chamber opening.

55. The patient interface system of claim 52, wherein, The mouth chamber coupling component includes a clip mechanism extending around the mouth chamber opening and arranged to form part of a resilient clip connection.

56. The patient interface system of claim 55, wherein the clip mechanism includes a resilient hinge.

57. The patient interface system of claim 52, wherein the mouth chamber coupling component includes at least a partial perimeter extending around the mouth chamber opening.

58. The patient interface system of claim 57, wherein the at least partial perimeter includes at least one of a protrusion or a recess to allow an interlocking connection.

59. The patient interface system of claim 57, wherein the at least partial perimeter includes a ramped surface to provide a lead-in surface to a resilient connection.

60. The patient interface system of claim 52, wherein the mouth chamber coupling component forms part of a latching connection.

61. The patient interface system of claim 52, wherein the mouth chamber coupling component is formed as an overmold incorporating a silicone cover layer and a rigid backing.

62. The patient interface system of claim 52, wherein, The anti-asphyxia vent is integrally formed with the mouth chamber coupling component.

63. The patient interface system of claim 42, wherein, the mouth portion includes a mouth chamber and a mouth seal portion adapted to form a seal with the patient's mouth, the mouth chamber including a mouth chamber coupling component adapted to receive pressurized breathable gas; and The removable vent is an anti-asphyxia vent formed as part of the mouth chamber coupling component.

64. The patient interface system of claim 63, wherein the mouth chamber coupling component is formed as an overmold incorporating a silicone cover layer and a rigid backing.

65. The patient interface system of claim 63, wherein, The at least one guide vane directs a flow of gas towards the anti-asphyxia vent.

66. The patient interface system of claim 65, wherein, The anti-asphyxia vent includes a valve flap, and the at least one guide vane is arranged to direct the flow of gas onto the valve flap.

67. A patient interface system for use in delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal seal portion adapted to form a seal with the patient's nares, the nasal chamber including a nasal opening; the anti-asphyxia vent includes a valve flap, and the at least one guide vane is arranged to direct the flow of gas onto the valve flap. a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with the patient's mouth, the mouth chamber comprising an opening adapted to receive pressurized breathable gas; an inlet conduit connected to at least one of the nasal portion or the mouth portion to deliver the pressurized breathable gas; a connector enabling the mouth portion to be coupled to the nasal portion to provide a sealed connection between the nasal opening in the nasal chamber and the opening in the mouth chamber, the connector comprising an anti-asphyxia vent; and a removable vent module adapted to be attached to the nasal chamber to exhaust gas exhaled by the patient; the removable vent module is arranged to be releasably connected with the nasal chamber, enabling the patient interface system to be configured in a first mode in which the vent module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal only patient interface, and a second mode in which the vent module is removed from the nasal chamber so that the patient interface system is configurable such that the nasal portion is coupled to the mouth portion by the connector to enable a portion of the pressurized breathable gas to be transferred between the nasal chamber and the mouth chamber, with the anti-asphyxia vent disposed between the nasal portion and the mouth portion.

68. The patient interface system of claim 67, wherein, the anti-asphyxia vent comprises a valve flap extending across an internal passageway of the connector.

69. The patient interface system of claim 68, wherein, the connector comprises one or more vanes extending across at least a portion of the internal passageway to direct airflow onto the valve flap.

70. The patient interface system according to any one of claims 15, 51, and 67, wherein, at least one of the nasal portion and the mouth portion comprises a headgear connector adapted to be connected to a headgear.

71. The patient interface system of claim 70, wherein, both the nasal portion and the mouth portion comprise headgear connectors to be connected to the headgear.

72. The patient interface system of claim 71, wherein, the headgear further comprises a complementary patient interface connector adapted to connect the headgear to either or both of the nasal portion and the mouth portion.

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