Patient interface and positioning and stabilizing structure for a patient interface - Patents.com

Abstract

A patient interface system for delivering respiratory therapy to a patient includes a nasal section including a nasal chamber including an opening that forms a seal with the patient's face and surrounds an entrance to the patient's nares, and a nasal sealing section; an inlet conduit connected to the nasal section for delivering breathable pressurized gas to the nasal chamber; and a nasal chamber connection component adapted to form part of a releasable fluid connection that allows the nasal section to be fluidly connected to the mouth section for communicating a portion of the breathable pressurized gas through the nasal chamber opening to the mouth section.

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit of Australian Provisional Application No. 2019903367, filed September 10, 2019, Australian Provisional Application No. 2020901773, filed May 29, 2020, and Australian Provisional Application No. 2020900590, filed February 28, 2020, all of which are incorporated herein by reference in their entireties. [Background technology]

[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

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

[0004] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into the respiratory bronchioles and ultimately the alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory zone. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

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

[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous illnesses and conditions that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disease characterized by muscle impairment that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); and (ii) degenerative or slowly progressive disease characterized by muscle impairment that worsens over years but only mildly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to benefit otherwise healthy individuals. However, these suffer from several deficiencies.

[0016] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0018] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0020] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0021] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with ambient pressure for treatment to occur (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.

[0024] Certain other patient interface systems may be functionally inadequate in this field. For example, a purely cosmetic patient interface may not be able to maintain a suitable pressure. A patient interface system used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0025] Certain patient interfaces may be clinically undesirable with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] Certain patient interfaces may be uncomfortable or impractical in this technology if the patient must insert a portion of the mask structure into their mouth and create and maintain a seal via their lips.

[0027] Certain patient interfaces may be impractical for use while sleeping (eg, when sleeping on one's side in bed with one's head resting on a pillow).

[0028] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0029] These challenges can lead to one or more of the following: some patient interfaces can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While patient interfaces specifically designed for aviators, personal protective equipment (e.g., filter masks), masks designed as part of SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such patient interfaces may be undesirably uncomfortable to wear for extended periods (e.g., several hours). This discomfort can reduce patient compliance with treatment, especially if the patient interface is worn while sleeping.

[0030] CPAP therapy is highly effective in treating certain respiratory conditions if patients comply with the therapy. If the patient interface is uncomfortable or difficult to use, patients may not comply with therapy. Because patients are often encouraged to clean their patient interface regularly, if the patient interface is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their patient interface, which can affect patient compliance.

[0031] Patient interfaces designed for use in treating sleep-disordered breathing may be suitable for other applications, while patient interfaces for other applications (e.g., aviators) may be unsuitable for treating sleep-disordered breathing.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0034] Patient interfaces may be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region during use, for example, by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These various types of patient interfaces may be known by various names depending on the manufacturer, such as nasal patient interfaces, full-face patient interfaces, nasal pillows, nasal puffs, and oronasal patient interfaces.

[0035] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure can be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both must be adapted to form a seal.

[0037] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface while the seal-forming structure is engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed from an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the patient interface to provide a self-sealing action against the patient's face when positive pressure is applied within the patient interface. As with older style seal-forming sections, a poor fit between the face and the patient interface can require additional force to achieve a seal or cause the patient interface to leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can crease or buckle during use, resulting in leakage.

[0039] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find this uncomfortable.

[0040] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0041] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0042] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0043] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGELIBERTY® Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications Nos. WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); and International Patent Application No. WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0044] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0045] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0046] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0047] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example, by actuating the device to generate a flow of air for delivery to an interface with the airway. This flow of air can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0048] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort in the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0049] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0050] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0051] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0052] 2.2.3.5 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0053] The vent may include an orifice through which gas may flow when the patient interface is in use. Many such vents are noisy. Others may block during use, resulting in insufficient pumping. Some vents may disrupt the sleep of the patient 1000 and their bedmate, for example, due to noise or concentrated airflow.

[0054] ResMed has developed several improved patient interface ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; 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; U.S. Patent Application Publication No. 2009 / 0044808. Summary of the Invention [Means for solving the problem]

[0055] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0056] One aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0057] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0058] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0059] One aspect of the present technology is directed to a patient interface system that can be used as both a nasal-only patient interface and an oronasal patient interface.

[0060] Another aspect of the present technology relates to an oronasal patient interface comprised of generally flexible components.

[0061] Another aspect of the present technology relates to an oral-nasal patient interface that is stabilized at a nasal seal location separate from the oral seal location.

[0062] Another aspect of the present technology relates to an oronasal patient interface having at least a first headgear connection point at a nasal region of the patient interface and at least a second headgear connection point at a mouth region of the patient interface.

[0063] Another aspect of the present technology relates to a modular patient interface system adapted for use in a nostril-only configuration or a nostril and mouth configuration.

[0064] Another aspect of the present technology relates to a modular patient interface system adapted for use in a nostril-only configuration, a mouth-only configuration, or a nostril and mouth configuration.

[0065] One aspect of the present technology is directed to a patient interface comprising at least one plenum chamber for a patient interface, the plenum chamber being pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle.

[0066] In one form of the present technology, the patient interface system is provided with a nose site and a mouth site, and at the patient's option, both the nose site and the mouth site, or just the nose site, can be used. When used in conjunction with the nose site, the mouth site can be used to deliver respiratory therapy to the patient's mouth or can be used as a mouth seal.

[0067] In one form of the present technology, the patient interface system is provided with nasal and oral sites, and is at the patient's option to use both nasal and oral sites, just the nasal sites, or just the oral sites.

[0068] In one form of the present technology, the patient interface system is provided with nasal and oral regions, the nasal regions including nostril sealing regions adapted to form a seal with the patient's nares, the nostril sealing regions being configured to extend or curve outwardly from a support wall that defines an airway to the nostril sealing regions.

[0069] Another aspect of the present technology relates to a patient interface system that includes a nose region and a mouth region, the mouth region adapted for use in both a first configuration in which at least a portion of the breathable pressurized gas is delivered to the patient's mouth, and a second configuration in which the mouth region functions as a mouth seal to prevent any of the breathable pressurized gas from being delivered to the patient's mouth.

[0070] Another aspect of the present technology relates to a method of providing a patient interface kit for delivering respiratory therapy to a patient, wherein the nasal and oral sites are at the patient's option to use both the nasal and oral sites, only the nasal sites, or only the oral sites.

[0071] Another aspect of the present technology is a method of providing a patient interface kit for delivering respiratory therapy to a patient, wherein nasal and oral sites are available for use, at the patient's option, either both the nasal and oral sites, only the nasal sites, or only the oral sites, and when both the nasal and oral sites are utilized, both the nasal and oral sites may be utilized to deliver pressurized air to the patient's nostrils and mouth, respectively, or one of the nasal and oral sites may be utilized to deliver pressurized air to the patient's nostrils or mouth while the other of the nasal and oral sites is utilized as a nostril seal or mouth seal.

[0072] Another aspect of the present technology relates to a method of converting a patient interface system having nasal and oral sites between a first mode and a second mode, wherein in the first mode the patient interface system is usable at the nasal and oral sites and in the second mode the patient interface system is usable at only the nasal sites.

[0073] Another aspect of the present technology relates to a kit that provides dedicated nostril sites for delivering respiratory therapy to a patient's nostrils, the dedicated nostril sites adapted to function in conjunction with the mouth site.

[0074] Another aspect of the present technology relates to a kit that provides an oral section for delivering respiratory therapy to a patient's mouth, the oral section adapted to function in conjunction with a nasal section.

[0075] Another aspect of the present technology relates to a method of providing respiratory treatment to one of a patient's nostrils only, a patient's mouth only, or both a patient's nostrils and mouth, and periodically varying the respiratory treatment to another one of the patient's nostrils only, a patient's mouth only, or both a patient's nostrils and mouth.

[0076] Another aspect of the present technology relates to a method of respiratory therapy, wherein a first patient interface having a first footprint is applied to a patient for a period of time and then removed, and a second patient interface having a second footprint different from the first footprint is applied to the patient for a second period of time.

[0077] Another aspect of the present technology relates to an oral section for delivering respiratory therapy to a patient's mouth, the oral section including a docking station adapted to receive a nasal section, which can function as a nostril-only device for delivering pressurized gas to the patient's nostrils.

[0078] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: nose sites adapted to form a seal with the patient's nares; an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas; and a mouth sealing site adapted to form a seal with the patient's mouth; and an inlet conduit connected to at least one of the nose sites or the mouth sites for delivering the breathable pressurized gas, the patient interface system adapted to selectively utilize the nose sites and / or the mouth sites in a first mode utilizing both the nose sites and the mouth sites, and a second mode utilizing the nose sites but not the mouth sites.

[0079] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: nose sections adapted to form a seal with the patient's nares; a mouth section including an oral plenum chamber and a mouth sealing section adapted to form a seal with the patient's mouth; and an inlet conduit connected to at least one of the nose section and the mouth section for delivering breathable pressurized gas to the patient, the nose section and the mouth section adapted to connect to each other, and the mouth section adapted to selectively function in both a first configuration in which at least a portion of the breathable pressurized gas is delivered to the patient's mouth, and a second configuration in which the mouth section functions as a mouth seal to prevent delivery of any breathable pressurized gas to the patient's mouth.

[0080] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface including a sealing portion including a nostril sealing portion and a mouth sealing portion, the nostril sealing portion adapted to form a seal with the patient's nares, the nostril sealing portion configured to extend or curve outwardly from a support wall defining an airway into the nostril sealing portion, the mouth sealing portion adapted to form a seal with the patient's mouth, the sealing portion adapted to connect to at least one inlet conduit for receiving a supply of breathable pressurized gas and to headgear for retaining the sealing assembly in place on the patient's head.

[0081] Another aspect of the present technology is a method of providing a patient interface system kit for delivering respiratory therapy to a patient, the method comprising: providing nose sites adapted to form a seal with the patient's nares; providing a mouth site comprising an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas; and a mouth sealing site adapted to form a seal with the patient's mouth; and providing an inlet conduit connectable to at least one of the nose site or the mouth site for delivering breathable pressurized gas, at the option of the patient, the patient interface system selectively utilizing the nose site and / or the mouth site in at least first and second modes, the first mode utilizing the nose site and the mouth site to deliver respiratory therapy to the patient's nares and the mouth site configured to either deliver respiratory therapy to the patient's mouth or seal the mouth site; and the second mode utilizing the nose site to deliver respiratory therapy to the patient's nose and not utilizing the mouth site as a seal or for delivering respiratory therapy.

[0082] Another aspect of the present technology relates to a method of converting a patient interface system for delivering respiratory therapy to a patient between a first mode and a second mode, the method including: providing a nose section adapted to form a seal with the patient's nares; providing a mouth section including an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas; and a mouth seal section adapted to form a seal with the patient's mouth; assembling the patient interface system in the first mode utilizing the nose section and the mouth section to provide respiratory therapy to the patient's nose; utilizing the mouth section to provide respiratory therapy to the patient's mouth or utilizing the mouth section as a mouth seal; and converting the patient interface system to a second mode utilizing the nose section to provide respiratory therapy to the patient's nose and not utilizing the mouth section. The nose section may include an upper lip section configured to seal with the patient's upper lip in use, the upper lip section having a stiffness similar to that of the central section, the upper lip section having a wall thickness approximately the same as that of the central section, and the upper lip section having a wall thickness thinner than that of the middle section.

[0083] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a mouth section including an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth; and a nose section docking station formed on the mouth section, the nose section docking station adapted to receive nose sections that can function as nostril-only devices for delivering pressurized gas to the patient's nares.

[0084] Another aspect of the present technology relates to a medical package including a kit for converting a CPAP device with nasal sections into a CPAP device having nostril and mouth sections, the medical package including a mouth section including an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas and a mouth sealing section adapted to form a seal with a patient's mouth, a vent plug adapted to occlude holes in the nostril sections, and headgear adapted to secure at least the mouth section to the patient's head.

[0085] Another aspect of the present technology relates to a system kit adapted to convert a nostril-only device for delivering respiratory therapy to a patient into a nostril and mouth device for delivering respiratory therapy to a patient, the system kit including: an oral section including an oral plenum chamber including an opening adapted to selectively receive breathable pressurized gas; and a mouth sealing section adapted to form a seal with the patient's mouth, such that the nostril-only device functions as a nostril and mouth device; a plug adapted to connect to either the opening of the oral plenum chamber or the opening of the nostril-only device; and headgear adapted to secure at least the oral section to the patient's head.

[0086] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a nose section adapted to form a seal with the patient's nares, a mouth section including an oral plenum chamber and a mouth seal section adapted to form a seal with the patient's mouth, and a bifurcated elbow having one branch connected to the nose section and another branch connected to the mouth section, for example, to deliver breathable pressurized gas to the nose and mouth sections.

[0087] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nose region adapted to form a seal with the patient's nares; an oral region including an oral plenum chamber and a mouth sealing region adapted to form a seal with the patient's mouth; and a covering flap extending from the oral region to cover the nose region and / or the patient's nares in use.

[0088] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a nose portion including a nostril sealing portion adapted to form a seal with the patient's nares, and a mouth portion including a mouth sealing portion adapted to form a seal with the patient's mouth, the mouth sealing portion being oriented in a generally horizontal direction and the nostril sealing portion being oriented in a generally vertical direction.

[0089] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nasal section including nostril sealing sections adapted to form a seal with the patient's nares and nostril supports; and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, wherein the nostril supports are of a semi-rigid material and the nostril sealing sections are of a flexible material.

[0090] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a nose section including nostril sealing sections adapted to form a seal with the patient's nares and nostril supports, and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, wherein the mouth section and / or nose section include magnets to hold the mouth section and / or nose section in place.

[0091] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nose region adapted to form a seal with the patient's nares; a mouth region adapted to form a seal with the patient's mouth; and a foam portion adapted to be fastened to at least one of the nose region and the mouth region to form a seal between the patient interface system and the patient.

[0092] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nose section including nostril sealing sections adapted to form a seal with the patient's nares and nostril supports; a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth; and a connecting ring adapted to connect the mouth section to the nose section, the connecting ring having a first channel adapted to receive the mouth section and a second channel adapted to receive the nose section.

[0093] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a nasal section including a sealing section adapted to form a seal with the patient's nares and a nostril support, and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, the nostril sealing section having indentations adapted to form an interference fit with the mouth section.

[0094] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nasal section including a sealing section and a nostril support adapted to form a seal with the patient's nares; a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth; upper headgear adapted to connect to the nasal section, the upper headgear including a back strap adapted to wrap around a back of the patient's head; and lower headgear adapted to connect to the mouth section, the lower headgear having loops to receive the back straps of the upper headgear.

[0095] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nose section including nostril sealing sections adapted to form a seal with the patient's nares; an elbow connected to the nose section for delivery of pressurized gas, the elbow including an ear; and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, the mouth section including an aperture selectively connectable to the elbow ear to connect the mouth section to the nose section.

[0096] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including: a nose section including nostril sealing sections adapted to form a seal with the patient's nares; and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, the mouth sealing section including a cushion shaped to receive the nose section and having corresponding pockets or regions of reduced stiffness.

[0097] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a nose section including nostril sealing sections and nostril supports adapted to form a seal with the patient's nares, and a mouth section including a mouth sealing section adapted to form a seal with the patient's mouth, the mouth section including a cushion and a cushion veneer section adapted to connect to the cushion, the cushion having a connection with an aperture adapted to receive a ring for connecting the nose section to the mouth section.

[0098] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system including a mouth seal portion that includes a mouth portion adapted to form a seal with a patient's mouth, the mouth seal portion not including a pocket.

[0099] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: nasal sections including nasal chambers including openings that form a seal with the patient's face and surround entrances to the patient's nares; nasal sealing sections; an inlet conduit connected to the nasal sections for delivering breathable pressurized gas to the nasal chambers; and a nasal chamber connection component that forms part of a releasable fluid connection that allows the nasal sections to be fluidly connected to the mouth sections for communicating a portion of the breathable pressurized gas through the nasal chamber openings to the mouth sections.

[0100] In some embodiments, (a) the nasal region comprises a nasal cushion forming at least a portion of the nasal chamber, the nasal chamber opening and the connecting component being formed in the nasal cushion, the nasal cushion being a pillow cushion; (b) the nasal cushion being a cradle cushion; (c) the connecting component comprising a clip mechanism extending near the nasal chamber opening and positioned to form a portion of the resilient clip connection; (d) the clip mechanism comprising a resilient hinge; (e) the connecting component comprising at least a partial periphery extending near the nasal chamber opening; (f) the periphery comprising at least one of a protrusion or a recess to enable a mating connection; (g) the periphery comprising a rake surface to provide a lead-in surface for the resilient connection; and / or (g) the connecting component forming a portion of the latch connection.

[0101] In some forms, the patient interface further comprises a removable vent module adapted to be attached to the nasal chambers for venting gases exhaled by the patient, the removable vent module being arranged for releasable connection to the nasal chamber connection components such that the patient interface system is configurable in a first mode in which the vent module is fluidly coupled to the nasal chambers 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 to fluidly couple the nose regions to the mouth regions to communicate a portion of the breathable pressurized gas to the mouth regions through the nasal chamber openings.

[0102] In some forms, (a) the patient interface further includes at least one guide vane that provides an obstruction to the fluid connection to direct the flow of gases from the nasal chambers 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 valve (AAV); and / or (d) the AAV includes a flap, and the at least one guide vane is positioned to direct gases from the nasal chambers onto the flap.

[0103] In some forms, the patient interface further comprises a mouth region including an oral region including an opening adapted to receive breathable pressurized gas and a mouth sealing region adapted to form a seal with the patient's mouth, such that when fluidly coupled, the nasal region communicates a portion of the breathable pressurized gas through the nasal chamber openings and the oral region opening to the mouth region.

[0104] In some embodiments, (a) the oral region includes a vent opening adapted to receive a vent adapted to exhaust gases exhaled by the patient; (b) the vent opening is configured to receive a removable vent module; (c) the mouth region includes a mouth cushion forming at least a portion of the oral region, the opening being formed in the mouth cushion; (d) the mouth region further includes a coupling component arranged to form a portion of a fluid coupling for connecting the nose region and the mouth region; and (e) the mouth region coupling component is configured to couple the periphery of the oral region opening to the mouth cushion. (f) the mouth area connection component includes a clip mechanism extending near the oral opening and positioned to form a portion of the resilient clip connection; (g) the clip mechanism includes a resilient hinge; (h) the mouth area connection component includes at least a partial periphery extending near the oral opening; (i) the periphery includes at least one of a protrusion or a recess to enable a mating connection; (j) the periphery includes a rake surface to provide a lead-in surface for the resilient connection; (k) the mouth area connection component forms a portion of the latch connection; and (l) a mouth area connection configuration. the element is formed as an overmold incorporating a silicone overlay and a hard backing material, (m) the oral section connection component is adapted to connect directly with the nasal chamber connection component to form a fluid connection, (n) the patient interface is adapted to form a portion of the fluid connection and further includes a connector having a nose section end attachable to the nasal chamber connection component, an opposing mouth section end attachable to the mouth section connection component, and a passageway extending between the nose section end and the mouth section end, (o) the connector further comprises at least one vane disposed in the connector passageway, (p) at least one of the nose section end or the mouth section end includes a clipping mechanism that engages with the mouth section connection component, (q) at least one of the nose section end or the mouth section end is resiliently deformable for connection with the nose section or the mouth section connection component, (r) at least one of the nose section end or the mouth section end includes at least one of a protrusion or a depression that enables a mating connection with the nose section or the mouth section connection component, and (s) at least one of the nose section end or the mouth section end(t) the connector incorporates a connector chamber intermediate the nose and mouth ends; (u) the connector is formed as a unitary structure; (v) the connector is formed from multiple components; (w) the anti-asphyxiation valve (AAV) is integrally formed with the mouth-region connection component; (x) the connector incorporates an anti-asphyxiation valve (AAV) disposed between the nostril and mouth-region ends; (y) the AAV includes a flap extending across an interior of the connector passageway; (z) the connector includes one or more guide vanes extending across at least a portion of the interior of the connection portion to direct gas flow within the connector passageway; (aa) the one or more guide vanes are positioned to direct gas from the nasal chamber onto the flap; and / or (ab) the patient interface further includes a locking member that forms part of the connection formed in at least one of the nose region or mouth-region connection component upon fluidly connecting the nose region to the mouth region.

[0105] In some embodiments, the mouth region further comprises a connection component arranged to form part of a fluid connection for connecting the nose region and the mouth region.

[0106] In some configurations, the oral chamber connection component is adapted to connect directly with the nasal chamber connection component to form a fluid connection.

[0107] In some forms, the patient interface is adapted to form part of the fluid connection and further comprises a connector having a nose-region end attachable to the nasal chamber connection component, an opposing mouth-region end attachable to the mouth-region connection component, and a passageway extending between the nose-region end and the mouth-region end.

[0108] In some embodiments, the connector incorporates an anti-asphyxiation valve (AAV) disposed between the nostril-region end and the mouth-region end.

[0109] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: nasal chambers including openings that form a seal with the patient's face to surround entrances to the patient's nares; nasal sections including nasal sealing sections; an inlet conduit connected to the nasal sections for delivering breathable pressurized gas to the nasal chambers; a vent fluidly connected to the openings in the nasal chambers to exhaust gases exhaled by the patient; and at least one guide vane that provides an obstruction to the fluid connection to direct the flow of gas from the nasal chambers through the vent.

[0110] In some embodiments, (a) the nose sections include nasal cushions that form at least a portion of the nasal chambers, the nasal chamber openings being formed in the nasal cushions; (b) the nasal cushions are pillow cushions; (c) the nasal cushions are cradle cushions; (d) the vent is attached to the nose section and forms part of a vent module incorporating at least one guide vane; (e) the patient interface further includes a connector adapted to form part of a fluid connection between the nasal chambers and the vent section, the connector having a nose section end adapted to be attached to the nasal chambers, an opposite vent end adapted to be attached to the vent section, and a passageway extending between the nose section end and the vent end; (f) the connector further includes at least one guide vane disposed in the connector passageway; (g) the vent is an anti-asphyxiation valve (AAV); and / or (h) the AAV includes a flap, the at least one guide vane being positioned to direct gases from the nasal chambers onto the flap.

[0111] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: an oral section including an opening adapted to receive breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth; and an oral section connection component adapted to form part of a releasable fluid connection that allows the mouth section to be fluidly connected to the nasal section for receiving a portion of the breathable pressurized gas from the nasal section through the mouth section opening.

[0112] In some embodiments, (a) the mouth area comprises a mouth cushion forming at least a portion of the oral area, and an opening is formed in the mouth cushion; (b) the mouth area connection component extends around the oral area opening; (c) the mouth area connection component comprises a clip mechanism extending near the oral area opening and positioned to form a portion of the elastic clip connection; (d) the clip mechanism comprises a resilient hinge; (e) the mouth area connection component comprises at least a partial periphery extending near the oral area opening; (f) the periphery comprises at least one of a protrusion or a recess to enable a mating connection; (g) the periphery comprises a rake surface to provide a lead-in surface for the elastic connection; (h) the mouth area connection component forms a portion of the latch connection; (i) the connection component is formed as an overmold incorporating a silicone overlay and a hard backing; and / or (j) the anti-asphyxiation valve (AAV) is integrally formed with the mouth area connection component.

[0113] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: an oral section including a connecting component adapted to receive a breathable pressurized gas; a mouth sealing section adapted to form a seal with the patient's mouth; and an anti-asphyxiation valve (AAV) forming part of the oral section connecting component.

[0114] In some forms, (a) the connecting component is formed as an overmold incorporating a silicone overlay and a hard backing material; (b) the patient interface further comprises at least one guide vane for directing gas flow into the AAV; and / or (c) the AAV includes a flap, and the at least one guide vane is positioned to direct gas flow onto the flap.

[0115] Another aspect of the present technology relates to a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: nose sections including nasal chambers including openings and nose sealing sections adapted to form a seal with the patient's nares; an oral section including an opening adapted to receive breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth; an inlet conduit connected to at least one of the nose section or the mouth section for delivering the breathable pressurized gas; and a connector adapted to connect the mouth section to the nose section to provide a sealed connection between the opening in the nasal chambers and the opening in the oral section, the connector including an anti-asphyxiation valve (AAV), wherein the patient interface system is configurable such that the nose section is connected to the mouth section through the connector to communicate a portion of the breathable pressurized gas between the nasal chambers and the oral section using the AAV disposed between the nose section and the mouth section.

[0116] In some forms, (a) the AAV includes a flap extending across an internal passage of the connector, (b) the connector includes one or more vanes extending across at least a portion of the internal passage and directing gas flow onto the flap, (c) at least one of the nose region and the mouth region includes a headgear connector adapted to connect to the headgear, (d) both the nose region and the mouth region include headgear connectors for connecting to the headgear, and (e) the headgear further includes a complementary patient interface connector adapted to connect the headgear to either or both of the nose region and the mouth region.

[0117] In accordance with another aspect of the present technology, there is provided a method of providing a patient interface system kit for delivering respiratory therapy to a patient, the method including: providing a nose section including a nasal chamber including an opening and a nose sealing section adapted to form a seal with the patient's nares, providing an inlet conduit connected to the nose section for delivering breathable pressurized gas to the nasal chamber, providing a mouth section including an oral section including an opening adapted to receive the breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth, providing a fluid connection for enabling a sealed connection between the opening in the nasal chamber and the opening in the oral section, and providing a removable nasal vent module adapted to attach to the opening in the nasal chamber. wherein, at the patient's option, the patient system selectively utilizes a patient interface in at least first and second modes, the first mode having the nasal sites connected to the mouth sites through a fluid connection to communicate a portion of the breathable pressurized gas between the nasal chambers and the oral site to deliver respiratory therapy through both the nasal sites and the mouth sites, and in the second mode the mouth sites are not connected to the nasal sites through the fluid connection and a nasal vent module is attached to an opening in the nasal chambers such that the patient interface system can deliver respiratory therapy as a nasal-only patient interface.

[0118] In accordance with another aspect of the present technology, there is provided a method of providing a patient interface system kit for delivering respiratory therapy to a patient, the method including: providing nose sections including nasal chambers including openings and nose sealing sections adapted to form a seal with the patient's nares; providing an inlet conduit connected to at least one of the nose sections or mouth sections for delivering breathable pressurized gas to the nasal chambers; providing a mouth section including an oral section including an opening adapted to receive the breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth; and providing a connector adapted to couple the mouth section to the nose section to provide a sealed connection between the opening in the nasal chamber and the opening in the oral section, the connector including an anti-asphyxiation valve (AAV), wherein the patient interface system is configurable such that the nose section is coupled to the mouth section through the connector for communicating a portion of the breathable pressurized gas between the nasal chambers and the oral section with the AAV disposed between the nose section and the mouth section.

[0119] In accordance with another aspect of the present technology, there is provided a method of converting a patient interface system, which is a mask system for delivering respiratory therapy to a patient, between a first mode and a second mode, the method including providing a nose section including a nasal chamber including an opening and a nose sealing section adapted to form a seal with the patient's nares, providing a mouth section including an oral section including an opening adapted to selectively receive breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth, assembling the mask system in the first mode utilizing the nose section and the mouth section to provide respiratory therapy to the patient's nares and utilizing the mouth section to provide respiratory therapy to the patient's mouth, and converting the mask system in the second mode utilizing the nose section to provide respiratory therapy to the patient's nares by disconnecting the mouth section from the nose section and incorporating a vent in the nasal chamber opening.

[0120] In accordance with another aspect of the present technology, there is provided a positioning and stabilizing structure for maintaining a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway in use for sealed delivery of airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure includes a first strap configured to pass around a posterior portion of the patient's head in use, and a fitting disposed on the first strap and forming part of a coupling for releasably attaching to the first strap a second strap connectable, at the patient's option, to additional components of the seal-forming structure selectively associated with the seal-forming structure.

[0121] According to another aspect of the present technology, there is provided a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on a patient's head, the patient interface comprising nasal regions including nasal chambers and nasal sealing regions adapted, in use, to form a seal with the patient's nares to hermetically deliver a flow of air at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure comprising: a first strap configured, in use, to pass around a back of the patient's head; and a fitting disposed on the first strap, the fitting forming part of a coupling for releasably attaching to the first strap a second strap connectable, at the patient's option, to a mouth region selectively associated with the nasal region such that the patient interface can deliver respiratory therapy through both the nasal region and the mouth region.

[0122] In some embodiments, (a) the attachment device includes an attachment region that allows for repositioning of the second strap within the attachment region; (v) the attachment device is formed from multiple components; (c) the connecting portion includes one or more hook or loop (hook and loop) fastening mechanisms; (d) the connecting portion includes at least one snap fastener; (e) the attachment device includes a guide portion to facilitate proper positioning of the second strap relative to the first strap; (f) the guide portion is in the form of indicia disposed on the first strap; (g) the guide portion includes at least one protrusion or depression, where at least one protrusion or depression allows for a mating connection with at least one corresponding protrusion or depression of the second strap; (h) the attachment device includes two or more guide portions spaced apart along the first strap; and (i) the attachment device includes at least one guide portion along a portion of the first strap. (j) the positioning and stabilizing structure further comprises a second strap having a complementary attachment for forming an interlock with the attachment of the first strap; (k) the complementary attachment comprises a flap extending laterally from the second strap, the flap being capable of passing through the slit in use to releasably attach the second strap to the first strap; (l) once threaded through the slit in use, the flap is releasably attached to the first strap to form at least a portion of the interlock; (m) once threaded through the slit in use, the flap 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 interlock; and / or (n) the interlock assists in dynamic stability of the positioning and stabilizing structure to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0123] In accordance with another aspect of the present technology, there is provided a patient interface system for delivering respiratory therapy to a patient, the patient interface system comprising: nasal chambers including openings that form a seal with the patient's face to surround entrances to the patient's nares, and nasal sealing regions; an inlet conduit connected to the nasal regions for delivering breathable pressurized gas to the nasal chambers; a positioning and stabilizing structure for holding the patient interface in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a first strap configured, in use, to pass around a posterior portion of the patient's head; and a fitting disposed on the first strap, the fitting forming part of a coupling for releasably attaching to the first strap a second strap connectable, at the patient's option, to oral regions selectively associated with the nasal regions so that the patient interface can deliver respiratory therapy through both the nasal and oral regions.

[0124] In some forms, (a) the patient interface system further comprises a mouth region selectively combined with the nose region at the patient's option and a second strap connected to the mouth region, the second strap having a complementary attachment for forming a connection with the attachment of the first strap; (b) the patient interface system further comprises a nasal chamber connection component adapted to form part of a releasable fluid connection that allows the nose region to be fluidly connected to the mouth region for communicating a portion of the breathable pressurized gas through the nasal chamber openings to the mouth region; and / or (c) the connection assists in the dynamic stability of the positioning and stabilizing structure to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

[0125] According to another aspect of the present technology, there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapy pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including: one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapy pressure for breathing by the patient; and a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more apertures therein such that the flow of air at the therapy pressure is delivered to entrances to the patient's nares and through the one or more apertures to the patient's mouth, said seal-forming structure constructed and arranged to maintain the therapy pressure within the plenum chamber throughout the patient's respiratory cycle, in use, said seal-forming structure including a nose region configured to form a seal with the patient's face at or near the patient's nose, and a mouth region configured to form a seal with the patient's face around the patient's mouth, said seal-forming structure including a first surface finish in the nose region and a second surface finish in the mouth region that is different from the first surface finish.

[0126] In examples, the first surface finish and the second surface finish differ such that the coefficient of friction between the seal-forming structure and the patient's face is higher in the mouth region than in the nose region, the first surface finish is configured to impart a smooth feel on the patient's face in the nose region (e.g., for comfort) and the second surface finish is configured to impart a gripping contact with the patient's face in the mouth region (e.g., for a more secure seal), the first surface finish may be a matte surface finish and the second surface finish may be a polished surface finish, the interface between the first surface finish and the second surface finish is located on a portion of the seal-forming structure that contacts the patient's cheeks in use, the nose region may include an upper lip region having the first surface finish, and / or the non-patient-contacting surface of the nose region may include a surface finish other than the first surface finish and the non-patient-contacting surface of the nose region may include the second surface finish.

[0127] In accordance with another aspect of the present technology, there is provided a patient interface comprising: a plenum chamber according to the above aspect of the present technology; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie is located on a region of the patient's head above an upper ear-base point of the patient's head; and a venting structure that moves a continuous flow of gases exhaled by the patient from within the plenum chamber to the ambient environment, the venting structure being sized and shaped such that, in use, a therapeutic pressure can be maintained within the plenum chamber, the patient interface configured to allow the patient to breathe from the ambient environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port.

[0128] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0129] One aspect of the present technology is a method for manufacturing a device.

[0130] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0131] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0132] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a humidifier tank that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0133] One aspect of the present technology discloses a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway in use to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure includes a first strap and an attachment. The first strap is configured to pass around the back of the patient's head in use. The attachment 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 is connectable to an additional component of the seal-forming structure that is selectively combined with the seal-forming structure at the patient's option.

[0134] In a further aspect of the present technology, a positioning and stabilizing structure for maintaining a patient interface in a therapeutically effective position on a patient's head is disclosed. The patient interface includes nasal regions including nasal chambers and nasal sealing regions adapted to form a seal with the patient's nares 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. The first strap is configured to pass around the back of the patient's head in use. The attachment is disposed on the first strap and forms part of a connector for releasably attaching a second strap to the first strap. The second strap is connectable, at the patient's option, to an oral region selectively coupled with the nasal region so that the patient interface can deliver respiratory therapy through both the nasal and oral regions.

[0135] In some forms, the attachment device may include an attachment area that allows for varying the attachment position of the second strap within the attachment area.

[0136] In some forms, the fixture may be formed from multiple components.

[0137] In some forms, the linkage may include one or more of a hook or loop fastening mechanism.

[0138] In some forms, the connection may include at least one snap fastener.

[0139] In some embodiments, the attachment may include a guide portion to facilitate proper positioning of the second strap relative to the first strap. In some embodiments, the guide portion may be in the form of indicia disposed on the first strap. In some embodiments, the guide portion may include at least one of a protrusion or a depression, where at least one protrusion or depression may enable a mating connection with at least one corresponding protrusion or depression of the second strap. In some embodiments, the attachment may include two or more guide portions spaced apart along the first strap.

[0140] In some forms, the attachment may include at least one slit along a portion of the first strap.

[0141] In some forms, the positioning and stabilizing structure may further include a second strap, which may include a complementary attachment for forming a connection with the attachment of the first strap.

[0142] In some forms, the complementary attachment may include a flap extending laterally from the second strap that can be passed through a slit in use to releasably attach the second strap to the first strap. In some forms, the flap, once threaded through the slit in use, may be releasably attached to the first strap to form at least a portion of the connection. In some forms, the flap, once threaded through the slit in use, may be releasably attached to the second strap, whereby the second strap is releasably attached to the first strap to form at least a portion of the connection.

[0143] In some forms, the interlocking portion may assist in the dynamic stability of the positioning and stabilizing structure to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0144] In a further aspect of the present technology, a patient interface system for delivering respiratory therapy to a patient is disclosed. The patient interface system includes nasal sections, an inlet conduit, and a positioning and stabilizing structure. The nasal sections include nasal chambers and nasal sealing sections that form a seal with the patient's face and surround entrances to the patient's nares. The nasal chambers include openings. The inlet conduits are connected to the nasal sections to deliver breathable pressurized gas to the nasal chambers. The positioning and stabilizing structure holds the patient interface in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a first strap and an attachment. The first strap is configured to pass around the back of the patient's head in use. The attachment 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 is connectable to an oral section that is selectively coupled with the nasal section so that the patient interface can deliver respiratory therapy through both the nasal and oral sections, at the patient's option.

[0145] In some embodiments, the patient interface system may further include a mouth region selectively combined with the nose region at the patient's option, and a second strap connected to the mouth region, the second strap including a complementary attachment for forming a connection with the attachment of the first strap.

[0146] In some forms, the patient interface system may further comprise a nasal chamber connection component adapted to form part of a releasable fluid connection that allows the nasal region to be fluidly connected to the mouth region for communicating a portion of the breathable pressurized gas through the nasal chamber openings to the mouth region.

[0147] In some forms, the interlocking portion may assist in the dynamic stability of the positioning and stabilizing structure to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0148] In a further aspect of the present technology, a retention assembly for connecting a patient interface to a positioning and stabilizing structure configured to generate a force to maintain the patient interface in a therapeutically effective position on a patient's head is disclosed. The patient interface comprises: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle in use; one or more plenum chamber inlet ports sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use; a seal-forming structure defining at least a portion of the plenum chamber, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway and constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and a shell defining at least a portion of the plenum chamber, the shell supporting the seal-forming structure. The retention assembly comprises a connector and a patient interface engaging portion. The connector comprises a connecting portion configured to engage the positioning and stabilizing structure and a retaining portion 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 retainer are configured to releasably engage with one another through the first and second retainer devices.

[0149] In some embodiments, the first retention device is a mechanical device.

[0150] In some embodiments, the first retention device includes a complementary protrusion adapted to retain the retention portion against the patient interface engagement portion in a direction along the surface of the patient interface.

[0151] In some embodiments, the second retention device is magnetic.

[0152] In some embodiments, the second retention device is adapted to retain the retention portion relative to the patient interface in a direction away from the patient interface. In some embodiments, the patient interface engaging portion protrudes from a surface of the patient interface. In some embodiments, the engaging portion protrudes from the shell. In some embodiments, the positioning and stabilizing structure comprises a strap configured to extend circumferentially over the patient's head and hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0153] In some forms, the retention assembly further comprises a hinge element intermediate the connecting portion and the retention portion and configured to hinge the connecting portion and the retention portion relative to one another.

[0154] In some forms, the hinge comprises a living hinge.

[0155] In a further aspect of the present technology, a retaining assembly for connecting a patient interface to a positioning and stabilizing structure configured to generate a force to maintain the patient interface in a therapeutically effective position on a patient's head is disclosed. The patient interface comprises: a plenum chamber pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle; one or more plenum chamber inlet ports sized and configured, in use, to receive a flow of air at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle; a seal-forming structure defining at least a portion of the plenum chamber, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, and constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a shell defining at least a portion of the plenum chamber, the shell supporting the seal-forming structure. The retaining assembly comprises a connector and a patient interface engaging portion. The connector includes 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 intermediate the connecting portion and the retaining portion configured to hinge the connecting portion and the retaining portion relative to one another. The patient interface engaging portion is located on the patient interface. The patient interface engaging portion and the retaining portion are configured to releasably engage with one another via a magnetic retention device.

[0156] In a further aspect of the present technology, a patient interface is disclosed comprising: a plenum chamber pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle; one or more plenum chamber inlet ports sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle, in use, throughout the patient's respiratory cycle; a seal-forming structure defining at least a portion of the plenum chamber, the shell constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, and in use constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a shell defining at least a portion of the plenum chamber, the shell supporting the seal-forming structure; and a patient interface engaging portion protruding from the shell and configured for attachment with a connector for positioning and stabilizing structure configured to generate a force to hold the patient interface in a therapeutically effective position on the patient's head, the connector and the patient interface engaging portion engaging through a first mechanical retention device and a second magnetic retention device.

[0157] In some forms, the patient interface engagement portion comprises a protrusion protruding from the shell and including a magnet configured to magnetically engage the connector and a shoulder configured to mechanically engage the connector.

[0158] 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 a surface of the patient interface.

[0159] In a further aspect of the present technology, a patient interface system is disclosed comprising: a plenum chamber pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle; one or more plenum chamber inlet ports sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient throughout the patient's respiratory cycle, in use, throughout the patient's respiratory cycle; a seal-forming structure defining at least a portion of the plenum chamber, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, and constructed and arranged, in use, to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a shell defining at least a portion of the plenum chamber, the shell supporting the seal-forming structure; a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; and a retaining assembly comprising a connector and a patient interface engaging portion. The connector includes 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 intermediate the connecting portion and the retaining portion and configured to hinge the connecting portion and the retaining portion relative to one another. The patient interface engaging portion is located on the patient interface. The patient interface engaging portion and the retaining portion are configured to releasably engage with one another through the first and second retaining devices.

[0160] In some embodiments, (a) the first retaining device is a mechanical device, (b) the first retaining device includes complementary protrusions adapted to retain the retaining portion relative to the patient interface engaging portion in a direction along the surface of the patient interface, (c) the second retaining device is magnetic, (d) the second retaining device is adapted to retain the retaining portion relative to the patient interface in a direction away from the patient interface, (e) the patient interface engaging portion protrudes from a surface of the patient interface, (f) the engaging portion protrudes from the shell, (g) the positioning and stabilizing structure comprises a strap configured to extend circumferentially over the patient's head and hold the seal-forming structure in a therapeutically effective position on the patient's head, and / or (h) the hinge comprises a living hinge.

[0161] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0162] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0163] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0164] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]

[0165] [Figure 1A]4.1 Treatment System: Shown is a system including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. Bed companions are also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal patient interface, receiving air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of a full face patient interface and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy, including the upper lip, vermilion, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D]A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral side of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal patient interface in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C]3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 1 shows a patient interface cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome and saddle regions are shown. [Figure 3H] 1 shows a patient interface cushion. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The linear distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a patient interface with an inflatable bladder as a cushion. [Figure 3M]3L is a cross-sectional view of the patient interface of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3L shows a further cross section of the patient interface of FIG. 3L, with the inner surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] FIG. 10 is a diagram of a patient interface including the signature of the torsion of the space curve defined by the edges of the sealing membrane in different regions of the patient interface. [Figure 3U] A view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3209. This tendon rests on the midsagittal plane and contacts the plenum chamber cushion only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3229). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X]The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "plane of the face" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is of a nasal patient interface, with the upper point 3220 resting approximately on the cerion and the lower point 3229 resting on the upper lip. 4.4 RPT Device [Figure 4] 1 shows an RPT device in accordance with one form of the present technology. [Figure 5] 4.5 Respiratory Waveforms [Figure 6] A model of a typical human respiratory waveform during sleep is shown. 4.6 Example of a patient interface for this technology [Figure 7-1] FIG. 13 shows a front view of a patient interface system in nostril-only mode attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 7-2] FIG. 13 shows a front view of a patient interface system in nostril and mouth mode attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 7-3] FIG. 13 shows a front view of a patient interface system in nostril and mouth mode attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 7-4]

[0033] Fig. 14 shows a front view of a patient interface system in mouth-only mode worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 7-5]

[0033] Fig. 13 shows a front exploded view of a patient interface system illustrating how the nose region may connect to the mouth region in accordance with an embodiment of the present technology. [Figure 8] FIG. 7-1 shows a front view of the patient interface system of FIGS. 7-1 to 7-5 without an elbow connector in accordance with an embodiment of the present technology. [Figure 9] FIG. 7-1 shows a rear view of the patient interface system of FIGS. 7-1 to 7-5 in accordance with an embodiment of the present technology. [Figure 10] FIG. 7-1 shows a rear isometric view of the patient interface system of FIGS. 7-1 to 7-5 in accordance with an embodiment of the present technology. [Figure 11-1] FIG. 13 shows a front isometric view of a patient interface system worn on the head of a model patient in accordance with another embodiment of the present technology. [Figure 11-2] 11-2 shows a front isometric view of the patient interface system of FIG. 11-1 mounted on a model patient's head in nostril-only mode. [Figure 12] FIG. 12 shows a side view of the patient interface system of FIG. 11 in use in accordance with an embodiment of the present technology. [Figure 13] FIG. 11-2 shows a rear isometric view of headgear used with the patient interface system of FIG. 11-1 in accordance with an embodiment of the present technology. [Figure 14] FIG. 11-2 shows a front isometric view of the patient interface system of FIG. 11-1 without an elbow connector in accordance with an embodiment of the present technology. [Figure 15] FIG. 11-2 shows a front view of the patient interface system of FIG. 11-1 without an elbow connector in accordance with an embodiment of the present technology. [Figure 16] FIG. 11-2 shows a top view of the patient interface system of FIG. 11-1 without the nasal sections in accordance with an embodiment of the present technology. [Figure 17] FIG. 11-2 shows a rear isometric view of the patient interface system of FIG. 11-1 in accordance with an embodiment of the present technology. [Figure 18] FIG. 11-2 shows a rear view of the patient interface system of FIG. 11-1 in accordance with an embodiment of the present technology. [Figure 19]and a front view of the portion of the patient interface system of FIG. 11-1 without the nose region and elbow connectors and with headgear in accordance with an embodiment of the present technology. [Figure 20]

[0033] Fig. 13 shows a front view of a patient interface system worn on the head of a model patient in accordance with another embodiment of the present technology. [Figure 21] FIG. 21 shows a side view of the patient interface system of FIG. 20 being worn on the head of a model patient in accordance with an embodiment of the present technology. [Figure 22]

[0033] Fig. 19 shows a rear view of a patient interface system with decoupling sites and connections removed in accordance with another embodiment of the present technology. [Figure 23] FIG. 23 shows a front isometric view of the patient interface system of FIG. 22 in accordance with an embodiment of the present technology. [Figure 24] FIG. 23 shows a front isometric view of the patient interface system of FIG. 22 in accordance with an embodiment of the present technology. [Figure 25]

[0033] Fig. 14 shows a rear isometric view of a nose region that may be used in conjunction with a patient interface system in accordance with an embodiment of the present technology. [Figure 26] FIG. 26 shows a front isometric view of the nasal region of FIG. 25 in accordance with an embodiment of the present technology. [Figure 27] FIG. 13 shows a front isometric view of a patient interface system in nostril-only mode attached to a model patient's head in accordance with another embodiment of the present technology. [Figure 28] FIG. 28 shows a front isometric view of the patient interface system of FIG. 27 in the nostril and mouth configuration attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 29] FIG. 13 shows a front isometric view of a patient interface system worn on the head of a model patient in accordance with another embodiment of the present technology. [Figure 30]

[0033] Fig. 13 shows a side view of a patient interface system mounted on the head of a model patient in accordance with another embodiment of the present technology. [Figure 31]

[0033] Fig. 13 shows a side view of a patient interface system mounted on the head of a model patient in accordance with another embodiment of the present technology. [Figure 32] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 33] FIG. 13 shows a schematic cross-sectional view of an integrated patient interface system worn on the head of a model patient in accordance with an embodiment of the present technology. [Figure 34] FIG. 13 shows a schematic cross-sectional view of an integrated patient interface system worn on the head of a model patient in accordance with an embodiment of the present technology. [Figure 35-1] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 35-2] FIG. 35-2 shows a schematic top view of the mouth seal portion of the patient interface system of FIG. 35-1 in accordance with an embodiment of the present technology. [Figure 35-3] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 36-1]

[0033] Fig. 16 shows a schematic cross-sectional view of a modular patient interface worn on the head of a model patient in accordance with an embodiment of the present technology. [Figure 36-2] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 37]

[0033] Fig. 13 shows a cross-sectional view of an integrated patient interface system being worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 38(a)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(b)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(c)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(d)]12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(e)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(f)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(g)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(h)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(i)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 38(k)] 12 is a schematic diagram of pressurized gas flow through various configurations of a patient interface system in accordance with an embodiment of the present technology; [Figure 39]

[0023] Fig. 14 shows a schematic diagram of a nostril and mouth kit according to an embodiment of the present technology. [Figure 40] FIG. 13 shows a schematic diagram of a modular patient interface system attached to the head of a model patient in accordance with an embodiment of the present technology. [Figure 41]

[0033] Fig. 14 shows a front view of a nostril sealing site according to an embodiment of the present technology. [Figure 42] FIG. 42 shows a front perspective view of the nostril sealing site of FIG. 41 according to an embodiment of the present technology. [Figure 43] 1 shows a prior art nostril-only CPAP device worn on the head of a model patient. [Figure 44] FIG. 44 shows a retrofit kit used to convert the nostril-only CPAP device of FIG. 43 into a nostril-and-oral CPAP device in accordance with an embodiment of the present technology. [Figure 45]FIG. 44 shows a retrofit kit used to convert the nostril-only CPAP device of FIG. 43 into a nostril-and-oral CPAP device in accordance with an embodiment of the present technology. [Figure 46] 1 shows a prior art nostril-only CPAP device. [Figure 47] FIG. 47 shows a retrofit kit for converting the nostril-only CPAP device of FIG. 46 into a nostril-and-oral CPAP device worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 48] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 49] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 50] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 50A] FIG. 10 is a cross-sectional view of a nose region according to an embodiment of the present technology. [Figure 50B] FIG. 10 is a cross-sectional view of a nose region according to an embodiment of the present technology. [Figure 51] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 52] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 53] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 54]

[0033] Fig. 10 shows a schematic partial cross-sectional view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 55]

[0033] Fig. 13 shows an exploded view of a modular patient interface system attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 56]FIG. 13 shows a schematic cross-sectional view of an integrated (or modular) patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 57] FIG. 57 shows a perspective view of the integrated (or modular) patient interface system of FIG. 56 attached to the head of a model patient. [Figure 58] FIG. 58 shows a side view of the integrated (or modular) patient interface system of FIG. 57. [Figure 59] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 60] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 61]

[0033] Fig. 14 shows a rear view of the nasal region of a patient interface system in accordance with an embodiment of the present technology. [Figure 61A] 61A is a cross-sectional view taken along line 61A-61A in FIG. 61. [Figure 62]

[0033] Fig. 14 shows a rear view of the nasal region of a patient interface system in accordance with an embodiment of the present technology. [Figure 62A] 62A is a cross-sectional view taken along line 62A-62A in FIG. 62. [Figure 63] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system worn on a model patient's head in accordance with an embodiment of the present technology. [Figure 64] FIG. 13 shows a side view of an integrated or modular patient interface system attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 65]

[0033] Fig. 14 shows a perspective view of an integrated or modular patient interface system attached to a model patient's head in accordance with an embodiment of the present technology. [Figure 66]

[0033] Fig. 14 shows a rear view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 67]FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 68] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 69]

[0033] Fig. 12 shows an exploded view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 70] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 71] FIG. 13 shows a schematic cross-sectional view of a modular patient interface system mounted on a model patient's head in accordance with an embodiment of the present technology. [Figure 72]

[0033] Fig. 12 shows an exploded view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 73]

[0033] Fig. 12 shows an exploded view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 74]

[0033] Fig. 14 shows a perspective view of a modular patient interface system in accordance with an embodiment of the present technology. [Figure 75] FIG. 75 shows a front view of the modular patient interface system of FIG. 74. [Figure 76] FIG. 75 shows a top view of the modular patient interface system of FIG. 74. [Figure 77] FIG. 75 illustrates a bottom view of the modular patient interface system of FIG. 74. [Figure 78] FIG. 75 shows a side view of the modular patient interface system of FIG. 74. [Figure 79] 75A shows a cross-sectional view taken along line 75-75 of FIG. [Figure 80] FIG. 75 illustrates a perspective view of the nasal portion of the patient interface system of FIG. 74; [Figure 81] FIG. 75 shows a perspective view of the mouth section of the patient interface system of FIG. 74; [Figure 82]FIG. 75 illustrates a perspective view of the cushion portion of the patient interface system of FIG. 74. [Figure 83] FIG. 75 illustrates a front view of the cushion portion of the patient interface system of FIG. 74. [Figure 84] FIG. 75 illustrates a top view of the cushion portion of the patient interface system of FIG. 74. [Figure 85] FIG. 75 illustrates a bottom view of the cushion portion of the patient interface system of FIG. 74. [Figure 86] 80 shows a cross-sectional view taken along line 80-80 of FIG. 83. [Figure 87] 81 shows a cross-sectional view taken along line 81-81 of FIG. 83. [Figure 88] A cross-sectional view taken along line 82-82 of FIG. 83 is shown. [Figure 89] 83 is a cross-sectional view taken along line 83-83 of FIG. [Figure 90] A cross-sectional view taken along line 84-84 of FIG. 83 is shown. [Figure 91] 78 shows a cross-sectional view taken along line 85-85 of FIG. 77. [Figure 92] FIG. 75 illustrates a rear view of the cushion portion of the patient interface system of FIG. 74. [Figure 93] FIG. 75 illustrates a right side view of the cushion portion of the patient interface system of FIG. 74. [Figure 94] FIG. 75 illustrates a left side view of the cushion portion of the patient interface system of FIG. 74. [Figure 95] FIG. 75 illustrates a perspective view of the cushion portion of the patient interface system of FIG. 74. [Figure 96] 10 depicts a headgear system convertible between two and four point support in accordance with an example of the present technology. [Figure 97A] 10 depicts a headgear system convertible between two and four point support in accordance with an example of the present technology. [Figure 97B] 10 depicts a headgear system convertible between two and four point support in accordance with an example of the present technology. [Figure 98A] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 98B] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 98C] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 98D] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 98E] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99A] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99B] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99C] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99D] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99E] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99F] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99G] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99H] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 99I] 13 depicts a mouth cushion according to one variation of the present technology. [Figure 100] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 101] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 102] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 103] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 104] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 105] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 106] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 107]13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 108] 13 depicts a cushion and decorative panel connection in accordance with an example of the present technology. [Figure 109] 13 depicts a lip seal in accordance with an example of the present technology. [Figure 110] FIG. 10 is an exploded view of a patient interface system in accordance with an embodiment of the present technology. [Figure 111] FIG. 111 is a rear view of the assembled patient interface system of FIG. 110. [Figure 112] FIG. 111 is a top view of the assembled patient interface system of FIG. 110. [Figure 113] FIG. 111 is a bottom view of the assembled patient interface system of FIG. 110; [Figure 114] FIG. 111 shows a left side view of the patient interface system of FIG. 110 in an assembled state. [Figure 115] FIG. 119 is a cross-sectional view taken along line 109-109 of FIG. [Figure 116] FIG. 110 is a cross-sectional view taken along line 110-110 of FIG. [Figure 117] FIG. 117 is a detailed view of a portion of FIG. 116. [Figure 118] FIG. 111 is a rear isometric view of the oral cushion of the patient interface system of FIG. 110. [Figure 119] FIG. 111 is a front isometric view of the oral cushion of the patient interface system of FIG. 110. [Figure 120] FIG. 111 is a front view of the oral cushion of the patient interface system of FIG. 110. [Figure 121] FIG. 111 is a top view of the oral cushion of the patient interface system of FIG. 110. [Figure 122] FIG. 111 is a bottom view of the oral cushion of the patient interface of FIG. 110; [Figure 123] FIG. 111 is a right side view of the oral cushion of the patient interface system of FIG. 110. [Figure 124]FIG. 111 is a front view of the oral cushion of the patient interface system of FIG. 110. [Figure 125] 129 is a cross-sectional view of the mouth cushion taken along line 119-119 of FIG. 124. [Figure 126] 120 is a cross-sectional view of the mouth cushion taken along line 120-120 of FIG. 124. [Figure 127] 121 is a cross-sectional view of the mouth cushion taken along line 121-121 of FIG. 124. [Figure 128] 122 is a cross-sectional view of the mouth cushion taken along line 122-122 of FIG. 124. [Figure 129] 123 is a cross-sectional view of the mouth cushion taken along line 123-123 of FIG. 124. [Figure 130] 124 is a cross-sectional view of the mouth cushion taken along line 124-120 of FIG. 124. [Figure 131] FIG. 111 is a rear isometric view of the cushion clip of the patient interface system of FIG. 110. [Figure 132] FIG. 132 is a front isometric view of the cushion clip of FIG. 131. [Figure 133] FIG. 132 is a top view of the cushion clip of FIG. 131. [Figure 134] FIG. 132 is a bottom view of the cushion clip of FIG. 131. [Figure 135] FIG. 132 is a left side view of the cushion clip of FIG. 131. [Figure 136] FIG. 132 is a rear view of the cushion clip of FIG. 131. [Figure 137] FIG. 137 is a cross-sectional view taken along line 131-131 of FIG. 136. [Figure 138] FIG. 111 is a front isometric view of the decorative panel of the patient interface system of FIG. 110. [Figure 139] FIG. 139 is a front view of the decorative panel of FIG. 138. [Figure 140] FIG. 139 is a rear view of the decorative panel of FIG. 138. [Figure 141] FIG. 139 is a top view of the decorative panel of FIG. 138. [Figure 142] FIG. 139 is a bottom view of the decorative panel of FIG. 138. [Figure 143]FIG. 139 is a right side view of the decorative panel of FIG. 138. [Figure 144] FIG. 138 is a cross-sectional view taken along line 138-138 of FIG. 139. [Figure 145] FIG. 10 is a front isometric view of a cushion clip according to an embodiment of the present technology. [Figure 146] FIG. 146 is a rear isometric view of the cushion clip of FIG. 145. [Figure 147] FIG. 146 is a front view of the cushion clip of FIG. 145. [Figure 148] FIG. 146 is a top view of the cushion clip of FIG. 145; [Figure 149] FIG. 146 is a bottom view of the cushion clip of FIG. 145. [Figure 150] FIG. 146 is a left side view of the cushion clip of FIG. 145. [Figure 151] FIG. 145 is a cross-sectional view taken along line 145-145 of FIG. 147. [Figure 152] FIG. 10 is a perspective view of a modular patient interface system according to an embodiment of the present technology; [Figure 153] FIG. 153 is an exploded side view of the modular patient interface system of FIG. 152. [Fig. 154] FIG. 153 is a perspective view of the modular patient interface system of FIG. 152 in nostril-only mode. [Figure 155A] FIG. 153 is a perspective view of the mouth section of the modular patient interface system of FIG. 152; [Figure 155B] FIG. 155B is a left side view of the mouth region of FIG. 155A. [Figure 155C] FIG. 155B is a rear view of the mouth region of FIG. 155A. [Figure 155D] FIG. 155B is a rear perspective view showing the mouth region of FIG. 155A connected to the nose region. [Figure 155E] FIG. 155B is a front perspective view of the mouth region of FIG. 155A connected to the nose region. [Figure 155F] FIG. 1 is a top view of a nose area including a pillow cushion. [Figure 155G] FIG. 1 is a top view of the nose area including the prongs. [Figure 156A] 153 illustrates one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 156B] FIG. 153 is a schematic diagram of one embodiment of a coupling device for a vent or cover of the modular patient interface system of FIG. 152. [Figure 156C] FIG. 153 is a schematic diagram of one embodiment of a mouth-site coupling device of the modular patient interface system of FIG. 152; [Figure 157] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 158A] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 158B] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 159] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 160] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 161] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 162] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 163] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Fig. 164] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 165] FIG. 153 is a schematic diagram of one embodiment of a connector for components of the modular patient interface system of FIG. 152. [Figure 166]FIG. 153 is a schematic diagram of one embodiment of a variation of the modular patient interface system of FIG. 152 incorporating an intermediate chamber. [Figure 167] FIG. 153 is a schematic diagram of an embodiment of a variation of the connector of the modular patient interface system of FIG. 152. [Figure 168A] FIG. 10 is a cross-sectional left side view of a nasal patient interface with AAV according to an embodiment of the present technology. [Figure 168B] FIG. 168B is a top perspective view of the nasal patient interface of FIG. 168A having an AAV. [Figure 169] FIG. 168B is a dorsal side view of the AAV connector module for the patient interface of FIG. 168A. [Figure 170] FIG. 168B is a cross-sectional side view of the AAV of the patient interface of FIG. 168A. [Figure 171A] FIG. 153 is a front perspective view of the connector of the patient interface of FIG. 152; [Figure 171B] FIG. 171B is a top perspective view of the connector of the patient interface of FIG. 171A. [Figure 172A] Detail views of cross sections of nose and mouth area headgear when joined by various embodiments of a connector with one or more Velcro® portions, where the mouth area headgear is either V-shaped and has two Velcro® portions, or U-shaped and has two Velcro® portions, or is a single piece that can be attached to the two Velcro® portions of the nose area headgear. [Figure 172B] Detail views of cross sections of nose and mouth area headgear when joined by various embodiments of a connector with one or more Velcro® portions, where the mouth area headgear is either V-shaped and has two Velcro® portions, or U-shaped and has two Velcro® portions, or is a single piece that can be attached to the two Velcro® portions of the nose area headgear. [Figure 172C]10A-10C are detailed cross-sectional views of nose and mouth area headgear when joined by various embodiments of a connector having one or more Velcro® portions, where the mouth area headgear is either V-shaped and has two Velcro® portions, or U-shaped and has two Velcro® portions, or is a single piece that can be attached to the two Velcro® portions of the nose area headgear. [Figure 173A] Detail views of cross sections of nose and mouth area headgear configured to be coupled by various embodiments of connectors having multiple snap connectors, the nose area headgear having two male snap connectors each or spaced apart alternating male / female snap connectors. [Figure 173B] Detail views of cross sections of nose and mouth area headgear configured to be coupled by various embodiments of connectors having multiple snap connectors, the nose area headgear having two male snap connectors each or spaced apart alternating male / female snap connectors. [Figure 173C] Detail views of cross sections of nose and mouth area headgear configured to be coupled by various embodiments of connectors having multiple snap connectors, the nose area headgear having two male snap connectors each or spaced apart alternating male / female snap connectors. [Fig. 174] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by one embodiment of a connector comprising multiple tabs and latches. [Figure 175A] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by various embodiments of a connector, the nose and mouth area headgear also comprising one embodiment of an alignment guide comprising one or more markings, shapes or patterns. [Figure 175B] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by various embodiments of a connector, the nose and mouth area headgear also comprising one embodiment of an alignment guide comprising one or more markings, shapes or patterns. [Figure 176A] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by various embodiments of a connector, the nose and mouth area headgear also comprising an embodiment of an alignment guide, the nose area comprising a single recessed groove, multiple recesses, or recessed loops that each engage a correspondingly shaped protrusion on the mouth area headgear. [Figure 176B] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by various embodiments of a connector, the nose and mouth area headgear also comprising an embodiment of an alignment guide, the nose area comprising a single recessed groove, multiple recesses, or recessed loops that each engage a correspondingly shaped protrusion on the mouth area headgear. [Figure 176C] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by various embodiments of a connector, the nose and mouth area headgear also comprising an embodiment of an alignment guide, the nose area comprising a single recessed groove, multiple recesses, or recessed loops that each engage a correspondingly shaped protrusion on the mouth area headgear. [Figure 177] FIG. 10 is a detailed cross-sectional view of nose and mouth area headgear configured to be coupled by one embodiment of a connector having hook tabs and corresponding latches, the nose area headgear also including recesses around the hook tabs and corresponding latches of the connector. [Figure 178A] 1 is a detailed cross-sectional view of nose and mouth area headgear configured to be joined by one embodiment of a connector configured on a flap of the mouth area headgear, the flap being threaded through a slit in the nose area headgear, the flap being narrower than the slit, the flap being sized to correspond to the slit, or multiple flaps being threaded through each slit. [Figure 178B] 1 is a detailed cross-sectional view of nose and mouth area headgear configured to be joined by one embodiment of a connector configured on a flap of the mouth area headgear, the flap being threaded through a slit in the nose area headgear, the flap being narrower than the slit, the flap being sized to correspond to the slit, or multiple flaps being threaded through each slit. [Figure 178C] 1 is a detailed cross-sectional view of nose and mouth area headgear configured to be joined by one embodiment of a connector configured on a flap of the mouth area headgear, the flap being threaded through a slit in the nose area headgear, the flap being narrower than the slit, the flap being sized to correspond to the slit, or multiple flaps being threaded through each slit. [Figure 179] 13 depicts a connector for connecting headgear to a patient interface in accordance with an example of the present technology. [Figure 180] 13 depicts a chassis including a chassis connector in accordance with an example of the present technology. [Figure 181] 179 connected to the chassis depicted in FIG. 180 according to an example of the present technology. [Figure 182] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 183] FIG. 183 is a rear view of the plenum chamber 3200 of FIG. [Figure 184] FIG. 183 is a side view of the plenum chamber 3200 of FIG. [Figure 185] FIG. 183 is a top view of the plenum chamber 3200 of FIG. [Figure 186] FIG. 183 is a bottom view of the plenum chamber 3200 of FIG. 182. [Figure 187] FIG. 183 is a perspective view of the plenum chamber 3200 of FIG. 182. [Figure 188] FIG. 183 is another perspective view of the plenum chamber 3200 of FIG. 182. [Figure 189] FIG. 183 is another perspective view of the plenum chamber 3200 of FIG. 182. DETAILED DESCRIPTION OF THE INVENTION

[0166] 5 Detailed description of examples of this technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0167] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any of these examples may constitute an additional example.

[0168] While anatomical directional terms are used in describing aspects and examples of the present technology (e.g., "anterior," "posterior," "superior," "inferior," "lateral," "medial"), these directions apply in the context of the present technology during use by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is anterior to the patient when the patient interface is worn in its intended manner.

[0169] When describing a surface or area as facing in a certain direction (e.g., "upward facing," "forward facing"), unless the context clearly indicates otherwise, the surface or area is to be understood as facing at least partially in a particular direction. If an area faces generally upward, the area may be said to "face upward" even if it also faces partially in another direction.

[0170] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0171] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0172] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0173] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0174] 5.3 Patient Interface The patient interface system of the present technology delivers breathable pressurized gas to the patient and includes a nasal region, a mouth region, a positioning and stabilizing structure, and an air delivery system. A sealing region for forming a seal or nearly sealing with the patient's nose and / or mouth may be included with the nasal region and / or mouth region. The nasal region and / or mouth region may also include one or more vents for venting gas exhaled by the patient. However, the patient interface may be non-breathable and used in hospital / ventilation settings. The patient interface system may also be provided with an anti-asphyxiation valve (AAV).

[0175] The sealing portions are positioned to form a seal or substantially seal with the patient's nose and / or mouth to deliver pressurized gas to the patient. The sealing portions preferably include a nostril sealing portion and a mouth sealing portion. The nostril sealing portion and the mouth sealing portion may be integrally formed or may be in the form of separate elements. The nostril sealing portion and the mouth sealing portion may be independently or separately connected to or otherwise positioned to seal with the patient's nose and mouth, respectively.

[0176] A positioning and stabilizing structure may be connected to the sealing portion and adapted to engage the sealing portion with a patient. The positioning and stabilizing structure may have an upper portion and a lower portion constructed and arranged to avoid the patient's eyes and ears in use. The upper and lower portions may be integral with one another, separate and not connected to one another, or separate and connected to one another. The positioning and stabilizing structure may have a rear portion adapted to engage the occipital area of ​​the patient's head in use. The rear portion may interconnect the upper and lower portions.

[0177] An air delivery system may connect the sealing site to the flow generator. The air delivery system may include an elbow and / or a tube.

[0178] The patient interface system provides the patient with treatment options (nostril only, mouth only, or nostril and mouth treatment) without making the system too expensive, while at the same time making the patient interface system intuitive to use, allowing the patient to use the patient interface system without excessive or no instruction.

[0179] The patient interface system may be a modular patient interface system having nasal sections and oral sections, where the nasal sections may be utilized without the oral sections to provide respiratory treatment to the patient's nares, or the nasal sections may be utilized in conjunction with the oral sections to provide respiratory treatment to the patient's nostrils and mouth, or to provide respiratory treatment to the patient's nares and utilize the oral section as a mouth seal.

[0180] The patient interface system may be a modular patient interface system having a nose section and a mouth section, where the mouth section may be utilized without the nose section to provide respiratory treatment to the patient's mouth, or the mouth section may be utilized in conjunction with the nose section to provide respiratory treatment to the patient's nostrils and mouth, or to provide respiratory treatment to the patient's mouth and utilize the nose section as a nostril seal.

[0181] The patient interface system may be an integrated patient interface system having nasal and oral regions, where the nasal and oral regions are integrated and formed as a single unit, and pressurized gas may be provided to the nostril and oral regions for delivery to the nose and mouth, or pressurized gas may be delivered only to the nostril or oral regions, with pressurized gas shut off to other regions.

[0182] For example, as depicted in FIGS. 7-1 through 10 , the patient interface system 1 may include a nasal region 20, a mouth region 40, and a positioning and stabilizing structure that may include headgear 60. An air delivery system may deliver air to the patient interface system 1 through flexible tubing 5 or the like. The patient interface systems of FIGS. 7-1 through 10 are adapted for use with the nasal region 20 and the mouth region 40 independently of one another (in a nostril-only mode or a mouth-only mode), or the nasal region 20 and the mouth region 40 may be utilized together (in a nostril-and-mouth mode). When utilized in the nostril-and-mouth mode, one of the nasal region 20 and the mouth region 40 may be utilized to deliver pressurized gas, and the other of the nasal region 20 and the mouth region 40 may be utilized as a nostril or mouth seal. In another form, when utilized in the nostril-and-mouth mode, both the nasal region 20 and the mouth region 40 may be utilized to deliver pressurized gas to the patient's airway. Alternatively, patient interface system 1 may be formed as an integrated patient interface system in which nasal region 20 and oral region 40 are formed as a single element.

[0183] FIGS. 11-1 through 19 illustrate another patient interface system 1, which may be in the form of a modular patient interface, where the nose section 20 and the mouth section 40 may be used independently of one another, or where the nose section 20 and the mouth section 40 may function together to deliver breathable pressurized gas to the patient's nostrils and mouth. In FIGS. 11-1 and 12 through 19, a flexible tube 5 is connected to the swivel ring 4 via the elbow 2 to direct breathable pressurized gas to the chamber in the mouth section 40 and to the nose section 20. FIGS. 11-1 and 12 through 18 illustrate the modular patient interface system in a nostril-and-mouth mode, where both the nose section 20 and the mouth section 40 are utilized. FIG. 5-2 illustrates the patient interface system 1 in a nostril-only mode, where the nose section 20 is used without the mouth section 40. In the nostril-only mode, the elbow 2, flexible tube 5, and swivel ring 4 are connected to the openings in the nose section 20.

[0184] 20 and 21 illustrate an integrated patient interface system 101 including a nose region 120, a mouth region 140, and positioning and stabilizing structure that may include headgear 160. In an integrated patient interface system, the nose region 120 and the mouth region 140 are typically inseparable and are formed as a single, integral unit. An air delivery system may deliver air to the patient interface system 101, such as through a flexible tube 105 connected to the mouth region 140 via an elbow 102.

[0185] 22-24 depict another patient interface system 201, which may be an integrated patient interface system, including a nasal region 220 and an oral region 240. An air delivery system may deliver air to the patient interface system 201.

[0186] 27 and 29 show a modular patient interface system 301 in accordance with an embodiment of the present technology. The patient interface system 301 includes a nose region 320, a mouth region 340, and headgear 360. An air delivery system may deliver air to the patient interface system 301, such as through flexible tubing 305 connected to the mouth region 340 or the nose region 320 via a connector 306 and an optional 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 that can absorb external forces that may break the seal of the nose region 320 and / or the mouth region 340 with the patient, such as may be caused by tubing drag. FIG. 27 shows the patient interface system 301 in a nostril-only mode, and FIG. 28 shows the patient interface system 301 in a nostril-and-mouth mode.

[0187] 29 shows a modular patient interface system 370 in accordance with an embodiment of the present technology. The patient interface 370 includes a nose region 372, a mouth region 380, and headgear 360. An air delivery system including an air delivery tube or conduit 379 may deliver air to the patient interface system 370. Furthermore, the tube 379 may function as headgear in addition to being an air delivery tube or conduit.

[0188] 30 shows a modular patient interface 401 according to an embodiment of the present technology. The patient interface 401 includes a nose region 420, a mouth region 440, and headgear 460. An air delivery system can deliver air to the patient interface system 401, such as through a flexible tube 405 connected to the mouth region 440 via a connector, such as an elbow 402 and an optional swivel connector 444.

[0189] 31 shows an integrated patient interface 501 according to an embodiment of the present technology. The patient interface 501 includes a nose region 520, a mouth region 540, and headgear 560. An air delivery system may deliver air to the patient interface system 501, such as through a flexible tube 505 connected to the mouth region 540 via a connector, such as an elbow 502 and an optional swivel connector 544.

[0190] Figure 40 depicts a patient interface 701 which may be in the form of a modular patient interface, with the nose region 720 and mouth region 740 being usable independently of one another, or the nose region 720 and mouth region 740 functioning together to deliver breathable pressurized gas to the patient's nares and mouth. Figure 40 depicts the patient interface system 701 utilized in a nostril and mouth mode, where a flexible tube 705 connected to swivel rings 710 and 744 via a bifurcated elbow 712 directs breathable pressurized gas to the chamber in the mouth region 740 and the nose region 720.

[0191] In the nostril-only mode, only the nose portion 720 is utilized, and not the mouth portion 740. In this mode, the bifurcated elbow 712 is removed and the mouth portion 740 is removed. The patient utilizes only the nose portion 720 and connects the tubing 705 to a connector 710, such as a swivel ring. An elbow, such as Elbow 2, may be utilized to connect the tubing 705 to the connector 710, such as a swivel ring.

[0192] In the mouth-only mode, only the mouth region 740 is utilized, and not the nose region 720. In this mode, the bifurcated elbow 712 is removed and the nose region 720 is removed. The patient utilizes only the mouth region 740 and connects the tubing 705 to a connector 744, such as a swivel ring. An elbow, such as Elbow 2, may be utilized to connect the tubing 705 to the connector 744, such as a swivel ring.

[0193] 5.3.1 Nasal area The nasal portion is intended to form a seal with the patient's nasal airway during use. The nasal portion may be a seal disposed on the outside of the patient's nose, such as a cradle-style patient interface or a typical nasal patient interface. Alternatively, the nasal portion may be a peri-nasal seal, such as a pillow-style patient interface, or an intra-nasal seal, such as a nose plug. For patients with upper airway obstruction, a nasal seal may be an appropriate choice. Breathing through the nose may have other benefits, such as naturally filtering the air inhaled.

[0194] 7-1 through 10, the modular patient interface system 1 may include a nasal region 20. The nasal region 20 may include a nostril sealing region 22, a decoupling region 25, a headgear connector 21, a swivel ring 4, and a plug 3. The headgear connector 21 may include a headgear tab 31 adapted to connect to a headgear.

[0195] Decoupling region 25 may function to decouple forces applied to nose region 20, such as tube drag applied by swivel ring 4 due to movement of flexible tubing 5, from nostril sealing region 22. Swivel ring 4 fits into an opening in decoupling region 25 located in the front of nose region 20. Decoupling region 25 may have a thinned portion, e.g., less than 1 mm, to achieve flexibility in this region.

[0196] The plug 3 is adapted to fit over a swivel ring. The plug 3 may include a number of optional vent holes 6 that allow air exhaled from the patient's nose to exit the nasal region 20. The vent holes 6 are arranged in a diffusing arrangement to prevent air from escaping the vent. In some embodiments, the plug 3 may be removed and replaced with a connection to tubing 5.

[0197] Figure 7.1 shows the nasal section 20 of the patient interface system 1 utilized in a nostril-only mode. The nasal section 20 is utilized without the mouth section 40, and includes a swivel ring 4 to which the elbow 2 and flexible tubing 5 are connected.

[0198] The nasal section 20 depicted in FIGS. 7-1 through 10 may be, for example, a modified version of the Swift™ FX marketed by ResMed (e.g., as described in WO 2009 / 052560 A1 and WO 2010 / 139014 A1, both of which are incorporated herein by reference in their entireties), although other nasal sections may also be utilized. The nasal section 20 may be a modified version of the Swift™ FX marketed by ResMed, as depicted in FIGS. 7-1, 7-5, and 9, to include a connector 30 that connects the chamber 49 of the nasal section 20 with an opening 46 in the mouth section 40 to allow air to flow between the nasal section 20 and the mouth section 40 under pneumatic pressure. When used in the nostril-only configuration depicted in FIG. 7-1, the connector 30 is removed from the opening 46 and engages with a plug 35, as shown in the exploded view of FIG. 7-5. The plug 35 is shaped to fit either the opening 46 or the connector 30, as needed. The plug 3 can be removed from the nose section 20 and the elbow 2 and flexible tubing 5 can be connected to the nose section 20 via the swivel ring 4 to deliver breathable pressurized gas to the nose section 20 .

[0199] 11-1 through 19 illustrate a patient interface system 1 that includes a nasal region 20. The nasal region 20 may include a nostril sealing region 22, a decoupling region 25, a headgear connector 21, and a swivel ring 4. The headgear connector 21 may include a headgear tab 31 adapted to connect to a headgear 60.

[0200] 11-19 may be, for example, a Swift™ FX nasal section commercially available from ResMed, Inc., although other nasal sections may also be utilized. Further details of such nasal sections 20 are disclosed in WO 2009 / 05256 A1, the disclosure of which is incorporated herein by reference in its entirety.

[0201] 25 and 26 depict another nose region 220 that may be utilized with any of the embodiments disclosed herein. The nose region 220 may include a nostril sealing region 222, a support membrane 252, a support portion 253, and a headgear connector 230 having headgear tabs 231 for connecting to headgear. The support membrane 252 may be adapted to connect to a connector such as a swivel ring for connection to a source of breathable pressurized gas. Further details of the nose region 220 are disclosed in WO 2010 / 139014 A1, the entire contents of which are incorporated herein by reference.

[0202] Figures 20 and 21 depict an integrated patient interface system 1 including a nasal section 120. The nasal section 120 may include a nostril sealing section 122, a decoupling section 125, and a headgear connector 121 adapted to connect to headgear 160. A nasal section such as the commercially available Swift™ FX nasal section, a modified version of the commercially available Swift™ FX nasal section, or the nasal section of Figures 25 and 26 may be used in conjunction with or integrated with the embodiment of Figures 20 and 21.

[0203] 22-24 depict a patient interface system 201 that may include nasal sections 220. The nasal sections 220 may include nostril seal sections 222 and orifices 226 for receiving breathable pressurized gas. While the patient interface system 201 is depicted with nasal sections 220, such as those depicted in FIGS. 25 and 26, other nasal sections may also be utilized, such as the commercially available Swift™ FX nasal sections or modified versions of the commercially available Swift™ FX nasal sections.

[0204] 27 and 28 depict a modular patient interface system 301 that includes a nasal region 320. The nasal region 320 may include a nostril seal region 322, a decoupling region 325, and a headgear connector 321 for connecting to headgear 360. The nasal region 320 may be adapted to connect to the connector 306 by including an opening 326 adapted to receive the connector 306.

[0205] 29 shows an integrated patient interface system including a nose region 372 connected to a mouth region 380 and headgear 360. Nasal region 372 includes nostril sealing regions 374 adapted to form a seal with the patient's nares.

[0206] Figure 30 illustrates an integrated patient interface system 401 including a nasal section 420 connected to a mouth section 440 and headgear 460. The nasal section 420 includes a nostril sealing section 422 adapted to form a seal with the patient's nares, a decoupling section 425, and a headgear connector 421 adapted to connect to the headgear 460. The nasal section 420 is illustrated as a membrane type as depicted in Figures 25 and 26, although other nasal sections may be utilized, such as the commercially available Swift™ FX nasal section or a modified version of the commercially available Swift™ FX nasal section.

[0207] Figure 31 illustrates an integrated patient interface system 501 including a nasal section 520 connected to a mouth section 540 and headgear 560. The nasal section 520 includes a nostril sealing section 522 adapted to form a seal with the patient's nares, a decoupling section 525, and a headgear connector 521 adapted to connect to the headgear 560. The nasal section 520 is illustrated as a membrane type as depicted in Figures 25 and 26, although other nasal sections may be utilized, such as the commercially available Swift™ FX nasal section or a modified version of the commercially available Swift™ FX nasal section.

[0208] Figure 40 illustrates a modular patient interface system 701 including a nasal section 720 connected to a mouth section 740 and headgear 760. The nasal section 720 includes a nostril sealing section 722 adapted to form a seal with the patient's nares, a decoupling section 725, and a headgear connector 721 adapted to connect to the headgear 760. The nasal section 720 may be a commercially available Swift™ FX nasal section, although other nasal sections may also be utilized, such as the commercially available Swift™ FX nasal section or the nasal sections depicted in Figures 25 and 26.

[0209] Figures 61, 61A, 62, and 62A depict nasal regions 1380, 1390, each including a foam section 1382, 1392. The foam sections 1382, 1392 have holes 1384, 1394 that allow air to pass into the patient's nares. As shown in Figure 61A, the foam section 1382 is conformable and, when compressed, exposes nasal prongs that roll back to hold the foam section 1392 in place and provide a relatively flat surface for contact with the nose, as shown in Figure 62A.

[0210] 5.3.2 Oral area The mouth-site may surround the patient's mouth and form a seal with the patient's airway at the mouth-site. The mouth-site seal may be a flap-type seal, such as a membrane-type seal, or may be a compression seal utilizing a material such as foam, gel, fabric, or the like.

[0211] 7-2 through 10 may include a mouth seal portion 42, a decoupling portion 45 for decoupling a force applied from the mouth seal portion 42 to the mouth portion 40, a lower headgear connector 41, and a swivel connector 44. The mouth portion 40 forms a chamber 49 into which air may be delivered and directed to the patient's mouth.

[0212] A swivel connector 44 may be disposed at the front hole 52 of the mouth-site 40. The swivel connector 44 may be a swivel ring adapted to connect to a tubing connector, such as an elbow 2, for connecting to a flexible tubing 5 that may deliver breathable gas to the mouth-site 40. The swivel connector 44 may be detachable from the front hole of the mouth-site 40. Alternatively, the tubing 5 may connect directly to the mouth-site 40.

[0213] The mouth region 40 depicted in Figures 7-1 through 10 is also adapted to connect to the nose region 20. Specifically, as depicted in Figures 7-4 and 7-5, the mouth region 40 may include a hole or opening 46 adapted to receive and seal with the connector 30 of the nose region 20 to pneumatically connect the nose region 20 to a chamber 49 of the mouth region 40. The patient interface system 1 may be provided with a plug 35 adapted to fit within and connect to the connector 30 or opening 46. The nose region 20 may also function in a nostril-only mode without the mouth region 40.

[0214] The mouth section 40 may function as a docking station, where the mouth section 40 is adapted to dock with (removably receive) the nasal section 20. As shown in FIG. 7-5, the mouth section may include a nasal section docking station 56 formed on the mouth section 40, where the nasal section docking station 56 is adapted to receive the nasal section 20. Once received, the nasal section 20 may function as a dedicated nasal chamber device for delivering breathable pressurized gas to the patient's nose.

[0215] The nose section docking station 56 may be adapted to receive the nose section 20 by having a shape selected to mate with the shape of the nose section. For example, as shown in FIG. 7-5 , the nose section docking station may have a curved upper surface that matches the curved lower surface of the mouth section 40. The nose section docking station 56 may be adapted to receive the nose section 20 by having a hole or opening, such as hole 46, that is adapted to receive a protrusion or connector, such as connector 30, of the nose section 20. Alternative connections of the docking station 56 to the nose section 20 are also possible, such as utilizing a notch or groove to hold the nose section 20 in place. A plug 35 may be provided that is adapted to block either the connector 30 or the opening 46.

[0216] A plug 35 may be disposed within connector 30 of nose section 20 to prevent pneumatic flow of air between nose section 20 and mouth section 40 when connector 30 of nose section 20 is connected to aperture 46 of mouth section 40. Mouth section 40 may alternatively include a valve 55, as shown in FIG. 9, that selectively opens and closes aperture 46 to prevent pneumatic flow of air between nose section 20 and mouth section 40. A patient may selectively operate valve 55, such as by turning knob 54, as shown in FIGS. 8 and 9.

[0217] In some embodiments, such as depicted in FIG. 7-3, the elbow 2 and flexible tube 5 are not connected to the swivel connector 44 but may instead be replaced by a plug 3. The plug 3 may or may not include an optional vent hole 6.

[0218] 11-1 through 19 illustrate a modular patient interface system 1 including a mouth section 40 that includes an alternative connection to the nose section 20. In particular, in the embodiment of FIGS. 11-1 through 19, a nose section connector 43 is utilized to connect the mouth section 40 to the nose section 20. The nose section connector 43 fits over the nose section 20 and seals with the nose section so that air from the flexible tubing 5 can be delivered to the mouth section 40 and pass through the nose section connector 43 to the nose section. A decoupling section 45 can decouple forces on the swivel ring 4, such as tubing drag, from both the sealing section 22 of the nose section 20 and the sealing section 42 of the mouth section 40.

[0219] The sealing region 42 of the mouth region 40 may include a bottom 79, side regions 81, a top region 85, and a neck region 87. The bottom region 79 may be adapted to form a seal with the patient's lower lip or chin area. The top region 85 may be adapted to form a seal with the patient's upper lip area. The side regions may be adapted to form a seal with the patient's face at the side areas of the patient's mouth. The side regions 81 extend between the bottom region 79 and the top region 85. The neck region 87 connects the top region 85 to the nose region connector 43. The sealing region 42 continues from the top region 85 into the neck region 87, which is narrower than the top region 85 to fit the size and shape of the nose region connector 43. Having a narrower neck region 87 may improve pressure and airflow into the sealing region 42. FIGS. 20 and 21 show a patient interface system 101 including a mouth region 140. The mouth region 140 may include a structural portion 147, a mouth sealing region 142, a decoupling region 145, a headgear connector 141 for connecting to headgear, and a vent portion 103 which may include one or more vent holes or slots for venting gases exhaled by the patient. If the nose region 120 and the mouth region 140 are not formed as a unitary element, a nose region connector 143 may be utilized for connecting to the nose region 120. A flexible tube 105 may be connected to the mouth region 140 via the elbow 102. The structural portion 147 may be constructed and arranged to stiffen the periphery of the sealing region so that the shape of the sealing region is maintained and sufficient sealing force is applied to the patient's face.

[0220] 22-24 illustrate a patient interface system 201 that includes a mouth section 240. The mouth section 240 includes a mouth seal 242, which may be in the form of a cushion for sealing with the patient's mouth, a frame 247, a mouth orifice 246 for receiving breathable pressurized air, a decoupling section 245, and a nostril connection 243 for connecting with the nose section. FIG. 16 illustrates the frame 247, decoupling section 245, and connection 243 removed. Although not shown, the mouth section may include a connection to flexible tubing for delivering breathable pressurized gas, such as a swivel connector, elbow, and flexible tubing shown in other embodiments.

[0221] Figures 27 and 28 illustrate a modular patient interface system 301 that includes a mouth region 340. The mouth region 340 includes a decoupling region 345, an opening 348, and a connector 349. The connector 306 is adapted to connect to the opening 326 in the nose region 320 depicted in Figure 27 or the opening 348 in the mouth region 340 depicted in Figure 28. The mouth region connector 349 is adapted to connect to the opening 326 in the nose region 320 when the patient interface 301 is utilized in the nostril and mouth mode. A plug may be provided for connecting the connector 349 when the patient interface 301 is utilized in the mouth-only mode.

[0222] 29 may include a mouth region 380. The mouth region 380 may include a mouth seal region 375 and may be adapted to connect to the headgear 360 and to connect to the nose region 372. The patient interface system may include an air delivery conduit or tube 379 that may be integrated into the headgear. The air delivery tube 379 eliminates the need for an elbow connected to the mouth region 380, provides a "ducted" air delivery, and gives the patient interface system 375 a more streamlined appearance.

[0223] 30 includes a mouth area 440. The mouth area 440 includes a mouth seal area 442, a headgear connector 441 for connecting to headgear 460, and a disconnect area 445. A swivel connector 444 may connect the mouth area 440 to the elbow 402 and flexible hose 405, which delivers breathable pressurized gas to the patient interface system 401.

[0224] The patient interface system 501 depicted in FIG. 31 includes a mouth region 540. The mouth region 540 includes a mouth sealing region 542, a headgear connector 541 for connecting to the headgear 560, a swivel connector 544, and a foam patient-contacting portion 569. The foam may be positioned around the periphery of the mouth sealing region 542, but may optionally be positioned only in selected areas, such as the upper lip area, for comfort. Silicone or another sealing means may be positioned in the area around the mouth sealing region 542 that does not include the foam. The mouth region 540 may also include an optional decoupling region 545. The swivel connector 544 may connect to the elbow 502 and flexible hose 505, which delivers breathable pressurized gas to the patient interface system 501. The foam patient-contacting portion 569 may contact and form a seal with the patient's upper lip area, thereby forming part of the mouth seal.

[0225] The patient interface system 701 depicted in Figure 40 includes a mouth region 740. The mouth region 740 may include a mouth seal region 742, a decoupling region 745, and a headgear connector 741 for connecting to headgear 760. A connector 744, such as a swivel ring, may also be used to connect to a flexible hose 705 via a bifurcated elbow 712.

[0226] 5.3.3 Sealing area The sealing region may comprise at least two portions: a nostril sealing region and a mouth sealing region. By providing at least the nostril sealing region and the mouth sealing region, the patient may selectively receive breathable pressurized gas through the nose and / or mouth.

[0227] The nostril seal portion may function independently from the mouth seal portion, so in some embodiments, a patient may remove the mouth seal portion by removing the mouth portion, if desired, and use only the nose portion with the nostril seal portion. The mouth seal portion may function independently from the nostril seal portion, so in some embodiments, a patient may remove the nose portion and nostril seal portion, and use only the mouth portion and mouth seal portion.

[0228] Both the nostril and mouth sealing regions may be required to form a seal with the patient's upper lip. However, due to the limited surface area in the upper lip region for locating the nostril and mouth sealing regions, in various embodiments, structural elements are utilized to achieve a seal at both the nostril and mouth sealing regions in the patient's upper lip region.

[0229] The mouth seal may fit a wide range of people. The mouth seal may have a single size that fits most people. However, the mouth seal may be provided in a variety of sizes to accommodate a wide range of people. The mouth seal may be longitudinally adjustable to accommodate people of different sizes.

[0230] The nostril sealing area can fit a wide range of people. Preferably, the nostril sealing area comes in one or two sizes to accommodate a wide range of people.

[0231] 5.3.3.1 Nostril seal area The nostril seal regions are adapted to provide a comfortable and effective seal with the patient's nostrils.

[0232] The nostril seal may be a pillow, prong, membrane seal such as a nasal cradle, and / or a nasal chamber.

[0233] The nostril sealing site may be a pillow seal as disclosed in PCT Application No. WO2009 / 052560A1, which is incorporated herein by reference in its entirety.

[0234] The nostril sealing region is preferably flexible and conformable so as to conform to the shape of the patient's nose and / or nostrils in use.

[0235] The nostril sealing regions are preferably constructed from polymers such as silicone, thermoplastic elastomers, thermoplastic urethanes, etc. Alternatively, the nostril seals may be constructed from conformable materials such as foams, gels, fabrics, etc. Alternatively, the nostril sealing regions may be constructed from any other combination of the above materials, such as laminates of foam and fabric, combinations of fabric and polymers, etc.

[0236] As depicted in Figures 7-1 through 10, various embodiments of the present technology may include nostril sealing regions 22 in the form of pillow or prong-type nostril seals. The nostril sealing regions 22 may alternatively be membrane-type nasal seals or nasal chambers. The nostril sealing regions 22 are adapted to form a seal with the patient's nostrils during use. The nostril sealing regions 22 may be positioned to underlie the patient's nose and may be shaped to form an effective seal.

[0237] 25 and 26, nose section 220 can include nostril sealing section 222, support membrane 252, support section 253, and headgear connector 230 having headgear tabs 231 for connecting to headgear. In all embodiments disclosed herein, nostril sealing sections in the form of nostril sealing section 222 can be used when used in conjunction with membrane-type nose sections.

[0238] The nostril sealing region 222 may include a nose tip engagement portion 254, an upper lip engagement portion 256, and a thickened corner region 258. The support portion 253 may include a posterior thickened portion 262 and an anterior thickened portion 260. Portions of high-rigidity material in the support portion 253 may be used in place of or in addition to the thickened portions 260 and 262 to enhance support in these areas. The anterior thickened portion 260 is positioned adjacent to the area of ​​the sealing region that contacts the sides of the patient's nose in use and converts the load of the headgear into a clamping force on the sides of the patient's nose to provide an effective seal. The anterior thickened portion 260 may have a thickness that increases from top to bottom. The posterior 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.

[0239] The nose tip engagement portion 254 is formed as a depending flexible membrane. The sides of the sealing portion 222 are connected or glued to the support portion 253, while there is a front gap between the center of the sealing portion 222 and the support portion 253, and the support portion 253 exists between the front anchor points 257. By utilizing this depending flexible membrane, the nose tip engagement portion 254 provides a flexible surface that maintains tensile contact with the nose during movement of the patient interface, better accommodating various nose shapes. The nose tip engagement portion 254 engages and seals with the patient's nose and extends toward the support portion 253. The sides of the sealing portion 222 engage and seal with the sides of the patient's nose.

[0240] The sealing portion 222 includes an upper lip engaging portion 256 that engages the patient's upper lip in use. The upper lip engaging portion 256 is formed as a depending flexible membrane with a back gap between the upper lip engaging portion 256 of the sealing portion 222 and the support portion 253. The back gap is located between back anchoring points 259 that anchor the sealing portion 222 to the support portion 253. The flexible depending membrane provides a flexible surface that maintains tensile contact with the patient's upper lip during movement of the patient interface, and by allowing movement of the upper lip engaging portion 256, can stretch to accommodate a variety of facial shapes.

[0241] The posterior thickened portion 262 may have a curved portion 268. The posterior thickened portion 262 may include a centering portion 270 to reduce the bulk of the silicone and shorten the cure time. The posterior thickened portion 262 is located directly below the thickened corner region 258 of the sealing portion 222, as can be seen in FIG. 20 . When used in conjunction with a headgear connector, such as those depicted in FIGS. 24 and 25 , the posterior thickened portion 262 transfers load from the headgear connector to the thickened corner region 258 and the inferior corner of the patient's nose, helping to provide an effective seal, and increasing load transfer to the inferior corner of the patient's nose as the headgear is tensioned. In use, bending forces from the headgear connector are transferred by the posterior thickened portion 262 to the thickened corner region 258 of the sealing portion 222, applying a sealing force to the area of ​​the patient's nose adjacent the nasolabial fold as an anchoring force.

[0242] Nostril sealing regions 222 are structured to extend or curve outward from support walls 221 formed in holes 226 that define the air pathways through nose regions 220 .

[0243] Further details of the nostril sealing region 222 are disclosed in WO2010 / 139014A1, which is incorporated herein by reference in its entirety.

[0244] All of the embodiments disclosed herein may use pillow or prong-type nasal seals, membrane-type nasal seals as depicted in Figures 25 and 26, or nostril sealing sites in the form of nasal chambers.

[0245] Figures 41 and 42 depict nostril sealing region 820 that may be utilized to form a seal with a patient's nares for delivering breathable pressurized gas to the patient's nose through patient interface system opening 826 and inlet tube 830. Nostril sealing region 820 may be a membrane-type nasal seal, such as sealing region 222 depicted in Figures 25 and 26.

[0246] Disposed on the bottom surface of nostril sealing region 820 are a dial 822 and a rigid element 823. There may be four such rigid elements 823, although any number may be used. The rigid elements 823 may be disposed to extend radially from the dial 822, which may be disposed around opening 826. Turning the dial 822 rotates a bevel gear, causing the rigid element 823 to move up or down, which in turn may cause the sides of nostril sealing region 820 to move up or down, increasing or decreasing the clamping force on the sides of the patient's nostrils during use.

[0247] 5.3.3.2 Mouth sealing area The mouth seal portion may be adapted to seal with the patient's mouth. The mouth seal portion is preferably flexible and conformable so as to conform to the shape of the patient's nose and / or nostrils during use. The mouth seal portion may include a stretchable membrane over the patient's upper lip and chin area, i.e., more flexible than the side regions of the membrane that interface with the patient's cheeks. Because the cheeks and sides of the mouth are less sensitive to pressure from the force of the patient interface system, more force may be applied to the cheek and side regions, thereby anchoring the mouth portion over the patient's mouth. Furthermore, the flexibility of the upper lip and chin area allows the mouth seal portion to flex from a generally planar position to conform to a flat / pancake-shaped face, as well as to flex into a concave position to conform to a pointed / angular face.

[0248] The mouth seal is preferably constructed from a polymer such as silicone, a thermoplastic elastomer, or a thermoplastic urethane. Alternatively, the mouth seal may be constructed from a conformable material such as foam, gel, fabric, etc. Alternatively, the mouth seal may be constructed from a combination of the above materials, such as a laminate of foam and fabric, or any other combination of fabric and polymer.

[0249] As depicted in FIGS. 7-1 through 10, various embodiments of the present technology may include a mouth sealing region 42. The mouth sealing region 42 is adapted to form a seal with the patient's mouth during use. The mouth sealing region 42 may be positioned to fit around the patient's mouth and may be shaped to form an effective seal. The mouth sealing region 42 may be in the form of a cushion that defines a rear opening 50 for insertion of the patient's mouth. The cushion may be a soft silicone cushion that contacts and forms a seal with the patient's mouth area. All of the embodiments disclosed herein may include a mouth sealing region as described above.

[0250] As depicted in the schematic cross-sectional view of Figure 32, mouth seal region 42 may seal with the patient 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 the patient's chin. As further depicted in Figure 32, mouth seal region 42 may be disposed between decoupling region 25 and the patient's upper lip.

[0251] 5.3.3.3 Unbinding There may be a decoupling or force absorbing element positioned as part of the nose region or the mouth region, and the decoupling element may be located between the first portion of the nose region and the second portion of the nose region and / or the first portion of the mouth region and the second portion of the mouth region to prevent movement or forces acting on the nostril or mouth region from compromising the seal of the respective sealing region.

[0252] In one embodiment, the decoupling element may be a spring.

[0253] In another embodiment, the decoupling element may be a gusset or a flexible chamber.

[0254] 7-4, decoupling region 25 may be disposed between nostril sealing portion 22 and swivel ring 4. Decoupling region 25 may be a thin, flexible region of resilient material adapted to absorb force and / or movement by flexing and / or changing its shape. For example, decoupling region 25 decouples force or movement acting on swivel ring 4 from being transmitted to nostril sealing region 22.

[0255] The mouth sealing portion 40 may also include a decoupling portion 45, which may be disposed between the frame 47 and the swivel connector 44. The decoupling portion 45 may be a thin, flexible region adapted to absorb force and / or movement by flexing and / or changing its shape. For example, the decoupling portion 45 may decouple forces or movement, such as tube drag acting on the flexible tubing 5, the swivel connector 44, and / or the elbow 2, from being transmitted to the mouth sealing portion 42, enhancing the seal with the patient. All of the embodiments disclosed herein may include one or more decoupling portions as described, which may be part of the nose portion and / or mouth portion.

[0256] In the patient interface system 1180 of Figure 52, movement of the nose region 1190 in the mouth region 1182 is decoupled by decoupling region 1181. Decoupling region 1181 allows the nose region 1190 to remain in sealing engagement with the patient's nares even when the air hose 1185 and / or mouth region 1182 move. The nose region 1190 can rotate relative to the mouth region 1182. The covering flap 1183 moves with the air hose 1185 and / or mouth region 1182.

[0257] 5.3.3.4 Relationship between nostrils and mouth seal area The sealing region may be constructed in one piece including a nostril sealing region and a mouth sealing region.

[0258] The sealing portion may be constructed of more than one piece and then coupled together to operate as a nasal and oral patient interface. For example, the nostril sealing portion may be constructed of a first piece and the mouth sealing portion may be constructed of a second piece, and then the first and second pieces may be joined.

[0259] In further preferred embodiments, the sealing portions may be constructed of more than one piece, each of which may be used independently of the others or may be attached to the others, with each device still providing treatment to the patient. For example, a nose portion including a nostril sealing portion may be separate from a mouth portion including a mouth sealing portion, and the nose portion including a nostril sealing portion may be used without the mouth portion including the mouth sealing portion attached and still deliver treatment to the patient's nares.

[0260] 5.3.3.5 Headgear connection to nostrils and mouth area Headgear 60 can be connected to each of the nose region 20 and the mouth region 40. This differs from many prior art devices in which the headgear connects only to the mouth region, which is structured and positioned to place the nose region into sealing engagement with the patient's nose.

[0261] 7-1 through 19, the nose region 20 may include a headgear connector 21. The headgear connector 21 may include a headgear tab 31 that may interface with or connect to a hole 70, which may be in the form of a slot or loop, on the headgear strap 61.

[0262] The mouth area 40 may include a lower headgear connector 41 for receiving a locking device 64 from a lower headgear strap 63 .

[0263] Alternative connection devices are contemplated for the nose region 20 and mouth region 40. For example, hook and loop type connections, push-fit connections, interference fits, ball joints, etc. may be used.

[0264] 5.3.4 Positioning and stabilizing structures This positioning and stabilizing structure in the form of headgear 60 may be adapted to maintain the patient interface system in sealing engagement with the patient's nostrils and mouth. The headgear 60 may include straps adapted to secure the position of the headgear 60 on the patient's head. These straps may include side headgear straps 61, lower headgear straps 63, a posterior headgear portion 65, and a parietal headgear portion 66. These straps may also direct a pulling force on the patient interface to seal it with the patient's face.

[0265] 5.3.4.1 Headgear sides 7-1 to 7-3 and 11-1 to 13 show the headgear 60 in use. Side headgear straps 61 may be positioned over the patient's cheeks, under the eyes, and above the ears. The side headgear straps 61 may be connected to the headgear connectors 21 in the nose region 20.

[0266] The side headgear straps 61 may include side headgear connectors 62 for connecting with the headgear connectors 21 of the nose region 20. The side headgear connectors 62 may be in the form of loops for gripping the headgear tabs 31 of the nose region 20. Any connection method is contemplated, such as hook and loop connections, clips, push-in tabs, etc. Alternatively, the side headgear straps 61 may be integrally formed with the nose region 20.

[0267] The side headgear straps 61 are preferably constructed of a flexible material that may be longitudinally stretchable. The side straps 61 may be constructed of fabric, foam, a foam and fabric composition, silicone, nylon, elastic, or any other flexible material.

[0268] The side headgear straps 61 may provide an upward vector to the patient interface system 1 to help maintain the patient interface system 1 in a desired position. This upward vector may be angled upward relative to the vector applied by the lower headgear straps 63.

[0269] 5.3.4.2 Headgear top The headgear 60 may further include a crown or top strap portion 66 that may be positioned over the top or crown of the patient's head in use. The crown strap portion 66 may provide an upward vector to the patient interface system to assist in maintaining the patient interface system in a desired position.

[0270] The crown strap portion 66 may be continuous with or otherwise connected to the side headgear straps 61. The crown strap portion 66 and / or the side headgear straps 61 may further include a strap loop 68. The strap loop 68 may be configured to receive the rear portion 65.

[0271] The crown strap portion 66 may further include an adjustment mechanism 69. The adjustment mechanism 69 may be as described in WO2009 / 052560A1, which is incorporated herein by reference in its entirety.

[0272] The crown strap portion 66 is preferably constructed of a flexible material that may be longitudinally stretchable. The crown strap portion 66 may be constructed of any flexible material, such as fabric, foam, a foam and fabric composition, silicone, nylon, elastic, etc.

[0273] 5.3.4.3 Lower headgear The headgear 60 may further include lower headgear straps 63 that may connect to the mouth region 40 of the patient interface system 1. The lower headgear straps 63 may direct a vector force normal to the patient's face and thus a pulling force on the mouth region 40 to seal the mouth region 40 to the patient's face.

[0274] The lower headgear straps 63 may be straps that are oriented generally below the patient's ears.

[0275] The lower headgear straps 63 may be connected or otherwise formed with the rear headgear portion 65 .

[0276] 5.3.4.4 Rear of headgear The headgear 60 may further include a rear portion or strap 65. The rear portion 65 may be continuous with or otherwise attached to the side headgear straps 61 or the top strap portion 66. The rear portion 65 may be threaded through strap loops 68 and positioned over the patient's ears. The rear portion 65 may descend down the sides of the patient's head in use and grip the back of the head to secure the headgear 60 in place. The rear portion 65 may further connect to the lower headgear straps 63 at a connection region 67.

[0277] The rear portion 65 may provide a downward and rearward (i.e., away from the patient's face) vector to counterbalance the upward vector of the crown strap portion 66 and may assist in pulling the patient interface system 1 into sealing engagement with the patient's face.

[0278] The rear portion 65 may be secured in place under the back of the patient's head by connecting to the lower strap 63 (see FIG. 13). The connection may be at a connection region 67. The connection region 67 may comprise a stitched joint, a hook and loop joint, or any other joint. The connection region 67 may also be a permanent joint such that the rear portion 65 and the lower strap 63 are integrally formed.

[0279] The rear portion 65 is preferably constructed of a flexible material that may be longitudinally stretchable. The rear portion 65 may be constructed of any flexible material, such as fabric, foam, a foam and fabric composition, silicone, nylon, elastic, etc.

[0280] 5.3.4.5 Headgear Options Various embodiments of the patient interface system and kit may include various headgear options, such as those depicted in Figure 39. For example, when used in a nostril-only mode, nose-region headgear 812 may be used to secure the nose region to the patient's head. When used in a mouth-only mode, mouth-region headgear 850 may be used to secure the mouth region to the patient's head.

[0281] The nose-area headgear 812 utilizes an upwardly angled headgear vector to align the nostril sealing force with the patient's nares. The mouth-area headgear 850 utilizes a headgear vector oriented generally in the horizontal plane to align the mouth sealing force with the patient's mouth. In the examples shown in Figures 39 and 43-44, these headgear vectors are angled relative to each other. However, in the examples of Figures 40-41, these headgear vectors are generally parallel to each other due to the nature of the cushions and the sealing forces involved.

[0282] When utilized in nostril and mouth mode, nose region headgear 812 and mouth region headgear 850 may be utilized together to secure the nose region and mouth region to the patient's head. Alternatively, nostril and mouth region headgear 860 may be utilized that includes a connection region on its back, such as connection region 67 depicted in FIG. 13. Nostril and mouth region headgear 860 creates a headgear vector that moves back and forth along the patient's head to secure nose region 820 to the patient's nostrils and moves back along the patient's head to secure mouth region 840 to the patient's head.

[0283] The nasal-region headgear 812 and the oral-region headgear 850 can each connect at two points to either the nasal or oral region of the patient interface system of the present technology. In some configurations, when both the nasal and oral regions of a patient interface system are used together as a system, both the nasal-region headgear 812 and the oral-region headgear 850 can be used, thus together providing a positioning and stabilizing structure with four connection points. Converting the positioning and stabilizing structure from a two-point to a four-point configuration may allow the user to optimize or at least improve the force vector of the reconfigured patient interface system. As such, the improved vector of the reconfigured four-point positioning and stabilizing structure may increase the effectiveness of the seal-forming structure and, in some embodiments, may also provide improved overall comfort for the user. In some configurations, the addition of the oral-region headgear 850 may increase the stability of the patient interface system. This may be particularly useful in configurations with a patient interface system having an overall seal-forming structure that engages both the patient's oral and nasal air passages.

[0284] For example, by providing the patient interface system as separable nose and mouth sections with respective removable and adjustable attached headgear systems when reconfiguring the nasal interface to a dual nose and mouth (i.e., oral-nasal) interface, or similarly when reconfiguring the oral interface to a dual nose and mouth interface, the patient interface system may be modularly configurable by the user to suit individual treatment requirements and desired comfort levels. A modularly configurable patient interface system may also improve manufacturing cost efficiency of the patient interface system.

[0285] In some forms, the nose and mouth-region headgear of the disclosed patient interface system can be configured independently of one another (e.g., FIG. 44). In some forms, a connector 856 can be used to facilitate connection of the nostril and mouth-region headgear 870. For example, as shown in FIG. 39, a connector 856 can be used to facilitate connection of the nose-region headgear and the mouth-region headgear at one or more locations along each headgear. For example, the connector 856 can be positioned toward the center-rear of the user's head, adjacent the occipital bone.

[0286] As will be appreciated by those skilled in the art, the connector(s) used to connect the nose-area headgear and mouth-area headgear can take many forms. Functionally, the combined nose-area and mouth-area headgear together provide a positioning and stabilizing structure with four connection points to the facial interface structure that provides treatment.

[0287] In some forms, the nose-area headgear and mouth-area headgear can each include one or more connectors, with the connector(s) of the nose-area headgear corresponding in opposite engagement to the connector(s) of the mouth-area headgear. The connectors 856 can be Velcro connectors, hook and loop material connectors, or the like. Any of the above headgear options can be utilized in various embodiments.

[0288] For example, in some forms, the nose-area headgear 8812 can be formed from a material that can releasably engage, at the mouth, a Velcro®-equipped connector 8856 on the mouth-area headgear 8850 (e.g., FIGS. 172A and 172B). Alternatively, in some forms, the nose-area headgear 8812 can include one or more connectors 8856 that include a layer of Velcro® (or similar material) that releasably engages the material of the mouth-area headgear 8850 (e.g., FIG. 172C).

[0289] In a further example, in some forms, the connectors 8856 can include one or more male snap connectors 8856′ on the nose-region headgear 8812 and one or more female snap connectors 8856″ on the mouth-region headgear 8850, or the order can be reversed (e.g., FIGS. 173A and 173B). The plurality of male snap connectors 8856′ can be spaced along the nose-region headgear 8812 to correspond to and releasably engage with a plurality of similarly spaced female snap connectors 8856″ on the mouth-region headgear 8850. In some forms, the male and female snap connectors 8856′, 8856″ can be thermoformed into the material of the respective headgear portions 8812, 8850. In some alternative forms, the male and female snap connectors 8856′, 8856″ can be countersunk and embedded in the material of the respective headgear portions 8812, 8850 by a riveting process. There may be advantages to reducing the profile of the connector 8856. For example, reducing the profile of the connector 8856 may improve user comfort in some forms.

[0290] In a further example, in some forms, the connector 8856 can include one or more tabs 8857 extending laterally from the mouth-area headgear 8850 and releasably engage by hooking onto one or more latches 8858, which in turn receive one or more of the one or more tabs 8857 on the nasal conduit system headgear straps, or vice versa (e.g., FIG. 174). In some forms, each of the one or more tabs 8857 can be formed as a fixed piece of material. In some forms, each of the one or more tabs 8857 can be formed from a material that is elastically stretchable, allowing the one or more tabs 8857 to stretch and reach a corresponding one of the one or more latches 8858.

[0291] In configurations with a pair of corresponding connectors 856, the position of one or more connectors on one headgear piece 8812, 8850 can limit the range in relative space within which the corresponding connector 856 and the other of the headgear piece 8812, 8850 can be located. This can facilitate conversion from a two-point to a four-point positioning and stabilizing configuration and can allow for a more intuitive connection, as the connector(s) 856 can guide the user.

[0292] For example, in some forms, spaced apart connectors 856 may be positioned along the nose-area headgear 8812. As such, the spaced apart connectors 856 can act as guides for the user by limiting the allowable deviation of where a corresponding connector 856 on the mouth-area headgear 8850 can engage (e.g., FIGS. 172A-173C).

[0293] 172A , in a further example, mouth-area headgear 8850 includes a U-shaped segment 8852, with a flange at each distal end of the U-shape including a layer of Velcro®. In some forms, the entire nose-area headgear 8812 can be formed from a material that engages with Velcro®, while in other forms, the material of the nose-area headgear 8812 can be formed from a material that does not engage with Velcro®; instead, two segments of Velcro®-engaging material can be layered on the nose-area headgear 8812 to guide the user in placing the Velcro® at each distal end of the U-shaped segment of the mouth-area headgear 8850.

[0294] Referring to FIG. 173A, in a further example, separate male and female snap connectors 8856′, 8856″ may be spaced apart along each headgear portion 8812, 8850, thereby limiting the range of deviation allowed when connecting the nose-region headgear 8812 and mouth-region headgear 8850. Referring to FIG. 173C, in some forms, the male and female snap connectors 8856′, 8856″ may be staggered such that a male snap connector 8856′ is spaced apart from a female snap connector 8856″ on the same headgear portion. This may help guide a user to correctly connect the headgear portions 8812, 8850 to one another.

[0295] In some further forms, at least one of the nose-region headgear 8812 and the mouth-region headgear 8850 can include alignment guides 8860 to provide guidance to the user when engaging the connector 856. The alignment guides 8860 can assist in at least one of positioning and / or orienting the connector 856 such that the vector of the reconfigured four-point positioning and stabilization structure is improved.

[0296] For example, referring to FIGS. 175A and 175B, the connector 8856 and the alignment guide 8860 may have the same pattern, multiple visible lines (e.g., FIG. 175A), or shape (e.g., FIG. 175B). As such, the alignment guide 8860 can indicate the location and / or orientation on the headgear piece. The user simply places the connector 8856 over the matching pattern, line, or shape of the alignment guide 8860. This allows the user to intuitively understand the position and angle at which the connectors should engage.

[0297] 176A-176C, in a further example, the alignment guide 8860 can take the form of one or more protrusions and / or one or more depressions on at least one of the nose-region headgear 8812 and the mouth-region headgear 8850. In some forms, the one or more protrusions and / or depressions of the alignment guide 8860 can be heat molded into each headgear strap. The one or more protrusions and / or depressions of the alignment guide 8860 can be formed as a single protrusion or depression (e.g., FIG. 176A), as multiple protrusions or depressions (e.g., FIG. 176B), or as protrusions or depressions formed as loops (e.g., FIG. 176C) to correspond to the number and shape of corresponding protrusion or depression connector(s) 8856 that fit within the alignment guide 8860 to engage therein.

[0298] In some forms, the nose area headgear 8812 and mouth area headgear 8850 can include a combination of multiple types of connectors 8856 and alignment guides 8860. For example, referring to FIG. 177 , the connector 8856 can include a plurality of corresponding raised island-shaped embossed hooks and tabs within the otherwise recessed alignment guide 8860 area of ​​the nose area headgear 8812.

[0299] In some forms, the mouth-region headgear 8850 can include a connector 8856 including one or more flaps 8862 extending laterally from the mouth-region headgear 8850 and adapted to be threaded through a corresponding portion defined in or by the nose-region headgear 8812. The one or more flaps 8862 threaded through the slits 8814 can be folded and secured to hold the nose-region headgear 8812 and the mouth-region headgear 8850 together (e.g., FIG. 178A). In some forms, the folded flaps 8862 can be secured to themselves or to the nose-region headgear 8812 via the connectors 8856. The one or more flaps 8862 can include a connector 8856 layer formed from a layer of Velcro®, a snap connector, or other similar corresponding fastening means (e.g., FIG. 178B). In some forms, the flaps 8862 can have a width that extends partially along the width of the slit 8814 (e.g., FIG. 178A). In other configurations, the flaps 8862 and slits 8814 can be correspondingly sized (e.g., FIG. 178B). In some other configurations, multiple flaps 8862 can pass through a single slit 8814 (e.g., FIG. 178C).

[0300] Also, a connected nostril and mouth area headgear 870 may be utilized, which includes a connector 856 for connecting the nostril-only headgear and the mouth-only headgear at the back. The connector 856 may be a Velcro connector, a hook and loop material connector, or the like. Any of the above headgear options may be utilized in various embodiments.

[0301] Other alternatives that allow for selective attachment and detachment are also contemplated, including, for example, referring to FIG. 73 below, a back loop 1622 through which the back strap 1619 passes.

[0302] Another variation is shown in Figures 96 and 97, illustrating another option for converting from two-point headgear to four-point headgear. The headgear 2000 includes two-point headgear 2001 including a pair of front straps for supporting a patient interface, as shown in Figures 39 and 73, for example. In addition, the rear of the headgear 2000 includes a first rear strap 2002 connected to the pair of front straps, and a second rear strap 2006, which may be connected to the first rear strap by, for example, a press stud device or snaps.

[0303] In particular, the first rear strap 2002 may have a male portion 2002.1 to allow for selective attachment and detachment, and the second rear strap 2006 may have a complementary / female portion 2006.2.

[0304] 5.3.5 Ventilation Various embodiments of the present technology may utilize one or more vents in the patient interface system to vent gases exhaled by the patient, which vent(s) may be arranged to vent exhaled gases from the nasal region 20, the mouth region 40, or from the nasal region 20 and the mouth region 40.

[0305] For example, nose region 20 includes plug 3, which may include a vent 6 for venting exhaled gases from the patient's nares. Elbow 2 connected to mouth region 40 may optionally include another vent 6 for venting exhaled gases from the patient's mouth. In particular, if either nose region 20 or mouth region 40 is used as a seal, such as a region that does not deliver breathable gas, then either vent 6 may be omitted.

[0306] The vent 6 may be in the form of a series or array of individual vent holes. Alternatively, the vent 6 may be in the form of a slot or series of slots as depicted in Figures 11 and 12, or in the form of another hole(s).

[0307] 5.3.6 Air Delivery System Air in the form of breathable pressurized gas is delivered to the patient interface system 1 through flexible tubing 5. Flexible tubing 5 is connected to an air delivery device, such as a blower / humidifier, that delivers the breathable pressurized gas to the patient for therapy.

[0308] 5.3.7 Modular Patient Interface System Various embodiments of the patient interface system disclosed herein may be a modular patient interface system including a nose region, a mouth region, and headgear. The modular patient interface system may allow a patient to selectively use the nose region and / or the mouth region in a first mode and a second mode. In the first mode, the patient may use both the nose region and the mouth region. In the second mode, the patient may use only the nose region without using the mouth region.

[0309] Some of these embodiments may also allow the modular patient interface system to be used in a third mode in which the mouth site is utilized but the nose site is not. In various embodiments providing a third mode, the mouth site is utilized to provide air to the patient's mouth site, while the nose site is not utilized or worn by the user. Additionally, in some embodiments, the nose site and mouth site may have openings and / or connectors between the chambers that allow air to flow freely between the nose site and the mouth site chambers. Some embodiments may include a plug or selectively operable valve that can be used to block the opening or connector to prevent air from flowing between the nose site and the mouth site. The plug may also be used to block the opening or connector when the nose site or the mouth site is used alone. All modular patient interface systems may alternatively be formed as an integrated patient interface system in which the nose site is not separable from the mouth site and cannot be used separately.

[0310] Figures 38(a) through 38(k) are schematic diagrams of the nose section 20 and the mouth section 40 used in various modes. In a first mode, a patient may use both the nose section and the mouth section by using the nose section 20 to deliver air to the patient's nostrils while using the mouth section 40 to deliver air to the patient's mouth, as shown in Figures 38(e), 38(f), 38(g), 38(h), and 38(k). In Figure 38(e), the nose section 20 and the mouth section 40 do not include a connection between the nose section and the mouth section chambers, and pressurized air is applied separately to both the nose section 20, which delivers air to the patient's nostrils, and the mouth section 40, which delivers air to the patient's mouth. In Figure 38(f), a connection exists between the chamber of the nose section 20 and the chamber of the mouth section 40. Pressurized air is applied to the chamber in the mouth region 40, flows through the mouth region 40 into the patient's mouth, and flows from the mouth region 40 through connections to the nose region 20 and into the patient's nostrils.

[0311] In FIG. 38( g ), a connection exists between the chamber in nose region 20 and the chamber in mouth region 40. Pressurized air is applied to the chamber in nose region 20, flows through nose region 20 to the patient's nares, and flows from nose region 20 through the connection to mouth region 40 to the patient's mouth. In FIG. 38( h ), a connection exists between the chamber in nose region 20 and the chamber in mouth region 40. Pressurized air is applied to the chamber in nose region 20 and the chamber in mouth region 40 and can flow through the connection between nose region 20 and the mouth region 40. In FIG. 38( k ), a connection exists between the chamber in nose region 20 and the chamber in mouth region 40, but the connection is blocked with a plug, valve, or the like. Pressurized air is applied to the chamber in nose region 20 and the chamber in mouth region 40, flows through nose region 20 to the patient's nose, and flows through mouth region 40 to the patient's mouth.

[0312] In a first mode, as shown in Figures 38(c) and 38(i), a patient may utilize both the nose region 20 and the mouth region 40 by utilizing the nose region 20 as a nostril seal while utilizing the mouth region 40 to deliver air to the patient's mouth. In Figure 38(c), there is no connection between the nose region 20 and the mouth region 40; pressurized air is delivered to the patient's mouth through the mouth region 40, and the nose region is utilized as a nostril seal. In Figure 38(i), there is a connection between the nose region 20 and the mouth region 40, but this connection is closed with a plug, valve, or the like. Pressurized air is delivered to the patient's mouth through the mouth region 40, and the nose region 20 is utilized as a nostril seal.

[0313] In a first mode, as shown in Figures 38(d) and 38(j), the patient may utilize both nose region 20 and mouth region 40 by utilizing nose region 20 to deliver air to the patient's nares while utilizing mouth region 40 as a mouth seal. In Figure 38(d), there is no connection between nose region 20 and mouth region 40, and pressurized air is delivered through nose region 20 to the patient's mouth, with mouth region 40 being utilized as a mouth seal.

[0314] In the second mode, the nose section 20 is used alone to deliver air to the patient's nose, as shown in Figure 38(a), while the mouth section is not used or worn by the patient. In embodiments utilizing a connection to allow air flow between the nose section and the mouth section, when the nose section 20 is used alone, a plug, valve, or the like may be used to occlude the opening.

[0315] In a third mode, as shown in Figure 38(b), the mouth region 40 is used alone to deliver air to the patient's mouth, while the nose region 20 is not used or worn by the patient. In various embodiments utilizing a connection to allow air to flow between the nose region 20 and the mouth region 40, a plug, valve, or the like may be used to occlude the opening when the mouth region 40 is used alone.

[0316] The embodiment of Figures 7-1 through 10 is a modular patient interface system 1 in which the nose sites 20 may be utilized with a patient in a nostril-only mode without the mouth sites 40, the mouth sites 40 may be utilized with a patient in a mouth-only mode without the nose sites 20, or the nose sites 20 may be utilized with the mouth sites 40 in a nostril and mouth mode. Figures 7-2 and 8 through 10 depict the patient interface system 1 in a nostril and mouth mode in which the nose sites 20 are utilized in conjunction with the mouth sites 40. When utilized in the nostril and mouth mode, the patient interface system 1 may utilize the nose sites 20 to deliver air to the patient's nose and the mouth sites 40 to deliver air to the patient's mouth, the patient interface system 1 may utilize the nose sites 20 to deliver air to the patient's nares and the mouth sites 40 may be utilized as a mouth seal without delivering air to the patient's mouth, or the patient interface system 1 may utilize the mouth sites 40 to deliver air to the patient's mouth and the nose sites 20 may be utilized as a nostril seal without delivering air to the patient's nares.

[0317] Both the nose section 20 and the mouth section 40 are adapted to connect to a source of breathable pressurized gas. In particular, in the various embodiments of Figures 7-2 through 10, both the nose section 20 and the mouth section 40 are adapted to connect to a source of breathable pressurized gas, such as flexible tubing 5, via elbow 2, although only one of these sections may be connected. Flexible tubing 5 may be connected to either or both of the nose section 20 and the mouth section 40. Connection to both the nose section 20 and the mouth section 40 may be made by utilizing a connector, such as, for example, the bifurcated elbow 712 depicted in Figure 40.

[0318] 7-2 and 8-10, nose region 20 and mouth region 40 are interconnected to allow air to flow between them, such as by utilizing a connector 30 at the nose region connected to opening 46 in mouth region 40, although other connection methods may be used. If it is desired to prevent air from flowing between nose region 20 and mouth region 40, this connection may be interrupted using plug 35 or valve 55 actuated by knob 54.

[0319] The patient interface system 1 connects the elbow 2 and flexible tubing 5 to either the swivel connector 4 of the nose site 20 or the swivel connector 44 of the mouth site 40 so that breathable pressurized gas is received by the patient's nares and mouth, and the breathable gas can flow through the connector 30 and opening 46. The patient interface system 1 can also function as a mouth seal or a nostril seal, in which case the connector 30 and / or opening 46 is blocked by utilizing the plug 35 or activating a valve with the knob 54 to connect only one of the nose site 20 or the mouth site 40 to the elbow 2 and flexible tubing 5. For example, when the elbow 2 and flexible tubing 5 are connected to the nose site 20 and the connector 30 and / or opening 46 are blocked by utilizing the plug 35 or activating the valve 55 with the knob 54, pressurized air is delivered to the nose site 20, and the mouth site 40 acts as a mouth seal that does not deliver pressurized air to the patient's mouth. Alternatively, when the elbow 2 and flexible tubing 5 are connected to the mouth region 40 and the connector 30 and / or opening 46 are blocked by utilizing the plug 35 or by activating the valve 55 with the knob 54, pressurized air is delivered to the mouth region 40 and the nose region 20 acts as a nostril seal that does not deliver pressurized air to the patient's nares.

[0320] The patient interface system 1 is also adapted to function in a nostril-only mode, utilizing the nose region 20 without the mouth region 40, as depicted in Figure 7-1. In this mode, the mouth region 40 and lower headgear straps 63 are not utilized, the plug 3 is removed from the nose region 20, and the elbow 2 and flexible tubing 5 are connected to the nose region 20 for delivering breathable pressurized gas to the patient's nares. The connector 30 is plugged with a plug 35.

[0321] The patient interface system 1 is also adapted to function in a mouth-only mode, as shown in FIG. 7-4, utilizing the mouth site 40 without the nose site 20. In this mode, the nose site 20 with the headgear straps 61 is not utilized, and the elbow 2 and flexible tubing 5 are connected to the mouth site 40 via a swivel connector 44 for delivering breathable pressurized gas to the patient's mouth. The mouth site opening 46 is blocked by a plug 35.

[0322] Figures 11-1 through 19 illustrate another embodiment of a patient interface system 1, which may be a modular patient interface system. Figures 11-1 and 12-19 illustrate the modular patient interface system 1 in nostril and mouth mode. A flexible tube 5 is connected to the elbow 2 via a swivel ring 4 and directs breathable pressurized gas into a chamber in the mouth region 40 and into the nose region 20 via a nose region connector 43.

[0323] A decoupling portion 45 is connected between the swivel ring 4 and both the nose portion 20 and the mouth portion 40. Additionally, the nose portion 20 may also include a decoupling portion 25, such that the nose portion benefits from two decoupling portions to decouple force or movement applied to the flexible tube 5, elbow 2, and / or swivel ring 4 from being transmitted to the sealing portion 22 of the nose portion 20.

[0324] In the various embodiments of Figures 11-1 through 19, the nostril sealing region 22 can be in the form of nasal pillows as depicted in Figures 14, 15, 17, and 18, membrane seals such as prongs, nasal cradles, and / or nasal chambers. For example, the nasal region of Figures 11 through 19 can be in the form of the nasal region 220 depicted in Figures 25 and 26. The support portion 252 may or may not be included. When the nasal region 220 is in use, the sealing region 222 that seals with the patient's nose is configured to extend or curve outward from the support wall 221 that defines an airway through the sealing region 222, forming a seal with the patient's nose tip, upper lip, and nostrils.

[0325] As shown in FIG. 11-2 , the patient interface system may be utilized in a nostril-only mode. In this mode, the patient interface system is utilized in conjunction with the nose region 20, and the mouth region 40 is not utilized by the patient. To convert the patient interface system from the nostril and mouth mode to the nostril-only mode, the swivel ring 4, elbow 2, and flexible tubing 5 are removed from the mouth region 40, the mouth region 40 is disconnected from the nose region 20 by disconnecting the nose region connector 43 from the nose region 20, and the swivel ring 4, elbow 2, and flexible tubing 5 are connected to the nose region. While the illustrated headgear 60 shows a connection region 67, the connection region 67 may be omitted to facilitate use of the patient interface system 1 in a nostril-only configuration without using the lower headgear straps 63.

[0326] 27 and 28 show a patient interface system 301 in accordance with an embodiment of the present technology. The patient interface system 301 is adapted to be utilized in a nostril-only mode, a mouth-only mode, or a nostril and mouth mode. The patient interface system 301 includes a nose region 320, a mouth region 340 and headgear 360, a connector 306, an optional swivel connector 308, and a flexible tube 305. The connector 306 may be in the form of an elbow or other type of connector.

[0327] Nose region 320 includes nostril sealing region 322, headgear connector 321 for connecting to headgear 360, release region 325, and opening 326. Nostril sealing region 322 may be in the form of a pillow, prongs, nasal chamber, or membrane seal, and may be in the form of nostril sealing region 222 depicted in Figures 25 and 26. Mouth region 340 includes release region 345, opening 348, and connector 349. Connector 306 is adapted to connect to either opening 326 of nose region 320 or opening 348 of mouth region 340.

[0328] 33, the patient interface system 301 is adapted for use by a patient in a nostril-only mode without the mouth site 340. The connector 306 connects to the opening 326 of the nose site 320. An optional swivel connector 308 may be utilized between the connector 306 and a flexible tube 305 that delivers breathable pressurized gas to the nose site 320.

[0329] 28, the nostril-only configuration of FIG. 27 can be converted to the nostril-and-mouth configuration by removing connector 306 from opening 326 of nose site 320, connecting connector 349 of the mouth site to opening 326, and connecting connector 306 to opening 348 of mouth site 340. In the nostril-and-mouth configuration, the nose site can receive breathable pressurized gas through connector 349 and opening 326. Alternatively, nose site 320 can be used as a nostril seal by plugging connector 349 so that breathable pressurized air is not delivered to nose site 320.

[0330] The mouth region 340 may be utilized in a mouth-only configuration without the nose region 320. In the mouth-only configuration, the nose region 320 is not utilized and the connector 349 is plugged to provide a seal.

[0331] 30 shows a modular patient interface system 401 in accordance with an embodiment of the present technology. The patient interface system 401 includes a nose region 420, a mouth region 440, and headgear 460.

[0332] The nasal region 420 includes nostril sealing regions 422 for forming a seal with the patient's nares and a headgear connector 421 adapted to connect to headgear 460. The nasal region 420 is shown having nostril sealing regions 422 such as the type depicted in FIGS. 25 and 26, although other nostril sealing regions such as pillows, prongs, nasal chambers, etc. may be used. An optional decoupling region 425 may be included for decoupling any force applied to the nasal region 420. The headgear 460 may be the same as the headgear 60 depicted in FIGS. 7-1 through 10.

[0333] The mouth region 440 includes a mouth seal region 442, a headgear connector 441 for connecting to headgear 460, and a swivel connector 444. The mouth region may also include an optional decoupling region 445. The swivel connector 444 may connect to the elbow 402 and a flexible hose 405, which delivers breathable pressurized gas to the patient interface system 401. The patient interface system 401 may alternatively be formed as a modular patient interface system, in which the mouth region 440 is separable from the nasal region 420, both regions being usable individually, and the flexible tubing 405 is connectable to the nasal region 420, such as via a swivel connector 444. A flexible portion 443 may be disposed between the decoupling region 425 and the decoupling region 445. The flexible portion 443 may be a gusset or foldable portion between the mouth region 440 and the nose region 420, allowing the nose region 420 to adopt the nasolabial angle (the angle between the patient's nasal septum and upper lip).

[0334] 31 shows a modular patient interface system 501 in accordance with an embodiment of the present technology. The patient interface system 501 includes a nose region 520, a mouth region 540, and headgear 560.

[0335] Nasal region 520 includes nostril sealing regions 522 adapted to form a seal with the patient's nares and headgear connectors 521 for connecting to headgear 560. Nasal region 520 is shown having nostril sealing regions 522 such as the type depicted in FIGS. 25 and 26, although other nostril sealing regions may be utilized, such as pillows, prongs, nasal chambers, etc. An optional decoupling region 525 may be included for decoupling any force applied to nasal region 520. Headgear 560 may be the same as headgear 60 depicted in FIGS. 7-1 through 11.

[0336] The mouth region 540 includes a mouth sealing region 542, a headgear connector 541 for connecting to the headgear 560, a swivel connector 544, and a foam sealing or patient-contacting portion 569. The foam patient-contacting portion 569 may be a wedge utilized as at least a portion of the mouth seal. The mouth region 540 may also include an optional decoupling region 545. The swivel connector 544 may connect to the elbow 502 and a flexible hose 505, which delivers breathable pressurized gas to the patient interface system 501. The patient interface system 501 may alternatively be formed as an integrated patient interface system, in which the mouth region 540 is separable from the nasal region 520 and both regions are usable individually, with the flexible tubing 505 connectable to the nasal region 420 via the swivel connector 544 or the like.

[0337] 40 illustrates another modular patient interface system 701. Patient interface system 701 includes a nose region 720, a mouth region 740, and headgear 760. In this embodiment, nose region 720 is modularly connected to mouth region 740 such that nose region 720 can be utilized without mouth region 740 in a first nostril-only mode, mouth region 740 can be utilized without nose region 740 in a second mouth-only mode, or nose region 720 can be used in conjunction with mouth region 740 in a third nostril-and-mouth mode.

[0338] The nasal region 720 may include a sealing region 722 adapted to form a seal with the patient's nares, an optional decoupling region 725, and a headgear connector 721 for connecting to headgear 760. A connector 710 such as a swivel ring may also be utilized. The sealing region 722 may be in the form of a pillow, prongs, nasal chambers, or nostril sealing region, such as the membrane type depicted in FIGS.

[0339] The mouth region 740 may include a mouth sealing region 742, a decoupling region 745, and a headgear connector 741 for connecting to headgear 760. A connector 744 such as a swivel ring may also be used.

[0340] In the mouth and nostril mode, as depicted in Figure 40, both the nose region 720 and the mouth region 740 are utilized and connected to flexible tubing 705 through a bifurcated elbow 712. The bifurcated elbow 712 includes two elbow fittings so that it can connect to both the nose region 720 and the mouth region 740 to deliver breathable pressurized air to the patient's nostrils and mouth. The nose region 720 and the mouth region 740 may or may not be pneumatically connected.

[0341] In the nostril-only mode, only the nose portion 720 is utilized, and not the mouth portion 740. In this mode, the bifurcated elbow 712 is removed and the mouth portion 740 is removed. The patient utilizes only the nose portion 720 and connects the tubing 705 to a connector 710, such as a swivel ring. An elbow, such as Elbow 2, may be utilized to connect the tubing 705 to the connector 710, such as a swivel ring.

[0342] In the mouth-only mode, only the mouth region 740 is utilized, and not the nose region 720. In this mode, the bifurcated elbow 712 is removed and the nose region 720 is removed. The patient utilizes only the mouth region 740 and connects the tubing 705 to a connector 744, such as a swivel ring. An elbow, such as Elbow 2, may be utilized to connect the tubing 705 to the connector 744, such as a swivel ring.

[0343] 32 shows a schematic cross-sectional view of patient interface system 1 utilized in nostril and mouth mode. In this embodiment, mouth region 40 may include a sealing ring 51 that connects and seals mouth region 40 to nose region 20. Alternatively, sealing ring 51 may be formed as part of nose region 20 and may connect and seal with mouth region 40. Additionally, other types of connectors may be used, or nose region 20 and mouth region 40 may be formed as a unitary element such that a sealing ring or other type of connector is not required.

[0344] 32, the flexible tubing 5 is connected to the mouth area 40 via a gusset 8 and an optional in-line AAV (anti-asphyxiation valve) adapter 10, without utilizing the elbow 2 and swivel connector 4. This embodiment provides a very streamlined appearance by moving the flexible tubing 5 away from the front of the patient's face.

[0345] 35-1 shows a schematic cross-sectional view of patient interface system 401 utilized in nostril and mouth mode. Nasal region 420 may include a support portion 458 and a sealing region 422. Sealing region 422 includes a nose tip engagement portion 454 that engages and seals with the tip of the patient's nose, an upper lip engagement portion 456 that engages and seals with the patient's upper lip area, and a sealing ring 472 that engages and seals with mouth region 440. Sealing ring 472 may optionally be part of mouth region 440 rather than part of nose region 420.

[0346] Mouth region 440 may include a swivel ring 444 that connects to flexible tubing 405. Flexible tubing 405 may connect directly to swivel ring 444 or may connect through an elbow, such as elbow 402. Mouth sealing region 442 forms a seal around the patient's mouth and includes an upper lip engaging portion 448 that forms a seal with the patient's upper lip area.

[0347] Limited space exists on the patient's upper lip for the upper lip engaging portion 456 of the nose portion 420 and the upper lip engaging portion 448 of the mouth portion 442. Therefore, the upper lip engaging portion 448 can be disposed between the support portion 458 of the nose portion 420 and the patient's upper lip. FIG. 35-2 illustrates the mouth sealing portion 442 having the upper lip engaging portion 448. The upper lip engaging portion 448 can be an ultra-thin, flat membrane having a thickness of approximately 0.1 to 0.3 mm, preferably approximately 0.2 mm, while the remainder of the mouth sealing portion 442 can have a thickness of approximately 0.3 to 2 mm, preferably approximately 0.5 mm. However, portions of the mouth sealing portion 442 can include thickened portions 409 around the sides of the mouth region corresponding to the patient's cheek area for added support. These thickened regions 409 can have a thickness of, for example, approximately 1.5 mm.

[0348] Figure 35-3 is a schematic cross-sectional view depicting further details of patient interface system 401. Figure 35-3 particularly illustrates how mouth sealing portion 442 extends around the patient's mouth and how nostril flare engagement portion 427 engages with the flares of the patient's nostrils. Additionally, the trailing edge of nostril sealing area 470 is depicted, along with the edge of nostril sealing portion 422.

[0349] 36-1 depicts a schematic cross-sectional view of patient interface system 501 utilized in nostril and mouth mode. Nasal region 520 may include a support portion 558, a sealing region 522, and an optional decoupling region 525. Sealing region 522 includes a nose tip engagement portion 554 that engages and seals with the tip of the patient's nose and an upper lip engagement portion 556 that engages and seals with the patient's upper lip area. A sealing ring 572 may be attached to this decoupling region to engage and seal with mouth region 540. Sealing ring 572 may optionally be part of mouth region 540 rather than part of nose region 520.

[0350] The mouth region 540 may include an optional cushion stiffening material 573 to increase the rigidity of the sealing region 522. The cushion stiffening material 573 may be made from a polymer such as polycarbonate, nylon, or polypropylene; a high-density foam; a fabric with low stretch such as a 3D weave; or a silicone or gel with a high Shore hardness, such as 70 Shore A. There is limited space on the patient's upper lip for the upper lip engaging portion 556 of the nose region and the upper lip engaging portion of the mouth region. Therefore, a foam patient contact 569 may be disposed in the gap between the cushion on the mouth region 540 and the upper lip engaging portion 556. The foam patient contact 569 may contact and form a seal with the patient's upper lip area, thereby forming part of the mouth seal.

[0351] FIG. 36-2 shows a schematic cross-sectional view of the patient interface system 501 utilized in the second nostril and mouth mode. A sealing ring 572 is formed as part of the mouth region 540 and is adapted to engage and seal with the decoupling region 525 of the nose region 520. Limited space exists on the patient's upper lip for the upper lip engaging portion 556 of the nose region and the upper lip engaging portion of the mouth region. In this embodiment, a foam patient-contacting portion 569 is disposed against cushions on the decoupling region 525 and the mouth region 540 and contacts and forms a seal with the patient's upper lip area. The foam patient-contacting portion 569 may form part of the mouth seal. The cushion stiffening material 573 of FIG. 36-1 may be used in the embodiment of FIG. 36-2, as well as any of the other embodiments disclosed herein.

[0352] FIG. 48 shows a schematic cross-sectional view of a patient interface system 1100 utilized in nostril and mouth mode. The patient interface system 1100 may be a variation of the patient interface system 701 shown in FIG. 40. The patient interface system 1100 includes a nose region 1120, a mouth region 1130, and a bifurcated elbow 1140. A lower end 1141 of the bifurcated elbow 1140 is adapted to connect to a swivel 1105, which may be connected to a flexible tube for delivering air to the patient interface system 1100. The lower end 1141 may connect to the swivel 1105 with a ball and socket arrangement (as shown). The ball and socket arrangement is adapted to increase the mobility of the swivel, and therefore the air delivery tube. Alternatively, the lower end 1141 may connect to the swivel 1105 with any arrangement, such as an interference fit or overmolding.

[0353] A first air passageway or branch passageway 1146 of the bifurcated elbow 1140 communicates with an aperture in the mouth region 1130, and a second air passageway or branch passageway 1148 of the bifurcated elbow 1140 communicates with an aperture in the nose region 1120. A first elbow ring 1142 and a second elbow ring 1144 are used to connect the bifurcated elbow 1140 to the nose region 1120 and the mouth region 1130, respectively, although other types of connectors may be utilized. The bifurcated elbow may include barbed ends 1143 at the ends of the first branch passageway 1146 and the second branch passageway 1148 that engage with the mouth region 1130 and the nose region 1120.

[0354] The mouth region 1130 includes a lower lip engaging portion 1134 adapted to form a seal under the patient's lower lip and an upper lip engaging portion 1132 adapted to form a seal just above the patient's upper lip. The nose region 1120 includes a nozzle 1122 adapted to position the nose region 1120 proximate the patient's nares and position the foam portion 1154 in sealing engagement with the patient's nares, although pillows, nasal chambers, nasal cradles (nostril seals), or membrane seals could also be used to form a seal with the patient's nares.

[0355] The mouth area 1130 may be a single wall or fabric / foam composition mouth area having a relatively low Shore A hardness. The nose area 1120 may have a hardness of, for example, 40 Shore A.

[0356] FIG. 49 shows a schematic cross-sectional view of a patient interface system 1100 utilized in nostril and mouth mode, similar to the patient interface system 1100 of FIG. 48 with a different nasal section 1150. The nasal section 1150 includes a support section 1153 that supports a nozzle 1152 and a foam section 1154. The nozzle 1152 and foam section 1154 together form a sealing section adapted to form a seal with the patient's nares. The nozzle 1152 may have an air passageway that gradually narrows as air approaches the patient's nares. The support section 1153 may have a hardness of, for example, 40 Shore A. The nozzle 1152 helps hold the foam section 1154 in place proximal to the patient's nares. The foam section 1154 provides a wider range of fit due to its compressibility, allowing it to conform to various nostril sizes. The foam section 1154 also provides comfort to the patient.

[0357] 50 shows a schematic cross-sectional view of patient interface system 1100 utilized in nostril and mouth mode and having a nasal section 1160. Nasal section 1160 includes a support section 1162 and a sealing section 1164. Support section 1162 may be constructed of silicone and serves as an intermediate section or connection between bifurcated elbow 1140 and sealing section 1164.

[0358] The support portion 1162 positions the sealing portion 1164 under the user's nostrils and maintains the sealing portion 1164 in this position. The support portion 1162 may include generally parallel sides and an edge 1165 formed generally perpendicular to the sides. The edge 1165 provides an interface for the sealing portion 1164. The sealing portion 1164 may be constructed of foam, gel, or other conformable material. The sealing portion 1164 is preferably more flexible than the support portion 1162 to aid in the comfort and fit of the seal. The sealing portion 1164 may be a foam with holes that forms a seal with the patient's nose tip, upper lip, and nostrils. In one example, as shown in FIG. 50A , the support portion may include a support wall 1162-1 (e.g., constructed of silicone or a material with greater rigidity than the foam sealing portion) to prevent the foam from compressing and blocking the nostrils. In another example, as shown in FIG. 50B, the foam sealing portion 1164 may have a trumpet shape (e.g., an outward flare) with a silicone support wall underneath to ensure structural stability of the foam and also ensure sealing engagement with the patient.

[0359] 51 shows a schematic cross-sectional view of patient interface system 1100 utilized in nostril and mouth mode and having a nose portion 1170. Nasal portion 1170 includes a support portion 1172 and a sealing portion 1174. Sealing portion 1174 includes a nose tip engagement portion 1176 and an upper lip engagement portion 1178. Support portion 1172 may form a seal directly above the patient's upper lip and may be positioned between the patient's upper lip and the upper lip engagement portion 1132 of mouth portion 1130.

[0360] The support portion 1172 may have a higher Shore A hardness than the sealing portion 1174. For example, the support portion may have a Shore A hardness of 20 to 80, preferably 30 to 60, or about 40, while the sealing portion 1174 has a Shore A hardness of about 5 to 40, or about 20. The hardness of the sealing portion is generally lower than that of the support portion.

[0361] 52 depicts a schematic cross-sectional view of a patient interface system 1180 utilized in a nostril and mouth mode, having a mouth region 1182 and a nose region 1190. The nose region 1190 may be removable from the patient interface system 1180 and replaceable with a plug such that the patient interface system 1180 may be used in a mouth-only mode.

[0362] The mouth area 1182 includes a hole for connecting an air supply to deliver air to the patient interface system 1180. An elbow 1188 connects to the hole via a sealing ring 1189. A swivel 1187 may be connected between the elbow 1188 and the air hose 1185. A swivel cuff (not shown) may be connected between the swivel 1187 and the air hose 1185.

[0363] The mouth region 1182 includes a lower lip engaging portion 1184 adapted to form a seal under the patient's lower lip, an upper lip engaging portion 1186 adapted to form a seal just above the patient's upper lip, and a cosmetic flap for covering the patient's nostrils and / or tip of the nose (primarily for covering the tip of the nose) or a covering flap 1183 adapted to cover the patient's nostril and nose region 1190, thereby enhancing the visual appeal of the patient interface system 1180. The covering flap 1183 extends upwardly to a height sufficient to cover the patient's nostrils and nose region 1190.

[0364] The nose portion 1190 can 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 can be connected to and seated within the upper orifice of the mouth portion 1182 via a mouth clip 1198 and a nostril clip 1198.1. When the nose portion 1190 is not being used with the patient interface system 1180, the nose portion 1190 can be removed from the mouth clip 1198 and a plug can be placed in the mouth clip 1198 or orifice to provide a seal. The mouth clip 1198 can be silicone or another material such as nylon or polypropylene.

[0365] 53 depicts a schematic cross-sectional view of a patient interface system 1200 utilized in a nostril and mouth mode, having a mouth region 1202 and a nose region 1220. The nose region 1220 may be removable from the patient interface system 1200 and replaceable with a plug so that the patient interface system 1200 can be used in a mouth-only mode and the nose region can be used in a nostril-only mode.

[0366] The mouth region 1202 includes a front portion 1204 or veneer, a lower lip engagement portion 1206, an upper lip engagement portion 1208, a nose region tab 1210, a cosmetic or covering flap 1212, and a release region 1214. The front portion or veneer 1204 may have a large transparent window that allows viewing of the patient's mouth area. The nose region tab 1210 may be adapted to receive and sealingly engage a nose region 1220.

[0367] Nose region 1220 includes an attachment ring 1229 adapted to sealingly engage mouth region 1202, a support portion 1222, and a sealing region 1224. Attachment ring 1229 may be co-molded, welded, permanently snap-fit, or removably attached to the remainder of nose region 1220. Sealing region 1224 includes a nose 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.

[0368] The covering flap 1212 is positioned adjacent to the nose tip engagement portion 1228 of the nose region 1220. Therefore, movement of the covering flap 1212 may also move the nose tip engagement portion 1228. Therefore, a decoupling portion 1214 is included in the mouth region 1202 below the covering flap 1212. The decoupling portion 1214 serves to decouple forces applied to the mouth region 1202 (which may be generated by forces applied by movement of the air hose 1232) from being transmitted to the nose region 1220.

[0369] The mouth area 1202 includes a lower aperture adapted to receive an elbow 1230, such as a gusseted elbow, that is connected to an air delivery tube 1232. The gusseted elbow 1230 may include an anti-asphyxiation valve and / or one or more vent holes for venting exhaled gases. When in nasal-only mode, this tube may connect to a nasal cushion or pillow.

[0370] 54 and 55 illustrate a modular patient interface system 1260 that includes a mouth region 1262 and a nose region 1280. The patient interface system 1260 is adapted for use in a mouth-only mode, a nostril-only mode, or a mouth and nostril mode.

[0371] Mouth region 1262 includes a lower lip engagement portion 1264, an upper lip engagement portion 1266 that compresses the nose seal to engage the face, a decoupling (bellows) portion 1270, and a hole 1272. A hole (not shown) may be provided in the front or bottom of the mouth region for connecting an air source such as an air hose connected by an elbow or the like. Flexible portion 1270 may be air-actuated or may be thinner-walled, e.g., less rigid, to form a decoupling portion that decouples so that forces applied to mouth region 1262 are not applied to nose region 1280. When used in mouth-only mode, hole 1272 may be blocked to provide an airtight seal.

[0372] The nose region 1280 includes a support region 1282, a sealing region 1284, and a headgear connector 1290. The sealing region 1284 is adapted to seal with the patient's upper lip and nose tip. When used in the nostril-only mode, the holes 1274 can be connected to an air source or blocked if air is alternatively supplied. When used in the nostril and mouth mode, the nostril clips 1286 can be connected, preferably permanently, to or otherwise formed into the support region 1282, and the mouth clip 1268 can be connected, preferably permanently, to or otherwise formed into the cushion of the mouth region 1262. The nostril clips 1286 and the mouth clip 1268 are adapted to form a sealing connection, such as through notches formed in the clips, such that the mouth region 1262 can be connected to the nose region 1280 in the nostril and mouth mode.

[0373] 60 shows a cross-sectional view of a modular patient interface system 1350 including a mouth region 1352 and a nose region 1360. The nose region 1360 may be removable from the patient interface system 1350 and replaceable with a plug so that the patient interface system 1350 can be used in a mouth-only mode or the nose region 1360 can be used in a nostril-only mode.

[0374] The mouth section includes a frame 1354 and a mouth seal 1355. A first hole 1351 is positioned in the frame 1354 that is adapted to receive an elbow 1374 for delivery from an air hose via a swivel 1376, and a second hole 1357 is formed in the frame 1354 that can be blocked when the patient interface system is used in a mouth-only mode and can be connected to a nose section 1360 when the patient interface system 1350 is used in a nostril and mouth mode.

[0375] The frame 1354 may be a rigid material such as, for example, polycarbonate or a semi-rigid material. The mouth seal 1355 may be a flexible material such as silicone. The mouth seal 1355 includes a lower lip engaging portion 1356 adapted to form a seal under the patient's lower lip and an upper lip engaging portion 1358 adapted to form a seal just above the patient's upper lip (when used in mouth-only mode).

[0376] Nose region 1360 includes a support portion 1362 and a sealing region 1364. Sealing region 1364 includes a nose tip engagement portion 1368 adapted to form a seal with the tip of the patient's nose and an upper lip engagement portion 1370 adapted to form a seal just above the patient's upper lip. Support portion 1362 may also form a seal just above the patient's upper lip. A ring 1359 may be used to connect nose region 1360 to mouth region 1352.

[0377] 66 illustrates a modular patient interface system 1430 that includes a mouth region 1432 and a nose region 1440. The mouth region 1432 includes a cushion portion 1434 that is adapted to form a seal around the patient's mouth.

[0378] The nose 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 the corners of the nose region 1447 and the upper lip engaging portion 1443.

[0379] Magnets 1436, 1448 may be placed in the mouth region 1432 and nose region 1440 so that nose region 1440 is properly oriented relative to mouth region 1432. Either of the pair of magnets 1436, 1448 may be replaceable by a metal portion. The magnet 1448 in nose region 1440 may be placed at the corner of the nose region 1447 to ensure sufficient tension of the nostril seal over the patient's upper lip and corners of the nose.

[0380] 67 shows a cross-sectional view of a modular patient interface system 1480 including a mouth region 1482 and a nose region 1490. The nose region 1490 may be removable from the patient interface system 1480 and replaceable with a plug so that the patient interface system 1480 can be used in a mouth-only mode or the nose region 1490 can be used in a nostril-only mode. Alternatively, the system may be used in a nostril-and-mouth mode. In one example, separate foam components may be provided for the mouth and nose seals so that the patient interface system can be used in a mouth-only or nostril-only mode.

[0381] The mouth area 1482 includes a frame 1484, a cosmetic or covering flap 1486, a lower hole 1485 for connecting a swivel or cuff 1498 and an air hose 1499, and an upper hole 1487 for connecting a nose area 1490. The frame 1484 can be a rigid material such as, for example, polycarbonate, or a semi-rigid material such as, for example, semi-rigid nylon. The foam section 1492 can have a clip 1493 for attaching to the frame 1484.

[0382] Nose region 1490 may include a flexible portion 1496, a foam portion 1492 connectable to flexible portion 1496 with one or more clips 1493, and a nozzle portion 1494. A covering portion 1486 of mouth region 1482 may support nose region 1490. Alternatively, a permanent connection may be used, such as, for example, a foam portion directly attached to the flexible portion.

[0383] 67, 68, and 69 depict a modular patient interface system 1500 that includes a mouth region 1502 and a nose region 1510. The nose region 1510 may be removable from the patient interface system 1500 and replaceable with a plug so that the patient interface system 1500 can be used in a mouth-only mode or the nose region 1510 can be used in a nostril-only mode.

[0384] The mouth area 1502 includes a frame 1504, a cosmetic or covering flap 1509, a lower hole 1505 for connecting an elbow section 1507, and an upper hole 1503 for connecting a nose area 1510. The frame 1504 can be a rigid material such as, for example, polycarbonate, or can be semi-rigid or flexible such as, for example, nylon or silicone. The foam section 1506 can have a clip 1508 for attaching to the frame 1504.

[0385] The nose region 1510 may include a flexible portion 1512, such as silicone, and a foam portion 1516 connectable to the flexible portion 1512 with one or more clips 1514. The covering portion 1509 of the mouth region 1502 may be spaced apart from the nose region 1510. The clips 1508, 1514 may have surfaces facing the foam portion that are angled to bias or encourage the foam to apply force in a particular direction, such as toward the patient's lips.

[0386] 70 depicts a modular patient interface system 1520 that includes a mouth region 1522 and a nose region 1540. The nose region 1540 may be removable from the patient interface system 1520 and replaceable with a plug so that the patient interface system 1520 can be used in a mouth-only mode or the nose region 1540 can be used in a nostril-only mode. Alternatively, the system may be used in both a mouth and nose mode.

[0387] The mouth region 1522 includes a frame 1523, a lower hole 1527 for connecting an elbow 1560 (which may include a vent hole 1562) and an air hose 1566, and an upper hole 1528 for connecting the nose region 1540. The frame 1523 may be a rigid material such as, for example, polycarbonate, or may be a more flexible material such as, for example, silicone. The lower lip engaging portion 1524 is adapted to form a seal with the patient's lower lip, and the upper lip engaging portion 1526 is adapted to form a seal with the patient's upper lip.

[0388] The nose region 1540 includes a support portion 1542 and a sealing region 1544. The sealing region 1544 includes an upper lip engagement portion 1548 adapted to seal directly over the patient's upper lip and a nose tip engagement portion 1546 adapted to form a seal with the tip of the patient's nose or the area adjacent to the tip. In the upper lip area, the support portion 1542 may contact the upper lip engagement portion 1526 of the mouth region 1522. When used in nostril-only mode, the holes 1528 can be connected to an air source or blocked if air is to be supplied alternatively.

[0389] When used in the nostril and mouth mode, a connecting ring 1550 may be utilized. The connecting ring 1550 has a first channel 1552 and a second channel 1554. The first channel 1552 is adapted to receive the mouth region 1522, and the second channel 1554 is adapted to receive the nose region 1540.

[0390] 71 shows a modular patient interface system 1580 that includes a mouth section 1582 that provides a flexible connection between the nose and mouth components and a nose section 1590. The nose section 1590 may be removable from the patient interface system 1580 and replaceable with a plug so that the patient interface system 1580 can be used in a mouth-only mode or the nose section 1590 can be used in a nostril-only mode.

[0391] The mouth region 1582 includes a frame 1589, an elbow 1581, a lower hole 1579 for connecting an air hose 1587, and an upper hole 1577 for connecting a nose region 1590. In one example, the elbow may include a button that allows the elbow to be quickly released. A vent hole 1585 may be formed in the elbow 1581, for example, via a vent ring interconnecting the elbow and frame, or alternatively, may be formed in the mouth region 1582. The lower lip engaging portion 1584 is adapted to form a seal with the patient's lower lip, and the upper lip engaging portion 1586 is adapted to form a seal with the patient's upper lip.

[0392] Nasal region 1590 includes a support portion 1592 and a sealing region 1594. Sealing region 1594 includes an upper lip engaging portion 1598 adapted to form a seal with the patient's upper lip and a nose tip engaging portion 1596 adapted to form a seal with the tip of the patient's nose.

[0393] The nose region 1590 may have a recess 1595 that forms an interference fit with the mouth region 1582. The nose region 1590 may be elastic and may squeeze inward to receive the mouth region into the recess, then return to its original shape. A "buffer" shape on the mouth region provides a lead-in to guide the nose region into place. A thin silicone wall may also be provided to seal around the nose region.

[0394] FIG. 72 shows a modular patient interface system 1600 including a mouth region 1602, a nose region 1610, elbows and swivels 1612, upper headgear 1618 with back straps 1619, and lower headgear 1620 with back loops 1622.

[0395] The upper headgear 1618 is adapted to connect to the nose area 1610 via connector 1617, and the lower headgear 1620 is adapted to connect to the mouth area 1602 via connector 1615. The back straps 1619 of the upper headgear 1618 may be inserted through the back loops 1622 of the lower headgear 1620. Alternatively, a separate strap may be connected from the back straps 1619 to the back loops 1622.

[0396] 73 illustrates a modular patient interface system 1630 including a mouth section 1632, a nose section 1640, an elbow 1644, and an air hose 1646. The mouth section 1632 may have a hole 1634 adapted to receive a lug on the back of the elbow 1644. Thus, the nose section 1640 may operate independently of the mouth section 1632 or may be connected to the mouth section 1632. In this example, the mouth section may be connected to the nose section without disconnecting the elbow.

[0397] Cushion example 1

[0398] Figures 74-79 illustrate a patient interface system 1650 having a mouth region 1652 and a nose region 1660. Figure 80 illustrates the nose region 1660, and Figure 81 illustrates the mouth region, veneer, or support structure 1652. Figures 82-95 illustrate a cushion 1654 in the mouth region 1652.

[0399] The mouth section 1652 is detachable from the nasal section 1660, although the sections may be co-molded. A sealing ring 1665 ( FIG. 79 ) may be used to connect the mouth section 1652 to the nasal section 1660. Holes 1656 are adapted to connect to an air source for delivering air to the patient interface system 1650. The mouth section includes a cushion veneer portion 1657 (which may be transparent or translucent) and a decoupling section 1659, which may be thinner than the rest of the front of the mouth section to decouple forces applied by movement of the elbow / air hose connected to hole 1656 from the rest of the patient interface system 1650.

[0400] A cosmetic or covering flap 1658 covers / supports the patient's nostril area. The cosmetic flap preferably covers all or part of the nostril seal 1660. Such an arrangement may reduce vision obstruction for the patient and may help stabilize the nostril seal 1660.

[0401] Cushion 1654 connects to cushion veneer portion 1657 to form a seal around the patient's mouth. The connection between cushion 1654 and cushion veneer portion 1658 may be by an interference fit, such as a tongue and groove, for example.

[0402] A lower headgear connector (not shown) can be positioned in front of the mouth region 1652 in a manner similar to that depicted in FIG. 30 . The cushion 1654 and cushion veneer portion 1657 can both have a hardness of approximately 40 Shore A. Alternatively, the cushion veneer portion 1657 can have a relatively high hardness compared to the cushion 1654. The cushion veneer portion 1657 can be constructed of a semi-rigid polymer such as nylon, polycarbonate, polypropylene, or the like. The cushion veneer portion 1657 can have a hardness of 40 to 80 Shore A. The cushion 1654 can be constructed of a conformable material such as, for example, silicone, foam, gel, TPE, or the like. The cushion 1654 can be constructed of a material having a hardness of 5 to 25 Shore A, for example, 5 to 40 Shore A.

[0403] The cushion 1654 may be constructed of a combination of materials, such as a first portion adjacent to the cushion veneer portion having a first hardness and a second portion adjacent to the patient-contacting portion having a second hardness. The first hardness is preferably higher than the second hardness to provide structural support to the patient-contacting 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, e.g., 1-3 mm, 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 a thin wall and soft material in the second portion increases the cushion's flexibility and flexibility, allowing it to conform to the patient's face. The thicker first portion provides structure for stability. These combine to form a single-wall cushion that generally mimics a double-wall cushion.

[0404] Cushion 1654 is preferably flexible and / or has a low durometer (e.g., 5-15 Shore A) in chin region 1693 so that when the cushion is placed on a user's face, the cushion stretches to fit over the patient's chin. The stretching of the cushion in chin region 1693 allows the cushion to be in tension over the patient's chin, which can form a tight seal with the patient's chin and allow the cushion to conform to a wider range of jaw shapes.

[0405] The cushion 1654 includes a cushion veneer connection portion 1655 ( FIG. 82 ) adapted to connect to the cushion veneer 1657, a ring connection portion 1680, and a pocket 1684. Alternatively, the cushion veneer and cushion may be integrally formed. The ring connection portion 1680 includes a hole 1682 adapted to receive a connecting ring (for connecting the mouth region 1652 to the nose region 1660). Alternatively, the ring connection portion and the connecting ring may be integrally formed. As a further alternative, the cushion may be formed with a first connecting ring and the nose region may be formed with a second connecting ring, with the first connecting ring being received by the second connecting ring (or vice versa).

[0406] The pocket 1684 is adapted and shaped to receive other portions of the nose region 1660, such as the gusset 1671 ( FIG. 80 ) of the nose region 1660, or the headgear connector portion of the nose region 1660. If a different nose region is used, a different shaped pocket may be used. The pocket 1684 is recessed into the cushion 1654 so as not to interfere with the seal of the cushion 1654 when the nose region 1660 is in the pocket 1684. That is, the pocket 1684 may be disposed or offset below or below the top surface of the mouth cushion 1654.

[0407] The pocket 1684 may be a depression, groove, sulcus, hollow, pouch, alcove, depression, recess, fossa, valley, or depression, i.e., an area of ​​the cushion adapted to receive the nasal region and having an alternating or deepening geometric shape when compared to the remainder of the oral cushion. The pocket may not be a hole, cutout, or aperture. In some cases, the pocket is airtight. In some cases, the pocket is formed by a soft, conformable material, such as the oral cushion, rather than a frame. Such an arrangement is preferred because the conformable pocket allows for adjustment of the position of the nasal region, thereby fitting more patients. In some cases, the pocket allows for vertical movement of the nasal region to accommodate different nasal heights among patients. In some cases, the pocket may increase in firmness, for example, when air pressure is applied to the oral cushion. The pocket may stabilize the nostril region in position in the medial and lateral directions. This may be achieved by the shape of the pocket being adapted to conform to the shape of the nasal region. Such an arrangement may ensure that the nasal portions maintain sealing engagement with the patient's nares in use when forces, such as tubing drag, are applied to the sides of the patient interface.

[0408] The nasal seal may reside or be located within the pocket. The patient-contacting portion of the nasal seal may be located outside of, above, or higher than the pocket. Such an arrangement may ensure that the patient can see the nasal seal in contact with the nose and ensure alignment and sealing.

[0409] In one form, the nose seal may not be in airflow communication with the mouth area through the pocket.

[0410] The pocket may have a lower hardness than the surrounding portion of the oral cushion. The pocket may have relatively thinner walls than other areas of the oral cushion. The pocket may be formed from a different material than the remainder of the oral cushion.

[0411] In some cases, the pocket is contiguous with or integrally formed with the upper lip contact area of ​​the mouth cushion, thereby providing sealing engagement with the patient's upper lip.

[0412] The mouth cushion may include an upper lip region adapted to interface with the patient's upper lip. The mouth cushion may further include cheek regions adapted to interface with the patient's cheeks and / or sides of the mouth. The mouth cushion defines a wall located between the patient-contacting portion of the mouth cushion and the frame-contacting portion. The wall may include various portions, such as an upper lip wall, a chin wall, and two cheek walls, corresponding to the upper lip, chin, and cheek regions of the patient's face, respectively. In one form, the cheek wall may be relatively stiffer than the upper lip wall. In another form, the chin wall may be relatively stiffer than the upper lip wall. In some forms, the upper lip portion may be less stiff than the cheek walls. In such an arrangement, the cheek-contacting portion may apply pressure to the patient's cheek, thereby placing the upper lip and chin regions in tension.

[0413] Pocket 1684 in this example may comprise a curved groove with lobes or regions 1661 as shown in Fig. 84. Lobes 1661 may be shaped to correspond to gussets 1671 as shown in Fig. 80. The lobes may be separated by ridges or depressions 1663 that are designed to indicate alignment or positioning of nose region 1660.

[0414] The pocket 1684 may have a maximum width w1 of about 30-60 mm. In some embodiments, the pocket 1684 may have a maximum width w1 of about 35-45 mm. In some cases, the pocket 1684 may have a maximum width w1 of about 40-45 mm.

[0415] Pocket 1684 may have a length d5 ​​of about 15-40 mm, as shown in FIG. 91. In some cases, pocket 1684 may have a length d5 ​​of about 20-30 mm, which may be the approximate length from the veneer-contacting side of the pocket to the outermost edge of leaf 1661.

[0416] The leaves 1661 of the pocket 1684 may be offset or angled relative to one another to position the nose seal so that it is positioned in the angular region of the maxilla (the patient's upper lip). The leaves 1661 of the pocket 1684 may be angled α1 of about 90-180° relative to one another. The leaves 1661 of the pocket 1684 may be angled α1 of about 90-150° relative to one another. The leaves 1661 of the pocket 1684 may be angled α1 of about 90-180° relative to one another. The leaves 1661 of the pocket 1684 may be angled α1 of about 90-150° relative to one another.

[0417] The chin or lower seal area 1693 of the mouth cushion 1654 may be rounded or curved to conform to the patient's chin. The radius of curvature r1 is preferably 20-50 mm. The radius of curvature r1 may be 30-40 mm. The radius of curvature r1 may be 35-45 mm.

[0418] The nose section may be secured to the cushion 1654 by connection with a connecting ring. The cushion may also have a thickened section 1686 (FIGS. 86 and 87) to support the connection with the cushion veneer section 1657. The thickened section 1686 also supports the sealing section in place and prevents collapse of the sealing section, especially if the sealing section is constructed of a low durometer, thin material, which would lack structural rigidity.

[0419] The nose region 1660 includes a sealing region 1662 adapted to form a seal with the patient's nares and a headgear connector 1670 for connecting to headgear. The sealing region 1662 may be in the form of a nozzle, although other sealing regions, such as pillows or prongs, may also be used. An exemplary sealing region is disclosed in WO2009 / 052560A1, which is incorporated herein by reference in its entirety.

[0420] The cross-sections depicted in FIGS. 88-90 are shaped like a question mark to accommodate a patient's flat or pointed face. FIG. 89 shows a cross-section in a horizontal plane that may be positioned generally in line with the patient's cheek or mouth. In this region, the cushion cross-section shows a relatively longer membrane than in the bony upper or lower jaw regions (shown in FIGS. 88 and 90). This may be because a longer membrane can absorb more force than a shorter membrane, thereby reducing the force of the cushion on the patient's cheek compared to the bony upper or lower jaw regions. This may be because the patient's cheek is more sensitive than the bony parts of the face. The shape of the cushion is shaped to conform to the shape of the face, such as a C-shape, as shown in FIG. 85. As shown, the sealing membrane includes a varying thickness along its length, e.g., from a thicker to a thinner end. This varying thickness may allow the thicker region to support and position the patient-contacting portion, while the thinner region may provide comfort and conformability to the patient-contacting region. The patient-contacting portion can be approximately 0.2-2 mm. In some configurations, the patient-contacting portion can be approximately 0.8-1.2 mm. The thicker region 1686 can be approximately 0.5-4 mm. In some configurations, the thicker region 1686 can be approximately 2-3 mm.

[0421] In a further example, the load that the cushion imparts to the user's face in the upper lip region 1692 may exceed the load that the cushion imparts to the user's face in the chin region 1693. This may be achieved by having a relatively greater thickness in the upper lip region 1692 compared to the thickness in the chin region 1693. Such an arrangement may help anchor the cushion to the patient's face while reducing the force exerted on the lower jaw. It is desirable to exert less force on the patient's lower jaw, and therefore on the chin region 1693, because high force on the lower jaw can collapse the upper airway, thereby exacerbating obstructive sleep apnea.

[0422] The pocket 1684 is configured to accommodate the nose section, ensuring that air within the nose section creates a secure seal against the upper lip. The nesting nose section and cushion reduce the obstruction of the patient interface. The pocket 1684 may have a depth d1 of approximately 5-30 mm. In some configurations, the pocket 1684 may have a depth d1 of approximately 5-20 mm. In some configurations, the pocket 1684 may have a depth d1 of approximately 5-10 mm. The pocket depth d1 can be seen in Figures 86-87.

[0423] As best shown in FIG. 86 , the pocket 1684 may be adjacent to or connected to the flap seal at the upper lip region 1692. A ridge or peak 1694 may be formed between the pocket 1684 and the upper lip region 1692. The ridge 1694 may serve to separate the pocket from the upper lip region as well as provide a hinge or spring point for the upper lip region.

[0424] As best shown in Figures 86-87, the pocket 1684 may be generally curved or rounded in a cup-like shape indicated by c1.

[0425] In the chin region 1693, as best shown in FIG. 86, the cushion may have a depth d2, i.e., the distance from the sealing area or patient-contacting portion of the chin region to the connection region 1655, of approximately 0.5-3 mm. Depth d2 may be approximately 1-2 mm. In some forms, depth d2 may be approximately 1.5-2 mm. This depth may be desired to ensure that different chin shapes fit securely within the mouth cushion 1654. The chin lip region 1693 shown in FIG. 91 exhibits a depth d4. Depth d4 may be approximately similar to depth d1.

[0426] The cushion 1654 may have a cheek region 1695 where the cushion may have a depth d2, as shown in FIGS. 88, 89, and 90. The depth d2 may be greater than d1 and d4. Such an arrangement may be preferable because the cushion 1654 may flex and deform more at the cheek than at the upper lip, allowing the cushion to settle on the upper lip and accommodating variations in the patient's facial shape. For example, some patients have relatively flat faces, while others have relatively pointed faces, so the cushion needs to be able to conform to each facial contour. For example, the depth d2 may be approximately 10-50 mm. In some embodiments, the depth d2 may be approximately 20-35 mm. In some embodiments, the depth d2 may be approximately 20-30 mm.

[0427] The curvature of the cushion's upper lip region 1692 ensures tension and therefore a seal on the patient's upper lip. The spring-shaped cross section of the upper lip reduces force displacement on the patient's upper lip (a sensitive area).

[0428] FIG. 92 shows the mouth cushion 1654 from the patient-contacting side. The upper lip region 1692 has a height d6, which may be less than the height d7 of the chin region 1693. This may be because, on a human face, the distance between the upper lip and the bottom of the nose is typically shorter than the distance between the lower lip and the tip of the chin. For example, the height d6 may be between 5 and 15 mm. In some embodiments, the height d6 may be approximately 8 to 10 mm. The height d7 may be approximately 10 to 25 mm. In some embodiments, the height d7 may be approximately 12 to 16 mm.

[0429] Cushion example 2

[0430] 98A-98E and 99A-99I depict variations of the oral cushion 2100 similar to that shown in Figures 82-95, sharing common features such as a pocket adapted to receive a nose seal and a single side wall 2104 that is thicker at the base where it connects to the veneer and thinner at the distal end where it seals with the patient. This side wall has a sickle or question mark shape.

[0431] The mouth cushion 2100 may have an upper lip region 2692, a chin region 2693, and a cheek region 2695. The mouth cushion may further include a connection region 2655 for interfacing the mouth cushion with a clip, frame, or other portion of a patient interface assembly.

[0432] The upper lip region 2692 and chin region 2693 of the seal are generally flat so that they can be stretched (under tension) over the patient's face to strengthen the seal, which is beneficial because the sealing force in this area cannot be significantly altered as the headgear is tightened.

[0433] Pocket 2102 is thinner compared to pocket 1684 of FIG. 82. This allows the nose seal to apply some sealing force component more directly. That is, the nose seal can stiffen when pressurized, thereby applying force to the upper lip seal. The reduced thickness can also reduce weight and / or material.

[0434] Additionally, the cushion 2100 does not have the ring connector 1680 seen in (for example) Figures 92-95. Therefore, airflow to the nasal seal is not conducted through the mouth cushion. Instead, a clip may be provided that is adapted to receive both the mouth and nasal cushions, and the clip may provide a path for air to be conducted to the nasal cushion.

[0435] The pocket 2102 is not necessarily cup-shaped, but may have an open back and may curve upward to a ridge 2694 before adjoining the upper lip 2692 (see C1 shown in Figures 99D and 99E).

[0436] Pocket 2102 can have a depth similar to pocket 1684, as shown by depth e1 in Figures 99D and 99E. Also, depth e3 can be similar to depth d3, depth e4 can be similar to depth e4, and length e5 can be similar to length e5.

[0437] Depth e2 shown in FIG. 99D indicates the distance from the edge or connection region to the patient-contacting portion. Depth e2 may be approximately 10-30 mm, preferably approximately 15-25 mm. Radius of curvature r2 may be greater than radius of curvature r1 of Example 1. Such depth and radius of curvature r2 may be such that the depth in the chin region 2693 is similar to the depth in the cheek region 2695. This may flatten the cushion in the chin region so that when the patient positions their chin against the chin region 2693, the membrane stretches to cover the chin. This may ensure a more stable seal and a wider wearing range.

[0438] Width w2, as shown in FIG. 99A, may be greater than width w1. This may be to accommodate a longer nose seal or to move the nose seal as in Example 1 further down the mouth seal 2100 (i.e., to position the nose seal further from the top surface or deeper in the mouth cushion 2100). Width w2 may be approximately 50-70 mm. In some embodiments, width w2 may be approximately 50-60 mm.

[0439] Cushion example 3

[0440] 110-137 , a patient interface system 4001 according to an embodiment of the present technology includes an oral cushion 4100, a cushion clip 4200, and a decorative plate 4300. The oral cushion 4100 shares several common features with cushion example 2, such as a pocket 4102 adapted to receive a nose seal and a sealing portion 4106 configured to form a seal with the patient's face. Other common features may be apparent from the following description of the patient interface system 4001. The oral cushion 4100 may be formed of, for example, silicone. The cushion clip 4200 may be formed of, for example, a thermoplastic resin. The decorative plate 4300 may be formed of, for example, a thermoplastic resin.

[0441] The oral cushion 4100 may be overmolded onto the cushion clip 4200. It should be understood that the oral cushion 4100 may be removably connected to the cushion clip 4200 in the manner described below. The oral cushion 4100 includes a pocket 4102 and an upper connection portion 4104 adapted to receive the nose seal connection portion 4202 of the cushion clip 4200 and secure the oral cushion 4100 to the decorative sheet 4300. For example, with reference to FIG. 123 , the upper connection portion 4104 is angled or offset away from the sealing portion 4106 so that the nose seal portion (not shown) can be oriented toward the patient's nasolabial angle. For example, with reference to FIGS. 110 , 118 , and 119 , the rear edge 4108 of the pocket 4102 and the upper connection portion 4104 form an aperture 4110 that receives the nose seal connection portion 4202 of the cushion clip 4200. The nose seal connection portion 4202 of the cushion clip 4200 fits within the hole 4110 in the upper connection portion 4104 and the rear edge 4108 of the pocket 4102 .

[0442] For example, referring to FIGS. 126-130 , the oral cushion 4100 includes a groove 4114 configured to receive the cushion clip 4200. The groove 4114 almost completely surrounds the cushion clip 4200. The groove 4114 includes a small gap to allow the tab 4218 ( FIGS. 139-145 ) of the cushion clip 4200 to extend outward to engage and interlock with the slot 4310 ( FIGS. 140 , 141 , and 144 ) of the decorative sheet 4300. The oral cushion 4100 further includes a lip seal 4112 for interfacing with the groove 4302 ( FIGS. 110 , 115-117 , and 144 ) of the decorative sheet 4300 formed by the tab 4304. For example, as shown in FIGS. 116 and 117 , the lip seal 4112 overlaps the tab 4304 of the groove 4302 of the decorative sheet 4300. However, it should be understood that in the assembled state, the relatively flexible lip seal 4112 deforms and bends into the groove 4302 and is retained by the tabs 4304 of the decorative sheet 4300 .

[0443] 131-137, the cushion clip 4200 includes a mating portion 4204 for receiving a ring of a nose seal (not shown). The mating portion 4204 includes a buffer portion 4206 for allowing flexing of the mating portion 4204 and a tab 4208 for retaining the ring of the nose seal. The cushion clip 4200 further includes support regions or support portions 4210 at the lower corners of the clip 4200 to increase stability and force of the cushion 4100 on the patient's cheek areas and increase the stability of the seal on the flexible areas of the patient's face. The support regions 4210 at the lower corners of the clip 4200 may be thicker or harder than adjacent portions of the cushion clip 4200. A decorative laminate contact lip 4212 is provided to engage a groove 4302 in the decorative laminate 4300. A cushion contact lip 4214 is provided to engage a groove 4114 in the mouth cushion 4100.

[0444] 138-151, the decorative sheet 4300 includes a lower headgear connector 4306 for connecting to headgear and an elbow connector 4308 for connecting to an elbow adapted to be connected to a gas delivery tube or conduit. The rear surface of the decorative sheet 4300 includes a groove 4302 (FIG. 144) adapted to engage the flexible lip seal 4112 of the mouth cushion 4100. The rear surface also includes a slot 4310 configured to receive and interlock with the tab 4218 of the cushion clip 4200. As shown in FIGS. 144 and 151, the tab 4218 is rounded to smoothly guide the tab 4218 into the slot 4310 of the decorative sheet 4300. The tab 4218 may also be rounded so that the upper tab adjacent to the mating portion 4204 can first connect to a first position, and then the cushion clip can rotate to position the upper tab in a second position, in which the lower tab adjacent to the lower headgear connector 4310 (when in use) can engage with the decorative panel 4300. 5.3.8 Interface between cushion and veneer

[0445] Figures 100 through 108 show examples of interfaces between the cushion and the veneer. Figures 100 and 101 show an assembled patient interface assembly including a pillow 3001, a mouth cushion subassembly 3002, and an elbow 3004. Figure 102 shows an exploded view of the patient interface assembly.

[0446] 103 is an exploded view of a subassembly 3002 including a cushion 3006 and a decorative sheet 3008. The cushion 3006 includes a clip 3010 that may be overmolded to the cushion. The cushion 3006 may be removably connected to the clip 3010.

[0447] The clip 3010 may have a mating portion 3012 for attaching to the pillow 3001. The mating portion 3012 may include a bumper 3013 that allows the mating portion 3012 to flex inward, thereby receiving the nose seal. The mating portion 3012 may also include a tab 3014 that locks or maintains the position of the nose seal once connected. The mating portion 3012 may be angled to present the nose seal directly toward the patient's nares. For example, FIGS. 100 and 101 show the nose seal 3001 oriented to approximate the patient's nasolabial angle.

[0448] The clip may be stiffer than the cushion and may be made of Hytrel, polypropylene, nylon, injection molded plastic, or the like.

[0449] FIG. 104A shows the patient side of the decorative sheet 3008. The decorative sheet 3008 may include a recessed portion 3008.1 at the top of the decorative sheet and a recessed portion 3008.2 at the lower corners of the decorative sheet. The decorative sheet 3008 may further include lugs or raised portions 3008.3 to align and / or position the mouth seals and / or clips. The outer or non-patient-contacting side of the decorative sheet 3008 may be curved or stepped so that the middle portion is raised compared to the sides. This may allow the patient to grasp the curved area and make it easier to lift the decorative sheet. These curved areas may further include gripping features (not shown), such as dowels or overmolded buttons, to assist the patient in grasping the decorative sheet.

[0450] FIG. 103 is a further exploded view showing that the decorative sheet 3008 and set clip 3010 can be fastened together in several locations, for example, two or more locations, in this case, three locations. As shown in FIGS. 104A, 104B, and 105, the decorative sheet 3008 can have a recess 3008.1 to receive the protrusion 3010.1 of the clip 3010. FIGS. 106-108 show a series of exemplary mating assemblies between the subassemblies 3002. FIG. 106 shows the initial engagement between the protrusion 3010.1 and the recess 3008.1 on the top of the patient interface, after which the interface is pivoted in FIG. 107. The clip clicks into place when the bottom edge meets the bottom of the decorative sheet 3008, completing the assembly.

[0451] The clip may include an integral (silicone) lip seal to prevent leakage between the clip and the decorative sheet 3008. This increases the robustness of the assembly and reduces the reliance on tolerances to prevent leakage. The lip seal may be located proximal to the protrusions 3010.1 or 3010.2. FIG. 109 shows one example of a lip seal 3011 that may be used in such an assembly. 5.3.9 Integrated Patient Interface Systems

[0452] 20 and 21 show another integrated patient interface system 101. The patient interface system 101 includes a nose region 120, a mouth region 140, and a flexible tube 105 connected to the mouth region 140 via an elbow 102.

[0453] The nasal section 120 may utilize a nostril sealing section 122, which may be in the form of a membrane seal, such as nasal pillows, prongs, a nasal cradle, and / or a nasal chamber. The nostril sealing section 122 may be in the form of the nostril sealing section 222 depicted in Figures 25 and 26. The nasal section 120 may further include a decoupling section 125 and a headgear connector 121 adapted to connect to headgear 160.

[0454] The mouth region 140 may include a structural portion 147, a mouth seal region 142, a decoupling region 145, a headgear connector 141, and a vent region 103 which may include one or more vent holes or slots for venting gases exhaled by the patient. If the nose region 120 and the mouth region 140 are not formed as an integral element, a nose region connector 143 adapted to connect to the nose region 120 may be utilized. The patient interface system 101 may alternatively be formed as a modular patient interface system, where the nose region 120 and the mouth region 140 are separable and can be used individually, with the nose region 120 connectable to the flexible tube 105 via the elbow 102.

[0455] 22-24 illustrate another patient interface system 201 including a nasal region 220 and a mouth region 240. The nasal region 220 may include a nostril sealing region 222 and an orifice 226 for receiving pressurized breathable gas. While the patient interface system 201 is illustrated with the nostril sealing region 222 as depicted in FIGS. 25 and 26, other nostril sealing regions may be utilized, such as pillows, prongs, nasal chambers, etc.

[0456] Mouth region 240 includes a mouth seal 242, which may be in the form of a cushion for sealing with the patient's mouth, a frame 247, a mouth orifice 246 for receiving breathable pressurized air, a decoupling region 245, and a nostril connection 243 for connecting to the nose region. Frame 247, decoupling region 245, and connection 243 are shown removed in FIG. 22. While not shown, mouth region 240 may include a connection to a flexible tube for delivering the breathable pressurized gas, such as a swivel connector, elbow, and flexible tube shown in other embodiments.

[0457] The patient interface system 201 may alternatively be configured as a modular patient interface system, in which the nose region 220 and mouth region 240 are separable and can be used individually, and the nose region 220 is connectable to the flexible tube 105 via the elbow 202.

[0458] 29 illustrates a patient interface system 370 that may include a nose region 372, a mouth region 380, and headgear 360. In this embodiment, the patient interface system 370 may integrate the nose region 372 and the mouth region 380. Lower headgear straps 379 pass under the patient's ears and provide the normal headgear vector or sealing force to the patient's face. Headgear straps 360 provide support to help position and stabilize the mouth region 380 on the patient's face. The headgear straps 360 are not connected near the patient's mouth to help minimize the obscurity of the patient interface.

[0459] The nose region 372 may include a nostril sealing region 374 and a mouth sealing region 375, and may include a decoupling region.

[0460] Figure 33 shows a schematic cross-sectional view of an integrated patient interface system 201 in which the nose region 220 and mouth region 240 are formed as a unitary element. A decoupling region 245 is formed in the mouth region 240 to allow decoupling of forces applied from the mouth region 240 to the patient interface system (such as from a flexible supply tube). The nostril sealing region 222 is the nostril sealing region depicted in Figures 25 and 26. The nose tip engagement region 254 seals with the tip of the patient's nose, and the upper lip engagement region seals with the patient's upper lip. Connections to the flexible tubes have been omitted from this schematic cross-sectional view.

[0461] 34 shows a schematic cross-sectional view of an integrated patient interface system 101 in which the nose region 120 and the mouth region 140 are formed as a unitary element. In this schematic cross-sectional view, the connection to the flexible tubing 105 has been omitted. In this embodiment, a mouth sealing region 142 extends from the mouth region 140, which seals with the area between the patient's lower lip and the patient's chin, and from the nose region 120, which seals with the patient's upper lip area. Decoupling regions may be formed in the mouth region 140 to decouple forces applied to the patient interface system from the mouth region 140 (such as from a flexible supply tube).

[0462] 37 depicts a schematic cross-sectional view of an integrated patient interface system 370 in which a nose region 372 and a mouth region 380 are formed as a unitary element. The nose region 372 includes a nostril seal region 374 that forms a seal with the patient's nares and a mouth seal region 375 that forms a seal with the patient's mouth. A gusset 376 may be provided to connect the mouth region 380 to the flexible tubing 305. The gusset 376 may function to decouple movement of the flexible tubing 305 to prevent loss of the seal of the mouth region 380 and / or nose region 372.

[0463] 56-58 illustrate an integrated patient interface system 1300. The patient interface system 1300 includes an oral region 1302 and a nasal region 1310. The mouth seal of the oral region 1302 may be oriented generally horizontally, while the nasal region 1310 is oriented generally vertically to anatomically match the patient's mouth and nares. A gas irrigation vent may also be included.

[0464] Mouth region 1302 includes a lower lip engaging portion 1304 adapted to form a seal with the patient's lower lip, an upper lip engaging portion 1306 adapted to form a seal with the patient's upper lip, and an aperture adapted to receive pressurized air from an air supply hose 1318. An elbow and / or swivel may be used in combination with air supply hose 1318.

[0465] Nose region 1310 includes nostril engagement portion 1314 adapted to form a seal with the patient's upper lip, nose tip engagement portion 1312 adapted to form a seal with the tip of the patient's nose, and bellows or decoupling portion 1316 (see, e.g., FIG. 56 ). Bellows portion 1316 decouples force applied to mouth region 1302 from being applied to nose region 1310. This bellows portion may be filled with air and may provide a tighter seal by using air pressure to increase force.

[0466] 59 illustrates an integrated patient interface system 1320. The patient interface system 1320 includes an oral region 1322 and a nasal region 1330.

[0467] The mouth region 1322 includes a lower lip engaging portion 1324 adapted to form a seal with the patient's lower lip, and a frame 1326. The frame 1326 may be a rigid material such as, for example, polycarbonate. The lower lip engaging portion 1324 may be co-molded with the frame 1326.

[0468] Nose portion 1330 can include a support portion 1332, a sealing portion 1334, and a clip portion 1338 that engages sealing portion 1334 with support portion 1332. Support portion 1332 can be a semi-rigid material such as, for example, nylon. Clip portion 1338 can be a semi-rigid material such as, for example, nylon or polypropylene.

[0469] The sealing portion 1334 includes an upper lip engaging portion 1337 adapted to form a seal with the patient's upper lip and a nose tip engaging portion 1336 adapted to form a seal with the tip of the patient's nose. The sealing portion 1334 may be a flexible material such as, for example, silicone. The sealing portion 1334 may be co-molded as an integral part of the frame 1326.

[0470] An air supply hose 1344 may be connected to the mouth area 1322 by a swivel 1342. The swivel 1342 may be a rigid material such as, for example, polycarbonate.

[0471] Figure 63 depicts a modular patient interface system 1400, while Figures 64 and 65 depict an associated integrated patient interface system (which may also be modular). The patient interface system 1400 includes a mouth region 1402 and a nose region 1410. An elbow 1407 connects an air supply hose 1409 to the mouth region 1402 for delivering air to the patient interface system 1400. Headgear 1420 connects to the patient interface system 1400 for securing the patient interface system 1400 to the patient's head.

[0472] The mouth area 1402 includes a front portion 1404 and a lower foam portion 1405. The lower foam portion 1405 is positioned to form a seal between the patient's lower lip / chin and the mouth area 1402. The front portion 1404 may be clear to allow visualization of the patient's mouth area. The front portion 1404 may be silicone, for example.

[0473] The nose region 1410 may include a support portion 1412 and a sealing portion 1414. The sealing portion 1414 may include a nose tip engagement portion 1416 adapted to form a seal with the tip of the patient's nose and an upper lip engagement portion 1418 adapted to form a seal with the patient's upper lip. The support portion 1412 may also form a seal with the patient's upper lip. The upper foam portion 1406 may be disposed between the nose region 1410 and the patient's upper lip to enhance comfort. The outer foam portion 1408 may be disposed between the anterior portion 1404 and the nose region 1410. The upper foam portion 1406 and the outer foam portion 1408 may be a single piece of foam, such as a ring-shaped foam, with a hole formed in the foam for insertion of the nose region 1410.

[0474] 5.3.10 Kits The various components of the disclosed patient interface system may be utilized in one or more kits that may be provided. For example, FIG. 39 illustrates a nostril-only kit 805 that may be provided in accordance with an embodiment of the present technology. The nostril-only kit 805 may include a nasal section 820 adapted to seal with a patient's nares to provide respiratory therapy, and a nasal section headgear 812. The nostril-only kit may optionally include a connector 802, such as an elbow, that may connect the nasal section 820 to a source of pressurized air, which may be provided as part of the nasal section 820. The nasal section 820 may include the plug 35 in the embodiment of FIGS. 7-1 through 10. However, the nostril-only kit 805 may be equipped with a commercially available patient interface, such as the Swift FX patient interface. The plug 35 may be removed when used in conjunction with the mouth section 840.

[0475] The nostril-only kit 805 is adapted to deliver respiratory treatment to a patient's nostrils. This form of respiratory treatment delivered only to the nostrils is preferred because it is less obtrusive to wear, more comfortable for the patient, and many patients only require treatment of the nostrils. However, some patients may require treatment of only the mouth or treatment of both the mouth and nostrils. For example, some patients may be mouth breathers and may require a mouth section to provide a mouth seal so that effective treatment can be applied to the nostrils. On the other hand, other patients may require treatment of only the mouth or treatment of both the mouth and nostrils.

[0476] As such, oral kit 810 may be provided to a patient needing treatment for only the mouth, or to a patient needing treatment for both the mouth and nostrils but who already owns a nostril-only device or nostril-only kit 805. Oral kit 810 may include a mouth section 840 adapted to seal with the patient's mouth to provide respiratory treatment, and mouth section headgear 850. Mouth section 840 may be adapted to provide respiratory treatment only to the patient's mouth. Oral kit 810 may optionally include a connector 802, such as an elbow, that may connect mouth section 840 to a source of pressurized air if such a connector is not incorporated into mouth section 840.

[0477] The mouth section 840 may optionally be adapted to pneumatically connect to the nasal section 820 or another nostril-only CPAP device. For example, the mouth section 840 may include the hole 46 shown in FIGS. 7-5 for connecting to the nasal section, in which case a plug 35 may be provided in the oral kit 810 to occlude the hole 46. The mouth section 840 may also optionally include a valve 55 for selectively closing the hole 46. Additionally, the oral kit 810 may optionally be provided with a plug 803. The plug 803 may be used to occlude a hole in the front of the mouth section 840, and may optionally be provided with a bifurcated elbow 855 that may be used to connect both the mouth section 840 and the nasal section 820 to a source of pressurized air. The mouth section 840 may function as a docking station and be adapted to dock with the nasal section 820.

[0478] The mouth kit 810 may also optionally include nostril and mouth area headgear 860 that includes a connection area at its rear, such as connection area 67 depicted in Fig. 13. The nostril and mouth area headgear 860 may be used in place of the nose area headgear 812 and the mouth area headgear 850. Additionally, the mouth kit 810 may also optionally be provided with connected nose and mouth area headgear 870, which includes a connector 856 for connecting the nostril-only headgear and the mouth-only headgear at their rear.

[0479] Nostril-only kit 805 may be utilized as a retrofit kit for a patient with an oral site, such as oral site kit 810, who wishes to convert their oral-only device to an oral and nostril device, optionally provided with bifurcated elbow connector 855, plug 803, and nostril-and-mouth site headgear 860 or connected nostril-and-mouth site headgear 870. Similarly, oral kit 810 may be provided as a retrofit kit for a patient with a nasal site, such as nostril-only kit 805, who wishes to convert their nostril-only device to a nostril and mouth device.

[0480] A patient may convert a nasal-only CPAP device to a nasal-and-oral CPAP device in several ways using the nasal-only kit 805 and / or oral kit 810. The patient may remove a connector, such as an elbow, from the nasal section 820 and connect a bifurcated elbow connector 855 to both the nasal section 820 and the oral section 840, such that air is delivered to both the nasal section 820 and the oral section 840 through the bifurcated elbow connector 855. The patient may use the original nasal section headgear 812 in the nasal section in combination with the oral section headgear 850 in the oral section 840. A connector 856 may optionally be used to connect the nasal section headgear 812 to the oral section headgear 850. Alternatively, a nasal-and-oral section headgear 860 may be provided to connect from the nasal section 820 to the oral section 840. The nasal-and-oral section headgear 860 may be connected at the back, such as using a connection region 67 or integrated straps as depicted in FIG. 13 . If nose section 820 includes structure adapted to connect to a mouth section, such as connector 30 shown in FIG. 7-5, mouth section 840 included in oral kit 810 may include structure for connecting nose section 820 to mouth section 840, such as opening 46 shown in FIG. 11-1. Valve 55 and knob 54 may also be provided.

[0481] In various embodiments including structure, such as connector 30 and opening 46, that allows for a pneumatic connection between nose region 820 and mouth region 840, a patient may connect connector 30 to opening 46 and deliver air to the patient's nares using connector 802, such as an elbow on nose region 820, and deliver air to the patient's mouth through connector 30 and opening 46 to mouth region 840. In this embodiment, plug 803 is connected to the opening in the front of mouth region 840. Structure, such as plug 35 or valve 55, may be used to occlude the connection between nose region 820 and mouth region 840, after which mouth region 840 may be used as a mouth seal.

[0482] Alternatively, in various embodiments including structure that allows for a pneumatic connection between nose region 820 and mouth region 840, such as connector 30 and opening 46, the patient may connect connector 30 to opening 46 and utilize plug 803 to block the opening in nose region 820. A connector 802, such as an elbow, may then be connected to the opening in the front of mouth region 840 to deliver pressurized air to mouth region 840 and through connector 30 and opening 46 to nose region 820. Structure, such as plug 35 or valve 55, may be used to block the connection between nose region 820 and mouth region 840, after which nose region 820 may be used as a nostril seal.

[0483] Nostril and mouth kit 801 may include components of nostril-only kit 805 and mouth kit 810. Nostril and mouth kit 801 may enable a patient to selectively switch between using nasal region 820 alone, oral region 840 alone, or both nasal region 820 and oral region 840. This allows a patient to periodically vary the fit of the device on their face. For example, if the patient's nostril area becomes irritated (e.g., by the air jets and / or concentrated sealing force), the patient can switch between using nasal region 820 and oral region 840, or oral region 840 alone. The patient may switch periodically, for example, nightly, weekly, monthly, etc.

[0484] FIG. 43 illustrates a prior art nostril-only CPAP device 901 that provides CPAP therapy to a patient's nostrils. The CPAP device 901 includes nasal sections 910 that form a seal with the patient's nostrils and an elbow connector 912 that connects the nasal sections 910 to a tube 915 that delivers pressurized gas to the nasal sections 910. The tube extends along the patient's nose, between the patient's eyes, and over the patient's head and can be connected to a source of pressurized gas. The elbow connector can include a vent 914 with a removable insert for venting gas exhaled by the patient. The nasal sections 910 can include nostril-sealing sections such as nasal pillows, nasal prongs, nasal membranes, or nasal chambers. Headgear 918 can secure the nasal sections 910 to the patient's head.

[0485] 44 shows a side view illustrating how a prior art nasal-only device 901 can be converted into a nostril and mouth patient interface system 940 in accordance with an embodiment of the present technology. The nose section 910 and elbow 912 can be removed, and the patient interface system 940 can be connected to tubing 915, such as by connector 924. The prior art nasal-only device can be, for example, a Breeze® Sleepgear® device.

[0486] The patient interface system 940 may include an oral region 942 for forming a seal with the patient's mouth and a nasal region 952 for forming a seal with the patient's nares. The oral region 942 may include a headgear connector 946 for connecting to headgear 954, and the nasal region 952 may include a headgear connector 944 for connecting to headgear 950. The patient interface system 940 may be a modular patient interface system or an integrated patient interface system and may deliver pressurized air to the patient's nares and / or mouth.

[0487] The patient interface system 940 may alternatively utilize the nose region 910 and add a mouth region, in which case the patient interface system 940 is the mouth region. In this embodiment, the vent 914 of the elbow 912 is used to connect to the mouth region 942, and the insert in the vent 914 is removed, allowing the mouth region 942 to connect to the vent air pressure. In this embodiment, air can flow from the vent 914 to the mouth region 942, and the original headgear, such as headgear 918, can be retained.

[0488] 45 depicts a schematic side view of another variation of the nostril dedicated device 901. In this embodiment, the nasal pillows 960 are removed from the openings 920 of the nostril dedicated device 901, and instead of the nasal pillows 960, a patient interface system 962 is connected to the nostril dedicated device 901. The patient interface system 962 has a pair of connectors 964 that are adapted to connect to these openings.

[0489] Patient interface system 962 includes a mouth region 968 and a nasal region 969. The mouth region 968 forms a seal with the patient's mouth at a mouth seal 974 and receives pressurized air through a connector 964. The mouth region 968 is connected to the nasal region 969 at a connector 976. The nasal region 969 may include a nostril engagement portion 970 adapted to form a seal with the patient's nares and a support portion 972. The nasal region 969 may alternatively be another type of nasal region, such as nasal pillows or prongs, or a nasal chamber.

[0490] Patient interface systems 940 and 962 may be used to convert a nostril-only device for delivering respiratory therapy to a patient into a device for delivering nasal and / or mouth breathing therapy to a patient.

[0491] 46 illustrates a prior art nostril-only CPAP device 980 that provides CPAP therapy to a patient's nares. The CPAP device 980 may include a nasal section 982 including cushions 988 that form a seal with the patient's nares, a connector 990 for connecting to a pressurized gas source, a headgear connector 985 for connecting to headgear, and a forehead section 984. The forehead section 984 includes a forehead support pad 986 and a dial 994 for adjusting the position of the forehead support pad 986. The cushions 988 may be removed by pulling in the direction of the arrow.

[0492] 47 shows a side view illustrating how a prior art nasal-only device 980 can be converted into a nostril and mouth patient interface system 993 in accordance with an embodiment of the present technology. The cushion 988 can be removed, and in place of the cushion 988, the nostril and mouth patient interface system 993 can be connected to the nasal-only device.

[0493] The nostril and mouth patient interface system 993 may be formed with an interface 987 that is the same shape as the cushion 988, thereby connecting to the frame of the nasal-only device 980 instead of the cushion. The nostril and mouth patient interface system 993 includes the cushion 998 that is adapted to seal with the patient's face and may include a nose engaging portion 994 and a lower lip engaging portion 995. A headgear connector 996 may connect to the headgear 997. Thus, the nostril and mouth patient interface system 993 may be utilized to convert the nostril-only device 980 into the nostril and mouth patient interface system 993. A front portion 999 of the patient interface system 993 may be formed from a stiffening material to increase rigidity.

[0494] The nostril and mouth patient interface system 993 may include an AAV (anti-asphyxiation valve), which may have an opening 1002 and a flap 1004. When pressure, such as delivered from an air delivery tube, is applied to the patient interface system 993, the flap 1004 is in a closed position. When no pressure is applied, the flap 1004 moves to an open position 1006, allowing the user to breathe through the opening 1002. Although not shown, the embodiment of FIG. 45 may also include such an AAV.

[0495] The patient interface systems described herein may be used to provide a method of providing respiratory therapy to one of a patient's nostrils only, a patient's mouth only, or both a patient's nostrils and mouth, and periodically changing the respiratory therapy to another of a patient's nostrils only, a patient's mouth only, or both a patient's nostrils and mouth. For example, the respiratory therapy may first be provided to a patient's nostrils only, and then periodically changed from application to only a patient's nostrils to application to a patient's nostrils and mouth.

[0496] Modular use of the nasal cradle (...

Claims

1. 1. A patient interface system for delivering respiratory therapy to a patient, comprising: a nose region including a nasal chamber including an opening and a nose sealing region configured to form a seal with the patient's face and surround an entrance to the patient's nares; an inlet conduit connected to an inlet opening in the nasal region for delivering breathable pressurized gas to the nasal chamber, the inlet conduit constructed and arranged to contact at least a region of the patient's head above the superior ear base point of the patient's head; a nasal chamber connection component adapted to form part of a releasable fluid connection that allows the nasal region to be fluidly connected to the mouth region for communicating a portion of the breathable pressurized gas through the nasal chamber openings to the mouth region; a removable ventilation module adapted to be attached to the nasal chambers for venting gases exhaled by the patient, the removable ventilation module being arranged to be releasably connected to a connecting component of the nasal chambers such that the patient interface system can be configured in a first mode in which the ventilation module is fluidly connected to the nasal chambers to enable the patient interface system to operate as a nasal-only patient interface, and a second mode in which the ventilation module is removed to fluidly connect the nose region to a mouth region to communicate a portion of the breathable pressurized gas to the mouth region through the nasal chamber openings.

2. 2. The patient interface system of claim 1, wherein the nasal region includes a nasal cushion forming at least a portion of the nasal chamber, the nasal chamber opening and the connecting component being formed in the nasal cushion.

3. the nasal cushions include pillow cushions constructed and arranged to form a seal with each nostril of the patient's nose; The patient interface system of claim 2 , wherein the pillow cushion has a circular outer edge when viewed from the side facing the user.

4. 4. A patient interface system according to claim 1, wherein the connecting component comprises a clip mechanism extending adjacent the nasal chamber opening and arranged to form part of a resilient clip connection.

5. The patient interface system of claim 4 , wherein the clip mechanism includes a resilient hinge.

6. 4. A patient interface system according to claim 1, wherein the connecting component includes at least a partial periphery extending adjacent the nasal chamber openings.

7. The patient interface system of claim 6 , wherein the periphery includes at least one of a protrusion or a recess to allow for a mating connection.

8. 8. A patient interface system according to claim 6 or 7, wherein the periphery includes a rake surface to provide a lead-in surface for a resilient connection.

9. A patient interface system according to claim 1 , wherein the coupling component forms part of a latch connection.

10. 10. A patient interface system according to any one of claims 1 to 9, further comprising at least one guide vane providing an obstacle to the fluid connection to direct the flow of gases from the nasal chambers through the ventilation module.

11. The patient interface system of claim 10 , wherein at least one of the guide vanes forms part of the ventilation module.

12. 12. A patient interface system according to any one of claims 1 to 11, wherein the ventilation module is an anti-asphyxiation valve (AAV).

13. 13. A patient interface system according to claim 12, wherein the anti-asphyxiation valve (AAV) includes a flap, and at least one guide vane is positioned to direct gases from the nasal chambers onto the flap.

14. 14. A patient interface system according to any one of claims 1 to 13, further comprising a mouth section including an oral section including an opening adapted to receive breathable pressurized gas and a mouth sealing section adapted to form a seal with the patient's mouth, wherein when fluidly connected, the nose section communicates a portion of the breathable pressurized gas through the nasal chamber openings and the oral section opening to the mouth section.

15. 15. A patient interface system according to claim 14, wherein the oral portion includes a vent opening adapted to receive a vent adapted to exhaust gases exhaled by the patient.

16. 16. A patient interface system according to claim 15, when dependent on claim 1, wherein the vent opening is configured to receive the removable vent module.

17. 17. A patient interface system according to any one of claims 14 to 16, wherein the mouth area includes a mouth cushion forming at least a portion of the oral cavity, the aperture being formed in the mouth cushion.

18. 18. A patient interface system according to any one of claims 14 to 17, wherein the mouth area further comprises a connection component arranged to form part of the fluid connection for connecting the nose area and the mouth area.

19. 20. A patient interface system according to claim 18, wherein the mouth area connecting component extends around an opening in the oral cavity.

20. 20. A patient interface system according to claim 18 or 19, wherein the mouth area connection component comprises a clip mechanism arranged to extend near an opening of the oral cavity and form part of a resilient clip connection.

21. 21. A patient interface system according to claim 20, wherein the clip mechanism includes a resilient hinge.

22. 20. A patient interface system according to claim 18 or 19, wherein the mouth area connecting component includes at least a partial periphery extending about an opening of the oral cavity.

23. 23. A patient interface system according to claim 22, wherein the periphery includes at least one of a protrusion or a recess to allow for a mating connection.

24. 24. A patient interface system according to claim 22 or 23, wherein the periphery includes a rake surface to provide a lead-in surface for a resilient connection.

25. 20. A patient interface system according to claim 18 or 19, wherein the mouth area coupling component forms part of a latch connection.

26. 26. A patient interface system according to any one of claims 18 to 25, wherein the mouth area connecting component is formed as an overmold incorporating a silicone overlay and a hard backing material.

27. 27. A patient interface system according to any one of claims 18 to 26, wherein the oral connection component is adapted to connect directly with a connection component of the nasal chambers to form the fluid connection.

28. 27. A patient interface system according to any one of claims 18 to 26, further comprising a connector adapted to form part of the fluid connection and having a nose region end attachable to a connecting component of the nasal chamber, an opposing mouth region end attachable to a connecting component of the mouth region, and a passageway extending between the nose region end and the mouth region end.

29. 30. A patient interface system according to claim 28, wherein the connector further comprises at least one vane disposed in the connector passageway.

30. 30. A patient interface system according to claim 28 or 29, wherein at least one of the nose area end or the mouth area end includes a clipping mechanism that engages with the connecting component of the mouth area.

31. 31. A patient interface system according to any one of claims 28 to 30, wherein at least one of the nose section end or the mouth section end is resiliently deformable for connection with the connecting component of the nose section or mouth section.

32. 32. A patient interface system according to any one of claims 28 to 31, wherein at least one of the nose area end or the mouth area end includes at least one of a protrusion or a depression to enable a mating connection with the connecting component of the nose area or mouth area.

33. 33. A patient interface system according to any one of claims 28 to 32, wherein at least one of the nose section end or the mouth section end includes a part latching formation enabling a latching connection of the nose section or mouth section with the connecting component.

34. 34. A patient interface system according to any one of claims 28 to 33, wherein the connector incorporates a connector chamber intermediate the nasal end and the oral end.

35. 35. A patient interface system according to any one of claims 28 to 34, wherein the connector is formed as a unitary structure.

36. 35. A patient interface system according to any one of claims 28 to 34, wherein the connector is formed from multiple components.

37. 37. A patient interface system according to any one of claims 18 to 36, wherein an anti-asphyxiation valve (AAV) is integrally formed with the mouth-site connecting component.

38. 37. A patient interface system according to any one of claims 28 to 36, wherein the connector incorporates an anti-asphyxiation valve (AAV) disposed between a nostril site end and a mouth site end.

39. 40. A patient interface system according to claim 38, wherein the anti-asphyxiation valve (AAV) includes a flap extending across the interior of the connector passageway.

40. 40. A patient interface system according to claim 39, wherein the connector includes one or more guide vanes extending across at least a portion of the interior of a connection portion to direct gas flow within the connector passageway.

41. 41. A patient interface system according to claim 40, wherein the one or more guide vanes are positioned to direct gases from the nasal chambers onto a flap.

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