Conduit headgear connector for patient interface

Abstract

To provide an improved patient interface.SOLUTION: The patient interface includes: a plenum chamber at least partly defining a patient interface chamber; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face, at least one conduit; at least one conduit connector configured to pneumatically connect the at least one conduit to the plenum chamber to provide a flow of air at a therapeutic pressure to the patient interface chamber for breathing by the patient; and a positioning and stabilizing structure to provide a force to hold the seal-forming structure on the patient's head, the positioning and stabilizing structure including at least one tie.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0002] 1 Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 609,909, filed December 22, 2017, which is incorporated herein by reference in its entirety. [Background technology]

[0003] 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.

[0004] 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 oral cavity form the entrance to a patient's airways.

[0005] 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 from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0007] 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.

[0008] 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).

[0009] 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).

[0010] 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:

[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0012] 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.

[0013] 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.

[0014] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses 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 disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and results in only a modest reduction in 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.

[0015] 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.

[0016] 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.

[0017] 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).

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another form of treatment system is a mandibular repositioning device.

[0024] 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 therapy 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 atmospheric pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure). In other forms of therapy, 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.

[0025] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems 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.

[0026] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0027] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0029] 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 chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0030] These challenges can lead to one or more of the following: some masks 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 masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask must be worn while sleeping.

[0031] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0032] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0033] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0034] 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.

[0035] Patient interfaces can 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 can 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 can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the oral cavity region during use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0036] 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.

[0037] A particular seal-forming structure may 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 may need to be adapted to form a seal.

[0038] 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 with the seal-forming structure engaging 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 of 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.

[0039] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and the mask can require additional force to achieve a seal or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can fold or buckle during use, causing leakage.

[0040] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0041] Another form of seal-forming structure may use adhesives to achieve a seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0042] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004310; WO2006 / 074513; WO2010 / 135785).

[0043] 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.

[0044] 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. Embodiments of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO2004 / 073778 (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. WO2005 / 063328 and WO2006 / 130903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full-face mask); and International Patent Application No. WO2009 / 052560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0045] 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.

[0046] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0047] 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.

[0048] 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 implement one or more of the above-mentioned therapies, for example, by actuating the device to generate a flow of air delivered to an interface with the airway. This flow of air can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0049] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0050] One example of a special requirement for a particular RPT device is acoustic noise.

[0051] [Table 1]

[0052] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent respiratory support for patients for a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0053] The ResMed Elise´e® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0054] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters.

[0055] 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 of 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.

[0056] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0057] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0058] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use.

[0059] 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.

[0060] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0061] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0062] 2.2.3.5 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the mouth before a patient goes to sleep and removed afterward. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include bite impression sections designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0063] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0064] In such a design, the length of the connecting rod is selected so that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion required for the mandible, and the length of the connecting rod is then determined.

[0065] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in a forward position. The devices also reduce or minimize dental and temporomandibular joint (TMJ) side effects. As such, the devices are configured to minimize or prevent any movement of one or more teeth.

[0066] 2.2.3.6 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).

[0067] The vents may include orifices through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0068] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034665; International Patent Application Publication No. WO2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0069] [Table 2]

[0070] ( * (Only one sample was measured at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0071] [Table 3]

[0072] 2.2.4 Screening, diagnostic, and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing is particularly unsuitable for home use.

[0073] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. While some screening / diagnostic systems are adapted solely for screening / diagnosis, some can also be used for monitoring.

[0074] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. Summary of the Invention

[0075] 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.

[0076] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0077] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0078] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0079] Aspects of the present technology relate to a patient interface including: a plenum chamber at least partially forming a patient interface chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airway; a first conduit and a second conduit each sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; a first conduit connector configured to pneumatically connect the first conduit to the plenum chamber to provide the airflow at the therapeutic pressure to the patient interface chamber for breathing by the patient; and a second conduit connector configured to pneumatically connect the second conduit to the plenum chamber to provide the airflow at the therapeutic pressure to the patient interface chamber for breathing by the patient; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head and includes at least one tie; and a positioning and stabilizing structure including an anti-asphyxiation valve configured to allow the patient to breathe from atmosphere through their oral cavity in the absence of the pressurized airflow. In a further embodiment, at least one of the first conduit connector and the second conduit connector may include an anti-asphyxiation valve.

[0080] Aspects of the present technology relate to a patient interface including: a plenum chamber at least partially forming a patient interface chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a first plenum chamber aperture and a second plenum chamber aperture, each of the first plenum chamber aperture and the second plenum chamber aperture sized and configured to receive an airflow at the therapeutic 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, the seal-forming structure having at least one aperture therein to allow the airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the patient interface chamber throughout the patient's respiratory cycle, in use. the seal-forming structure; a first conduit and a second conduit, each sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; a first conduit connector configured to connect the first conduit to air pressure at the first plenum chamber opening to provide the air flow at the therapeutic pressure to the patient interface chamber for breathing by the patient; and a second conduit connector configured to connect the second conduit to air pressure at the second plenum chamber opening to provide the air flow at the therapeutic pressure to the patient interface chamber for breathing by the patient; and a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head and includes at least one tie, wherein the first conduit connector and the second conduit connector each include an anti-asphyxiation valve configured to allow the patient to breathe from atmosphere through their oral cavity in the absence of pressurized air flow through the first plenum chamber opening and the second plenum chamber opening.

[0081] In embodiments, (a) the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector may include an anti-asphyxiation valve orifice, (b) each anti-asphyxiation valve orifice may be shaped and dimensioned to allow the patient to breathe when the other anti-asphyxiation valve orifice is blocked, (c) the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector may further include an anti-asphyxiation valve flap, and (d) the anti-asphyxiation valve flap in each of the first conduit connector and the second conduit connector may be blocked when the first conduit connector and the second conduit connector are in a closed position. and (e) in an open position, the anti-asphyxiation valve flaps in each of the first and second conduit connectors are configured to block the anti-asphyxiation valve holes of the corresponding one of the first and second conduit connectors, thereby preventing air flow at therapeutic pressure traveling through the corresponding one of the first and second conduit connectors from being directed to the patient interface chamber and leaking to atmosphere through the anti-asphyxiation valve holes. (f) the anti-asphyxiation valve orifices in each of the first and second conduit connectors may be divided by an anti-asphyxiation valve orifice divider that prevents a corresponding anti-asphyxiation valve flap from passing through the anti-asphyxiation valve orifice; (g) each anti-asphyxiation valve flap may include at least one vent hole that allows a portion of the air flow at the treatment pressure to leak to the atmosphere; and (h) each of the first and second conduit connectors may include at least one vent hole that allows a portion of the air flow at the treatment pressure to leak to the atmosphere. the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector may include an anti-asphyxiation valve flap connector hole, and the anti-asphyxiation valve flap in each of the first conduit connector and the second conduit connector may include an anti-asphyxiation valve flap connector that connects the anti-asphyxiation valve flap to the anti-asphyxiation valve flap connector hole of a corresponding one of the anti-asphyxiation valves in the first conduit connector and the second conduit connector, (i) the anti-asphyxiation valves in each of the first conduit connector and the second conduit connector may be configured to operate independently of each other, and (h) each of the first conduit connector and the second conduit connector(k) each of the first and second conduit connectors includes a conduit connector vent configured to direct a continuous flow of exhaled gases by the patient from the interior of the patient interface chamber to the atmosphere, the at least one conduit connector vent being sized and shaped to maintain a therapeutic pressure within the patient interface chamber in use; and (k) each of the first and second conduit connectors includes a conduit connector vent configured to direct a continuous flow of exhaled gases by the patient from the interior of the patient interface chamber to the at least one conduit connector vent. (l) each of the first conduit connector and the second conduit connector may include a conduit connector vent outlet configured to direct a continuous flow of exhaled gases by the patient from the at least one conduit connector vent to atmosphere; (m) each of the first conduit connector and the second conduit connector may include a septum that prevents air flow at a therapeutic pressure passing through each of the first conduit connector and the second conduit connector from passing directly to atmosphere via the at least one conduit connector vent; and (n) each of the first conduit connector and the second conduit connector may include a septum that prevents air flow at a therapeutic pressure passing through the first conduit connector and the second conduit connector from passing directly to atmosphere via the at least one conduit connector vent. (o) the diffuser cavity and the diffuser material may be disposed downstream of at least one conduit connector vent with respect to the continuous gas flow to diffuse the continuous gas flow before it escapes to the atmosphere; (p) each of the first conduit connector and the second conduit connector may include a diffuser cover that encapsulates the diffuser material within the diffuser cavity; (q) the diffuser cover may be removable to allow for removal and replacement of the diffuser material; and (l) the first conduit connector and the second conduit connector may include a diffuser cover that encapsulates the diffuser material within the diffuser cavity; Each of the connectors may include a conduit connector vent outlet arranged such that at least a portion of the continuous gas flow passes through the diffuser material before leaking to the atmosphere through the conduit connector vent outlet, (s) each of the first conduit connector and the second conduit connector may include a conduit connector spacer that maintains a gap between each of the first conduit connector and the second conduit connector and a portion of the plenum chamber to allow the continuous gas flow to leak from each of the first conduit connector and the second conduit connector to the atmosphere, and (t) the plenum chamber may include:(u) the plenum chamber may include at least one plenum chamber vent; (v) each of the first conduit connector and the second conduit connector may include a conduit connection end configured to connect to a corresponding one of the first conduit and the second conduit; (w) each of the first conduit connector and the second conduit connector may include a conduit connector end defining a conduit connector inlet hole configured to receive air flow at a therapeutic pressure from a corresponding one of the first conduit and the second conduit; and (x) the first conduit connector Each of the first and second conduit connectors may include a conduit connector outlet defining a conduit connector outlet hole configured to direct air flow at the treatment pressure into the patient interface chamber, (y) each conduit connector end may be oriented substantially perpendicular to the corresponding conduit connector outlet, (z) the plenum chamber may include a connecting rim at the corresponding one of the first and second plenum chamber holes, and the first and second conduit connectors may be configured to connect the first and second plenum chamber holes to the corresponding one of the first and second plenum chamber holes. (aa) each of the first conduit connector and the second conduit connector may be removable from the plenum chamber; (bb) each of the first conduit connector and the second conduit connector may be permanently connected to the plenum chamber; (cc) each of the first conduit connector and the second conduit connector may be configured to remain stationary when connected to the plenum chamber; and (dd) the patient interface may include at least one conduit connector mounting structure configured to connect to a connecting rim of a corresponding one of the conduit connectors. The conduit connector may further include a seal between each of the first conduit connector and the second conduit connector and the corresponding one of the first plenum chamber aperture and the second plenum chamber aperture, (ee) the seal may be formed in each of the first conduit connector and the second conduit connector, the seal configured to engage the plenum chamber in the corresponding one of the first plenum chamber aperture and the second plenum chamber aperture, (ff) the seal may be permanently joined to the corresponding one of the first conduit connector and the second conduit connector, and (gg) the seal may be(hh) the positioning and stabilizing structure may include a pair of upper ties, each of the upper ties constructed and arranged such that, in use, at least a portion of the upper tie rests on a region of the patient's head above a supra-ear point of the patient's head; and the positioning and stabilizing structure may include a pair of lower ties, each of the lower ties constructed and arranged such that, in use, at least a portion of the lower tie rests on a region of the patient's head below a sub-ear point of the patient's head; (ii) each of the first and second conduit connectors may include a lower tie connector configured to connect to a corresponding one of the lower ties; (jj) the clip may releasably connect each of the lower ties to a corresponding one of the lower tie connectors; (kk) the clip may include a magnet; and (ll) the patient interface may further include a pair of lower tie tabs each configured to connect to a corresponding one of the lower ties; and each of the first and second conduit connectors may further include a flange configured to connect to a corresponding one of the lower tie tabs. (mm) each of the flanges may further include a flange opening and a recess, and each of the lower tie tabs may further include a tab connector configured to join each of the lower tie tabs to a corresponding one of the flanges by passing each of the lower tie tabs through the corresponding flange opening and engaging the corresponding recess, (nn) the patient interface may further include a clip configured to connect to each of the lower ties, and each of the lower tie tabs may further include a clip receiver configured to releasably connect to a corresponding one of the clips connecting the lower ties, (oo) each of the clips and each of the clip receivers may include a magnet oriented and charged to facilitate the releasable connection, (pp) each of the clip receivers may include a notch, and each of the clips includes a protrusion, and each protrusion is configured to engage a corresponding notch to limit rotation of the clip relative to the corresponding clip receiver, (qq) each of the first conduit connector and the second conduit connectorThe conduit connector may further include a first tab and a second tab that releasably connect to the plenum chamber at the first plenum chamber hole and the second plenum chamber hole, respectively; (rr) the first tab and the second tab may be configured such that the first conduit connector and the second conduit connector can only connect to the plenum chamber by engaging the first tab with the plenum chamber and then engaging the second tab with the plenum chamber; and (ss) the first tab and the second tab may be configured such that the first conduit connector and the second conduit connector can only connect to the plenum chamber by engaging the second tab with the plenum chamber. After disengagement, the first conduit connector and the second conduit connector may be configured to be disconnectable from the plenum chamber only by disengaging the first tab from the plenum chamber, (tt) the plenum chamber may further include a slot proximal to each of the first plenum chamber aperture and the second plenum chamber aperture, and the first tab of each of the first conduit connector and the second conduit connector may be configured to engage with a slot interlocked with a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture, and The first conduit connector and the second conduit connector may be rotatable about the corresponding slot when a first tab of each of the first conduit connector and the second conduit connector is engaged with the corresponding slot, and (uu) the plenum chamber may further include a detent proximal to each of the first plenum chamber aperture and the second plenum chamber aperture, and the second tab of each of the first conduit connector and the second conduit connector may further include a catch, the catch engaging a detent associated with a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture in a snap-fit ​​manner. (vv) the second tab of each of the first conduit connector and the second conduit connector may be flexible; (ww) each of the first conduit connector and the second conduit connector may further include gaps on either side of the corresponding second tab, thereby allowing the second tab to be cantilevered from each of the first conduit connector and the second conduit connector; (xx) the seal-forming structure may include a nose portion configured to seal around the patient's nares and a mouth portion configured to seal around the patient's mouth; and (yy) the seal-forming structure may include(zz) the patient interface may include a connection port housing, the first conduit and the second conduit each in pneumatic communication with the connection port housing, and a connection port connected to the connection port housing, the connection port configured to provide pneumatic communication between the patient's nares and the patient interface chamber, and the seal-forming structure may include a mouth-site hole configured to provide pneumatic communication between the patient's mouth and the patient interface chamber; (zz) the patient interface may include a connection port housing, the first conduit and the second conduit each in pneumatic communication with the connection port housing, and a connection port connected to the connection port housing, the connection port configured to provide a treatment pressure, (aaa) the connection port may include an elbow; (bbb) the connection port may include at least one vent; (ccc) the connection port may be pivotally connected to the connection port housing; and / or (ddd) the connection port and the connection port housing may be configured to be positioned above the patient's head in use.

[0082] Another aspect of the present technology relates to a respiratory treatment system that may include: a patient interface according to any of the embodiments of the previous three paragraphs; a respiratory pressure treatment device configured to generate an airflow at a therapeutic pressure; and an air circuit configured to direct the airflow at the therapeutic pressure from the respiratory pressure treatment device to the patient interface.

[0083] 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.

[0084] One aspect of the present technology is a method for manufacturing a device.

[0085] 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.

[0086] 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).

[0087] 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 patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0088] 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).

[0089] 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.

[0090] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]

[0091] 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:

[0092] 4.1 Treatment System [Figure 1A]1A shows a system including a patient 1000 wearing a patient interface 3000, which 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. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] 1B shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask 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. [Figure 1C] 1C shows a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from 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.

[0093] 4.2 Respiratory System and Facial Anatomy [Figure 2A] Figure 2A shows an overview 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] FIG. 2B is a 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] Figure 2C is a front view of the 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 directions of superior, inferior, radially inward, and radially outward are also noted. [Figure 2D]Figure 2D is a side 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, ala crest, supra- and sub-auricular points. The directions of superior and inferior, anterior and posterior are also indicated. [Figure 2E] Figure 2E is a further lateral view of the head. The approximate locations of the Frankfort horizontal and nasolabial angle are noted. The coronal view is also noted. [Figure 2F] FIG. 2F is a bottom view of the nose including several features including the nasolabial fold, lower lip, vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 2G is a side view of the surface features of the nose. [Figure 2H] Figure 2H shows 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] Figure 2I shows a mid-nasal incision approximately a few millimeters from the midsagittal plane, specifically showing the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] Figure 2J is a bony frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal turbinates are shown along with the maxilla and mandible. [Figure 2K] Figure 2K 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] Figure 2L shows the anterolateral aspect of the nose.

[0094] 4.3 Patient Interface [Figure 3A] FIG. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B]Figure 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, 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] Figure 3C 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 positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in Figure 3B. [Figure 3D] Figure 3D is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown and the curvature at this point is zero. [Figure 3E] Figure 3E is a schematic cross-sectional view of the structure taken 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 Figure 3F. [Figure 3F] Figure 3F is a schematic cross-sectional view of the structure taken at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in Figure 3E. [Figure 3G] 3G shows a mask 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] 3H shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] Figure 3I shows the surface of a structure with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] Figure 3J is a cross-sectional view through the structure of Figure 31. The surfaces shown bound a two-dimensional hole in the structure of Figure 31. [Figure 3K]Figure 3K is a perspective view of the structure of Figure 3I including two-dimensional and one-dimensional holes, and also illustrates the surfaces bounding the two-dimensional holes in the structure of Figure 3I. [Figure 3L] FIG. 3L shows a mask with an inflatable bladder as a cushion. [Figure 3M] Figure 3M is a cross-sectional view of the mask of Figure 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] Figure 3N shows a further cross section through the mask of Figure 3L, the interior surface also being shown. [Figure 3O] Figure 3O illustrates the left-hand rule. [Figure 3P] Figure 3P illustrates the right-hand rule. [Figure 3Q] FIG. 3Q shows the left ear including the left ear helix. [Figure 3R] FIG. 3R shows the right ear including the right ear helix. [Figure 3S] Figure 3S shows a right-handed spiral. [Figure 3T] FIG. 3T is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] FIG. 3U is a view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] Figure 3V is 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] Figure 3W is a cross-sectional view through the plenum chamber of Figure 3V, the cross-section being taken in the midsagittal plane shown in Figure 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 3210. The tendon 3210 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 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] Figure 3X shows the plenum chamber 3200 of Figure 3U 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 "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip.

[0095] 4.4 RPT Device [Figure 4A] 4 shows an RPT device 4000 in accordance with one form of the present technology. [Figure 4B] 1 is a schematic diagram of an air pressure path of an RPT device 4000 in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] FIG. 40 is a schematic diagram of the electrical components of an RPT device 4000 in accordance with one aspect of the present technology.

[0096] 4.5 Humidifier [Figure 5A] FIG. 5A is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] FIG. 5B is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] FIG. 5C is a schematic diagram of a humidifier in accordance with one form of the present technology.

[0097] 4.6 Respiratory waveform [Figure 6]FIG. 6 shows a model of a typical human respiratory waveform during sleep.

[0098] 4.7 Example of a patient interface for the technology [Figure 7] FIG. 7 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 8] FIG. 8 is a rear perspective view of a patient interface according to an embodiment of the present technology. [Figure 9] FIG. 9 is an inferior view of a patient interface in accordance with an embodiment of the present technology. [Figure 10] FIG. 10 is a front view of a patient interface in accordance with an embodiment of the present technology. [Figure 11] FIG. 11 is a rear view of a patient interface according to an embodiment of the present technology. [Figure 12] 12 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 12-12 of FIG. [Figure 13] FIG. 13 is a side view of a patient interface according to an embodiment of the present technology. [Figure 14] 14 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 14,15-14,15 of FIG. [Figure 15] 15 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 14,15-14,15 of FIG. 13. [Figure 16] FIG. 16 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 17] FIG. 17 is a rear perspective view of a patient interface according to an embodiment of the present technology. [Figure 18] FIG. 18 is a top view of a patient interface in accordance with an embodiment of the present technology. [Figure 19] FIG. 19 is a front perspective view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 20]FIG. 20 is a front view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 21] FIG. 21 is a rear perspective view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 22] FIG. 22 is a rear view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 23] 23 is a cross-sectional view of a subassembly of a patient interface in accordance with an embodiment of the present technology taken through line 23-23 of FIG. 22. [Figure 24] FIG. 24 is a side view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 25] FIG. 25 is a front perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 26] FIG. 26 is a rear perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 27] FIG. 27 is a side perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 28] FIG. 28 is a top view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 29] 29 is a cross-sectional view of a conduit connector for a patient interface in accordance with an embodiment of the present technology taken through line 29,30-29,30 of FIG. 28. [Figure 30] 30 is a cross-sectional view of a conduit connector for a patient interface in accordance with an embodiment of the present technology taken through line 29, 30-29, 30 of FIG. 28. [Figure 31] FIG. 31 is a front perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 32] FIG. 32 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 33] FIG. 33 is a front view of a patient interface according to an embodiment of the present technology. [Figure 34] FIG. 34 is a front perspective view of a patient interface according to an embodiment of the present technology as it is being worn by a patient. [Figure 35] FIG. 35 is a side view of a patient interface according to an embodiment of the present technology as it is being worn by a patient. [Figure 36] FIG. 36 is a front perspective view of a patient interface according to an embodiment of the present technology as it is being worn by a patient. [Figure 37] FIG. 37 is a top perspective view of a connection port for a patient interface according to an embodiment of the present technology. [Figure 38] FIG. 38 is a bottom perspective view of a connection port for a patient interface according to an embodiment of the present technology. [Figure 39] FIG. 39 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 40] FIG. 40 is a rear perspective view of a patient interface according to an embodiment of the present technology. [Figure 41] FIG. 41 is an inferior view of a patient interface according to an embodiment of the present technology. [Figure 42] FIG. 42 is a front view of a patient interface according to an embodiment of the present technology. [Figure 43] FIG. 43 is a posterior view of a patient interface according to an embodiment of the present technology. [Figure 44] FIG. 44 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 44-44 of FIG. 43. [Figure 45] FIG. 45 is a side view of a patient interface according to an embodiment of the present technology. [Figure 46] 46 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 46, 47-46, 47 of FIG. 45. [Figure 47] 47 is a cross-sectional view of a patient interface in accordance with an embodiment of the present technology taken through line 46, 47-46, 47 of FIG. 45. [Figure 48]FIG. 48 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 49] FIG. 49 is a rear perspective view of a patient interface according to an embodiment of the present technology. [Figure 50] FIG. 50 is a top view of a patient interface according to an embodiment of the present technology. [Figure 51] FIG. 51 is a front perspective view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 52] FIG. 52 is a front view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 53] FIG. 53 is a rear perspective view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 54] FIG. 54 is a rear view of a subassembly of a patient interface according to an embodiment of the present technology. [Figure 55] FIG. 55 is a cross-sectional view of a subassembly of a patient interface taken through line 55-55 of FIG. 54 in accordance with an embodiment of the present technology. [Figure 56] FIG. 56 is a rear perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 57] FIG. 57 is an exploded rear perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 58] FIG. 58 is an exploded front perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 59] FIG. 59 is a superior view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 60] 60 is a cross-sectional view of a conduit connector for a patient interface in accordance with an embodiment of the present technology taken through line 59, 60-59, 60 of FIG. 58. [Figure 61] 61 is a cross-sectional view of a conduit connector for a patient interface in accordance with an embodiment of the present technology taken through line 59,60-59,60 of FIG. 58. [Figure 62] FIG. 62 is a front perspective view of a conduit connector for a patient interface according to an embodiment of the present technology. [Figure 63] FIG. 63 is a cross section view of a conduit connector for joining a patient interface to a conduit according to an embodiment of the present technology. [Figure 64] FIG. 64 is a front view of a patient interface according to an embodiment of the present technology. [Figure 65] FIG. 65 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 66] FIG. 66 is a posterior view of a positioning and stabilizing structure in accordance with an embodiment of the present technology. [Figure 67] FIG. 67 is a perspective view of a clip according to an embodiment of the present technology. [Figure 68] FIG. 68 is a perspective view of a clip according to an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0099] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0100] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0101] 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.

[0102] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0103] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0104] 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.

[0105] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0106] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0107] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0108] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0109] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0110] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0111] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0112] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0113] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0114] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0115] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0116] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0117] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0118] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0119] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0120] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0121] 5.3.1.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0122] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0123] 5.3.1.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip region (ie, upper lip) of the patient's face.

[0124] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0125] 5.3.1.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin area of ​​the patient's face.

[0126] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0127] 5.3.1.5 Frontal area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber may cover the eyes when in use.

[0128] 5.3.1.6 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0129] Nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected.

[0130] 5.3.1.7 Seal forming structure 3100 of the present technology A seal-forming structure 3100 according to embodiments of the present technology may separately seal around the patient's nostrils and mouth (ie, mouth-nose).

[0131] The seal-forming structure 3100 may include a nose region 3101 having nose region openings 3103 for sealing against the patient's nares. In the illustrated embodiment, one nose region opening 3103 is provided to provide airflow to both of the patient's nares. In another embodiment, the nose region opening 3103 may be split into two separate openings, each corresponding to one of the patient's nares. A portion of the nose region 3101 may be separated into two separate openings.

[0132] The seal-forming structure 3100 may include a mouth area 3102 having a mouth area aperture 3104 for sealing with the patient's mouth.

[0133] The seal-forming structure 3100 may at least partially form a patient interface chamber 3001 that is pressurized by the air flow. A plenum chamber 3200 may join with the seal-forming structure 3100 to further form the patient interface chamber 3001.

[0134] 5.3.2 Plenum chamber The plenum chamber 3200 has a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0135] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0136] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0137] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0138] A plenum chamber 3200 according to embodiments of the present technology may include a plenum chamber hole 3201 on each side. The plenum chamber 3201 may provide pneumatic communication between the conduit connector 3800 (described in more detail below) and the patient interface chamber 3001. The plenum chamber 3200 may include a connecting rim 3202 around each plenum chamber hole 3201. The connecting rim 3202 may facilitate a mechanical connection (e.g., a snap or friction fit) with each conduit connector. The plenum chamber 3200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the conduit connector 3800 is connected to or disconnected from the plenum chamber 3200.

[0139] The seal-forming structure 3100 may connect to the plenum chamber 3200. The connection may be permanent or the seal-forming structure 3100 may be removable from the plenum chamber 3200. The seal-forming structure 3100 may be overmolded onto the plenum chamber 3200. The seal-forming structure 3100 and the plenum chamber 3200 may be joined by a mechanical interlock, in which no chemical bond is formed between the plenum chamber 3200 and the seal-forming structure 3100.

[0140] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0141] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0142] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0143] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0144] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0145] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0146] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0147] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling section located between an anterior section of the positioning and stabilizing structure 3300 and a posterior section of the positioning and stabilizing structure 3300. The decoupling section does not resist compression and can be a flexible or flimsy strap, for example. The decoupling section is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling section prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0148] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0149] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the straps can be configured as ties.

[0150] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a point above the ear base of the patient's head, covering a portion of the parietal bone without covering the occipital bone.

[0151] In one form of the present technology, suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes below the sub-ear point on the underside of the patient's head and covers or rests below the occipital bone of the patient's head.

[0152] In one form of the present technology suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart.

[0153] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0154] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0155] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0156] The positioning and stabilizing structure 3300 may include a clip 3301 for securing each tie to a conduit connector 3800, as shown in Figures 32-36, for example. The clip 3301 and the conduit connector 3800 each have magnets 3305 disposed thereon with opposite polarities to facilitate connection therebetween. The clip 3301 may also include a cross bar 3306 around which a lower tie 3303 is provided for securing the clip 3301 to the cross bar 3306.

[0157] FIG. 66 shows an exemplary positioning and stabilizing structure 3300 that may include an upper tie 3302 , a lower tie 3303 , and a posterior portion 3304 .

[0158] 5.3.4 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).

[0159] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when the pressure within the plenum chamber is positive relative to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0160] Ventilation section 3400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0161] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure (e.g., a swivel).

[0162] 32 and 33 show one embodiment of a vent 3400 located on a connection port 3600. Variations of these embodiments may include venting 3400 from the connection port 3600.

[0163] The conduit connector 3800, described in more detail below, may also include a venting feature.

[0164] 5.3.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0165] 5.3.6 Connection Port The connection port 3600 allows for connection to the air circuit 4170. The connection port 3600 in accordance with one embodiment of the present technology may be connected to a connection port housing 3903. The connection port 3600 may be swivelable relative to the connection port housing 3903, and the connection to the air circuit 4170 may also be swivelable.

[0166] The connection port 3600 and connection port housing 3903 may be positioned above the patient's head in use.

[0167] 37 and 38 show a connection port 3600 for a patient interface 6000 in accordance with another embodiment of the present technology. While the present technology will be described with respect to a patient interface 6000, it should be understood that the present technology is not limited to such particular embodiment and may be adapted for use with other suitable interface arrangements and types.

[0168] In the illustrated embodiment, the connection port 3600 takes the form of a connection port constructed and arranged to provide a releasable connection between the patient interface 6000 and the air circuit 4170 .

[0169] The connection port 3600 includes an elbow assembly 7700 configured to connect to the air circuit 4170 (e.g., via a swivel connector 7790) and a ring member 7900 configured to connect to the patient interface 6000. As described in more detail below, the elbow assembly 7700 is repeatedly engageable and releasably disengageable (i.e., connectable and disconnectable) from the ring member 7900, thereby facilitating releasable or separable connectivity between the remainder of the patient interface 3000 and the air circuit 4170.

[0170] 5.3.6.1 Elbow Assembly The elbow assembly 7700 includes an elbow member 7710 having a first end and a second end. In the illustrated embodiment, the elbow member 7710 includes a 90° bend such that the first end is generally perpendicular to the second end (i.e., the central axis of the first end is at a 90° angle with respect to the central axis of the second end). However, it should be understood that the first end and second end may be arranged in other configurations (e.g., non-perpendicular to one another).

[0171] A clip member 7730 is provided at the first end. In the illustrated embodiment, the clip member 7730 is constructed and arranged to provide a releasable connection (e.g., a releasable snap-fit ​​connection or a separable snap-joint assembly with the ring member 7900). The second end includes a swivel connector 7790 adapted to connect to the air circuit 4170 (e.g., a swivel connector 7790 permanently connected to the second end).

[0172] A plurality of vent holes 7720 (e.g., at least 10 vent holes, e.g., 10-20 vent holes) are provided along the rear wall of the elbow member 7710 to allow the exit of exhaust gases from the patient interface 3000. As shown, the vent holes 7720 are arranged in a row, although it should be understood that the vent holes may be arranged in other suitable manners (e.g., concentrically). In one embodiment, each vent hole 7720 may include a contour or taper along its length (e.g., each hole converges in the direction of exhaled gases). However, each vent hole 7720 may have other suitable shapes for directing exhaust or exhaled gases. Furthermore, in the illustrated embodiment, the vent holes 7720 may be located on a portion of the rear wall that is generally flat or planar, such that the exit end of each vent hole is located along a generally flat or planar surface. However, it should be understood that the vent 7720 may be provided on a portion of the elbow member 7710 having other shapes (such as circular or convex).

[0173] The clip member 7730 includes a pair of resilient quick-release pinch arms 7740 and a connecting portion 7760 interconnecting the pinch arms 7740 (ie, a pinch arm 7740 is provided at each end of the connecting portion 7760).

[0174] Each pinch arm 7740 includes a catch portion 7750 and a button or trigger portion 7780. The pinch arms 7740 are constructed and arranged to provide a releasable snap-fit ​​connection or separable snap joint assembly with the ring member 7900 (e.g., the catch portion 7750 configured to deflect or snap into a recess or undercut on the ring member 7900). The button portion 7780 is constructed and arranged to be manually pinched or squeezed, thereby deflecting the catch portion 7750 and separating or releasing it from the ring member 7900, thereby separating the elbow assembly 7700 from the ring member 7900.

[0175] Each catch portion 7750 includes a barbed end, rib, or catch structured to provide a snap-fit ​​assembly with the ring member 7900. Each button or trigger portion 7780 includes a finger grip portion 7781 (e.g., a recess adjacent the free end of the pinch arm 7740).

[0176] In the illustrated embodiment, the clip member 7730 and the elbow member 7710 comprise separately molded parts (i.e., separate and individual structures). These parts are then connected to one another (e.g., a snap-fit ​​connection). For example, the clip member 7730 may comprise a material that is more flexible than the material of the elbow member 7710, so that the clip member 7730 can flex and connect onto the first end of the elbow member 7710. In one embodiment, a retention arrangement is provided to secure the clip member to the elbow member (e.g., a snap-fit ​​connection or snap-joint assembly).

[0177] In the illustrated embodiment, the clip member 7730 includes an open-ended configuration with a semi-flexible, generally semi-circular connecting portion 7760, which allows the clip member 7730 to be connected to the elbow member 7710 (e.g., in a manner similar to a circlip).

[0178] In one embodiment, the catch portion 7750 of the clip member 7730 may be biased inward so that when the clip member 7730 is connected to the elbow member 7710, the catch portion 7750 is biased to grip the elbow member 7710 and provide further resistance to removal from the elbow member 7710.

[0179] In the illustrated embodiment, the elbow member 7710 and the clip member 7730 form a two-part assembly or structure. An exemplary advantage of such a two-part structure is that it allows for manufacturing with fewer material constraints. For example, the clip member 7730 and the elbow member 7710 comprise separately molded parts, thereby reducing codependency between the clip member 7730 and the elbow member 7710 (e.g., the clip member 7730 is not constrained by the material of the elbow member 7710). In one embodiment, the clip member 7730 and the elbow member 7710 comprise different materials and / or different material properties from one another. In one embodiment, the clip member 7730 and the elbow member 7710 are not molded as one piece from the same material.

[0180] In one embodiment, the elbow member 7710 can comprise a material (e.g., polycarbonate) that is more rigid than the material (e.g., nylon-12) of the clip member 7730. The material (e.g., nylon-12) of the clip member 7730 can be relatively flexible and sturdy (e.g., allowing the pinch arm to flex more easily, resistant to wear, and maintaining a connection to the elbow member), while the material (e.g., polycarbonate) of the elbow member 7710 can be relatively rigid (e.g., resistant to wear, clear for easy cleaning, and easy to manufacture).

[0181] Additionally, the two-part construction allows for less complex geometry for each part, which may result in easier manufacturing setup for assembly.

[0182] In the illustrated embodiment, the clip member 7730 is constructed and arranged to provide a releasable connection, such as a snap-fit ​​connection with the elbow member 7710. Such a releasable or separable arrangement can be advantageous because it facilitates cleaning of the clip member 7730 and elbow member 7710 upon separation.

[0183] In another embodiment, the clip member 7730 may not be removably connected to the elbow member 7710 (e.g., the clip member may be permanently connected to the elbow member). Such a non-removable arrangement may be advantageous because it reduces the likelihood of the clip member being lost or broken. Because the clip member is outside the air flow path, thorough cleaning is less important than, for example, parts exposed to the air flow path.

[0184] In one embodiment, the clip member 7730 and the elbow member 7710 may comprise separately molded pieces that may then be permanently interconnected such that the clip member 7730 cannot be separated from the elbow member 7710. Any suitable means may be used to permanently join or connect the clip member and elbow member.

[0185] In one embodiment, the clip member 7730 and the elbow member 7710 may be welded or glued (e.g., ultrasonically welded) together. For example, after connecting the clip member 7730 to the elbow member 7710 as described above, one or more portions (e.g., a central portion) of the connection portion 7760 of the clip member 7730 may be welded or glued to the elbow member 7710 to permanently secure the clip member to the elbow member. This connection allows for sufficient torsion (and torsion resistance) at the connection portion for movement of the pinch arm 7740.

[0186] Alternatively, the elbow assembly may be constructed such that disassembly is difficult or complicated due to the construction of the elbow and / or clip members, which allows for easy assembly of the clip member to the elbow member. In such elbow assemblies in which the elbow and clip members are manufactured separately, desired benefits (e.g., fewer constraints on material selection) may be achieved while avoiding additional welding or adhesive operations to secure the clip member to the elbow member.

[0187] The ring member 7900 is configured to be removably and sealingly secured in an opening or aperture in the connection port housing 3903. The elbow assembly 7700 releasably connects (e.g., a snap fit or snap joint assembly) to the ring member 7900 via the pinch arm 7740.

[0188] The connection port 3600 allows for decoupling of the air circuit 4170 from the patient interface (eg, improved decoupling of tubing drag on the patient interface to avoid instability).

[0189] One form of decoupling is provided by pinch arm 7740, which forms a swivel connection that allows elbow assembly 7700 to freely rotate 360 ​​degrees relative to ring member 7900. Another form of decoupling is provided by swivel connector 7790, which allows free 360 ​​degree rotation of swivel connector 7790 relative to elbow member 7710 (and connection of air circuit 4170 to swivel connector 7790).

[0190] 5.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0191] 7-36 show examples of patient interfaces of the present technology that do not include a forehead support. Variations of patient interfaces of the present technology may include a forehead support.

[0192] 5.3.8 Conduit A patient interface 3000 according to embodiments of the present technology may include a conduit 3900 for providing pressurized air flow from the connection port 3600 to the patient interface chamber 3001. The conduit 3900 may be joined above the patient's head at the connection port housing 3903 and may pass along the side of the patient's head between the patient's corresponding eyes and ears. The conduit 3900 may be connected to the plenum chamber 3200 via a conduit connector 3800 to provide pressurized air flow to the patient interface chamber 3001, as described below.

[0193] The conduit 3900 may also allow for stabilization and positioning of the seal-forming structure 3100 on the patient's face. Thus, the conduit 3900 may function similarly to a tie in the positioning and stabilizing structure 3300. Thus, the mechanical connection from the conduit 3900 to the conduit connector 3800 may be sufficient to transfer tensile forces in the conduit 3900 through the conduit connector 3800 to the seal-forming structure 3100.

[0194] The conduit 3900 may include features of similar conduits disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated by reference in its entirety. For example, the conduit 3900 of the present technology may include features of the headgear tube 3350 described in Figures 3A-3L and related description herein.

[0195] The conduit 3900 may be provided with a sleeve 3901 to cushion and protect the patient's face from the conduit 3900. The sleeve 3901 may be removable. The sleeve 3901 may be constructed from a breathable material.

[0196] The conduit 3900 may also include a tie connector 3902 to facilitate connection with a tie of the positioning and stabilizing structure 3300.

[0197] 5.3.9 Conduit Connectors According to an embodiment of the present technology, the patient interface 3000 may include a conduit connector 3800. The conduit connector 3800 connects the conduit 3900 to the plenum chamber 3200 to provide a flow of pressurized air to the patient interface chamber 3001. The conduit connectors 3800 may each be formed with a conduit connector housing 3801. The conduit connectors 3800 may provide other functions as described below (e.g., venting the patient interface chamber 3001, connection to the positioning and stabilizing structure 3300, and preventing asphyxiation through the inclusion of an anti-asphyxiation valve 3850).

[0198] Figures 7-18 show several views of a conduit connector 3800 on a patient interface 3000 in accordance with an embodiment of the present technology. Figures 25-31 show several views of a conduit connector 3800 in isolation in accordance with an embodiment of the present technology. Figures 32-36 show several views of a complete patient interface 3000 with a conduit 3900 and positioning and stabilizing structure 3300 connected to the conduit connector 3800 in accordance with an embodiment of the present technology.

[0199] 7-18, the conduit connectors 3800 are shown attached to the plenum chamber 3200 at the plenum chamber apertures 3201. As can be appreciated, one conduit connector 3800 is provided on each side of the patient interface 3000, with each conduit connector 3800 connected to a plenum chamber aperture 3201 on a corresponding side of the patient interface 3000. Each of the conduit connectors 3800 may include a conduit connector mounting structure 3807 for connecting each of the conduit connectors 3800 to a respective plenum chamber aperture 3201 at the connecting rim 3202. This connection may be mechanical (e.g., snap-fit ​​or friction-fit). This connection may also be detachable. The materials of the conduit connectors 3800 and the plenum chamber 3200 may each be selected to facilitate the desired connection features. For example, the material of the conduit connector 3800 and the material of the plenum chamber 3200 may each be relatively rigid to allow for auditory and / or tactile feedback in conjunction with the snap fit. The material of the conduit connector 3800 and the material of the plenum chamber 3200 may be different in at least one embodiment, or the materials may be the same. The conduit connector 3800 may be permanently connected to the plenum chamber 3200 at the plenum chamber hole 3201. For example, the conduit connector 3800 may be ultrasonically welded to the plenum chamber 3200 at the plenum chamber hole 3201. The connection between the conduit connector 3800 and the plenum chamber 3200 may be removable or permanent and may also be designed to be robust enough to transmit tension from the conduit 3900 to the plenum chamber 3200 (without disturbing the connection). This is because, as mentioned above, the conduit connector 3800 may facilitate positioning and stabilizing the seal-forming structure 3100 on the patient's head.

[0200] The conduit connector 3800 may be attached to the side of the plenum chamber 3200 to improve the aesthetics of the patient interface 3000. As noted above, constructing the plenum chamber 3200 from a transparent or translucent material may allow for visibility of the patient's facial features. For example, by providing the conduit connector 3800 to the side of the plenum chamber as shown in the illustrated embodiment, greater visibility of the patient's face is achieved, and this arrangement may improve the aesthetics of the patient interface 3000. This is in contrast to alternative designs where the elbow and air circuit may be joined to the center of the plenum chamber 3200, thereby obstructing the patient's face.

[0201] The conduit connector 3800 and plenum chamber aperture 3201 may also be positioned such that at least a portion of the conduit connector housing 3801 extends into the patient interface chamber 3001. This arrangement reduces dead volume within the patient interface chamber 3001 by utilizing the volume within the patient interface chamber 3001 occupied by the conduit connector 3800. Thus, less of the overall volume of the conduit connector 3800 extends outward from the patient interface 3000. This may be advantageous as it reduces excess structure that may interfere with bedding and provides a more appealing appearance to the patient.

[0202] Each conduit connector 3800 may also include a conduit connection end 3802 that connects to a respective conduit 3900. The connection between the conduit 3900 and the conduit connector 3800 at the conduit connection end 3802 may be removable or permanent. A conduit connector inlet hole 3803 may be formed in the conduit connector housing 3801 at the conduit connection end 3802 to receive a flow of pressurized air. The conduit connector 3800 may include structure (e.g., an undercut) to facilitate a removable snap-fit ​​connection with the corresponding conduit 3900. Each conduit 3900 may include a relatively rigid structure at its end that connects to the conduit connector 3800 to facilitate such a connection. The conduit connector 3800 may mate to the conduit 3900 via a friction fit. Again, as described above, conduit 3900 provides positioning and stabilizing functions for placing the seal-forming structure at a therapeutically effective sealing position on the patient's face, thereby ensuring a connection between conduit 3900 and conduit connector 3800 at conduit connection end 3802 that is sufficiently reliable to allow the transmission of tensile forces from conduit 3900 to conduit connector 3800 (without interfering with the connection between conduit 3900 and conduit connector 3800 at conduit connection end 3802).

[0203] The conduit connector 3800 may also provide a venting function for the patient interface 3000. The conduit connector housing 3801 may include a conduit connector vent inlet 3832 that is in pneumatic communication with the patient interface chamber 3001 when the patient interface 3000 is assembled. The conduit connector housing 3801 may also include at least one conduit connector vent hole 3831. As can be seen in the illustrated embodiment, each conduit connector housing 3801 includes multiple conduit connector vent holes 3831. The conduit connector housing 3801 may also include a baffle 3805 to prevent air that enters the patient interface chamber 3001 via the conduit connector outlet hole 3804 from directly escaping through the conduit connector vent(s) 3831. This allows for proper mixing of newly introduced air with the air already in the patient interface chamber 3001, which improves carbon dioxide displacement and increases the amount of fresh air provided to the patient for breathing. The conduit connector housing 3801 may also include at least one conduit connector vent spacer 3833. Figures 25-31 show multiple conduit connector vent spacers 3833 in these embodiments that provide a path for exhaled gases to escape from the conduit connector 3800 to the environment via the conduit connector vent outlet 3830. The conduit connector vent spacers 3833 may be distributed around a portion of the edge of the conduit connector housing 3801. The conduit connector vent spacers 3833 may maintain spacing between a portion of the conduit connector housing 3801 and the plenum chamber 3200 for the conduit connector vent outlet 3830.

[0204] The conduit connector housing 3801 may also include a diffuser cavity 3871 that may contain a diffuser material (not shown). The diffuser material may be enclosed within the diffuser cavity 3871 by a diffuser cover 3870. The diffuser cover 3870 may be permanently attached to the conduit connector housing 3801 so that the patient cannot change the diffuser material if it becomes blocked due to contaminants. In this embodiment, the diffuser cover 3870 may be ultrasonically welded to the conduit connector housing 3801. Alternatively, the diffuser cover 3870 may be removably attached to the conduit connector housing 3801 via, for example, a snap or friction fit, allowing the patient to change the diffuser material.

[0205] As shown in FIGS. 32-36, the conduit connector 3800 may also provide connection to the ties of the positioning and stabilizing structure 3300. The lower tie may be joined to the conduit connector 3800 by a clip 3301. The clip 3301 and the conduit connector 3800 may include magnets of opposite polarity to facilitate connection. The connection between the tie of the positioning and stabilizing structure 3300 and the conduit connector 3800 may be releasable. Tension from the lower tie of the positioning and stabilizing structure 3300 may urge a lower portion of the seal-forming structure 3100 into sealing engagement with the patient's face (e.g., around the mouth). Although not shown in FIGS. 25-31, structure for connecting the clip 3301 may be formed on the diffuser cover 3870. Alternatively, the connecting structure for the clip 3301 may be formed directly on the conduit connector housing 3801.

[0206] Figures 39-66 show other examples of the present technology that include similar features to the embodiment shown in Figures 7-36. The examples in Figures 39-66 also include different features than the embodiment shown in Figures 7-36.

[0207] 39-66, the plenum chamber 3200 includes a plurality of plenum chamber vents 3401. These plenum chamber vents 3401 allow gases (including exhaled carbon dioxide) to be vented from the patient interface chamber 3001 to the environment. Thus, because the size, shape, and number of plenum chamber vents 3401 are sufficient to allow for the expulsion of carbon dioxide, the conduit connector 3800 of this embodiment does not include any of the vent structures present in the previous examples (i.e., conduit connector vent outlet 3830, conduit connector vent 3831, conduit connector vent inlet 3832, etc.).

[0208] In another embodiment, the conduit connector 3800 may include a conduit connector vent outlet 3830, a conduit connector vent hole 3831, a conduit connector vent inlet 3832, etc., and multiple plenum chamber vent holes 3401 are also provided on the plenum chamber 3200. This arrangement may be advantageous as it may allow for additional and / or more diffuse ventilation.

[0209] The conduit connectors 3800 of this embodiment do not include any venting structure (i.e., conduit connector vent outlet 3830), but again, for safety reasons, an anti-asphyxiation valve assembly 3850 is provided on each of the conduit connectors 3800. Figures 46 and 47 show the movement of the anti-asphyxiation valve flap 3851 between open and closed positions similar to the previous embodiment.

[0210] In the embodiment of Figures 39-66, the plenum chamber 3200 may not have a sealing structure over the plenum chamber aperture 3201. In this embodiment, a seal between the conduit connector 3800 and the plenum chamber 3200 may be achieved by a conduit connector outlet seal 3861 bonded around the outer periphery of the conduit connector outlet 3808. The conduit connector outlet seal 3861 may be comprised of an elastomeric material (e.g., silicone) that deforms when it contacts the connecting rim 3202 around each plenum chamber aperture 3201. The conduit connector outlet seal 3861 may be overmolded onto the conduit connector outlet 3808. When the conduit connector 3800 is installed into the corresponding plenum chamber aperture 3201, the conduit connector outlet seal 3861 deforms against the connecting rim 3202, thereby ensuring a seal therebetween. In this embodiment, the conduit connector outlet seal 3861 may extend around the entire conduit connector outlet 3808, or the conduit connector outlet seal 3861 may be provided only at one or more selected locations of the conduit connector outlet 3808.

[0211] Alternatively, it is contemplated that the conduit connector outlet seal 3861 may be provided such that the connecting rim 3202 of each plenum chamber aperture 3201 contacts and deforms against the conduit connector outlet 3808 of each conduit connector 3800. In this embodiment, the conduit connector outlet seal 3861 may extend around the entire plenum chamber aperture 3201, or the conduit connector outlet seal 3861 may be provided only at one or more selected locations around the plenum chamber aperture 3201.

[0212] In yet another embodiment, there is no deformable sealing component between the conduit connector 3800 and the connecting rim 3202 of the corresponding plenum chamber aperture 3201. Therefore, leakage may occur in this alternative, or the tolerance between the conduit connector 3800 and the connecting rim 3202 of the corresponding plenum chamber aperture 3201 may be so small that leakage is negligible.

[0213] 39-66, the conduit connector 3800 may be configured to provide a releasable connection to the plenum chamber 3200 at the corresponding plenum chamber aperture 3201. The conduit connector 3800 may be constructed of a relatively rigid plastic material (e.g., polycarbonate) to facilitate the connection described below.

[0214] A slot 3203 and detent 3204 may be formed on the plenum chamber 3200 at each plenum chamber hole 3201 to engage with corresponding structure on the conduit connector 3800. The engagement process may be initiated by engaging a first tab 3890 with the slot 3203 from the front side of the plenum chamber 3200 (i.e., the side that will face away from the patient in use). The first tab 3890 may be relatively rigid and, once the first tab 3890 engages the slot 3203, may act as a fulcrum, allowing the conduit connector 3800 to rotate about the slot 3203, completing the engagement process. The engagement process may be completed by a second tab 3891 having a catch 3892 that engages with a detent 3204 on the plenum chamber 3204. When the conduit connector 3800 is rotated to engage the plenum chamber 3200 in the corresponding plenum chamber aperture 3201, the conduit connector outlet seal 3861 can engage the corresponding connecting rim 3202 to establish a pneumatic seal. Additionally, the conduit connector outlet 3808 can extend at least partially through the corresponding plenum chamber aperture 3201, allowing gas to travel between the patient interface chamber 3001 and the conduit connector 3800. The second tab 3891 can be flexible so that a snap-fit ​​connection is established when the catch 3892 and detent 3204 engage. This can benefit the patient because the snap-fit ​​connection provides tactile and audible feedback that a connection has been established. Providing a gap 3893 between one side of the second tab 3891 and the conduit connector outlet 3808 allows the second tab 3891 to cantilever, facilitating deformation during the engagement and disengagement processes.

[0215] The disengagement process is performed in reverse by first disengaging the catch 3892 from the corresponding detent 3204 by rotating the conduit connector 3800 forward, away from the plenum chamber 3200. Because the second tab 3891 is flexible, applying sufficient force to the second tab causes the second tab 3891 to flex and disengage the catch 3892 from the detent 3204. The conduit connector 3800 is then rotated further, causing the first tab 3890 to disengage from the slot 3203. During the disengagement process, the conduit connector outlet seal 3861 disengages from the corresponding connecting rim 3202 and the conduit connector outlet 3808 exits the corresponding plenum chamber hole 3201.

[0216] When engaged, the conduit connector 3800 may protrude forward relative to the plenum chamber 3200, causing the conduit 3900 to be directed laterally from the plenum chamber 3200. Locating the conduit 3900 forward of the plenum chamber 3200 allows the conduit 3900 to remain intact and engaged when a lateral force pulls the conduit 3900 away from the plenum chamber 3200, and also reduces the force required to disengage the conduit connector 3800, and thus the conduit 3900, from the plenum chamber 3200. Thus, the conduit 3900 may be joined to the conduit connector 3800 with sufficient strength to withstand lateral disengagement, as described further below, and also allows the conduit connector 3800 to be relatively easily removed from the plenum chamber 3200 (by rotating it from the plenum chamber hole 3201 as described above). Such an arrangement can be advantageous in typical applications, since side forces are common during use (i.e., sleep). It would be advantageous for the patient interface 3000 to withstand these forces (without disrupting the connection, and thus gas flow, between the conduit 3900 and the plenum chamber 3200). However, the forces that cause the disengagement process described above are less common during sleep. Therefore, the first tab 3890 and the second tab 3891 can be designed to engage and disengage with the slot 3203 and detent 3204 with relatively little force in each direction, allowing the patient to easily engage and disengage the conduit connector 3800. The disengagement force in this example can be as low as 8-12 Newtons.

[0217] Furthermore, the force required to disengage the conduit connector 3800 is small enough that the conduit connector 3800 can be disengaged by applying a forward force on the flange 3885 configured for magnetic fastening of the positioning and stabilizing structure 3300.

[0218] The conduit connector 3800 may also include a flange 3885 that connects the lower tie 3303 to the conduit connector 3800 via the clip 3301. The flange 3885 may extend from the conduit connector 3800. The flange 3885 may be molded as one piece with the conduit connector 3800. The flange 3885 may include a flange opening 3887 and a recess 3886 that receives the tab connector 3884 of the lower tie tab 3880. To attach the lower tie tab 3880 to the flange 3885, the tab connector 3884 passes through the flange opening 3887 and engages in the recess 3886. The lower tie tab 3880 may include a clip receiver 3881. The clip receiver 3881 may house a magnet that allows for releasable connection to a corresponding magnet in the clip 3301. The clip receiver 3881 may also engage the overhang 3307 of the clip 3301 to keep the clip 3301 engaged with the lower tie tab 3880. Thus, the attraction between the magnet of the clip 3301 and the clip receiver 3881 provides a locating function, and the engagement of the overhang 3307 and the clip receiver 3881 keeps the clip 3301 securely connected to the lower tie tab 3880. It should be understood that the connection between the clip 3301 and the lower tie tab 3880 can be released by applying enough force to overcome the attractive force between the two magnets. The lower tie tab 3880 may also include a notch 3882.

[0219] The conduit 3900 can be permanently or removably joined to the conduit connector 3800 at the conduit connector end 3802. Figure 63 shows an example of a permanent connection in which an intermediate conduit connector inlet seal 3860 (e.g., made of silicone) is molded around the conduit connector end 3802. The conduit 3900, which may also be made of silicone, is molded over the intermediate conduit connector inlet seal 3860.

[0220] 5.3.10 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve. As can be seen in the embodiments shown in Figures 7-18 and 25-31, each conduit connector 3800 may include an anti-asphyxiation valve assembly 3850. Thus, the patient interface 3000 may include two anti-asphyxiation valve assemblies 3850. Each anti-asphyxiation valve assembly 3850 may operate independently of the other (i.e., in response to cessation of pressurized air flow). For example, if the patient is sleeping on their side and the pressurized air flow is stopped and one anti-asphyxiation valve assembly 3850 is blocked (e.g., by a pillow), the other anti-asphyxiation valve assembly 3850 may function to prevent the patient from asphyxiating.

[0221] The anti-asphyxiation valve assembly 3850 can include an anti-asphyxiation valve flap 3851 that covers the anti-asphyxiation valve hole 3852 in a closed position. The cross-sectional views of FIGS. 14 and 29 show the anti-asphyxiation valve flap 3851 in the closed position. It can be seen in these views that the anti-asphyxiation valve flap 3851 prevents the pressurized airflow entering the conduit connector 3800 from escaping to the environment through the anti-asphyxiation valve hole 3852 and directs the pressurized airflow into the patient interface chamber 3001 via the conduit connector outlet hole 3804. The anti-asphyxiation valve flap 3851 can be configured to remain in the closed position throughout the patient's breathing cycle (i.e., inspiration and expiration). Thus, the patient receives the pressurized airflow into their airway to ensure sufficient patency of the patient's airway during inspiration and expiration. FIGS. 15 and 30 show the anti-asphyxiation valve flap 3851 in the open position. In this open position, the anti-asphyxiation valve hole 3852 is uncovered, allowing the patient to breathe from the environment through the anti-asphyxiation valve hole 3852 unless the pressurized air flow is stopped. Further, the anti-asphyxiation valve flap 3851 may be configured such that the open position is a default, neutral, or undeformed position, such that the anti-asphyxiation valve flap 3851 moves to the closed position (under the force of the pressure and / or air flow) only when pressurized air flow is applied up to at least a minimum flow rate and / or pressure. Further, the anti-asphyxiation valve hole 3852 may be sized sufficiently such that if one of the anti-asphyxiation valve assemblies 3850 becomes blocked and the patient is unable to breathe, the patient can adequately breathe through the unblocked anti-asphyxiation valve assembly 3850. Further, the anti-asphyxiation valve flap 3851 may be sized to completely block the anti-asphyxiation valve hole 3852 in the closed position. Alternatively, the anti-asphyxiation valve flap 3851 may include holes in the closed position to allow air to move to the surroundings, for example for ventilation.

[0222] The anti-asphyxiation valve flap 3851 may be joined to the conduit connector housing 3801 by an anti-asphyxiation valve flap connector 3854 that extends into the anti-asphyxiation valve flap connector hole 3853. The anti-asphyxiation valve flap 3851 may be permanently attached to the conduit connector housing 3801 at the anti-asphyxiation valve flap connector hole 3853 by being overmolded onto the conduit connector housing 3801. The anti-asphyxiation valve flap 3851 may be made of a flexible, resilient material such that it can deflect from an open position to a closed position under the force of pressure and / or air flow.

[0223] The anti-asphyxiation valve assembly 3850 may also include an anti-asphyxiation valve orifice divider 3855 on the anti-asphyxiation valve orifice 3852. The anti-asphyxiation valve orifice divider 3855 may prevent the anti-asphyxiation valve flap 3851 from being forced out of the anti-asphyxiation valve orifice 3852 (due to pressure in the patient interface chamber 3001).

[0224] 5.3.11 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0225] 5.4 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.

[0226] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0227] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0228] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0229] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0230] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0231] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.

[0232] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0233] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0234] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0235] 5.4.1.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0236] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0237] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0238] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed within a blower housing, for example, in a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.

[0239] The pressure generator 4140 is under the control of the therapy device controller 4240 .

[0240] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0241] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).

[0242] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0243] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0244] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).

[0245] 5.4.1.4.1 Flow Sensor A flow sensor 4274 according to the present technology may be based on a differential pressure transducer (eg, SDP600 series differential pressure transducers from SENSIRION).

[0246] In one form, a signal indicative of the flow rate from the flow sensor 4274 is received by the central controller 4230.

[0247] 5.4.1.4.2 Pressure Sensor A pressure sensor 4272 according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0248] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0249] 5.4.1.4.3 Motor Speed ​​Converter In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0250] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0251] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0252] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0253] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0254] In one form, input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0255] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0256] Suitable processors may include x86 INTEL processors, processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the S®32 series of microcontrollers from ST Micro Electronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series microcontrollers from ST Micro Electronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0257] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0258] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0259] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220 and the humidifier 5000.

[0260] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0261] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms expressed as a computer program stored in a non-transitory computer-readable recording medium, such as memory 4260). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect respiratory-related events through analysis of recorded data (e.g., from any of the sensors described herein).

[0262] 5.4.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .

[0263] 5.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module and forms part of the algorithms executed by the central controller 4230.

[0264] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0265] 5.4.2.6 Protection circuit The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0266] 5.4.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes memory 4260 (e.g., non-volatile memory). In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0267] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0268] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (eg, a memory card made in accordance with the Secure Digital (SD) standard).

[0269] In one form of the present technology, memory 4260 functions as a non-transitory computer-readable storage medium on which computer program instructions (e.g., one or more algorithms) embodying one or more of the methods described herein are recorded.

[0270] 5.4.2.8 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0271] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0272] In one form, remote external communications network 4282 is the Internet. Data communications interface 4280 may use wired communications (e.g., via Ethernet or fiber optics) or may use wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0273] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).

[0274] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by an appropriately authorized person (e.g., a clinician).

[0275] The local external device 4288 may be a personal computer, a cell phone, a tablet or a remote control.

[0276] 5.4.2.9 Optional displays and output devices, including alarms Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile units. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0277] 5.4.2.9.1 Display Driver The display driver 4292 receives as input characters, symbols or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols or images.

[0278] 5.4.2.9.2 Display Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0279] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0280] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0281] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0282] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0283] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0284] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0285] 5.6.2 Humidifier Components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0286] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0287] According to one form, the reservoir 5110 may be laterally removable from the humidifier 5000, for example as shown in Figures 5A and 5B.

[0288] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0289] 5.6.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0290] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).

[0291] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0292] 5.6.2.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C . The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducer may be located external to the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0293] 5.6.2.5.1 Pressure Transducers One or more pressure transducers 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided in the RPT device 4000.

[0294] 5.6.2.5.2 Flow Converter In addition to or instead of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided in the humidifier 5000.

[0295] 5.6.2.5.3 Temperature Converter The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature of the air flow downstream of the humidifier outlet 5004). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air.

[0296] 5.6.2.5.4 Humidity Converter In one form, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0297] 5.6.2.6 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.

[0298] In some forms, the heating element 5240 may be provided in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0299] 5.6.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.

[0300] In one form, the humidifier controller 5250 may receive measurements of properties (e.g., temperature, humidity, pressure, and / or flow rate) as inputs (e.g., measurements of airflow, water in the reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0301] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4170, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0302] 5.7 Respiratory waveform Figure 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time, and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4 L / sec; expiratory time, Te, 2.4 seconds; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe at approximately 15 breaths per minute (BPM), with a ventilation, Vent, of approximately 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0303] 5.8 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0304] 5.8.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).

[0305] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0306] For example, the atmosphere for a humidifier humidityThis may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0307] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0308] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0309] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0310] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0311] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, reference to flow rate refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be simply called "flow."

[0312] In the example of a patient's breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0313] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0314] Leakage: The term "leakage" refers to unintended airflow. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the perimeter.

[0315] Noise Conduction (Acoustic): In this document, conducted noise refers to noise carried to the patient by the pneumatic path (e.g., the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0316] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.

[0317] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0318] Patient: A person with or without a respiratory disease.

[0319] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0320] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this time, is designated by the symbol Pt.

[0321] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to atmosphere.

[0322] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.

[0323] 5.8.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. References to silicone herein refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this registered trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45, as measured by ASTM D2240.

[0324] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0325] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0326] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0327] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.

[0328] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0329] Floppy structure or component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0330] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application would be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0331] As one example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0332] 5.8.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a predetermined threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0333] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0334] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0335] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0336] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0337] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0338] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area, followed by a downswing. (ii) M-shaped: has two local peaks, one at the rise and one at the fall, with a relatively flat region between these two peaks. (iii) Chair-like: A single local peak occurs at the rising part, followed by a relatively flat region. (iv) Inverted chair: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0339] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when flow is reduced below a threshold rate for a sustained period of time. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form, hypopnea may be considered when any of the following occur in adults: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting at least 10 seconds and associated desaturation of at least 3% or arousal occurs.

[0340] Hyperventilation: An increase in flow to a level higher than normal.

[0341] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0342] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0343] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0344] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0345] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory airflow, and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0346] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhaled volume Vi and the exhaled volume Ve).

[0347] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0348] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0349] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0350] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be centered).

[0351] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0352] Vent: A measure of the total amount of gas exchange performed by a patient's respiratory system. Measurements of ventilation can include either or both inspiratory and expiratory flow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0353] 5.8.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0354] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered to the patient by the ventilator (when not triggered by spontaneous breathing efforts).

[0355] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.

[0356] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added within a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.

[0357] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0358] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0359] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).

[0360] Servo-ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the level of pressure support to bring the patient ventilation closer to the target ventilation.

[0361] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0362] Swing: A term equivalent to pressure assistance.

[0363] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0364] 5.8.4 Anatomy 5.8.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0365] Alare: The outermost point on the ala of the nose.

[0366] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.

[0367] Pinna: the entire visible part of the ear.

[0368] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0369] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.

[0370] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0371] Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasal point.

[0372] Frankfort horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.

[0373] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal direction of the forehead.

[0374] Lateral nasal cartilage: a generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.

[0375] Greater alar cartilage: a cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0376] Nostrils (nares): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.

[0377] Nasolabial fold or nasolabial crease: a fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0378] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0379] Subbasal point of the ear: the lowest point of attachment of the pinna to the facial skin.

[0380] Suprabasal point of the ear: the highest point of attachment of the pinna to the facial skin.

[0381] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0382] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0383] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0384] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0385] Sagittal plane: A vertical plane running from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0386] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0387] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0388] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.

[0389] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0390] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0391] 5.8.4.2 Skull anatomy Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.

[0392] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0393] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.

[0394] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape from person to person. They lie side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0395] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0396] Occipital bone: The occipital bone is located at the back and underside of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity connects with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0397] Orbit: bony cavity in the skull that contains the eyeball.

[0398] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0399] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.

[0400] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0401] 5.8.4.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0402] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0403] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchi, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0404] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. The sides of the nasal cavity contain three horizontal extensions called turbinates or nasal conchae. The nasal cavity opens anteriorly into the nose and posteriorly into the nasopharynx via the choanae.

[0405] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0406] 5.8.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.

[0407] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0408] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0409] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more posts, ties, and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0410] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0411] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0412] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0413] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0414] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0415] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0416] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0417] Tie (noun): A structure designed to resist tension.

[0418] Vent: (noun): A structure that allows airflow to the ambient atmosphere inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, for clinically effective flushing, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure.

[0419] 5.8.6 Structural Shape Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.

[0420] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictitious little person standing upright on the surface.

[0421] 5.8.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0422] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0423] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.

[0424] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this fictitious little person were to walk away from point p, they would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0425] 5.8.6.2 Two-dimensional surface curvature A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0426] Principal curvature and direction: The directions of the normal plane in which the curvature of a curve reaches its maximum and minimum values ​​are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0427] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0428] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0429] Dome area: an area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")

[0430] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0431] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0432] Surface Edge: The boundary or limit of a surface or area.

[0433] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)

[0434] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface.)

[0435] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance as the crow flies.)

[0436] 5.8.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0437] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character were flying along the curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.

[0438] Unit normal vector: As the fictional character moves along the curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0439] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0440] Oscillating plane: the plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0441] Torsion of a Space Curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, because T2 > T1, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S.

[0442] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0443] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.

[0444] 5.8.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.

[0445] A structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's inner surface. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0446] 5.9 Other Notes Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0447] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0448] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0449] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0450] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0451] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0452] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically described.

[0453] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0454] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects can be performed simultaneously or even synchronously.

[0455] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0456] [Section 1] 1. A patient interface comprising: a plenum chamber at least partially forming a patient interface chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a first plenum chamber aperture and a second plenum chamber aperture, the first plenum chamber aperture and the second plenum chamber aperture each sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow a flow of air at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the patient interface chamber throughout the patient's respiratory cycle; a first conduit and a second conduit each sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a first conduit connector configured to pneumatically connect a first conduit to a first plenum chamber opening to provide a flow of air at the therapeutic pressure to the patient interface chamber for breathing by a patient, and a second conduit connector configured to pneumatically connect a second conduit to a second plenum chamber opening to provide a flow of air at the therapeutic pressure to the patient interface chamber for breathing by a patient; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including at least one tie; a patient interface, wherein the first conduit connector and the second conduit connector each include an anti-asphyxiation valve configured to allow a patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the first plenum chamber aperture and the second plenum chamber aperture. [Section 2] 2. The patient interface of claim 1, wherein the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector includes an anti-asphyxiation valve orifice. [Section 3] 3. A patient interface as described in paragraph 2, wherein each anti-asphyxia valve orifice is shaped and dimensioned to allow the patient to breathe when other anti-asphyxia valve orifices are blocked. [Section 4] 4. A patient interface according to any one of claims 2 to 3, wherein the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector further comprises an anti-asphyxiation valve flap. [Section 5] 5. A patient interface as described in paragraph 4, wherein the anti-asphyxiation valve flaps in each of the first and second conduit connectors are configured to block the anti-asphyxiation valve orifices in the corresponding one of the first and second conduit connectors when the anti-asphyxiation valve flaps are in a closed position, thereby preventing air flow at the therapy pressure traveling through the corresponding one of the first and second conduit connectors from being directed into the patient interface chamber and leaking through the anti-asphyxiation valve orifices to atmosphere throughout the patient's entire respiratory cycle. [Section 6] 6. A patient interface as described in any one of clauses 4 to 5, wherein in an open position, the anti-asphyxiation valve flaps in each of the first conduit connector and the second conduit connector are configured to allow a patient to mouth breathe from atmosphere through the corresponding anti-asphyxiation valve opening of either the first conduit connector or the second conduit connector in the absence of pressurized air flow through the first plenum chamber opening and the second plenum chamber opening. [Section 7] 7. A patient interface as described in any one of clauses 4 to 6, wherein the anti-asphyxiation valve holes in each of the first conduit connector and the second conduit connector are divided by an anti-asphyxiation valve hole divider that prevents the corresponding anti-asphyxiation valve flap from passing through the anti-asphyxiation valve hole. [Section 8] 8. A patient interface as described in any one of clauses 4 to 7, wherein each anti-asphyxiation valve flap further comprises at least one vent hole that allows a portion of the air flow at the therapeutic pressure to leak to atmosphere. [Section 9] the anti-asphyxiation valve in each of the first conduit connector and the second conduit connector further includes an anti-asphyxiation valve flap connector hole; 9. A patient interface as described in any one of clauses 4 to 8, wherein the anti-asphyxiation valve flap in each of the first conduit connector and the second conduit connector further includes an anti-asphyxiation valve flap connector that connects the anti-asphyxiation valve flap to the anti-asphyxiation valve flap connector hole of the corresponding one of the anti-asphyxiation valves of the first conduit connector and the second conduit connector. [Section 10] 10. A patient interface as described in any one of clauses 1 to 9, wherein the anti-asphyxiation valves in each of the first conduit connector and the second conduit connector are configured to operate independently of each other. [Section 11] 11. A patient interface as described in any one of clauses 1 to 10, wherein each of the first conduit connector and the second conduit connector further comprises at least one conduit connector vent configured to allow continuous flow of exhaled gases by a patient from the interior of the patient interface chamber to atmosphere, the at least one conduit connector vent being sized and shaped to maintain a therapeutic pressure within the patient interface chamber in use. [Section 12] 12. The patient interface of claim 11, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector vent inlet configured to direct a continuous flow of exhaled gases by a patient from the interior of the patient interface chamber to the at least one conduit connector vent. [Section 13] 13. A patient interface as described in any one of clauses 11 to 12, wherein each of the first conduit connector and the second conduit connector further comprises a conduit connector vent outlet configured to direct a continuous flow of exhaled gas by the patient from at least one conduit connector vent to atmosphere. [Section 14] 14. A patient interface as described in any one of clauses 11 to 13, wherein each of the first conduit connector and the second conduit connector further comprises a septum that prevents air flow at the therapy pressure passing through each of the first conduit connector and the second conduit connector from passing directly to atmosphere through the at least one conduit connector vent. [Section 15] 15. A patient interface according to any one of clauses 11 to 14, wherein each of the first conduit connector and the second conduit connector further comprises a diffuser cavity containing a diffuser material. [Section 16] 16. A patient interface as described in paragraph 15, wherein the diffuser cavity and the diffuser material are positioned downstream of at least one conduit connector vent relative to the continuous gas flow to diffuse the continuous gas flow before it escapes to the atmosphere. [Section 17] 17. A patient interface according to any one of clauses 15 to 16, wherein each of the first conduit connector and the second conduit connector further comprises a diffuser cover that encloses the diffuser material within the diffuser cavity. [Section 18] 18. A patient interface as described in clause 17, wherein the diffuser cover is removable to allow removal and replacement of the diffuser material. [Section 19] 19. A patient interface as described in any one of clauses 15 to 18, wherein each of the first conduit connector and the second conduit connector further comprises a conduit connector vent outlet, the conduit connector vent outlet being positioned such that at least a portion of the continuous gas flow passes through the diffuser material before escaping to the atmosphere through the conduit connector vent outlet. [Section 20] 20. A patient interface as described in any one of clauses 11 to 19, wherein each of the first conduit connector and the second conduit connector further comprises a conduit connector spacer that maintains a gap between each of the first conduit connector and the second conduit connector and a portion of the plenum chamber to allow continuous gas flow to leak from each of the first conduit connector and the second conduit connector to atmosphere. [Section 21] 11. A patient interface according to any one of clauses 1 to 10, wherein the plenum chamber includes at least one plenum chamber vent. [Section 22] 22. A patient interface as described in clause 21, wherein the plenum chamber includes a plurality of plenum chamber vents. [Section 23] 23. A patient interface as described in any one of clauses 1 to 22, wherein each of the first conduit connector and the second conduit connector further includes a conduit connection end configured to connect to a corresponding one of the first conduit and the second conduit. [Section 24] 24. A patient interface as described in any one of clauses 1 to 23, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector end defining a conduit connector inlet hole configured to receive air flow at the treatment pressure from the corresponding one of the first conduit and the second conduit. [Section 25] 25. A patient interface as described in clause 24, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector outlet defining a conduit connector outlet hole configured to direct air flow at the treatment pressure into the patient interface chamber. [Section 26] 26. A patient interface as described in clause 25, wherein each conduit connector end is oriented substantially perpendicular to a corresponding conduit connector outlet. [Section 27] the plenum chamber further includes a connecting rim at a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture; 27. A patient interface as described in any one of clauses 1 to 26, wherein the first conduit connector and the second conduit connector further include at least one conduit connector mounting structure configured to connect to the connecting rim of the corresponding one of the first plenum chamber aperture and the second plenum chamber aperture. [Section 28] 28. A patient interface according to any one of clauses 1 to 27, wherein each of the first conduit connector and the second conduit connector is removable from the plenum chamber. [Section 29] 29. A patient interface according to any one of clauses 1 to 28, wherein each of the first conduit connector and the second conduit connector is permanently connected to the plenum chamber. [Section 30] 30. A patient interface as described in any one of clauses 1 to 29, wherein each of the first conduit connector and the second conduit connector is configured to remain stationary when connected to the plenum chamber. [Section 31] 31. A patient interface as described in any one of clauses 1 to 30, further comprising a seal between each of the first conduit connector and the second conduit connector and the corresponding one of the first plenum chamber aperture and the second plenum chamber aperture. [Section 32] 32. A patient interface as described in clause 31, wherein the seal may be formed in each of the first conduit connector and the second conduit connector, and the seal is configured to engage the plenum chamber at a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture. [Section 33] 33. A patient interface according to clause 32, wherein the seal is permanently joined to a corresponding one of the first conduit connector and the second conduit connector. [Section 34] 34. A patient interface according to any one of clauses 31 to 33, wherein the seal is constructed from silicone. [Section 35] the positioning and stabilizing structure further includes a pair of upper ties, each of the upper ties constructed and arranged such that, in use, at least a portion of the upper tie rests on a region of the patient's head above an ear base of the patient's head; 35. A patient interface as described in any one of clauses 1 to 34, wherein the positioning and stabilizing structure further includes a pair of lower ties, each of the lower ties constructed and arranged such that, in use, at least a portion of the lower tie rests on an area of ​​the patient's head below the sub-ear point of the patient's head. [Section 36] 36. A patient interface as described in clause 35, wherein each of the first conduit connector and the second conduit connector further includes a lower tie connector configured to connect to a corresponding one of the lower ties. [Section 37] 37. A patient interface as described in clause 36, further comprising a clip for releasably connecting each of the lower ties to a corresponding one of the lower tie connectors. [Section 38] 38. A patient interface according to clause 37, wherein the clip further comprises a magnet. [Section 39] further comprising a pair of lower tie tabs each configured to connect to a corresponding one of the lower ties; 36. A patient interface as described in clause 35, wherein each of the first conduit connector and the second conduit connector further includes a flange configured to connect to a corresponding one of the lower tie tabs. [Section 40] each of the flanges further including a flange opening and a recess; 40. A patient interface as described in clause 39, wherein each of the lower tie tabs further includes a tab connector configured to join each of the lower tie tabs to a corresponding one of the flanges by passing through the corresponding flange opening and engaging the corresponding recess. [Section 41] further comprising a clip configured to connect to each of the lower ties; 41. A patient interface as described in clause 39 or clause 40, wherein each of the lower tie tabs further includes a clip receiver configured to removably connect to a corresponding one of the clips to which the lower tie is connected. [Section 42] 42. A patient interface as described in clause 41, wherein each of the clips and each of the clip receivers includes a magnet oriented and charged to facilitate detachable connection. [Section 43] 43. A patient interface as described in any one of clauses 41 to 42, wherein each of the clip receivers includes a notch and each of the clips includes a protrusion, each protrusion configured to engage with a corresponding notch to limit rotation of the clip relative to the corresponding clip receiver. [Section 44] 44. A patient interface described in any one of clauses 1 to 43, wherein each of the first conduit connector and the second conduit connector further includes a first tab and a second tab that releasably connect the first conduit connector and the second conduit connector to the plenum chamber at the first plenum chamber hole and the second plenum chamber hole, respectively. [Section 45] 45. A patient interface as described in clause 44, wherein the first tab and the second tab are configured such that the first conduit connector and the second conduit connector can be connected to the plenum chamber only by engaging the first tab with the plenum chamber and then engaging the second tab with the plenum chamber. [Section 46] 46. ​​A patient interface as described in clause 45, wherein the first tab and the second tab are configured such that the first conduit connector and the second conduit connector can be disconnected from the plenum chamber only by disengaging the second tab from the plenum chamber and then disengaging the first tab from the plenum chamber. [Section 47] the plenum chamber further includes a slot proximal to each of the first plenum chamber aperture and the second plenum chamber aperture; the first tab of each of the first conduit connector and the second conduit connector is configured to engage the slot associated with a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture; 47. A patient interface as described in paragraph 45 or 46, wherein each of the first conduit connector and the second conduit connector is rotatable about the corresponding slot when the first tab of each of the first conduit connector and the second conduit connector is engaged with the corresponding slot. [Section 48] the plenum chamber further includes a detent proximal to each of the first plenum chamber aperture and the second plenum chamber aperture; 48. A patient interface as described in clause 47, wherein the second tab of each of the first conduit connector and the second conduit connector further includes a catch configured to engage in a snap-fit ​​with the detent associated with a corresponding one of the first plenum chamber aperture and the second plenum chamber aperture. [Section 49] 49. A patient interface according to clause 48, wherein the second tab of each of the first conduit connector and the second conduit connector is flexible. [Section 50] 49. A patient interface as described in any one of clauses 48 or 49, wherein each of the first conduit connector and the second conduit connector further includes a gap on either side of the corresponding second tab, thereby allowing the second tab to be cantilevered from each of the first conduit connector and the second conduit connector. [Section 51] 51. A patient interface as described in any one of clauses 1 to 50, wherein the seal-forming structure further comprises a nose region configured to seal around the patient's nostrils and a mouth region configured to seal around the patient's mouth. [Section 52] the seal-forming structure further includes nasal holes configured to provide pneumatic communication between the patient's nares and the patient interface chamber; 52. A patient interface as described in any one of clauses 1 to 51, wherein the seal-forming structure further comprises a mouth-site hole configured to provide pneumatic communication between the patient's mouth and the patient interface chamber. [Section 53] a connection port housing, the first conduit and the second conduit each being in pneumatic communication with the connection port housing; 53. A patient interface as described in any one of clauses 1 to 52, further comprising a connection port connected to the connection port housing, the connection port configured to be connected to an air circuit to receive air flow at the therapeutic pressure. [Section 54] 54. A patient interface as described in clause 53, wherein the connection port further includes an elbow. [Section 55] 55. A patient interface according to any one of clauses 53 to 54, wherein the connection port further comprises at least one vent hole. [Section 56] 56. A patient interface according to any one of clauses 53 to 55, wherein the connection port is pivotally connected to the connection port housing. [Section 57] 57. A patient interface according to any one of clauses 53 to 56, wherein the connection port and the connection port housing are configured to be positioned above the patient's head in use. [Section 58] 1. A respiratory treatment system comprising: Item 1-57: A patient interface according to any one of items 1-57; a respiratory pressure treatment device configured to generate an airflow at the treatment pressure; an air circuit configured to direct a flow of air at the treatment pressure from the respiratory pressure treatment device to the patient interface. [Explanation of symbols]

[0457] 5.10 List of Reference Symbols 1000 patients 1100 Bedmate 3000 Patient Interface 3001 Patient Interface Chamber 3002 Subassembly 3100 Seal forming structure 3101 Nose area 3102 Mouth part 3103 Nasal hole 3104 Oral foramen 3105 Nasal aperture divider 3200 Plenum Chamber 3201 Plenum chamber hole 3202 Connecting Rim 3203 Slot 3204 Detent 3210 Tendon 3220 Upper point 3230 Down 3300 Positioning and Stabilizing Structures 3301 clips 3302 Kamigata Thailand 3303 Downward tie 3304 Posterior part 3305 Clip Magnet 3306 Crossbar 3307 Overhang 3400 Ventilation section 3401 Plenum Chamber Vent 3600 connection port 3700 Forehead support 3800 Conduit Connector 3801 Conduit Connector Housing 3802 Conduit Connector End 3803 Conduit connector inlet hole 3804 Conduit connector outlet hole 3805 Baffle 3806 Conduit Connector Spacer 3807 Conduit connector mounting structure 3808 Conduit Connector Outlet 3830 Conduit Connector Vent Outlet 3831 Conduit Connector Vent 3832 Conduit Connector Vent Inlet 3833 Conduit Connector Ventilated Spacer 3850 Anti-Asphyxiation Valve Assembly 3851 Anti-asphyxiation valve flap 3852 Anti-choking valve hole 3853 Anti-asphyxiation valve flap connector hole 3854 Anti-asphyxiation valve flap connector 3855 Anti-choking valve hole divider 3856 Anti-asphyxiation valve flap hinge 3860 Intermediate Conduit Connector Inlet Seal 3861 Conduit Connector Outlet Seal 3870 Diffuser Cover 3871 Diffuser Cavity 3880 Lower tie tab 3881 Clip Receiver 3882 Notch 3883 Flexible part 3884 Tab Connector 3885 flange 3886 Recess 3887 Flange opening 3890 First Tab 3891 Second Tab 3892 Catch 3893 gap 3900 Conduit 3901 Sleeve 3902 Tie Connector 3903 Connection Port Housing 3904 Bellows Section 4000 RPT devices 4010 Outer Housing 4012 Internal part 4014 Lower 4015 Panel 4016 chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Supplemental Oxygen 4200 Electrical Components 4202 Printed Circuit Board Assembly (PBCA) 4210 Power supply 4220 input devices 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed ​​Converter 4280 data communications interface 4282 Remote External Communications Network 4284 Local External Communication Network 4286 Remote External Device 4288 Local Foreign Device 4290 output device 4292 display driver 4294 display 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Air pressure sensor 5214 Flow Converter 5216 Temperature Sensor 5218 Humidity Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 7700 Elbow Assembly 7710 Elbow member 7720 Ventilation hole 7730 Clip material 7740 Pinch Arm 7750 Catch part 7760 Connection part 7780 Button or trigger area 7781 Finger grip part 7790 Swivel Connector 7900 Ring member

Claims

[Claim 1] 10. A patient interface as described herein.

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