Patient interface

Abstract

A patient interface, comprising: a frame assembly (16100) comprising a connector operably attachable to a headgear; a bumper assembly (16175) comprising a housing (161800) and a seal-forming structure (16200) configured to form a seal with the nose and / or mouth of the patient; and an air delivery connector (16600). The bumper assembly and the air delivery connector are configured to releasably connect to the frame assembly independently of each other. A static face seal and a separate static diameter seal are between the air delivery connector (16600) and the frame (16100). A dynamic face seal and a separate dynamic diameter seal are between the air delivery connector (16600) and the frame (16100). A separate claim (Fig. 6) for a frame assembly (16100) having an upper headgear connector arm (16134) includes at least one slot (6146) (claim 17) or flexible portion (claim 22) to form a hinge constructed and arranged to accommodate varying facial profiles.

Description

[0001] This application is a divisional application of the patent application with application number 202110726367.1, application date September 23, 2016, and invention name “PATIENT INTERFACE”. The patent application with application number 202110726367.1 is a divisional application of the patent application with application number 201680064877.4, application date September 23, 2016, and invention name “PATIENT INTERFACE”. The patent application with application number 201680064877.4 is the Chinese national phase application of PCT application with application number PCT / AU2016 / 050891.

[0002] 1 Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 222,593, filed September 23, 2015, and U.S. Provisional Application No. 62 / 376,961, filed August 19, 2016, each of which is incorporated herein by reference in its entirety. 2 Technical Background 2.1 Technical Field

[0004] The present technology relates to one or more of the following: detection, diagnosis, treatment, prevention, and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0005] 2.2 Description of Related Technologies

[0006] 2.2.1 Human respiratory system and its disorders

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

[0008] The airway includes a series of branching tracheae, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expel carbon dioxide. The trachea is divided into the left main bronchus and the right main bronchus, which are ultimately divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Other branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to "Respiratory Physiology," 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2011.

[0009] There are a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0010] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Comorbid symptoms are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there is a rhythmic alternation of boom-and-bust ventilation called a CSR cycle. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated arousals from sleep, which lead to severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

[0013] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0014] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) is a group of lower airway diseases that share certain common features. These diseases include increased resistance to air flow, a prolonged expiratory phase of breathing, and a loss of the lungs' normal elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include difficulty breathing during exercise, a chronic cough, and sputum production.

[0016] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, the need for wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage over several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage over several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, difficulty swallowing, dyspnea during exertion and at rest, fatigue, drowsiness, morning headaches, difficulty concentrating, and mood changes.

[0017] Chest wall disorders are a group of thoracic deformities that result in inefficient connection between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of treatments have been used to treat or alleviate these conditions. Furthermore, these treatments can be used to prevent breathing problems in otherwise healthy individuals. However, these treatments have a number of drawbacks.

[0019] 2.2.2 Treatment

[0020] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure ventilation acts as a pneumatic splint and can prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated with CPAP can be voluntary, so if the patient finds any one or more of the devices used to provide such treatment to be uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0021] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which is in the form of OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0022] Invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0023] 2.2.3 Treatment system

[0024] These treatments can be provided by treatment systems or devices.Such systems and devices can also be used to diagnose conditions without treating the condition.

[0025] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0026] Another form of treatment system is a mandibular repositioning device.

[0027] 2.2.3.1 Patient interface

[0028] The patient interface can be used to couple the respiratory apparatus to its wearer, for example, by providing a flow of air to the entrance of the airway. The flow of air can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O to the airway.

[0029] Some other mask systems may not be functionally suitable for this field. For example, a mask that is simply decorative may not be able to maintain the appropriate pressure. Masks used for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the environment inside.

[0030] Certain masks may be clinically unfavorable for this technology, for example in that they block airflow through the nose and only allow it through the mouth.

[0031] Certain masks may be uncomfortable or impossible for the present technology to implement if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0032] Certain masks may not be practical for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0033] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory treatment session.

[0034] Due to these challenges, some masks face one or more of the following problems: being obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for extended periods of time or when the patient is unfamiliar with the system. A mask of the wrong size results in reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics may be acceptable for their original purpose, but are not as comfortable as ideal for wearing for extended periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is especially true if the mask is worn during sleep.

[0035] CPAP therapy is very effective in treating certain breathing disorders, assuming patient compliance. Patients may not comply with treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their masks, which may affect patient compliance.

[0036] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0037] For these reasons, a diverse field has emerged for patient interfaces used to deliver CPAP during sleep.

[0038] 2.2.3.1.1 Seal forming part

[0039] The patient interface may include a seal-forming portion. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming portion may directly affect the effectiveness and comfort of the patient interface.

[0040] The patient interface is characterized in part according to the design intent of the seal-forming portion to engage with the face in use. In one form of patient interface, the seal-forming portion may include two sub-portions to engage with the respective left and right nostrils. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils in use. Such a single element may be designed, for example, to cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming portion may include an element that surrounds the mouth area in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the mouth area in use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0041] A seal-forming portion that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because of the different shapes, structures, variations, and sensitive areas of the patient's face. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0042] Certain seal-forming portions can be designed for mass manufacturing so that one design is suitable, 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 portion of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0043] One type of seal-forming portion extends around the periphery of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in facing engagement with the patient's face. The seal-forming portion may comprise an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming portion, if the fit is inadequate, a gap will exist between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0044] Another type of seal-forming portion includes a sheet-like seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal-forming portions, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming portion does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0045] Another type of seal-forming portion may include friction-fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0046] Another form of seal forming portion can use adhesive to achieve the seal.Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

[0047] A range of patient interface seal forming part technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0048] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0049] ResMed Limited already manufactures the following products, including nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and SWIFT TMLIBERTY™ full face mask. The following patent applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes ResMed Ltd.'s SWIFT TM Other aspects of nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY TM Other aspects of full face mask); International patent application WO 2009 / 052,560 (which describes ResMed Ltd. SWIFT TM Other aspects of the FX nasal pillows).

[0050] 2.2.3.1.2 Positioning and stabilization

[0051] The seal forming portion of the patient interface for positive air pressure therapy is subjected to the corresponding force of air pressure to destroy seal.Therefore, various techniques have been used to position the seal forming portion and keep it in a sealing relationship with the appropriate part of the face.

[0052] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0053] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0054] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0055] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size, and weight requirements for medical devices. Furthermore, even devices designed for medical use may have drawbacks related to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0056] An example of a special requirement for some RPT devices is noise.

[0057] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0058] RPT device name A-weighted sound pressure level dB(A) Years (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[Equipped with H4i TM S8 Escape with humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0059] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Inc. Another example of an RPT device is a ventilator. TM The ventilators in our range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients, for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0060] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and air pressure ventilation modes with single or dual channel circuits. An RPT device typically includes a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0061] The designer of the device may be provided with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0062] 2.2.3.3 Humidifier

[0063] Delivering an unhumidified air stream can lead to airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air, often applied to the facial area in and around the patient interface, is more comfortable than cold air. A range of artificial humidification devices and systems are known, however, they may not meet the specialized requirements of medical humidifiers.

[0064] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the ambient air when needed, typically where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0065] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0066] 2.2.3.4 Data Management

[0067] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as that the patient has used their RPT device according to certain "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period, and compare to the compliance rule. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rule, the healthcare provider may inform the patient of the third component of compliance.

[0068] There are other aspects of patient treatment that may benefit from the communication of treatment data to a third party or external system.

[0069] Existing methods of communicating and managing such data can be one or more of the following: expensive, time-consuming, and error-prone.

[0070] 2.2.3.5 Mandibular reduction

[0071] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite impression portion that is designed to allow it to fit over the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, puts tension on the pharyngeal walls to reduce collapse of the airway and reduces vibrations of the palate.

[0072] In some embodiments, the mandibular advancement device may include an upper plate intended to engage or cooperate with teeth on the upper jaw or maxilla, and a lower plate intended to engage or cooperate with teeth on the upper jaw or mandible. The upper and lower plates are laterally connected by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower plates.

[0073] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in a protruded position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0074] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (e.g., ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Thus, it is configured to minimize or prevent any movement of one or more teeth.

[0075] 2.2.3.6 Vent Technology

[0076] Some forms of patient interface systems may include a vent to allow for flushing of exhaled carbon dioxide. The vent may allow gas to flow from the interior space of the patient interface (e.g., a plenum) to the exterior space of the patient interface, e.g., to the environment. The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, thereby providing insufficient flushing. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, e.g., by making noise or by converging airflow.

[0077] ResMed Inc. has developed many improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0078] Noise table of existing masks (ISO17510-2:2007, pressure of 10cmH2O at 1m)

[0079]

[0080]

[0081] (*This is just one sample, measured at 10cmH2O using the test method specified in ISO3744 in CPAP mode) The sound pressure values ​​for various objects are shown below.

[0082]

[0083] 2.2.4 Diagnostic and monitoring systems

[0084] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves professional clinical medical staff to apply the system. PSG usually involves placing 15 to 20 contact sensors on the human body to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea has involved two nights of observation of the patient in the clinic, i.e. one night for pure diagnosis and a second night for the clinician to determine the treatment parameters. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0085] A clinical expert can appropriately diagnose or monitor a patient based on visual observation of PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply different criteria at different times.

[0086] 3. Technical Description

[0087] The present technology is directed to providing medical devices for diagnosing, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0088] A first aspect of the present technology relates to an apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0089] Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing breathing disorders.

[0090] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0091] One aspect of the present technology relates to a patient interface comprising a frame assembly including a connector operably attached to a headgear; a buffer assembly provided to the frame assembly, the buffer assembly including a seal-forming structure configured to form a seal with the patient's nose and / or mouth; and an air delivery connector provided to the frame assembly, the air delivery connector operably connected to an air delivery tube for supplying air under positive pressure along an air flow path. The buffer assembly is configured to releasably connect to the frame assembly independently of the air delivery connector. The air delivery connector is configured to releasably connect to the frame assembly independently of the buffer assembly.

[0092] In one example, a first seal for an air flow path may be formed between the air delivery connector and the frame assembly. In one example, a second seal may be formed between the frame assembly and the buffer assembly. In one example, the first seal includes a dynamic diameter seal and a dynamic face seal. In one example, the second seal includes a static diameter seal and a static face seal. In one example, the air delivery connector is configured to engage the buffer assembly to provide a seal for the air flow path. In one example, the buffer assembly includes a lip seal configured to provide a seal with the air delivery connector. In one example, the air delivery connector includes an elbow assembly. In one example, the elbow assembly is adapted to rotate relative to the frame assembly. In one example, the air delivery connector includes a vent adapter connector. In one example, the air delivery connector includes a pair of quick-release spring arms configured and arranged to releasably connect to the frame assembly. In one example, the buffer assembly includes a housing provided to the seal-forming structure, the housing and the seal-forming structure cooperating to form an inflatable chamber. In one example, the frame assembly includes an upper headband connector configured to connect to an upper headband strap and a lower headband connector configured to connect to a lower headband strap. In one example, the upper headband connector includes a pair of upper headband connector arms, each arm including one or more flexible portions constructed and arranged to accommodate different facial contours. In one example, each flexible portion includes one or more slots configured to form one or more hinges. In one example, the lower headband connector includes a pair of lower headband connector arms, each including a magnetic connector configured to connect to a magnetic headband clip. In one example, each lower headband connector arm includes a slot configured to form a hinge portion. In one example, the frame assembly includes a relatively rigid shield, and the upper and lower headband connectors are provided to the shield. In one example, the shield includes upper and lower slots configured to receive the respective upper and lower headband connectors. In one example, the frame assembly is provided in one size and is configured to be selectively engageable with buffer assemblies of multiple sizes. In one example, the frame assembly includes a blocking feature configured and arranged along the air flow path to prevent direct connection or insertion of an air delivery tube. In one example, the blocking feature includes a plurality of protrusions configured and arranged to extend toward the air flow path. In one example, the lockout feature comprises a single annular protrusion constructed and arranged to extend toward the air flow path. In one example, the air delivery connector comprises an elbow assembly having a plurality of vent apertures and an anti-asphyxia valve assembly. In one example, a frame assembly is provided in the air flow path.

[0093] Another aspect of the present technology relates to a frame assembly for a patient interface, the frame assembly including an upper headgear connector configured to connect to an upper strap of a headgear. The upper headgear connector includes a pair of upper headgear connector arms, each arm including one or more flexible portions configured and arranged to accommodate different facial contours.

[0094] In one example, each flexible portion includes one or more slots configured to form one or more hinges. In one example, each upper headband connector arm includes a first flexible portion and a second flexible portion between the first flexible portion and an upper headband connection point configured to connect to a corresponding upper strap. In one example, the first flexible portion includes a single slot and the second flexible portion includes a plurality of slots. In one example, the frame assembly also includes a lower headband connector configured to connect to a lower strap of the headband, the lower headband connector including a pair of lower headband connector arms.

[0095] In another example, a frame assembly for a patient interface is provided that includes an upper headband connector configured to connect to an upper strap of a headband, the upper headband connector including a pair of upper headband connector arms, each arm including multiple flexible portions configured and arranged to accommodate different facial contours, wherein each flexible portion forms multiple hinges.

[0096] Another aspect of the present technology relates to a patient interface comprising a frame assembly including a connector operably attached to a headband; a buffer assembly provided to the frame assembly, the buffer assembly including a seal-forming structure configured to form a seal with the patient's nose and / or mouth; and an air delivery connector (e.g., an elbow assembly) provided to the frame assembly, the air delivery connector operably connected to an air delivery tube for supplying air under positive pressure. In one example, a first seal for an air flow path is formed between the elbow assembly and the frame assembly, and a separate second seal is formed between the frame assembly and the buffer assembly. For example, the elbow assembly is configured to form a rigid connection and a dynamic seal with the frame assembly, and the buffer assembly is configured to form a separate rigid connection and a static seal with the frame assembly.

[0097] Another aspect of the present technology relates to a patient interface comprising a frame assembly including a connector operably attached to a headband; a buffer assembly provided to the frame assembly, the buffer assembly including a seal-forming structure constructed to form a seal with the patient's nose and / or mouth; and an air delivery connector (e.g., an elbow assembly) provided to the frame assembly, the air delivery connector operably connected to an air delivery tube for supplying air under positive pressure. In one example, the frame assembly includes a blocking feature constructed and arranged along an opening in the air flow path to prevent direct connection or insertion of the air delivery tube. This arrangement requires the use of an elbow assembly to interconnect the frame assembly and the air delivery tube, thereby ensuring that the elbow assembly (e.g., and its vent and anti-asphyxia valve (AAV)) is present in the system.

[0098] Another aspect of one form of the present technology is a patient interface that is cast or otherwise constructed using a perimeter shape that is complementary to the shape of the intended wearer.

[0099] One aspect of one form of the present technology is a method of manufacturing a device.

[0100] One aspect of some forms of the present technology is a medical device that is easy to use, such as by individuals without medical training, individuals with limited dexterity, vision, or individuals with limited experience using medical devices of this type.

[0101] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home (eg, in soapy water) without the need for specialized cleaning equipment.

[0102] The methods / systems / devices / apparatuses described herein may provide improved functionality in processors, such as processors of dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the methods / devices / apparatuses may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0103] Of course, parts of each aspect can form sub-aspects of the present technology. In addition, each aspect in the sub-aspects and / or aspects can be combined in any manner and also constitute other aspects or sub-aspects of the present technology.

[0104] Other features of the technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. 4 Brief Description of the Figures

[0106] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements, including:

[0107] 4.1 Treatment System

[0108] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown.

[0109] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0110] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0111] 4.2 Respiratory system and facial anatomy

[0112] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0113] Figure 2B A view of the human upper airway is shown, including the nasal cavity, nasal bones, external nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0114] Figure 2C It is a front view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal ala, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0115] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subnasal septum, upper lip, lower lip, supramental point, nasal bridge, apex of the nose, superior and inferior bases of the ears. The superior-inferior and anterior-posterior directions are also indicated.

[0116] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfort plane and nasolabial angle are indicated. The coronal plane is also indicated.

[0117] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermilion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and sagittal plane.

[0118] Figure 2G A side view of the nasal surface features is shown.

[0119] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0120] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0121] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible are also indicated.

[0122] Figure 2K A side view of the skull is shown, with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0123] Figure 2L An anterolateral view of the nose is shown.

[0124] 4.3 Patient Interface

[0125] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0126] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign and when Figure 3C The curvature magnitude shown is relatively large in comparison.

[0127] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign and when Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0128] Figure 3DA schematic diagram of a cross section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a value of zero.

[0129] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and when Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0130] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and when Figure 3E The curvature magnitude shown is relatively large in comparison.

[0131] Figure 3G A bumper for a mask including two pillows is shown. The outer surface of the bumper is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0132] Figure 3H Shown is a bumper for a face mask. The outer surface of the bumper is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle areas and one dome area are indicated.

[0133] Figure 3I A surface of a structure is shown with a one-dimensional hole on the surface. Planar curve 301D forms the boundary of the one-dimensional hole.

[0134] Figure 3J Shown through Figure 3I The cross section of the structure. Figure 3I The surface 302D of the two-dimensional hole in the structure.

[0135] Figure 3K Show Figure 3I A perspective view of a structure comprising a two-dimensional hole and a one-dimensional hole. Figure 3I The surface 302D of the two-dimensional hole in the structure.

[0136] Figure 3L A mask with an inflatable bladder as a shock absorber is shown.

[0137] Figure 3M Shown through Figure 3L A cross-section of the mask showing the interior surface of the airbag.

[0138] Figure 3N The left-hand rule is shown.

[0139] Figure 3OThe right-hand rule is shown.

[0140] Figure 3P The left ear is shown, including the left ear helix.

[0141] Figure 3Q The right ear is shown, including the right ear helix.

[0142] Figure 3R A right-hand helix is ​​shown.

[0143] Figure 3S A view of a mask is shown including torque signatures of spatial curves defined by the edge of the sealing membrane in different areas of the mask.

[0144] Figure 4 A perspective view of a patient interface shown on a patient's head according to an example of the present technology.

[0145] Figure 5 for Figure 4 Side view of the patient interface shown.

[0146] Figure 6 is a perspective view of a patient interface according to an example of the present technology, shown with headgear removed and arm covers removed from the upper arms of the frame assembly.

[0147] Figure 7 for Figure 6 Front view of the patient interface shown.

[0148] Figure 8 for Figure 6 Rear view of the patient interface shown.

[0149] Figure 9 for Figure 6 Side view of the patient interface shown.

[0150] Figure 10 An exploded view of a patient interface according to one example of the present technology showing a bumper assembly, a frame assembly, an arm cover, and an elbow assembly.

[0151] Figure 11 is an exploded view of a patient interface according to one example of the present technology showing a bumper assembly and a frame assembly removably connected with an elbow assembly removed.

[0152] Figure 12 is an exploded view of a patient interface according to one example of the present technology showing a frame assembly and an elbow assembly detachably connected with a bumper assembly removed.

[0153] Figure 13 A cross-sectional view of a patient interface according to an example of the present technology.

[0154] Figure 14 for Figure 13 An enlarged view of the patient interface is shown.

[0155] Figure 15 1 is a front exploded view of a bumper assembly according to one example of the present technology.

[0156] Figure 16 for Figure 15 Rear exploded view of the bumper assembly shown.

[0157] Figure 17 for Figure 15 Front view of the buffer assembly shown.

[0158] Figure 18 is a front perspective view of a frame assembly according to one example of the present technology.

[0159] Figure 19 for Figure 18 Rear perspective view of the frame assembly shown.

[0160] Figure 20 for Figure 18 Side view of the frame assembly shown.

[0161] Figure 21 for Figure 18 Rear view of the frame assembly shown.

[0162] Figure 22 for Figure 18 Front view of the frame assembly shown.

[0163] Figure 23 for Figure 21 A cross-sectional view of the frame assembly is shown.

[0164] Figure 24 for Figure 18 Front exploded view of the frame assembly shown.

[0165] Figure 25 for Figure 18 Rear exploded view of the frame assembly shown.

[0166] Figure 26 for Figure 22 A cross-sectional view of the frame assembly is shown.

[0167] Figure 27 A top view of a pipe elbow assembly according to an example of the present technology.

[0168] Figure 28 for Figure 27 A perspective view of the elbow assembly is shown.

[0169] Figure 29is a side view of a patient interface shown on a patient's head according to an example of the present technology.

[0170] Figure 30 is a perspective view of a patient interface according to an example of the present technology, shown with headgear removed.

[0171] Figure 31 for Figure 30 Front view of the patient interface shown.

[0172] Figure 32 for Figure 30 Rear view of the patient interface shown.

[0173] Figure 33 for Figure 30 Side view of the patient interface shown.

[0174] Figure 34 An exploded view of a patient interface according to one example of the present technology illustrating a bumper assembly, a frame assembly, and an elbow assembly.

[0175] Figure 35 is an exploded view of a patient interface according to one example of the present technology showing a bumper assembly and a frame assembly removably connected with an elbow assembly removed.

[0176] Figure 36 is an exploded view of a patient interface according to one example of the present technology showing a frame assembly and an elbow assembly detachably connected with a bumper assembly removed.

[0177] Figure 37 A cross-sectional view of a patient interface according to an example of the present technology.

[0178] Figure 38 for Figure 37 An enlarged view of the patient interface is shown.

[0179] Figure 39 1 is a front exploded view of a bumper assembly according to one example of the present technology.

[0180] Figure 40 for Figure 39 Rear exploded view of the bumper assembly shown.

[0181] Figure 41 for Figure 39 Front view of the buffer assembly shown.

[0182] Figure 42 is a front perspective view of a frame assembly according to one example of the present technology.

[0183] Figure 43 for Figure 42Rear perspective view of the frame assembly shown.

[0184] Figure 44 for Figure 42 Side view of the frame assembly shown.

[0185] Figure 45 for Figure 42 Rear view of the frame assembly shown.

[0186] Figure 46 for Figure 42 Front view of the frame assembly shown.

[0187] Figure 47 for Figure 46 A cross-sectional view of the frame assembly is shown.

[0188] Figure 48 for Figure 42 Front exploded view of the frame assembly shown.

[0189] Figure 49 for Figure 42 Rear exploded view of the frame assembly shown.

[0190] Figure 50 A perspective view of a pipe elbow assembly according to an example of the present technology.

[0191] Figure 51 for Figure 50 Exploded view of the elbow assembly shown.

[0192] Figure 52 A perspective view of a pipe elbow assembly according to an example of the present technology.

[0193] Figure 53 for Figure 52 Exploded view of the elbow assembly shown.

[0194] Figure 54A 、 54B 54C are rear views of a small bumper assembly, a medium bumper assembly, and a large bumper assembly according to an example of the present technology.

[0195] Figure 55 Exploded view of a patient interface according to an alternative embodiment of the present technology.

[0196] Figure 56 for Figure 55 A cross-sectional view of the patient interface is shown.

[0197] Figure 57 A top view of an elbow assembly according to an alternative embodiment of the present technology.

[0198] Figure 58To illustrate a patient interface attached to an example according to the present technology Figure 57 Cross-sectional view of the elbow assembly.

[0199] Figure 59 A perspective view of a patient interface shown on a patient's head according to an example of the present technology.

[0200] Figure 60 for Figure 59 Side view of the patient interface shown.

[0201] Figure 61 is a perspective view of a patient interface according to an example of the present technology, shown with headgear removed.

[0202] Figure 62 for Figure 61 A perspective view of the patient interface is shown with the arm cover of the upper arm of the frame assembly removed.

[0203] Figure 63 for Figure 62 Front view of the patient interface shown.

[0204] Figure 64 for Figure 62 Rear view of the patient interface shown.

[0205] Figure 65 for Figure 62 Side view of the patient interface shown.

[0206] Figure 66 for Figure 61 An exploded view of the patient interface is shown illustrating the bumper assembly, frame assembly, arm shield, and elbow assembly.

[0207] Figure 67 for Figure 62 An exploded view of the patient interface is shown showing the bumper assembly and frame assembly removably connected with the elbow assembly removed.

[0208] Figure 68 for Figure 62 An exploded view of a patient interface is shown showing the frame assembly and elbow assembly removably connected with the bumper assembly removed.

[0209] Figure 69 for Figure 63 A cross-sectional view of the patient interface is shown.

[0210] Figure 70 for Figure 69 An enlarged view of the patient interface is shown.

[0211] Figure 71 for Figure 65A cross-sectional view of the patient interface is shown.

[0212] Figure 72 for Figure 71 An enlarged view of the patient interface is shown.

[0213] Figure 73 1 is a front exploded view of a bumper assembly according to one example of the present technology.

[0214] Figure 74 for Figure 73 Rear exploded view of the bumper assembly shown.

[0215] Figure 75 is a front perspective view of a frame assembly according to one example of the present technology.

[0216] Figure 76 for Figure 75 Rear perspective view of the frame assembly shown.

[0217] Figure 77 for Figure 75 Side view of the frame assembly shown.

[0218] Figure 78 for Figure 75 Front view of the frame assembly shown.

[0219] Figure 79 for Figure 75 Rear view of the frame assembly shown.

[0220] Figure 80 for Figure 78 A cross-sectional view of the frame assembly is shown.

[0221] Figure 81 for Figure 75 Front exploded view of the frame assembly shown.

[0222] Figure 82 for Figure 75 Rear exploded view of the frame assembly shown.

[0223] Figure 83 is a front perspective view of a shroud for a frame assembly according to one example of the present technology.

[0224] Figure 84 for Figure 83 Rear perspective view of the shroud shown.

[0225] Figure 85 for Figure 83 Front view of the shroud shown.

[0226] Figure 86 for Figure 83 Rear view of the shroud shown.

[0227] Figure 87 2 is a front view of an upper anchor or upper arm connector for a shield according to one example of the present technology.

[0228] Figure 88 for Figure 84 An enlarged view of the shroud is shown.

[0229] Figure 89A is a front view of a shroud for a frame assembly according to another example of the present technology.

[0230] Figure 89B A rear view of a shroud for a frame assembly according to another example of the present technology.

[0231] Figure 90 is an exploded view illustrating the connection of the lower headband connector arm to the shroud of the frame assembly according to one example of the present technology.

[0232] Figure 91 is a cross-sectional view illustrating the connection of a lower headband connector arm to a shroud of a frame assembly according to one example of the present technology.

[0233] Figure 92 A front view of a frame assembly according to another example of the present technology.

[0234] Figure 93 and 94 for Figure 92 Exploded view of the lower headband connector arm of the frame assembly.

[0235] Figure 95 for Figure 92 Rear perspective view of the lower headband connector arm of the frame assembly.

[0236] Figure 96 A manufacturing process of a lower headband connector arm according to one example of the present technology is shown.

[0237] Figure 97 A manufacturing process of a lower headband connector arm according to another example of the present technology is shown.

[0238] Figure 98 is an exploded view illustrating the connection of a lower headband connector arm to a shroud of a frame assembly according to another example of the present technology.

[0239] Figure 99 1 is an exploded view illustrating the connection of an upper headband connector arm to a shroud of a frame assembly according to one example of the present technology.

[0240] Figure 100 is a cross-sectional view illustrating the connection of an upper headband connector arm to a shroud of a frame assembly according to one example of the present technology.

[0241] Figure 101 is a front perspective view of a headband clip according to one example of the present technology.

[0242] Figure 102 for Figure 101 A rear perspective view of the headband clip is shown.

[0243] Figure 103 To illustrate an example of the present technology Figure 101 Cross-sectional view of the connection of the headband clip to the lower headband connector arm of the frame assembly.

[0244] Figure 104 1 is a cross-sectional view illustrating the connection of the upper headband straps to the upper headband connection points of the frame assembly according to one example of the present technology. 5. Specific Implementation Methods

[0245] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0246] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute a further example.

[0247] 5.1 Treatment

[0248] In one form, the present technology comprises a method of treating a breathing disorder comprising the step of applying positive pressure to an entrance to the airway of a patient 1000 .

[0249] In certain examples of the present technology, a positive pressure supply of air is provided to the patient's nasal passages via one or both nostrils.

[0250] In certain examples of the present technology, mouth breathing is restricted, limited, or prevented.

[0251] 5.2 Treatment System

[0252] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000, e.g., see Figures 1A to 1C .

[0253] 5.3 Patient Interface

[0254] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned around the entrance to the patient's airway to facilitate the supply of positive pressure air to the airway.

[0255] Figures 4 to 28 A non-invasive patient interface 6000 is shown according to one aspect of the present technology, comprising a frame assembly 6100, a buffer assembly 6175 (including a seal-forming structure 6200), an air delivery connector (e.g., an elbow assembly 6600), and a positioning and stabilizing structure (e.g., a headband 6800). Figure 4 and 5 is an exemplary view of the patient interface 6000 on the patient's head (with the arm cover 6750 for the upper arm 6134 of the frame assembly 6100 attached), and Figures 6 to 10 6800 and arm shields 6750. In use, a form of the seal-forming structure 6200 is disposed around the inlet of the patient's 1000 airway to facilitate the supply of positive pressure air to the airway. The seal-forming structure 6200 (e.g., constructed of silicone) may also be generally referred to as a buffer. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects.

[0256] In one form of the present technology, the frame assembly 6100 is connected to the bumper assembly 6175 and the elbow assembly 6600 as an intermediate component. That is, the bumper assembly 6175 is connected to the frame assembly 6100 (via a first retaining feature on the frame assembly) independently of the elbow assembly 6600 (see Figure 11 ), and the elbow assembly 6600 is connected to the frame assembly 6100 (via a second retaining feature on the frame assembly) independently of the buffer assembly 6175 (see Figure 12 ). However, a seal for the air flow path is formed between the elbow assembly 6600 and the buffer assembly 6175, i.e., the frame assembly 6100 is not in the air flow path (e.g., see Figure 13 and 14). Alternatively, a first seal for the air flow path may be formed between the elbow assembly 6600 and the frame assembly 6100, while a separate, second seal may be formed between the frame assembly 6100 and the bumper assembly 6175. In this case, the frame assembly 6100 may remain in the air flow path. The retaining connections of the bumper assembly 6175 and the elbow assembly 6600 to the frame assembly 6100 are separate and distinct from one another and allow for independent engagement / disengagement, such as allowing the frame assembly 6100 to remain connected to either of these components when disconnected from either the bumper assembly 6175 or the elbow assembly 6600. For example, this arrangement allows the bumper assembly 6175 to be disconnected from the frame assembly 6100 (e.g., to change the bumper size) while maintaining the connection between the frame assembly 6100 and the elbow assembly 6600, and also maintains the ability to disconnect the elbow assembly 6600 from the frame assembly 6100.

[0257] In the example shown, the seal-forming structure 6200 of the patient interface 6000 of the present technology can be maintained in a sealed position during use by the headgear 6800. Figure 4 and 5 As shown, the headband 6800 includes a pair of upper side straps 6802 and a pair of lower side straps 6804 connected to a circular top strap that encloses the top of the patient's head. The upper side straps 6802 are connected to the upper headband connector 6130 of the frame assembly 6100 and the lower side straps 6804 are connected to the lower headband connector 6150 of the frame assembly 6100, for example, via headband clips 6160. The side straps 6802, 6804 may include adjustable hook and loop (Velcro) TM ) Connecting mechanism, such as Velcro TM Hook-like tabs are provided to facilitate attachment and / or adjustment.

[0258] Figures 59 to 100 A patient interface 16000 according to another example of the present technology is shown. The patient interface includes a frame assembly 16100, a bumper assembly 16175 (including a seal-forming structure 16200), an air delivery connector (e.g., an elbow assembly 16600), and a positioning and stabilizing structure (e.g., a headgear 16800 including upper side straps 16802, lower side straps 16804, and crown straps 16806). Figures 59 to 61 is an exemplary view of the patient interface 16000 having the arm cover 16750 for the upper arm 16134 of the frame assembly 16100 attached, and Figures 62 to 68 is an exemplary view of the patient interface 16000 with the headband 16800 and the arm covers 16750 removed.

[0259] Similar to the examples described above, the bumper assembly 16175 is connected to the frame assembly 16100 (via a first retaining feature on the frame assembly) independently of the elbow assembly 16600 (see Figure 67 ), and elbow assembly 16600 is connected to frame assembly 16100 (via a second retaining feature on the frame assembly) independently of buffer assembly 16175 (see Figure 68 ). That is, the retaining connections of the bumper assembly 16175 and the elbow assembly 16600 to the frame assembly 16100 are separate and distinct from each other and allow for independent engagement / disengagement.

[0260] In the example of patient interface 16000, a first seal in the air flow path is formed between elbow assembly 16600 and frame assembly 16100, and a separate second seal is formed between frame assembly 16100 and bumper assembly 16175. In this example, frame assembly 16100 is provided in the air flow path. That is, elbow assembly 16600 is configured to form a rigid connection and a dynamic seal with frame assembly 16100, and bumper assembly 16175 is configured to form a separate rigid connection and a static seal with frame assembly 16100.

[0261] Furthermore, in the example of patient interface 16000, frame assembly 16100 includes a lockout feature along opening 16105 that is constructed and arranged to prevent direct connection or insertion of air circuit 4170 (e.g., air delivery tube). This arrangement requires the use of elbow assembly 16600 to interconnect frame assembly 16100 and air delivery tube 4170, thereby ensuring that elbow assembly 16600 (e.g., and its vent and anti-asphyxia valve (AAV)) is present in the system.

[0262] exist Figures 4 to 28 In the examples shown in Figures 59-100, the patient interface is a full facial / oronasal interface type configured to form a seal around the patient's nose and mouth, including a seal-forming structure 6200. However, the methods of the present technology can be adapted for use with other suitable interface types (e.g., nasal interfaces, nasal prongs).

[0263] For example, Figures 29 to 54C A non-invasive patient interface 7000 according to another aspect of the present technology is shown. In this example, the patient interface is a nasal interface type that is constructed to form a seal around the patient's nose, including a seal-forming structure 7200. The patient interface 7000 includes a frame assembly 7100, a bumper assembly 7175 (including the seal-forming structure 7200), an elbow assembly 7600, and a positioning and stabilizing structure (e.g., headband 7800). Similar to the above, the bumper assembly 7175 is connected to the frame assembly 7100 independently of the elbow assembly 7600 (e.g., see FIG. Figure 35), and the elbow assembly 7600 is connected to the frame assembly 7100 independently of the buffer assembly 7175 (see, for example, Figure 36 In this example, a seal for the air flow path is formed between elbow assembly 7600 and buffer assembly 6175 (see, e.g., Figure 37 and 38 ).

[0264] Framework components

[0265] like Figures 18 to 26 , the frame assembly 6100 includes a shield or wall member 6110, an upper headband connector 6130 provided to an upper portion of the shield 6110, and a lower headband connector 6150 provided to a lower portion of the shield 6110. The frame assembly 6100 provides a connection between the bumper assembly 6175 and the elbow assembly 6600, and also provides a connection between the bumper assembly 6175 and the headband 6800, such as in a removable manner or in a more permanent manner to allow sealing forces to be transferred from the headband 6800 to the bumper assembly 6175. In the example shown, the upper headband connector 6130 and the lower headband connector 6150 provide a four-point connection to the headband 6800.

[0266] The shroud 6110 (e.g., constructed of a relatively hard plastic material such as polycarbonate) includes an opening 6105 through which the elbow assembly 6600 sealingly engages the bumper assembly 6175 (e.g., see FIG. Figure 13 and 14 ).

[0267] In the illustrated example, the opening 6105 is defined by an annular flange 6115 that projects forwardly from the front or forward side of the shroud 6110. The flange 6115 includes a rim 6117 along its free end that defines an annular channel 6120 configured to engage the elbow assembly 6600.

[0268] The front or rear side of the shield 6110 includes a plurality of spring arms 6125 (e.g., 3, 4, 5, or more spring arms) spaced about the opening 6105. Each spring arm 6125 includes a hook end configured to provide a mechanical interlock (e.g., a snap-fit ​​connection) with the bumper assembly 6175.

[0269] In an alternative embodiment, if Figures 75 to 100 As best shown in the figures, the frame assembly 16100 includes a shield or wall member 16110, a pair of (i.e., right and left) upper headband connector arms 16134 (each including two flexible portions 16140, 16145) extending from respective sides of the upper portion of the shield 16110, and a pair of (i.e., right and left) lower headband connector arms 16154 extending from respective sides of the lower portion of the shield 16110.

[0270] In the illustrated example, opening 16105 of shroud 16110 (eg, constructed of a relatively hard plastic material such as polycarbonate) is defined by outer annular flange 16115 and inner annular flange 16125 .

[0271] An outer annular flange 16115 projects forwardly from a front or forward side of the shroud 16110. The flange 16115 includes a lip 16117 along a free end thereof that defines an annular channel 16120 configured to engage the elbow assembly 16600.

[0272] An inner annular flange 16125 projects rearwardly from the rear or front side of the shroud 16110. The flange 16125 includes a plurality of tabs or buckles 16127 along its perimeter (e.g., see Figure 70 、 76 , 84, 86, and 88), such as 2, 3, 4, or more tabs configured to provide a mechanical interlock (e.g., a snap-fit ​​connection) with the bumper assembly 16175 to releasably connect the frame assembly 16100 to the bumper assembly 16175. In the example shown, the tabs 16127 are provided on the front and undersides (i.e., the east and south sides) of the flange, however, alternative arrangements are possible, such as tabs provided on the front and rear sides (e.g., the east and west sides) of the flange.

[0273] Additionally, radially inwardly extending ridges 16400 protrude from flange 16125 into opening 16105. As described in more detail below, ridges 16400 act as stops that prevent over-insertion of elbow assembly 16600 into frame assembly 16100. Furthermore, ridges 16400 provide a dynamic face seal with elbow assembly 16600.

[0274] Furthermore, the spine 16400 includes a plurality of protrusions (e.g., 2, 3, 4, or more protrusions) along its perimeter that are configured to provide a lockout feature along the opening 16105 to prevent the air circuit 4170 (e.g., an air delivery tube) from being directly connected or inserted into the frame assembly 16100. This arrangement ensures that the elbow assembly 16600 (and its vent and anti-asphyxia valve (AAV)) is used to interconnect the frame assembly 16100 and the air circuit 4170.

[0275] In the illustrated example, the plurality of protrusions 16405 are constructed and arranged to have minimal or no effect on noise (created by flow through the openings 16105), air delivery impedance (inlet to the patient), and CO2 flushing (vent to the elbow assembly 16100).

[0276] In the case of nasal interfaces, see, for example, Figures 42 to 49, the frame assembly 7100 includes a shield 7110 and a headband connector 7130 provided to the shield 7110 to provide a four-point connection with the headband 7800. The shield 7110 (e.g., constructed of a relatively hard plastic material such as polycarbonate) includes an opening 7105, thereby providing an annular edge configured to engage with the elbow assembly 7600. The front or back side of the shield 7110 includes a plurality of locking tabs or spring arms 7125 (e.g., 2, 3, 4, 5, or more tabs or spring arms) spaced around the opening 7105 and configured to provide a mechanical interlock (e.g., a snap-fit ​​connection) with the bumper assembly 7175.

[0277] Upper headband connector and lower headband connector

[0278] The upper headband connector 6130 includes a shield connection portion 6132 provided to the upper portion of the shield 6110 and a pair (i.e., right and left) of rigid upper headband connector arms 6134 (each including two flexible portions 6140, 6145) extending from respective sides of the shield connection portion 6132 and configured to connect to respective upper headband straps of the headband. The lower headband connector 6150 includes a shield connection portion 6152 provided to the lower portion of the shield 6110 and a pair (i.e., right and left) of lower headband connector arms 6134 extending from respective sides of the shield connection portion 6152 and configured to connect to respective lower headband straps of the headband.

[0279] In the illustrated example, each upper headband connector arm 6134 includes an upper headband connection point in the form of a slot 6135 configured to receive a corresponding upper headband strap 6802 of the headband. In the illustrated example, each lower headband connector arm 6154 includes a magnet 6162 in the form of a magnetic connector 6155 configured to locate and connect to a headband clip 6160 provided to a corresponding lower headband strap 6804 of the headband. However, it should be understood that the upper headband connector arms 6134 and the lower headband connector arms 6154 may be connected to the headband straps of the headband in other suitable manners.

[0280] Each upper headband connector arm 6134 is structurally rigid to resist torque (twist) and each includes a central flexible portion 6140 and a peripheral flexible portion 6145 to accommodate different facial contours. The central flexible portion 6140 of each arm 6134 is positioned adjacent to the shield 6110 and the shield connection portion 6132. The peripheral flexible portion 6145 of each arm 6134 is positioned between the upper headband connection point 6135 and the central flexible portion 6140. The central flexible portion 6140 is separated from the peripheral flexible portion 6145 by a first rigid portion 6134. The peripheral flexible portion 6145 is separated from the upper headband connection point 6135 by a second rigid portion 6134.

[0281] Each upper arm 6134 extends and bends in an upward direction between the eyes and ears to avoid blocking the patient's vision, positions the headgear attachment points (e.g., slots 6135) so that the upper headgear straps extend upward and away from the patient's ears, and provides a force vector extending generally parallel to the Frankfurt horizontal line (e.g., see FIG. Figure 4 and 5 ).

[0282] The upper arms 6134 are also curved (normal to the plane of the face) to accommodate facial contours, for example the arms curve to generally match the curvature of the cheekbones and avoid loading on the temples.

[0283] The rigidity of the upper arm 6134 resists deformation so as to maintain its predetermined shape to ensure that the frame assembly 6100 positions the headband attachment points in the same position and avoids converting headband tension into compressive forces that cause uncomfortable facial contact with the upper arm.

[0284] The rigidity of the upper arms 6134 also resists the tension that may be provided by the headgear straps to prevent these arms from twisting.

[0285] In one example, the rigidity or hardness of the upper arms is such that they maintain a preformed 3D shape (not floppy) that is configured to conform to the contours of the face and to position the headband attachment points in the appropriate locations. Each upper arm maintains its preformed shape in a particular orientation due to its rigidity or hardness. The upper arms are configured to have less resistance (less hardness or rigidity) to bending toward and away from the face to accommodate different facial widths. The rigidity of the upper arms is such that they remain substantially undeformed under the tension applied by the headgear straps, thereby acting as an intermediary between the headgear straps and the buffer assembly to convert the tension from the headgear straps into a compressive force applied to the seal-forming structure to provide a seal and stability on the face. The shape of the upper arms also applies an appropriate force vector to the seal-forming structure via the housing to achieve a stable and comfortable seal. In one example, the seal-forming structure is pulled into the face (i.e., directly back into the face) under an appropriate compressive force that is also consistent with the Frankfurt plane.

[0286] In one example, the rigidity of the upper arm provides torsional rigidity to resist deformation under torsion. The upper arms also resist bending deformation vertically upward and downward along the face (i.e., remain at the correct height above the ears. However, the upper arms are also constructed to provide a predetermined level of deformation to allow flexion (allowing bending toward / away from the face) to adjust for different face widths. In addition, the upper arms are also resilient / elastic in this orientation to allow the upper arms to return to their original position. This feature also prevents discomfort by minimizing the loads / forces applied by the frame assembly when the headgear straps are tightened by absorbing some of these tensions due to their flexibility. In some positions, the upper arms also provide substantial rigidity / stiffness to avoid contact with the face, where the arms can act as supports to resist bending deformation or compression to the face from headgear tension. Conversely, in other positions, the flexibility of the arms can allow the arms to collapse under tension or compression from side loads (such as when a patient is sleeping on their side, thereby applying side loads to the patient interface. The arms absorb the compressive forces applied by the side loads and prevent them from moving the seal-forming structure. This flexibility also allows for a better conform to the face, which increases comfort and also prevents seal instability from side loads.

[0287] The central flexible portion 6140 is configured to allow the respective arms 6134 to flex to accommodate different facial widths (between patients). For example, for a wide face, the central flexible portion 6140 allows the arms 6134 to flex outward away from each other and away from the face, and for a narrow face, the central flexible portion 6140 allows the arms 6134 to flex toward each other and toward the face. In the example shown, the central flexible portion 6140 of each arm includes a single slot 6141 (on the front side) that forms a hinge.

[0288] It should be understood that the slots 6141 can include other suitable arrangements and configurations to change the position and flexibility characteristics of the arm, such as more than one slot, slots on one or both sides (front and / or back) of the arm, spacing between slots, width, depth, orientation or angle of the slots on the arm. In one example, the slots 6141 can be filled with a flexible material. In alternative examples, the hinge can be provided by many different methods, such as, for example, a thinner cross-section or using a flexible material joint.

[0289] The first rigid portion 6143 and the second rigid portion 6147 provide structural rigidity to the arm 6134 to support its predetermined shape.

[0290] The peripheral flexible portion 6145 is configured to allow the corresponding arm 6134 to adapt to different curvatures or contours of the user's face, such as to accommodate variations in cheeks between patients. For example, the peripheral flexible portion 6145 hinges to accommodate the width and contour of the user's cheek above the cheekbone. In the illustrated example, the peripheral flexible portion 6145 of each arm 6134 includes a plurality of slots 6146 (on each side of the nose, i.e., slots on the front and back sides of the nose) that form a plurality of hinges on the cheek area. The hinges allow the arms 6134 to articulate and accommodate slight variations in the cheek area and distribute the load more evenly across the face under headband tension, for example, when compared to a rigid arm without any flexure.

[0291] In the example shown, the slots 6146 are generally parallel to each other, generally evenly spaced from each other, and comprise similar widths and depths into the thickness of the arm. However, it will be appreciated that the slots 6146 may comprise other suitable arrangements and configurations to vary the position and flexibility characteristics of the arm 6134, such as the number of slots, slots on one or both sides (front and / or back) of the arm, the spacing between the slots, the width, depth, orientation, or angle of the slots on the arm (e.g., slots angled relative to each other to provide bending in different orientations). In one example, one or more slots 6146 may be filled with a flexible material. In an alternative example, the hinge may be provided by a plurality of flexible portions (through a material) separated by rigid sections.

[0292] In alternative examples, it will be appreciated that the upper headband connector arm 6134 may include any suitable number of flexible portions along its length to vary its flexibility characteristics, such as one, two, three, or more flexible portions.

[0293] In the example shown, to minimize discomfort, the upper arms 6134 may have a smooth and curved surface profile to distribute the load and allow the arms to roll over the face without concentrating the load or digging into the face. Figure 26 As shown, each upper arm 6134 can include a generally diamond-shaped cross-section, eg, generally flat but slightly domed on either side to increase contact comfort.

[0294] In one example, the lower headband connector arms 6154 are relatively more flexible than the upper headband connector arms 6134, e.g., the lower headband connector arms 6154 have less resistance to torque so that they can twist with the lower headband strap of the headband. This flexibility allows the lower arms 6154 to twist and rotate with the lower headband strap to prevent the retention feature from being forced to disconnect under these forces, i.e., to maintain the connection between the lower arms and the lower headband strap.

[0295] Each lower arm 6154 includes a magnetic connector 6155 (e.g., a shielded magnet) configured to locate and connect to a headband clip 6160 provided to a corresponding lower headband strap of the headband. The magnetic connector 6155 also provides a receptacle 6156 that allows a corresponding protrusion (e.g., provided by a magnet 6162 of the headband clip 6160) to be inserted and retained to resist disconnection from tension of the headband strap. This retention allows the connection to be maintained while allowing the headband clip 6160 to rotate relative to the corresponding lower arm 6154. That is, the protrusion / magnet 6162 of the headband clip 6160 and the receptacle 6156 of the magnetic connector 6155 include corresponding cylindrical shapes to allow relative rotation. These magnets are used to position the headband clip in the correct position to maintain engagement by engaging the protrusion / magnet 6162 member with the receptacle 6156.

[0296] The upper arm 6134 and the lower arm 6154 are connected to the shield 6110 by respective shield connection portions 6132, 6152. In the illustrated example, the upper arm 6134 and the lower arm 6154 are permanently (e.g., co-molded, overmolded) connected to the shield 6110. As shown, each shield connection portion 6134, 6154 includes a plurality of pins 6133, 6153 received in respective openings 6113, 6114 provided to the shield 6110, which form rivets to mechanically secure the upper arm 6134 and the lower arm 6154 to the shield 6110 after the molding process (e.g., see Figure 21 、 24 and 25). In the example shown, the shield 6110 includes an upper slot 6111 and a lower slot 6112 configured to receive the corresponding shield connection portions 6132, 6152 of the upper and lower headband connectors, and openings 6113, 6114 for securing the upper and lower headband connectors are provided in these slots 6111, 6112 (see, for example, Figure 24 and 25 ). However, it should be understood that the upper headband connector arms 6134 and the lower headband connector arms 6154 can be connected to the shield 6110 in other suitable manners, such as a detachable connection.

[0297] In one example, the upper arm 6134 and / or the lower arm 6154 may be covered with fabric, for example, for aesthetic reasons, to increase the softness / comfort feel. Figure 4 and 5 A fabric arm cover or pad 6750 is shown provided to the upper arm 6134, while Figures 6 to 10 For example, the upper arm 6134 is shown with the arm cover 6750 removed.

[0298] The upper and lower arms can provide the target flexibility in alternative ways. For example, the arms can be formed from a single material having different cross-sectional thicknesses for the target flexibility, for example, the flexible region may be thinner to provide a living hinge, while the thicker region will have reduced flexibility. In another example, the arms can be formed from two or more materials, each having different elastic properties / Young's modulus, for example, the rigid portion can be formed from a rigid material such as polycarbonate, while each rigid region can be connected to a medium flexible / soft material such as liquid silicone resin to provide the target flexion. In another example, the arms can be formed from different material layers, for example, the arms can be formed from at least one flexible or flexible first layer. The flexible first layer can provide a base surface for multiple rigid portions, which are spaced apart to form a second rigid layer. The rigid portions can bend relative to each other while being supported by the first layer. In one example, the base layer in this example has the desired tensile properties to provide the desired tension to the patient interface. In the current example, the base layer has minimal to no stretch to prevent the tension from being absorbed by the base layer.

[0299] These arms provide the desired stiffness for maintaining the patient interface in a desired position (e.g., resisting torque forces, maintaining a preformed shape, etc.). However, these arms may, in some cases, provide reduced comfort due to the stiffness and rigidity of the components (i.e., resistance to conforming to the face). This discomfort is due to a combination of tactile sensation and resistance to conforming to changing facial contours, which can place undesirable loads on sensitive parts of the face. To overcome this, the arms can be coated or covered with a softer and, in some cases, less rigid material. Such material can be used to absorb some or all of the compressive forces applied by the arms to the user's face. Additionally, a soft and / or less rigid material can be used to conform to changing facial contours, thereby acting as an adapting layer. Furthermore, the arms can be coated or covered with a tactile layer having the desired tactile sensation of direct contact with the user's face. The tactile layer can include a desired fabric having enhanced tactile sensation and desired predetermined stretch characteristics. The arms can also include a compliant layer comprising a less rigid and / or soft material, such as foam, for absorbing the compressive forces applied by the arms to the user's face and / or conforming to facial changes by conforming to facial contours.

[0300] In one example, the tactile layer and the compliant layer can be constructed to not substantially alter the function of the arms or include materials that do not substantially alter the function of the arms. That is, the layers should not alter the preformed shape of the arms. In addition, the layers should allow the arms to bend / flex in a defined, specific orientation. Therefore, the layers should be constructed to maintain the function of the arms or include materials selected to maintain the function of the arms. In addition, the layers can be permanently or semi-permanently fixed to the arms. Alternatively, the arms can include a removable layer covering the arms. For example, the removable layer can be a fabric cover or padding. The arms can include an upper surface for contacting the user's face. The upper surface can include a foam layer above a rigid material, which is then covered by the tactile layer. The arms can also include a lower surface covered by the tactile layer.

[0301] There are many ways to secure these layers to the arms. In one example, the compliant layer is a foam, such as memory foam, that is glued, laminated, molded, mechanically attached, etc., to the upper surface of the arms. The tactile layer is then attached to the foam compliant layer by laminating, stitching, gluing, etc. the tactile layer to the foam. In one example, in both cases, the attachment method should not change the shape and rigidity of the arms. That is, the attachment method of the layers should not substantially change the bend / flex of the arms, nor change the ability of the arms to maintain their pre-formed shape.

[0302] exist Figures 75 to 100 In the alternative example shown, each upper headband connector arm 16134 includes a shield connection portion 16132 provided to a corresponding upper portion of the shield 16110, and each lower headband connector arm 16154 includes a shield connection portion 16152 provided to a corresponding lower portion of the shield 16110.

[0303] In the example shown, each upper headband connector arm 16134 includes an upper headband connection point in the form of a slot 16135 configured to receive a corresponding upper headband strap 16802 of the headband. Figure 104 As best shown in FIG, the bridge or crossbar 16136 defining the slot 16135 includes a tapered leading edge 16136A (e.g., like a knife-like edge) to facilitate assembly / disassembly of the upper headband strap 16802 of the headband. For example, the tapered leading edge 16136A can easily slide through a Velcro TM The hook piece 16803 and the rest of the upper headband strap 16802 are slid between them to facilitate assembly / disassembly without the need to Velcro TMThe hook tab 16803 is completely released from the remainder of the upper headband strap 16802. In the illustrated example, each lower headband connector arm 16154 includes a magnet in the form of a magnetic connector 16155 and is configured to locate and connect to a headband clip 16160 provided to a corresponding lower headband strap 16804 of the headband. However, it should be understood that the upper headband connector arm 16134 and the lower headband connector arm 16154 can be connected to the headband strap of the headband in other suitable manners.

[0304] Similar to the upper headband connector arms described above, each upper headband connector arm 16134 is structurally rigid to resist torque (twist) and each includes a central flexible portion 16140 and a peripheral flexible portion 16145 to accommodate different facial contours. The central flexible portion 16140 (i.e., the first flexible portion) of each arm 16134 is positioned adjacent to the shield connection portion 16132. The peripheral flexible portion 16145 (i.e., the second flexible portion) of each arm 16134 is positioned between the upper headband connection point 16135 and the central flexible portion 16140.

[0305] In the example shown, the central flexible portion 16140 of each arm 16134 includes a single slot 16141 (on the back side) that forms a hinge. In the example shown, the peripheral flexible portion 16145 of each arm 16134 includes multiple slots 16146 (on each side of the nose, i.e., slots on the front and / or back side of the nose) that form multiple hinges on the cheek area.

[0306] In an example, the peripheral flexible portion 16145 of each arm need not include slots on the front or back sides. Instead or in addition, the flexible portion may include one or more interconnected elastomeric (e.g., silicone) portions that can form a flush or smooth transition between relatively hard plastic portions, but allow bending, flexing, and / or pivoting. These can be performed by insert or overmolding, where the harder plastic portion is placed in a mold and the interconnecting portion is molded over the harder plastic portion.

[0307] Each lower headband connector arm 16154 includes a magnetic connector 16155 (including armor magnet 16155B) configured to locate and connect to a headband clip 16162 (including armor magnet 16162) provided to a corresponding lower headband strap of the headband, see e.g. Figure 103 In the example shown, the end of each lower arm 16154 includes a magnet receiving portion 16155A that receives and aligns the magnet 16155B and a cover 16155C that encloses and retains the magnet 16155B to the magnet receiving portion 16155A. As shown, the magnetic connector 16155 provides a protrusion that allows it to be inserted into and retained in a corresponding receptacle provided by the headband clip 16160, see for example Figure 103The headband clip 16160 includes a buckle or retaining wall 16164 that resists disconnection from tension in the headband strap while allowing the headband clip 16160 to rotate relative to the corresponding lower arm 16154 (e.g., allowing 360° rotation). In the example shown, as Figure 101 、 102 103, a buckle or retaining wall 16164 (e.g., a semicircular cross-section or U-shape) provides a mechanical retaining member to mechanically engage the semicircular perimeter area of ​​the connector 16155. In one example, the magnetic connector 16155 and / or the buckle or retaining wall 16164 can be angled or beveled to provide an undercut that facilitates retaining the headband clip 16160 to the magnetic connector 16155.

[0308] In one example, Figure 96 As shown, each lower headband connector arm 16154 and its magnetic connector 16155 can be manufactured by molding a cover 16155C, assembling a magnet 16155B in the cover 16155C, inserting the assembled cover / magnet into a lower arm molding tool, and then molding the lower arm 16154 to the cover / magnet. In one example, the cover 16155C can include an orientation feature, such as a slot 16159, to facilitate proper orientation and alignment of the cover 16155C relative to the lower arm 16154.

[0309] In an alternative embodiment, if Figure 97 As shown, each lower headband connector arm 16154 and its magnetic connector 16155 can be manufactured by molding the lower arm 16154, assembling the magnet 16155B in the magnet receiving portion 16155A of the lower arm 16154, inserting the assembled lower arm / magnet in a cover molding tool and then overmolding the cover 16155C to the lower arm / magnet.

[0310] In the example shown, each lower headband connector arm 16154 includes a single slot 16156 (on the rear side) forming a hinge portion, see for example Figure 75 and 76 This hinge portion is constructed and arranged to accommodate variations in facial width by allowing the lower arm 16154 to flex away from the patient's face during use, e.g., to allow for simple adjustment during initial assembly of the patient interface and to allow for adaptation to facial geometry without affecting the seal of the patient interface. Furthermore, the hinge portion allows the lower arm 16154 to move or flex with the corresponding headgear clip 16160 during use, e.g., to prevent inadvertent disengagement of the headgear clip 16160 from the corresponding magnetic connector 16155.

[0311] The upper arm 16134 and the lower arm 16154 are connected to the shroud 16110 by respective shroud connecting portions 16132, 16152. In the illustrated example, the upper arm 16134 and the lower arm 16154 are permanently connected (e.g., ultrasonically welded) to the shroud 16110.

[0312] like Figures 83 to 86 As shown, the shield 16110 includes a pair of upper anchors or upper arm connectors 16450 on respective sides (i.e., right and left sides) of an upper portion of the shield 16110 and a pair of lower anchors or lower arm connectors 16460 on respective sides (i.e., right and left sides) of a lower portion of the shield 16110. Each upper anchor 16450 provides an opening 16452 and each lower anchor 16460 provides an opening 16462.

[0313] like Figure 90 and 91 As shown, the shield connection portion 16152 of each lower arm 16154 includes a protrusion 16153 that is received in an opening 16462 of the corresponding lower anchor 16460. The protrusion 16153 includes an opening 16153A that receives a protrusion 16158 provided to the cover 16157, which engages and interlocks the shield connection portion 16152 to the cover 16157. The shield connection portion 16152 and the cover 16157 are ultrasonically welded to secure the shield connection portion 16152 to the cover 16157, thereby securing the lower arm 16154 to the lower anchor 16460.

[0314] In the example shown, the cover 16157 is symmetrical to facilitate manufacturing and assembly. However, it should be understood that the cover used to secure the lower arm can be asymmetrical. For example, Figures 92 to 95 An alternative arrangement is shown in which lower arms 17154 are secured to shroud 17110 via corresponding asymmetric covers 17157 .

[0315] Similarly, if Figure 99 and 100 As shown, the shield connection portion 16132 of each upper arm 16134 includes a protrusion 16133 that is received in an opening 16452 of the corresponding upper anchor 16450. The protrusion 16133 includes an opening 16133A that receives a protrusion 16138 provided to the cover 16137, engaging and interlocking the shield connection portion 16132 to the cover 16137. The shield connection portion 16132 and the cover 16137 are ultrasonically welded to secure the shield connection portion 16132 to the cover 16137, thereby securing the upper arm 16134 to the upper anchor 16450.

[0316] However, it should be understood that the upper headband connector arms 16134 and the lower headband connector arms 16154 can be connected to the shield 16110 in other suitable manners, such as removable connections. Figure 98 Connector arm 17134 is shown connected to anchor 17450 by a slide-in engagement, such as by push-in engagement arrangement including pegs configured to engage within corresponding openings by a slide-in fit.

[0317] In one example, the upper anchor 16450 and / or the lower anchor 16460 of the shield 16110 can be configured to enhance strength. For example, sharp corners along the anchor can be eliminated to reduce stress concentrations, for example, the edges of the openings along the anchors can be rounded (e.g., see Figure 87 ). Furthermore, the bridge member of the anchor may be provided with increased thickness to increase the strength of the part, see Figure 87 In addition, the ridges may provide additional strength to the arms of the anchors, for example, as provided to Figure 87 The rib 16456 of the arm of the upper anchor 16450.

[0318] In one example, the upper arm 16134 and / or the lower arm 16154 may be covered with fabric, for example, for aesthetics, to increase the soft / comfortable feel, to provide comfort on the face, and to minimize markings. Figures 59 to 61 A fabric arm cover or pad 16750 is shown provided to the upper arm 16134, while Figures 62 to 65 For example, the upper arm 16134 is shown with the arm cover 16750 removed. The cover 16750 hides the upper arm 16134, leaving the outer surface smooth to increase comfort on the face, e.g., without markings and easily sliding over the facial surface. The cover 16750 can be optionally removable.

[0319] In one example, at least a portion of the upper arm 16134 and / or the lower arm 16154 includes dimples or a pattern of gold balls, for example, for aesthetic purposes.

[0320] In the case of nasal interfaces, see, for example, Figures 42 to 49 The headband connector 7130 includes a shield connecting portion 7132 connected to the shield 7110, a pair of (i.e., right and left) upper headband connector arms 7134 configured to be connected to corresponding upper headband straps 7802 of the headband 7800, a pair of (i.e., right and left) lower headband connector arms 7154 configured to be connected to corresponding lower headband straps 7804 of the headband 7800, and a middle portion 7133 interconnecting the upper arms 7134 and the lower arms 7154 with the shield connecting portion 7132.

[0321] In the illustrated example, each upper headband connector arm 7134 includes an upper headband connection point in the form of a slot 7135 configured to receive a corresponding upper headband strap 7802 of the headband 7800 (see FIG. Figure 29 In the example shown, each lower headband connector arm 7154 includes a magnet in the form of a magnetic connector 7155 configured to locate and connect to a headband clip 7160 associated with a corresponding lower headband strap 7804 provided to the headband 7800 (see FIG. Figure 29 ). However, it will be appreciated that the upper headband connector arms 7134 and the lower headband connector arms 7154 may be connected to the headband straps of the headband in other suitable manners.

[0322] Similar to the above examples, each intermediate portion 7133 of the headband connector 7130 assembly includes a flexible portion 7140 that adapts to different facial contours, such as varying facial widths. In the illustrated example, the flexible portion 7140 includes a single slot (on the front and / or back side) that forms a hinge portion adjacent to the bumper assembly.

[0323] like Figure 48 and 49 As shown, the headband connector 7130 may include a multi-layer configuration, such as layers of different materials to provide the desired flexibility.

[0324] Buffer components

[0325] In one form of the present technology, a bumper assembly or bumper module 6175 includes a body, chassis or housing 6180 connected to or otherwise provided to a seal forming structure or bumper 6200 (see Figure 15 and 16 The housing 6180 can be permanently (e.g., co-molded, overmolded) or removably (e.g., mechanically interlocked) connected to the bumper 6200. In one example, the bumper 6200 is constructed of a relatively flexible or soft material (e.g., silicone) and the housing 6180 is constructed of a relatively rigid material (e.g., polycarbonate). The housing 6180 and the bumper 6200 cooperate to form the plenum 6500.

[0326] The housing 6180 includes an opening 6305 through which breathable gas is delivered to the plenum 6500. The opening 6305 is defined by an annular flange 6310 adapted to connect to the frame assembly 6100 and adapted to interface (e.g., seal) with an elbow assembly 660 that is connected to the gas delivery tube 4180.

[0327] The housing 6180 has multiple functions. For example, the housing forms a plenum chamber for delivering pressurized gas to the patient's airway entrance. The housing 6180 is a rigid structure that directs force to the seal-forming structure to seal to the patient's face. The force is provided by the tension generated by tightening the headgear straps. These forces are transferred from a pair of upper and lower headgear straps to corresponding upper and lower arms. In one embodiment, the upper and lower arms are provided to a frame assembly, which provides headgear tension to the housing 6180.

[0328] The housing 6180 also provides an outer surface (or front surface) for engaging the inner surface (or rear surface) of the frame assembly's shield to achieve a seal. The housing also includes separate retention features or is otherwise configured to removably engage with the inner surface of the frame assembly. The patient interface is modular, with a single frame assembly size being able to connect to multiple bumper assembly sizes (e.g., small to large). Accordingly, the housing can also be removably engaged to the frame assembly so that the frame assembly is connected to a predetermined configuration corresponding to its respective bumper assembly size. For example, a smaller bumper assembly has an overall reduced height relative to a medium or large bumper assembly. Thus, the frame assembly is connected in a position relative to the bumper assembly to position the upper headband attachment point in its correct position (between the eyes and ears, while providing an attachment point where the upper headband straps avoid the ears). This means that the frame assembly is connected at a higher position on the housing compared to the medium or large bumper assembly sizes. In one embodiment, the medium and / or large sizes may not have this requirement and be connected so that the frame assembly is positioned in substantially the same position.

[0329] exist Figures 75 to 100 In the illustrated alternative embodiment, the bumper assembly 16175 includes a housing 16180 connected to or otherwise provided to a seal-forming structure or bumper 16200 (see FIG. Figure 73 and 74 ). The housing 16180 and the buffer 16200 cooperate to form the plenum 16500 (see, for example, Figure 69 and 71 ). Housing 16180 includes an opening 16305 through which breathable gas is delivered to plenum 16500. Opening 16305 is defined by an annular flange 16310 that is adapted to be connected to frame assembly 16100.

[0330] In the case of nasal interfaces, see, for example, Figures 39 to 41, the buffer assembly 7175 includes a housing 7180 permanently (e.g., co-molded, overmolded) connected to a seal forming structure or buffer 7200. In one example, the buffer 7200 is constructed of a relatively flexible or soft material (e.g., silicone) and the housing 7180 is constructed of a relatively rigid material (e.g., polycarbonate). The housing 7180 and the buffer 7200 cooperate to form the plenum chamber 7500. In the example shown, a flexible flange or lip seal 7250 (i.e., the seal 7250 provides a seal with the elbow assembly 7600) is provided in one piece with the buffer 7200, such as interconnected by the connecting portion 7149. Figure 38 and 39 Seal 7250 and buffer 7200 are shown.

[0331] Connection between the buffer assembly and the frame assembly

[0332] In one form of the present technology, the housing 6180 of the bumper assembly 6175 is repeatably engageable and removably disengageable with the shroud 6110 of the frame assembly 6100 via a mechanical interlock (e.g., a snap-fit ​​connection).

[0333] The bumper assembly 6175 and the frame assembly 6100 include cooperating retaining structures that connect the bumper assembly 6175 to the frame assembly 6100. In one example, the frame assembly 6100 is removably connected to the bumper assembly 6175 to facilitate placement and / or cleaning, and to allow alternative frame assemblies and bumper assemblies to be connected to each other. This arrangement allows multiple seals (e.g., types and sizes) to be used with the patient interface and thereby provide a patient interface suitable for multi-patient multi-use (MPMU) usage situations. In an alternative example, the frame assembly 6100 may be permanently connected to the bumper assembly 6175 or formed integrally as a one-piece, e.g., co-molded.

[0334] In the illustrated example, the housing 6180 includes an opening 6305 defined by an annular flange 6310 that projects forwardly from the housing 6180. The flange 6310 includes a plurality of tabs or buckles 6315 along its perimeter (e.g., see Figure 15 and 17 ), such as 3, 4, 5 or more pieces, which are constructed to engage or interlock (e.g., slide-fit connection) with corresponding spring arms 6125 on the rear side of the shield 6110 to releasably connect the buffer assembly 6175 to the frame assembly 6100.

[0335] The bumper assembly 6175 also includes one or more recesses 6320 along the perimeter of the flange 6310 (see, for example, Figure 15 and 17) (e.g., upper and lower recesses) that are constructed to engage or interlock with corresponding protrusions 6127 on the rear side of the shield 6110, for example to facilitate alignment and prevent relative rotation.

[0336] In the illustrated example, the housing 6180 of the bumper assembly 6175 and the shroud 6110 of the frame assembly 6100 are relatively rigid (e.g., formed from a relatively hard material such as polycarbonate) so that the engagement between the housing 6180 and the shroud 6110 provides a rigid connection. Furthermore, the perimeter, shape, and geometry of the mating surfaces provided by the housing 6180 and the shroud 6110 are predetermined to facilitate alignment and mechanical / structural engagement, such as clean, smooth, curved mating surfaces. That is, the relative rigidity or rigidity of the shroud and housing maintains the pre-formed structure of the components. The rigidity allows the components to maintain their shape, allowing for easy alignment for connection.

[0337] It will be appreciated that the bumper assembly may be connected or interlocked with the frame assembly in other suitable ways. For example, the components may be connected by clips.

[0338] In an alternative embodiment, such as Figure 70 and 72 As best shown in FIG, inner annular flange 16125 of shroud 16110 extends through opening 16305 of housing 16180, and tabs or snaps 16127 of flange 16125 engage or interlock on the rear side of annular flange 16310 of housing 16180 to removably connect frame assembly 16100 to bumper assembly 16175. This connection maintains ease of use, provides a sealed, rigid connection, eliminates vibration and wiggle movement between components, and reduces the impact on stability. Furthermore, this connection stability holds bumper assembly 16175 in place while allowing the proper force vector to be applied to bumper assembly 16175 to seal.

[0339] Furthermore, the frame assembly 16100 is configured to form a static diameter seal and a static face seal with the bumper assembly 16175 to minimize and control leakage. Figure 70 and 72 As shown, shroud 16110 of frame assembly 16100 includes a channel adapted to receive flange 16310 of bumper assembly 16175. Leading edge 16310A of flange 16310 and end wall 16112A of the channel are configured and arranged to provide a static facial seal, and outer side 16310B of flange 16310 and side wall 16112B of the channel are configured and arranged to provide a static diametrical seal.

[0340] In the case of nasal interfaces, see, for example, Figures 30 to 49, the housing 7180 includes a plurality of tabs or latches 7315 along the perimeter of the flange 7310 that are configured to engage or interlock (e.g., by a slide-fit) with corresponding tabs or arms 7125 on the rear side of the shield 7110 to removably connect the buffer assembly 7175 to the frame assembly 7100.

[0341] The bumper assembly 7175 also includes one or more recesses 7320 along the perimeter of the flange 7310 (see, for example, Figure 41 ) (e.g., a lower recess) that is configured to engage or interlock with a corresponding protrusion 7127 on the rear side of the shield 7110 (e.g., see Figure 43 ), for example to facilitate alignment and prevent relative rotation.

[0342] In another example, Figures 55 to 58 As shown, the housing of the buffer assembly 8175 may include a central bore having an interior surface configured to receive the annular central flange of the frame assembly 8100. The housing includes a retaining feature that interlocks or connects to the retaining feature on the frame assembly. Additionally, a gap is maintained within the housing bore to allow the bellows structure 8250 ( Figure 55 and 56 ) or elbow assembly 8600 ( Figure 57 and 58 ) engages with the shell surface 8275 to achieve a facial seal.

[0343] The bumper assembly 6175 and frame assembly 6100 are constructed to maintain engagement during use and to prevent any unintentional or partial disassembly during use.

[0344] In one form of the present technology, the frame assembly 6100 engages with the buffer assembly 6175 by moving the frame assembly 6100 rearward toward the buffer assembly 6175 in a direction substantially parallel to the Frankfurt plane, and the frame assembly 6100 disengages from the buffer assembly 6175 by moving the frame assembly 6100 forward away from the buffer assembly 6175 in a direction substantially parallel to the Frankfurt plane.

[0345] elbow components

[0346] like Figure 27 and 28 As shown, the elbow assembly 6600 includes a first end portion 6610 that is repeatedly engageable with and removably detachable from the shroud 6110 of the frame assembly 6100 and a second end portion 6620 suitable for connection to the air circuit 4170, such as via a swivel connector 6625.

[0347] The first end portion 6610 includes a pair of resilient, quick-release squeeze arms 6650, i.e., cantilevered spring arms. Each spring arm or squeeze arm 6650 includes a hook end or tab 6652 configured to provide a mechanical interlock (e.g., a slip-fit ​​connection) with the flange 6115 of the shroud 6110.

[0348] The first end portion 6610 includes an annular sidewall 6630 configured to extend through the frame assembly 6100 and form a seal with the bumper assembly 6175 .

[0349] In the illustrated example, a vent 6700 is integrated into the first end portion 6610 to allow for flushing of exhaled air, eg, a vent outlet of the vent is provided along the perimeter of the first end portion 6610 .

[0350] In an alternative embodiment, such as Figure 59 、 65 , 70 and 72 , the elbow assembly 16600 includes a first end portion 16610 having a squeeze arm 16650 that is releasably engaged with the frame assembly 16100 and a second end portion 16620 that is adapted to be connected to the air circuit 4170 , for example, via a swivel connector 16625 .

[0351] In this example, the first end portion 16610 includes an inner radial wall 16630 and an outer radial wall 16640 that define a radial channel 16645 that forms a plurality of vent apertures 16700 to allow exhaust gases to escape from the patient interface.

[0352] Additionally, elbow assembly 16600 is configured to accommodate an AAV assembly, including configurations to allow the patient to breathe through the port if pressurized gas is not available in sufficient quantity or is not being delivered.

[0353] Figure 50 and 51 An elbow assembly 7600 configured to connect to a nasal patient interface 7000 is shown. Figure 52 and 53 An alternative elbow assembly 9600 configured to connect to a nasal patient interface 7000 is shown.

[0354] In the illustrated example, each side of the elbow assembly 7600, 9600 includes a cantilevered button and slots along the sides of the button that allow the button to flex. Each button includes a tab or buckle adapted to engage an edge of the opening 7105 of the frame assembly 7100 by a snap fit to releasably secure the elbow assembly 7600, 9600 to the frame assembly 7100.

[0355] like Figure 51 and 53As best shown in the figure, the raised portion of the button and the webbing within the groove along each side of the button are constructed of a soft-touch material (e.g., TPE). The raised portion provides a soft touch for ease of use and grip, and the webbing provides a seal, a soft touch, and a spring force (clip return force). In one example, the raised portion and webbing are overmolded to the elbow body (including the button).

[0356] like Figure 50 and 51 As shown, elbow assembly 7600 includes a vent assembly 7700 that allows for flushing of exhaled air.

[0357] Connection between elbow assembly and frame assembly

[0358] The elbow assembly 6600 is releasably connected and retained to the frame assembly 6100 via the squeeze arms 6650, such as a quick release slip-on fit. The flange 6115 of the shroud 6110 defines a circular channel 6120 that is configured to receive the hook end 6652 of the squeeze arms 6650 to releasably retain the elbow assembly 6600 to the frame assembly 6100 and form a swivel connection (see, for example, FIG. Figure 6 ), for example, allowing the elbow assembly 6600 to rotate freely 360° relative to the frame assembly 6100.

[0359] Because the elbow assembly 6600 is connected to the frame assembly 6100 independently of the bumper assembly 6175, the patient is able to remove and exchange bumper assemblies of different sizes without disconnecting the elbow assembly 6600, the frame assembly 6100, and the headgear.

[0360] Similarly, in an alternative embodiment, such as Figure 72 As best shown in FIG, circular channel 16120 of frame assembly 16100 is configured to receive hook end 16652 of squeeze arm 16650 to releasably retain elbow assembly 16600 to frame assembly 16100.

[0361] Sealing between elbow assembly and buffer assembly

[0362] In one example, the bumper assembly 6175 includes a flexible flange or lip seal 6250 to provide a seal with the elbow assembly 6600. The lip seal 6250 is provided to the flange 6310 of the housing 6180 and includes a free end that extends radially inwardly into the opening 6305. Figure 13 and 14 As shown in , the elbow assembly 6600 is constructed to mechanically interlock with the frame assembly 6100, but is constructed and arranged to sealingly engage with the sealing membrane 6250 of the buffer assembly 6175 to form a seal in the air flow path, i.e., the sealing mechanism is separate from the retention feature.

[0363] As shown, the leading edge of the sidewall 6630 of the elbow assembly 6600 forms a face seal with the lip seal 6250. This type of engagement minimizes the contact surface area to reduce friction, thereby allowing a seal to form between the components while allowing the elbow assembly 6600 to rotate freely relative to the frame assembly 6100 and the bumper assembly 6175.

[0364] In the case of nasal interfaces, see, for example, Figure 37 and 38 , the elbow assembly 7600 is constructed to mechanically interlock with the frame assembly 7100, and the leading edge of the side wall 7630 of the elbow assembly 7600 is constructed and arranged to sealingly engage with the lip seal 7250 of the buffer assembly 7175 to form a seal in the air flow path.

[0365] Sealing between elbow assembly and frame assembly

[0366] In an alternative embodiment, elbow assembly 16600 is configured to establish a rigid connection and seal with frame assembly 16100. Figure 72 As best shown in FIG, a dynamic diameter seal is formed between the cylindrical outer surface of outer wall 16640 of elbow assembly 16600 and the inner surface provided by annular flanges 16115, 16125 of frame assembly 16100. Furthermore, annular flange 16125 of frame assembly 16100 includes radially inwardly extending ridges 16400, which act as a stop to prevent over-insertion of elbow assembly 16600 into frame assembly 16100. The surface of ridge 16400 also provides a dynamic face seal with the leading edge or surface of outer wall 16640 of elbow assembly 16600. The diameter seal and face seal provided between the surface of outer wall 16640 and the surfaces of annular flanges 16115, 16125 / ridge 16400 provide two mating contact surfaces between elbow assembly 16600 and frame assembly 16100, which increases the contact surface area between elbow assembly 16600 and frame assembly 16100. The two mating surfaces are configured and arranged to minimize and control leakage by providing a tortuous leak path, ie, a leak path between the two mating surfaces extending radially to axially from the interior of the patient interface to the atmosphere.

[0367] Lockout feature

[0368] As described above, the spine 16400 of the frame assembly 16100 includes a plurality of protrusions 16405 configured to provide a lockout feature to prevent the air circuit 4170 from being directly connected or inserted into the frame assembly 16100 .

[0369] like Figure 72As best shown in FIG, each protrusion 16405 extends to the inner wall 16630 of the elbow assembly such that the protrusion 16405 does not extend significantly into the patient's inlet flow path. Additionally, each protrusion 16405 includes an opening 16407 (e.g., see FIG. Figure 72 、 83 and 88) such that the protrusions 16405 do not significantly block the outlet flow to the passage 16645 leading to the vent aperture 16700 of the elbow assembly 16100. Thus, the plurality of protrusions 16405 are constructed and arranged to have minimal or no effect on noise (generated by flow through the openings 16105), air delivery impedance (inlet to the patient), and CO2 flush (into the vent of the elbow assembly 16100).

[0370] In an alternative embodiment, if Figure 89A As shown, each protrusion 16405 can be provided without an opening.

[0371] In another alternative, such as Figure 89B As shown, the blocking feature may be provided by a single annular protrusion 16405 extending along the entire circumference of the ridge 16400. As shown, an opening 16407 is provided along the protrusion 16405, for example so that the protrusion 16405 does not significantly block outlet flow to the channel 16645 forming the vent aperture 16700.

[0372] Vent adapter connector

[0373] In an alternative example, a vent adapter connector can be provided to the patient interface, for example as an alternative to the elbow assembly 6600. Similar to the arrangement described above, the vent adapter connector can be releasably connected to the frame assembly 6100 independently of the bumper assembly 6175 and can sealingly engage the sealing membrane 6250 of the bumper assembly 6175 to form a seal with the air flow path.

[0374] Alternative connection / seal for elbow assembly / vent adapter connector

[0375] As described above, the patient interface may be connected to the elbow assembly and the vent adapter connector, eg, the elbow assembly / vent adapter connector may be releasably connected to the frame assembly and sealingly engaged with the bumper assembly.

[0376] In an alternative embodiment, if Figures 55 to 58As shown, elbow assembly 8600 / vent adapter connector 8900 includes a seal or bellows structure 8250 (e.g., formed of silicone) that is configured to engage an inner surface 8275 of a housing provided to a bumper assembly 8175. The bellows structure is configured to move toward the inner surface of the housing when pressure within the component increases, i.e., a pressure-supported seal. The bellows structure engages the inner surface of the housing along the inlet opening to provide a bellows face seal.

[0377] The seal forming structure of the vent adapter connector / elbow assembly and the housing is separate from the retaining forming feature. In one example, the frame includes a retaining feature that includes a pair of resilient arms adapted to be inserted into corresponding slots in the vent adapter connector / elbow assembly. The connection is also a swivel connection that allows the vent adapter connector / elbow assembly to rotate relative to the buffer assembly and the frame assembly. Therefore, another advantage of the bellows face seal is that it achieves a seal between the components with minimal friction to allow a large amount of relative movement without damaging the seal. In one example, the frame assembly is constructed so that it cannot form part of the patient air delivery path, but is constructed to hold the buffer assembly and the vent adapter connector / elbow assembly in place. The vent adapter connector / elbow assembly forms a seal directly with the housing of the buffer assembly through an aperture provided in the frame assembly.

[0378] This configuration allows the user to remove the vent adapter connector / elbow assembly from the patient interface without disconnecting the frame assembly from the bumper assembly, i.e., the patient can discontinue treatment while the patient interface remains on their face. This configuration also allows the user to remove the bumper assembly from the frame assembly and vent adapter connector / elbow assembly without disconnecting the frame assembly from the vent adapter connector / elbow assembly. In one example, the frame assembly is connected to the headband, so the headband can remain connected to the frame assembly and the vent adapter connector / elbow assembly while the user tries out different bumper assembly sizes (e.g., small, medium, large) without having to reassemble multiple parts.

[0379] Modularity

[0380] In the illustrated example, the frame assembly 6100 can be provided in one size (i.e., a common frame assembly) that can be selectively engaged with different sized bumper assemblies 6175, such as small, medium, and large bumper assemblies differentiated by the volume / footprint of the patient's face. Thus, the patient has the freedom to change the bumper size without having to replace the frame assembly 6100. In one example, regardless of size, the patient interface provides a similar location for the headgear connector (e.g., based on headgear vectoring and clearance of the patient's eyes) and a connection for the elbow assembly (e.g., to optimize gas flushing).

[0381] In this example, the housing of each different sized buffer assembly includes a connector (annular flange type connector) that is common or similar (e.g., common retaining features) for all sizes, which allows one size or common frame assembly to be connected to each different sized buffer assembly, i.e., each buffer assembly includes common frame retaining features on the housing for all buffer sizes.

[0382] Similar to the above, a nasal interface type frame assembly 7100 can be provided in one size (i.e., a common frame assembly) that can be selectively engaged with bumper assemblies 7175 of different sizes (e.g., small bumper, medium bumper, and large bumper). For example, Figure 54A 、 54B 54C are rear views of a small bumper, a medium bumper, and a large bumper assembly 7175 according to an example of the present technology. As shown, each size provides a different volume or footprint on the patient's face.

[0383] 5.3.1 Sealing structure

[0384] In one form of the present technology, the seal-forming structure provides a seal-forming surface and may additionally provide a cushioning function.

[0385] The seal-forming structure according to the present technology can be constructed of a soft, flexible and resilient material such as silicone. In an alternative embodiment, the seal-forming structure can include a foam pad, including a foam seal-forming portion. In this embodiment, this foam pad can be provided to the housing to allow connection to the frame assembly 6100.

[0386] In one form, the seal forming structure includes a sealing flange and a support flange. The sealing flange includes a relatively thin component having a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum. The support flange can be relatively thicker than the sealing flange. The support flange is arranged between the sealing flange and the edge of the plenum and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange in use to prevent it from bending. In use, the sealing flange can easily respond to the system pressure in the plenum that acts on its bottom surface, thereby forming a tight sealing engagement with the face.

[0387] In one form, the seal-forming portion of the non-invasive patient interface includes a pair of nasal puffs or pillows, each constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0388] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal against the bottom surface of a patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. Furthermore, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can act together to facilitate forming a universal connection structure that is adjustable with respect to relative movement, both displacement and angular, between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0389] In one form, the non-invasive patient interface includes a seal-forming portion that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0390] In one form, the non-invasive patient interface comprises a seal-forming portion which, in use, forms a seal on the chin region of the patient's face.

[0391] In some forms of the present technology, a seal-forming structure is configured to correspond to a specific head size and / or facial shape. For example, one form of seal-forming structure may be suitable for a large head but not for a small head. In another example, one form of seal-forming structure may be suitable for a small head but not for a large head.

[0392] 5.3.2 Inflatable chamber

[0393] In the area where the seal is formed during use, the plenum has a perimeter that is shaped to complement the surface contours of an average human face. During use, the boundary edge of the plenum is in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend along the entire perimeter of the plenum during use.

[0394] 5.3.3 Positioning and stabilizing the structure

[0395] The seal-forming structure of the patient interface of the present technology may be maintained in a sealed position during use by a positioning and stabilizing structure.

[0396] In one form of the present technology, a positioning and stabilizing structure is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small lateral or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0397] In one form of the present technology, a positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0398] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the bumper against a portion of the patient's face. In one example, the strap can be configured as a lace.

[0399] In some forms of the present technology, the positioning and stabilizing structure comprises a strap that is flexible, i.e., non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0400] In certain forms of the present technology, a positioning and stabilizing structure provides a retention force that is configured to correspond to a specific head size and / or facial shape. For example, one form of the positioning and stabilizing structure provides a retention force that is suitable for a large head size, but not for a small head size. In one example, one form of the positioning and stabilizing structure provides a retention force that is suitable for a small head size, but not for a large head size.

[0401] 5.3.4 Ventilation

[0402] In one form, the patient interface includes a vent constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0403] One form of a vent according to the present technology comprises a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0404] The vent may be located in the plenum. Alternatively, the vent is located in a decoupling structure such as a swivel.

[0405] 5.3.5 Decoupling Structure

[0406] In one form, the patient interface includes at least one decoupling structure, such as a swivel or a ball and socket.

[0407] 5.3.6 Connection Port

[0408] The connection port allows connection to the air circuit.

[0409] 5.3.7 Forehead support

[0410] In the illustrated example, the frame assembly 6100 is provided without a forehead support.

[0411] In another form, the patient interface may include a forehead support, for example the frame assembly may include the forehead support.

[0412] 5.3.8 Anti-asphyxia valve

[0413] In one form, the patient interface includes an anti-asphyxia valve.

[0414] 5.3.9 Port

[0415] In one form of the present technology, the patient interface includes one or more ports that allow access to the volume within the plenum. In one form, this allows the clinician to provide supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum, such as pressure.

[0416] 5.4 Glossary

[0417] For purposes of this disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0418] 5.4.1 General

[0419] Air: in some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0420] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0421] For example, relative to the environment of the humidifier humidity This may be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0422] In another example, the environment pressure This can be pressure directly around the body or external to the body.

[0423] In some forms, the environment (e.g., acoustics) noise It can be thought of as the background noise level in the room the patient is in addition to the noise generated, for example, by the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0424] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, eg, varying with each breath, depending on whether there is an indication of an SBD event.

[0425] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0426] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated to 'flow'.

[0427] In the example of a patient breathing, the flow rate can 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 (Qt) is the flow of air leaving the RPT device. Ventilation flow (Qv) is the flow of air leaving the vent to allow for flushing by exhaled gases. Leakage flow (Ql) is the flow leaking from the patient interface system. Respiratory flow (Qr) is the flow of air received into the patient's respiratory system.

[0428] Leakage: The word leakage is to be considered as undesirable air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return elbow to the ambient environment.

[0429] Noise, Conducted (Acoustic): Conducted noise in this context refers to the noise brought to the patient through the pneumatic path (such as 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.

[0430] Noise, radiated (acoustic): Radiated noise in this context refers to the noise that is carried to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0431] Noise, ventilation (acoustic): Ventilation noise in this context refers to the noise generated by the flow of air through any vent, such as the vent in a patient interface.

[0432] Patient: A person, whether or not they have a respiratory illness.

[0433] Pressure: Force per unit area. Pressure can be expressed in units including cm H2O, gf / cm 2 1 cm H2O is equal to 1 g-f / cm 2 and is about 0.98 hectopascals. In this specification, pressures are given in cm H2O unless otherwise stated.

[0434] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0435] Respiratory Pressure Therapy (RPT): The application of an air supply to the entrance of the airway at a therapeutic pressure, which is usually positive relative to atmospheric pressure.

[0436] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0437] 5.4.1.1 Materials

[0438] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0439] Polycarbonate: A transparent thermoplastic polymer typically of bisphenol A carbonate.

[0440] 5.4.1.2 Mechanical properties

[0441] Resilience: The ability of a material to absorb energy during elastic deformation and release that energy during decompression.

[0442] 'Resilient': Releases substantially all of its energy when deflated. Includes certain silicones and thermoplastic elastomers.

[0443] Hardness: A material's ability to resist deformation (e.g., as described by Young's modulus, or the indentation hardness scale measured on a standard sample size).

[0444] • 'Soft' materials may include silicone or thermoplastic elastomer (TPE) and may deform easily, for example under finger pressure.

[0445] • 'Hard' materials may include polycarbonate, polypropylene, steel or aluminium and may not deform easily, for example under finger pressure.

[0446] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions.

[0447] • 'Floppy' structure or component: A structure or component that will change shape, eg bend, when made to support its own weight for a relatively short period of time, such as 1 second.

[0448] 'Rigid' structure or component: A structure or component that will not substantially change shape when subjected to loads typically encountered in use. One example of this use may be placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway, for example under a load of approximately 20 to 30 cm H2O pressure.

[0449] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction compared to a second, orthogonal direction. In another example, a structure or component is soft in a first direction and rigid in a second direction.

[0450] 5.4.2 Respiratory cycle

[0451] Apnea: According to some definitions, apnea is considered to occur when flow falls below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is said to have occurred when apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0452] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0453] Duty cycle: The ratio of inspiratory time (Ti) to total respiratory time (Ttot).

[0454] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0455] Expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0456] Flow Limitation: Flow limitation is considered a state of affairs in a patient's breathing where an increase in the patient's effort does not produce a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the respiratory cycle, it may be described as expiratory flow limitation.

[0457] Type of flow rate limiting inspiratory waveform:

[0458] (i) Flat: having an ascending portion followed by a relatively flat portion and then a descending portion.

[0459] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0460] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat portion.

[0461] (iv) Inverse chair shape: has a relatively flat portion followed by a single local peak at the trailing edge.

[0462] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow, but not a cessation of flow. In one form, hypopnea is said to have occurred when flow drops below a threshold for a sustained period of time. Central hypopnea is said to have occurred when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0463] (i) A 30% decrease in the patient's breathing lasting at least 10 seconds with an associated 4% desaturation; or

[0464] (ii) A decrease (but at least 50%) in the patient's breathing lasting at least 10 seconds, with an associated desaturation or arousal of at least 3%.

[0465] Hyperpnea: Increased flow to a level above normal flow.

[0466] Inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow will be considered the inspiratory portion of the respiratory cycle.

[0467]

[00145] Patency (airway): The degree to which an airway is open, or the degree to which an airway is patent. An open airway is patent. Airway patency can be quantified, for example, with a value of one (1) for open and a value of zero (0) for closed (obstructed).

[0468] Positive End-Expiratory Pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of exhalation.

[0469] Leak flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0470] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory air flow, as opposed to "true respiratory flow" or "true respiratory air flow", which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0471] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra effort is exerted.

[0472] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0473] (Expiratory) Time (Ti): Duration of the expiratory portion of the respiratory flow waveform.

[0474] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0475] Typical recent ventilation: The ventilation value around which recent values ​​on some predetermined time scale tend to cluster, that is, a measure of the central tendency of recent values ​​of ventilation.

[0476] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This can be associated with a state of flow limitation, where flow increases only slightly or can even decrease as the pressure difference across the upper airway increases (Starling impedance behavior).

[0477] Ventilation (Vent): A measurement of the flow of gases exchanged by a patient's respiratory system. Ventilation measurements can include either or both the inspiratory and expiratory flow rates per unit time. When expressed in volumes per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume, understood as volume per minute.

[0478] 5.4.3 Ventilation volume

[0479] Adaptive servo ventilator (ASV): A servo ventilator with a variable target ventilation volume rather than a fixed target ventilation volume. The variable target ventilation volume can be derived from some characteristics of the patient (e.g., the patient's breathing characteristics).

[0480] Backup Rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically in breaths per minute) that the ventilator will deliver to the patient if not elicited by spontaneous respiratory effort.

[0481] Cycling: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, the ventilator is considered to have cycled to stop delivering a breath at the end of the inspiratory portion of the respiratory cycle.

[0482] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the varying pressures during a breath are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0483] End-Expiratory Pressure (EEP): The desired mask pressure that the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) is zero-valued at end-expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP is equal to EPAP.

[0484] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure the ventilator will attempt to achieve during the inspiratory portion of a breath.

[0485] Pressure Support: A number that indicates the increase in pressure during inspiration over the pressure during expiration, and usually refers to the difference between the maximum and base pressures during inspiration (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0486] Servo ventilator: A ventilator that measures patient ventilation, has a target ventilation volume, and adjusts the pressure support level to bring the patient ventilation toward the target ventilation volume.

[0487] Spontaneous / Timed (S / T): A mode in which a ventilator or other device attempts to detect breath activation in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined time period, the device will automatically initiate the delivery of a breath.

[0488] Swing: An equivalent term for pressure support.

[0489] Initiated: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be initiated to do so at the beginning of the respiratory portion of the breathing cycle by the patient's effort.

[0490] Typical recent ventilation: Typical recent ventilation, Vtyp, is the value around which recent measurements of ventilation on some predetermined time scale tend to cluster. For example, a measure of the central tendency of ventilation measurements in recent history may be a suitable value for typical recent ventilation.

[0491] 5.4.4 Anatomy

[0492] 5.4.4.1 Facial anatomy

[0493] Alae: The outer wall or "wing" of each nostril (plural: alars)

[0494] Alar tip: The outermost point on the wing of the nose.

[0495] Alar bend (or alar apex) point: The most posterior point in the base of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0496] Pinna: The entire external, visible part of the ear.

[0497] (Nose) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0498] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0499] Columella: The strip of skin that separates the nostrils and extends from the protruding point of the nose to the upper lip.

[0500] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where both lines intersect at the lower point of the nasal septum).

[0501] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left cochlea, which is the deepest point in the notch above the tragus of the auricle.

[0502] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0503] External nasal cartilage: A generally triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla, and its lower edge connected to the greater alar cartilage.

[0504] Lower lip (midpoint of lower lip):

[0505] Upper lip (midpoint of upper lip):

[0506] The greater alar cartilage is a cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four smaller cartilages of the alar.

[0507] Nostril: The approximately oval-shaped opening that forms the entrance to the nasal cavity. The singular nostril is "nostril." The nostrils are separated by the nasal septum.

[0508] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0509] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0510] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0511] Auricular base: The highest point where the auricle attaches to the facial skin.

[0512] Nasal protuberance: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0513] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0514] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0515] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0516] Sagittal plane: A vertical plane that passes from anterior (front) to posterior (back) and divides the body into right and left halves.

[0517] Nasal bridge point: The most concave point on the soft tissue covering the forehead and nasal suture area.

[0518] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0519] Posterior superior lateral: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (upper) lip.

[0520] The subnasal point is located on the soft tissue at the point where the columella and upper lip meet in the midsagittal plane.

[0521] Mandibular alveolar seat: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue.

[0522] 5.4.4.2 Anatomy of the skull

[0523] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to the area called the forehead.

[0524] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0525] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0526] Nasal bones: The nasal bones are two oval bones that vary in size and form among different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0527] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0528] Occipital bone: The occipital bone is located at the back and bottom of the skull. It contains an oval hole (the foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0529] Orbit: The bony cavity in the skull that houses the eyeball.

[0530] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0531] Temporal bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0532] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0533] 5.4.4.3 Anatomy of the respiratory system

[0534] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity (which contains the heart, lungs, and ribs) from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0535] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0536] Lung: The respiratory organ of humans. The conducting zone of the lungs consists of the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone consists of the respiratory bronchioles, alveolar ducts, and alveoli.

[0537] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the middle of the face, above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the turbinates (singular "nasal conchae") or nasal conchae. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0538] Pharynx: The part of the throat located just below (underneath) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (epipharynx) (the nasal portion of the pharynx), the oropharynx (mesopharynx) (the oral portion of the larynx), and the hypopharynx (hypopharynx).

[0539] 5.4.5 Patient interface

[0540] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0541] Elbow: An elbow is an example of a structure that directs the axis of air flow to change direction through a certain angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a cross-section that is approximately circular. In another form, the elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can be rotated, for example, through approximately 360 degrees relative to the mating component. In some forms, the elbow can be removable from the mating component, for example, by a snap connection. In some forms, the elbow can be assembled to the mating component during the manufacturing process with a disposable snap, but cannot be removed by the patient.

[0542] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points with the headgear. A mask frame can be a non-airtight, load-bearing structure in a mask. However, some forms of mask frames can also be airtight.

[0543] Functional dead space:

[0544] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed to be placed on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcement bars configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0545] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0546] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the walls of the mask plenum.

[0547] Seal: can be a noun indicating structure ("seal") or a verb indicating action ("to seal"). Two elements can be constructed and / or arranged to seal between them or achieve a "seal" between them without the need for a separate "sealing" element itself.

[0548] Shell: Shell will be understood to mean a curved, relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a mask can be the shell. In some forms, the shell can be multi-faceted. In some forms, the shell can be multi-faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0549] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0550] Bracing: Bracing will be taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0551] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel can be configured to rotate through an angle of less than 360 degrees. When used in the context of air delivery conduits, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There can be little or no air flow leakage from the swivel during use.

[0552] Lace (noun): A structure designed to resist tension.

[0553] Vent: (noun): A structure that allows air to flow from the interior of a mask or conduit to the ambient air to allow clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0554] 5.4.6 Shape of the structure

[0555] Products according to the present technology may include one or more three-dimensional mechanical structures, such as mask buffers or thrusters. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other characteristics. For example, a structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the buffer structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, the structure may include a first surface and a second surface.

[0556] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure. Figures 3B to 3F , which show examples of a cross section at a point p on the surface and the resulting plane profile. Figures 3B to 3FThe outward normal vector at point p is also shown. The outward normal vector at point p points away from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0557] 5.4.6.1 Curvature in One Dimension

[0558] The curvature of a planar curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0559] Positive curvature: If the curve at point p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person leaves that point p, they must be walking uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0560] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally, without going up or down). Figure 3D .

[0561] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person leaves that point p, they must be walking downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0562] 5.4.6.2 Curvature of Two-Dimensional Surfaces

[0563] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. The multiple cross sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve having a corresponding curvature. The different curvatures at the points may have the same sign or different signs. Each curvature at the point has a magnitude, e.g., a relatively small magnitude. Figures 3B to 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0564] Principal curvatures and principal directions: The directions of the normal planes where the curvature of a curve takes its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example of Figure 3Band the minimum value appears at Figure 3F ,therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0565] Region of a surface: A connected set of points on a surface. Points in a region may have similar characteristics, such as curvature or sign.

[0566] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other negative (depending on the direction in which the imagined individual is turning, they can be walking up or down).

[0567] Dome region: A region where the principal curvatures at every point have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0568] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0569] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0570] Edge of a surface: The boundary or limit of a surface or area.

[0571] Path: In some forms of this technology, 'path' will mean a path in the mathematical-topological sense, e.g., a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technology, a 'path' can be described as a route or course, comprising, for example, a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0572] Path Length: In some forms of this technology, the 'path length' will be the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imaginary individual will be the distance they walk along the path on the surface).

[0573] Straight-line distance: Straight-line distance is the distance between two points on a surface, regardless of the surface. In a planar area, a path on the surface can have the same path length as the straight-line distance between two points on the surface. On a non-planar surface, a path with the same path length as the straight-line distance between two points can not exist. (For an imaginary person, straight-line distance would correspond to a distance as a 'straight line'.)

[0574] 5.4.6.3 Space curve

[0575] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be thought of as one-dimensional slices of three-dimensional space. An imaginary person walking on a DNA helix would walk along a space curve. A typical human left ear consists of a left-handed helix, see Figure 3P The typical human right ear includes a right-handed helix, see Figure 3Q . Figure 3R A right-handed spiral is shown. The edges of structures, such as membranes or propellers, can follow space curves. In general, a space curve can be described by the curvature and torque at each point on the space curve. Torque is a measure of how the curve deviates from the surface. Torque has a sign and a magnitude. The torque at a point on a space curve can be characterized with reference to the tangent plane, the normal, and the binormal vector at that point.

[0576] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point indicates the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person were to fly along the curve and stop at a specific point, the direction of the tangent vector would be the direction they would be traveling.

[0577] Unit Normal Vector: As the imaginary person moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0578] Binormal unit vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3O ) or alternatively by the left-hand rule ( Figure 3N ) to confirm.

[0579] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Figure 3N and Figure 3O .

[0580] Torque of a space curve: The torque at a point on a space curve is the amount of change of the binormal vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies on a plane has zero torque. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torque (e.g., a slightly tilted spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torque (e.g., a sharply tilted spiral path). Reference Figure 3R , although T2>T1, in Figure 3R The torque near the top spiral coil is greater than Figure 3RThe amount of torque on the bottom spiral coil.

[0581] refer to Figure 3O According to the right-hand rule, a space curve that turns toward the right-hand binormal can be considered to have a right-hand positive torque (e.g., Figure 3R A space curve that deviates away from the right-handed binormal direction can be considered to have a right-handed negative torque (e.g., a left-handed spiral).

[0582] Likewise and referring to the left-hand rule (see Figure 3N ), a space curve that turns in the direction of the left-handed binormal can be considered to have a left-handed positive torque (e.g., a left-handed helix). Therefore, a left-handed positive torque is equivalent to a right-handed negative torque. Figure 3S .

[0583] 5.4.6.4 Holes

[0584] A surface can have one-dimensional pores, for example pores defined by a plane curve or by a space curve. A thin structure (e.g., a membrane) having pores can be described as having one-dimensional pores. For example, see Figure 3I A one-dimensional hole in the structure surface shown in , which is defined by a planar curve 301D.

[0585] A structure may have a two-dimensional aperture, such as an aperture defined by a surface. For example, an inflatable tire has a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel has a two-dimensional aperture. For example, see Figure 3L The buffer and Figure 3M In another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also through Figure 3K The structure shown has a two-dimensional aperture defined by surface 302D.

[0586] 5.5 Other Notes

[0587] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0588] Unless the context clearly indicates otherwise and a numerical range is provided, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated or intervening value in that stated range, is broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges and are also encompassed within the present technology, subject to any specifically excluded limits in that stated range. Where the stated range includes one or both of the stated limits, ranges excluding one or both of those included limits are also encompassed within the present technology.

[0589] Furthermore, where a value or values ​​are described herein as being implemented as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0590] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0591] When a specific material is identified for use in configuring a component, obvious alternative materials with similar properties are used as substitutes. Additionally, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0592] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0593] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the themes of those publications. The publications discussed herein are only provided for the disclosure prior to the filing date of the present application. This paper cannot be interpreted as acknowledging that the present technology is not entitled to be earlier than such publications by virtue of prior invention. In addition, the publication date provided may be different from the actual publication date, and the publication date may need to be independently confirmed.

[0594] The terms “comprises” and “comprising” should be interpreted as meaning that the referenced elements, components or steps may be present, used or combined with other elements, components or steps not explicitly referenced in a non-exclusive manner.

[0595] The main headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the inventive subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0596] Although the present technology has been described with reference to specific embodiments, it should be understood that these examples only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order can be performed simultaneously or even synchronously.

[0597] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0598] For example, it should be understood that one or more features of any one patient interface example (e.g., patient interfaces 6000, 7000, 16000) can be combined with one or more features of another patient interface example (e.g., patient interfaces 6000, 7000, 16000) or other examples related thereto. For example, one or more aspects of the frame assembly 16100 (e.g., the lockout features, the headgear connector arms, the connections between the components, and the sealing arrangement) can be incorporated into the patient interfaces 6000, 7000.

[0599] Furthermore, it should be understood that one or more aspects of the present technology may be combined with one or more aspects of: PCT Publication No. PCT / AU2016 / 050892, filed September 23, 2016, and entitled “Elbow Assembly,” which publication claims the benefit of U.S. Provisional Application No. 62 / 222,435, filed September 23, 2015, and U.S. Provisional Application No. 62 / 376,718, filed August 18, 2016; U.S. Provisional Application No. 62 / 377,217, filed August 19, 2016, and entitled “Patient Interface with a Seal-Forming Structure having Varying Thickness”; U.S. Provisional Application No. 62 / 377,158, filed August 19, 2016, and entitled “Patient Interface with a Seal-Forming Structure having Varying Thickness”; and U.S. Provisional Application No. 62 / 377,158, filed September 23, 2016, and entitled “Vent Adaptor for a Respiratory Therapy No. 62 / 222,604, filed September 23, 2015; and / or PCT Application No. PCT / AU2016 / 050228, filed March 24, 2016, entitled “Patient Interface with Blowout Prevention for Seal-Forming Portion,” which claims the benefit of U.S. Provisional Application No. 62 / 138,009, filed March 25, 2015, and U.S. Provisional Application No. 62 / 222,503, filed September 23, 2015; each of which is incorporated herein by reference in its entirety.

[0600] 5.6 List of Reference Symbols

[0601] Numbered feature entries

[0602] 1000 patients

[0603] 1100 Bed Partner

[0604] 3000 Patient Interface

[0605] 3100 Seal forming structure

[0606] 3200 Inflatable Chamber

[0607] 3300 Positioning and stabilizing structures

[0608] 3400 Vent

[0609] 3600 port

[0610] 3700 Forehead Support

[0611] 4000 RPT device

[0612] 4170 Air Circuit

[0613] 5000 Humidifier

[0614] 6000 Patient Interface

[0615] 6100 Frame Assembly

[0616] 6105 Opening

[0617] 6110 Shield

[0618] 6111 slot

[0619] 6112 slot

[0620] 6113 Opening

[0621] 6114 Opening

[0622] 6115 flange

[0623] 6117 Edge

[0624] 6120 channels

[0625] 6125 Spring Arm

[0626] 6127 Protrusion

[0627] 6130 Upper Headband Connector

[0628] 6132 Shield connection part

[0629] 6133 Pin

[0630] 6134 Upper head with connector arm

[0631] 6135 Upper headband connection point

[0632] 6140 center flexible part

[0633] 6141 Slot

[0634] 6143 First rigid part

[0635] 6145 Peripheral flexible part

[0636] 6146 Slot

[0637] 6147 Second rigid part

[0638] 6150 Lower Headband Connector

[0639] 6152 Shield connection part

[0640] 6153 Pin

[0641] 6154 Lower Headband Connector Arm

[0642] 6155 Magnetic Connector

[0643] 6156 socket

[0644] 6160 Headband Clip

[0645] 6162 Magnet

[0646] 6175 Buffer Assembly

[0647] 6180 housing

[0648] 6200 Seal forming structure

[0649] 6250 Lip Seal

[0650] 6305 Opening

[0651] 6310 flange

[0652] 6315 Buckle

[0653] 6320 concave part

[0654] 6500 Inflatable Chamber

[0655] 6600 elbow assembly

[0656] 6610 first end part

[0657] 6620 Second end part

[0658] 6625 Swivel Connector

[0659] 6630 sidewall

[0660] 6650 Extrusion Arm

[0661] 6652 pieces

[0662] 6700 Vent

[0663] 6750 Arm Cover

[0664] 6800 Headband

[0665] 6802 Upper side strap

[0666] 6804 Lower side strap

[0667] 6806 Head Strap

[0668] 7000 Patient Interface

[0669] 7100 Frame Assembly

[0670] 7105 Opening

[0671] 7110 Shield

[0672] 7125 Spring Arm

[0673] 7127 Protrusion

[0674] 7130 Headband Connector

[0675] 7132 Shield connection part

[0676] 7133 middle part

[0677] 7134 Upper head with connector arm

[0678] 7135 Slot

[0679] 7140 Flexible part

[0680] 7149 Connecting part

[0681] 7154 Lower Headband Connector Arm

[0682] 7155 Magnetic Connector

[0683] 7160 Headband Clip

[0684] 7175 Buffer Assembly

[0685] 7180 housing

[0686] 7200 Seal forming structure

[0687] 7250 Seal

[0688] 7310 flange

[0689] 7315 Buckle

[0690] 7320 concave part

[0691] 7500 Inflatable Chamber

[0692] 7600 elbow assembly

[0693] 7630 sidewall

[0694] 7700 Vent Assembly

[0695] 7800 Headband

[0696] 7802 Upper headband

[0697] 7804 Lower headband strap

[0698] 8100 Frame Assembly

[0699] 8175 Buffer Assembly

[0700] 8250 bellows structure

[0701] 8275 Surface

[0702] 8600 elbow assembly

[0703] 8900 Vent Adapter Connector

[0704] 9600 elbow assembly

[0705] 16000 Patient Interface

[0706] 16100 Frame Assembly

[0707] 16105 Opening

[0708] 16110 Shield

[0709] 16112A End Wall

[0710] 16112B Sidewall

[0711] 16115 outer ring flange

[0712] 16117 Edge

[0713] 16120 channel

[0714] 16125 Inner ring flange

[0715] 16127 Plate or buckle

[0716] 16132 Shield connection part

[0717] 16133 Protrusion

[0718] 16133A Opening

[0719] 16134 Upper head with connector arm

[0720] 16135 Upper headband connection point

[0721] 16136 Bridge

[0722] 16136A Leading Edge

[0723] 16137 Cover

[0724] 16138 Protrusion

[0725] 16140 Central flexible part

[0726] 16141 Slot

[0727] 16145 Peripheral flexible part

[0728] 16146 Slot

[0729] 16152 Shield connection part

[0730] 16153 Protrusion

[0731] 16153A Opening

[0732] 16154 Lower Headband Connector Arm

[0733] 16155 Magnetic Connector

[0734] 16155A Magnet receiving part

[0735] 16155B Magnet

[0736] 16155C Cover

[0737] 16156 Slot

[0738] 16157 Cover

[0739] 16158 Protrusion

[0740] 16159 Slot

[0741] 16160 Headband Clip

[0742] 16162 Magnet

[0743] 16164 Buckle

[0744] 16175 Buffer Assembly

[0745] 16180 housing

[0746] 16200 Seal forming structure

[0747] 16305 Opening

[0748] 16310 flange

[0749] 16310A Leading Edge

[0750] 16310B outside

[0751] 16400 Ridge

[0752] 16405 Protrusion

[0753] 16407 Opening

[0754] 16450 Upper anchor

[0755] 16452 Opening

[0756] 16454 Bridge Component

[0757] 16456 ribs

[0758] 16460 Lower anchor

[0759] 16462 Opening

[0760] 16500 Inflatable Chamber

[0761] 16600 elbow assembly

[0762] 16610 First end part

[0763] 16620 Second end part

[0764] 16625 Swivel Connector

[0765] 16630 inner wall

[0766] 16640 outer wall

[0767] 16645 channel

[0768] 16650 Extrusion Arm

[0769] 16652 Hook End

[0770] 16700 Vent Hole

[0771] 16750 Arm Cover

[0772] 16800 Headband

[0773] 16802 Upper side strap

[0774] 16803 pieces

[0775] 16804 Lower side strap

[0776] 16806 Headband

[0777] 17110 Shield

[0778] 17134 Connector Arm

[0779] 17154 Lower Arm

[0780] 17157 Cover

[0781] 17450 Anchor.

Claims

1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to the airway of a patient, the entrance to the patient's airway comprising at least a nares of the patient, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above ambient air pressure, in use, throughout the patient's respiratory cycle while the patient is sleeping, to alleviate sleep-disordered breathing; The patient interface comprises: a frame assembly including a connector operably attachable to the headband; a bumper assembly provided to the frame assembly, the bumper assembly comprising a housing and a seal-forming structure provided to the housing and configured to form a seal with the patient's nose and / or mouth, the housing and seal-forming structure cooperating to form a plenum; and providing an air delivery connector to the frame assembly, the air delivery connector operatively connected to the air delivery tube to supply air under positive pressure along the air flow path, wherein the bumper assembly is configured to be releasably connected to the frame assembly independently of the air delivery connector, wherein the air delivery connector is configured to be releasably connected to the frame assembly independently of the bumper assembly, wherein a first seal for the air flow path is formed between the air delivery connector and the frame assembly, and a separate second seal is formed between the frame assembly and the buffer assembly, and Wherein the first seal comprises a dynamic diameter seal and a dynamic face seal, and the second seal comprises a static diameter seal and a static face seal.

2. A patient interface according to claim 1, wherein the air delivery connector comprises an elbow assembly.

3. A patient interface according to claim 2, wherein the elbow assembly is adapted to rotate relative to the frame assembly.

4. A patient interface according to any one of claims 1 to 3, wherein the air delivery connector includes a pair of quick release spring arms constructed and arranged to releasably connect to the frame assembly.

5. A patient interface according to any one of claims 1 to 4, wherein the frame assembly includes an upper headgear connector configured to connect to an upper strap of the headgear and a lower headgear connector configured to connect to a lower strap of the headgear.

6. A patient interface according to claim 5, wherein the upper headgear connector comprises a pair of upper headgear connector arms, each of the upper headgear connector arms comprising one or more flexible portions constructed and arranged to accommodate different facial contours.

7. A patient interface according to claim 6, wherein each said flexible portion comprises one or more slots configured to form one or more hinges.

8. A patient interface according to any one of claims 5 to 7, wherein the lower headgear connector comprises a pair of lower headgear connector arms, each of the lower headgear connector arms comprising a magnetic connector configured to connect to a magnetic headgear clip.

9. A patient interface according to claim 8, wherein each of the lower headgear connector arms includes a slot configured to form a hinge portion.

10. A patient interface according to any one of claims 1 to 9, wherein the frame assembly is provided in one size and is configured to be selectively engageable with a plurality of sizes of the bumper assemblies.

11. A patient interface according to any one of claims 1 to 10, wherein the frame assembly includes a lockout feature along the air flow path constructed and arranged to prevent direct connection or insertion of the air delivery tube.

12. A patient interface according to claim 11, wherein the lockout feature comprises a plurality of protrusions constructed and arranged to extend toward the air flow path.

13. A patient interface according to claim 11, wherein the lockout feature comprises a single annular protrusion constructed and arranged to extend toward the air flow path.

14. A patient interface according to any one of claims 1 to 13, wherein the air delivery connector comprises an elbow assembly having a plurality of vent apertures and an anti-asphyxia valve assembly.

15. A patient interface according to any one of claims 1 to 14, wherein the frame assembly is provided in the air flow path.

16. A treatment system for treating sleep-disordered breathing, comprising: A patient interface according to any one of claims 1 to 15; Respiratory pressure therapy (RPT) devices that supply breathable gas at positive pressure; as well as An air delivery tube communicates the breathable gas from the RPT device to the patient interface.

17. A frame assembly for a patient interface, comprising: An upper headband connector configured to connect to an upper strap of a headband, the upper headband connector comprising a pair of upper headband connector arms, each of the upper headband connector arms comprising one or more flexible portions configured and arranged to accommodate different facial contours, wherein each of the flexible portions comprises one or more slots configured to form one or more hinges.

18. The frame assembly of claim 17, wherein each upper headband connector arm includes a first flexible portion and a second flexible portion between the first flexible portion and an upper headband connection point configured to connect to a corresponding upper strap.

19. The frame assembly of claim 18, wherein the first flexible portion includes a single slot and the second flexible portion includes a plurality of slots.

20. The frame assembly of any one of claims 17 to 19, further comprising a lower headband connector configured to connect to a lower strap of the headband, the lower headband connector comprising a pair of lower headband connector arms.

21. A treatment system for treating sleep-disordered breathing, comprising: a patient interface comprising a frame assembly according to any one of claims 17 to 20; Respiratory pressure therapy (RPT) devices that supply breathable gas at positive pressure; as well as An air delivery tube communicates the breathable gas from the RPT device to the patient interface.

22. A frame assembly for a patient interface, comprising: An upper headband connector configured to connect to an upper strap of a headband, the upper headband connector comprising a pair of upper headband connector arms, each of the upper headband connector arms comprising a plurality of flexible portions configured and arranged to accommodate different facial contours, wherein each of the flexible portions forms a plurality of hinges.

23. The frame assembly of claim 22, further comprising a lower headband connector configured to connect to a lower strap of the headband, the lower headband connector comprising a pair of lower headband connector arms, each of the lower headband connector arms comprising a flexible portion.

Images