Patient interface

Abstract

A patient interface includes: a frame component (16100) that includes a connector operably attachable to a headband; a buffer component (16175) including a housing (161800) and a seal-forming structure (16200) configured to form a seal with a patient's nose and / or mouth; and an air delivery connector (16600). The buffer component and the air delivery connector are configured to be releasably connected to the frame component independently of each other. There is a static face seal and a separate static diameter seal between the air delivery connector (16600) and the frame (16100). There is a dynamic face seal and a separate dynamic diameter seal between the air delivery connector (16600) and the frame (16100). A separate claim (Figure 6) for a frame component (16100) having an upper headband connector arm (16134) includes at least one slot (6146) (Claim 17) or a flexible portion (Claim 22) to form a hinge configured and arranged to accommodate varying facial profiles.

Description

[0001] This application is a divisional application of the patent application with application number 201680064877.4, filing date September 23, 2016, and invention title "Patient Interface". The patent application with application number 201680064877.4 is the national phase application in China of the 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 hereby incorporated by reference in its entirety. Technical background 2.1 Technical field

[0005] This technology relates to one or more of the detection, diagnosis, treatment, prevention, and improvement of respiratory - related disorders. This technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Related art description

[0007] 2.2.1 The human respiratory system and its disorders

[0008] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0009] The airway includes a series of branching bronchi that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the air and expelling carbon dioxide. The trachea divides into the left and right main bronchi, which ultimately divide further into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Other branches of the airway lead to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is the region where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th Edition, published by John B. West, Lippincott Williams & Wilkins in 2011.

[0010] There is a series of respiratory disorders. Some disorders can be characterized by specific events such as apnea, hypopnea, and hyperventilation.

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

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

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO 2 to meet the needs of the patient. Respiratory failure can include some or all of the following disorders.

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

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

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

[0017] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and disorders that directly or indirectly impair muscle function via either intrinsic muscle pathology or neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of mobility, wheelchair dependence, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage 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 muscle damage worsening 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 on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

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

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

[0020] 2.2.2 Treatments

[0021] 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 by CPAP can be voluntary, so if a patient finds the device used to provide such treatment: uncomfortable, difficult to use, expensive, and / or unaesthetic in any one or more respects, the patient may choose not to comply with the treatment.

[0022] Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and / or to maintain an appropriate oxygen level in the body by performing some or all of the work of breathing. The ventilation support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which are in the forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0023] 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.

[0024] 2.2.3 Treatment systems

[0025] These treatments can be provided by a treatment system or device. Such systems and devices can also be used to diagnose a condition without treating the condition.

[0026] A treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0027] Another form of treatment system is a mandibular repositioning device.

[0028] 2.2.3.1 Patient interface

[0029] A patient interface can be used to engage a breathing device to its wearer, for example by providing an air flow to the entrance of the airway. The air flow 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 cause gas to be delivered at a pressure with a sufficient difference from the ambient pressure (e.g., a positive pressure of approximately 10 cmH 2 O) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include sufficient means to deliver a pressure of approximately 10 cmH2 Positive-pressure gas of O is delivered to the seal of the airway.

[0030] Some other mask systems may not be functionally applicable to the present field. For example, a purely decorative mask may not be able to maintain a suitable pressure. A mask for underwater swimming or diving may be configured to prevent water from flowing in from the external high pressure, rather than maintaining air at a pressure higher than the ambient pressure inside.

[0031] Some masks may be clinically disadvantageous to the present technology, for example, in that they block the airflow through the nose and only allow it to pass through the mouth.

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

[0033] Some masks may be infeasible for use during sleep, for example, when sleeping on the side in bed with the head on a pillow.

[0034] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The sizes and shapes of the nose and head vary significantly from person to person. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible or lower jawbone can move relative to the other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0035] Due to these challenges, some masks face one or more of the following problems: protrusion, unaesthetic appearance, high cost, disproportion, difficulty in use, and discomfort especially when worn for a long period of time or when the patient is not familiar with the system. A mask of the wrong size causes reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (such as filter masks), SCUBA masks, or masks designed to administer anesthetic agents are acceptable for their original uses, but for long-term (e.g., several hours) wear, such masks are not as comfortable as desired. This discomfort may lead to reduced patient compliance with the treatment. This is especially true if the mask is worn during sleep.

[0036] Assuming the patient complies with the treatment, CPAP treatment is very effective in treating certain respiratory disorders. If the mask is uncomfortable or difficult to use, the patient may not comply with the treatment. Since patients are usually advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect the patient's compliance.

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

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

[0039] 2.2.3.1.1 Seal-forming portion

[0040] The patient interface can include a seal-forming portion. Because of its direct contact with the patient's face, the shape and construction of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0041] The patient interface is characterized in part by the design intent of the seal-forming portion to engage with the face during use. In one form of patient interface, the seal-forming portion can include two sub-portions to engage with the respective left and right nostrils. In one form of patient interface, the seal-forming portion can include a single element that surrounds both nostrils during use. Such a single element can be designed to cover, for example, the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming portion can include an element that surrounds the mouth region during use, for example, by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming portion can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oro-nasal masks.

[0042] A seal-forming portion that is effective in one area of the 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 a swim goggle that covers the patient's forehead may not be suitable for use on the patient's nose.

[0043] Certain seal-forming portions can be designed for mass production such that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming portion of a mass-produced patient interface, one or both must adapt to form a seal.

[0044] A type of seal-forming portion extends around the periphery of the patient interface and is adapted to seal the patient's face when a force is applied to the patient interface while the seal-forming portion is in face-to-face engagement with the patient's face. The seal-forming portion can include an air or fluid-filled pad or a molded or formed surface of an elastomeric sealing element (such as rubber). For this type of seal-forming portion, if the fit is inadequate, there will be a gap between the seal-forming portion and the face, and additional force will be required to press the patient interface against the face to achieve a seal.

[0045] Another type of seal-forming portion includes a sheet-like seal of thin material positioned around the perimeter of the face mask to provide a self-sealing action against the patient's face when positive pressure is applied within the face mask. Similar to the previously described forms of seal-forming portions, if the match between the face and the face mask is poor, additional force may be required to achieve a seal, or the face mask may leak. Additionally, if the shape of the seal-forming portion does not match the shape of the patient, it may wrinkle or bend during use, resulting in leakage.

[0046] Another type of seal-forming portion can include friction-fit elements, such as those adapted to be inserted into the nostrils, although some patients find these uncomfortable.

[0047] Another form of seal-forming portion can use an adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove the adhesive to their face.

[0048] A series of patient interface seal-forming portion techniques are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

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

[0050] ResMed Limited has manufactured 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 Pillow Mask and SWIFT TMLIBERTYTM full face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (which describes other aspects of the ResMed Limited SWIFT TM nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes other aspects of the ResMed Limited SWIFT TM LT nasal pillows); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (which describe other aspects of the ResMed Limited MIRAGE LIBERTY TM full face mask); International Patent Application WO2009 / 052,560 (which describes other aspects of the ResMed Limited SWIFT TM FX nasal pillows).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] The seal-forming portion of a patient interface for positive air pressure therapy is subjected to a corresponding force of air pressure to break the seal. Accordingly, various techniques have been used to position the seal-forming portion and maintain its sealed relationship with the appropriate portion of the face.

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

[0054] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the problems of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0055] 2.2.3.2 Respiratory pressure therapy (RPT) devices

[0056] Air pressure generators are known in a series 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 the reliability, size, and weight requirements of medical devices. In addition, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0057] An example of a specific requirement for some RPT devices is noise.

[0058] Table of noise output levels of existing RPT devices (only a sample, measured at 10 cmH 2 O using the test method specified in ISO 3744 in CPAP mode).

[0059] RPT device name A-weighted sound pressure level dB(A) Year(approx.) <![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

[0060] A known RPT device for treating sleep disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar TM series of adult and paediatric ventilators can provide support for invasive and non-invasive non-dependent ventilation for a range of patients for treating a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0061] ResMed Elisée TM 150 ventilator and the ResMed VS III TM ventilators can provide support for traumatic and non-invasive dependent ventilation for adult or paediatric patients suitable for treating a variety of conditions. These ventilators provide volume and pressure ventilation modes with single or dual channel circuits. RPT devices generally include a pressure generator such as a motor-driven blower or a compressed gas reservoir and are configured to supply an air stream to a patient's airway. In some cases, the air stream can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as that described above.

[0062] The designers of the device may have provided an infinite number of choices that can be made. Design criteria often conflict, meaning that some design choices are far from conventional or inevitable. Additionally, the comfort and efficacy of some aspects may be highly sensitive to small and subtle changes in one or more parameters.

[0063] 2.2.3.3 Humidifier

[0064] Delivering an air stream without humidification can cause airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas to minimize drying of the nasal mucosa and increase patient airway comfort. Additionally, in colder climates, warm air typically applied to the patient interface and the facial area 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 specific requirements of a medical humidifier.

[0065] A medical humidifier is used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically where a patient may be sleeping or resting (e.g., in a hospital). A medical humidifier for bedside placement can be 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 surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air a patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. Additionally, medical humidifiers can have more stringent safety limitations than industrial humidifiers.

[0066] Although many medical humidifiers are known, they can have one or more drawbacks. Some medical humidifiers may provide inadequate humidification, and some can be difficult or inconvenient for a patient to use.

[0067] 2.2.3.4 Data management

[0068] There can be many clinical reasons to obtain data that determines whether a patient being treated with a respiratory therapy prescription is "compliant", e.g., the patient has used their RPT device according to certain "compliance rules". An example of a compliance rule for CPAP therapy is that for a patient to be considered compliant, the patient is required to use the RPT device for at least four hours per night for at least 21 or 30 consecutive days. To determine a patient's compliance, a provider of the RPT device such as a healthcare provider can manually obtain data describing the patient's treatment using the RPT device, calculate the use over a predetermined period of time and compare it to the compliance rule. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rule, the healthcare provider can inform the patient of the third part of the compliance.

[0069] There are other aspects of patient treatment that can benefit from the communication of treatment data to a third party or external system.

[0070] Existing methods of communicating and managing such data can be one or more of the following: expensive, time-consuming, and error-prone.

[0071] 2.2.3.5 Mandibular reduction

[0072] 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 that can be purchased from a dentist or other suppliers, which holds the lower jaw (mandible) in a forward position during sleep. The MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after waking up. Therefore, the MRD is not designed to be worn all the time. The MRD can be custom-made or produced in a standard form and includes a bite impression part designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible enlarges the space behind the tongue, applies tension to the pharyngeal wall to reduce airway collapse and reduce vibration of the palate.

[0073] In some instances, the mandibular advancement device may include an upper splint designed to engage or mate with the teeth on the maxilla or maxillary bone and a lower splint designed to engage or mate with the teeth on the mandible or mandibular bone. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0074] In this design, the length of the connecting rods is selected such that when the MRD is placed in the patient's mouth, the mandible remains in the forward position. The length of the connecting rods can be adjusted to change the degree of protrusion of the lower jaw. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rods.

[0075] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs (e.g., ResMed NarvalCC TM MRD) are designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0076] 2.2.3.6 Vent Port Technology

[0077] Some forms of patient interface systems can include vent ports to allow flushing of exhaled carbon dioxide. The vent port can allow gas to flow from the internal space (e.g., the inflation chamber) of the patient interface to the external space of the patient interface, such as to the environment. The vent port can include an orifice, and gas can flow through the orifice when using a face mask. Many such vent ports are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vent ports can disrupt the sleep of the patient's bed partner 1100 of patient 1000, for example, by noise or a concentrated airflow.

[0078] ResMed Limited has developed a number of improved mask ventilation techniques. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. US2009 / 0044808.

[0079] Noise table of existing masks (ISO17510-2:2007, pressure of 10 cmH 2 O at 1 m)

[0080]

[0081]

[0082] (*Only a sample, measured at 10 cmH using the test method specified in ISO3744 in CPAP mode 2 O) The sound pressure values of various objects are shown below

[0083]

[0084] 2.2.4 Diagnostic and Monitoring Systems

[0085] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases and usually involves professional clinical medical staff applying 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 observing patients in the clinic for two nights, namely one night for pure diagnosis and the second night for clinicians to determine treatment parameters. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0086] Clinical experts can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinical experts may not be available or may not be affordable. Different clinical experts may have different opinions on the patient's condition. In addition, a given clinical expert may apply different criteria at different times.

[0087] 3 Technical Summary

[0088] This technology aims to provide a medical device for diagnosing, improving, treating, or preventing respiratory disorders, which has one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0089] A first aspect of the present technology relates to a device for diagnosing, ameliorating, treating, or preventing a respiratory disorder.

[0090] Another aspect of the present technology relates to a method for diagnosing, ameliorating, treating, or preventing a respiratory disorder.

[0091] One aspect of certain forms of the present technology is for providing a method and / or device for improving a patient's compliance with respiratory therapy.

[0092] One aspect of the present technology relates to a patient interface that includes a frame assembly, the frame assembly including a connector operably attached to a headband; a cushion assembly provided to the frame assembly, the cushion assembly including a seal-forming structure configured to form a seal with a patient's nose and / or mouth; and an air delivery connector provided to the frame assembly, the air delivery connector being operably connected to an air delivery tube for supplying air along an air flow path under positive pressure. The cushion assembly is configured to be releasably connected to the frame assembly independent of the air delivery connector. The air delivery connector is configured to be releasably connected to the frame assembly independent of the cushion assembly.

[0093] In one example, a first seal of the 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 of 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 providing to the seal forming structure, and the housing and the seal forming structure cooperate to form an inflatable chamber. In one example, the frame assembly includes an upper headband connector configured to connect to an upper headband strap of a headband and a lower headband connector configured to connect to a lower headband strap of the headband. In one example, the upper headband connector includes a pair of upper headband connector arms, each arm including one or more flexible portions configured and arranged to accommodate different facial profiles. 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 lower headband connector arm 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 shroud, and the upper headband connector and the lower headband connector are provided to the shroud. In one example, the shroud includes upper and lower slots configured to receive the respective upper headband connector and lower headband connector. 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 blocking features configured and arranged along the air flow path to prevent direct connection or insertion of an air delivery tube. In one example, the blocking features include a plurality of protrusions configured and arranged to extend towards the air flow path. In one example, the blocking features include a single annular protrusion configured and arranged to extend towards the air flow path. In one example, the air delivery connector includes an elbow assembly having a plurality of vent holes and an anti-asphyxiation valve assembly. In one example, the frame assembly is provided in the air flow path.

[0094] Another aspect of the present technology relates to a frame component for a patient interface, the frame component including an upper headband connector configured to connect to an upper strap of a headband. The upper headband connector includes a pair of upper headband connector arms, each arm including one or more flexible portions configured and arranged to accommodate different facial profiles.

[0095] In one instance, each flexible portion includes one or more slots configured to form one or more hinges. In one instance, 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 instance, the first flexible portion includes a single slot and the second flexible portion includes multiple slots. In one instance, the frame component further 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.

[0096] In another instance, there is provided a frame component for a patient interface, which 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 profiles, wherein each flexible portion forms multiple hinges.

[0097] Another aspect of the present technology relates to a patient interface, which includes a frame component, the frame component including a connector operably attached to a headband; a buffer component provided to the frame component, the buffer component including a seal-forming structure configured to form a seal with a patient's nose and / or mouth; and an air delivery connector (e.g., elbow assembly) provided to the frame component, the air delivery connector being operably connected to an air delivery tube for supplying air under positive pressure. In one instance, a first seal of the air flow path is formed between the elbow assembly and the frame component, and a separate second seal is formed between the frame component and the buffer component. For example, the elbow assembly is configured to form a rigid connection and a dynamic seal with the frame component, and the buffer component is configured to form a separate rigid connection and a static seal with the frame component.

[0098] Another aspect of the present technology relates to a patient interface that includes a frame component, the frame component including a connector operably attached to a headband; a cushioning component provided to the frame component, the cushioning component including a seal-forming structure configured to form a seal with a patient's nose and / or mouth; and an air delivery connector (e.g., a elbow assembly) provided to the frame component, the air delivery connector being operably connected to an air delivery tube for supplying air under positive pressure. In one example, the frame component includes a blocking feature along an air flow path that is configured and arranged to prevent direct connection or insertion of the air delivery tube. This arrangement requires the use of an elbow assembly to interconnect the frame component and the air delivery tube, thereby ensuring that the elbow assembly (e.g., and its vent and anti-asphyxiation valve (AAV)) is present in the system.

[0099] 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.

[0100] One aspect of one form of the present technology is a method of manufacturing a device.

[0101] One aspect of certain forms of the present technology is an easy-to-use medical device, such as for use by an individual who has not had medical training, by an individual with limited dexterity, vision, or by an individual with limited experience using this type of medical device.

[0102] One aspect of one form of the present technology is a patient interface that can be cleaned (e.g., in soapy water) in a patient's home without the need for specialized cleaning equipment.

[0103] The methods / systems / devices / apparatuses described herein can provide improved functionality in a processor, such as in a processor of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Additionally, the methods / devices / apparatuses can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0104] Of course, portions of the aspects can form sub-aspects of the present technology. Additionally, the various aspects within the sub-aspects and / or aspects can be combined in any manner and also form other aspects or sub-aspects of the present technology.

[0105] Other features of the present technology will become apparent by considering the information contained in the detailed description, abstract, drawings, and claims set forth below. Brief Description of the Drawings

[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 and include:

[0107] 4.1 Treatment System

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

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

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

[0111] 4.2 Respiratory System and Facial Anatomy

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

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

[0114] Figure 2C A front view of a face with several identified surface anatomical features including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial groove, and oral commissure. The upper, lower, radially inward, and radially outward directions are also indicated.

[0115] Figure 2D A side view of a head with several identified surface anatomical features including the glabella, nasion, nasal prominence, subnasal septum point, upper lip, lower lip, supra-mental point, nasal bridge, alar apex, superior auricular point, and inferior auricular point. The up-down and front-back directions are also indicated.

[0116] Figure 2E A side view of the other side of the head. The approximate positions of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0117] Figure 2F The bottom view of the nose showing several features with identifiers, including the nasolabial fold, lower lip, vermilion of the upper lip, nostril, subnasal point, columella, nasion, long axis of the nostril, and sagittal plane.

[0118] Figure 2G The side view showing the surface features of the nose.

[0119] Figure 2H The subcutaneous structure of the nose is shown, including the lateral cartilage, septal cartilage, major alar cartilage, minor alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0120] Fig.2I The medial anatomical view of the nose about several millimeters from the sagittal plane is shown, showing, among other things, the medial crura of the septal cartilage and major alar cartilage.

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

[0122] Figure 2K The side view of the skull with the head surface contour and several muscles is shown. The following bony parts are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

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

[0124] 4.3 Patient interface

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

[0126] Figure 3B A schematic cross-section of 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 has a relatively large magnitude when compared with Figure 3C the magnitude of the curvature shown.

[0127] Figure 3C A schematic cross-section of 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 has a relatively small magnitude when compared with Figure 3B the magnitude of the curvature shown.

[0128] Figure 3DA schematic view 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 zero value.

[0129] Figure 3E A schematic view 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 negative sign and has a relatively small magnitude when compared with Figure 3F the magnitude of the curvature shown.

[0130] Figure 3F A schematic view 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 negative sign and has a relatively large magnitude when compared with Figure 3E the magnitude of the curvature shown.

[0131] Figure 3G A buffer for a face mask including two pillows is shown. The outer surface of the buffer is indicated. The edge of the surface is indicated. The dome region and the saddle region are indicated.

[0132] Figure 3H A buffer for a face mask is shown. The outer surface of the buffer is indicated. The edge of the surface is indicated. A path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and a dome region are indicated.

[0133] Fig. 3I A surface of a structure is shown, on which a one-dimensional hole is provided. The planar curve 301D forms the boundary of the one-dimensional hole.

[0134] Figure 3J A cross-section through a Fig. 3I structure is shown. The surface 302D defining a two-dimensional hole in the Fig. 3I structure is indicated.

[0135] Figure 3K A perspective view of a Fig. 3I structure including a two-dimensional hole and a one-dimensional hole is shown. The surface 302D defining a two-dimensional hole in the Fig. 3I structure is indicated.

[0136] Figure 3L A face mask having an inflatable airbag as a buffer is shown.

[0137] Figure 3M A cross-section through a Figure 3L face mask is shown, and the inner surface of the airbag is shown.

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

[0139] Fig.3OShows the right-hand rule.

[0140] Figure 3P Shows the left ear, including the left ear helix.

[0141] Figure 3Q Shows the right ear, including the right ear helix.

[0142] Figure 3R Shows the right-hand helix.

[0143] Figure 3S Shows a facemask view that includes a torque signature of a space curve defined by the edges of a sealing film in different regions of the facemask.

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

[0145] Figure 5 Is Figure 4 A side view of the shown patient interface.

[0146] Figure 6 Is a perspective view of a patient interface according to an example of the present technology, the patient interface being shown with the headband removed and the arm cuffs of the upper arms of the frame assembly removed.

[0147] Figure 7 Is Figure 6 A front view of the shown patient interface.

[0148] Figure 8 Is Figure 6 A rear view of the shown patient interface.

[0149] Fig. 9 Is Figure 6 A side view of the shown patient interface.

[0150] Fig.10 Is an exploded view of a patient interface according to an example of the present technology, which shows a buffer assembly, a frame assembly, arm cuffs, and an elbow assembly.

[0151] Fig.11 Is an exploded view of a patient interface according to an example of the present technology, which shows a buffer assembly and a frame assembly detachably connected to a removed elbow assembly.

[0152] Fig.12 Is an exploded view of a patient interface according to an example of the present technology, which shows a frame assembly and an elbow assembly detachably connected to a removed buffer assembly.

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

[0154] Fig.14 An enlarged view of the patient interface shown in Fig.13 Figure

[0155] Fig.15 A front exploded view of the buffer assembly according to an example of the present technology.

[0156] Fig.16 Is Fig.15 A rear exploded view of the buffer assembly shown in

[0157] Fig.17 Is Fig.15 A front view of the buffer assembly shown in

[0158] Fig.18 A front perspective view of the frame assembly according to an example of the present technology.

[0159] Fig.19 Is Fig.18 A rear perspective view of the frame assembly shown in

[0160] Fig. 20 Is Fig.18 A side view of the frame assembly shown in

[0161] Fig.21 Is Fig.18 A rear view of the frame assembly shown in

[0162] Fig. 22 Is Fig.18 A front view of the frame assembly shown in

[0163] Fig.23 Is Fig.21 A cross-sectional view of the frame assembly shown in

[0164] Fig.24 Is Fig.18 A front exploded view of the frame assembly shown in

[0165] Fig.25 Is Fig.18 A rear exploded view of the frame assembly shown in

[0166] Fig.26 Is Fig. 22 A cross-sectional view of the frame assembly shown in

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

[0168] Fig.28 Is Fig. 27 A perspective view of the elbow assembly shown in

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

[0170] Fig.30 Perspective view of a patient interface according to an example of the present technology, with the headband shown removed.

[0171] Fig.31 Is Fig.30 Front view of the patient interface shown.

[0172] Fig.32 Is Fig.30 Rear view of the patient interface shown.

[0173] Fig.33 Is Fig.30 Side view of the patient interface shown.

[0174] Fig.34 Exploded view of a patient interface according to an example of the present technology, showing a buffer assembly, a frame assembly, and an elbow assembly.

[0175] Fig.35 Exploded view of a patient interface according to an example of the present technology, showing a buffer assembly and a frame assembly detachably connected to a removed elbow assembly.

[0176] Fig.36 Exploded view of a patient interface according to an example of the present technology, showing a frame assembly and an elbow assembly detachably connected to a removed buffer assembly.

[0177] Fig.37 Cross-sectional view of a patient interface according to an example of the present technology.

[0178] Fig.38 Is Fig.37 Enlarged view of the patient interface shown.

[0179] Fig.39 Front exploded view of a buffer assembly according to an example of the present technology.

[0180] Fig.40 Is Fig.39 Rear exploded view of the buffer assembly shown.

[0181] Fig.41 Is Fig.39 Front view of the buffer assembly shown.

[0182] Fig.42 Front perspective view of a frame assembly according to an example of the present technology.

[0183] Fig.43 Is Fig.42Rear perspective view of the frame component shown.

[0184] Fig.44 is Fig.42 Side view of the frame component shown.

[0185] Fig.45 is Fig.42 Rear view of the frame component shown.

[0186] Fig.46 is Fig.42 Front view of the frame component shown.

[0187] Fig.47 is Fig.46 Cross-sectional view of the frame component shown.

[0188] Fig.48 is Fig.42 Front exploded view of the frame component shown.

[0189] Fig.49 is Fig.42 Rear exploded view of the frame component shown.

[0190] Fig.50 Perspective view of an elbow component according to an example of the present technology.

[0191] Fig.51 is Fig.50 Exploded view of the elbow component shown.

[0192] Fig.52 Perspective view of an elbow component according to an example of the present technology.

[0193] Fig.53 is Fig.52 Exploded view of the elbow component shown.

[0194] Fig.54A , 54B and 54C are rear views of a small buffer component, a medium buffer component, and a large buffer component according to an example of the present technology.

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

[0196] Fig.56 is Fig.55 Cross-sectional view of the patient interface shown.

[0197] Fig.57 Top view of an elbow component according to an alternative example of the present technology.

[0198] Fig.58To show the Fig.57 cross-sectional view of the elbow pipe assembly attached to the patient interface according to an example of the present technology.

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

[0200] Fig.60 Is Fig.59 Side view of the patient interface shown.

[0201] Fig.61 Perspective view of the patient interface according to an example of the present technology, with the headband shown removed.

[0202] Fig.62 Is Fig.61 Perspective view of the patient interface shown, with the arm cover of the upper arm of the frame assembly removed.

[0203] Fig.63 Is Fig.62 Front view of the patient interface shown.

[0204] Fig.64 Is Fig.62 Rear view of the patient interface shown.

[0205] Fig.65 Is Fig.62 Side view of the patient interface shown.

[0206] Fig.66 Is Fig.61 Exploded view of the patient interface shown, which shows the buffer assembly, the frame assembly, the arm cover, and the elbow pipe assembly.

[0207] Fig.67 Is Fig.62 Exploded view of the patient interface shown, which shows the buffer assembly and the frame assembly detachably connected to the removed elbow pipe assembly.

[0208] Fig.68 Is Fig.62 Exploded view of the patient interface shown, which shows the frame assembly and the elbow pipe assembly detachably connected to the removed buffer assembly.

[0209] Fig.69 Is Fig.63 Cross-sectional view of the patient interface shown.

[0210] Fig.70 Is Fig.69 Enlarged view of the patient interface shown.

[0211] Fig.71 Is Fig.65Cross-sectional view of the patient interface shown.

[0212] Fig.72 is Fig.71 Enlarged view of the patient interface shown.

[0213] Fig.73 Front exploded view of the buffer assembly according to an example of the present technology.

[0214] Fig.74 is Fig.73 Rear exploded view of the buffer assembly shown.

[0215] Fig.75 Front perspective view of the frame assembly according to an example of the present technology.

[0216] Fig.76 is Fig.75 Rear perspective view of the frame assembly shown.

[0217] Fig.77 is Fig.75 Side view of the frame assembly shown.

[0218] Fig.78 is Fig.75 Front view of the frame assembly shown.

[0219] Fig.79 is Fig.75 Rear view of the frame assembly shown.

[0220] Fig.80 is Fig.78 Cross-sectional view of the frame assembly shown.

[0221] Fig.81 is Fig.75 Front exploded view of the frame assembly shown.

[0222] Fig.82 is Fig.75 Rear exploded view of the frame assembly shown.

[0223] Fig.83 Front perspective view of the shield for the frame assembly according to an example of the present technology.

[0224] Fig.84 is Fig.83 Rear perspective view of the shield shown.

[0225] Fig.85 is Fig.83 Front view of the shield shown.

[0226] Fig.86 is Fig.83 Rear view of the shield shown.

[0227] Fig.87 Front view of the upper anchor or upper arm connector for a shield according to one example of the present technology.

[0228] Fig.88 Is Fig.84 An enlarged view of the shield shown.

[0229] Fig.89A Front view of the shield for a frame assembly according to another example of the present technology.

[0230] Fig.89B Rear view of the shield for a frame assembly according to another example of the present technology.

[0231] Fig.90 Exploded view showing the connection of the lower headband connector arm to the shield of the frame assembly according to one example of the present technology.

[0232] Fig.91 Cross-sectional view showing the connection of the lower headband connector arm to the shield of the frame assembly according to one example of the present technology.

[0233] Fig.92 Front view of a frame assembly according to another example of the present technology.

[0234] Fig.93 And 94 Is Fig.92 Exploded view of the lower headband connector arm of the frame assembly of

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

[0236] Fig.96 Shows the manufacturing process of the lower headband connector arm according to one example of the present technology.

[0237] Fig.97 Shows the manufacturing process of the lower headband connector arm according to another example of the present technology.

[0238] Fig.98 Exploded view showing the connection of the lower headband connector arm to the shield of the frame assembly according to another example of the present technology.

[0239] Fig.99 Exploded view showing the connection of the upper headband connector arm to the shield of the frame assembly according to one example of the present technology.

[0240] Fig.100 Cross-sectional view showing the connection of the upper headband connector arm to the shield of the frame assembly according to one example of the present technology.

[0241] Fig.101 Front perspective view of a headband clip according to an example of the present technology.

[0242] Fig.102 Is Fig.101 Rear perspective view of the headband clip shown.

[0243] Fig.103 Is a cross-sectional view showing the connection of the Fig.101 headband clip to the lower headband connector arm of the frame assembly according to an example of the present technology.

[0244] Fig.104 Is a cross-sectional view showing the connection of the upper headband strap to the upper headband connection point of the frame assembly according to an example of the present technology. Detailed Description

[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, and the specific examples described herein may be changed. It should also be understood that the terms used in this disclosure are only for the purpose of describing the specific examples described herein and are 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. Additionally, 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 includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to the entrance of the airway of a patient 1000.

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

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

[0251] 5.2 Treatment System

[0252] In one form, the present technology includes a device or apparatus for treating a respiratory disorder. The device or apparatus 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, for example see Figures 1A to 1C .

[0253] 5.3 Patient Interface

[0254] The non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in the form of a connection to an 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, a single entity component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of positive pressure air to the airway.

[0255] Figures 4 to 28 There is shown a non-invasive patient interface 6000 according to one aspect of the present technology, the patient interface including a frame assembly 6100, a buffer assembly 6175 (including a seal-forming structure 6200), an air delivery connector (such as an elbow assembly 6600), and a positioning and stabilization structure (such as a headband 6800). Figure 4 and 5 is an exemplary view of the patient interface 6000 on a patient's head (with an arm cuff 6750 having an upper arm 6134 for an attached frame assembly 6100), and Figures 6 to 10 is an exemplary view of the patient interface 6000 with the headband 6800 and arm cuff 6750 removed. In use, one form of the seal-forming structure 6200 is arranged to surround the entrance of the patient 1000's airway so as to facilitate the supply of positive pressure air to the airway. The seal-forming structure 6200 (constructed of silicone, for example) may also commonly be referred to as a buffer. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single entity component may provide one or more functional aspects.

[0256] In one form of the present technology, the frame assembly 6100 is connected as an intermediate component to the buffer assembly 6175 and the elbow assembly 6600. That is, the buffer assembly 6175 is connected to the frame assembly 6100 independently of the elbow assembly 6600 (via a first retention feature on the frame assembly) (see Fig.11 ), and the elbow assembly 6600 is connected to the frame assembly 6100 independently of the buffer assembly 6175 (via a second retention feature on the frame assembly) (see Fig.12 ). However, a seal for the air flow path is formed between the elbow assembly 6600 and the buffer assembly 6175, that is, the frame assembly 6100 is not in the air flow path (for example, see Fig.13 and 14)。Alternatively, a first seal of 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 buffer assembly 6175. In this case, the frame assembly 6100 may be retained in the air flow path. The retention connections of the buffer assembly 6175 and the elbow assembly 6600 to the frame assembly 6100 are separate and distinct from each other and allow independent engagement / disengagement, such that the frame assembly 6100 may remain connected to either of these components when disconnected from either the buffer assembly 6175 or the elbow assembly 6600. For example, this arrangement allows the buffer assembly 6175 to be disconnected from the frame assembly 6100 (e.g., to change the buffer 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 illustrated example, the seal forming structure 6200 of the patient interface 6000 of the present technology may be held in the sealed position by the headband 6800 in use. As Figure 4 and 5 shown, the headband 6800 includes a pair of upper side straps 6802 and a pair of lower side straps 6804 connected to a circular crown strap that encircles the crown of the patient's head. The upper side straps 6802 are connected to the upper headband connectors 6130 of the frame assembly 6100 and the lower side straps 6804 are connected to the lower headband connectors 6150 of the frame assembly 6100, e.g., via headband clips 6160. The side straps 6802, 6804 may include an adjustable hook and loop (Velcro TM ) connection mechanism, such as Velcro TM -like hook tabs, to facilitate connection and / or adjustment.

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

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

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

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

[0262] In the Figures 4 to 28 example shown in FIGS. 59 - 100, the patient interface is a full face / nasal-oral interface type configured to form a seal around the patient's nose and mouth and includes a seal-forming structure 6200. However, the methods of the present technology can be adapted to be used with other suitable interface types (such as nasal interfaces, nasal plugs).

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

[0264] Frame assembly

[0265] As Figures 18 to 26 best shown, the frame assembly 6100 includes a shroud or wall member 6110, an upper headband connector 6130 provided to the upper portion of the shroud 6110, and a lower headband connector 6150 provided to the lower portion of the shroud 6110. The frame assembly 6100 provides a connection between the buffer assembly 6175 and the elbow assembly 6600, and also provides a connection between the buffer assembly 6175 and the headband 6800, for example, in a detachable or more permanent manner, to allow the sealing force to be transferred from the headband 6800 to the buffer assembly 6175. In the example shown, the upper headband connector 6130 and the lower headband connector 6150 provide a four-point connection with the headband 6800.

[0266] The shroud 6110 (e.g., made of a relatively rigid plastic material such as polycarbonate) includes an opening 6105 through which the elbow assembly 6600 passes and sealingly engages with the buffer assembly 6175 (see, for example, Fig.13 and 14 ).

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

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

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

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

[0271] The outer annular flange 16115 projects forward from the front or positive side of the shroud 16110. The flange 16115 includes an edge 16117 along its free end, the edge defining an annular channel 16120 configured to engage the elbow assembly 16600.

[0272] The inner annular flange 16125 projects rearward from the rear or front side of the shroud 16110. The flange 16125 includes a plurality of tabs or latches 16127 (e.g., see Fig.70 , 76 , 84, 86, and 88), e.g., 2, 3, 4 or more tabs, which are configured to provide a mechanical interlock (e.g., a slip-fit connection) with the buffer assembly 16175 to releasably connect the frame assembly 16100 to the buffer assembly 16175. In the illustrated example, the tabs 16127 are provided on the front and lower sides (i.e., the east and south sides) of the flange, however, alternative arrangements are possible, e.g., tabs provided on the front and rear sides (e.g., the east and west sides) of the flange.

[0273] Additionally, a radially inwardly extending ridge 16400 projects from the flange 16125 into the opening 16105. As described in more detail below, the ridge 16400 acts as a stop to prevent over-insertion of the elbow assembly 16600 into the frame assembly 16100. Moreover, the ridge 16400 provides a dynamic face seal with the elbow assembly 16600.

[0274] Moreover, the ridge 16400 includes a plurality of protrusions (e.g., 2, 3, 4 or more protrusions) along its circumference, which are configured to provide a blocking 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-asphyxiation 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 configured and arranged to have a minimal or no effect on noise (generated by flow through the opening 16105), to have an air delivery impedance (at the inlet to the patient), and to have a CO 2 flush (into the vent of the elbow assembly 16100).

[0276] In the nasal interface example, e.g., see 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., made of a relatively rigid 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 rear 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 slip-fit connection) with the buffer 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 extending from the respective sides of the shield connection portion 6132 and configured to connect to the respective upper headband straps of the headband. Each of the upper headband connector arms 6134 includes two flexible portions 6140, 6145. 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 the respective sides of the shield connection portion 6152 and configured to connect to the 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 and configured to receive the respective upper headband strap 6802 of the headband. In the illustrated example, each lower headband connector arm 6154 includes a magnetic connector 6155 in the form and configured to locate and connect to a magnet 6162 associated with a headband clip 6160 provided to the respective 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 can be connected to the headband straps of the headband in other suitable ways.

[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 profiles. 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 curves upwardly between the eye and the ear to avoid blocking the patient's vision, positions headband attachment points (such as slots 6135) such that the upper headband strap extends upwardly and clears the patient's ear, and provides a force vector that extends generally parallel to the Frankfurt horizontal plane (see, for example, Figure 4 and 5 ).

[0282] The upper arms 6134 are also curved (orthogonal to the facial plane) to conform to the facial profile, for example, these arms curve to generally match the curvature of the cheekbones and avoid loading on the temples.

[0283] The rigidity of the upper arms 6134 resists deformation to maintain their pre - determined shape to ensure that the frame assembly 6100 positions the headband attachment points in the same location and avoids converting headband tension into compressive forces that cause uncomfortable facial contact with the upper arms.

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

[0285] In one example, the rigidity or stiffness of the upper arms causes them to maintain a pre - formed 3D shape (not floppy) configured to conform to the facial profile and position the headband attachment points in place. Each upper arm maintains its pre - formed shape due to its rigidity or stiffness in a particular orientation. The upper arms are configured to have less resistance (less stiffness or rigidity) to bending into and away from the face to accommodate different facial widths. The rigidity of the upper arms causes them to be substantially undeformed under the tension applied by the headband straps, thereby acting as an intermediary between the headband straps and the cushioning assembly to convert the tension from the headband straps into compressive forces applied to the seal - forming structure to provide a seal and stability on the face. The shape of the upper arms also applies appropriate force vectors via the housing to the seal - forming structure to achieve a stable and comfortable seal. In one example, the seal - forming structure is pulled into the face (i.e., directly pulled back onto 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 stiffness to resist deformation under torsion. The upper arm also resists bending deformation vertically up and down along the face (i.e., remains at the correct height above the ear). However, the upper arm is also configured to provide a predetermined level of deformation to allow bending (allowing bending towards / away from the face) for adjustment to different face widths. Additionally, the upper arm also has resilience / elasticity in this orientation to allow the upper arm to return to its initial position. When the headband strap is tightened by absorbing some of these tensions due to its flexibility, this feature also prevents discomfort by minimizing the load / force applied by the frame assembly. In some positions, the upper arm also provides substantially rigidity / hardness to avoid contacting the face, where these arms can act as supports to resist bending deformation from headband tension or compression into the face. Conversely, in other positions, the flexibility of the arms can allow these arms to collapse under tension or compression from side loads (e.g., when the patient sleeps on their side, thereby applying a side load to the patient interface. These arms absorb the compressive force applied by the side load and prevent it from moving the seal-forming structure. This flexibility also allows for better adaptation 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 bend to accommodate different face widths (between patients). For example, for a wide face, the central flexible portion 6140 allows the arms 6134 to bend away from each other and outwardly away from the face, and for a narrow face, the central flexible portion 6140 allows the arms 6134 to bend towards each other and towards 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 slot 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 side and / or rear side) of the arm, the spacing between slots, the width, depth, orientation, or angle of the slot on the arm. In one example, the slot 6141 can be filled with a flexible material. In alternative examples, the hinge can be provided by many different methods, such as 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 respective arm 6134 to adapt to different curvatures or contours of the user's face, such as adapting to cheek variations between patients. For example, the peripheral flexible portion 6145 is hinged to adapt to the cheek width and contour above the user's cheekbones. In the illustrated example, the peripheral flexible portion 6145 of each arm 6134 includes a plurality of slots 6146 (slots on each side of the nose, i.e., on the front and back sides of the nose) that form a plurality of hinges in the cheek area. The hinges allow the arm 6134 to articulate and adapt to minor variations in the cheek area and distribute the load more evenly over the face under headband tension, e.g., when compared to a rigid arm without any bending.

[0291] In the illustrated example, the slots 6146 are generally parallel to each other, generally evenly spaced from each other, and include a similar width and depth into the arm thickness. However, it should be understood that the slots 6146 may include other suitable arrangements and configurations to alter 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 of the slots 6146 may be filled with a flexible material. In an alternative example, the hinge may be provided by a plurality of flexible portions (by material) spaced apart by rigid segments.

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

[0293] In the illustrated example, to minimize discomfort, the upper arm 6134 may have a smooth and curved surface profile to distribute the load and allow these arms to flip over the face without a concentrated load or piercing into the face. For example, as Fig.26 shown, each upper arm 6134 may include a generally diamond-shaped cross-section, e.g., generally flat on either side but slightly domed-shaped, to increase contact comfort.

[0294] In one example, the lower headband connector arm 6154 is relatively more flexible than the upper headband connector arm 6134, e.g., the lower headband connector arm 6154 has less resistance to torque such that they can twist with the lower headband strap of the headband. This flexibility allows the lower arm 6154 to twist and turn with the lower headband strap to prevent the retention feature from being forced disconnected under these forces, i.e., maintaining the connection of the lower arm to the lower headband strap.

[0295] Each lower arm 6154 includes a magnetic connector 6155 (such as an armored magnet) configured to locate and connect to a headband clip 6160 that provides a corresponding lower headband strap to the headband. The magnetic connector 6155 also provides a socket 6156 that allows insertion and retention of a corresponding protrusion (e.g., provided by a magnet 6162 of the headband clip 6160) to resist disconnection from 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 socket 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 into the socket 6156.

[0296] The upper arm 6134 and the lower arm 6154 are connected to the shield 6110 through 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, and these pins form rivets to mechanically fix the upper arm 6134 and the lower arm 6154 to the shield 6110 after the molding process (e.g., see Fig.21 , 24 and 25). In the illustrated example, the shield 6110 includes an upper slot 6111 and a lower slot 6112 configured to receive the respective shield connection portions 6132, 6152 of the upper headband connector and the lower headband connector, and the openings 6113, 6114 for fixing the upper headband connector and the lower headband connector are provided within these slots 6111, 6112 (e.g., see Fig.24 and 25 ). However, it should be understood that the upper headband connector arm 6134 and the lower headband connector arm 6154 can be connected to the shield 6110 in other suitable ways (e.g., detachable connection).

[0297] In one example, the upper arm 6134 and / or the lower arm 6154 can be covered with fabric, for example, for aesthetics and to increase the soft / comfortable feeling. For example, Figure 4 and 5 show a fabric arm cover or pad 6750 provided to the upper arm 6134, while Figures 6 to 10 e.g., shows the upper arm 6134 with the arm cover 6750 removed.

[0298] The upper and lower arms can provide the target flexibility in alternative ways. For example, these arms can be formed of a single material with 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, these arms can be formed of two or more materials, each with different elastic properties / Young's moduli. For example, the rigid portions can be formed of a rigid material such as polycarbonate, and each rigid region can be connected by a moderately flexible / soft material such as liquid silicone resin to provide the target flexion. In another example, these arms can be formed of different material layers. For example, these arms can be formed of at least one bendable or flexible first layer. The flexible first layer can provide a base surface for a plurality of rigid portions that 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 required stiffness (e.g., resistance to torque forces, maintaining a preformed shape, etc.) for maintaining the patient interface in the desired position. However, in some cases, these arms can provide reduced comfort due to the hardness and rigidity of the components (i.e., the resistance to conform to the face). This discomfort is due to a combination of the tactile sensation and the resistance to conform to changes in the facial contour, which can provide an unwanted load on sensitive parts of the face. To overcome this aspect, these arms can be coated or covered with a softer and in some cases less rigid material. The material can be used to absorb some or all of the compressive forces exerted by the arms on the user's face. Additionally, the soft and / or less rigid material can be used to conform to changes in the facial contour, thus acting as a conforming layer. Further, the arms can be coated or covered with a tactile layer that has a desired tactile sensation when in direct contact with the user's face. The tactile layer can include a desired fabric having an enhanced tactile sensation and a desired predetermined stretch characteristic. The arms can also include a conforming layer for absorbing the compressive forces exerted by the arms on the user's face and / or following facial changes by conforming to the facial contour, the conforming layer including a less rigid and / or soft material such as foam.

[0300] In one example, the haptic layer and the compliant layer can be constructed to not substantially change the functionality of these arms or include materials that do not substantially change the functionality of these arms. That is, these layers should not change the preformed shape of these arms. Additionally, these layers should allow these arms to bend / flex in the specific orientations defined. Thus, these layers should be constructed to maintain the functionality of these arms or include selected materials to maintain the functionality of these arms. Additionally, these layers can be permanently or semi-permanently fixed to these arms. Alternatively, these arms can include a detachable layer that covers these arms. For example, the detachable layer can be a fabric cover or padding. The arms can include an upper surface for contact with the user's face. The upper surface can include a foam layer over a rigid material, which is then covered by the haptic layer. The arms can also include a lower surface covered by the haptic layer.

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

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

[0303] In the example shown, each upper headband connector arm 16134 includes a headband connection point in the form of a slot 16135 and configured to receive a corresponding upper headband strap 16802 of the headband. As Fig.104As best shown, the bridge or crossbar 16136 that defines the slot 16135 includes a tapered leading edge 16136A (such as a knife-like edge) to facilitate the assembly / dismantling of the upper headband strap 16802 of the headband. For example, the tapered leading edge 16136A can easily slide through the VelcroTM-like hook piece 16803 and the rest of the upper headband strap 16802 and slide between them to facilitate assembly / dismantling without having to completely release the VelcroTM-like hook piece 16803 from the rest of the upper headband strap 16802. In the illustrated example, each lower headband connector arm 16154 includes a magnetic connector 16155 in the form of a magnetic connector and is configured to locate and connect to a magnet associated with the headband clip 16160 provided to the 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 straps of the headband in other suitable ways.

[0304] Similar to the upper headband connector arms described above, each upper headband connector arm 16134 is structurally rigid to resist torque (twisting) and each includes a central flexible portion 16140 and a peripheral flexible portion 16145 to accommodate different facial profiles. 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 illustrated example, the central flexible portion 16140 of each arm 16134 includes a single slot 16141 (on the rear side) that forms a hinge. In the illustrated example, the peripheral flexible portion 16145 of each arm 16134 includes a plurality of slots 16146 (on each side of the nose, i.e., slots on the front side and / or rear side of the nose) that form a plurality of hinges in the cheek region.

[0306] In an example, the peripheral flexible portion 16145 of each arm does not need to include slots on the front side or rear side. Instead or additionally, the flexible portion can include one or more interconnected elastomeric (such as silicone) portions that can form a flush or smooth transition between relatively rigid plastic portions, but allow bending, flexing, and / or pivoting. These can be done by insert or overmolding, where the relatively rigid plastic portions are placed in a mold and the interconnected portions are molded over the relatively rigid plastic portions.

[0307] Each lower headband connector arm 16154 includes a magnetic connector 16155 (including an armored magnet 16155B) configured to locate and connect to a headband clip 16162 (including an armored magnet 16162) provided to the corresponding lower headband strap of the headband. For example, see Fig.103。In the illustrated example, the end of each lower arm 16154 includes a magnet receiving portion 16155A that receives and aligns magnet 16155B and a cover 16155C that encloses and holds magnet 16155B to the magnet receiving portion 16155A. As shown, the magnetic connector 16155 provides a protrusion that allows it to be inserted and retained in a corresponding socket provided by the headband clip 16160, for example see Fig.103 。The headband clip 16160 includes a buckle or retaining wall 16164 that resists disconnection from the headband strap tension while allowing the headband clip 16160 to rotate relative to the corresponding lower arm 16154 (e.g., allowing 360° rotation). In the illustrated example, as Fig.101 、 102 and 103 show, the buckle or retaining wall 16164 (e.g., semi-circular cross-section or U-shaped) provides a mechanism retaining member to mechanically engage with the semi-circular peripheral region of the connector 16155. In one example, the magnetic connector 16155 and / or the buckle or retaining wall 16164 may be angled or tilted to provide an undercut that facilitates retaining the headband clip 16160 on the magnetic connector 16155.

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

[0309] In an alternative example, as Fig.97 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 into the cover molding tool and then over-molding the cover 16155C to the lower arm / magnet.

[0310] In the illustrated example, each lower headband connector arm 16154 includes a single slot 16156 (on the rear side) that forms a hinge portion, for example see Fig.75 and 76This hinge portion is constructed and arranged to accommodate facial width variations by allowing the lower arm 16154 to bend away from the patient's face during use, such as allowing for simple adjustment during initial fitting of the patient interface and allowing accommodation of facial geometry without affecting the seal of the patient interface. Further, the hinge portion allows the lower arm 16154 to move or bend with the corresponding headband tab 16160 during use, such as to prevent inadvertent disengagement of the headband tab 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 connection 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] As Figures 83 to 86 shown, the shroud 16110 includes a pair (i.e., right and left) of upper anchors or upper arm connectors 16450 on respective sides of the upper portion of the shroud 16110 and a pair (i.e., right and left) of lower anchors or lower arm connectors 16460 on respective sides of the lower portion of the shroud 16110. Each upper anchor 16450 provides an opening 16452 and each lower anchor 16460 provides an opening 16462.

[0313] As Fig.90 and 91 shown, the shroud connection portion 16152 of each lower arm 16154 includes a protrusion 16153 received in the 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 shroud connection portion 16152 to the cover 16157. The shroud connection portion 16152 and the cover 16157 are ultrasonically welded to secure the shroud connection portion 16152 to the cover 16157, thereby securing the lower arm 16154 to the lower anchor 16460.

[0314] In the illustrated example, the cover 16157 is symmetric to facilitate manufacturing and assembly. However, it should be understood that the cover for securing the lower arm can be asymmetric. For example, Figures 92 to 95 an alternative arrangement is shown where the lower arm 17154 is secured to the shroud 17110 by a respective asymmetric cover 17157.

[0315] Similarly, as Fig.99 and 100As shown, the shroud connection portion 16132 of each upper arm 16134 includes a protrusion 16133 received in an opening 16452 of a corresponding upper anchor 16450. The protrusion 16133 includes an opening 16133A that receives a protrusion 16138 provided to the cover 16137, joining and interlocking the shroud connection portion 16132 to the cover 16137. The shroud connection portion 16132 and the cover 16137 are ultrasonically welded to fix the shroud connection portion 16132 to the cover 16137, thereby fixing the upper arm 16134 to the upper anchor 16450.

[0316] However, it should be understood that the upper headband connector arm 16134 and the lower headband connector arm 16154 can be connected to the shroud 16110 in other suitable ways (e.g., detachable connection). For example, Fig.98 A connector arm 17134 connected to an anchor 17450 by a slip-in joint is shown, for example, pushed through a slip-in joint arrangement that includes a peg configured to engage within a corresponding opening by a slip fit.

[0317] In one example, the upper anchor 16450 and / or the lower anchor 16460 of the shroud 16110 can be configured to enhance strength. For example, sharp corners along the anchor can be eliminated to reduce stress concentration, such as the edges along the opening of the anchor can be rounded (e.g., see Fig.87 ). Also, the bridging member of the anchor can be provided with an increased thickness to increase the strength of the part, see the bridging member 16454 of the upper anchor 16450 in Fig.87 . Additionally, ribs can be provided to the arms of the anchor to enhance strength, such as the ribs 16456 provided to the arms of the upper anchor 16450 in Fig.87 .

[0318] In one example, the upper arm 16134 and / or the lower arm 16154 can be covered with fabric, for example, for aesthetics, to increase the soft / comfortable feeling, to provide comfort on the face, and to minimize markings. For example, Figures 59 to 61 A fabric arm cover or pad 16750 provided to the upper arm 16134 is shown, while Figures 62 to 65 for example, the upper arm 16134 with the arm cover 16750 removed is shown. The cover 16750 hides the upper arm 16134, making the outer surface smooth to increase comfort on the face, for example, without markings and easy to slide on the face surface. The cover 16750 can be optionally detachable.

[0319] In one example, at least a portion of the upper arm 16134 and / or the lower arm 16154 includes a dent or a gold ball pattern, for example, for aesthetics.

[0320] In the nasal interface example, for example, see Figures 42 to 49, the headband connector 7130 includes a shroud connection portion 7132 connected to the shroud 7110, a pair (i.e., right and left) of upper headband connector arms 7134 configured to connect to the corresponding upper headband strap 7802 of the headband 7800, a pair (i.e., right and left) of lower headband connector arms 7154 configured to connect to the corresponding lower headband strap 7804 of the headband 7800, and an intermediate portion 7133 that interconnects the upper arm 7134 and the lower arm 7154 with the shroud connection 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 and is configured to receive the corresponding upper headband strap 7802 of the headband 7800 (see Fig.29 ). In the illustrated example, each lower headband connector arm 7154 includes a magnetic connector 7155 in the form and is configured to locate and connect to a magnet associated with a headband tab 7160 provided to the corresponding lower headband strap 7804 of the headband 7800 (see Fig.29 ). However, it should be understood that the upper headband connector arms 7134 and the lower headband connector arms 7154 can be connected to the headband straps of the headband in other suitable ways.

[0322] Similar to the above example, each intermediate portion 7133 of the headband connector 7130 assembly includes a flexible portion 7140 that accommodates different facial profiles, such as accommodating changes in facial width. In the illustrated example, the flexible portion 7140 includes a single slot (on the front side and / or rear side) that forms a hinge portion adjacent to the buffer assembly.

[0323] As Fig.48 and 49 shown, the headband connector 7130 can include a multi - layer configuration, such as different material layers to provide the required flexibility.

[0324] Buffer assembly

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

[0326] The housing 6180 includes an opening 6305 through which breathable gas is delivered to the inflation chamber 6500. The opening 6305 is defined by an annular flange 6310 that is adapted to connect to the frame assembly 6100 and is 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 an inflation chamber for delivering pressurized gas to the patient airway inlet. The housing 6180 is a rigid structure that directs forces onto a seal-forming structure to seal to the patient's face. The forces are provided by the tension generated by fastening the headband straps. These forces are transferred from a pair of upper headband straps and lower headband straps to corresponding upper and lower arms. In one example, the upper and lower arms provide to a frame assembly that provides headband tension to the housing 6180.

[0328] The housing 6180 also provides an outer (or front) surface to engage the inner (or back) surface of a shroud of the frame assembly to effect a seal. The housing also includes separate retention features or is otherwise configured to removably engage to the inner surface of the frame assembly. The patient interface is modular such that a single frame assembly size is capable of connecting to multiple cushion assembly sizes (e.g., small to large). Thus, the housing is also removably engageable to the frame assembly such that the frame assembly is connected to a predetermined configuration that corresponds to its respective cushion assembly size. For example, a smaller cushion assembly has an overall reduced height relative to a medium or large cushion assembly. Thus, the frame assembly is connected in a position relative to the cushion assembly to position the upper headband attachment point in its correct location (between the eyes and ears while providing an attachment point where the upper headband strap clears the ears). This means that the frame assembly is connected at a higher location on the housing compared to a medium or large cushion assembly size. In one example, a medium size and / or large size may not have this requirement and are connected such that the frame assembly is positioned in substantially the same location.

[0329] In Figures 75 to 100 the alternative example shown, the cushion assembly 16175 includes a housing 16180 that is connected to or otherwise provides to a seal-forming structure or cushion 16200 (see Fig.73 and 74 ). The housing 16180 and the cushion 16200 cooperate to form an inflation chamber 16500 (e.g., see Fig.69 and 71 ). The housing 16180 includes an opening 16305 through which breathable gas is delivered to the inflation chamber 16500. The opening 16305 is defined by an annular flange 16310 that is adapted to connect to the frame assembly 16100.

[0330] In a nasal interface example, for example see Figures 39 to 41 , the buffer assembly 7175 includes a housing 7180 that is permanently (e.g., co-molded, overmolded) connected to a seal-forming structure or buffer 7200. In one example, the buffer 7200 is made of a relatively flexible or soft material (e.g., silicone) and the housing 7180 is made of a relatively rigid material (e.g., polycarbonate). The housing 7180 and the buffer 7200 cooperate to form an inflatable chamber 7500. In the illustrated example, a flexible flange or lip seal 7250 (i.e., the seal 7250 provides a seal with the elbow assembly 7600) is provided integrally with the buffer 7200, e.g., interconnected by a connecting portion 7149 Fig.38 and 39 the seal 7250 and the buffer 7200 shown.

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

[0332] In one form of the present technology, the housing 6180 of the buffer assembly 6175 is repeatedly engageable with and removable from the shroud 6110 of the frame assembly 6100 by mechanical interlocking (e.g., a slip-fit connection).

[0333] The buffer assembly 6175 and the frame assembly 6100 include cooperating retention structures that connect the buffer assembly 6175 to the frame assembly 6100. In one example, the frame assembly 6100 is removably connected to the buffer assembly 6175 to facilitate placement and / or cleaning and to allow alternative frame assemblies and buffer 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 thus provides a patient interface suitable for multi-patient multi-use (MPMU) usage scenarios. In an alternative example, the frame assembly 6100 may be permanently connected to or integrally formed as one piece with the buffer assembly 6175, e.g., co-molded

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

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

[0336] In the illustrated example, the housing 6180 of the buffer assembly 6175 and the shroud 6110 of the frame assembly 6100 are relatively rigid (e.g., formed of a relatively hard material such as polycarbonate) such that the engagement between the housing 6180 and the shroud 6110 provides a rigid connection. Moreover, 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, e.g., clean, smooth, curved mating surfaces. That is, the relative rigidity or hardness of the shroud and the housing maintains the preformed structure of the component. The hardness allows the component to maintain its shape such that it can be easily aligned for connection.

[0337] It should be understood that the buffer assembly can be connected or interlocked with the frame assembly in other suitable ways. For example, these components can be connected by clips.

[0338] In an alternative example, as Fig.70 and 72 best shown in, the inner annular flange 16125 of the shroud 16110 extends through the opening 16305 of the housing 16180, and the tabs or latches 16127 of the flange 16125 engage or interlock on the rear side of the annular flange 16310 of the housing 16180 to detachably connect the frame assembly 16100 to the buffer assembly 16175. This connection maintains ease of use, provides a sealed rigid connection, allows for vibrational and rocking movement between components, and reduces the impact on stability. Moreover, this connection stability holds the buffer assembly 16175 in place while allowing an appropriate force vector to be applied to the buffer assembly 16175 for sealing.

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

[0340] In the nose interface example, for example, see Figures 30 to 49, the housing 7180 includes a plurality of tabs or latches 7315 along the perimeter of the flange 7310, which are configured to engage or interlock (e.g., by a slip fit) with corresponding tabs or arms 7125 on the rear side of the shroud 7110 to detachably connect the buffer assembly 7175 to the frame assembly 7100.

[0341] The buffer assembly 7175 also includes one or more recesses 7320 (e.g., see Fig.41 )(e.g., downward recesses) along the perimeter of the flange 7310, which are configured to engage or interlock with corresponding protrusions 7127 on the rear side of the shroud 7110 (e.g., see Fig.43 ), e.g., to facilitate alignment and prevent relative rotation.

[0342] In another example, as Figures 55 to 58 shown, the housing of the buffer assembly 8175 may include a central hole having an inner surface, which is configured to receive the annular central flange of the frame assembly 8100. The housing includes a retaining feature that interlocks or connects to a retaining feature on the frame assembly. Additionally, a clearance is maintained within the housing bore to allow the bellows structure 8250 ( Fig.55 and 56 ) of the vent adapter 8900 or the elbow assembly 8600 ( Fig.57 and 58 ) to engage the housing surface 8275 to achieve a face seal.

[0343] The buffer assembly 6175 and the frame assembly 6100 are configured to maintain engagement during use and prevent any inadvertent or partial disassembly during use.

[0344] In one form of the present technology, the frame assembly 6100 engages the buffer assembly 6175 by moving the frame assembly 6100 rearwardly towards 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 forwardly away from the buffer assembly 6175 in a direction substantially parallel to the Frankfurt plane.

[0345] Elbow assembly

[0346] As Fig. 27 and 28 shown, the elbow assembly 6600 includes a first end portion 6610 that is repeatedly engageable with and detachably separable from the shroud 6110 of the frame assembly 6100 and a second end portion 6620 that is adapted to be connected to the air circuit 4170, e.g., by 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 buffer assembly 6175.

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

[0350] In an alternative example, as Fig.59 、 65 、shown in 70 and 72, the elbow assembly 16600 includes a first end portion 16610 having squeeze arms 16650 releasably engageable with the frame assembly 16100 and a second end portion 16620 adapted to be connected to the air circuit 4170, e.g., by 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 defining a radial channel 16645, the radial channel forming a plurality of vent holes 16700 to allow the discharged gas to escape from the patient interface.

[0352] Additionally, the elbow assembly 16600 is configured to accommodate an AAV assembly, which includes a configuration to allow the patient to breathe through the port if the pressurized gas is not in sufficient quantity or not delivered.

[0353] Fig.50 and 51 An elbow assembly 7600 configured to be connected to a nasal-type patient interface 7000 is shown. Fig.52 and 53 An alternative elbow assembly 9600 configured to be connected to the nasal-type patient interface 7000 is shown.

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

[0355] As Fig.51 and 53Best shown in , the raised portion of the button and the side strips within the slots along each side of the button are constructed of a soft tactile material (such as TPE). The raised portion provides a soft touch for easy use and grasping, and the side strips provide sealing, a soft touch, and spring force (clip return force). In one example, the raised portion and the side strips are overmolded onto the elbow body (including the button).

[0356] As Fig.50 and 51 shown, the elbow assembly 7600 includes a vent assembly 7700 that allows exhaled air to be flushed out.

[0357] Connection between the elbow assembly and the frame assembly

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

[0359] Since the elbow assembly 6600 is connected to the frame assembly 6100 independently of the buffer assembly 6175, the patient can remove and exchange buffer assemblies of different sizes without disconnecting the elbow assembly 6600, the frame assembly 6100, and the headband.

[0360] Similarly, in an alternative example, as Fig.72 best shown in , the circular channel 16120 of the frame assembly 16100 is configured to receive the hook end 16652 of the extrusion arm 16650 to releasably hold the elbow assembly 16600 to the frame assembly 16100.

[0361] Seal between the elbow assembly and the buffer assembly

[0362] In one example, the buffer 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 inward into the opening 6305. As Fig.13 and 14 shown, the elbow assembly 6600 is configured to mechanically interlock with the frame assembly 6100 but is constructed and arranged to sealingly engage with the seal film 6250 of the buffer assembly 6175 to form a seal of 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 form 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 nasal interface example, see, for example, Fig.37 and 38 , the elbow assembly 7600 is configured to mechanically interlock with the frame assembly 7100, and the leading edge of the sidewall 7630 of the elbow assembly 7600 is configured and arranged to sealingly engage with the lip seal 7250 of the bumper assembly 7175 to form a seal of the air flow path.

[0365] Seal between elbow assembly and frame assembly

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

[0367] Blocking feature

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

[0369] As Fig.72Best shown in, each protrusion 16405 extends to the inner wall 16630 of the elbow assembly such that the protrusion 16405 does not significantly extend into the patient's inlet flow path. Additionally, each protrusion 16405 includes an opening 16407 (e.g., see Fig.72 , 83 and 88), such that the protrusion 16405 does not significantly block the flow of the outlet to the passage 16645 leading to the vent hole 16700 of the elbow assembly 16100. Accordingly, the plurality of protrusions 16405 are constructed and arranged to have a minimal or no effect on the noise (generated by the flow through the opening 16105), have an air delivery impedance (into the patient's inlet), and have CO 2 flushing (into the vent of the elbow assembly 16100).

[0370] In an alternative example, as Fig.89A shown, each protrusion 16405 may be provided without an opening.

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

[0372] Vent adapter connector

[0373] In an alternative example, a vent adapter connector may 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 may be releasably connected to the frame assembly 6100 independent of the buffer assembly 6175 and may be sealingly engaged with the sealing membrane 6250 of the buffer assembly 6175 to form a seal of the air flow path.

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

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

[0376] In an alternative example, as Figures 55 to 58As shown, the elbow assembly 8600 / vent adapter connector 8900 includes a seal or bellows structure 8250 (e.g., formed of silicone), which is configured to engage an inner surface 8275 of a housing that provides access to the buffer assembly 8175. The bellows structure is configured to move toward the inner surface of the housing when the pressure within the component increases, i.e., a pressure - supported seal. The bellows structure engages the inner surface on 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 retention - forming features. In one example, the frame includes retention features that include 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. Thus, another advantage of the bellows face seal is that it provides a seal between components with minimal friction to allow a large amount of relative movement without breaking the seal. In one example, the frame assembly is configured such that it does not form part of the patient air delivery path, but is configured 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 a hole 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 buffer assembly, i.e., the patient can stop treatment but the patient interface remains on the face. This configuration also allows the user to remove the buffer assembly from the frame assembly and the 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 a headband, so the headband can remain connected to the frame assembly and the vent adapter connector / elbow assembly while the user tries different buffer assembly sizes (e.g., small, medium, large) without having to reassemble multiple components.

[0379] Modularity

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

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

[0382] Similar to the above, a frame component 7100 of a nasal interface type can be provided in one size (i.e., a common frame component), which can selectively engage with buffer components 7175 of different sizes (e.g., small buffers, medium buffers, and large buffers). For example, Fig.54A 、 54B 54C are rear views of small, medium, and large buffer components 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 Seal-forming structure

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

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

[0386] In one form, the seal-forming structure includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness less than about 1 mm, e.g., about 0.25 mm to about 0.45 mm, which extends around the perimeter of the inflation chamber. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the edge of the inflation chamber and extends around at least a portion of the perimeter path. The support flange is or includes a spring-like element and serves to support the seal flange against bending during use. In use, the seal flange can easily respond to the system pressure acting on its bottom surface in the inflation chamber, thereby forming a tight seal engagement with the face.

[0387] In one form, the seal-forming portion of the non-invasive patient interface includes a pair of nasal jets or nasal pillows, each of which is 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 frustum of a cone that forms a seal on at least a portion of the bottom surface of a patient's nose; a stem; and a flexible region on the bottom surface of the frustum of the cone that connects the frustum of the cone to the stem. Additionally, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can cooperate to facilitate the formation of a universal connection structure that is capable of adjusting with respect to relative movement including both displacement and angular movement between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the position of the frustum of the cone can be axially moved towards the structure to which the stem is connected.

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

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

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

[0392] 5.3.2 Inflatable chamber

[0393] In the region that forms a seal in use, the inflatable chamber has a perimeter that is complementary to the surface profile of an average person's face. In use, the boundary edge of the inflatable chamber is in very close proximity to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure. The seal-forming structure can extend along the entire perimeter of the inflatable chamber in use.

[0394] 5.3.3 Positioning and stabilization structure

[0395] The seal-forming structure of the patient interface of the present technology can be held in a sealed position in use by a positioning and stabilization structure.

[0396] In one form of the present technology, a positioning and stabilization structure is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilization structure has a reduced side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilization structure includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure includes at least one flat strap.

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

[0398] In certain forms of the present technology, the positioning and stabilization 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 forces to make the buffer seal in contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0399] In certain forms of the present technology, the positioning and stabilization structure includes a strap that is bendable, e.g., non-rigid. The 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, the positioning and stabilization structure provides a holding force that is configured to correspond to a particular head size and / or face shape. For example, one form of the positioning and stabilization structure provides a holding force suitable for a large-sized head and not suitable for a small-sized head. In one example, one form of the positioning and stabilization structure provides a holding force suitable for a small-sized head and not suitable for a large-sized head.

[0401] 5.3.4 Ventilation Ports

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

[0403] One form of the ventilation port according to the present inventive technology includes a plurality of holes, e.g., from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0404] The ventilation ports can be located in the inflation chamber. Alternatively, the ventilation ports are located in a decoupling structure such as a swivel shaft.

[0405] 5.3.5 Decoupling Structure

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

[0407] 5.3.6 Connection Port

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

[0409] 5.3.7 Forehead Bracket

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

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

[0412] 5.3.8 Anti-asphyxiation valve

[0413] In one form, the patient interface includes an anti-asphyxiation 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 inflation chamber. In one form, this enables a clinician to provide supplemental oxygen. In one form, this enables direct measurement of the properties of the gas within the inflation chamber, such as pressure.

[0416] 5.4 Glossary

[0417] For the purposes of implementing the disclosure of the present technology, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

[0418] 5.4.1 General principles

[0419] Air: In certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to refer to some other combination of breathable gases, such as oxygen-rich atmospheric air.

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

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

[0422] In another example, the environment pressure may be the pressure directly surrounding the body or outside the body.

[0423] In certain forms, the environment (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, apart from, for example, the noise generated by the RPT device or from the mask or patient interface. The ambient noise may be generated by a sound source outside the room.

[0424] Automated Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy where the therapy pressure is automatically adjustable between a minimum and a maximum, e.g., varying with each breath, depending on the indication of the presence of an SBD event.

[0425] Continuous Positive Airway Pressure (CPAP) Therapy: A form of respiratory pressure therapy where the therapy pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increasing in response to detection of an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

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

[0427] In an example of patient breathing, flow can be nominally positive for the inspiratory portion of the patient's respiratory cycle and thus negative for the expiratory portion of the patient's respiratory cycle. Total flow (Qt) is the air flow leaving the RPT device. Ventilation flow (Qv) is the air flow leaving the vent to allow the exhaled gas to flush. Leakage flow (Ql) is the leakage flow from the patient interface system. Respiratory flow (Qr) is the air flow received into the patient's respiratory system.

[0428] Leakage: The word leakage will be considered an undesired air flow. In one example, leakage can occur due to an imperfect seal between the mask and the patient's face. In another example, leakage can occur in the return elbow to the surrounding environment.

[0429] Noise, Conducted (Acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and the 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 document refers to the noise brought 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, ventilatory (acoustic): The ventilatory noise in this document refers to the noise generated by the air flow through any vent (such as the vent in the patient interface).

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

[0433] Pressure: Force per unit area. Pressure can be measured in units including cm H 2 O, g-f / cm 2 and hectopascals. 1 cm H 2 O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in units of cm H 2 O.

[0434] The pressure in the patient interface is given by the symbol Pm, while the therapeutic pressure is given by the symbol Pt, and the therapeutic pressure represents the target value obtained through the mask pressure Pm at the current moment.

[0435] Respiratory pressure therapy (RPT): Applying an air supply to the inlet of the airway at a therapeutic pressure, which is typically positive relative to atmospheric pressure.

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

[0437] 5.4.1.1 Materials

[0438] Silicone or silicone elastomer: A synthetic rubber. In this specification, the reference to silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is the Wacker Group. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or type A) indentation hardness in the range of approximately 35 to approximately 45 as measured using ASTM D2240.

[0439] Polycarbonate: A transparent thermoplastic polymer typically 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 the energy when relaxed.

[0442] · 'Rebounding': Will release substantially all of the energy when relaxed. Includes certain silicone rubbers and thermoplastic elastomers.

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

[0444] · 'Soft' materials can include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure.

[0445] · 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and are not easily deformed, for example, under finger pressure.

[0446] Hardness (or stiffness) 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] · 'Soft' structure or component: A structure or component that will change shape, such as bend, when made to support its own weight within a relatively short period of time, such as 1 second.

[0448] · 'Rigid' structure or component: A structure or component that will essentially not change shape when subjected to loads typically encountered in use. An example of such use can be setting and maintaining a patient interface in a sealed relationship with the inlet of a patient airway, for example, under a load of about 20 to 30 cm H 2 O pressure.

[0449] As an example, an I-beam can include different bending hardness (resistance to bending load) 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 the flow drops below a predetermined threshold for a continuous period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow even with patient effort. Central apnea is said to have occurred when a respiratory arrest is detected due to reduced or absent respiratory effort although the airway is open. 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 respiratory rate, usually measured in breaths per minute.

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

[0454] Effort (breathing): The work done by a spontaneously breathing patient in attempting to breathe.

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

[0456] Flow limitation: Flow limitation will be considered a state in a patient's breathing where an increase in the patient's effort does not result in 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] Inspiratory waveform with type-limited flow rate:

[0458] (i) Flat: Having a rising then relatively flat portion, then descending.

[0459] (ii) M-shaped: Having 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-shaped: Having a single local peak at the leading edge, followed by a relatively flat portion.

[0461] (iv) Reverse chair-shaped: Having a relatively flat portion, followed by a single local peak at the trailing edge.

[0462] Hypopnea: By some definitions, hypopnea will be considered a decrease in flow, but not a cessation of flow. In one form, hypopnea may be said to have occurred when flow drops below a threshold for a period of time. Central hypopnea may be 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% reduction in the patient's breathing lasting at least 10 seconds plus a related 4% decrease in saturation; or

[0464] (ii) A reduction (but at least 50%) in the patient's breathing lasting at least 10 seconds, accompanied by a related decrease in saturation of at least 3% or arousal.

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

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

[0467] Open (airway): The degree to which the airway is open, or the extent of airway patency. 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 ventilation (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of exhalation.

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

[0470] Respiratory flow, patient air flow, breathing air flow (Qr): These terms can be understood to refer to the RPT device's estimate of the breathing air flow, as opposed to the "true respiratory flow" or "true breathing 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 additional effort is applied.

[0472] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0473] (Expiratory) time (Te): The 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 subsequent inspiratory portion of the respiratory flow waveform.

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

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

[0477] Ventilation volume (Vent): A measured value of the gas flow exchanged by a patient's respiratory system. The measured value of ventilation volume can include one or both of the inspiratory and expiratory flows per unit time. When expressed in volume / minute, this quantity is typically referred to as "minute ventilation". Minute ventilation is sometimes given only in volume form and is understood to be volume / minute.

[0478] 5.4.3 Ventilation volume

[0479] Adaptive Servo-Ventilator (ASV): A servo-ventilator with a variable target ventilation volume instead of a fixed target ventilation volume. The variable target ventilation volume can be obtained from some characteristics of the patient (such as the patient's respiratory 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 it is not caused by spontaneous breathing efforts.

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

[0482] Expiratory Positive Airway Pressure (EPAP): The baseline pressure to which the varying pressure in the breath is 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 at the end of 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 that the ventilator will attempt to achieve during the inspiratory portion of the breath.

[0485] Pressure support: A number indicating the increase in pressure during inspiration of the ventilator over the pressure during expiration of the ventilator, and typically means the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator is intended to achieve, rather than the difference actually achieved.

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

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

[0488] Swing: A term equivalent to pressure support.

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

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

[0491] 5.4.4 Anatomical structure

[0492] 5.4.4.1 Anatomical structure of the face

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

[0494] Alar tip: The outermost point on the alar.

[0495] Alar bend (or alar crest) point: The rearmost point in the curved baseline of each alar, which is found in the fold formed by the junction of the alar and the cheek.

[0496] Auricle: The entire visible outer part of the ear.

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

[0498] (Nasal) soft skeleton: The nasal soft skeleton includes the septum, lateral, major, and minor cartilages.

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

[0500] Columella angle: The angle between the line drawn through the midpoint of the nostril and the line drawn perpendicular to the Frankfurt plane (while the two lines intersect at the subnasal point of the nasal septum).

[0501] Frankfurt plane: The line extending from the lowest point of the orbital margin to the left cochlea. The cochlea is the deepest point in the notch of the upper tragus of the auricle.

[0502] Glabella: Located on the soft tissue, the most prominent point in the median sagittal plane of the forehead.

[0503] External nasal cartilage: A generally triangular cartilage plate. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the major alar cartilage.

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

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

[0506] Major alar cartilage: A cartilage plate located under the external nasal cartilage. It curves around the front of the nostril. Its rear end is connected to the frontal process of the maxilla through a tough fibrous membrane containing three or four small cartilages of the alar.

[0507] Nostril (Naris): An approximately oval-shaped opening that forms the entrance to the nasal cavity. The singular form of nostril is nostril (Naris). The nostrils are separated by the nasal septum.

[0508] Nasolabial groove or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0509] Nasolabial angle: The angle between the columella and the upper lip (meeting at the subnasal point).

[0510] Infraauricular basal point: The lowest point where the auricle attaches to the facial skin.

[0511] Supraauricular basal point: The highest point where the auricle attaches to the facial skin.

[0512] Nasal prominence point: The most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

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

[0514] Gnathion: Located on the soft tissue, the midpoint of the most anterior part of the chin.

[0515] Ridge (Nose): The nasal ridge is a midline prominence of the nose that extends from the nasion to the nasal prominence point.

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

[0517] Nasion: Located on the soft tissue, the most concave point covering the fronto-nasal suture area.

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

[0519] Posterior-superior lateral piece: The point at the lower edge of the alar base where the alar base connects to the skin of the upper (superior) lip.

[0520] Subnasal point: Located on the soft tissue, the point where the columella and the upper lip meet in the median sagittal plane.

[0521] Gnathion point: The point of maximum concavity in the midline of the lower lip, located between the midpoint of the lower lip and the soft tissue gnathion.

[0522] 5.4.4.2 Anatomical Structure of the Skull

[0523] Frontal bone: The frontal bone includes a large vertical part (frontal squama), which corresponds to the area known as the forehead.

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

[0525] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

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

[0527] Nasion: The intersection of the frontal bone and the two nasal bones, directly between the eyes and in the depressed area above the bridge of the nose of the nose.

[0528] Occipital bone: The occipital bone is located at the posterior and lower part of the skull. It includes an oval opening (foramen magnum), through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

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

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

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

[0532] Zygomatic bone: The face includes two zygomatic bones, which are located in the upper and lateral parts of the face and form the prominent parts of the cheeks.

[0533] 5.4.4.3 Anatomical Structure of the Respiratory System

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

[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 lung contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains respiratory bronchioles, alveolar ducts, and alveoli.

[0537] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical ridge called the nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called nasal turbinates (singular "turbo") or conchae. The front of the nasal cavity is the nose, and the back joins the nasopharynx via the internal nares.

[0538] Pharynx: A part of the throat located immediately below the nasal cavity (beneath) and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (lower pharynx).

[0539] 5.4.5 Patient Interface

[0540] Anti - asphyxia valve (AAV): A component or sub - assembly of a mask system that reduces the risk of patient re - breathing by opening to the atmosphere in a fail - safe manner, reducing excessive CO 2 to the patient.

[0541] Elbow: An elbow is an example of a structure that redirects the axis of the air flow 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 an approximately circular cross - section. In another form, the elbow can have an elliptical or rectangular cross - section. In some forms, the elbow can rotate relative to a mating part, for example, by approximately 360 degrees. In some forms, the elbow can be detachable from the mating part, for example, by snap - fit connection. In some forms, the elbow can be assembled to the mating part by a one - time snap during the manufacturing process but cannot be disassembled by the patient.

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

[0543] Functional dead space:

[0544] Headband: A headband will be considered to mean a form of structure designed for positioning and stabilizing on the head. For example, a headband can include a set of one or more support rods, laces, and reinforcing rods, which are configured to position and hold the patient interface on the patient's face in a position for delivering respiratory therapy. Some laces are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric.

[0545] Membrane: A membrane will be considered to mean a typically thin element that preferably has substantially no resistance to bending but has resistance to stretching.

[0546] Inflation chamber: A mask inflation chamber will be considered to mean a part of the patient interface having a wall that encloses a volume of space that, in use, has air pressurized within it to a pressure above atmospheric pressure. The housing can form part of the wall of the mask inflation chamber.

[0547] Seal: It can be a noun form indicating a structure ("seal") or a verb form indicating a function ("to seal"). Two components can be constructed and / or arranged to seal between them or achieve "sealing" between them without a separate "seal" component itself.

[0548] Housing: The housing will be considered to mean a curved and relatively thin structure having bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face mask can be a housing. In some forms, the housing can be polyhedral. In some forms, the housing can be polyhedral. In some forms, the housing can be airtight. In some forms, the housing can not be airtight.

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

[0550] Support: The support will be considered to mean a structural component designed to increase the compressive 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 at low torque. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the rotating member can be configured to rotate through an angle less than 360 degrees. When used in the case of an air delivery conduit, the subassembly of components preferably includes a pair of matching cylindrical conduits. There can be little or no air flow leakage from the swivel during use.

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

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

[0554] 5.4.6 Shape of the Structure

[0555] The product according to the present technology can include one or more three-dimensional mechanical structures, such as a face mask buffer or a thruster. The three-dimensional structures can be bonded by two-dimensional surfaces. These surfaces can be distinguished using markings to describe relevant surface orientations, positions, functions, or some other characteristics. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the buffer structure can include a surface (e.g., an external surface) that contacts the face and a separate surface (e.g., a lower side or an inner surface) that does not contact the face. In another example, the structure can include a first surface and a second surface.

[0556] To assist in describing the shape of three-dimensional structures and surfaces, first consider a cross-section through a point p on the surface of the structure. See FIG. 3B to FIG. 3F , which show examples of cross-sections at a point p on the surface and the resulting planar profiles. Figures 3B to 3F Also shown is the outward normal vector at p. The outward normal vector at point p points away from the surface. In some examples, the surface is described from the viewpoint of an imaginary little 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 (e.g., positive, negative) and a magnitude (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0559] Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken as positive (if the imaginary little people leave point p, they must walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C ) and Figure 3C (relatively small positive curvature compared to Figure 3B ). Such curves are generally referred to as concave.

[0560] Zero curvature: If the curve at p is a straight line, the curvature will be taken as zero (if the imaginary little people leave point p, they can walk horizontally, neither uphill nor downhill). See Figure 3D .

[0561] Negative curvature: If the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken as negative (if the imaginary little people leave point p, they must walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F ) and Figure 3F (relatively large negative curvature compared to Figure 3E ). Such curves are generally referred to as convex.

[0562] 5.4.6.2 Curvature of Two-Dimensional Surfaces

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

[0564] Principal curvatures and principal directions: The directions of the normal planes in which the curve curvature takes its maximum and minimum values are called principal directions. In Figures 3B to 3F the instance of [it], the maximum curvature occurs at Figure 3B and the minimum value occurs at Figure 3F thus Figure 3B and Figure 3F are cross-sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

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

[0566] Saddle region: A region where the principal curvatures have opposite signs at each point, i.e., one sign is positive and the other sign is negative (depending on the direction in which an imaginary individual turns, they can walk up or down).

[0567] Dome region: A region where the principal curvatures have the same sign at each point, such as two positives (“concave dome”) or two negatives (“convex dome”).

[0568] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is not zero.

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

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

[0571] Path: In some forms of the present technology, ‘path’ will mean a path in the mathematical-topological sense, such as a continuous space curve on a surface from f(0) to f(1). In some forms of the present technology, ‘path’ can be described as a route or a process, including, for example, a set of points on a surface. (The path of an imaginary individual is the path in which they walk on the surface and is similar to a garden path).

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

[0573] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without considering the surface. In a planar region, there can exist on the surface a path having a path length equal to the straight-line distance between two points on the surface. In a non-planar surface, there may not exist a path having a path length equal to the straight-line distance between two points. (For an imaginary individual, the straight-line distance would correspond to the distance as a 'line'.)

[0574] 5.4.6.3 Space curve

[0575] Space curve: Different from a planar curve, a space curve does not have to lie in any particular plane. A space curve can be considered as a one-dimensional slice of three-dimensional space. An imaginary individual walking on a DNA helical strand walks along a space curve. A typical human left ear includes a left-handed helix, see Figure 3P . A typical human right ear includes a right-handed helix, see Figure 3Q . Figure 3R A right-handed helix is shown. Structural edges, such as the edges of a membrane or a propeller, can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve deviates from a surface. Torsion has a sign and a magnitude. The torsion 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 as well as the magnitude starting from that point. The tangent unit vector is the unit vector pointing in the same direction as the curve at that point. If an imaginary individual is flying along the curve and stops at a particular point, the direction of the tangent vector is the direction in which it would travel.

[0577] Unit normal vector: As the imaginary individual moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction in which 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 ).

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

[0580] Torque of a space curve: The torque at a point on a space curve is the magnitude of the rate of change of the binormal vector at that point. It measures how much the curve deviates from the osculating plane. A space curve lying in a plane has zero torque. A space curve that deviates relatively little from the osculating plane will have a relatively small torque magnitude (e.g., a slightly inclined helical path). A space curve that deviates relatively much from the osculating plane will have a relatively large torque magnitude (e.g., a steeply inclined helical path). Refer to Figure 3R , although T2 > T1, the torque magnitude near the top helical coil of Figure 3R is greater than the torque magnitude of the bottom helical coil of Figure 3R .

[0581] Refer to Figure 3O 's right-hand rule. A space curve that turns in the direction of the right-hand binormal can be considered to have a right-hand positive torque (e.g., a right-hand helix as shown in Figure 3R ). A space curve that deviates away from the right-hand binormal direction can be considered to have a right-hand negative torque (e.g., a left-hand helix).

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

[0583] 5.4.6.4 Holes

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

[0585] A structure can have two-dimensional holes, e.g., holes defined by a surface. For example, an inflatable tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a sac having a cavity for air or gel has a two-dimensional hole. For example, see the buffer of Figure 3L and the exemplary cross-section passing through it in 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. Also see the two-dimensional hole of the structure shown in Figure 3K , which is defined by the surface 302D.

[0586] 5.5 Other Notes

[0587] A part of the disclosure of this patent document contains copyrighted material. The copyright owner does not oppose the reproduction by anyone of the patent document or patent disclosure in the form of a copy thereof as it appears in the patent office's patent document or records, but reserves all copyright rights in other respects.

[0588] Unless the context clearly dictates otherwise and a numerical range is provided, it should be understood that each intermediate value between the upper and lower limits of the said range, to one-tenth of the unit of the lower limit, as well as any other said value or intermediate value within the said range is broadly included within the present technology. The upper and lower limits of these intermediate ranges may independently be included within the intermediate range and also within the present technology, subject to any explicit exclusionary bounds within the said range. When the said range includes one or both of the said bounds, ranges excluding one or both of the included bounds are also included within the present technology.

[0589] In addition, where one or more values are described in the present technology as being part of an implementation of the present technology, it should be understood that such values may be approximate unless otherwise stated, and such values may be used to any appropriate number of significant digits to the extent permitted or required by the practical technology 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 for the present invention may also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0591] When a particular material is identified for 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 unless the context clearly dictates otherwise, as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents.

[0593] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials as the subject matter of those publications. The publications discussed herein are provided only for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publications by virtue of prior invention. Additionally, the provided publication dates may differ from the actual publication dates, and the publication dates may need to be independently verified.

[0594] The terms "comprises" and "comprising" are to be interpreted as the elements, components or steps referred to in a non-exclusive manner may be presented, used or combined with other elements, components or steps not explicitly referred to.

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

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

[0597] Accordingly, it should be understood that various modifications may be made to the exemplary examples and other arrangements may be designed 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 patient interface example (e.g., patient interfaces 6000, 7000, 16000) may be combined with one or more features of another patient interface example (e.g., patient interfaces 6000, 7000, 16000) or one or more features of other examples associated therewith. For example, one or more aspects of the frame assembly 16100 (e.g., the locking feature, the headband connector arm, the connections and sealing arrangements between components) may be incorporated into patient interfaces 6000, 7000.

[0599] Moreover, it should be understood that one or more aspects of the present technology may be combined with one or more aspects of the following: PCT Publication No. PCT / AU2016 / 050892, filed on September 23, 2016, and entitled “Elbow Assembly,” which publication claims the benefit of U.S. Provisional Application Nos. 62 / 222,435, filed on September 23, 2015, and 62 / 376,718, filed on August 18, 2016; U.S. Provisional Application No. 62 / 377,217, filed on August 19, 2016, and entitled “Patient Interface with a Seal-Forming Structure having Varying Thickness”; U.S. Provisional Application No. 62 / 377,158, filed on August 19, 2016, and entitled “Patient Interface with a Seal-Forming Structure having Varying Thickness”; U.S. Provisional Application No. 62 / 377,158, filed on August 19, 2016, and entitled “Vent Adaptor for a Respiratory Therapy No. PCT / AU2016 / 050893, entitled “Patient Interface with Blowout Prevention for Seal-Forming Portion,” filed on March 24, 2016, which claims the benefit of U.S. Provisional Application No. 62 / 222,604, filed on September 23, 2015; and / or PCT Application No. PCT / AU2016 / 050228, entitled “Patient Interface with Blowout Prevention for Seal-Forming Portion,” filed on March 24, 2016, which claims the benefit of U.S. Provisional Application No. 62 / 138,009, filed on March 25, 2015, and U.S. Provisional Application No. 62 / 222,503, filed on September 23, 2015; each of the above-mentioned applications is incorporated herein by reference in its entirety.

[0600] 5.6 List of reference numerals

[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 Connection Port

[0610] 3700 Forehead Bracket

[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 Groove

[0619] 6112 Groove

[0620] 6113 Opening

[0621] 6114 Opening

[0622] 6115 Flange

[0623] 6117 Edge

[0624] 6120 Channel

[0625] 6125 Spring Arm

[0626] 6127 Protrusion

[0627] 6130 Upper Headband Connector

[0628] 6132 Shield Connection Part

[0629] 6133 Pin

[0630] 6134 Upper Headband Connector Arm

[0631] 6135 Upper Headband Connection Point

[0632] 6140 Central 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 Shroud 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 formation structure

[0649] 6250 Lip seal

[0650] 6305 Opening

[0651] 6310 Flange

[0652] 6315 Buckle

[0653] 6320 Recess

[0654] 6500 Inflatable chamber

[0655] 6600 Elbow assembly

[0656] 6610 First end part

[0657] 6620 Second end part

[0658] 6625 Swivel connector

[0659] 6630 Side wall

[0660] 6650 Extrusion arm

[0661] 6652 Piece

[0662] 6700 Vent

[0663] 6750 Arm cover

[0664] 6800 Headband

[0665] 6802 Upper strap

[0666] Lower strap 6804

[0667] Top strap 6806

[0668] Patient interface 7000

[0669] Frame assembly 7100

[0670] Opening 7105

[0671] Shield 7110

[0672] Spring arm 7125

[0673] Protrusion 7127

[0674] Headband connector 7130

[0675] Shield connection part 7132

[0676] Middle part 7133

[0677] Upper headband connector arm 7134

[0678] Slot 7135

[0679] Flexible part 7140

[0680] Connection part 7149

[0681] Lower headband connector arm 7154

[0682] Magnetic connector 7155

[0683] Headband clip 7160

[0684] Buffer assembly 7175

[0685] Housing 7180

[0686] Seal formation structure 7200

[0687] Seal 7250

[0688] Flange 7310

[0689] Buckles 7315

[0690] Recess 7320

[0691] Inflatable chamber 7500

[0692] Elbow assembly 7600

[0693] Side wall 7630

[0694] Ventilation port assembly 7700

[0695] 7800 Headband

[0696] 7802 Upper Headband Strap

[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 Shroud

[0709] 16112A End Wall

[0710] 16112B Side Wall

[0711] 16115 Outer Annular Flange

[0712] 16117 Edge

[0713] 16120 Channel

[0714] 16125 Inner Annular Flange

[0715] 16127 Piece or Buckle

[0716] 16132 Shroud Connection Portion

[0717] 16133 Protrusion

[0718] 16133A Opening

[0719] 16134 Upper Headband Connector Arm

[0720] 16135 Upper Headband Connection Point

[0721] 16136 Bridge

[0722] 16136A Leading Edge

[0723] Cover 16137

[0724] Projection 16138

[0725] Central flexible part 16140

[0726] Slot 16141

[0727] Peripheral flexible part 16145

[0728] Slot 16146

[0729] Shroud connection part 16152

[0730] Projection 16153

[0731] Opening 16153A

[0732] Lower headband connector arm 16154

[0733] Magnetic connector 16155

[0734] Magnet receiving part 16155A

[0735] Magnet 16155B

[0736] Cover 16155C

[0737] Slot 16156

[0738] Cover 16157

[0739] Projection 16158

[0740] Slot 16159

[0741] Headband clip 16160

[0742] Magnet 16162

[0743] Buckles 16164

[0744] Buffer assembly 16175

[0745] Housing 16180

[0746] Seal forming structure 16200

[0747] Opening 16305

[0748] Flange 16310

[0749] Leading edge 16310A

[0750] Outer side 16310B

[0751] 16,400 ridges

[0752] 16,405 protrusions

[0753] 16,407 openings

[0754] 16,450 upper anchor

[0755] 16,452 openings

[0756] 16,454 bridge member

[0757] 16,456 ribs

[0758] 16,460 lower anchor

[0759] 16,462 openings

[0760] 16,500 inflation chamber

[0761] 16,600 elbow assembly

[0762] 16,610 first end portion

[0763] 16,620 second end portion

[0764] 16,625 swivel connector

[0765] 16,630 inner wall

[0766] 16,640 outer wall

[0767] 16,645 passage

[0768] 16,650 extrusion arm

[0769] 16,652 hook end

[0770] 16,700 vent hole

[0771] 16,750 arm cover

[0772] 16,800 headband

[0773] 16,802 upper side strap

[0774] 16,803 piece

[0775] 16,804 lower side strap

[0776] 16,806 top-of-head strap

[0777] 17,110 shield

[0778] 17,134 connector arm

[0779] Lower arm 17154

[0780] Cover 17157

[0781] Anchoring member 17450.

Claims

1. A frame component for a patient interface for treating sleep apnea, the frame component being configured to connect a headband of the patient interface to a buffer component of the patient interface, the frame component comprising: A shroud (16110), made of a rigid plastic material and including an opening formed therein for receiving an air flow from an air delivery tube, the shroud configured to facilitate supporting the buffer component on a patient's face during use; and A pair of upper headband connector arms (16134) permanently attached to respective sides of an upper portion of the shroud and extending from the respective sides of the upper portion of the shroud, and in use, the pair of upper headband connector arms configured to extend along respective sides of a patient's face, each upper headband connector arm having a shape that curves upward during use such that the upper headband connector arm extends between a patient's eye and ear; Each upper headband connector arm includes: A headband connection point (16135) adapted to receive a respective headband strap; A shroud connection portion (16132) connected to the respective side of the upper portion of the shroud; and A first flexible portion (16140) positioned adjacent to the shroud connection portion (16132) and between the shroud connection portion and the headband connection point, the first flexible portion configured to allow the upper headband connector arm to bend outward away from the patient's face and inward toward the patient's face during use to accommodate different face widths, wherein the first flexible portion (16140) is a living hinge formed by a thin portion of the upper headband connector arm adjacent to a thick portion of the upper headband connector arm to form a flexible region, wherein each upper headband connector arm further includes a second flexible portion (16145) disposed between the first flexible portion and the headband connection point, wherein the second flexible portion allows the upper headband connector arm to hinge during use to conform to the width and contour of a patient's cheek region, wherein the first flexible portion is structurally different from the second flexible portion, and wherein the flexible regions of the second flexible portion and the first flexible portion are separated by a first rigid portion.

2. The frame component according to claim 1, wherein, the shroud is made of polycarbonate.

3. The frame component according to claim 2, wherein, the pair of upper headband connector arms is made of a material different from the polycarbonate of the shroud.

4. The frame component according to claim 3, wherein, the pair of upper headband connector arms includes a plastic material.

5. The frame component according to claim 1, wherein, each headband connection point includes a slot adapted to receive a respective headband strap.

6. The frame component according to claim 1, wherein, A fabric material (16750) surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface configured to contact a patient's skin during use, the non-patient contact surface hiding the upper headband connector arm, the fabric material being less rigid than the material of the upper headband connector arm.

7. The frame assembly according to claim 1, wherein, the shield includes a pair of upper arm connectors on respective sides of the upper portion of the shield.

8. The frame assembly according to claim 7, wherein, the shield connection portion of each upper headband connector arm is directly connected to a respective one of the upper arm connectors of the shield.

9. The frame assembly according to claim 1, wherein, each upper headband connector arm is structurally rigid to resist torque.

10. The frame assembly according to any one of claims 1 to 9, wherein, the second flexible portion includes a plurality of slots formed in the upper headband connector arm to form a plurality of hinges, thereby allowing the upper headband connector arm to articulate in use and conform to variations in the patient's cheek region.

11. The frame assembly according to claim 10, wherein, each upper headband connector arm includes a first side and a second side opposite the first side, the first side configured to face the patient's face in use, the second side configured to face away from the patient's face in use, and the second flexible portion includes: a first series of slots formed in the first side of the upper headband connector arm of the plurality of slots, and a second series of slots formed in the second side of the upper headband connector arm of the plurality of slots, the first series of slots and the second series of slots forming a plurality of hinges.

12. The frame assembly according to claim 10, wherein, the plurality of slots of the second flexible portion are substantially parallel to each other.

13. The frame assembly according to claim 10, wherein, the plurality of slots of the second flexible portion are substantially evenly spaced from each other.

14. The frame assembly according to claim 6, wherein, a portion of each upper headband connector arm forms a fabric receiving area between the first flexible portion and the headband connection point, and a fabric material covers the second flexible portion.

15. The frame assembly according to any one of claims 1 to 9, wherein, each shield connection portion is ultrasonically welded to the upper portion of the shield.

16. The frame assembly according to any one of claims 1 to 9, further comprising a pair of lower headband connector arms (16154) extending from respective sides of the lower portion of the shield, each lower headband connector arm including a lower headband connection point adapted to be connected to a lower headband strap.

17. The frame assembly according to claim 1, further comprising a pair of lower headband connector arms extending from respective sides of the lower portion of the shield, each lower headband connector arm including a lower headband connection point adapted to be connected to a lower headband strap, wherein the shield is made of polycarbonate, wherein the pair of upper headband connector arms includes a plastic material, and the polycarbonate of the shield has greater rigidity than the plastic of the upper headband connector, wherein each upper headband connection point includes a slot adapted to receive a respective upper headband strap, wherein a fabric material surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface being configured to contact the patient's skin in use, the non-patient contact surface hiding the upper headband connector arm, the fabric material being less rigid than the material of the upper headband connector arm, wherein the shroud includes a pair of upper arm connectors at respective sides of an upper portion of the shroud, wherein the shroud connection portion of each upper headband connector arm is directly connected to a respective one of the upper arm connectors of the shroud, wherein each upper headband connector arm further includes a second flexible portion disposed between the first flexible portion and the headband connection point, wherein the second flexible portion includes a plurality of slots formed in the upper headband connector arm to form a plurality of hinges to allow the upper headband connector arm to articulate in use and conform to variations in the patient's cheek region, wherein the plurality of slots of the second flexible portion are substantially parallel to each other, wherein the plurality of slots of the second flexible portion are substantially evenly spaced apart from each other.

18. The frame assembly according to claim 17, wherein, each shroud connection portion is permanently attached to an upper portion of the shroud.

19. The frame assembly according to claim 1, further comprising a pair of lower headband connector arms extending from respective sides of a lower portion of the shroud, each lower headband connector arm including a lower headband connection point adapted to connect to a lower headband strap, wherein the shroud is made of polycarbonate, wherein the pair of upper headband connector arms includes a plastic material, the polycarbonate of the shroud being harder than the plastic of the upper headband connector, wherein each upper headband connection point includes a slot adapted to receive a respective upper headband strap, wherein a fabric material surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface being configured to contact the patient's skin in use, the non-patient contact surface hiding the upper headband connector arm, the fabric material being less rigid than the material of the upper headband connector arm, wherein the shroud includes a pair of upper arm connectors at respective sides of an upper portion of the shroud, wherein the shroud connection portion of each upper headband connector arm is directly connected to a respective one of the upper arm connectors of the shroud, and wherein a thick portion of the first flexible portion of the upper headband connector arm includes the first rigid portion, the first rigid portion being positioned adjacent to a flexible region of the first flexible portion and between the flexible region and the headband connection point.

20. A patient interface for delivering an air supply to a patient to treat a sleep disordered breathing, which comprises: the frame assembly according to any one of claims 1 to 9 and 17 to 19; a buffer assembly including a housing and a seal-forming structure configured to form a seal with a patient's face in use; and A headband for holding the seal-forming structure in a sealed position during use, the headband including a pair of upper headband straps configured to be respectively connected to the pair of upper headband connector arms, wherein the housing has greater rigidity compared to the seal-forming structure, and wherein an opening is formed in the housing to receive an air flow from the air delivery tube.

21. The patient interface according to claim 20, wherein, the housing of the buffer assembly is made of polycarbonate and the seal-forming structure includes an elastomeric material.

22. The patient interface according to claim 20, wherein, the housing and the shroud have matching shapes such that the inner surface of the shroud has a shape corresponding to the outer surface of the housing.

23. The patient interface according to claim 22, wherein, the housing includes a ridge formed therein, the ridge surrounding the opening in the housing, and the shroud has a perimeter corresponding to the ridge.

24. A treatment system for treating sleep apnea, which comprises: the patient interface according to claim 20; a respiratory pressure therapy (RPT) device for supplying breathable gas at positive pressure; and an air delivery tube for delivering breathable gas from the RPT device to the patient interface.

25. A frame assembly for a patient interface for treating sleep apnea, the frame assembly configured to connect a headband of the patient interface to a buffer assembly of the patient interface, the frame assembly comprises: a shroud made of a rigid plastic material and including an opening formed therein to receive an air flow from an air delivery tube, the shroud configured to facilitate supporting the buffer assembly on a patient's face during use; and a pair of upper headband connector arms extending from respective sides of an upper portion of the shroud and configured to extend along respective sides of a patient's face in use, each upper headband connector arm having a shape that curves upwardly in an upward direction in use such that the upper headband connector arm extends between a patient's eyes and ears; each upper headband connector arm includes: an upper headband connection point adapted to receive a respective upper headband strap; a shroud connection portion connected to the respective side of the upper portion of the shroud; a first flexible portion positioned adjacent to the shroud connection portion and between the shroud connection portion and the upper headband connection point, the first flexible portion configured to allow the upper headband connector arm to bend outwardly away from the patient's face and inwardly toward the patient's face in use to accommodate different face widths; and a second flexible portion disposed between the first flexible portion and the upper headband connection point, the second flexible portion allowing the upper headband connector arm to articulate in use to conform to the width and contour of a patient's cheek area, wherein the first flexible portion is structurally different from the second flexible portion, wherein the flexible regions of the second flexible portion and the first flexible portion are separated by a first rigid portion, and Wherein a fabric material surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface being configured to contact the patient's skin in use, the non-patient contact surface hiding the upper headband connector arm, and the fabric material being removably mounted on the upper headband connector.

26. The frame assembly according to claim 25, wherein the second flexible portion includes a plurality of slots formed in the upper headband connector arm to form a plurality of hinges, thereby allowing the upper headband connector arm to hinge in use and conform to changes in the patient's cheek area.

27. The frame assembly according to claim 26, wherein, the plurality of slots of the second flexible portion are substantially parallel to each other.

28. The frame assembly according to claim 26, wherein, the plurality of slots of the second flexible portion are spaced from each other substantially uniformly.

29. The frame assembly according to claim 25, wherein, the shield is made of polycarbonate.

30. The frame assembly according to claim 29, wherein, the pair of upper headband connector arms are made of a material different from the polycarbonate of the shield.

31. The frame assembly according to claim 30, wherein, the pair of upper headband connector arms include a plastic material.

32. The frame assembly according to claim 25, wherein each upper headband connection point includes a slot adapted to receive a corresponding upper headband strap.

33. The frame assembly according to claim 25, wherein, the rigidity of the fabric material is less than that of the material of the upper headband connector arm.

34. The frame assembly according to any one of claims 25 to 33, further comprising a pair of lower headband connector arms (16154) extending from respective sides of the lower portion of the shield, each lower headband connector arm including a lower headband connection point adapted to connect to a lower headband strap.

35. The frame assembly according to claim 25, further comprising a pair of lower headband connector arms extending from respective sides of the lower portion of the shield, each lower headband connector arm including a lower headband connection point adapted to connect to a lower headband strap, wherein the shield is made of polycarbonate, wherein the pair of upper headband connector arms include a plastic material, and the polycarbonate of the shield has a greater rigidity than the plastic of the upper headband connector, wherein each upper headband connection point includes a slot adapted to receive a corresponding upper headband strap, wherein a fabric material surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface being configured to contact the patient's skin in use, the non-patient contact surface hiding the upper headband connector arm, and the rigidity of the fabric material is less than that of the material of the upper headband connector arm, wherein the shield includes a pair of upper arm connectors at respective sides of the upper portion of the shield, wherein the shield connection portion of each upper headband connector arm is directly connected to a corresponding one of the upper arm connectors of the shield, The second flexible portion includes a plurality of slots formed in the upper headband connector arm to form a plurality of hinges, thereby allowing the upper headband connector arm to articulate in use and conform to variations in the patient's cheek region. The plurality of slots of the second flexible portion are substantially parallel to each other. The plurality of slots of the second flexible portion are substantially evenly spaced from each other.

36. A patient interface for delivering an air supply to a patient to treat sleep disordered breathing, which comprises: A frame assembly according to any one of claims 25 to 33 and 35; A buffer assembly, the buffer assembly including a housing and a seal-forming structure configured to form a seal with the patient's face in use; and A headband for holding the seal-forming structure in a sealed position during use, the headband including a pair of upper headband straps configured to be connected to the pair of upper headband connector arms respectively, wherein the housing has greater rigidity compared to the seal-forming structure, and wherein an opening is formed in the housing to receive an air flow from an air delivery tube.

37. A patient interface for delivering an air supply to a patient to treat sleep disordered breathing, which comprises: A buffer assembly, the buffer assembly including a housing and a seal-forming structure configured to form a seal with the patient's face in use; and A pair of upper headband connector arms (16134) configured to extend along respective sides of the patient's face in use, each upper headband connector arm having a shape that curves upwardly in use such that the upper headband connector arm extends between the patient's eyes and ears; A headband for holding the seal-forming structure in a sealed position during use, the headband including a pair of upper headband straps configured to be connected to the pair of upper headband connector arms respectively; wherein each upper headband connector arm includes: An upper headband connection point (16135) adapted to receive a respective one of the upper headband straps; A first flexible portion (16140) configured to allow the upper headband connector arm to bend outwardly away from the patient's face and inwardly towards the patient's face in use to accommodate varying facial widths; and A second flexible portion (16145) provided between the first flexible portion and the upper headband connection point, the second flexible portion allowing the upper headband connector arm to articulate in use to conform to the width and contour of the patient's cheek region, wherein the first flexible portion is structurally different from the second flexible portion, wherein the flexible regions of the second flexible portion and the first flexible portion are separated by a first rigid portion, wherein the housing is made of polycarbonate and has greater rigidity compared to the seal-forming structure, and wherein an opening is formed in the housing to receive an air flow from an air delivery tube.

38. The patient interface according to claim 37, wherein the first flexible portion is a living hinge formed by a thin portion of the upper headband connector arm adjacent to a thick portion of the upper headband connector arm to form a flexible region, and wherein the second flexible portion includes a plurality of slots formed in the upper headband connector arm to form a plurality of hinges, thereby allowing the upper headband connector arm to articulate in use and conform to variations in the patient's cheek region.

39. The patient interface according to claim 38, wherein, the plurality of slots of the second flexible portion are substantially parallel to each other.

40. The patient interface according to claim 38, wherein, the plurality of slots of the second flexible portion are substantially evenly spaced from each other.

41. The patient interface according to claim 37, further comprising a shroud constructed of a rigid plastic material and including an opening formed therein to receive an air stream from an air delivery tube, the shroud configured to facilitate supporting the cushion assembly on the patient's face in use, wherein the pair of upper headband connector arms (16134) extend from respective sides of an upper portion of the shroud, and wherein, the pair of upper headband connector arms comprises a plastic material.

42. The patient interface according to any one of claims 37 to 41, wherein each upper headband attachment point includes a slot adapted to receive a respective upper headband strap.

43. The patient interface according to any one of claims 37 to 41, wherein a fabric material (16750) surrounds a portion of each upper headband connector arm to provide a patient contact surface and a non-patient contact surface, the patient contact surface configured to contact the patient's skin in use, the non-patient contact surface hiding the upper headband connector arm, the fabric material being less rigid than the material of the upper headband connector arm.

44. The patient interface according to any one of claims 37 to 41, further comprising a pair of lower headband connector arms (16154), each lower headband connector arm including a lower headband attachment point adapted to connect with a lower headband strap.

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