Bent pipe assembly

Abstract

An elbow member includes a pivot member (6610) connected to a patient interface (6000) by a pair of spring arms (6650) and coupled to the elbow member (6620) by a ball-and-socket joint and a hinge joint (6645), the hinge joint allowing pivoting about a single axis. The hinge joint prevents the bend member from contacting the spring arm. The pivot member includes an inner radial wall (6630) and an outer radial wall (6640) defining a radial passage (7633) to a scavenge port aperture (6640) for gas flushing, a rail or guide wall (7637) within the passage providing discrete flow paths to the scavenge port aperture, inwardly extending edges or serrations (8631) redirecting flow to reduce noise and / or minimize flow directly onto the face sensitive portion. The ball portion (6664) includes a pair of opposing recesses (6664) that engage pivot pins (6645) on the pivot member to form a hinge joint. The elbow member houses a pair of anti-suffocation valves (6680).

Description

[0001] This application is a divisional application of the patent application with application number 202011562324.6, application date September 23, 2016, and invention name “Bend Pipe Assembly”. The patent application with application number 202011562324.6 is a divisional application of the patent application with application number 201680062437.5, application date September 23, 2016, and invention name “Bend Pipe Assembly”. The patent application with application number 201680062437.5 is an application entering the Chinese national phase of the PCT international application with application number PCT / AU2016 / 050892.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 222,435, filed September 23, 2015, and U.S. Provisional Application No. 62 / 376,718, filed August 18, 2016, each of which is incorporated herein by reference in its entirety. Technical Background 2.1 Technical Background

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

[0006] 2.2 Description of related technologies

[0007] 2.2.1 Human respiratory system and its disorders

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

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

[0010] There is a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

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

[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 rise and fall ventilation called CSR cycles. CSR is characterized by causing repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated micro-awakenings from sleep, which leads to 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 cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may 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 during wakefulness 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 have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: difficulty breathing during exercise, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term that covers many diseases and disorders that damage muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of mobility, the need for wheelchairs, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage over several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage over several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulohumeral muscular dystrophy and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, difficulty swallowing, dyspnea during exertion and at rest, fatigue, lethargy, morning headaches, and difficulty concentrating and mood changes.

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

[0019] A range of treatments have been used to treat or alleviate such conditions. In addition, these treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0020] 2.2.2 Treatment

[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 treated by CPAP can be voluntary, so if the patient finds any one or more of the devices used to provide such treatment: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0022] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of 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 system

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

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

[0028] 2.2.3.1 Patient interface

[0029] The patient interface can be used to engage the respiratory apparatus 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 such as the patient's face, thereby causing gas to be delivered at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O to the airway.

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

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

[0032] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0033] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0034] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0035] Due to these challenges, some masks face one or more of the following problems: obtrusive, unaesthetic, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. The wrong size mask causes reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original purpose, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0036] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are generally 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 patient compliance.

[0037] While masks used in other applications (eg, pilots) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

[0038] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0039] 2.2.3.1.1 Seal forming part

[0040] The patient interface may include a seal forming portion. Since it is in direct contact with the patient's face, the shape and configuration of the seal forming portion may directly affect the effectiveness and comfort of the patient interface.

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

[0042] A seal-forming portion that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because of different shapes, structures, variations, and sensitive areas of a patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

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

[0044] One type of seal forming portion extends around the periphery of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal forming portion is in facing engagement with the patient's face. The seal forming portion may include an air or fluid filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal forming portion, if the fit is inadequate, there will be a gap between the seal forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0045] Another type of seal forming portion includes a sheet seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal forming portion does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0046] Another type of seal-forming portion may include friction fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

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

[0048] A range of patient interface seal forming part technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

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

[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 Pillows Mask and SWIFT TMLIBERTY™ full face mask. The following patent applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes the SWIFT TM Other aspects of nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the MIRAGE LIBERTY TM Other aspects of full face mask); International patent application WO2009 / 052,560 (which describes ResMed Ltd. SWIFT TM Other aspects of the FX nasal pillows).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] The seal forming part of the patient interface for positive air pressure therapy is subjected to the corresponding force of air pressure to break the seal. Therefore, various techniques have been used to position the seal forming part and keep it in a sealing relationship with the appropriate part of the face.

[0053] One technique is to use an adhesive. See, for example, US 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 of these harnesses suffer from one or more 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 range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have 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 special requirement for some RPT devices is noise.

[0058] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0059]

[0060]

[0061] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Inc. Another example of an RPT device is a ventilator. TM The range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients, for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0062] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and air pressure ventilation modes with single or dual channel circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0063] The designer of the device may be provided with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0064] 2.2.3.3 Humidifier

[0065] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in colder climates, warm air is often more comfortable than cold air applied to the facial area in and around the patient interface. A range of artificial humidification devices and systems are known, however they may not meet the specialized requirements of medical humidifiers.

[0066] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. Medical humidifiers can be configured to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, but these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0067] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0068] 2.2.3.4 Data Management

[0069] There may be many clinical reasons to obtain data to determine whether a patient being prescribed a respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with certain "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the usage over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0070] There are other aspects of patient treatment that may benefit from communication of treatment data to a third party or external system.

[0071] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0072] 2.2.3.5 Mandibular reduction

[0073] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom made or produced in a standard form and include a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduce vibrations of the palate.

[0074] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0075] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0076] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs (e.g., the ResMed Narval CCTMMRD) are designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Thus, it is configured to minimize or prevent any movement of one or more teeth.

[0077] 2.2.3.6 Ventilation port technology

[0078] Some forms of patient interface systems may include ventilation ports to allow flushing of exhaled carbon dioxide. The ventilation ports may allow gas to flow from the interior space of the patient interface (e.g., a plenum) to the exterior space of the patient interface, such as to the environment. The ventilation ports may include an orifice through which gas may flow when a mask is used. Many such ventilation ports are noisy. Others may become blocked during use, thereby providing insufficient flushing. Some ventilation ports may disrupt the sleep of a bed partner 1100 of the patient 1000, such as by making noise or gathering airflow.

[0079] ResMed Ltd. has developed many improved mask ventilation technologies, 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.

[0080] Noise table of existing masks (ISO17510-2:2007, pressure of 10cmH2O at 1m)

[0081]

[0082]

[0083] (* Only one sample, measured at 10cmH2O in CPAP mode using the test method specified in ISO3744) The sound pressure values ​​of various objects are as follows

[0084]

[0085] 2.2.4 Diagnostic and monitoring systems

[0086] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves professional clinical medical staff to apply the system. PSG usually involves placing 15 to 20 contact sensors on the human body to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea has involved two nights of observation of the patient in the clinic, one night of pure diagnosis and the second night when the treatment parameters are determined by the clinician. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0087] 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 where clinical experts may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply different criteria at different times.

[0088] 3. Technical Description

[0089] The present technology is directed to providing a medical device for diagnosing, ameliorating, treating or preventing respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0090] A first aspect of the present technology relates to an apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0091] Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing breathing disorders.

[0092] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0093] Another aspect of the present technology relates to an elbow assembly for a patient interface, the elbow assembly comprising a swivel component adapted to connect to the patient interface and an elbow component adapted to connect to an air circuit. The swivel component is coupled to the elbow component via a ball and socket joint and a hinge joint that allows the elbow component to pivot about a single axis relative to the swivel component.

[0094] Another aspect of the present technology relates to an elbow assembly for a patient interface, the elbow assembly comprising a swivel component adapted to connect to a patient interface and an elbow component adapted to connect to an air circuit. The swivel component is coupled to the elbow component by a hinge joint that allows the elbow component to pivot relative to the swivel component about a single axis.

[0095] In one example, the swivel component includes a pair of spring arms constructed and arranged to be connected to the patient interface. In one example, the hinge joint is constructed and arranged to prevent the elbow component from rotating into or contacting the spring arms. In one example, the swivel component includes a plurality of ventilation port holes for gas flushing. In one example, the swivel component includes an inner radial wall and an outer radial wall defining a radial channel to produce a plurality of ventilation port holes. In one example, a rail or guide wall is arranged in the channel to provide a discrete flow path to the plurality of ventilation port holes. In one example, at least a portion of the inner radial wall includes an inwardly extending edge or sawtooth constructed and arranged to redirect the flow in a manner that reduces noise and / or minimizes the flow directly into the sensitive part of the patient's face. In one example, the elbow component includes a ball portion engaged in the swivel component opening to form a ball-and-socket joint. In one example, the ball portion includes a pair of opposite recesses engaged with the corresponding pivot pins of the swivel component to form a hinge joint. In one example, each recess includes a tapered side surface, resulting in a substantially circular opening. In one example, the elbow component accommodates a pair of anti-asphyxia valves. In one instance, the elbow component houses a pair of anti-asphyxia valves. In one instance, the elbow component includes a first end and a second end connected by an ultrasonic welded connection. In one instance, a swivel connector is provided to the elbow component and is suitable for connection to the air circuit. In one instance, the swivel connector is connected to the elbow component by a slide-fit connection. In one instance, the swivel connector is connected to the elbow component by an overmolding connection. In one instance, the swivel component includes a hard-to-hard connection with a patient interface. In one instance, the swivel component is configured to form a dynamic diameter seal and a dynamic face seal with the patient interface to provide a curved leakage path.

[0096] One aspect of some forms of the present technology is a medical device that is easy to use, such as by individuals without medical training, individuals with limited dexterity, vision, or individuals with limited experience using medical devices of this type.

[0097] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home (eg, in soapy water) without the need for specialized cleaning equipment.

[0098] Of course, parts of various aspects can form sub-aspects of the present technology. In addition, various aspects in sub-aspects and / or aspects can be combined in any manner and also constitute other aspects or sub-aspects of the present technology.

[0099] Other features of the present technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to similar elements, including:

[0101] 4.1 Treatment system

[0102] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of nasal pillows receiving a supply of air at a positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown.

[0103] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0104] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0105] 4.2 Respiratory system and facial anatomy

[0106] Figure 2AShown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0107] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0108] Figure 2C is a front view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0109] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subseptal point, upper lip, lower lip, supramental point, nasal bridge, nasal wing apex, supra-auricular base point, and sub-auricular base point. The superior-inferior and anterior-posterior directions are also indicated.

[0110] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort plane and nasolabial angle are indicated. The coronal plane is also indicated.

[0111] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and the sagittal plane.

[0112] Figure 2G A side view of the nasal surface features is shown.

[0113] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0114] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0115] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also indicated, as well as the maxilla and mandible.

[0116] Figure 2KA side view of the skull with the outline of the head surface and several muscles is shown. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0117] Figure 2L An anterolateral view of the nose is shown.

[0118] 4.3 Patient Interface

[0119] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0120] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3C The curvature magnitude shown is relatively large in comparison.

[0121] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3B The curvature magnitude shown is relatively small in comparison.

[0122] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0123] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3F The curvature magnitude shown is relatively small in comparison.

[0124] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3E The curvature magnitude shown is relatively large in comparison.

[0125] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The dome area and the saddle area are indicated.

[0126] Figure 3HA cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle areas and one dome area are indicated.

[0127] Fig. 3I The surface of the structure is shown, with a one-dimensional hole on the surface. The plane curve 301D forms the boundary of the one-dimensional hole.

[0128] Figure 3J Shown through Fig. 3I Cross section of the structure. Indicating the restraint Fig. 3I The surface 302D of the two-dimensional hole in the structure.

[0129] Figure 3K Show Fig. 3I A perspective view of a structure including a two-dimensional hole and a one-dimensional hole. Indicates the bound Fig. 3I The surface 302D of the two-dimensional hole in the structure.

[0130] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0131] Figure 3M Shown through Figure 3L A cross section of a mask showing the interior surface of the airbag.

[0132] Figure 3N The left-hand rule is shown.

[0133] Fig.3O The right-hand rule is shown.

[0134] Figure 3P The left ear is shown, including the left ear helix.

[0135] Figure 3Q The right ear is shown, including the right ear helix.

[0136] Figure 3R A right-hand helix is ​​shown.

[0137] Figure 3S A view of a mask is shown including torque signatures of spatial curves defined by the edge of the sealing membrane in different regions of the mask.

[0138] Figure 4 is a perspective view of a patient interface shown on a patient's head, the patient interface including an elbow assembly according to an example of the present technology.

[0139] Figure 5 for Figure 4 A perspective view of a patient interface with the headgear removed is shown.

[0140] Figure 6 for Figure 5 Front view of the patient interface shown.

[0141] Figure 7 for Figure 5 Side view of the patient interface shown.

[0142] Figure 8 for Figure 5 An exploded view of a patient interface showing the cushion assembly and frame assembly removably connected with the elbow assembly removed.

[0143] Fig. 9 for Figure 7 A cross-sectional view of the patient interface is shown.

[0144] Fig.10 for Figure 5 A cross-sectional view of the patient interface is shown.

[0145] Fig.11 for Fig.10 An enlarged view of the patient interface is shown.

[0146] Fig.12 A front perspective view of a bending tube assembly according to an example of the present technology.

[0147] Fig.13 for Fig.12 A rear perspective view of the elbow assembly is shown.

[0148] Fig.14 for Fig.12 A side view of the elbow assembly is shown.

[0149] Fig.15 for Fig.12 Front view of the elbow assembly shown.

[0150] Fig.16 for Fig.12 Rear view of elbow assembly shown.

[0151] Fig.17 for Fig.12 A top view of the elbow assembly is shown.

[0152] Fig.18 for Fig.12 Bottom view of the elbow assembly shown.

[0153] Fig.19 for Fig.12 Front exploded view of elbow assembly shown.

[0154] Fig. 20 for Fig.12 Rear exploded view of the elbow assembly shown.

[0155] Fig.21 for Fig.15 A cross-sectional view of the elbow assembly is shown.

[0156] Fig. 22 for Fig.14 A cross-sectional view of the elbow assembly is shown.

[0157] Fig.23 for Fig.14 A cross-sectional view of the elbow assembly is shown.

[0158] Fig.24 for Fig.14 A cross-sectional view of the elbow assembly is shown.

[0159] Fig.25 A front perspective view of a bending tube assembly according to an example of the present technology.

[0160] Fig.26 for Fig.25 A rear perspective view of the elbow assembly is shown.

[0161] Fig. 27 for Fig.25 A side view of the elbow assembly is shown.

[0162] Fig.28 for Fig.25 Front view of the elbow assembly shown.

[0163] Fig.29 for Fig.25 Another front view of the elbow assembly is shown.

[0164] Fig.30 for Fig.25 Rear view of elbow assembly shown.

[0165] Fig.31 for Fig.25 A top view of the elbow assembly is shown.

[0166] Fig.32 for Fig.25 Bottom view of the elbow assembly shown.

[0167] Fig.33 for Fig.25 Front exploded view of elbow assembly shown.

[0168] Fig.34 for Fig.25 Rear exploded view of the elbow assembly shown.

[0169] Fig.35 for Fig.28 A cross-sectional view of the elbow assembly is shown.

[0170] Fig.36 for Fig.35 Perspective view of a cross section.

[0171] Fig.37 for Fig. 27 A cross-sectional view of the elbow assembly is shown.

[0172] Fig.38 for Fig. 27 A cross-sectional view of the elbow assembly is shown.

[0173] Fig.39 for Fig.30 A cross-sectional view of the elbow assembly is shown.

[0174] Fig.40 for Fig. 27 A cross-sectional view of the elbow assembly is shown.

[0175] Fig.41 for Fig.40 An enlarged portion of the cross section.

[0176] Fig.42 for Fig.40 Perspective view of a cross section.

[0177] Fig.43 for Fig.42 An enlarged portion of the cross section.

[0178] Fig.44 for Fig.25 A perspective view of the swivel component of the elbow assembly is shown.

[0179] Fig.45 for Fig.25 A perspective view of a first end of a tube elbow component of a tube elbow assembly is shown.

[0180] Fig.46 for Fig.25 A perspective view of a second end of the elbow component of the elbow assembly is shown.

[0181] Fig.47 To illustrate an example of the present technology and Fig.25 The assembly is shown as a cross-sectional view of a cushion assembly and a frame assembly to which an elbow assembly is removably connected.

[0182] Fig.48A is a perspective view of a patient interface shown on a patient's head, the patient interface including an elbow assembly according to an example of the present technology.

[0183] Fig.48B for Fig.48A A perspective view of a patient interface having a Fig.48A The bending part of the bending assembly shown is the bending part of the bending assembly pivoted upward.

[0184] Fig.48C for Fig.48A A perspective view of a patient interface having a Fig.48A The elbow assembly shown is a rotating elbow assembly.

[0185] Fig.48D for Fig.48C A perspective view of a patient interface having a Fig.48C The bending part of the bending assembly shown is the bending part of the bending assembly pivoted upward.

[0186] Fig.49 A rear perspective view of a bending tube assembly according to an example of the present technology.

[0187] Fig.50 for Fig.49 Rear view of elbow assembly shown.

[0188] Fig.51 for Fig.49 A cross-sectional view of the elbow assembly is shown.

[0189] Fig.52 for Fig.49 A cross-sectional view of the elbow assembly shown from a slight perspective angle.

[0190] Fig.53 is a cross-sectional view of a patient interface shown on a patient's head, the patient interface including an example of the present technology Fig.49 elbow components. DETAILED DESCRIPTION

[0191] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0192] The following description is provided for various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute a further example.

[0193] 5.1 Treatment

[0194] In one form, the present technology includes a method of treating a breathing disorder, the method comprising the step of applying positive pressure to an entrance to the airway of a patient 1000 .

[0195] In certain examples of the present technology, a positive pressure supply of air is provided to the patient's nasal passages via one or both nostrils.

[0196] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0197] 5.2 Treatment system

[0198] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000, e.g., see Figures 1A to 1C .

[0199] 5.3 Patient Interface

[0200] A 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 stabilizing structure 3300, a ventilation port 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of positive pressure air to the airway.

[0201] Figures 4 to 11 A non-invasive patient interface 6000 is shown in accordance with one aspect of the present technology and includes a frame assembly 6100, a cushion assembly 6175 (including a seal-forming structure 6200), an elbow assembly 6600, and a positioning and stabilizing structure (eg, headgear 6800). Figure 4 is an exemplary view of a patient interface 6000 on a patient's head, Figures 5 to 11 is an exemplary view of a patient interface 6000 without a headband 6800, and Figures 12 to 24 6600 according to an example of the present technology. In use, a form of the seal-forming structure 6200 is arranged to surround the entrance of the patient's 1000 airway so as to facilitate the supply of positive pressure air to the airway. The seal-forming structure 6200 (e.g., constructed of silicone) may also be generally referred to as a cushion. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects.

[0202] In one form of the present technology, the frame assembly 6100 is connected to the cushion assembly 6175 and the elbow assembly 6600 as an intermediate component. For example, the elbow assembly 6600 is connected to the frame assembly 6100 (via retaining features on the frame assembly) independently of the cushion assembly 6175 (see, for example, Figure 8 ). However, a seal for the air flow path is formed between the elbow assembly 6600 and the cushion assembly 6175, i.e., the frame assembly 6100 is not in the air flow path (see, e.g., Fig. 9 , 10 and 11).

[0203] In the illustrated example, the patient interface is a full facial / oronasal interface type configured to form a seal around the patient's nose and mouth, including a seal-forming structure 6200. However, the methods of the present technology may be adapted for use with other suitable interface types (e.g., nasal interfaces, nasal prongs).

[0204] Bending pipe components

[0205] like Figure 4-24 As shown, the elbow assembly 6600 includes a swivel component 6610 that is repeatedly engageable with and removably disengageable from the frame assembly 6100 of the patient interface 6000 and an elbow assembly 6620 that is suitable for connecting to the air circuit 4170, for example, via a swivel connector 6625.

[0206] The swivel component 6610 is connected to the elbow component 6620 via a ball joint and a hinge joint, which allows the elbow component 6620 to pivot around a single axis relative to the swivel component 6610, i.e., the hinge joint prevents the elbow component 6620 from rotating relative to the swivel component 6610 in multiple axes.

[0207] Figures 25 to 47 An elbow assembly 7600 according to one example of the present technology is shown. The elbow assembly 7600 includes a swivel component 7610, an elbow component 7620, and a swivel connector 7625, wherein the swivel component 7610 is coupled to the elbow component 7620 as described above via a ball joint and a hinge joint that allows the elbow component 7620 to pivot relative to the swivel component 7610 about a single axis.

[0208] Figures 48A to 53A patient interface 8000 and elbow assembly 8600 according to another example of the present technology are shown. Elbow assembly 8600 is substantially similar to elbow assembly 7600, i.e., elbow assembly 8600 includes a swivel component 8610 coupled to elbow component 7620 via a ball and socket joint and a hinge joint. Instead, swivel component 8610 of elbow assembly 8600 includes structure to redirect flow in a manner that reduces noise and / or minimizes flow onto sensitive portions of the patient's face, as described in more detail below.

[0209] Ventilation port layout

[0210] exist Figures 4 to 24 In the illustrated example of the embodiment of the present invention, the swivel component 6610 includes a swivel member 6612, a diffuser material 6614, and a diffuser cover 6616. The swivel member 6612 includes an inner wall 6630, an outer wall 6632, and a bottom wall 6634 between the inner wall 6630 and the outer wall 6632. A plurality of vent holes 6640 are provided along the bottom wall 6634 (e.g., at least 30 vent holes, e.g., 30 to 60 vent holes) to allow exhaust gases to be exhausted from the patient interface. As shown, the vent holes 6640 are arranged to define a substantially circular shape that surrounds an opening 6635 defined by the inner wall 6630. In one example, each hole 6640 may include a profile or taper along its length, e.g., each hole converges in the direction of the exhaust gas.

[0211] The inner wall 6630 and the outer wall 6632 define a channel (annular recess) that is adapted to receive or accommodate the diffuser material 6614 so that the diffuser material 6614 is positioned adjacent to the outlet end of each ventilation port hole 6640. The diffuser cover 6616 is connected to the swivel member 6612 to retain the diffuser material 6614 within the channel. The diffuser cover 6616 includes a top wall and spaced-apart side walls, each of which includes a retaining structure configured to secure the diffuser material 6616 to the swivel member 6612 (e.g., permanently attach the diffuser cover to the swivel member). The spaced-apart side walls define an opening or outlet 6618 therebetween that allows the exhausted gas to pass into the atmosphere. Specifically, the swivel member 6610 provides a ventilation port flow path that passes through the ventilation port holes 6640, through the diffuser material 6614 within the channel, and is discharged into the atmosphere through the outlet 6618 of the diffuser cover 6616. This arrangement allows the exhaust gases to be directed radially outward from the elbow assembly, i.e., the diffuser cover 6616 redirects the flow through the diffuser material 6614.

[0212] In an alternative embodiment, an elbow assembly without diffuser material may be provided. Figures 25 to 47As shown in the example of , the swivel component 7610 includes an inner radial wall 7630, an outer radial wall 7632, and a bottom wall 7634 between the inner radial wall 7630 and the outer radial wall 7632. The inner radial wall 7630 and the outer radial wall 7632 define a radial channel 7633, thereby creating a plurality of ventilator holes 7640 (e.g., at least 20 ventilator holes, such as 20 to 60 ventilator holes) provided along the outer radial wall 7632 to allow exhaust gases to be discharged from the patient interface to the atmosphere. As shown, the ventilator holes 7640 are arranged along the outer radial wall 7632 to allow exhaust gases to be directed radially outward from the elbow assembly 7600.

[0213] like Fig.30 , 35 , 36, 39, 42 and 43, rails or guide walls 7637 are provided in the passage 7633 adjacent each vent hole 7640 to provide a discrete flow path for directing the exhaust gas to the vent hole 7640. In the illustrated example, each rail or guide wall 7637 extends radially between the inner wall 7630 and the outer wall 7632 and cooperates to define a flow path or passage 7639 to produce each vent hole 7640, i.e., each vent hole 7640 includes an associated passage 7639 provided by these rails or guide walls 7637.

[0214] In the illustrated embodiment, the vent holes 7640 and associated passages 7639 are provided only along a portion of the circumference of the elbow assembly, for example to accommodate the squeeze arm 7650 and / or to prevent gas flushing from being directed into the squeeze arm 7650. As shown, the swivel member 7610 includes vent holes 7640 along an upper portion or upper part of its circumference and along a lower portion or lower part of its circumference. However, it should be understood that the vent holes can be provided along the entire circumference of the swivel member 7610 or one or more selected portions of its circumference.

[0215] In the example shown, Figures 40 to 43 As best shown in FIG. 1 , each vent hole 7640 and associated passage 7639 includes a generally U-shaped cross-sectional shape, such as an arcuate opening including a generally rectangular shape having one of the shorter walls with a contour. However, each vent hole 7640 and associated passage 7639 may have other suitable shapes for directing exhaust or flushing gases.

[0216] In use, the inner radial wall 7630 extends rearwardly to act as a baffle and separate the flow path of pressurized air entering from the RPT device from the exhaust flow path through the vent, for example to reduce circulation noise. Exhaust gas flows into the channel 7633 and then into the passage 7639 associated with the corresponding vent hole 7640. Fig.35 , 36As best shown in and 39, the bottom wall 7634 at one end of each passage 7639 is curved to more smoothly direct the exhaust flow from a generally axial direction as the exhaust flow travels downward from the passage 7639 to a generally radial direction as the exhaust flow exits the ventilation port hole 7640, and is directed into the atmosphere.

[0217] Similar to elbow assembly 7600 described above, swivel 8610 of elbow assembly 8600 includes an inner radial wall 8630 and an outer radial wall 8632 defining a radial passage 8633, thereby creating a plurality of ventilator holes 8640 (e.g., at least 20 ventilator holes, such as 20 to 60 ventilator holes) provided along outer radial wall 8632 to allow exhaust gases to be exhausted from the patient interface to the atmosphere (e.g., as Figures 49 to 53 ).

[0218] However, in Figures 49 to 53 In an example, at least a portion of the inner radial wall 8630 includes an inwardly extending edge or serrations 8631 constructed and arranged to redirect flow in a manner that reduces noise and / or minimizes flow directly onto sensitive portions of the patient's face.

[0219] In the example shown, the edge or serration 8631 is curved and extends inwardly from the inner radial wall 8630 toward the flow path of the incoming pressurized air. As shown, the edge or serration 8631 is provided along the upper or upper portion of the circumference of the inner wall 8630 (e.g., see Fig.49 and Fig.50 ). However, it will be appreciated that the edge or serrations 8631 may be provided along the entire circumference of the inner wall 8630 or along one or more selected portions of the inner wall circumference.

[0220] In use, such as Fig.53 As best shown in FIG. 1 , the inner radial wall 7630 and the edge or serrations 8631 separate the inlet flow of incoming pressurized air from the outlet flow of outgoing air through the vent. In addition, the edge or serrations 8631 are constructed and arranged to redirect the inlet flow away from the outlet flow so that turbulence and turbulence related noise are reduced, such as vent noise is reduced by deflecting air that generally hugs the upper quadrant of the elbow assembly (avoiding air / turbulence). In one example, the edge or serrations 8631 are constructed and arranged to minimize squeaking sounds (e.g., hissing or popping noises) from the air flow.

[0221] In addition, if Fig.53 As best shown in FIG. 8 , the edges or serrations 8631 are constructed and arranged to redirect inlet flow away from sensitive portions of the patient's face such as the tip of the nose or nasal prominence, for example, which are known to cause an itchy sensation.

[0222] Squeeze Arm

[0223] exist Figures 4 to 24 In the example of the embodiment, the swivel member 6612 includes a pair of resilient, quick-release squeeze arms 6650, i.e., cantilever spring arms or squeeze arms. Each spring arm or squeeze arm 6650 includes a hook end or pull ring 6652 configured to provide a mechanical interlock (e.g., a slide-in fit connection) with the frame assembly 6100.

[0224] exist Figures 25 to 47 In the example of FIG. 76, the hinge portion 7655 of each squeeze arm 7650 includes a generally trapezoidal or conical shape along its length (see, for example, FIG. 76). Fig.29 , 40 44, that is, the width of the hinge portion 7655 at the connection portion thereof with the main body of the swivel member 7610 is greater than the width of the hinge portion at the connection portion thereof with the extrusion arm 7650. This shape of the hinge portion 7655 enables convenient use, such as facilitating flexure of the extrusion arm 7650 while maintaining a sufficient holding base and allowing rotational movement on the frame assembly.

[0225] Furthermore, a gap or spacing C between each squeezing arm 7650 and the elbow member 7620 is opened (see, for example, Fig.29 and 38 ) so that the elbow member 7620 acts as a stop to prevent each squeezing arm 7650 from being pressed too far inward toward the elbow member 7620, which ensures that each squeezing arm 7650 returns to its original position in order to retain the elbow assembly to its frame assembly.

[0226] Each spring arm 7650 includes a hook end or peg-catch 7652 configured to provide a slide-fit connection with the frame assembly. Furthermore, each spring arm 7650 includes a finger grip portion 7657, such as a square protrusion, adjacent the free end.

[0227] In the illustrated example, the swivel member 7610 may be comprised of a material (e.g., polybutylene terephthalate (PBT), such as Pocan) that is more flexible and resilient than the material of the elbow member 7620 (e.g., polycarbonate, such as Makrolon), which helps the resilient arm 7650 flex during use.

[0228] Similar to the elbow assembly 7600 described above, Figures 48A to 53 In an example of the embodiment, the swivel component 8610 of the elbow assembly 8600 includes a pair of resilient quick release squeeze arms 8650 configured to provide a mechanical interlock (e.g., a slip-fit ​​connection) with the frame assembly 8100 of the patient interface 8000.

[0229] Inner and outer walls of the swivel member

[0230] exist Figures 4 to 24In the example of the embodiment, the inner wall 6630 of the swivel member 6612 defines an opening 6635 that provides a socket for the ball and socket joint. In addition, a pair of opposite, protruding and cylindrical pivot pins or pegs 6645 extend from the inner wall 6630 to the opening 6635 for forming a hinge connection of the hinge joint.

[0231] Moreover, in Figures 4 to 24 In the illustrated example, the outer wall 6632 is constructed to extend through the frame assembly 6100 and form a seal with the cushion assembly 6175.

[0232] Similarly, the inner wall 7630 of the swivel member 7610 defines an opening 7635 that provides a socket for the ball and socket joint. Also, a cylindrical pivot pin or peg 7645 extends from the inner wall 7630 for forming a hinge connection for the hinge joint. However, as described below, in Figures 25 to 47 In the example of FIG. 76, the outer wall 7632 is configured to engage with the frame assembly 7100 and form a rigid connection and seal therewith (see Fig.47 ).

[0233] The first end and the second end of the elbow member

[0234] exist Figures 4 to 24 In the illustrated example of FIG. 6 , the elbow component 6620 includes a first end 6660 and a second end 6670 provided to the swivel member 6612. The second end 6670 is provided with a swivel connector 6625 adapted to be connected to the air circuit 4170 (e.g., the swivel connector is permanently connected to the second end). In this example, the swivel connector 6625 is overmolded to a tubular end portion 6671 of the second end 6670 (e.g., see FIG. 6 ). Fig.21 ). As shown, the tubular end portion 6671 defines a channel to receive the swivel connector 6625 and retain the connector axially on the second end 6670.

[0235] Figures 25 to 47The elbow component 7620 in the embodiment includes a first end 7660 provided to the swivel component 7610 and a second end 7670 provided with a swivel connector 7625. In this example, the elbow component 7620 and the swivel connector 7625 include separately molded components that are subsequently mechanically connected to each other, such as a slip-fit ​​connection. For example, the swivel connector 7625 may be composed of a material (e.g., polybutylene terephthalate (PBT), such as Pocan) that is more flexible than the material of the elbow component 7620 (e.g., polycarbonate, such as Makrolon), thereby allowing the swivel connector 7625 to flex on the tubular end portion 7671 of the second end 7670 of the elbow component 7620. The tubular end portion 7671 of the second end 7670 includes a groove 7671A along its outer surface suitable for receiving a tongue 7626, which is provided along the inner surface of the swivel connector 7625 (see, for example, Fig.35 ), i.e., a slip-fit ​​tongue and groove for connection. The connection between the elbow member 7620 and the swivel connector 7625 also provides a tortuous path therebetween to control and minimize leakage.

[0236] Ball and socket joints and hinge joints

[0237] The first end 6660 of the elbow member 6620 includes a ball portion 6662 that provides a ball for the ball and socket joint. In addition, the ball portion 6620 includes a pair of opposing recesses 6664 for forming a hinge connection of the hinge joint.

[0238] The ball portion 6662 engages within the opening 6635 of the swivel member 6612 to form a ball and socket joint and the recess 6664 engages with a corresponding pivot pin 6645, such as using a slip-fit, to form a hinge joint.

[0239] Similarly, the ball portion 7662 of the elbow member 7620 engages within the opening 7635 of the swivel member 7610 to form a ball and socket joint, and the opposing recess 7664 engages with the corresponding pivot pin 7645, such as using a slip-fit, to form a hinge joint. As shown, the opening 7635 includes a rim 7636 that further retains the ball portion 7662 within the opening 7635 (see, for example, Fig.35 and 44 ).

[0240] exist Figures 25 to 47In the example of , each recess 7664 (also referred to as a peg engagement portion, which is configured to engage with a corresponding pivot pin or peg 7645) includes tapered sides forming a generally circular opening, which is configured to elastically expand to surround or more substantially enclose the pivot pin 7645 during engagement. This type of engagement is configured to limit relative movement between the ball portion 7662 and the opening 7635 of the ball and socket joint, thereby providing a controlled gap between the outer surface provided by the ball portion 7662 and the inner surface provided by the opening 7635. The controlled gap allows any leakage between the ball portion 7662 and the opening 7635 to be relatively the same in any relative configuration between the swivel component 7610 and the elbow component 7620, thereby allowing predictable leakage, which helps to adjust the ventilation port arrangement.

[0241] AAV components

[0242] The first end 6660 and the second end 6670 of the elbow member 6620 (e.g., constructed of a polycarbonate such as Makrolon) are coupled to each other (e.g., permanently connected) and are constructed to accommodate a dual-flap, anti-asphyxia valve (AAV) assembly, including a pair of AAVs 6680 (e.g., constructed of liquid silicone rubber (LSR)). The first end 6660 includes a pair of ports 6665 that can be selectively closed by corresponding flap portions 6682 of the AAV 6680. If the pressurized gas provided to the elbow assembly has sufficient amplitude, the flap portions 6682 of the AAV 6680 will rise to block the ports 6665. In this case, the pressurized gas will be directed through the elbow assembly for delivery to the patient interface and the patient's airway. If the pressurized gas does not have sufficient amplitude or is not delivered, the flap portions 6682 will remain in a "resting" position (e.g., see Fig.21 and Fig.24 ) so that the patient can breathe ambient air and exhale through port 6665.

[0243] The first end 6660 includes a pair of openings 6667 just below the respective ports 6665, which are configured to secure the AAV 6680 within the elbow component. Each AAV 6680 includes a connecting portion 6684 configured to be lockingly engaged (e.g., mechanically interlocked) within the respective openings 6667. Each flap portion 6682 is movably disposed to (e.g., hingedly connected to) the connecting portion 6684 via a hinge portion, which allows the flap portion 6682 to pivot to selectively close the port 6665.

[0244] The second end 6670 includes a bottom wall 6672 defining an interior opening that is selectively closed by a corresponding flap portion 6682 of the AAV 6680. One or more ribs 6675 extend from the bottom wall 6672 to the opening to define a stop for the flap portion 6682. In the example shown, the bottom wall 6672 includes wall portions 6672A, 6672B oriented at an angle relative to each other (see, e.g., FIG. 1 ). Fig. 20 and Fig.24 ), which, when in the "resting" position, define the baffle portions 6682 at an angle relative to each other (see, for example, Fig.24 ).

[0245] Similarly, first end 7660 and second end 7670 (constructed from a polycarbonate such as Makrolon) of elbow member 7620 are coupled to one another and are configured to receive a pair of AAVs 7680. First end 7660 includes a pair of ports 7665 selectively closable by corresponding flap portions 7682 of AAVs 7680, as described above. Fig.37 The flap portion 7682 is shown in a "resting" position. Each AAV 7680 includes a connecting portion 7684 configured to lockingly engage within a corresponding opening 7667 of the first end 7660 (eg, a mechanical interlock).

[0246] like Fig.33 , 34 46, the second end 7670 includes a bottom wall 7672 defining a pair of openings or treatment ports 7673 that are selectively closed by respective flap portions 7682 of the AAV 7680. The openings 7673 are separated by a bridge 7674 that prevents the flap portions 7682 from contacting each other, thereby preventing friction interference between the flap portions 7682. In addition, the bridge 7674 prevents any gaps from forming between the flap portions 7682 to prevent exhaust gases from escaping through the openings 7673 when the flap portions 7682 are in the "resting" position.

[0247] A rib 7675 extends from each side of the bridge 7674 into the corresponding opening 7673 to define a stop for the flap portion 7682, for example, to prevent the flap portion 7682 from traveling under the bridge 7674 and binding.

[0248] In the example shown, the bottom wall 7672 includes wall portions 7672A, 7672B oriented at an angle relative to each other (see, e.g., Fig.46), which defines the flap portion 7682 at an angle relative to each other when in a "resting" position. This arrangement pre-loads or pre-bends the flap portion 7682 so that the flap portion 7682 maintains a minimum force against the edge or edge of the opening 7673 (i.e., the sealing surface) to block the opening 7673 when pressurized gas is not being delivered. The flap portion 7682 is constructed so that it completely blocks the opening 7673 when the treatment pressure ceases. This complete blockage prevents any exhausted gas from flowing through the opening 7673 and subsequently being re-breathed by the patient (i.e., all exhausted gas is exhausted via the AAV port 7665). Moreover, the pre-loaded configuration maintains the flap portion 7682 in a resting or closed position (i.e., resists opening during movement or under gravity) throughout the movement of the elbow assembly.

[0249] The hinge portion 7685 pivotally or hingedly connects the baffle portion 7682 to the connecting portion 7684 (see, for example, Fig.34 and Fig.37 ) can be adjusted to easily open and fully occlude the AAV port 7665 under therapeutic pressure.

[0250] Fig.49 , 51 52 show an additional feature of the elbow connection, showing a rim 8665.1 that at least partially surrounds the port 8665. In this example the rim surrounds three sides of the port and has a tapered thickness along its two depending legs. The rim 8665.1 is positioned and sized to contact the flap 8682 of the corresponding AAV when the elbow is pressurized. The rim minimizes the contact surface area of ​​the AAV with the inner wall of the elbow to minimize the risk of the AAV adhering to the inner wall. Adherence of the AAV to the inner wall of the elbow can cause the port to remain blocked even when the treatment pressure is stopped.

[0251] Connection of the first end and the second end of the elbow component

[0252] In one example, the first end 6620 and the second end 7620 of the elbow member can be coupled to each other by ultrasonic welding to permanently connect the first end and the second end. In this arrangement, the first end and the second end can include structures that facilitate orientation and welding of the first end and the second end.

[0253] In one example, if Fig.34 and Fig.45 As best shown in FIG. 1 , the first end 7660 of the elbow component 7620 includes an elongated support groove 7690 along its outer perimeter that is adapted to engage with a welding station that positions and supports the first end 7660 during the ultrasonic welding process. Furthermore, the first end 7660 of the elbow component 7620 includes an orientation feature (e.g., Fig.45An opposite flat surface 7692 is shown to position and align the second end 7670.

[0254] like Fig.46 As best shown in FIG. 1 , the second end 7670 of the elbow component 7620 includes a weld bead 7695 configured to be ultrasonically welded to the inner perimeter of the first end 7660. As shown, the weld bead 7695 includes an orientation feature (e.g., an opposing flat surface 7696) that corresponds to the orientation feature (e.g., opposing flat surface 7692) of the first end 7660 to position and align the weld bead 7695 within the inner perimeter of the first end 7660. Moreover, the second end 7670 provides a flat surface 7695 (e.g., see FIG. 1 ) that is opposite to the weld bead 7695. Fig.35 ), the flat surface being suitable for engaging with a welding head to apply acoustic vibrations to the second end 7670 during an ultrasonic welding process.

[0255] Components

[0256] In one example, assembly of the elbow assembly 7600 may include assembling the AAV 7680 to the second end 7670 of the elbow member 7620, connecting the first end 7660 and the second end 7670 of the elbow member 7620 (e.g., via ultrasonic welding), assembling the swivel connector 7625 to the second end 7670 of the elbow member 7620 (e.g., a snap-fit ​​connection), and then assembling the swivel member 7610 to the elbow member 7620 (e.g., a snap-fit ​​connection). However, it should be appreciated that assembly of the elbow assembly may include alternative steps and / or sequences.

[0257] Connection between elbow assembly and frame assembly

[0258] The elbow assembly 6600 is releasably connected to the frame assembly 6100 via the squeeze arm 6650, such as a quick release slip-on fit. The frame assembly 6100 includes a circular channel 6120 that is configured to receive the hook end 6652 of the squeeze arm 6650 to releasably retain the elbow assembly 6600 to the frame assembly 6100 and form a swivel connection (see, for example, Figure 7 and Fig. 9 ), i.e., allowing the elbow assembly 6600 to rotate freely 360° around the axis of the circular channel relative to the frame assembly 6100 (see, for example, Figure 6 ).

[0259] As in Fig.47 As best shown in the figures, the extrusion arm 7650 of the elbow assembly 7600 is releasably connected to the frame assembly 7100 in a similar manner, i.e., the hook end 7652 of the extrusion arm 7650 engages within the circular channel 7120 of the frame 7100, such as a quick release slide-in fit, to releasably hold the elbow assembly 7600 to the frame assembly 7100 and form a swivel connection.

[0260] In the illustrated example, the swivel component 7610 of the elbow assembly 7600 and the corresponding holes in the frame assembly 7100 that communicate with the swivel component 7610 include a diameter (e.g., approximately 25-35 mm) that is larger than the diameter provided by the swivel connector 7625 suitable for connection to an air circuit or gas delivery tube (e.g., approximately 22 mm).

[0261] Sealing between elbow assembly and cushion assembly

[0262] exist Figures 4 to 24 In the illustrated example, the cushion assembly 6175 includes a flexible flange or lip seal 6250 to provide a seal with the elbow assembly 6600. Fig.10 and Fig.11 As shown in , the elbow assembly 6600 is constructed to mechanically interlock with the frame assembly 6100, but is constructed and arranged to sealingly engage with the sealing membrane 6250 of the cushion assembly 6175 to form a seal in the air flow path, i.e., the sealing mechanism is separate from the retention feature.

[0263] As shown, the leading edge of the outer wall 6632 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 be formed between the components while allowing the elbow assembly 6600 to rotate freely relative to the frame assembly 6100 and the cushion assembly 6175.

[0264] In an alternative arrangement, the elbow assembly 6600 may form a substantially sealed engagement with the frame assembly 6100. The substantially sealed engagement between the frame assembly 6100 and the elbow assembly 6600 may allow the elbow assembly 6600 to rotate freely while maintaining a controlled level of leakage through the substantially sealed engagement. In this arrangement, the frame assembly 6100 may form a separate sealed engagement with the cushion assembly 6175. The arrangement allows the cushion assembly 6175 to be detached from the frame assembly 6100 independently of the elbow assembly 6600, which may be detached from the frame assembly 6100 separately.

[0265] For example, Fig.47As shown, the elbow assembly 7600 is configured to establish a rigid connection and seal with the frame assembly 7100. As shown, a dynamic diameter seal is formed between the cylindrical outer surface 7632A of the outer wall 7632 of the elbow assembly 7600 and the inner surface 7115A of the annular flange 7115 of the frame assembly 7100. Moreover, the annular flange 7115 of the frame assembly 7100 includes a radially inwardly extending ridge 7125 that acts as a stop to prevent over-insertion of the elbow assembly 7600 into the frame assembly 7100. The surface of the ridge 7125 also provides a dynamic face seal with the leading edge or surface 7632B of the outer wall 7632 of the elbow assembly 7600. The diameter seal and face seal between the surfaces 7632A, 7632B of the outer wall 7632 and the surface of the annular flange 7115 / ridge 7125 provide two mating contact surfaces between the elbow assembly 7600 and the frame assembly 7100, which increases the contact surface area between the elbow assembly 7600 and the frame assembly 7100. 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 the interior of the patient interface to the atmosphere.

[0266] Moreover, if Fig.47 As shown, the frame assembly 7100 is configured to form a static diameter seal and a static face seal with the cushion assembly 7175 to minimize and control leakage. As shown, the frame assembly 7100 includes a channel 7105 adapted to receive a connection portion 7176 provided to the cushion assembly 7175. The leading edge 7176A of the connection portion 7176 and the end wall 7105A of the channel 7105 are configured and arranged to provide a static face seal, and the outer side 7176B of the connection portion 7176 and the side wall 7105B of the channel 7105 are configured and arranged to provide a static diameter seal.

[0267] Decoupled layout

[0268] In the illustrated example, the elbow assembly 6600, 7600, 8600 provides two different forms of decoupling to allow the elbow assembly 6600, 7600, 8600 to rotate freely relative to the frame assembly 6100, 7100, 8100 and the cushion assembly 6175, 7175, 8175, for example to enhance the decoupling of tube resistance on the patient interface to prevent seal instability.

[0269] The first form of decoupling is provided by the extrusion arms 6650, 7650, 8650 forming a swivel connection that allows the elbow assembly 6600, 7600, 8600 to freely rotate 360° relative to the frame assembly 6100, 7100, 8100 (see, e.g., Figure 6 ). Moreover, Fig.48AAn example of a elbow assembly 8600 is shown in a first position and Fig.48C An example of an elbow assembly 8600 is shown rotated relative to a first position to a second position via a swivel connection.

[0270] A second form of decoupling is provided by a ball and socket joint and a hinge joint that allows the elbow member 6620, 7620, 8620 to pivot relative to the swivel member 6610, 7610, 8610 about a single axis, such as about the axis of the pivot pin 6645, 7645 (see, e.g., Figure 7 ). Moreover, Fig.48A An example of a elbow assembly 8600 is shown in a first position and Fig.48B An example of an elbow assembly 8600 is shown pivoting upwardly relative to a first position to a second position via a ball and socket joint and a hinge joint. Fig.48D It also shows that relative to Fig.48A The elbow assembly is shown positioned with the elbow assembly swivel and pivoted upward. In one example, the ball joint and hinge joint provide a range of motion of about 10-30 degrees, such as a range of motion of about 15 degrees, a range of motion of about 25-30 degrees (e.g., 26 degrees). This hinge connection between the elbow member 6620, 7620, 8620 and the swivel member 6610, 7610, 8610 prevents free rotation or full 360 degree movement so as to prevent the elbow member 6620, 7620, 8620 from rotating into or contacting the squeeze arms 6650, 7650, 8650 (e.g., which could inadvertently release the elbow assembly from the frame assembly). The hinge connection between the elbow member 6620 , 7620 , 8620 and the swivel member 6610 , 7610 , 8610 also allows the pivot pin 6645 , 7645 to act as a stop to prevent the ball portion 6662 , 7652 from being fully inserted into the opening or socket 6635 , 7635 .

[0271] Therefore, the bending tube assembly 6600, 7600, 8600 is allowed to rotate as a whole relative to the frame assembly 6100, 7100, 8100 and the cushion assembly 6175, 7175, 8175, while the bending tube component 6620, 7620, 8620 is able to pivot relative to the rotation axis component 6610, 7610, 8610 in any rotation axis position of the bending tube assembly 6600, 7600, 8600, that is, the bending tube component 6620, 7620, 8620 is able to pivot relative to the rotation axis component 6610, 7610, 8610 regardless of the orientation of the bending tube assembly 6600, 7600, 8600 relative to the rotation position of the frame assembly 6100, 7100, 8100 and the cushion assembly 6175, 7175, 8175.

[0272] 5.3.1 Sealing structure

[0273] In one form of the present technology, the seal-forming structure provides a seal-forming surface and may additionally provide a cushioning function.

[0274] The seal-forming structure according to the present technology can be constructed from a soft, flexible and elastic material such as silicone.

[0275] In one form, the seal forming structure includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum. The support flange can be relatively thicker than the sealing flange. The support flange is arranged between the sealing flange and the edge of the plenum and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange in use to prevent it from bending. In use, the sealing flange can easily respond to the system pressure in the plenum that acts on its bottom surface, so that it forms a tight sealing engagement with the face.

[0276] In one form, the seal-forming portion of the non-invasive patient interface includes a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0277] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the handle. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate forming a universal connection structure that can adjust with relative movement of both displacement and angular movement between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the handle is connected.

[0278] In one form, the non-invasive patient interface comprises a seal forming portion which, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0279] In one form, the non-invasive patient interface comprises a seal forming portion which, in use, forms a seal over a chin region of a patient's face.

[0280] In some forms of the present technology, the seal-forming structure is constructed to correspond to a specific head size and / or facial shape. For example, one form of the seal-forming structure is suitable for large-sized heads but not for small-sized heads. In another example, one form of the seal-forming structure is suitable for small-sized heads but not for large-sized heads.

[0281] 5.3.2 Inflatable chamber

[0282] In the area where the seal is formed in use, the plenum has a perimeter that is shaped complementary to the surface contour of an average human face. In use, the boundary edge of the plenum is in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend along the entire perimeter of the plenum in use.

[0283] 5.3.3 Positioning and stabilizing the structure

[0284] The seal-forming structure of the patient interface of the present technology may be maintained in a sealed position during use by a positioning and stabilizing structure.

[0285] In one form of the present technology, a positioning and stabilizing structure is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0286] In one form of the present technology, the positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material for engaging with a hook material portion.

[0287] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in tension when in use and to direct a force to seal the cushion against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0288] In some forms of the present technology, the positioning and stabilizing structure comprises a strap that is flexible, e.g., non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0289] In some forms of the present technology, a positioning and stabilizing structure provides a retention force that is configured to correspond to a specific head size and / or facial shape. For example, one form of a positioning and stabilizing structure provides a retention force that is suitable for a large sized head, but not suitable for a small sized head. In one example, one form of a positioning and stabilizing structure provides a retention force that is suitable for a small sized head, but not suitable for a large sized head.

[0290] 5.3.4 Ventilation port

[0291] In one form, the patient interface includes a ventilation port constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0292] One form of a vent according to the present technology comprises a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0293] The ventilation port may be located in the plenum chamber. Alternatively, the ventilation port is located in a decoupling structure such as a swivel.

[0294] 5.3.5 Decoupling structure

[0295] In one form, the patient interface includes at least one decoupling structure, such as a swivel or a ball and socket.

[0296] 5.3.6 Connection Port

[0297] The connection port allows connection to the air circuit 4170.

[0298] 5.3.7 Forehead support

[0299] In the illustrated example, the frame assembly 6100 is provided without a forehead support.

[0300] In another form, the patient interface may include a forehead support, for example the frame assembly may include the forehead support.

[0301] 5.3.8 Anti-asphyxia valve

[0302] In one form, the patient interface includes an anti-asphyxia valve.

[0303] 5.3.9 Ports

[0304] In one form of the present technology, the patient interface includes one or more ports that allow access to the volume within the plenum. In one form, this allows the clinician to provide supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum, such as pressure.

[0305] 5.4 Glossary

[0306] For purposes of this technology disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0307] 5.4.1 General

[0308] Air: in some 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 mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0309] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0310] For example, relative to the humidifier environment humidity This may be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0311] In another example, the environment pressure This can be pressure directly around the body or outside the body.

[0312] In some forms, the environment (e.g., acoustic) noise It can be considered as the background noise level in the room the patient is in addition to the noise generated, for example, by the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0313] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0314] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the treatment pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0315] Flow: Volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, references to flow will be to a scalar quantity, i.e. a quantity having only magnitude. In other cases, references to flow will be to a vector quantity, i.e. a quantity having both magnitude and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow'.

[0316] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow (Qt) is the air flow leaving the RPT device. Ventilation flow (Qv) is the air flow leaving the ventilator port to allow for flushing of exhaled gases. 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.

[0317] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return elbow to the ambient environment.

[0318] Noise, Conducted (Acoustic): Conducted noise in this context refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0319] Noise, radiated (acoustic): Radiated noise in this context refers to the noise that is carried to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0320] Noise, ventilation (acoustic): Ventilation noise in this context refers to the noise generated by the flow of air through any ventilation openings, such as the ventilation openings in a patient interface.

[0321] Patient: A person, whether or not they have a respiratory illness.

[0322] Pressure: Force per unit area. Pressure can be expressed in units including cm H2O, gf / cm 2 1 cm H2O is equal to 1 g-f / cm 2 and is about 0.98 hectopascals. In this specification, unless otherwise stated, pressures are given in cm H2O.

[0323] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0324] Respiratory Pressure Therapy (RPT): The application of an air supply to the entrance of the airway at a therapy pressure, which is usually positive relative to atmospheric pressure.

[0325] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0326] 5.4.1.1 Materials

[0327] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0328] Polycarbonate: A transparent thermoplastic polymer typically of bisphenol A carbonate.

[0329] 5.4.1.2 Mechanical properties

[0330] Resilience: The ability of a material to absorb energy when it is elastically deformed and release that energy when it is deflated.

[0331] 'Resilient': Releases substantially all of its energy when deflated. Includes some silicones and thermoplastic elastomers.

[0332] Hardness: The ability of a material to resist deformation of itself (e.g., as described by Young's modulus, or the indentation hardness scale measured for a standard sample size).

[0333] 'Soft' materials may include silicone or thermoplastic elastomer (TPE), and may deform easily, for example under finger pressure.

[0334] 'Hard' materials may include polycarbonate, polypropylene, steel or aluminium, and may not deform easily under finger pressure, for example.

[0335] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending or torsion. A structure or component can provide different resistance in different directions.

[0336] 'Floppy' structure or component: A structure or component that will change shape, for example bend, when made to support its own weight for a relatively short period of time, such as 1 second.

[0337] 'Rigid' structure or component: A structure or component that will not substantially change shape when subjected to loads typically encountered in use. One example of this use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient's airway, for example under a load of about 20 to 30 cm H2O pressure.

[0338] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction compared to a second, orthogonal direction. In another example, a structure or component is floppy in a first direction and rigid in a second direction.

[0339] 5.4.2 Respiratory cycle

[0340] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea will be said to have occurred when apnea is detected due to reduced or absent respiratory effort despite an open airway. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0341] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0342] Duty cycle: The ratio of inspiratory time (Ti) to total breathing time (Ttot).

[0343] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0344] Expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0345] Flow Limitation: Flow limitation will be considered as a state of affairs in a patient's breathing where an increase in the patient's effort does not produce a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0346] Type of flow rate limiting inspiratory waveform:

[0347] (i) Flat: Having a rise followed by a relatively flat portion and then a fall.

[0348] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0349] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0350] (iv) Reverse chair shape: has a relatively flat portion followed by a single local peak at the trailing edge.

[0351] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow, but not a cessation of flow. In one form, hypopnea is said to have occurred when flow drops below a threshold for a period of time. Central hypopnea is said to have occurred when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0352] (i) A 30% decrease in the patient's breathing lasting at least 10 seconds with an associated 4% desaturation; or

[0353] (ii) A decrease (but at least 50%) in the patient's breathing lasting at least 10 seconds, with an associated desaturation or arousal of at least 3%.

[0354] Hyperpnea: Increased flow to a level above normal flow.

[0355] Inspiratory portion of the breathing cycle: The time period from the start of inspiratory flow to the start of expiratory flow will be considered the inspiratory portion of the breathing cycle.

[0356]

[00136] Patency (airway): The degree to which an airway is open, or the degree to which an airway is patent. An open airway is open. Airway patency can be quantified, for example with a value of one (1) for open and a value of zero (0) for closed (obstructed).

[0357] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of exhalation.

[0358] Leak flow (Qpeak): The maximum value of the flow during the expiratory portion of the respiratory flow waveform.

[0359] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of the respiratory air flow, as opposed to "true respiratory flow" or "true respiratory air flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0360] Tidal volume (Vt): The volume of air inspired or exhaled during normal breathing when no extra effort is exerted.

[0361] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0362] (Expiratory) Time (Ti): Duration of the expiratory portion of the respiratory flow waveform.

[0363] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0364] Typical recent ventilation: The ventilation value around which recent values ​​on some predetermined time scale tend to cluster, that is, a measure of the central tendency of recent values ​​of ventilation.

[0365] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This can be associated with a state of flow limitation, where flow increases only slightly or can even decrease as the pressure difference across the upper airway increases (Starling impedance behavior).

[0366] Ventilation (Vent): A measure of the flow of gases exchanged by a patient's respiratory system. Measurements of ventilation may include either or both of the inspiratory and expiratory flow per unit time. When expressed in volumes per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given as volume only, understood to be volume per minute.

[0367] 5.4.3 Ventilation volume

[0368] Adaptive servo ventilator (ASV): A servo ventilator with a variable target ventilation rather than a fixed target ventilation. The variable target ventilation may be known from some characteristics of the patient, such as the patient's breathing characteristics.

[0369] Backup Rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically in breaths per minute) that the ventilator will deliver to the patient if not elicited by spontaneous respiratory effort.

[0370] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering 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 a breath.

[0371] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the varying pressures during a breath are added to produce the desired mask pressure that the ventilator will try to achieve at a given time.

[0372] End-expiratory pressure (EEP): The desired mask pressure that the ventilator will attempt to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) is zero-valued at the end of exhalation, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.

[0373] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure the ventilator will attempt to achieve during the inspiratory portion of a breath.

[0374] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference in pressure between the maximum and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0375] Servo ventilator: A ventilator that measures the patient's ventilation, has a target ventilation volume, and adjusts the pressure support level to bring the patient's ventilation volume toward the target ventilation volume.

[0376] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect breath activation in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0377] Swing: An equivalent term for pressure support.

[0378] Induced: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be induced to do so at the beginning of the breathing portion of the breathing cycle by the patient's effort.

[0379] Typical recent ventilation: Typical recent ventilation Vtyp is the value around which recent measurements of ventilation on some predetermined time scale tend to cluster. For example, a measure of the central tendency of ventilation measurements in recent history may be a suitable value for typical recent ventilation.

[0380] 5.4.4 Anatomy

[0381] 5.4.4.1 Facial anatomy

[0382] The outer wall or "wing" of each nostril (plural: alars)

[0383] Alar tip: The outermost point on the wing of the nose.

[0384] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0385] Auricle: The entire external visible part of the ear.

[0386] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0387] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0388] Columella: The strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0389] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where both lines intersect at the lower point of the nasal septum).

[0390] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0391] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0392] External nasal cartilage: A generally triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla and its lower edge connected to the greater alar cartilage.

[0393] Lower lip (midpoint of lower lip):

[0394] Upper lip (midpoint of upper lip):

[0395] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar.

[0396] Nostril: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular nostril is nostril. The nostrils are separated by the nasal septum.

[0397] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0398] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0399] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0400] Auricular base: The highest point where the auricle attaches to the facial skin.

[0401] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0402] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0403] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0404] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0405] Sagittal Plane: A vertical plane that passes from anterior (front) to posterior (back) and divides the body into right and left halves.

[0406] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0407] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0408] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (upper) lip.

[0409] The subnasal point is located on the soft tissue at the point where the columella and upper lip meet in the midsagittal plane.

[0410] Mandibular alveolar seat point: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue.

[0411] 5.4.4.2 Anatomy of the skull

[0412] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0413] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0414] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0415] Nasal Bones: The nasal bones are two oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0416] Nasion: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0417] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0418] Orbit: The bony cavity in the skull that holds the eyeball.

[0419] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0420] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0421] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0422] 5.4.4.3 Anatomy of the respiratory system

[0423] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0424] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0425] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0426] 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 wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the turbinates (singular "nasal conchae") or nasal conchae. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0427] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the larynx), and the hypopharynx (hypopharynx).

[0428] 5.4.5 Patient interface

[0429] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0430] Elbow: An elbow is an example of a structure that directs the axis of an air flow to change direction through a certain angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater or less than 90 degrees. The elbow can have a cross-section that is approximately circular. In another form, the elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can be rotated relative to a mating component, for example, through about 360 degrees. In some forms, the elbow can be removable from a mating component, such as by a snap connection. In some forms, the elbow can be assembled to the mating component during the manufacturing process with a disposable snap, but cannot be removed by the patient.

[0431] Frame: A frame will be considered to mean the mask structure that carries the tension load between two or more connection points with the headband. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0432] Functional dead space:

[0433] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcing bars configured to position and maintain a patient interface in position on a patient's face for delivery of respiratory therapy. Some straps are formed of soft, pliable, resilient materials, such as a laminate composite of foam and fabric.

[0434] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0435] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the walls of the mask plenum.

[0436] Seal: can be a noun indicating structure ("seal") or a verb indicating action ("to seal"). Two elements can be constructed and / or arranged to seal between them or achieve a "seal" between them without the need for a separate "sealing" element itself.

[0437] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0438] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0439] Bracing: Bracing will be taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0440] Swivel (n): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel in use.

[0441] Tie (noun): A structure designed to resist tension.

[0442] Ventilation port: (noun): A structure that allows air flow from the interior of a mask or conduit to ambient air to allow clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0443] 5.4.6 Shape of the structure

[0444] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a cushion structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0445] To help describe the shape of three-dimensional structures and surfaces, we first consider a cross section through a point p on the surface of the structure. FIG. 3B to FIG. 3F , which show examples of cross sections at a point p on the surface and the resulting planar profile. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at point p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0446] 5.4.6.1 Curvature in one dimension

[0447] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0448] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person were to leave that point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0449] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0450] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0451] 5.4.6.2 Curvature of a Two-Dimensional Surface

[0452] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), 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, such as a relatively small magnitude. FIG. 3B to FIG. 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0453] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example of Figure 3B and the minimum value appears at Figure 3F ,therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0454] Region of a surface: A connected set of points on a surface. The points in a region can have similar characteristics, such as curvature or sign.

[0455] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction in which the imagined individual is turning, they can be walking up or down).

[0456] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0457] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0458] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0459] Edge of a surface: The boundary or limit of a surface or area.

[0460] Path: In some forms of the present technology, 'path' will mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0461] Path length: In some forms of the present technology, the '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 may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0462] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there can be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there can be no path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.)

[0463] 5.4.6.3 Space curve

[0464] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be thought of as one-dimensional slices of three-dimensional space. An imaginary individual walking on a DNA helix walks along a space curve. A typical human left ear consists of a left-handed helix, see Figure 3P The typical human right ear includes a right-handed helix, see Figure 3Q . Figure 3R A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or propeller, can follow a space curve. In general, a space curve can be described by the curvature and torque at each point on the space curve. Torque is a measure of how the curve departs from the surface. Torque has a sign and a magnitude. The torque at a point on a space curve can be characterized with reference to the tangent plane, normal, and binormal vectors at that point.

[0465] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point indicates the direction from that point as well as the amount. The tangent unit vector is a unit vector pointed in the same direction as the curve at that point. If an imaginary individual were flying along the curve and stopped at a particular point, the direction of the tangent vector is the direction it would be traveling.

[0466] Unit Normal Vector: As the imaginary individual moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0467] 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, e.g. Fig.3O ) or alternatively by the left-hand rule ( Figure 3N ) to determine.

[0468] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Figure 3N and Fig.3O .

[0469] Torque of a space curve: The torque at a point on a space curve is the amount of change in 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 that lies on a plane has zero torque. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torque (e.g., a slightly tilted spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torque (e.g., a sharply tilted spiral path). Figure 3R , although T2>T1, in Figure 3R The torque near the top spiral coil is greater than Figure 3R The amount of torque on the bottom spiral coil.

[0470] refer to Fig.3O According to the 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., Figure 3R A space curve that deviates away from the right-handed binormal direction can be considered to have a right-handed negative torque (e.g., a left-handed spiral).

[0471] Similarly and referring to the left-hand rule (see Figure 3N ), a space curve that turns in the direction of the left-handed binormal can be considered to have a left-handed positive torque (e.g., a left-handed helix). Thus, a left-handed positive torque is equivalent to a right-handed negative torque. Figure 3S .

[0472] 5.4.6.4 Holes

[0473] A surface may have one-dimensional pores, for example pores defined by a plane curve or by a space curve. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. For example, see Fig. 3I A one-dimensional hole in the structure surface shown in FIG. 3 is defined by a plane curve 301D.

[0474] The structure may have a two-dimensional aperture, such as an aperture defined by a surface. For example, an inflatable tire has a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel has a two-dimensional aperture. See, for example, Figure 3L Cushions and Figure 3M In another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Figure 3K The structure shown has a two-dimensional aperture defined by surface 302D.

[0475] 5.5 Other Notes

[0476] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0477] Unless the context clearly indicates and provides a numerical range, it is understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other such value or intervening value in the range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the range. When the range includes one or both of the limits, ranges excluding one or both of the limits of those included limits are also included in the present technology.

[0478] Furthermore, where one or more values ​​of the present technology are implemented as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0479] 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 the technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology, a limited number of exemplary methods and materials are described herein.

[0480] When a specific material is identified for use in configuring a component, obvious alternative materials with similar properties are used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0481] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0482] All publications mentioned herein are incorporated by reference to disclose and describe methods and / or materials as the subject of those publications. The publications discussed herein are only provided for disclosures prior to the filing date of the present application. This article cannot be interpreted as acknowledging that the present technology is not entitled to be earlier than such publications by virtue of prior invention. In addition, the publication date provided may be different from the actual publication date, and the publication date may need to be independently confirmed.

[0483] The terms “comprises” and “comprising” should be interpreted as meaning that the referenced elements, components or steps may be present, used or combined with other elements, components or steps not explicitly referenced in a non-exclusive manner.

[0484] The main headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the inventive subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0485] Although the present technology has been described with reference to specific embodiments, it should be understood that these examples only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method 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.

[0486] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0487] For example, it should be appreciated that one or more features of any one elbow assembly example (e.g., elbow assemblies 6600, 7600, 8600) can be combined with one or more features of another elbow assembly example (e.g., elbow assemblies 6600, 7600, 8600) or other examples related thereto. For example, one or more aspects of elbow assembly 8600 (e.g., edge or serrations 8631) can be incorporated into elbow assemblies 6600, 7600.

[0488] 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 / 050891, filed on September 23, 2016, and entitled “Patient Interface,” which publication claims the benefit of U.S. Provisional Application Nos. 62 / 222,593, filed on September 23, 2015, and 62 / 376,961, filed on August 19, 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 “VentAdaptor for a Respiratory Therapy No. 62 / 222,604, filed on September 23, 2015; and / or PCT Application No. PCT / AU2016 / 050228, filed on March 24, 2016 and entitled “Patient Interface with Blowout Prevention for Seal-Forming Portion,” 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.

[0489] 5.6 Reference Symbols List

[0490] Numbered Feature Entries

[0491] 1000 patients

[0492] 1100 Bed Partner

[0493] 3000 Patient Interface

[0494] 3100 Seal forming structure

[0495] 3200 Inflatable Chamber

[0496] 3300 Positioning and stabilizing structures

[0497] 3400 Ventilation port

[0498] 3600 port

[0499] 3700 Forehead Support

[0500] 4000 RPT device

[0501] 4170 Air Circuit

[0502] 5000 Humidifier

[0503] 6000 Patient Interface

[0504] 6100 Frame Assembly

[0505] 6120 channels

[0506] 6175 Mat Assembly

[0507] 6200 Seal forming structure

[0508] 6250 Lip Seal

[0509] 6600 elbow assembly

[0510] 6610 Swivel Parts

[0511] 6612 Swivel Component

[0512] 6614 Diffuser Material

[0513] 6616 Diffuser Cover

[0514] 6618 Export

[0515] 6620 elbow parts

[0516] 6625 Swivel Connector

[0517] 6630 Inner wall

[0518] 6632 outer wall

[0519] 6634 bottom wall

[0520] 6635 Opening

[0521] 6640 Ventilation hole

[0522] 6645 Pivot Pin

[0523] 6650 Extrusion Arm

[0524] 6652 Hook end

[0525] 6660 First End

[0526] 6662 Ball Part

[0527] 6664 concave part

[0528] Port 6665

[0529] 6667 Opening

[0530] 6670 Second End

[0531] 6671 Tubular end section

[0532] 6672 bottom wall

[0533] 6672A Wall Section

[0534] 6672B Wall section

[0535] 6675 Ribs

[0536] 6680 AAV

[0537] 6682 Baffle part

[0538] 6684 Connection part

[0539] 6800 Headband

[0540] 7100 Frame Assembly

[0541] 7105 Channel

[0542] 7105A End wall

[0543] 7105B Sidewall

[0544] 7115 Ring flange

[0545] 7115A Inner surface

[0546] 7120 channels

[0547] 7125 Ridge

[0548] 7175 Mat Assembly

[0549] 7176 Connection part

[0550] 7176A Leading Edge

[0551] 7176B Outer side

[0552] 7600 elbow assembly

[0553] 7610 Swivel Parts

[0554] 7620 elbow parts

[0555] 7625 Swivel Connector

[0556] 7626 Tongue

[0557] 7630 Inner wall

[0558] 7632 outer wall

[0559] 7632A External surface

[0560] 7632B Leading Edge

[0561] 7633 Channel

[0562] 7634 bottom wall

[0563] 7635 Opening

[0564] 7636 Edge

[0565] 7637 Track

[0566] 7639 access

[0567] 7640 Ventilation hole

[0568] 7645 Pivot Pin

[0569] 7650 Extrusion Arm

[0570] 7652 Hook end

[0571] 7655 Articulated part

[0572] 7657 Finger grip

[0573] 7660 First End

[0574] 7662 Ball Part

[0575] 7664 concave part

[0576] Port 7665

[0577] 7667 Opening

[0578] 7670 Second End

[0579] 7671 Tubular end section

[0580] 7671A Slot

[0581] 7672 bottom wall

[0582] 7672A Wall Section

[0583] 7672B Wall Section

[0584] 7673 Opening

[0585] 7674 Bridge

[0586] 7675 Ribs

[0587] 7680 AAV

[0588] 7682 Baffle part

[0589] 7684 Connection part

[0590] 7685 Hinge part

[0591] 7690 slots

[0592] 7692 Flat Surface

[0593] 7695 Welding Pass

[0594] 7696 Flat Surface

[0595] 7698 Flat Surface

[0596] 8000 Patient Interface

[0597] 8100 Frame Assembly

[0598] 8175 cushion assembly

[0599] 8600 elbow assembly

[0600] 8610 Swivel Parts

[0601] 8620 elbow parts

[0602] 8630 Inner wall

[0603] 8631 Edge or serration

[0604] 8632 outer wall

[0605] 8633 Channel

[0606] 8640 Ventilation hole

[0607] 8650 Extrusion Arm

[0608] Port 8665

[0609] 8665.1 Edge

[0610] 8682 AAV retaining plate.

Claims

1. An elbow assembly for a patient interface, the elbow assembly comprising: a component adapted to be connected to a patient interface; wherein the component comprises a plurality of ventilation ports for gas flushing, wherein the member includes an inner radial wall and an outer radial wall defining a radial passage leading to the plurality of ventilation port holes, and Wherein at least a portion of the inner radial wall includes an inwardly extending edge or serrations constructed and arranged to redirect flow in a manner that reduces noise and / or minimizes flow directly onto sensitive portions of the patient's face.

2. The elbow assembly of claim 1, wherein the component is a swivel component adapted to allow the elbow assembly to rotate relative to the patient interface.

3. The elbow assembly according to claim 2, wherein the swivel component is suitable for allowing the elbow assembly to rotate freely 360° around the axis relative to the patient interface.

4. An elbow assembly according to any one of claims 2 to 3, wherein the swivel component includes a rigid connection to the patient interface.

5. The elbow assembly of any one of claims 2 to 4, wherein the swivel component is configured to form a dynamic diameter seal and a dynamic face seal with the patient interface to provide a tortuous leak path.

6. A patient interface for providing positive pressure therapy to a patient to improve sleep-disordered breathing, the patient interface comprising: Frame components; a seal-forming structure provided to the frame assembly and adapted to form a seal with the patient's face; and A pipe elbow assembly according to any one of claims 1 to 15.

7. A patient interface for providing positive pressure therapy to a patient to improve sleep-disordered breathing, the patient interface comprising: Frame components; a seal-forming structure provided to the frame assembly and adapted to form a seal with the patient's face; and an elbow assembly, the elbow assembly comprising a swivel member adapted to be connected to the frame assembly and an elbow member adapted to be connected to an air circuit, The swivel component is coupled to the elbow component via a hinge joint, and the hinge joint allows the elbow component to pivot relative to the swivel component.

8. A patient interface for providing positive pressure therapy to a patient to improve sleep-disordered breathing, the patient interface comprising: Frame components; a seal-forming structure provided to the frame assembly and adapted to form a seal with the patient's face; and An anti-asphyxia valve includes a flap designed to close a port upon application of pressurized gas, wherein the port is at least partially surrounded by a protruding rim to engage the flap to close the port upon pressure loading.

9. A patient interface for providing positive pressure therapy to a patient to improve sleep-disordered breathing, the patient interface comprising: Frame components; a seal-forming structure provided to the frame assembly and adapted to form a seal with the patient's face; and The frame assembly is configured to form a dynamic diameter seal and a dynamic face seal with the elbow assembly.

10. A patient interface for providing positive pressure therapy to a patient to improve sleep-disordered breathing, the patient interface comprising: Frame components; a seal-forming structure provided to the frame assembly and adapted to form a seal with the patient's face; and A vent device includes a vent hole and a cover that redirects exhausted gases radially outward.

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