Gasket

Abstract

The utility model relates to a liner. A cushion configured to seal a portion of a patient's face around an entrance to a patient's airway, the cushion comprising: at least one first opening and at least one second opening, one of the at least one first opening and the at least one second opening configured to receive a flow of pressurized air, one of the at least one first opening and the at least one second opening is configured to receive an inflation chamber of the cushion, and the other of the at least one first opening and the at least one second opening is configured to receive a connection structure acting as a plug to limit entry and / or exit of pressurized air from the inflation chamber of the cushion, characterized in that a rigid member arm extends from the connection structure, the rigid member arm is configured to facilitate holding the pad in an operative position.

Description

[0001] This application is a divisional application of application No. 202323392753.5, with a filing date of October 28, 2022, the title of which is “Patient interface”, which is a divisional application of application No. 202222870695.1, with a filing date of October 28, 2022, the title of which is “Patient interface”.

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of Singapore Provisional Application No. 10202112048R filed October 29, 2021, the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of a respiratory-related disorder. The present technology also relates to medical devices or apparatuses, and their use. The present technology particularly relates to a cushion. BACKGROUND

[0005] 2.2 DESCRIPTION OF RELATED ART

[0006] 2.2.1 The Human Respiratory System and Its Disorders

[0007] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0008] The airways include a sequence of branching tubes when the branching airways penetrate deeper into the lung, they become narrower, shorter and more numerous. The main function of the lung is gas exchange, allowing oxygen from inhaled air to enter the venous blood and carbon dioxide to leave the blood to be exhaled. The trachea divides into the left and right bronchial tubes, which ultimately subdivide into end- bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and ultimately to the alveoli. The alveolar region of the lung is where gas exchange occurs, and is called the respiratory zone. See West, John B. Respiratory Physiology, 9thedition, Lippincott Williams & Wilkins, 2012.

[0009] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0010] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest Wall Disorders.

[0011] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) that involves partial or complete obstruction of the upper airway. Posterior- lingual collapse is the most common site of obstruction. Obstruction can occur over the entire cross-sectional area of the airway or can be localized to one side. Snoring results from obstruction of the pharynx, which causes vibration of the soft palate and uvula. When apnea occurs, the patient may experience 100% oxyhemoglobin desaturation and arousal. The apnea-hypopnea index (AHI) is the number of apneic and hypopneic episodes per hour. An AHI of 5 is considered abnormal. OSA is the most common form of SDB and is a common disorder in middle aged males, although it is also found in women and in all age groups. It is more prevalent in obese patients and in those with a large neck circumference. OSA is associated with hypertension, cardiac arrhythmias, and heart attacks. It is also associated with brain damage, including stroke, dementia, and death. 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 central nervous system that manifests itself in a characteristic pattern of breathing during sleep. In CSR, there is a regularly repeating cycle of increasing and decreasing ventilatory effort. This cycling of hyperpnea and hypopnea is associated with repetitive oxyhemoglobin desaturation and reoxygenation. The cycling is typically of 1 minute period, although this can vary between 40 and 2 minutes. CSR is a form of SDB, but it is not currently considered to be a form of obstructive sleep apnea. It is associated with heart failure and is a marker of poor cardiovascular prognosis. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is a term used to describe diseases of the respiratory system in which the lungs cannot take in sufficient oxygen or remove sufficient CO2 to meet the needs of the patient. Respiratory failure can encompass some or all of the following disorders.

[0014] A patient with respiratory insufficiency, a form of respiratory failure, can experience abnormally short breaths when exercising.

[0015] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnea in the presence of a normal ventilatory drive. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0016] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the single most important risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly through intrinsic muscle pathology, or indirectly as a result of nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, dysphagia, respiratory muscle weakness, and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular sclerosis (DMD) in teenagers). (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly shortens life expectancy (e.g. Limb girdle, Facioscapulohumeral, and Myotonic muscular disorders). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling of the respiratory muscles to the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion and at rest, peripheral oedema, orthopnea, repeated chest infections, morning headache, fatigue, poor sleep quality, and poor concentration.

[0019] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals can take advantage of such therapies to prevent respiratory disorders from arising. However, these therapies have a number of drawbacks.

[0020] 2.2.2 Treatment

[0021] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV) and high flow therapy (HFT) have been used to treat one or more of the above respiratory disorders.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the supply of air to the entrance of the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as with a tank ventilator or a conduit ventilator).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnoea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and thus a patient can elect not to comply with the therapy if the patient finds the device used to provide such therapy to be any one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0025] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient's breathing and / or to maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which presents in forms such as OHS, COPD, NMD and Chest Wall Disorder. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] Invasive ventilation (IV) provides ventilatory support to a patient who is unable to breathe effectively on their own and can be provided using an tracheostomy or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] 2.2.2.2 Flow therapy

[0028] Not all respiratory therapies aim to deliver a prescribed treatment pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow curve over a target duration (possibly superimposed on a positive baseline pressure). In other cases, the interface to the patient's airways is "open" (unsealed) and the respiratory therapy can supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow Therapy (HFT) is the provision of a continuous, heated, humidified flow of air through an unsealed or "open" patient interface to the entrance of the airways at a "treatment flow rate" that can remain approximately constant throughout the respiratory cycle. This treatment flow rate is nominally set to exceed the peak inspiratory flow rate of the patient. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow of air at the entrance of the airways improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomic dead space. HFT is therefore sometimes referred to as deadspace therapy (DST). Other benefits can include elevated warmth and humidity (possibly beneficial in secretion management) and the possibility of modestly elevating airway pressures. As an alternative to a constant flow, the treatment flow rate can follow a curve that varies over the respiratory cycle.

[0029] Another form of flow therapy is Long Term Oxygen Therapy (LTOT) or supplemental oxygen therapy. A physician can prescribe a continuous flow of oxygen enriched air to be delivered to the patient's airways at a specified oxygen concentration (from 21%, the fraction of oxygen in ambient air, to 100%) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0030] 2.2.3 Respiratory therapy system

[0031] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used to screen for, diagnose, or monitor a disorder without treating it.

[0032] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0033] 2.2.3.1 Patient interface

[0034] A patient interface can be used to interface a respiratory device to its wearer, e.g., by providing a flow of air to the entrance of the airways. The flow of air can be provided via a mask to the nose and / or mouth of a patient, via a tube to the mouth, or via a tracheal tube to the tracheal of a patient. Depending on the treatment to be applied, the patient interface can form a seal with a region of the patient's face, e.g., the nose and mouth of the patient, to facilitate the delivery of gas pressure to the airways that is sufficiently different from ambient pressure to effect therapy, e.g., positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, e.g., oxygen delivery, a patient interface can not include a seal sufficient to deliver gas pressure about 10 cmH20 above ambient to the airways. For flow therapies such as nasal HFT, the patient interface is configured to blow gas into the nares, but specifically avoids a full seal. One example of such a patient interface is a nasal cannula.

[0035] Certain other mask systems can not be functionally suitable for use in the art. For example, purely decorative masks can not be able to maintain an appropriate pressure. Mask systems for use in underwater swimming or diving can be configured to prevent water from the higher pressure outside from entering, but do not maintain the internal air at a pressure higher than ambient.

[0036] Certain masks can be clinically disadvantageous for the present technology, e.g., where they block airflow through the nose and only allow it through the mouth.

[0037] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal through their lips, this can be uncomfortable or impractical for the present technology.

[0038] Certain masks can not be achievable for use while sleeping, e.g., when lying on one's side in bed with one's head on a pillow.

[0039] 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 varies greatly among different individuals. As the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible, or lower jaw, can move relative to other bones of the skull. The entire head can move during the course of a period of respiratory therapy.

[0040] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0041] Assuming patient adherence, nasal CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0042] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0043] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0044] 2.2.3.1.1 Sealing Formation Structure

[0045] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0046] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region 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.

[0047] A seal-forming structure that can be effective in one region of a patient's face can not be suitable in another region, for example because of differences in the shape, structure, variability and sensitive areas of a patient's face. For example, a seal on swimming goggles that covers a patient's forehead can not be suitable for use on a patient's nose.

[0048] Certain seal-forming structures can be designed for mass production, such that one design is suitable, comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface, one or both must accommodate to form a seal.

[0049] One type of seal-forming structure extends around the periphery of a patient interface and is intended to seal against a patient's face when a force is applied to the patient interface while the seal-forming portion is in confronting engagement with the patient's face. The seal-forming structure can comprise an air or fluid-filled cushion, or a molded or shaped surface of an elastomeric (e.g. rubber) sealing element. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0050] Another type of seal-forming structure incorporates a sheet-like seal of thin material around the periphery of the mask to provide a self-sealing action against a patient's face when positive pressure is applied within the mask. Like the previous type of seal-forming portion, if the fit between the face and the mask is not good, additional force can be required to achieve a seal, or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can wrinkle or buckle in use, causing a leak.

[0051] Another type of seal-forming structure can include a friction-fit element, such as for insertion into a nostril, however some patients find these uncomfortable.

[0052] Another form of seal-forming structure can use adhesive to achieve a seal. Some patients can find it inconvenient to apply and remove adhesive from their face on a regular basis.

[0053] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0054] One form of nasal pillow was 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.

[0055] ResMed manufactures the following products that include nose pillows: SWIFT™ Nose Pillow Cover, SWIFT™ II Nose Pillow Cover, SWIFT™ LT Nose Pillow Cover, SWIFT™ FX Nose Pillow Cover, and MIRAGE LIBERTY™ Full Face Cover. The following patent applications assigned to ResMed Inc. describe examples of nose pillow covers: International Patent Application WO2004 / 073778 (which describes other aspects of ResMed's SWIFT™ Nose Pillow), U.S. Patent Application 2009 / 0044808 (which describes other aspects of ResMed's SWIFT™ LT Nose Pillow); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which describe aspects of ResMed's MIRAGE LIBERTY™ Full Face Cover); International Patent Application WO2009 / 052560 (which describes other aspects of ResMed's SWIFT™ FX Nose Pillow).

[0056] 2.2.3.1.2 Positioning and Stability

[0057] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0058] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0059] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of use.

[0060] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0061] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of a number of therapies described above, for example by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0062] The designer of the device can be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, comfort and efficacy in certain respects can be highly sensitive to small, subtle changes in one or more parameters.

[0063] 2.2.3.3 Air circuit

[0064] An air circuit is a conduit or tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as an RPT device and a patient interface. In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for inhalation and exhalation.

[0065] 2.2.3.4 Humidifier

[0066] Delivering a flow of air without humidification can cause drying of the airways. Using a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in cooler climates, warm air applied generally to the face area surrounding and in the patient interface is more comfortable than cold air.

[0067] 2.2.3.5 Data management

[0068] There can be many clinical reasons to obtain data that determines whether a patient prescribed with respiratory therapy is "compliant", e.g. that the patient has used their RPT device according to one or more "compliance rules". One example of a compliance rule for CPAP therapy is that a patient is required to use the RPT device for at least four hours a night for at least 21 or 30 consecutive days in order to be considered compliant. To determine the compliance of a patient, a provider of the RPT device, such as a health care provider, can manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period and compare to the compliance rules. Once the health care provider has determined that the patient has used their RPT device according to the compliance rules, the health care provider can inform a third party that the patient is compliant.

[0069] There can be other aspects of patient therapy that would benefit from communication of therapy data to a third party or external system.

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

[0071] 2.2.3.6 Vent Technologies

[0072] Some forms of therapy systems can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow a flow of gas from an interior space of the patient interface, such as a plenum chamber, to an exterior of the patient interface, such as to ambient. The vent can be positioned to minimise the disturbance to the patient 1000 and / or their bed partner 1100.

[0073] The vent can include an orifice and in use of the mask gas can flow through the orifice. Many such vents are noisy. Others can become obstructed during use, providing an inadequate flush of exhaled carbon dioxide.

[0074] Riethmacher, et al. have developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034665; and International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0075] Noise table for existing masks (ISO 17510-2:2007, 10 cm H20 pressure at 1 m)

[0076]

[0077] (* only one sample, measured at 10 cm H20 in CPAP mode using test method specified in ISO 3744).

[0078] The sound pressure values for various objects are listed below

[0079]

[0080]

[0081] 2.2.4 Screening, Diagnosis and Monitoring Systems

[0082] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiorespiratory disorders, and typically involves a professional clinical staff applying the system. PSG typically involves placing 15 to 20 contact sensors on a patient to record various body signals, such as electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing involves observing a patient for two nights in a clinic, one night purely for diagnosis and a second night for the clinician to titrate treatment parameters. PSG is therefore expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0083] Screening and diagnosis generally describe the identification of a disorder from signs and symptoms of the disorder. Screening typically gives a true / false result indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis can produce clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progression of the condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some can also be used for monitoring.

[0084] A clinical specialist can be able to adequately screen, diagnose or monitor a patient from visual observation of PSG signals. However, there are situations where a clinical specialist can not be available or can not be affordable. Different clinical specialists can disagree on a patient's condition. Furthermore, a given clinical specialist can apply different criteria at different times. Innovations

[0085] The present technology is directed towards providing a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0086] A first aspect of the present technology concerns apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0087] A further aspect of the present technology concerns methods for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0088] One aspect of certain forms of the present technology is to provide methods and / or apparatuses to improve patient compliance with respiratory therapy.

[0089] One form of the present technology includes a sleeve to facilitate connection between a headgear and a cushion of a positioning and stabilising structure.

[0090] A further aspect of one form of the present technology is a series of modular elements that can be interconnected so as to form different types of patient interface.

[0091] One aspect of one form of the present technology is a patient interface comprising

[0092] a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure, said plenum chamber including at least one plenum chamber inlet port sized and structured to receive a flow of air at said therapeutic pressure for breathing by the patient,

[0093] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and

[0094] characterized in that the patient interface further comprises:

[0095] a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising:

[0096] a non-extensible element configured to cover the patient's cheeks,

[0097] a sleeve configured to cover at least a portion of the non-extensible element, the sleeve being removably positioned about at least a portion of the non-extensible element, the sleeve comprising:

[0098] a longitudinal extension forming a passageway having a lower opening, the passageway being configured for receiving the at least a portion of the non-extensible element,

[0099] a lower extension positioned outside of the passageway and adjacent to the lower opening, and

[0100] a connection member connected to the lower extension, and

[0101] a headgear strap configured to be detachably connected to the connection member of the lower extension of the sleeve and configured to provide at least a portion of the force to hold the seal-forming structure in a sealing position;

[0102] wherein

[0103] the patient interface is configured to allow the patient to breath from ambient through their mouth without a flow of pressurised air passing through the plenum chamber inlet port, or the patient interface is configured such that the patient's mouth is not covered.

[0104] In one form, a) at least one sleeve is included in the modular element; b) the sleeve is constructed of a comfort material; and / or c) the at least one sleeve is selectively used for use in a tube-up or tube-down arrangement with a cushion.

[0105] In one form, a) a cushion is included in the modular element; b) the cushion includes at least one first opening and at least one second opening; and / or c) the plenum chamber of the cushion is configured for receiving pressurized air through either the at least one first opening or the at least one second opening, depending on the style selected.

[0106] In one form, each modular element has at least two versions or types. These versions or types can be used interchangeably with one another to form different modular assemblies.

[0107] Another aspect of one form of the present technology is a sleeve configured to be selectively used in a modular patient interface, the sleeve being configured to at least partially contain a portion of a positioning and stabilising structure, and the sleeve having at least two connection points for removably connecting to a strap of the headgear.

[0108] In one form, a) the sleeve is configured to substantially or completely cover the rigidiser arm; b) the sleeve includes a pair of tabs configured to receive a strap; c) the sleeve includes a lower extension having a connector configured to be detachably connected to a strap; and / or d) the connector is a magnet.

[0109] In one form, a) the sleeve is configured to partially cover a conduit for delivering pressurized air to a patient; b) the sleeve includes a pair of tabs configured to receive a strap; c) the sleeve includes a lower extension having a connector configured to be detachably connected to a strap; and / or d) the connector is a magnet.

[0110] In one form, the sleeve is configured to connect to a cushion for a tube-down configuration in which a pressurized air flow is delivered to a patient from in front of the patient's head.

[0111] In one form, the sleeve is configured to connect to a cushion for a tube-up configuration in which a pressurized air flow is delivered to a patient through a conduit headgear.

[0112] Another aspect of one form of the present technology is a conduit sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve including:

[0113] a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway being configured to receive a fluid conduit;

[0114] a lower extension positioned outside the passageway and adjacent the lower opening; and

[0115] a connecting member connected to the lower extension.

[0116] In some forms, a) the lower extension is more rigid than the passageway; b) the lower extension is formed from a rigid material (e.g., plastic); c) the lower extension is made rigid using a stitching method (e.g., flat knitting); and / or d) the lower extension is substantially inextensible.

[0117] In some forms, a) the connecting member is a magnet; and / or b) the connecting member and the connecting member are oriented in opposite directions.

[0118] In some forms, a) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; and / or b) the material between the upper opening and the lower opening is substantially inextensible.

[0119] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of a patient interface; b) the upper opening is configured to be positioned, in use, under a patient’s ear; and / or c) the conduit sleeve is one of a pair of conduit sleeves, each conduit sleeve of the pair of conduit sleeves being configured to be removably connected to a fluid conduit of a conduit headgear.

[0120] Another aspect of one form of the present technology is a four-point arm sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve comprising:

[0121] an upper section; and

[0122] a pair of lower sections, each lower section of the pair of lower sections comprising,

[0123] a passageway having a lower opening, the passageway being configured for receiving a rigidiser arm,

[0124] a lower extension connected proximate to the lower opening, the lower extension being positioned out of the passageway, a connecting member connected to the lower extension, and

[0125] a tab arranged proximate to the upper section and configured for receiving one headgear strap.

[0126] In some forms, a) the lower extension is more rigid than the passageway; b) the lower extension is formed from a rigid material (e.g., plastic); c) the lower extension is made rigid using a stitching method (e.g., flat knitting); and / or d) the lower extension is substantially inextensible.

[0127] In some forms, a) the connecting member is a magnet; and / or b) the connecting member and the connecting member are oriented in opposite directions.

[0128] In some forms: a) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening; b) the remaining lower sections are substantially inextensible; and / or c) the upper portion is substantially inextensible.

[0129] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of the patient interface; b) the tab is configured to be positioned at a location over an ear of the patient in use; and / or c) the upper section.

[0130] Another aspect of one form of the present technology is a two-point arm sleeve configured to connect to a positioning and stabilising structure of a patient interface, the conduit sleeve comprising:

[0131] an upper section; and

[0132] a pair of lower sections, each of the pair of lower sections comprising,

[0133] a passage having a lower opening, the passage being configured for receiving a rigidiser arm,

[0134] a connection member connected to the lower extension, and

[0135] a tab arranged proximate the upper section and configured for receiving one headgear strap.

[0136] In some forms: a) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening; b) the remaining lower sections are substantially inextensible; and / or c) the upper portion is substantially inextensible.

[0137] In some forms: a) in use, the lower opening is configured to be positioned proximate to a cushion of the patient interface; b) the tab is configured to be positioned at a location over an ear of the patient in use; and / or c) the upper section.

[0138] Another aspect of one form of the present technology is a cushion configured to seal a portion of a patient's face about an entrance to a patient's airways. The cushion includes at least one first opening and at least one second opening. One of the at least one first opening and the at least one second opening is configured to receive a flow of pressurised air, and the other of the at least one first opening and the at least one second opening is configured to receive a plug to restrict ingress and / or egress of pressurised air from a plenum chamber of the cushion.

[0139] In some forms, a) the first plug is removably received in the at least one first opening and the second plug is removably received in the at least one second opening; b) the first plug is different to the second plug; c) the at least one first opening comprises a pair of first openings and a pair of first plugs are removably received within the pair of first openings when the at least one second opening is configured to receive a flow of pressurized air; and / or d) the first plug is connected to the elongate member.

[0140] Another aspect of one form of the present technology is a method of assembling a modular system, comprising providing a positioning and stabilising structure, and connecting the positioning and stabilising structure to a first cushion or a second cushion.

[0141] Another aspect of one form of the present technology is a method of assembling a modular system, comprising:

[0142] providing an interface structure, the interface structure comprising a first cushion and a second cushion, the first cushion configured to seal against a patient's nares and mouth, the second cushion configured to seal against a patient's nares and to leave a patient's mouth exposed, wherein the first cushion and the second cushion each comprise an inlet port;

[0143] providing a positioning and stabilising structure, the positioning and stabilising structure comprising a conduit head strap configured to deliver a flow of pressurised air and a rigidiser arm, wherein the conduit head strap and the rigidiser arm are configured to be removably connected to the inlet port of the first cushion or the second cushion;

[0144] providing a sleeve, the sleeve comprising a conduit sleeve removably connected to the conduit head strap and an arm sleeve removably connected to the rigidiser arm, wherein the conduit sleeve and the arm sleeve each comprise at least two connection points;

[0145] providing a headgear comprising a two-point headgear and a four-point headgear, wherein each of the two-point headgear and the four-point headgear is configured to connect to the at least two connection points on the conduit sleeve or the arm sleeve;

[0146] selecting one interface structure, one positioning and stabilising structure, one sleeve, one headgear; and

[0147] assembling the selected interface structure, positioning and stabilising structure, sleeve and headgear.

[0148] In some forms, at least one of the selected interface structure, positioning and stabilising structure, sleeve and headgear can be replaced with a different version or type and assembled into a different structure.

[0149] In some forms, different types or versions of the interface structure, positioning and stabilising structure, sleeve and headgear can be interchangeable.

[0150] Another aspect of one form of the present technology comprises a patient interface, the patient interface comprising:

[0151] a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure, said plenum chamber including at least one plenum chamber inlet port sized and structured to receive a flow of air at said therapeutic pressure for breathing by the patient,

[0152] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use,

[0153] a positioning and stabilising structure to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising:

[0154] a non-extensible element configured to cover the patient's cheeks,

[0155] a sleeve configured to cover at least a portion of the non-extensible element, and

[0156] a headgear strap configured to provide at least a portion of the force;

[0157] wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured to not cover the patient's mouth,

[0158] In one form, the non-extensible element is a conduit headgear comprising a pair of conduits, each conduit configured to deliver a flow of air at therapeutic pressure to the plenum chamber; and the sleeve is a first conduit sleeve, the positioning and stabilising structure further comprising a second conduit sleeve, the second conduit sleeve having the same structure as the first conduit sleeve, the second conduit sleeve being removably connected to one of the pair of conduits, wherein the first and second conduit sleeves each comprise: a longitudinal extension forming a passageway extending between an upper opening and a lower opening, the passageway configured to receive one of the pair of conduits; a lower extension positioned out of the passageway and adjacent the lower opening; and a connection member connected to the lower extension.

[0159] In one form, the non-extensible element is a pair of rigid piece arms configured to extend along the contours of the patient's face; and the sleeve is a single sleeve configured to receive both of the pair of rigid piece arms, the sleeve comprising: an upper section, and a pair of lower sections, wherein each of the pair of lower sections is connected to the upper section, wherein each of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one of the pair of rigid piece arms, wherein each of the pair of lower sections further comprises: a lower extension connected proximate to the lower opening, the lower extension positioned outside of the passageway; and a connecting member connected to the lower extension.

[0160] In one form, the non-extensible element is a pair of rigid piece arms configured to extend along the contours of the patient's face; and the sleeve is a single sleeve configured to receive both of the pair of rigid piece arms, the sleeve comprising: an upper section that is substantially non-extensible; and a pair of lower sections that are at least partially extensible, wherein each of the pair of lower sections is connected to the upper section, wherein each of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive a rigid piece arm of the pair of rigid piece arms, wherein each passageway is isolated from the other passageway.

[0161] In some forms: a) the non-extensible element is a conduit headband comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to an inflation chamber; b) each conduit of the pair of conduits comprises a tab; c) an upper strap of the headband harness, the upper strap configured to be removably connected to the tabs; and / or d) each tab is configured to be positioned over a patient's ear in use.

[0162] In some forms: a) the at least one inflation chamber inlet is a pair of inflation chamber inlet ports, the pair of conduits removably connected to the pair of inflation chamber inlet ports; b) each conduit of the pair of conduits comprises a clip, the clip configured to engage one of the pair of inflation chamber inlet ports; c) the sleeve comprises a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway configured to receive a fluid conduit of the pair of fluid conduits; d) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; e) the material between the upper opening and the lower opening is substantially non-extensible; f) the lower opening is configured to be positioned proximate to the inflation chamber in use; and / or g) the upper opening is configured to be positioned at a location below a patient's ear in use.

[0163] In some forms, a) the sleeve includes a lower extension that is positioned outside the passageway and adjacent the lower opening; b) the lower extension is more rigid than the passageway; c) the lower extension is formed from a rigid material; d) the lower extension is rigidized using a stitching method; e) the lower extension is substantially non-extensible; f) a connecting member is connected to the lower extension; g) the connecting member is a magnet; and / or h) the lower opening and the connecting member are oriented in opposite directions.

[0164] In some forms, a) the sleeve is a first conduit sleeve, the positioning and stabilizing structure further includes a second conduit sleeve having the same structure as the first conduit sleeve, the second conduit sleeve being removably connected to one of the pair of conduits; and / or b) the seal-forming structure is configured to form a seal around a patient's mouth and a patient's nares.

[0165] In some forms, a) the non-extensible element is a pair of rigidizer arms configured to extend along the contours of a patient's face; b) the plenum chamber inlet port is configured to align with a patient's mouth; c) the plenum chamber further includes a pair of arm openings; d) the pair of rigidizer arms are removably connected to the pair of arm openings; e) the pair of rigidizer arms are flexible in one direction and rigid in another direction, the pair of rigidizer arms being configured to bend so as to conform to the shape of a patient's cheeks; f) each rigidizer arm of the pair of rigidizer arms includes a free end and a clip opposite the free end, the clip being configured to engage one of the pair of arm openings; g) each clip is configured to restrict airflow through the respective arm opening; and / or h) the sleeve is a single sleeve configured to receive both rigidizer arms of the pair of rigidizer arms.

[0166] In some forms, a) the sleeve includes an upper section; b) the sleeve includes a pair of lower sections; c) each lower section of the pair of lower sections is connected to the upper section; d) each lower section of the pair of lower sections includes a longitudinal extension forming a passageway having a lower opening; and / or e) the passageway is configured to receive one of the pair of rigidizer arms.

[0167] In some forms, a) each passageway is separate from another passageway; b) the upper section is constructed from a different material than the pair of lower sections; c) the upper section is substantially non-extensible and the pair of lower sections are at least partially extensible; and / or d) the material around the lower opening is elastic and configured to allow the lower opening to stretch and expand the width of the respective opening.

[0168] In some forms, a) the upper section includes a length-adjustable section and is configured to be adjusted based on the size of the patient's head; b) each of the pair of lower sections further includes a tab disposed proximate the upper section and configured to receive a headgear strap; c) each of the pair of lower sections includes a lower extension connected proximate the lower opening, the lower extension positioned outside the passageway; d) the lower extension is more rigid than the passageway; e) the lower extension is formed of a rigid material; f) the lower extension is rigidized using a stitching method; g) the lower extension is substantially non-extensible; h) a connecting member is connected to the lower extension; i) the connecting member is a magnet; and / or j) the connecting member and the connecting member are oriented in opposite directions.

[0169] In some forms, a) the seal-forming structure is configured to form a seal around the patient's mouth and nares; and / or b) the seal-forming structure is configured to form a seal around the patient's nares and is configured to leave the patient's mouth exposed to ambient.

[0170] Another aspect of one form of the present technology comprises a patient interface comprising:

[0171] a plenum chamber pressurisable to a therapeutic pressure above ambient pressure at least 4 cmH20, said plenum chamber including a pair of first and second openings, said plenum chamber being structured and arranged to receive a flow of air at said therapeutic pressure for breathing by a patient,

[0172] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance of the patient's nares, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance of the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle,

[0173] a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure comprising:

[0174] at least one non-extensible element configured to cover the patient's cheeks, said at least one non-extensible element connected to said pair of first openings,

[0175] a sleeve configured to cover at least a portion of the non-extensible element, and

[0176] a headgear connected to said at least one non-extensible element and / or said sleeve, said headgear configured to provide at least a portion of the force;

[0177] wherein

[0178] The patient interface can be configured to allow the patient to breathe from ambient through their mouth in the absence of a pressurised airflow through the inlet port of the plenum chamber, or the patient interface is configured so that the patient's mouth is not covered,

[0179] In one form, the non-extensible element is a conduit head strap comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber; and the sleeve comprises a longitudinal extension forming a passageway extending between the upper opening and the lower opening, the passageway configured to receive a fluid conduit of the pair of fluid conduits, wherein the sleeve further comprises a lower extension positioned outside of the passageway and proximate to the lower opening, and a connection member connected to the lower extension; the head strap band is directly connected to the connection member and the conduit head strap.

[0180] In one form, the non-extensible element is a pair of rigid arms configured to extend along the contours of the patient's face, each rigid arm of the pair of rigid arms connected to a first opening of the pair of first openings; and the sleeve is a single sleeve configured to receive both rigid arms of the pair of rigid arms, the sleeve comprising: an upper section, and a pair of lower sections, wherein each lower section of the pair of lower sections is connected to the upper section, wherein each lower section of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one rigid arm of the pair of rigid arms, wherein each lower section of the pair of lower sections comprises a lower extension connected proximate to the lower opening, the lower extension positioned outside of the passageway.

[0181] In some forms, the non-extensible element is a pair of rigid arms configured to extend along the contours of the patient's face, each rigid arm of the pair of rigid arms connected to a first opening of the pair of first openings; and the sleeve is a single sleeve configured to receive both rigid arms of the pair of rigid arms, the sleeve comprising: an upper section, and a pair of lower sections constructed from a different material to the upper section, wherein each lower section of the pair of lower sections is connected to the upper section, wherein each lower section of the pair of lower sections comprises a longitudinal extension forming a passageway having a lower opening, the passageway configured to receive one rigid arm of the pair of rigid arms, each lower section of the pair of lower sections further comprising a tab disposed proximate to the upper section and configured to receive a head strap band.

[0182] In some forms: a) the non-extensible element is a conduit head strap comprising a pair of conduits, each conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber; b) the head strap band is directly connected to the conduit head strap; and / or c) the conduit head strap is connected to the pair of first openings by a snap-fit connection.

[0183] In some forms: a) the sleeve includes a longitudinal extension forming a passageway extending between the upper opening and the lower opening; b) the passageway is configured to receive one of the pair of fluid conduits; c) the material surrounding the upper opening and / or the lower opening is elastic and configured to allow the upper opening and / or the lower opening to stretch and expand the width of the corresponding opening; d) the sleeve includes a lower extension positioned outside of the passageway and adjacent to the lower opening; e) the lower extension is more rigid than the passageway; f) the lower extension is formed from a rigid material; g) the lower extension is rigidized using a stitching method; and / or h) the lower extension is substantially non-extensible.

[0184] In some forms: a) the connection member is connected to the lower extension; b) the headgear strap is directly connected to the connection member; c) the lower opening and the connection member are oriented in opposite directions from one another; and / or d) a vent connected to the second opening and configured to allow fluid to exit the plenum.

[0185] In some forms: a) the non-extensible element is a pair of rigidizer arms configured to extend along the contours of the patient's face; b) each of the pair of rigidizer arms is connected to a first opening of the pair of first openings; c) each of the pair of rigidizer arms includes a free end and a clip opposite the free end; d) the clip is configured to be connected to a first opening of the pair of first openings using a snap fit; and / or e) the sleeve is a single sleeve configured to receive both of the pair of rigidizer arms.

[0186] In some forms: a) the sleeve includes an upper section; b) the sleeve includes a pair of lower sections; c) each of the pair of lower sections is connected to the upper section; d) each of the pair of lower sections includes a longitudinal extension forming a passageway having a lower opening; and / or: f) the passageway is configured to receive one of the pair of rigidizer arms.

[0187] In some forms: a) each passageway is isolated from the other passageway; b) the upper section is constructed from a different material than the pair of lower sections; c) each of the pair of lower sections further includes a tab disposed proximate the upper section and configured to receive a headgear strap; d) each of the pair of lower sections includes a lower extension connected proximate the lower opening, the lower extension positioned outside of the passageway; e) the lower extension is more rigid than the passageway; f) a connection member connected to the lower extension; and / or g) the headgear strap is directly connected to the connection member.

[0188] Another aspect of one form of the present technology includes a method comprising:

[0189] providing a plenum pressurizable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the plenum including a pair of first openings and a second opening;

[0190] a first non-extensible member is a conduit head strap and the second non-extensible member is a pair of rigidiser arms;

[0191] a first sleeve that is useable with the first non-extensible member and a second sleeve that is useable with the second non-extensible member are provided;

[0192] one of the first non-extensible member and the second non-extensible member is selected;

[0193] a corresponding one of the first sleeve and the second sleeve is selected;

[0194] the selected one of the first non-extensible member and the second non-extensible member is connected to the corresponding one of the first sleeve and the second sleeve; and

[0195] the selected one of the first non-extensible member and the second non-extensible member is connected to the pair of first openings of the plenum chamber.

[0196] In some forms, the selected one of the first non-extensible member and the second non-extensible member is connected to the pair of first openings of the plenum chamber using a snap fit.

[0197] Additional steps can include: a) providing a first headgear strap band useable with the first non-extensible member and a second headgear strap band useable with the second non-extensible member; and / or b) connecting a selected one of the first headgear strap band and the second headgear strap band directly to the selected one of the first non-extensible member and the second non-extensible member and / or the selected one of the first non-extensible member and the second non-extensible member.

[0198] Additional steps can include: a) providing a vent useable with the first non-extensible member and a conduit useable with the second non-extensible member and connecting one of the conduit and the vent to the second opening; and / or b) the plenum chamber is a first plenum chamber, the method further comprising providing a second plenum chamber and selecting one of the first plenum chamber and the second plenum chamber.

[0199] Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed to have a peripheral shape that is complementary to a peripheral shape of an intended wearer.

[0200] An aspect of one form of the present technology is a method of manufacturing a device.

[0201] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0202] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in a person's home).

[0203] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.

[0204] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0205] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0206] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0207] This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including:

[0208] 4.1 Respiratory Therapy System

[0209] FIG. 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The 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. The patient sleeps in a supine position.

[0210] FIG. 1BA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0211] FIG. 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0212] 4.2 Respiratory System and Facial Anatomy

[0213] FIG. 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0214] FIG. 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0215] FIG. 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. The directions of up, down, radial inward, and radial outward are also indicated.

[0216] FIG. 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, supralipal, sublipal, supramental, nasal ridge, nasal alar apex, supraauricular, and subauricular points. The vertical and anteroposterior directions are also indicated.

[0217] FIG. 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0218] FIG. 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, sublipus, upper vermilion border, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0219] FIG. 2G A side view showing the surface features of the nose.

[0220] FIG. 2HThe 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.

[0221] FIG. 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0222] FIG. 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0223] FIG. 2K This diagram shows a side view of the skull, including the surface contours of the head and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0224] FIG. 2L The frontal lateral view of the nose is shown.

[0225] 4.3 Patient Interface

[0226] FIG. 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0227] FIG. 3B A schematic diagram of a cross-section of 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... FIG. 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0228] FIG. 3C A schematic diagram of a cross-section of 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... FIG. 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0229] FIG. 3D A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a zero value.

[0230] FIG. 3E A schematic diagram of a cross-section of 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... FIG. 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0231] FIG. 3FA schematic diagram of a cross-section of 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... FIG. 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0232] FIG. 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The vaulted and saddle-shaped areas are shown.

[0233] FIG. 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0234] FIG. 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0235] FIG. 3J It shows crossing FIG. 3I The cross-section of the structure. The surface shown is in FIG. 3I The structure defines a two-dimensional hole.

[0236] FIG. 3K It shows FIG. 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... FIG. 3I The surface of the two-dimensional hole is defined in the structure.

[0237] FIG. 3L A face mask with an inflatable airbag as padding is shown.

[0238] FIG. 3M It shows crossing FIG. 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0239] FIG. 3N Showing through FIG. 3L Another cross-section of the mask. The inner surface is also indicated.

[0240] FIG. 3O The left-hand rule is shown.

[0241] FIG. 3P The right-hand rule is shown.

[0242] FIG. 3Q The left ear is shown, including the left ear spiral.

[0243] FIG. 3R The right ear is shown, including the right ear spiral.

[0244] FIG. 3S A right-handed spiral is shown.

[0245] FIG. 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0246] FIG. 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0247] FIG. 3V It shows FIG. 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. FIG. 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0248] FIG. 3W It shows crossing FIG. 3V The cross-section of the inflation chamber, which is in FIG. 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the gasket of the inflation chamber at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the gasket in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0249] FIG. 3X It shows FIG. 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane generally corresponds to the 'facial plane'. FIG. 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0250] 4.4RPT device

[0251] FIG. 4A An RPT device of one form according to the present technology is shown.

[0252] FIG. 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0253] 4.5 Humidifier

[0254] FIG. 5A An isometric view of one form of humidifier according to the present technology is shown.

[0255] FIG. 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0256] 4.6 Respiratory waveform

[0257] FIG. 6 The diagram shows a typical breathing waveform of a person during sleep.

[0258] 4.7 Module Aspects

[0259] FIG. 7 A perspective view of the padding of the patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0260] FIG. 8 It shows FIG. 7 Front view of the liner.

[0261] FIG. 9 It shows FIG. 7 Rear view of the liner.

[0262] FIG. 10 A perspective view of the padding of the patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0263] FIG. 11 It shows FIG. 10 The front view of the padding.

[0264] FIG. 12 It shows FIG. 10 Rear view of the liner.

[0265] FIG. 13 It shows that it can be used with FIG. 7 padding or FIG. 10 A perspective view of the catheter headband used with the liner.

[0266] FIG. 14 It shows that it can be used with FIG. 7 padding or FIG. 10 A perspective view of the rigid arm used with the padding.

[0267] FIG. 15 Is it possible to... FIG. 7 A perspective view of the headband straps used with the padding.

[0268] FIG. 16 Is it possible to... FIG. 10 A perspective view of the headband straps used with the padding.

[0269] FIG. 17 It shows removable assembly to FIG. 13 catheter headband or FIG. 14 Front view of a pair of sleeves on a rigid arm.

[0270] FIG. 18 It shows the detachable assembly to FIG. 13 catheter headband or FIG. 14 A front view of an optional sleeve on a rigid member arm.

[0271] FIG. 19 It shows FIG. 17 Rear view of a pair of sleeves.

[0272] FIG. 20 It shows a detachable mounting to FIG. 14 Front view of the complete sleeve on the rigid arm.

[0273] FIG. 21 It shows removable installation to FIG. 14 Front view of the optional full sleeve on the rigid arm.

[0274] FIG. 22 It shows FIG. 20 Rear view of the complete sleeve.

[0275] FIG. 23 It shows removable assembly to FIG. 14 A front perspective view of another optional form of the rigid arm's complete sleeve.

[0276] FIG. 24 It shows FIG. 23 Another optional form of the complete sleeve is shown in the front perspective view.

[0277] FIG. 25 It shows that FIG. 17 The sleeve is connected to FIG. 13 The first step of the catheter headband is in which the sleeve and the catheter headband do not come into contact.

[0278] FIG. 26 It shows that FIG. 17 The sleeve is connected to FIG. 13 The second step is the insertion of the catheter headband, in which the catheter headband initially slides into the sleeve.

[0279] FIG. 27 It shows that FIG. 17 The sleeve is connected to FIG. 13 The third step of the catheter headband involves positioning the end of the catheter headband through an opening in the sleeve.

[0280] FIG. 28 It shows that FIG. 17 The sleeve is connected to FIG. 13 The fourth step of the catheter headband is when the sleeve is fully attached to the catheter headband.

[0281] FIG. 28-1 It shows the connection to FIG. 13 The catheter headband FIG. 17 Front perspective view of the sleeve.

[0282] FIG. 28-2 It shows the connection to FIG. 13 The catheter headband FIG. 17 Rear perspective view of the sleeve.

[0283] FIG. 29 It shows that FIG. 20 The sleeve is connected to FIG. 14 The first step of the rigid arm is in which the sleeve and the arm do not contact each other.

[0284] FIG. 30 It shows that FIG. 20 The sleeve is connected to FIG. 14 The second step of the rigid arm, in which the arm initially slides into the sleeve.

[0285] FIG. 31 It shows that FIG. 20 The sleeve is connected to FIG. 14 The third step of the rigid arm is that the arm slides further into the sleeve.

[0286] FIG. 32 It shows that FIG. 20 The sleeve is connected to FIG. 14 The fourth step of the rigid arm, wherein the end of the rigid arm is positioned through an opening in the sleeve.

[0287] FIG. 33 It shows that FIG. 20 The sleeve is connected to FIG. 14 The fifth step of the rigid arm, in which the sleeve is fully connected to the guide tube headband.

[0288] FIG. 33-1 It shows FIG. 20 The sleeve relative to FIG. 14 Front perspective view of the rigid arm.

[0289] FIG. 33-2 It shows FIG. 20 The sleeve relative to FIG. 14 Rear perspective view of the rigid arm.

[0290] FIG. 34 It shows that FIG. 23 The sleeve is connected toFIG. 14 The first step of the rigid arm is in which the sleeve and the arm do not contact each other.

[0291] FIG. 35 It shows that FIG. 23 The sleeve is connected to FIG. 14 The second step of the rigid arm, in which the arm initially slides into the sleeve.

[0292] FIG. 36 It shows that FIG. 23 The sleeve is connected to FIG. 14 The third step of the rigid arm is that the arm slides further into the sleeve.

[0293] FIG. 37 It shows that FIG. 23 The sleeve is connected to FIG. 14 The fourth step of the rigid arm, wherein the end of the rigid arm is positioned through an opening in the sleeve.

[0294] FIG. 38 It shows that FIG. 23 The sleeve is connected to FIG. 14 The fifth step of the rigid arm, in which the sleeve is fully connected to the guide tube headband.

[0295] FIG. 38-1 It shows FIG. 23 The sleeve relative to FIG. 14 Front perspective view of the rigid arm.

[0296] FIG. 38-2 It shows FIG. 23 The sleeve relative to FIG. 14 Front perspective view of the rigid arm.

[0297] FIG. 39 It shows FIG. 14 Rear perspective view of the rigid arm. FIG. 20 The sleeve in the middle is connected to FIG. 7 The padding.

[0298] FIG. 40 It shows FIG. 14 Front perspective view of the rigid member arm, in which FIG. 20 The sleeve is connected to FIG. 7 The padding.

[0299] FIG. 41 It is removably connected to FIG. 7 A perspective view of the vent of the liner.

[0300] FIG. 42 It is removably connected to FIG. 7 A perspective view of the airflow duct with a liner.

[0301] FIG. 43 It is worn connected toFIG. 13 catheter headband, FIG. 15 headband and strap FIG. 17 The sleeve FIG. 7 A front view of the patient with the padding.

[0302] FIG. 44 Is wearing FIG. 43 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is oriented in an upright position.

[0303] FIG. 44-1 Is wearing FIG. 43 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is positioned in a supine sleeping position.

[0304] FIG. 44-2 Is wearing FIG. 43 Side view of the patient with padding, catheter headband, headband straps, and sleeves. Patient's lateral sleeping position orientation.

[0305] FIG. 45 It is connected to FIG. 13 catheter headband, FIG. 15 headband and strap FIG. 17 The sleeve FIG. 7 Front view of the liner.

[0306] FIG. 46 yes FIG. 45 Exploded view of the padding, catheter headband, headband strap, and sleeve.

[0307] FIG. 47 It is worn connected to FIG. 14 rigid arm, FIG. 15 headband and FIG. 20 The sleeve FIG. 7 A front view of the patient with the padding.

[0308] FIG. 48 Is wearing FIG. 47 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is oriented in an upright position.

[0309] FIG. 48-1 Is wearing FIG. 47 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is positioned in a supine sleeping position.

[0310] FIG. 48-2 Is wearing FIG. 47 Side view of the patient with padding, catheter headband, headband straps, and sleeves. Patient's lateral sleeping position orientation.

[0311] FIG. 49 It is connected to FIG. 14 rigid arm, FIG. 15headband and FIG. 20 The sleeve FIG. 7 Front view of the liner.

[0312] FIG. 50 yes FIG. 49 Exploded view of the padding, catheter headband, headband strap, and sleeve.

[0313] FIG. 51 It is worn connected to FIG. 13 catheter headband and FIG. 16 headband FIG. 10 The front view of the patient with the padding.

[0314] FIG. 52 Is wearing FIG. 51 A side view of the patient with the padding, catheter headband, and headband straps. The patient is oriented in an upright position.

[0315] FIG. 52-1 Is wearing FIG. 51 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is positioned in a supine sleeping position.

[0316] FIG. 52-2 Is wearing FIG. 51 Side view of the patient with padding, catheter headband, headband straps, and sleeves. Patient's lateral sleeping position orientation.

[0317] FIG. 53 It is connected to FIG. 13 catheter headband and FIG. 16 headband FIG. 10 Front view of the liner.

[0318] FIG. 54 yes FIG. 53 Exploded view of the padding, catheter headband, and headband strap.

[0319] FIG. 55 It is worn connected to FIG. 14 rigid arm, FIG. 16 headband and FIG. 23 The sleeve FIG. 10 A front view of the patient with the padding.

[0320] FIG. 56 Is wearing FIG. 55 A side view of the patient, showing the padding, rigid arms, headband straps, and sleeves. The patient is oriented in an upright position.

[0321] FIG. 56-1 Is wearing FIG. 55 A side view of the patient with the padding, catheter headband, headband strap, and sleeve. The patient is positioned in a supine sleeping position.

[0322] FIG. 56-2 Is wearingFIG. 55 Side view of the patient with padding, catheter headband, headband straps, and sleeves. The patient is in a side-lying sleeping position.

[0323] FIG. 57 It is connected to FIG. 14 rigid arm, FIG. 16 headband and FIG. 23 The sleeve FIG. 10 Front view of the liner.

[0324] FIG. 58 yes FIG. 57 Exploded view of the padding, rigid arm, headband, and sleeve.

[0325] FIG. 59 This is a schematic diagram illustrating possible combinations of patient interfaces. Detailed Implementation

[0326] Before describing this technology in more detail, it should be understood that this technology is not limited to the specific instances that may vary as described herein. It should also be understood that the terminology used in this invention is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0327] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0328] 5.1 Treatment

[0329] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0330] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0331] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0332] 5.2 Respiratory Therapy System

[0333] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0334] 5.3 Patient Interface

[0335] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an airway 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0336] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0337] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to the environment.

[0338] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0339] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cm H2O relative to the environment.

[0340] Patient interfaces 6000-1, 6000-2, 7000-1, and 7000-2 can be similar to FIG. 3A The patient interface shown, and FIG. 3A The features and descriptions are applicable to any of the patient interfaces 6000-1, 6000-2, 7000-1, and 7000-2.

[0341] The following describes only some similarities and differences between different patient interfaces. While a feature can be described specifically for one example, that description may apply to other examples.

[0342] 5.3.1 Sealing Formation Structure

[0343] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0344] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0345] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0346] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicon.

[0347] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0348] As described in more detail below, in some forms of the present technology, the sealing structure 6100 includes: a first sealing structure 6101 connected to the mouth portion 6201 of the inflation chamber 6200 and configured and arranged to seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth; and a second sealing structure 6102 connected to the nose portion 6202 of the inflation chamber 6200 and configured and arranged to seal with the area of ​​the patient's face surrounding the entrance to the patient's nose (see, for example...). FIG. 9 The phrase “connected to” is used in this text to refer to parts or components formed as single pieces, as well as parts or components formed separately and subsequently joined together. In some cases, parts may be connected by intermediate parts.

[0349] In some forms, the first sealing structure 6101 seals the patient’s face independently of the second sealing structure 6102.

[0350] In some forms, the first sealing structure 6101 and the second sealing structure 6102 cooperate to form a single common seal against the patient's face.

[0351] In one configuration, the target sealing area is located on the outer surface of the sealing structure 6100.

[0352] In some forms of this technology, the hermetically molded structure 6100 is made of biocompatible materials (e.g., silicone rubber, fabric, foam, etc.).

[0353] The sealing structure 6100 according to this technology can be made of a soft, flexible, and elastic material (such as silicone, fabric, foam, etc.). The sealing structure 6100 can also be composed of a variety of soft, flexible, and elastic materials. For example, a part of the sealing structure 6100 can be silicone resin, while another part can be fabric.

[0354] In some forms of this technology, a system is provided that includes more than one sealing formation structure 6100, each sealing formation structure configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 6100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0355] In other forms of this technology, the sealing structure 7100 may be connected to the air chamber 7200, which is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nose (see example...). FIG. 12 ).

[0356] In one configuration, the target sealing area is located on the outer surface of the sealing structure 7100.

[0357] In some forms of this technology, the hermetic molding structure 7100 is made of biocompatible materials (e.g., silicone rubber, fabric, foam, etc.).

[0358] The sealing structure 7100 according to this technology can be made of a soft, flexible, and elastic material (such as silicone, fabric, foam, etc.). The sealing structure 7100 can also be composed of a variety of soft, flexible, and elastic materials. For example, a part of the sealing structure 7100 can be silicone resin, while another part can be fabric.

[0359] In some forms of this technology, a system is provided that includes more than one sealing formation structure 7100, each sealing formation structure configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 7100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0360] 5.3.1.1 Sealing Mechanism

[0361] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0362] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0363] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0364] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0365] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0366] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0367] 5.3.1.2 Nasal region

[0368] See next. FIG. 9 In some forms of this technology, the second sealing structure 6102 includes a central portion 6110 configured to seal against a surface of a patient's nose in use. This central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils) and against the patient's upper lip. In an example, a portion of the sealing structure 6100 may engage a patient's septum. The second sealing structure 6102 may further include a lateral portion 6111 on a lateral side of the central portion 6110. In an example, the sealing structure 6102 may be configured to contact the patient's face below the bridge of the nose or below the nasal protuberance.

[0369] In some forms, the central portion 6110 may include nasal openings 6112 for delivering pressurized breathable gas to the patient's nostrils. Each nostril may have one nasal opening 6112 (although there may be a single nasal opening). The periphery of the nasal opening 6112 may be sealed against the patient's nose (e.g., against the patient's wing).

[0370] Continue to refer to FIG. 9 Some forms of the central portion 6110 may include a bridging portion 6114 formed between the nostrils 6112. In use, the bridging portion 6114 may contact the patient's columella and / or the subnasal septum region. The bridging portion 6114 may also contact the patient's nose near the nasal protuberance, but may not contact the ridge of the patient's nose. In other examples, the bridging portion 6114 may not contact the patient's nose beyond or substantially beyond the patient's nasal protuberance to avoid contact with the ridge of the patient's nose. The bridging portion 6114 may seal against the patient's nose such that the entire periphery of each nasal opening 6112 seals against the patient's nose (e.g., to limit leakage). The bridging portion 6114 may also limit the patient's nose from extending into the inflation chamber 6200.

[0371] In some forms, the bridging portion 6114 may be substantially flat between the nasal openings 6112. This may be the result of a molding process that gives the bridging portion 6114 its shape. In some examples, the bridging portion 6114 may be in a taut position before patient use. In other examples, the bridging portion 6114 may be at least partially relaxed before use and may be under tension due to contact with the patient's nose.

[0372] See also FIG. 9 Some examples of the bridging portion 6114 may be curled to apply localized tension to the bridging portion 6114 prior to use. For example, the second sealing forming structure 6102 may initially be constructed with a relaxed bridging portion 6114, and curling may be applied during manufacturing to increase tension in the bridging portion 6114. In some forms, the bridging portion 6114 may be curled to allow the second sealing forming structure 6102 (or the entire sealing forming structure 6100) to be constructed from a fabric material with complex curvatures (e.g., curvatures along multiple non-parallel axes). The curled bridging portion 6114 can limit the interaction between various complex curvatures to limit the occurrence of leakage-forming creases across the surface of the second sealing forming structure 6102. The curling method is described in International Application No. PCT / AU2021 / 050344 and U.S. Patent Application Publication No. 2020 / 0246572, the entire contents of which are incorporated herein by reference.

[0373] In some forms, an adhesive (e.g., glue) can be used to apply the curl to the bridging portion 6114. In some forms, stitching can be used to apply the curl to the bridging portion 6114. In some forms, ultrasonic welding can be used to apply the curl to the bridging portion 6114. In some forms, radio frequency (RF) welding can be used to apply the curl to the bridging portion 6114. In some forms, a variety of techniques can be used to form the curl on the bridging portion 6114.

[0374] In some forms, the central portion 6110 may include a positive curvature between the lateral portions 6111. The central portion 6110 may have a substantially small radius of curvature in order to have a close fit around the patient's nose.

[0375] like FIG. 12 As shown, the sealing structure 7100 may have a similar shape and / or a similar structure compared to the sealing structure 6100 described above. Therefore, only some similarities and differences between the sealing structures 6100 and 7100 will be described below.

[0376] The sealing structure 7100 may include a central portion 7110 configured to seal onto a surface of a patient's nose in use. This central portion may seal onto the lower periphery of the patient's nose (e.g., around the patient's nostrils) and onto the patient's upper lip. In an example, a portion of the sealing structure 7100 may engage a patient's septum. A second sealing structure 7102 may further include a lateral portion 7111 on a lateral side of the central portion 7110. In an example, the sealing structure 7102 may be configured to contact the patient's face below the bridge of the nose or below the nasal protuberance.

[0377] In some forms, the central portion 7110 may include nasal openings 7112 for delivering pressurized breathable gas to the patient's nostrils. Each nostril may have one nasal opening 7112 (although there may be a single nasal opening). The periphery of the nasal opening 7112 may be sealed against the patient's nose (e.g., against the patient's wing).

[0378] Continue to refer to FIG. 12 Some forms of the central portion 7110 may include a bridging portion 7114 formed between the nostrils 7112. In use, the bridging portion 7114 may contact the patient's columella and / or the area below the nasal septum. Additionally, the bridging portion 7114 may contact the patient's nose near the nasal tip (e.g., down to avoid extending beyond the nasal tip), but may not contact the ridge of the patient's nose.

[0379] As described above, the bridging portion 7114 can be rolled up according to the rolling process described in International Application No. PCT / AU2021 / 050344 and U.S. Publication Patent Application No. 2020 / 0246572.

[0380] 5.3.1.3 Port Area

[0381] As mentioned above, FIG. 9 One form of a non-invasive patient interface 6000 is shown, which includes a first sealing formation structure 6101 that forms a seal at least partially around the patient's mouth during use. The first sealing formation structure 6101 can form a seal on a lower region of the patient's face (e.g., the area below the patient's lips and / or the supramental region).

[0382] The sealing structure 6100 includes a sublipal portion 6130 that forms a seal against the patient's sublip and / or supramental region. The sublipal portion 6130 may be connected to (e.g., adjacent to) a supralipal portion 6131, which forms a seal against the patient's supralipal region. The connection between the sublipal portion 6130 and the supralipal portion 6131 may form an orifice 6133.

[0383] The sealing structure 6100 has a relatively low wall thickness (compared to other parts of the interface) at the periphery of the orifice 6133, for example, less than 0.7 mm. The lower lip 6130 of the sealing structure abuts against the lower region and at least against the center of the lower lip 6130. This low wall thickness in these locations contributes to an effective and comfortable seal. The sealing structure 6100 in these regions can easily conform to any complex geometry.

[0384] In some forms of this technology, the orifice 6133 is substantially trapezoidal rather than oval or elliptical in order to more precisely correspond to the shape of the patient's face (e.g., wider below the patient's mouth and narrower near the patient's nose). This shape of the orifice allows the interface 6000 to be particularly compact and is substantially no wider than the width of the patient's nostrils. In other examples, the orifice 6133 can be rectangular, circular, elliptical, or any other shape.

[0385] In some forms, the lower lip portion 6130 may be continuous with the upper lip portion 6131, which can limit seams or other discontinuities that might otherwise cause discomfort.

[0386] like FIG. 10 to 12 As shown, the sealing structure 7100 includes only the mouth portion and is not intended to seal the patient's mouth. Therefore, when using patient interfaces 7000-1 and 7000-2 that include the sealing structure 7100, the patient's mouth may be exposed to the surrounding environment.

[0387] 5.3.1.4 Boundary between the nose and mouth regions

[0388] like FIG. 9 As shown, in one form of this technology, the boundary between the first sealing forming structure 6101 and the second sealing forming structure 6102 forms or includes a corner or ridge 6120. The corner or ridge 6120 may provide at least a partially sharp boundary between the first and second sealing forming structures 6101, 6102. The corner or ridge 6120 may be rounded, but may include a small radius of curvature.

[0389] A corner or ridge 6120 can form a separator between the upper lip portion 6131 of the first sealing structure 6101 and the central portion 6110 of the second sealing structure 6102. In use, the corner or ridge 6120 can engage the patient's face above the lip and directly below the nose. The sharp boundary allows the corner or ridge 6120 to contact the subnasal point, but the slight radius of curvature does not significantly reduce patient comfort (e.g., because the corner or ridge 6120 penetrates deep into the patient's face).

[0390] In some forms, the ridge 6120 forms a relatively sharp angle between the first and second sealing structures 6101, 6102. This sharp angle reduces the likelihood of creases forming on or near the corner or ridge 6120 in the first and / or second sealing structures 6101, 6102 when the mask is worn and treatment is applied. Some oronasal patient interfaces that do not use this structure may require a very thin, rounded structure in this area, which is less resistant to wrinkling. In contrast, the corner or ridge 6120 can be stiffer than such interfaces and can better maintain its shape, and therefore can better seal indentations and creases present around the patient's nose. This effect can be enhanced in embodiments provided with support portions that resist or abut against compression in this area.

[0391] In some forms of this technology, the radius of the corner or ridge 6120 can be less than 2 mm, for example, about 1.75 mm. In one form of this technology, the radius can vary from about 1.75 mm at the center of the ridge to about 0.75 mm at the lateral portion.

[0392] The angle formed by the first and second sealing structures can be from about 20 degrees to about 90 degrees, for example, about 36 degrees.

[0393] In some forms of this technology, the corner or ridge 6120 may extend across substantially the entire boundary 6103 between the first sealing formation 6101 and the second sealing formation 6102. In embodiments, the corner or ridge 6120 may engage the patient's face at least close to the entrance of the nostril, for example, where the flap meets the face above the lips.

[0394] In other forms, the boundary between the first and second sealing structures 6101, 6102 may include a smooth or substantially smooth transition. Smooth surfaces along the smooth boundary can improve patient comfort because sharp surfaces are reduced.

[0395] As described above, the sealing structure 7100 may not include a boundary region because the sealing structure 7100 only seals the patient's nose and not the patient's mouth.

[0396] 5.3.1.5 Nasal bridge or nasal ridge area

[0397] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0398] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face.

[0399] like FIG. 43 and FIG. 47 As shown, the sealing structure 6100 can contact the patient's face to minimize contact with the bridge or ridge of the nose. In some examples, the sealing structure 6100 can be positioned such that the patient's nasal protuberance is exposed during use. This can increase patient comfort because sensitive areas along the bridge or ridge of the nose are not under pressure.

[0400] like FIG. 51 and FIG. 55 As shown, the sealing structure 7100 can similarly minimize contact with the bridge of the nose or nasal ridge area of ​​the patient's face.

[0401] In other examples (not shown), the sealing structure 6100 and / or the sealing structure 7100 may be configured to contact and seal against the patient's nasal ridge.

[0402] 5.3.1.6 Upper lip area

[0403] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that, in use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0404] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of the patient's face during use.

[0405] As described above, the upper lip region can help form a seal that at least partially surrounds the patient's nostrils and at least partially surrounds the patient's mouth (e.g., in a full-face patient interface). The upper lip region can also help form a seal only around the patient's nostrils (e.g., in a nose-only patient interface).

[0406] 5.3.1.7 Chin region

[0407] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, during use, forms a seal on the chin region of the patient's face.

[0408] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of ​​a patient's face.

[0409] 5.3.1.8 Forehead area

[0410] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0411] 5.3.1.9 Nasal pillow

[0412] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0413] A nasal pillow according to one aspect of the present technology includes: a truncated cone, 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 truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0414] 5.3.2 Inflation Chamber

[0415] like FIG. 3AAs shown, in the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 (or at least a portion of the air chamber 3200) and the sealing structure 3100 (or at least a portion of the sealing structure 3100) are formed from a single homogeneous sheet of material (e.g., molded silicone, woven fabric, etc.). The combination of the sealing structure 3100 and the air chamber 3200 can be considered as a pad.

[0416] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0417] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0418] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0419] 5.3.2.1 Flexible Shell

[0420] In some forms of this technology, the inflation chamber 6200 may include a housing 6250, which may be made of a rigid material (e.g., polycarbonate). The rigid material may provide support for the hermetically molded structure 6100.

[0421] like FIG. 7 to 12 As shown, some forms of housing 6250, or parts thereof, or other forms of the technology, may be slightly flexible (e.g., made of soft, flexible, elastic materials such as silicone, fabric, foam, etc.). For example, in this example, housing 6250 may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of the technology, housing 6250 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of the technology, housing 6250 may be made of a material with a Young's modulus of 0.7 MPa or less, for example, between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0422] In some forms, the housing 6250 and one or both of the first sealing structure 6101 and the second sealing structure 6102 may be formed of the same material (e.g., silicone, fabric, etc.). The housing 6250 and the sealing structures 6101, 6102 may be removable from each other, or may be a single homogeneous sheet of material.

[0423] In some forms of this technology, the housing 6250 may be constructed substantially entirely of a flexible material, which provides the housing 6250 with maximum freedom of movement (i.e., virtually no rigid and / or thickened portions restricting bending). The housing 6250 may require the addition of one or more components to provide desired rigidity in one or more areas of the housing 6250 (e.g., to limit creases in the sealing formation 6100 near the nose region). For example, one or more vent modules; connection ports; headband connectors; headband connectors connected to rigid member arms and rigid member components may be attached to the housing 6250 in a manner that increases the rigidity of the inflation chamber 6200 in areas adjacent to the components, as further described below. In some forms of this technology, these components may be releasably attached to the flexible housing 6250.

[0424] Additionally or alternatively, one or more components may be permanently attached to the housing 6250, for example, by bonding and / or overmolding. Rigidifying members may also be used to increase rigidity and / or support the shape of the sealing formation 6100. In some forms of this technology, the permanently attached rigidifying member may be a dedicated hardening member or a rigidifying member (e.g., without other function).

[0425] In some forms of this technology, the housing 6250 may be generally flexible, but may include a stiffened portion having a greater thickness than the adjacent portion of the housing 6250. This stiffened portion may be configured as a rib or band, for example, extending laterally through the housing and / or extending in the vertical direction, although many other configurations are also possible. In some forms, the housing may include a substantially rigid portion, for example, made of polycarbonate, as well as slightly flexible portions.

[0426] In some forms of this technology, the central portion 6251 on the front side of the mouth portion 6201 of the inflation chamber may preferably have greater rigidity than the rest of the inflation chamber 6200. In some forms of this technology, the region of increased rigidity may be directly below the nose portion 6202 and / or directly above the mouth portion 6201. In one form of this technology, part or all of the first front wall portion 6240 may be a region of increased rigidity rather than a region of increased flexibility. Providing increased rigidity in one or more of these regions can provide shape stability and can limit the degree to which the housing 6250 deforms due to head-carrying forces. Excessive deformation can cause the second sealing structure 6102 to obstruct the nostrils. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important for patients with narrow noses, or in some cases undesirable. Furthermore, the described region of increased rigidity can help reduce torsional deformation of the interface, which could otherwise cause one side of the second sealing structure 6102 to lose contact with the patient's nose, thereby creating a leakage path.

[0427] 5.3.2.1.1 Multiple openings

[0428] like FIG. 7 to 12 As shown, the air chambers 6200 and 7200 can be formed as part of the multi-opening gaskets 6050 and 7050. In the example shown, each of the gaskets 6050 and 7050 includes three openings, but alternative gaskets can be formed with more or fewer openings.

[0429] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0430] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, one opening can serve as both an inlet and an outlet.

[0431] Multiple openings allow for various configurations of air delivery to the inflation chambers 6200 and 7200. For example, depending on the patient's needs and / or comfort, the patient may use a given pad 6050 or 7050 in a "tube-up" configuration (e.g., using a catheter headband as described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0432] 5.3.2.1.1.1 Full-face padding

[0433] like FIG. 7 to 9 As shown, the air chamber 6200 may be included in the full-face patient interface 6000 (e.g., a full-face mask, an ultra-compact full-face mask, etc.), and the full-face patient interface includes the first and second sealing structures 6101 and 6102 described above.

[0434] like FIG. 8 and 9 As shown, the inflation chamber 6200 includes a pair of inflation chamber inlet ports 6254, which can be used to deliver gas into and / or out of the inflation chamber 6200. The inflation chamber inlet ports 6254 may be located on opposite sides of the inflation chamber 6200 (e.g., left and right sides).

[0435] In some forms, each inflatable chamber inlet port 6254 includes a partially rectangular shape. For example, the inflatable chamber inlet port 6254 may include at least one substantially straight side. The corners between different sides may also be rounded. In the illustrated example, each inflatable chamber inlet port 6254 may include a curved side 6255. The curved side 6255 may be arranged near the center of the inflatable chamber 6200 and may generally extend in the vertical direction. The remaining portions of the illustrated side of the inflatable chamber inlet port 6254 may be substantially straight sides, although any number of sides may be curved.

[0436] In other examples, the inflation chamber inlet port 6254 may include an ellipse, a circle, or any similar shape. For example, the inflation chamber inlet port 6254 may include a circle. In other forms, the inflation chamber inlet port 6254 may be symmetrical about only a single axis.

[0437] like FIG. 8 As shown, each inlet port 6254 of the inflation chamber can be symmetrical about only a single axis. For example, the axis bisecting the curved side 6255 of each inlet port 6254 can form an axis of symmetry. As described below, this helps prevent incorrect connection of the conduit. Additionally, in other forms, the inlet ports 6254 may not be aligned with each other and / or the inlet ports 6254 may not have any axis of symmetry.

[0438] In some configurations, an inlet port 6254 may be disposed on the mouth portion 6201 of the inlet chamber 6200. In the example shown, each inlet port 6254 may extend near the transition between the mouth portion 6201 and the nose portion 6202 of the inlet chamber 6200. The inlet port 6254 may be positioned at least partially above the patient's mouth (e.g., as determined when the patient is in an upright position, when using the patient interface 6000, an axis passing through the inlet port 6254 (e.g., perpendicular to the inlet port 6254) may be aligned with the patient's mouth).

[0439] In some forms, the opening portion 6201 of the inflation chamber 6200 may have a substantially negative dome curvature (e.g., when facing the anterior surface). The inflation chamber inlet port 6254 may be positioned on a curved surface of the central portion 6251 of the inflation chamber 6200, and may be on either side of the apex of curvature. The inflation chamber inlet ports 6254 may be aligned such that a single axis can pass through both inflation chamber inlet ports 6254. The axis may be substantially perpendicular to the patient's sagittal plane.

[0440] In some forms, the inflation chamber 6200 may also include at least one ventilation opening 6402 (see example...) FIG. 7 The vent opening 6402 can be located at the center of the inflation chamber 6200. For example, the vent opening 6402 can be arranged between the inflation chamber inlet ports 6254.

[0441] In some configurations, the vent opening 6402 may be positioned below at least a portion of each inflation chamber inlet port 6254. For example, the vent opening may be positioned adjacent to the lowest portion of the inflation chamber 6200.

[0442] In some forms, the vent opening 6402 may have a rounded perimeter. For example, the vent opening 6402 may have a circular perimeter. In other examples, the vent opening 6402 may have an elliptical perimeter, or it may have a perimeter formed by different polygonal shapes (e.g., triangles, rectangles, etc.). These polygonal shapes may have angled corners, or they may have rounded corners.

[0443] In some configurations, when using the patient interface, the ventilation opening 6402 can be aligned with the patient's mouth. In other words, when the patient wears the patient interface 6000, the ventilation opening 6402 can be positioned directly in front of the patient's mouth. Air exhaled by the patient (e.g., through his mouth) can travel directly toward the ventilation opening 6402.

[0444] In some forms, the material surrounding the ventilation opening 6402 may be substantially flush with the central portion 6251 of the inflation chamber 6200. This helps to maintain a substantially small device footprint. For example, when using the patient interface 6000, the material surrounding the central portion 6251 may not extend substantially away from the patient's face and may not obstruct the patient's view. In other examples, the material surrounding the ventilation opening 6402 may protrude from the central portion 6251.

[0445] like FIG. 7 and 8 As shown, some forms of the inflation chamber 6200 may include a groove 6266 that can be arranged along the side of the inflation chamber 6200.

[0446] In some forms, the inflation chamber 6200 may include a pair of recesses 6266. Each recess 6266 may be arranged near one of the inflation chamber inlet ports 6254. Each recess 6266 may form a partially recessed surface.

[0447] In some forms, the area of ​​each recess 6266 may be larger than the area of ​​each inflation chamber inlet port 6254. Additionally, the shape of each recess 6266 may not correspond to the shape of each inflation chamber inlet port 6254 (although they may). For example, each inflation chamber inlet port 6254 may be close to the upper end of the corresponding recess 6266. The recess 6266 may extend towards the lower portion of the inflation chamber 6200 beyond the periphery of the corresponding inflation chamber inlet port 6254. Each recess 6266 may have substantially the same depth (although the depth may vary).

[0448] 5.3.2.1.1.2 Nasal Liner

[0449] like FIG. 10 and 12 As shown, an inflation chamber 7200 may be included in a nasal patient interface 7000, which is sealed only in or around the patient's nostrils and exposes the patient's mouth to the surrounding environment. As described above, the nasal patient interface 7000 includes only a single sealing structure 7100 (e.g., similar to a second sealing structure 6102) and does not include separate first and second sealing structures as in the full-face patient interface 6000.

[0450] The air chamber 7200 of the nasal patient interface 7000 can be similar to the air chamber 6200 of the full-face patient interface 6000. The following describes only some similarities and differences between air chambers 6200 and 7200.

[0451] like FIG. 11 and 12 As shown, the inflation chamber 7200 includes a pair of inflation chamber inlet ports 7254, which can be used to deliver gas into and / or out of the inflation chamber 7200. The inflation chamber inlet ports 7254 may be located on opposite sides of the inflation chamber 7200 (e.g., left and right sides).

[0452] In the example shown, the shape of the inflation chamber inlet port 7254 can be substantially the same as that of the inflation chamber inlet port 6254 described above. As described below, this allows a single connector to be interchangeably connected to the inflation chamber inlet ports 6254 and 7254 on either of the inflation chambers 6200 and 7200.

[0453] In some forms, the inflation chamber 7200 may also include at least one ventilation opening 7402 (see example...) FIG. 10The vent opening 7402 can be located at the center of the inflation chamber 7200. For example, the vent opening 7402 can be arranged between the inflation chamber inlet ports 7254.

[0454] In the example shown, the inlet port 7254 and the ventilation opening 7402 can be aligned along a single axis on the inlet chamber 7200. For example, the inlet port 7254 can be located in a similar position to the inlet port 6254 relative to the patient's face. However, because the overall inlet chamber 7200 is smaller than the inlet chamber 6200 (i.e., because the inlet chamber 7200 does not receive the patient's mouth), the ventilation opening 7402 cannot be positioned in a straight line with the patient's mouth as it is in the inlet chamber 6200. The ventilation opening 7402 of the inlet chamber 7200 must therefore be positioned higher on the patient's face since the inlet chamber 7200 only includes the nasal portion.

[0455] In some configurations, when the patient is wearing padding 7050, the ventilation opening 7402 of the air chamber 7200 can be aligned with the patient's upper lip.

[0456] In some forms, the material surrounding the ventilation opening 7402 may be substantially flush with the central portion 7251 of the inflation chamber 7200. This helps to maintain a substantially small device footprint. For example, when using the patient interface 7000, the material surrounding the central portion 7251 may not extend substantially away from the patient's face and may not obstruct the patient's view. In other examples, the material surrounding the ventilation opening 7402 may protrude from the central portion 7251.

[0457] like FIG. 10 and 11 As shown, some forms of the inflation chamber 7200 may include a groove 7266 that can be arranged along the side of the inflation chamber 7200.

[0458] In some forms, the inflation chamber 7200 may include a pair of recesses 7266. Each recess 7266 may be arranged near one of the inflation chamber inlet ports 7254. Each recess 7266 may form a partially recessed surface.

[0459] Unlike the aforementioned groove 6266, the dimensions of groove 7266 can be substantially the same as those of the inflation chamber inlet port 7254. In other words, groove 7266 does not need to extend further in a direction lower than the lateral direction.

[0460] 5.3.3 Positioning and Stabilizing Structure

[0461] like FIG. 3A As shown, the sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0462] Positioning and stabilizing structure 3300 provides positioning and stabilizing structural force F in one form. PSS This is at least sufficient to overcome the effect of the positive pressure in the 3200 air chamber, thereby causing the surface to detach (i.e., F). 充气 room).

[0463] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0464] See also FIG. 3A The positioning and stabilizing structure 3300 provides a positioning and stabilizing structural force F. PSS (or positioning and stabilizing force F) PSS This positioning and stabilizing structural force helps maintain the air chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different components of the positioning and stabilizing structure 3300. For example, the headband strap can provide a strap force F individually. 绑带 This is to ensure that the sealing structure 3100 is held in place on the patient's face. 绑带 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 3100 and the inflation chamber 3200, but gravity will act on the entire patient interface 3000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0465] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 in the downward direction (e.g.) FIG. 3A (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the 6050 pad in place). Despite the frictional force F f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of the positioning and stabilizing structure 3300 and any other part of the patient interface 3000. gConversely, friction can act at any point along the patient interface 3000 where it contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0466] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气室 The seal-forming structure 3100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 3100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. As described below, when using the patient interface 3000, the positioning and stabilizing force F required to achieve balance can be determined by various positions of the patient's head. PSS .

[0467] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0468] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0469] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0470] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0471] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or loose bandage. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0472] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0473] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In an example, the strap may be configured as a tie.

[0474] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the base of the upper ear on the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0475] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the base of the lower ear on the patient's head and covers or is located below the occipital bone of the patient's head.

[0476] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0477] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping.

[0478] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to be transferred through the straps.

[0479] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0480] In some forms, a positioning and stabilizing structure of one type can be interchanged with multiple types or varieties of pads having sealing formation structures and inflation chambers. For example, two different pads have been described in the preceding section; the full-face pad 6050 and the nose pad 7050. A single positioning and stabilizing structure can be used interchangeably with two types of pads 6050, 7050 (or other forms not explicitly described herein).

[0481] Interchangeability of positioning and stabilization structures between different types or styles of liners can simplify manufacturing and / or allow patients to easily switch between different liners without needing to obtain entirely new components.

[0482] 5.3.3.1 Catheter headband

[0483] Catheters, such as headbands, can provide force F that helps with positioning and stability. PSS The force. For example, each conduit can provide a force F in the backward direction and the corresponding lateral direction. 导管 This is to hold the sealing structure 3100 on the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the air chamber 3200 to lift it away from the face (i.e., F 充气室 The guiding force F 导管 It can also be guided at least partially in the upward direction to overcome gravity F. g .

[0484] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. For example, the catheter can expand as pressurized air is delivered through it. This force can help grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0485] The position of the patient's head can also change the clamping force of the catheters. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface such as a pillow) can expand additionally to maintain substantially the same pressurized airflow rate.

[0486] like FIG. 13 As shown, some forms of the patient interface 6000 may include a tube or catheter 6320 that can be coupled (e.g., removably coupled or permeably coupled) to each catheter connection structure 6500. Each catheter 6320 can deliver a pressurized breathable gas flow (e.g., from the RPT device 4000) to the patient's airway. The pressurized breathable gas flow can enter the inflation chamber 6200 through the catheter connection structure 6500 and the inflation chamber inlet port 6254. A sealing engagement between each catheter connection structure 6500 and the inflation chamber inlet port 6254 can limit the flow of pressurized breathable gas from leaking into the surrounding environment through this interface.

[0487] In use (see, for example) FIG. 43 , 44 (51 and 52), catheter 6320 can form catheter headband 6319 and can extend along the patient's head (e.g., along the patient's cheek and toward the upper region of the patient's head). Catheter 6320 can replace the upper headband of patient interface 6000. Accordingly, catheter 6320 can be constructed of flexible or semi-rigid materials (e.g., silicone, fabric, etc.) and can be flexible when the patient wears patient interface 6000. The length of catheter 6320 can be non-adjustable, and all adjustment can be from the lower band.

[0488] In some forms, conduit 6320 can be removably connected to pad 6050 using conduit connection structure 6500. Conduit 6320 can be integrally connected to conduit connection structure 6500, which in turn connects to inflation chamber inlet port 6254. Conduit connection structure 6500 can be removably connected to pad 6050 via inflation chamber inlet port 6254 via a mechanical connection (e.g., snap-fit, press-fit, friction fit, etc.). In other examples, conduit connection structure 6500 can be permanently connected to inflation chamber inlet port 6254, and conduit 6320 can be removed from conduit connection structure 6500. In other examples, conduit connection structure 6500 can be removably connected from conduit 6320 and inflation chamber inlet port 6254.

[0489] As described above, the recess 6266 may be larger than the inflatable chamber inlet port 6254. For example, the recess 6266 may extend through the inflatable chamber inlet port 6254 in any lateral direction. The catheter connection structure 6500 may also be larger than the inflatable chamber inlet port 6254 and may contact the surface of the recess 6266 when connected to the inflatable chamber inlet port 6254. This allows the catheter connection structure 6500 to be at least partially recessed when connected to the inflatable chamber inlet port 6254 in order to maintain a low-profile patient interface 6000.

[0490] In some forms, the area formed by the lateral extension of the groove 6266 and the inflation chamber inlet port 6254 can be approximately the same size as the conduit connection structure 6500. The conduit connection structure 6500 can therefore be secured within the groove and the inflation chamber inlet port 6254. For example, the conduit connection structure 6500 can be connected to the groove 6266 using a press fit, friction fit, snap fit, or similar mechanical connection.

[0491] Back FIG. 13 Some forms of the catheter 6320 may include a tab 6324 through which a headband strap (described below) may pass. The tab 6324 may be integrally formed with the rest of the catheter 6320.

[0492] See also FIG. 13 Some forms of the conduit 6320 may include an accordion-style section 6328, which is formed as a series of ridges and grooves on the surface of the conduit 6320. The accordion-style section 6328 may be oriented toward a retracted position (e.g., FIG. 13 The catheter 6320 is biased and can be moved to an extended position when the patient wears the catheter headband 6319. Because the catheter 6320 can be substantially non-stretchable, the accordion-shaped section 6328 allows the catheter headband 6319 to extend to accommodate different head sizes. In other words, the material of the catheter 6320 can be substantially non-stretchable, but the geometry of the accordion-shaped section 6328 allows for a predetermined extension. Extending the accordion-shaped section 6328 allows a single-size catheter 6320 to be used with multiple head sizes. For example, as a result of the accordion-shaped section 6328, the catheter 6320 can be “one-size-fits-all.” Alternatively or additionally, the catheter 6320 and / or the accordion-shaped section 6328 can be manufactured in multiple sizes (e.g., small, medium, large). Patients can select the catheter length that best fits their head, and the accordion-shaped section 6328 can be adjusted slightly to accommodate individual patients.

[0493] When the patient wears catheter 6320, the accordion-shaped segment 6328 can expand to fit around the patient's head. When the patient removes catheter 6320, the accordion-shaped segment 6328 can return to its initial position (i.e., FIG. 13 The total length of the accordion-style segment 6328 expansion can depend on the size of the patient's head and the initial length of the catheter 6320.

[0494] In some configurations, the accordion-shaped section 6328 may be higher than the tabs 6324. In other words, these tabs 6324 may be arranged between the conduit connection structure 6500 and the accordion-shaped section 6328.

[0495] In the form shown, the accordion-shaped section 6328 may not extend completely into the tab 6324. In other words, the accordion-shaped section 6328 is spaced apart from the tab 6324 such that the tab 6324 is not directly connected to the accordion-shaped section 6328.

[0496] In some forms, duct 6320 may include an inlet 6332 for receiving a pressurized airflow. In the illustrated example, inlet 6332 may be located between accordion-style sections 6328. FIG. 43 and 51 As shown, the inlet 6332 can be located on the upper part of the patient's head during use. For example, the inlet 6332 can cover the patient's frontal and / or parietal bones during use.

[0497] In some forms, the inlet 6332 may be located in the middle of the conduit 6320. For example, the conduit 6320 may be symmetrical about the inlet 6332 via at least one axis.

[0498] In some forms, the catheter 6320 may be a standard component that can be used interchangeably with the full-face pad 6050 and the nasal pad 7050. The catheter 6320 may be connected to each type of pad 6050, 7050 in a similar manner, so that the catheter 6320 can be easily interchanged between pads 6050, 7050 as needed.

[0499] 5.3.3.2 Rigid Arm

[0500] like FIG. 14 As shown, the rigid arm 6340 may be an elongated rigid member that helps hold the liner 6050 in the operating position. The rigid arm 6340 may contact one side of the patient's head and provide force to limit the sealing structure 6100 from sliding off the patient's nose and / or mouth.

[0501] In some forms, the rigid arm 6340 is made of a rigid material (e.g., plastic). The rigid material does not allow the rigid arm 6340 to extend. Additionally, the rigid arm 6340 may be substantially non-flexible and may be inflexible. The rigid arm 6340 may be pre-molded into a desired shape to fit the patient's head. For example, the rigid arm 6340 may be molded into a curved shape to substantially correspond to the shape of the patient's head side (e.g., covering the masseter muscle and / or temporal bone).

[0502] In some forms, the rigid arm 6340 can be molded to fit the head of a particular patient (e.g., a custom rigid arm 6340).

[0503] In some forms, the rigid arm 6340 may be flexible in at least one direction. For example, the rigid arm 6340 may be flexible with respect to its width and may be inflexible along its length. In other words, the rigid arm 6340 may bend about an axis along its width, but not about an axis perpendicular to its width. This allows individual patients to adjust the rigid arm 6340 to better fit their individual head.

[0504] In some configurations, the rigid arm 6340 can remain in its new position after bending. This allows patients to adjust the shape of the rigid arm 6340 to suit their specific head shape, and then the arm 6340 will maintain the desired shape during use to enhance patient comfort.

[0505] In some forms, the first end or free end 6342 of the rigid arm 6340 may be a free end, and the second end 6344 of the rigid arm 6340 (e.g., opposite to the first end 6342) may be fixed. The first end 6342 may be curved to minimize sharp edges that could cause patient discomfort. In use, the first end 6342 may also cover the patient's head near the temporal bone. The second end 6344 may be fixed to the arm connection structure 6504. The rigid arm 6340 may be connected at an angle relative to the arm connection structure 6504.

[0506] In some forms, the arm connection structure 6504 may resemble the conduit connection structure 6500. For example, the arm connection structure 6504 and the conduit connection structure 6500 may have substantially the same shape. This allows the conduit connection structure 6500 or the arm connection structure 6504 to fit into the recess 6266 and connect to the inflation chamber inlet port 6254. The arm connection structure 6504 may be connected to the gasket 6050 in substantially the same manner as the conduit connection structure 6500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0507] In some forms, the arm connection structure 6504 can be used as a plug for the inflation chamber inlet port 6254. Unlike the conduit 6320, the rigid arm 6340 does not deliver pressurized air to the inflation chamber 6200. The rigid arm 6340 can be used in a 'tube-down' configuration, where a hose is connected to the vent opening 6402 and through which air is delivered to the inflation chamber 6200. In this example, air does not need to travel into or out of the inflation chamber inlet port 6254. Therefore, the arm connection structure 6504 can form a seal with the inflation chamber inlet port 6254 to restrict airflow into or out of the inflation chamber 6200.

[0508] like FIG. 13As shown, a pair of rigid arms 6340 are used with an inflation chamber 6200. The rigid arms 6340 can be separated from each other, allowing them to be independently connected in a groove 6266. Additionally, individual arms 6340 can be individually formed (e.g., during molding or manually by bending) to accommodate different profiles on different sides of the patient's head.

[0509] In some forms, the rigid arm 6340 can be a standard component that can be used interchangeably with the full-face pad 6050 and the nose pad 7050. The rigid arm 6340 can be connected to each type of pad 6050, 7050 in a similar manner, so that the rigid arm 6340 can be easily interchanged between pads 6050, 7050 as needed.

[0510] 5.3.3.3 Headband Straps

[0511] like FIG. 15 and 16 As shown, some forms of the positioning and stabilizing structure 6300 include a headband 6302, which can be worn by the patient to help seal the formation structure 6100 to be properly oriented relative to the patient's face (e.g., to limit or prevent leakage).

[0512] In some forms, the headband 6302 may be made of a fabric material that can comfortably conform to the patient's skin. The fabric may be flexible to conform to various facial contours. Although the fabric may include rigid elements along a selected length, this can limit the bending, flexing, and / or stretching of the headband 6302.

[0513] In some forms, the headband 6302 may be at least partially extended. For example, the headband 6302 may comprise an elastic or similar stretchable material. This allows the headband 6302 to extend under tension, which can help provide a sealing force for the seal-forming structure 6100.

[0514] The extendable headband 6302 can also function similarly to the accordion-style segment 6328. The extendable headband 6302 can begin in an unstretched position and can stretch to an unfolded position when worn by a patient. In some examples, the headband 6302 can be "one-size-fits-all," while in other examples, multiple sizes of headband 6302 (e.g., small, medium, large) can be present to control the overall length expansion of the headband 6302. When the patient removes the headband 6302, the headband 6302 can return to its initial position.

[0515] In some forms, only selected portions of headband 6302 are extendable. Other portions of headband 6302 may be non-extendable. For example, portions of the headband may not be elastic and / or may include rigid elements (e.g., stiffening lines) to limit or prevent stretching of those portions of headband 6302. In other examples, the entire headband 6302 may be non-extendable. The use of rigid elements helps to selectively determine where the headband can extend, which can provide better fit and / or increase comfort for the patient.

[0516] 5.3.3.3.1 Four-point connection

[0517] like FIG. 15 As shown, some forms of headband 6302 can be a four-point connection headband. This means that headband 6302 can be connected to four separate locations and can therefore include four different straps that provide tension to help maintain the sealing structure 6100 in the sealed position.

[0518] In some forms, the headband 6302 may include a lower strap 6304, which may be attached to the lower part of the padding 6050. The lower strap 6304 may extend along the patient's cheek toward the back of the patient's head. For example, the lower strap 6304 may cover the masseter muscle on either side of the patient's face. Thus, the lower strap 6304 may contact the patient's head below the ear. The lower strap 6304 may meet at the back of the patient's head and may cover the occipital bone and / or the trapezius muscle.

[0519] The headband 6302 may also include an upper bandage 6305 that may cover the temporal, parietal, and / or occipital bones. The upper bandage 6305 may also be connected to the conduit 6320 (e.g., by abutting against a tab 6324).

[0520] The posterior bandage 6307 may extend between the upper bandage 6305 and the lower bandage 6304. The lower and upper bandages 6304, 6305 on a given side (e.g., left or right) may also be connected adjacent to each other to the posterior bandage 6307. Therefore, the height of the posterior bandage 6307 can be approximated as the combined height of the lower bandage 6304 and the upper bandage 6305. The posterior bandage 6307 may cover the occipital and / or parietal bones during use. This allows the posterior bandage 6307 to help anchor the headband 6302 to the patient's head.

[0521] In the example shown, the headband 6302 may be formed in a generally X shape. The lower strap 6304 and the upper strap 6305 may be attached to the rear strap 6307 by sewing, ultrasonic welding or any similar process.

[0522] In some forms, the lower strap 6304 is connected to the magnetic member 6306. For example, each lower strap 6304 may pass through the magnetic member 6306, allowing the length of each lower strap 6304 to be adjusted. The magnetic member 6306 may be removably connected to the magnet 6370 (described below), allowing the lower strap 6304 to be disconnected from the inflation chamber 6200, but without affecting the length of the lower strap 6304.

[0523] In some configurations, the upper strap 6305 can be directly attached to the tab 6324 of the conduit 6320. The upper strap 6305 can pass through the tab 6324 to adjust the length and control the tension of each upper strap 6305.

[0524] In some configurations, headband 6302 may be used only with full-face pad 6050 (e.g., because nose pad 7050 does not have four connection points). However, headband 6302 may be used interchangeably with catheter headband 6319 and rigid arm 6340.

[0525] 5.3.3.3.2 Two-point connection

[0526] like FIG. 16 As shown, some forms of the headband 7302 can be a two-point connected headband. This means that the headband 7302 can be connected to two separate locations, and therefore can include two different straps that provide tension to help maintain the sealing structure 7100 in the sealed position.

[0527] The headband 7302 may also include an upper bandage 7305 that may cover the temporal, parietal, and / or occipital bones. The upper bandage 7305 may also be connected to the conduit 6320 (e.g., by abutting against a tab 6324). The upper bandage 7305 may contact the patient's head at substantially the same location as the upper bandage 6305.

[0528] In some forms, the headband 7302 may not include a separate posterior bandage. Instead, the upper bandage 7305 may be used as a posterior bandage. For example, the upper bandage 7305 may also contact the back of the patient's head and may cover the occipital bone and / or the trapezius muscle.

[0529] In some forms, the upper bandage 7305 may be formed from a continuous sheet of material. In other words, the headband 7302 may not be formed from multiple bandages joined together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different bandages. In other forms, the headband 7302 may be formed from multiple bandages joined together (e.g., two upper bandages, a back bandage, etc.).

[0530] like FIG. 16As shown, the headband 7302 may be at least partially forked. For example, the rear portion 7307 of the headband 7302 (e.g., configured to contact the back of a patient's head) may be wider than the surrounding portion of the headband 7302. The middle portion 7308 of the rear portion 7307 may include a slit 7309. Thus, due to the slit 7309, the upper section of the rear portion 7307 may be movable relative to the lower section. This may allow for greater bandage coverage over the back area of ​​the patient's head, which may help to better anchor the headband 7302 to the patient's head, since there is no lower bandage (e.g., 6304).

[0531] In some configurations, headband 7302 may be used only with nasal pad 7050 (e.g., because full-face pad 6050 does not have four connection points). However, headband 6302 may be used interchangeably with catheter headband 6319 and rigid arm 6340.

[0532] 5.3.3.4 Sleeve

[0533] The sleeve can be used with the guide tube headband 6319 and / or the rigid arm 6340. The sleeve can at least partially surround the guide tube headband 6319 and / or the rigid arm 6340. FIG. 17 to 24 As shown, sleeves of different shapes can be used, corresponding to different types of positioning and stabilization structures 6300. In some forms, the sleeve can be customized to fit the face of a specific user. For example, the sleeve can be configured in a relatively posterior area of ​​the patient's head.

[0534] In some forms, the sleeve can be made of comfortable materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfortable materials can come into contact with the patient during use and feel soft against the patient's skin in order to improve patient compliance.

[0535] The material can also be flexible to facilitate putting on or taking off the sleeve from the catheter headband 6319 or the rigid arm 6340. For example, the material may allow the sleeve to bend to conform to the shape of the catheter headband 6319 or the rigid arm 6340, which can be modified according to the shape of an individual patient's head.

[0536] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to extend). The elastic material can help the sleeve extend to fit around the catheter headband 6319 or the rigid arm 6340. The elastic material can then return to its initial position, which is in close contact with the catheter headband 6319 or the rigid arm 6340, to limit sleeve slippage during use.

[0537] As described in more detail below, some forms of sleeves can be specifically designed for rigid elements (e.g., catheter headband 6319 and / or rigid arm 6340). However, sleeves can facilitate interchangeable connection of rigid elements with pads (e.g., full-face pad 6050, nasal pad 7050, etc.) of different types or forms.

[0538] 5.3.3.4.1 Catheter sleeve

[0539] like FIG. 17 to 19 As shown, one example of a sleeve is a catheter sleeve 6350, which can be used with the catheter headband 6319 described above.

[0540] like FIG. 17 As shown, the catheter sleeve 6350 may include similar components. FIG. 13 The catheter headband 6319 shown is in a curved shape. The flexible material used to construct the catheter sleeve 6350 allows the catheter sleeve 6350 to be further bent to correspond to the shape of the catheter 6320 (e.g., when worn by a patient).

[0541] In some forms, the catheter sleeve 6350 may include a first or upper opening 6352. The upper opening 6352 may be located at one end of the catheter sleeve 6350. The upper opening 6352 may be an opening in a passage extending along at least a portion of the catheter sleeve 6350.

[0542] In some forms, the catheter sleeve 6350 may be at least partially elastic near the upper opening 6352. As described above, elasticity allows the catheter sleeve 6350 to extend around the opening 6352 in order to increase the diameter of the opening 6352.

[0543] like FIG. 17 to 19 Some forms of the catheter sleeve 6350 may also include a lower extension 6354. The lower extension 6354 may be positioned on the end of the catheter sleeve 6350 opposite to the upper opening 6352. The catheter sleeve 6350 may be customized to fit the face of a particular user. For example, the lower extension 6354 of the catheter sleeve 6350 may be configured in a relatively posterior or anterior region of the patient's head.

[0544] Some forms of the lower extension 6354 may include a rigid or semi-rigid element (e.g., within the sleeve 6350). The rigid or semi-rigid element may be made of a plastic material or a similar material. Alternatively, the lower extension 6354 may be rigidified using manufacturing processes (e.g., stitching rigid threads, plain knitting, using a thicker material).

[0545] In some configurations, the lower extension 6354 may be separate from the passage through the catheter sleeve 6350. In other words, the catheter 6320 inserted into the catheter sleeve 6350 may not extend into the lower extension 6354.

[0546] like FIG. 17 and 18 As shown, some forms of the lower extension 6354 may include a connecting member 6356. In the example shown, the connecting member 6356 may be a magnet, although in other examples, the connecting member 6356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). The connecting member 6356 may also be positioned at the end of the lower extension 6354, although the connecting member 6356 may also be positioned anywhere along the lower extension 6354.

[0547] In some forms, the connecting member 6356 (e.g., a magnet) may be removably connected to the magnet 6370 of the headband 6302. For example, when the catheter sleeve 6350 is connected to the catheter 6320 (described below), the magnet 6370 connected to the lower strap 6304 may be removably connected to the connecting member 6356 to provide tension.

[0548] like FIG. 17 and 18 As shown, the lower extension 6354 can be disposed at different positions along the catheter sleeve 6350. For example, as described above, the lower extension 6354 can be positioned near the end of the catheter sleeve 6350 (see, for example, [reference needed]). FIG. 17 Alternatively, the lower extension 6354 may be located at an intermediate position between the upper opening 6352 and the opposite ends of the catheter sleeve 6350.

[0549] In some configurations, changing the position of the lower extension 6354 can alter the position of the connecting member 6356. Changing the position of the connecting member 6356 can also alter the force vector when the lower strap 6304 (via magnet 6370) is connected to the catheter sleeve 6350. This repositioning can facilitate a sliding fit for patients with various head shapes and sizes.

[0550] In some forms, the lower extension 6354 is formed together with the rest of the catheter sleeve 6350. For example, the catheter sleeve 6350 may be formed from a single piece of material. Alternatively, the lower extension 6354 may be sewn onto the rest of the catheter sleeve 6350. In either case, the lower extension 6354 cannot be moved from its position. Instead, the catheter sleeve 6350 may be manufactured with the lower extension 6354 in various positions to better accommodate a wider range of head sizes.

[0551] Alternatively, the lower extension 6354 may be removably connected to the remainder of the catheter sleeve 6350 (e.g., using hook and loop materials, mechanical fasteners, magnets, etc.). In other forms, the lower extension 6354 may slide relative to the remainder of the catheter sleeve 6350. In either case, the patient may move the lower extension 6354 to a desired position relative to the remainder of the catheter sleeve 6350. Depending on the type of adjustment, the adjustment may be between discrete positions or between an unlimited number of positions.

[0552] like FIG. 19 As shown, the catheter sleeve 6350 may further include a lower opening 6358 located at the end of the catheter sleeve 6350 opposite to the upper opening 6352. The passage may extend between the upper opening 6352 and the lower opening 6358.

[0553] In the example shown, the lower opening 6358 leads to the surface of the catheter sleeve 6350. In other words, the lower opening 6358 can open perpendicularly to the upper opening 6352.

[0554] In some forms, the lower opening 6358 may comprise an elastic material similar to the upper opening 6352. The elasticity allows the lower opening 6358 to expand, enabling the conduit 6320 to fit through the opening.

[0555] FIG. 19 The example shown illustrates a lower opening 6358 aligned with the lower extension 6354 (e.g., the lower extension 6354 is located at...). FIG. 17 (as shown in the image). Move the lower extension 6354 to another position (e.g., as shown in the image). FIG. 18 As shown, the position of the lower opening 6358 can remain unchanged. In other words, even if the lower extension 6354 is in a new position, the lower opening 6358 can always be located at the end of the conduit sleeve 6350.

[0556] 5.3.3.4.2 Four-point arm sleeve

[0557] like FIG. 20 to 22 As shown, another example of a sleeve is a four-point arm sleeve 6380, which can be used with the rigid arm 6340 described above.

[0558] like FIG. 20 As shown, the four-point arm sleeve 6380 may include and FIG. 14 The rigid arm 6340 shown has a similar curved shape. The flexible material used to construct the four-point arm sleeve 6380 allows the four-point arm sleeve 6380 to be further bent to correspond to the shape of the rigid arm 6340 (e.g., when worn by a patient and / or bent by a patient).

[0559] like FIG. 17 to 19As shown, some forms of the four-point arm sleeve 6380 may include a lower extension 6384. The lower extension 6384 may be positioned at an end of the four-point arm sleeve 6380.

[0560] In the illustrated example, the shape and / or structure of the lower extension 6384 is substantially the same as that of the lower extension 6354. For example, the lower extension 6384 may be more rigid than the rest of the four-point arm sleeve 6380 (e.g., due to rigidification of the thread or rigid material).

[0561] like FIG. 17 and 18 As shown, some forms of the lower extension 6384 may include a connecting member 6386. In the example shown, the connecting member 6386 may be a magnet, although in other examples, the connecting member 6386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). The connecting member 6386 may also be positioned at the end of the lower extension 6384, although the connecting member 6386 may also be positioned anywhere along the lower extension 6384.

[0562] In some forms, the connecting member 6386 (e.g., a magnet) may be removably connected to the magnet 6370 of the headband 6302. For example, when the four-point arm sleeve 6380 is connected to the rigid arm 6340 (described below), the magnet 6370 connected to the lower strap 6304 may be removably connected to the connecting member 6386 to provide tension.

[0563] like FIG. 20 and 21 As shown, the lower extension 6384 can be arranged at different locations along the four-point arm sleeve 6380. For example, as described above, the lower extension 6384 can be positioned near the end of the four-point arm sleeve 6380 (see, for example, [reference needed]). FIG. 20 Alternatively, the lower extension 6384 can be positioned toward the center of the four-point arm sleeve 6380 and away from that end (see, for example...). FIG. 21 ).

[0564] As described above regarding the catheter sleeve 6350, changing the position of the lower extension 6384 can alter the position of the connecting member 6386. Changing the position of the connecting member 6386 also alters the force vector when the lower strap 6304 (via magnet 6370) is connected to the four-point arm sleeve 6380. This repositioning can facilitate a sliding fit for patients with various head shapes and sizes.

[0565] The lower extension 6384 can be connected to the four-point arm sleeve 6380 in a similar manner to how the lower extension 6354 is connected to the conduit sleeve 6350, as described above. For example, the lower extension 6384 can be permanently connected to the four-point arm sleeve 6380 in a fixed position, or the lower extension 6384 can be movably or removably connected to the four-point arm sleeve 6380.

[0566] like FIG. 22 As shown, the four-point arm sleeve 6380 may include a lower opening 6388 located at one end of the four-point arm sleeve 6380. The lower opening 6388 may form an opening for a passage through the four-point arm sleeve 6380. In the example shown, the lower opening 6388 may open to a surface of the conduit sleeve 6380.

[0567] In some forms, the lower opening 6388 may include an elastic material similar to the upper opening 6352 of the conduit sleeve 6350. The elasticity allows the lower opening 6388 to extend, enabling the rigid arm 6340 to fit through the opening.

[0568] FIG. 22 The example shown illustrates a lower opening 6388 aligned with the lower extension 6384 (e.g., the lower extension 6384 is located at...). FIG. 20 (as shown in the image). Move the lower extension 6384 to another position (e.g., as shown in the image). FIG. 21 As shown, the position of the lower opening 6388 can remain unchanged. In other words, even if the lower extension 6384 is in a new position, the lower opening 6388 can always be located at the end of the four-point arm sleeve 6380.

[0569] like FIG. 20 to 22 As shown, the four-point arm sleeve 6380 can be formed as a single sleeve (e.g., unlike the catheter sleeve 6350, which can be part of a pair of sleeves). The shape of the four-point arm sleeve 6380 can be similar to the catheter headband 6319 described above, and can be placed on the patient's head in a similar position.

[0570] The four-point arm sleeve 6380 may include a lower opening 6388 at either end. The four-point arm sleeve 6380 may also include a lower extension 6384 at either end. Thus, the four-point arm sleeve 6380 may be symmetrical to the catheter headband 6319.

[0571] In the illustrated example, the lower opening 6388 may be the only opening of the four-point arm sleeve 6380. In other words, the four-point arm sleeve 6380 may not include an upper opening (e.g., similar to upper opening 6352). Additionally, the four-point arm sleeve 6380 may include multiple passages instead of a single connected passage.

[0572] For example, each lower opening 6388 can be an opening leading to a single passage. Each passage may include only one opening (i.e., the corresponding lower opening 6388), and the passages may not be connected to each other. The length of each passage may be approximately the length of the rigid arm 6340.

[0573] like FIG. 22 As shown, the four-point arm sleeve 6380 may include a pair of lower segments 6390 and upper segments 6392. This pair of lower segments 6390 includes a first lower segment 6390 and a second lower segment 6390. The lower segments 6390 may be positioned on the right and left sides of the four-point arm sleeve 6380 and may include the corresponding lower openings 6388 described above. The lower segments 6390 may also include a tab 6394, which may resemble the tab 6324 on the catheter headband 6319. When the patient wears the four-point arm sleeve 6380, the tab 6394 may be positioned on the patient's head at substantially the same location as the tab 6324 is positioned when the patient wears the catheter headband 6319. The lower segments 6390 may also include access pathways.

[0574] In some forms, the upper end of each lower segment 6390 (e.g., away from the lower opening 6388 and adjacent to the upper segment 6392) may include a closed end. For example, the end of the lower segment 6390 opposite the lower opening 6388 may be sewn closed to form the end of the corresponding passage.

[0575] The upper segment 6392 can be connected between the lower segments 6390. For example, the upper segment 6392 can be sutured to two lower segments 6390 (although another connection method can be used). In use, the upper segment 6392 can contact the upper region of the patient's head (e.g., covering the frontal and / or parietal bones).

[0576] The upper segment 6392 may be substantially flat and without an internal passage. However, some forms of the upper segment 6392 may include an outer fabric layer with an inner foam layer to provide additional cushioning to the patient's head.

[0577] 5.3.3.4.3 Double-point arm sleeve

[0578] like FIG. 23 and 24 As shown, another example of a sleeve is the two-point arm sleeve 6380-1, which can be used with the rigid arm 6340 described above.

[0579] In some forms, the two-point arm sleeve 6380-1 can be similar to the four-point arm sleeve 6380 described above. Only some similarities and differences are described below.

[0580] like FIG. 23As shown, the two-point arm sleeve 6380-1 may include a lower opening 6388-1 located at one end of the two-point arm sleeve 6380-1. The lower opening 6388-1 may form an opening for a passage through the two-point arm sleeve 6380-1. In the example shown, the lower opening 6388-1 may open to a surface of the conduit sleeve 6380-1.

[0581] In some forms, the lower opening 6388-1 may include an elastic material similar to the upper opening 6352 of the conduit sleeve 6350. The elasticity allows the lower opening 6388-1 to extend, so that the rigid arm 6340 can fit through the opening.

[0582] like FIG. 23 As shown, the two-point arm sleeve 6380-1 can be formed as a single sleeve (e.g., similar to the four-point arm sleeve 6380). The shape of the two-point arm sleeve 6380-1 can be similar to the catheter headband 6319 described above, and it can be placed on the patient's head in a similar position.

[0583] like FIG. 24 As shown, another form of the two-point arm sleeve 6380-1 can be formed as multiple parts. For example, the upper section 6392-1 can be formed as two parts that can be selectively connected to each other (e.g., with hook and loop material, snaps, etc.). This allows the patient to adjust the size of the sleeve for a better fit to their head. Although not shown, similar multi-piece adjustable sleeves can be used with the four-point arm sleeve 6380 described above.

[0584] The two-point arm sleeve 6380-1 may include a lower opening 6388-1 at either end. Therefore, the two-point arm sleeve 6380-1 may be symmetrical to the catheter headband 6319.

[0585] In the illustrated example, the lower opening 6388-1 may be the only opening of the two-point arm sleeve 6380-1. In other words, the two-point arm sleeve 6380-1 may not include an upper opening (e.g., similar to upper opening 6352). Additionally, the two-point arm sleeve 6380-1 may include multiple passages instead of a single connected passage.

[0586] For example, each lower opening 6388-1 can be an opening leading to a single passage. Each passage may consist of only one opening (i.e., the corresponding lower opening 6388-1), and the passages may not be connected to each other. The length of each passage may be approximately the length of the rigid arm 6340.

[0587] like FIG. 23As shown, the two-point arm sleeve 6380-1 may include a pair of lower segments 6390-1 and upper segments 6392-1. This pair of lower segments 6390-1 includes a first lower segment 6390-1 and a second lower segment 6390-1. The lower segments 6390-1 may be positioned on the right and left sides of the two-point arm sleeve 6380-1 and may include the corresponding lower openings 6388-1 described above. The lower segments 6390-1 may also include a tab 6394-1, which may resemble the tab 6324 on the catheter headband 6319. When the patient wears the two-point arm sleeve 6380-1, the tab 6394-1 may be positioned on the patient's head at substantially the same location as the tab 6324 is positioned when the patient wears the catheter headband 6319. The lower segments 6390-1 may also include a pathway.

[0588] In some forms, the upper end of each lower segment 6390-1 (e.g., away from the lower opening 6388-1 and adjacent to the upper segment 6392-1) may include a closed end. For example, the end of the lower segment 6390-1 opposite to the lower opening 6388-1 may be sewn closed to form the end of the corresponding passage.

[0589] The upper segment 6392-1 can be connected between the lower segments 6390-1. For example, the upper segment 6392-1 can be sutured to two lower segments 6390-1 (although another connection method can be used). In use, the upper segment 6392-1 can contact the upper region of the patient's head (e.g., covering the frontal and / or parietal bones).

[0590] The upper segment 6392-1 may be substantially flat and without internal access. However, some forms of the upper segment 6392-1 may include an outer fabric layer with an inner foam layer to provide additional cushioning to the patient's head.

[0591] Therefore, the two-point arm sleeve 6380-1 can be substantially similar to the four-point arm sleeve 6380. However, the two-point arm sleeve 6380-1 may not include a lower extension or connecting member. Therefore, the strap from the headband 6302 can be connected to the two-point arm sleeve 6380-1 only via the tab 6394.

[0592] 5.3.4 Vent

[0593] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0594] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0595] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0596] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure such as a rotary joint.

[0597] like FIG. 41 As shown, the ventilation port 6400 can be used with the patient interface 6000. The ventilation port 6400 may have a shape substantially similar to that of the ventilation port 6402 (e.g., a substantially circular shape).

[0598] The vent 6400 can be used with the full-face patient interface 6000 (e.g., as shown in the image). FIG. 7 to 9 (as shown in the image) or nasal patient interface 7000 (e.g., in...) FIG. 10 to 12 (as shown in the image).

[0599] See also FIG. 41 The vent 6400 may include a vent housing or a vent body 6404, which may be configured to engage with the vent opening 6402. The vent housing 6404 may be made of a rigid or semi-rigid material. For example, the vent housing 6404 may be made of plastic, metal, or any similar material. The vent housing 6404 may increase the rigidity of the patient interface 6000 (e.g., to limit undesirable bending that could affect the position of the seal-forming structure 6100 on the patient's face).

[0600] The vent housing 6404 may include a front surface 6408, a rear surface 6412, and a recess 6416. The front surface 6408 faces away from the patient's face during use and can be positioned outside the pressurized area of ​​the inflation chamber 6200. The rear surface 6412 is positioned opposite the front surface 6408. During use, the rear surface 6412 can face the patient and can be arranged within the pressurized volume of the inflation chamber 6200. The recess 6416 may be formed between the front and rear surfaces 6408 and 6412. A portion of the inflation chamber 6200 may be received within the recess 6416 to hold the vent 6400 in place.

[0601] In some forms, diffuser 6448 can be used with vent housing 6404. Diffuser 6448 helps limit decibel output from any patient interface 6000 (or any other patient interface). Specifically, diffuser 6448 helps limit the decibel level associated with air output (e.g., exhaled air) from patient interface 6000, although diffuser 6448 can limit the decibel level at any point within the patient interface.

[0602] The diffuser 6448 may include a damping member (not shown) and a cover 6456. The damping member and the cover 6456 may be coupled to the vent body 6404. The diffuser may be made of a sound-damping material, and the cover 6456 may hold the damping member in place.

[0603] like FIG. 41 As shown, some forms of the cover 6456 may not extend to the edge of the vent housing 6404. A gap 6464 may be formed between the edge of the cover 6456 and the surface of the vent body 6404. Airflow may exit from the vent 6400 through the gap 6464 to be discharged into the environment.

[0604] 5.3.5 Decoupling Structure

[0605] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or ball head and ball socket.

[0606] 5.3.6 Connection Port

[0607] Connection port 3600 allows connection to air circuit 4170.

[0608] 5.3.7 Forehead Stent

[0609] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0610] 5.3.8 Anti-asphyxiation valve

[0611] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0612] Port 5.3.9

[0613] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0614] 5.3.10 Modularity

[0615] As mentioned above, pads, headbands, and sleeves can come in different styles to correspond to different uses (e.g., mouth breathing, nose breathing, etc.). Patients or clinicians can choose certain combinations of pads, headbands, and sleeves to optimize treatment effectiveness and / or individual patient comfort.

[0616] In some forms, different types of padding, headbands, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as it allows for the creation of a greater variety of patient interfaces using fewer parts. Additionally or optionally, these combinations can allow patients to change the type of patient interface without altering each component.

[0617] For example, air can be delivered to the patient in one of two main ways. First, the patient can receive a pressurized airflow through the catheter headband 6319. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. Second, the patient can receive a pressurized airflow through a flexible tube that is directly connected to the pad and located in front of the patient's face. This can be referred to as a "tube-down" configuration, and the airflow duct can be separated from the positioning and stabilization device. Even when wearing the same type of patient interface (e.g., full-face patient interface 6000, nasal patient interface 7000, etc.), some patients may prefer one type of air delivery over another, and / or one type of air delivery may be more conducive to their individual sleep type. Therefore, it may be beneficial to allow a single type of patient interface (e.g., full-face patient interface 6000, nasal patient interface 7000) to be used with either a "tube-up" or "tube-down" configuration.

[0618] Patients or clinicians can select different components (e.g., padding, headband, and sleeves) to create modular components for a specific patient. These different components are interchangeable, allowing patients to swap out one or more components for different types of the same component (e.g., a nasal mask for a full-face mask), forming different modular components. Alternatively or additionally, clinicians can recommend that different patients exchange at least some components to create different patient interfaces.

[0619] The following description illustrates the various combinations that can be achieved by assembling different components together.

[0620] 5.3.10.1 Components

[0621] The various components of the aforementioned patient interfaces (e.g., pads, headbands, sleeves) can generally be generic. In other words, they do not need to be manufactured with a specific structure (although they can be in different sizes to fit patients of different sizes). This allows those assembling patient interfaces (e.g., manufacturers, clinicians, patients, etc.) to select standard parts to assemble a usable patient interface.

[0622] 5.3.10.1.1 Full-face tube upward configuration

[0623] like Figures 25 to 28-2 As shown, the catheter sleeve 6350 can be connected to the catheter headband 6319. This combination will allow patients to experience a "tube-up" air delivery type with a full-face patient interface 6000.

[0624] As described above, a pair of catheter sleeves 6350 can be used with a catheter headband 6319. The following description and related figures specifically relate to the connection between one catheter sleeve 6350 and one catheter 6320 of the catheter headband 6319. The other catheter sleeve 6350 will be connected to the other catheter 6320 of the catheter headband 6319 in substantially the same manner.

[0625] like Figure 25 As shown, catheter 6320 and catheter sleeve 6350 can begin to separate from each other. The patient can position the upper opening 6352 of catheter sleeve 6350 near the catheter connection structure 6500 of catheter 6320.

[0626] In some forms, the catheter sleeve 6350 may be substantially flat when not in use. As described above, at least some portions of the catheter sleeve 6350 may include an elastic material (e.g., surrounding the upper opening 6352). The patient can stretch the area around the upper opening 6352 to create a sufficiently wide space to accommodate the catheter connection structure 6500.

[0627] Figure 25 The configuration shown illustrates the inner surface of catheter 6320 and the rear surface of catheter sleeve 6350. In other words, Figure 25 The surfaces of the catheter 6320 and catheter sleeve 6350 shown will face and / or contact the patient during use. During assembly, the catheter 6320 and catheter sleeve 6350 are aligned in the same direction so that the catheter connection structure 6500 can be ultimately connected to the inflation chamber 6200.

[0628] like Figure 26As shown, the upper opening 6352 of the catheter sleeve 6350 can receive the catheter clip structure 6500 and can be positioned at least partially along the length of the catheter 6320. The previously resilient portion of the catheter sleeve 6350 that allows the upper opening 6352 to extend and receive the catheter clip structure 6500 can return to its original position. This can create a sliding engagement between the catheter sleeve 6350 and the catheter 6320 (which limits relative movement between the catheter sleeve 6350 and the catheter 6320 to limit slippage during patient wear). The patient may need to continue stretching the upper opening 6352 to allow the catheter sleeve 6350 to continue moving along the catheter 6320.

[0629] See also Figure 26 The catheter clamp structure 6500 can be completely contained within the catheter sleeve 6350. In other words, the catheter clamp structure 6500 may not be aligned with the lower opening 6358 (and may not be exposed to the patient). Therefore, the patient may not be able to attach the catheter clamp structure 6500 to the inflation chamber 6200 in this position.

[0630] like Figure 27 As shown, the catheter sleeve 6350 can continue to slide along the surface of the catheter 6320. Specifically, the upper opening 6352 can be positioned further away from the catheter clamp structure 6500 (e.g., closer to the accordion-shaped segment 6328). As described above, the patient can continue to extend the upper opening 6352 to facilitate movement along the catheter 6320.

[0631] Figure 27 A catheter clip structure 6500 exposed to the patient is also shown. Specifically, the catheter clip structure 6500 can be aligned with a lower opening 6358. This can occur when the catheter 6320 has fully slid through the catheter sleeve 6350. Similar to the upper opening 6352, the lower opening 6358 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6358 to allow the catheter clip structure 6500 to be positioned through the lower opening 6358.

[0632] When the catheter clamp structure 6500 is positioned at Figure 27 When the orientation is correct, the catheter 6320 may not be positioned in the lower extension 6354. As described above, the lower extension 6354 can be cut from the passage of the catheter sleeve 6350 (e.g., by suturing, ultrasonic welding, etc.).

[0633] like Figure 28 As shown, the catheter sleeve 6350 can be fully connected to the catheter 6320. Specifically, the catheter clamp structure 6500 can be positioned through the lower opening 6358 (e.g., in...). Figure 27(After the lower opening 6358 is stretched). In some forms, the elasticity of the lower opening 6358 allows the shape of the lower opening to relax and return to its initial position (e.g., causing it to fit snugly against the catheter clamp structure 6500 and restricting slippage). In this position, the catheter clamp structure 6500 can connect to the inflation chamber 6200 without substantial interference from the catheter sleeve 6350.

[0634] like Figure 28-1 and 28-2 As shown, after the catheter sleeve 6350 is fully connected, the catheter clamp structure 6500 can remain exposed, allowing it to be connected to the pads 6050 and 7050. The catheter clamp structure 6500 can extend from the catheter sleeve 6350 to limit interference when connecting the catheter 6320 to the pads 6050 and 7050.

[0635] 5.3.10.1.2 Full-face tube downward configuration

[0636] like Figures 29 to 33-2 As shown, the four-point arm sleeve 6380 can be connected to the rigid arm 6340. This combination will allow patients to experience a "tube-down" air delivery type with a full-face patient interface 6000.

[0637] As described above, a single four-point arm sleeve 6380 can be used with a pair of rigid arms 6340. The following description and related figures specifically relate to the connection between one rigid arm 6340 and the four-point arm sleeve 6380. The other rigid arm 6340 will be connected to the four-point arm sleeve 6380 in substantially the same manner.

[0638] like Figure 29 As shown, the rigid arm 6340 and the four-point arm sleeve 6380 can begin to separate from each other. The patient can position the lower opening 6388 of the four-point arm sleeve 6380 close to the first end 6342 of the rigid arm 6340.

[0639] In some forms, the four-point arm sleeve 6380 may be substantially flat when not in use. As described above, at least some portions of the four-point arm sleeve 6380 may include an elastic material (e.g., around the lower opening 6388). The patient can stretch the area around the lower opening 6388 to create a sufficiently wide space to accommodate the first end 6342 of the rigid arm 6340.

[0640] In some forms, the rigid arm 6340 (e.g., particularly the first end 6342) may be substantially flat. This allows the patient to insert the rigid arm 6340 into the four-point arm sleeve 6380 without substantially stretching the lower opening 6388 (e.g., the first end 6342 may be smaller than the lower opening 6388 and may be able to slide in without stretching the opening 6388).

[0641] Figure 29 The configuration shown illustrates the inner surface of the four-point arm sleeve 6380 and the rear surface of the rigid arm 6340. In other words, Figure 29 The surfaces of the rigid arm 6340 and the four-point arm sleeve 6380 shown both face and / or contact the patient during use. During assembly, the connection between the four-point arm sleeve 6380 and the rigid arm 6340 is oriented in the same direction, such that the arm connection structure 6504 can be ultimately connected to the inflation chamber 6200.

[0642] like Figure 30 and 31 As shown, the lower opening 6388 of the four-point arm sleeve 6380 can receive the first end 6342 of the rigid arm 6340 and can be positioned at least partially along the length of the rigid arm 6340. The elastic portion of the four-point arm sleeve 6380, which allows the lower opening 6388 to be stretched and receives the free end 6342, can return to its original position (if initially stretched).

[0643] In some forms, the rigid arm 6340 may have a width substantially no greater than that of the four-point arm sleeve 6380. The patient may not need to continuously stretch the four-point arm sleeve 6380 to move the rigid arm 6340 through it. Instead, the rigid arm 6340 can slide through the four-point arm sleeve 6380 without significant resistance. The flexible material of the four-point arm sleeve 6380 can be bent along the shape of the rigid arm 6340 (if the rigid arm 6340 is bent to better conform to the patient's face). For example, in... Figure 30 and Figure 31 Between these, the patient is able to slide the rigid arm 6340 through the four-point arm sleeve 6380 without substantially needing to stretch the lower opening 6388.

[0644] See also Figure 30 and 31 The catheter clip structure 6504 can be located entirely outside the four-point arm sleeve 6380. In other words, the arm clip structure 6504 can be without passing through the lower opening 6388 (and exposed to the patient).

[0645] like Figure 32As shown, the four-point arm sleeve 6380 can continue to slide along the surface of the rigid arm 6340. The lower opening 6388 can be positioned closer to the arm clamp structure 6504. Specifically, the arm clamp structure 6504 can be positioned at least partially through the lower opening 6388 while remaining exposed to the patient. The arm clamp structure 6504 can be aligned with the lower opening 6388. This may occur when the rigid arm 6340 has fully slid through the four-point arm sleeve 6380. As previously described, the lower opening 6388 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6388 to allow the arm clamp structure 6504 to be positioned through the lower opening 6388.

[0646] When the arm clamp structure 6504 is positioned Figure 32 In the orientation, the rigid arm 6340 (e.g., arm clamp structure 6504) may not be positioned in the lower extension 6384. As described above, the lower extension 6384 can be cut from the passage of the four-point arm sleeve 6380 (e.g., by stitching, ultrasonic welding, etc.).

[0647] like Figure 33 As shown, the four-point arm sleeve 6380 can be fully connected to the rigid arm 6340. Specifically, the arm clamp structure 6504 can be partially positioned through and surrounded by the lower opening 6388 (e.g., in...). Figure 32 (After the lower opening 6388 is stretched). In some forms, the elasticity of the lower opening 6388 allows the shape of the lower opening to relax and return to its initial position (e.g., causing it to fit snugly against the arm clamp structure 6504 and restricting slippage). In this position, the arm clamp structure 6504 can connect to the inflation chamber 6200 without substantial interference from the four-point arm sleeve 6380.

[0648] See also Figure 33 The first end 6342 of the rigid arm 6340 (see example) Figure 29 The lower segment 6390 can be positioned at one end adjacent to the upper segment 6392. As described above, the upper segment 6392 may not include a passage for receiving the rigid member arm 6340. The length of the lower segment 6390 may be substantially similar to or equal to the length of the rigid member arm 6340, such that the rigid member arm 6340 is adjacent to or substantially close to the end of the lower segment 6390.

[0649] like Figure 33-1 and 33-2 As shown, after the four-point arm sleeve 6380 is fully engaged, the arm clamp structure 6504 remains exposed, allowing it to be connected to the gaskets 6050 and 7050. The arm clamp structure 6504 can extend from the four-point arm sleeve 6380 to limit interference when connecting the rigid arm 6340 to the gaskets 6050 and 7050 (see...). Figure 39 and 40 ).

[0650] 5.3.10.1.3 Downward Nasal Tube Configuration

[0651] like Figures 34 to 38-2 As shown, the two-point arm sleeve 6380-1 can be connected to the rigid arm 6340. This combination will allow patients to experience a "tube-down" air delivery type with a nasal patient interface 7000.

[0652] As described above, a single two-point arm sleeve 6380-1 can be used with a pair of rigid arms 6340. The following description and related drawings specifically relate to the connection between one rigid arm 6340 and the two-point arm sleeve 6380-1. The other rigid arm 6340 will be connected to the two-point arm sleeve 6380-1 in substantially the same manner.

[0653] like Figure 34 As shown, the rigid arm 6340 and the two-point arm sleeve 6380-1 can begin to separate from each other. The patient can position the lower opening 6388-1 of the two-point arm sleeve 6380-1 close to the first end 6342 of the rigid arm 6340.

[0654] In some forms, the two-point arm sleeve 6380-1 may be substantially flat when not in use. As described above, at least some portions of the two-point arm sleeve 6380-1 may include an elastic material (e.g., around the lower opening 6388-1). The patient can stretch the area around the lower opening 6388-1 to create a sufficiently wide space to accommodate the first end 6342 of the rigid arm 6340.

[0655] In some forms, the rigid arm 6340 (e.g., particularly the first end 6342) can be substantially flat. This allows the patient to insert the rigid arm 6340 into the two-point arm sleeve 6380-1 without substantially stretching the lower opening 6388-1 (e.g., the first end 6342 may be smaller than the lower opening 6388-1 and can slide in without stretching the opening 6388-1).

[0656] Figure 34 The configuration shown illustrates the inner surface of the two-point arm sleeve 6380-1 and the rear surface of the rigid arm 6340. In other words, Figure 34 The surfaces of the rigid arm 6340 and the two-point arm sleeve 6380-1 shown will face and / or contact the patient during use. During assembly, the connection between the two-point arm sleeve 6380-1 and the rigid arm 6340 is oriented in the same direction, such that the arm connection structure 6504 can be ultimately connected to the inflation chamber 6200.

[0657] like Figure 35 and 36As shown, the lower opening 6388-1 of the two-point arm sleeve 6380-1 can receive the first end 6342 of the rigid arm 6340 and can be positioned at least partially along the length of the rigid arm 6340. The elastic portion of the two-point arm sleeve 6380-1, which allows the lower opening 6388-1 to be stretched and receives the free end 6342, can return to its original position (if initially stretched).

[0658] In some forms, the rigid arm 6340 may have a width substantially no greater than that of the two-point arm sleeve 6380-1. The patient may not need to continuously stretch the two-point arm sleeve 6380-1 to move the rigid arm 6340 through it. Instead, the rigid arm 6340 can slide through the two-point arm sleeve 6380-1 without significant resistance. The flexible material of the two-point arm sleeve 6380-1 can be bent along the shape of the rigid arm 6340 (if the rigid arm 6340 is bent to better conform to the patient's face). For example, in... Figure 35 and Figure 36 Between these, the patient is able to slide the rigid arm 6340 through the two-point arm sleeve 6380-1 without substantially needing to stretch the lower opening 6388-1.

[0659] Reference Figure 36 The arm clamp structure 6504 can be located entirely outside the two-point arm sleeve 6380-1. In other words, the arm clamp structure 6504 can be without passing through the lower opening 6388-1 (and exposed to the patient).

[0660] like Figure 37 As shown, the two-point arm sleeve 6380-1 can continue to slide along the surface of the rigid arm 6340. The lower opening 6388-1 can be positioned closer to the arm clamp structure 6504. Specifically, the arm clamp structure 6504 can be positioned at least partially through the lower opening 6388-1 while remaining exposed to the patient. The arm clamp structure 6504 can be aligned with the lower opening 6388-1. This may occur when the rigid arm 6340 has fully slid through the two-point arm sleeve 6380-1. As previously described, the lower opening 6388-1 can be biased to a normally closed position, but can be formed of an elastic material. The patient can stretch the material around the lower opening 6388-1 to allow the arm clamp structure 6504 to be positioned through the lower opening 6388-1.

[0661] like Figure 38 As shown, the two-point arm sleeve 6380-1 can be fully connected to the rigid arm 6340. Specifically, the arm clamp structure 6504 can partially pass through and be surrounded by the lower opening 6388-1 (e.g., at the lower opening 6388-1 in...). Figure 37(After being stretched). In some forms, the elasticity of the lower opening 6388-1 allows the shape of the lower opening to relax and return to its initial position (e.g., so that it fits snugly against the arm clamp structure 6504 and restricts sliding). In this position, the arm clamp structure 6504 can connect to the inflation chamber 6200 without substantial interference from the two-point arm sleeve 6380-1.

[0662] The first end 6342 of the rigid arm 6340 can be positioned at the end of the lower segment 6390-1 adjacent to the upper segment 6392-1 (see example). Figure 23 As described above, the upper segment 6392-1 may not include a passage for receiving the rigid arm 6340. The length of the lower segment 6390-1 may be substantially similar to or equal to the length of the rigid arm 6340, such that the rigid arm 6340 is adjacent to or substantially close to the end of the lower segment 6390-1.

[0663] like Figure 38-1 and 38-2 As shown, after the two-point arm sleeve 6380-1 is fully connected, the arm clamp structure 6504 can remain exposed, allowing it to be connected to the gaskets 6050 and 7050. The arm clamp structure 6504 can extend from the two-point arm sleeve 6380-1 to limit interference when the rigid arm 6340 is connected to the gaskets 6050 and 7050.

[0664] 5.3.10.1.4 Nasal tube upward configuration

[0665] Patients who manage to use the "tube-up" configuration as part of the nasal patient interface 7000 do not need to use a sleeve to complete the assembly. The patient can connect the catheter headband 6319 directly to the inflation chamber 7200 (e.g., via the arm clip structure 6504).

[0666] In some configurations, the patient can attach a sleeve (not shown) to the catheter 6320 of the catheter headband 6319. The sleeve may be similar to the catheter sleeve 6350 and may be formed of a fabric material. Some forms of the sleeve may also be at least partially elastic. Additionally, each catheter 6320 may include a separate sleeve. The sleeve is designed for patient comfort (e.g., because the fabric material comfortably conforms to the patient's skin).

[0667] 5.3.10.1.5 Connection

[0668] Figure 39 and 40The process of connecting a rigid arm 6340 with a four-point arm sleeve 6380 to a full-face inflation chamber 6200 is shown. The following description will refer specifically to this configuration. However, the same description will apply to other configurations (e.g., since the catheter clamp structure 6500 and the arm clamp structure 6504 are of the same shape and are connected to the inflation chambers 6200 and 7200 in the same manner).

[0669] like Figure 39 As shown, air circuit 4170 is connected to ventilation opening 6402 to indicate that pad 6050 is being assembled into a tube-down configuration. Thus, the patient can choose rigid arm 6340 (e.g., as a result of the tube-down configuration) and four-point arm sleeve 6380 (e.g., as a result of the full-face pad 6050).

[0670] The four-point arm sleeve 6380 and the rigid arm 6340 can be connected as described above. Once connected, the assembly can be connected to the inflation chamber inlet port 6254.

[0671] Continue to refer to Figure 39 The lower opening 6388-1 of the four-point arm sleeve 6380 (see, for example, see...) Figures 34 to 37 It can be positioned around the arm clamp structure 6504 to avoid blocking the arm clamp structure 6504.

[0672] In the example shown, the arm clamp structure 6504 may include at least one protrusion 6508 extending from the surface of the rigid arm 6340. The at least one protrusion 6508 may have a shape similar to the inflation chamber inlet port 6254 and may be shaped to fit within the inflation chamber inlet port 6254.

[0673] In some forms, at least one protrusion 6508 can be fitted into the inflation chamber inlet port 6254 using a snap-fit, press-fit, and / or friction fit. This connection can create a substantially airtight engagement while also allowing the connection to be removable.

[0674] In some forms, the arm clamp structure 6504 also includes at least one protrusion 6512. Figure 39 and 40 (One is shown in the figure), which can be connected to at least one protrusion 6508. For example, a protrusion 6512 can be positioned at one end of at least one protrusion 6508 and can extend in a direction substantially perpendicular to at least one protrusion 6508 (although other positions and angles may be used). Protrusion 6512 can be adapted into a recess 6286 adjacent to the inflation chamber inlet port 6254.

[0675] In some forms, the engagement between the protrusion 6512 and the recess 6286 can help to properly orient at least one protrusion 6508 in the inflation chamber inlet port 6254. For example, the arm clip structure 6504 can engage in only one direction, allowing the headband to be properly connected and making the interface substantially airtight.

[0676] In some forms, the engagement between the protrusion 6512 and the recess 6286 can facilitate further connection of the arm clamp structure 6504 to the inflation chamber 6200. For example, the protrusion 6512 may be fitted into the recess 6286 by press-fit, snap-fit, and / or friction fit.

[0677] like Figure 39 and 40 As shown, the patient can align the arm clamp structure 6504 with the inlet port 6254 of the inflation chamber, such that the protrusion 6512 aligns with the groove 6286. The patient can then move the arm clamp structure 6504 so that at least one protrusion 6508 fits into the inlet port 6254 of the inflation chamber, and the arm clamp structure 6504 is connected to the inflation chamber 6200.

[0678] 5.3.10.2 Patient Interface for Assembly

[0679] like Figures 43 to 58 As shown, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between different types of patient interfaces.

[0680] 5.3.10.2.1 Full-face tube upward interface

[0681] exist Figures 43 to 46 As shown, the patient can wear the pad 6050 in the tube-up configuration with the catheter headband 6319, the four-point headband 6302 and the catheter sleeve 6350.

[0682] These components can be assembled as described above. For example, the catheter sleeve 6350 can be connected to the catheter 6320 of the catheter headband 6319. The catheter 6320 (via the catheter connection structure 6500) can be used to connect the catheter headband 6319 to the pad 6050. The catheter sleeve 6350 provides a magnet 6356 for connection to the magnet 6370 of the four-point headband 6302 (see, for example). Figure 15 ).

[0683] like Figure 43 and 44 As shown, the four-point headband 6302 can be connected at four separate locations to provide tension for holding the pad 6050 in a sealed position on the patient's head.

[0684] For example, a lower bandage 6304 (e.g., via a magnetic member 6306) can be removably attached to a magnet 6370 of the catheter sleeve 6350. In use, each lower bandage 6304 can contact the patient's cheek (e.g., covering the masseter muscle). The lower bandage 6304 can also extend below the patient's ear.

[0685] Tension can be applied along the lower bandage 6304 toward the posterior region of the patient's head (e.g., toward the occipital bone). The tensile force can pull the pad 6050 into the patient's head. Specifically, tension can be applied at the magnet 6370 on the catheter sleeve 6350. Because the lower extension 6354 is made of a rigid or semi-rigid material, it can remain substantially fixed when tension is applied (e.g., due to wearing the four-point headband 6302 attached to the pad 6050).

[0686] In some configurations, when the catheter headband 6319 is connected, the magnet 6370 may be positioned close to the lower portion of the gasket 6050. This may cause tension to act specifically on the lower region of the gasket 6050. In other words, the tension provided by the lower strap 6304 keeps the first sealing structure 6101 in the sealed position. Of course, the tension from the lower strap 6304 may also help keep the second sealing structure 6102 in the sealed position.

[0687] Continue to refer to the appendix Figure 43 and 44 The catheter 6320 can be positioned along the patient's cheek and can extend to a location above the patient's ear. For example, each catheter 6320 can extend along one side of the patient's head toward the coronal portion of the head. This allows each catheter 6320 to cover the sphenoid and / or temporal bones and extend toward the frontal and / or parietal bones.

[0688] The catheter sleeve 6350 may cover a portion of the catheter headband 6319. In other words, the catheter sleeve 6350, rather than the catheter headband 6319, may contact the patient along at least a portion of the length of the catheter headband 6319. Figure 43 and 44 As shown, the upper part of each catheter 6320 can contact the patient's head, while the inner part can be covered by the catheter sleeve 6350 (so that the catheter sleeve 6350 contacts the patient along the patient's cheek).

[0689] The second sealing structure 6102 can contact the lower side of the patient's nose. For example, the second sealing structure 6102 can avoid contact with the patient's nasal ridge and can contact the patient's nose at or below the nasal protuberance and abut against the columella. The catheter 6320 can provide additional tensile force in the upward and backward directions (e.g., as shown in the image). Figure 44(As shown). In this way, the second sealing structure 6102 can be pulled upwards onto the underside of the patient's nose in a sealed position (e.g., due to a higher orientation force). The catheter 6320 can also pull the pad 6050 into the patient's head to hold the pad 6050 in a sealed position (and help seal the first sealing structure 6101).

[0690] In some forms, the catheter 6320 may be generally non-extensible and may be configured to provide tension when worn by a patient. As described above, the length of the catheter 6320 may be less than the length of the patient's head, so that it provides tension when worn. Even when the accordion-shaped segment 6328 expands, the catheter 6320 can fit snugly against the patient's head, and the passage through the catheter 6320 can remain wide enough to allow for continuous airflow.

[0691] The catheter headband 6319 may include a tab 6324 on any catheter 6320. For example... Figure 44 As shown, the upper bandage 6305 can be connected to the corresponding tab 6324. When the catheter headband 6319 is worn by the patient, the tab 6324 can be positioned above the patient's ear. This allows the upper bandage 6305 connected to the tab 6324 to also be positioned above the patient's ear. For example, each tab 6324 can be positioned close to the temporal bone, and each upper bandage 6305 can cover the temporal bone and extend toward the occipital bone.

[0692] The upper bandage 6305 provides tension directed toward the back of the patient's head. In the example shown, the upper bandage 6305 may extend in an oblique direction toward the lower region of the patient's head (e.g., toward the occipital bone). The tension force may hold the catheters 6320 in the desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to hold the seal-forming structure 6100 in a sealed position.

[0693] In some forms, the positioning and stabilizing structure 6300 provides positioning and stabilizing forces F. PSS This positioning and stabilizing force helps hold the pad 6050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0694] exist Figure 44 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0695] For example, catheter headband 6319 can provide catheter force F.管 This is to ensure that the sealing structure 6100 is held on the patient's face. As described above, the catheter headband 6319 can be sized so that it fits snugly against the patient's head. The accordion-style segment 6328 can be extended to provide the necessary F 管 Pipe force F 管 It can point upwards and / or backwards.

[0696] F 管 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 6100 and the inflation chamber 6200, but gravity will act on the entire patient interface 6000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0697] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 6050 downwards (as shown in the image). Figure 44 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 6100). f This is to resist movement in the downward direction (which helps stabilize the 6050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 6050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 6300 and the patient interface 6000. g Conversely, friction can act at any point along the patient interface 6000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0698] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 6100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0699] In some forms, the sum of all forces can equal zero, so that the patient interface 6000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F gand blowing force F 充气室 The seal-forming structure 6100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 6100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 6100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 6000 is zero and the positioning and stabilizing force F... PSS When the strength is sufficiently high to achieve this, maximum patient comfort can be achieved. As described below, various positions of the patient's head when using the patient interface 6000 can determine the positioning and stabilizing force F required to achieve balance. PSS .

[0700] The magnitude of the force can vary depending on the position of use (e.g., when the patient sleeps in different positions). Figure 44-1 This shows the forces acting on the patient while they are lying on their back. In this position, gravity F... g Pointing towards the patient's face, friction force F f Pointing away from the patient's face. Therefore, gravity F g It can point to force F PSS In a similar direction. Therefore, gravity F g It can be independent of positioning and stabilizing force F PSS Conversely, this allows for a less tighter positioning and stabilization of the 6300 structure while maintaining the same sealing force (e.g., improving patient comfort).

[0701] Similarly, Figure 44-2 The forces acting on the patient when lying on their side are shown. In the example shown, gravity F... g Represented by an "x" inside a circle to indicate the force pointing towards the page. Gravity F g It can be basically perpendicular to the inflation chamber force F 充气室 and / or positioning and stabilizing force F PSS As mentioned above, the positioning and stabilizing force F PSS The gravitational force F must be counteracted g and inflation chamber force F 充气室 Furthermore, the inflation chamber 6200 and / or the catheter headband 6319 may tend to compress on the lower side and remain taut on the upper side. Frictional force F f It can still point to gravity F g The opposite direction (e.g., leaving the page).

[0702] In some forms, pipe traction can provide additional force on the system.Figures 44 to 44-2 In the tube-up configuration shown, tube drag may act on the upper region of the patient's head. Depending on the tube's orientation (e.g., the angular position of the rotating component), tube drag can assist in positioning and stabilizing the force F. PSS and / or counter-positioning and stabilizing force F PSS This can change as the position of the tube changes throughout the entire usage process.

[0703] 5.3.10.2.2 Full-face tube upward interface

[0704] like Figures 47 to 50 As shown, the patient can wear pad 6050 in a tube-down configuration with rigid arm 6340, four-point headband 6302, and four-point arm sleeve 6380. The same pad 6050 and four-point headband 6302 can be used in two full-face configurations (e.g., Figures 43-46 (and 47-50). In other words, the rigid arm 6340 can be interchanged with the conduit 6320 to form a tube-down configuration (i.e., the opposite of the tube-up configuration described above). The four-point arm sleeve 6380 can be used in place of the conduit sleeve 6350 to facilitate this interchangeability.

[0705] These components can be assembled as described above. For example, the four-point arm sleeve 6380 can be connected to the rigid arm 6340. The rigid arm 6340 (via arm connection structure 6504) can be used to connect the rigid arm 6340 to the pad 6050. The four-point arm sleeve 6380 provides a magnet 6386 for connection to the four-point headband 6302.

[0706] like Figure 47 and 48 As shown, the four-point headband 6302 can be connected at four separate locations to provide tension for holding the pad 6050 in a sealed position on the patient's head.

[0707] For example, the lower bandage 6304 (e.g., via magnetic member 6306) can be removably attached to the magnet 6386 of the four-point arm sleeve 6380. In use, each lower bandage 6304 can contact the patient's cheek (e.g., covering the masseter muscle). The lower bandage 6304 can also extend below the patient's ear.

[0708] Tension can be applied along the lower bandage 6304 toward the posterior region of the patient's head (e.g., toward the occipital bone). The tensile force can pull the pad 6050 into the patient's head. Specifically, tension can be applied at the magnet 6386 on the four-point arm sleeve 6380. Because the lower extension 6384 is made of a rigid or semi-rigid material, it can remain substantially fixed when tension is applied (e.g., due to wearing the four-point headband 6302 attached to the pad 6050).

[0709] In some configurations, when the rigid arm 6340 is connected, the magnet 6386 may be positioned close to the lower portion of the gasket 6050. This may result in tension acting specifically on the lower region of the gasket 6050. In other words, the tension provided by the lower strap 6304 keeps the first sealing structure 6101 in the sealed position. Of course, the tension from the lower strap 6304 may also help keep the second sealing structure 6102 in the sealed position.

[0710] Continue to refer to Figure 47 and 48 The rigid arm 6340 (e.g., within the lower segment 6390) can be positioned along the patient's cheek and can extend to a location above the patient's ear. For example, each rigid arm 6340 can extend along one side of the patient's head toward the coronal portion of the head. This allows each rigid arm 6340 to cover the sphenoid and / or temporal bones and extend toward the frontal and / or parietal bones. In some forms, the rigid arm 6340 can extend along a patient's facial path similar to that of the catheter 6320.

[0711] In these figures, the rigid arm 6340 can be covered by the four-point arm sleeve 6380, such that each rigid arm 6340 is positioned inside the four-point arm sleeve 6380. Therefore, the rigid arm 6340 is not visible and does not directly contact the patient.

[0712] The second sealing structure 6102 can contact the lower side of the patient's nose. For example, the second sealing structure 6102 can avoid contact with the patient's nasal ridge and can contact the patient's nose at or below the nasal protuberance and abut against the columella. The four-point arm sleeve 6380 and the rigid arm 6340 (e.g., disposed within the four-point arm sleeve 6380, such as...) Figures 29 to 33 The steps shown can provide additional tension in the upward and backward directions (e.g., as indicated by the steps). Figure 48 (As shown). In this way, the second sealing structure 6102 can be pulled upwards onto the underside of the patient's nose in a sealed position (e.g., due to a higher orientation force). The four-point arm sleeve 6380 and / or the rigid arm 6340 can also pull the pad 6050 into the patient's head to hold the pad 6050 in the sealed position (and help seal the first sealing structure 6101).

[0713] In some forms, the rigid arm 6340 may be generally non-extendable and may be configured to provide tension when worn by a patient. The four-point arm sleeve 6380 may also be at least partially non-extendable along its length (although it may be able to extend). The upper section 6392 of the four-point arm sleeve 6380 may be adjustable (e.g., by means of hook and loop material) to secure the four-point arm sleeve 6380 to the patient's head and generate tension.

[0714] The four-point arm sleeve 6380 may include a tab 6394 on the lower section 6390. For example... Figure 48 As shown, the upper bandage 6305 can be connected to the corresponding tab 6394. When the patient wears the four-point arm sleeve 6380, the tab 6394 can be positioned above the patient's ear (e.g., at approximately the same location as the tab 6324 of the catheter headband 6319). This allows the upper bandage 6305 connected to the tab 6394 to also be positioned above the patient's ear. For example, each tab 6394 can be positioned close to the temporal bone, and each upper bandage 6305 can cover the temporal bone and extend toward the occipital bone.

[0715] The upper bandage 6305 provides tension directed toward the back of the patient's head. In the example shown, the upper bandage 6305 may extend in an oblique direction toward the lower region of the patient's head (e.g., toward the occipital bone). This tension force may hold the four-point arm sleeves 6380 in the desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to hold the sealing formation 6100 in a sealed position.

[0716] In some forms, the positioning and stabilizing structure 6300 provides force F. PSS The F PSS This helps to hold the pad 6050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0717] exist Figure 48 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0718] For example, the four-point connecting sleeve 6380 can provide sleeve force F. 套筒 This is to hold the sealing structure 6100 on the patient's face. As described above, the size of the four-point connecting sleeve 6380 can be (and / or adjusted) to ensure a tight fit against the patient's head. Sleeve force F 套筒 It can point upwards and / or backwards.

[0719] Force F 套筒 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 6100 and the inflation chamber 6200, but gravity will act on the entire patient interface 6000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0720] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 6050 downwards (as shown in the image). Figure 48 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 6100). f This is to resist movement in the downward direction (which helps stabilize the 6050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 6050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 6300 and the patient interface 6000. g Conversely, friction can act at any point along the patient interface 6000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0721] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 6100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0722] In some forms, the sum of all forces can equal zero, so that the patient interface 6000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气室 The seal-forming structure 6100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 6100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 6100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 6000 is zero and the positioning and stabilizing force F... PSSWhen the strength is sufficiently high to achieve this, maximum patient comfort can be achieved. As described below, various positions of the patient's head when using the patient interface 6000 can determine the positioning and stabilizing force F required to achieve balance. PSS .

[0723] The magnitude of the force can vary depending on the position of use (e.g., when the patient sleeps in different positions). Figure 48-1 This shows the forces acting on the patient while they are lying on their back. In this position, gravity F... g Pointing towards the patient's face, friction force F f Pointing away from the patient's face. Therefore, gravity F g It can point to force F PSS In a similar direction. Therefore, gravity Fg may not be opposite to the positioning and stabilizing force FPSS, which allows the positioning and stabilizing structure 6300 to be less tight and maintain the same sealing force (e.g., improving patient comfort).

[0724] Similarly, Figure 48-2 The forces acting on the patient when lying on their side are shown. In the example shown, gravity F... g Represented by an "x" inside a circle to indicate the force pointing towards the page. Gravity F g It can be basically perpendicular to the inflation chamber force F 充气室 and / or positioning and stabilizing force F PSS As mentioned above, the positioning and stabilizing force F PSS The gravitational force F must be counteracted g and inflation chamber force F 充气室 Furthermore, the air chamber 6200 and / or the four-point connecting sleeve 6380 may tend to be compressed on the lower side and stretched on the upper side. Friction force F f It can still point to gravity F g The opposite direction (e.g., leaving the page).

[0725] In some forms, pipe traction can provide additional force on the system. Figures 48 to 48-2 In the downward-facing tube configuration shown, tube drag may act near the patient's nose and / or mouth. Depending on the tube's orientation (e.g., the angular position of the rotator), the tube drag can be related to gravity F. g Action and / or with frictional force F f Function. This can change as the position of the tube changes throughout its use.

[0726] 5.3.10.2.3 Nasal tube upward interface

[0727] exist Figures 51 to 54Patients can wear pad 7050 in the tube-up configuration with catheter headband 6319 and two-point headband 7302. The same catheter headband 6319 can be used with optional tube-up configurations. In other words, catheter headband 6319 can be interchanged between tube-up configurations (i.e., catheter headband 6319 can be attached to either pad 6050 or 7050). As mentioned above, this configuration can also be without a sleeve.

[0728] These components can be assembled as described above. For example, catheter 6320 (via catheter connection structure 6500) can be used to connect catheter headband 6319 to liner 7050. Nasal liner 7050 does not require catheter sleeve 6350 because a two-point headband 7302 is used. However, sleeve 7350 can be used to cover catheter 6320 and provide a comfortable material against the patient's head.

[0729] In other words, the interior of the sleeve 7350 can accommodate at least a portion of the catheter 6320. The patient cannot directly contact the portion of the catheter 6320 covered by the catheter sleeve 7350. Figures 51 to 52-2 As shown, a portion of the catheter headband 6319 is exposed and in contact with the patient, while another portion is covered by the sleeve 7350, such that the sleeve 7350, rather than the catheter headband 6319, contacts the patient at that location.

[0730] In some configurations, because the connection between the catheter headband 6319 and either liner is substantially the same, one liner (e.g., full-face liner 6050) can be interchanged with another liner (e.g., nasal liner 7050). This can be particularly useful in setups where components are shared between multiple patients. For example, the first patient can use the full-face liner 6050, and the second patient can use the nasal liner 7050. The same catheter headband 6319 can be interchanged between the two liners 6050 and 7050, thereby reducing the total number of configurations.

[0731] like Figure 51 and 52 As shown, the two-point headband 7302 can be connected in two separate positions to provide tension to hold the pad 7050 in a sealed position on the patient's head.

[0732] Continue to refer to the appendix Figure 51 and 52 The catheter 6320 can be positioned along the patient's cheek and can extend to a location above the patient's ear. For example, each catheter 6320 can extend along one side of the patient's head toward the coronal portion of the head. This allows each catheter 6320 to cover the sphenoid and / or temporal bones and extend toward the frontal and / or parietal bones.

[0733] The second sealing structure 6102 can contact the lower side of the patient's nose. For example, the sealing structure 7100 can avoid contact with the patient's nasal ridge and can contact the patient's nose at or below the nasal protuberance and abut against the columella. The catheter 6320 can provide additional tensile force in the upward and backward directions (e.g., as shown in the image). Figure 52 (As shown). In this way, the seal-forming structure 7100 can be pulled upwards onto the underside of the patient's nose in a sealed position (e.g., due to a higher orientation force). The catheter 6320 can also pull the pad 7050 into the patient's head to hold the pad 6050 in a sealed position (and help seal the first seal-forming structure 6101).

[0734] In some forms, the catheter 6320 may be generally non-extensible and may be configured to provide tension when worn by a patient. As described above, the length of the catheter 6320 may be less than the length of the patient's head, so that it provides tension when worn. Even when the accordion-shaped segment 6328 expands, the catheter 6320 can fit snugly against the patient's head, and the passage through the catheter 6320 can remain wide enough to allow for continuous airflow.

[0735] The catheter headband 6319 may include a tab 6324 on any catheter 6320. For example... Figure 52 As shown, the upper bandage 7305 can be connected to the corresponding tab 6324. When the catheter headband 6319 is worn by the patient, the tab 6324 can be positioned above the patient's ear. This allows the upper bandage 7305 connected to the tab 6324 to also be positioned above the patient's ear. For example, each tab 6324 can be positioned close to the temporal bone, and each upper bandage 7305 can cover the temporal bone and extend toward the occipital bone.

[0736] The upper bandage 7305 provides tension directed toward the back of the patient's head. In the example shown, the upper bandage 7305 may extend in an oblique direction toward the lower region of the patient's head (e.g., toward the occipital bone). The tension force may hold the catheters 6320 in the desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to hold the seal-forming structure 7100 in a sealed position.

[0737] In some configurations, the presence of a tab 6324 on the catheter 6320 allows for interchangeability between different headbands and the same catheter headband 6319. As described above, the upper strap 7305 of the two-point connection headband 7302 is connected to the tab 6324. When in use, the upper strap 6305 of the four-point connection headband 6302 is also connected to the tab 6324. This common connection point allows for interchangeability between the two types of headbands 6302 and 7302.

[0738] In some configurations, the positioning and stabilizing structure 6300 provides a force FPSS that helps hold the pad 7050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0739] exist Figure 52 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0740] For example, catheter headband 6319 can provide catheter force F. 管 This is to ensure that the sealing structure 7100 is held on the patient's face. As described above, the catheter headband 6319 can be sized so that it fits snugly against the patient's head. The accordion-style section 6328 can be extended to provide the necessary F 管 Pipe force F 管 It can point upwards and / or backwards.

[0741] F 管 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 7100 and the inflation chamber 7200, but gravity will act on the entire patient interface 7000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0742] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 7050 in the downward direction (e.g.) Figure 52 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 7100). f This is to resist movement in the downward direction (which helps stabilize the 7050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 7050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 7300 and the patient interface 7000. gConversely, friction can act at any point along the patient interface 7000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0743] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 7100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0744] In some forms, the sum of all forces can equal zero, so that the patient interface 6000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气室 The seal-forming structure 6100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 6100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 6100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 6000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. As described below, when using the patient interface 7000, the positioning and stabilizing force F required to achieve balance can be determined by various positions of the patient's head. PSS .

[0745] The magnitude of the force can vary depending on the position of use (e.g., when the patient sleeps in different positions). Figure 52-1 This shows the forces acting on the patient while they are lying on their back. In this position, gravity F... g Pointing towards the patient's face, friction force F f Pointing away from the patient's face. Therefore, gravity F g It can point to force F PSS In a similar direction. Therefore, gravity Fg may not be opposite to the positioning and stabilizing force FPSS, which allows the positioning and stabilizing structure 7300 to be less tight and maintain the same sealing force (e.g., improving patient comfort).

[0746] Similarly, Figure 52-2 The forces acting on the patient when lying on their side are shown. In the example shown, gravity F... gRepresented by an "x" inside a circle to indicate the force pointing towards the page. Gravity F g It can be basically perpendicular to the inflation chamber force F 充气室 and / or positioning and stabilizing force F PSS As mentioned above, the positioning and stabilizing force F PSS The gravitational force F must be counteracted g and inflation chamber force F 充气室 Furthermore, the inflation chamber 7200 and / or the catheter headband 6319 may tend to compress on the lower side and remain taut on the upper side. Frictional force F f It can still point to gravity F g The opposite direction (e.g., leaving the page).

[0747] In some forms, pipe traction can provide additional force on the system. Figures 52 to 52-2 In the tube-up configuration shown, tube drag may act on the upper region of the patient's head. Depending on the tube's orientation (e.g., the angular position of the rotating component), tube drag can assist in positioning and stabilizing the force F. PSS and / or counter-positioning and stabilizing force F PSS This can change as the position of the tube changes throughout the entire usage process.

[0748] 5.3.10.2.4 Nasal tube downward interface

[0749] like Figures 55 to 59 As shown, the patient can wear the pad 7050 in a tube-down configuration with a rigid arm 6340, a two-point headband 7302, and a two-point arm sleeve 6380-1. The same pad 7050 and two-point headband 7302 can be used in two nasal configurations (e.g., Figures 51 to 54 (and 55-58).

[0750] These components can be assembled as described above. For example, the two-point arm sleeve 6380-1 can be connected to the rigid arm 6340. The rigid arm 6340 (via arm connection structure 6504) can be used to connect the rigid arm 6340 to the gasket 7050.

[0751] like Figure 55 and 56 As shown, the two-point headband 7302 can be connected in two separate positions to provide tension for holding the pad 7050 in a sealed position on the patient's head.

[0752] Continue to refer to the appendix Figure 55 and 56The rigid arm 6340 (covered by the two-point arm sleeve 6380-1) can be positioned along the patient's cheek and can extend to a position above the patient's ear. For example, each rigid arm 6340 can extend along one side of the patient's head toward the coronal portion of the head. This allows each rigid arm 6340 to cover the sphenoid and / or temporal bones and extend toward the frontal and / or parietal bones. In some forms, the rigid arm 6340 can extend along a similar path to the patient's face as the catheter 6320.

[0753] In these figures, the rigid arm 6340 can be covered by the two-point arm sleeve 6380-1, such that each rigid arm 6340 is positioned inside the two-point arm sleeve 6380-1. Therefore, the rigid arm 6340 is not visible and does not directly contact the patient.

[0754] The sealing structure 7100 can contact the lower side of the patient's nose. For example, the sealing structure 7100 can avoid contact with the patient's nasal ridge and can contact the patient's nose at or below the nasal protuberance and abut against the columella. The two-point arm sleeve 6380-1 and the rigid arm 6340 can provide additional tension in the upward and backward directions (e.g., as shown in the image). Figure 56 (As shown). In this way, the sealing structure 7100 can be pulled upwards onto the underside of the patient's nose in the sealing position (e.g., due to a higher orientation force). The two-point arm sleeve 6380-1 and / or the rigid arm 6340 can also pull the pad 7050 into the patient's head to hold the pad 7050 in the sealing position.

[0755] In some forms, the rigid arm 6340 may be generally non-extendable and may be configured to provide tension when worn by a patient. The two-point arm sleeve 6380-1 may also be at least partially non-extendable along its length (although it may be able to extend). The upper section 6392-1 of the two-point arm sleeve 6380-1 may be adjustable (e.g., by means of hook and loop material) to secure the two-point arm sleeve 6380-1 to the patient's head and generate tension.

[0756] The two-point arm sleeve 6380-1 may include a tab 6394-1 located on the lower section 6390-1. For example... Figure 56 As shown, the upper bandage 7305 can be connected to the corresponding tab 6394-1. When the patient wears the two-point arm sleeve 6380-1, the tab 6394-1 can be positioned above the patient's ear (e.g., at approximately the same location as the tab 6324 of the catheter headband 6319). This allows the upper bandage 6305 connected to the tab 6394-1 to also be positioned above the patient's ear. For example, each tab 6394-1 can be positioned close to the temporal bone, and each upper bandage 6305 can cover the temporal bone and extend toward the occipital bone.

[0757] The upper bandage 6305 provides tension directed toward the back of the patient's head. In the example shown, the upper bandage 6305 may extend in an oblique direction toward the lower region of the patient's head (e.g., toward the occipital bone). This tension force may hold the four-point arm sleeves 6380 in the desired position (e.g., so that they do not slip past the patient's eyes) and / or provide additional force to hold the sealing formation 7100 in a sealed position.

[0758] In some configurations, the tabs 6394 and 6394-1 on the corresponding sleeves 6380 and 6380-1 can be positioned in approximately the same location on the patient's head. As described above, the upper strap 7305 of the two-point connecting headband 7302 is connected to the tab 6394-1. When in use, the upper strap 6305 of the four-point connecting headband 6302 is also connected to the tab 6394. The two types of sleeves 6380 and 6380-1 with similarly positioned tabs 6394 and 6394-1 facilitate the interchangeability of the four-point and two-point connecting headbands 6302 and 7302 with the same rigid arm 6340.

[0759] In some configurations, the positioning and stabilizing structure 6300 provides a force FPSS that helps hold the pad 6050 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various force vectors from different elements of the positioning and stabilizing structure 6300.

[0760] exist Figure 56 In the example shown, the patient is oriented in an upright position, therefore force F PSS It acts to counteract external forces acting in that direction. In other orientations of the patient, force F PSS The magnitude (and any other force) can change.

[0761] For example, the two-point connecting sleeve 6380-1 can provide sleeve force F. 套筒 This is to ensure that the sealing structure 7100 is held on the patient's face. As described above, the dimensions of the two-point connecting sleeve 6380-1 can be (and / or adjusted) to ensure a tight fit over the patient's head. Sleeve force F 套筒 It can point upwards and / or backwards.

[0762] Force F 套筒 It can also point at least partially upwards in order to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 7100 and the inflation chamber 7200, but gravity will act on the entire patient interface 7000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0763] Gravity F g It can be related to frictional force F f Conversely, friction can act in relation to gravity F. g In the opposite direction. When gravity pulls the pad 7050 in the downward direction (e.g.) Figure 56 (As shown in the diagram), frictional force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F above their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 7100). f This is to resist movement in the downward direction (which helps stabilize the 7050 pad in place). Despite the frictional force F f Specifically shown as the weight F of the pad 7050 g Conversely, however, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 7300 and the patient interface 7000. g Conversely, friction can act at any point along the patient interface 7000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0764] In addition, the headband straps can provide strap force F independently. 绑带 This is to hold the sealing structure 7100 on the patient's face. Each bandage can provide a different bandage force F based on the degree to which the individual bandage is tightened. 绑带 .

[0765] In some forms, the sum of all forces can equal zero, so that the patient interface 7000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气室 The seal-forming structure 7100 tends to move away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气室 (and any frictional force F) f And maintain the proper positioning of the sealing structure 7100. Despite the positioning and stabilizing force F PSS It may exceed the sum of other forces and still hold the seal-forming structure 7100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 7000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. As described below, when using the patient interface 7000, the positioning and stabilizing force F required to achieve balance can be determined by various positions of the patient's head.PSS .

[0766] The magnitude of the force can vary depending on the position of use (e.g., when the patient sleeps in different positions). Figure 56-1 This shows the forces acting on the patient while they are lying on their back. In this position, gravity F... g Pointing towards the patient's face, friction force F f Pointing away from the patient's face. Therefore, gravity F g It can point to force F PSS In a similar direction. Therefore, gravity F g It can be independent of positioning and stabilizing force F PSS Conversely, this allows for a less tighter positioning and stabilization of the 7300 structure while maintaining the same sealing force (e.g., improving patient comfort).

[0767] Similarly, Figure 56-2 The forces acting on the patient when lying on their side are shown. In the example shown, gravity F... g Represented by an "x" inside a circle to indicate the force pointing towards the page. Gravity F g It can be basically perpendicular to the inflation chamber force F 充气室 and / or positioning and stabilizing force F PSS As mentioned above, the positioning and stabilizing force F PSS The gravitational force F must be counteracted g and inflation chamber force F 充气室 Furthermore, the inflation chamber 7200 and / or the two-point connecting sleeve 6380-1 may tend to compress on the lower side and be in a stretched state on the upper side. Friction force F f It can still point to gravity F g The opposite direction (e.g., leaving the page).

[0768] In some forms, pipe traction can provide additional force on the system. Figures 48 to 48-2 In the downward-facing tube configuration shown, tube drag may act near the patient's nose and / or mouth. Depending on the tube's orientation (e.g., the angular position of the rotator), the tube drag can be related to gravity F. g Action and / or with frictional force F f Function. This can change as the position of the tube changes throughout its use.

[0769] 5.3.10.2.5 Component Module

[0770] Figure 59This illustrates how different components can be combined to form the four different patient interfaces described above. As shown, different parts can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because a large number of the same parts can be produced and used in multiple styles. The only part not used in multiple styles could be a sleeve. However, sleeves are easier to manufacture.

[0771] 5.4RPT device

[0772] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0773] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0774] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0775] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as pressure sensors and flow sensors.

[0776] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0777] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0778] 5.4.1 Mechanical and pneumatic components of the RPT device

[0779] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0780] 5.4.1.1 Air Filter

[0781] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0782] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0783] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0784] 5.4.1.2 Muffler

[0785] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0786] In one embodiment of this technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0787] In one embodiment of this technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0788] 5.4.1.3 Pressure Generator

[0789] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cm H2O to about 20 cm H2O, or in other forms up to about 30 cm H2O, for example, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,14; U.S. Patent No. 8,636,479; and PCT Patent Application WO 2013 / 020167.

[0790] The pressure generator 4140 can be controlled by the treatment device controller 4240.

[0791] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0792] 5.4.1.4 Transducer

[0793] The transducer can be inside or outside the RPT device. An external transducer can be located, for example, on or form part of an air circuit such as a patient interface. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0794] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate a signal representing airflow characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0795] In one form of this technology, one or more converters 4270 may be positioned proximal to the patient interface 3000.

[0796] In one embodiment, the signal from transducer 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0797] 5.4.1.5 Anti-overflow valve

[0798] In one embodiment of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the electric motor 4144.

[0799] 5.4.2 RPT Device Algorithm

[0800] As described above, in some forms of this technology, the central controller can be configured to implement one or more algorithms represented as computer programs stored in a non-transient computer-readable storage medium (such as memory). Algorithms are generally grouped into groups called modules.

[0801] 5.5 Air Circuit

[0802] According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000.

[0803] like Figure 42 As shown, the air circuit 4170 can be a flexible hose capable of delivering a pressurized airflow. The air circuit 4170 can be directly connected to the inflation chambers 6200, 7200 (e.g., in the corresponding ventilation openings 6402, 7402). In this configuration (i.e., "tube-down"), the patient interfaces 6000, 7000 may not include the ventilation port 6400. Alternatively, the hose of the air circuit 4170 may include a ventilation port.

[0804] Air circuit 4170 can also be used in a tube-up configuration and can be connected to inlet 6332.

[0805] 5.6 Humidifier

[0806] 5.6.1 Overview of Humidifiers

[0807] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0808] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0809] 5.6.2 Humidifier Components

[0810] 5.6.2.1 Water Storage Tank

[0811] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0812] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0813] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0814] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any hole and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0815] 5.6.2.2 Conducting Part

[0816] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0817] 5.6.2.3 Humidifier reservoir dock

[0818] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown), it is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0819] 5.6.2.4 Water level indicator

[0820] The humidifier storage unit 5110 may include, for example: Figures 5A to 5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0821] 5.6.2.5 Heating element

[0822] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0823] In some configurations, the heating element 5240 may be housed within the humidifier base 5006, such as... Figure 5B The heat shown can be supplied to the humidifier reservoir 5110 mainly through conduction.

[0824] 5.7 Respiratory waveform

[0825] Figure 6 The diagram shows a typical respiratory waveform of a sleeping human. The horizontal axis represents time, and the vertical axis represents respiratory flow. Parameter values ​​can vary, but a typical breath may have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow Qpeak -0.5 L / s. The total duration of respiration, Ttot, is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM) with a ventilation rate of approximately 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0826] 5.8 Terminology

[0827] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0828] 5.8.1 General Rules

[0829] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0830] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0831] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0832] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0833] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0834] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0835] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0836] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0837] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the air flow rate leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the air flow rate leaving the ventilator to allow flushing of exhaled air. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the air flow rate received into the patient's respiratory system.

[0838] Flow therapy: Breathing therapy, which involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0839] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0840] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one instance, a leak could occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a bend in the swivel tube leading to the surrounding environment.

[0841] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, 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.

[0842] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered 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 under discussion according to ISO 3744.

[0843] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as a ventilation opening for a patient interface).

[0844] Patient: A person, regardless of whether they have a respiratory illness.

[0845] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cm H2O.

[0846] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0847] Respiratory pressure therapy: Applying air supply to the airway inlet at a typical therapeutic pressure that is positive relative to the atmosphere.

[0848] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0849] 5.8.1.1 Materials and their properties

[0850] Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the product range sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45.

[0851] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0852] 5.8.1.2 Mechanics

[0853] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0854] Stiffness: The ability of a structure or component to resist deformation in response to an applied load. A structure or component can have axial stiffness, bending stiffness, and torsional stiffness. A structure or component is considered rigid when it is not easily deformed under mechanical forces. The stiffness of a structure or component is related to its material properties and its shape. The reciprocal of stiffness is flexibility.

[0855] Elasticity: The ability of a material to return to its original geometry after deformation.

[0856] Viscosity: The ability of a material to resist flow.

[0857] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0858] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0859] 5.8.1.3 Structural Components

[0860] Beam: A beam is generally considered to be a relatively long element in one direction.

[0861] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0862] Membrane: A membrane is generally considered to refer to a typically thin element that preferably has essentially no bending resistance but has tensile resistance. It may also have compressive resistance. A membrane can be relatively long in two dimensions and thin in one dimension.

[0863] Plate: A plate is considered to be relatively long in two dimensions and thin in one dimension. Plates have bending, tensile, and compressive stiffness.

[0864] Load-transferring member: A structural member that transfers loads from one location to another.

[0865] Load-bearing member: A structural member that transfers loads from one location to a non-structural item (e.g., a surface).

[0866] Tension member: A structural element that bears tension.

[0867] Lacing (noun): A structure designed to resist tension.

[0868] Compression components: Structural elements that withstand pressure.

[0869] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0870] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0871] Elbow: An elbow is an example of a structure that guides the axis of an airflow traveling through it to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, about 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0872] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0873] Sealing: can be the noun form of a structure (sealant) or the verb form of the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0874] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotating shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotating shaft.

[0875] 5.8.2 Respiratory cycle

[0876] Apnea: According to some definitions, apnea is considered to occur when the flow rate 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 prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0877] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0878] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0879] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0880] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0881] Hyperventilation: Increased airflow to above normal levels.

[0882] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0883] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0884] Peak flow (Q peak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0885] Respiratory flow, patient air flow, and respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0886] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (volume of air inhaled) equals the expiratory volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0887] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0888] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0889] (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 a subsequent respiratory flow waveform.

[0890] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0891] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0892] Ventilation: A measurement of the flow rate of gases exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0893] 5.8.3 Anatomy

[0894] 5.8.3.1 Facial Anatomy

[0895] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0896] Alar tip: the outermost point on the ala of the nose.

[0897] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0898] Auricle: The entire visible external part of the ear.

[0899] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0900] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0901] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0902] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0903] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0904] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0905] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0906] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0907] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0908] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0909] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0910] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0911] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0912] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0913] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0914] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0915] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0916] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into the right and left halves.

[0917] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0918] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0919] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0920] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0921] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.

[0922] 5.8.3.2 Anatomical Structure of the Skull

[0923] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0924] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0925] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0926] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0927] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0928] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0929] The eye socket is the bony cavity in the skull that houses the eyeball.

[0930] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0931] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0932] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0933] 5.8.3.3 Anatomical Structure of the Respiratory System

[0934] Diaphragm: A muscular plate that extends across the bottom of the ribcage. 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.

[0935] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0936] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0937] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal chambers is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0938] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is routinely divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0939] 5.8.4 Patient Interface

[0940] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0941] Headband: A headband will be understood as a form of positioning and stabilization structure designed to hold devices such as face masks on the head.

[0942] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0943] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0944] 5.8.5 Shape of the structure

[0945] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. 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 seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0946] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. See alsoFigures 3B to 3F They show examples of cross-sections at point p on the surface and the resulting planar curves. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is depicted from the viewpoint of an imaginary little person standing upright on the surface.

[0947] 5.8.5.1 Curvature in one dimension

[0948] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0949] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if you imagine little figures leaving point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave.

[0950] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0951] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are usually called convex.

[0952] 5.8.5.2 Curvature of Two-Dimensional Surfaces

[0953] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross sections at a specific point.

[0954] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross section in the principal direction. The principal curvature at P is the curvature in the principal direction.

[0955] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0956] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0957] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0958] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0959] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0960] Surface edge: The boundary or limit of a surface or region.

[0961] Path: In some forms of this technique, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0962] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0963] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0964] 5.8.5.3 Space Curves

[0965] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0966] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0967] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0968] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0969] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Appendix. Figure 3O and 3P .

[0970] Twist of a space curve: The twist of a space curve at a point is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero twist. A space curve deviating relatively small from the osculating plane will have a relatively small amount of twist (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of twist (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3S The amount of twist of the bottom coil of the spiral.

[0971] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0972] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral)....

Claims

1. A pad configured to seal a portion of a patient's face around the entrance of a patient's airway, said pad comprising: The liner includes at least one first opening and at least one second opening, one of which is configured to receive a pressurized airflow, and the other of which is configured to receive a connecting structure that acts as a plug to restrict the entry and / or exit of pressurized air from the inflation chamber of the liner. The liner is characterized by a rigid arm extending from the connecting structure, the rigid arm being configured to help hold the liner in an operating position.

2. The gasket according to claim 1, wherein, A first plug is removably received in at least one first opening, and a second plug is removably received in at least one second opening.

3. The gasket according to claim 2, wherein, The first plug is different from the second plug.

4. The gasket according to claim 1, wherein, The at least one first opening includes a pair of first openings, and when the at least one second opening is configured to receive pressurized airflow, a pair of first plugs are removably received within the pair of first openings.

5. The gasket according to any one of claims 2 to 4, wherein, The first plug is connected to the elongated member.

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