Full-face patient interface

Abstract

A patient interface includes a plenum chamber, a first seal-forming structure for forming a seal around the patient's mouth, and a second seal-forming structure for forming a seal around the patient's nares. The patient interface further includes at least one stop rib disposed in a cavity of the plenum chamber, spaced apart from the first seal-forming structure in a rest position. The first seal-forming structure is configured to contact the at least one stop rib in an operating position. The at least one stop rib is configured to resist compression of the first seal-forming structure in an anterior direction. The second seal-forming structure is not configured to contact the at least one stop rib.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of SG Provisional Patent Application No. 10202105065S, filed on May 14, 2021, and SG Provisional Patent Application No. 10202102386Q, filed on March 9, 2021, each of which is incorporated herein by reference in its entirety.

[0003] International application PCT / AU2020 / 050953, filed September 9, 2020, claims priority to U.S. Provisional Patent Application No. 63 / 058,001, filed July 29, 2020, both of which are incorporated herein by reference in their entirety. Technical Field

[0004] This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Technology

[0005] Human respiratory system and its disorders

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0007] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood, while carbon dioxide moves in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones. See John B. West, *Respiratory Physiology*, Lippincott Williams & Wilkins, 9th edition, published in 2012.

[0008] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0009] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related malventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events of upper airway closure or obstruction during sleep. It is caused by a combination of abnormally small loss of upper airway and normal muscle tone in the tongue, soft palate, and posterior oropharyngeal wall regions during sleep. This condition causes affected patients to stop breathing, typically for 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can potentially cause cardiovascular disease and brain damage. This syndrome is a common disorder, especially among middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system characterized by rhythmic alternating cycles of increased and decreased ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated awakenings from sleep, which can lead to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders.

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

[0014] Obesity-induced malventilation syndrome (OHS) is defined as a combination of severe obesity and waking chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased resistance to air movement, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: shortness of breath upon exertion, chronic cough, and sputum production.

[0016] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, difficulty breathing at exertion and rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood changes.

[0017] Chest wall disorders are a group of chest deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies have many drawbacks.

[0019] therapy

[0020] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0021] Respiratory pressure therapy

[0022] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that CPAP acts as a pneumatic splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to the therapy if they find one or more of the following to be true: uncomfortable, difficult to use, expensive, or unsightly.

[0024] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of their breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0025] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] Flow therapy

[0027] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed volume of air by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one instance, high-flow-rate therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high-flow-rate air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead zone. Therefore, HFT is sometimes referred to as dead-space therapy (DST). Other benefits may include increased warmth and humidity (which may be beneficial for secretion management) and the possibility of moderately increasing airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0028] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched gas into the patient's airway at a specified oxygen concentration (21% to 100% of the oxygen fraction in ambient air) and at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0029] Replenish oxygen

[0030] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0031] Respiratory therapy system

[0032] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0033] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0034] Another form of therapeutic system is the mandibular repositioning device.

[0035] Patient Interface

[0036] Patient interfaces are used to connect breathing equipment to their wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to deliver gas at a pressure sufficiently different from ambient pressure to achieve the therapy, such as a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of about 10 cmH2O to the airway. For flow-through therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0037] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but cannot maintain internal air at a pressure higher than ambient pressure.

[0038] Certain masks may be clinically disadvantageous for this technology, such as those that block airflow through the nose and only allow airflow through the mouth.

[0039] If some masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, then for this technology, these masks may be uncomfortable or impractical.

[0040] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0041] The design of patient interfaces presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy.

[0042] Due to these challenges, some masks present one or more problems: they are obtrusive, unsightly, expensive, poorly fitted, difficult to use, and uncomfortable, especially when worn for extended periods or when patients are unfamiliar with a system. Incorrectly sized masks can lead to decreased adherence, reduced comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics may be acceptable for their original application, but prolonged wear (e.g., for several hours) can be uncomfortable. This discomfort can lead to decreased patient adherence to treatment. This is especially true if the mask is worn during sleep.

[0043] CPAP therapy is very effective in treating certain breathing disorders, provided the patient adheres to the therapy. Patients may not adhere to the therapy 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.

[0044] 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.

[0045] For these reasons, a unique field has emerged for patient interfaces used to deliver CPAP during sleep.

[0046] Sealing Formation Structure

[0047] 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.

[0048] 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 named by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal puffs, and oronasal masks.

[0049] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​the patient's face may not be suitable for use in another area. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0050] Certain seal-forming structures can be designed for mass production, allowing a single design to conform to a wide variety of facial shapes and sizes while remaining comfortable and effective. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0051] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface, wherein the seal-forming structure engages face-to-face with the patient's face. The seal-forming structure may include an air- or fluid-filled liner, or a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist 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.

[0052] Another type of seal-forming structure comprises a sheet-like seal of thin material located near the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, causing leakage.

[0053] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these elements uncomfortable.

[0054] Another form of sealing structure can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0055] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0056] One form of nose pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nose pillow or nose pad is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0057] ResMed Ltd. manufactures the following products that incorporate a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (particularly describing ResMed Ltd.'s SWIFT...) TM (Various aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (particularly describing ResMed Inc.'s SWIFT) TM (various aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (particularly describing ResMed Ltd. MIRAGE LIBERTY) TM(All aspects of the full-face mask); International Patent Application WO2009 / 052,560 (particularly describing ResMed Ltd.'s SWIFT) TM (Various aspects of the FX nose pillow).

[0058] Positioning and stability

[0059] The sealing structure of the patient interface used in positive pressure therapy is subject to corresponding pneumatic forces, which can disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a tight seal with the appropriate parts of the face.

[0060] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0061] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems such as ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0062] Respiratory Pressure Therapy (RPT) device

[0063] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0064] air circuit

[0065] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system (such as the RPT device and the patient interface) during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for both inhalation and exhalation.

[0066] humidifier

[0067] Delivering an unhumidified airflow can lead to airway dryness. Humidifiers with an RPT device and patient interface generate humidified air, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in cooler climates, warm air applied to the area inside and around the patient interface on the face is generally more comfortable than cold air. Therefore, humidifiers typically have the function of both heating and humidifying the airflow.

[0068] oxygen source

[0069] Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, including slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the necessity of mobility has long been recognized. Until recently, this mobility was achieved through the use of small compressed oxygen cylinders or tanks mounted on trolleys with wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0070] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making them difficult and impractical for ordinary walking activities. Recently, companies that manufacture large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices small and portable, the various systems required to produce oxygen-enriched gas are compressed. POCs aim to utilize the oxygen they produce as efficiently as possible, minimizing weight, size, and power consumption. This is achieved by delivering oxygen in a series of pulses or “boli”, each bolus occurring at the time of the start of inspiration. This mode of therapy is called pulsed or on-demand (oxygen) delivery (POD), in contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators.

[0071] Data Management

[0072] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy is “adherent,” such as the patient having used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is that a patient must use the RPT device for at least four hours nightly for at least 21 days out of a 30-day period to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, may manually obtain data describing the therapy used by patients using the RPT device, calculate usage over a predetermined time period, and compare it to the adherence rules. Once a healthcare provider has determined that a patient has used their RPT device according to the adherence rules, the healthcare provider can notify a third party that the patient is adherent.

[0073] Transmitting therapy data to third-party or external systems may benefit other aspects of the patient's therapy.

[0074] Existing processes for communicating and managing such data may be costly, time-consuming, and error-prone.

[0075] Mandibular repositioning

[0076] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in an forward position during sleep. The MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, the MRD is not designed to be worn all the time. The MRD can be custom-made or manufactured in a standard form and includes an occlusal impression portion designed to allow for a close fit to the patient's teeth. This mechanical protrusion of the jaw widens the space behind the tongue, applies tension to the pharyngeal walls to reduce airway collapse, and reduces hard palate vibration.

[0077] In some instances, a mandibular advancement device may include an upper splint for engaging or fitting with teeth on the maxilla or mandible and a lower splint for engaging or fitting with teeth on the maxilla or mandible. The upper and lower splints are laterally connected together via a pair of links. These links are symmetrically fixed to the upper and lower splints.

[0078] In this design, the length of the link is chosen so that the mandible remains in an anteriorly positioned position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will determine the length of the link.

[0079] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as ResMed Narval CC) TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0080] Ventilation technology

[0081] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., to the surrounding environment).

[0082] Ventilation ports may include openings through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by noise or concentrated airflow.

[0083] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0084] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0085]

[0086] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0087] The sound pressure levels of various objects are listed below.

[0088]

[0089] Screening, diagnosis and monitoring systems

[0090] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and its application typically involves a clinical specialist. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). For sleep-disordered breathing, PSG involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0091] Screening and diagnosis typically describe identifying a condition from its signs and symptoms. Screening usually yields a true / false result, indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis may provide clinically actionable information. Screening and diagnosis are often one-off processes, while monitoring of condition progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0092] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may not be available or may not be able to afford them. Different clinicians may have different opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0093] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more improvements in comfort, cost, efficacy, ease of use, and manufacturability.

[0094] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0095] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0096] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0097] One form of this technology includes a patient interface, which includes:

[0098] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0099] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0100] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0101] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0102] The patient interface also includes:

[0103] A pair of support portions are disposed on opposite sides of the interface between the second sealing structure and the front wall of the inflation chamber, wherein the support portions are configured to resist compression in the longitudinal direction.

[0104] In the embodiment:

[0105] a) The support portion is connected to the portion of the second sealing structure, which fits snugly against the patient's upper lip during use;

[0106] b) The support portion is connected to the portion of the second sealing structure, which seals against the patient's upper lip directly below the lower corner of the patient's nose during use;

[0107] c) When viewed in a cross-section parallel to the sagittal plane, the supporting portion appears curved;

[0108] d) When viewed in a cross-section parallel to the anterior sagittal plane, the supporting portion is curved;

[0109] e) The inflation chamber includes an oral cavity portion and a nasal cavity portion;

[0110] f) Each support portion connects to the oral portion of the inflatable chamber at the boundary between the transverse sidewall portion of the oral portion and the transverse sidewall portion of the nasal portion.

[0111] g) Each support portion connects to the oral portion of the shell at the boundary between the anterior wall portion of the oral cavity portion and the anterior wall portion of the nasal cavity portion;

[0112] h) The transverse sidewall portions of the inflatable chamber curve inward at the boundary adjacent to the nasal cavity portion, wherein each support portion is substantially adjacent to the adjacent transverse sidewall portion.

[0113] i) The second sealing structure includes at least one nostril, the at least one nostril being configured to deliver an airflow under the treatment pressure to the inlet of the patient's nostril, wherein, in use, no part of any support portion is directly below the nostril or each nostril.

[0114] j) The interface also includes a positioning and stabilizing structure configured to generate forces to hold the seal-forming structure in a therapeutically effective position on the patient’s head;

[0115] k) The air chamber is at least partially formed by the shell, and the ventilation structure is provided on the shell; and / or

[0116] l) The support portion is connected to the second sealing structure and to the front wall of the inflation chamber.

[0117] Another form of this technology includes a patient interface, which includes:

[0118] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0119] A first sealing structure is connected to the oral portion of the inflatable chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's oral cavity, such that an airflow under the therapeutic pressure is delivered to the oral cavity. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0120] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with a region of the patient's face surrounding the nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0121] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0122] in

[0123] The first anterior wall portion of the nasal cavity of the air chamber is adjacent to the boundary of the oral cavity portion of the air chamber and is more flexible than the adjacent area of ​​the oral cavity portion of the air chamber. The second anterior wall portion of the nasal cavity portion of the air chamber is adjacent to the first anterior wall portion and is located on the side of the first anterior wall portion opposite to the boundary of the oral cavity portion of the air chamber, and its flexibility is less than that of the adjacent anterior wall portion.

[0124] In the example:

[0125] a) The first anterior wall portion is thinner than the adjacent portion of the inflation chamber wall;

[0126] b) The second front wall portion is thicker than the adjacent portion of the inflation chamber wall;

[0127] c) The first front wall portion and the second front wall portion are made of the same material;

[0128] d) The first anterior wall portion extends substantially across the entire width of the nasal cavity portion that passes through the inflation chamber;

[0129] e) The second anterior wall portion extends through at least a majority of the width of the nasal portion of the inflatable chamber;

[0130] f) The first front wall portion extends upward around at least one lateral edge of the second front wall portion;

[0131] g) The second anterior wall portion extends substantially across the entire width of the nasal cavity portion that passes through the inflation chamber;

[0132] h) The central portion of the first front wall extends further in the upward direction than the transverse portion of the first front wall;

[0133] i) The upper boundary of the first anterior wall portion is curved;

[0134] i) The lower boundary of the first anterior wall portion is curved;

[0135] k) The air chamber is at least partially formed by the shell, and the ventilation structure is provided on the shell;

[0136] l) The second anterior wall portion includes a strip that extends through the first anterior wall portion and is configured to extend toward the patient through the inflation chamber;

[0137] m) The transition between the first and second front wall portions inside the inflation chamber is a substantially stepped surface;

[0138] m) The transition between the first and second front wall portions of the inflatable chamber is a substantially smooth surface; and / or

[0139] o) In use, the first front wall portion extends higher than at least a portion of the strip.

[0140] Another form of this technology includes a patient interface, which includes:

[0141] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0142] A first sealing structure is connected to the oral portion of the inflatable chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's oral cavity, such that an airflow under the therapeutic pressure is delivered to the oral cavity. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0143] A second sealing structure is connected to the nasal portion of the inflatable chamber. The second sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nose, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0144] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0145] in

[0146] The rear surface of the lateral portion of the second sealing structure slopes upward in the forward direction from the boundary between the first sealing structure and the second sealing structure.

[0147] In the example:

[0148] a) The bevel of each horizontal section forms an angle between 20 and 90 degrees with the middle contact plane of the mask;

[0149] b) During use, no part of the patient interface will come into contact with the tip of the patient's nose.

[0150] c) The interface is configured to prevent nasal obstruction, or at least reduce obstruction compared to prior art interfaces; and / or

[0151] d) The air chamber is at least partially formed by the shell, and the ventilation structure is located on the shell.

[0152] Another form of this technology includes a patient interface, which includes:

[0153] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0154] A first sealing structure is connected to the oral portion of the inflatable chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's oral cavity, such that an airflow under the therapeutic pressure is delivered to the oral cavity. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0155] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with a region of the patient's face surrounding the nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0156] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0157] in

[0158] The boundary between the first sealing structure and the second sealing structure includes a ridge.

[0159] In the example:

[0160] a) The radius of curvature of the spine is less than 2 mm;

[0161] b) The ridge extends substantially through the entire boundary between the first sealing structure and the second sealing structure;

[0162] c) During use, the spine joins the patient's face near the nostril entrance, and at the nostril entrance, the nasal wings join the face above the upper lip.

[0163] d) The ridge prevents creases from forming in the first and / or second sealing structures adjacent to the ridge; and / or

[0164] e) In use, the air chamber is at least partially formed by the shell, and the ventilation structure is located on the shell.

[0165] Another form of this technology includes a patient interface, which includes:

[0166] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0167] A first sealing structure is connected to the oral portion of the inflatable chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's oral cavity, such that an airflow under the therapeutic pressure is delivered to the oral cavity. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0168] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with a region of the patient's face surrounding the nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0169] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0170] in,

[0171] At least a portion of the oral cavity of the air chamber includes a flexible shell, wherein the flexible shell is formed of a material with a Young's modulus of less than 0.4 GPa.

[0172] In the example:

[0173] a) The flexible shell is formed of a material with a Young's modulus of less than 0.1 GPa, preferably between 0.3 and 0.7 MPa.

[0174] b) At least one component is connected to the flexible shell, wherein at least one component is more rigid than a portion of the flexible shell adjacent to that component;

[0175] c) At least one component includes one or more of the following: a ventilation module; a hood connector; a hood connector connected to a rigid arm; a rigid member; a less flexible shell portion;

[0176] d) At least one component is releasably connected to the flexible shell;

[0177] e) At least one component is permanently connected to the flexible shell;

[0178] f) At least one component is overmolded into the flexible shell;

[0179] g) The flexible shell includes a reinforcing portion whose thickness is greater than that of the adjacent portion of the flexible shell;

[0180] h) At least one component is configured as a reinforcing rib or reinforcing strip;

[0181] i) The central portion of the oral cavity section of the air chamber has greater rigidity than the rest of the air chamber; and / or

[0182] j) The air chamber is at least partially formed by the shell, and the ventilation structure is located on the shell.

[0183] Another form of the technology includes a frame configured to be coupled to an inflation chamber, the frame including a central portion coupled to the outside of the cavity to the inflation chamber and a plurality of connectors including a pair of upper connectors and a pair of lower connectors, the pair of lower connectors being flush with the central portion and the pair of upper connectors being configured to extend away from the central portion in a rearward direction through the inflation chamber.

[0184] In the example:

[0185] a) Each of the upper connectors in the pair includes a slot configured to receive a headband;

[0186] b) Each slot includes a protrusion near the corresponding arm;

[0187] c) Each protrusion has a curved shape;

[0188] d) Each upper connector includes a rib near the center portion;

[0189] e) The combined width of the ribs and arms near the center is approximately equal to the width of the arms near the slot;

[0190] f) Each of the lower connectors in the pair includes a magnet;

[0191] g) Each of the lower connectors in the pair includes a groove configured to act as a hinge and allow each lower connector to bend relative to the central portion.

[0192] Another form of the technology includes a frame configured to be coupled to an inflation chamber, the frame including a central portion coupled to the inflation chamber from the outside of the cavity and a pair of arms that are configured to extend in a rearward direction away from the central portion through the inflation chamber and are more flexible than the central portion.

[0193] In the example:

[0194] a) Each arm in the pair of arms is more flexible than the frame;

[0195] b) The central portion is thicker than each of the arms in the pair;

[0196] c) The central portion and each of the arms in the pair are constructed of the same material;

[0197] d) Each of the arms in the pair includes a first connection point, and the headgear strap is connected to the first connection point of each arm;

[0198] e) The first connection point is a loop, and the headband is connected to the loop such that the band is perpendicular to the edge of each loop and applies a force vector perpendicular to the edge;

[0199] f) The first connection point is a loop and includes a region of reduced thickness, which the headband can contact;

[0200] g) A first magnet is overmolded onto the central portion of the frame, and the headband includes a second magnet removably connected to the first magnet;

[0201] h) The first magnet includes a shell that at least partially encapsulates a magnetic material, the shell including a planar surface and a lip extending from the planar surface;

[0202] i) The overhang is spaced apart from the second magnet and is configured to engage the lip when the second magnet is attached to a magnetic material;

[0203] j) The central portion is configured to be positioned within a recess in the inflation chamber;

[0204] k) The central portion is removably positioned within the groove;

[0205] l) The groove includes a protrusion, and the central portion includes a complementary slot configured to receive the protrusion;

[0206] m) The slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to receive through the wider opening before the narrower opening;

[0207] n) The sleeve covers at least a portion of one of the arms in the pair;

[0208] o) The slot has a raised portion having a curvature configured to conform to the curvature of the sleeve; and / or

[0209] p) Each of the arms includes a rib near the center portion, which is configured to fix the sleeve.

[0210] Another form of this technology includes a patient interface, which includes:

[0211] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0212] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0213] A second sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s nasal inlet, such that an airflow under the treatment pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0214] A ventilation structure that allows exhaled air from the patient to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain therapeutic pressure within the inflation chamber during use; and

[0215] A positioning and stabilizing structure configured to maintain a first sealing formation structure and a second sealing formation structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0216] A frame connected to the inflation chamber, the frame comprising:

[0217] The central portion, which is connected to the inflation chamber outside the cavity, and

[0218] A pair of arms extending rearwardly away from the central portion through a second sealing structure, the pair of arms being more flexible than the central portion; and

[0219] The headband, which is attached to the frame, is configured to provide tension to the first sealing structure and the second sealing structure via the frame, allowing it to enter the patient's face.

[0220] In the example:

[0221] a) Each arm in the pair of arms is more flexible than the frame;

[0222] b) The central portion is thicker than each of the arms in the pair;

[0223] c) The central portion and each of the arms in the pair are constructed of the same material;

[0224] d) Each of the arms in the pair includes a first connection point, and the headgear strap is connected to the first connection point of each arm;

[0225] e) The first connection point is a loop, and the headband is connected to the loop such that the band is perpendicular to the edge of each loop and applies a force vector perpendicular to the edge;

[0226] f) The first connection point is a loop and includes a region of reduced thickness, which the headband can contact;

[0227] g) A first magnet is overmolded onto the central portion of the frame, and the headband includes a second magnet removably connected to the first magnet;

[0228] h) The first magnet includes a shell that at least partially encapsulates a magnetic material, the shell including a planar surface and a lip extending from the planar surface;

[0229] i) The overhang is spaced apart from the second magnet and is configured to engage the lip when the second magnet is attached to a magnetic material;

[0230] j) The inflation chamber includes a groove, with the central portion positioned within the groove;

[0231] k) The central portion is removably positioned within the groove;

[0232] l) The groove includes a protrusion, and the central portion includes a complementary slot configured to receive the protrusion;

[0233] m) The slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to receive through the wider opening before the narrower opening;

[0234] n) The protrusion includes a hanging portion configured to extend over the slot and retain the frame relative to the inflation chamber;

[0235] o) The inflation chamber includes a protrusion disposed adjacent to the recess, the protrusion being configured to retain the central portion within the recess;

[0236] p) The outer surface of the central portion is flush with the outer surface of the inflation chamber, and the outer surfaces of the central portion and the inflation chamber are configured to be away from the patient during use;

[0237] q) The central part includes an annular shape, with the inlet port of the inflation chamber radially located within the central part, and the frame connected to the inflation chamber;

[0238] r) The inlet port of the inflation chamber is configured to receive a bend that is spaced apart from the central portion when received within the inlet port of the inflation chamber.

[0239] s) Each arm is formed as a cantilever structure relative to the central portion;

[0240] t) The thickness of each arm decreases from the fixed end to the free end;

[0241] u) The arm includes a fan-shaped area on its inner surface, which is configured to face the patient's skin;

[0242] v) Each arm may pivot about a pivot point relative to the central portion; and / or

[0243] w) The pivot point is the movable hinge.

[0244] Another form of this technology includes a patient interface, which includes:

[0245] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0246] A sealing structure is configured and arranged to form a seal with an area of ​​the patient's face, allowing airflow at the therapeutic pressure to be delivered to the airway. This sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0247] Positioning and stabilizing structures are configured to maintain the seal-forming structure in the effective therapeutic position.

[0248] Another aspect of this technology is a more compact and less obtrusive mouth-nose patient interface.

[0249] Another aspect of this technology is a mouth-nose patient interface having a nasal pad portion that provides an improved fit to the lower corner of the nose.

[0250] Another aspect of this technology is a mouth-nose patient interface that reduces obstructive contact on the nose.

[0251] Another aspect of this technology is a mouth-nose patient interface that can self-adjust to accommodate patients with various nasal wing angles.

[0252] Another aspect of this technology is a mouth-nose patient interface with a relatively flexible shell.

[0253] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0254] Another form of this technology includes a patient interface, which includes:

[0255] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0256] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0257] A second sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s nasal inlet, such that an airflow under the treatment pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0258] A ventilation structure that allows exhaled air from the patient to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain therapeutic pressure within the inflation chamber during use; and

[0259] A positioning and stabilizing structure configured to maintain a first sealing formation structure and a second sealing formation structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0260] A headband configured to provide tension via a frame to a first sealing structure and a second sealing structure into the patient's face, wherein the headband includes a first width and a second width greater than the first width; and

[0261] The headband selectively passes through the opening to adjust the tension, a first width is configured to fit through the opening, and a second width is configured to prevent it from passing through the opening.

[0262] Another form of this technology includes a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective location, the positioning and stabilizing structure comprising:

[0263] A headband configured to provide tension via a frame to a sealing structure for entry into the patient's face, wherein the headband includes a first width and a second width greater than the first width; and

[0264] The headband selectively passes through the opening to adjust the tension, a first width is configured to fit through the opening, and a second width is configured to prevent it from passing through the opening.

[0265] Another form of this technology includes an inflation chamber, which comprises:

[0266] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0267] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0268] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0269] A positioning and stabilizing structure configured to maintain a first sealing formation structure and a second sealing formation structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0270] A frame connected to the inflation chamber, the frame comprising:

[0271] A pair of upper arms, and

[0272] A pair of forearms, and

[0273] A headband is attached to the pair of upper arms and the pair of lower arms, and the headband is configured to provide tension to the first sealing structure and the second sealing structure via the frame to enter the patient's face.

[0274] Another form of this technology includes a framework comprising:

[0275] Central part;

[0276] A pair of upper arms that extend backward away from the center portion and are more flexible than the center portion;

[0277] A pair of first connectors are coupled to the pair of upper arms, the pair of first connectors being configured to selectively connect to a pair of upper straps;

[0278] A pair of forearms that extend away from the central portion;

[0279] A pair of second connectors are attached to the lower arms, and the pair of second connectors are configured to selectively connect to a pair of lower bands.

[0280] In the example:

[0281] a) The first connector pair is different from the second connector pair;

[0282] b) The first connector is selected from a group consisting of a slot, a ladder lock, and a stop;

[0283] c) The first connector is a slot;

[0284] d) Each of the first connectors includes a first ring segment and a second ring segment;

[0285] e) The second connector is a magnet; and / or

[0286] f) The first connector is longer than the second connector.

[0287] Another form of this technology includes a patient interface, which includes:

[0288] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0289] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0290] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0291] A positioning and stabilizing structure configured to maintain a first sealing formation structure and a second sealing formation structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0292] A frame, the frame including a central portion connected to the inflation chamber;

[0293] The inflation chamber includes a recess that is configured to removably receive the central portion of the frame.

[0294] In the example:

[0295] a) At the joint position, at least a portion of the central part of the frame is spaced apart from the groove;

[0296] b) When the central portion is attached to the frame, the upper rod of the central portion is spaced apart from the groove; and / or

[0297] c) The second sealing structure is spaced apart from the upper rod before use, and the second sealing structure is configured to contact the upper rod during use.

[0298] Another form of this technology includes a patient interface, which includes:

[0299] An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0300] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0301] A second sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's nasal inlet, such that an airflow under the therapeutic pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0302] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0303] The patient interface also includes:

[0304] At least one region disposed in the inflation chamber and spaced apart from the first sealing structure is configured to resist compression of the first sealing structure in the forward direction.

[0305] In the example:

[0306] a) At least one area is at least one stop rib;

[0307] b) At least one stop rib includes a plurality of stop ribs spaced apart from each other;

[0308] c) Multiple stop ribs are arranged in a C-shape;

[0309] d) Multiple stop ribs extend substantially around the entire periphery of the first seal forming structure;

[0310] e) At least one stop rib is a slender member;

[0311] f) At least one stop rib includes an inclined edge;

[0312] g) The sloping edge is the back edge;

[0313] h) The inclined edge is configured to contact the first sealing structure during use in order to limit the forward movement of the first sealing structure;

[0314] i) At least one stop rib includes a length substantially perpendicular to the first sealing structure and a width substantially perpendicular to the length.

[0315] j) Length is greater than width;

[0316] k) The first sealing structure is configured to contact at least one stop rib along its width during use;

[0317] l) At least one region is at least one reinforced region;

[0318] m) At least one reinforced region includes multiple reinforced regions;

[0319] n) At least one reinforced region includes a first thickness near the inlet port and a second thickness away from the inlet port, wherein the second thickness is less than the first thickness;

[0320] o) At least one reinforcing region is disposed on the front surface of the inflation chamber; and / or

[0321] p) At least one area is integrally formed with the inflation chamber.

[0322] Another form of this technology includes a patient interface, which includes:

[0323] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0324] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered to the airway. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0325] A positioning and stabilizing structure configured to maintain the sealing-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0326] A frame connected to the inflation chamber, the frame comprising:

[0327] The central portion, which is removably positioned within a groove on the air chamber outside the cavity, and

[0328] A pair of upper arms that extend away from the central portion; and

[0329] A pair of forearms that extend away from the central portion;

[0330] The headband, which is attached to the frame, is configured to provide tension to the first sealing structure and the second sealing structure via the frame, allowing it to enter the patient's face.

[0331] In the example:

[0332] a) The upper arm is longer than the lower arm;

[0333] b) Each of the upper arms includes a first connector, and each of the lower arms includes a second connector different from the first connector;

[0334] c) The first connector is selected from a group consisting of a free ring, a ladder lock, and a rope stop;

[0335] d) The first connector is a ring, which includes a first ring portion and a second ring portion adjacent to the first ring portion;

[0336] e) The ring includes a partition wall that at least partially separates the first ring portion from the second ring portion;

[0337] f) The belt in the headgear is configured to selectively insert into the first loop portion and contact the partition wall under optimal tension during use, and wherein the belt is configured to move into the second loop portion under tension greater than the optimal tension;

[0338] g) The second connector is a magnetic component;

[0339] h) The magnetic component has a generally elliptical shape;

[0340] i) The second connector is a magnetic component;

[0341] j) The housing is removably and magnetically connected to the magnetic component;

[0342] k) The housing includes a belt connector for connecting to the headgear strap, the belt connector being selected from a group consisting of a free ring, a ladder lock, and a rope stop;

[0343] l) The housing is configured to engage the lip of the outer shell;

[0344] m) At least one of the headbands includes a first width and a second width greater than the first width;

[0345] n) The first width may be selectively received through the first connector, and the second width is substantially prevented from passing through the first connector; and / or

[0346] o) The first arm and the second arm are integrally formed with the central part.

[0347] Another form of this technology includes an inflation chamber, which comprises:

[0348] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose dimensions and structure are designed to receive an airflow at the treatment pressure for the patient to breathe.

[0349] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered to the airway. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0350] Positioning and stabilizing structures are configured to maintain the sealing-forming structure in the effective therapeutic position;

[0351] The air chamber includes a lip that extends around at least a portion of the inlet port and into the cavity.

[0352] Another form of this technology includes an inflation chamber, which comprises:

[0353] Another form of this technology includes a system for providing pressurized air to a patient, the system comprising:

[0354] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber comprising an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for patient breathing, wherein the inflation chamber comprises a lip extending at least partially around the inflation chamber inlet port.

[0355] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered to the airway. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0356] Positioning and stabilizing structures, configured to maintain the sealing-forming structure in a therapeutically effective location; and

[0357] An air circuit, removably connected to the inflation chamber and configured to provide an airflow at therapeutic pressure from an airflow generator to the cavity, the air circuit including a venting ring configured to at least partially insert through an inlet port of the inflation chamber, the venting ring comprising:

[0358] The rear surface has a first diameter.

[0359] A front surface having a second diameter smaller than the first diameter, and

[0360] A ring extending between the front and rear surfaces;

[0361] The rear surface is configured to be positioned within the cavity, and the front surface is configured to remain outside the cavity when connected to the inflation chamber;

[0362] The lip edge is configured to contact the vent ring along the annulus between the rear and front surfaces; and

[0363] The first diameter is larger than the diameter of the lip.

[0364] In the example:

[0365] a) The main body of the vent is inclined between the rear and front surfaces;

[0366] b) The rear surface is configured to contact the lip and the front wall of the air chamber within the cavity during use;

[0367] c) The ring body includes an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall;

[0368] d) The annular seal is positioned within the groove;

[0369] e) The outer diameter of the annular seal is smaller than the outer diameter of the groove;

[0370] f) The ring body includes a central opening configured to receive a bend connector;

[0371] g) The system includes a quick-release connector;

[0372] h) The quick-release connector is a rotatable connector or a latching connector;

[0373] i) The quick-release connector is configured to connect to the complementary connector; and / or

[0374] j) The sealing structure is spaced apart from the ventilation ring, and the patient's face is not configured to contact the ventilation ring.

[0375] Another form of this technology includes a patient interface, which includes:

[0376] An air chamber having a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure;

[0377] A first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the cavity of the inflatable chamber during the patient's entire respiratory cycle in use.

[0378] A second sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's nostrils; the second sealing structure is configured and arranged to maintain the therapeutic pressure in the cavity of the inflatable chamber throughout the patient's respiratory cycle during use; and

[0379] A ventilation structure that allows the patient's exhaled air to be continuously vented from the interior of the inflation chamber to the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the inflation chamber during use;

[0380] The patient interface also includes:

[0381] At least one stop rib is disposed in the cavity inflation chamber and spaced apart from the first sealing structure in the rest position. The first sealing structure is configured to contact the at least one stop rib in the operating position. The at least one stop rib is configured to resist compression of the first sealing structure in the forward direction.

[0382] The second sealing structure is not configured to contact at least one stop rib.

[0383] In the example:

[0384] a) The upper lip portion is located below the second sealing structure and is configured to contact the upper lip;

[0385] b) The upper lip portion is not configured to contact at least one stop rib;

[0386] c) Multiple stop ribs are arranged in a C-shape;

[0387] d) Multiple stop ribs are spaced unequally apart within the cavity;

[0388] e) Multiple stop ribs extend around most of the periphery of the sealing structure;

[0389] f) At least one stop rib is a slender member;

[0390] g) At least one stop rib includes an inclined edge;

[0391] h) The sloping edge is the back edge;

[0392] i) The inclined edge is configured to contact the sealing forming structure during use in order to limit the forward movement of the sealing forming structure in the operating position;

[0393] j) The inclined edge is positioned away from the center of the inflation chamber and away from the sealing structure in the resting position;

[0394] k) At least one stop rib includes a length substantially perpendicular to the length of the seal-forming structure and a width substantially perpendicular to the length of the seal-forming structure, wherein the length is greater than the width;

[0395] l) The first sealing forming structure is configured to contact at least one stop rib along the width in the operating position;

[0396] m) The width is substantially consistent along the length of at least one stop rib;

[0397] n) The width varies along the length of at least one stop rib; and / or

[0398] o) At least one stop rib is integrally formed with the air chamber.

[0399] Another form of this technology includes a patient interface, which includes:

[0400] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure and a groove formed on the surface of the inflation chamber outside the cavity and exposed to ambient pressure, the inflation chamber being formed entirely of a flexible material.

[0401] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, the sealing structure being configured and arranged to maintain the therapeutic pressure in the cavity of the inflatable chamber throughout the patient's respiratory cycle during use.

[0402] A positioning and stabilizing structure configured to maintain the sealing-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0403] A frame connected to the inflation chamber, the frame comprising:

[0404] The central portion includes a removably positioned recess.

[0405] A pair of upper arms that extend away from the center, and

[0406] A pair of forearms that extend away from the central portion; and

[0407] The headband, which is attached to the pair of upper arms and the pair of lower arms of the frame, is configured to provide tension through the frame to the sealing structure into the patient's face.

[0408] In the example:

[0409] a) The upper arm is longer than the lower arm;

[0410] b) Each of the upper arms includes a connector of the first type, and each of the lower arms includes a connector of the second type, which is different from the connector of the first type;

[0411] c) The first type of connector consists of a free ring, a ladder lock, and a rope stop;

[0412] d) The first type of connector is a ring, which includes a first ring portion and a second ring portion adjacent to the first ring portion;

[0413] e) The ring includes a partition wall that at least partially separates the first ring portion from the second ring portion;

[0414] f) The belt in the headgear is configured to selectively insert into the first loop portion and contact the partition wall under optimal tension during use;

[0415] g) The belt is configured to move into the second loop section under a tension greater than the optimal tension;

[0416] h) The second type of connector is a magnetic component;

[0417] i) The magnetic component has a generally elliptical shape;

[0418] j) The housing is removably and magnetically connected to the magnetic component;

[0419] k) The housing includes a belt connector for connecting to the headgear strap, the belt connector being selected from a group consisting of a free ring, a ladder lock, and a rope stop;

[0420] l) The housing is configured to engage the lip of the outer shell;

[0421] m) At least one of the headbands includes a first width and a second width greater than the first width;

[0422] n) The first width may be selectively received through the first connector, and the second width is substantially prevented from passing through the first connector;

[0423] o) The upper arms and lower arms are integrally formed with the central portion.

[0424] p) The inflation chamber includes at least one protrusion extending from the groove;

[0425] q) The central portion of the frame includes at least one slot configured to selectively receive at least one protrusion;

[0426] r) The lower arm is basically flush with the center part;

[0427] s) The sealing structure also includes a first sealing structure, which is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s mouth;

[0428] t) The sealing structure also includes a second sealing structure, which is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the entrance to the patient’s nostrils;

[0429] u) The groove is located below the second sealing structure and on the air chamber opposite to the first sealing structure;

[0430] v) A system for providing pressurized air to a patient, the system comprising: a patient interface of any of the foregoing examples; a respiratory therapy system (RPT) device configured to provide an airflow at a therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the conduit being configured to deliver the airflow to the patient interface;

[0431] w) The conduit connects to the inlet port of the inflation chamber, which is spaced apart from the inner periphery of the central portion of the frame;

[0432] x) The central portion includes an inner periphery and an outer periphery that are removably positioned within the recess;

[0433] y) A groove is formed radially outward at the inlet port, and the groove forms a closed perimeter; and / or

[0434] The inner periphery of z) is configured to be spaced apart from the inlet port when positioned within the groove.

[0435] Another form of this technology includes a patient interface, which includes:

[0436] An inflation chamber comprising a cavity capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber comprising an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for patient breathing, wherein the inflation chamber comprises a lip that extends at least partially around the inflation chamber inlet port and extends into the cavity.

[0437] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered to the airway. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0438] Positioning and stabilizing structures, configured to maintain the sealing-forming structure in a therapeutically effective location; and

[0439] An air circuit, removably connected to the inflation chamber and configured to provide an airflow at therapeutic pressure from an airflow generator to the cavity, the air circuit including a venting ring configured to at least partially insert through an inlet port of the inflation chamber, the venting ring comprising:

[0440] The rear surface has a first diameter.

[0441] A front surface having a second diameter smaller than the first diameter, and

[0442] An annular body extending between a front surface and a rear surface, the annular body including an inner wall, an outer wall and a groove disposed between the inner wall and the outer wall;

[0443] in:

[0444] The rear surface is configured to be positioned within the cavity, and the front surface is configured to remain outside the cavity when connected to the inflation chamber;

[0445] The rear surface includes at least one vent opening, which is configured to provide communication between the cavity and the surrounding environment via a recess;

[0446] The lip edge is configured to contact the vent ring along the annulus between the rear and front surfaces; and

[0447] The first diameter is larger than the diameter of the lip.

[0448] In the example:

[0449] a) The ring is inclined between the rear and front surfaces;

[0450] b) The rear surface is configured to contact the lip and the front wall of the air chamber within the cavity during use;

[0451] c) The annular seal is positioned within the groove;

[0452] d) The outer diameter of the annular seal is smaller than the outer diameter of the groove;

[0453] e) The ring body includes a central opening, and the system also includes a bend connector, the central opening being configured to receive the bend connector;

[0454] f) The bend connector is rotatably connected to the ring body, and the ring body is rotatably connected to the inflation chamber;

[0455] g) At least one vent is a plurality of vents spaced apart around the periphery of the groove.

[0456] h) The system includes a quick-release connector;

[0457] i) The quick-release connector is either a rotatable connector or a latching connector;

[0458] j) Wherein the quick-release connector is configured to connect to the complementary connector;

[0459] k) The quick-release connector includes at least one flat surface;

[0460] l) At least one flat surface is a pair of flat surfaces spaced approximately 180° apart;

[0461] m) At least one flat surface is configured to redistribute the leakage of airflow from the system;

[0462] n) The sealing structure is spaced apart from the ventilation ring, and the patient's face is not configured to contact the ventilation ring;

[0463] o) The quick-release connector includes a vent that is configured to allow a portion of the airflow to escape into the surrounding environment;

[0464] p) The ring body includes an extension;

[0465] q) The annulus includes a disc configured to be positioned within the cavity and to restrict the exhaled air from escaping into the surrounding environment; and / or

[0466] r) The disk extends radially beyond a portion of the rear surface, which includes at least one vent opening.

[0467] In the example:

[0468] a) The bend connector includes at least one button configured to be selectively actuated to disengage the connection between the bend connector and the center opening;

[0469] b) At least one button is formed as a cantilever structure;

[0470] c) At least one button includes a button lip configured to selectively engage the ring body and move relative to the remainder of the bend when at least one button is actuated;

[0471] d) The button lip is configured to selectively engage the inner periphery of the inner wall of the ring;

[0472] e) At least one button includes a finger configured to selectively engage the ring body and move relative to the remainder of the bend when at least one button is actuated;

[0473] f) The fingers are configured to selectively engage the ring body radially outward on the inner wall; and / or

[0474] g) The inlet port of the inflation chamber includes an extension, and an annular body is connected to the extension and spaced apart from the surface of the inflation chamber.

[0475] Another form of this technology includes a bend configured to be removably connected to an inflation chamber, the bend including a button that can be selectively engaged by a patient.

[0476] Another form of this technology includes a bend configured to be removably connected to the inflation chamber, the bend comprising:

[0477] The body includes a first end configured to be at least partially inserted into a cavity of an inflation chamber and a second end configured to be connected to an air circuit, the body also including:

[0478] A button having a fixed end near the first end and a free end extending away from the free end;

[0479] The outer lip extends substantially around at least a portion of the periphery of the main body; and

[0480] The button can be selectively engaged by the patient to selectively detach the body from the inflation chamber.

[0481] In the example:

[0482] a) The button forms part of the perimeter of the main body;

[0483] b) The inner lip edge is spaced apart from the outer lip edge and is positioned closer to the first end than the outer lip edge.

[0484] c) The width of the inner lip is approximately the same as the width of the button;

[0485] d) The inner lip extends along a portion of the periphery of the body;

[0486] e) The channel extends around a portion of the button, forming a free end;

[0487] f) Button is the first button, and the main body also includes a second button;

[0488] g) The second button is spaced approximately 180° apart from the first button;

[0489] h) The first and second buttons are configured to move toward each other due to the patient's selective engagement;

[0490] i) The outer lip is configured to be adjacent to the vent ring and restrict the translational movement of the bend;

[0491] j) The button can be selectively engaged by the patient to selectively move the inner lip edge relative to the outer lip edge;

[0492] k) The inner lip is configured to be in a pressurized volume when connected to the inflation chamber and pressurized air is supplied;

[0493] l) The inner lip is configured to selectively engage the recess and is configured to disengage from the recess when the button is applied; and / or

[0494] m) The outer lip basically extends around the periphery of the body.

[0495] In the example:

[0496] a) The button includes fingers extending from a fixed end;

[0497] b) The finger-like component extends toward the first end of the main body;

[0498] c) The finger-like element is formed as a cantilever structure relative to the button;

[0499] d) The button is the first button, and the main body also includes a second button;

[0500] e) The second button is approximately 180° apart from the first button;

[0501] f) The first and second buttons are configured to move toward each other due to the patient's selective engagement;

[0502] g) The outer lip is positioned between the first button and the second button;

[0503] h) The distance between one end of the finger and the first end of the main body is less than the distance between the outer lip and the first end of the main body;

[0504] i) The outer lip is configured to be adjacent to the vent ring and restrict the translational movement of the bend;

[0505] j) The fingers are configured to selectively connect to a vent ring outside the pressurized volume; and / or

[0506] k) The selective engagement of the button is configured to further space the finger from the surface of the body.

[0507] Another form of this technology includes a bend configured to be removably connected to the inflation chamber, the bend comprising:

[0508] The body includes a first end configured to be at least partially inserted into a cavity of an inflation chamber and a second end configured to be connected to an air circuit, the body also including:

[0509] A button, spaced apart from the surface of the body; and

[0510] Finger-shaped components connected to the button;

[0511] The button can be selectively engaged by the patient to move it relative to the surface of the body; and

[0512] The finger-shaped component can move together with the button.

[0513] In the example:

[0514] a) The button is configured to move toward the surface of the body, and the fingers are configured to move away from the surface of the body when the button is engaged;

[0515] b) The button is the first button, and the main body also includes a second button;

[0516] c) The second button is approximately 180° away from the first button;

[0517] d) The first and second buttons are configured to move toward each other due to the patient's selective engagement; and / or

[0518] e) The fingers are configured to selectively connect to a vent ring outside the pressurized volume.

[0519] Another form of this technology includes a bend configured to be removably connected to the inflation chamber, the bend comprising:

[0520] The body includes a first end configured to be at least partially inserted into a cavity of an inflation chamber and a second end configured to be connected to an air circuit, the body also including:

[0521] A button, which forms part of the surface of the body, is configured to move into the interior of the body due to external force; and

[0522] A finger, which is attached to the button and spaced apart from the surface of the body, is configured to move due to an external force applied to the button.

[0523] In the example:

[0524] a) The fingers are configured to engage the outer surface of the vent ring;

[0525] b) The button is offset toward the relaxed position, in which the button is substantially flush with the surrounding surface of the body;

[0526] c) The finger is spaced apart from the surface of the body by a first distance in the relaxed position, and spaced apart from the surface of the body by a second distance when an external force is applied, the second distance being greater than the first distance;

[0527] d) The button is the first button, and the main body also includes a second button;

[0528] e) The second button is approximately 180° apart from the first button;

[0529] f) The fingers are essentially hook-shaped; and / or

[0530] g) The fulcrum is located between the button and the finger, with the button forming a cantilever structure relative to the fulcrum and the finger forming a cantilever structure relative to the fulcrum.

[0531] Another form of this technology includes a vent ring configured to connect to an inflation chamber and increase the humidity within the chamber, the vent ring comprising:

[0532] A rear surface, configured to be positioned within a pressurized environment, includes at least one vent opening configured to vent air from an inflation chamber; and

[0533] The front surface is spaced apart from the rear surface and is configured to be positioned outside the pressurized environment.

[0534] In the example:

[0535] a) The disk is attached to the rear surface and configured to be positioned within a pressurized environment;

[0536] b) The width of the disk is basically the same as the width of the rear surface;

[0537] c) Extending radially outward from the location of at least one vent opening on the rear surface of the disc;

[0538] d) The disc is configured to deflect exhaled air back into the inflation chamber;

[0539] e) The extension may be connected to a vent ring near the rear surface, and the extension is configured to space at least one vent opening from the surface of the inflation chamber.

[0540] f) At least one vent is a plurality of vents spaced apart around the periphery of the rear surface.

[0541] g) Multiple vent openings are equidistantly spaced around the perimeter of the rear surface; and / or

[0542] h) Multiple ventilation openings extend around less than half of the perimeter of the rear surface.

[0543] Another form of this technology is a connector component having a first side and a second side opposite to the first side. Each of the first and second sides includes connector material. The connector material is configured to be removably attached to a positioning and stabilizing structure of the patient interface.

[0544] In the example:

[0545] a) The first side uses the same connector material as the second side;

[0546] b) Where the connector material is a hook material or a ring material; and / or

[0547] c) The connector can be connected to an unlimited number of locations.

[0548] Another form of the technology includes a positioning and stabilizing structure comprising at least one lateral band having an inner surface configured to cover an inner surface of the patient's temporal bone and an outer surface opposite the inner surface; and a connecting member removably connected to the outer surface having a first side and a second side each including connecting material; wherein the connecting member can be connected to multiple locations along the length of at least one lateral band.

[0549] In the example:

[0550] a) The first and second sides of the connecting member include hook material;

[0551] b) The outer surface includes a ring material;

[0552] c) The connecting member can be connected to an unlimited number of locations along the length of at least one side strip;

[0553] d) The patient interface includes a frame and positioning and stabilizing structures; wherein the frame includes a ring configured to removably receive at least one side strap; and wherein at least one strap is folded after passing through the ring, such that the other side of the connecting member is removably connected to at least one strap;

[0554] e) In use, the first and second sides are removably connected to at least one strip;

[0555] f) The positioning and stabilizing structure also includes a posterior band configured to cover the patient's occipital bone, and at least one lateral band includes a pair of inferior lateral bands configured to be removably connected to the frame and a pair of superior lateral bands configured to be removably connected to the frame. Each of the superior and inferior lateral bands includes a connecting member; and / or

[0556] g) The connecting member on each of the upper and lower belts can be removably connected to an infinite number of locations along the length of the respective belt.

[0557] Another form of the technology includes a positioning and stabilizing structure comprising at least one side strap, the at least one strap including an elastic portion that can be stretched between a first length and a second length, and the at least one strap including a portion that is substantially hidden in the first position but visible when the strap is extended in the second position.

[0558] In the example:

[0559] a) The hidden portion has a different color from the rest of at least one band;

[0560] b) The hidden parts are glowing;

[0561] c) The concealed portion includes electroluminescent elements (e.g., LEDs);

[0562] d) At least one strip includes a tactile response element on either side of the concealed portion, the tactile response element being configured to be joined together in a first position and separated in a second position;

[0563] e) The tactile response element is a magnet; and / or

[0564] f) The tactile response element is a mechanical connector.

[0565] Another form of this technology includes a positioning and stabilizing structure having a posterior band configured to cover the patient's occipital bone, a pair of inferior bands configured to be removably connected to a frame, and a pair of superior bands configured to be removably connected to a frame. Each of the superior and inferior bands includes a connecting member.

[0566] In the example:

[0567] a) The connecting member can be removably connected to the corresponding belt;

[0568] b) Each connecting member includes hook material on each side for removable connection;

[0569] c) At least one strip includes a first portion having a first width, a second portion having a second width, and a transition portion between the first portion and the second portion;

[0570] d) The second width is greater than the first width and is configured to be greater than the loop on the frame that receives the strip;

[0571] e) At least one strip includes multiple protrusions;

[0572] f) Multiple protrusions are evenly spaced along at least a portion of at least one band;

[0573] g) At least one band includes a raised portion of first density and a raised portion of second density;

[0574] h) At least one strip includes a cut edge;

[0575] i) The cut edge is a square edge, a triangular edge, or a round edge;

[0576] j) The cut edges are evenly spaced along at least a portion of at least one strip;

[0577] k) At least one strip includes a first density cut edge and a second density cut edge;

[0578] l) At least one strip includes an elastic portion that can be stretched between a first length and a second length;

[0579] m) At least one band includes a portion that is substantially hidden in the first position but is visible when the band extends into the second position;

[0580] n) The hidden portion has a different color and / or texture than the rest of the band;

[0581] o) At least one strip includes a tactile response element on either side of the concealed portion, the tactile response element being configured to be joined together in a first position and separated in a second position;

[0582] p) The top band is configured to cover the patient's temporal and / or frontal bones, the top band having a first segment and a second segment and selectively connected by a buckle; and / or

[0583] q) The patient interface is removably connected to the positioning and stabilization structure.

[0584] One aspect of this technology is a method for manufacturing equipment.

[0585] One aspect of certain forms of this technology is an easy-to-use medical device that is easy for people without medical training, people with limited dexterity and vision, or people with limited experience in using this type of medical device.

[0586] One aspect of this technology is a portable RPT device that can be carried by a person, for example, in a person's home.

[0587] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment.

[0588] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of a processor, such as a processor for a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0589] Of course, parts 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.

[0590] 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

[0591] The technology is illustrated by way of example and not limitation in the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0592] Respiratory therapy system

[0593] Figure 1A A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow and receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0594] Figure 1B A system including 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.

[0595] Figure 1C A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a full-face mask and receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0596] Respiratory system and facial anatomy

[0597] Figure 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.

[0598] Figure 2B The diagram shows a view of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0599] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. Up, down, radially inward, and radially outward directions are also indicated.

[0600] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, upper ear base, and lower ear base. The vertical and anteroposterior directions are also marked.

[0601] Figure 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.

[0602] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0603] Figure 2G A side view showing the surface features of the nose is shown.

[0604] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0605] Figure 2I An anatomical view of the nasal region is shown, approximately a few millimeters from the midsagittal plane, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0606] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal concha, maxilla, and mandible are labeled.

[0607] Figure 2K This is a side view of the skull showing 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 marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0608] Figure 2LThe frontal lateral view of the nose is shown.

[0609] Patient Interface

[0610] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0611] Figure 3B A schematic cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is positive when compared with... Figure 3C The curvature shown has a relatively large size compared to the previous value.

[0612] Figure 3C A schematic cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is positive when compared with... Figure 3B The curvature shown has a relatively small amplitude compared to that shown.

[0613] Figure 3D A schematic diagram of a cross-section through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0614] Figure 3E A schematic cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is... Figure 3F The curvature shown has a relatively small amplitude compared to that shown.

[0615] Figure 3F A schematic cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is... Figure 3E The curvature shown has a relatively large amplitude compared to that shown.

[0616] Figure 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 indicated. The vaulted and saddle-shaped areas are indicated.

[0617] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. 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.

[0618] Figure 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.

[0619] Figure 3J It shows crossing Figure 3IThe cross-section of the structure. The surface shown in the figure is... Figure 3I The structure defines a two-dimensional hole.

[0620] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0621] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0622] Figure 3M It shows crossing Figure 3L The cross-section of the mask is shown, and the inner surface of the airbag is also shown. The inner surface defines two-dimensional holes in the mask.

[0623] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0624] Figure 3O The diagram illustrates the left-hand rule.

[0625] Figure 3P The right-hand rule is illustrated.

[0626] Figure 3Q The left ear is shown, including the left ear spiral.

[0627] Figure 3R The right ear is shown, including the right ear spiral.

[0628] Figure 3S A right-handed spiral is shown.

[0629] Figure 3T A view of the face mask is shown, including twisted symbols representing spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0630] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact surface.

[0631] Figure 3V It shows Figure 3U Rear view of the inflation chamber. This view is oriented perpendicular to the center contact surface. Figure 3V The radial surface in the middle divides the inflation chamber into the left and right sides.

[0632] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3VThe image shows a section taken at the sagittal plane. The "intermediate contact" surface is shown. The intermediate contact surface is perpendicular to the sagittal plane. The direction of the intermediate contact surface corresponds to the direction of chord 3210, which lies in the sagittal plane and contacts the inflator liner only at two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the liner in this region, the intermediate contact surface can be a tangent at the upper and lower points. For oronasal interfaces configured with inflator liner portions having separate oral and nasal portions, such as ultra-compact full-face (UCFF) masks, the upper and lower points are on the sealing formation structure of the oral portion of the mask.

[0633] Figure 3X It shows Figure 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 generally coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact surface generally corresponds to the "facial plane". Figure 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.

[0634] RPT device

[0635] Figure 4A An RPT device of one form according to the present technology is shown.

[0636] Figure 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 with reference to the blower and 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. Items within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0637] humidifier

[0638] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0639] Figure 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.

[0640] respiratory waveform

[0641] Figure 6 The diagram shows a typical breathing waveform of a person during sleep.

[0642] Patient interface example of this technology

[0643] Figure 7 This is a rear perspective view of an inflatable chamber according to the present technology, wherein the inlet port is not shown.

[0644] Figure 8 yes Figure 7 Rear view of the inflation chamber.

[0645] Figure 9 yes Figure 7 Front view of the inflation chamber.

[0646] Figure 10 yes Figure 7 Side view of the air chamber.

[0647] Figure 11 yes Figure 7 A top view of the air chamber.

[0648] Figure 12 It is the cross-section of the air chamber passing through plane 12-12.

[0649] Figure 13 yes Figure 7 A bottom view of the air chamber.

[0650] Figure 14 It is the cross-section of the air chamber passing through plane 14-14.

[0651] Figure 15 It is the cross-section of the air chamber passing through plane 15-15.

[0652] Figure 16 It is the cross-section of the air chamber passing through plane 16-16.

[0653] Figure 16-1 It is the cross-section of the air chamber passing through plane 16-1-16-1.

[0654] Figure 16-2 yes Figure 16-1 The diagram shows the cross-section of the air chamber in the deformed position.

[0655] Figure 16-3 yes Figure 16 The cross-section of another view of the inflatable chamber shown illustrates the liner of the first dimension.

[0656] Figure 16-4 yes Figure 16 The cross-section of another view of the inflatable chamber shown illustrates the second-dimension liner.

[0657] Figure 16-5 yes Figure 16 The cross-section of another view of the inflatable chamber shown illustrates the liner of the third dimension.

[0658] Figure 17It is the cross-section of the air chamber passing through plane 17-17.

[0659] Figure 18 It is the cross-section of the air chamber passing through plane 18-18.

[0660] Figure 18-1 It is the cross-section of the air chamber passing through plane 18-1-18-1.

[0661] Figure 18-2 It is the cross-section of the air chamber passing through plane 18-2-18-2.

[0662] Figure 19 A side view of the inflatable chamber is shown with the patient's face in the use position; the inflatable chamber is shown in outline for clarity.

[0663] Figure 20 The patient's face is shown, with specific areas marked to indicate the seal forming the structural joint.

[0664] Figure 21 This is a front perspective view of another form of patient interface according to this technology.

[0665] Figure 21-1 This is a front perspective view of another form of patient interface according to this technology.

[0666] Figure 22 This is a front perspective view of another form of patient interface according to the present technology, in which the ventilation port has been removed.

[0667] Figure 23 It is a front perspective view of the patient interface with a frame for attaching the headgear strap to the inflation chamber.

[0668] Figure 23-1 Is wearing Figure 23 The patient interface provides a front perspective view of the patient.

[0669] Figure 23-2 This is a front perspective view of another version with a patient interface for attaching the headgear strap to the inflation chamber.

[0670] Figure 24 yes Figure 23 A breakdown diagram of the patient interface.

[0671] Figure 24-1 yes Figure 23-2 A breakdown diagram of the patient interface.

[0672] Figure 25 This is a front view of a frame and an air chamber according to one form of this technology.

[0673] Figure 26 This is a front view of a frame and an air chamber in another form according to this technology.

[0674] Figure 26-1 yes Figure 26 A side perspective view of the frame and the air chamber.

[0675] Figure 26-2 This is observed along section 26-26. Figure 26-1 Cross-sectional view of the frame and the air chamber.

[0676] Figure 26-2a This is observed along section 26-26. Figure 26-1 A cross-sectional view of another example of the frame and the air chamber.

[0677] Figure 26-3 yes Figure 26 A top view of the frame and the air chamber.

[0678] Figure 26-4 yes Figure 26 A perspective view of the frame and the air chamber, illustrating the arm of the frame that can move between a first position and a second position.

[0679] Figure 26-5 yes Figure 26-4 The rear perspective view of the frame and the air chamber illustrates the curvature of the air chamber in the second position.

[0680] Figure 27 yes Figure 26 The rear view of the frame shows the tapered opening.

[0681] Figure 27-1 yes Figure 26 The top perspective view of the frame shows the decreasing thickness of the frame arms.

[0682] Figure 27-2 yes Figure 26 A perspective view of the frame, illustrating the rings on the free ends of the frame.

[0683] Figure 27-3 yes Figure 26 A perspective view of the frame, showing the cross-section of the frame's arms.

[0684] Figure 28 This is a front view of a frame and air chamber based on another form of this technology.

[0685] Figure 28-1 This is a perspective view of secondary connection points that can be used with a frame in one form of this technology.

[0686] Figure 28-2 yes Figure 28 A cross-sectional view of the frame and inflation chamber, illustrating the magnet and Figure 28-1 The connection between secondary connection points.

[0687] Figure 29 This is a detailed view of an air chamber according to another form of the present technology, illustrating a clamp support configured to selectively contact the frame.

[0688] Figure 30 It is connected to the frame. Figure 29 A bottom view of the inflation chamber, which is in contact with the clamp support.

[0689] Figure 31 This is a front view of an air chamber connected to a frame according to another form of the present technology, the air chamber including a clamp support.

[0690] Figure 32 This is a front view of a frame according to another form of the present technology, illustrating ribs used to restrict the movement of connecting members.

[0691] Figure 33 This is a front view of a frame according to another form of the present technology, illustrating a pair of ribs used to restrict the movement of the connecting members.

[0692] Figure 34 This is a front view of a frame according to another form of the present technology, illustrating an arm with connection points.

[0693] Figure 35 This is a perspective view of another form of frame according to the present technology, illustrating the protrusion near the eyelet.

[0694] Figure 35-1 It is a side perspective view based on the frame of another instance.

[0695] Figure 35-2 yes Figure 35 Detailed view of the hole.

[0696] Figure 36 This is a front view of a frame according to another form of the present technology, illustrating the upper rod of the frame connected to the air chamber closer to the bend.

[0697] Figure 37 This is a front view of a frame according to another form of the present technology, illustrating the upper rod of the frame spaced apart from the inflation chamber.

[0698] Figure 38 yes Figure 37 A perspective view of the frame.

[0699] Figure 39 yes Figure 37 Top view of the frame.

[0700] Figure 40 This is a side perspective view of another form of liner according to the present technology, illustrating a protrusion extending from the front surface of the air chamber.

[0701] Figure 41 Is it possible to... Figure 23 A detailed view of the positioning and stabilizing structure band used with the patient interface, the band having a first width and a second width.

[0702] Figure 41-1 Is it possible to... Figure 23 A detailed view of another example of a positioning and stabilizing structure band used with a patient interface, the band having a raised portion.

[0703] Figure 41-1-1 It has Figure 23 A detailed view of another instance of the patient interface positioning and stabilization structure band, which has a more detailed view than the band with the patient interface positioning and stabilization structure. Figure 41-1 The raised portion is different from the raised portion in another configuration.

[0704] Figure 41-2 Is it possible to... Figure 23 A detailed view of another example of a positioning and stabilizing structure band used with a patient interface, the band having cut edges.

[0705] Figure 41-3 Is it possible to... Figure 23 A detailed view of another instance of a positioning and stabilizing structure used with the patient interface, the band being positioned in the first position.

[0706] Figure 41-4 yes Figure 41-3 A detailed view of the band, illustrating the band in its second extended position, where the indicator becomes visible.

[0707] Figure 41-5 Is it possible to... Figure 23 A detailed view of another instance of a positioning and stabilizing structure band used with the patient interface, the band being positioned at a second extension where the indicator becomes visible.

[0708] Figure 41-6 It is a perspective view of a double-sided connecting member with hook or ring material.

[0709] Figure 41-7 It is attached to the headgear in the first position. Figure 41-6 Rear view of the double-sided connecting components.

[0710] Figure 41-8 It is attached to the headgear in the second position. Figure 41-6 Rear view of the double-sided connecting components.

[0711] Figure 42 Is using Figure 41 The with Figure 23 The front perspective view of the patient interface.

[0712] Figure 42-1 It's a diagram. Figure 42 Another version of the front perspective view shows the patient interface with a sleeve on the arm of the frame.

[0713] Figure 42-2 It uses another version that comes with it. Figure 23 The front perspective view of the patient interface.

[0714] Figure 43 This is a rear view of another form of the liner, with the stop ribs shown in dashed lines.

[0715] Figure 44 It is observed along line 44-44. Figure 43 A cross-sectional view of the liner, illustrating the shape of the stop rib.

[0716] Figure 45 yes Figure 44 A side view of a cross-sectional view.

[0717] Figure 45-1 It is observed along line 45-1-45-1. Figure 43 A cross-sectional view of the liner, illustrating the shape of the stop rib.

[0718] Figure 46 yes Figure 26 A front view of the inflation chamber, illustrating the groove for receiving the frame.

[0719] Figure 47 This is a rear view of another form of pad according to the present technology, with the reinforced area shown in dashed lines.

[0720] Figure 47-1 It comes from Figure 47 The cross-section of the padding is shown, illustrating the reinforced area.

[0721] Figure 48 This is a cross-section of a liner according to another form of the present technology, illustrating another form of the reinforced area.

[0722] Figure 49 yes Figure 48 A cross-sectional view of the liner.

[0723] Figure 50 This is a cross-sectional view of a liner according to another form of the present technology, illustrating the spacing between the sealing structure and the front surface of the inflation chamber.

[0724] Figure 50-1 This is a cross-sectional view of a gasket of another form according to the present technology, illustrating an offset vent ring to create a gap between the sealing structure and the bend.

[0725] Figure 51The illustration shows the device worn by the patient. Figure 50 A cross-sectional view of the liner.

[0726] Figure 52 This is a perspective view of the arm of a frame based on another example, which includes a first ring portion and a second ring portion.

[0727] Figure 53 yes Figure 52 A perspective view of the arm, illustrating the headband attached to the first loop section at optimal tension.

[0728] Figure 54 It is a perspective view of 52, illustrating the headband attached to the second loop section under tension exceeding the optimal tension value.

[0729] Figure 55 This is a perspective view of the patient interface based on another example, illustrating a frame with a ladder lock connected to the headgear strap.

[0730] Figure 55-1 This is a perspective view of the patient interface based on another example, illustrating a frame with a ladder lock connected to the headgear strap.

[0731] Figure 56 This is a perspective view of the patient interface based on another example, illustrating a frame with a rope stop attached to the headgear strap.

[0732] Figure 56-1 This is a perspective view of the patient interface based on yet another example, illustrating a frame with a cord stop connected to the headgear strap.

[0733] Figure 57 This is a cross-sectional view of the patient interface based on another example, illustrating the ventilation ring connected to the lip edge of the inlet port of the inflation chamber.

[0734] Figure 58 It is used to connect to Figure 57 An exploded view of the air circuit for the patient interface.

[0735] Figure 58-1 Is Figure 58 A perspective view of the quick-release connector used in the air circuit.

[0736] Figure 59 yes Figure 57 A perspective view of the ventilation ring.

[0737] Figure 60 yes Figure 59 The bottom view of the vent ring shows multiple vent holes.

[0738] Figure 61This is a bottom view of another version of the housing for the magnet, which is removably attached to the connection point of the frame in any previous instance.

[0739] Figure 62 It is a perspective view based on another form of disconnected structure, which includes a connector for engaging inside the vent ring.

[0740] Figure 63 It is based on another instance used with Figure 62 A perspective view of the vent ring with its disconnected connection structure.

[0741] Figure 63-1 It is connected to Figure 63 The ventilation ring Figure 62 A cross-sectional view of the disconnected structure.

[0742] Figure 64 It is a perspective view based on another form of disconnected structure, which includes a connector for engaging outside the vent ring.

[0743] Figure 65 It is a perspective view based on another form of disconnected structure, which includes a connector for engaging inside the vent ring.

[0744] Figure 66 It is based on another instance used with Figure 64 or Figure 65 A perspective view of the vent ring with its disconnected connection structure.

[0745] Figure 66-1 It is connected to Figure 66 The ventilation ring Figure 64 A perspective view of the disconnected structure.

[0746] Figure 66-2 It is connected to Figure 66 The ventilation ring Figure 65 A perspective view of the disconnected structure.

[0747] Figure 66-3 It is connected to the inflation chamber. Figure 66-2 A cross-sectional view of the disconnected connection structure and the vent ring.

[0748] Figure 67 It is a perspective view based on another form of disconnected connection structure, which includes a connector for engaging outside the vent ring.

[0749] Figure 68 This is based on yet another instance used with Figure 67 A perspective view of the vent ring with its disconnected connection structure.

[0750] Figure 69 It is connected to Figure 68The ventilation ring Figure 67 A perspective view of the disconnected structure, illustrating the arm of the disconnected structure engaged with the vent ring.

[0751] Figure 69-1 It is connected to Figure 68 The ventilation ring Figure 67 A perspective view of the disconnected connection structure, illustrating the arm of the disconnected connection structure detached from the vent ring.

[0752] Figure 70 It is connected to the inflation chamber. Figure 69 A cross-sectional view of the disconnected connection structure and the vent ring.

[0753] Figure 71 This is a perspective view of another type of bent tube connector that is connected to the air chamber and spaced apart from the surface of the air chamber when fully connected.

[0754] Figure 71-1 yes Figure 71 Cross-sectional view of the bend connector and the air chamber.

[0755] Figure 72 This is another form of side perspective view of a bent tube connector, including a serrated floral pattern.

[0756] Figure 73 yes Figure 72 Front perspective view of the bend connector.

[0757] Figure 73-1 It is connected to the inflation chamber. Figure 73 A cross-sectional view of a bent pipe connector.

[0758] Figure 74 This is a perspective view of another type of bend connector with fewer vents.

[0759] Figure 75 Is with Figure 74 A perspective view of the rotating body used with the bend connector, illustrating the vent. Detailed Implementation

[0760] Before describing this technology in more detail, it should be understood that this technology is not limited to the specific instances described herein. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0761] The following description is provided for various instances that may share one or more common characteristics and / or features. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, any single feature or combination of features in any instance may constitute another instance.

[0762] When anatomical directional terms are used to describe aspects and instances of this technology, such as “anterior,” “posterior,” “superior,” etc., the direction should be understood within the context of this technology during patient use. For example, the anterior side of a patient interface refers to the side of the patient interface that is positioned in front of the patient when the patient wears the interface in the intended manner.

[0763] If a surface or part is described as facing a certain direction, such as "upward," "front-facing," etc., unless the context explicitly requires otherwise, such surface or part should be understood as at least partially facing that particular direction. If a part generally faces the upward direction, it may also be "upward-facing" even if it also partially faces another direction.

[0764] therapy

[0765] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0766] In some instances of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0767] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0768] Respiratory therapy system

[0769] 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.

[0770] Patient Interface

[0771] According to one aspect of the present technology, a non-invasive patient interface 3000 includes the following functional aspects: a sealing formation structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 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 formation structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0772] In some embodiments of this technology, the inflation chamber is at least partially formed by the shell 3250. In some embodiments, the shell 3250 or a portion thereof may have a degree of flexibility, as discussed further below.

[0773] In some instances of this technology, the patient interface is an oronasal patient interface, meaning that the patient interface is configured to seal around both the patient's nasal and oral airways. In some instances, the patient interface includes separate seals around each of the nasal and oral airways.

[0774] exist Figures 7 to 22 In the example shown, the sealing structure for the nasal cavity is not located above the bridge or ridge of the nose on the patient's face, but rather on the lower surface of the patient's nose.

[0775] 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.

[0776] 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 cmH2O relative to the surrounding environment.

[0777] 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 cmH2O relative to the surrounding environment.

[0778] 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 cmH2O relative to the surrounding environment.

[0779] Sealing Formation Structure

[0780] 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 over time and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0781] As described in more detail below, in some forms of the invention, the sealing forming structure 3100 includes a first sealing forming structure 3101 and a second sealing forming structure 3102. The first sealing forming structure 3101 is connected to the oral cavity portion 3201 of the inflation chamber and is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's oral cavity. The second sealing forming structure 3102 is connected to the nasal cavity portion 3202 of the inflation chamber 3200 and is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's nose. The phrase "connected to" herein is used to refer to a part or component formed as a single piece as well as parts or components formed separately and subsequently joined together. In some cases, components may be connected by intermediate components.

[0782] In some forms, the first sealing structure 3101 seals the patient’s face independently of the second sealing structure 3102.

[0783] In some forms, the first sealing structure 3101 and the second sealing structure 3102 cooperate to form a single common seal against the patient's face.

[0784] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0785] In some forms of this technology, the sealing structure 3100 is constructed of a biocompatible material (e.g., silicone rubber).

[0786] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, and elastic material (such as silicone).

[0787] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one form of sealing formation structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another form of sealing formation structure 3100 that is suitable for small-sized heads but not for large-sized heads.

[0788] Sealing mechanism

[0789] In one embodiment, the sealing structure 3100 includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the positive system pressure acting on its underside within the inflation chamber 3200, promoting a tight, sealed engagement with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0790] 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 at least partially around the periphery. The support flange is or includes a spring-like element and serves to support the sealing flange from buckling during use. Limiting buckling can prevent the formation of wrinkles in the sealing structure 3100, which could lead to leakage and loss of therapeutic pressure.

[0791] In one embodiment, the sealing structure 3100 may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0792] In one embodiment, the sealing structure 3100 includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by an adjacent area of ​​the sealing flange.

[0793] In one form, the sealing forming structure 3100 includes a region having an adhesive or bonding surface.

[0794] In some forms of this technology, the sealing structure 3100 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.

[0795] Nasal cavity area

[0796] Next reference Figures 7 to 18 In some forms of this technology, the second sealing structure 3102 includes a central portion 3110 configured to seal against the surface of a patient's nose in use. The central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils) and the patient's upper lip. In an example, a portion of the sealing structure may engage a patient's septum. The second sealing structure 3102 may also include a lateral portion 3111 on the lateral side of the central portion 3110. In an example, the sealing structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the nasal protuberance.

[0797] As in Figure 10 and Figures 16 to 19 In the best view, the rear surface 3112 of the transverse portion 3111 slopes forward in an upward / forward direction from the boundary 3103 of the first sealing structure 3101 and the second sealing structure 3102, so that the rear side of the nose portion of the mask slopes forward in shape.

[0798] In an embodiment with a ridge 3120 (as further described below), the rear surface 3112 of the transverse portion 3111 can be tilted forward from the ridge 3120.

[0799] In some forms of this technology, the rear surface 3112 of the transverse portion 3111 forms an angle between 20° and 90° with the intermediate contact surface of the mask. The intermediate contact surface may be perpendicular to the sagittal plane and may extend substantially along the length of the ridge 3120 and the chord 3210. This angle can be... Figure 16 The angle is measured in the clockwise direction, although it can also be measured in the counterclockwise direction, such that the measured angle is the supplement of the aforementioned angle (i.e., between 90° and 160°).

[0800] like Figures 16-3 to 16-5 As shown, the second sealing structure 3102 can be formed at different angles relative to the intermediate contact surface, allowing patients with noses of different sizes to comfortably wear the patient interface 3000. As illustrated, the two different angles of the second sealing structure 3102 can be modified on patient interfaces 3000 of different sizes to provide a better fit for a wider range of patients.

[0801] The first angle 6056 can be measured from the intermediate contact surface to the first sealing shaft 6060 extending along the upper boundary 3247 of the second front wall portion 3242 and intersecting with the nostril 3135. In some forms, the first angle 6056 can be between approximately 50° and approximately 150°. In some forms, the first angle 6056 can be between approximately 75° and approximately 125°. In some forms, the first angle 6056 can be between approximately 100° and approximately 110°. For example, Figure 16-3 This could include a first angle of approximately 108°, 6056-1. Figure 16-4 It can include a first angle of approximately 105°, 6056-2, and Figure 16-5 This can include a first angle 6056-3 of approximately 109°. As shown in the figure, the first angle 6056 is... Figures 16-3 to 16-5 The angle 6056 is measured in the counterclockwise direction as shown. However, the first angle 6056 can be measured in the clockwise direction, such that the measured angle is the supplement of the aforementioned angle.

[0802] The second angle 6064 can be measured from the intermediate contact surface to a second sealing axis 6068 extending along the surface of the second sealing forming structure 3102 configured to contact the patient and intersecting with the nostril 3135. In some forms, the second angle 6064 can be between approximately 50° and approximately 160°. In some forms, the second angle 6064 can be between approximately 100° and approximately 145°. In some forms, the second angle 6064 can be between approximately 110° and approximately 130°. For example, Figure 16-3 This could include a second angle of approximately 127.5°, 6064-1. Figure 16-4 It can include a second angle of approximately 116.5°, 6064-2, and Figure 16-5 This can include a second angle 6064-3 of approximately 122°. As shown in the figure, the second angle 6064 is... Figures 16-3 to 16-5 The angle 6064 is measured in the counterclockwise direction as shown. However, the second angle 6064 can be measured in the clockwise direction, such that the measured angle is the supplement of the aforementioned angle.

[0803] The difference between the first angle 6056 and the second angle 6064 can form the inclination of the second sealing structure 3102. As described above, in some forms, this difference can be between approximately 1° and approximately 110°. In some forms, this difference can be between approximately 5° and approximately 50°. In some forms, this difference can be between approximately 10° and approximately 20°. For example, Figure 16-3 This could include a difference of approximately 19.5°. Figure 16-4 This can include a difference of approximately 11.5°, and Figure 16-5 This can include a difference of approximately 13°. In some forms, this difference may resemble the angle measured between the rear surface 3112 and the intermediate contact surface described above, although the two angles are different.

[0804] Figures 16-3 to 16-5 The different angles shown can correspond to patients with different nasolabial angles (e.g., see...). Figure 2E The patient interface 3000 shown in each of the three figures may represent an interface of different sizes (e.g., small, medium, or large), each of which can comfortably fit the patient within a certain nasolabial angle range.

[0805] like Figure 50 and Figure 51 As shown, Figures 16-3 to 16-5The first angle 6056 and the second angle 6064 can provide relief for patients with long nasal tips (e.g., a large distance between the nasal tip and the alar apex). For example, the second anterior wall portion 3242 can be sufficiently spaced from the second sealing structure 3102 such that the contact between the patient's nostril and the second sealing structure 3102 maintains a sufficient distance from the second anterior wall 3242 to allow airflow. This distance 6072 can extend between the second anterior wall portion 3242 and the nostril 3135. The distance 6072 can be the shortest distance sufficiently spaced between the second anterior wall portion 3242 and the second sealing structure 3102, and this distance may not extend along the first axis 6060. Although in other instances, the first distance 6072 may extend substantially along the first sealing axis 6060. This allows the second sealing structure 3102 to stretch in the forward direction without contacting the second anterior wall portion 3242 (e.g., when the patient's nasal tip is long).

[0806] like Figure 19 As shown, in some embodiments, the lateral portion 3111 is configured such that no part of the patient interface 3000 will come into contact with the apex 1020 of the patient's nose during use.

[0807] The lateral portion 3111 is configured to tilt in such a way that a smaller portion of the nasal portion of the interface 3000 than some similar interfaces in the prior art extends along the sides of the nasal ala. In some forms of this technology, this results in the nasal ala portion in contact with the sealing formation 3100 being smaller relative to the interface having a lateral portion tilted backward toward the patient's face, thereby reducing the proportion of the nasal ala that can be deformed and blocked by the sealing formation 3100, for example, when the patient is sleeping on their side and the interface is in contact with a pillow.

[0808] The boundary between the oral and nasal cavities

[0809] For details, please refer to the following: Figure 7 , Figure 8 and Figures 16 to 18 In one form of this technology, the boundary between the first sealing structure 3101 and the second sealing structure 3102 forms or includes a corner or ridge 3120. In use, the corner or ridge 3120 can engage the patient's face above the upper lip and directly below the nose.

[0810] In an embodiment, the corner or ridge 3120 forms a sharper angle than some equivalent portions or areas of prior art mouth and nose masks, such as those described in PCT application PCT / AU2019 / 050278.

[0811] When the mask is worn and treatment is performed, the sharper angle reduces the likelihood of wrinkles forming on or near the first sealing formation structure 3101 and / or the second sealing formation structure 3102 at or near the corner or ridge 3120. Some oronasal patient interfaces that do not use this structure may require a very thin, rounded structure to be formed in this area, which may be less resistant to wrinkles. In contrast, the corner or ridge 3120 can be stiffer than such an interface and can better maintain its shape, and therefore can better seal in depressions and wrinkles present around the patient's nose. In embodiments with a support portion (such as the support portion 3260 described herein), this effect may be enhanced because the support portion can resist or prevent compression of the area.

[0812] In some forms of this technology, the radius of the corner or ridge 3120 may be less than 2 mm, for example, about 1.75 mm. In one form of this technology, the radius may vary from about 1.75 mm at the center of the ridge to about 0.75 mm in the transverse portion.

[0813] The angle formed by the first sealing structure and the second sealing structure can be between 20 degrees and 90 degrees, for example, 36 degrees.

[0814] In some forms of this technology, the corner or ridge 3120 may extend through substantially the entire boundary 3103 between the first sealing structure 3101 and the second sealing structure 3102. In embodiments, the corner or ridge 3120 may engage the patient's face at least near the nasal opening, for example, where the nasal ala intersects with the face above the upper lip. Figure 20 As shown in region 1010.

[0815] oral region

[0816] As described above, in one form, the non-invasive patient interface 3000 includes a first seal-forming structure 3101 that forms a seal around the patient's mouth during use. The first seal-forming structure 3101 can form a seal on the chin area of ​​the patient's face.

[0817] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0818] The sealing structure 3100 includes a sublipal portion 3130 that abuts against the patient's chin area and / or the patient's sublip and / or suprachin to form a seal. The sublipal portion 3130 may be connected to (e.g., adjacent to) the supralipular portion 3131 via a perioral portion 3132, such as... Figure 16 As shown.

[0819] The sealing structure 3100 includes a relatively low wall thickness (compared to other parts of the interface), for example, less than 0.7 mm, at the perioral portion 3132, the sublip portion 3130 of the sealing structure abutting the chin region, and at least at the center of the sublip portion 3130. This low wall thickness at these locations contributes to an effective and comfortable seal. The sealing structure in these areas can easily conform to any complex geometry.

[0820] In some forms of this technology, the oral cavity 3133 is essentially trapezoidal rather than oval or elliptical in order to more accurately correspond to the shape of the patient's nose. This shape of the oral cavity allows the interface 3000 to be particularly compact and substantially no wider than the width of the patient's nostrils.

[0821] like Figure 51 As shown, the patient's oral cavity may be spaced apart from the inlet port 3604 (and therefore from the bend 3500 and / or ventilation ring 3504, as...). Figure 50 (As shown). This distance 6076 can be measured in a direction substantially parallel to distance 6072. This distance 6076 provides sufficient clearance for the patient's lips, which extend into the cavity 3272 and are forward of the second sealing structure 3102. The patient can slightly compress the second sealing structure 3102 in the forward direction, and the distance 6076 can be large enough to prevent contact with the bend 3500 and / or the ventilation ring 3504. However, the distance 6076 cannot be too large, so that the patient interface 3000 maintains a compact shape.

[0822] Moreover, or in addition, such as Figure 50-1 As shown, the ventilation ring 3504 (described in more detail below) may include an offset to create an additional gap between the bend 3500 and the first sealing structure 3101 (and thus the patient's lips). The ventilation ring 3504 may include an offset 3506 (described below) that can space the bend 3500 from the cavity 3272 of the inflation chamber 3200. For example, as Figure 57 As shown, the bend 3500 contacts the front surface 3512 of the ventilation ring 3504 and extends beyond the rear surface 3508 of the inflation chamber 3200. This allows for a more compact design (e.g., because it minimizes the extension in the forward direction away from the patient's face), but the bend 3500 extends into distance 6076. In other words, distance 6076 (as in...) Figure 51 The distance measured in the middle is no longer the maximum distance between the patient's lips and the front of the patient interface 3000. Applying offset 3506 can increase the distance the patient interface 3000 extends in front of the patient's face, but it also separates the bend 3500 from the patient's lips, so that distance 6076 remains the maximum separation distance in the forward direction between the patient's lips and the patient interface 3000.

[0823] nose pillow

[0824] In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal flaps or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0825] 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 underside of a patient's nose; a rod; and a flexible region located on the underside of the truncated cone and connecting the truncated cone to the rod. Additionally, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the rod. These flexible regions can work together to facilitate a universal joint structure that accommodates the relative movement of both the displacement and angle of the truncated cone and the structure to which the nasal pillow is connected. For example, the truncated cone can be axially displaced toward the structure to which the rod is connected.

[0826] Inflation chamber

[0827] In some forms, the inflation chamber 3200 (or at least a portion of the inflation chamber 3200) and the sealing structure 3100 are formed from a single homogeneous sheet of material (e.g., molded silicone). The combination of the sealing structure 3100 and the inflation chamber 3200 can be considered as a gasket.

[0828] The angle of the nasal cavity is adjustable.

[0829] For details, please refer to the following: Figure 9 , Figure 10 and Figures 16 to 18-2 In one embodiment of this technology, a first anterior wall portion 3240 of the nasal cavity portion 3202 of the inflation chamber 3200 is more flexible than the adjacent region of the oral cavity portion 3201. The first anterior wall portion 3240 may be positioned adjacent to the boundary 3241 of the nasal cavity portion and the oral cavity portion of the inflation chamber 3200. In embodiments, the first anterior wall portion 3240 may be symmetrical about the midsagittal plane and may extend through at least 50%, for example, at least 80%, of the width of the nasal cavity portion 3202 through the inflation chamber. In some embodiments, the first anterior wall portion 3240 may extend substantially through the entire width of the nasal cavity portion 3202 through the inflation chamber.

[0830] In some forms of this technology, the second anterior wall portion 3242 is less flexible than the adjacent portion of the anterior wall. In some embodiments, the second anterior wall portion 3242 is adjacent to the first anterior wall portion 3240 on opposite sides of the boundary 3241 of the nasal and oral portions of the inflatable chamber. In embodiments, the second anterior wall portion 3242 may be symmetrical about the midsagittal plane and may extend through at least 50%, for example, at least 80%, of the width of the nasal portion 3202 of the inflatable chamber. In some embodiments, the second anterior wall portion 3242 may extend substantially through the entire width of the nasal portion 3202 of the inflatable chamber.

[0831] The flexible first anterior wall portion 3240 allows the patient contact portion 3110 of the second sealing formation 3102 to pivot or hinge around a region on the rear side of the interface 3000. This can help allow the interface to accommodate patients with various angles (i.e., nasolabial angles) between the base of the nose and the upper lip.

[0832] In embodiments characterized by a corner or ridge 3120 between the first sealing structure 3101 and the second sealing structure 3102, as described above, the patient contact portion 3110 may pivot or hinge around the corner or ridge 3120 or an adjacent area. In embodiments provided with one or more support portions 3260 (further described below), the hinged or pivoting area may be located directly above the support portion 3260.

[0833] like Figure 9 As shown, the first front wall portion 3240 may have an upper boundary 3243 and a lower boundary 3244. One or both of the upper boundary 3243 and the lower boundary 3244 may be curved, for example, such that the center portion of the boundary is below the transverse portion, as shown. The first front wall portion 3240 may have substantially the same height in its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary in its width, for example, such that the height of the center portion of the first front wall portion 3240 is greater than the height of the transverse portion, as shown. Figure 9 As shown in the embodiment. Changing the curvature of one or both of the boundaries 3243, 3244 and / or the height of the first front wall portion 3240 can change the stiffness of the first front wall portion 3240, that is, change its resistance to collapse or folding in response to forces on the patient contact portion 3110 of the second sealing forming structure 3102.

[0834] Similarly, the second front wall portion 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of the present art, the lower boundary 3248 of the second front wall portion 3242 is the same as the upper boundary 3243 of the first front wall portion 3240. Both the upper boundary 3247 and the lower boundary 3248 of the second front wall portion 3242 may be curved, for example, such that the central portion of the boundary is located below the transverse portion. The second front wall portion 3242 may have substantially the same height in its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary in its width, for example, such that the height of the central portion of the second front wall portion 3242 is less than the height of the transverse portion.

[0835] In some forms of this technology, in addition to or as an alternative to a curved boundary, the first front wall portion 3240 can be configured to have the desired stiffness in other ways. For example, the thickness of the first front wall portion 3240 can be selected to provide the desired stiffness. In an example, the first front wall portion 3240 may be thinner than the adjacent portion of the inflation chamber wall. Additionally and / or alternatively, the first front wall portion 3240 may extend in the upward direction around the lateral edge of the second front wall portion 3242, such as... Figure 21 As shown, this provides reduced stiffness / compression resistance or collapse resistance compared to embodiments where the first front wall portion 3240 is not formed in this manner.

[0836] The second anterior wall portion 3242 (e.g., strip 3270) can help prevent collapse of the nasal cavity portion 3202 and can provide support for the patient contact portion 3110 of the second seal-forming structure 3102, which is typically relatively thin. An insufficiently supported patient contact portion may suffer bursting at the seal against the patient's face. In one form, the second anterior wall portion 3242 is thicker than the adjacent portion of the inflatable chamber wall. In some forms, the second anterior wall portion 3242 is provided as a thickened strip of material 3270, such as... Figures 16 to 19 As shown. The first front wall portion 3240 and the second front wall portion 3242 can be made of the same material, for example, as part of a one-piece molded shell 3250.

[0837] In some forms, the first anterior wall portion 3240 and the second anterior wall portion 3242 may include different thicknesses. For example, the thickness of the second anterior wall portion 3242 may be greater than the thickness of the first anterior wall portion 3240, which may provide increased stiffness in the second anterior wall portion 3242 (e.g., compared to the first anterior wall portion 3240). Specifically, the second anterior wall portion 3242 may be a strip 3270 extending into the cavity 3272 of the inflation chamber 3200. For example, the strip 3270 may extend through the first anterior wall portion 3240 and toward the patient wearing the patient interface 3000. The outer surface of the nasal cavity portion 3202 may be substantially smooth, while the inner surface of the nasal cavity portion (e.g., within the cavity 3272) may be stepped (or otherwise include discontinuities).

[0838] like Figure 16-1 and Figure 16-2 As shown, the first anterior wall portion 3240 can act as a hinge and allow the nasal cavity portion 3202 to bend. The first anterior wall portion 3240 may be the thinnest area of ​​the nasal cavity portion 3202 and is therefore likely to be most susceptible to bending moments. The increased thickness of the strip 3270 directs bending moments away from the second anterior wall portion 3242 and towards the thinner first anterior wall portion 3240. The greater height of the strip 3270 (i.e., the greater distance between the upper boundary 3247 and the lower boundary 3248) can also make the nasal cavity portion 3202 stiffer and less capable of bending around the first anterior wall portion 3240. When bending occurs, the first anterior wall portion 3240 and the second anterior wall portion 3242 can move in a forward direction (e.g., away from the patient).

[0839] like Figure 18-1 and Figure 18-2 As shown, the upper boundary 3243 of the first anterior wall portion 3240 differs from the lower boundary 3248 of the second anterior wall portion 3242. Instead, the upper boundary 3243 is at least partially higher than the lower boundary 3248 and can be at least partially aligned with the upper boundary 3247 of the second anterior wall portion 3242. This allows the first anterior wall portion 3240 to be at least partially disposed alongside (e.g., and around) the strip 3270 on both sides or more sides. In other words, the first anterior wall portion 3240 can be disposed on at least one end of the strip 3270. This can provide greater flexibility to the first anterior wall portion 3240, allowing the nasal cavity portion 3202 to bend further (e.g., in the forward direction).

[0840] like Figure 21-1As shown, the nasal cavity portion 3202 can also be formed without a hinge. In other words, a strip can be omitted from the second anterior wall portion 3242, allowing the first anterior wall portion 3240 and the second anterior wall portion 3242 to have substantially the same thickness. The nasal cavity portion 3202 can still be bent even without the strip because it can be constructed of silicone, which allows the nasal cavity portion 3202 to have a degree of conformability to accommodate different nasolabial angles.

[0841] Flexible shell

[0842] In some forms of this technology, the shell 3250 may be made of a rigid material such as polycarbonate. However, in other forms of this technology, the shell 3250 or a portion thereof may be flexible to some extent. For example, in some instances, the shell 3250 may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the shell 3250 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the shell 3250 may be made of a material with a Young's modulus of 0.7 MPa or lower (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone resin.

[0843] In the example, the shell 3250 and one or both of the first sealing structure 3101 and the second sealing structure 3102 may be formed of the same material (e.g., silicone resin, fabric, etc.).

[0844] In some forms of this technology (e.g., see...) Figures 23 to 28-2 The shell 3250 can be constructed substantially entirely of a flexible material, which provides the shell 3250 with maximum freedom of movement (i.e., substantially no rigid and / or thickened portions restricting bending). The shell 3250 can be flexible enough that one or more components can be added to provide the required stiffness in one or more regions or areas of the shell 3250 (e.g., the region of contact area 1010). For example, one or more of the following components—ventilation module; connection port; headgear connector; headgear connector connected to rigid arms and rigid members—can be attached to the shell 3250 in such a way as to increase the stiffness of the inflation chamber 3200 in the region adjacent to the components, for example, as further described below. In some forms of this technology, these components can be releasably attached to the flexible shell 3250. Additionally or alternatively, one or more components can be permanently attached to the shell 3250, for example, by adhesive and / or overmolding. Rigid members can also be used to increase the stiffness of the sealing formation 3100 and / or support the shape of the sealing formation.

[0845] In some forms of this technology, the shell 3250 may typically be flexible, but may include reinforcing portions having a greater thickness than the adjacent portion of the shell 3250. Such reinforcing portions may be configured as ribs or strips, for example, extending laterally through the shell and / or extending in the vertical direction, although many other configurations are also possible. In some forms, the shell may include substantially rigid portions, such as portions made of polycarbonate, as well as slightly flexible portions.

[0846] In some embodiments of this technology, it may be preferable that the central portion 3251 on the anterior side of the oral cavity portion 3201 of the air chamber has greater rigidity than the rest of the air chamber 3200. In some embodiments of this technology, the region of increased rigidity may be located directly below the nasal cavity portion 3202, such as... Figure 21 As shown and further described below, and / or located directly above the oral cavity portion 3201. In one form of this technology, part or all of the first anterior wall portion 3240 may be a region of increased stiffness rather than increased flexibility. Providing increased stiffness in one or more of these regions can provide shape stability and can limit the extent to which the shell 3250 deforms due to headgear forces. Excessive deformation may cause the second sealing formation 3102 to block 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. Additionally, the described regions of increased stiffness may help reduce torsional deformation of the interface, which could otherwise cause one side of the second sealing formation 3102 to lose contact with the patient's nose, creating a leakage path.

[0847] like Figure 21 and Figure 21-1 As shown, in one embodiment of this technology, the housing 3250 may have a rigid portion 3263, or at least one portion that is more rigid than the rest of the housing, on which one or more connection ports 3600 are provided, for example, molded. In one embodiment of this technology, the rigid portion 3263 may be made of polycarbonate. This can provide greater rigidity than a housing made solely of silicone. In one embodiment of this technology, a hole forming a vent 3400 is molded into the rigid portion 3263. In some embodiments of this technology, a connector 3310 for positioning and stabilizing the structure is mounted on an arm 3320, providing some rigidity to the housing.

[0848] In one embodiment of this technology, the rigid portion 3263 extends laterally through the front of the inflation chamber near the upper boundary of the first front wall portion 3240, for example, directly below the second front wall portion 3242. The rigid portion 3263 may extend continuously between the connection ports 3600 and may provide an airflow path for pressurized airflow entering the inflation chamber 3200 through the connection ports 3600.

[0849] In some forms of this technology, the cross-section of the connection port 3600 may be approximately elliptical. The connection port 3600 may be oriented such that the centerline of each port is substantially parallel to the outer surface of the inflation chamber of the adjacent port.

[0850] In some forms of this technology, the rigid portion 3263 may project in the forward direction relative to the adjacent face of the first front wall portion 3240 and may be shaped to increase resistance to bending.

[0851] In some forms of this technology (e.g., see...) Figure 21 Connector 3310 and arm 3320 are located below connection port 3600, facing the lateral edge of inflation chamber 3200. Connector 3310 may be located at the lateral end of arm 3320. Connector 3310 may provide additional rigidity to inflation chamber 3200 and / or sealing structure 3100.

[0852] In some forms of this technology (e.g., see...) Figure 21-1 Connector 3310 does not include arm 3320, but connects directly to inflation chamber 3200. This allows inflation chamber 3200 to be more... Figure 21 The 3200 air chamber is more flexible.

[0853] Figure 22 An air chamber 3200 with a vent mounting hole 3410 is shown, into which a suitable vent portion or module can be inserted. The vent portion can be made of a relatively rigid material to increase the rigidity of the air chamber. In some forms of this art, the vent mounting hole 3410 can be generally elliptical in shape, with the minor axis of the ellipse substantially parallel to the sagittal plane.

[0854] exist Figure 22 In the embodiment shown, the vent mounting hole is positioned facing the upper edge of the oral cavity portion 3201 of the inflation chamber 3200.

[0855] Figure 22The illustrated embodiment includes a connector 3310 for positioning and stabilizing the structure. The connector 3310 can be mounted in a relatively thicker area of ​​the housing 3250. In the illustrated embodiment, the connector 3310 is located below the vent mounting hole 3410 and towards the lateral side of the inflation chamber 3200. In some forms of this technology, the connector 3310 is a substantially circular magnetic headgear connector.

[0856] Although Figures 7 to 19 The diagram of the inflation chamber does not show an inlet or connection port, but those skilled in the art will understand that in practice one or more inlet ports will be provided, for example... Figures 21 to 22 The inlet port 3600 is shown. Inlet port 3600 allows an interface to be connected to air circuit 4170, as further described herein. In some forms of this technology, one or more components of air circuit 4170 may also serve as components for positioning and stabilizing the structure.

[0857] like Figure 24 As shown, some forms of patient interface 3000 may include a single inlet port 3604. The inlet port 3604 may be generally circular and may be centered on the oral portion 3201 of the air chamber 3200.

[0858] like Figure 57 As shown, the entry port 3604 may include a lip 3608 extending around at least a portion of the periphery of the entry port 3604 (e.g., see...). Figure 49 For example, the lip 3608 may extend around the entire circumference of the circular inlet port 3604. The lip 3608 may extend into the cavity 3272 (e.g., see...). Figure 18-1 The lip edge 3608 may be inclined toward the outer periphery of the circumference of the inlet port 3604.

[0859] In some configurations, the lip 3608 is approximately perpendicular to the periphery of the circumference of the inlet port, such that the diameter of the inlet port 3604 is approximately equal to the diameter of the opening formed by the lip 3608 within the cavity 3272. In other words, the lip 3608 may extend substantially parallel to the port axis 3612 extending through the inlet port 3604.

[0860] In other forms, the lip 3608 is inclined between approximately 1° and approximately 60° relative to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 2° and approximately 50° relative to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 5° and approximately 30° relative to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 10° and approximately 15° relative to the port axis 3612.

[0861] In some forms of this technology, the air chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). Using transparent materials reduces the obtrusiveness of the patient interface and helps improve adherence to the therapy. Transparent materials also help clinicians observe how the patient interface is positioned and functions.

[0862] In some forms of this technology, the air chamber 3200 is constructed of a translucent material (e.g., translucent silicone). Using a translucent material can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0863] In some forms of this technology, dedicated reinforcing or rigid members (e.g., without other function) may be included on the air chamber 3200. These members may be formed of a material that is more rigid than the air chamber 3200 (e.g., more rigid than silicone). The dedicated reinforcing members may be overmolded into the air chamber 3200 to provide greater rigidity than the rigid portion 3263 of the shell 3250 or arm 3320.

[0864] Support section

[0865] As in Figure 12 and Figures 14 to 18 As best shown, in one embodiment of this technology, the support portion 3260 is disposed on the opposite side of the interface 3000 between the second sealing structure 3102 and the front wall of the inflation chamber 3200. Figure 12 As shown, in one example, each support portion 3260 extends to the lateral edge of the interface.

[0866] The support portion 3260 does not act as a base pad, but is configured to resist or impede compression in the anterior-posterior direction. The support portion 3260 thereby supports and / or reinforces the portion of the second sealing structure 3102 that engages with the patient's upper lip. Specifically, the support portion 3260 may support and / or reinforce an area of ​​the second sealing structure 3102 that may contact an area 1010 of the patient's face near the nasal inlet, where the nasal ala intersects with an area above the upper lip, such as... Figure 20 As shown. In other words, region 1010 can be located directly below each lower corner of the patient's nose.

[0867] The support portion 3260 helps ensure that no wrinkles form in the sealing structure 3100. Wrinkles can form in the sealing structure due to its large radius of curvature and its conformity to the patient's face, which is highly flexible. The sealing structure may fold or wrinkle itself due to its excessive flexibility, leading to leakage within the sealing structure. Wrinkles may be particularly important to consider when the sealing structure seals the area 1010 of the patient's face. The support portion 3260 may be particularly advantageous when the sealing structure is configured to form corners and / or ridges 3120 as described herein. The corners and / or ridges 3120 can be sharper curves (e.g., curves with a lower radius of curvature) compared to a sealing structure without the support portion 3260. The added support and / or stiffness by the support portion 3260 reduces the ability of the second sealing structure 3102 to conform to the patient's face. To maintain patient comfort, the corners and / or ridges 3120 are selected and / or sized to substantially match the geometry (e.g., contour) of the patient's face. For example, the sealing structure 3100 for a particular patient can be selected from a variety of sizes to substantially conform to the nasal alar region (i.e., near region 1010). A sharper curvature allows the second sealing structure 3102 to seal various gaps around the patient's nose, thereby reducing the likelihood of wrinkles forming.

[0868] Specifically, such as Figures 14 to 16 As shown, in one embodiment of the present technology, the support portion 3260 is connected to the front side of the oral cavity portion 3201 of the inflation chamber, adjacent to the boundary 3241 of the oral cavity portion 3201 and the nasal cavity portion 3202. In some embodiments, when the support portion 3260 is viewed in a cross-section parallel to the sagittal plane (e.g. Figures 16 to 18 (as shown) and / or when viewed in a cross section parallel to the anterior sagittal plane (e.g.) Figure 14 and Figure 15 The curvature (as shown) can be curved. The curvature can be positive or negative. In the illustrated example, the curvature can be negative (e.g., relative to the patient's nose). In some instances, the lateral sidewall portion 3245 of the inflation chamber 3200 may be curved inward at the boundary 3241 adjacent to the nasal cavity portion 3202, and the support portion 3260 may be substantially abutted against the adjacent lateral sidewall portion 3245. Figure 18As shown, when viewed in a cross-section parallel to the sagittal plane, at least a portion of the support portion 3260 may have a reduced thickness between a first end 3261 adjacent to the front wall of the inflation chamber 3200 and a second end 3262 adjacent to the sealing formation 3100. For example, the support portion 3260 may be thicker near the first end 3261, which may help provide increased support and / or stiffness to the second sealing formation 3102. In some instances, the support portion 3260 may vary in thickness between 0.1 mm (e.g., near the second end 3262) and 3.5 mm (e.g., near the first end 3261). In some instances, the support portion 3260 may vary in thickness between 0.3 mm (e.g., near the second end 3262) and 3 mm (e.g., near the first end 3261). In some instances, the support portion 3260 may vary in thickness between 1.3 mm (e.g., near the second end 3262) and 2.5 mm (e.g., near the first end 3261).

[0869] Support portions 3260 with different geometries can be used for different patients. For example, a patient requiring more support and / or stiffness in the second seal-forming structure 3102 can use a seal-forming structure 3100 with a thicker (e.g., closer to the first end 3261 and / or anywhere along the length) and / or more curved (e.g., a lower radius of curvature) support portion 3260. For example, a patient wanting a more flexible second seal-forming structure 3102 can use a seal-forming structure 3100 with a thinner (e.g., closer to the first end 3261 and / or anywhere along the length) and / or less curved (e.g., a larger radius of curvature) support portion 3260.

[0870] Specifically, such as Figure 14 and Figure 15 As shown, in one embodiment of the present technology, the support portion 3260 is connected to the oral cavity portion 3201 of the inflation chamber, adjacent to the boundary of the lateral sidewall portion 3245 of the oral cavity portion 3201 and the lateral sidewall portion 3246 of the nasal cavity portion 3202.

[0871] In some forms of this technology, the support portion 3260 is shaped to provide a substantially unobstructed flow path from the oral portion 3201 of the inflation chamber to the nostril 3135 during inhalation. In some forms of this technology, no part of any support portion 3260 is located directly below the nostril 3135.

[0872] Overstretched support

[0873] like Figures 43 to 45As shown, the patient interface 3000 may include a stop rib 6040 within the cavity 3272 of the inflation chamber 3200. The stop rib 6040 may be disposed within the oral cavity portion 3201 of the inflation chamber 3200 and provide support around the patient's oral cavity. The stop rib 6040 may be integrally formed with the inflation chamber 3200 (e.g., in the same molding process), such that the stop rib 6040 is integral with the remainder of the inflation chamber 3200.

[0874] like Figure 43 As shown, the patient interface 3000 may include a plurality of stop ribs 6040 that extend at least partially around the periphery of the oral portion 3201 of the inflation chamber 3200 and the first sealing formation 3101. Figure 43 As shown, the stop rib 6040 may extend only partially around the patient interface 3000 (e.g., in a C- or U-shape), and the stop rib 6040 may not be located near the supralipal portion 3131 (e.g., directly in front of it). In other forms, the stop rib 6040 may extend around the entire periphery of the oral cavity portion 3201 and the first sealing formation 3101, or may extend around the periphery of the oral cavity portion 3201 and the first sealing formation 3101. Figure 43 The oral cavity portion 3201 and the different portions of the first sealing structure 3101 shown extend.

[0875] Continue to refer to Figure 43 The stop ribs 6040 are spaced apart from each other such that no stop rib 6040 contacts any other stop rib 6040. In some forms, the stop ribs 6040 may be equidistant, such that there is an equal distance between each pair of adjacent stop ribs 6040. In other forms, the stop ribs 6040 may be unequally spaced, such that at least some pairs of stop ribs 6040 are closer together than other stop ribs. For example, the stop ribs 6040 may be closer together in areas of contact with the patient's face that are more suitable for receiving force (e.g., near the nasolabial fold).

[0876] like Figures 44 to 45-1 As shown, the stop rib 6040 may be an elongated member extending from the inner surface of the inflation chamber 3200 toward the sealing structure 3100. The stop rib 6040 may be connected to the oral portion 3201 of the inflation chamber 3200 and at least partially spaced from the first sealing structure 3101 in a resting or unused position. For example, the edge 6042 (e.g., the rear edge) of each stop rib 6040 may be inclined (e.g., not perpendicular to the front-rear direction). This can provide additional spacing between the stop rib 6040 and the first sealing structure 3101 in the unused position.

[0877] In use, the patient's face contacts the sealing structure 3100 and pushes the first sealing structure 3101 forward. Because each patient can individually tighten the headband 3354 (described in more detail below), the patient may overtighten the headband 3354, causing the sealing structure 3100 to press too firmly against the patient's face. If the overtightened sealing structure 3100 folds or wrinkles and allows pressurized air to escape from the inflation chamber 3200, this may cause patient discomfort and / or potentially reduce the quality of the seal. To limit overtightening, stop ribs 6040 are spaced apart from the first sealing structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the first sealing structure 3101 contacts each stop rib 6040 at its edge 6042 along its width (e.g., substantially parallel to the narrow width measured by the first sealing structure 3101). Because the length of the stop ribs 6040 is greater than their width, the stop ribs 6040 act as reinforcing members and limit the total distance that the first seal-forming structure 3101 can move. The stop ribs 6040 may also be thicker than the first seal-forming structure 3101 in any direction. This allows the stop ribs 6040 to be sized such that the patient can pull the headband 3354 to a predetermined point to form the desired seal, but not beyond that predetermined point to minimize discomfort and / or reduced seal. The slope of the edge 6042 allows the patient's face sufficient space to fit comfortably within the inflation chamber 3200, while also limiting excess space (e.g., which could lead to over-tightening) and providing support for the patient's face. The stop ribs 6040 may also include curvature along the width surface (e.g., see...). Figure 45-1 ).

[0878] Furthermore, each stop rib 6040 may extend more than half (e.g., two-thirds, three-quarters, etc.) along the length of the first sealing structure 3101. This can help ensure that movement is restricted substantially throughout the first sealing structure 3101.

[0879] like Figures 47 to 49 As shown, the patient interface 3000 may include a reinforcing region 6044 within the cavity 3272 of the air chamber 3200. The reinforcing region 6044 may be disposed within the oral cavity portion 3201 of the air chamber 3200 and provide support around the patient's oral cavity. The reinforcing region 6044 may be integrally formed with the air chamber 3200 (e.g., in the same molding process), such that the reinforcing region 6044 is integral with the remainder of the air chamber 3200.

[0880] The reinforcement region 6044 may be formed on the anterior surface 6046 of the air chamber 3200 within the cavity 3272, and close to the lateral side of the oral cavity portion 3201. When the patient interface 3000 is worn, the reinforcement region 6044 may be directly opposite the patient. The reinforcement region 6044 may be substantially symmetrical on either side of the oral cavity portion 3201 and may extend around the lateral region 6048 of the air chamber 3200.

[0881] like Figure 47 As shown, the height of the reinforcing region 6044 can be substantially the same as the height of the inlet port 3604. In other words, the reinforcing region 6044 can extend substantially along the length of the oral cavity portion 3201 of the inflation chamber 3200. In some forms, the thickness can vary along the reinforcing region 6044. For example, the reinforcing region 6044 can be thicker near the inlet port 3604 and can decrease in thickness away from the inlet port 3604 (although this can also be the opposite). In other instances, the reinforcing region 6044 can be thicker near the lower part of the oral cavity portion 3201 and thinner near the upper part of the oral cavity portion 3201 (e.g., near the nasal cavity portion 3202), although these two cases can be reversed.

[0882] like Figure 47-1 As shown, in some forms, the reinforced region 6044 may be approximately 0.01 mm to approximately 10 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be approximately 0.1 mm to approximately 5 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be approximately 1 mm to approximately 2 mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be approximately 1.8 mm thicker than the surrounding unreinforced region. In some forms, this may be a constant thickness throughout the reinforced region 6044, while in other instances, this may be the maximum value of a variable thickness throughout the reinforced region 6044.

[0883] like Figure 48 and Figure 49 As shown, another version of enhanced region 6044 may be smaller. Figure 47 The reinforcing region described herein. In another version, the reinforcing region may be located in the lower part of the oral cavity portion 3201 near the inflation chamber 3200. The reinforcing region 6044 may also extend in an inclined direction. For example, each reinforcing region 6044 may be inclined in the vertical direction, such that the reinforcing region 6044 is positioned higher closer to the inlet port 3604 than further away from the inlet port 3604.

[0884] Figure 48 and Figure 49Some forms of reinforcement region 6044 may extend only along the front surface 6046 of cavity 3272, and may not extend along the side region 6048 of inflation chamber 3200. During use, reinforcement region 6044 may be positioned directly in front of the patient's face. Figure 49 As shown, the reinforcing region 6044 may extend to the side region 6048 (e.g., adjacent to or in contact with the side region 6048), but may not extend around the side region 6048.

[0885] like Figure 48 As shown, the thickness of the reinforcing region 6044 can vary on its surface. For example, the reinforcing region 6044 can be thicker near the center and thinner near the sides. Although in other instances, this may be the opposite. In some forms, the reinforcing region 6044 can be stepped, so that there is no gradual transition between the thicker and thinner portions. In other instances, the transition can be gradual.

[0886] When using Figures 47 to 49 When the patient interface 3000 is in use, the patient's face contacts the sealing structure 3100 and pushes the first sealing structure 3101 forward. Because each patient can individually tighten the headband 3354 (described in more detail below), the patient may overtighten the headband 3354, causing the sealing structure 3100 to press too firmly against the patient's face. If the overtightened sealing structure 3100 folds or wrinkles and allows pressurized air to escape from the inflation chamber 3200, this may cause patient discomfort and / or may reduce the quality of the seal. To limit overtightening, a reinforcing region 6044 is spaced apart from the first sealing structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the reinforcing region 6044 limits the compression of the first sealing structure 3101 in the forward direction. The reinforcing region 6044 may function similarly to a stop rib 6040 and limit the total distance the first sealing structure 3101 can move. However, the reinforced area 6044 may not provide a stop, but rather limit compression, as a thicker area requires greater force to compress. The size of the reinforced area 6044 can be set such that the patient can pull the headband 3354 to a predetermined point to form the desired seal, but not beyond that predetermined point to minimize discomfort and / or reduced seal.

[0887] Positioning and stabilizing structure

[0888] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0889] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift the face away.

[0890] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0891] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of disturbance forces on the patient interface 3000, such as from tube resistance or unintended interference with the patient interface.

[0892] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with how a patient wears it while sleeping. In one instance, the positioning and stabilization structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one instance, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one instance, the positioning and stabilization structure 3300 includes at least one flat strip.

[0893] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0894] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large and bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on a pillow.

[0895] In one embodiment of this technology, the positioning and stabilizing structure 3300 is provided with a disengaging portion located between the front and rear portions of the positioning and stabilizing structure 3300. The disengaging portion does not resist compression and may be, for example, a flexible or soft band. The disengaging 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 breaking the seal.

[0896] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip 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 strip. In one form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0897] In some forms of this technology, the positioning and stabilizing structure 3300 includes a stretchable band, such as an elastically stretchable band. For example, the band can be configured to be tensioned during use and to guide forces to seal the sealing structure into a portion of the patient's face. In an example, the band can be configured as a tie.

[0898] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of its lower edge passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0899] In one form of the technology applicable to a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap, which is configured and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0900] In one form of this technology applicable to nasal 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.

[0901] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient when they are sleeping.

[0902] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.

[0903] 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, and another form of positioning and stabilizing structure suitable for small-sized heads but not for large-sized heads.

[0904] Figure 21 and Figure 22 An embodiment is shown with a connector 3310, such as a magnetic connector, for connection to the positioning and stabilizing structure 3300.

[0905] In some forms, the band of the positioning and stabilizing structure 3300 may be constructed from a stretchable (e.g., elastic) material. The positioning and stabilizing structure 3300 can be stretched to accommodate patients with different head sizes.

[0906] In some forms, the band of the positioning and stabilizing structure 3300 may be constructed from at least partially inextensible material. This may limit the band's tensile strength. Different sizes of bands can be used for patients of different sizes to accommodate different head sizes. The band of the positioning and stabilizing structure 3300 may also be length-adjustable.

[0907] like Figure 23-2 , Figure 24-1 , Figure 42-2 , Figure 55-1 and Figure 56-1 As shown, some forms of the positioning and stabilizing structure 3300 may include an upper band 3357 that covers the patient's parietal and / or frontal bones during use. The upper band 3357 may be length-adjustable to accommodate different head sizes (e.g., using a buckle 3369). Each patient can tighten or loosen the upper band 3357 to fit their individual head. Tightening or loosening the band adjusts the tension in the upper band 3357 to provide comfort for the patient wearing the positioning and stabilizing structure 3300.

[0908] frame

[0909] like Figures 23 to 28-2 As shown, the frame 3350 is connected to the air chamber 3200 and helps maintain the therapeutically effective position of the sealing formation 3100. Figures 23 to 28-2 The air chamber 3200 shown is specifically illustrated with a curved tube 3500 connected to the front of the patient's face, although the frame can be used with other types of air chambers 3200 (e.g., Figures 21 to 22 The inflation chamber 3200 is used in conjunction with the catheter head cover.

[0910] In some forms, the frame 3350 is constructed of a rigid or semi-rigid material and provides support for the sealing-forming structure 3100 and / or the air chamber 3200. For example, the frame 3350 may help maintain the shape of the sealing-forming structure 3100 and / or the air chamber 3200 to reduce pressurized air leakage due to folds and / or wrinkles when the sealing-forming structure 3100 engages with the patient's face.

[0911] In some forms, frame 3350 provides at least one connection point 3352, which can facilitate indirect connection of headband 3354 to inflation chamber 3200 and / or sealing formation 3100. Connection point 3352 may be a loop (e.g., fully circumferentially molded) for receiving a portion of headband 3354. For example, a section of upper left headband 3356 may pass through the first loop 3352a and be pulled away from inflation chamber 3200 to apply tension via upper left headband 3356. Upper left headband 3356 may be folded relative to itself and held at a selected length (e.g., using Velcro, magnets, adhesives, etc.) to maintain the applied tension. Similar steps may be performed regarding adjusting the tension in upper right headband 3358 in second loop 3352b. In other forms, connection point 3352 may include an open periphery (e.g., U-shaped or C-shaped).

[0912] In some forms, each ring 3352a, 3352b can be oriented such that the force vector applied by the corresponding upper straps 3356, 3358 is substantially perpendicular to the inner surface 3351 of the ring in contact with the upper straps 3356, 3358. For example... Figure 23 As shown, the upper right headband 3358 engages ring 3352b approximately at the center of the inner surface 3351 of the ring. When the upper right headband 3358 is tightened, the force vector is applied substantially in a linear direction, rather than being inclined relative to the inner surface 3351 of the ring. This can improve the seal of the seal-forming structure 3100 because the force is guided along the arm 3362, rather than being inclined relative to the arm 3362, which might require further tightening of the upper headbands 3356, 3358 to achieve the same sealing effect (e.g., impairing patient comfort), and / or may prevent the seal-forming structure 3100 from properly engaging the patient's face (e.g., causing leakage).

[0913] like Figure 41 and Figure 42 As shown, the headbands 3356 and 3358 may include different widths along their length. For example, a first portion of each band 3356 and 3358 may have a first width 3359, and a second portion of each band 3356 and 3358 may have a second width 3361 greater than the first width. In some forms, a large portion of the headbands 3356 and 3358 may have the second width 3361.

[0914] Although not shown, the lower headbands 3366 and 3368 may also include different widths (e.g., and include tapered shapes), similar to the description of the upper headbands 3356 and 3358. Therefore, any description relating to the upper headbands 3356 and 3358 may apply to the lower headbands 3366 and 3368.

[0915] In the illustrated example, each headband 3356, 3358 may taper gradually between a first width 3359 and a second width 3361. The headbands 3356, 3358 may include a substantially linear side 3363 between the first width 3359 and the second width 3361. In other examples, the headbands 3356, 3358 may be curved between the first width 3359 and the second width 3361. In yet another example, the headbands 3356, 3358 may not include the transition between the first width 3359 and the second width 3361, but may instead be stepped between the first width 3359 and the second width 3361.

[0916] like Figure 41-1 and Figure 41-2 As shown, additional feedback features can be used to alert the patient that the headbands 3356 and 3358 are being overstretched. The illustrated examples show these features independently incorporated into the headbands 3356 and 3358 (e.g., in bands with a substantially uniform width). However, Figure 41-1 and Figure 41-2 The feedback characteristics can be incorporated into Figure 41 The conical structure (or stepped band) in the middle.

[0917] like Figure 41-1 As shown, the upper bands 3356 and 3358 may include dots 6128 (e.g., silicone dots). Dots 6128 can provide increased resistance as the band passes through the corresponding rings 3352a and 3352b of the frame 3350. In other words, dots 6128 can rub against the corresponding rings 3352a and 3352b and provide a tactile response to the patient, thereby alerting the patient that the upper bands 3356 and 3358 are too tight.

[0918] In some forms, point 6128 may protrude from the surface of bands 3356, 3358 to contact rings 3352a, 3352b and provide a tactile response to the patient.

[0919] In the diagram, point 6128 is used in conjunction with a band of substantially the same width. The width can be approximately the width of each loop 3352a, 3352b (e.g., at least a portion of the band width can be slightly larger than the width of loops 3352a and 3352b). If a patient attempts to pull either upper band 3356, 3358 through the corresponding loops 3352a, 3352b, point 6128 will provide further resistance to the movement through the loops 3352a and 3352b. For example, the patient can feel a vibration at point 6128 contacting the loops 3352a, 3352b.

[0920] In another form, in addition to the conical shape of the upper bands 3356 and 3358, a point 6128 is used. Therefore, the point 6128 can serve as an additional signal to the patient indicating that the upper bands 3356 and 3358 are overstretched. In other words, the point 6128 can be positioned on the portion of each upper band 3356 and 3358 with a second width 3361. If the patient attempts to pull the second width 3361 of any upper band 3356 or 3358 through the corresponding loops 3352a and 3352b, the point 6128 will provide further resistance to movement through the loops 3352a and 3352b.

[0921] In some forms, dots 6128 can be uniformly distributed across the upper bands 3356 and 3358. In other forms, dots 6128 can be non-uniformly distributed. For example, the concentration of dots 6128 can increase in a direction away from the free ends of the corresponding bands 3356 and 3358. This can provide an initial warning to the patient of potential overstretching and can be converted into a greater number of dots 6128 to alert the patient that overstretching has already occurred.

[0922] In other instances (for example, see...) Figure 41-1-1 Point 6128 can be used to help guide the patient to the correct position. For example, points 6128 can be arranged in a linear pattern with uniform spacing. As the patient passes the straps 3356, 3358 through the corresponding loops 3352a, 3352b, points 6128 can provide feedback at each interval to communicate the distance the strap has passed (e.g., similar to holes on a belt). In other words, the patient can adjust the strap to a specific position based on the number of discrete feedback signals they receive.

[0923] In some forms, this may help to provide a more targeted adjustment for the patient's head. Point 6128 can draw the patient's attention to a specific band length that is beneficial to their head, rather than simply reminding them of excessive tightness.

[0924] In some forms, the shape, size, and / or density of the dots 6128 can vary along the length of the bands 3356 and 3358. For example, the dots 6128 can be spaced evenly (or substantially evenly) before overstretching to help the patient select the appropriate length, as described above. The configuration of the dots 6128 can be altered (e.g., made denser) at locations where the patient would overstretch the bands 3356 and 3358. Changes in the configuration of the dots 6128 can produce different tactile responses that can alert the patient to overstretching.

[0925] In some configurations, point 6128 can extend substantially across the entire length of the corresponding bands 3356, 3358. This can provide tactile cues for patients with a wide range of head sizes. In this example, points 6128 can be spaced substantially evenly (although configuration may vary as described above). Points 6128 allow the patient to continuously select the desired location, rather than being alerted to a specific location of excessive tension.

[0926] Although the description above uses the word "point," any suitable shape can be used. For example, silicone (or other similar materials) can include triangles, rectangles, or any other similar shapes.

[0927] like Figure 41-2 As shown, the upper bands 3356 and 3358 may include a cutting edge 6132 (e.g., a square cut, a triangular cut, a circular cut, etc.). The cutting edge 6132 can provide a tactile response to the patient, thereby alerting the patient that the upper bands 3356 and 3358 are too tight.

[0928] In the illustrated form, the cut edge 6132 is used in conjunction with a band of substantially the same width. The width can be approximately the width of each loop 3352a, 3352b (e.g., at least a portion of the band width can be slightly larger than the width of loops 3352a and 3352b). If a patient attempts to pull any of the upper bands 3356, 3358 through the corresponding loops 3352a, 3352b, the variation between the full width and discontinuities of the cut edge 6132 will provide further indication to the patient to stop pulling the upper bands 3356, 3358 through the loops 3352a, 3352b.

[0929] In other forms, besides the tapered shape of the upper bands 3356 and 3358, a cutting edge 6132 is used. Therefore, the cutting edge 6132 can serve as an additional signal to the patient indicating that the upper bands 3356 and 3358 are overstretched. In other words, the cutting edge 6132 can be positioned on the portion of each upper band 3356 and 3358 with a second width 3361. If the patient attempts to pull the second width 3361 of any upper band 3356 or 3358 through the corresponding loops 3352a and 3352b, the variation between the entire second width 3361 and the discontinuity of the cutting edge 6132 will provide the patient with further indication to stop pulling the upper bands 3356 and 3358 through the loops 3352a and 3352b.

[0930] In some forms, the cutting edges 6132 may be uniformly distributed along a portion of the upper bands 3356, 3358. In other words, the distance between each adjacent cut on each cutting edge 6132 may be equal. In other forms, the cutting edges 6132 may be non-uniformly distributed. For example, the distance between each cut on the cutting edge 6132 and / or the size of the cut may decrease in a direction away from the free end of each upper band 3356, 3358.

[0931] In other instances, the cutting edge 6132 can be used to help guide a patient to the correct position. For example, the cutting edge 6132 can be arranged in a linear pattern with uniform spacing. As the patient passes the straps 3356, 3358 through the corresponding loops 3352a, 3352b, the cutting edge 6132 can provide feedback at each interval to communicate the distance the strap has traveled (e.g., similar to holes in a belt). In other words, the patient can adjust the strap to a specific position based on the number of discrete feedback signals they receive.

[0932] In some forms, this may help to provide a more targeted adjustment for the patient's head. The cut edge 6132 can draw the patient's attention to a specific band length that is beneficial to their head, rather than simply reminding them of excessive tension.

[0933] In some forms, the shape, size, and / or density of the cutting edges 6132 may vary along the length of the bands 3356, 3358. For example, the cutting edges 6132 may be evenly (or substantially evenly) spaced before overstretching to help the patient select the appropriate length, as described above. The configuration of the cutting edges 6132 may be altered at locations where the patient would overstretch the bands 3356, 3358 (e.g., becoming smaller and / or closer together). Changes in the configuration of the cutting edges 6132 may produce different tactile responses that could alert the patient to overstretching.

[0934] In some forms, the cutting edge 6132 may extend substantially across the entire length of the corresponding bands 3356, 3358. This can provide tactile cues for patients with a wide range of head sizes. In this example, the cutting edges 6132 may be spaced substantially evenly (although there may be variations in configuration as described above). The cutting edges 6132 allow the patient to continuously select the desired location, rather than being alerted to a specific location of over-tension.

[0935] In use, as described above, each headband 3356, 3358 passes through the corresponding rings 3352a, 3352b. Since the first width is smaller than the width of rings 3352a, 3352b, the first width 3359 can selectively insert through the openings of the corresponding rings 3352a, 3352b. At least some transition sections may also be narrower than the width of rings 3352a, 3352b, allowing the transition sections to also be received through the openings. However, the second width 3361 may be wider than the width of rings 3352a, 3352b and may not be able to slide through any opening. The larger second width 3361 can provide a stop and limit the total length that can pass through the corresponding rings 3352a, 3352b. This may reduce the likelihood of the patient over-tightening the headband due to the second width 3361. In some forms, the length of the headbands 3356, 3358 with a first width 3359 (or the length of the first width 3359 plus the transition portion 3363) can be designed for patients with larger heads. Therefore, the headbands 3356, 3358 can be adjusted to achieve the desired tightness before the second width reaches the corresponding loops 3352a, 3352b. For patients with smaller heads, the headbands 3356, 3358 can withstand greater tension if adjusted to the second width 3361. However, the second width 3361 still prevents the patient from over-tightening the headbands 3356, 3358 and limits deformation and leakage of the sealing structure 3100. Alternatively, positioning and stabilizing structures 3300 of different sizes can be constructed for patients with different head sizes (i.e., such that the second width 3361 acts as a stop to limit over-tightening by patients with various head sizes).

[0936] In other instances, an extender can be attached to the upper headband 3356, 3358 to provide a greater length than the first width 3359. This allows a single positioning and stabilizing structure 3300 designed for smaller patient heads to be used for larger patient heads.

[0937] In some forms, the band extender may have connectors on both sides. The illustrated examples show the same type of connector on either side, although the connectors on each side may differ. For example, the band extender may include hook-and-loop material. In some forms, loop material is formed on both sides, while in others, hook material is formed on both sides. In still other forms, hook material is formed on one side, and loop material is formed on the other side.

[0938] In some forms, a band extender can be used to provide additional length so that the patient does not overstretch the band (e.g., upper band 3356, 3358 and / or lower band 3366, 3368).

[0939] In some forms, the extension may include... Figures 41 to 41-5The band shown has similar features. For example, a band extender may include features such as... Figure 41 The tapered shape shown can also include a stepped shape. This limits the distance the belt extender can pass through rings 3352a, 3352b to prevent over-tensioning. The belt extender can also include point 6128 as described above (e.g., see...). Figure 41-1 ) and / or cut edges (e.g., see Figure 41-2 This provides an indication of overstretching (e.g., tactile response). The band extender may also include similar features. Figures 41-3 to 41-5 The hidden portion 3365 can provide visual and / or tactile indications of excessive tension. Alternatively, the hidden portion 3365 can be referred to as a warning portion.

[0940] Figures 41 to 41-5 Any features described herein, and those included in the band extender, may prompt the patient to adjust the band extender relative to the headgear 3354. In some forms, this may involve adjusting the connection position of the band extender relative to the corresponding bands on the headgear (e.g., upper bands 3356, 3358 and / or lower bands 3366, 3368). For example, the patient may connect the band extender closer to the portion having the second width 3361 to shorten the effective length of the band, or the patient may connect the band extender closer to the portion having the first width to increase the effective length of the band.

[0941] In some forms, the straps of the headgear 3354 (e.g., upper straps 3356, 3358 and / or lower straps 3366, 3368) may include connectors of extended lengths configured to mate with connectors on the strap extender. For example, upper straps 3356, 3358 may include hook or loop material along at least a portion of a first width 3359 and / or a portion of a second width 3361.

[0942] The patient can adjust the position of the band extender along the length of each band to select the appropriate available length for the patient (e.g., to provide sufficient sealing force without overstretching the band).

[0943] In some forms, different sizes of band extenders may be available (e.g., small, medium, large), allowing patients to make more targeted adjustments for their specific head and reducing variations in band extender overstretching.

[0944] Furthermore, or alternatively, the headbands 3356, 3358 can be constructed of an elastic material. The elastic material may change its visual appearance due to stretching under tension (e.g., it may change color). Expansion of the headbands 3356, 3358 can also provide the patient with a tactile response indicating that the bands 3356, 3358 are overstretched. This change in visual appearance can alert the patient (or a third party like a bed partner) to the overstretching of the headbands 3356, 3358. This can be beneficial when the patient has fully tightened the headbands 3356, 3358 before the second width reaches the individual loops 3352a, 3352b.

[0945] For example, Figures 41-3 to 41-5 Examples of straps (e.g., headband straps 3356, 3358) are illustrated, which may include features that alert the patient that the strap has been overstretched, which may remind the patient that the strap should be loosened and / or that a different size (e.g., a larger) headband strap 3354 is needed.

[0946] exist Figure 41-3 In the illustration, the example strap is shown in the first position. This could be the position where the strap was not stretched before the patient used it. Figure 41-3 You can also illustrate how to tension a band to the correct length. For example, a patient can use the band and adjust it to the appropriate length so that it is not overstretched.

[0947] exist Figure 41-4 In the illustration, the example band is shown in a second position, stretched and / or extended from its initial position. As described above, the band may include a portion 3365 that is normally hidden but exposed in the second position. For example, the hidden portion 3365 may be elastic and stretch to its extended length when the tension applied to the band exceeds a threshold. The hidden portion 3365 may be a different color and / or texture to alert the patient that the tension in the band has exceeded a predetermined limit. This change in appearance and / or feel may alert the patient that the band is overstretched.

[0948] In some forms, the hidden portion 3365 can be luminescent and glow when exposed. In a dark room, the faint light emitted from the hidden portion 3365 can be observed, thus alerting the patient to the excessive stretching of the headband 3354.

[0949] In some forms, the concealed portion 3365 may include a noise output device (e.g., a speaker) that outputs sound when the concealed portion 3365 is exposed in order to alert the patient.

[0950] In some forms, the concealed portion 3365 may include electrical components (e.g., a light-emitting element) that output light when the concealed portion 3365 is exposed. The output of light may alert the patient that the headband 3354 is overstretched. In some forms, the headband 3354 may include a battery (not shown) and / or wires for supplying power to the electrical components.

[0951] In some cases, the patient may not be able to see that the band has exceeded the threshold tension and that the hidden portion is exposed (e.g., the band may no longer be visible to the patient when the patient is wearing it). Figure 41-5 As shown, the band may include a tactile response element 3367, which can provide a tactile response to the patient to indicate that the tension in the band has exceeded a certain threshold.

[0952] In some forms, the tactile response element 3367 is a pair of magnets. When the strip is in a first position, the magnets 3367 are connected to each other. When the tension in the strip exceeds the magnetic force, the magnets 3367 separate and the hidden portion 3365 is exposed. Thus, the strip can be under tension and can be stretched (e.g., if it is elastic) before the magnets 3367 separate.

[0953] When magnet 3367 is disengaged, the patient may receive a disable response. This can be in the form of vibration along the band when magnet 3367 is disconnected and / or an auditory signal. Either or both of these can alert the patient that the band is too tight. Removing excessive tension from the band allows magnets 3367 to reconnect with each other.

[0954] In other forms, the tactile response element 3367 can be an alternative connector (e.g., a mechanical connector). For example, the tactile response element 3367 can be constructed of plastic and / or silicone. Instead of magnetism, the tactile response element 3367 can be connected using mechanical connections (e.g., snap-fit) or similar connections (e.g., hook-and-loop connectors). These alternative tactile response elements 3367 can have a holding force that allows for a certain extension below a separation threshold before the tactile response element 3367 is activated. Similar to the magnet 3367, separation of the tactile response element 3367 can generate a vibration that the patient can detect and determine that the band is overstretched.

[0955] In some forms, the tactile response element 3367 can be compared to bandwidth. This can provide the patient with additional visual cues to determine if the band tension has exceeded a threshold.

[0956] Although not illustrated, Figures 41-3 to 41-5The overstretching features shown and described can also be incorporated into other straps on headband 3354. For example, lower headbands 3366, 3368 can be fastened to the magnet in a similar manner, making overstretching possible. Additionally or alternatively, an adjustable upper strap 3357 (e.g., see...) Figure 23-2 , Figure 24-1 , Figure 42-2 , Figure 55-1 and Figure 56-1 The headband 3354 may include a concealed portion 3365 to alert the patient to excessive tension. The adjustable top band 3357 may also include a tapered band to limit excessive stretching. The tapered band may be used with a band extender to allow a single headband 3354 to be used for various head sizes.

[0957] like Figures 41-6 to 41-8 As shown, the headband 3354 can utilize the bilateral connecting members 6136 to allow the patient to adjust the available length. Figure 41-6 As shown, the bilateral connecting member 6136 may include hook material (or loop material) on both sides (e.g., the first side 6136-1 and the second side 6136-2 may be functionally identical). The patient can attach the hook material to the loop material (or hook material) of the headband 3354 at the desired location. For example, the entire length of the headband 3354 may include hook material, such that there are an unlimited number of locations to position the bilateral connecting member 6136. The patient can adjust this position as needed. For example, the patient can repeatedly connect and disconnect the bilateral connecting member 6136 from the headband 3354. Once connected, the patient can use the headband 3354 like any other headband 3354, and fold the free end of the band back onto itself to connect the exposed side of the bilateral connecting member 6136 to the headband 3354 (e.g., in use, both sides are connected to the respective headband 3354).

[0958] Because the bilateral connecting member 6136 can include the same connecting material on either side, the patient can connect either side to the headband 3354.

[0959] In some configurations, the double-sided connecting member 6136 can be used in conjunction with the headband 3354, which would otherwise lack a fixed connector.

[0960] like Figure 41-7 As shown, the bilateral connecting member 6136 can be positioned in a first location (e.g., near the free end of the various straps). This can result in a longer usable length of the headband strap 3354. For example, a patient with a large head can attach the bilateral connecting member 6136 to the first location to achieve a proper fit.

[0961] In the first position, individuals with smaller heads may overstretch the headband 3354 to achieve a proper fit. Therefore, the patient can move the bilateral connecting members 6136 to the second position (i.e., away from the free ends of the various straps, such as...). Figure 41-8 (As shown). This results in a smaller usable length, allowing patients with smaller heads to achieve a close fit using the same headband 3354 without excessive tension.

[0962] In some configurations, the patient can cut off the free end of the band beyond where the bilateral connecting members 6136 are located. In other configurations, the excess free end can be retained, allowing different patients (e.g., with different head sizes) to readjust the bilateral connecting members 6136 to fit their heads.

[0963] In some forms, the double-sided connecting member may have a hook material on one side and a ring material on the other side, so that the two sides are functionally different.

[0964] like Figure 27-2 As shown, certain forms of rings 3352a, 3352b may include eyelet incisions 3353, which may be formed on the patient side of each ring 3352a, 3352b (e.g., the side closer to the patient's skin during use). The eyelet incisions 3353 may form a region of reduced thickness along the periphery of each ring 3352a, 3352b. The eyelet incisions 3353 may extend around a portion of the periphery of each ring 3352a, 3352b (e.g., less than 360°). In the illustrated example, when received through rings 3352a, 3352b, the corresponding headband 3354 may contact the eyelet incisions 3353. The reduced thickness of the eyelet incisions 3353 may result in less material being used to manufacture rings 3352a, 3352b, which may lead to reduced manufacturing time and / or lower manufacturing costs. The eyelet incisions 3353 may also (or instead) result in reduced skin scarring and improved patient comfort.

[0965] In one configuration, at least one of the loops 3352a and 3352b may not be formed entirely around the outer periphery. In other words, loops 3352a and 3352b may be C-shaped and / or U-shaped. The upper left and / or upper right headbands 3356 and 3358 may be individually folded relative to themselves and then inserted into the corresponding loops 3352a and 3352b. This allows the patient to maintain the same length adjustment in each of the upper headbands 3356 and 3358 when the sealing structure 3100 is removed from the therapeutically effective position.

[0966] like Figure 35-2As shown, some forms of the frame 3350 include a ring 3352 with a raised profile. For example, the illustrated ring 3352b includes a raised portion 3390 near the arm 3362b. The sleeve 6124 can be bent due to its connection to the arm 3362b. The raised portion 3390 can reflect the curvature of the sleeve to provide a more constant interface between the ring 3352b and the sleeve 6124.

[0967] The protrusion 3390 may include a circle (e.g., a semicircle). In some forms, the protrusion 3390 may protrude from about 0.01 mm to about 1 cm. In some forms, the protrusion 3390 may protrude from about 0.05 mm to about 5 mm. In some forms, the protrusion 3390 may protrude from about 0.1 mm to about 3 mm. In some forms, the protrusion 3390 may protrude from about 0.5 mm to about 1.5 mm. In some forms, the protrusion 3390 may protrude from about 1.2 mm.

[0968] like Figures 52 to 54 As shown, another example of a frame 3350 includes a ring 6080. In the illustrated example, the ring 6080 may include a double-eyelet shape. For example, each ring 6080 may include the shape of two adjacent rings 3352a, 3352b, with a partition wall 6084 formed between them. The partition wall 6084 may divide the ring 6080 into a first ring segment 6080-1 and a second ring segment 6080-2. The first ring segment 6080-1 may be adjacent to a corresponding arm 3362, and the second ring segment 6080-2 may form the free end of the frame 3350. The partition wall 6084 may not extend completely through the width of the ring 6080, such that each ring 6080 includes a single opening (e.g., if the partition wall 6084 extends completely through, there would be two openings instead). In other words, the first ring segment 6080-1 and the second ring segment 6080-2 are not completely separated, and the belt can move between the two segments. The partition wall 6084 can be formed into two sections, with a central space 6088 in between.

[0969] like Figure 53 As shown, the upper sleeves 3356 and 3358 can be connected to the corresponding ring 6080 in a similar manner to that described above with respect to rings 3352a and 3352b. For example, the upper sleeves 3356 and 3358 can pass through the corresponding ring 6080 and apply a substantially perpendicular force relative to the partition wall 6084 in order to hold the sealing structure 3100 in the proper sealing position.

[0970] Continue to refer to Figure 53The partition wall 6084 helps the patient limit excessive tension of the headbands 3356 and 3358. The width of each headband 3356 and 3358 may be greater than the space between the partition walls 6084. Each headband 3356 and 3358 may rest on the corresponding partition wall 6084 and provide a backward-pointing force when the band is tightened. When the headbands 3356 and 3358 remain slack or within the required tension range, the headbands 3356 and 3358 contact the partition wall 6084 and remain within the corresponding first loop segment 6080-1.

[0971] like Figure 54 As shown, if the user applies excessive tension (e.g., tightening each headband 3356, 3358 at the upper limit of the required tension range), the headbands 3356, 3358 can move into the second loop segment 6080-2. Due to the excessive tension, the headbands 3356, 3358 may bend or fold. In other words, excessive force pulls each headband 3356, 3358 through the central space 6088 and into the second loop segment 6080-2. The stiffness in the headbands 3356, 3358 can resist this bending movement (e.g., being pulled through the central space 6088), while the applied force remains within or below the required tension range. Once the tension exceeds this range, the applied tension exceeds the stiffness of the headbands 3356, 3358, causing the center of each headband 3356, 3358 to bend (i.e., because the center is not supported by the partition wall 6084). Once the headbands 3356 and 3358 have moved through the central space 6088, they contact the second ring segment 6080-2 and apply a vertical force. The movement of the headbands 3356 and 3358 can alert the patient or a third party (e.g., via visual and / or tactile stimulation) that the headbands 3356 and 3358 are being pulled too tight. The patient can then loosen the headbands 3356 and 3358 and reposition them against the corresponding partition wall 6084.

[0972] Since the upper headbands 3356 and 3358 do not require as much stretching in the second ring segment 6080-2, their tension can also be reduced by moving from the first ring segment 6080-1 to the second ring segment 6080-2. This can temporarily reduce the tension in each of the upper headbands 3356 and 3358. However, it may not prevent a further increase in tension.

[0973] like Figure 55As shown, certain forms of the frame 3350 may include a ladder lock 6092 instead of a ring (any one of rings 3352a, 3352b, or 6080). Headbands 3356, 3358 may pass through the corresponding ladder lock 6092 to tighten the sealing structure 3100 against the patient's face. In some forms, the ladder lock 6092 may be molded to the arm 3362 of the frame 3350. In other instances, the ladder lock 6092 may be a separate element (e.g., if two straps are joined together, for example, in the upper region of the patient's head). For example, the housing 3371 may include a ladder lock 6092.

[0974] like Figure 56 As shown, certain forms of the frame 3350 may include a stop 6096 that can facilitate adjustment of the length of the headbands 3356, 3358. The stop 6096 may be attached to any arm 3362 and used in place of a ring (e.g., rings 3352a, 3352b, or ring 6080). Each headband 3356, 3358 may pass through the corresponding stop 6096. The stop 6096 may include a spring-loaded button 6100 that holds the corresponding headband 3356, 3358 in place. The patient can actuate the button 6100 and move the corresponding headband 3356, 3358 (e.g., tighten or loosen) to establish a proper fit. For example, the housing 3371 may include the stop 6096.

[0975] like Figures 24 to 28 As shown, some forms of the frame 3350 include a central portion 3360 connected to the inflation chamber 3200. The central portion 3360 may have an annular shape and may have a profile corresponding to the shape of the inflation chamber 3200 (e.g., approximating a dome curvature).

[0976] In one configuration, a single-sized central portion 3360 can be used with various sizes of inflatable chambers 3200 and / or sealing structures 3100. For example, the sealing structure 3100 can have multiple sizes (e.g., small, medium, large, etc.) and / or shapes (e.g., narrow, wide, etc.) to better seal patients with various facial shapes. Regardless of the size of the inflatable chamber 3200 and / or the sealing structure 3100, the engagement area of ​​the central portion 3360 can remain substantially the same. Therefore, the central portion 3360 can be coupled to pads of various shapes and / or sizes and provide substantially the same support.

[0977] In one configuration, the central portion 3360 can be removably attached to the air chamber 3200. The patient can use the same frame 3350 with multiple air chambers 3200. This can be useful when a patient is starting treatment for the first time and is trying different sizes of air chambers 3200 to find a proper fit. Removing the frame 3350 may also be helpful when cleaning the patient interface 3000, as the different components of the patient interface 3000 can be cleaned individually to help ensure a more thorough cleaning.

[0978] In other forms, different frames with central portions of different sizes and / or shapes can be used with inflatable chambers of different sizes and / or patients of different sizes to provide a comfortable fit for a variety of patients. Figures 36 to 39 As shown, the central portions 13360 and 23360 of frames 13350 and 23350 may include shapes to allow for a comfortable seal when used by patients with a large nasal length (e.g., the distance between the apex of the patient's nose and the nasal protuberance measured in the anteroposterior direction).

[0979] like Figure 36 As shown, frame 13350 may include less than Figure 25 The central portion 3360 of the central portion 13360. For example, when the various frames 3350, 13350 are connected to the inflation chamber 3200, the upper rod 16036 on the frame 13350 can be positioned below a similar upper rod 6036. This allows the upper portion of the inflation chamber 3200 (e.g., the nasal portion 3202) and / or the sealing structure 3100 (e.g., the second sealing structure 3102) to move or bend when worn by a patient. This may be helpful for patients with larger noses. Although the higher upper rod 6036 (e.g., as Figure 25 (As shown) can provide more rigid support, but the inflation chamber 3200 and / or sealing structure 3100 may not be able to move enough to receive a larger nose. Lowering the height of the upper rod 16036 (e.g., in...) can provide more rigid support, but the inflation chamber 3200 and / or sealing structure 3100 may not be able to move enough to receive a larger nose. Figure 36 (Middle) provides flexibility and a better fit for patients with larger noses.

[0980] like Figures 37 to 39As shown, frame 23350 may include a central portion 23360 having an upper rod 26036, which is not in the same plane as the rest of the central portion 23360. For example, the upper rod 26036 may extend forward from the rest of the central portion 23360 (e.g., when connected to the inflation chamber 3200). Thus, the upper rod 26036 may be spaced apart from the nasal portion 3202 of the inflation chamber 3200. The central portion 23360 may include a coverage area substantially similar to the central portion 3360, such that it can be used with the same inflation chamber 3200. However, the spacing between the inflation chamber 3200 and the upper rod 26036 may allow the inflation chamber 3200 and / or the sealing formation 3100 to further deform and comfortably receive a larger nose.

[0981] In some configurations, the upper bar 26036 can still provide support for the patient during use. For example, due to wearing the patient interface 3000, the patient may deform the nasal portion 3202 of the inflation chamber 3200, causing the nasal portion 3202 to contact the upper bar 26036. The upper bar 26036 can be far enough in the neutral (i.e., unworn) position to allow the nasal portion 3202 to expand comfortably when the patient is wearing it, but in contact with the upper bar 26036, which provides support and limits excessive bending of the nasal portion 3202. This can mimic the frame 3350, but its size is advantageous for patients with larger noses.

[0982] In some forms, frame 3350 includes an arm 3362 extending away from the central portion 3360. Rings 3352a and 3352b are formed at the ends of the arm 3362. In use, the arm 3362 may extend at least partially in a rearward direction, which may position the rings 3352a and 3352b further rearward than the inflation chamber 3200 and / or the sealing formation 3100. The arm 3362 may also extend in a lateral direction (e.g., to the left or right, respectively) to generally follow the contours of the patient's face.

[0983] In some forms, when a patient wears the patient interface 3000, the arm 3362 engages with a portion of the patient's face. For example, the arm 3362 may contact the patient's cheek. The shape of the arm 3362 may correspond to the curvature of the patient's face (e.g., extending backward and laterally).

[0984] In some configurations, the arm 3362 may not be significantly stretched due to tension applied by the corresponding headbands 3356, 3358 via the corresponding rings 3352a, 3352b (e.g., the arm 3362 may be rigid and / or may be non-extendable). Tension may be transmitted along the arm 3362 to the inflation chamber 3200 and / or the sealing structure 3100 to maintain effective therapeutic pressure and limit leakage.

[0985] In one form, the arms 3362 are constructed from a more flexible material than the material used to construct the central portion 3360. These two materials can be molded together, allowing the frame 3350 to be constructed as a single, integral structure. The arms 3362 can have a degree of rigidity to help maintain their shape. However, the arms 3362 can be flexible, allowing the patient to adjust their shape to correspond to their facial structure. Allowing the patient to adjust the shape of the arms 3362 can increase patient comfort, which can increase patient adherence to the therapy. In this way, the arms 3362 can be bent or flexed relative to the central portion 3360 (e.g., due to the cantilever construction), but may not be able to stretch further in the rearward direction (e.g., due to their non-stretchability). Additionally, the relatively flexible material used to construct each arm 3362 can help reduce facial traces and increase patient comfort.

[0986] In one configuration, the arms 3362 and the central portion 3360 are constructed of the same material. This material provides sufficient flexibility to allow for shape adjustment and sufficient rigidity to maintain the adjusted shape. Due to its connection to the inflation chamber 3200, the central portion 3360 can be more rigid than the arms 3362. Additionally or alternatively, the central portion 3360 can be thicker than the arms 3362, which may also result in increased rigidity of the central portion 3360. Each arm 3362 is formed in a cantilever shape, such that the ends near the corresponding rings 3352a, 3352b are unsupported. Furthermore, the thickness of the frame 3350 can decrease along the length of each arm 3362 in the direction of the respective rings 3352a, 3352b (e.g., see...). Figure 27-1 This allows each arm 3362 to have the flexibility required for bending and / or shaping, so as to substantially correspond to the shape of the patient's face (e.g., cheek). Reducing the width of each arm 3362 also reduces cheek contact between the corresponding arm 3362 and the patient's cheek, which can improve patient comfort. Reducing the width along the length of each arm 3362 also allows for greater flexibility near each corresponding ring 3352a, 3352b.

[0987] In one configuration, sleeve 6124 can be used in conjunction with arm 3362 to provide additional comfort to the patient. For example... Figure 42-1 As shown, sleeve 6124 can extend substantially along the length of the two arms 3362. For example, each sleeve 6124 can extend from the fixed end of each arm 3362 to a central portion 3360 near the frame 3350. Each sleeve 6124 can extend toward the free end of each arm 3362 to a ring 3352 (or 6080) near the frame 3350.

[0988] In the illustrated example, sleeve 6124 may not cover the central portion 3360 or ring 3352 (or 6080) of frame 3350. In this way, sleeve 6124 may not obstruct the strap connection to ring 3352, and / or may not obstruct the connection of central portion 3360 to inflation chamber 3200. In other examples, sleeve may be used with central portion 3360 (e.g., to give patient interface 3000 a bedding appearance).

[0989] In some forms, the sleeve 6124 can be constructed of a comfortable material, which may be flexible and / or soft to the touch. As described above, the arm 3362 can be bent and / or shaped to conform to the shape of the patient's face (e.g., the patient's cheek). As a result, at least a portion of the arm 3362 is in close contact with the patient's skin. By including the sleeve 6124, the patient's skin can be in contact with a material that is comfortable to wear for extended periods. This material can be fabric and / or foam, or any similar material.

[0990] In some forms, the sleeve 6124 may be constructed of an elastic material. This allows the sleeve to stretch on the ring 3352, enabling the sleeve 6124 to be removed from the arm 3362 (e.g., for cleaning). In other instances, the sleeve 6124 may be wound around the arm 3362 by a hook, loop, magnetic, or mechanical connection. This connection can be disconnected to remove the sleeve 6124 from the arm 3362.

[0991] In one embodiment, each ring 3352 may include a protrusion 3390 having a circular shape. The protrusion 3390 may include a smooth surface in the direction from the ring 3352 toward the arm 3362, which allows the sleeve 6124 to slide past the ring 3352 without being hooked. The end 3392 of the protrusion 3390 near the arm 3362 may be formed as a protrusion or overhang. This can limit the sleeve from sliding in the opposite direction (i.e., by sliding on the ring 3352 and disengaging from the ring frame 3350).

[0992] In other forms (not shown), arm 3362 may be present only on the inner surface of arm 3362 (e.g., the surface including sector 3373 (e.g., see...)). Figure 27 The sleeve includes a comfort material. This can be a piece of material attached to the surface that contacts the patient's skin during use, rather than a sleeve. This material can be attached to the arm 3362 with an adhesive and can be removed and / or replaced with a new material sheet (e.g., a clean material sheet).

[0993] In some forms, the fixed end of each arm 3362 may have a thickness between approximately 2 mm and approximately 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 2.5 mm and approximately 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 3 mm and approximately 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 4 mm.

[0994] In some forms, the free end of each arm 3362 may have a thickness between approximately 0 mm and approximately 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 0.5 mm and approximately 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 1 mm and approximately 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 2 mm.

[0995] like Figure 27-3 As shown, the cross-section of each arm 3362 can be substantially rectangular in some forms. The corners of the generally rectangular shape (e.g., one corner, two corners, four corners, etc.) can be rounded. This can help improve patient comfort by reducing the number of sharp surfaces in contact with the patient's skin. Each arm 3362 can also have a height greater than its thickness. The height can be designed to comfortably distribute pressure on the patient's skin (e.g., by increasing the height) without obstructing the patient's peripheral vision or otherwise causing discomfort.

[0996] In some configurations, the height of each arm 3362 can be between approximately 5 mm and approximately 15 mm. In some configurations, the height of each arm 3362 can be between approximately 6.5 mm and approximately 13.5 mm. In some configurations, the height of each arm 3362 can be between approximately 8 mm and approximately 12 mm. In some configurations, the height of each arm 3362 can be between approximately 9.5 mm and approximately 10.5 mm. In some configurations, the height of each arm 3362 can be approximately 10 mm.

[0997] like Figure 35As shown, some forms of the frame 3350 may include ribs 3394 on the arms 3362, which may extend from the lower surface of each arm 3362. Each arm 3362 may include at least one rib 3394. For example, the illustrated frame 3350 includes one rib 3394 on each arm 3362, wherein the rib 3394 is positioned near the central portion 3360 of the frame 3350. In other instances, each arm 3362 may have more than one rib 3394, and / or the ribs 3394 may be positioned at different locations along the length of the arm 3362 (e.g., near the respective rings 3352 and / or on different surfaces of the arm 3362).

[0998] In some forms, each rib 3394 may include a circular profile (e.g., having a semi-circular shape). Circular profiles can reduce or limit discomfort caused by sharp or angular shapes.

[0999] As described above, the sleeve 6124 can be positioned around each arm 3362 to provide additional comfort to the patient. The dimensions of the arm 3362 (e.g., the thickness, height, and cross-section described above) provide a surface around which the sleeve 6124 can extend. However, in some instances, the sleeve 6124 may be larger than the arm 3362 (e.g., due to its passage through the ring 3352) and may droop over the corresponding arm 3362. For example, the height of the arm 3362 may be greater near the ring 3352. This may appear and / or feel uncomfortable to a patient wearing the patient interface 3000. Ribs 3394 on each arm 3362 can provide additional height (and / or thickness, depending on the positioning of the ribs 3394) to the corresponding arm 3362 to extend the sleeve 6124 and minimize slack (e.g., to match the height of the arm 3362 near the ring 3352).

[1000] The smooth contour of rib 3394 can prevent sleeve 6124 from being hooked and / or torn on rib 3394. It also allows sleeve 6124 to be attached to or removed from arm 3362 without damaging sleeve 6124.

[1001] like Figure 26-4 and Figure 26-5 As shown, certain forms of the frame 3350 allow for pivoting motion between each arm 3362 and the central portion 3360. This pivoting motion can differ from the bending motion described above because the pivot point 6012 connects each arm 3362 to the central portion 3360 and allows the entire arm 3362 to move by substantially the same angular distance. As mentioned above, in addition to pivoting, each arm 3362 is also capable of bending.

[1002] In one configuration, pivot point 6012 is positioned at approximately the same location on either side of frame 3350. In other words, each arm 3362 can be connected to the central portion 3360 at substantially the same height, and each arm 3362 can extend approximately the same length past pivot point 6012. This allows the patient to make mirror adjustments to the arms 3362. The patient can then individually flex or bend each arm for adjustment on one side.

[1003] In one configuration, each pivot point 6012 is a movable hinge. In other words, the frame 3350 can be constructed of a substantially uniform material (or the transition between each arm 3362 and the central portion 3360 can be constructed of a substantially uniform material). The thickness at each hinge 6012 can be significantly less than the thickness of the arm 3362 and the central portion 3360 immediately adjacent to the hinge 6012. For example, the hinge 6012 can be formed as a recess on the surface of the frame 3350 facing away from the patient during use. Constructing the hinge 6012 uniformly and integrally from substantially the same material as the arms 3362 and the central portion 3360 can help reduce manufacturing costs (e.g., compared to hinges constructed from different materials).

[1004] Each arm 3362 can pivot about the corresponding hinge 6012 between a first position and a second position. Rings 3352a and 3352b can be closer together in the second position than in the first position.

[1005] In one configuration, the first position can be a relaxed position, and the second position can be an offset position. When an external force is applied, arm 3362 can move to the second position, and when the external force is removed, it can return to the first position.

[1006] In one configuration, arm 3362 can also be positioned in either a first or second position without the need for continuous external force. Arm 3362 can be moved to the second position such that arms 3362 overlap each other (e.g., like eyeglasses). This can help to provide a smaller footprint for packaging and / or storage.

[1007] In other forms (not shown), each arm 3362 may be detached from the central portion 3360 and may be coupled to the central portion 3360 via a rotary hinge (e.g., a pin joint). In yet another form, each arm 3362 may be coupled to the central portion 3360 by overlaying a molded flexible element therebetween, which may allow some pivoting movement.

[1008] In some forms, the frame 3350 also includes at least one secondary connection point 3364 spaced apart from the rings 3352a, 3352b. The secondary connection point 3364 provides additional connection locations that can further facilitate the indirect connection of the headgear strap 3354 to the inflation chamber 3200 and / or the sealing formation 3100.

[1009] In some configurations, frame 3350 includes two secondary connection points 3364 (e.g., left secondary connection point 3364a and right secondary connection point 3364b). When the patient wears patient interface 3000, the secondary connection points 3364a and 3364b may be located below rings 3352a and 3352b. Headband 3354 may also include a lower left headband 3366 and a lower right headband 3368, each configured to engage with the corresponding secondary connection points 3364a and 3364b. Headband 3354 as a whole is capable of providing force to the upper and lower regions of the sealing structure 3100 and / or the inflation chamber 3200.

[1010] In some configurations, secondary connection points 3364a and 3364b are formed directly on the central portion 3360. When the patient wears the patient interface 3000, the secondary connection points 3364a and 3364b can be positioned further forward than the rings 3352a and 3352b.

[1011] In some forms, the secondary connection points 3364a and 3364b can be constructed from a single component, which can help reduce processing and / or manufacturing costs.

[1012] In some forms, the left and / or right lower headbands 3366, 3368 are removably coupled to corresponding secondary connection points 3364a, 3364b. The secondary connection points 3364a, 3364b may be magnetic, and the left and / or right lower headbands 3366, 3368 may pass through a housing 3371, which includes a magnet 3370 having the opposite polarity to the secondary connection points 3364a, 3364b. The housing 3371 may be flexible or semi-rigid to aid coupling and better retain the magnet in the coupled position. The lengths of the left and / or right lower headbands 3366, 3368 can be adjusted by folding the respective bands 3366, 3368 themselves around a crossbar 3386 (e.g., as done with the left and / or right upper headbands 3356, 3358). In addition, the lower headbands 3366 and 3368 may include a first width 3359 and a second width 3361. Figure 41The straps shown can be similarly used as part of the lower headbands 3366, 3368. Therefore, the lower headbands 3366, 3368 may include a stop having a second width 3361 to prevent or limit over-tension. In some forms (not shown), the housing 3371 may include a pair of rings, and the crossbar 3386 may not extend entirely between the two rings. Therefore, the housing 3371 may include... Figures 52 to 54 The shape described herein can similarly alert the patient when the lower headbands 3366 and 3368 are overstretched. This can be used in conjunction with, or instead of, the lower headbands 3366 and 3368 having a first width 3359 and a second width 3361.

[1013] Alternatively or additionally, the lower left and / or right headbands 3366, 3368 may include a point 6128 and / or a cut edge 6132 as shown on the upper headbands 3356, 3358 (see, for example). Figure 41-1 and Figure 41-2 The description of point 6128 and / or cut edge 6132 on the upper headband can also be applied to the lower headbands 3366 and 3368 to remind the patient that the band is too tight.

[1014] In other instances, ladder lock 6092 and / or stop 6096 may be connected to frame 3350 to provide adjustment for lower headbands 3366, 3368.

[1015] Each magnet 3370 can be removed from the corresponding secondary connection points 3364a, 3364b without altering the length adjustment of the left and / or right lower headbands 3366, 3368. The patient can put on and / or take off the patient interface 3000 while removing the magnet 3370 only from the corresponding secondary connection points 3364a, 3364b (e.g., without removing the left and / or right upper headbands 3356, 3358 from the corresponding rings 3352a, 3352b).

[1016] like Figure 28-1 and Figure 28-2 As shown, each secondary connection point 3364a, 3364b can be constructed to improve the holding force with the corresponding magnet 3370. The housing 3376 of each secondary connection point 3364a, 3364b may include a substantially planar (e.g., flat) surface 3378 and a lip 3380 extending from the planar surface 3378.

[1017] In the illustrated example, the outer shell 3376 may have a generally elliptical shape, and the lip 3380 may extend to a vertex near the planar surface 3378. The lip 3380 may also extend only a portion of the planar surface 3378 (e.g., less than 360°). In some examples, the lip 3380 may extend less than 180° around the planar surface 3378 (e.g., the lip 3380 may not extend to any common vertex of the generally elliptical planar surface 3378).

[1018] like Figure 28-2 As shown, each secondary connection point 3364a, 3364b can be connected to the frame 3350, such that the lip 3380 is positioned close to the center of the frame 3350. In other words, each secondary connection point 3364a, 3364b can be oriented such that when the frame 3350 is connected to the inflation chamber 3200, the lip 3380 is positioned close to the bend 3500.

[1019] Magnet 3370 includes a planar surface that can engage with a planar surface 3378 of housing 3376. While engaging planar surface 3378, magnet 3370 can be magnetically coupled to magnetic elements 3382 at secondary connection points 3364a, 3364b. A dangling portion 3384 can be spaced apart from magnet 3370. As shown, dangling portion 3384 can be positioned on one side (e.g., inner side) of lip edge 3380, and magnet 3370 can be positioned on the other side (e.g., outer side) of lip edge 3380. In use, the patient can adjust the length of each of the lower headbands 3366, 3368. Tightening one of the lower headbands 3366, 3368 can apply a force away from the center of frame 3350 (e.g., in a laterally outward direction). This force can be greater than the magnetic force between magnet 3370 and magnetic element 3382, and may cause magnet 3370 to move relative to planar surface 3378.

[1020] The dangling portion 3384 prevents the magnet 3370 from detaching from the magnetic material 3382 due to tightening of the lower headbands 3366, 3368. When the magnet 3370 begins to move, the dangling portion 3384 can contact the lip edge 3380, thereby limiting further movement away from the center of the frame 3350. The engagement between the lip edge 3380 and the dangling portion 3384 thus helps reduce accidental detachment of the magnet 3370 from the corresponding secondary connection points 3364a, 3364b when the lower headbands 3366, 3368 are tightened, but does not limit the patient's ability to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., to remove the positioning and stabilizing structure 3300).

[1021] like Figures 29 to 35As shown, other constructions can be used to improve the holding force between the connection points 3364a, 3364b and the corresponding magnet 3370. Figures 29 to 35 The forms described in the text can be used individually or in any combination thereof. Figures 29 to 35 Any form described herein may also be used with Figure 28-1 and Figure 28-2 The lip edge 3380 shown is used in conjunction with this.

[1022] like Figure 29 and Figure 30 As shown, the oral cavity portion 3201 of the inflation chamber 3200 may include at least one clamp support 6016. Figure 29 As shown, the clamp support 6016 can be disposed radially outward of the groove 3280, near the edge of the oral cavity portion 3201. In some embodiments, the second clamp support 6016 can be disposed on the other side of the inflation chamber 3200, and... Figure 29 The clamp support 6016 shown is in a mirror position. When the frame 3350 is connected to the inflation chamber 3200, the clamp support 6016 can be spaced apart from the frame 3350 (and therefore spaced apart from the connection points 3364a, 3364b).

[1023] like Figure 29 As shown, some forms of clamp support 6016 can be spaced apart from the recess 3280 such that the distance between the respective connection points 3364a, 3364b and the clamp support 6016 is approximately the length of the housing or connecting member 3371. In other words, the overhang 3384 (e.g., see...) Figure 28-2 ) and crossbar 3386 (for example, see Figure 28 The length between them is approximately the length between each connection point 3364a, 3364b and the clamp support 6016.

[1024] Continue to refer to Figure 29 Some forms of clamp support 6016 may protrude from the surface of the oral cavity portion 3201. The clamp support 6016 may be integrally formed with the oral cavity portion 3201 as a single structure (e.g., using an injection molding process). Therefore, the clamp support 6016 may be formed from the same material as the oral cavity portion 3201. For example, the clamp support 6016 may be constructed of silicone material and may be flexible, bendable, and / or compressible. An increased thickness of the clamp support 6016 (e.g., compared to the rest of the oral cavity portion 3201) may limit the flexibility, bendability, and / or compressibility of the clamp support 6016. The increased thickness may also allow the clamp support 6016 to function as a further rigid member (e.g., in addition to the frame 3350) to further increase the stiffness of the oral cavity portion 3201.

[1025] In some forms, the clamp support 6016 may also be curved or extend along an arcuate path. For example... Figure 29 As shown, the clamp support 6016 may include a constant curvature (although a varying curvature may be used). The center of curvature may be the location of the respective connection points 3364a, 3364b.

[1026] like Figure 46 As shown, in some forms, the clamp support 6016 can be connected to the recessed rib 6052 and can be formed as a single molded part. The shape can be changed along the length to form the clamp support 6016 and the recessed rib 6052 separately. In other forms, the clamp support 6016 can be spaced apart from the recessed rib 6052.

[1027] like Figure 30 As shown, frame 3350 can be connected to oral cavity portion 3201, and magnet 3370 can be connected to corresponding connection points 3364a, 3364b. The end of connecting member 3371 near crossbar 3386 can extend upward and / or slightly beyond the corresponding clamp support 6016. In some forms where connecting member 3371 is rotatable relative to frame 3350, the rotation of connecting member 3371 can substantially follow the curvature of clamp support 6016, such that connecting member 3371 extends the same distance relative to clamp support 6016 throughout its angular motion.

[1028] In some forms, the height of the clamp support 6016 above the oral cavity portion 3201 can be less than the distance between the crossbar 3386 and the oral cavity portion 3201. Therefore, the crossbar 3386 and the clamp support 6016 can be slightly spaced apart in a neutral position. This spacing provides a gap around the crossbar 3386 for each lower strap 3366, 3368. Once the respective lower straps 3366, 3368 are connected to the respective connecting member 3371, the connecting member 3371 can be substantially close to or in contact with the clamp support 6016. This can limit or prevent the connecting member 3371 from swaying and / or pivoting toward the surface of the oral cavity portion 3201. If the lower straps 3366, 3368 are tightened, the lip 3380 and the overhang 3384 (e.g., see...) Figure 28-2If the connection member 3371 is not fully engaged, and / or if the patient presses the connecting member 3371 near the crossbar 3386 (e.g., while the patient is sleeping), swaying or pivoting may occur. In the case including the clamp support 6016, the crossbar 3386 contacts the clamp support 6016 before any significant swaying or pivoting movement. Therefore, if the patient inadvertently contacts the connecting member 3371 while sleeping, the magnet 3370 can remain connected to the corresponding connection points 3364a, 3364b, thereby helping to ensure that the seal-forming structure 3100 remains in its proper position. During use, the clamp support 6016 can be at least partially covered, allowing the patient interface 3000 to maintain its compact appearance.

[1029] like Figure 31 As shown, another form may include a clamp support 6020 on the frame 3350 instead of on the inflation chamber 3200. The clamp support 6020 may be integrally formed with the frame 3350. The clamp support 6020 and the frame 3350 may be constructed of the same material, or different materials may be used to construct each (e.g., separate materials may be introduced into the mold to form the clamp support 6020). The shape of the clamp support 6020 may be substantially similar to that of the clamp support 6016. For example, the clamp support 6020 may extend beyond approximately the length of the connecting member 3371 beyond the corresponding connection points 3364a, 3364b. The clamp support 6020 may also extend in a curved or arcuate path, which may include a constant curvature around the corresponding connection points 3364a, 3364b.

[1030] In some forms, the clamp support 6020 may be at least partially flush with the center portion 3360 of the frame 3350. For example, the interface between the proximal end of the clamp support 6020 and the center portion 3360 may be substantially flush, such that the center portion 3360 and the clamp support 6020 each have the same thickness. In other forms, the clamp support 6020 may have a thickness less than that of the center portion 3360. In this case, the clamp support 6020 may be flush with only a portion of the center portion 3360 (e.g., the clamp support 6020 may be flush with the upper or lower edge of the center portion 3360).

[1031] In some forms, the distal end 6021 of the clamp support 6020, opposite the proximal end, may be bent or flexed and extend away from the surface of the oral cavity portion 3201. The bending or flexing at the distal end 6021 may... Figure 29 and Figure 30A protrusion of a similar shape is formed in the clamp support 6016. In other words, the distal portion 6021 can extend the same distance from the surface of the oral portion 3201. Therefore, the engaging connecting member 3371 can be restricted or prevented from swaying or pivoting in substantially the same manner as the clamp support 6016.

[1032] like Figure 32 and Figure 33 As shown, frame 3350 may include at least one rib 6024 near each connection point 3364a, 3364b. Rib 6024 may restrict rotational movement of connection member 3371, which may maintain the desired orientation of lower bands 3366, 3368 (e.g., to maintain proper force vector).

[1033] like Figure 32 As shown, the central portion 3360 of the frame 3350 may include a pair of ribs 6024 near each connection point 3364a, 3364b. In the illustrated example, one rib 6024 may be positioned above each connection point 3364a, 3364b, and another rib 6024 may be positioned below each connection point 3364a, 3364b. In some forms, the ribs 6024 may be evenly spaced around the respective connection points 3364a, 3364b.

[1034] In the illustrated example, the rib 6024 can be substantially rectangular, although any similar shape (e.g., ellipse, circle, triangle, etc.) can be used. The rib 6024 may protrude from the surface of the central portion 3360. In some forms, the rib 6024 may extend to a height substantially equal to the height of the connecting member 3371, although the rib 6024 may extend to a position below the upper surface of the connecting member 3371.

[1035] When connected, each connecting member 3371 is fitted between a corresponding pair of ribs 6024. Each rib 6024 may contact or be substantially close to the corresponding connecting member 3371. This limits or prevents the connecting member 3371 from rotating about a vertical axis passing through each corresponding connection point 3364a, 3364b. This helps maintain the desired orientation of the force vector of each lower band 3366, 3368 and also helps minimize accidental disengagement of the magnet 3370 from the corresponding connection points 3364a, 3364b.

[1036] like Figure 33 As shown, another form of frame 3350 may include ribs 6024 disposed adjacent to each connection point 3364a, 3364b. This form may include only a single rib 6024 associated with each connection point 3364a, 3364b, although it may also include ribs 6024 from... Figure 32A pair of ribs 6024. A single rib 6024 may be configured such that it is approximately aligned with the center of each connection point 3364a, 3364b (e.g., neither higher nor lower than the center of the connection points 3364a, 3364b).

[1037] The connecting member 3371 may include a cutout 6028 located between the overhang 3384 and the crossbar 3386. The shape of the cutout 6028 may substantially correspond to the shape of the rib 6024. When the connecting member 3371 engages the corresponding connection points 3364a, 3364b, the cutout 6028 receives the rib 6024. The rib 6024 may contact the cutout 6028, or substantially proximate the cutout 6028, to prevent or limit rotational movement of the respective connecting members 3371. Thus, a single rib 6024 can achieve substantially the same benefits as multiple ribs 6024.

[1038] like Figure 34 and Figure 35 As shown, connection points 3364a and 3364b may not be formed directly on the central portion 3360 of the frame 3350. Instead, the frame 3350 may include arms 6032 extending radially outward from either side of the central portion 3360. Each arm 6032 may be connected to the frame 3350 at a location substantially the same as the connection points 3364a and 3364b in the previous example (e.g., Figure 28 Each connection point 3364a, 3364b may alternatively be connected to the distal end of the corresponding arm 6032.

[1039] Positioning connection points 3364a and 3364b at the ends of arm 6032 allows for lateral and / or rearward movement of connection points 3364a and 3364b. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the central portion 3360 by approximately 5 mm to approximately 50 mm (e.g., measured along the surface of arm 6032). In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the central portion 3360 by approximately 10 mm to approximately 40 mm. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the central portion 3360 by approximately 20 mm to approximately 30 mm. In some embodiments, connection points 3364a and 3364b on either arm 6032 may be spaced from the central portion 3360 by approximately 29 mm. In some configurations, the connection points 3364a and 3364b on any arm 6032 may be spaced approximately 21 mm apart from the central portion 3360.

[1040] In some forms, arm 6032 can be integrally formed with the central portion 3360 as a single structure. In this example, the central portion 3360 and arm 6032 can be constructed from substantially the same material. In other examples, arm 6032 can be constructed from different materials, but integrally formed with the central portion 3360 (e.g., introducing multiple materials in an injection molding process). In other examples, arm 6032 can be formed using a different process than the central portion 3360 and can be attached to the frame 3350 using attachment means (e.g., adhesives, magnets, mechanical fasteners). In this example, arm 6032 can be permanently attached or it can be removable.

[1041] like Figure 35 and Figure 35-1 As shown, arm 6032 can be substantially flush with the upper surface of the central portion 3360. This helps to enhance the compact aesthetic, as arm 6032 does not protrude beyond frame 3350 in the forward direction. This also helps to promote patient compliance, as the compact design does not significantly obstruct the patient's line of sight.

[1042] Figures 34 to 35-1 Arm 6032 is arranged in a cantilever configuration, such that the distal ends, including connection points 3364a and 3364b, are unsupported. In some instances, arm 6032 may be flexible or semi-rigid and may be capable of bending or flexing. For example, arm 6032 may flex in a posterior direction as the patient tightens the lower bands 3366 and 3368 of the connection. Although arm 6032 may be capable of flexing, the total distance that arm 6032 can flex is likely to be minimal. In this way, arm 6032 can maintain the force vector of the lower bands 3366 and 3368. If arm 6032 flexes, it returns to its original position when the force is removed (e.g., when magnet 3370 is removed from the respective connection points 3364a and 3364b).

[1043] like Figure 35-1 As shown, some forms of the arm 6032 may include a groove 6033, which may be positioned on the front and / or rear surfaces. The groove 6033 can serve as a hinge to help bend the individual arms 6032. Figure 35-1 The frame 3350 can be a separate frame, or the groove 6033 can be combined with it. Figure 34 and / or Figure 35 Within the framework (or any other framework described herein).

[1044] In use, the patient can connect the connecting member 3371 to the corresponding connecting points 3364a and 3364b in a similar manner to when the connecting points 3364a and 3364b are directly connected to the central portion 3360. Therefore, it is unlikely to affect the patient's ability to connect the magnet 3370 to the connecting points 3364a and 3364b. Furthermore, creating wider connecting points 3364a and 3364b (i.e., further spaced from the central portion 3360 of the frame 3350) can limit the possibility of the magnet 3370 accidentally detaching from the corresponding connecting points 3364a and 3364b. For example, the at least partially flexible nature of the arm 6032 allows for bending in the rearward direction, which may limit the swaying of the connecting member 3371 at the corresponding connecting points 3364a and 3364b. Therefore, the magnet 3370 is less likely to detach accidentally, and the seal between the patient's face and the sealing structure 3100 can be better maintained.

[1045] In some forms, arm 6032 may bend or flex relative to the central portion 3360. For example, arm 6032 may bend inward toward the inflation chamber 3200 (and toward the patient's face when the patient interface 3000 is worn). Bending or flexing may be a result of forces acting on the positioning and stabilizing structure 3300 (e.g., tension straps 3366, 3368 may cause bending motion in arm 6032). As a result of bending, arm 6032 may be positioned very close to or in contact with the inflation chamber 3200 and / or the patient's face. This can help reduce the occurrence of swaying or accidental disengagement of magnet 3370.

[1046] In some forms, the connection points 3364a and 3364b on arm 6032 may not include the lip 3380. Instead, connection points 3364a and 3364b may be substantially planar. The displacement of connection points 3364a and 3364b from the central portion 3360, combined with the flexibility of arm 6032, can reduce the likelihood of accidental detachment of the magnet during use. Specifically, the rearward positioning of connection points 3364a and 3364b can reduce the torque on housing 3371 and magnet 3370, which could potentially lead to disengagement.

[1047] like Figure 61As shown, some forms of patient interface 3000 may include a flexible housing 6104 that can removably connect a strap to frame 3350. The flexible housing 6104 may be substantially similar to housing 3371. For example, the flexible housing 6104 may include a magnet 6108 (or a connector of a similar type) for removable engagement with connection points 3364a, 3364b. Additionally, the flexible housing 6104 includes a crossbar 6112 for receiving a strap (e.g., any one of straps 3356, 3358, 3366, 3368). A flexible segment 6116 may be disposed between the magnet 6108 and the crossbar 6112. The flexible segment 6116 may be a thin segment of the flexible housing 6104 and may be capable of elastically bending without breaking. For example, the flexible segment 6116 may bend about a bending axis 6120, causing the crossbar 6112 to pivot relative to the magnet 6108. When the magnet 6108 is connected to the corresponding connection points 3364a, 3364b, bending about the bending axis 6120 may occur due to the tension applied in the strips around the crossbar 6112. Movement about the bending axis 6120 may be preferred over movement of the magnet 6108, preventing the housing 6104 from accidentally detaching from the corresponding connection points 3364a, 3364b. In some forms, the flexible housing 6104 may be used in place of the arm 6032 (e.g., when the connection points 3364a, 3364b are on the central portion 3360). In some forms, the flexible housing 6104 may be used in conjunction with the arm 6032.

[1048] The length of the bendable section 6116 determines the total allowable bending within the bendable housing 6104. A longer bendable section 6116 allows for more bending than a shorter bendable section 6116. In some forms, the bendable section 6116 is between approximately 0.1 mm and approximately 20 mm. In some forms, the bendable section 6116 is between approximately 1 mm and approximately 10 mm. In some forms, the bendable section 6116 is approximately 5 mm.

[1049] like Figure 24 As shown, the engagement area of ​​the inflation chamber 3200 may include a recess 3280. In the illustrated example, the recess 3280 may be included on the oral portion 3201 of the inflation chamber 3200 and may be radially located outside the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the recess 3280. The shape of the central portion 3360 may substantially correspond to the shape of the recess 3280, which may help the patient properly orient the frame 3350 relative to the inflation chamber 3200 (e.g., in an example where the frame 3350 is removably attached to the inflation chamber 3200).

[1050] like Figures 37 to 39As shown, the upper rod 6036 of the central portion 3360 can extend forward from the rest of the central portion 3360 and can be spaced apart from the groove 3280. In other words, the upper rod 6036 can be in contact with the groove 3280 or any other part of the inflation chamber 3200 before use.

[1051] In some forms, the groove 3280 may have a fully formed periphery that is substantially annular in shape. In any size gasket, the periphery may have substantially the same length.

[1052] In some forms, the recess 3280 is recessed relative to the rest of the outer surface of the inflation chamber 3200. The recessed recess 3280 may not extend substantially into the inflation chamber 3200 and may not obstruct the patient's face. The recess 3280 may have substantially the same depth over its entire periphery.

[1053] In some forms, the width of the recess 3280 may be smaller than the width of the central portion 3360 of the frame 3350. The compliant nature of the gasket allows the wider central portion 3360 to be received within the recess 3280. This allows the central portion 3360 to be engaged with the recess 3280 via press-fit, friction fit, and / or snap-fit. The engagement between the recess 3280 and the central portion 3360 can help provide rigidity to the inflation chamber 3200 and / or the sealing structure 3100, as the rigidity of the frame 3350 (e.g., compared to the inflation chamber 3200) may limit some of the flexibility of the inflation chamber 3200 itself.

[1054] In some forms, the liner may be molded to the frame 3350, allowing the recess 3280 to be formed during the molding process. The material of the inflation chamber 3200 (e.g., silicone) may be molded at least partially around the central portion 3360 of the frame 3350, and may restrict the removal of the central portion 3360 from the recess 3280.

[1055] like Figure 25 As shown, frame 3350 can be constructed from multiple pieces of material (e.g., each piece is constructed from a different material). For example, the central portion can be constructed from a first material (e.g., rigid plastic). Arm 3362 can be attached to the central portion 3360 (e.g., via glue, molding, etc.) and can be constructed from a second material that is more flexible than the first material (e.g., flexible plastic, foam, etc.). A third material can be a magnetic material and can be attached to the central portion 3360 (e.g., via adhesive). Once attached, arm 3362 can similarly move within the monolithic structure described above.

[1056] like Figure 26 and Figure 27As shown, frame 3350 can be constructed from a single piece of material. For example, frame 3350 can be constructed from a TPE material, such as Hytrel. As described above, the material used to construct frame 3350 can provide rigidity and flexibility to frame 3350. Magnet 3370 can be overmolded (or otherwise attached to) the central portion 3360.

[1057] In some forms, the central portion 3360 includes a slot 3372, which may be formed on either lateral side of the central portion 3360. The slot 3372 may have a generally elongated shape (e.g., rectangular, elliptical, etc.) and may be formed entirely within the boundary of the central portion 3360.

[1058] like Figure 27 As shown, some forms of the central portion 3360 may include a tapered slot 3372. Specifically, the opening leading to the slot 3372 may be wider near the rear surface of the central portion 3360 (e.g., the surface in contact with the inflation chamber 3200). The opening leading to the slot 3372 may uniformly decrease in size towards the front surface of the central portion 3360.

[1059] Figure 27 The illustration also shows some forms of arm 3362a (or arm 3362b) that may include a recess or fan shape 3373. The fan shape 3373 may be formed on the inner surface of arm 3362a and may be positioned close to the patient's skin when the positioning and stabilizing structure 3300 is worn. The fan shape 3373 reduces the thickness along a portion of arm 3362a and may reduce the likelihood of recesses forming in arm 3362a during manufacturing (e.g., injection molding). The fan shape 3373 may also result in less material being used to manufacture arm 3362a, which may lead to reduced manufacturing time and / or lower manufacturing costs.

[1060] return Figures 26 to 26-2a The inflation chamber 3200 may include protrusions 3284 on the oral cavity portion 3201. The protrusions may be elongated and may have a shape similar to the slot 3372 (e.g., tapered). The protrusions 3284 may be disposed within the recess 3280 such that they mate with the frame 3350 during assembly.

[1061] like Figure 40 As shown, the protrusion 3284 may extend substantially obliquely to the front surface of the inflation chamber 3200. The front surface of the inflation chamber 3200 may be partially curved or angled, and the protrusion 3284 may extend in a non-perpendicular direction relative to this surface, such that the protrusion 3284 is aligned along the insertion direction of the frame 3350. In other words, when the patient interface 3000 is worn, the protrusion 3284 may extend in the anteroposterior direction.

[1062] like Figure 26-2 and Figure 26-2a As shown, some forms of protrusion 3284 may include overhangs 6000 extending at least partially over the recess 3280. The overhangs 6000 may be formed asymmetrically around the periphery of the protrusion 3284. In other words, the overhangs 6000 may extend further over the recess 3280 on one side than on the other. Figure 26-2a As shown, the opposite side 6002 can extend outward and form a slight overhang. For example, with Figure 26-2 Compared to the example shown, the opposite side 6002 can extend from about 1° to about 20° (e.g., 10°), which can increase the length of the opposite side 6002 by about 0.1 mm to about 5 mm (e.g., about 1 mm). This can provide additional holding force for retaining the frame 3350 in the groove 3280.

[1063] like Figure 40 As shown, the top surface of the protrusion 3284 can be slightly inclined, allowing the overhang 6000 to extend substantially parallel to the surface of the recess 3280. This allows a larger portion of the protrusion 3284 to extend over the recess 3280. As described in more detail below, this helps to better retain the frame 3350 within the recess 3280 and limits accidental disengagement.

[1064] In some forms, the recess 3280 may also be asymmetrical. The recess 3280 may include an undercut 6004 and an inclined surface 6008 located on one side of the protrusion 3284. The overhang 6000 may extend further on the undercut 6004 than on the inclined surface 6008. The length of the overhang 6000 extending on the undercut 6004 may limit the ability of the frame 3350 to be removed from the inflation chamber 3200 in the vertical direction. The angle of the inclined surface 6008 may point towards the overhang 6000 and limit the ability of the frame 3350 to be removed in the inclined direction.

[1065] When the frame 3350 is assembled into the inflation chamber 3200 (e.g., via press-fit, friction fit, snap-fit, etc.), the patient can align the protrusions 3284 with the slots 3372 such that the protrusions 3284 are received within the slots 3372 during use. The wider openings near the rear surface of the slots 3372 help the patient align each protrusion 3284 within its corresponding slot. The protrusions 3284 may be slightly wider than the front opening of each slot 3372, but due to the flexible nature of the inflation chamber 3200 (e.g., constructed of an elastic material such as silicone), they can be received within the slots 3372. The protrusions 3284 may deform slightly as they enter their respective slots 3372 (e.g., due to the narrowing of the slots 3372).

[1066] Once the protrusions 3284 have passed through the slots 3372, they can substantially return to their original shape. For example, when the slots 3372 receive the protrusions 3284, the overhangs 6000 may deform (e.g., elastically deform), and once the central portion 3360 is received within the recesses 3280, the overhangs 6000 can return to their initial position. The patient can experience this deformation as a tactile response to more easily observe the proper connection between the frame 3350 and the air chamber 3200. The overhangs 6000 of the protrusions 3284 may be wider than the front opening of the corresponding slots 3372 in the relaxed or initial position.

[1067] Furthermore, the width of the undercut 6004 can be substantially the same as that of the center portion 3360, allowing the frame 3350 to be tightly received within the groove 3280. The flexible material of the inflation chamber 3200 allows the undercut 6004 to be slightly smaller than the center portion 3360, enabling the undercut 6004 to bend and receive the frame 3350 via press fit, friction fit, snap fit, etc.

[1068] Therefore, the frame 3350 may not be easily removed from the inflation chamber 3200. The patient may have to apply force to the frame 3350 to remove it from the recess 3280. This force applied by the user can allow the frame 3350 to move in a vertical or inclined direction and overcome the retention provided by the overhang 6000. For example, the patient can lift the frame 3350 from the area of ​​the contact inclined surface 6008 of the central portion 3360 to provide a force for detaching the frame 3350 from the inflation chamber 3200.

[1069] This force may exceed the force generated by the normal movement of the air chamber 3200 and / or the sealing structure 3100. In other words, the sealing structure 3100 and / or the air chamber 3200 can move relative to the frame 3350 while the protrusion 3284 is received within the corresponding slot 3372. This allows the sealing structure 3100 and / or the air chamber 3200 to flex and conform to the patient's face without detaching from the frame 3350 and without unintentionally causing the slot 3372 to disengage from the protrusion 3284.

[1070] In other forms, the air chamber 3200 can be molded onto the frame 3350, and the protrusion 3284 can be produced by the molding process to permanently maintain the position of the frame 3350 relative to the air chamber 3200.

[1071] like Figure 26-3As shown, some forms of the frame 3350 can be oriented to reduce cheek contact when a patient wears the connected frame 3350 and the air chamber 3200. For example, arms 3362a, 3362b can be oriented (e.g., bent) to substantially conform to at least a portion of the patient's face (e.g., their cheeks). However, in some instances, the entire length of each arm 3362 may not contact the patient's skin, as the patient may feel uncomfortable with a foreign object in contact with their face. Instead, a portion of each arm 3362 may be spaced apart from the patient's face, such that a smaller surface area of ​​the arm 3362 contacts the patient's face. While maintaining substantially the same curvature in each arm 3362, shifting the contact point between each arm 3362 and the air chamber 3200 (e.g., through manufacturing processes) can change the total length of each arm 3362 that contacts the patient's face. For example, if each arm 3362 contacts the air chamber 3200 closer to the bend 3500, the maximum gap between each arm 3362 and the patient's face will be larger. This means that a larger portion of each arm 3362 will be spaced apart from the patient's face (e.g., the opposite of if each arm 3362 were in contact with the inflation chamber 3200 at the distal end of the bend 3500). Less contact between each arm 3362 and the patient's face can improve patient comfort.

[1072] Furthermore, each arm 3362 that contacts the inflation chamber 3200 at a location closer to the bend and thus further away from the rear surface 3112 can provide less support at the transverse portion 3111 of the inflation chamber 3200 (e.g., because the rigid or semi-rigid arms engage the transverse portion 3111 less). Therefore, the transverse portion 3111 can have a greater degree of flexibility and may be able to better conform to the shape of the patient's nose and produce an effective seal.

[1073] like Figure 26-4 and Figure 26-5 As shown, some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the central portion 3360. The hinge 6012 may allow movement of the arms 3362 (e.g., pivoting movement) without affecting the connection between the frame 3350 and the inflation chamber 3200. In other words, pivoting any arm 3362 about the corresponding hinge 6012 may not cause the protrusion 3284 to disengage from the slot 3372.

[1074] In some configurations, the patient can move arm 3362 to a second position to provide a better fit. For example, the distance between rings 3352a and 3352b in the first position may be greater than the size of a typical patient's head. Therefore, the patient can move arm 3362 toward the second position to provide a proper fit (e.g., contact between arm 3362 and the patient's head). By adjusting the upper headbands 3356 and 3358, arm 3362 can be held in the second position (i.e., the upper headbands 3356 and 3358 can provide external force).

[1075] Similar to arm 3362, the inflation chamber 3200 and / or sealing structure 3100 can be larger than the size of a typical patient's face. For example, the sealing structure 3100 can engage the patient's mouth and / or nose without being too tight. The inflation chamber 3200 and / or sealing structure 3100 can also be moved to a more compact position for better engagement with individual patients' faces.

[1076] like Figure 26-5 As shown, moving arm 3362 to the second position may directly result in the sealing structure 3100 and / or the inflation chamber 3200 moving to a more compact position. Arm 3362 may contact the inflation chamber 3200 along the second front wall portion 3242. Arm 3362 may also contact the second front wall portion 3242, near the center of the inflation chamber 3200 and away from the transverse portion 3111.

[1077] The pivoting motion of each arm 3362 about hinge 6012 can provide an inward force to the inflation chamber 3200. This can reduce the distance between the lateral portions 3111 of the second seal-forming structure 3102 and position the second seal-forming structure 3102 close to the patient's nose. Compression of the seal-forming structure 3100 and / or the inflation chamber 3200 can provide a better seal to the patient's face (e.g., by limiting the occurrence of leakage). Additionally, an inward force is applied near the center of the inflation chamber 3200 (e.g., as per...). Figure 26-3 The formation of wrinkles in the sealing structure 3100 can be limited by limiting the total compression of the inflation chamber 3200.

[1078] like Figure 46As shown, the air chamber 3200 may include a recessed rib 6052, which may be positioned in front of the recess 3280 when the patient wears the patient interface 3000. The recessed rib 6052 may be integrally formed with the air chamber 3200 and may be formed together during the molding process. The recessed rib 6052 may protrude forward from the surface of the air chamber 3200 and may form the lower boundary of the recess 3280. The recessed rib 6052 may be thicker than the surrounding portion of the air chamber 3200 and may act as a reinforcing member. The recessed rib 6052 may restrict bending or flexing of the lower portion of the oral cavity portion 3201. This may help maintain the shape of the recess 3280, thereby helping to retain the frame 3350 within the recess 3280.

[1079] like Figure 28 As shown, the shape of frame 3350 can be similar to Figure 26 and Figure 27 The frame 3350 can be constructed from a single material (e.g., one with semi-rigid properties). The frame 3350 can be thicker near the central portion 3360 and thinner toward each corresponding ring 3352a, 3352b.

[1080] In some forms, the central portion 3360 of the frame 3350 may be substantially solid and may not include the slot 3372, and the inflation chamber 3200 may not include the protrusion 3284 within the recess 3280. Instead, the inflation chamber 3200 may include a protrusion 3288 radially disposed within the recess 3280. The protrusion 3288 may protrude from the remainder of the front surface of the inflation chamber 3200. The protrusion 3288 may also extend at least partially in a radially outward direction. In other words, the protrusion 3288 may extend at least partially over the recess 3280 (e.g., the protrusion 3288 is spaced apart from the recess 3280).

[1081] While assembling the removable frame 3350 into the inflation chamber 3200, the patient may need to position the frame 3350 so that it extends into the recess 3280 and below the protrusion 3288. Once the central portion 3260 is positioned, the protrusion 3288 helps hold the central portion 3360 in place. To disengage the frame 3350 from the inflation chamber 3200, the patient may push at least one of the protrusions 3288 (e.g., in a lateral direction toward the other protrusion 3288) so that the protrusion no longer extends over the recess 3280. In other forms, the inflation chamber 3200 may be molded to the frame 3350, and the protrusion 3288 may prevent the central portion 3360 from being removed.

[1082] In some forms, when positioned within the recess 3280, the frame 3350 of any of the above examples can be substantially flush with the outer surface of the inflation chamber 3200. The depth of the recess 3280 substantially corresponds to the thickness of the central portion 3360. Similarly, the shape of the central portion can substantially approximate the shape of the liner as described above. The resulting assembly can have a substantially uniform surface. This helps maintain the low-profile appearance of the patient interface 3000 because the frame 3350 does not protrude in front of the liner, which could otherwise obstruct the patient's view.

[1083] Vent

[1084] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases (e.g., carbon dioxide).

[1085] In some configurations, the airway 3400 is...

Claims

1. A patient interface, comprising: An inflatable chamber, formed entirely of a flexible material, comprising: A cavity capable of being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. An inlet port, configured to provide fluid communication between the cavity and the surrounding environment, and A groove is formed on the surface of the air chamber outside the cavity and exposed to ambient pressure; the groove is formed radially outward of the inlet port and forms a closed periphery. At least one protrusion extending from the groove; A sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure being configured and arranged to maintain the therapeutic pressure within the cavity of the inflatable chamber throughout the patient's respiratory cycle during use, the sealing structure comprising: A first sealing structure is constructed and arranged to sealably engage the area of ​​the patient’s face surrounding the entrance to the patient’s mouth during use; A second sealing structure is constructed and arranged to sealably engage the patient's upper lip and the lower periphery of the patient's nose during use, such that the second sealing structure is configured to contact only the patient's face below the bridge of the nose. A positioning and stabilizing structure configured to maintain the sealing structure in a therapeutically effective position, the positioning and stabilizing structure comprising: A frame connected to the inflation chamber, the frame comprising: The central portion includes an inner periphery and an outer periphery, the inner and outer peripheries being removably positioned within the groove, the inner periphery being configured to be spaced apart from the inlet port when positioned within the groove. The central portion includes at least one slot forming a through-hole in the frame and is configured to selectively receive the at least one protrusion. A pair of upper arms extending in a posterior direction away from the central portion, the pair of upper arms being configured to extend over the patient's cheek during use, and A pair of lower arms, the pair of lower arms extending away from the central portion, and A headband, which is attached to the pair of upper arms and the pair of lower arms of the frame, is configured to provide a pulling force through the frame to the sealing structure into the patient's face.

2. The patient interface according to claim 1, wherein the upper arm is longer than the lower arm.

3. The patient interface according to any one of claims 1 to 2, wherein each of the pair of upper arms includes a first type of connector, and each of the pair of lower arms includes a second type of connector different from the first type of connector.

4. The patient interface according to claim 3, wherein the connector of the first type is selected from the group consisting of a free ring, a ladder lock, and a rope stop.

5. The patient interface according to any one of claims 3 to 4, wherein the connector of the first type is the ring, the ring comprising a first ring portion and a second ring portion adjacent to the first ring portion.

6. The patient interface of claim 5, wherein the ring includes a partition wall that at least partially separates the first ring portion from the second ring portion.

7. The patient interface of claim 6, wherein the strap in the headband is configured to selectively insert into the first ring portion and contact the partition wall under optimal tension during use, and wherein the strap is configured to move into the second ring portion under tension greater than the optimal tension.

8. The patient interface according to any one of claims 3 to 7, wherein the second type of connector is a magnetic component.

9. The patient interface of claim 8, wherein the magnetic component comprises a substantially elliptical shape.

10. The patient interface according to any one of claims 8 to 9, wherein the housing is removably and magnetically connected to the magnetic member.

11. The patient interface of claim 10, wherein the housing includes a strap connector for connecting to a strap of the headgear strap, the strap connector being selected from the group consisting of a free loop, a ladder lock, and a rope stop.

12. The patient interface according to any one of claims 10 to 11, wherein the housing is configured to engage the lip of the outer shell.

13. The patient interface according to any one of claims 3 to 12, wherein at least one of the headbands includes an elastic portion stretchable between a first position and a second position, and wherein the at least one band includes an alert portion configured to be visible in the second position and substantially hidden in the first position.

14. The patient interface of claim 13, wherein the at least one strip further comprises a tactile response element comprising a first portion and a second portion disposed on either side of the alert portion, and wherein the first portion and the second portion of the tactile response element are connected at the first location and configured to separate at the second location to alert the patient.

15. The patient interface of claim 14, wherein the tactile response element is a magnet.

16. The patient interface according to any one of claims 3 to 13, wherein at least one of the headbands comprises a first width and a second width greater than the first width.

17. The patient interface of claim 16, wherein the first width is selectively received through the connector of the first type, and wherein the second width is prevented from passing through the connector of the first type.

18. The patient interface according to any one of claims 3 to 13, wherein at least one of the headbands includes a plurality of raised portions configured to provide a tactile response when passing through a connector of the first type.

19. The patient interface of claim 18, wherein the plurality of protrusions are adhesive dots.

20. The patient interface according to any one of claims 3 to 13, wherein at least one of the headbands includes a cut edge configured to provide a tactile response when passing through a connector of the first type.

21. The patient interface of claim 20, wherein the cut edge comprises a triangle, a rectangle, and / or a circle.

22. The patient interface according to any one of claims 1 to 17, wherein the pair of upper arms and the pair of lower arms are integrally formed with the central portion.

23. The patient interface according to any one of claims 1 to 22, wherein the at least one protrusion comprises a pair of protrusions extending from the groove, and wherein the at least one slot comprises a pair of slots.

24. The patient interface according to any one of claims 1 to 23, wherein the pair of forearms are substantially flush with the central portion.

25. The patient interface according to any one of claims 1 to 24, wherein The groove is disposed below the second sealing structure and on the air chamber opposite to the first sealing structure.

26. The patient interface according to any one of claims 1 to 25, wherein a fabric sleeve is connected to each of the pair of upper arms.

27. A system for providing pressurized air to a patient, the system comprising: Patient interface according to any one of claims 1 to 26; A respiratory therapy system device configured to provide an airflow at the therapeutic pressure; as well as A catheter that connects the respiratory therapy system device to the patient interface, the catheter being configured to deliver the airflow to the patient interface; The conduit is connected to the inlet port of the inflation chamber.

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