Seal-forming structure for patient interface having multiple sealing materials

Abstract

A patient interface includes a seal-forming structure configured and arranged to form a seal with a region of a patient's face surrounding an entrance to a patient's airways. The seal-forming structure includes a first section and a second section. The first section is composed of a first material. The first section is configured to sealingly engage against a first region of the patient's face. The second section is composed of a second material that is different from the first material. The second section is configured to sealingly engage against a second region of the patient's face. The second material is a foam. The patient interface also includes a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims the benefit of Australian Provisional Patent Application No. 2020902681, filed on July 30, 2020, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

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

[0006] 2.2 Description of relevant technologies

[0007] 2.2.1 The Human Respiratory System and Its Disorders

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

[0009] 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 enter the venous blood from inhaled air and carbon dioxide to be expelled 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 but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0010] A range of breathing disorders exist. Some conditions can be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected individuals to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes occurring 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0014] Respiratory failure is a broad term encompassing 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 cover some or all of the following disorders.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without any other known cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0017] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, 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 exertional dyspnea, chronic cough, and sputum production.

[0018] 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, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0019] Chest wall disorders are a group of chest wall 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 during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0021] 2.2.2 Treatment

[0022] 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.

[0023] 2.2.2.1 Respiratory pressure therapy

[0024] 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 braces).

[0025] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air 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 treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, or if so, in any of these ways.

[0026] 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 the work of 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, it can improve the comfort and effectiveness of these treatments.

[0027] Invasive ventilation (IV) provides ventilatory support to patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0028] 2.2.2.2 Flow Therapy

[0029] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In others, 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 therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface to maintain a substantially constant "therapeutic flow rate" throughout the respiratory cycle. The 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 of air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial for secretion management) and the possibility of a moderate increase in airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies with the respiratory cycle.

[0030] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. A physician can prescribe a continuous flow of oxygen-rich gas into the patient's airway at a specified oxygen concentration (21% (part of oxygen in ambient air) to 100%) and a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0031] 2.2.2.3 Supplementing oxygen

[0032] 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 supplemental oxygen therapy (RPT). When oxygen is added to HFT, the resulting treatment is called supplemental oxygen therapy (HFT).

[0033] 2.2.3 Respiratory Therapy System

[0034] 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.

[0035] 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.

[0036] Another form of treatment system is the mandibular repositioning device.

[0037] 2.2.3.1 Patient Interface

[0038] Patient interfaces can be used to connect respiratory equipment to its wearer, for example, by providing an airflow into the airway inlet. 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 treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow-based treatments 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.

[0039] 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 water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0040] Some masks may be clinically disadvantageous for this technology, such as when they block airflow through the nose and only allow it through the mouth.

[0041] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0042] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0043] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The mandible or jawbone can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0044] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the face shield is worn during sleep.

[0045] If patients adhere to treatment, CPAP therapy is very effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to wash (e.g., difficult to assemble or disassemble), patients may not wash their masks, which could affect adherence.

[0046] 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.

[0047] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0048] 2.2.3.1.1 Sealing Formation Structure

[0049] 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.

[0050] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0051] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0052] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. 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.

[0053] 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 and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient 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.

[0054] Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or 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, leading to leakage.

[0055] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0056] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0057] 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.

[0058] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0059] ResMed Ltd. has manufactured the following products that combine 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 WO 2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT...) TM Other aspects of the LT nose pillow); International patent applications WO2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TMOther aspects of the full-face mask); International Patent Application WO2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0060] 2.2.3.1.2 Positioning and Stability

[0061] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0062] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0063] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use.

[0064] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0065] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, 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 therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0066] 2.2.3.3 Air Circuit

[0067] An air circuit is a conduit or tube configured 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 inspiratory and expiratory breathing. In other cases, a single-branch air circuit is used for both inspiratory and expiratory breathing.

[0068] 2.2.3.4 Humidifier

[0069] 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 colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to both heat and humidify the airflow.

[0070] 2.2.3.5 Oxygen Source

[0071] Experts in this field have recognized that exercise provides long-term benefits for patients with respiratory failure, 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 need for mobility has long been recognized. Until recently, this mobility was facilitated by the use of small compressed oxygen cylinders or tanks mounted on vehicles with trolley wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0072] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making ordinary mobile operations difficult and impractical. 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 for mobility, the various systems required to produce oxygen-enriched gas are simplified. 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” bursts, each time timed to coincide with the start of inspiration. This mode of treatment is called pulsed or on-demand (oxygen) delivery (POD), in contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators.

[0073] 2.2.3.6 Data Management

[0074] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is requiring the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0075] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0076] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0077] 2.2.3.5 Mandibular repositioning

[0078] 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 a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0079] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0080] In this type of design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0081] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (such as ResMed Narval CC) are designed to do so. TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.6 Vent technology

[0083] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0084] Ventilation ports may include openings through which air can flow when a mask is used. Many of these ventilators are noisy. Others may become blocked during use, thus providing insufficient flushing. Some ventilators can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0085] ResMed has developed numerous improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0086] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0087]

[0088] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0089] The sound pressure levels for various objects are listed below.

[0090]

[0091] 2.2.4 Screening, Diagnosis and Monitoring System

[0092] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinicians applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0093] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0094] 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 differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. 3. Summary of the Invention

[0096] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0097] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0098] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0099] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0100] One form of this technology includes a patient interface, which includes:

[0101] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0102] A first sealing structure is configured and arranged to seal with an area of ​​the patient’s face surrounding the mouth, thereby allowing an airflow under the therapeutic pressure to be delivered to the mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0103] A second sealing structure is configured and arranged to seal with an area of ​​the patient's face surrounding an inlet to the patient's nose, thereby allowing an airflow under the therapeutic pressure to be delivered to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0104] A ventilation structure that allows continuous airflow of gas exhaled by the patient from inside the inflatable chamber to the surrounding environment, the size and shape of said ventilation structure being determined to maintain therapeutic pressure within the inflatable chamber during use; the patient interface also includes:

[0105] 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.

[0106] In the implementation plan:

[0107] a) A portion of the support part is connected to a portion of the second sealing structure, which abuts against the patient's supralip seal during use;

[0108] b) The support portion is connected to multiple portions of the second sealing structure, which are sealed to the patient's lips during use, and directly to the lower corner of the patient's nose;

[0109] c) When viewed in a section parallel to the sagittal plane, the supporting portion appears curved;

[0110] d) When viewed in a section parallel to the front plane, the supporting portion appears curved;

[0111] e) The inflation chamber includes the mouth and nose;

[0112] f) The boundary between the transverse sidewall portion of each support part adjacent to the mouth and the transverse sidewall portion of the nose is connected to the mouth of the inflation chamber.

[0113] g) The boundary between the front wall portion of each support portion adjacent to the mouth and the front wall portion of the nose is connected to the mouth portion of the shell;

[0114] h) The transverse sidewall portions of the inflation chamber curve inward adjacent to the boundary with the nose, wherein each support portion is substantially adjacent to the adjacent transverse sidewall portion.

[0115] i) The second sealing structure includes at least one nasal opening 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 nasal opening or each nasal opening.

[0116] 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; and / or

[0117] k) The air chamber is at least partially formed by the shell and the shell is provided with a ventilation structure.

[0118] Another form of this technology includes a patient interface that comprises:

[0119] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0120] A first sealing structure is connected to the opening of the inflation 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 mouth, thereby allowing an airflow under the therapeutic pressure to be delivered to the mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0121] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby allowing airflow at the therapeutic pressure to be 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.

[0122] A ventilation structure that allows continuous airflow from the patient's exhaled air from inside the inflatable chamber to the surrounding environment, the size and shape of which are determined to maintain therapeutic pressure in the inflatable chamber during use;

[0123] in

[0124] The first front wall portion of the nose of the air chamber is adjacent to the boundary of the air chamber's opening and is more flexible than the adjacent area of ​​the air chamber's opening. The second front wall portion of the nose of the air chamber is adjacent to the first front wall portion and is located on the side of the first front wall portion opposite to the boundary of the air chamber's opening, and is less flexible than the adjacent portion of the front wall.

[0125] In the example:

[0126] a) The first anterior wall portion is thinner than the adjacent portion of the inflation chamber wall;

[0127] b) The second anterior wall portion is thicker than the adjacent portion of the inflation chamber wall;

[0128] c) The first front wall portion and the second front wall portion are made of the same material;

[0129] d) The first anterior wall portion extends across substantially the entire width of the nose of the inflation chamber;

[0130] e) The second anterior wall portion extends across at least a majority of the width of the nose portion of the inflation chamber;

[0131] f) The first front wall portion extends upward around at least one lateral edge of the second front wall portion;

[0132] g) The second anterior wall portion extends across substantially the entire width of the nose portion of the inflation chamber;

[0133] h) The central portion of the first front wall portion extends further in the upward direction than the transverse portion of the first front wall portion;

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

[0135] j) The lower boundary of the first anterior wall portion is curved; and / or

[0136] k) The air chamber is at least partially formed by the shell and the shell is provided with a ventilation structure.

[0137] Another form of this technology includes a patient interface that comprises:

[0138] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0139] A first sealing structure is connected to the opening of the inflation 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 mouth, thereby allowing an airflow under the therapeutic pressure to be delivered to the mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0140] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby allowing airflow at the therapeutic pressure to be 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.

[0141] A ventilation structure that allows continuous airflow from the patient's exhaled air from inside the inflatable chamber to the surrounding environment, the size and shape of which are determined to maintain therapeutic pressure in the inflatable chamber during use;

[0142] in

[0143] The rear surface of the lateral portion of the second sealing structure slopes upward and forward from the boundary between the first sealing structure and the second sealing structure.

[0144] In the example:

[0145] a) The inclined surface of each transverse section forms an angle between 20 and 90 degrees with the middle contact plane of the cover;

[0146] b) During use, none of the parts of the patient interface came into contact with the patient's wing spine;

[0147] c) Compared to existing interfaces, the interface is configured to prevent, or at least reduce, obstruction of the patient's nasal passages; and / or

[0148] d) The air chamber is at least partially formed by the shell and the shell is provided with a venting structure.

[0149] Another form of this technology includes a patient interface that comprises:

[0150] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0151] A first sealing structure is connected to the opening of the inflation 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 mouth, thereby allowing an airflow under the therapeutic pressure to be delivered to the mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0152] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby allowing airflow at the therapeutic pressure to be 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.

[0153] A ventilation structure that allows continuous airflow from the patient's exhaled air from inside the inflatable chamber to the surrounding environment, the size and shape of which are determined to maintain therapeutic pressure in the inflatable chamber during use;

[0154] in

[0155] The boundary between the first sealing structure and the second sealing structure includes a ridge.

[0156] In the example:

[0157] a) The ridge has a radius of curvature of less than 2 mm;

[0158] b) The ridge extends substantially across the entire boundary between the first sealing structure and the second sealing structure;

[0159] c) In use, the ridge joins the patient's face near the entrance of the nostrils, where the nasal wings meet the face above the lips;

[0160] d) The ridge resists wrinkles formed in the first and / or second sealing structures adjacent to the ridge; and / or

[0161] e) In use, the air chamber is at least partially formed by the shell and the shell is provided with a ventilation structure.

[0162] Another form of this technology includes a patient interface that comprises:

[0163] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0164] A first sealing structure is connected to the opening of the inflation 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 mouth, thereby allowing an airflow under the therapeutic pressure to be delivered to the mouth. The first sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0165] A second sealing structure, connected to the nasal portion of the inflatable chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby allowing airflow at the therapeutic pressure to be 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.

[0166] A ventilation structure that allows continuous airflow from the patient's exhaled air from inside the inflatable chamber to the surrounding environment, the size and shape of which are determined to maintain therapeutic pressure in the inflatable chamber during use;

[0167] in

[0168] At least a portion of the opening of the inflation chamber comprises a flexible shell, wherein the flexible shell is formed of a material with a Young's modulus of less than 0.4 GPa.

[0169] In the example:

[0170] 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.

[0171] b) Connecting at least one component to the flexible housing, wherein at least one component is more rigid than a portion of the flexible housing adjacent to that component;

[0172] c) At least one component includes one or more of the following: a ventilation module; a headband connector; a headband connector connected to the rigid arm; a rigid member; a less flexible housing portion;

[0173] d) At least one component is releasably connected to the flexible housing;

[0174] e) At least one component is permanently connected to the flexible housing;

[0175] f) Overmolding at least one component into a flexible housing;

[0176] g) The flexible shell includes multiple reinforcing sections, the thickness of which is greater than that of the adjacent section of the flexible shell;

[0177] h) At least one component is configured as a reinforcing rib or strip;

[0178] i) The central portion of the opening of the inflation chamber is more rigid than the rest of the inflation chamber; and / or

[0179] j) The air chamber is at least partially formed by the shell and the shell is provided with a venting structure.

[0180] Another form of this technology includes a patient interface that comprises:

[0181] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0182] A sealing structure, configured and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, for sealing the delivery of pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the sealing structure comprising:

[0183] A first segment, made of a first material, is configured to sealably engage with a first region abutting the patient's face, and

[0184] The second section, which is composed of a second material different from the first material, is configured to sealably engage with a second region abutting the patient's face, wherein the second material is foam.

[0185] Positioning and stabilizing the structure to provide the force needed to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0186] In the example:

[0187] a) The primary material is silicone;

[0188] b) The first section is flush with the second section at the transition point;

[0189] c) The inflation chamber includes a mounting surface, and a second section of the sealed structure is connected to the mounting surface;

[0190] d) During use, the mounting surface is substantially flat and substantially perpendicular to the anterior-posterior direction of the patient's head;

[0191] e) The mounting surface is made of a first material;

[0192] f) The first section extends beyond the mounting surface and forms a cantilever relative to the mounting surface;

[0193] g) The drape is configured to contact the patient adjacent to each nasal ala;

[0194] h) The inlet port of the inflation chamber is formed in front of the mounting surface during use, and wherein the second material does not contact the inlet port of the inflation chamber;

[0195] i) The mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient's upper lip so that the patient's philtrum is not covered by the mounting surface.

[0196] j) The first section and the air chamber are integrally formed into a one-piece structure during the molding process;

[0197] k) The air chamber is at least partially made of the first material;

[0198] l) Connect the second section to the inflation chamber using adhesive;

[0199] m) The second section includes varying thickness;

[0200] n) The second segment includes a first thickness and a second thickness greater than the first thickness, wherein the first thickness is adjacent to the second thickness;

[0201] o) The sealing structure is configured to form a seal against the patient's face, wherein the first segment and the second segment are each combined to form part of the seal;

[0202] p) The sealing structure is a nose pad or nose support;

[0203] q) In use, the second section is configured for the patient's nasal ala region;

[0204] r) The sealing structure is a mouth and nose pad, an ultra-compact full-face mask, or a full-face mask;

[0205] s) The first section is configured to contact the patient's nose during use, at least between the patient's nasal protuberance and the patient's subnasal point, and at least between each of the patient's nasal alae;

[0206] t) The second section is configured to contact the patient's mouth during use, at least between the patient's upper lip and lower lip, and at least adjacent to each of the patient's nostrils beyond the width of the patient's mouth;

[0207] u) The beam section of the second segment is configured to contact the patient's lips during use;

[0208] v) At least a portion of the beam is unbacked and configured to move into the inflation chamber when touched by the patient's lips;

[0209] w) The transition section is located between the beam and the first section;

[0210] x) The sealing structure is configured to not seal against the patient's philtrum;

[0211] y) A portion of the second section is configured to seal the area below the patient's nostrils and close to the patient's nasal wings;

[0212] z) The first segment is thinner than the second segment;

[0213] aa) When viewed in cross-section, the second segment has a substantially rectangular outline;

[0214] bb) The second section includes a generally square edge configured to come into contact with the patient during use;

[0215] The essentially square edges are configured to contact the vicinity of the nasal ala at the junction of the patient's nasal corner area and the patient's lips; and / or

[0216] The first segment is configured to receive a first component of the force and the second segment is configured to receive a second component of the force, wherein the first segment and the second segment are configured to apply the same sealing force to the patient when the first component is less than the second component.

[0217] Another aspect of this technology includes a patient interface comprising:

[0218] An inflatable chamber, formed of a first material and pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, includes an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe, and includes a mounting surface.

[0219] A sealing structure, configured and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, is used to seal the delivery of pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The sealing structure includes:

[0220] A first segment, made of a first material, is configured to sealably engage with a first region abutting the patient's face, and

[0221] The second section, made of a second material different from the first material, is connected to the mounting surface and configured to sealably engage with a second region abutting the patient's face.

[0222] Positioning and stabilizing the structure to provide the force needed to hold the seal-forming structure in a therapeutically effective position on the patient's head;

[0223] Wherein the mounting surface is recessed by a first distance relative to the first section; and

[0224] The second segment includes a thickness that is substantially equal to the first distance, such that the first and second segments are substantially flush with each other.

[0225] In the example:

[0226] a) The second material is foam;

[0227] b) The primary material is silicone;

[0228] c) The sealing structure is a mouth and nose pad, an ultra-compact full-face mask, or a full-face mask;

[0229] d) During use, the mounting surface is substantially flat and substantially perpendicular to the anterior-posterior direction of the patient's head;

[0230] e) The first section extends beyond the mounting surface and forms a cantilever relative to the mounting surface;

[0231] f) The drapes are configured to be adjacent to each nasal ala in contact with the patient; and / or

[0232] g) The mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient's upper lip so that the patient's philtrum is not covered by the mounting surface.

[0233] Another aspect of this technology includes a patient interface comprising:

[0234] An inflatable chamber, pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, comprising:

[0235] The inlet port of the inflation chamber is sized and structured to receive an airflow under therapeutic pressure for the patient to breathe, and the inlet port has at least one substantially straight side.

[0236] The mounting surface is inclined relative to a substantially straight surface;

[0237] A sealing structure, configured and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, is used to seal the delivery of pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The sealing structure includes:

[0238] A first segment, made of a first material, is configured to sealably engage with a first region abutting the patient's face, and

[0239] The second section, made of a second material different from the first material, is connected to the mounting surface and configured to sealably engage with a second region abutting the patient's face.

[0240] Positioning and stabilizing the structure to provide the force needed to hold the seal-forming structure in a therapeutically effective position on the patient's head;

[0241] The straight surface is configured to be positioned substantially parallel to the patient's sagittal plane during use; and

[0242] The positioning and stabilizing structure is configured to provide greater force to the second section during use due to the position of the straight surface.

[0243] In the example:

[0244] a) The second material is foam;

[0245] b) The primary material is silicone;

[0246] c) The inflation chamber inlet port is the first inflation chamber inlet port, wherein the inflation chamber also includes a second inflation chamber inlet port;

[0247] d) The first section extends beyond the mounting surface and forms a cantilever relative to the mounting surface;

[0248] e) The drapes are configured to contact the patient near each nasal ala;

[0249] f) The mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient's upper lip so that the patient's philtrum is not covered by the mounting surface.

[0250] g) The second section is permanently connected to the mounting surface;

[0251] h) The second section is removably connected to the mounting surface;

[0252] i) The second segment is configured to contact the second region at the patient's upper lip; and / or

[0253] j) The first segment is configured to contact the first region at the wing edge of the patient.

[0254] Another aspect of this technology includes a sealing structure configured and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's airway, for sealing the delivery of pressurized airflow at a therapeutic pressure at least 6 cmH2O above the ambient air pressure throughout the patient's respiratory cycle during use, the sealing structure comprising:

[0255] The first segment, which is made of the first material, is configured to sealably engage with a first region abutting the patient's face, and

[0256] The second section, which is made of a second material different from the first material, is connected to the mounting surface and is configured to sealably engage with a second area against the patient's face, wherein the second material is foam.

[0257] Another aspect of this technology includes a patient interface comprising:

[0258] An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe;

[0259] A sealing structure, configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, is used to seal the delivery of pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use; and

[0260] Positioning and stabilizing the structure to provide the force needed to hold the seal-forming structure in a therapeutically effective position on the patient's head;

[0261] In some forms, a) the first segment is made of a first material, and the second segment is made of a second material different from the first material; b) the first material is configured to contact the patient's face; c) the second material is configured to contact the patient's face; d) the first material is silicone; and / or e) the second material is foam.

[0262] Another aspect of this technology is a mouth-nose patient interface that is more compact and less disruptive to the patient.

[0263] Another aspect of this technology is a mouth-nose patient interface having a nasal pad portion that improves the fit to the lower corner of the nose.

[0264] Another aspect of this technology is a mouth-nose patient interface that reduces obstructive contact on the nose.

[0265] Another aspect of this technology is a mouth-nose patient interface that can self-adjust to accommodate patients with multiple nasolabial angles.

[0266] Another aspect of this technology is a mouth-nose patient interface with a relatively flexible shell.

[0267] 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.

[0268] One aspect of this technology is a method for manufacturing equipment.

[0269] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, a person with limited dexterity, vision, or limited experience in using this type of medical device.

[0270] One aspect of this technology is a portable RPT device that can be carried by a person, for example, in their home.

[0271] One aspect of this technology is a patient interface that can be washed at the patient's home, for example, with soapy water, without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be washed at the patient's home, for example, with soapy water, without the need for specialized cleaning equipment.

[0272] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as processors for dedicated computers, respiratory monitors, and / or respiratory therapy devices. 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.

[0273] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0274] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0276] This technology is illustrated by way of example rather than limitation in the various figures of the accompanying drawings, and similar reference numerals in the drawings refer to similar elements, including:

[0277] 4.1 Respiratory Therapy System

[0278] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is 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 sleeps in a supine position.

[0279] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0280] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0281] 4.2 Respiratory System and Facial Anatomy

[0282] 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.

[0283] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0284] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, lower lip, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. The directions of up, down, radial inward, and radial outward are also indicated.

[0285] 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, subnasal septum, supralipal, sublipal, supramental, nasal ridge, nasal alar apex, upper auricular base, and lower auricular base. The vertical and anteroposterior directions are also marked.

[0286] 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.

[0287] Figure 2FA bottom view of a nose with several distinctive features is shown, including the nasolabial folds, sublipus, vermilion border of the upper lip, nostrils, subseptal point, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0288] Figure 2G A side view showing the surface features of the nose.

[0289] 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.

[0290] Figure 2I The diagram shows the medial anatomy of the nose, approximately a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0291] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0292] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0293] Figure 2L The frontal lateral view of the nose is shown.

[0294] 4.3 Patient Interface

[0295] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0296] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0297] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0298] Figure 3D A schematic diagram of a 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 zero value.

[0299] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0300] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0301] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0302] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0303] 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.

[0304] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0305] 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.

[0306] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0307] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0308] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0309] Figure 3O The left-hand rule is shown.

[0310] Figure 3P The right-hand rule is shown.

[0311] Figure 3Q The left ear is shown, including the left ear spiral.

[0312] Figure 3R The right ear is shown, including the right ear spiral.

[0313] Figure 3S A right-handed spiral is shown.

[0314] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0315] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0316] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0317] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3229). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points. For mouth-nose interfaces configured with inflation chambers having separate mouth and nose sections, such as ultra-compact full-face masks (UCFF), the upper and lower points are located on the sealing formation structure of the mask's mouth section.

[0318] 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 approximately coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, this intermediate contact plane generally corresponds to the 'plane of the face'. 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.

[0319] 4.4RPT device

[0320] Figure 4A An RPT device of one form according to the present technology is shown.

[0321] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to the present technology. Reference is made to the blower and patient interface to indicate upstream and downstream directions. The blower is positioned upstream of the patient interface, and the patient interface is positioned downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are positioned downstream of the blower and upstream of the patient interface.

[0322] 4.5 Humidifier

[0323] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0324] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, showing the humidifier tank 5110 removed from the humidifier tank connector 5130.

[0325] 4.6 Respiratory waveform

[0326] Figure 6 A typical breathing waveform model of a person during sleep is shown.

[0327] 4.7 Patient Interface Examples of This Technology

[0328] Figure 7 This is a rear perspective view of an inflatable chamber according to one form of the present technology, wherein the inlet port is not shown.

[0329] Figure 9 yes Figure 7 A front view of the air chamber.

[0330] Figure 10 yes Figure 7 Side view of the air chamber.

[0331] Figure 11 yes Figure 7 A top view of the air chamber.

[0332] Figure 12 It is the cross section of the air chamber through plane 12-12.

[0333] Figure 13 yes Figure 7 Bottom view of the inflation chamber.

[0334] Figure 14 It is the cross-section of the air chamber through plane 14-14.

[0335] Figure 15It is the cross section of the air chamber through plane 15-15.

[0336] Figure 16 It is the cross-section of the air chamber through plane 16-16.

[0337] Figure 16-1 It is the cross section of the air chamber through plane 16-1—16-1.

[0338] Figure 16-2 yes Figure 16-1 The cross-section of the air chamber shows the air chamber in a deformed position.

[0339] Figure 17 It is the cross-section of the air chamber through plane 17-17.

[0340] Figure 18 It is the cross-section of the air chamber through plane 18-18.

[0341] Figure 18-1 It is the cross section of the air chamber through plane 18-1—18-1.

[0342] Figure 18-2 It is the cross section of the air chamber through plane 18-2—18-2.

[0343] Figure 19 A side view of the inflatable chamber in the use position is shown on the patient's face, with the inflatable chamber shown in outline for clarity.

[0344] Figure 20 The patient's face is shown with a specific area joined by the sealing structure shown.

[0345] Figure 21 This is a front perspective view of another form of patient interface according to this technology.

[0346] Figure 21-1 This is a front perspective view of another form of patient interface according to this technology.

[0347] 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.

[0348] Figure 23 It is a front perspective view of the patient interface with a frame for connecting the headband to the inflation chamber.

[0349] Figure 24 yes Figure 23 A breakdown diagram of the patient interface.

[0350] Figure 25 This is a front view of a frame and an air chamber according to one form of this technology.

[0351] Figure 26 This is a front view of a frame and an air chamber in another form according to this technology.

[0352] Figure 27 yes Figure 26 The rear view of the frame shows the tapered opening.

[0353] Figure 28 This is a front view of a frame and an air chamber according to another form of this technology.

[0354] Figure 29 This is a rear view of the patient interface with foam inserts.

[0355] Figure 30 yes Figure 29 The back perspective view of the patient interface.

[0356] Figure 30A yes Figure 30 The patient interface passes through the cross section of plane 30A-30A.

[0357] Figure 31 yes Figure 29 A side view of the patient interface.

[0358] Figure 31A yes Figure 31 The patient interface passes through the cross section of plane 31A-31A.

[0359] Figure 32 This is a rear view of a patient interface with foam inserts according to another form of the present technology.

[0360] Figure 33 yes Figure 32 A side view of the patient interface.

[0361] Figure 34 This is a rear perspective view of an inflatable chamber, which includes a mounting flange for mounting foam material. The inflatable chamber can be used as a full-face mask.

[0362] Figure 35 yes Figure 34 Side view of the air chamber.

[0363] Figure 36 This is a rear perspective view of the inflatable chamber, which includes a mounting flange for attaching foam material. The inflatable chamber can be used solely as a nose mask.

[0364] Figure 37 This is a rear perspective view of the patient interface, which includes connections to... Figure 36 The foam material of the air chamber.

[0365] Figure 38 yes Figure 37 A side view of the patient interface. 5. Detailed Implementation

[0367] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0368] The following description relates to various instances that may share one or more common features and / or characteristics. 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, in any instance, any single feature or combination of features may constitute another instance.

[0369] When anatomical directional terms such as “anterior,” “posterior,” and “upper” are used in describing aspects and examples of this technology, the direction is interpreted in the context of this technology during patient use. For example, the front side of a patient interface refers to the side of the patient interface that is in front of the patient when the patient wears the interface in the intended manner.

[0370] When a surface or part is described as facing a direction, such as "facing upwards," "facing forwards," etc., the surface or part should be understood to be at least partially facing that particular direction unless the context clearly requires otherwise. If the part generally faces the upward direction, it may also be "facing upwards" even if the part is also partially facing another direction.

[0371] 5.1 Treatment

[0372] 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.

[0373] In some instances of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0374] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0375] 5.2 Respiratory Therapy System

[0376] 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 pressurized air to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0377] 5.3 Patient Interface

[0378] According to one aspect of the present technology, the noninvasive 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 inlet of the patient's airway. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0379] In some embodiments of this technology, the inflation chamber is at least partially formed by the housing 3250. In some embodiments, the housing 3250 or a portion thereof may be slightly flexible, as discussed further below.

[0380] In some instances of this technology, the patient interface is an oronasal patient interface, meaning 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.

[0381] exist Figures 7 to 22 In the example shown, the sealing structure at the nose is not located on the bridge or ridge of the nose on the patient's face, but rather seals against the lower surface of the patient's nose.

[0382] 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.

[0383] 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 environment.

[0384] 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 environment.

[0385] 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 environment.

[0386] 5.3.1 Sealing Formation Structure

[0387] 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 area where a seal actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0388] As described in more detail below, in some forms of the invention, the sealing structure 3100 includes a first sealing structure 3101 connected to the opening 3201 of the inflation chamber and configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's mouth; and a second sealing structure 3102 connected to the nose 3202 of the inflation chamber 3200, configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose. The phrase "connected to" herein is used to refer to parts or components formed as a single piece as well as parts or components formed separately and subsequently joined together. In some cases, components may be connected via intermediate components.

[0389] In some forms, the first sealing structure 3101 seals against the patient's face independently of the second sealing structure 3102.

[0390] 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.

[0391] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0392] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0393] The sealing structure 3100 according to this technology can be made of a soft, flexible elastic material (such as silicone).

[0394] 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 type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0395] 5.3.1.1 Sealing Mechanism

[0396] In one embodiment, the sealing structure 3100 includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure within the inflation chamber 3200, which acts on the underside of the inflation chamber 3200 to promote a tight seal with the face. The pressure-assisted mechanism can act in conjunction with elastic tension in the positioning and stabilizing structure.

[0397] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends 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 a spring-like element or includes a spring-like element and serves to support the sealing flange from bending during use. Limiting the occurrence of bending can prevent the formation of wrinkles in the sealing structure 3100, which can lead to pressure leakage and loss.

[0398] 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, due to elastic tension in the positioning and stabilizing structure.

[0399] In one embodiment, the sealing structure 3100 includes a tensioning portion. During use, the tensioning portion remains taut, for example, through the adjacent area of ​​the sealing flange.

[0400] In one form, the sealing forming structure 3100 includes a region having an adhesive or bonding surface.

[0401] 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.

[0402] 5.3.1.2 Nasal region

[0403] See next. Figures 7 to 18In some forms of this technology, the second sealing structure 3102 includes a central portion 3110 configured to seal the surface of a patient's nose in use. This central portion may seal to the lower periphery of the patient's nose (e.g., around the patient's nostrils) and to the patient's lips. 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 located 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 anterior nasal region.

[0404] like Figure 10 and Figures 16 to 19 As best shown, 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, such that the rear side of the nose portion of the mask slopes forward in the profile.

[0405] 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.

[0406] 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 plane of the mask. The intermediate contact plane may be perpendicular to the sagittal plane and may extend substantially along the length of the ridge 3120 and the chord 3210.

[0407] like Figure 19 As shown, in some embodiments, the lateral portion 3111 is configured such that no part of the patient interface 3000 contacts the patient's wing spine 1020 during use.

[0408] The lateral portion 3111 is configured to tilt in such a way that the portion of the nasal portion of the interface 3000 extending on the side of the nasal ala is smaller compared to some similar interfaces in the prior art. In some forms of this technology, this reduces the size of the nasal ala portion in contact with the sealing structure 3100 relative to an interface having a lateral portion that tilts backward toward the patient's face, thereby reducing the proportion of the nasal ala portion, which can be deformed and blocked by the sealing structure 3100, for example, when the patient sleeps with the side of the interface in contact with a pillow facing it.

[0409] 5.3.1.3 Boundaries of the Mouth and Nose Region

[0410] See details Figure 7 , Figure 8 and Figures 16 to 18In 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 with the patient's face located above the lips and directly below the nose.

[0411] In the implementation, 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.

[0412] A sharper angle reduces the likelihood of wrinkles forming in or near the first sealing structure 3101 and / or the second sealing structure 3102 at or near the corner or ridge 3120 when the mask is worn and treatment is performed. Some oronasal patient interfaces that do not use such structures may require a very thin, rounded structure in this area, which is less wrinkle-resistant. Conversely, the corner or ridge 3120 can be stiffer than such interfaces and can better maintain its shape, and therefore can better seal depressions and wrinkles present around the patient's nose. In embodiments with a support portion, such as the support portion 3260 described herein, which resists or counteracts compression in this area, this effect can be enhanced.

[0413] 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 at the transverse portion.

[0414] 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.

[0415] In some forms of this technology, the corner or ridge 3120 may extend across substantially the entire boundary 3103 between the first sealing structure 3101 and the second sealing structure 3102. In embodiments, such as Figure 20 As shown in region 1010, the corner or ridge 3120 may engage the patient’s face at least near the entrance of the nostril, for example, where the face meets the nasal wing and the lips.

[0416] 5.3.1.4 Port Area

[0417] As described above, in one form, the non-invasive patient interface 3000 includes a first sealing structure that forms a seal around the patient's mouth during use. The first sealing structure 3101 can form a seal on the patient's chin area.

[0418] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the patient's chin area during use.

[0419] The sealing structure 3100 includes a sublipal portion 3130 that forms a seal against the patient's chin region and / or the patient's sublipal portion and / or supramental region. The sublipal portion 3130 may be connected to (e.g., adjacent to) the supralipal portion 3131 via a perioral portion 3132, such as... Figure 16 As shown.

[0420] 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 periphery portion 3132 of the orifice, with 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.

[0421] In some forms of this technology, the orifice 3133 is essentially trapezoidal rather than oval or elliptical in order to more precisely correspond to the shape of the patient's nose. This shape of the orifice allows the interface 3000 to be particularly compact and is substantially no wider than the width of the patient's nostrils.

[0422] 5.3.1.5 Nasal pillow

[0423] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0424] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of the truncated cone and the nasal pillow-connecting structure with displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0425] 5.3.1.6 Foam Sealing Part

[0426] like Figure 29 As shown in Figure 40, some forms of the patient interface 3000 are made of various materials that together form a cavity 3272, which receives pressurized airflow and air exhaled by the patient.

[0427] In some forms, the sealing structure 3100 is composed of a first material 3150 and a second material 3152, the second material 3152 including at least one material property different from that of the first material 3150. The first material 3150 and the second material 3152 cooperate to form a seal. Each of the first material 3150 and the second material 3152 is capable of sealing the patient's face and limiting the leakage of pressurized air from the cavity 3272.

[0428] In some configurations, the sealing structure 3100 is entirely made of the second material 3152, and the inflation chamber 3200 (described below) is made of the first material 3150. The first material 3150 may not come into contact with the patient.

[0429] In some forms, the seal-forming structure 3100 may include separate seals for sealing around the patient's nostrils and for sealing around the patient's mouth. Each separate seal may be made of a different material (e.g., one made of a first material 3150 and the other made of a second material 3152).

[0430] In some forms, the sealing structure 3100 may be composed of a first material 3150 and a second material 3152 throughout the sealing structure 3100. For example, in a mouth and nose mask (i.e., as...) Figures 7 to 23 In the patient interface shown (which seals around the nostrils and mouth), a first material 3150 and a second material 3152 may be included on the portion sealing around the patient's nose and the portion sealing around the patient's mouth. Although they may be included, the first material 3150 and the second material 3152 do not need to be used in equal amounts when forming the seal-forming structure 3100. The first material 3150 and the second material 3152 may be used in specific locations to improve patient comfort and / or enhance the seal.

[0431] In some forms, the first material 3150 is silicone or other similar flexible material. Silicone 3150 can be biocompatible, ensuring patient comfort when using the patient interface 3000. Additionally, silicone 3150 can be flexible and capable of sealing with various facial structures.

[0432] In some forms, the second material 3152 is foam, although it can also be fabric or other similar materials. Like the silicone of the first material 3150, foam 3152 can be biocompatible and will not irritate the patient when in contact with their skin. Compared to the first material 3150, foam 3152 can be softer, lighter, and / or provide additional comfort.

[0433] In some forms, foam 3152 may be incorporated into portions of the sealing-forming structure 3100 that come into contact with areas of the patient's face where movement is possible. For example, these may include areas with various contours, ridges, and / or folds (e.g., nasal alar regions, nasolabial folds, etc.), where foam 3152 may be required to deform in order to effectively seal the patient's face. For example, nasolabial folds are areas where the skin folds and / or wrinkles due to the patient moving their mouth. Foam 3152 can effectively deform to fill folds (e.g., when the patient's mouth is open) and relax to contact the flatter surfaces of the patient's skin (e.g., when the patient's mouth is closed and the folds flatten). This property allows foam 3152 to dynamically adjust to changes in facial contours while maintaining an effective seal (e.g., by substantially eliminating leakage).

[0434] In some forms, foam 3152 is permanently attached to silicone 3150. In other words, foam 3152 may not need to be removed without damaging the patient interface 3000. Foam 3152 may be attached to silicone 3150 using adhesives and / or mechanical fasteners. Alternatively or additionally, silicone 3150 may be molded to foam 3152.

[0435] In some forms, foam 3152 is removably attached to silicone 3150 and can be removed by the patient. The patient can remove foam 3152 and replace it with a separate foam sheet 3152 after a period of time (e.g., to provide clean foam 3152). Depending on patient preference and / or comfort, the patient can also interchange one type of foam 3152 with another type of foam 3152.

[0436] like Figure 29 As shown, the patient interface 3000 includes a full-face mask (e.g., an ultra-compact full-face mask) that surrounds the patient's nostrils and seals around the patient's mouth (e.g., independently or using a single seal).

[0437] In some forms, the second sealing structure 3102 may be made of silicone 3150. In other words, at least a portion of the sealing structure 3100 surrounding the patient's nostril is made of the first material 3150. The first material 3150 may contact at least a portion of the patient's undernose and / or the patient's nasal ala. Additionally, a nostril opening 3135 may be formed through the first material 3150.

[0438] In some forms, the first sealing structure 3101 may be made of foam 3152. In other words, at least a portion of the sealing structure 3100 surrounding the patient's mouth is made of a second material 3152. The second material 3152 may contact the area below the patient's lips and the lateral area beyond the width of the patient's mouth.

[0439] In some forms, the foam of the second material 3152 can be configured to be substantially airtight in order to limit air leakage through the second material.

[0440] In some forms, the foam of the second material 3152 may be permeable, but may be coated with an impermeable material (e.g., a silicone layer). The coating may be applied to the inner surface of the second material 3152 (e.g., the surface within the cavity 3272) so that the patient comes into contact with the second material 3152 without contacting the coating. In other forms, the coating may be applied to the outer surface, either separately or in place of the inner surface.

[0441] In some forms, the supralipal portion 3131 extends between the lateral sides of the sealing forming structure 3100 and can separate the first sealing forming structure 3101 from the second sealing forming structure 3102. The supralipal portion 3131 contacts the patient's upper lip during use and can be composed of foam 3152.

[0442] In one configuration, the supralipal portion 3131 does not apply any sealing force to the patient's lips during use. Only the outer periphery of the seal-forming structure 3100 forms a seal with the patient's face. Therefore, the first seal-forming structure 3101 and the second seal-forming structure 3102 can cooperate to form a seal around the patient's nostrils and mouth.

[0443] In one embodiment, the supralipal portion 3131 applies a sealing force to the patient's lips during use. The position of the supralipal portion 3131 between the first sealing structure 3101 and the second sealing structure 3102 allows it to facilitate the formation of a seal around both the nostrils and the mouth. Even when a seal is formed individually around each opening, the patient's nostrils and mouth are in fluid communication with the cavity 3272 of the inflation chamber 3200.

[0444] like Figures 30 to 31A As shown, the first sealing structure 3101 and the second sealing structure 3102 can be flush with each other. In other words, there can be a substantially smooth transition between the first sealing structure 3101 and the second sealing structure 3102. A smooth transition can be comfortable for the patient and thus improve patient compliance because there is no substantially sharp or otherwise uncomfortable transition between the two materials.

[0445] like Figure 30AAs shown, the second material 3152 can be thicker than the first material 3150. This can improve the impermeability of the second material 3152 and / or improve patient comfort. Because the first material 3150 can be thinner than the second material 3152, the first material 3150 can be flush with the second material 3152 across its entire width. Alternatively, the first material 3150 can be flush at the corner or spine region 3120. This region 3120 can be angled as described above to improve sealing without causing substantial discomfort. Alternatively, the spine region 3120 can be completely smooth, such that it has a constant radius of curvature on either side of the spine region 3120. The first material 3150 can be flush with the second material 3152 only on the patient contact side and can be not flush with the second material 3152 within the cavity 3272.

[0446] In some forms, the transition may be located at the boundary 3103 between the second sealing structure 3102 and the upper lip portion 3131. See details. Figure 31 The upper lip portion 3131 includes a curvature that substantially corresponds to the curvature of the second sealing forming structure 3102 and also corresponds to the curvature of the remaining portion of the first sealing forming structure 3101. A smooth, continuous surface may extend between the first sealing forming structure 3101 and the second sealing forming structure 3102 (e.g., without serrated and / or discontinuous portions).

[0447] like Figure 32 As shown, the first sealing structure 3101, including the upper lip portion 3131, can be constructed from a single piece of foam 3152. In other words, the entire first sealing structure 3101 is a single piece and can move together. This can facilitate the assembly of the sealing structure 3100 because constructing the first sealing structure 3101 as a single piece reduces the number of parts and limits the possibility of incorrect positioning of the parts relative to each other.

[0448] 5.3.1.6.1 Shape of the foam

[0449] In some forms, the foam 3152 of the first sealing structure 3101 may include an annular shape to provide an opening for receiving the patient's mouth. As described above, the foam 3152 contacts the area around the patient's mouth to seal around the opening. The patient may desire a minimal width for the first sealing structure 3101 (e.g., the distance between the inner and outer diameters) because less material in contact with the patient's face can improve patient comfort and compliance.

[0450] In some forms, the sealing periphery of the first sealing formation 3101 is minimized to maximize patient comfort and compliance. Reducing the sealing periphery (e.g., as close as possible to the width of the mouth, and / or the upper and / or lower vermilion border, while still maintaining a seal around the patient's mouth) can lessen the sensation of the patient wearing the medical device.

[0451] Reducing the size of the sealing perimeter also reduces the volume of cavity 3272. Because less airflow is needed in cavity 3272 to achieve the desired pressure, this improves system efficiency.

[0452] Therefore, if the outer diameter is already at its minimum (e.g., to construct the minimum seal circumference), the inner diameter can be adjusted to reduce the total contact area between the patient and the first seal forming structure 3101.

[0453] like Figure 32 As shown, by increasing the inner diameter of foam 3152 (i.e., to reduce the width), the orifice 3133 receiving the patient's mouth becomes larger (e.g., compared to...). Figure 29 (Compared to) Larger orifices 3133 can improve patient comfort because they increase the space between the mouth and the foam 3152. This allows the patient to move their lips without actually contacting the foam 3152.

[0454] The foam 3152 in the first sealing structure 3101 may include an average width. The width may be substantially the same along the entire periphery of the first sealing structure 3101, such that the width at a given location is substantially the same as the average width. In some forms, the average width may be between about 1 mm and about 20 mm. In some forms, the average width may be between about 5 mm and about 15 mm. In some forms, the average width may be about 10 mm. This may be less than... Figure 29 The average width of the first sealing structure 3101 in the middle can be at least 15 mm.

[0455] In some forms, the width can be entirely along the periphery of the first seal-forming structure 3101, although the average width can still be between about 1 mm and about 20 mm. Variable width allows the first seal-forming structure 3101 to fit various areas of the patient's face and provide increased sealing and / or cushioning in some locations, while providing less sealing and / or cushioning in others.

[0456] In some forms, the first sealing structure 3101 may be formed in a substantially polygonal shape. In some instances, the first sealing structure 3101 may be formed in a substantially trapezoidal shape. The upper lip portion 3131 may be a shorter, substantially parallel side of a substantially trapezoidal shape.

[0457] In some forms, the first sealing structure 3101 may include a varying thickness. For example, the foam 3152 at the upper lip portion 3131 may be thinner than the adjacent foam 3152.

[0458] In some forms, the corners 3153 of the first sealing structure 3101 may be substantially square. This can help reduce the feeling of congestion in the patient's nose and / or mouth caused by foam 3152.

[0459] In some forms, the supralipal portion 3131 may have a curvature. For example, the supralipal portion 3131 may have a positive curvature relative to the patient's nasal septum. The lowest point of the supralipal portion 3131 may be close to the center of the supralipal portion 3131. This curvature may also move the supralipal portion 3131 away from the nostrils and reduce the likelihood of obstruction or other forms of nasal obstruction.

[0460] In one form, only a portion of the supralipal portion 3131 may be curved. For example, a portion of the supralipal portion 3131 may be straight, and a portion of the supralipal portion 3131 may be curved. In other words, only the central portion of the supralipal portion 3131 may have curvature.

[0461] In some forms, the transition 3154 between the straight and curved sections of the supralipal portion 3131 can be sharp. In other words, the transition 3154 can be substantially angled and not smooth. This allows the foam 3152 of the supralipal portion 3131 to more easily enter small gaps in the patient's face (e.g., near the patient's nostrils). This improves the seal because it restricts air escape through these areas. Because the foam 3152 is flexible, the angled shape of the transition 3154 does not cause patient discomfort. The sharp edges of the foam 3152 reduce the feeling of obstruction and thus increase patient compliance.

[0462] However, as mentioned above, alternatively, the surface can be smooth, such as... Figure 31 The example shown.

[0463] like Figure 33 As shown, when viewed from one side (e.g., left or right) or in cross-section, foam 3152 can have a substantially rectangular shape. The rectangular profile can have sharp or angled edges, which can provide the benefit of allowing foam 3152 to more easily enter small gaps in the patient's face (e.g., between the nasolabial fold and the nostrils). In other words, the edges of the rectangular profile facilitate dynamic sealing, allowing foam 3152 to more effectively deform into folds in the patient's skin during formation and return to a relaxed position when flattening, minimizing air leakage from the inflation chamber 3200 to the surrounding environment. Due to the compliant nature of foam 3152, the sharp edges do not cause patient discomfort.

[0464] In some forms, the rectangular outline may have rounded edges, particularly in the area of ​​the foam 3152 configured to contact the patient's face. The rounded edges may not extend completely around the periphery of the first sealing structure 3101, and a portion of the foam 3152 may have spaced edges. The rounded portion may be located near the lower part of the first sealing structure 3101 and may be configured near the patient's mouth. The pointed portion may be located near the upper part of the first sealing structure 3101 and may be configured near the patient's nose.

[0465] 5.3.2 Inflation Chamber

[0466] 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.

[0467] 5.3.2.1 The angle of the nose is adjustable.

[0468] See details Figure 9 , Figure 10 and Figures 16 to 18-2 In one embodiment of this technology, the first anterior wall portion 3240 of the nose portion 3202 of the inflation chamber 3200 is more flexible than the adjacent region of the mouth portion 3201. The first anterior wall portion 3240 may be configured adjacent to the boundary 3241 of the nose and mouth portions of the inflation chamber 3200. In embodiments, the first anterior wall portion 3240 may be symmetrical about the midsagittal plane and may extend across at least 50%, for example, at least 80%, of the width of the nose portion 3202 across the inflation chamber. In some embodiments, the first anterior wall portion 3240 may extend across substantially the entire width of the nose portion 3202 across the inflation chamber.

[0469] In some forms of this technology, the second front wall portion 3242 is less flexible than the adjacent portion of the front wall. In some embodiments, the second front wall portion 3242 is adjacent to the first front wall portion 3240 on the opposite side of the boundary 3241 between the nose and mouth of the inflation chamber. In embodiments, the second front wall portion 3242 may be symmetrical about the midsagittal plane and may extend across at least 50%, for example, at least 80%, of the width of the nose 3202 of the inflation chamber. In some embodiments, the second front wall portion 3242 may extend across substantially the entire width of the nose 3202 of the inflation chamber.

[0470] The flexible first anterior wall portion 3240 allows the patient contact portion 3110 of the second seal forming structure 3102 to pivot or hinge around a region on the rear side of the interface 3000. This can help allow the interface to accommodate the patient at various angles between the base of the nose and the top of the lip (i.e., the nasolabial angle).

[0471] 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 an area at or near the corner or ridge 3120. In embodiments with one or more support portions 3260 (further described below), the hinged or pivoting area may be located directly above the support portion 3260.

[0472] 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 central portion of the boundary is lower than 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 central portion of the first front wall portion 3240 is greater than the height of the transverse portion, as... Figure 9 As shown in the implementation scheme. 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, its resistance to collapse or folding in response to forces on the patient contact portion 3110 of the second sealing forming structure 3102.

[0473] 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 lower than 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.

[0474] In some forms of this technology, besides curved boundaries or as an alternative, 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 21As shown, this reduces the stiffness / resistance to compression or collapse compared to an embodiment in which the first front wall portion 3240 is not formed in this manner.

[0475] The second anterior wall portion 3242 (e.g., strip 3270) helps prevent collapse of the nose portion 3202 and provides 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 an integrally molded housing 3250.

[0476] In some forms, the first front wall portion 3240 and the second front wall portion 3242 may include different thicknesses. For example, the thickness of the second front wall portion 3242 may be greater than the thickness of the first front wall portion 3240, which may increase the stiffness in the second front wall portion 3242 (e.g., compared to the first front wall portion 3240). Specifically, the second front 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 front wall portion 3240 and toward the patient wearing the patient interface 3000. The outer surface of the nose portion 3202 may be substantially smooth, while the inner surface of the nose portion (e.g., within the cavity 3272) may be stepped (or otherwise include discontinuous portions).

[0477] like Figure 16-1 and Figure 16-2 As shown, the first anterior wall portion 3240 can act as a hinge and allow the nose 3202 to bend. The first anterior wall portion 3240 can be the thinnest area of ​​the nose 3202, and therefore most susceptible to bending moments. The increased thickness of the strip 3270 guides 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) also makes the nose 3202 stiffer and less able to bend 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).

[0478] like Figure 18-1 and Figure 18-2As shown, the upper boundary 3243 of the first front wall portion 3240 differs from the lower boundary 3248 of the second front 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 front wall portion 3242. This allows the first front wall portion 3240 to be arranged at least partially adjacent to the strip 3270 (e.g., and around the strip 3270 on two or more sides). In other words, the first front wall portion 3240 can be disposed on at least one end of the strip 3270. This can provide greater flexibility to the first front wall portion 3240, allowing the nose portion 3202 to bend further (e.g., in the forward direction).

[0479] like Figure 21-1 As shown, the nose portion 3202 can also be formed without a hinge. In other words, a strip can be omitted from the second front wall portion 3242, allowing the first front wall portion 3240 and the second front wall portion 3242 to have substantially uniform thickness. The nose portion 3202 can still bend even without the strip because it can be made of silicone, which allows for some compliance in the nose portion 3202 to accommodate different nasolabial angles.

[0480] 5.3.2.2 Flexible Shell

[0481] In some forms of this technology, the housing 3250 may be made of a rigid material, such as polycarbonate. However, in other forms of this technology, the housing 3250, or multiple portions thereof, may be slightly flexible. For example, in some instances, the housing 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 housing 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 housing 3250 may be made of a material with a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0482] In the example, the housing 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, fabric, etc.).

[0483] In some forms of this technology (see, for example) Figures 23 to 28The housing 3250 can be constructed substantially entirely of a flexible material, which provides the housing 3250 with maximum freedom of movement (i.e., substantially no rigid and / or thickened portions restricting bending). The housing 3250 can be flexible enough that one or more components can be added to provide the desired stiffness in one or more regions of the housing 3250 (e.g., the region of contact region 1010). For example, one or more ventilation modules; connection ports; headband connectors; headband connectors connected to rigidification arms and rigidification members can be attached to the housing 3250 in a manner that increases the stiffness of the inflation chamber 3200 in the region adjacent to the components, as described further below. In some forms of this technology, these components can be releasably attached to the flexible housing 3250. Additionally or alternatively, one or more components can be permanently attached to the housing 3250, for example, by bonding and / or overmolding. Rigidification members can also be used to increase stiffness and / or support the shape of the sealing formation 3100.

[0484] In some forms of this technology, the housing 3250 may be generally flexible, but may include reinforcing portions having a greater thickness than adjacent portions of the housing 3250. Such reinforcing portions may be constructed as ribs or strips, for example, extending laterally across the housing and / or vertically; however, many other constructions are also possible. In some forms, the housing may include substantially rigid portions, for example, made of polycarbonate, as well as slightly flexible portions.

[0485] In some embodiments of this technology, the rigidity of the central portion 3251 on the front side of the opening 3201 of the inflation chamber can preferably be greater than that of the rest of the inflation chamber 3200. In some embodiments of this technology, the area of ​​increased rigidity can be just below the nose 3202, such as... Figure 21 As shown and further described below, and / or just above the mouth 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. Increased stiffness in one or more of these regions can stabilize the shape and limit the degree to which the housing 3250 deforms due to head-carrying forces. Excessive deformation can cause the second sealing structure 3102 to obstruct the nostril. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important for patients with narrow noses, or in some cases undesirable. Furthermore, the described regions of increased stiffness can help reduce torsional deformation of the interface, which would otherwise cause one side of the second sealing structure 3102 to lose contact with the patient's nose, thus creating a leakage path.

[0486] like Figure 21 and Figure 21-1As shown, in one form of the present technology, the housing 3250 may be provided with a rigid portion 3263, or at least a portion that is more rigid than the rest of the housing, which is provided with one or more connection ports 3600, for example, molded. In one form of the present technology, the rigid portion 3263 may be made of polycarbonate. This can provide greater rigidity than a housing made solely of silicone. In one form, a technical hole forming a vent 3400 is molded into the rigid portion 3263. In some forms of the technology, a connector 3310 for positioning and stabilizing the structure is mounted on an arm 3320, which provides some rigidity to the housing.

[0487] In one embodiment of this technology, the rigid portion 3263 extends laterally across 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.

[0488] In some forms of this technology, the connection port 3600 may have a substantially elliptical cross-section. 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 adjacent to that port.

[0489] In some forms of this technology, the rigid portion 3263 may project forward relative to the adjacent surface of the first front wall portion 3240 and may be shaped to increase resistance to bending.

[0490] In some forms of this technology (see, for example) 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.

[0491] In some forms of this technology (see, for example) 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.

[0492] Figure 22An air chamber 3200 with a vent mounting port 3410 is shown, into which a suitable venting section or module can be inserted. The venting section can be made of a relatively rigid material to increase the rigidity of the air chamber. In some forms of this art, the shape of the vent mounting port 3410 can be substantially elliptical, wherein the minor axis of the ellipse is substantially parallel to the sagittal plane.

[0493] exist Figure 22 In the embodiment shown, the vent mounting hole is set at the upper boundary of the opening 3201 facing the inflation chamber 3200.

[0494] Figure 22 The illustrated embodiment includes a connector 3310 for positioning and stabilizing the structure. The connector 3310 can be installed 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 headband connector.

[0495] Although Figures 7 to 19 The accompanying drawings of the inflation chamber do not show inlet or connection ports, but those skilled in the art will understand that one or more inlet ports will actually 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.

[0496] In some forms of this technology, the air chamber 3200 is made of a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce the prominence of the patient interface and help improve treatment adherence. The use of transparent materials can help clinicians observe the location and function of the patient interface.

[0497] In some forms of this technology, the air chamber 3200 is constructed of a translucent material, such as translucent silicone. The use of translucent materials can reduce the protrusion of the patient interface and help improve treatment adherence.

[0498] In some forms of this technology, dedicated reinforcing or strengthening members (e.g., without other functions) 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 onto the air chamber 3200 to provide greater rigidity than the rigid portion 3263 of the housing 3250 or the arm 3320.

[0499] 5.3.2.3 Installing the flange

[0500] like Figure 34 and Figure 35 As shown, some forms of the inflation chamber 3200 include a mounting flange or support surface 3290. The mounting flange 3290 can be a substantially flat surface. When worn by a patient, the mounting flange 3290 can be perpendicular to the anterior-posterior direction (e.g., parallel to the patient's sagittal plane).

[0501] In some forms, the mounting flange 3290 includes a first free end 3291 and a second free end 3292 spaced apart from the first free end 3291. Therefore, the mounting flange 3290 may not form a continuous annular shape. When the inflation chamber 3200 is used, the space or gap 3293 between the first free end 3291 and the second free end 3292 can be close to the patient's lips.

[0502] In some forms, the mounting flange 3290 may have a generally C-shaped form, wherein a portion of the mounting flange 3290 extends toward the philtrum of the patient during use.

[0503] In some forms, the mounting flange 3290 may have a substantially U-shaped form, wherein the mounting flange 3290 does not extend toward the philtrum of the patient during use.

[0504] In some forms, the inflation chamber 3200 with mounting flange 3290 is constructed together with the second sealing structure 3102. For example, the inflation chamber 3200 and the second sealing structure 3102 may be made of the same material (e.g., silicone) and may be molded together. In other forms, however, the inflation chamber 3200 may be at least partially made of a material different from that of the second sealing structure 3102 (e.g., rigid plastic). In other forms, the mounting flange 3290 and the second sealing structure may be made of the same material, but the mounting flange 3290 may be thicker or otherwise more rigid.

[0505] In some forms, the second sealing structure 3102 may extend rearward beyond the mounting flange 3290. In other words, the second sealing structure may form a cantilever 3294 relative to the mounting flange 3290.

[0506] In some forms, the second sealing structure 3102 includes two dangling portions 3294 that can be positioned on either lateral side of the patient's nose when the patient wears the patient interface 3000. The dangling portions 3294 of the second sealing structure 3102 may not extend across the gap 3293. Instead, the dangling portions 3294 may extend to corresponding first free ends 3291 and second free ends 3292, such that the width of the gap 3293 is not obstructed by the dangling portions 3294.

[0507] In some configurations, the width of the gap 3293 is approximately the width of the patient's nose. In use, the patient's nose can be fitted into the gap 3293, allowing the drape 3294 to be positioned on either side of the patient's nose. The inner surface of each drape 3294 can contact the patient near the corresponding nasal ala.

[0508] like Figure 35 As shown, the lower surface 3295 of each overhang 3294 can be substantially flat and can be formed perpendicular to the support flange 3290. The upper surface 3296 of each overhang 3294 can be inclined and / or curved, such that the thickness of each overhang 3294 can decrease in the rearward direction. Therefore, the thickness of each overhang 3294 can be greater near the mounting flange 3290 and smaller away from the mounting flange 3290.

[0509] In some forms, the connection port 3600 (described below) can be molded together with the inflation chamber 3200 and the second sealing structure 3102. In other words, the connection port 3600 can be formed as a single piece with the inflation chamber 3200 and can be retained without being removed from the inflation chamber 3200.

[0510] like Figure 31 As shown, some forms of the patient interface 3000 include a connection port 3600 spaced apart from the support flange 3290. For example, when using the patient interface 3000, the connection port 3600 may be positioned further forward than the support flange 3290. In this way, the support flange 3290 may not be obstructed by the connection port 3600 or the air circuit 4170 (described below).

[0511] like Figure 33 As shown, some forms of the patient interface 3000 may include a connection port 3600 that is offset from the vertical orientation (e.g., with a port 3600 that is generally oriented along the vertical direction). Figure 31 (The vertical positioning is opposite). For example, during assembly, the upper end of the connection port 3600 can rotate towards the patient, while the lower end of the connection port 3600 can rotate away from the patient (i.e., along...). Figure 33 (The clockwise direction is shown).

[0512] In some forms, the connection port may have a substantially straight surface 3604, which may be inclined relative to the mounting flange 3290.

[0513] In some forms, the connection port 3600 may be substantially D-shaped, and the straight surface 3604 may be adjacent to the mounting flange 3290.

[0514] The rotating connector port 3600 allows the patient interface 3000 to be worn in a rotated position. For example, when in use, the connector port 3600 can be aligned vertically. Because the connector port 3600 is rotated (e.g., during assembly), the inflation chamber 3200 must be in the opposite direction (e.g., as...). Figure 33 The connector port 3600 is rotated (counterclockwise as shown) (e.g., when worn) to orient the connector port 3600 as described above. This causes the inflation chamber 3200 to rotate away from the patient's nose and towards the patient's mouth. Rotating away from the patient's nose reduces the load experienced by the patient in areas close to their forehead (e.g., around the periphery of the wing) or similar areas where excessive load might be uncomfortable for the patient. It also gives the patient's nose more space within the cavity 3272, preventing the patient's nose from touching or "bottoming out" the surface of the inflation chamber before a proper seal is established.

[0515] For example, such as Figure 33 As shown, the mounting flange 3290 is oriented approximately along the vertical axis of the page. The straight surface 3604 is inclined relative to the vertical direction. In use, the patient interface 3000 can be accessed from... Figure 33 The position shown is oriented towards Figure 19 Rotate the position shown (e.g., along) Figure 33 (in the counterclockwise direction), so that the straight surface of Figure 3604 is more closely aligned with the vertical direction of the page (and can also be substantially parallel to the patient's sagittal plane).

[0516] In this position, the tension provided by the catheter (or the band from the positioning and stabilizing structure 3000) connected to the connection port 3600 can pull the first sealing structure 3101 into the patient's face with greater force than the second sealing structure 3102, which may be more comfortable for the patient.

[0517] 5.3.2.3.1 Connection with the first seal to form a structure

[0518] In some forms, after the inflation chamber 3200 has been constructed (e.g., after the inflation chamber 3200 and the second sealing structure 3102 have been molded together), the first sealing structure 3101 can be coupled to the inflation chamber 3200.

[0519] In some forms, the mounting flange 3290 provides a mounting surface for the first sealing formation 3101. The first sealing formation 3101 can be coupled to the mounting flange 3290 such that it is positioned to contact the patient's face in use. The first sealing formation 3101 can be coupled to the mounting flange 3290 using adhesives (e.g., glue), mechanical fasteners (e.g., snaps, buckles, etc.), magnets, hook and loop materials, or any other similar connection means. Alternatively, a combination of two or more connecting devices can be used.

[0520] like Figure 32 and Figure 33 As shown, the foam 3152 forming the first sealing structure 3101 can be made of a single sheet material. When attached to the mounting flange 3290, a portion of the foam 3152 extends across the gap 3293 between the first free end 3291 and the second free end 3292, such that, unlike the mounting flange 3290, the foam can extend around the entire periphery of the patient's mouth.

[0521] In some configurations, the foam 3152 spanning gap 3293 is unbacked. In other words, the foam 3152 spanning gap 3293 is unsupported and can be moved into and / or out of cavity 3272 of inflation chamber 3200. The remainder of foam 3152 is supported by mounting flange 3290 and does not move freely, although it may be compressed due to contact with the patient's face. For example, as... Figure 31A As shown, the foam 3152 configured to contact the patient's lips is unbacked and therefore movable relative to the rest of the foam 3152 (e.g., its contact mounting flange 3290).

[0522] In use, at least a portion of the upper lip portion 3131 of the first sealing forming structure 3101 spans the gap 3293 and is not supported by the mounting flange 3290. Therefore, the patient's upper lip (e.g., the philtrum) can contact the unsupported portion of the foam 3152. When the patient wears the patient interface 3000, the upper lip portion 3131 can move at least partially into the cavity 3272 (e.g., as a result of a force applied by the patient's upper lip). When the patient removes the patient interface, the upper lip portion 3131 can move in the opposite direction to return to its essentially initial position.

[0523] In some forms, movement of the supralipal portion 3131 can provide additional comfort to the patient wearing the patient interface. For example, the supralipal portion 3131 may be under tension before contact with the patient's supralipal portion. When the patient contacts the supralipal portion 3131, the tension increases and provides a supporting surface for the patient's supralipal portion. Patients with supralipal portions of various sizes can experience substantially similar support (i.e., through tension in the supralipal portion 3131).

[0524] See also Figure 33 The foam 3152 of the first sealing structure 3101 can be substantially flush with the second sealing structure 3102. This can form a substantially continuous surface without discontinuities in order to limit discomfort for the patient wearing the patient interface 3000.

[0525] In some configurations, foam 3152 may contact the lower surface 3295 after being attached to the support flange 3290. Foam 3152 may press against the lower surface 3295 such that there is no gap between the first sealing structure 3101 and the second sealing structure 3102 along either overhang 3294.

[0526] In some forms, foam 3152 and pendant 3294 may extend posteriorly to the same location. In other words, pendant 3294 and foam 3152 may extend to a common plane (e.g., a plane substantially parallel to the patient's coronal plane). This may limit uneven contact of the seal-forming structure 3100 with the patient, which may reduce patient comfort (e.g., because seal-forming structures 3101, 3102 extending further posteriorly may penetrate deeper into the patient's body and cause irritation as the patient continues to push seal-forming structures 3100 toward their face in order to properly orient them). The compliant properties of the materials comprising the first seal-forming structure 3101 and the second seal-forming structure 3102 (e.g., foam and silicone) allow both to compress, such that they maintain a substantially constant surface when the patient interface 3000 is worn. Additionally, since the first sealing forming structure 3101 and the second sealing forming structure 3102 are joined together (e.g., via an adhesive), they typically move together when compressed, even though one material (e.g., foam 3152) may be more compliant than the other (e.g., the compression surface may therefore be inclined and / or curved).

[0527] In use, the foam 3152 of the first sealing structure 3101 can provide patient comfort by using a soft, supple material. The low density and weight of the foam (e.g., compared to silicone, plastic, etc.) can provide additional patient comfort (e.g., because the patient interface 3000 is lighter and more comfortable in contact with the patient's skin). Additionally, the foam 3152 effectively seals the patient's face near the suture area (i.e., corner of the mouth) and / or the nasal alar area (i.e., corner of the nose), where numerous gaps exist that could disrupt the seal. The foam 3152 can deform into these gaps due to contact with the patient's face to restrict air escape from the inflation chamber 3200.

[0528] When worn by a patient, silicone 3150 contacts and at least partially seals around the patient's nostrils, while foam 3152 contacts and at least partially seals around the patient's mouth. As described above, foam 3152 is positioned around the mouth to seal against the complex facial contours present therein. However, the force required to seal with foam 3152 may be greater than with another material such as silicone 3150. Therefore, the patient may have to withstand greater force around their mouth to produce a therapeutically effective seal. The area around the patient's mouth is adapted to handle greater force, so the force required to seal with foam 3152 does not cause discomfort to the patient.

[0529] However, the patient's nose and nasal area may be more sensitive, and the force used to seal foam 3152 onto the patient's face may be comfortable if felt around the nose. Therefore, since a lower sealing force is required to achieve a therapeutically effective seal, silicone 3150 is used to seal around the patient's nostrils. Thus, patient comfort around the nose can be balanced with the sealing effect around the mouth, allowing for the selection of materials that can optimize the seal based on facial morphology and / or sensitivity. Different forces can be achieved by adjusting the upper and lower bands of the positioning and stabilizing structure 3300 separately, such that different components of the total force provided by the positioning and stabilizing structure 3300 are supplied to each material 3150, 3152.

[0530] In some forms, foam 3152 may not be airtight, but it is able to maintain therapeutic pressure within the air chamber 3200 due to mounting flange 3290. In other words, because mounting flange 3290 can be formed of an airtight material (e.g., silicone), air may not be able to reach or pass through foam 3152. Variations in foam 3152 simply allow for a tighter (and more personalized) fit, such that mounting flange 3290 or the second sealing structure 3102 fits snugly against the patient's face.

[0531] In some forms, because the supralipal portion 3131 is not supported by the mounting flange 3290 (or an airtight material like a silicone membrane), air can pass through the supralipal portion 3131. In other words, the seal-forming structure 3100 may not seal the entire supralipal portion of the patient. Specifically, the supralipal portion 3131 may not seal the philtrum of the patient. This can provide additional comfort to the patient because a small surface area of ​​their face is sealed. Because the supralipal portion 3131 (particularly the portion that contacts the philtrum of the patient) is within the outermost perimeter of the seal-forming structure 3100, pressurized air will not leak from the inflation chamber 3200 through the supralipal portion 3131.

[0532] In some configurations, the unbacked upper lip portion 3131 may be thinner than the adjacent foam 3152 that contacts the mounting flange 3290. A thinner upper lip portion 3131 may allow for easier movement into the inflation chamber 3200.

[0533] In some forms, foam 3152 is airtight or supported by an airtight membrane. The airtightness of foam 3152 can be combined with mounting flange 3290 to at least partially seal around the patient's mouth.

[0534] For example, the inner side of foam 3152 may be lined with an airtight material as described above. These sides of foam 3152 form openings to orifice 3133 and are within the pressurized volume when the patient interface is used, but do not contact the mounting flange 3290. An airtight membrane may be applied to restrict the escape of pressurized air from the cavity. However, these surfaces do not contact the patient's skin, so the patient's skin can still contact foam 3152 without contacting the membrane.

[0535] In other forms, at least a portion of foam 3152 may not have an airtight membrane. For example, the supralipal portion 3131 not supported by mounting flange 3290 may be unbacked. When the seal-forming structure 3100 contacts the patient's face, the unsupported section of supralipal portion 3131 lies within the seal periphery, and the seal is unnecessary (e.g., airflow leaking through the unsupported section of supralipal portion 3131 remains within the seal periphery). Additionally, as previously mentioned, a seal against the patient's lips can be uncomfortable. The unsupported section of supralipal portion 3131 does not include a backing membrane, which allows airflow to leak through foam 3152 and contact the patient's lips. This airflow can help cool the patient's skin, making the patient interface 3000 more comfortable.

[0536] like Figures 36 to 38 As shown, foam 3152 may also include a nose-only sealing structure 3100. Foam 3152 can be similarly assembled to the inflation chamber 3200 (e.g., by using an adhesive on the mounting flange 3290), as in the full-face mask described above. Additionally, many benefits of including the foam surface can also be applied. Figures 36 to 38 The patient interface is 3000. At least some similarities and differences are described below.

[0537] Since only the nasal mask does not seal around the patient's mouth (i.e., the patient's upper and lower lips are not located within the inflation chamber 3200), the first material and the second material (e.g., foam and silicone) constitute the first sealing structure 3101.

[0538] In some forms, foam 3152 is secondary to the silicone of the sealing structure 3100. Foam 3152 can contact the patient's lips. Because the outer periphery of the sealing structure 3100 contacts the patient's lips, foam 3152 can seal the patient's philtrum.

[0539] In the illustrated example, foam 3152 may not be provided around the nose opening 3135. In other forms, foam 3152 may not form the periphery of the nose opening 3135. For example... Figure 37 As shown, the first material 3150 can form the periphery of the nose opening 3135, and the length of the first material 3150 can exist between the edge of the nose opening 3135 and the foam 3152. Furthermore, the foam 3152 can contact the mounting flange 3290 and the overhang 3294, so that the foam 3152 does not form the surface of the cavity of the inflation chamber 3200. Therefore, the foam 3152 does not need to be supported by an airtight membrane.

[0540] 5.3.3 Supporting Part

[0541] like Figure 12 and Figures 14 to 18 As best shown, in one form of the technology, the support portion 3260 is disposed on the opposite side of the interface 3000 between the second sealing forming structure 3102 and the front wall of the inflation chamber 3200. For example... Figure 12 As shown, in one example, each support portion 3260 extends to the lateral edge of the interface.

[0542] The support portion 3260 does not function as a lower pad, but is configured to resist or impede compression in the anteroposterior direction. The support portion 3260 thereby supports and / or reinforces portions of the second sealing structure 3102, which engages with the patient's lip. Specifically, as... Figure 20 As shown, the support portion 3260 can support and / or reinforce the area of ​​the second sealing structure 3102, which can contact the area 1010 of the patient's face near the nasal inlet, where the nasal ala meets the area above the upper lip. In other words, the area 1010 can be directly below each lower corner of the patient's nose.

[0543] The support portion 3260 helps ensure that no wrinkles form in the sealing structure 3100. As a result of a very flexible sealing structure, wrinkles can form in the sealing structure, which has a large radius of curvature and conforms to the patient's face. Due to its excessive flexibility, the sealing structure can fold or wrinkle itself, leading to leakage within the sealing structure. Wrinkling may be of particular concern in the case where the sealing structure seals the area 1010 of the patient's face. The support portion 3260 can be particularly advantageous when the sealing structure is configured to produce 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., adjacent region 1010). A sharper curvature allows the second sealing structure 3102 to seal over various gaps around the patient's nose, reducing the likelihood of wrinkles forming.

[0544] Specifically, such as Figures 14 to 16 As shown, in one embodiment of this technology, the support portion 3260 is connected to the front side of the mouth 3201 of the inflation chamber, adjacent to the boundary 3241 between the mouth 3201 and the nose 3202. In some embodiments, when viewed in a cross-section parallel to the sagittal plane (e.g. Figures 16 to 18 (as shown) and / or when viewed in a section parallel to the front plane (e.g.) Figure 14 and Figure 15 As shown), the support portion 3260 may be curved. The curvature may be positive or negative. In the example shown, the curvature may 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 near the boundary 3241 with the nose 3202, and the support portion 3260 may be substantially abutting the adjacent lateral sidewall portion 3245. Figure 18As shown, when viewed in a cross-section parallel to the sagittal plane, the thickness of at least a portion of the support portion 3260 may decrease between the first end 3261 adjacent to the front wall of the inflation chamber 3200 and the second end 3262 adjacent to the seal forming structure 3100. For example, the support portion 3260 may be thicker near the first end 3261, which can help provide increased support and / or stiffness to the second seal forming structure 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).

[0545] 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 at any location along the length) and / or a larger curvature (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 at any location along the length) and / or less curvature (e.g., a larger radius of curvature) support portion 3260.

[0546] Especially Figure 14 and Figure 15 As shown, in one embodiment of the present technology, the support portion 3260 is connected to the opening 3201 of the inflation chamber, adjacent to the boundary between the lateral sidewall portion 3245 of the opening 3201 and the lateral sidewall portion 3246 of the nose 3202.

[0547] In some forms of this technology, the support portion 3260 is shaped to provide a substantially clear flow path from the mouth portion 3201 of the inflation chamber to the nasal orifice 3135 during inhalation. In some forms of this technology, no portion of any support portion 3260 is directly below the nasal orifice 3135.

[0548] 5.3.4 Positioning and Stabilizing Structure

[0549] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0550] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0551] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0552] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0553] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient during sleep. In one instance, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one 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.

[0554] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0555] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0556] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0557] 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.

[0558] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one instance, the strap may be configured as a tie.

[0559] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the base of the upper ear of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0560] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second tether that is configured and arranged such that, in use, at least a portion of the upper edge of the second tether passes below the base of the lower ear on the patient's head and covers or is located below the occipital bone of the patient's head.

[0561] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0562] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt that is flexible and, for example, non-rigid. An advantage of this aspect is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0563] 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.

[0564] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0565] Figure 21 and 22 An embodiment is shown with a connector 3310 (e.g., a magnetic connector) for connection to a positioning and stabilizing structure.

[0566] 5.3.4.1 Framework

[0567] like Figures 23 to 28As shown, frame 3350 is connected to inflation chamber 3200 (e.g., as shown in the diagram). Figures 7 to 19 (As shown) and helps maintain the effective position of the sealing structure 3100 for treatment.

[0568] In some forms, the frame 3350 is made of a rigid or semi-rigid material and provides support for the sealing structure 3100 and / or the air chamber 3200. For example, the frame 3350 can help maintain the shape of the sealing structure 3100 and / or the air chamber 3200 to reduce leakage of pressurized air due to folds and / or wrinkles when the sealing structure 3100 is engaged with the patient's face.

[0569] In some forms, frame 3350 provides at least one connection point 3352 that helps to indirectly connect the headband strap 3354 to the inflation chamber 3200 and / or the sealing formation 3100. Connection point 3352 may be a loop (e.g., having a fully formed periphery) receiving a portion of the headband strap 3354. For example, a length of the upper left headband strap 3356 may pass through the first loop 3352a and be pulled away from the inflation chamber 3200 to apply tension through the upper left headband strap 3356. The upper left headband strap 3356 may be folded against itself and held at a selected length (e.g., using Velcro, magnets, adhesives, etc.) to maintain the applied tension. Similar steps can be performed to adjust the tension in the upper right headband strap 3358 in the second loop 3352b.

[0570] In some forms, each loop 3352a, 3352b can be oriented such that the force vector exerted by the corresponding upper headband straps 3356, 3358 is substantially perpendicular to the inner surface 3351 of the loop in contact with the upper headband straps 3356, 3358. For example... Figure 23 As shown, the upper right headband strap 3358 engages ring 3352b substantially at the center of the inner surface 3351 of the ring. When the upper right headband strap 3358 is tightened, the force vector is applied in a substantially straight 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 oriented along the arm 3362, rather than being inclined relative to the arm 3362, which may require further tightening of the upper headband straps 3356, 3358 to achieve the same sealing effect (e.g., in cases where patient comfort is compromised), and / or may prevent the seal-forming structure 3100 from properly engaging the patient's face (e.g., leading to leakage).

[0571] 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 straps 3356 and 3358 of the upper left and / or right headbands may be individually folded against themselves and then inserted through the corresponding loops 3352a and 3352b. This allows the patient to maintain the same length adjustment in the corresponding upper headband straps 3356 and 3358 when the sealing structure 3100 is removed from the therapeutically effective position.

[0572] In some forms, the frame 3350 includes 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., an approximate dome curvature).

[0573] In one configuration, the single dimension of the central portion 3360 can be used with various sizes of the air chamber 3200 and / or the sealing structure 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 dimensions of the air 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 attached to pads of various shapes and / or sizes, providing substantially the same support.

[0574] In one configuration, the central portion 3360 can be detachably connected to the air chamber 3200. The patient can use the same frame 3350 with multiple air chambers 3200. This can be useful when the patient first begins treatment and tries different sizes of air chambers 3200 to find a proper fit. Removing the frame 3350 also helps when cleaning the patient interface 3000, as the different components of the patient interface 3000 can be cleaned separately to help ensure a more thorough cleaning.

[0575] In some forms, frame 3350 includes arms 3362 extending away from the central portion 3360. Rings 3352a, 3352b are formed at the ends of arms 3362. In use, these arms 3362 may extend at least partially in a rearward direction, which may position the rings 3352a, 3352b further rearward than the inflation chamber 3200 and / or the sealing formation 3100. Arms 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.

[0576] 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 arm 3362 may be shaped to correspond to the curvature of the patient's face (e.g., extending in the posterior and lateral directions).

[0577] In some forms, the arm 3362 may be substantially non-extended due to the tension applied by the corresponding headband straps 3356, 3358 via the corresponding rings 3352a, 3352b (e.g., the arm 3362 may be rigid and / or non-extendable). The 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.

[0578] In one form, the arms 3362 are made of a more flexible material than the material used to construct the central portion 3360. These two materials can be molded together, so that the frame 3350 is constructed as a single, monolithic structure. The arms 3362 may have some stiffness 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 treatment. In this way, the arms 3362 can bend or flex relative to the central portion 3360 (e.g., due to the cantilever configuration), but may not be able to extend further in the posterior direction (e.g., due to their non-extensibility). Additionally, the relatively flexible material used to construct each of the arms 3362 can help reduce facial imprinting and increase patient comfort.

[0579] In one configuration, the arms 3362 and the central portion 3360 are made of the same material. This material provides sufficient flexibility to allow for shape adjustment and sufficient rigidity to maintain the adjusted shape. Since the central portion 3360 is attached to the inflation chamber 3200, it can be more rigid than the arms 3362. Additionally or alternatively, the central portion 3360 can be thicker than the arms 3362, which can also result in increased rigidity. Each arm 3362 is formed in a cantilever shape such that the ends adjacent to 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 corresponding rings 3352a, 3352b. This provides each arm 3362 with the flexibility necessary for bending and / or shaping 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 in accessing each corresponding ring 3352a, 3352b.

[0580] In some forms, the fixed end of each arm 3362 may have a thickness between about 2 mm and about 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 2.5 mm and about 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 3 mm and about 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 4 mm.

[0581] In some forms, the free end of each arm 3362 may have a thickness between about 0 mm and about 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 0.5 mm and about 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness between about 1 mm and about 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 2 mm.

[0582] In some forms, the frame 3350 also includes at least one second connection point 3364 spaced apart from the rings 3352a, 3352b. The second connection point 3364 provides an additional connection location that can further facilitate the indirect connection of the headband strap 3354 to the inflation chamber 3200 and / or the sealing formation 3100.

[0583] In some forms, frame 3350 includes two second connection points 3364 (e.g., left second connection point 3364a and right second connection point 3364b). When the patient wears patient interface 3000, the second connection points 3364a, 3364b may be lower than loops 3352a, 3352b. The headband straps 3354 may also include a lower left headband strap 3366 and a lower right headband strap 3368, both configured to engage with the corresponding second connection points 3364a, 3364b. The headband straps 3354 as a whole are then capable of providing force to the upper and lower regions of the sealing forming structure 3100 and / or the inflation chamber 3200.

[0584] In some configurations, these second connection points 3364a, 3364b are formed directly on the central portion 3360. When the patient wears the patient interface 3000, the second connection points 3364a, 3364b can be positioned further forward than the rings 3352a, 3352b.

[0585] In some forms, the second connection points 3364a, 3364b can be made up of a single component, which can help reduce processing and / or manufacturing costs.

[0586] In some configurations, the left and / or lower right headband straps 3366, 3368 are detachably connected to corresponding second connection points 3364a, 3364b. The second connection points 3364a, 3364b may be magnetic, and the left and / or lower right headband straps 3366, 3368 may pass through magnets 3370 having opposite polarity to the second connection points 3364a, 3364b. The length of the left and / or lower right headband straps 3366, 3368 can be adjusted by folding the corresponding straps 3366, 3368 themselves (e.g., as with the left and / or upper right headband straps 3356, 3358). Each magnet 3370 can be removed from the corresponding second connection point 3364a, 3364b without altering the length adjustment of the left and / or lower right headband straps 3366, 3368. The patient can put on and / or take off the patient interface 3000 while removing the magnet 3370 only from the corresponding second connection points 3364a, 3364b (e.g., it is not necessary to remove the left and / or right upper headband straps 3356, 3358 from the corresponding rings 3352a, 3352b).

[0587] 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 opening 3201 of the inflation chamber 3200 and may be located radially outward of 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 correctly 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).

[0588] 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.

[0589] In some configurations, the recess 3280 is recessed relative to the remainder of the outer surface of the inflation chamber 3200. The recess 3280 may not extend substantially into the inflation chamber 3200 and obstruct the patient's face. The recess 3280 may have substantially the same depth over its entire periphery.

[0590] 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 liner allows the wider central portion 3360 to be received within the recess 3280. This allows the central portion 3360 to be engaged to 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, because the rigidity of the frame 3350 (e.g., compared to the inflation chamber 3200) can individually limit some of the flexibility of the inflation chamber 3200.

[0591] In some forms, the liner can be molded to the frame 3350, allowing the groove 3280 to be created during the molding process. The material of the inflation chamber 3200 (e.g., silicone) can be molded at least partially around the central portion 3360 of the frame 3350, and the central portion 3360 can be restricted from removal from the groove 3280.

[0592] like Figure 25 As shown, frame 3350 can be composed of multiple components (e.g., each component is made of a different material). For example, the central portion can be made of a first material (e.g., rigid plastic). Arm 3362 can be attached to the central portion 3360 (e.g., via gluing, molding, etc.) and can be made of 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 move similarly to the monolithic construction described above.

[0593] like Figure 26 and Figure 27 As shown, frame 3350 can be constructed from a single piece of material. For example, frame 3350 can be made of 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 to (or otherwise attached to) central portion 3360.

[0594] In some forms, the central portion 3360 includes an opening or 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.

[0595] like Figure 27As 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 decrease uniformly toward the front surface of the central portion 3360.

[0596] Figure 27 Some forms of arm 3362a (or arm 3362b) are also shown, which may include a notch or fan-shaped portion 3373. The fan-shaped portion 3373 may be formed on the inner surface of arm 3362a and may be positioned adjacent to the patient's skin when the positioning and stabilizing structure 3300 is worn by the patient. The fan-shaped portion 3373 reduces the thickness along a portion of arm 3362a and may reduce the likelihood of sink marks forming in arm 3362a during manufacturing (e.g., injection molding) processes. The fan-shaped portion 3373 may also result in less material being used to manufacture arm 3362a, which may lead to shorter manufacturing time and / or lower manufacturing costs.

[0597] Back Figure 26 The inflation chamber 3200 may include a protrusion 3284 located on the opening 3201. The protrusion may be elongated and may have a shape similar to the slot 3372 (e.g., conical). The protrusions 3284 may be arranged within the recess 3280 such that they cooperate with the frame 3350 during assembly. When the frame 3350 is assembled to 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 opening of the slots 3372 near the rear surface helps the patient align each protrusion 3284 within the corresponding slot 3372. 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., made of a silicone-like elastic material), the protrusions 3284 can be received within the slots. The protrusions 3284 may deform slightly as they enter the corresponding slots 3372 (e.g., due to the narrowing of the slots 3372). Once the protrusions 3284 have passed through the slots 3372, they may substantially return to their original shape. Specifically, the ends of the protrusions 3284 may become wider than the front opening of the corresponding slots 3372. 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. In other forms, the inflation chamber 3200 may be molded to the frame 3350, and the protrusions 3284 may be produced by the molding process to permanently hold the frame 3350 in position relative to the inflation chamber 3200.

[0598] like Figure 28As shown, the shape of frame 3350 can be similar to Figure 26 and Figure 27 The frame 3350 can be made of a single material (e.g., having semi-rigid properties). The frame 3350 can be thicker near the central portion 3360 and thinner toward each corresponding ring 3352a, 3352b.

[0599] 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. Alternatively, the inflation chamber 3200 may include a protrusion 3288 radially disposed within the recess 3280. The protrusion 3288 may rise 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 above the recess 3280 (e.g., the protrusion 3388 is spaced apart from the recess 3380).

[0600] While assembling the removable frame 3350 into the inflation chamber 3200, the patient may need to position the frame 3350 such 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 above 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.

[0601] In some forms, when positioned within the recess 3280, the frame 3350 of any of the above examples may 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 may substantially approximate the shape of the liner as described above. The resulting assembly may 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, where it might obstruct the patient's view.

[0602] 5.3.5 Vent

[0603] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0604] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0605] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0606] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disintegration structure (e.g., a rotating shaft).

[0607] Although Figures 7 to 18 The ventilation structure is not shown, but Figures 7 to 18 The embodiment of this technology shown may have a suitable ventilation structure, for example, in an inflation chamber ( Figure 21 An example of it is shown in the figure.

[0608] 5.3.6 Dissociated Structure

[0609] In one form, the patient interface 3000 includes at least one disengagement structure 3500, such as a swivel or ball joint and socket. In some instances, the disengagement structure may be an elbow 3500 that connects (e.g., detachably connected, permanently connected, etc.) to the inflation chamber 3200 (e.g., the inflation chamber inlet port).

[0610] like Figures 23 to 28 As shown, the central portion 3360 of the frame 3350 has an annular shape, such that the central region of the opening 3201 of the inflation chamber 3200 is not covered by the frame 3350. In some embodiments, the opening 3201 includes an opening for receiving the elbow 3500. The opening may be significantly wider than the opening for receiving the elbow 3500, such that the frame 3350 is completely spaced from the opening. In other words, there is a length between the inner edge of the central portion 3360 and the opening for receiving the elbow 3500. The arms 3362a, 3362b and the second connecting portions 3342a, 3342b are each spaced from the opening and the elbow 3500, such that the headband strap 3358 does not interfere with the movement (e.g., rotation) of the elbow.

[0611] Although Figures 7 to 19 The air chamber shown in the accompanying drawings is not explicitly depicted, but those skilled in the art will understand that in practice, an elbow 3500 (e.g., as shown in the accompanying drawings) can be provided. Figure 23 (as shown), and allows the interface to be connected to the air circuit 4170.

[0612] 5.3.7 Connection Port

[0613] Connection port 3600 allows connection to air circuit 4170 (e.g., a removable connection via snap-fit, a permanent connection, etc.). Patient interface 3000 may include two connection ports 3600, one on each side of inflation chamber 3200. A catheter may be connected to the connection ports 3600 to deliver pressurized breathable gas to the patient. In some forms, the catheter may be a catheter headband and may contact the patient's head. The catheter may extend toward the coronal portion of the patient's head, where disengagement structure 3500 is located.

[0614] 5.3.8 Forehead Stent

[0615] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0616] 5.3.9 Anti-asphyxiation valve

[0617] In one embodiment, the patient interface 3000 includes an anti-asphyxiation valve 3059.

[0618] 5.3.10 port

[0619] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0620] 5.4RPT device

[0621] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electronic components and is configured to perform one or more algorithms 4300, such as any methods described herein, in whole or in part. The RPT device 4000 can be configured to generate an airflow delivered to a patient's airway, such as for treating one or more respiratory conditions described elsewhere herein.

[0622] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0623] The RPT device may have a housing 4010, an upper portion 4012, and a lower portion 4014 formed in two parts. Furthermore, the housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0624] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0625] One or more air passage components may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of chassis 4016.

[0626] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electronic components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0627] 5.4.1.1 Air Filter

[0628] One form of RPT device according to the present technology may include one or more air filters 4110.

[0629] In one configuration, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0630] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0631] 5.4.1.2 Muffler

[0632] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0633] In one embodiment of this technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0634] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0635] 5.4.1.3 Pressure Generator

[0636] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or supplying air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the entire contents of which are incorporated herein by reference: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0637] The pressure generator 4140 can be under the control of the treatment device controller 4240.

[0638] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0639] 5.4.1.4 Transducer

[0640] The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of it. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that sends or transmits data to or from the RPT device.

[0641] In one embodiment of this technology, one or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. The one or more transducers 4270 may be configured and arranged to generate signals representing airflow characteristics, such as flow rate, air pressure, or temperature at a point in the aerodynamic path.

[0642] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.

[0643] In one configuration, the signal from transducer 4270 can be filtered, such as by low-pass, high-pass, or band-pass filtering.

[0644] 5.4.1.5 Anti-overflow valve

[0645] In one embodiment of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and configured to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0646] 5.4.2 Electronic Components of the RPT Device

[0647] 5.4.2.1 Power Supply

[0648] The power supply 4210 can be located inside or outside the housing 4010 of the RPT device 4000.

[0649] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0650] 5.4.3 RPT Device Algorithm

[0651] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300, which are represented as computer programs stored in a non-transient computer-readable storage medium such as memory 4260. The algorithms 4300 are typically grouped into multiple groups referred to as modules.

[0652] In other forms of this technology, some or all of the algorithm 4300 may be implemented by the controller of an external device (such as a local external device 4288 or a remote external device 4286). In such forms, the input signals and / or intermediate algorithm outputs required to represent the portion of the algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such forms, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program stored in a non-transient computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute portions of the algorithm 4300.

[0653] In this form, treatment parameters generated by an external device via the treatment engine module 4320 (if thus forming part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 for transmission to the treatment control module 4330.

[0654] 5.5 Air Circuit

[0655] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000.

[0656] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0657] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be connected to a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0658] 5.5.1 Supplemental Gas Delivery

[0659] In one form of this technology, supplemental gas (e.g., oxygen) may be delivered to one or more points in the pneumatic path (such as upstream of the pneumatic block), air circuit 4170, and / or patient interface 3000.

[0660] 5.6 Humidifier

[0661] 5.6.1 Overview of Humidifiers

[0662] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), it changes the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0663] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0664] 5.6.2 Humidifier Components

[0665] 5.6.2.1 Water Storage Tank

[0666] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or retain a volume of liquid to be evaporated (e.g., water) for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum volume of water to provide sufficient humidification for at least the duration of respiratory therapy (such as one night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water, such as 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (such as a building's water supply system).

[0667] According to one aspect, the water reservoir 5110 is configured to add humidity to an airflow as it passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate an airflow traveling through the reservoir 5110 in a tortuous path when in contact with a certain volume of water therein.

[0668] According to one form, the storage 5110 can, for example, be along... Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0669] The reservoir 5110 may also be configured to prevent liquid from flowing out of the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any orifice and / or between its sub-components). When the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent pneumatic pressure loss through leakage and / or flow resistance.

[0670] 5.6.2.2 Conducting Part

[0671] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., about 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using a material with lower conductivity and a suitable geometry.

[0672] 5.6.2.3 Humidifier storage container docking parts

[0673] In one embodiment, the humidifier 5000 may include a humidifier reservoir interface 5130 (e.g., Figure 5B As shown, the humidifier reservoir interface is configured to receive humidifier reservoir 5110. In some arrangements, the humidifier reservoir docking member 5130 may include locking features, such as a locking lever 5135, which is configured to retain the reservoir 5110 in the humidifier reservoir docking member 5130.

[0674] 5.6.2.4 Water level indicator

[0675] Humidifier reservoir 5110 may include, for example Figures 5A to 5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as a patient 1000 or a caregiver) regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion (such as 25%, 50%, or 75%) of water, or a volume such as 200 ml, 300 ml, or 400 ml.

[0676] 5.7 Respiratory waveform

[0677] Figure 6 A typical breathing waveform model of a person during sleep is shown. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume Vt 0.5L, inspiratory time Ti 1.6s, and peak inspiratory flow rate Q. 峰值 0.4 L / s, expiratory time Te 2.4 s, peak expiratory flow rate Q 峰值 -0.5 L / s. The total duration of respiration, Ttot, is approximately 4 seconds. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), with a ventilation volume (Vent) of approximately 7.5 L / min. The typical duty cycle (the ratio of Ti to Ttot) is approximately 40%.

[0678] 5.8 Breathing Therapy Mode

[0679] The disclosed respiratory therapy system can achieve various respiratory therapy modes, including CPAP therapy and bilevel therapy.

[0680] 5.9 Glossary

[0681] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0682] 5.9.1 General Rules

[0683] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0684] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0685] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0686] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0687] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0688] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0689] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0690] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0691] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the air flow rate leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the air flow rate leaving the ventilator to allow flushing of exhaled air. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the air flow rate received into the patient's respiratory system.

[0692] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the airway inlet at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0693] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0694] Leakage: The word "leakage" is considered to refer to unintended airflow. In one instance, leakage can occur due to an incomplete seal between the mask and the patient's face. In another instance, leakage can occur in a turnaround point to the surrounding environment.

[0695] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0696] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0697] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as the ventilation port of the patient interface).

[0698] Patient: A person, regardless of whether they have a respiratory illness.

[0699] Pressure: Force per unit area. Pressure can be expressed in a series of units, including cmH2O, gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 standard atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0700] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0701] Respiratory pressure therapy (RPT): Applying air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0702] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0703] 5.9.1.1 Materials

[0704] Silicone or silicone elastomer: a synthetic rubber. In this specification, the reference to silicone refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0705] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0706] 5.9.1.2 Mechanical Properties

[0707] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0708] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0709] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or by an indentation hardness scale measured on a standardized sample size).

[0710] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0711] • "Hard" materials can include polycarbonate, polypropylene, steel or aluminum, and are not easily deformed, for example, under finger pressure.

[0712] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.

[0713] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0714] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0715] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0716] 5.9.2 Respiratory cycle

[0717] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0718] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0719] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0720] Effort (breathing): The work done by a spontaneously breathing person in trying to breathe.

[0721] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0722] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0723] Types of flow-limited inhalation waveforms:

[0724] (i) Flattened: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0725] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0726] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0727] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0728] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate drops below a threshold and persists for a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0729] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0730] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0731] Hyperventilation: Increased airflow to above normal levels.

[0732] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0733] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0734] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0735] Peak flow (Q) 峰值 ): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0736] Respiratory flow, patient air flow, and respiratory air flow (Qr): These synonymous terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0737] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0738] (Inhalation) time (T) i ): The duration of the inspiratory portion of the respiratory flow waveform.

[0739] (Exhalation) Time (T) e ): The duration of the expiratory portion of the respiratory flow waveform.

[0740] Total Time (T) tot ): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0741] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0742] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0743] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0744] 5.9.3 Ventilation

[0745] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's breathing characteristics.

[0746] Standby rate: A parameter of the ventilator that determines the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0747] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to end at the end of the inspiratory portion of the respiratory cycle.

[0748] Expiratory positive airway pressure (EPAP): The base pressure to which the pressure changes within the respiratory tract are added to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0749] End-expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory phase. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0, then EEP equals EPAP when Π(Φ) = 1.

[0750] Inspiratory positive airway pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0751] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0752] Servo ventilator: A ventilator that measures a patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0753] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of breathing in a patient with gray hair. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0754] Oscillation: A term equivalent to pressure support.

[0755] Triggered: When a ventilator delivers breathing air to a patient who is breathing spontaneously, it is considered to be triggered by the patient's effort at the beginning of the breathing portion of the respiratory cycle.

[0756] 5.9.4 Anatomy

[0757] 5.9.4.1 Facial Anatomy

[0758] Alar (ala): The outer wall or "wing" of each nostril (plural: alar).

[0759] Nasal alar angle:

[0760] Alar tip: the outermost point on the ala of the nose.

[0761] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0762] Auricle: The entire visible external part of the ear.

[0763] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0764] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0765] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0766] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0767] Frankfurt plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0768] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0769] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0770] Lip, lower lip (midpoint of the lower lip):

[0771] Lip, upper lip (midpoint of the upper lip):

[0772] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilages. It curves around the front of the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0773] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0774] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0775] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0776] Inferior auricular base: the lowest point where the auricle attaches to the facial skin.

[0777] Upper ear base: the highest point where the auricle attaches to the facial skin.

[0778] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0779] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0780] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0781] The nasal ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0782] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into the right and left halves.

[0783] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0784] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0785] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0786] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0787] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0788] 5.9.4.2 Anatomical Structure of the Skull

[0789] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0790] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0791] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the eye socket. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0792] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the bridge of the nose through their junction.

[0793] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.

[0794] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0795] The eye socket is the bony cavity in the skull that houses the eyeball.

[0796] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0797] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0798] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent part of the cheek.

[0799] 5.9.4.3 Anatomical Structure of the Respiratory System

[0800] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0801] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0802] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0803] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0804] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0805] 5.9.5 Patient Interface

[0806] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0807] Elbow: An elbow is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0808] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0809] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0810] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0811] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0812] Sealing: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve a "seal" between them without the need for a separate "seal" element itself.

[0813] Shell: A shell is considered to mean a curved and relatively thin structure with partial bending, stretching, and compressive stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell or a portion of the shell can be non-rigid. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0814] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0815] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0816] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0817] Lacing (noun: a structure used to resist tension).

[0818] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0819] 5.9.6 Shape of the structure

[0820] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0821] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure, see [reference needed]. Figures 3B to 3F They show examples of cross sections at point p on the surface and the resulting planar curves. Figures 3B to 3FThe outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some instances, the surface is depicted from the viewpoint of an imaginary figure standing upright on the surface.

[0822] 5.9.6.1 Curvature in one dimension

[0823] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0824] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0825] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0826] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0827] 5.9.6.2 Curvature of Two-Dimensional Surfaces

[0828] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal sections. These sections may cut through the surface in a plane including an outward normal (“normal plane”), and each section may be cut in a different direction. Each section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve can be an instance of multiple such cross sections at a specific point.

[0829] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum value appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross section in the principal direction. The principal curvature at point p is the curvature in the principal direction.

[0830] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0831] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0832] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0833] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0834] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0835] Edge of a surface: the boundary or limit of a surface or region.

[0836] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or process, including, for example, a set of points on a surface. (Imagined personal paths are those in which they travel on a surface and resemble garden paths).

[0837] Path length: In some forms of this technique, "path length" will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imagined individual would be the distance they walk along the path on the surface).

[0838] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. In a planar region, a path with the same length as the straight-line distance between two points on the surface can exist on the surface. In a non-planar surface, a path with the same length as the straight-line distance between two points may not exist. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0839] 5.9.6.3 Space Curves

[0840] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. An imaginary human walking along one strand of a DNA helix travels along a space curve. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0841] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0842] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0843] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0844] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See appendix. Figure 3O and 3P .

[0845] Torque of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the plane has zero torsion. A space curve deviating relatively small from the osculating plane will have a relatively small torsion (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large torsion (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3SThe amount of twist of the bottom coil of the spiral.

[0846] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0847] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0848] 5.9.6.4 holes

[0849] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0850] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The structure shown has a two-dimensional hole whose boundary is defined by the surface shown.

[0851] 5.10 Other Remarks

[0852] This patent document discloses a portion of material protected by copyright. The copyright holder does not object to any reproduction of the patent document or patent disclosure appearing in the patent office's patent documents or records, but retains all copyrights.

[0853] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other such value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where the range includes one or both of the limit values, this technique also includes ranges that exclude any one or both of those included limit values.

[0854] Furthermore, where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technique for any appropriate valid digits.

[0855] In addition, “approximately,” “basically,” “about,” or any similar terms used herein refer to + / - 5-10% of the cited value.

[0856] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of representative methods and materials are described herein.

[0857] When a particular material is identified for use in constructing a component, a clearly alternative material with similar properties is used as its substitute. Furthermore, unless otherwise specified, all components herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0858] It must be noted that, unless the context clearly specifies otherwise, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents.

[0859] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided only for those published prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to priority of these publications due to prior invention. Furthermore, the publication dates provided may differ from the actual publication dates and may require separate verification.

[0860] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0861] The headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found in this disclosure or throughout the claims. The headings should not be used to interpret the scope of the claims or to limit the claims.

[0862] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required for the practice of the technology. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order may be performed simultaneously or even concurrently.

[0863] Therefore, it should be understood that numerous modifications can be made to this exemplary implementation, and that other arrangements can be designed without departing from the spirit and scope of this technology.

[0864] 5.11 List of Reference Symbols

[0865]

[0866]

[0867]

[0868]

Claims

1. A patient interface, comprising: An inflatable chamber pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the size and structure of which are determined to receive an airflow at the treatment pressure for patient breathing, wherein the inflatable chamber includes a mounting surface; A sealing structure, configured and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, for sealing the delivery of a pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the sealing structure comprising: A first segment, made of a first material, is configured to sealably engage with a first region abutting the patient's face. The second segment, which is made of a second material different from the first material, is configured to sealably engage with a second region abutting the patient's face, wherein the second material is foam, and wherein the second segment forming the seal is coupled to the mounting surface. The foam is configured to contact the patient's mouth during use, and the foam has a closed-loop structure configured to extend around the entire periphery of the patient's mouth during use. as well as, Positioning and stabilizing the structure to provide the force needed to hold the seal-forming structure in a therapeutically effective position on the patient's head. The first section and the air chamber are integrally formed into a one-piece structure during the molding process.

2. The patient interface of claim 1, wherein, The first material is silicone.

3. The patient interface of claim 1, wherein, At the transition between the first section and the second section, the first section and the second section are flush.

4. The patient interface of claim 1, wherein, In use, the mounting surface is configured to be oriented substantially perpendicular to the anterior-posterior direction of the patient's head.

5. The patient interface of claim 1, wherein, The mounting surface is made of the first material.

6. The patient interface of claim 1, wherein, The first section extends beyond the mounting surface and forms a cantilever relative to the mounting surface.

7. The patient interface of claim 6, wherein, The overhang is configured to contact the patient adjacent to each nasal wing.

8. The patient interface according to claim 1, wherein, In use, the inflation chamber inlet port is formed in front of the mounting surface, and the second material does not contact the inflation chamber inlet port.

9. The patient interface according to claim 1, wherein, The mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient's upper lip so that the patient's philtrum is not covered by the mounting surface.

10. The patient interface according to any one of claims 1 to 9, wherein, The air chamber is at least partially made of the first material.

11. The patient interface according to any one of claims 1 to 9, wherein, The second section is connected to the inflation chamber by an adhesive.

12. The patient interface according to any one of claims 1 to 9, wherein, The second section includes varying thickness.

13. The patient interface according to claim 12, wherein, The second segment includes a first thickness and a second thickness greater than the first thickness, wherein the first thickness is adjacent to the second thickness.

14. The patient interface according to any one of claims 1 to 9, wherein, The sealing structure is configured to form a seal against the patient's face, wherein the first segment and the second segment are each combined to form part of the seal.

15. The patient interface according to any one of claims 1 to 9, wherein, The sealing structure comprises an airtight material.

16. The patient interface according to claim 15, wherein, The second section is configured to contact the patient's nasal alar region during use.

17. The patient interface according to any one of claims 1 to 9, wherein, The sealing structure is a mouth and nose pad, an ultra-compact full-face mask, or a full-face mask.

18. The patient interface according to claim 17, wherein, The first section is configured to contact the patient's nose during use, at least between the patient's nasal protuberance and the patient's subnasal point, and at least between each of the patient's nasal alae.

19. The patient interface according to claim 1, wherein, The foam is configured to contact the patient's mouth during use, at least between the patient's upper lip and lower lip, and at least adjacent to each of the patient's nostrils beyond the width of the patient's mouth.

20. The patient interface according to claim 3, wherein, The beam portion of the second section is configured to contact the patient's lips during use.

21. The patient interface according to claim 20, wherein, At least a portion of the beam is unbacked and configured to move into the air chamber when touched by the patient's lips.

22. The patient interface according to claim 20, wherein, The transition section is located between the beam and the first section.

23. The patient interface according to claim 17, wherein, The sealing structure is configured to not seal against the patient's philtrum.

24. The patient interface according to claim 17, wherein, A portion of the second section is configured to seal the area below the patient's nostrils and adjacent to the patient's nasal wings.

25. The patient interface according to claim 17, wherein, The first segment is thinner than the second segment.

26. The patient interface according to claim 17, wherein, When viewed in cross-section, the second segment has a substantially rectangular outline.

27. The patient interface according to claim 17, wherein, The second section includes a substantially square edge, which is configured to contact the patient in use.

28. The patient interface according to claim 27, wherein, The generally square edges are configured to contact the nasal wing at the junction of the patient's nasal corner region and the patient's lips.

29. The patient interface according to any one of claims 1 to 9, wherein, The mounting surface is substantially flat.

Images