Oral-nasal patient interface

Abstract

A patient interface includes a positioning and stabilizing structure configured to hold a first seal-forming structure and a second seal-forming structure in a therapeutically effective position. The positioning and stabilizing structure includes a frame coupled to a plenum chamber. The frame includes a central portion coupled to the plenum chamber outside of a cavity. The frame further includes a pair of arms extending in a rearward direction away from the central portion past the second seal-forming structure. The pair of arms are more flexible than the central portion. The positioning and stabilizing structure further includes a headgear strap coupled to the frame configured to provide tension into the patient's face via the frame to the first seal-forming structure and the second seal-forming structure.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 058,001, filed July 29, 2020, and Australian Provisional Patent Application No. 2019903360, filed September 10, 2019, both of which are incorporated herein by reference in their entirety. 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 related 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 branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Physiology of the Respiratory System*, published in 2012 by John B. West, Lippincott Williams & Wilkins. Respiratory Physiology ( ), 9th edition.

[0010] A range of respiratory disorders exist. Some disorders may 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 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 disorder 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 the term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

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

[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes 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 diseases 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 worsening within months and leading to death within years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage worsening over many years and only slightly reducing life expectancy (e.g., limb girdle, scapular humerus, and myotonic dystrophy). 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 therapies have been used to treat or improve these symptoms. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies 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 tamponade (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0023] 2.2.2.1 Respiratory pressure therapy

[0024] Respiratory pressure therapy involves 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 that of a canister ventilator or endotracheal ventilator).

[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, so 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.

[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 respiratory disease (NMD), and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] Noninvasive ventilation (IV) provides ventilation support for 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 therapies 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 example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing away exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0030] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched fluid to be delivered to the patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%).

[0031] 2.2.2.3 Supplementing oxygen

[0032] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[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 a condition without treating it.

[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 is a mandibular repositioning device.

[0037] 2.2.3.1 Patient Interface

[0038] Patient interfaces can be used to attach breathing equipment to their 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 therapy to be administered, 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 administer the therapy. For other forms of therapy, 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 therapies such as nasal HFT, the patient interface is configured to blow 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 can be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0040] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0041] If a patient needs to insert part of the mask structure into their mouth to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.

[0042] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

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

[0044] Due to these challenges, some masks suffer from one or more problems, including protrusion, aesthetic undesirability, high cost, poor fit, difficulty in use, and discomfort, especially during prolonged wear or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original application; however, such masks can still cause undesirable discomfort when worn for extended periods (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the mask is worn during sleep.

[0045] CPAP therapy is highly effective for treating certain breathing disorders, provided the patient adheres to the treatment. If the mask is uncomfortable or difficult to use, the patient may not adhere to the therapy. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean it, and this can affect patient adherence.

[0046] While masks designed for other applications (such as navigators) 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 Sealing Formation Structure

[0049] The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0050] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may comprise 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, the sealing structure may comprise a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover the upper lip and bridge of the nose region of the face. In another form, the sealing structure may comprise, for example, an element that surrounds the mouth region during use by forming a seal on the lower lip region of the face. In yet another form, the sealing structure may comprise a single element that surrounds both the nostrils and mouth regions during use. These different types of patient interfaces can be known by various names given to them by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0051] A sealing structure that works in one area of ​​a patient's face may not be suitable for another area, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers 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 and comfortable and effective for a wide range of different facial shapes and sizes. Due to 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 adjusted to form a seal.

[0053] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface, engages with the patient's face to seal the face. The seal-forming structure may include an air- or fluid-filled pad, or a molded or shaped surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0054] Another type of seal-forming structure incorporates a sheet-like seal of thin material surrounding the periphery of the mask to provide a self-sealing effect on 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, causing leakage.

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

[0056] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently 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 discovered in the Adam circuitry 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 Limited manufactures the following products that combine nose pillows: SWIFT TM Nose pillow mask, SWIFT T MII Nose Pillow Mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGELIBERTY TM Full-face mask. The following patent application assigned to ResMed Limited describes an example of a nose pillow mask: International Patent Application WO 2004 / 073,778 (particularly describing ResMed Limited SWIFT). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (particularly describing ResMed Limited SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063328 and WO2006 / 130,903 (particularly describing ResMed Limited MIRAGE LIBERTY) TMOther aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (particularly describing ResMed Limited SWIFT) TM Other aspects of the FX nose pillow).

[0060] 2.2.3.1 Positioning and Stability

[0061] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain 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, the use of adhesives may be uncomfortable for some people.

[0063] Another technique is to use one or more straps and / or stabilizing straps. Many such electrical wirings suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of 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 constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches for inspiratory and expiratory air circuits. In other cases, a single limb air circuit is used for both inspiratory and expiratory functions.

[0068] 2.2.3.4 Humidifier

[0069] Delivering airflow without humidification can lead to airway dryness. The use of humidifiers with an RPT device and patient interface produces humidified gas that minimizes dryness of the nasal mucosa and increases 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 the long-term benefits of exercise 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 using small compressed oxygen cylinders or tanks mounted on a trolley. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are bulky, 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 routine rescue 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 highly portable, various systems used to produce oxygen-enriched gas need to be condensed. POCs aim to utilize the oxygen they produce as efficiently as possible while minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, or "injections," each pulse timed to coincide with the start of inspiration. This mode of therapy is called pulsed or on-demand (oxygen) delivery (POD cycle) compared to the traditional continuous flow delivery more suited to stationary oxygen concentrators.

[0073] 2.2.3.6 Data Management

[0074] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has been "adherent," such as the patient having used their RPT device according to one or more "adherence rules." One example of an adherence rule for CPAP therapy is that, in order to be considered adherent, a patient is required to use the RPT device for at least 4 hours one night for at least 21 out of a 30-day period. To determine patient adherence, the RPT device provider (such as a healthcare provider) may manually obtain data describing the patient's therapy using the RPT device, calculate usage over a predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that a patient has used their RPT device according to the adherence rules, the healthcare provider can be informed that the patient is adherent.

[0075] There may be other aspects of patient treatment that would benefit from communication of treatment data to third-party or external systems.

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

[0077] 2.2.3.7 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 mandible (lower jawbone) in a forward position during sleep. An MRD is a removable device that patients insert into their mouths before sleeping and remove afterward. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include an occlusal impression designed to allow for a proper fit to the patient's teeth. This mechanical protrusion of the mandible widens the space behind the tongue, applies tension to the pharyngeal walls to reduce airway collapse, and reduces palatal vibration.

[0079] In some examples, the mandibular advancement device may include an upper splint for engaging or fitting with teeth in the maxilla or maxilla, and a lower splint for engaging or fitting 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 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 level of mandibular projection. The dentist can determine the level of mandibular projection, which will determine the length of the connecting rod.

[0081] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others MADs (such as the ResMedNarval CC™ MRD) are designed to hold the mandible in an forward position. The device also reduces or minimizes tooth and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.8 Vent technology

[0083] Some forms of treatment systems may include ventilation ports to allow the exhaled carbon dioxide to escape. Ventilation ports can allow gas to flow from the internal space of the patient interface, such as a pressurization chamber, to the external space of the patient interface, such as the surrounding environment.

[0084] The vent may include an opening through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0085] ResMed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. 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. 2009 / 0044808.

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

[0087]

[0088] ( (Single 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 diagnosing and monitoring cardiopulmonary disorders and typically involves a clinician in its application. 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 for providing methods and / or devices to improve patient adherence to respiratory therapy.

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

[0101] A pressurization chamber capable of pressurizing to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by the patient;

[0102] A first sealing structure is configured and arranged to seal with an area of ​​the patient’s face surrounding the patient’s mouth, such that an airflow at the treatment pressure is delivered to the mouth, and the first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient’s respiratory cycle in 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 delivering an airflow under the therapeutic pressure to the nose. This second sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0104] A ventilation port structure that allows the patient's exhaled air to flow continuously from the interior of the pressurization chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the pressurization chamber during use;

[0105] The patient interface further includes:

[0106] A pair of supports are disposed on opposite sides of the interface between the second sealing structure and the front wall of the pressurization chamber, wherein the supports are configured to resist compression in the longitudinal direction.

[0107] In the implementation plan:

[0108] a) The portion of the support connected to the second sealing structure, which abuts against the upper part of the patient's lip for sealing during use;

[0109] b) The support portion is connected to the portion of the second sealing structure, which seals to the upper part of the patient's lip during use, directly below the corner of the patient's nose;

[0110] c) When viewed in a cross-section parallel to the sagittal plane, the support is curved;

[0111] d) When viewed in a cross-section parallel to the front, these supports appear curved;

[0112] e) The pressurization chamber includes the mouth and nose;

[0113] f) Each support is connected to the mouth of the pressurization chamber at the junction of the transverse sidewall of the adjacent mouth and the transverse sidewall of the nose;

[0114] g) Each support is connected h to the mouth of the outer shell at the junction of the front wall of the adjacent mouth and the front wall of the nose;

[0115] h) The transverse sidewall portions of the pressurization chamber curve inward near the junction with the nose, wherein each support portion is substantially adjacent to the adjacent transverse sidewall portion.

[0116] i) The second sealing structure includes at least one nostril, which is 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 is directly below the nostril or each nostril.

[0117] j) The interface also includes a positioning and stabilizing structure configured to generate a force that holds the sealing-forming structure in a therapeutically effective position on the patient's head;

[0118] k) The pressurization chamber is at least partially formed by the outer shell and the vent structure is provided to the outer shell; and / or

[0119] l) The support is connected to the second sealing structure and to the front wall of the pressurization chamber.

[0120] Another form of this technology includes a patient interface, which comprises:

[0121] A pressurization chamber capable of pressurizing to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by the patient;

[0122] A first sealing structure is connected to the opening of the pressurization chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0123] A second sealing structure, connected to the nasal portion of the pressurization chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby delivering an airflow at the therapeutic pressure to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0124] A ventilation port structure that allows the patient's exhaled air to flow continuously from the interior of the pressurization chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the pressurization chamber during use;

[0125] in

[0126] The first front wall portion of the nose of the pressurization chamber is more flexible than the adjacent area of ​​the mouth of the pressurization chamber at the junction with the mouth of the pressurization chamber, and the second front wall portion of the nose of the pressurization chamber is more flexible than the adjacent portion of the front wall at the junction of the first front wall portion and the mouth of the pressurization chamber.

[0127] In the example:

[0128] a) The first anterior wall portion is thinner than the adjacent portion of the pressurization chamber wall;

[0129] b) The second anterior wall portion is thicker than the adjacent portion of the pressurization chamber wall;

[0130] c) The first and second front wall portions are made of the same material;

[0131] d) The first anterior wall portion extends across substantially the entire width of the nose portion of the pressurization chamber;

[0132] e) The second anterior wall extends across at least a majority of the width of the nose of the pressurization chamber;

[0133] f) The first front wall portion extends in the upward direction around at least one side edge of the second front wall portion;

[0134] g) The second anterior wall portion extends substantially across the entire width of the nose portion of the pressurization chamber;

[0135] h) The central portion of the first front wall extends further in the upward direction than the transverse portion of the first front wall;

[0136] i) The upper junction of the first anterior wall is curved;

[0137] j) The lower junction of the first anterior wall is curved;

[0138] k) The pressurization chamber is at least partially formed by the outer shell and the vent structure is provided to the outer shell;

[0139] 1) The second anterior wall portion includes a band that extends through the first anterior wall portion and is configured to extend toward the patient through the pressure chamber;

[0140] m) The transition between the first and second front wall portions in the pressurization chamber is a substantially stepped surface;

[0141] n) The transition outside the pressurization chamber between the first and second front wall sections is a substantially smooth surface; and / or

[0142] o) The first front wall portion extends higher than at least a portion of the belt during use.

[0143] Another form of this technology includes a patient interface, which comprises:

[0144] A pressurization chamber capable of pressurizing to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by the patient;

[0145] A first sealing structure is connected to the opening of the pressurization chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0146] A second sealing structure, connected to the nasal portion of the pressurization chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby delivering an airflow at the therapeutic pressure to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0147] A ventilation port structure that allows the patient's exhaled air to flow continuously from the interior of the pressurization chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the pressurization chamber during use;

[0148] in

[0149] The rear surface of the transverse portion of the second sealing structure slopes upward and forward from the junction of the first and second sealing structures.

[0150] In the example:

[0151] a) The ramp of each transverse section forms an angle between 20 degrees and 90 degrees with the middle contact plane of the mask;

[0152] b) During use, no part of the patient interface comes into contact with the tip of the patient's nose.

[0153] c) The interface is configured to prevent nasal obstruction in patients, or at least reduce obstruction compared to prior art interfaces; and / or

[0154] d) The pressurization chamber is at least partially formed by the outer shell and the vent structure is provided to the outer shell.

[0155] Another form of this technology includes a patient interface, which comprises:

[0156] A pressurization chamber capable of pressurizing to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by the patient;

[0157] A first sealing structure is connected to the opening of the pressurization chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0158] A second sealing structure, connected to the nasal portion of the pressurization chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby delivering an airflow at the therapeutic pressure to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0159] A ventilation port structure that allows the patient's exhaled air to flow continuously from the interior of the pressurization chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the pressurization chamber during use;

[0160] in

[0161] The junction between the first sealing structure and the second sealing structure includes a ridge.

[0162] In the example:

[0163] A) The radius of curvature of the ridge splint is less than 2 mm;

[0164] b) The ridge extends across substantially the entire junction between the first sealing structure and the second sealing structure;

[0165] c) During use, the spine joins the patient's face at the nasal inlet, near where the face meets the upper part of the lip;

[0166] d) The ridge prevents the formation of wrinkles in the first and / or second sealing structures adjacent to the ridge; and / or

[0167] e) In use, the pressurization chamber is at least partially formed by the housing and the vent structure is provided to the housing.

[0168] Another form of this technology includes a patient interface, which comprises:

[0169] A pressurization chamber capable of pressurizing to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by the patient;

[0170] A first sealing structure is connected to the opening of the pressurization chamber. The first sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's mouth, such that an airflow under the treatment pressure is delivered to the mouth. The first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0171] A second sealing structure, connected to the nasal portion of the pressurization chamber, is configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose, thereby delivering an airflow at the therapeutic pressure to the nose. The second sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0172] A ventilation port structure that allows the patient's exhaled air to flow continuously from the interior of the pressurization chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain the treatment pressure in the pressurization chamber during use;

[0173] in

[0174] At least a portion of the inlet of the pressurization 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.

[0175] In the example:

[0176] 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 0.9 MPa.

[0177] b) Attaching at least one component to the flexible housing, wherein at least one component is more rigid than a portion of an adjacent component of the flexible housing;

[0178] c) At least one component includes one or more of the following: a vent module; a headband connector; a headband connector connected to a rigid arm; a rigidification member; a less flexible housing portion;

[0179] d) At least one component is releasably connected to the flexible housing;

[0180] e) At least one component is permanently attached to the flexible housing;

[0181] f) Overmolding at least one component into a flexible housing;

[0182] g) The flexible housing includes a reinforcing portion that is thicker than the adjacent portion of the flexible housing;

[0183] h) At least one component is configured as a reinforcing rib or band;

[0184] i) The central portion of the inlet of the pressurization chamber has greater rigidity than the rest of the pressurization chamber; and / or

[0185] j) The pressurization chamber is at least partially formed by the outer shell and the vent structure is provided to the outer shell.

[0186] Another form of this technology includes a patient interface, which comprises:

[0187] A pressurization chamber comprising a cavity pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by a patient;

[0188] A first sealing structure is configured and arranged to seal with an area of ​​the patient’s face surrounding the patient’s mouth, such that an airflow at the treatment pressure is delivered to the mouth, and the first sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient’s respiratory cycle in use.

[0189] A second sealing structure is configured and arranged to form a seal with an area of ​​the patient’s face surrounding the entrance to the patient’s nose, such that an airflow under the treatment pressure is delivered to the nose. The second sealing structure is configured and arranged to maintain the treatment pressure in the pressurization chamber throughout the patient’s respiratory cycle during use.

[0190] A ventilation port structure that allows continuous flow of exhaled air from the patient's exhaled air through the pressure chamber to ventilate the surrounding environment, the size and shape of which are designed to maintain treatment pressure within the pressure chamber during use; and

[0191] A positioning and stabilizing structure configured to hold a first sealing formation structure and a second sealing formation structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

[0192] A frame connected to the pressurization chamber, the frame comprising,

[0193] The external connection to the center of the pressurization chamber is located outside the cavity, and

[0194] A pair of arms extending rearward away from the center through the second sealing structure, these arms being more flexible than the center; and

[0195] A headband strap, which is attached to a frame and configured to provide tension to the first sealing structure and the second sealing structure via the frame, allowing it to enter the patient's face.

[0196] In the example:

[0197] a) Each of the two arms is more flexible than the frame;

[0198] b) The central portion is thicker than each of the two arms;

[0199] c) The central portion of the pair of arms and each arm are made of the same material;

[0200] d) Each of the two arms includes a first connection point, to which the headband strap is attached;

[0201] e) The first connection point is a loop, and the headband strap is connected to the loop such that the strap is perpendicular to the edge of the loop and applies a force vector perpendicular to the edge;

[0202] f) The first connection point is a loop and includes a region of reduced thickness, which the headband strap can contact;

[0203] g) The first magnet is overmolded onto the center of the frame, and the headband strap includes a second magnet removably connected to the first magnet;

[0204] h) The first magnet includes an outer shell that at least partially surrounds a magnetic material, the outer shell including a flat surface and a lip extending from the flat surface;

[0205] i) A pendant spaced apart from the second magnet and configured to engage the lip when the second magnet is attached to a magnetic material;

[0206] j) The pressurization chamber includes a recess, and the central portion is positioned within the recess;

[0207] k) The central portion is removably positioned within the groove;

[0208] l) The groove includes a protrusion, and the central portion includes a complementary groove configured to receive the protrusion;

[0209] m) The groove is tapered and includes a wider opening and a narrower opening, the protrusion being received through the wider opening before the narrower opening;

[0210] n) The protrusion includes a hanging element configured to extend above the slot and retain the frame relative to the pressurization chamber;

[0211] o) The pressurization chamber includes a protrusion disposed adjacent to the recess, the protrusion being configured to retain the center portion within the recess;

[0212] p) The outer surface of the central portion is flush with the outer surface of the pressurization chamber, and the outer surfaces of the central portion and the pressurization chamber are configured to be away from the patient during use;

[0213] q) The central section includes an annular shape, and when the frame is connected to the pressurization chamber, the inlet port of the pressurization chamber is radially arranged within the central section;

[0214] r) The pressurization chamber inlet is configured to receive a bend, which is configured to be spaced apart from the center when received in the pressurization chamber inlet.

[0215] s) Each arm forms a cantilever structure relative to the center;

[0216] t) The thickness of each arm decreases from the fixed end to the free end;

[0217] u) The arm includes a fan-shaped region on the inner surface configured to face the patient's skin;

[0218] v) Each arm may pivot relative to the center about the pivot point; and / or

[0219] w) The pivot point is the movable hinge.

[0220] Another form of this technology includes a patient interface, which comprises:

[0221] A pressurization chamber comprising a cavity pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for respiration by a patient;

[0222] A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face, thereby allowing airflow under therapeutic pressure to be delivered to these airways. The sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0223] A positioning and stabilizing structure is configured to hold the sealing-forming structure in a therapeutically effective position.

[0224] Another form of this technology is the oral-nasal patient interface, which is more compact and less noticeable to the patient.

[0225] Another aspect of this technology is an oronasal patient interface having a nasal pad that provides an improved fit with the corners of the nose.

[0226] Another aspect of this technology is a mouth-nose patient interface that reduces occlusion on the nose.

[0227] Another aspect of this technology is an oronasal patient interface that can self-adjust to accommodate patients with various nasal base angles.

[0228] Another aspect of this technology is an oral-nasal patient interface with a relatively flexible shell.

[0229] Another aspect of this technology is a patient interface that is molded or otherwise configured to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0230] One aspect of this technology is a method for manufacturing equipment.

[0231] One aspect of certain forms of this technology is an easy-to-use medical device, for example, that can be easily used by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0232] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., a person in that person's household).

[0233] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.

[0234] 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 technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0235] 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.

[0236] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Description of the attached figures

[0238] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0239] 4.1 Breathing Therapy System

[0240] Figure 1A A system is shown in which a patient 1000, wearing a patient interface 3000 in a nasal pillow configuration, 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.

[0241] 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.

[0242] Figure 1CA 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.

[0243] 4.2 Respiratory System and Facial Anatomy

[0244] Figure 2A An overview 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.

[0245] 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, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0246] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper vermilion border, lower vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. The directions of up, down, radially inward, and radially outward are also indicated.

[0247] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, upper auricular base, and lower auricular base. The vertical and anteroposterior directions are also marked.

[0248] 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.

[0249] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, upper lip vermilion border, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0250] Figure 2G A side view showing the surface features of the nose is shown.

[0251] 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.

[0252] Figure 2IThe diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0253] 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.

[0254] 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.

[0255] Figure 2L This is a frontal view of the nose.

[0256] 4.3 Patient Interface

[0257] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0258] 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.

[0259] 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.

[0260] 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.

[0261] 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.

[0262] 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.

[0263] Figure 3G A padding material for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0264] Figure 3H The padding used for the face mask is shown. The outer surface of the padding 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.

[0265] Figure 3I The diagram shows a surface with a structure having one-dimensional holes. The planar curves shown form the boundaries of the one-dimensional holes.

[0266] 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.

[0267] 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.

[0268] Figure 3L A mask with a pressurized airbag as a pad is shown.

[0269] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0270] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0271] Figure 3O The left-hand rule is shown.

[0272] Figure 3P The right-hand rule is shown.

[0273] Figure 3Q The left ear is shown, including the left ear spiral.

[0274] Figure 3R The right ear is shown, including the right ear spiral.

[0275] Figure 3S It demonstrates a right-handed spiral.

[0276] Figure 3TA 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.

[0277] Figure 3U A view of the pressurization chamber 3200 is shown, which shows the sagittal plane and the intermediate contact plane.

[0278] Figure 3V It shows Figure 3U This is a view of the rear of the pressurization chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the pressurization chamber into two equal parts, left and right.

[0279] Figure 3W It shows crossing Figure 3V The cross-section of the pressurization 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 pressurization chamber liner at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). 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 pressurization chambers having separate mouth and nose sections, such as ultra-compact full-face (UCFF) masks, the upper and lower points are on the sealing formation structure of the mask's mouth section.

[0280] Figure 3X It shows Figure 3U The pressurization chamber 3200 is positioned for use on the face. When the pressurization chamber is in the use position, the sagittal plane of the pressurization chamber 3200 approximately coincides with the central sagittal plane of the face. When the pressurization chamber is in the use position, this intermediate contact plane generally corresponds to the 'plane of the face'. Figure 3X In the middle, the pressurization chamber 3200 is the pressurization chamber of the nasal 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 part of the lip.

[0281] 4.4 RPT device

[0282] Figure 4A An RPT device of one form according to the present technology is shown.

[0283] Figure 4BThis is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0284] 4.5 Humidifier

[0285] Figure 5A This is an isometric view of one form of humidifier according to this technology.

[0286] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, which shows the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0287] 4.6 Respiratory waveform

[0288] Figure 6 The diagram shows a typical breathing waveform of a person during sleep.

[0289] 4.7 Patient Interface Example of This Technology

[0290] Figure 7 This is a rear perspective view of a pressurization chamber according to one form of the present technology, wherein the inlet port is not shown.

[0291] Figure 8 yes Figure 7 Rear view of the pressurization chamber.

[0292] Figure 9 yes Figure 7 A front view of the pressurization chamber.

[0293] Figure 10 yes Figure 7 Side view of the pressurization chamber.

[0294] Figure 11 yes Figure 7 A top view of the pressurization chamber.

[0295] Figure 12 It is the cross-section of the pressurization chamber passing through plane 12-12.

[0296] Figure 13 yes Figure 7 A bottom view of the pressurization chamber.

[0297] Figure 14 It is the cross-section of the pressurization chamber passing through plane 14-14.

[0298] Figure 15It is the cross-section of the pressurization chamber passing through plane 15-15.

[0299] Figure 16 It is the cross-section of the pressurization chamber passing through plane 16-16.

[0300] Figure 16-1 It is the cross-section of the pressurization chamber passing through plane 16-1-16-1.

[0301] Figure 16-2 yes Figure 16-1 A cross-sectional view of the pressurization chamber, showing the pressurization chamber in a deformed position.

[0302] Figure 17 It is the cross-section of the pressurization chamber passing through plane 17-17.

[0303] Figure 18 It is the cross-section of the pressurization chamber passing through plane 18-18.

[0304] Figure 18-1 It is the cross-section of the pressurization chamber passing through plane 18-1-18-1.

[0305] Figure 18-2 It is the cross-section of the pressurization chamber passing through plane 18-2-18-2.

[0306] Figure 19 A side view of the pressurization chamber in its use position is shown above the patient's face, with the pressurization chamber outlined for clarity.

[0307] Figure 20 The patient's face is shown, with specific areas joined by the sealing structure shown.

[0308] Figure 21 This is a front perspective view of another form of patient interface according to this technology.

[0309] Figure 21-1 This is a front perspective view of another form of patient interface according to this technology.

[0310] Figure 22 This is a front perspective view of another form of patient interface according to the present technology, in which the airway is removed.

[0311] Figure 23 This is a front perspective view of the patient interface with a frame for connecting the headband strap to the pressure chamber.

[0312] Figure 24 yes Figure 23 A breakdown diagram of the patient interface.

[0313] Figure 25 This is a front view of a frame and a pressurization chamber according to one form of this technology.

[0314] Figure 26 This is a front view of the frame and pressurization chamber according to another form of this technology.

[0315] Figure 26-1 yes Figure 26 Side perspective view of the frame and the pressurization chamber.

[0316] Figure 26-2 This is observed along cross section 26-26. Figure 26-1 Cross-sectional view of the frame and the pressurization chamber.

[0317] Figure 26-3 yes Figure 26 A top view of the frame and the pressurization chamber.

[0318] Figure 26-4 yes Figure 26 A perspective view of the frame and pressurization chamber, showing multiple arms of the frame that can move between a first position and a second position.

[0319] Figure 26-5 yes Figure 26-4 The rear perspective view of the frame and the pressurization chamber shows the curvature of the pressurization chamber in the second position.

[0320] Figure 27 yes Figure 26 The rear view of the frame shows the tapered opening.

[0321] Figure 27-1 yes Figure 26 The top perspective view of the frame shows the reduced thickness of the frame arms.

[0322] Figure 27-2 yes Figure 26 A perspective view of the frame, showing the rings on the free ends of the frame.

[0323] Figure 28 This is a front view of another form of frame and pressurization chamber according to this technology.

[0324] Figure 28-1 It is a perspective view of the second connection point that can be used with a frame of this technology.

[0325] Figure 28-2 yes Figure 28 A cross-sectional view of the frame and pressurization chamber, showing Figure 28-1 The connection between the magnet and the auxiliary connection point. 5. Detailed Implementation

[0327] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples 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.

[0328] The following description provides various examples of things that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features can form another example.

[0329] Anatomical directional terms are used to describe aspects and examples of this technology, such as “anterior,” “posterior,” “upper,” etc., and are read 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 relative to the patient in front of the patient when the patient wears the interface in the intended manner.

[0330] A surface or part is described as facing a direction, such as "facing upwards," "facing forwards," etc., unless the context clearly requires otherwise. A surface or part should be understood as at least partially facing a particular direction. If a part is generally facing upwards, it may also be "facing upwards" even if it is also partially facing another direction.

[0331] 5.1 Therapy

[0332] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0333] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0334] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0335] 5.2 Respiratory Therapy System

[0336] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0337] 5.3 Patient Interface

[0338] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, a pressurization chamber 3200, a positioning and stabilization structure 3300, an airway 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0339] In some examples of this technology, the pressurization chamber is at least partially formed by the housing 3250. In these examples, the housing 3250 or a portion thereof may be slightly flexible, as discussed further below.

[0340] In some examples of this technology, the patient interface is an oronasal patient interface, that is, the patient interface is configured to seal around the patient's nasal and oral airways. In some examples, the patient interface includes separate seals around each nasal and oral airway.

[0341] exist Figure 7-22 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.

[0342] 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.

[0343] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to the environment.

[0344] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to the environment.

[0345] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 20 cmH2O relative to the environment.

[0346] 5.3.1 Sealing Formation Structure

[0347] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0348] As described in more detail below, in some forms of the invention, the sealing forming structure 3100 includes a first sealing forming structure 3101 connected to the opening 3201 of the pressurization chamber and configured and arranged to seal the entrance of the patient's face around the patient's mouth with the area of ​​the pressurization chamber, and a second sealing forming structure 3102 connected to the nose 3202 of the pressurization chamber 3200 and configured and arranged to seal the area of ​​the patient's face around the entrance of the patient's nose. The phrase "connected to" herein is used to refer to a part or component formed as a single piece, as well as a part or component formed separately and subsequently joined together. In some cases, components may be connected by intermediate components.

[0349] In some forms, the first sealing structure 3101 seals the patient’s face independently of the second sealing structure 3102.

[0350] 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.

[0351] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0352] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0353] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0354] In some forms of this technology, a system is provided comprising more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may comprise 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.

[0355] 5.3.1.1 Sealing Mechanism

[0356] In one embodiment, the sealing structure 3100 includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface from within the pressurization chamber 3200, thereby forming a tight seal with the surface. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0357] 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, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the pressure 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 pressure chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use. Limiting buckling can limit the formation of creases in the sealing structure 3100, which can lead to leakage and loss of treatment pressure.

[0358] In one embodiment, the sealing structure 3100 may include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0359] In one form, the sealing structure includes a tensioning section. In use, the tensioning section is maintained tension, for example, by adjacent areas of the sealing flange.

[0360] In one form, the sealing forming structure 3100 includes a region having an adhesive or bonding surface.

[0361] 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.

[0362] 5.3.1.2 Nasal region

[0363] The following is for reference. Figures 7 to 18In some forms of this technology, the second sealing structure 3102 includes a central portion 3110 configured to seal against the surface of a patient's nose in use. This central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils) and against the upper part of the patient's lips. In an example, a portion of the sealing structure may engage the patient's septum. The second sealing structure 3102 may also include a lateral portion 3111 on the lateral side of the central portion 3110. In an example, the sealing structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the anterior bridge of the nose.

[0364] like Figure 10 As best shown in 16-19, the rear surface 3112 of the lateral portion 3111 is inclined forward in the upward / forward direction from the junction 3103 of the first sealing forming structure and the second sealing forming structures 3101, 3102, such that the rear lateral portion of the nose of the mask is inclined forward in the contour.

[0365] In an embodiment where a ridge 3120 is provided (as further described below), the rear surface 3112 of the transverse portion 3111 may be inclined forward from the ridge 3120.

[0366] In some technical embodiments, the rear surface 3112 of the transverse portion 3111 forms an angle between 20° and 90° with the intermediate contact plane of the mask. This 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.

[0367] like Figure 19 As shown, in some embodiments, these lateral portions 3111 are configured such that no part of the patient interface 3000 contacts the apex 1020 of the patient's nose during use.

[0368] The transverse portions 3111 are configured to tilt in such a way that a smaller portion of the nasal portion of the interface 3000 than some similar interfaces in the prior art extends along the sides of the nasal ala. In some forms of this technology, this results in a reduction in the portion of the nasal ala that contacts the sealing structure 3100 relative to the interface with the transverse portions tilted backward toward the patient's face, thereby reducing the proportion of the nasal ala that can be deformed and blocked by the sealing structure 3100, for example, when the patient is sleeping on their side and the interface is in contact with the pillow.

[0369] 5.3.1.3 The junction of the mouth and nose areas

[0370] For details, please refer to the following: Figure 7 , 8In one form of this technology, as shown in 16-18, a corner or ridge 3120 is formed or included at the junction between the first sealing structure 3101 and the second sealing structure 3102. In use, the corner or ridge 3120 may engage the patient's face above the upper lip and directly below the nose.

[0371] In the example, the corner or ridge 3120 forms an angle that is sharper than the equivalent portion or area of ​​some prior art mouth and nose masks, such as those described in PCT application number PCT / AU2019 / 050278.

[0372] When the mask is worn and treatment is performed, the sharper angle reduces the likelihood of wrinkles forming in the first sealing structure 3101 and / or the second sealing structure 3102 on or near the corner or ridge 3120. Some oronasal patient interfaces that do not use this structure may require a very thin, rounded structure in this area, which may be less resistant to wrinkles. In contrast, the corner or ridge 3120 can be more rigid than such an interface and can better maintain its shape, and therefore can seal better over depressions and wrinkles present around the patient's nose. This effect can be enhanced in embodiments provided with supports that resist or counteract compression in this area (e.g., support 3260 as described herein).

[0373] In some forms of this technology, the radius of the corner or ridge 3120 can be less than 2 mm, for example, about 1.75 mm. In one form of this technology, the radius can vary from about 1.75 mm at the center of the ridge to about 0.75 mm at the side.

[0374] 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.

[0375] In some forms of this technology, the corner or ridge 3120 may extend through substantially the entire junction 3103 between the first sealing formation 3101 and the second sealing formation 3102. In an example, the corner or ridge 3120 may engage with the patient's face at least near the nasal opening, for example, where the face meets the nasal ala and the upper part of the lips of the mouth. Figure 20 As shown in region 1010.

[0376] 5.3.1.4 Oral region

[0377] As described above, in one form, the non-invasive patient interface 3000 includes a first sealing structure 3101 that forms a seal around the patient's mouth during use. The first sealing structure 3101 can form a seal on the chin area of ​​the patient's face.

[0378] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0379] The sealing structure 3100 includes a sublip portion 3130 that forms a seal against the patient's chin area and / or the patient's sublip and / or nasal ridge. The sublip portion 3130 may be connected to (e.g., adjacent to) the supralip portion 3131 via a perioral portion 3132, such as... Figure 16 As shown.

[0380] The sealing structure 3100 has a relatively low wall thickness (compared to other parts of the interface), for example, less than 0.7 mm, at the periphery of the orifice 3132, the lower lip 3130 of the sealing structure abutting the chin region, and at least at the center of the lower lip 3130. This low wall thickness in these locations contributes to an effective and comfortable seal. The sealing structure in these areas can easily conform to any complex geometry.

[0381] 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 orifice shape allows the interface 3000 to be particularly compact and substantially no wider than the width of the patient's nostrils.

[0382] 5.3.1.5 Nasal pillow

[0383] 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 constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0384] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0385] 5.3.2 Pressurization Chamber

[0386] In some forms, the pressurization chamber 3200 (or at least a portion thereof) 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 pressurization chamber 3200 can be considered as a gasket.

[0387] 5.3.2.1 The angle of the nose is adjustable.

[0388] Special Reference Figure 9 , 10 In one embodiment, as shown in 16 to 18-2, the first front wall portion 3240 of the nose portion 3202 of the pressurization chamber 3200 is more flexible than the adjacent region of the mouth portion 3201. This first front wall portion 3240 may be positioned adjacent to the junction 3241 of the nose and mouth portions of the pressurization chamber 3200. In several embodiments, the first front 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 of the pressurization chamber. In some embodiments, the first front wall portion 3240 may extend across substantially the entire width of the nose portion 3202 of the pressurization chamber.

[0389] In some forms of this technology, the flexibility of the second front wall portion 3242 is less than that of the adjacent front wall portion. In some embodiments, the second front wall portion 3242 is adjacent to the first front wall portion 3240 on the opposite side of the junction 3241 of the nose and mouth of the pressurization chamber. In several 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 portion 3202 of the pressurization chamber. In some embodiments, the second front wall portion 3242 may extend across substantially the entire width of the nose portion 3202 of the pressurization chamber.

[0390] The flexible first anterior wall portion 3240 allows the patient contact portion 3110 of the second sealing forming structure 3102 to pivot or hinge around a region on the rear side of the interface 3000. This helps allow the interface to adapt to the patient at various angles (i.e., the nasolabial angle) between the base of the nose and the upper lip.

[0391] In embodiments characterized by an angle 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 about the area at or near the angle or ridge 3120. In embodiments equipped with one or more supports 3260 (further described below), the hinged or pivoting area may be directly above these supports 3260.

[0392] like Figure 9As shown, the first front wall portion 3240 may have an upper junction 3243 and a lower junction 3244. One or both of the upper junction 3243 and the lower junction 3244 may be curved, for example, such that the center portion of the junction 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 junction and the lower junction may be substantially parallel), or the height may vary in its width, for example, such that the height of the center portion of the first front wall portion 3240 is greater than the height of the transverse portion, as shown. Figure 9 As shown in the embodiment. Changing the curvature of one or both of the junctions 3243 and 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 the force on the patient contact portion 3110 of the second sealing forming structure 3102.

[0393] Similarly, the second front wall portion 3242 may have an upper junction 3247 and a lower junction 3248. In some forms of the present art, the lower junction 3248 of the second front wall portion 3242 is the same as the upper junction 3243 of the first front wall portion 3240. The upper and lower junctions 3247 and 3248 of the second front wall portion 3242 may be curved, for example, such that the center portion of the junction is lower than the transverse portions. The second front wall portion 3242 may be substantially the same height in its width (i.e., the upper and lower junctions may be substantially parallel), or the height may vary in its width, for example, such that the height of the center portion of the second front wall portion 3242 is less than the height of these transverse portions.

[0394] In some forms of this technology, in addition to or alternatively at the curved junction, 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 the example, the first front wall portion 3240 may be thinner than the adjacent portion of the pressurization chamber wall. Additionally and / or alternatively, the first front wall portion 3240 may extend in an upward direction around the side edge of the second front wall portion 3242, such as... Figure 21 As shown, this provides reduced rigidity / resistance to compression or collapse compared to embodiments where the first front wall portion 3240 is not shaped in this manner.

[0395] The second anterior wall portion 3242 (e.g., band 3270) helps prevent collapse of the nose portion 3202 and can provide support for the patient contact portion 3110 of the second sealing formation 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 pressurization chamber wall. In some forms, the second anterior wall portion 3242 is configured as a thickened band of material 3270, such as... Figure 16-19 As shown. The first front wall portion 3240 and the second front wall portion 3242 can be made of the same material, for example, as part of a monolithically molded housing 3250.

[0396] 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 provide increased 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 band 3270 that extends into the cavity 3272 of the pressurization chamber 3200. For example, the band 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 discontinuities).

[0397] like Figure 16-1 and 16-2 As shown, the first anterior wall portion 3240 can act as a hinge and allow the nose portion 3202 to bend. The first anterior wall portion 3240 can be the thinnest area of ​​the nose portion 3202, and therefore can be the most sensitive to bending moments. The increased thickness of the band 3270 directs bending moments away from the second anterior wall portion 3242 and towards the thinner first anterior wall portion 3240. The greater height of the band 3270 (i.e., the greater distance between the upper junction 3247 and the lower junction 3248) can also make the nose portion 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).

[0398] like Figure 18-1 and 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 alongside the belt 3270 (e.g., surrounding the belt 3270 on both sides or more sides). In other words, the first front wall portion 3240 can be arranged on at least one of the ends of the belt 3270. This can provide greater flexibility to the first front wall portion 3240, allowing the nose portion 3202 to bend further (e.g., bend in the forward direction).

[0399] like Figure 21-1 As shown, the nose portion 3202 can also be formed without a hinge. In other words, a band 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 even be flexible without a band because it can be made of silicone, which allows for some conformability in the nose portion 3202 to accommodate different nasolabial angles.

[0400] 5.3.2.2 Flexible outer shell

[0401] 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 one example, the housing 3250 may be formed of a material (e.g., foam) having a Young's modulus of 0.4 GPa or lower. In some forms of this technology, the housing 3250 may be made of a material such as rubber having a Young's modulus of 0.1 GPa or lower. In other forms of this technology, the housing 3250 may be made of a material having a Young's modulus of 0.9 MPa or less, for example, between 0.9 MPa and 0.8 MPa. An example of such a material is silicone.

[0402] 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.).

[0403] In some forms of this technology (see, for example) Figures 23 to 28-2The housing 3250 may be constructed substantially entirely of a flexible material that provides the housing 3250 with maximum freedom of movement (i.e., substantially no rigid and / or thickened portions restricting bending). The housing 3250 may be flexible enough that one or more components may be added to provide the required stiffness in one or more regions of the housing 3250 (e.g., the region in contact with region 1010). For example, one or more vent modules; connection ports; headband connectors; headband connectors connected to the hardened arm and hardened member may be connected to the housing 3250 in a manner that increases the stiffness of the pressurization chamber 3200 in the region adjacent to the component, as described further below. In some forms of the present technology, these components may be releasably attached to the flexible housing 3250. Additionally or alternatively, one or more components may be permanently attached to the housing 3250, for example, by bonding and / or overmolding. The rigidifying member may also be used to increase the stiffness of the sealing formation 3100 and / or support the shape of the sealing formation 3100.

[0404] In some forms of this technology, the housing 3250 may be generally flexible, but may include multiple reinforcing portions having a greater thickness than the adjacent portions of the housing 3250. While many other configurations are possible, such reinforcing portions may be configured as ribs or bands, for example, extending laterally across the housing and / or extending in the vertical direction. In some forms, the housing may include a substantially rigid portion, for example, made of polycarbonate, as well as slightly flexible portions.

[0405] In some embodiments of this technology, it may be preferable that the central portion 3251 on the front side of the inlet 3201 of the pressurization chamber has greater rigidity than the rest of the pressurization chamber 3200. In some embodiments of this technology, the area of ​​increased rigidity may be directly below the nose 3202, such as... Figure 21 As shown and further described below, and / or directly above the mouth portion 3201. In one form of this technology, part or all of the first front wall portion 3240 may be a region of increased stiffness rather than increased flexibility. Providing increased stiffness in one or more of these regions can provide shape stability and can limit the degree to which the housing 3250 deforms due to head-carrying forces. Excessive deformation may cause the second sealing formation 3102 to block the nostrils. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses and may be less important for patients with narrow noses, or in some cases undesirable. Furthermore, the described regions of increased stiffness can help reduce torsional deformation of the interface, which could otherwise cause one side of the second sealing formation 3102 to lose contact with the patient's nose, thereby creating a leakage path.

[0406] like Figure 21and 21-1 As shown, in one form of this technology, the housing 3250 may have a rigid portion 3263, or at least a portion that is more rigid than the rest of the housing, to which one or more connection ports 3600 are disposed, for example, molded. In one form of this technology, the rigid portion 3263 may be made of polycarbonate. This can provide greater rigidity than a housing made solely of silicone. In one form, process holes forming vents 3400 are molded into the rigid portion 3263. In some forms of this technology, a connector 3310 for positioning and stabilizing the structure is mounted on an arm 3320 that provides some rigidity to the housing.

[0407] In one embodiment of this technology, the rigid portion 3263 extends laterally across the front of the pressurization chamber near the upper junction of the first front wall portion 3240, for example, just below the second front wall portion 3242. The rigid portion 3263 can extend continuously between the connection ports 3600 and can provide an airflow path for the pressurized airflow entering the pressurization chamber 3200 through the connection ports 3600.

[0408] In some forms of this technology, the connection ports 3600 may have a substantially elliptical cross-section. These connection ports 3600 may be oriented such that the centerline of each port is substantially parallel to the outer surface of the pressurization chamber adjacent to that port.

[0409] In some forms of this technology, the rigid portion 3263 may protrude in a forward direction relative to the adjacent surface of the first front wall portion 3240, and may be shaped to increase resistance to bending.

[0410] In some forms of this technology (see, for example, see...) Figure 21 Connector 3310 and arm 3320 are positioned below connection port 3600 at the side edges facing the pressure chamber 3200. Connector 3310 may be positioned at the lateral end of arm 3320. Connector 3310 may provide additional rigidity to pressure chamber 3200 and / or sealing structure 3100.

[0411] In some forms of this technology (see, for example, see...) Figure 21-1 Connector 3310 does not include arm 3320, but is directly connected to pressure chamber 3200. This allows pressure chamber 3200 to be more... Figure 21 The 3200 pressure chamber is more flexible.

[0412] Figure 22A pressurization chamber 3200 is shown with a vent mounting port 3410 into which a suitable vent portion or module can be inserted. This vent portion may be made of a relatively rigid material to increase the rigidity of the pressurization chamber. In some forms of this art, the vent mounting port 3410 may be of a substantially elliptical shape, wherein the minor axis of the ellipse is substantially parallel to the sagittal plane.

[0413] exist Figure 22 In the embodiment shown, the vent mounting hole is configured to face the upper boundary of the opening 3201 of the pressurization chamber 3200.

[0414] Figure 22 The illustrated embodiment includes a connector 3310 for positioning and stabilizing the structure. The connector 3310 can be mounted in a relatively thicker area of ​​the housing 3250. In the illustrated embodiment, the connector 3310 is located below the vent mounting aperture 3410 and faces the lateral side of the pressurization chamber 3200. In some forms of this technology, the connector 3310 is a substantially circular magnetic headband connector.

[0415] Although Figure 7-19 The diagram of the pressurization chamber does 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... Figure 21-22 The inlet port 3600 is shown. These inlet ports 3600 allow the interface to be connected to the air circuit 4170, as further described herein. In some forms of this art, one or more components of the air circuit 4170 may also serve as components for positioning and stabilizing the structure.

[0416] In some forms of this technology, the pressurization chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The use of a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0417] In some forms of this technology, the pressurization chamber 3200 is made 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 compliance.

[0418] In some forms of this technology, the pressurization chamber 3200 may include dedicated reinforcing or rigidifying members (e.g., without other functions). These members may be formed of a material that is more rigid than the pressurization chamber 3200 (e.g., a material more rigid than silicone). These dedicated reinforcing members may be overmolded onto the pressurization chamber 3200 to provide greater rigidity than the rigid portion 3263 or arm 3320 of the housing 3250.

[0419] 5.3.3 Support section

[0420] like Figure 12 and 14 As best seen in -18, in one form of the technology, the support 3260 is disposed on the opposite side of the interface 3000 between the second sealing forming structure 3102 and the front wall of the pressurization chamber 3200. (See also...) Figure 12 As shown, in one example, each support 3260 extends to the lateral edge of the interface.

[0421] These supports 3260 do not act as base pads but are instead configured to resist or impede compression in the forward and backward directions. The supports 3260 thereby support and / or reinforce the portion of the second sealing structure 3102 that engages with the patient's upper lip. Specifically, the supports 3260 may support and / or reinforce the area 1010 of the second sealing structure 3102 that can contact the patient's face near the nasal inlet, where the nasal ala meets the area above the upper lip, such as... Figure 20 As shown. In other words, region 1010 can be directly below every corner of the patient's nose.

[0422] Supports 3260 help ensure that no wrinkles form in the sealing structure 3100. Wrinkles in the sealing structure can result from a very flexible sealing structure with a large radius of curvature that conforms to the patient's face. Due to excessive flexibility, the sealing structure may fold or wrinkle itself, leading to leakage within the sealing structure. Wrinkles may be of particular concern when the sealing structure seals against the area 1010 of the patient's face. These supports 3260 can be particularly advantageous when the sealing structure is configured to produce corners and / or ridges 3120 as described herein. Corners and / or ridges 3120 can be sharper curves (e.g., curves with a lower radius of curvature) compared to a sealing structure without supports 3260. The added support and / or stiffness by the supports 3260 reduces the ability of the second sealing structure 3102 to conform to the patient's face. To maintain patient comfort, 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., proximity region 1010). A sharper curvature allows the second sealing structure 3102 to seal various gaps around the patient's nose while reducing the likelihood of wrinkles forming.

[0423] like Figure 14-14As seen, particularly in one form of the present technology, the support 3260 is connected to the front side of the mouth 3201 of the pressurization chamber adjacent to the junction 3241 of the mouth 3201 and the nose 3202. In some embodiments, when viewed in a cross-section parallel to the sagittal plane (e.g. Figure 16-18 (as shown in the image) and / or when viewed in a cross section parallel to the frontal plane (as shown in the image) Figure 14 and 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 examples, the lateral sidewall portion 3245 of the pressurization chamber 3200 may be curved inward adjacent to the junction 3241 with the nose portion 3202, and the support portion 3260 may be substantially adjacent to the adjacent lateral sidewall portion 3245. Figure 18 As shown, when viewed in a cross-section parallel to the sagittal plane, at least a portion of the support 3260 can reduce the thickness between the first end 3261 of the front wall adjacent to the pressurization chamber 3200 and the second end 3262 adjacent to the sealing formation 3100. For example, the support 3260 can be thicker near the first end 3261, which can help provide increased support and / or stiffness for the second sealing formation 3102. In some examples, the support 3260 can 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 examples, the support 3260 can 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 examples, the thickness of the support portion 3260 may vary between 1.3 mm (e.g., near the second end 3262) and 2.5 mm (e.g., near the first end 3261).

[0424] Support portions 3260 with different geometries can be used for different patients. For example, a patient requiring more support and / or rigidity in the second sealing structure 3102 can use a sealing structure 3100 having a thicker (e.g., closer to the first end 3261 and / or at any location along the length) and / or more curved (e.g., a smaller radius of curvature) support portion 3260. For example, a patient desiring a more flexible second sealing structure 3102 can use a sealing structure 3100 having a thinner (e.g., closer to the first end 3261 and / or at any location along the length) and / or less curved (e.g., a larger radius of curvature) support portion 3260.

[0425] For example, especially in Figure 14 and 15As seen in this embodiment of the technology, the support portion 3260 is connected to the mouth portion 3201 of the pressurization chamber at the junction of the transverse sidewall portion 3245 of the mouth portion 3201 and the transverse sidewall portion 3246 of the nose portion 3202.

[0426] In some forms of this technology, these supports 3260 are shaped to provide a substantially unobstructed flow path from the mouth 3201 of the pressurization chamber to one or more nostril openings 3135 during inhalation. In some forms of this technology, no portion of any support 3260 is directly below one or more nostril openings 3135.

[0427] 5.3.4 Positioning and Stabilizing Structure

[0428] 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.

[0429] 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 pressurization chamber 3200 to lift the face away.

[0430] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0431] 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.

[0432] 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 while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0433] 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.

[0434] 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.

[0435] In one embodiment 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 or soft bandage. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0436] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0437] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to be taut in use and to guide forces to create a seal-forming structure that makes seal contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0438] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the base of the upper ear on the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0439] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0440] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0441] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0442] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to be transferred through the straps.

[0443] 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.

[0444] 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.

[0445] 5.3.4.1 Framework

[0446] like Figures 23 to 28-2 As shown, the frame 3350 is connected to the pressurization chamber 3200 and helps maintain the effective therapeutic position of the sealing formation structure 3100. Figures 23 to 28-2 The pressure chamber 3200 shown specifically depicts a curved tube 3500 connected to the front of the patient's face, but the frame can be used with other types of pressure chambers 3200 (e.g., those used with catheter headbands). Figure 21-22 Used together with the 3200 pressure chamber.

[0447] In some forms, the frame 3350 is constructed of a rigid or semi-rigid material and provides support for the seal-forming structure 3100 and / or the pressurization chamber 3200. For example, the frame 3350 can help maintain the shape of the seal-forming structure 3100 and / or the pressurization chamber 3200 to reduce pressurized air leakage due to folding and / or wrinkling when the seal-forming structure 3100 engages with the patient's face.

[0448] In some forms, frame 3350 provides at least one connection point 3352 that helps indirectly connect headband strap 3354 to pressurization chamber 3200 and / or sealing formation 3100. Connection point 3352 may be a loop (e.g., having a fully formed periphery) receiving a portion of headband strap 3354. For example, a length of upper left headband strap 3356 may pass through the first loop 3352a and be pulled away from pressurization chamber 3200 to apply tension through upper left headband strap 3356. 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 may be performed regarding adjusting the tension in upper right headband strap 3358 in second loop 3352b.

[0449] In some configurations, each ring 3352a, 3352b may be oriented such that the force vector applied by the corresponding upper headband straps 3356, 3358 is substantially perpendicular to the inner surface 3351 of the ring, with the upper headband straps 3356, 3358 contacting the inner surface 3351 of the ring. For example... Figure 23 As shown, the upper right headband strap 3358 engages substantially at the center of the inner surface 3351 of the ring with the ring 3352b. When the upper right headband strap 3358 is tightened, a force vector is applied in a substantially straight direction and is not tilted relative to the inner surface 3351 of the ring. This can improve the seal of the seal-forming structure 3100 because the force is guided along the arm 3362 and is not tilted relative to the arm 3362, which might 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 could prevent the seal-forming structure 3100 from properly engaging with the patient's face (e.g., leading to leakage).

[0450] like Figure 27-2 As shown, certain forms of rings 3352a, 3352b may include eyelet incisions 3353, which may be formed on the patient side of the respective rings 3352a, 3352b (e.g., the side closer to the patient's skin during use). The eyelet incision 3353 may form a region of reduced thickness along the periphery of the respective rings 3352a, 3352b. The eyelet incision 3353 may extend around a portion (e.g., less than 360°) of the periphery of the respective rings 3352a, 3352b. In the example shown, when received through rings 3352a, 3352b, the corresponding headband strap 3354 may contact the eyelet incision 3353. The reduced thickness of the eyelet incision 3353 can result in less material being used to manufacture rings 3352a, 3352b, which can result in less manufacturing time and / or lower manufacturing costs. The eyelet incision 3353 may also (or instead) result in reduced skin scarring and improved patient comfort.

[0451] In one configuration, at least one of the loops 3352a and 3352b may not be formed entirely around the periphery. In other words, these loops 3352a and 3352b may be C-shaped and / or U-shaped. The upper left headband strap 3356 and / or the upper right headband strap 3358 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.

[0452] In some forms, the frame 3350 includes a central portion 3360 connected to the pressurization chamber 3200. The central portion 3360 may have an annular shape and may have a profile corresponding to the shape of the pressurization chamber 3200 (e.g., approximately a dome curvature).

[0453] In one embodiment, a single-sized central portion 3360 can be used with pressure chambers 3200 and / or sealing structures 3100 of various sizes. For example, to better seal patients with various facial shapes, the sealing structure 3100 can have various sizes (e.g., small, medium, large, etc.) and / or shapes (e.g., small, narrow, wide, etc.). The engagement area of ​​the central portion 3360 can remain substantially the same, regardless of the size of the pressure chamber 3200 and / or the sealing structure 3100. Thus, the central portion 3360 can be coupled to pads of various shapes and / or sizes, providing substantially the same support.

[0454] In one configuration, the central portion 3360 can be removably coupled to the pressure chamber 3200. Patients can use the same frame 3350 with multiple pressure chambers 3200. This can be useful when a patient is starting treatment for the first time and is trying different sizes of pressure chambers 3200 to find the appropriate fit. Removing the frame 3350 can also be helpful when cleaning the patient interface 3000, as the different components of the patient interface 3000 can be cleaned individually to help ensure a more thorough cleaning.

[0455] In some forms, the frame 3350 includes arms 3362 extending away from the central portion 3360. Rings 3352a, 3352b are formed at the ends of these 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 pressurization chamber 3200 and / or the sealing structure 3100. These arms 3362 may also extend in a lateral direction (e.g., left or right, respectively) to generally follow the contours of the patient's face.

[0456] In some forms, when the patient interface 3000 is worn by a patient, 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 rearward and lateral directions).

[0457] In some forms, the arm 3362 may not be substantially 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 may be non-extendable). Tension may be transmitted along the arm 3362 to the pressurization chamber 3200 and / or the sealing structure 3100 to maintain effective treatment pressure and limit leakage.

[0458] In one form, the arms 3362 are constructed from a material that is more flexible 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. These arms 3362 can have some rigidity to help maintain their shape. However, the arms 3362 can be flexible, allowing the patient to adjust their shape to correspond to their facial structure. Allowing the patient to adjust the shape of the arms 3362 can increase the comfort experienced by the patient, which can increase patient adherence to treatment. In this way, these 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 rearward direction (e.g., due to its non-extensibility). Additionally, the relatively flexible material used to construct each arm 3362 can help reduce facial imprints and increase patient comfort.

[0459] In one configuration, the arms 3362 and the center 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. The center portion 3360 may be more rigid than the arms 3362 due to its connection to the pressurization chamber 3200. Alternatively, the center portion 3360 may be thicker than the arms 3362, which may also result in increased rigidity of the center portion 3360. Each arm 3362 is formed in a cantilever shape such that the ends near the corresponding rings 3352a, 3352b are unsupported. Additionally, the thickness of the frame 3350 may decrease along the length of each arm 3362 in the direction of the corresponding rings 3352a, 3352b (see, for example). Figure 27-1 This provides the flexibility required for bending and / or shaping of each arm 3362 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 provides greater flexibility near each corresponding ring 3352a, 3352b.

[0460] In some forms, the fixed end of each arm 3362 may have a thickness between approximately 2 mm and approximately 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 2.5 mm and approximately 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 3 mm and approximately 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 4 mm.

[0461] In some forms, the free end of each arm 3362 may have a thickness between approximately 0 mm and approximately 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 0.5 mm and approximately 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness between approximately 1 mm and approximately 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 2 mm.

[0462] like Figure 27-3 As shown, the cross-section of each arm 3362 can be substantially rectangular in some forms. The corners of the substantially rectangular shape (e.g., one corner, two corners, four corners, etc.) can be rounded. This can help improve patient comfort by reducing the number of sharp surfaces in contact with the patient's skin. Each arm 3362 can also have a height greater than its thickness. This height can be designed to comfortably distribute pressure across the patient's skin (e.g., by increasing the height) without obstructing the patient's surrounding vision or otherwise causing discomfort.

[0463] In some configurations, the height of each arm 3362 can be between approximately 5 mm and approximately 15 mm. In some configurations, the height of each arm 3362 can be between approximately 6.5 mm and approximately 13.5 mm. In some configurations, the height of each arm 3362 can be between approximately 8 mm and approximately 12 mm. In some configurations, the height of each arm 3362 can be between approximately 9.5 mm and approximately 10.5 mm. In some configurations, the height of each arm 3362 can be approximately 10 mm.

[0464] As shown in the figure, certain forms of frame 3350 may allow pivotable movement between each arm 3362 and the center portion 3360. This pivotable movement may differ from the bending movement described above in that the pivot point 6012 connects each arm 3362 to the center portion 3360, allowing the entire arm 3362 to move substantially the same angular distance. In addition to pivoting, each arm 3362 is also capable of bending, as described above.

[0465] In one configuration, these pivot points 6012 are arranged in substantially the same location on either side of the frame 3350. In other words, each arm 3362 can be attached to the central portion 3360 at substantially the same height, and each arm 3362 can extend approximately the same length past the pivot point 6012. This allows the patient to make mirror adjustments to the arms 3362. The patient can then individually contract or bend each arm for adjustment on one side.

[0466] In one form, each pivot point 6012 is a movable hinge. In other words, the frame 3350 can be constructed of a substantially uniform material (or the transition between each arm 3362 and the center portion 3360 can be constructed of a substantially uniform material). The thickness at each hinge 6012 can be significantly less than the thickness of the arm 3362 and the center portion 3360 immediately adjacent to the hinge 6012. For example, the hinge 6012 can be formed as a groove on the surface of the frame 3350 facing away from the patient during use. Constructing the hinge 6012 uniformly and integrally from substantially the same material as the arms 3362 and the center portion 3360 can help reduce manufacturing costs (e.g., compared to hinges constructed from different materials) compared to hinges constructed from different materials.

[0467] Each arm 3362 is pivotable about its corresponding hinge 6012 between a first position and a second position. The rings 3352a, 3352b can be closer together in the second position than in the first position.

[0468] In one configuration, the first position can be a relaxed position, and the second position can be an offset position. When an external force is applied, arm 3362 can move to the second position, and when the external force is removed, arm 3362 can return to the first position.

[0469] In one configuration, arm 3362 can also be positioned in a first or second position without further application of external force. Arm 3362 can be moved to the second position such that arms 3362 overlap each other (e.g., similar to eyeglasses). This can help provide a small footprint for packaging and / or storage.

[0470] In other forms (not shown), each arm 3362 may be separate from the center portion 3360 and may be coupled to the center portion 3360 via a rotary hinge (e.g., a pin joint). In still other forms, each arm 3362 may be coupled to the center portion 3360 by overlaying a molded flexible element in the middle, which may allow some pivoting movement.

[0471] In some forms, frame 3350 further includes at least one auxiliary connection point 3364 spaced apart from rings 3352a, 3352b. Auxiliary connection point 3364 provides additional connection locations that can further facilitate the indirect connection of headband strap 3354 to pressure chamber 3200 and / or sealing formation 3100.

[0472] In some forms, frame 3350 includes two auxiliary connection points 3364 (e.g., left auxiliary connection point 3364a and right auxiliary connection point 3364b). When the patient interface 3000 is worn by a patient, auxiliary connection points 3364a, 3364b may be lower than rings 3352a, 3352b. Headband strap 3354 may further include a lower left headband strap 3366 and a lower right headband strap 3368, each configured to engage with the corresponding auxiliary connection points 3364a, 3364b. Thus, as a whole, headband strap 3354 is able to provide force to the upper and lower regions of the sealing structure 3100 and / or the pressurization chamber 3200.

[0473] In some configurations, auxiliary connection points 3364a and 3364b are formed directly on the central portion 3360. When the patient interface 3000 is worn by a patient, the auxiliary connection points 3364a and 3364b can be positioned further forward than the rings 3352a and 3352b.

[0474] In some forms, these auxiliary connection points 3364a, 3364b can be made up of a single component, which can help reduce tooling and / or manufacturing costs.

[0475] In some configurations, the left and / or right lower headband straps 3366, 3368 are removably connected to corresponding auxiliary connection points 3364a, 3364b. These auxiliary connection points 3364a, 3364b may be magnetic, and the left and / or right lower headband straps 3366, 3368 may pass through magnets 3370 with a polarity opposite to that of these auxiliary connection points 3364a, 3364b. The length of the left and / or right lower headband straps 3366, 3368 can be adjusted by folding the corresponding straps 3366, 3368 over themselves (e.g., as done using the left and / or right upper headband straps 3356, 3358). Each magnet 3370 can be removed from the corresponding auxiliary connection point 3364a, 3364b without altering the length adjustment of the left and / or right lower 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 auxiliary connection points 3364a, 3364b (e.g., without having to remove the upper left headband strap 3356 and / or upper right headband strap 3358 from the corresponding rings 3352a, 3352b).

[0476] As shown, in order to improve the holding force with the corresponding magnet 3370, each auxiliary connection point 3364a, 3364b can be constructed. The outer housing 3376 of each auxiliary connection point 3364a, 3364b may include a substantially flat (e.g., flat) surface 3378 and a lip 3380 extending from the flat surface 3378.

[0477] In the example shown, the outer housing 3376 may have a substantially elliptical shape, and the lip 3380 may extend near the vertex of the flat surface 3378. The lip 3380 may also extend only around a portion of the flat surface 3378 (e.g., less than 360 degrees). In some examples, the lip 3380 may extend less than 180 degrees around the flat surface 3378 (e.g., the lip 3380 may not extend to any common vertex of the substantially elliptical flat surface 3378).

[0478] like Figure 28-2 As shown, each auxiliary connection point 3364a, 3364b can be connected to the frame 3350 such that the lip 3380 is arranged close to the center of the frame 3350. In other words, each auxiliary connection point 3364a, 3364b can be oriented such that when the frame 3350 is connected to the pressurization chamber 3200, the lip 3380 is arranged adjacent to the bend 3500.

[0479] Magnet 3370 includes a substantially flat surface 3378 that can engage with a substantially flat surface 3376 of the outer housing 3376. When engaged with the flat surface 3378, magnet 3370 can be magnetically coupled to magnetic elements 3382 at auxiliary connection points 3364a, 3364b. A dangling object 3384 can be spaced apart from magnet 3370. As shown, dangling object 3384 can be positioned on one side (e.g., the inner side) of lip 3380, and magnet 3370 can be positioned on the other side (e.g., the outer side) of lip 3380. In use, the patient can adjust the length of the corresponding lower headband straps 3366, 3368. Tightening one of the lower headband straps 3366, 3368 applies a force oriented away from the center of frame 3350 (e.g., in a laterally outward direction). This force can be greater than the magnetic force between magnet 3370 and magnetic element 3382, and can cause magnet 3370 to move relative to plane 3378.

[0480] The dangling element 3384 prevents the magnet 3370 from detaching from the magnetic material 3382 due to tightening of the corresponding lower headband straps 3366, 3368. When the magnet 3370 begins to move, the dangling element 3384 contacts the lip edge 3380, thereby limiting further movement away from the center of the frame 3350. Therefore, when the corresponding lower headband straps 3366, 3368 are tightened, the engagement between the lip edge 3380 and the dangling element 3384 helps reduce accidental detachment of the magnet 3370 from the corresponding second connection points 3364a, 3364b, but does not restrict the patient's ability to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., for discarding the positioning and stabilizing structure 3300).

[0481] like Figure 24 As shown, the engagement area of ​​the pressure chamber 3200 may include a recess 3280. In the example shown, the recess 3280 may be included on the opening 3201 of the pressure chamber 3200 and may be 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 properly orient the frame 3350 relative to the pressure chamber 3200 (e.g., in an example where the frame 3350 is removably attached to the pressure chamber 3200).

[0482] In some forms, the groove 3280 may have a fully formed periphery with a substantially annular shape. This periphery may have substantially the same length in any size pad.

[0483] In some forms, the recess 3280 is recessed relative to the remainder of the outer surface of the pressurization chamber 3200. The recess 3280 may not extend substantially into the pressurization chamber 3200 and may obscure the patient's face. The recess 3280 may have substantially the same depth over its entire periphery.

[0484] In some forms, the width of the recess 3280 may be smaller than the width of the center portion 3360 of the frame 3350. The conforming nature of this cushioning pad allows the wider center portion 3360 to be received within the recess 3280. This allows the center portion 3360 to be engaged with the recess 3280 via press-fit, friction fit, and / or snap-fit. The engagement between the recess 3280 and the center portion 3360 helps provide rigidity to the pressure chamber 3200 and / or the sealing structure 3100, because the rigidity of the frame 3350 (e.g., compared to the pressure chamber 3200) can limit some of the flexibility of the pressure chamber 3200 alone.

[0485] In some forms, the liner can be molded onto the frame 3350, such that the groove 3280 can be created during the molding process. The material of the pressurization chamber 3200 (e.g., silicone) can be at least partially molded around the center portion 3360 of the frame 3350, and the center portion 3360 can be restricted from removal from the groove 3280.

[0486] like Figure 25 As shown, frame 3350 can be composed of multiple pieces (e.g., each piece is made of a different material). For example, the central portion can be constructed of a first material (e.g., rigid plastic). Arm 3362 can be attached to the central portion 3360 (e.g., by glue, molding, etc.) and can be constructed of a second material that is more flexible than the first material (e.g., plastic, 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 in a manner similar to that described in the monolithic single-piece structure.

[0487] like Figure 26 and 27 As shown, the frame 3350 can be constructed from a single piece of material. For example, the frame 3350 can be made of a TPE material, such as Hytrel. As described above, the material used to construct the frame 3350 can provide the frame 3350 with both rigidity and flexibility. These magnets 3370 can be overmolded (or otherwise attached to) the central portion 3360.

[0488] In some forms, the central portion 3360 includes grooves 3372, which may be formed on any lateral side of the central portion 3360. These grooves 3372 may have an generally elongated shape (e.g., rectangular, elliptical, etc.) and may be formed entirely within the junction of the central portion 3360.

[0489] like Figure 27 As shown, some forms of the central portion 3360 may include a tapered groove 3372. Specifically, the opening to the groove 3372 may be wider near the rear surface of the central portion 3360 (e.g., the surface in contact with the pressurization chamber 3200). The opening to the groove 3372 may decrease uniformly toward the front surface of the central portion 3360.

[0490] Figure 27Some 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 indentation 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 lower manufacturing time and / or lower manufacturing costs.

[0491] return Figures 26 to 26-2 The pressurization chamber 3200 may include protrusions 3284 on the opening 3201. These protrusions may be elongated and may have a shape similar to the groove 3372 (e.g., tapered). The protrusions 3284 may be arranged within the recess 3280 so that they cooperate with the frame 3350 during assembly.

[0492] like Figure 26-2 As shown, some forms of protrusions 3284 may include overhangs 6000 that extend at least partially over the recess 3280. The overhangs 6000 may be formed asymmetrically around the periphery of the protrusion 3284. In other words, the overhangs 6000 may extend further over the recess 3280 on one side than on the other.

[0493] In some forms, the recess 3280 may also be asymmetrical. The recess 3280 may include an undercut 6004 on one side of the protrusion 3284 and an inclined surface 6008. The overhang 6000 may extend further on the undercut 6004 than on the inclined surface 6008. The length of the overhang 6000 extending on the undercut 6004 may limit the ability of the frame 3350 to be removed from the pressurization chamber 3200 in the vertical direction. The angle of the inclined surface 6008 may point towards the overhang 6000 and limit the ability of the frame 3350 to be removed in the inclined direction.

[0494] When the frame 3350 is assembled into the pressure chamber 3200 (e.g., via press fit, friction fit, snap fit, etc.), the patient can align the protrusions 3284 with the slots 3372 such that the protrusions 3284 are received within the slots 3372 during use. The wider openings of these slots 3372 near the rear surface help the patient align each protrusion 3284 within its corresponding slot 3372. The protrusions 3284 may be slightly wider than the front opening of each slot 3372, but can be received within the slots 3372 due to the flexible nature of the pressure chamber 3200 (e.g., constructed of an elastic material such as silicone). These protrusions 3284 may deform slightly as they enter their corresponding slots 3372 (e.g., due to the narrowing of the slots 3372).

[0495] Once these protrusions 3284 pass through the groove 3372, they can substantially return to their original shape. For example, when the groove 3372 receives the protrusion 3284, the pendant 6000 can deform (e.g., elastically deform), and once the central portion 3360 is received within the recess 3280, the pendant 6000 can return to its initial position. The patient can experience this deformation as a tactile response to more easily observe the proper connection between the frame 3350 and the pressure chamber 3200. In the relaxed or initial position, the pendant 6000 of the protrusion 3284 can be wider than the front opening of the corresponding groove 3372.

[0496] Additionally, the width of the undercut 6004 can be substantially the same as that of the center portion 3360, so that the frame 3350 is received tightly within the groove 3280. The flexible material of the pressurization chamber 3200 allows the undercut 6004 to be slightly smaller than the center portion 3360, so that the undercut 6004 can flex and receive the frame 3350 via press fit, friction fit, snap fit, etc.

[0497] Therefore, the frame 3350 may not be easily removed from the pressure chamber 3200. The patient may have to apply force to the frame 3350 to remove it from the recess 3280. The force applied by the user may allow the frame 3350 to move in a vertical or inclined direction and overcome the holding force provided by the hanger 6000. For example, the patient may lift the frame 3350 from the area of ​​the contact inclined surface 6008 of the central portion 3360 to provide a force for disengaging the frame 3350 from the pressure chamber 3200.

[0498] This force can exceed the force generated by the normal movement of the pressure chamber 3200 and / or the sealing structure 3100. In other words, the sealing structure 3100 and / or the pressure chamber 3200 can move relative to the frame 3350 while the protrusion 3284 is received within the corresponding groove 3372. This allows the sealing structure 3100 and / or the pressure chamber 3200 to bend and conform to the patient's face without loosening from the frame 3350 and without unintentionally causing the groove 3372 to detach from the protrusion 3284.

[0499] In other forms, the pressure chamber 3200 can be molded onto the frame 3350, and these protrusions 3284 can be produced by the molding process to permanently maintain the position of the frame 3350 relative to the pressure chamber 3200.

[0500] like Figure 26-3 As shown, some forms of the frame 3350 can be oriented to reduce cheek contact when the connected frame 3350 and pressurization chamber 3200 are worn by a patient. For example, arms 3362a, 3362b can be oriented (e.g., bent) to substantially complement at least a portion of the patient's face (e.g., their cheeks). However, in some examples, the entire length of each arm 3362 may not contact the patient's skin, as the patient may feel uncomfortable having a foreign object in contact with their face. Instead, a portion of each arm 3362 may be spaced apart from the patient's face, such that a smaller surface area of ​​the arm 3362 contacts the patient's face. While maintaining substantially the same curvature in each arm 3362, moving the contact point between each arm 3362 and the pressurization chamber 3200 (e.g., via a manufacturing process) can change the total length of each arm 3362 that contacts the patient's face. For example, if each arm 3362 contacts the pressurization chamber 3200 closer to the bend 3500, the maximum gap between each arm 3362 and the patient's face is larger. This means that a larger portion of each arm 3362 will be spaced apart from the patient's face (e.g., as if each arm 3362 were in contact with the pressurization chamber 3200 away from the bend 3500). Less contact between each arm 3362 and the patient's face can improve patient comfort.

[0501] Additionally, each arm 3362 that contacts the pressure chamber 3200 near the elbow and thus away from the rear surface 3112 can provide less support at the transverse portion 3111 of the pressure chamber 3200 (e.g., because the rigid or semi-rigid arms engage the transverse portion 3111 less). Therefore, the transverse portion 3111 can have a greater degree of flexibility and can better conform to the shape of the patient's nose and produce an effective seal.

[0502] like Figure 26-4 and 26-5As shown, some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the center portion 3360. The hinge 6012 allows movement (e.g., pivoting) of the arms 3362 without affecting the connection between the frame 3350 and the pressurization chamber 3200. In other words, pivoting any arm 3362 about the corresponding hinge 6012 does not cause the protrusion 3284 to disengage from the slot 3372.

[0503] In some configurations, the patient can move arm 3362 into a second position to provide better fit. For example, the distance between rings 3352a and 3352b in the first position may be greater than the average patient's head size. Therefore, the patient can move arm 3362 into the second position to provide a suitable fit (e.g., contact between arm 3362 and the patient's head). Arm 3362 can be held in the second position by adjusting the upper headband straps 3356 and 3358 (i.e., the upper headband straps 3356 and 3358 can provide external force).

[0504] Similar to arm 3362, the pressure chamber 3200 and / or the sealing structure 3100 may be larger than the size of a typical patient's face. For example, the sealing structure 3100 may engage the patient's mouth and / or nose without being too tight. The pressure chamber 3200 and / or the sealing structure 3100 may also be moved to a more compact position for better engagement with an individual patient's face.

[0505] like Figure 26-5 As shown, moving the arms 3362 to the second position can directly cause the sealing structure 3100 and / or the pressurization chamber 3200 to move to a more compact position. These arms 3362 can contact the pressurization chamber 3200 along the second front wall portion 3242. The arms 3362 can also contact the second front wall portion 3242 near the center of the pressurization chamber 3200 and on the distal side of these transverse portions 3111.

[0506] The pivoting movement of each arm 3362 about hinge 6012 can provide an inward force to the pressure chamber 3200. This can reduce the distance between the sides 3111 of the second seal-forming structure 3102 and position the second seal-forming structure 3102 close to the patient's nose. Compression of the seal-forming structure 3100 and / or the pressure chamber 3200 can provide a better seal to the patient's face (e.g., by limiting leakage). Additionally, applying an inward force near the center of the pressure chamber 3200 (e.g., as per...) Figure 26-3 (As described) the formation of wrinkles in the sealing structure 3100 can be limited by limiting the total compression of the pressure chamber 3200.

[0507] like Figure 28 As shown, the shape of frame 3350 can be... Figure 26 and27 The frame is similar. In other words, the frame 3350 can be constructed from a single material (e.g., a material with semi-rigid properties). The frame 3350 can be thicker near the center 3360 and thinner toward each corresponding ring 3352a, 3352b.

[0508] In some forms, the central portion 3360 of the frame 3350 may be substantially solid and may not include the slot 3372, and the pressurization chamber 3200 may not include the plurality of protrusions 3284 within the recess 3280. Instead, the pressurization chamber 3200 may include protrusions 3288 radially arranged within the recess 3280. The protrusions 3288 may rise from the remainder of the front surface of the pressurization chamber 3200. The protrusions 3288 may also extend at least partially in a radially outward direction. In other words, the protrusions 3288 may extend at least partially above the recess 3280 (e.g., the protrusions 3388 are spaced apart from the recess 3280).

[0509] While assembling the removable frame 3350 into the pressure 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 pressure chamber 3200, the patient may push at least one of the protrusions 3288 (e.g., laterally toward the other protrusion 3288) so that the protrusion no longer extends over the recess 3280. In other forms, the pressure chamber 3200 may be molded onto the frame 3350, and these protrusions 3288 may prevent the central portion 3360 from being removed.

[0510] In some forms, when positioned within the recess 3280, the frame 3350 of any of the above examples can be substantially flush with the outer surface of the pressurization chamber 3200. The depth of the recess 3280 substantially corresponds to the thickness of the central portion 3360. Similarly, the shape of the central portion can substantially resemble the shape of the pad as described above. The resulting assembly can have a substantially uniform surface. This helps maintain the low-profile appearance of the patient interface 3000 because the frame 3350 does not protrude in front of the padding that might obstruct the patient's view.

[0511] 5.3.5 Vent

[0512] 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.

[0513] In some configurations, the vent 3400 is configured to allow continuous ventilation flow from the interior of the pressurization chamber 3200 to the surrounding environment, while the pressure within the pressurization chamber is positive relative to the surrounding environment. The vent 3400 is configured such that the vent flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the treatment pressure within the pressurization chamber during use.

[0514] 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.

[0515] Vent 3400 may be located in pressurization chamber 3200. Alternatively, vent 3400 may be located in decoupling structure (e.g., transition joint).

[0516] Although Figure 7-18 The vent structure is not shown, but Figure 7-18 The embodiments of the technology shown may be provided with suitable vent structures, for example in a pressurization chamber (one example of which is...). Figure 21 (As shown in the image).

[0517] 5.3.6 Decoupling Structure

[0518] In one form, the patient interface 3000 includes at least one decoupling structure, such as a joint or ball joint. In some examples, the decoupling structure may be a bend 3500 that connects (e.g., detachably connected, permanently connected, etc.) to a pressure chamber 3200 (e.g., a pressure chamber inlet port).

[0519] like Figure 23-28 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 pressurization chamber 3200 is not covered by the frame 3350. In some examples, the opening 3201 includes an opening for receiving the bend 3500. This opening may be significantly wider than the opening for receiving the bend 3500, such that the frame 3350 is completely spaced apart from the opening. In other words, there is a certain length between the inner edge of the central portion 3360 and the opening for receiving the bend 3500. The arms 3362a, 3362b and the auxiliary connecting portions 3342a, 3342b are each spaced apart from the opening and the bend 3500, such that the headband strap 3358 does not interfere with the movement (e.g., rotation) of the bend.

[0520] Although Figure 7-19 The accompanying drawings do not explicitly show the pressurization chamber, but those skilled in the art will understand that a 3500 bend can actually be provided (e.g., as shown in the diagram). Figure 23 (as shown in the diagram), and the bend 3500 allows the interface to be connected to the air circuit 4170.

[0521] 5.3.7 Connection Port

[0522] 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 one of the two connection ports 3600, on either side of pressurization chamber 3200. A catheter may be connected to connection port 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. These catheters may extend toward a crown of the patient's head, with decoupling structure 3500 located thereon.

[0523] 5.3.8 Forehead Stent

[0524] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0525] 5.3.9 Anti-suffocation valve

[0526] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0527] 5.3.10 port

[0528] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to a volume within the pressurization 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 pressurization chamber 3200, such as pressure.

[0529] 5.4 RPT device

[0530] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example for treating one or more respiratory conditions described elsewhere in this document.

[0531] In one embodiment, the RPT device 4000 is constructed 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.

[0532] 5.4.1.1 RPT Device Algorithm

[0533] As described above, in some forms of this technology, the central controller 4230 can be configured to implement one or more algorithms 4300, which are expressed as computer programs stored in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are generally grouped into groups called modules.

[0534] 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 this form, the input signals and / or intermediate algorithm outputs necessary for executing a portion of the algorithm 4300 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 this form, the portion of the algorithm 4300 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.

[0535] In this form, treatment parameters generated by an external device via the treatment engine module 4320 (if this forms part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 to be passed to the treatment control module 4330.

[0536] 5.5 Air Circuit

[0537] 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.

[0538] 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.

[0539] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the 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 communicated with 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.

[0540] 5.5.1 Supplementary pressurization body delivery

[0541] In one form of this technology, a pressurization body, namely supplemental oxygen 4180, is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), air circuit 4170 and / or patient interface 3000 or 3800.

[0542] 5.6 Humidifier

[0543] 5.6.1 Overview of Humidifiers

[0544] In one form of this technology, a humidifier 5000 is provided (e.g., as...). Figure 5A As shown), it changes the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0545] 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 also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0546] 5.7 Respiratory waveform

[0547] Figure 6 The diagram shows a typical respiratory waveform of a sleeping human. The horizontal axis represents time, and the vertical axis represents respiratory flow. Parameter values ​​can vary, but a typical breath may have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow Qpeak -0.5 L / s. The total duration of respiration, Ttot, is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM) with a ventilation rate of approximately 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0548] 5.8 Breathing Therapy Mode

[0549] The disclosed respiratory therapy system can implement various respiratory therapy modalities, including CPAP therapy and bilevel therapy.

[0550] 5.9 Vocabulary List

[0551] 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.

[0552] 5.9.1 General Concepts

[0553] 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.

[0554] 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.

[0555] 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.

[0556] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0557] 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.

[0558] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, for example, from one breath to another, between minimum and maximum, depending on the presence or absence of an SDB event indication.

[0559] Continuous positive airway pressure (CPAP) therapy: respiratory pressure therapy in which the treatment pressure remains substantially 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 some 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 an indication of partial upper airway obstruction.

[0560] 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'.

[0561] In the example of patient breathing, the 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 pressurization units 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 gas. 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.

[0562] Flow therapy: Flow therapy is a respiratory therapy that involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is typically positive throughout the patient’s respiratory cycle.

[0563] 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.

[0564] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak could occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a bend in the conduit leading to the surrounding environment.

[0565] 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.

[0566] Noise, Radiation (Acoustic): Radiated noise in this document refers to noise carried to the patient by ambient 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.

[0567] 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.

[0568] Patient: A person, whether or not they have a respiratory disorder.

[0569] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 gf / cm³ 2And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0570] The pressure in the patient interface is assigned the symbol Pm, while the treatment pressure, representing the target value achieved by the mask pressure Pm at the current moment, is assigned the symbol Pt.

[0571] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a treatment pressure that is normally positive relative to the atmosphere.

[0572] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0573] 5.9.1.1 Materials

[0574] Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the 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.

[0575] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0576] 5.9.1.2 Mechanical properties

[0577] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0578] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0579] 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).

[0580] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0581] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0582] 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 reciprocal of stiffness is flexibility.

[0583] 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.

[0584] 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.

[0585] As an example, an I-beam may contain 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.

[0586] 5.9.2 Respiratory and Circulatory Systems

[0587] Apnea: According to some definitions, apnea is considered to have occurred when airflow is below a predetermined threshold for a sustained period of time, such as 10 seconds. Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even when the patient is trying. 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.

[0588] Respiratory rate: Usually measured as the rate of spontaneous breathing of a patient per minute.

[0589] Duty cycle: The ratio of inhalation time Ti to total respiratory time Ttot.

[0590] Effort (breathing): This is the work done by a person who is trying to breathe voluntarily.

[0591] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0592] Flow limitation: Flow limitation is considered an event state in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Flow limitation occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow limitation. Flow limitation occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow limitation.

[0593] Flow-limited inhalation waveform type:

[0594] (i) Flattening: It has an ascending part, followed by a relatively flat part, and then a descending part.

[0595] (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.

[0596] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0597] (iv) Inverted chair type: has a relatively flat section, followed by a single local peak at the trailing edge.

[0598] 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 occur when the flow rate drops below a threshold and persists for a period of time. Central insufficient breathing is considered to occur 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:

[0599] (i) The patient's breathing decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0600] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0601] Hyperventilation: The flow rate increases to above normal levels.

[0602] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0603] Openness (airway): 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).

[0604] Positive end-expiratory pressure (PEEP): The pressure above the atmosphere in the lungs at the end of expiration.

[0605] Peak flow rate (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0606] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms can be understood as estimates of the respiratory flow rate of the RPT device, as opposed to “true respiratory flow rate” or “real respiratory rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0607] 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 quantity. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0608] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0609] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0610] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of a respiratory flow waveform and the start of the next inspiratory portion of the same waveform.

[0611] Typical recent ventilation: The most recent value of ventilation at a given time scale tends to cluster around the ventilation values; that is, it is a measure of the central tendency of the most recent values ​​of ventilation.

[0612] 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 gradient across the upper airway increases (Starling resistance behavior).

[0613] Ventilation: A measure of the rate at which a patient's respiratory system exchanges gases. 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.

[0614] 5.9.3 Ventilation

[0615] 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.

[0616] Backup rate: A ventilator parameter that determines the minimum respiratory rate (usually expressed as breaths per minute) that the ventilator will deliver to the patient if it is not triggered by spontaneous breathing effort.

[0617] Cycle: 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.

[0618] Positive Expiratory Airway Pressure (EPAP): Baseline pressure, the pressure that changes during breathing is increased to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0619] End-expiratory pressure (EEP): The desired mask pressure that the ventilator will attempt to achieve at the end of the expiratory phase of breathing. (If pressure waveform template...) ( It is zero at the end of exhalation, that is, when = 1 hour ( If EEP = 0, then EEP equals EPAP.

[0620] Inspiratory positive airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0621] Pressure support: Indicates a pressure increase during inspiration that exceeds the pressure increase during expiration, and typically means the pressure difference between the maximum inspiratory pressure 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.

[0622] Servo ventilator: A ventilator that measures patient ventilation with a target ventilation volume and adjusts the pressure support level to bring the patient's ventilation volume to the target ventilation volume.

[0623] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0624] Swaying: A term equivalent to pressure support.

[0625] Trigger: When a ventilator delivers breathing air to a patient who is breathing independently, it is said to be triggered by the patient's effort at the beginning of the breathing phase of the respiratory cycle to make this delivery possible.

[0626] 5.9.4 Anatomy

[0627] 5.9.4.1 Facial Anatomy

[0628] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0629] Alar tip: the outermost point on the ala of the nose.

[0630] Nasal wing curve (or nasal apex) point: the last point on the baseline of the curve of each nasal wing, found in the crease formed by the junction of the nasal wing and the cheek.

[0631] Auricle: The entire visible external part of the ear.

[0632] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nose of the frontal bone.

[0633] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0634] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper part of the lip.

[0635] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0636] 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.

[0637] 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.

[0638] 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.

[0639] Lip, lower part (lower lip): A point on the face between the mouth and the nasal ridge, located in the midsagittal plane.

[0640] Lip, upper part (upper lip): a point on the face between the mouth and nose, located in the midsagittal plane.

[0641] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0642] Nostrils: Generally oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril is nasal septum (nose eye). Nostrils are separated by the nasal septum.

[0643] 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 part of the lips.

[0644] Nasolabial angle: the angle between the columella and the upper part of the lip, which also intersects the lower side of the nose.

[0645] Inferior auricular base: the lowest point where the auricle attaches to the facial skin.

[0646] Upper auricular base: the highest point where the auricle attaches to the facial skin.

[0647] 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.

[0648] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0649] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0650] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0651] 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.

[0652] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0653] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0654] 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.

[0655] The subnasal point is located on the soft tissue at the intersection of the columella and the upper part of the lip in the midsagittal plane.

[0656] Nasal ridge: The point of greatest indentation between the midline of the lower lip and the soft tissue ridge.

[0657] 5.9.4.2 Anatomical Structure of the Skull

[0658] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0659] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0660] 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 junction.

[0661] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from individual to individual; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their joint.

[0662] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0663] 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.

[0664] The eye socket is the bony cavity in the skull that houses the eyeball.

[0665] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0666] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face called the temple.

[0667] 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.

[0668] 5.5.4.3 Anatomy of the Respiratory System

[0669] 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.

[0670] The larynx is a vocal cord or soundbox that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0671] Lungs: The human respiratory organs. 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.

[0672] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0673] 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 parts: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0674] 5.9.5 Patient Interface

[0675] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive 2CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0676] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, about 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0677] 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.

[0678] 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.

[0679] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0680] Pressure chamber: A mask pressure chamber is considered to refer to a 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 walls of the mask pressure chamber.

[0681] Sealing: can be the noun form referring to a structure (sealant) or the verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0682] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell or a portion of the shell may not be rigid. In some forms, the shell may be multifaceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0683] 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.

[0684] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0685] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotating shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotating shaft.

[0686] Lacing (noun): A structure used to resist tension.

[0687] 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.

[0688] 5.9.6 Shape of the structure

[0689] 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 outer surface) and separate surfaces that do not contact the face (e.g., the underside or inner surface). In another example, a structure may include a first surface and a second surface.

[0690] 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 This shows an example of a cross-section at a point p far from the surface. 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 examples, the surface is depicted from the viewpoint of an imaginary little person standing upright on the surface.

[0691] 5.9.6.1 Curvature in one dimension

[0692] 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).

[0693] Positive curvature: If the curve at point p turns towards the outward normal, then the curvature at that point will be positive (if the imagined figures leave point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0694] 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 .

[0695] 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 the figures in the image were to leave point p, they would have to 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.

[0696] 5.9.6.2 Curvature of Two-Dimensional Surfaces

[0697] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0698] 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 3BIn the middle, and the minimum value appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at p is the curvature along the principal direction.

[0699] 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.

[0700] 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).

[0701] 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").

[0702] 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.

[0703] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0704] Surface edge: The boundary or limit of a surface or region.

[0705] 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 individual paths are those in which they travel on a surface and resemble garden paths).

[0706] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imaginary individual would be the distance they walk along the path on the surface).

[0707] 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'.)

[0708] 5.9.6.3 Space Curves

[0709] 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.

[0710] 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.

[0711] 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.

[0712] 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.

[0713] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See appendix. Figure 3O and 3P .

[0714] 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 amount of torsion (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of torsion (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3SThe amount of twist near the top coil of the spiral is greater than Figure 3S The amount of twist of the bottom coil of the spiral.

[0715] 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 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).

[0716] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve pointing 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 .

[0717] 5.9.6.4 Hole

[0718] 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 at the intersection of a planar curve.

[0719] The structure can have two-dimensional pores, such as pores defined by a surface. For example, a turbocharged tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder with cavities 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 at the junction defined by the surface shown.

[0720] 5.10 Other Remarks

[0721] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0722] 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 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 that range. Where the range includes one or both of the extreme values, this technique also includes ranges that exclude any one or both of those included extreme values.

[0723] 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.

[0724] 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.

[0725] 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 stated, any and all components herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0726] 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.

[0727] 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.

[0728] 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.

[0729] 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.

[0730] 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 present technology. In some cases, terms and symbols may imply specific details not required for the practice of the present technology. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order, 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.

[0731] Therefore, it should be understood that numerous modifications can be made to this exemplary embodiment, and that other arrangements can be designed without departing from the spirit and scope of the present technology.

[0732] 5.11 List of Reference Symbols

[0733]

[0734]

[0735]

[0736]

Claims

1. A patient interface, comprising: A pressurization chamber, which at least partially forms a cavity, the cavity being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are designed to receive an airflow at treatment pressure for respiration by a patient; A first sealing structure is configured and arranged to form a seal with an area of ​​the patient's face surrounding the patient's mouth during use, such that an airflow at the treatment pressure is delivered to the patient's mouth, and the first sealing structure is configured and arranged to maintain the treatment pressure in the cavity throughout the patient's respiratory cycle during use. A second sealing structure is configured and arranged to form a seal with an area of ​​the patient’s face surrounding the patient’s nose during use, such that an airflow under the treatment pressure is delivered to the patient’s nose, and the second sealing structure is configured and arranged to maintain the treatment pressure in the cavity throughout the patient’s respiratory cycle during use. The pressurization chamber has a front wall formed of silicone resin, and the pressurization chamber inlet port is an opening formed in the silicone resin of the front wall; The pressurization chamber, wherein the first sealing structure and the second sealing structure are formed of the same silicone resin material; as well as A ventilation port structure that allows gas exhaled by the patient to flow continuously from the cavity to ventilate the surrounding environment, the size and shape of the ventilation port structure being designed to maintain therapeutic pressure in the cavity during use; The patient interface further includes: A pair of support portions are arranged within the cavity and on opposite sides of the pressurization chamber, the pair of support portions contacting the second sealing structure and extending from the second sealing structure through the cavity and contacting the front wall of the pressurization chamber, wherein the pair of support portions are configured to resist compression in the forward and rearward directions.

2. The patient interface of claim 1, wherein the support portion is connected to a plurality of portions of the second sealing structure, the portions sealingly abutting against the upper lip of the patient during use.

3. The patient interface of claim 1, wherein the support portion is connected to a plurality of portions of the second sealing structure, the portions being sealed to the upper lip of the patient during use, directly below the corner of the patient's nose.

4. The patient interface according to claim 1, wherein the support is curved when viewed in a cross-section parallel to the sagittal plane.

5. The patient interface according to claim 1, wherein the support is curved when viewed in a cross-section parallel to the front.

6. The patient interface of claim 1, wherein the pressurization chamber comprises a mouth and a nose.

7. The patient interface of claim 6, wherein each support is connected to the mouth of the pressurization chamber at the junction of the transverse sidewall portion adjacent to the mouth and the transverse sidewall portion of the nose.

8. The patient interface of claim 6, wherein each support is connected to the mouth portion of the pressurization chamber, adjacent to the junction of the front wall portion of the mouth portion and the front wall portion of the nose portion.

9. The patient interface of claim 7, wherein the transverse sidewall portion of the pressurization chamber bends inward adjacent to the junction with the nose portion, wherein each support portion is adjacent to the adjacent transverse sidewall portion.

10. The patient interface according to any one of claims 1 to 9, wherein the second sealing formation includes at least one nostril, the at least one nostril being configured to deliver an airflow under the treatment pressure to the inlet of the patient's nostril, wherein in use, no portion of any support is directly below the nostril or each nostril.

11. The patient interface according to any one of claims 1 to 9, wherein the interface further comprises a positioning and stabilizing structure configured to generate forces to hold the sealing formation in a therapeutically effective position on the patient's head.

12. The patient interface according to any one of claims 1 to 9, wherein the pressurization chamber is at least partially formed by the housing and the vent structure is provided to the housing.

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