Dual chamber patient interface with airflow regulation

Abstract

A patient interface may include a dual-chamber liner assembly having a nasal chamber and an oral chamber. The nasal chamber may be arranged to deliver pressurized breathable gas to the patient's nasal passage, and the oral chamber may be arranged to deliver pressurized breathable gas to the patient's oral passage. The nasal chamber may be pressurized to a different level than the oral chamber to facilitate nasal breathing. An air passage may fluidly connect the nasal and oral chambers, allowing pressurized breathable gas to flow from the nasal chamber to the oral chamber.

Description

[0001] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights. 1. Cross-references to related applications

[0002] This application claims the benefit of Australian Provisional Application No. 2019903204, filed on August 31, 2019, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

[0004] 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.

[0005] 2.2 Description of relevant technologies

[0006] 2.2.1 The Human Respiratory System and Its Disorders

[0007] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0008] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0009] A range of breathing disorders exist. Some conditions may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0010] 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.

[0011] 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 patients 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).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is a 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.

[0014] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0015] 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.

[0016] 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.

[0017] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0018] 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.

[0019] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0020] 2.2.2 Treatment

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

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] 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 duct ventilator).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0025] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0026] Invasive ventilation (IV) provides ventilatory support to patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube or endotracheal intubation. In some forms, the comfort and effectiveness of these treatments can be improved.

[0027] 2.2.2.2 Flow Therapy

[0028] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In others, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one instance, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained 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, a therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0029] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors can specify a continuous flow of oxygen-enriched air 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 (the oxygen fraction in ambient air, from 21% to 100%).

[0030] 2.2.2.3 Oxygen Supplementation

[0031] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is called HFT with supplemental oxygen.

[0032] 2.2.3 Respiratory Therapy System

[0033] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0034] 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.

[0035] Another form of treatment system is the mandibular repositioning device.

[0036] 2.2.3.1 Patient Interface

[0037] 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 treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow therapy such as nasal HFT, the patient interface is configured to blow into the nostrils, but a complete seal is specifically avoided. An example of such a patient interface is a nasal cannula.

[0038] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0039] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0040] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0041] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0042] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The mandible or jawbone can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0043] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the face shield is worn during sleep.

[0044] If patients adhere to treatment, CPAP therapy is very effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to wash (e.g., difficult to assemble or disassemble), patients may not wash their masks, which could affect adherence.

[0045] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0046] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0047] 2.2.3.1.1 Sealing Formation Structure

[0048] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0049] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0050] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0051] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0052] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0053] Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0054] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0055] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0056] 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.

[0057] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0058] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO 2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TMOther aspects of the full-face mask); International Patent Application WO2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0059] 2.2.3.1.2 Positioning and Stability

[0060] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0061] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0062] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use.

[0063] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0064] 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.

[0065] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0066] One example of a specific requirement for certain RPT devices is noise.

[0067] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0068] RPT device name A-weighted sound pressure level in dB(A) Year (approximately) C Series Tango™ 31.9 2007 C-Series Tango™ with Humidifier 33.1 2007 S8 Escape™ II 30.5 2005 S8 Escape™ II with H4i™ humidifier 31.1 2005 S9 AutoSet™ 26.5 2010 S9 AutoSet™ with H5i humidifier 28.6 2010

[0069] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a CPAP machine. CPAP machines include ResMed Stellar... TM The range of adult and pediatric ventilators can support a range of patients with invasive and non-invasive non-dependent ventilation for the treatment of a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0070] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single- or dual-branch circuits. RPT devices typically include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0071] The designer of a device may be presented with an almost infinite number of options. Design standards often conflict, meaning that some design choices are far from unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0072] 2.2.3.3 Air Circuit

[0073] 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 of the air circuit for inspiratory and expiratory breathing. In other cases, a single-branch air circuit is used for both inspiratory and expiratory breathing.

[0074] 2.2.3.4 Humidifier

[0075] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas 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.

[0076] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0077] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0078] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0079] 2.2.3.5 Oxygen Source

[0080] 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 handcart with wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0081] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are bulky and cumbersome, 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 smaller and more portable, the 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 is achieved by delivering oxygen in a series of pulses, or “boli,” each pulse timed to coincide with the start of inspiration. In contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators, this mode of treatment is called pulsed oxygen delivery (POD) or on-demand delivery.

[0082] 2.2.3.6 Data Management

[0083] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is requiring the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0084] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0085] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0086] 2.2.3.7 Mandibular repositioning

[0087] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting into the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0088] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0089] 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 degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0090] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as ResMed Narval CC)TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0091] 2.2.3.8 Vent technology

[0092] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0093] Ventilation ports may include openings through which air can flow when a mask is used. Many of these ventilators are noisy. Others may become blocked during use, thus providing insufficient flushing. Some ventilators can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0094] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0095] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0096]

[0097] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0098] The sound pressure levels for various objects are listed below.

[0099]

[0100] 2.2.4 Screening, Diagnosis and Monitoring System

[0101] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinicians applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0102] 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.

[0103] 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

[0104] 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.

[0105] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0106] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0107] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0108] One aspect of this technology relates to a patient interface comprising: at least one inflatable chamber for the patient interface, the inflatable chamber being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use.

[0109] Another aspect of this technology relates to a patient interface that includes a dual-chamber liner assembly.

[0110] Another aspect of this technology relates to a patient interface comprising a liner assembly having a nasal chamber and an oral chamber, the oral chamber being pressurizable to a different level than the nasal chamber.

[0111] Another aspect of this technology relates to a patient interface for hermetically delivering an airflow under a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least a patient nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use to improve sleep-disordered breathing, the patient interface including a liner assembly configured to deliver the airflow to the patient airway.

[0112] In the example: (a) the liner assembly includes a nasal chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the nasal chamber being configured to deliver an airflow to a patient's nasal passage during use; (b) the liner assembly includes an oral chamber pressurizable to a different level than the nasal chamber, the oral chamber being configured to deliver an airflow to a patient's mouth during use; (c) the liner assembly includes at least one inlet port, the at least one inlet port being sized and configured to receive at least an airflow entering the nasal chamber; (d) the liner assembly includes a sealing formation structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing formation structure having at least one hole therein, such that an airflow is delivered at least to the patient's nostril inlet; (e) the liner assembly includes a partition formed as a wall extending between and separating the nasal chamber and the oral chamber.

[0113] In a further example: (a) a first surface of the wall is disposed in the nasal chamber, and a second surface of the wall opposite the first surface is disposed in the oral chamber; (b) a plurality of holes are formed in the wall, the plurality of holes extending through the first and second surfaces to allow airflow from the nasal chamber to the oral chamber in a manner that maintains the pressure in the oral chamber at a level lower than that in the nasal chamber, thereby facilitating nasal breathing; (c) the plurality of holes includes at least three holes; (d) the pressure in the nasal chamber is at least 2 cmH2O higher than the pressure in the oral chamber; (e) the pressure in the nasal chamber is at least 5 cmH2O higher than the pressure in the oral chamber.

[0114] In a further example: (a) the liner assembly also includes a flow regulator comprising a passage fluidly connecting the nasal chamber to the oral chamber to allow airflow from the nasal chamber to the oral chamber; (b) the flow regulator is configured to adjust the size of the passage to control the volume of airflow from the nasal chamber to the oral chamber; (c) the flow regulator is an adjustable valve; (d) the size of the passage is manually adjustable; (e) the flow regulator also includes a rotatable dial for manually adjusting the size of the passage; (f) the size of the passage is automatically adjustable; (g) the patient interface also includes a sensor for determining the resistance level in the patient's nasal passage, wherein, in use, when the resistance level in the patient's nasal passage exceeds a first threshold, the flow regulator is configured to automatically adjust the airflow to increase the pressure in the oral chamber.

[0115] In a further example: (a) the separator comprises silicone; (b) the sealing formation comprises a nasal seal including at least one orifice such that airflow is delivered at least to the patient's nasal inlet; (c) the sealing formation comprises a mouth seal having an orifice therein for delivering airflow to the patient's mouth; (d) the liner assembly is a mouth-nose liner assembly, and the sealing formation is configured to form a seal below the patient's nasal protuberance in use; (e) the patient interface further comprises a pair of headband tubes configured to deliver airflow to the liner assembly, the headband tubes being configured to extend along the respective sides of the patient's face between the patient's eyes and ears in use.

[0116] In a further example: (a) the pad assembly is a full-face pad assembly, and the sealing forming structure is configured to form a seal above the patient's nasal protuberance during use; (b) the sealing forming structure is configured to form a seal along the patient's nasal bridge during use; (c) the wall extends from the patient contact side of the pad assembly to the non-patient contact side of the pad assembly; (d) the wall forms the upper surface of the oral cavity chamber and the lower surface of the nasal cavity chamber; (e) the patient interface also includes a connector that forms a hollow interior to allow fluid connection between the nasal cavity chamber and the oral cavity chamber, the wall being disposed within the hollow interior of the connector.

[0117] In a further example: (a) the liner assembly further includes a nasal liner and a separate oral liner, wherein the sealing forming structure includes a nasal seal, the nasal seal including at least one orifice such that airflow is delivered at least to the patient's nostril inlet, the nasal liner including the nasal seal, wherein the sealing forming structure includes an oral seal, the oral seal having an orifice formed therein to deliver airflow to the patient's mouth, the oral liner including the oral seal; (b) a wall is disposed in the nasal liner, in the oral liner, or in a fluid connection structure between the nasal liner and the oral liner.

[0118] In a further example: (a) the liner assembly is configured such that, during use, the nasal chamber is pressurized to a range of 8 to 14 cmH2O higher than ambient air pressure, and the oral chamber is pressurized to a range of 4 to 7.5 cmH2O higher than ambient air pressure; (b) the liner assembly is configured such that, during use, the nasal chamber is pressurized to a range of 14 to 20 cmH2O higher than ambient air pressure, and the oral chamber is pressurized to a range of 7.5 to 10.5 cmH2O higher than ambient air pressure; (c) the patient interface also includes a positioning and stabilizing structure that provides forces to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being constructed and arranged such that, during use, at least a portion covers the area of ​​the patient's head above the supraaural base point of the patient's head.

[0119] Another aspect of this technology relates to a patient interface for hermetically delivering an airflow under a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least a patient nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use to improve sleep-disordered breathing, the patient interface including a liner assembly configured to deliver the airflow to the patient airway.

[0120] In the example: (a) the liner assembly includes a nasal chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the nasal chamber being configured to deliver an airflow to the patient's nasal passage during use; (b) the liner assembly includes an oral chamber pressurizable to a different level than the nasal chamber, the oral chamber being configured to deliver an airflow to the patient's mouth during use; (c) the liner assembly includes at least one inlet port, the at least one inlet port being sized and configured to receive at least the airflow entering the nasal chamber; (d) the liner assembly includes a sealing formation structure configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet. (e) The liner assembly includes a separator formed between and separating the nasal and oral chambers by a wall extending across the interior of the liner assembly from the patient contact side to the non-patient contact side, such that a first surface of the wall is disposed in the nasal chamber and a second surface of the wall opposite to the first surface is disposed in the oral chamber; (f) The liner assembly includes a flow regulator that cooperates with the separator and includes a passage that fluidly connects the nasal and oral chambers to allow airflow from the nasal chamber to the oral chamber.

[0121] In this example: (a) the flow regulator is configured to adjust the size of the passage to control the volume of airflow from the nasal chamber to the oral chamber; (b) the flow regulator is configured to maintain the treatment pressure in the nasal chamber at a level at least 2 cmH2O higher than the pressure in the oral chamber during use to facilitate nasal breathing; (c) the flow regulator is an adjustable valve; (d) the size of the passage is manually adjustable; and (e) the flow regulator also includes a rotatable dial for manually adjusting the size of the passage.

[0122] In a further example: (a) the size of the channel is automatically adjustable; (b) the patient interface also includes a sensor for determining the resistance level in the patient's nasal passage, wherein, in use, when the resistance level in the patient's nasal passage exceeds a first threshold, the flow regulator is configured to automatically adjust the airflow to increase the pressure in the oral cavity.

[0123] In a further example: (a) the separator comprises silicone; (b) the liner assembly is a mouth-nose liner assembly, and the sealing formation structure is configured to form a seal below the patient's nasal protuberance during use; (c) the patient interface also includes a pair of headband tubes configured to deliver airflow to the liner assembly, the pair of headband tubes being configured to extend along the respective sides of the patient's face between the patient's eyes and ears during use.

[0124] Another aspect of this technology relates to a method for training patients to breathe primarily through the nasal passages.

[0125] Another aspect of this technology relates to a method for training patients to increase nasal breathing.

[0126] Another aspect of this technology relates to a method for training a patient to increase nasal breathing, which promotes nasal breathing by creating a pressure difference in the nasal and oral chambers of the liner assembly, thereby moving the patient's soft palate forward, thereby reducing resistance in the nasal passage and increasing resistance in the oral passage.

[0127] Another aspect of this technology relates to a method for training a patient to increase nasal breathing by gradually reducing the treatment pressure in the oral cavity during multiple treatments.

[0128] Another aspect of this technology relates to a method for training a patient to increase nasal breathing from an airflow provided at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least the patient's nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure in use during the patient's sleep throughout the patient's respiratory cycle within a range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure to improve sleep-disordered breathing, the method comprising providing a padding assembly for the patient interface configured to deliver the airflow to the patient airway.

[0129] In the example: (a) the liner assembly includes a nasal chamber configured to deliver an airflow to the patient's nasal passage; (b) the liner assembly includes an oral cavity chamber configured to deliver an airflow to the patient's mouth, the oral cavity chamber being pressurized to a different level than the nasal chamber; (c) during a first treatment, a therapeutic pressure is provided in the oral cavity chamber to enable the patient to breathe through the patient's mouth; (d) during subsequent treatments, the therapeutic pressure in the oral cavity chamber is gradually reduced to train the patient to breathe primarily through the patient's nasal passage.

[0130] In a further example: (a) during the first treatment, the treatment pressure in the oral cavity chamber is greater than or equal to the treatment pressure in the nasal cavity chamber; (b) during the first treatment, the treatment pressure in the oral cavity chamber is in the range of 6 to 30 cmH2O higher than the ambient air pressure; (c) during the first treatment, the treatment pressure in the nasal cavity chamber is in the range of 6 to 30 cmH2O higher than the ambient air pressure; (d) during subsequent treatments, the treatment pressure in the oral cavity chamber is gradually reduced to a level below 15 cmH2O higher than the ambient air pressure; (e) during subsequent treatments, the treatment pressure in the oral cavity chamber is gradually reduced to a level below 10 cmH2O higher than the ambient air pressure.

[0131] In a further example: (a) the liner assembly further includes a separator formed between and separating the nasal and oral chambers; (b) the liner assembly further includes at least one channel that fluidly connects the nasal and oral chambers to deliver an airflow from the nasal chamber to the oral chamber; (c) the liner assembly further includes an adjustable flow regulator to control the treatment pressure in the oral chamber; and (d) the treatment pressure in the oral chamber is controlled by adjusting the volume of the airflow delivered from the nasal chamber to the oral chamber.

[0132] Another aspect of this technology relates to a patient interface for delivering respiratory therapy to a patient to facilitate nasal breathing, the patient interface comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils; the nasal chamber including an opening adapted to selectively receive pressurized breathable gas; and an inlet conduit connected to the patient interface for delivering pressurized breathable gas, wherein the patient interface may be adapted to deliver pressurized breathable gas to the nasal portion such that the pressure in the nasal chamber may be greater than the natural resistance of the patient's nasal passages.

[0133] Another aspect of this technology relates to a method for promoting nasal breathing, comprising: attaching a patient interface to a patient, the patient interface including a nostril portion including a nasal chamber and a nostril sealing portion adapted to form a seal with the patient's nostrils; and delivering pressurized breathable gas to the nostril portion such that the pressure in the nasal chamber can be greater than the natural resistance of the patient's nasal passage.

[0134] Another aspect of this technology relates to a patient interface for promoting nasal breathing as a nasal breathing training aid. This patient interface for promoting nasal breathing can be used as part of respiratory therapy, such as CPAP therapy.

[0135] Another aspect of this technology relates to a patient interface including a nasal portion comprising a nasal chamber and a nasal sealing portion adapted to form a seal with a patient's nostrils; the nasal chamber including an opening adapted to selectively receive pressurized breathable gas; and an inlet conduit connected to the patient interface for delivering pressurized breathable gas, wherein the patient interface is adapted to deliver pressurized breathable gas to the nasal portion such that the pressure in the nasal chamber is greater than the natural resistance of the patient's nasal passages. The pressurized breathable gas can be delivered through the nasal passages, allowing the gas to escape through the patient's mouth, creating an undesirable and uncomfortable mouth leak, thereby prompting the patient to close their mouth and breathe through the nose, thus promoting nasal breathing.

[0136] Another aspect of this technology relates to a patient interface that further includes a mouth portion comprising an oral cavity chamber and an oral sealing portion adapted to form a seal with the patient's mouth, wherein both the nasal cavity chamber and the oral cavity chamber include openings adapted to selectively receive pressurized breathable gas, an inlet conduit is connected to at least one of the nasal portion and the mouth portion to deliver pressurized breathable gas, and wherein the patient interface may be adapted to preferentially deliver pressurized breathable gas to the nasal portion.

[0137] Another aspect of this technology is a patient interface for delivering respiratory therapy to a patient, comprising: a nasal portion including a nasal chamber and a nasal sealing portion adapted to form a seal with the patient's nostrils; a mouth portion including an oral cavity chamber and an oral sealing portion adapted to form a seal with the patient's mouth, both the nasal chamber and the oral cavity chamber including openings adapted to selectively receive pressurized breathable gas; and an inlet conduit connected to at least one of the nasal portion and the mouth portion to deliver pressurized breathable gas, wherein the patient interface may be adapted to preferentially deliver pressurized breathable gas to the nasal portion, wherein, regarding the preferential delivery of pressurized breathable gas to the nasal portion, the pressure in the nasal chamber may be greater than the natural resistance of the patient's nasal passage, thereby delivering more air into the nasal passage than into the mouth to promote nasal breathing.

[0138] Another aspect of this technology is a patient interface for delivering respiratory therapy to a patient, wherein the pressure in the nasal chamber can be greater than the pressure in the oral chamber.

[0139] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0140] 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.

[0141] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0142] One aspect of this technology is a patient interface that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment.

[0143] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0144] 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.

[0145] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0146] 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:

[0147] 4.1 Respiratory Therapy System

[0148] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified 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.

[0149] 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.

[0150] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0151] 4.2 Respiratory System and Facial Anatomy

[0152] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0153] 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.

[0154] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0155] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0156] 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.

[0157] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0158] Figure 2G A side view showing the surface features of the nose.

[0159] Figure 2HThe subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0160] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0161] 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.

[0162] 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.

[0163] Figure 2L The frontal lateral view of the nose is shown.

[0164] 4.3 Patient Interface

[0165] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0166] 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.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] Figure 3FA schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0171] 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.

[0172] 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.

[0173] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0174] 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.

[0175] 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.

[0176] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0177] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0178] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0179] Figure 3O The left-hand rule is shown.

[0180] Figure 3P The right-hand rule is shown.

[0181] Figure 3Q The left ear is shown, including the left ear spiral.

[0182] Figure 3R The right ear is shown, including the right ear spiral.

[0183] Figure 3S A right-handed spiral is shown.

[0184] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0185] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0186] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0187] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 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.

[0188] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, this intermediate contact plane generally corresponds to the 'plane of the face'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0189] Figure 3Y A patient interface in the form of a nasal cannula is shown according to the present technology.

[0190] 4.4RPT device

[0191] Figure 4A An RPT device of one form according to the present technology is shown.

[0192] 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.

[0193] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0194] Figure 4D This is a schematic diagram of an algorithm implemented in an RPT device according to one form of the present technology.

[0195] Figure 4E This illustrates one form of the invention based on the present technology. Figure 4D The flowchart shows the method executed by the treatment engine module.

[0196] 4.5 Humidifier

[0197] Figure 5A This is an isometric view of one form of humidifier according to the present technology.

[0198] 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.

[0199] Figure 5C A schematic diagram of one form of humidifier according to the present technology is shown.

[0200] 4.6 Respiratory waveform

[0201] Figure 6A The diagram shows a typical breathing waveform of a person during sleep.

[0202] 4.7 Patient Interface Examples of This Technology

[0203] Figure 7-1 This is a schematic diagram of a dual-chamber liner assembly according to an example of the present technology.

[0204] Figure 7-2 This is a schematic diagram of a dual-chamber liner assembly according to another example of the disclosed technology.

[0205] Figure 8 A valve located in the air path between the airflow generator and the patient's airway is shown as an example of the present technology.

[0206] Figure 9A view of the human upper airway according to an example of the present technology is shown, illustrating how the soft palate can be displaced to facilitate nasal breathing.

[0207] Figure 10 This is a graph illustrating an example of comparing the set pressure of an airflow generator according to an example of the present technology with the pressure provided in the nasal and oral chambers of the patient interface.

[0208] Figure 11 A patient interface worn by a patient is shown as an example of this technology.

[0209] Figure 12 This is a perspective view of the patient interface according to another instance of this technology.

[0210] Figure 13 yes Figure 12 A perspective view of the air chamber at the patient interface.

[0211] Figure 14 yes Figure 13 Rear view of the inflation chamber.

[0212] Figure 15-1 It is along Figure 14 The cross-sectional view taken from line 15-1-15-1.

[0213] Figure 15-2 It is along Figure 14 The cross-sectional view taken by line 15-2-15-2 in the figure.

[0214] Figure 15-2A yes Figure 15-2 An enlarged view of a portion of the air chamber.

[0215] Figure 15-2B This is an enlarged view of a portion of an air chamber according to another embodiment of the present technology.

[0216] Figure 15-3 It is along Figure 14 The cross-sectional view taken by line 15-3-15-3 in the figure.

[0217] Figure 15-4 It is along Figure 14 The cross-sectional view taken by line 15-4-15-4 in the figure.

[0218] Figure 16 This is a perspective view of an air chamber according to another example of the present technology.

[0219] Figure 17-1 yes Figure 16 An enlarged view of a portion of the inflation chamber shows a regulating valve according to an example of the present technology.

[0220] Figure 17-2 and 17-3 This is a top view of a control valve according to an example of this technology.

[0221] Figure 18 yes Figure 16 Rear view of the inflation chamber.

[0222] Figure 19-1 It is along Figure 18 The cross-sectional view taken by line 19-1-19-1 in the figure.

[0223] Figure 19-2 It is along Figure 18 The cross-sectional view taken by line 19-2-19-2 in the figure.

[0224] Figure 19-3 It is along Figure 18 The cross-sectional view taken by line 19-3-19-3 in the figure.

[0225] Figure 19-4 It is along Figure 18 The cross-sectional view taken by line 19-4-19-4 in the middle.

[0226] Figure 20 A patient interface worn by a patient is shown as another example of this technology.

[0227] Figure 21 yes Figure 20 A perspective view of the padding assembly of the patient interface in the image.

[0228] Figure 22 yes Figure 21 Rear view of the liner assembly.

[0229] Figure 23 It is along Figure 22 The cross-sectional view taken by line 23-1-23-1 in the figure.

[0230] Figure 24 A patient interface worn by a patient is shown as another example of this technology.

[0231] Figure 25 yes Figure 24 A perspective view of the padding assembly of the patient interface in the image.

[0232] Figure 26 This is a partial cross-sectional view showing a patient interface worn by a patient, according to another example of the present technology.

[0233] Figure 27 A patient interface worn by a patient is shown as another example of this technology.

[0234] Figure 28 yes Figure 27 The back perspective view of the patient interface.

[0235] Figure 29 It shows the device worn by the patient. Figure 27 A partial cross-sectional view of the patient interface.

[0236] Figure 30 This is a front perspective view of a liner assembly according to another example of the present technology.

[0237] Figure 31 yes Figure 30 Rear perspective view of the liner assembly. 5. Detailed Implementation

[0238] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific instances described herein only and is not intended to be limiting.

[0239] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may constitute another instance.

[0240] 5.1 Treatment

[0241] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0242] In some instances of this technique, positive pressure air is supplied to the patient’s nasal passages through one or both nostrils.

[0243] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0244] 5.2 Respiratory Therapy System

[0245] 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.

[0246] 5.3 Patient Interface

[0247] For example, refer to Figure 3AAccording to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an airway 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0248] In some instances of this technology (for example, see...) Figure 12 The inflation chamber 3200 is formed at least partially by a housing 3210 and a sealing structure 3100. For example, the inflation chamber 3200 may include, or be referred to as, a liner module or liner assembly. The housing 3210 may serve as the chassis of the sealing structure 3100.

[0249] An unsealed patient interface 3800 in the form of a nasal cannula includes nasal tips 3810a, 3810b that can deliver air to the corresponding nostrils of a patient 1000 via corresponding orifices in their tips. These nasal tips typically do not form a seal with the inner or outer skin surface of the nostril. This type of interface intentionally (deliberately) creates one or more gaps during use, but their dimensions are generally not fixed, making them potentially unpredictable due to movement during use. Unlike other types of mask-based respiratory therapy systems, this can present complex aerodynamic variability factors for the respiratory therapy system when implementing pneumatic control and / or evaluation. Air can be delivered to the nasal tips by one or more air supply lumens 3820a, 3820b coupled to the nasal cannula-type unsealed patient interface 3800. Lumens 3820a, 3820b lead from the nasal cannula-type unsealed patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. Excess airflow escapes into the surrounding environment through the "vent" or gap at the unsealed patient interface 3800, which is a passageway through the patient's nostrils to the atmosphere between the tips 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800.

[0250] 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.

[0251] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0252] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0253] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0254] 5.3.1 Sealing Formation Structure

[0255] 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.

[0256] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0257] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0258] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0259] In some forms of this technology, a system is provided that includes 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 include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0260] 5.3.1.1 Sealing Mechanism

[0261] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0262] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0263] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and positioned in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0264] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0265] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0266] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0267] 5.3.1.2 Nasal bridge or nasal ridge area

[0268] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0269] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0270] 5.3.1.3 Upper lip area

[0271] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0272] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0273] 5.3.1.4 Chin area

[0274] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on an area of ​​the patient's face during use.

[0275] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of ​​a patient's face.

[0276] 5.3.1.5 Forehead area

[0277] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0278] 5.3.1.6 Nasal pillow

[0279] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0280] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the structure connected to the nasal pillow of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate the formation of a universal joint structure capable of accommodating relative movement of both the truncated cone and the structure connected to the nasal pillow in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the structure connected to the handle.

[0281] 5.3.2 Inflation Chamber

[0282] In the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0283] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0284] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment compliance. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0285] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve compliance with treatment.

[0286] See Figures 11 to 19-4 The patient interface 3000 may include a pad assembly (inflatable chambers 3200, 3200A) having a sealing formation 3100 configured to seal separately around the patient’s nostrils and mouth, i.e., a mouth-nose (or full-face) pad assembly. Figures 11 to 19-4 The padding assemblies shown can be referred to as ultra-compact full-face masks because they seal below or at the nasal protuberance, rather than extending over the patient's nose. The seal-forming structure 3100 may include a nasal portion 3230 having a pair of nasal openings 3272 for sealing with the patient's nostrils. The seal-forming structure 3100 may include an oral portion 3260 having oral portion openings 3271 for sealing with the patient's mouth.

[0287] According to an embodiment of the present technology, the inflation chamber 3200 is at least partially formed by a housing 3210 and a sealing formation 3100 attached to the housing. The sealing formation may be oriented on the patient contact side 3202 of the inflation chamber 3200, and the housing 3210 may be oriented on the non-patient contact side 3204 of the inflation chamber, for example as... Figure 13 As shown. Multiple vents 3400 can be formed in the housing 3210 to discharge exhaust gases. Additionally, an anti-asphyxiation valve (AAV) 3270 can be formed in the inflation chamber 3200. The AAV can be configured to open when there is no pressure within the inflation chamber 3200, allowing air to flow between the interior of the inflation chamber 3200 and the surrounding environment.

[0288] In some instances, the sealing structure 3100 is overmolded onto the housing 3210. Alternatively, the sealing structure 3100 may be formed separately from the housing 3210 and configured to be permanently or removably attached to the housing 3210. The sealing structure 3100 and the housing 3210 may be integrally formed. The inflation chamber may be referred to as a liner assembly, which includes, for example, the housing and the sealing structure.

[0289] In this example, the housing 3210 may be formed of polycarbonate, and the sealing structure 3100 may be formed of silicone. The silicone may have a Shore A hardness of 30 or 40. Silicone or similar materials with this hardness are advantageous for comfort and flexibility in conforming to and sealing the patient's face. It is advantageous to use polycarbonate (or other harder materials) with higher hardness and stiffness than silicone to provide greater resistance to deformation of the parts with less material than is required to provide the same resistance as silicone. Alternatively, the sealing structure 3100 may be formed of a suitable foam or any suitable thermoplastic elastomer.

[0290] The liner assembly (e.g., housing 3210) may include one or more inflation chamber inlet ports 3240. In the illustrated example, for example... Figure 13 The inflation chamber 3200 includes two inlet ports 3240. The inlet ports 3240 are located on the lateral side of the housing 3210. In these examples, the inlet ports 3240 are configured to connect to a catheter that connects to a decoupling component located above the patient's head, where the catheter connects to an air circuit. The catheters may form part of the positioning and stabilization structure 3300; i.e., they are "headband catheters." In other examples, the inflation chamber 3200 may include a single inlet port (e.g., centrally located within the housing 3210).

[0291] 5.3.3 Positioning and Stabilization Structure

[0292] 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.

[0293] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0294] According to an example of this technology, the patient interface 3000 may include a catheter (e.g., a headband tube 3340) to provide a pressurized airflow from the connection port 3600 to the inflation chamber 3200, such as Figure 11 and 12 As shown. The headband tube 3340 can be connected above the patient's head and can pass along the side of the patient's head between the corresponding eyes and ears. The headband tube 3340 can be connected via the headband tube connector 3344 ( Figure 16 Connect to the inflation chamber 3200 to provide a pressurized airflow to the inflation chamber, such as Figure 12 As shown. The headband tube 3340 may include an extendable accordion section 3904 (e.g., including one or more folds, pleats, corrugations, or bellows to form a flexible and length-extendable portion of the headband tube).

[0295] The positioning and stabilizing structure 3300 includes a catheter headband inlet 3390 located at the junction of the two headband tubes 3340, such as Figure 12 As shown. The tube headband inlet 3390 is configured to receive a pressurized gas flow, for example, via a bend including a connection port 3600, and to allow the gas flow into the hollow interior of the headband tube 3340.

[0296] like Figure 12 As shown, in addition to the headband tube 3340, the positioning and stabilization structure 3300 may include one or more straps. In one example, the positioning and stabilization structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and lower straps 3320 are joined together. The joints between these upper straps 3310 and lower straps 3320 are configured to lie flat against the posterior surface of the patient's head during use, thereby providing anchorage for the upper straps 3310 and lower straps 3320. The front ends of the upper straps 3310 are connected to the headband tube 3340. In this example, each headband tube 3340 includes a tab 3342 with an opening through which the corresponding upper strap 3310 can pass, then loop back and secure itself to secure the upper headband 3310 to the headband tube 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 disposed at the front end of each lower strap 3320. Each lower strap clip 3326 is configured to connect to a lower connection point 3325 on the inflation chamber 3200. In this example, the lower strap clip 3326 is magnetically secured to the lower connection point 3325. In some examples, a mechanical engagement also exists between the lower strap clip 3326 and the lower connection point 3325.

[0297] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0298] 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.

[0299] 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.

[0300] 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.

[0301] 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.

[0302] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or loose bandage. This 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.

[0303] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminated material comprising a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another embodiment, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0304] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide force to pull the sealing structure into sealed contact with a portion of the patient's face. In one instance, the strap may be configured as a tie.

[0305] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is configured and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0306] 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.

[0307] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0308] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0309] 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.

[0310] 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.

[0311] 5.3.4 Dual-chamber gasket assembly

[0312] According to examples of this technology, dual-chamber liner assemblies can promote and increase nasal breathing in patients during treatment of sleep-disordered breathing (such as sleep apnea). Breathing primarily through the nasal passage has many benefits compared to breathing through the oral cavity.

[0313] For example, the nose acts as a filter and traps small particles, including pollen, in the air. Additionally, the nose can add moisture to the inhaled air, preventing the lungs and bronchi from drying out. Another advantage of nasal breathing is that oxygen can be absorbed more effectively during exhalation. The back pressure created in the lungs, combined with the slower exhalation of nasal breathing, allows more time for the lungs to transport oxygen to the blood. Conversely, exhaling through the mouth can expel the necessary carbon dioxide too quickly, resulting in less oxygen absorption. Another reason nasal breathing allows for greater oxygen absorption is that nitric oxide can be produced in the nasal cavity, which can increase the efficiency of oxygen exchange (e.g., by up to 18%). In contrast, mouth breathing does not inhale nitric oxide, which can lead to less oxygen absorption. Ultimately, when less oxygen is absorbed, a range of sleep, performance, energy level, and ADHD problems can occur.

[0314] Furthermore, people who don't breathe through their nose may experience a worsening of snoring or obstructive sleep apnea. Several medical conditions can affect people who rely on mouth breathing. With less oxygen delivered to the brain, muscles, and all the cells in the body, bodily functions may not be optimal. Moreover, sleep may be disrupted and of poor quality. Chronic mouth breathing can also cause bad breath, gum disease, and may worsen symptoms of other conditions.

[0315] It should generally be understood that the resistance in the oral cavity leading to the lungs is less than that in the nasal cavity. Therefore, when using a traditional mouth-nose (i.e., full-face) mask to treat sleep apnea, most of the air inhaled by the patient passes through the patient's oral cavity.

[0316] like Figure 7-1 As shown, the liner assembly or air chamber 3200 according to this technology can be configured with a dual-chamber structure, separating the nasal chamber and the oral chamber, so that the two chambers can be pressurized to different levels. The nasal chamber can supply pressurized air to the patient's nasal airway, and the oral chamber can supply pressurized air to the patient's mouth. This arrangement can promote and increase nasal breathing by providing a higher pressure in the nasal chamber than in the oral chamber. Figure 9 As shown, the pressure gradient generated by the pressure difference between the nasal and oral chambers causes the soft palate 12 to move forward, and the soft palate 12 tends to block the oral passage, thereby promoting and increasing nasal breathing.

[0317] Because the oral cavity has relatively reduced pressure, the force exerted on the patient's face as a whole by the pad assembly can be less compared to a conventional full-face mask. Therefore, the retention force required by the positioning and stabilizing structures to secure the pad to the patient's face is less, thus improving comfort. Additionally, the headband can be minimized (e.g., a single-strap headband). In other instances, the minimized headband can be used in conjunction with pads that are adhesively attached to the patient's face. In other instances, adhesive pads can be used without any headband. Furthermore, a relatively small airflow generator (e.g., a wearable airflow generator) can be used.

[0318] like Figure 7-1 As shown, the airflow from the airflow generator can be supplied only to the nasal chamber. An air passage can be provided between the nasal and oral chambers to allow airflow from the nasal chamber to the oral chamber. The air passage can be formed by one or more holes (e.g., 2, 3, 4, 5, 1 to 5, 1 to 10, or 5 or more) in the partitions or partition walls between the chambers, and can be configured to allow a desired level of airflow to the oral chamber to achieve a desired pressure differential. These holes can be constructed or arranged (e.g., the number and arrangement of the holes) to maintain the pressure in the oral chamber at a desired level lower than the pressure in the nasal chamber to facilitate nasal breathing.

[0319] exist Figures 13 to 15-4 In the example shown, a separator 3280 can be arranged in an inflation chamber 3200 to form separate nasal chambers 3234 and oral chambers 3264. The separator 3280 may have one or more openings (e.g., air passages) therein to deliver airflow from the nasal chambers to the oral chambers. The separator may form a wall, which is arranged such that a first surface of the wall is disposed in the nasal chamber and a second surface of the wall is disposed in the oral chamber.

[0320] The separator 3280 can extend across the interior of the liner assembly from the patient contact side 3202 to the non-patient contact side 3204 of the inflatable chamber and can be formed as part of the seal-forming structure 3100. In the illustrated example, the separator extends from the inner edge of the seal-forming structure forming the oral cavity 3271, as shown... Figure 15-2 and 15-2A As shown. However, in other instances, such as Figure 15-2B As shown, the separator 3280 can extend from the portion of the sealed structure that is spaced apart from the inner edge. The separator 3280 is connected below the inlet port 3240 to the non-patient contact side 3204 of the inflation chamber (e.g., housing 3210), such that airflow from the headband tube 3340 is delivered to the nasal chamber 3234.

[0321] It should be noted that the separator 3280 may be formed of silicone or other suitable materials. The separator 3280 may be integrally formed with the sealing structure and / or the inflation chamber 3200 (e.g., molded together), or may be attached to it (e.g., by gluing or other suitable methods). Additionally, it should be noted that the thickness of the separator may vary in different portions of the separator. For example, the portion of the separator 3280 connected to (or adjacent to) the patient contact side 3202 of the inflation chamber may have a reduced thickness to increase the compliance and flexibility of the separator 3280 in that area, thereby enhancing patient comfort.

[0322] In other instances, instead of the orifice in the separator, a fixed or adjustable flow regulator (e.g., valve 10) can be used. Figure 8 This provides an air passage between the nasal and oral chambers. In other instances, the orifice in the separator can be combined with an adjustable air passage provided by a flow regulator, allowing the pressure differential to be further adjusted from the default differential. The adjustable flow regulator allows the pressure in the oral chamber to be adjusted to the individual patient's needs. For example, by adjusting the regulator to reduce the pressure in the oral chamber, a "lightweight oral ventilator" can reduce headband tension, thereby enhancing comfort.

[0323] exist Figures 16 to 19-4 In the example shown, the adjustable flow regulator can be in the form of a regulating valve 3250. The regulating valve 3250 can cooperate with the separator 3280 to allow adjustment of the size of the air passage between the nasal and oral chambers (e.g., formed as a connecting passage 3256) (see [reference]). Figure 17-2 , 17-3 (and 19-3). The first opening into the connecting channel 3256 can be arranged in the nasal chamber 3234, and the second opening into the connecting channel can be arranged in the oral chamber 3264. (As shown in the image) Figures 16 to 17-3As shown, the regulating valve 3250 may include a housing 3252 that rotatably supports the regulating mechanism 3253 (e.g., a dial). The dial can be rotated to change the size of the connection channel 3256 from, for example, Figure 17-2 The minimum size shown is adjusted to, for example Figure 17-3 The maximum size shown is used to select the desired differential pressure. A portion of the regulating valve (e.g., housing 3252) may be integrally formed with or attached to the inflation chamber (e.g., housing 3210). A dial may extend from the non-patient contact side 3204 of the inflation chamber for manual adjustment by the patient. It should be noted that other adjustable flow regulators, such as valve 10, or other suitable flow regulators, may be used. It should also be noted that... Figures 18 to 19-4 In addition to the regulating valve 3250, the separator in the middle can also have holes formed in it.

[0324] In one example, the flow regulator can be automatically controlled to regulate the airflow through the air passage. For instance, if resistance in the nasal passage increases beyond a threshold (e.g., because the patient's nasal passage is blocked), the flow regulator can be adjusted to increase the airflow into the oral cavity to a level sufficient to allow the patient to breathe through their mouth. In other examples, the flow regulator can be operated to automatically adjust in response to conditions (e.g., pressure and / or flow rate) at the patient interface. This can be achieved using, for example, sensors with electronic valve systems or mechanical systems that respond to changes in pressure or flow rate.

[0325] The pad assembly may include exhaust vents in the nasal and / or oral chambers. The pressure difference between the vents and the chambers can be adjusted to allow the pad assembly to deliver sufficient CO2 outflow from the mask. Additionally, the advantage of a dual-pad assembly is that the relatively lower pressure in the oral chamber makes exhalation through the mouth easier.

[0326] See Figure 7-2 This illustrates another example of an air chamber 3200 with a dual-chamber configuration. Figure 7-2 The air chamber 3200 in the middle and Figure 7-1 Similar to the inflatable chambers described herein, except that airflow from the airflow generator can be simultaneously supplied to both the nasal and oral chambers (e.g., via separate catheters (e.g., headband catheters) and / or connected to a supply tube). It should be noted that any instance described herein is configured such that airflow from the airflow generator is supplied to the chambers described herein and... Figure 7-2 The nasal and oral chambers are shown. A flow regulator (e.g., valve 10) can be installed. Figure 8Flow regulators are used to control the flow rate to the chambers. For example, to reduce pressure in the oral cavity, a flow regulator can be adjusted to limit the flow rate to the oral cavity, thereby promoting or enhancing nasal breathing. In other instances, flow regulators in the air supply path and flow regulators between the nasal and oral cavities can be uniformly adjusted to achieve a desired pressure differential.

[0327] Turning Figure 10 Exemplary pressure ranges for the nasal and oral chambers are shown. For example, the air passage and / or flow regulator can be adjusted such that when the flow generator (FG) is set to deliver 10 cmH2O, the dual-chamber liner assembly provides 10 cmH2O to the nasal chamber and approximately 5 cmH2O to the oral chamber. Under the same adjustment, when the flow generator (FG) is set to deliver 20 cmH2O, the dual-chamber liner assembly provides 20 cmH2O to the nasal chamber and approximately 10.25 cmH2O to the oral chamber (other examples of this exemplary adjustment are readily available from...). Figure 10 (As can be seen from the image). In other instances, the air passage and / or flow regulator can be adjusted differently to provide smaller or larger pressure differentials.

[0328] For example, the liner assembly can be configured to provide a therapeutic pressure in the nasal chamber at a level at least 2 cmH2O higher than the pressure in the oral chamber to facilitate nasal breathing. In other instances, the pressure in the nasal chamber can be at least 3 cmH2O, at least 4 cmH2O, at least 5 cmH2O, at least 10 cmH2O, 2–10 cmH2O, 3–8 cmH2O, or 4–7 cmH2O higher than the pressure in the oral chamber.

[0329] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of WO 2019 / 183680, filed on 28 March 2019, which is incorporated herein by reference in its entirety.

[0330] For example, the inflation chamber, sealing structure, and positioning and stabilizing structure of this technology may include any features of the inflation chamber, sealing structure, and positioning and stabilizing structure in any instance of the '680 application. Furthermore, the inflation chamber, sealing structure, and positioning and stabilizing structure disclosed herein may replace any inflation chamber, sealing structure, and positioning and stabilizing structure in any patient interface disclosed in the '680 application, and the inflation chamber, sealing structure, and positioning and stabilizing structure of this technology may include any features of the inflation chamber, sealing structure, and positioning and stabilizing structure in any instance of the '680 application.

[0331] 5.3.4.1 Nasal Breathing Training

[0332] Dual-chamber liner assemblies can also be used to train patients to increase nasal breathing and / or primarily breathe through the nasal passages. For example, with oral ventilators, the pressure differential can be gradually increased during treatment (e.g., by adjusting the airflow / flow regulator) to reduce the pressure in the oral chamber, thereby promoting nasal breathing. For example, over a period of weeks or months, the pressure differential can be gradually increased during treatment to train the patient to breathe through the nasal passages, thereby increasing nasal breathing. Ultimately, all or almost all of the airflow from the airflow generator can be maintained in the nasal chamber for inhalation through the patient's nasal passages.

[0333] In one instance, during the first treatment, the liner assembly can be adjusted to provide therapeutic pressure within the oral chamber that allows the patient to breathe through their mouth. For example, during the first treatment, the oral chamber can be pressurized to the same level as the nasal chamber (or less than the nasal chamber but sufficient to allow mouth breathing). Then, during subsequent treatments, the liner assembly can be adjusted to gradually reduce the therapeutic pressure within the oral chamber, thereby training the patient to increase nasal breathing and / or primarily breathe through their nasal passages.

[0334] In one instance, during the first treatment, the treatment pressure in the oral cavity can be greater than or equal to the treatment pressure in the nasal cavity. For example, during the first treatment, the treatment pressure in the nasal cavity can be within the range of 6 to 30 cmH2O above the ambient air pressure, and the treatment pressure in the oral cavity can also be within the range of 6 to 30 cmH2O above the ambient air pressure.

[0335] In one example, during subsequent treatments, the treatment pressure in the oral cavity could be gradually reduced to a level 15 cmH2O higher than ambient air pressure. In other examples, during subsequent treatments, the treatment pressure in the oral cavity could be gradually reduced to a level 10 cmH2O, 7 cmH2O, or 5 cmH2O higher than ambient air pressure.

[0336] 5.3.4.2 Other Explanatory Examples of Dual-Chamber Liner Assemblies

[0337] The separators and / or flow regulators (and any other features) discussed in the examples above can be used in other patient interfaces (such as the exemplary patient interfaces described below).

[0338] 5.3.4.2.1 Full-face mask over the nose

[0339] Figures 20 to 23A patient interface 7000 according to another embodiment of the present technology is shown. This patient interface includes a frame assembly 7100, a liner assembly 7175 including a sealing forming structure 7200, an air delivery connector (e.g., a bend assembly 7600), and positioning and stabilizing structures (e.g., a headband 7800 including an upper side strap 7802, a lower side strap 7804, and a top head strap 7806). The frame assembly 7100 includes a shield or wall member 7110, a pair (i.e., left and right) of upper headband connector arms 7134 extending from corresponding sides of the upper portion of the shield 7110, and a pair (i.e., left and right) of lower headband connector arms 7154 extending from corresponding sides of the lower portion of the shield 7110. In the illustrated example, the shield 7110 (e.g., made of a relatively rigid plastic material such as polycarbonate) has an opening 7105 formed therein.

[0340] The gasket assembly 7175 can be connected to the frame assembly 7100 independently of the elbow assembly 7600, and the elbow assembly 7600 can be connected to the frame assembly 7100 independently of the gasket assembly 7175.

[0341] Each lower headband 7804 may include a headband clip 7160, which is configured to connect to a corresponding lower headband connector arm 7154 (e.g., using a mating magnetic connector).

[0342] In the illustrated example, each lower headband connector arm 16154 includes a lower headband connection point in the form of a magnetic connector 16155, which is configured to be positioned and connected to a magnet associated with a headband clip 16160 provided with a corresponding lower headband strap 16804 of the headband. However, it should be understood that the upper headband connector arm 16134 and the lower headband connector arm 16154 can be connected to the headband strap of the headband in other suitable ways.

[0343] The pad assembly 7175 is a full-face pad assembly configured to deliver pressurized air to the patient's nasal and oral passages. The seal-forming structure 7200 is configured to surround the patient's nose and mouth and can seal above the patient's nasal prominence (e.g., along the patient's nasal bridge).

[0344] like Figure 21-23 As shown, the liner assembly 7175 may include a separator 7280 to form different nasal chambers 7234 and oral chambers 7264. The separator 7280 may include the components described above. Figures 7-1 to 19-4 Any features described. For example, the separator 7280 may have multiple holes 7282 formed therein, such as... Figure 22 As shown. Additionally, the gasket assembly 7175 may include a flow regulator according to the example described above.

[0345] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of US 2018 / 0250486, filed March 12, 2018, which is incorporated herein by reference in its entirety.

[0346] For example, the frame assembly, elbow assembly, and headband of this technology may be identical to those in any instance of the '486 application. Additionally, the padding assembly disclosed herein may replace any padding assembly in any patient interface disclosed in the '486 application, and the padding assembly of this technology may include any features of the padding assembly in any instance of the '486 application.

[0347] 5.3.4.2.2 Full-face mask with separate nose and mouth pads

[0348] Figures 24 to 26 A patient interface 8000 according to another embodiment of the present technology is shown. This patient interface includes a liner assembly 8001 having a nostril portion 8020 and an oral cavity portion 8040. The nostril portion 8020 may at least partially form a nasal chamber 8034, and the oral cavity portion 8040 may at least partially form an oral cavity chamber 8064, as shown. Figure 25 As shown. The supply tube can be connected to the turnaround head assembly 8002 to direct pressurized breathable gas at least to the nasal portion 8020 of the liner assembly. The turnaround head may include an airway 8006 and can be connected via an orifice 8052 to the front non-patient contact side of the liner assembly, as shown. Figure 25 As shown. However, in other instances, the oral cavity portion 8020 and / or the nostril portion 8040 may include vents.

[0349] The nostril portion 8020 may include a nostril sealing portion 8022 adapted to form a seal with the patient's nostrils, a decoupling portion 8025, and a headband connector 8021 adapted to connect to a headband 8060. Figure 24 and 25 In the example shown, the nostril sealing portion 8022 may include a pair of nasal pillows. The decoupling portion 8025 (e.g., a thin-walled portion) may be used to decouple the force applied to the nostril portion 8020 from the nostril sealing portion 8022.

[0350] The oral cavity portion 8040 may include an oral sealing portion 8042 adapted to seal around the patient's mouth, a decoupling portion 8045 decoupling the force applied to the oral cavity portion 8040 from the oral sealing portion, and a lower headband connector 8041 adapted to connect to a headband 8060.

[0351] The headband 8060 may include a strap adapted to secure the padding assembly 8001 to a patient's face. The strap may include a side headband strap 8061, a lower headband strap 8063, a rear headband portion 8065, and a top headband portion 8066. The side headband strap 8061 may include a side headband connector 8062 for connection to a headband connector 8021 of the nostril portion 8020.

[0352] Reference Figure 26 In the example shown, the nostril portion 8020 includes a nostril sealing portion 8594 configured to seal with the patient's nostrils. Figure 24 and 25 In contrast to the nasal pillow arrangement, the nostril sealing portion 8594 can abut against the lower side of the patient's nose for sealing, or, as shown, can seal above the patient's nasal protuberance but below the bridge of the nose. The frame 8589 can be connected to the nostril portion 8020 and / or the oral cavity portion 8040, and can include rigid or flexible structures (e.g., silicone).

[0353] like Figure 24-26 As shown, the liner assembly 8001 may include a separator 8082 to form different nasal chambers 8034 and oral chambers 8064. The separator 8082 may include the components described above. Figures 7-1 to 19-4 Any features described. For example, separator 8082 may have multiple holes 8586 formed therein. Figure 26 Additionally, the gasket assembly 8001 may include a flow regulator according to the above example.

[0354] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of US 9,737,678, filed March 28, 2013, which is incorporated herein by reference in its entirety.

[0355] For example, the nasal pads, oral pads (i.e., mouth pads), and positioning and stabilizing structures (headbands) of this technology may include any features of the nasal pads, oral pads (i.e., mouth pads), and headbands in any instance of the '678 application. Additionally, the nasal pads, oral pads, and headbands disclosed herein may replace any nasal pads, oral (mouth) pads, and headbands in any patient interface disclosed in the '678 application, and the nasal pads, oral pads, and headbands of this technology may include any features of the nasal pads, oral pads, and headbands in any instance of the '678 application.

[0356] 5.3.4.2.3 Modular face mask with connectable nose and mouth pads

[0357] Figure 27-31A patient interface 6000 with a modular construction according to one aspect of the present technology is illustrated. Depending on whether the nasal pad 6050 and / or oral pad 6060 are attached to a headband portion, the patient interface 6000 can be converted between a nasal (e.g., below the nose) sealing mask and a mouth-nose mask. That is, the pad assembly 6020 may include a nasal pad 6050 and an oral pad 6060. The nasal pad 6050 may include a nasal seal forming structure 6052, which is configured and arranged to form a seal with a region of the patient's face surrounding the patient's nasal inlet. The seal forming structure 6052 may be attached to a rigid or flexible (e.g., silicone) frame. The oral pad 6060 may include an oral seal forming structure 6062, which is configured and arranged to form a seal with a region of the patient's face surrounding the patient's mouth inlet. Figure 30 As shown, an air vent insert 3400 can be provided in the mouth liner. The nose liner may also include a suitable air vent structure. Examples of this technology provide independent seals for the nose and mouth.

[0358] The sealing structure 6052 may include a nasal support pad and provides airflow to the patient's nostrils by sealing against at least the lower side of the patient's nose. An exemplary sealing structure 6052 will engage the patient's face below the bridge of the nose, and depending on the size and shape of the patient's nose, some instances may engage the patient's nose below the nasal protuberance.

[0359] The interchangeability of the nasal pad 6050 and the oral pad 6060 allows nasal breathing patients to be treated with only the nasal pad 6050 attached. Additionally, the oral pad 6060 can be used together with the nasal pad 6050 for mouth breathing patients or during training patients to breathe through their nose. Furthermore, embodiments of this technology allow the oral seal-forming structure 6062 and the nasal seal-forming structure 3052 to move independently of each other to provide a comfortable fit and an effective seal.

[0360] The positioning and stabilizing structure 6300 may include a pair of headband tubes 6010 to deliver a breathable gas flow from the connection port 3600 to the nasal pad 6050. The headband tubes 6010 may be configured to extend along a corresponding side of the patient's face between the eyes and ears and may include an extendable accordion section 6362 (e.g., including one or more folds, pleats, corrugations, or bellows to form a flexible and length-extending portion of the headband tube). Each headband tube 6010 may include a pad interface 6012 for connection to a corresponding side of the nasal pad 6050. A turnaround head assembly 3610 may connect the headband tubes 6010 to the connection port 3600.

[0361] exist Figure 27In one example, the lower bandage 6326 may be adapted to pass below the patient's ear and includes a pair of ends that can be attached to the mouth liner 6060. Each end of the lower bandage 6326 may include a connector 6328 (e.g., including a magnet and / or a clip), which is configured to removably engage a corresponding lower headband connector 6066 on the mouth liner 6060.

[0362] Mouth pad 6060 and nose pad 6050 can be releasably connected to each other via connector 6068. Connector 6068 can be removably coupled to nose pad 6050 and mouth pad 6060 via openings in the nose pad and mouth pad, or can be permanently coupled to the mouth pad. Connector 6068 may have a hollow interior to allow fluid connection between nose pad 6050 and mouth pad 6060. Connector 6068 may include flexible structures (e.g., silicone material and / or bellows structure) to allow independent adjustment of the position of nose pad 6050 and mouth pad 6060.

[0363] Therefore, a breathable gas flow can be provided from the headband tube 6010 to the nasal pad 6050 and from the nasal pad 6050 to the oral pad 6060 via the connector 6068.

[0364] A separator can be provided in the liner assembly 6020 to form a nasal chamber 6034 and an oral chamber 6064, allowing the nasal chamber to be pressurized differently from the oral chamber. This separator can be provided at any suitable location in the nasal liner 6050, oral liner 6060, or connector 6068, provided that airflow from the headband tube is directly supplied to the nasal chamber 6034. The separator may include the features described above. Figures 7-1 to 19-4 Any features described. For example, the separator may have multiple holes formed therein. Additionally, the gasket assembly 6020 may include a flow regulator according to the example described above. Figure 29 In the example shown, the separator 6280 is disposed in the connector 6068 and includes a plurality of holes 6282 formed therein.

[0365] In another example, the nasal pad 6050 may include a pair of nasal sprays or nasal pillows, each spray or pillow being constructed and arranged to form a seal with the corresponding nostril of the patient's nose. Figure 30 and 31In the illustrated example, the nasal pad 6050 has a nasal seal forming structure provided by a pair of nasal pillows 6165. According to one aspect of the present technology, the nasal pillow 3165 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 structure connected to the nasal pillow of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate the formation of a universal joint structure capable of accommodating both displacement and angular movement of the truncated cone and the structure connected to the nasal pillow. For example, the truncated cone can be axially moved toward the structure connected to the handle.

[0366] In one embodiment, the nose pad 3050 and / or the mouth pad 3060 include a textile sealing surface mounted on a silicone body.

[0367] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of U.S. Provisional Application No. 62 / 928,213, filed October 30, 2019, which is incorporated herein by reference in its entirety.

[0368] For example, the nasal pads, oral pads (i.e., mouth pads), and positioning and stabilizing structures of this technology may include any features of the nasal pads, oral pads (i.e., mouth pads), and positioning and stabilizing structures in any instance of the `213 application`. Additionally, the nasal pads, oral pads, and connectors disclosed herein may replace any nasal pads, oral (mouth) pads, and connectors in any patient interface disclosed in the `213 application`, and the nasal pads, oral pads, and connectors of this technology may include any features of the nasal pads, oral pads, and connectors in any instance of the `213 application`.

[0369] 5.3.5 Vent

[0370] In one form, the patient interface includes a vent that is constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0371] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber to the surrounding environment, while the pressure within the inflation chamber is positive relative to the environment. The airway is configured such that the airflow is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0372] In one instance, the patient interface includes at least one airway 3400 among a nasal pad 6050 (e.g., in an inflatable chamber), a mouth pad 6060, and / or a connector 6068.

[0373] One form of the vent 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.

[0374] The vent may be located in the inflation chamber. Alternatively, the vent may be located in a decoupling structure, such as a rotating shaft.

[0375] 5.3.6 Decoupling Structure

[0376] In one form, the patient interface includes at least one decoupled structure, such as a spindle or a ball head and a ball socket.

[0377] 5.3.7 Connection Port

[0378] A connection port (e.g., connection port 3600) allows connection to air circuit 4170.

[0379] 5.3.8 Forehead Stent

[0380] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0381] 5.3.9 Anti-asphyxiation valve

[0382] In one form, the patient interface includes an anti-asphyxiation valve.

[0383] 5.3.10 port

[0384] In one form of this technology, the patient interface includes one or more ports that allow access to the volume within the liner assembly or inflation chamber. In one form, this allows a clinician to supply supplemental oxygen. In another form, this allows for direct measurement of the properties of the gas within the liner assembly or inflation chamber, such as pressure.

[0385] 5.4RPT device

[0386] 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.

[0387] 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.

[0388] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0389] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0390] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0391] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0392] 5.4.1 Mechanical and pneumatic components of the RPT device

[0393] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0394] 5.4.1.1 Air Filter

[0395] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0396] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0397] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0398] 5.4.1.2 Muffler

[0399] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0400] In one embodiment of this technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0401] In one embodiment of this technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0402] 5.4.1.3 Pressure Generator

[0403] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, for example, when delivering respiratory pressure therapy. The blower may be any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0404] The pressure generator 4140 can be controlled by the treatment device controller 4240.

[0405] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0406] 5.4.1.4 Converter

[0407] The transducer can be located inside or outside the RPT device. An external transducer can be positioned, for example, on or part of an air circuit such as a patient interface. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0408] In one embodiment of this technology, one or more converters 4270 may be located upstream and / or downstream of pressure generator 4140. One or more converters 4270 may be configured and arranged to generate a signal representing airflow characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0409] In one form of this technology, one or more converters 4270 may be positioned proximal to the patient interface 3000 or 3800.

[0410] In one embodiment, the signal from converter 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0411] 5.4.1.4.1 Flow Sensor

[0412] The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0413] In one configuration, a signal generated by flow sensor 4274 and representing flow rate is received by central controller 4230.

[0414] 5.4.1.4.2 Pressure Sensor

[0415] The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. A suitable example of a pressure sensor is the converter from the HONEYWELL ASDX series. An alternative suitable pressure sensor is the converter from the GENERALELECTRIC NPA series.

[0416] In one configuration, a signal generated by pressure sensor 4272 and representing pressure is received by central controller 4230.

[0417] 5.4.1.4.3 Motor speed converter

[0418] In one embodiment of this technology, a motor speed converter 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0419] 5.4.1.5 Anti-overflow valve

[0420] In one embodiment of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the electric motor 4144.

[0421] 5.4.2 Electrical components of RPT device

[0422] 5.4.2.1 Power Supply

[0423] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0424] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0425] 5.4.2.2 Input Device

[0426] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0427] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0428] 5.4.2.3 Central Controller

[0429] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0430] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. Processors such as the STM32 series microcontrollers from ST Microelectronics. In some alternative forms of this technology, 32-bit RISC CPUs such as the STR9 series microcontrollers from ST Microelectronics, or 16-bit RISC CPUs such as the MSP430 series microcontrollers from Texas Instruments, are equally applicable.

[0431] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0432] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0433] The central controller 4230 can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and humidifier 5000.

[0434] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controller 4240, data communication interface 4280 and humidifier 5000.

[0435] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, represented as computer programs stored in a non-transitory computer-readable storage medium such as memory 4260. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, the remote positioning device may determine control settings for the ventilator or detect respiratory-related events by analyzing stored data such as from any of the sensors described herein.

[0436] 5.4.2.4 Clock

[0437] RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0438] 5.4.2.5 Treatment device controller

[0439] In one form of this technology, the treatment device controller 4240 is a treatment control module 4330, which constitutes part of the algorithm 4300 executed by the central controller 4230.

[0440] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0441] 5.4.2.6 Protection Circuit

[0442] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0443] 5.4.2.7 Memory

[0444] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0445] The memory 4260 may be located on PCBA 4202. The memory 4260 may be in the form of EEPROM or NAND flash memory.

[0446] Alternatively or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card made according to the Secure Digital (SD) standard.

[0447] In one form of this technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0448] 5.4.2.8 Data Communication System

[0449] In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0450] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0451] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0452] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0453] In one form, the remote external device 4286 can be one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by appropriately authorized personnel, such as clinicians.

[0454] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0455] 5.4.2.9 Includes optional display and alarm output devices.

[0456] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0457] 5.4.2.9.1 Display Driver

[0458] The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0459] 5.4.2.9.2 Monitor

[0460] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0461] 5.4.3 RPT device algorithm

[0462] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs, which are stored in a non-transitory computer-readable storage medium such as memory 4260. The algorithms 4300 are generally grouped into groups called modules.

[0463] In other forms of this technology, some or all of the algorithm 4300 may be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In such a 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 such a form, the portion of the algorithm 4300 executed at the external device may be represented as a computer program, such as having processor control instructions executed by one or more processors, the computer program being stored in a non-transitory 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.

[0464] In this configuration, treatment parameters generated by an external device via the treatment engine module 4320 (if they form part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 for transfer to the treatment control module 4330.

[0465] 5.4.3.1 Preprocessing Module

[0466] According to one form of the present technology, the preprocessing module 4310 receives a signal from the converter 4270 (e.g., flow sensor 4274 or pressure sensor 4272) as input and performs one or more process steps to calculate one or more output values ​​that will be used as input to another module (e.g., treatment engine module 4320).

[0467] In one form of this technology, the output values ​​include interface pressure Pm, vent flow rate Qv, breathing flow rate Qr, and leakage flow rate Ql.

[0468] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilator flow estimation 4314, leakage flow estimation 4316, and breathing flow estimation 4318.

[0469] 5.4.3.1.1 Interface stress estimation

[0470] In one form of this technology, the interface pressure estimation algorithm 4312 receives a signal from pressure sensor 4272 indicating the pressure (device pressure Pd) in the pneumatic path near the outlet of the pneumatic block and a signal from flow sensor 4274 indicating the flow rate (device flow rate Qd) of the airflow leaving the RPT device 4000 as inputs. In the absence of any supplementary gas 4180, the device flow rate Qd can be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. For a specific air circuit 4170, the dependence of the pressure drop ΔP on the total flow rate Qt can be modeled using the pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides the estimated pressure Pm in the patient interface 3000 or 3800 as output. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP.

[0471] 5.4.3.1.2 Ventilation port flow rate estimation

[0472] In one embodiment of this technology, the ventilator flow estimation algorithm 4314 receives an estimated pressure Pm from the patient interface 3000 or 3800 of the interface pressure estimation algorithm 4312 as input, and estimates the ventilator flow rate Qv of the air from the ventilator 3400 in the patient interface 3000 or 3800. For a specific ventilator 3400, the dependence of the ventilator flow rate Qv on the interface pressure Pm during use can be modeled by the ventilator characteristic Qv(Pm).

[0473] 5.4.3.1.3 Leakage Flow Estimation

[0474] In one form of this technology, the leakage flow estimation algorithm 4316 receives the total flow rate Qt and the ventilator flow rate Qv as inputs and provides an estimate of the leakage flow rate Ql as output. In another form, the leakage flow estimation algorithm estimates the leakage flow rate Ql by calculating the average of the difference between the total flow rate Qt and the ventilator flow rate Qv over a sufficiently long time period (e.g., about 10 seconds) that includes several respiratory cycles.

[0475] In one form, the leakage flow estimation algorithm 4316 receives the total flow rate Qt, the ventilator flow rate Qv, and the estimated pressure Pm from the patient interface 3000 or 3800 as input, and provides the leakage flow rate Ql as output by calculating the leakage conductivity and determining the leakage flow rate Ql as a function of the leakage conductivity and pressure Pm. The leakage conductivity is calculated as the quotient of the low-pass filtered non-ventilator flow rate (equal to the difference between the total flow rate Qt and the ventilator flow rate Qv) and the square root of the low-pass filtered pressure Pm, where the low-pass filter time constant has a sufficiently long time to include the value of several respiratory cycles, for example, approximately 10 seconds. The leakage flow rate Ql can be estimated as the product of the leakage conductivity and the pressure Pm.

[0476] 5.4.3.1.4 Respiratory Flow Estimation

[0477] In one form of this technology, the respiratory flow estimation algorithm 4318 receives the total flow rate Qt, the ventilator flow rate Qv, and the leakage flow rate Ql as inputs, and estimates the respiratory flow rate Qr of the air flowing to the patient by subtracting the ventilator flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0478] 5.4.3.2 Healing Engine Module

[0479] In one form of this technology, the treatment engine module 4320 receives one or more of the pressure Pm and the respiratory flow rate Qr of the air flowing to the patient from the patient interface 3000 or 3800 as inputs, and provides one or more treatment parameters as outputs.

[0480] In one form of this technique, the treatment parameter is the treatment pressure Pt.

[0481] In one form of this technique, the treatment parameters are one or more of pressure change, baseline pressure, and target ventilation.

[0482] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow restriction determination 4324, apnea / insufficiency determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329.

[0483] 5.4.3.2.1 Phase Determination

[0484] In one form of this technology, the RPT device has an uncertain phase of 4000.

[0485] In one form of this technology, the phase determination algorithm 4321 receives a signal indicating respiratory flow Qr as input and provides the phase Φ of the patient's current respiratory cycle as output.

[0486] In some forms known as discrete phase determination, the phase output is a discrete variable. One implementation of discrete phase determination provides a dual-valued phase output Φ with either an inspiratory or expiratory value, for example, values ​​of 0 and 0.5 revolutions, respectively, when the start of spontaneous inspiration and expiration is detected, respectively. The RPT device 4000, which performs "triggering" and "cycling," effectively executes discrete phase determination because the trigger point and cycle point are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of dual-valued phase determination, the phase output Φ is determined to have a discrete value of 0 when the value of the respiratory flow Qr exceeds a positive threshold (thus "triggering" the RPT device 4000), and the phase output Φ is determined to have a discrete value of 0.5 revolutions when the value of the respiratory flow Qr is more negative than a negative threshold (thus "cycling" the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​of the time spent over many respiratory cycles when the phase Φ is equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.

[0487] Another implementation of discrete phase determination provides a three-valued phase output Φ, the value of which is one of the following: inhalation, mid-inhalation pause, and exhalation.

[0488] In other forms known as continuous phase determination, the phase output Φ is a continuous variable, such as varying from 0 to 1 revolution or 0 to 2 radians. The RPT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, fuzzy logic analysis of the respiratory flow Qr is used to determine the continuous phase value Φ. The continuous phase value determined in this implementation is often referred to as the "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0489] 1. If Qr is 0 and increases rapidly, then Φ is 0 revolutions.

[0490] 2. If Qr is a large positive number and stable, then Φ is 0.25 revolutions.

[0491] 3. If Qr is 0 and decreases rapidly, then Φ is 0.5 revolutions.

[0492] 4. If Qr is a large negative number and stable, then Φ is 0.75 revolutions.

[0493] 5. If Qr is 0 and stable, and the absolute value of the 5-second low-pass filter of Qr is large, then Φ is 0.9 revolutions.

[0494] 6. If Qr is positive and the phase is exhalation, then Φ is 0 revolutions.

[0495] 7. If Qr is negative and the phase is intake, then Φ is 0.5 revolutions.

[0496] 8. If the absolute value of the 5-second low-pass filter for Qr is large, then Φ increases at a steady rate equal to the patient’s respiratory rate, with a 20-second time constant low-pass filter.

[0497] The output of each rule can be represented as a vector, where the phase of the vector is the result of the rule and its magnitude is the degree of ambiguity of whether the rule is true. The degree of ambiguity for respiratory flow such as "large" or "stable" is determined using appropriate membership functions. The results of the rules, represented as vectors, are then combined using functions such as centroid. In such combinations, the rules can be weighted equally or differently.

[0498] In another implementation of continuous phase determination, as described above, the phase Φ is first estimated discretely from the respiratory flow rate Qr, and the inspiratory time Ti and expiratory time Te are also estimated in the same way. The continuous phase Φ at any given time can be determined as half the proportion of the inspiratory time Ti that has elapsed since the previous triggering time, or 0.5 revolutions plus half the proportion of the expiratory time Te that has elapsed since the previous cycle (the more recent time).

[0499] 5.4.3.2.2 Waveform Determination

[0500] In one form of this technology, the treatment parameter determination algorithm 4329 provides a substantially constant treatment pressure throughout the patient's respiratory cycle.

[0501] In other forms of this technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies according to the phase Φ of the patient's respiratory cycle, based on the waveform template Π(Φ).

[0502] In one form of this technology, waveform determination algorithm 4322 provides waveform template Π(Φ) for use by treatment parameter determination algorithm 4329, the value of waveform template Π(Φ) being in the range [0,1] over the domain of phase value Φ provided by phase determination algorithm 4321.

[0503] In one form, applicable to discrete or continuous phase values, the waveform template Π(Φ) is a square wave template with a value of 1 for phase values ​​up to and including 0.5 revolutions, and a value of 0 for phase values ​​above 0.5 revolutions. In another form, applicable to continuous phase values, the waveform template Π(Φ) comprises two smoothed curve portions: a smoothed curve (e.g., raised cosine) rising from 0 to 1 for phase values ​​up to 0.5 revolutions, and a smoothed curve (e.g., exponential) falling from 1 to 0 for phase values ​​above 0.5 revolutions. In yet another form, applicable to continuous phase values, the waveform template Π(Φ) is based on a square wave but has a smoothed rise from 0 to 1 for phase values ​​up to a “rise time” less than 0.5 revolutions, and a smoothed fall from 1 to 0 for phase values ​​within a “fall time” after 0.5 revolutions.

[0504] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a waveform template library based on the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table for the value Π of the phase value Φ. In other forms, the waveform determination algorithm 4322 uses a predetermined function form, which may be parameterized by one or more parameters (e.g., the time constant of the exponential curve portion), to calculate the "running" waveform template Π(Φ). The parameters of the function form can be predetermined or depend on the current state of the patient 1000.

[0505] In some forms of this technique, applicable to discrete two-valued phases of inhalation (Φ = 0 rpm) or exhalation (Φ = 0.5 rpm), waveform determination algorithm 4322 calculates a “running” waveform template Π as a function of the discrete phase Φ and the time t measured since the most recent trigger moment. In one such form, waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) for both parts (inhalation and exhalation) as follows:

[0506]

[0507] Where Πi(t) and Πe(t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such form, the inspiratory portion Πi(t) of the waveform template is a smooth rise from 0 to 1 parameterized by the rise time, and the expiratory portion Πe(t) of the waveform template is a smooth fall from 1 to 0 parameterized by the fall time.

[0508] 5.4.3.2.3 Determination of ventilation rate

[0509] In one form of this technology, the ventilation determination algorithm 4323 receives input of respiratory flow Qr and determines a measure Vent indicating the current patient ventilation.

[0510] In some implementations, the ventilation volume determination algorithm 4323 determines a measure Vent of the ventilation volume that is an estimate of the actual patient ventilation volume. One such implementation takes half of the absolute value of the respiratory flow Qr, optionally filtered by a low-pass filter (such as a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0511] In other implementations, the ventilation volume determination algorithm 4323 determines a measure Vent of the ventilation volume that is approximately proportional to the actual patient ventilation volume. One such implementation estimates the peak respiratory flow Qpeak during the inspiratory portion of the cycle. If the flow waveform shape does not vary much (here, when the flow waveforms of breaths are normalized in time and amplitude, the shapes of two breaths are considered similar), then this process and many other processes involving sampling the respiratory flow Qr produce measurements that are approximately proportional to the ventilation volume. Some simple examples include the median positive respiratory flow, the median of the absolute value of the respiratory flow, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow using positive coefficients, and even some using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average of the respiratory flow during the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow shape is constant, there are any number of measurements that are exactly proportional to the ventilation volume.

[0512] 5.4.3.2.4 Determination of Inspiratory Flow Limitation

[0513] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 to determine the degree of inspiratory flow limitation.

[0514] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow signal Qr as an input and provides as an output a measure of the degree to which the inspiratory portion of the breath exhibits an inspiratory flow limitation.

[0515] In one form of the present technology, the inspiratory portion of each breath is identified by a zero-crossing detector. A plurality of uniformly spaced points (e.g., sixty-five) representing time points are interpolated along the inspiratory flow-time curve of each breath by an interpolator. Then, the curve described by the points is scaled by a scalar to have unit length (duration / time period) and unit area to remove the effects of changing respiratory rate and depth. Then, the scaled breath is compared in a comparator to a pre-stored template representing a normal unobstructed breath (similar to Figure 6AThe inspiratory portion of the breathing shown is compared. Breaths that deviate from a specified threshold (typically one scaling unit) at any point during the inspiratory period of this template (determined by the test element), such as those caused by coughing, sighing, swallowing, and snoring, are discarded. For the data that is not discarded, the central controller 4230 calculates a moving average of the first such scaling point over a number of preceding inspiratory events. For the second such point, the operation is repeated on the same inspiratory event, and so on. Thus, for example, the central controller 4230 generates sixty-five scaling data points, and these sixty-five scaling data points represent the moving average of a number of preceding inspiratory events (e.g., three events). The moving average of the continuously updated values ​​of these (e.g., sixty-five) points is referred to below as the “scaling flow”, which is designated as Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0516] Based on the scaling flow, two shape factors related to the determination of partial blockage can be calculated.

[0517] The shape factor 1 is the ratio of the average of the intermediate (e.g., thirty-two) scaled flow points to the average of the overall (e.g., sixty-five) scaled flow points. A ratio greater than 1 indicates normal breathing. A ratio of 1 or less indicates obstructed breathing. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breathing, and is equal to the degree of obstruction allowed to maintain adequate oxygenation in a typical patient.

[0518] The shape factor 2 is calculated as the RMS deviation per unit scaled flow rate taken from an intermediate (e.g., thirty-two) point. An RMS deviation of approximately 0.2 units is considered normal. An RMS deviation of 0 is considered fully flow-restricted breathing. The closer the RMS deviation is to zero, the more flow-restricted the breathing is considered.

[0519] Shape factors 1 and 2 can be used as alternatives or combinations. In other forms of this technique, the number of sampling points, breaths, and midpoints can differ from those described above. Furthermore, the thresholds can differ from those described.

[0520] 5.4.3.2.5 Determination of Apnea and Insufficient Respiration

[0521] In one form of this technology, the central controller 4230 executes an apnea / insufficiency determination algorithm 4325 for determining the presence of apnea and / or insufficiency.

[0522] In one form, the apnea / insufficiency determination algorithm 4325 receives the respiratory flow signal Qr as input and provides a flag indicating that apnea or insufficiency has been detected as output.

[0523] In one form, apnea is considered detected when a function of respiratory flow Qr falls below a flow threshold for a predetermined period of time. This function can determine peak flow, relative short-term average flow, or the flow between the relative short-term average and peak flow, such as RMS flow. The flow threshold can be a relatively long-term measure of flow.

[0524] In one form, insufficiency is considered detected when a function of respiratory flow Qr falls below a second flow threshold for a predetermined period of time. This function can determine peak flow, relative short-term average flow, or the flow between the relative short-term average flow and peak flow, such as RMS flow. The second flow threshold can be a relatively long-term measure of flow. The second flow threshold is greater than the flow threshold used to detect apnea.

[0525] 5.4.3.2.6 Determining Snoring

[0526] In one form of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0527] In one form, the snoring determination algorithm 4326 receives the respiratory flow signal Qr as input and provides a measure of the degree of snoring presence as output.

[0528] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow signal within a range of 30-300 Hz. Furthermore, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise (e.g., the sound of airflow from a blower system).

[0529] 5.4.3.2.7 Determination of airway patency

[0530] In one form of this technology, the central controller 4230 executes one or more airway occupancy determination algorithms 4327 for determining the degree of airway occupancy.

[0531] In one form, the airway occupancy determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal in a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within this frequency range is considered an indication of an open airway. The absence of a peak is considered an indication of a closed airway.

[0532] In one approach, the frequency range for finding the peak is the frequency of small forced oscillations in the therapeutic pressure Pt. In one implementation, the forced oscillation frequency is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0533] In one form, the airway occupancy determination algorithm 4327 receives the respiratory flow signal Qr as input and determines the presence or absence of a cardiac signal. The absence of a cardiac signal is considered an indication of airway closure.

[0534] 5.4.3.2.8 Determination of target ventilation

[0535] In one form of this technology, the central controller 4230 takes the current ventilation volume measurement Vent as input and executes one or more target ventilation volume determination algorithms 4328 to determine the target value Vtgt of the ventilation volume measurement.

[0536] In some forms of this technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example by hard-coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0537] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from the value Vtyp, which indicates the patient's typical recent ventilation.

[0538] In some forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as a high percentage, but smaller than, the typical recent ventilation volume Vtyp. This high percentage can be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0539] In other forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated to be slightly greater than 1 times the typical recent ventilation volume Vtyp.

[0540] A typical recent ventilation volume, Vtyp, is a value around which the distribution of the current ventilation volume metric, Vent, tends to cluster at multiple moments on a predetermined time scale; that is, it is a measure of the central tendency of the current ventilation volume metric in recent history. In one implementation of the target ventilation volume determination algorithm 4328, the recent history is on the order of minutes, but in all cases should be longer than the time scale of the tidal cycle. The target ventilation volume determination algorithm 4328 can use any of a variety of well-known central tendency measures to determine the typical recent ventilation volume, Vtyp, based on the current ventilation volume metric, Vent. One such measure is the output of a low-pass filter on the current ventilation volume metric, Vent, where the time constant is equal to one hundred seconds.

[0541] 5.4.3.2.9 Determination of Treatment Parameters

[0542] In some forms of this technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0543] In one form of this technology, the treatment parameter is the instantaneous treatment pressure Pt. In one implementation of this form, the treatment parameter determination algorithm 4329 uses the following equation to determine the treatment pressure Pt.

[0544] Pt=AΠ(Φ,t)+P0 (1)

[0545] in:

[0546] A represents the amplitude.

[0547] ·Π(Φ,t) is the waveform template value (in the range of 0 to 1) at the current phase value Φ and time t, and

[0548] P0 is the base pressure.

[0549] If the waveform determination algorithm 4322 provides a waveform template Π(Φ,t) as a lookup table for the value Π indexed by the phase Φ, then the treatment parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current value Φ of the phase returned by the phase determination algorithm 4321, or by interpolating between two entries that span the current value Φ of the phase.

[0550] The values ​​of amplitude A and baseline pressure P0 can be determined by treatment parameter algorithm 4329 and set according to the selected respiratory pressure treatment mode in the manner described below.

[0551] 5.4.3.3 Treatment Control Module

[0552] According to one aspect of the present technology, the treatment control module 4330 receives treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input, and controls the pressure generator 4140 to deliver an airflow according to the treatment parameters.

[0553] In one form of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow at an interface pressure Pm equal to the treatment pressure Pt at the patient interface 3000 or 3800.

[0554] 5.4.3.4 Fault Detection

[0555] In one form of this technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:

[0556] • Power failure (no power or insufficient power)

[0557] • Converter fault detection

[0558] The component could not be detected.

[0559] • Operating parameters outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0560] • The test alarm failed to generate a detectable alarm signal.

[0561] When a fault condition is detected, the corresponding algorithm 4340 notifies the existence of the fault by signaling one or more of the following:

[0562] • Activate audible, visual, and / or dynamic (e.g., vibration) alarms.

[0563] Sending messages to external devices

[0564] • Log of events

[0565] 5.5 Air Circuit

[0566] 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 between two components, such as the RPT device 4000 and the patient interface 3000 or 3800.

[0567] 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.

[0568] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be connected to a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0569] 5.5.1 Supplemental Gas Delivery

[0570] In one form of this technology, supplemental gas, 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.

[0571] 5.6 Humidifier

[0572] 5.6.1 Overview of Humidifiers

[0573] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0574] 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.

[0575] 5.6.2 Humidifier Components

[0576] 5.6.2.1 Water Storage Tank

[0577] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0578] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0579] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0580] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any hole and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0581] 5.6.2.2 Conductive Component

[0582] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0583] 5.6.2.3 Humidifier reservoir dock

[0584] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, it is configured to receive humidifier reservoir 5110. In some arrangements, humidifier reservoir base 5130 may include locking mechanisms, such as locking lever 5135 configured to retain reservoir 5110 in humidifier reservoir base 5130.

[0585] 5.6.2.4 Water level indicator

[0586] Humidifier reservoir 5110 may include, for example Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0587] 5.6.2.5 Humidifier Converter

[0588] The humidifier 5000 may include one or more humidifier converters (sensors) 5210, in addition to or replacing the converter 4270 described above. For example... Figure 5C As shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that can communicate with a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter may be externally located to the humidifier 5000 (such as in the air circuit 4170) when communicating the output signal to the controller.

[0589] 5.6.2.5.1 Pressure Transmitter

[0590] In addition to or in addition to the pressure sensor 4272 provided in the RPT device 4000, one or more pressure converters 5212 may be provided to the humidifier 5000.

[0591] 5.6.2.5.2 Flow Converter

[0592] In addition to or in addition to the flow sensor 4274 provided in the RPT device 4000, one or more flow converters 5214 may be provided to the humidifier 5000.

[0593] 5.6.2.5.3 Temperature Converter

[0594] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0595] 5.6.2.5.4 Humidity Converter

[0596] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0597] 5.6.2.6 Heating element

[0598] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heating components such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0599] In some configurations, the heating element 5240 may be housed within the humidifier base 5006, such as... Figure 5B The heat shown can be supplied to the humidifier reservoir 5110 primarily through conduction.

[0600] 5.6.2.7 Humidifier Controller

[0601] According to one arrangement of this technology, such as Figure 5C The humidifier 5000 shown may include a humidifier controller 5250. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a standalone controller that can communicate with the central controller 4230.

[0602] In one embodiment, the humidifier controller 5250 may receive, for example, measurements of characteristics of airflow and waterflow (such as temperature, humidity, pressure, and / or flow rate) in the reservoir 5110 and / or humidifier 5000 as input. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0603] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heating air circuit controller 5254 configured to control the temperature of the heating air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0604] 5.7 Respiratory waveform

[0605] Figure 6AThe 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 rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate 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 tidal volume (Vent) of approximately 7.5 L / min. The typical duty cycle is the ratio of Ti to Ttot, which is approximately 40%.

[0606] 5.8 Breathing Therapy Mode

[0607] The disclosed respiratory therapy system can implement various respiratory therapy modes.

[0608] 5.8.1 CPAP Therapy

[0609] In some implementations of respiratory pressure therapy, the central controller 4230 sets the treatment pressure Pt according to the treatment pressure equation (1) as part of the treatment parameter determination algorithm 4329. In one such implementation, the amplitude A is equal to zero, so the treatment pressure Pt (which represents the target value achieved by the interface pressure Pm at the current moment) is equal to the baseline pressure P0 throughout the respiratory cycle. This implementation is typically grouped under the heading of CPAP therapy. In this implementation, the treatment engine module 4320 is not required to determine the phase Φ or the waveform template Π(Φ).

[0610] In CPAP therapy, the basal pressure P0 can be a constant value that is hard-coded or manually entered into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the basal pressure P0 based on indicators or measures of sleep apnea (such as one or more of flow restriction, apnea, hypopnea, open breathing, and snoring) returned by a corresponding algorithm in the therapy engine module 4320. This alternative is sometimes referred to as APAP therapy.

[0611] Figure 4E The flowchart of method 4500 is shown. When the pressure support A is equal to zero, the central controller 4230 executes method 4500 to continuously calculate the base pressure P0 as part of the APAP treatment implementation of the treatment parameter determination algorithm 4329.

[0612] Method 4500 begins at step 4520. In step 4520, the central controller 4230 compares a measure of the presence of apnea / insomnia with a first threshold and determines whether the measure of the presence of apnea / insomnia has exceeded the first threshold for a predetermined time period, indicating that apnea / insomnia is occurring. If so, method 4500 proceeds to step 4540; otherwise, method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares a measure of airway patency with a second threshold. If the measure of airway patency exceeds the second threshold, indicating that the airway is open, the detected apnea / insomnia is considered central, and method 4500 proceeds to step 4560; otherwise, the apnea / insomnia is considered obstructive, and method 4500 proceeds to step 4550.

[0613] In step 4530, the central controller 4230 compares the measure of the flow restriction with a third threshold. If the measure of the flow restriction exceeds the third threshold, indicating that the inspiratory flow is restricted, then method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0614] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, provided that the resulting treatment pressure Pt does not exceed the maximum treatment pressure Pmax. In one implementation, the predetermined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment ΔP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Then, method 4500 returns to step 4520.

[0615] In step 4560, the central controller 4230 reduces the base pressure P0 by a reduction amount, provided that the reduced base pressure P0 does not fall below the minimum therapeutic pressure Pmin. Then, method 4500 returns to step 4520. In one implementation, the reduction is proportional to the value of P0 - Pmin, such that the decrease from P0 to the minimum therapeutic pressure Pmin is exponential in the absence of any detected event. In one implementation, the proportionality constant is set such that the time constant τ for the exponential decrease of P0 is 60 minutes, and the minimum therapeutic pressure Pmin is 4 cmH2O. In other implementations, the time constant τ can be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum therapeutic pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the reduction of P0 can be preset so that the decrease from P0 to the minimum therapeutic pressure Pmin is linear in the absence of any detected event.

[0616] 5.8.2 Bilevel therapy

[0617] In other implementations of this form of the technique, the value of amplitude A in equation (1) can be positive. Such an implementation is called bilevel therapy because, when determining the treatment pressure Pt using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 causes the treatment pressure Pt to oscillate between two values ​​or levels synchronized with the patient's spontaneous respiratory effort of 1000. That is, based on the above-described typical waveform template □Π(Φ,t), the treatment parameter determination algorithm 4329 increases the treatment pressure Pt to P0+A (referred to as IPAP) at the start of inspiration or during inspiration, and decreases the treatment pressure Pt to the baseline pressure P0 (referred to as EPAP) at the start of expiration or during expiration.

[0618] In some forms of bilevel therapy, IPAP is a therapeutic pressure that serves the same purpose as the therapeutic pressure in CPAP therapy, and EPAP is IPAP minus amplitude A, which has a “small” value (a few cmH2O) sometimes referred to as expiratory pressure release (EPR). This form is sometimes referred to as CPAP therapy with EPR, and it is generally considered more comfortable than linear CPAP therapy. In CPAP therapy with EPR, one or both of IPAP and EPAP can be constant values ​​that are hard-coded or manually entered into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP in a manner similar to the calculation of the basal pressure P0 in APAP therapy described above, based on an index or measure of sleep apnea returned by the corresponding algorithm in the treatment engine module 4320.

[0619] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 completes part or all of the patient's breathing work. In this form, known as pressure support ventilation, the amplitude A is referred to as pressure support or oscillation. In pressure support ventilation, IPAP is the base pressure P0 plus pressure support A, and EPAP is the base pressure P0.

[0620] In some forms of pressure support ventilation therapy known as fixed pressure support ventilation, pressure support A is fixed at a predetermined value, such as 10 cmH2O. The predetermined pressure support value is the setting of the RPT device 4000 and can be set, for example, by hard coding during RPT device 4000 configuration or by manual input via input device 4220.

[0621] In other forms of pressure support ventilation therapy widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes some currently measured or estimated parameters of the respiratory cycle (e.g., a measure of the current tidal volume, Vent) and a target value for that respiratory parameter (e.g., a target tidal volume value, Vtgt) as inputs, and repeatedly adjusts the parameters of equation (1) to move the current measure of the respiratory parameter toward the target value. In a form of servo ventilation called adaptive servo ventilation (ASV) (which has been used to treat CSR), the respiratory parameter is the tidal volume, and the target tidal volume value Vtgt is calculated by the target tidal volume determination algorithm 4328 from the typical recent tidal volume Vtyp, as described above.

[0622] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method to repeatedly calculate the pressure support A so that the current measure of the respiratory parameter moves toward the target value. One such control method is proportional-integral (PI) control. In one implementation of PI control, applicable to ASV mode, the target tidal volume Vtgt is set slightly less than the typical recent tidal volume Vtyp, and the pressure support A is repeatedly calculated as:

[0623] A=G∫(Vent-Vtgt)dt (2)

[0624] Here, G is the gain controlled by PI. A larger gain value G may result in positive feedback in the treatment engine module 4320. A smaller gain value G may allow some remaining untreated CSR or central sleep apnea. In some implementations, the gain G is fixed to a predetermined value, such as 0.4 cmH2O / (L / min) / second. Alternatively, the gain G can be varied between treatment periods, starting smaller and then increasing from period to period until a value is reached that substantially eliminates the CSR. In such implementations, existing devices for retrospectively analyzing parameters of treatment periods to assess the severity of CSR during treatment periods can be used. In other implementations, the gain G can be varied based on the difference between the current tidal volume measure Vent and the target tidal volume Vtgt.

[0625] Other servo ventilation control methods that can be applied to the treatment parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0626] The pressure support value A calculated via equation (2) can be limited to a range of [Amin, Amax]. In this implementation, the pressure support A is at the minimum pressure support Amin by default, until the current ventilation measure Vent drops below the target ventilation Vtgt, at which point A begins to increase, and only decreases back to Amin when Vent exceeds Vtgt again.

[0627] The pressure support limits Amin and Amax are settings of the RPT device 4000, for example, by hard-coding during RPT device 4000 configuration or by manual input via input device 4220.

[0628] In pressure support ventilation therapy, EPAP is the baseline pressure P0. Similar to the baseline pressure P0 in CPAP therapy, EPAP can be a constant value specified or determined during titration. This constant EPAP can be set, for example, by hard-coding during the configuration of the RPT device 4000 or by manual input via the input device 4220. This alternative is sometimes referred to as fixed EPAP pressure support ventilation therapy. Similar to the titration of baseline pressure P0 in constant CPAP therapy, EPAP can be titrated by a clinician during the titration period for a given patient using a PSG to prevent obstructive apnea and thus maintain an open airway for pressure support ventilation therapy.

[0629] Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the basal pressure P0 during pressure support ventilation therapy. In such an implementation, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP based on indicators or measures of sleep apnea (such as flow restriction, apnea, hypopnea, open breathing, and snoring, or one or more of these) returned by the corresponding algorithm in the treatment engine module 4320. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is sometimes referred to as automatic EPAP titration, and this treatment mode is called automatic titration EPAP pressure support ventilation therapy or automatic EPAP pressure support ventilation therapy.

[0630] 5.8.3 High-flow therapy

[0631] In other forms of respiratory therapy, the pressure of the airflow is uncontrolled because it is used for respiratory pressure therapy. More precisely, the central controller 4230 controls the pressure generator 4140 to deliver the airflow, and the device flow rate Qd is controlled as a therapeutic or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle. These forms are often grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt can be a constant value that is hard-coded or manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is often referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve Qtgt(t) that varies with the respiratory cycle.

[0632] 5.9 Glossary

[0633] 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.

[0634] 5.9.1 General Rules

[0635] 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 air.

[0636] 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.

[0637] For example, relative to the environment of the humidifier humidity This could 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.

[0638] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0639] 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.

[0640] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0641] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0642] 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'.

[0643] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the air flow rate leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Vent flow rate Qv is the air flow rate leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Breathing flow rate Qr is the air flow rate received into the patient's respiratory system.

[0644] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the airway inlet at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0645] 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.

[0646] Leakage: The word "leakage" is considered to refer to unintended airflow. In one instance, leakage can occur due to an incomplete seal between the mask and the patient's face. In another instance, leakage can occur in a turnaround point to the surrounding environment.

[0647] 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.

[0648] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0649] 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).

[0650] Oxygen-enriched air: Air with an oxygen concentration greater than the atmospheric oxygen concentration (21%), such as at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 98%, or at least about 99%. “Oxygen-enriched air” is sometimes simply referred to as “oxygen”.

[0651] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0652] Patient: A person, regardless of whether they have a respiratory illness.

[0653] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0654] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0655] Respiratory pressure therapy: Applying air supply to the airway inlet at a typical therapeutic pressure that is positive relative to the atmosphere.

[0656] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0657] 5.9.1.1 Materials

[0658] Silicone resin 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.

[0659] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0660] 5.9.1.2 Mechanical Properties

[0661] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0662] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0663] 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).

[0664] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0665] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0666] 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.

[0667] 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.

[0668] 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.

[0669] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0670] 5.9.2 Respiratory cycle

[0671] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0672] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0673] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0674] Effort (breathing): The work done by a spontaneously breathing person in trying to breathe.

[0675] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0676] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0677] Types of flow-limited inhalation waveforms:

[0678] (i) Flattened: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0679] (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.

[0680] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0681] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0682] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate drops below a threshold and persists for a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0683] (ii) The patient's respiratory rate decreases by 30% for at least 10 seconds plus an associated 4% desaturation; or

[0684] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0685] Hyperventilation: Increased airflow to above normal levels.

[0686] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0687] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0688] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0689] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0690] Respiratory flow, patient air flow, and respiratory air flow (Qr): These synonymous terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0691] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0692] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0693] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0694] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0695] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0696] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0697] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0698] 5.9.3 Ventilation

[0699] 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.

[0700] Standby rate: A parameter of the ventilator that determines the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0701] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to end at the end of the inspiratory portion of the respiratory cycle.

[0702] Expiratory positive airway pressure (EPAP): The base pressure to which the pressure changes within the respiratory tract are added to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0703] End-expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory phase. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.

[0704] Inspiratory positive airway pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0705] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0706] Servo ventilator: A ventilator that measures a patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0707] 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.

[0708] Oscillation: A term equivalent to pressure support.

[0709] Triggering: When a ventilator or other respiratory therapy device, such as an RPT device or portable oxygen concentrator, delivers a volume of breathable gas to a spontaneously breathing patient, it is called being triggered. Triggering typically occurs at or near the beginning of the breathing portion of a respiratory cycle, through the patient's effort.

[0710] 5.9.4 Anatomy

[0711] 5.9.4.1 Facial Anatomy

[0712] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0713] Nasal alar angle:

[0714] Alar tip: the outermost point on the ala of the nose.

[0715] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0716] Auricle: The entire visible external part of the ear.

[0717] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0718] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0719] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0720] 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).

[0721] 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.

[0722] 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.

[0723] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0724] Lip, lower lip (midpoint of the lower lip):

[0725] Lip, upper lip (midpoint of the upper lip):

[0726] 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.

[0727] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0728] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0729] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0730] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0731] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0732] 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.

[0733] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0734] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0735] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0736] 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.

[0737] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0738] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0739] 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.

[0740] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0741] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0742] Anatomical structure of the skull

[0743] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0744] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0745] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0746] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0747] 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.

[0748] 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.

[0749] The eye socket is the bony cavity in the skull that houses the eyeball.

[0750] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0751] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0752] 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.

[0753] 5.9.4.2 Anatomical Structure of the Respiratory System

[0754] Diaphragm: A muscular plate that extends across the base 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.

[0755] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0756] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0757] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0758] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0759] 5.9.5 Patient Interface

[0760] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0761] Elbow: An elbow is an example of a structure that directs the axis of an airflow through it by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0762] 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.

[0763] Headband: A headband is considered to refer to a form of positioning and stabilizing structure designed for use on the head. For example, a headband may comprise an assembly of one or more supports, 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.

[0764] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0765] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0766] Sealing: can be the noun form of a structure (sealant) or the verb form of the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0767] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0768] 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.

[0769] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0770] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0771] Lacing (noun): A structure used to resist tension.

[0772] 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.

[0773] 5.9.6 Shape of the structure

[0774] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0775] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure, see [reference needed]. Figures 3B to 3F They show the cross-section at point p on the surface and the resulting example of the planar curve. Figures 3B to 3FThe outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some instances, the surface is depicted from the viewpoint of an imaginary figure standing upright on the surface.

[0776] 5.9.6.1 Curvature in one dimension

[0777] 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).

[0778] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0779] 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 .

[0780] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0781] 5.9.6.2 Curvature of Two-Dimensional Surfaces

[0782] 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 plane can be an instance of multiple cross-sections at a specific point.

[0783] 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.

[0784] 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.

[0785] 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).

[0786] 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").

[0787] 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.

[0788] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0789] Edge of a surface: the boundary or limit of a surface or region.

[0790] 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 walk on a surface and resemble garden paths).

[0791] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imagined individual would be the distance they travel along the path on the surface).

[0792] 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').

[0793] 5.9.6.3 Space Curves

[0794] 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.

[0795] 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.

[0796] 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.

[0797] 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.

[0798] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See appendix. Figure 3O and 3P .

[0799] 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 two normals 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.

[0800] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0801] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0802] 5.9.6.4 holes

[0803] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0804] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The structure shown has a two-dimensional hole whose boundary is defined by the surface shown.

[0805] 5.10 Other Remarks

[0806] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other such value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where the range includes one or both of the limit values, this technique also includes ranges that exclude any one or both of those included limit values.

[0807] 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.

[0808] 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.

[0809] When a particular material is identified for use in constructing a component, a readily available alternative material with similar properties is used as its substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0810] 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.

[0811] 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.

[0812] 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.

[0813] 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.

[0814] 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, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order may be performed simultaneously or even concurrently.

[0815] 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.

[0816] 5.11 List of Reference Symbols

[0817]

[0818]

[0819]

[0820]

[0821]

[0822]

Claims

1. A patient interface for sealably delivering a flow of air at a continuous positive pressure with respect to ambient air pressure to a patient airway entry including at least a patient nares entry, wherein, The patient interface is configured to maintain, throughout a patient's respiratory cycle while the patient is sleeping in use, a therapy pressure in the range of 4 cmH20 to 30 cmH20 above ambient air pressure to ameliorate sleep disordered breathing, the patient interface comprising: a cushion assembly configured to deliver the flow of air to the patient's airways, the cushion assembly comprising: a nasal chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the nasal chamber being configured to deliver the flow of air to the patient's nasal passages in use; an oral chamber pressurisable to a different level than the nasal chamber, the oral chamber being configured to deliver the flow of air to the patient's mouth in use; at least one inlet port sized and structured to receive a flow of air into at least the nasal chamber; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, the seal-forming structure having at least one hole formed therein so that the flow of air is delivered at least to the entrance to the patient's nares; and a partition forming a wall extending between and separating the nasal chamber from the oral chamber, wherein the wall extends across an interior of the cushion assembly from a patient contacting side of the cushion assembly to a non-patient contacting side of the cushion assembly, such that a first surface of the wall is disposed in the nasal chamber and a second surface of the wall, opposite the first surface, is disposed in the oral chamber, wherein a plurality of holes are formed in the wall, the plurality of holes extending through the first surface and the second surface to allow the flow of air to flow from the nasal chamber to the oral chamber in a manner that maintains a pressure in the oral chamber at a level that is lower than a pressure in the nasal chamber in use to encourage nasal breathing, wherein the pressure in the nasal chamber is at least 2 cmH20 higher than the pressure in the oral chamber, and wherein a thickness of the wall varies in different portions of the wall, such that a first portion of the wall has a thickness that is less than a thickness of a second portion of the wall, wherein the first portion of the wall is connected to the seal-forming structure of the patient contacting side of the cushion assembly.

2. The patient interface of claim 1, wherein, The plurality of holes comprises at least three holes.

3. The patient interface of claim 1, wherein, The pressure in the nasal chamber is at least 5 cmH20 higher than the pressure in the oral chamber.

4. The patient interface of claim 1, wherein, The pressure in the nasal chamber is at least 10 cmH20 higher than the pressure in the oral chamber.

5. The patient interface of claim 1, the cushion assembly further comprising a flow regulator, the flow regulator comprising a passageway fluidly connecting the nasal chamber and the oral chamber to allow the flow of air to flow from the nasal chamber to the oral chamber, wherein the flow regulator being configured to adjust a size of the passageway to control a volume of the flow of air that flows from the nasal chamber to the oral chamber.

6. The patient interface of claim 5, wherein, The flow regulator is an adjustable valve.

7. The patient interface of claim 5, wherein, The size of the passageway is manually adjustable.

8. The patient interface of claim 7, wherein, The flow regulator further includes a rotatable dial to manually adjust the size of the passageway.

9. The patient interface of claim 5, wherein, The size of the passageway is automatically adjustable.

10. The patient interface of claim 5, further comprising a sensor to determine a level of resistance in a nasal passage of the patient, wherein, The flow regulator is configured to automatically adjust the flow of air to increase pressure in the oral chamber when the level of resistance in the nasal passageway of the patient exceeds a first threshold in use.

11. The patient interface of any one of claims 1 to 10, wherein, The divider includes silicone.

12. The patient interface of any one of claims 1 to 10, wherein, The seal-forming structure includes a nasal seal including the at least one hole such that the flow of air is delivered at least to the patient's nare entrance.

13. The patient interface of any one of claims 1 to 10, wherein, The seal-forming structure includes an oral seal having a hole formed therein to deliver the flow of air to the patient's mouth.

14. The patient interface of any one of claims 1 to 10, wherein, The cushion assembly is an oral-nasal cushion assembly and the seal-forming structure is configured to form a seal under the patient's pronasale in use.

15. The patient interface of claim 14, further comprising a pair of headgear tubes configured to deliver the flow of air to the cushion assembly, the pair of headgear tubes being configured to extend along respective sides of the patient's face between the patient's eyes and ears in use.

16. The patient interface according to any one of claims 1 to 10, wherein, The cushion assembly is a full-face cushion assembly and the seal-forming structure is configured to form a seal over the patient's pronasale in use.

17. The patient interface of claim 16, wherein, The seal-forming structure is configured to form a seal along the patient's nasal bridge in use.

18. The patient interface of claim 14, wherein, The wall extends from a patient-contacting side of the cushion assembly to a non-patient contacting side of the cushion assembly.

19. The patient interface of any one of claims 1 to 10, wherein, The wall forms an upper surface of the oral chamber and a lower surface of the nasal chamber.

20. The patient interface of any one of claims 1 to 10, wherein, The cushion assembly further includes a nasal cushion and a separate oral cushion, wherein the seal-forming structure includes a nasal seal including the at least one hole such that the flow of air is delivered at least to the patient's nare entrance, the nasal cushion including the nasal seal, wherein the seal-forming structure includes an oral seal having a hole formed therein to deliver the flow of air to the patient's mouth, the oral cushion including the oral seal.

21. The patient interface of claim 20, wherein, The wall is disposed in the nasal cushion, in the oral cushion, or in a fluidic connection structure between the nasal cushion and the oral cushion.

22. The patient interface of claim 20, further comprising a junction forming a hollow interior to fluidly connect the nasal chamber and the oral chamber, wherein The wall is disposed in the hollow interior of the junction.

23. The patient interface according to any one of claims 1 to 10, wherein, The cushion assembly is configured such that, in use, the nasal chamber is pressurized to be in the range of 8 to 14 cmH20 above ambient air pressure, while the oral chamber is pressurized to be in the range of 4 to 7.5 cmH20 above ambient air pressure.

24. The patient interface according to any one of claims 1 to 10, wherein, The cushion assembly is configured such that, in use, the nasal chamber is pressurized to be in the range of 14 to 20 cmH20 above ambient air pressure, while the oral chamber is pressurized to be in the range of 7.5 to 10.5 cmH20 above ambient air pressure.

25. The patient interface of any one of claims 1 to 10, further comprising a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure being constructed and arranged so that, in use, at least a portion overlies a region of the patient's head superior to the patient's otobasion superior.

26. A patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to a patient airway entrance including at least entrance of a patient's nares, wherein, The patient interface is configured to maintain, in use, a therapy pressure in a range of 4 cmH20 to 30 cmH20 above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep disordered breathing, the patient interface comprising: a cushion assembly configured to deliver a flow of air to the patient's airways, the cushion assembly comprising: a nasal cavity chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the nasal cavity chamber being configured to deliver, in use, the flow of air to the patient's nasal passages; an oral cavity chamber pressurisable to a different level than the nasal cavity chamber, the oral cavity chamber being configured to deliver, in use, the flow of air to the patient's mouth; at least one inlet port sized and structured to receive a flow of air into at least the nasal cavity chamber; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airways, the seal-forming structure having at least one hole formed therein so that the flow of air is delivered at least to the entrance to the patient's nares; a partition forming a wall extending between and separating the nasal cavity chamber from the oral cavity chamber, the wall extending across an interior of the cushion assembly from a patient-contacting side of the cushion assembly to a non-patient contacting side of the cushion assembly so that a first surface of the wall is disposed in the nasal cavity chamber and a second surface of the wall, opposite the first surface, is disposed in the oral cavity chamber; and a flow regulator cooperating with the partition and comprising a passageway fluidly connecting the nasal cavity chamber and the oral cavity chamber to allow the flow of air to flow from the nasal cavity chamber to the oral cavity chamber, wherein the flow regulator is configured to adjust a size of the passageway to control a volume of the flow of air from the nasal cavity chamber to the oral cavity chamber, wherein the flow regulator comprises an adjustment mechanism to manually adjust the size of the passageway, the adjustment mechanism protruding from the non-patient contacting side of the cushion assembly for manual adjustment.

27. The patient interface of claim 26, wherein, The flow regulator is configured to maintain, in use, the therapy pressure in the nasal cavity chamber at a level at least 2 cmH20 above a pressure in the oral cavity chamber to promote nasal breathing.

28. The patient interface of claim 26, wherein, The flow regulator is an adjustable valve.

29. The patient interface of any one of claims 26 to 28, wherein, The size of the passageway is manually adjustable.

30. The patient interface of any one of claims 26 to 28, wherein, The adjustment mechanism further comprises a rotatable dial to manually adjust the size of the passageway.

31. The patient interface of any one of claims 26 to 28, wherein, The size of the passageway is automatically adjustable.

32. The patient interface of any one of claims 26 to 28, further comprising a sensor to determine a level of resistance in a nasal passage of the patient, wherein, In use, when the level of resistance in the nasal passages of the patient exceeds a first threshold, the flow regulator is configured to automatically regulate the flow of air to increase pressure in the oral cavity chamber.

33. The patient interface according to any one of claims 26 to 28, wherein, The divider comprises silicone.

34. The patient interface according to any one of claims 26 to 28, wherein, The cushion assembly is an oral-nasal cushion assembly, and the seal-forming structure is configured to form a seal, in use, under the patient's pronasale.

35. The patient interface of claim 34, further comprising a pair of headgear tubes configured to deliver the flow of air to the cushion assembly, the pair of headgear tubes being configured to extend, in use, along respective sides of the patient's face between the patient's eyes and ears.

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