Patient interface

Abstract

The utility model relates to a patient interface. A patient interface for treating sleep disordered breathing, the patient interface comprising: a strap comprising a front portion configured to be positioned in use in front of a patient's face; and a seal forming structure formed by or provided to the front portion; wherein the front portion of the belt is shaped to form an inflation chamber; wherein the strap forms a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

Description

[0001] Cross-references to related applications

[0002] not applicable Technical Field

[0003] 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. Background Technology

[0004] Human respiratory system and its disorders

[0005] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0006] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is known as the respiratory region. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0007] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0008] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0009] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is 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 tongue, soft palate, and posterior oropharyngeal wall regions 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. It often leads to excessive daytime sleepiness and can potentially cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly prevalent in middle-aged overweight men, but those affected may not be aware of the problem, see, for example, U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repetitive deoxygenation and reoxygenation of arterial blood. Due to repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive micro-arousals from sleep, which cause severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can cover some or all of the following disorders.

[0012] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0013] Obesity-hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These 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.

[0015] 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.

[0016] 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.

[0017] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies have many drawbacks.

[0018] therapy

[0019] 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 aforementioned respiratory disorders.

[0020] Respiratory pressure therapy

[0021] Respiratory pressure therapy is the application of supplying air to the inlet of the airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0022] 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 therapy can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to provide such therapy uncomfortable, difficult to use, expensive, or unsightly.

[0023] 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, the comfort and effectiveness of these therapies can be improved.

[0024] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0025] Respiratory therapy system

[0026] 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.

[0027] 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.

[0028] Another form of therapeutic system is the mandibular repositioning device.

[0029] Patient Interface

[0030] 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 patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be administered, the patient interface can form a seal with, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure). For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow-through therapy such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0031] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0032] Some masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow airflow through the mouth.

[0033] If some masks require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips, then these masks may be uncomfortable or impractical for this technology.

[0034] Some face masks may not be very practical to use while sleeping, for example, when the head is resting on a pillow and the person is sleeping on their side in bed.

[0035] Some masks may cause claustrophobia, anxiety, and / or a feeling of being too abrupt to some patients.

[0036] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0037] Therefore, some masks have drawbacks such as being obtrusive, unsightly, expensive, poorly fitted, difficult to use, and / or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Incorrectly sized masks can lead to decreased adherence, reduced comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics may be acceptable for their original application, 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 mask is worn during sleep.

[0038] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to therapy if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0039] While masks designed for other applications (such as pilots) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.

[0040] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0041] Sealing Formation Structure

[0042] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0043] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may 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 that surrounds both nostrils during use. This single element may be designed, for example, to cover the upper lip and bridge of the nose area of ​​the face. In another form of patient interface, the sealing structure may include an element that surrounds the mouth area during use, for example, by forming a seal on the lower lip area of ​​the face. In yet another form of patient interface, the sealing structure may include a single element that surrounds both nostrils and the mouth area 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.

[0044] For example, due to the different shapes, structures, variable areas, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​the patient's face may not be suitable in another area. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0045] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0046] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface, wherein the seal-forming structure engages face-to-face with the patient's face. The seal-forming structure may include an air- or fluid-filled liner, or a molded or 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.

[0047] Another type of seal-forming structure incorporates a wing seal of thin material positioned around the periphery of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0048] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0049] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0050] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0051] One form of nasal pillow was found in the AdamCircuit manufactured by Puritan Bennett Corporation. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0052] ResMed Inc. has manufactured the following products that incorporate a nose pillow: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (describes SWIFT). TM Other aspects of the nose pillow cover), U.S. Patent Application 2009 / 0044808 (describes SWIFT) TM Other aspects of the LT nose pillow cover); International patent applications WO 2005 / 063328 and WO 2006 / 130903 (describe MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052560 (describes SWIFT) TM Other aspects of the FX nose pillow cover).

[0053] Positioning and stabilizing structure

[0054] The seal-forming structure of a patient interface used in positive air pressure therapy is subjected to stress from air pressure that threatens to break the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain a tight seal with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: the effectiveness of the technique in maintaining the seal-forming structure in the desired position and sealing it against the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0055] One technique involves using adhesives, see, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0056] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more of the following problems: poor fit, bulkiness, discomfort, and inconvenience of use.

[0057] pressurized air duct

[0058] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit, which is fluidly connected to the patient interface at a position in front of the patient's face when the patient interface is positioned over the patient's face during use. The conduit can extend forward from the patient interface away from the patient's face.

[0059] Pressurized air ducts used for positioning / stabilizing sealing structures

[0060] Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also functions as part of a headgear to position and stabilize a sealing portion of the patient interface at the appropriate location on the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tubing." Such patient interfaces allow a catheter in the air circuit that provides a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US 2007 / 0246043, the contents of which are incorporated herein by reference, wherein a catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0061] The goal is to combine a patient interface with a head sleeve to ensure comfort for patients during extended periods of sleep, create an airtight and stable seal with the patient's face, and conform to a certain range of patient head shapes and sizes.

[0062] Respiratory Pressure Therapy (RPT) device

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

[0064] Device designers may face an almost limitless number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0065] air circuit

[0066] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as the RPT device and the patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0067] humidifier

[0068] Delivering an airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface generates humidified gas, which minimizes dryness of the nasal mucosa and increases airway comfort for the patient. Additionally, in cooler climates, warm air applied to the area inside and around the patient interface on the face is generally more comfortable than cold air.

[0069] Data Management

[0070] There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy has been "compliant," such as the patient having used their RPT device according to one or more "compliance rules." One example of a CPAP compliance rule is that, in order to be considered compliant, the patient is required to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient compliance, the RPT device provider (such as a healthcare provider) may manually obtain data describing the patient's therapy using the RPT device, calculate usage over a predetermined period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider may notify a third party of patient compliance.

[0071] The patient's treatment may benefit from other aspects such as transmitting treatment data to third parties or external systems.

[0072] Existing methods for transmitting and managing such data are likely to be one or more of the following: costly, time-consuming, and error-prone.

[0073] Ventilation technology

[0074] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., into the environment).

[0075] Ventilation ports may include openings through which gas can flow during mask use. Many such vents are noisy. Other vents may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or congested airflow.

[0076] Screening, diagnosis and monitoring systems

[0077] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary diseases, and it typically involves clinical specialists in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosing / monitoring sleep-disordered breathing at home.

[0078] Screening and diagnosis are generally described as identifying a condition based on its signs and symptoms. Screening typically provides a true / false result, indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis are often one-off processes, while monitoring the progression of the condition can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0079] Clinical specialists can adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinical specialists may be unavailable or unaffordable. Different clinical specialists may have differing opinions on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. Utility Model Content

[0080] 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.

[0081] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0082] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0083] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0084] One form of this technology includes a positioning and stabilizing structure configured to provide force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0085] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0086] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, sized and configured to receive an airflow at the treatment pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to seal with an inlet region of the patient's face surrounding the patient's airway. The sealing structure has an opening therein, allowing the airflow at the treatment pressure to be delivered to at least one inlet of the patient's nostril. The sealing structure is configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface also includes positioning and stabilizing structures to provide force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0087] Another aspect of this technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0088] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably to form different modular components.

[0089] One form of this technology includes a patient interface for treating sleep-disordered breathing, the patient interface comprising:

[0090] A strap configured to be worn by a patient during use, the strap comprising:

[0091] The front portion, configured to be positioned in front of the patient's face during use; and

[0092] A sealing structure formed by or provided to the front portion, the sealing structure being constructed and arranged to form a seal with an inlet of the patient’s face surrounding the patient’s airway, the sealing structure having an opening therein such that an airflow under the treatment pressure is delivered to at least one inlet of the patient’s nostril.

[0093] The front portion of the belt is shaped to form an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O higher than ambient air pressure. The inflatable chamber includes an inflatable chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for the patient to breathe. A sealing structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0094] The band forms a positioning and stabilizing structure to provide force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0095] One form of this technology includes a patient interface for treating sleep-disordered breathing, the patient interface comprising:

[0096] An inflation chamber that can be pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port whose size and structure are designed to receive an airflow at the treatment pressure for the patient to breathe;

[0097] A sealing structure is configured and arranged to form a seal with an inlet of the patient’s face surrounding the patient’s airway, the sealing structure having an opening therein such that an airflow under therapeutic pressure is delivered to at least one inlet of the patient’s nostril, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient’s respiratory cycle during use.

[0098] A positioning and stabilizing structure configured to provide force to hold the sealing-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a band configured to be arranged in use such that the front portion of the band is positioned in front of the patient's face in use.

[0099] A ventilation port that allows the patient's exhaled air to flow continuously from the interior of the inflation chamber into the environment, the ventilation port being configured to maintain the treatment pressure within the inflation chamber during use;

[0100] The front portion of the belt is shaped to form an air chamber;

[0101] The sealing structure is formed by or provided to the front part of the belt.

[0102] In the example:

[0103] The front part of the belt can be thermoformed into a three-dimensional shape that defines the inflation chamber;

[0104] The front portion of the belt includes a recessed portion that defines the inflation chamber;

[0105] A sealing structure is attached to the front portion of the belt;

[0106] The sealing structure includes a pad attached to the front portion of the band, the pad being configured to seal against the patient’s face during use;

[0107] The padding is made of foam;

[0108] The front portion of the belt is shaped to form a sealing structure;

[0109] The front portion of the belt is thermoformed into a three-dimensional shape that defines the air chamber and forms a sealed structure.

[0110] The front portion of the band includes a recessed portion defining an inflation chamber and a raised portion provided around the periphery of the recessed portion, the raised portion being configured to engage the patient’s face to form a sealing structure.

[0111] The band is thicker in the raised portion than in the recessed portion;

[0112] The belt includes multiple layers;

[0113] These layers are interconnected;

[0114] The belt includes at least one foam layer;

[0115] The belt includes an inward-facing layer configured to contact the patient’s head during use and is formed of a fabric material;

[0116] The belt includes a resiliently compressible inner liner layer;

[0117] The inner lining layer is formed of foam;

[0118] The inner liner includes a thickness varying with the shape of the sealing structure or a portion of the strip to which the sealing structure is attached;

[0119] The belt includes semi-rigid support components;

[0120] The support component is in the form of a sheet of plastic material;

[0121] The band consists of essentially non-extendable layers;

[0122] This essentially non-stretchable layer is formed of webbing;

[0123] The substantially non-stretchable layer includes a pair of high-strength portions disposed adjacent to the front portion on each side of the front portion and having a higher strength than the adjacent portions of the substantially non-stretchable layer.

[0124] The high-strength section is located at or near the lower edge of the belt;

[0125] The high-strength portion can be formed from high-strength webbing;

[0126] The belt includes an elastically compressible outer liner layer;

[0127] The outer liner is made of foam;

[0128] The band includes an outward-facing layer that is configured to face away from the patient's head during use and is formed of a fabric material.

[0129] The front portion of the belt is thermoformed into a three-dimensional shape to form an air chamber;

[0130] The strip has been cut into its final shape using a cutting process that not only cuts out the final shape of the strip but also bonds the layers of the strip together at the edges.

[0131] The cutting process is RF cutting;

[0132] The cutting process is performed after the front part of the strip has been thermoformed;

[0133] The band includes an outer portion on either side of the front portion, the outer portion being substantially flat at least when at rest;

[0134] The belt includes a thermoformed hinged portion between the front portion and the outer portion of the belt;

[0135] The thermoformed hinge portion includes a recessed portion of the band;

[0136] The strap includes a rear portion configured to engage the rear surface of the patient’s head and / or neck to hold the patient interface in the use position;

[0137] The strap includes a fastening portion at one end of the strap, which is configured to attach to another portion of the strap to secure the strap around the patient’s head.

[0138] The fastening part includes a hook material of a loop material configured to be attached to the surface of the belt;

[0139] Each fastener comprises multiple thermoformed indexing sections;

[0140] The indexing portion of a thermoformed part can be raised or recessed;

[0141] Each fastening part includes at least one protruding indexing portion and at least one recessed indexing portion;

[0142] The at least one recessed indexing portion includes hook material attached thereto and configured to form a hook-and-loop connection with at least one protruding indexing portion;

[0143] The patient interface includes a snap fastener, with each of the fastening components passing through the snap fastener and securing itself back into place;

[0144] The belt includes an opening formed in the front portion of the belt, the opening being connected to an inlet connector configured to be fluidly connected to and receive airflow from the air circuit;

[0145] An inlet connector is connected to an inlet conduit configured to be fluidly connected to and receive airflow from an air circuit conduit connected to a respiratory pressure therapy device that generates airflow during use.

[0146] The inlet connector forms the inlet port of the inflation chamber; and / or

[0147] The inlet connector also includes a vent.

[0148] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0149] One aspect of this technology is a method for manufacturing equipment.

[0150] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0151] One aspect of this technology is that it is an easy-to-use medical device, for example, easy for people without medical training, people with limited dexterity and vision, or people with limited experience in using this type of medical device.

[0152] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., around a person's home).

[0153] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment.

[0154] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors (such as processors in 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.

[0155] Of course, parts of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects within an aspect can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0156] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0157] The technology is illustrated by way of example and not limitation in the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0158] Respiratory therapy system

[0159] FIG. 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nose pillow is shown. The patient interface 3000 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 is sleeping in a supine position.

[0160] FIG. 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown. The patient interface 3000 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.

[0161] FIG. 1C A system including a patient 1000 wearing a full-face mask-like patient interface 3000 receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0162] Respiratory system and facial anatomy

[0163] FIG. 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0164] FIG. 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0165] FIG. 2CIt is a frontal view of a face with several identifiable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the directions of up, down, radially inward, and radially outward.

[0166] FIG. 2D It is a side view of the head with several identifiable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0167] FIG. 2E This is another side view of the head. It indicates the approximate location of the Frankfort plane and the nasolabial angle. The coronal plane is also indicated.

[0168] FIG. 2F A bottom view of the nose with several identifiable features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0169] FIG. 2G A side view showing the surface features of the nose.

[0170] FIG. 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0171] FIG. 2I An anatomical view of the medial part of the nose is shown, approximately a few millimeters from the midsagittal plane, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0172] FIG. 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0173] FIG. 2K A side view of the skull, showing the outline of the head surface and several muscles, is presented. 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0174] FIG. 2L The frontal lateral view of the nose is shown.

[0175] Patient Interface

[0176] FIG. 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0177] FIG. 3A-1 It shows the effect when in use. FIG. 3A The force on the patient interface.

[0178] FIG. 3B A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... FIG. 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0179] FIG. 3C A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... FIG. 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0180] FIG. 3D A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0181] FIG. 3E A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when compared with... FIG. 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0182] FIG. 3F A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when compared with... FIG. 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0183] FIG. 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The vaulted and saddle-shaped areas are indicated.

[0184] FIG. 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 points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome area are indicated.

[0185] FIG. 3I A surface with a structure having a one-dimensional hole is shown. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0186] FIG. 3J It shows crossing FIG. 3IThe cross-section of the structure. The surface defined in the illustration. FIG. 3I Two-dimensional holes in the structure.

[0187] FIG. 3K It shows FIG. 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. The definition is also shown. FIG. 3I The surface of a two-dimensional hole in a structure.

[0188] FIG. 3L A face mask with an inflatable airbag as padding is shown.

[0189] FIG. 3M It shows crossing FIG. 3L The image shows a cross-section of the mask, and the inner surface of the bladder is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0190] FIG. 3N It shows crossing FIG. 3L Another cross-section of the mask. The inner surface is also indicated.

[0191] FIG. 3O The left-hand rule is illustrated.

[0192] FIG. 3P The right-hand rule is illustrated.

[0193] FIG. 3Q The left ear is shown, including the left ear spiral.

[0194] FIG. 3R The right ear is shown, including the right ear spiral.

[0195] FIG. 3S A right-handed spiral is shown.

[0196] FIG. 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0197] FIG. 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0198] FIG. 3V It shows FIG. 3U This is a view of the rear of the inflation chamber. The orientation of this view is orthogonal to the central contact plane. FIG. 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0199] FIG. 3W It shows crossing FIG. 3V The cross-section of the inflation chamber, which is in FIG. 3VA section is shown at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies in the sagittal plane and contacts the gasket of the inflation chamber only at two points (upper point 3220 and lower point 3230) in the sagittal plane. Depending on the geometry of the gasket in this area, the intermediate contact plane can be a section at the upper and lower points.

[0200] FIG. 3X The location shown is for use on the face. FIG. 3U The air chamber 3200. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 generally coincides with the midsagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane generally corresponds to the "plane of the face". FIG. 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0201] FIG. 3Y A patient interface in the form of a nasal cannula according to the present technology is shown.

[0202] FIG. 3Z A patient interface with a catheter tip cap, according to this technology, is shown.

[0203] FIG. 3Z-1 It shows the effect when in use. FIG. 3Z The force on the patient interface.

[0204] RPT device

[0205] FIG. 4A An RPT device of one form according to the present technology is shown.

[0206] FIG. 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to the blower and patient interface. The blower is positioned upstream of the patient interface, and the patient interface is positioned downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0207] humidifier

[0208] FIG. 5A An isometric view of one form of humidifier according to the present technology is shown.

[0209] FIG. 5BAn isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0210] respiratory waveform

[0211] FIG. 6 The diagram shows a typical breathing waveform of a person while sleeping.

[0212] Other examples of this technology

[0213] FIG. 7A A rear view of the patient interface according to an example of this technology is shown.

[0214] FIG. 7B It shows FIG. 7A A breakdown view of the patient interface.

[0215] FIG. 7C A schematic cross-sectional view of a patient interface according to another example of the present technology is shown.

[0216] FIG. 8A to FIG. 8B A view of the patient interface according to another example of this technology is shown.

[0217] FIG. 9A to FIG. 9B A view of the patient interface according to another example of this technology is shown.

[0218] FIG. 10 An outside view of a patient interface according to another example of this technology is shown.

[0219] FIG. 11A to FIG. 11C A view of the patient interface according to another example of this technology is shown.

[0220] FIG. 11D Another example of a clasp according to this technology is shown.

[0221] FIG. 12 A perspective view of a patient interface according to another example of this technology is shown. Detailed Implementation

[0222] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific instances described herein, and the specific instances described herein may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0223] The following description is provided for instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, any single feature or combination of features in any instance may constitute another instance.

[0224] therapy

[0225] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0226] In some instances of this technique, a positive pressure air supply is provided to the patient’s nasal passages through one or both nostrils.

[0227] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0228] Respiratory therapy system

[0229] 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.

[0230] Patient Interface

[0231] According to one aspect of this technology, such as FIG. 3A The illustrated noninvasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0232] like FIG. 3Z As shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a connection for connecting to an air circuit (such as...). FIG. 1A to FIG. 1C The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which sense it or they may be replaced by different components (e.g., components of different sizes).

[0233] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal forks 3810a, 3810b that can deliver air to the corresponding nostrils of a patient 1000 via corresponding orifices in their tips. Such nasal forks typically do not form a seal with the inner or outer skin surface of the nostril. This type of interface creates one or more gaps that are intentionally present by design during use, but they are generally not fixed in size, making them susceptible to unpredictable changes due to movement during use. Unlike other types of mask-based respiratory therapy systems, this allows for complex aerodynamic variables in the respiratory therapy system when control and / or evaluation are achieved. Air to the nasal forks can be delivered via one or more air supply lumens 3820a, 3820b coupled to the unsealed patient interface 3800. Lumens 3820a, 3820b extend from the unsealed patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. The “vent” or gap at the unsealed patient interface 3800 is a passage between the ends of the forks 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, leading to the atmosphere via the patient's nostrils. Excess airflow escapes into the environment through this “vent” or gap.

[0234] 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.

[0235] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure above the environment (e.g., at least 2 cmH2O, 4 cmH2O, 6 cmH2O, 10 cmH2O, or 20 cmH2O relative to the environment).

[0236] Sealing Formation Structure

[0237] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary over time and from patient to patient within a given treatment session, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0238] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0239] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0240] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material (such as silicone resin).

[0241] 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 that is suitable for large-sized heads but not for small-sized heads, while another sealing formation structure is suitable for small-sized heads but not for large-sized heads.

[0242] Sealing mechanism

[0243] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on its underside within the inflation chamber 3200, thereby promoting a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0244] 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 (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange and prevent it from bending during use.

[0245] 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 arranged in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0246] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is kept under tension, for example, by a region adjacent to the sealing flange.

[0247] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0248] 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.

[0249] bridge or ridge of the nose

[0250] 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.

[0251] In one form, the sealing structure includes a saddle-shaped area configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0252] upper lip area

[0253] 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 part of the lip) of the patient's face during use.

[0254] In one form, the seal-forming structure includes a saddle-shaped area configured to form a seal on the upper lip area of ​​a patient's face during use.

[0255] Chin area

[0256] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin area of ​​the patient's face during use.

[0257] In one form, the seal-forming structure includes a saddle-shaped area configured to form a seal on the chin area of ​​a patient's face during use.

[0258] Forehead area

[0259] 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.

[0260] nose pillow

[0261] 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.

[0262] 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 underside of the patient's nose; a handle; and a flexible region located on the underside of the truncated cone and connecting the truncated cone to the handle. Furthermore, the structure to which the nasal pillow of the present invention is connected includes a flexible region adjacent to the base of the handle. These flexible regions can work together to facilitate a universal joint structure that accommodates relative displacement and angular movement of the truncated cone and the structure to which the nasal pillow is connected. For example, the truncated cone can be axially displaced toward the structure to which the handle is connected.

[0263] Pure nose mask

[0264] In one form, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway, but not around the patient's mouth. The sealing structure 3100 can be configured to seal to the patient's upper lip. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver a supply of air or breathable gas to the patient's two nostrils instead of the mouth. This type of patient interface can be identified as a pure nasal mask.

[0265] One form of the pure nasal mask according to the present technology is a mask conventionally identified as a "nasal mask," having a sealing forming structure 3100 configured to surround the nose on the patient's face and seal over the bridge of the nose. The shape of the nasal mask may be generally triangular. In one form, the non-invasive patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal against the upper lip region (e.g., the upper lip), against at least a portion of the patient's bridge or ridge of the nose above the nasal protuberance, and against the patient's face on each lateral side of the nose (e.g., near the patient's nasolabial folds). FIG. 1B The patient interface 3000 shown has this type of sealing structure 3100. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 through a single orifice.

[0266] Another form of the pure nasal mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad liner." In one form, for example... FIG. 3ZAs shown, the sealing forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal ala. The sealing forming structure 3100 can seal to the upper part of the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely fit the lower side of the patient's nose and may not contact the bridge region of the patient's nose or any portion of the patient's nose above the nasal protuberance. In one form of the nasal pad, the sealing forming structure 3100 includes a bridging portion that divides the opening into two orifices, each of which, during use, supplies air or breathable gas to the corresponding nostril of the patient. The bridging portion can be configured to contact or abut against the patient's columella during use. Alternatively, the sealing forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nostrils.

[0267] In some forms, a simple nasal mask may include a nasal pillow as described above.

[0268] Nose and mouth mask

[0269] In one form, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway and also around the patient's mouth. The sealing structure 3100 can be configured to seal against the patient's face near the chin area. This patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000. This type of patient interface can be identified as a nasogastric mask.

[0270] One form of the nose and mouth mask according to the present technology is a mask conventionally recognized as a "full-face mask" having a sealing forming structure 3100 configured to seal around the nose, below the mouth, and above the bridge of the nose on the patient's face. The nose and mouth mask may be generally triangular in shape. In one form, the patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), over at least a portion of the patient's bridge or ridge of the nose above the nasal protuberance, and over the cheek area of ​​the patient's face. FIG. 1C The patient interface 3000 shown is of this type. This patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of sealing structure 3100 can be referred to as a "nose-mouth liner".

[0271] In another form, the patient interface 3000 includes a sealing structure 3100 that, in use, forms a seal against the lower and / or anterior surface of the nasal projection portion of the patient's nose, the nasal alae of the patient's nose, and the patient's face on each lateral side of the patient's nose (e.g., near the nasolabial fold) in the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip). The sealing structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 of this type may have a single opening configured to deliver an airflow or breathable gas to the patient's nostrils and mouth, may have an orifice configured to provide air or breathable gas to the mouth and nostrils configured to provide air or breathable gas to the nostrils, or may have an orifice for delivering air to the patient's mouth and two nostrils for delivering air to the respective nostrils. A patient interface 3000 of this type may have a nasal portion and a mouth portion, the nasal portion being sealed to the patient's face in a location similar to a nose pad.

[0272] In another form of the nasal mask, the patient interface 3000 may include a sealing structure 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal on the patient's face around the patient's mouth.

[0273] In some forms, the sealing structure 3100 may have a nasal portion that is separate from and distinct from the mouth portion. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0274] It should be understood that the above instances of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the above instances of pure nasal mask and naso-oral mask.

[0275] Inflation chamber

[0276] The air chamber 3200 has a periphery whose shape is configured to complement the surface contour of the area of ​​a normal person's face that will form a seal during use. In use, the edges of the air chamber 3200 are positioned close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend around 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.

[0277] 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 forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve adherence to therapy.

[0278] In some forms of this technology, the air chamber 3200 is made of a transparent material (e.g., transparent polycarbonate). Using a transparent material reduces the obtrusiveness of the patient interface and helps improve adherence to the therapy. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0279] In some forms of this technology, the air chamber 3200 is made of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0280] In some forms, the air chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0281] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in some instances, it may be formed of a material with a Young's modulus of 0.4 GPa or lower (e.g., foam). In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower (e.g., rubber). In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0282] The inflation chamber 3200 may include at least one inflation chamber inlet port. This inlet port may be configured to allow an inflow of air or breathable gas at therapeutic pressure into the inflation chamber during use. In some instances, the patient interface 3000 may include multiple inflation chamber inlet ports. In some forms, the inflation chamber inlet port may also allow outflow from the inflation chamber 3200, for example, during the exhalation phase of the patient's respiratory cycle, or, for example, towards the ventilation port 3400 of the patient interface 3000 when no airflow or breathable gas is available to the inflation chamber inlet port.

[0283] Positioning and stabilizing structure

[0284] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 can include and function as a "headgear" because it engages with the patient's head to hold the patient interface 3000 in a sealed position. Examples of the positioning and stabilizing structure include... FIG. 3A and FIG. 3A-1 As shown in the image.

[0285] In one configuration, the positioning and stabilizing structure 3300 provides a holding force (i.e., F) sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift the face away. 充气 ).

[0286] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0287] Continue to refer to FIG. 3A-1 The 3300 provides force F for positioning and stabilizing the structure. PSS This force helps maintain the air chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, the headgear strap can provide a strap force F on its own. 带 This is to maintain a seal against the patient's face, forming structure 3100. Force F can also be guided at least partially in the upward direction. 带 In order to overcome gravity F g The gravity F can be specifically shown for the sealing structure 3100 and the inflation chamber 3200. g However, gravity will act on the entire patient interface 3000 (i.e., in relation to the gravity F illustrated). g (in the same direction).

[0288] Gravity F g It can be related to frictional force F f Conversely, this frictional force can be relative to gravity F. g Acting in the direct opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 in the downward direction (as in... FIG. 3A-1 (as observed in the text), frictional force F f It will act upwards (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 gConversely, however, the component of the total frictional force (not shown) will also be associated with the gravity F of any other part of the patient interface 3000 and the positioning and stabilizing structure 3300. g Relatively speaking, friction can act at any point along the patient interface 3000 in contact with the patient's skin (or hair). Friction force F f In relation to gravity F g In the opposite direction and along the patient's skin (or hair). In some forms, gravity F g It can also be counteracted by the vertical component of the reaction force from the patient's face acting on the sealing structure 3100, for example, in the nasal ridge area and chin area of ​​the patient's face.

[0289] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract the gravitational force F g And blowing force F 充气 (and any frictional force F) f And to keep the sealing structure 3100 correctly positioned. Although positioning and stabilizing force F PSS Possibly exceeding gravity F g And blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS (This is balanced by the reaction force from the patient's head acting on a portion of the patient interface 3000) and still maintaining the sealing structure 3100 in the proper sealing position, but patient comfort may be sacrificed. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some instances, the positioning and stabilizing structure 3300 can be adjustable, such that the positioning and stabilizing force F is adjusted during assembly. PSS Greater than the precise equilibrium gravity F g And blowing force F 充气 The required force is sufficient to hold the patient interface 3000 firmly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, when using the patient interface 3000, the positioning and stabilizing force F required to achieve balance can be determined at various positions of the patient's head. PSS .

[0290] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of destructive forces (such as those from tube resistance or unexpected interference with the patient interface) on the patient interface 3000.

[0291] In one form of this technology, a positioning and stabilizing structure 3300 is provided, configured in a manner consistent with how a patient wears it while sleeping. In one instance, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one instance, the positioning and stabilizing structure 3300 includes at least one strip having a rectangular cross-section. In one instance, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0292] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0293] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a side-lying position, wherein the side area of ​​the patient's head rests on a pillow.

[0294] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a disengaging connection portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. The disengaging connection portion does not resist compression and may be, for example, a flexible or loose band. The disengaging connection portion is constructed and arranged such that when the patient rests their head on the pillow, the presence of the disengaging connection portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0295] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip composed of a laminate consisting of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In another form, the fabric outer layer includes a loop material to engage with a hook material portion.

[0296] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) band. For example, the band can be configured to be tensioned during use and guide forces to create a seal-forming structure that makes sealing contact with a portion of the patient's face. In an example, the band can be configured as a tie.

[0297] In one form of the technology, the positioning and stabilizing structure includes a first frenulum that is configured and arranged such that, in use, at least a portion of its lower edge passes over an auricular base point on the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0298] In one form of this technology suitable for a pure nasal mask or a full face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0299] In one form of this technology suitable for a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to drift away from each other.

[0300] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient when they are sleeping.

[0301] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture transfer through the belt.

[0302] In some forms of this technology, a system is provided comprising 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.

[0303] catheter head cover

[0304] catheter head sleeve

[0305] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of an air circuit 4170 from the RPT device to the patient's airway, for example, through an inflation chamber 3200 and a sealing forming structure 3100. FIG. 3ZIn the illustrated form of the present technology, the positioning and stabilization structure 3300 includes two tubes 3350 for delivering air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to, in use, position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face (e.g., on the top of the patient's head).

[0306] Headband

[0307] In some forms, the positioning and stabilizing structure 3300 may include a headgear comprising at least one strap that can be worn by a patient to help properly orient the sealing structure 3100 against the patient's face (e.g., to limit or prevent leakage).

[0308] As mentioned above, some forms of headgear can be made of fabric materials that can comfortably conform to the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric may include a hardener along a selected length, it can restrict the bending, flexing, and / or stretching of the headgear.

[0309] In some forms, the hood may be at least partially stretchable. For example, the hood may comprise an elastic or similar stretchable material. For instance, the entire hood may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the hood to stretch under tension, which can help provide a sealing force for the seal-forming structure 3100.

[0310] Single with patient interface

[0311] In some forms of this technology, a patient interface 3000 is provided, which includes an inflation chamber 3200, a sealing forming structure 3100, a positioning and stabilizing structure 3300, and an air vent 3400. FIG. 7A to FIG. 12 Some such exemplary patient interfaces 3000 are shown. In these instances, the positioning and stabilizing structure 3300 includes a band 3310 configured to be arranged in use such that the front portion 3316 of the band 3310 is positioned in front of the patient's face.

[0312] Single with configuration

[0313] The 3310 can take different forms. FIG. 7A to FIG. 7C , FIG. 8A to FIG. 8B , FIG. 9A to FIG. 9B and FIG. 11A to FIG. 11D and FIG. 12In the illustrated example, the strap 3310 includes a rear portion configured to engage the rear surface of the patient's head and / or neck to hold the patient interface 3000 in a use position. In these examples, when worn, the strap 3310 wraps around the patient's head and neck. Therefore, the strap 3310 has a front portion 3316 positioned in front of the patient's face and a rear portion positioned on the back of the patient's head and covering the back of the patient's head (e.g., the back of the patient's head and / or neck). This form of strap 3310 also has outer portions 3315 positioned on both sides of the patient's head and covering both sides of the patient's head. The front, rear, and outer portions of the strap 3310 are joined together in a loop when worn. The outer portions 3315 may include narrow portions 3319. The narrow portion 3319 may be formed from a portion of each outer portion 3315, which has a reduced height in the vertical direction compared to the band 3310 near the front portion 3316 and / or near the first end 3312 and the second end 3314. Each narrow portion 3319 may be located between the front portion 3316 and a corresponding one of the first end 3312 and the second end 3314. The narrow portion 3319 may help the band 3310 avoid the ears and / or reduce the volume on both sides of the patient's neck.

[0314] In some instances, such as FIG. 7A to FIG. 12 As shown, the positioning and stabilizing structure 3300 consists of only a single strap 3310. That is, there are no other straps that are part of the positioning and stabilizing structure 3300, and the strap 3310 is capable of independently maintaining the sealing-forming structure 3100 in a therapeutically effective (e.g., sealing) position. Some conventional positioning and stabilizing structures for patient interfaces take the form of a headband, which consists of multiple straps attached together in different directions, as each strap is designed to be positioned on a different part of the patient's head. Such headband assemblies can be complex for patients to place and wear on their heads, especially in the dark and if the patient is fatigued or lacks flexibility. The form of the technique described herein, consisting of a single strap 3310, is simpler and more intuitive for patients to wear because only a single strap needs to be properly handled and oriented. This may encourage patients to use the patient interface and adhere to their therapy prescriptions.

[0315] The belt 3310 may be formed of one or more materials. In some forms where the belt 3310 is formed of multiple materials, these materials may be blended (e.g., woven together) to form a single blend. In other forms where the belt 3310 is formed of multiple materials, the belt may include multiple sections, each formed of a different material, which are joined together to form the belt 3310.

[0316] refer to FIG. 7A to FIG. 7C and FIG. 8A to FIG. 8BFor example, the band 3310 may include a fastening portion 3332 at one end of the band, which is configured to attach to another portion of the band to secure the band around the patient's head. In some forms of this technology, the band 3310 includes a first end 3312 and a second end 3314. The first end 3312 and the second end 3314 are separated by the length of the band. The first end 3312 may be configured to be secured to the second end 3314 to form a loop and may include the fastening portion 3332. In some forms, a hook-and-loop material may be used to secure the first end 3312 to the second end 3314. For example, a first hook-and-loop material segment (which may be a hook or loop segment) may be provided to the first end 3312, and a second hook-and-loop material segment (which is another of the hook or loop segments) may be provided to the second end 3312 on the other side of the band 3310. In use, the hook segment may be placed on the side of the band 3310 facing away from the patient to reduce the degree of discomfort experienced by the patient. In other forms, other connectors, such as snaps, domes, clips, etc., can be used to secure the two ends of the strap 3310 together. The strap 3310 with detachable ends can be put on relatively easily by the patient. A hook-and-loop fastening mechanism can also be advantageous because it allows for fine adjustment of the effective length of the strap 3310 to fit the patient's head. In technical forms using other connectors (e.g., snaps, domes, and clips), various connector examples can be provided for the strap 3310 to allow for adjustment of the effective length of the strap 3310.

[0317] In some instances, the fastening portion 3332 may include a hook material configured to attach to a complementary (e.g., loop) material on the surface of the belt 3310. In some instances, the belt 3310 may include fastening portions 3332 at each end of the belt. Each fastening portion 3332 may be configured to connect to another fastening portion 3332. Alternatively, each fastening portion 3332 may be configured to connect to a material forming the belt 3310, such as the outermost layer of the belt 3310. For example, see reference... FIG. 7A to FIG. 7C and FIG. 8A to FIG. 8B The band 3310 includes a fastening portion 3332 at each of the first end 3312 and the second end 3314. More generally, the fastening portion 3332 may be formed of a hook material configured to form a hook-and-loop connection with a surface of the band 3310 at or near the second end 3314, or to form a hook-and-loop connection with another (e.g., complementary) fastening portion 3332 at the second end 3314 (such as a fastening portion 3332 formed of a ring material).

[0318] In other forms of this technology, the band 3310 can be formed as a continuous loop without ends. In this form, it can be worn by pulling the band 3310 down above the top of the head.

[0319] In some instances, such as FIG. 8A and FIG. 8B In the example shown, the front portion 3316 may be located approximately midway between the first end 3312 and the second end 3314. When the band 3310 is worn by a patient, the front portion 3316 may be positioned approximately on the side of the patient's head opposite the area where the first end 3312 and the second end 3314 overlap or are otherwise connected to each other. In some forms, the band 3310 is configured such that, when worn, the front portion 3316 of the band 3310 is positioned over the patient's airway, and the posterior portion of the band 3310 covering the posterior region of the patient's neck includes the first end 3312 and / or the second end 3314. In other forms, the front portion 3316 may be positioned at different locations relative to the circumference of the patient's head. Arranging the band 3310 with its two ends joined together around the back of the head and the front portion 3316 directly in front of the patient may be more intuitive for the patient and also removes the two ends of the band 3310 (which may be more inclined to rub against the skin around the back of the patient's head) from the sensitive areas of the patient's face.

[0320] Inlet connector

[0321] For example, such as FIG. 7B , FIG. 9B , FIG. 11A and FIG. 11B As shown, the band 3310 may include an opening 3202 formed in the front portion 3316 of the band 3310. In use, the opening 3202 can be connected to the inlet connector 4702 (e.g., in...). FIG. 7A , FIG. 8A and FIG. 12 As shown in the diagram, inlet connector 4702 is configured to be fluidly connected to and receive airflow from air circuit 4170. Inlet connector 4702 may be connected to inlet conduit 3610 (e.g., a short tube), which is configured to be fluidly connected to and receive airflow from the conduit of air circuit 4170, which is connected to a respiratory pressure therapy device 4000 that generates airflow in use. Alternatively, inlet connector 4702 may be designed to connect directly to the conduit of air circuit 4170.

[0322] Inlet connector 4702 can form an inlet port 3205 for the inflation chamber, such as FIG. 7A As shown in the diagram. The dimensions and structure of the air chamber inlet port 3205 can be designed to receive an airflow under therapeutic pressure for the patient's breathing. Similarly, as... FIG. 7A , FIG. 8A and FIG. 12As shown, for example, inlet connector 4702 may include a vent 3400. Inlet connector 4702 may include a plurality of holes forming the vent 3400. In other instances, the vent 3400 may be provided separately, for example in the front portion 3316 of band 3310.

[0323] The band that forms the inflation chamber

[0324] In some forms of this technology, such as FIG. 7A to FIG. 7C , FIG. 8A to FIG. 8B , FIG. 9A to FIG. 9B , FIG. 10 and FIG. 11A to FIG. 11B As shown, the front portion 3316 of the band 3310 can be formed to create an air chamber 3200. The front portion 3316 can define the air chamber 3200. For example, the rear surface of the front portion 3316 of the band 3310 can at least partially define the air chamber 3200. It should be understood that even if the air chamber 3200 is partially formed by other parts such as the inlet connector 4702 or even the patient's face, it can be said that the front portion 3316 of the band 3310 defines the air chamber 3200. The band 3310 or at least its front portion 3316 can be configured to be airtight. Alternatively, in some instances, the front portion 3316 can be configured to allow controlled leakage of the material forming the front portion 3316 for the purpose of forming a vent 3400 by the material forming the front portion 3316. A sealing formation structure 3100 can be formed by or provided to the front portion 3316 of the band 3310.

[0325] In these examples, the inflation chamber 3200 can be pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient air pressure, and the inflation chamber 3200 may include an inflation chamber inlet port 3205, which is sized and configured to receive an airflow at the therapeutic pressure for patient breathing. A sealing structure 3100 can be constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway, and may have an opening therein such that an airflow at the therapeutic pressure is delivered to at least one inlet of the patient's nostril. The sealing structure 3100 can be constructed and arranged to maintain the therapeutic pressure in the inflation chamber 3200 throughout the patient's respiratory cycle during use.

[0326] The front portion 3316 can be semi-rigid and / or elastically deformable. In some instances, such as FIG. 7A to FIG. 11B The example shown involves thermoforming the front portion 3316 of the band 3310 into a three-dimensional shape defining an inflation chamber 3200. The front portion 3316 of the band 3310 may include a recessed portion defining the inflation chamber 3200. The front portion 3316 may form a cavity into which the patient's nose and lips can be received.

[0327] In some instances, the sealing structure 3100 may be attached to the front portion 3316. FIG. 7A The sealing structure 3100 in the illustrated example includes a pad 3130 attached to the front portion 3316 of the band 3310, the pad 3130 being configured to sealably engage with the patient's face in use. In this example, the pad 3130 may be formed from foam, an elastomeric material such as silicone or a thermoplastic elastomer, or a gel. FIG. 7A In this example, the sealing structure 3100 includes a foam padding 3130. In this example, both the band 3310 and the sealing structure 3100 are primarily formed of foam and fabric materials, which can provide a patient interface 3000 that can be highly comfortable and resemble pajamas more than a medical device, potentially encouraging patient adherence to therapy. FIG. 7A As shown, the sealing structure 3100 can be shaped to surround the patient's nose and mouth. The sealing structure 3100 can surround the patient's nasal airway and mouth. In other instances, the sealing structure 3100 may only surround the nasal airway. In such instances, the patient interface 3000 may be configured so that the patient's mouth is not covered. In some instances, the sealing structure 3100 may include a membrane configured to sealably engage with the patient's face. This membrane may be C-shaped or sickle-shaped, for example, as known in the art, and may form a pressure-activated seal with the patient's face during use.

[0328] In some instances of this technology, such as FIG. 8A to FIG. 8B In the example shown, the front portion 3316 of the band 3316 can be formed to create a sealing structure 3100 in addition to the air chamber 3200. The front portion 3316 of the band 3310 can be thermoformed to define the air chamber 3200 and form the sealing structure 3100 in a three-dimensional shape. The front portion 3316 of the band 3310 may include a recess defining the air chamber 3200, for example forming a cavity that can receive a patient's nose and lips therein, and may also include a protrusion provided around the periphery of the recess. This protrusion can be configured to engage the patient's face to form the sealing structure 3100. The protrusion can be elastically compressible to provide cushioning, which may be comfortable, and can be made to conform to and adapt to the surface geometry of the patient's face. The band 3310 may be thicker in the protrusion than in the recess, for example, to provide cushioning.

[0329] FIG. 9A to FIG. 9B , FIG. 10 and FIG. 11A to FIG. 11BThe examples shown may have a sealing formation 3100 having any of the configurations described herein. In some examples, the front portion 3316 of the band 3310 may be shaped to form the shape of the sealing formation 3100. In other examples, the band 3310 may include a pad 3130 inserted within a layer of material forming the band 3310. Furthermore, as described above, in another form, the sealing formation 3100 may be attached to the rear-facing / user-facing layer of the band 3310.

[0330] FIG. 12 A further configuration in which the sealing formation 3100 includes a padding module 6100 is shown. The padding module 6100 may be a separate component from the band 3310, which at least partially defines the inflation chamber 3200 and includes the sealing formation 3100. The padding module 6100 can be removed and replaced from the band 3310. The padding module 6100 may be formed from a single material, which may be an elastomeric material such as silicone or TPE, or a foam material. Alternatively, the padding module 6100 may be formed from multiple materials, such as substantially rigid materials, such as polycarbonate, elastomeric materials such as silicone or TPE, and / or foam materials. The band 3310 may cover the padding module 6100 and provide force in use to hold it against the patient's face in a sealed position. The padding module 6100 may include a chassis portion and a sealing membrane attached to the chassis portion. The chassis portion may be stiffer than the membrane (due to material thickness or material selection). The 3310 can cover and contact / engage the chassis portion. The membrane can be rolled inward around the periphery of the patient's airway to form a pressure-activated seal during use.

[0331] With materials / construction

[0332] FIG. 7A to FIG. 7C It shows FIG. 7A to FIG. 7C The exploded view of each layer shown is 3310, and FIG. 7B A schematic cross-sectional view of another example is shown. It should be understood that reference... FIG. 7C or FIG. 7B The described construct or any one or more of its features, properties and variations can be applied to FIG. 9B , FIG. 8A , FIG. 10 , FIG. 11A , FIG. 10 and FIG. 9A to FIG. 9B Any of the 3310 shown.

[0333] like FIG. 7A to FIG. 7CAs shown, the band 3310 may include multiple layers that can be bonded together, for example, during a thermoforming process. The band 3310 may include an inward-facing layer 3361 that can be configured to contact a patient's head during use. In some instances, the inward-facing layer 3361 is formed of a fabric material to provide a soft feel on the patient's face. The band 3310 may also include an elastically compressible inner lining layer 3362. FIG. 8A to FIG. 8B In the example shown, the inner lining layer 3362 is formed of foam.

[0334] Depending on the specific circumstances, the inner liner layer 3362 may include a varying thickness that forms the shape of the sealing structure 3100 or a portion of the band 3310 to which the sealing structure 3100 is attached. Some or all of the other layers may include a uniform thickness.

[0335] In some instances, the band 3310 includes a support member 3320. This support member 3320 may be semi-rigid (e.g., elastically deformable but sufficiently stiff to reinforce the band 3310 or at least its front portion 3316). In some instances, the support member 3320 may be provided only for the front portion 3316 and may have sufficient stiffness to reinforce the shape of the inflation chamber 3200 and / or the sealing forming structure 3100. The support member 3320 may be in the form of a sheet, for example, formed of a plastic material. The support member 3320 may form a semi-rigid layer of the band 3310. In some instances, the band 3310 may include multiple support members 3320, or the support member 3320 may be divided into two parts, such as an upper part and a lower part.

[0336] exist FIG. 11A to FIG. 11B In the illustrated example, the belt 3310 includes a substantially non-stretchable layer 3365 that can be formed from webbing. In some examples, the substantially non-stretchable layer 3365 may include a pair of high-strength portions 3366 disposed adjacent to the central region 3316 on each side of the central region 3316. In some examples, the high-strength portions 3366 may be disposed at or near the lower edge of the belt 3310. The high-strength portions 3366 may be formed from high-strength webbing and may have a higher strength than the adjacent portions of the substantially non-stretchable layer 3365. The substantially non-stretchable layer 3365 and, to a greater extent, the high-strength portions can stiffen the belt 3310, which can advantageously provide good stability in use. In other examples, such as FIG. 10 In the example shown, layer 3310 may not include layer 3365, which is essentially non-extendable.

[0337] The band 3310 may also include an elastically compressible outer padding layer 3363. The outer padding layer 3363 may be formed of foam. Additionally, the band 3310 may also include an outward-facing layer 3364 configured to face away from the patient's head during use and to define the outer surface of the band 3310. The outward-facing layer 3364 may be formed of a fabric material that advantageously provides an aesthetically pleasing patient interface 3000 and may have the appearance of pajamas rather than a medical device, which can help patient adherence to treatment.

[0338] At least some of the layers of the band 3310 forming the air chamber 3200 and the sealing structure 3100 (e.g., in the front portion 3316) may be airtight to maintain treatment pressure in the air chamber 3200. In some instances, all layers are airtight. In some instances, the inward-facing layer 3361, the inner liner layer 3362, the support member 3320, the substantially non-extensible layer 3365, and the outer liner layer 3363 may be airtight together. In other instances, the band 3310 may not be airtight in one or more areas, and instead, controlled leakage may be permitted to provide vents 3400 through the material forming the band 3310.

[0339] like FIG. 11A to FIG. 11D As shown, the strap 3310 in this example includes a fastening portion 3332 at one end of the strap 3310, which is configured to attach to another portion of the strap 3310 to secure the strap 3310 around the patient's head. In this example, the fastening portion 3332 includes a hook material configured to attach to a loop material on the surface of the strap 3310. In other examples, the two ends of the strap 3310 may be connected to each other by a buckle, by a magnetic connection, or by another suitable connection.

[0340] In some instances, the strip 3310 can be cut into its final shape (e.g., contour) using a cutting process that both cuts out the final shape of the strip 3310 and bonds the layers of the strip 3310 together at its edges. In one instance, the cutting process can be RF cutting, but other suitable cutting processes for cutting fabrics and foam materials can also be used. In some instances, the cutting process can be performed after the front portion 3316 of the strip 3310 has been thermoformed. In such instances, the cutting process can be a 3D RF cutting process, since the shape of the front portion 3316 of the strip 3310 will be three-dimensional.

[0341] Thermoformed parts and non-thermoformed parts

[0342] As described elsewhere in this document, the front portion 3316 of the band 3310 can be thermoformed into a three-dimensional shape to form the air chamber 3200.

[0343] In some instances, other portions of strip 3310 are also thermoformed (or alternatively). Other portions may be largely non-thermoformable. For example, a large portion of some sections may be non-thermoformable. In some strip sections, only localized areas may be thermoformable.

[0344] In some instances, such as FIG. 11C In the example shown, the strip 3310 includes an outer portion 3315 on either side of the front portion 3316. In this example, the outer portion 3315 is substantially flat, at least in a static state. It should be understood that if the strip portion is formed of sheet material and does not have a predetermined curved shape, the strip portion is flat. For example, a flat strip portion will lie flat on a stationary table. Other examples of this technology, such as... FIG. 11C , FIG. 11A and FIG. 11B The example shown also includes an outer portion 3315. In the example, the outer portion 3315 on either side of the front portion 3316 may be flat or may have some inherent three-dimensional curved shape, but for comfort, the outer portions 3315 are preferably soft and flexible, and so that they generally do not transmit unwanted destructive forces to the front portion 3316 of the band 3310.

[0345] In some instances, such as FIG. 11A to FIG. 11D In the example shown, the belt 3310 includes a thermoformed hinge portion 3318 between a front portion 3316 and an outer portion of the belt 3310. In this example, the thermoformed hinge portion 3318 includes a recessed portion of the belt 3310. Specifically, the recessed portion includes a series of recessed lines or channels forming one or more functional hinges. The hinge portion 3318 can cause the belt 3310 to bend along a predetermined line or axis, which can be defined by the length of the hinge portion 3318. That is, if the belt 3310 is subjected to a force that causes bending, the hinge portion 3318 can cause the belt 3310 to bend along the predetermined line or axis defined by the hinge portion 3318, for example by being more flexible than other portions of the belt 3310 and / or by resisting bending in a direction perpendicular to the length of the hinge portion 3318. Although the hinge portion 3318 has a... FIG. 11D The patient interface 3000, which is of a similar type to the one shown, is illustrated, but the hinge portion 3318 can also be applied. FIG. 11C , FIG. 11C or FIG. 3ZAny patient interface 3000 shown. Typically, in some instances, the band 3310 of the patient interface 3000 may include a hinge portion 3318 formed by a thermoformed portion of the band 3310, the hinge portion 3318 being structured to allow a portion of the band 3310 on a first side of the hinge portion 3318 to pivot about the hinge portion 3318 relative to a portion of the band 3310 on a second side of the hinge portion 3318. In some instances, the hinge portion 3318 may be formed from multiple thermoformed lines to create multiple possible lines or axes that can cause the band 3310 to bend about these multiple possible lines or axes. In some instances, the band 3310 may include multiple hinge portions 3318, such as one hinge portion 3318 on each outer side of the band 3310 (e.g., in a...). FIG. 3A (Next to the front part 3316), or such as two or more hinged parts 3318 on each outer side of the band 3310.

[0346] In some instances, the band 3310 may include additional thermoformed portions. (See reference) FIG. 5A In some instances, each fastening portion 3332 includes multiple thermoformed indexing portions. The indexing portions can assist the patient in adjusting the patient interface 3000 by forming tactile guides or by using the assist strap 3310 to maintain a specific adjustment state during and after adjustment. For example, the thermoformed indexing portions can be protruding or recessed. In some instances, each fastening portion 3332 may include at least one protruding indexing portion 3334 and at least one recessed indexing portion 3335. These are, for example, in... FIG. 5A As shown in the figure, FIG. 5B It shows FIG. 6 and Humidity The fastening portion of the first end 3312 of the band 3310 is shown in the figure. In some instances, one or more recessed indexing portions 3335 may include hook material attached thereto and configured to form a hook-and-loop connection with at least one protruding indexing portion 3334.

[0347] exist FIG. 3B to FIG. 3F In the example shown, each of the first end 3312 and the second end 3314 passes through the hook and loop 3333 and is secured back to itself, rather than each end of the strap 3310 being directly connected to the other end via a hook and loop connection. FIG. 3B to FIG. 3F The buckle 3333 is shown in isolation. More or fewer of each end 3312 and 3314 of the strap 3310 can be pulled through the buckle 3333 to adjust the effective length (e.g., circumference) of the strap 3310. In this example. In this particular example, refer to FIG. 3BThe recessed indexing portion 3335 includes hook material fixed thereto. The hook material can fill the recessed indexing portion 3335. The recess allows the hook material to be flush with the tape 3310, thereby reducing volume. Similarly... FIG. 3C As shown, the band 3310 includes five protruding indexing portions 3334 (in other instances, any number may be present). Recessed indexing portions 3335 can be attached to the protruding indexing portions 3334 after passing through the hook 3333. The protruding indexing portions 3334 may include loop material or have loop material provided thereto. In some instances, the outer layer of the band 3310 may effectively be a loop material formed of fabric material. The five protruding indexing portions 3334 guide the patient to attach the recessed indexing portions 3335 (and the hook material provided thereto) to a range of possible locations. For example, the patient may be guided to attach two recessed indexing portions 3335 to the first two, second two, third two, or fourth two protruding indexing portions 3334 to provide four predetermined configurations / sizes of the band 3310. In other instances, only the protruding indexing portions 3334 or only the recessed indexing portions 3335 may be present.

[0348] Vent

[0349] In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gas (e.g., carbon dioxide).

[0350] In some configurations, the airway 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The airway 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure within the inflation chamber during use.

[0351] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0352] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disengaged structure, such as a rotating shaft.

[0353] Disconnection structure

[0354] In one form, the patient interface 3000 includes at least one disconnection structure, such as a swivel or a ball socket.

[0355] Connection port

[0356] Connection port 3600 allows connection to air circuit 4170.

[0357] Forehead support

[0358] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0359] Anti-suffocation valve

[0360] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0361] port

[0362] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0363] Modular

[0364] Components of the patient interface 3000 (such as the padding modules or components of the positioning and stabilization structure 3300, such as headbands) may have different sizes or styles, which may correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). For example, patients or clinicians may select certain combinations of padding modules and headbands to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of this type of modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, which is incorporated herein by reference in its entirety.

[0365] In some forms, different styles of patient interface components can be used interchangeably to create different styles of patient interfaces. From a manufacturing perspective, this can be advantageous because fewer components can be used to create a greater variety of patient interfaces. Additionally or alternatively, various combinations can allow patients to change the style of their patient interface without altering each component.

[0366] Air can be delivered to the patient in one of two main ways. In one instance, the patient can be delivered via a head cannula 3350 (see example...). FIG. 3C This receives a pressurized airflow. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In other instances, the patient can be connected via a catheter to the inflation chamber 3200 (e.g., via connection port 3600 (see example)). FIG. 3BThis receives a pressurized airflow. This can be referred to as a "tube-down" configuration, where the airflow duct is positioned in front of the patient's face. Different patients may find one style of air delivery more comfortable than another (e.g., due to the patient's sleeping posture). Therefore, it may be beneficial to allow the use of a single style of patient interface in either a "tube-up" or "tube-down" configuration.

[0367] The Patient Interface 3000 can be part of a modular assembly with various interchangeable parts that patients and / or clinicians can swap out for one or more different styles of components.

[0368] RPT device

[0369] According to one aspect of the present technology, the RPT device 4000 includes mechanical, pneumatic, and / or electronic 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, such as for treating one or more respiratory conditions described elsewhere in this document.

[0370] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0371] air circuit

[0372] According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) during use.

[0373] Specifically, the air circuit 4170 may be in fluid connection with the outlet and patient interface of the pneumatic block 4020. This air circuit may be referred to as an air delivery tube. In some cases, separate branches of the circuit may exist for inhalation and exhalation. In other cases, a single branch is used.

[0374] In some forms, 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 loop and may include one or more transducers, such as temperature sensors. In one form, the heating wire loop may be helically wound around an axis of air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0375] humidifier

[0376] Humidifier Overview

[0377] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). FIG. 3D As shown), to change the absolute humidity of the air or gas intended for delivery to the patient relative to ambient air. Typically, a 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.

[0378] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as FIG. 3E and FIG. 3F 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 accommodate the humidifier reservoir 5110 and includes a heating element 5240.

[0379] respiratory waveform

[0380] FIG. 3F This diagram shows a typical respiratory waveform of a person sleeping. The horizontal axis represents time, and the vertical axis represents respiratory flow. (Respiratory therapy mode)

[0381] Various breathing therapy modalities can be implemented through publicly available breathing therapy systems.

[0382] Glossary

[0383] For the purposes of this 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.

[0384] General Concepts

[0385] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0386] Environment: In some forms of this technology, the term environment will be considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0387] For example, the environment relative to a humidifier FIG. 3E This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This ambient humidity can differ from the humidity outside the patient's bedroom.

[0388] In another instance, environmental stress can be stress that is either close to the body or outside the body.

[0389] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated, for example, by the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0390] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum (e.g., varying with each breath) depending on the presence of an indication of an SDB event.

[0391] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be a nearly constant respiratory pressure throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In other forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0392] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0393] Leakage: The term "leakage" will be considered as an unintended flow of air. In one instance, a leak may occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak may occur in a swivel bend leading to the environment.

[0394] Patient: A person, regardless of whether they have a respiratory illness.

[0395] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And hectopascals. 1 cmH2O equals 1 gf / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0396] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0397] Materials and their properties

[0398] Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., as measured according to ASTM D2240).

[0399] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0400] "Hard" materials can include polycarbonate, polypropylene, and can be, for example, not easily deformed under finger pressure.

[0401] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or compression-molded 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.

[0402] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0403] Mechanics

[0404] axis:

[0405] Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0406] Longitudinal axis: An axis that extends along the length of the shape. This axis typically passes through the center of the shape.

[0407] Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0408] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This can include stretching or compression, bending, and twisting.

[0409] Elasticity: The ability of a material to return to its original geometry after deformation.

[0410] Soft structures or components: Structures or components that will change shape (e.g., bend) when made to support their own weight for a relatively short period of time, such as 1 second.

[0411] Resilience: The ability of a material to absorb energy when it deforms elastically and to release energy when it is unloaded.

[0412] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0413] 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 this use is establishing and maintaining a seal between the patient interface and the patient's airway inlet, for example, under loads of approximately 20 cmH2O to 30 cmH2O.

[0414] 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.

[0415] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.

[0416] Viscosity: The ability of a material to resist flow.

[0417] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0418] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0419] Structural components

[0420] Compression component: A structural element that resists compressive forces.

[0421] A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have a generally circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a disposable snap-fit, but cannot be removed by the patient.

[0422] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points with the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0423] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0424] Lacing (noun): A structure designed to resist tension.

[0425] Thin structure:

[0426] Liang,

[0427] Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0428] membrane,

[0429] It is relatively long in two dimensions and relatively thin in one dimension. It deforms easily in response to bending forces. It resists tension (and may also resist compression).

[0430] Plates and shells

[0431] They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0432] Thick structure: solid

[0433] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve "sealing" between them without requiring a separate "sealing" element itself.

[0434] Shell: A shell is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive 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.

[0435] Reinforcement: Reinforcement is considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0436] Column: A column is considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0437] Rotary shaft (noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis, 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 conduits, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. In use, little or no airflow leaks from the rotary shaft.

[0438] anatomy

[0439] Facial Anatomy

[0440] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0441] Alar angle: The angle formed between the alae of each nostril.

[0442] Alar tip: the outermost point on the ala of the nose.

[0443] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0444] Auricle: The entire visible external part of the ear.

[0445] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0446] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0447] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0448] Columellar angle: The angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the Frankfurt horizontal plane and intersecting the subnasal point.

[0449] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0450] The glabella is the most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0451] Lateral nasal cartilage: a roughly triangular cartilaginous plate. 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.

[0452] Lower lip (midpoint of the lower lip): The lip that extends between the point below the nose and the mouth.

[0453] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental muscle.

[0454] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane, which contains three or four small cartilages of the alar.

[0455] Nares / Nostrils: Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nostrils are separated by the nasal septum.

[0456] Nasolabial folds or nasolabial grooves: 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.

[0457] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the subnasal point).

[0458] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0459] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0460] 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.

[0461] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0462] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0463] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0464] Sagittal plane: A vertical plane running from the front (anterior part) to the back (posterior part). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0465] The bridge of the nose point: located on the soft tissue, the most concave point covering the nasolabial fold area.

[0466] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0467] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0468] The subnasal point is located on the soft tissue at the junction of the columella and the upper lip in the midsagittal plane.

[0469] Supramental point: The point with the greatest concavity located on the midline of the lower lip, between the midpoint of the lower lip and the premental point of the soft tissue.

[0470] Skull Anatomy

[0471] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0472] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0473] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla protrudes upward from one side of the nose and forms part of its lateral boundary.

[0474] Nasal bones: The nasal bones are two small rectangular bones whose size and shape vary from individual to individual; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their intersection.

[0475] Nasal root: The indentation between the frontal bone and the two nasal bones, located directly between the eyes and above the bridge of the nose.

[0476] Occipital bone: The occipital bone is located in the dorsal and lower parts of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0477] The eye socket is the bony cavity in the skull that houses the eyeball.

[0478] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0479] 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.

[0480] Cheekbones: The face consists of two cheekbones, which are located on the upper and outer parts of the face and form the protrusions of the cheeks.

[0481] Patient Interface

[0482] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of a patient rebreathing excessive CO2 by opening to the atmosphere in a safe manner.

[0483] Headgear: Headgear is considered to refer to a form of positioning and stabilizing structure designed to hold a device (such as a mask) on the head.

[0484] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized to above atmospheric pressure. A shell may form part of the wall of the mask inflation chamber.

[0485] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve "sealing" between them without requiring a separate "sealing" element itself.

[0486] Ventilation port: (noun): A structure that allows air to flow from the inside of a mask or conduit into ambient air for clinically effective flushing of exhaled gases. For example, depending on the mask design and treatment pressure, clinically effective flushing can involve a flow rate from approximately 10 liters per minute to approximately 100 liters per minute.

[0487] The shape of the structure

[0488] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask liners or impellers. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe associated surface orientation, location, function, or some other characteristic. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contact (e.g., external) surface and separate non-face-contact (e.g., underside or inner) surfaces. In yet another example, the structure may include a first surface and a second surface.

[0489] To facilitate the description of the shape of the three-dimensional structure and surface, we first consider the cross-section through the surface of the structure at point p. See [link to documentation]. FIG. 3B to FIG. 3F The diagram illustrates an example of a cross-section at point p on the surface, and the resulting planar curve. FIG. 3B to FIG. 3F The diagram also illustrates the outward normal vector at point p. The outward normal vector at p points away from the surface. In some instances, we describe the surface from the perspective of an imaginary tiny person standing upright on it.

[0490] One-dimensional curvature

[0491] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and magnitude (e.g., 1 / radius of the circle that just touches the curve at p).

[0492] Positive curvature: If the curve at point p turns towards the outward normal, then the curvature at that point will be taken as positive (if the imaginary figures leave point p, they must walk uphill). See also FIG. 3B (and FIG. 3F Compared to a relatively large positive curvature) and FIG. 3B (and FIG. 3F (Compared to a relatively small positive curvature). Such curves are often referred to as concave curves.

[0493] 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 FIG. 3I .

[0494] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if the figures in the image were to leave point p, they would have to go downhill). See also FIG. 3L (and FIG. 3M Compared to a relatively small negative curvature) and FIG. 3N (and FIG. 3K (Compared to a relatively large negative curvature). Such curves are usually called convex curves.

[0495] Curvature of a two-dimensional surface

[0496] The description of the shape at a given point on a two-dimensional surface according to this technique may include multiple normal cross sections. These cross sections may cut 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, for example, a relatively small magnitude. ​ A planar curve in a plane can be an instance of multiple cross-sections at a specific point.

[0497] 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. ​ In the example, the maximum curvature occurs ​ In the middle, and the minimum curvature appears ​ Therefore ​ and ​ It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0498] Surface region: A set of connection points on a surface. The points in this region may have similar characteristics, such as curvature or sign.

[0499] Saddle-shaped zone: The zone where the principal curvature has opposite signs at each point, i.e., one is positive and the other is negative (depending on the direction the imagined person is turning, they can be going uphill or downhill).

[0500] Vault region: The region where the principal curvature has the same sign at each point, such as both being positive ("recessed vault") or both being negative ("convex vault").

[0501] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0502] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0503] Edge of a surface: the boundary or limit of a surface or area.

[0504] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imagined person is the place where they walk on the surface, and is similar to a garden path).

[0505] Path length: In some forms of this technique, "path length" will be considered to mean 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 person would be the distance they must walk along the path on the surface).

[0506] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar surface, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For the imaginary reader, straight-line distance will correspond to the distance "in a straight line".)

[0507] hole

[0508] 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 example. ​ The structure shown has a one-dimensional hole defined by a planar curve on its surface.

[0509] 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 example ​ padding and ​ and ​ An example cross-section through the liner is shown, indicating the inner surface defining the two-dimensional orifice. In yet another example, the 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 Through ​ The structure shown has a two-dimensional hole defined by the surface shown.

[0510] Other notes

[0511] This patent document contains a portion of copyrighted material. The copyright holder does not object to anyone faxing or copying the patent document or patent disclosure appearing in the patent office's patent files or records, but otherwise reserves all copyright.

[0512] Unless the context explicitly specifies otherwise and where a range of values ​​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 said or intermediate value within the range, are included in this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also included in this technique, but are subject to any explicit exclusions within the range. Where the range includes one or two limitations, the range excluding any one or both of those included limitations is also included in this technique.

[0513] Furthermore, where one or more values ​​are stated herein as part of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation may allow or require.

[0514] Furthermore, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5-10% of the stated value.

[0515] 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. While 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 exemplary methods and materials are described herein.

[0516] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein should be understood as being capable of being manufactured, and therefore can be manufactured together or separately.

[0517] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0518] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to any prior disclosure by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0519] The terms “comprises” and “comprising” should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the mentioned element, component, or step may be present, used, or combined with other elements, components, or steps not explicitly mentioned.

[0520] The headings used in the detailed embodiments are included for convenience of the reader only and should not be used to limit the subject matter throughout this disclosure or the claims. These headings should not be used to interpret the scope or limit of the claims.

[0521] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details not required for the practice of the techniques. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or that aspects thereof can be performed simultaneously or even concurrently.

[0522] Therefore, it should be understood that many modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A patient interface for treating sleep-disordered breathing, the patient interface comprising: An inflation chamber capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for the patient to breathe; A sealing structure is configured and arranged to form a seal with an inlet of the patient's face surrounding the patient's airway, the sealing structure having an opening therein such that the airflow under the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber during use throughout the patient's respiratory cycle; A positioning and stabilizing structure configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a band configured to be arranged in use such that the front portion of the band is positioned in front of the patient's face in use. A ventilation port that allows the patient's exhaled air to flow continuously from the interior of the inflation chamber into the environment, the ventilation port being configured to maintain the treatment pressure within the inflation chamber during use; The front portion of the belt is shaped to form the air chamber; The sealing structure is formed by or provided to the front portion of the belt.

2. The patient interface of claim 1, wherein the front portion of the band is thermoformed to define a three-dimensional shape defining the inflation chamber.

3. The patient interface of claim 2, wherein the front portion of the band includes a recessed portion defining the inflation chamber.

4. The patient interface according to claim 1 or claim 2, wherein the sealing structure is attached to the front portion of the strip.

5. The patient interface according to claim 1 or claim 2, wherein the sealing structure includes a pad attached to the front portion of the band, the pad being configured to sealably engage the patient's face in use.

6. The patient interface of claim 5, wherein the pad is formed of foam.

7. The patient interface of claim 1, wherein the front portion of the band is shaped to form the sealing structure.

8. The patient interface of claim 7, wherein the front portion of the band is thermoformed to define the air chamber and form the sealing structure in a three-dimensional shape.

9. The patient interface of claim 8, wherein the front portion of the band includes a recessed portion defining the inflation chamber and a protruding portion provided around the periphery of the recessed portion, the protruding portion being configured to engage the patient's face to form the sealing structure.

10. The patient interface of claim 9, wherein the band is thicker in the raised portion than in the recessed portion.

11. The patient interface according to claim 1 or claim 2, wherein the band comprises multiple layers.

12. The patient interface of claim 11, wherein the band includes an inward-facing layer configured to contact the patient's head in use and is formed of a fabric material.

13. The patient interface of claim 11, wherein the band includes an elastically compressible inner liner layer.

14. The patient interface of claim 13, wherein the inner lining layer is formed of foam.

15. The patient interface of claim 13, wherein the inner liner layer comprises a thickness varying with the shape forming the sealing structure or a portion of the band to which the sealing structure is attached.

16. The patient interface of claim 11, wherein the band includes a semi-rigid support member.

17. The patient interface of claim 11, wherein the strip comprises a substantially non-stretchable layer.

18. The patient interface of claim 17, wherein the substantially non-stretchable layer comprises a pair of high-strength portions disposed adjacent to the front portion on each side of the front portion and having a higher strength than the adjacent portions of the substantially non-stretchable layer.

19. The patient interface of claim 18, wherein the high-strength portion is disposed at or near the lower edge of the band.

20. The patient interface of claim 11, wherein the band includes an elastically compressible outer liner layer.

21. The patient interface of claim 20, wherein the outer liner layer is formed of foam.

22. The patient interface of claim 21, wherein the band includes an outward-facing layer configured to face away from the patient's head in use and is formed of a fabric material.

23. The patient interface according to claim 1 or claim 2, wherein the band includes an outer portion on either side of the front portion, the outer portion being substantially flat at least when at rest.

24. The patient interface of claim 23, wherein the band includes a thermoformed hinge portion between the front portion and the outer portion of the band.

25. The patient interface of claim 1 or claim 2, wherein the strap includes a fastening portion at one end of the strap, the fastening portion being configured to attach to another portion of the strap to secure the strap around the patient's head.

26. The patient interface of claim 25, wherein each fastening portion comprises a plurality of thermoformed indexing portions.

27. The patient interface of claim 26, wherein each fastening portion includes at least one protruding indexing portion and at least one recessed indexing portion.

28. The patient interface of claim 27, wherein the at least one recessed graduation portion includes a hook material attached to the at least one recessed graduation portion and configured to form a hook-and-loop connection with the at least one protruding graduation portion.

29. The patient interface of claim 1 or claim 2, wherein the band includes an opening formed in the front portion of the band, the opening being connected to an inlet connector configured to be fluidly connected to and receive airflow from an air circuit.

30. The patient interface of claim 29, wherein the inlet connector is connected to an inlet catheter configured to be fluidly connected to and receive the airflow from a conduit of the air circuit, the conduit of the air circuit being connected to a respiratory pressure therapy device that generates the airflow in use.

31. The patient interface of claim 29, wherein the inlet connector forms the inlet port of the inflation chamber.

32. The patient interface of claim 29, wherein the inlet connector further includes the vent.

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