Patient interface and CPAP system

Abstract

The utility model relates to a patient interface and a CPAP system. A patient interface comprising: a frame assembly; and a nasal pillow assembly configured to be removably and repeatedly connected to said frame assembly, characterized in that the frame assembly and the nasal pillow assembly form at least a portion of an inflation chamber pressurizable to a therapeutic pressure, the nasal pillow assembly comprising a single piece construction, the seal forming structure comprising a pair of nasal pillows, the seal forming structure includes a first elastomeric material, and the frame connecting structure includes a second elastomeric material, the frame connecting structure including an undercut, the frame connection structure is arranged along the inner surface or inner and outer periphery of the seal forming structure such that the frame connection structure and its undercut are arranged or oriented toward the interior of the nasal pillow assembly forming at least a portion of the inflation chamber, and at least a portion of the nasal pillow assembly is configured to directly contact the upper lip or upper lip of the patient in use.

Description

[0001] This patent document contains 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.

[0002] Cross-references to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 600,198, filed November 17, 2023, which is incorporated herein by reference in its entirety.

[0004] In addition, PCT application number PCT / IB2020 / 053311, filed on April 7, 2020, is incorporated herein by reference in its entirety. Technical Field

[0005] This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. In particular, this technology relates to patient interfaces and CPAP systems. Background Technology

[0006] Human respiratory system and its disorders

[0007] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0008] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to 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 called the respiratory zone. See John B. West's *Physiology of Respiratory Systems*, Lippincott Williams & Wilkins, 2012. Respiratory Physiology 9th edition of "The 9th Edition ...

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

[0010] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA), 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 U.S. Patent No. 4,944,310 (Sullivan).

[0012] 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, causing severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] 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.

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

[0015] Obesity hyperventilation 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.

[0016] 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.

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

[0018] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of 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.

[0020] therapy

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

[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. In some forms, the comfort and effectiveness of these therapies can be improved.

[0025] Treatment System

[0026] These therapies can be provided by treatment systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0027] The treatment system includes a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

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

[0029] Patient Interface

[0030] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the 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.

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

[0036] As a result of these challenges, some masks suffer from one or more of the following drawbacks: obtrusive, unsightly, expensive, poor fit, 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. This is especially true if the mask is worn during sleep.

[0037] 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 not be able to clean it, which could affect patient adherence.

[0038] 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.

[0039] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0040] Sealing Formation Structure

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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. To some extent, there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface; one or both must be fitted to form a seal.

[0045] 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.

[0046] 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.

[0047] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0048] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0049] The following patent applications assigned to ResMed Limited disclose a series of patient interface sealing structure technologies: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0050] 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.

[0051] ResMed Ltd. 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 assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (particularly describing ResMed Ltd.'s SWIFT...) TM (Various aspects of the nose pillow), US Patent Application 2009 / 0044808 (particularly describing ResMed Inc.'s SWIFT) TM (All aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (particularly describing ResMed Ltd. MIRAGE LIBERTY) TM(All aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (particularly describing ResMed Ltd.'s SWIFT) TM (All aspects of the FX nose pillow).

[0052] Positioning and stability

[0053] A sealing structure for a patient interface used in positive air pressure therapy is subjected to stress from air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a tight seal with appropriate portions of the face.

[0054] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0055] 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.

[0056] Respiratory Pressure Therapy (RPT) device

[0057] 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. This airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0058] Pneumatic generators are known in applications such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0059] One example of a specific requirement for certain RPT devices is acoustic noise.

[0060] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0061]

[0062] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat various conditions, including but not limited to NMD, OHS, and COPD.

[0063] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive ventilation in adults and pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes via single- or dual-branch circuits. RPT devices typically include a pressure generator (such as a motor-driven blower or compressed gas reservoir) and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[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. Utility Model Content

[0065] 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.

[0066] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0067] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0068] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0069] Another aspect of this technology relates to a patient interface that may include: an inflatable chamber; a sealing formation structure; and a positioning and stabilizing structure. The patient interface may also include a ventilation structure. The patient interface may be further configured to leave the patient's mouth uncovered, or if the sealing formation structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the environment without a pressurized airflow through the inlet port of the inflatable chamber.

[0070] Another aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing; 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 having at least one opening therein such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostril, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber during use throughout the patient's respiratory cycle; and a positioning and stabilizing structure configured to retain the sealing structure on the patient. The effective treatment location on the head, the positioning and stabilizing structure including a tether constructed and arranged such that at least a portion covers the area above the ear base point on the patient's head during use; and a ventilation structure configured to allow continuous flow of exhaled air from the interior of the inflatable chamber to the environment, the size and shape of the ventilation structure being designed to maintain treatment pressure in the inflatable chamber during use; wherein the patient interface is configured to leave the patient's mouth uncovered, or if the sealing formation is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the environment without pressurized airflow through the inflatable chamber inlet port.

[0071] One aspect of this technology relates to a patient interface including a frame assembly and a pad assembly configured to be removably and reusably attached to the frame assembly. The pad assembly includes a single-piece construction comprising a sealing-forming structure and a frame-connecting structure. The sealing-forming structure is configured and arranged to form a seal with an inlet to the patient's airway surrounding the patient's face. The frame-connecting structure is configured and arranged to removably and reusably attach the pad assembly to the frame assembly. The sealing-forming structure includes a first elastomeric material, and the frame-connecting structure includes a second elastomeric material, wherein the first elastomeric material has a lower Shore A hardness (durometer) or stiffness than the second elastomeric material.

[0072] In this example, each of the first elastomer material and the second elastomer material may include a TPE or a silicone material.

[0073] One aspect of this technology relates to a patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to the inlet of a patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlets of the patient's nostrils. The patient interface includes a frame assembly and a pad assembly configured to be removably and reusably attached to the frame assembly. The frame assembly and the pad assembly form at least a portion of an inflatable chamber pressurizable to a therapeutic pressure. The pad assembly includes a single-piece construction comprising a sealing formation structure and a frame connection structure. The sealing formation structure is configured and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, and the frame connection structure is configured and arranged to removably and reusably attach the pad assembly to the frame assembly. The sealing formation structure includes a first elastomeric material, and the frame connection structure includes a second elastomeric material, wherein the first elastomeric material has a lower Shore A hardness (durometer) or stiffness than the second elastomeric material. The frame connection structure includes an undercut that acts as an interface or retainer adapted to connect to the frame assembly. The frame connection structure is arranged along the inner surface or inner periphery of the sealing forming structure such that the frame connection structure and its undercut are arranged or oriented toward the interior of the liner assembly forming at least a portion of the inflation chamber.

[0074] In one example, the sealing structure may include a nasal pillow pad comprising a pair of nasal pillows configured to provide a pressurized gas flow to the patient's nostrils by forming a seal with the corresponding nostrils of the patient's nose (e.g., by forming a seal against the peripheral area of ​​the patient's nostrils).

[0075] In examples, the sealing structure may include a nasal pad adapted to form a seal against at least the lower side of a patient's nose. In examples, the sealing structure and the frame connection structure may include an overmolded construction to form a single integrated component. In examples, the frame connection structure may include a base mold, and the sealing structure may include an overmolded component disposed to the base mold. In examples, each of the first and second elastomeric materials may include a TPE or silicone material. In examples, the frame connection structure may include one or more mating surfaces configured to engage with the sealing structure. In examples, the first elastomeric material may include a hardness in the range of 30 to 50 Shore A, and the second elastomeric material may include a hardness in the range of 60 to 90 Shore A. In examples, the patient interface may also include a sealing lip disposed to the sealing structure of the first elastomeric material, the sealing lip being configured and arranged to form a seal with the frame assembly. In examples, the frame assembly may be relatively harder than the frame connection structure. In examples, the frame connection structure and its undercut may extend around the entire periphery or inner periphery of the sealing structure.

[0076] Another aspect of this technology relates to a patient interface including a positioning and stabilizing structure to provide force to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes: a first strap comprising an elastic material; a second strap comprising an elastic material; and a buckle configured and arranged to connect the first strap to the second strap and allow length adjustment in addition to the length adjustment provided by the elasticity of the first and second straps.

[0077] Another aspect of this technology relates to a patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to the inlet of the patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlets of the patient's nostrils. The patient interface includes a sealing-forming structure and a positioning and stabilizing structure. The sealing-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway. The positioning and stabilizing structure provides force to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes: a first strap comprising an elastic, textile material; a second strap comprising an elastic, textile material; and a buckle configured and arranged to connect the first strap to the second strap and allow length adjustment in addition to the length adjustment provided by the elasticity of the first and second straps. The first strap includes side strap portions that branch into two back strap portions. The second strap includes side strap portions. The side strap portions of the second strap include ends that are non-adjustably connected to the buckle, and the two back strap portions of the first strap pass through the buckle to adjustably connect the first strap to the buckle and allow length adjustment. The buckle includes a first opening and a pair of second openings, and includes a crossbar separating the first opening from the pair of second openings. Two back strap portions of the first strap pass around the crossbar through the first opening and through each of the second openings to adjustably connect the two back strap portions of the first strap to the buckle. The corresponding side strap portions of the first and second straps are adapted to extend along both sides of the patient's head, and the two back strap portions of the first strap are adapted to extend along the back of the patient's head.

[0078] In the example, in the intermediate, unstretched state, the first strap may be longer than the second strap in its original length. In the example, one of the two back strap portions may be adapted to be positioned above the patient's occipital lobe, while the other of the two back strap portions may be adapted to be positioned below the patient's occipital lobe. In the example, the buckle may include a first end portion and a second end portion, the second end portion being connected to the end of the side strap portion of the second strap, and the first end portion may be bent upwards or angled relative to the second end portion. In the example, each of the pair of second openings may include an angled edge or surface arranged to resist adjustment in use. In the example, when the buckle extends generally parallel to the two back strap portions, the buckle may include a locked position to resist unintentional adjustment due to friction between the two back strap portions and the angled edges or surfaces in the respective second openings, and when the buckle is lifted or pivoted, the buckle may include an unlocked position such that the buckle extends laterally to the two back strap portions to allow adjustment due to reduced friction between the two back strap portions and the angled edges or surfaces in the respective second openings. In this example, the positioning and stabilizing structure may further include a pair of hardener arms, with side strap portions of the first and second straps disposed on each of the pair of hardener arms. In this example, each side strap portion may include a tubular configuration adapted to receive a corresponding one of the hardener arms. In this example, each end of the first strap may include a reinforcing portion, and the second strap may include opposing ends opposite the ends connected to the hook and loop, each of these opposing ends including a reinforcing portion, and each reinforcing portion comprising a material different from that of the first and second straps.

[0079] One aspect of this technology relates to a patient interface that includes a vent designed and arranged to improve the diffusion of airflow in order to minimize noise during use.

[0080] One aspect of this technology relates to a patient interface that includes a vent with a shunt to shunt airflow.

[0081] One aspect of this technology relates to a patient interface including a vent having a diffuser for diffused airflow and a diverter for dividing the airflow into spaced and separate airflow paths around the periphery of the patient interface.

[0082] One aspect of this technology relates to a patient interface for delivering an airflow at a positive pressure relative to ambient air pressure to the inlet of a patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlets of the patient's nostrils. The patient interface includes a sealing formation structure configured and arranged to seal with a region of the patient's face surrounding the inlet of the patient's airway. The sealing formation structure forms at least a portion of an inflatable chamber pressurizable to a therapeutic pressure. The inflatable assembly is configured to provide an airflow to expel exhaled gas from the inflatable chamber into the environment. The inflatable assembly includes: a body including a plurality of orifices extending through the body to allow gas to be expelled from the inflatable chamber into the environment; a diffuser member configured and arranged such that the plurality of orifices are covered by the diffuser member, allowing an airflow through the diffuser member; and a plurality of ribs. The multiple ribs are configured and arranged to support the diffuser in relation to the outlet end of each of the multiple orifices, and to divide the gas flow into spaced and separate flow paths downstream of the diffuser around the periphery of the body.

[0083] In this example, the diffusion member may include filter material. In this example, the plurality of orifices may be arranged in an arc or U-shape. In this example, the plurality of ribs may be arranged along the periphery of the plurality of orifices to support the outer edge of the diffusion member. In this example, the ventilation assembly may also include a spacer disposed to the body, the spacer being arranged along the inner periphery of the plurality of orifices to support the diffusion member. In this example, the patient interface may also include a cap that holds the diffusion member to the body. In this example, the body and the cap may form a diffusion section including a diffusion section inlet and a diffusion section outlet, and the plurality of ribs are disposed within the diffusion section between the diffusion section inlet and the diffusion section outlet to divert the gas flow. In this example, the diffusion section inlet of the diffusion section may be provided by the outlet end of each of the plurality of orifices. In this example, the plurality of ribs and the diffusion member may be disposed within a recessed area of ​​the body, and the diffusion section outlet of the diffusion section may be provided by a gap formed between the periphery of the cap and the recessed area. In this example, the diffusion section outlet may be radially outwardly spaced from the diffusion section inlet. In one example, multiple ribs may be constructed and arranged to divert turbulent kinetic energy at the inlet of the diffusion section into sections toward the outlet of the diffusion section. In another example, multiple ribs may be constructed and arranged to divert turbulent kinetic energy into substantially equal sections. In another example, one or more of the multiple ribs may be disposed to a cover. In another example, one or more of the multiple ribs may comprise a single-piece construction integral with the cover. In another example, each of the multiple ribs may extend in a direction substantially orthogonal to the main surface of the body. In another example, multiple orifices may comprise a first porous ventilation device, and the ventilation assembly may further comprise a second porous ventilation device spaced apart from the first porous ventilation device, the second porous ventilation device comprising multiple orifices extending through the body. In another example, the ventilation assembly may further comprise a second diffusion member configured and arranged to cover the multiple orifices of the second porous ventilation device, and the multiple ribs may comprise ribs configured and arranged to support the second diffusion member. In another example, the patient interface may further comprise a frame assembly, and a sealing forming structure is disposed to the frame assembly. In another example, the body of the ventilation assembly may be provided by the frame assembly. In this example, the frame component may include a connection port adapted for connection to an air delivery duct. In this example, multiple orifices may be configured and arranged to prevent cross-flow. In this example, one or more of multiple ribs may be provided to the body. In this example, one or more of the multiple ribs may include a single-piece construction integral with the body.

[0084] One aspect of this technology relates to a patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to the inlet of a patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlet of the patient's nostrils. The patient interface includes a sealing formation structure and an air vent. The sealing formation structure is configured and arranged to seal with a region of the patient's face surrounding the inlet of the patient's airway. The sealing formation structure forms at least a portion of an inflatable chamber pressurizable to a therapeutic pressure. The air vent is configured to provide a flow of gas to discharge exhaled gas from the inflatable chamber into the environment. The air vent includes a body including a plurality of orifices extending through the body to allow gas to be discharged from the inflatable chamber into the environment. The body includes at least one ridge or rib providing a surface area, and an outlet end of each of the plurality of orifices is arranged along the surface area.

[0085] In one example, the body may include a plurality of ridges or ribs providing spaced-apart surface areas, and the outlet end of each of the plurality of orifices may be arranged along a corresponding one of these spaced-apart surface areas. In another example, the plurality of ridges or ribs may be arranged in a stepped arrangement providing the surface areas. In another example, the spaced-apart surface areas may be generally parallel to each other. In another example, the plurality of orifices may be arranged in rows, and each of these rows may be arranged along a corresponding one of the spaced-apart surface areas. In another example, the plurality of orifices may include a first multi-port ventilation device, and the ventilation port may also include a second multi-port ventilation device spaced apart from the first multi-port ventilation device, the second multi-port ventilation device including the plurality of orifices extending through the body. In another example, the patient interface may also include a frame assembly, and a sealing formation structure may be disposed to the frame assembly. In another example, the body of the ventilation port may be provided by the frame assembly.

[0086] One aspect of this technology relates to a patient interface for delivering a flow of air at positive pressure relative to ambient air pressure to the inlet of a patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlets of the patient's nostrils. The patient interface includes a frame assembly and a nasal pillow assembly configured to be removably and reusably connected to the frame assembly. The frame assembly and the nasal pillow assembly form at least a portion of an inflatable chamber pressurizable to a therapeutic pressure. The nasal pillow assembly includes a single-piece construction comprising a sealing formation structure and a frame connection structure. The sealing formation structure is configured and arranged to seal with a region of the patient's face surrounding the inlet of the patient's airway, and the frame connection structure is configured and arranged to removably and reusably connect the nasal pillow assembly to the frame assembly. The sealing formation structure includes a pair of nasal pillows configured to seal with respective nostrils of the patient's nose. The sealing formation structure includes a first elastomeric material, and the frame connection structure includes a second elastomeric material, wherein the first elastomeric material has a lower Shore A hardness (durometer) or stiffness than the second elastomeric material. The frame connection structure includes an undercut that acts as an interface or retainer adapted to connect to the frame assembly. The frame connection structure is arranged along the inner surface or inner periphery of the sealing structure such that the frame connection structure and its undercut are arranged or oriented toward the interior of the nasal pillow assembly forming at least a portion of the inflation chamber. At least a portion of the nasal pillow assembly is configured to directly contact the patient's upper lip or lip during use.

[0087] In the example, the inflation chamber includes a posterior wall comprising a posterior surface configured and arranged to directly contact the patient's upper lip. In the example, each of the pair of nasal pillows includes a truncated cone configured to form a seal against a peripheral region of the patient's nostril. In the example, each of the pair of nasal pillows includes a double-walled structure comprising an outer wall and an inner wall. In the example, the outer wall is relatively thinner than the inner wall. In the example, the sealing forming structure and the frame connection structure include an overmolded construction to form a single-piece integrated component. In the example, the frame connection structure includes a base mold, and the sealing forming structure includes an overmolded component disposed to the base mold. In the example, each of the first and second elastomeric materials includes a TPE or silicone material. In the example, the frame connection structure includes one or more mating surfaces configured to engage with the sealing forming structure. In the example, the first elastomeric material has a hardness in the range of 30 to 50 Shore A, and the second elastomeric material has a hardness in the range of 60 to 90 Shore A. In this example, the patient interface also includes a sealing lip disposed on a sealing forming structure of a first elastomeric material, the sealing lip being configured and arranged to form a seal with the frame assembly. In this example, the frame assembly is relatively rigid than the frame connection structure. In this example, the frame connection structure and its undercut extend around the entire periphery or inner periphery of the sealing forming structure. In this example, the patient interface also includes positioning and stabilizing structures to provide forces to hold the sealing forming structure in a therapeutically effective position on the patient's head. In this example, the patient interface also includes a liner assembly configured to be removably and repeatedly attached to the frame assembly, wherein the liner assembly includes a nasal pad adapted to form a seal against at least the lower side of the patient's nose, and wherein a selected one of the liner assembly and the nasal pillow assembly is interchangeably attached to the frame assembly.

[0088] One aspect of this technology relates to a patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to the inlet of the patient's airway to improve sleep-disordered breathing while the patient is sleeping. The inlet of the patient's airway includes at least the inlet of the patient's nostrils. The patient interface includes a frame assembly and a nasal pillow assembly configured to be removably and reusably attached to the frame assembly. The frame assembly and the nasal pillow assembly form at least a portion of an inflatable chamber pressurizable to a therapeutic pressure. One or more portions of the inflatable chamber formed by the nasal pillow assembly include reinforcements configured to increase the stiffness or rigidity of the inflatable chamber and / or increase the volume of the inflatable chamber.

[0089] In one example, the reinforcement includes a thickened wall region along one or more portions of the rear and / or front wall of the inflatable chamber formed by the nasal pillow assembly. In another example, the reinforcement includes one or more ribs along the boundary of the thickened wall region. In yet another example, the reinforcement includes a thickened wall region along a portion of the base of the inflatable chamber between the pair of nasal pillows.

[0090] One aspect of this technology relates to a CPAP system for providing a patient with positive pressure gas for respiratory therapy, the CPAP system including an RPT device configured to supply airflow at therapeutic pressure, a patient interface, and an air delivery conduit configured to transfer airflow at therapeutic pressure from the RPT device to the patient interface.

[0091] 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.

[0092] One aspect of this technology is a method for manufacturing equipment.

[0093] 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.

[0094] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0095] 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.

[0096] 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

[0097] The technology is illustrated by way of example and not limitation in the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0098] Treatment System

[0099] Figure 1AA 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.

[0100] Figure 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.

[0101] Figure 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.

[0102] Respiratory system and facial anatomy

[0103] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0104] Figure 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.

[0105] Figure 2C It 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.

[0106] Figure 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.

[0107] Figure 2EThis 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.

[0108] Figure 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.

[0109] Figure 2G A side view showing the surface features of the nose.

[0110] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0111] Figure 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.

[0112] Figure 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.

[0113] Figure 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.

[0114] Figure 2L The frontal lateral view of the nose is shown.

[0115] Patient Interface

[0116] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0117] Figure 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... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0118] Figure 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... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0119] Figure 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.

[0120] Figure 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... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0121] Figure 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... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0122] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The vaulted and saddle-shaped areas are indicated.

[0123] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between 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.

[0124] Figure 3I The diagram shows a surface with a structure containing a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0125] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface definition shown in the diagram. Figure 3I Two-dimensional holes in the structure.

[0126] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. The definition is also shown. Figure 3I The surface of a two-dimensional hole in a structure.

[0127] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0128] Figure 3M It shows crossing Figure 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.

[0129] Figure 3N It shows crossing Figure 3LAnother cross-section of the mask. The inner surface is also indicated.

[0130] Figure 3O The left-hand rule is illustrated.

[0131] Figure 3P The right-hand rule is illustrated.

[0132] Figure 3Q The left ear is shown, including the left ear spiral.

[0133] Figure 3R The right ear is shown, including the right ear spiral.

[0134] Figure 3S A right-handed spiral is shown.

[0135] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0136] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0137] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The orientation of this view is orthogonal to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0138] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V A 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.

[0139] Figure 3X The location shown is for use on the face. Figure 3U The inflation chamber 3200. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 generally coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane generally corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0140] Patient interface based on this technology

[0141] Figure 4 This is a perspective view showing a patient interface on a patient's head, based on an example of this technology.

[0142] Figure 5 This is based on an example of this technology. Figure 4 A perspective view of the patient interface.

[0143] Figure 6 yes Figure 5 The patient interface shown is a side view.

[0144] Figure 7 This is based on an example of this technology. Figure 5 A perspective view of the patient interface, shown with the headband assembly removed.

[0145] Figure 8 yes Figure 7 The patient interface shown is a front view.

[0146] Figure 9 Through Figure 8 The cross-sectional view of line 9-9.

[0147] Figure 10 Through Figure 8 The cross-sectional view of line 10-10.

[0148] Figure 11 yes Figure 10 The enlarged portion of the cross-section shown.

[0149] Figure 12 Through Figure 8 The cross-sectional view of line 12-12.

[0150] Figure 13 yes Figure 12 The enlarged portion of the cross-section shown.

[0151] Figure 14 This is based on an example of this technology. Figure 7 The patient interface shown is a front view, illustrating the airflow path of the ventilation port.

[0152] Figure 15 From Figure 7 The exploded view of the front view of the patient interface shown.

[0153] Figure 16 From Figure 7 Another exploded view of the front view of the patient interface shown.

[0154] Figure 17 From Figure 7The exploded view of the patient interface shown from the rear.

[0155] Figure 18 From Figure 7 The exploded view of the patient interface shown at the bottom.

[0156] Figure 19 yes Figure 7 The patient interface frame component shown is a perspective view of the main body.

[0157] Figure 20 yes Figure 19 The top view of the main body of the frame component shown.

[0158] Figure 21 yes Figure 19 The front view of the main body of the frame component shown.

[0159] Figure 22 yes Figure 21 The enlarged portion of the main body of the frame component shown.

[0160] Figure 23 yes Figure 7 The patient interface frame component shown is a perspective view of the cover.

[0161] Figure 24 yes Figure 23 Top view of the cover of the frame component shown.

[0162] Figure 25 yes Figure 7 A perspective view of the padding assembly of the patient interface shown.

[0163] Figure 26 yes Figure 25 Another perspective view of the liner assembly shown.

[0164] Figure 27 yes Figure 25 Another perspective view of the liner assembly shown.

[0165] Figure 28 yes Figure 25 The top view of the liner assembly shown.

[0166] Figure 29 Through Figure 28 Cross-sectional view of line 29-29.

[0167] Figure 30 yes Figure 29 The enlarged portion of the cross-section shown.

[0168] Figure 31 yes Figure 7 A perspective view of the padding assembly of the patient interface shown.

[0169] Figure 32 yes Figure 31 The front view of the pad assembly shown.

[0170] Figure 33 yes Figure 7 A perspective view of the padding assembly of the patient interface shown.

[0171] Figure 34 yes Figure 33 Another perspective view of the liner assembly shown.

[0172] Figure 35 yes Figure 33 Rear view of the liner assembly shown.

[0173] Figure 36 yes Figure 33 Side view of the liner assembly shown.

[0174] Figure 37 yes Figure 33 The bottom view of the pad assembly shown.

[0175] Figure 38 This is a top view of a padding assembly for a patient interface according to an example of the present technology.

[0176] Figure 39 yes Figure 38 Side view of the padding component.

[0177] Figure 40 This is a top view of a padding assembly for a patient interface according to an example of the present technology.

[0178] Figure 41 yes Figure 40 Side view of the padding component.

[0179] Figure 42 This is a top view of a padding assembly for a patient interface according to an example of the present technology.

[0180] Figure 43 yes Figure 42 Side view of the padding component.

[0181] Figure 44A This illustrates an example according to the present technology. Figure 4 A schematic perspective view of the patient interface headgear components.

[0182] Figure 44B It shows the way Figure 44A The cross section of line 44B-44B.

[0183] Figure 45 This is based on an example of this technology. Figure 4 A top view of the patient interface headgear with components.

[0184] Figure 46 yes Figure 45 The exploded view of the headgear with components.

[0185] Figure 47 yes Figure 45 An enlarged view of the end of the strap portion of the headgear assembly.

[0186] Figure 48 yes Figure 45 A perspective view of the buckle of the headgear with components.

[0187] Figure 49 yes Figure 48 Front view of the clasp.

[0188] Figure 50 yes Figure 48 A top view of the clasp.

[0189] Figure 51 yes Figure 48 Cross-sectional view of the clasp.

[0190] Figure 52 yes Figure 51 The enlarged portion of the cross-section shown.

[0191] Figure 53 and Figure 54 This is a cross-sectional view showing the belt adjustment of a headgear belt assembly according to an example of the present technology.

[0192] Figure 55 This is a side view of a patient interface on a patient's head, shown according to an example of the present technology, with the headband assembly in a first adjusted position.

[0193] Figure 56 This is a side view of a patient interface on a patient's head, shown according to an example of the present technology, with the headband assembly in a second adjusted position.

[0194] Figure 57 This is a perspective view of the cover of a frame component of a patient interface according to an example of the present technology.

[0195] Figure 58 This is a perspective view showing the main body of the framework components of a patient interface according to an example of this technology.

[0196] Figure 59 This is a perspective view of a padding assembly for a patient interface according to an example of the present technology.

[0197] Figure 60 This is a perspective view showing the main body of the framework components of a patient interface according to an example of this technology.

[0198] Figure 61 This is a cross-sectional view showing the alignment features of the body of the padding assembly and frame assembly of a patient interface according to an example of the present technology.

[0199] Figure 62 This is a top view of a padding assembly for a patient interface according to an example of the present technology.

[0200] Figure 63 yes Figure 62 A bottom view of the padding assembly.

[0201] Figure 64 yes Figure 62 A perspective view of the padding component.

[0202] Figure 65 yes Figure 62 Another perspective view of the liner assembly.

[0203] Figure 66 yes Figure 62 Cross-sectional view of the gasket assembly.

[0204] Figure 67 yes Figure 62 Another cross-sectional view of the liner assembly.

[0205] Figure 68 This is a top view of a padding assembly for a patient interface according to an example of the present technology.

[0206] Figure 69 yes Figure 68 A bottom view of the padding assembly.

[0207] Figure 70 yes Figure 68 A perspective view of the padding component.

[0208] Figure 71 yes Figure 68 Another perspective view of the liner assembly.

[0209] Figure 72 This is a perspective view of a padding assembly for a patient interface according to an example of the present technology.

[0210] Figure 73 yes Figure 72 The front view of the pad assembly shown.

[0211] Figure 74 This is based on an example of this technology. Figure 72 A perspective view of the padding assembly that is connected to the body of the frame assembly.

[0212] Figure 75 yes Figure 74An exploded view of the main body of the padding assembly and frame assembly shown.

[0213] Figure 76 This is a perspective view of a patient interface according to another example of the present technology, shown with the headband assembly removed.

[0214] Figure 77 From Figure 76 The exploded view of the front view of the patient interface shown.

[0215] Figure 78 From Figure 76 The exploded view of the patient interface shown from the rear.

[0216] Figure 79 This illustrates an example according to the present technology. Figure 76 The perspective view of the frame components of the patient interface shown.

[0217] Figure 80 yes Figure 79 The front view of the frame components shown.

[0218] Figure 81 yes Figure 79 The top view of the frame components shown.

[0219] Figure 82A yes Figure 79 The enlarged portion of the frame components shown.

[0220] Figure 82B yes Figure 82A The cross-sectional view of the frame component shown.

[0221] Figure 82C yes Figure 79 The patient interface shown is a cross-sectional view.

[0222] Figures 83A to 83D Various views of the fit of the patient interface according to an example of this technology are shown.

[0223] Figure 84A and Figure 84B Various views are shown illustrating the adjustment of the headband assembly of the patient interface according to an example of this technology.

[0224] Figure 85 This is a view showing the removal of the patient interface according to an example of this technology.

[0225] Figure 86A and Figure 86B Various views are shown illustrating the adjustment of the fasteners of the patient interface according to an example of this technology.

[0226] Figure 87This is a perspective view showing a patient interface on a patient's head, based on an example of this technology.

[0227] Figure 88 This is based on an example of this technology. Figure 87 A perspective view of the patient interface.

[0228] Figure 89 yes Figure 88 The patient interface shown is a side view.

[0229] Figure 90 This is based on an example of this technology. Figure 88 A perspective view of the patient interface, shown with the headband assembly removed.

[0230] Figure 91 yes Figure 90 The patient interface shown is a front view.

[0231] Figure 92 Through Figure 91 The cross-sectional view of line 92-92.

[0232] Figure 93 This is based on an example of this technology. Figure 92 A cross-sectional view of the nasal pillow assembly for the patient interface.

[0233] Figure 94 It is similar to Figure 92 A cross-sectional view shows the patient interface as having a nasal pillow assembly according to another example of the present technology.

[0234] Figure 95 This is based on an example of this technology. Figure 94 A cross-sectional view of the nasal pillow assembly for the patient interface.

[0235] Figure 96 This is based on an example of this technology. Figure 94 A cross-sectional view of the patient interface.

[0236] Figure 97 yes Figure 96 The enlarged portion of the cross-section shown.

[0237] Figure 98 From Figure 90 The exploded view of the front view of the patient interface shown.

[0238] Figure 99 From Figure 90 The exploded view of the patient interface shown from the rear.

[0239] Figure 100 yes Figure 90 A perspective view of the nasal pillow assembly for the patient interface shown.

[0240] Figure 101 yes Figure 100 Another perspective view of the nose pillow assembly shown.

[0241] Figure 102 yes Figure 100 The top view of the nose pillow assembly shown.

[0242] Figure 103 This is a partial cross-sectional view showing a portion of a patient interface on a patient's head according to an example of the present technology, shown in the case where the nasal pillow assembly is in contact with the patient's face during use.

[0243] Figure 104 This is a cross-sectional view of a nose pillow assembly according to an example of the present technology.

[0244] Figure 105 This is based on an example of this technology. Figure 104 and Figure 95 A cross-sectional view of the opposite nose pillow assembly.

[0245] Figure 106 This is based on an example of this technology. Figure 104 A cross-sectional view of the nose pillow assembly attached to the frame assembly.

[0246] Figure 107 This is based on an example of this technology. Figure 104 A cross-sectional view of the nose pillow assembly attached to the MPMU frame assembly. Detailed Implementation

[0247] 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.

[0248] 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.

[0249] therapy

[0250] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0251] In some instances of this technique, a positive pressure air supply is provided to the patient’s nasal passages through one or both nostrils.

[0252] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0253] Treatment System

[0254] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000, see, for example, [link to relevant documentation]. Figures 1A to 1C .

[0255] Patient Interface

[0256] Reference Figures 4 to 18 According to one aspect of the present technology, the noninvasive patient interface 3000 includes a frame assembly 3500, a liner assembly 3075 including a sealing forming structure 3100 and a frame connecting structure 3150, and a positioning and stabilizing structure 3300. In some forms, functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing forming structure 3100 is arranged to surround the inlet of the patient's airway to facilitate the supply of positively pressurized air to the airway.

[0257] In the illustrated example, as described in more detail below, the sealing formation 3100 of the pad assembly 3075 includes a nose pad configured to provide pressurized airflow to the patient's nostrils by sealing against at least the lower side of the patient's nose.

[0258] Figures 87 to 103 A non-invasive patient interface 7000 according to another aspect of the present technology is shown. In this example, the patient interface 7000 includes a nasal pillow assembly 7075, wherein a sealing forming structure 7100 includes a pair of nasal pillows 7130 configured to form a seal with the respective nostrils of the patient's nose, for example, by abutting against a peripheral region of the patient's nostrils. The nasal pillow assembly 7075 includes a frame connection structure 7150 designed and arranged to removably and repeatedly connect the nasal pillow assembly 7075 to a frame assembly 3500.

[0259] In the illustrated example, frame assembly 3500 serves as a common or central hub, which is configured to be interchangeably connected in a removable manner to a selected one of pad assembly 3075 and nasal pillow assembly 7075. That is, frame assembly 3500 may be manufactured in a common dimension, and a selected one of pad assembly 3075 and nasal pillow assembly 7075 may be interchangeably attached to a single frame assembly 3500 via connection features of common dimensions. For example, frame connection structure 3150 of pad assembly 3075 and frame connection structure 7150 of nasal pillow assembly 7075 include connection features of common dimensions configured to be attached to the common frame assembly 3500.

[0260] One aspect of this technology relates to a patient interface system comprising more than one sealing structure (i.e., a liner assembly 3075 including a sealing structure 3100 and a nasal pillow assembly 7075 including a sealing structure 7100), each sealing structure corresponding to an alternative sealing configuration. Each of the liner assembly 3075 and the nasal pillow assembly 7075 can be removably and repeatedly connected to a frame assembly 3500, for example, to facilitate cleaning, replacement, and / or replacement of different liner assemblies with different sealing structures.

[0261] That is, depending on the selection of either the pad assembly 3075 or the nasal pillow assembly 7075 connected to the frame assembly 3500, the patient interface system is configured to operate alternately in at least a first configuration and a second configuration. When the pad assembly 3075 is connected to the frame assembly 3500, the patient interface system is configured to operate in the first configuration, which includes a nasal pad configured to seal against at least the lower side of the patient's nose. When the nasal pillow assembly 7075 is connected to the frame assembly 3500, the patient interface system is configured to operate in the second configuration, which includes a pair of nasal pillows 7130 configured to form a seal with the respective nostrils of the patient's nose.

[0262] Furthermore, each of the pad assembly 3075 and the nasal pillow assembly 7075 can be manufactured in multiple sizes, which can be interchangeably attached to a single frame assembly 3500 via connection features of common dimensions. For example, the pad size includes sealing formation structures of different sizes, which have frame connection structures of common dimensions for attachment to the common frame assembly 3500. Therefore, the patient interface system according to an embodiment of the present technology can also include more than one pad assembly 3075 and / or more than one nasal pillow assembly 7075, each of which is configured to correspond to a different range of sizes and / or shapes. For example, the size and shape of the sealing formation structure 3100 and the sealing formation structure 7100 in different embodiments can be different, so each variation can provide an optimal fit for patients with noses and mouths of different shapes and sizes. As described above, the frame connection structure 3150 of the pad assembly 3075 and the frame connection structure 7150 of the nasal pillow assembly 7075 include a connection feature of common dimensions, which is configured to be removably and repeatedly connected to the common frame assembly 3500, for example to replace different pad assemblies and / or to replace different sizes of sealing formation structures.

[0263] In the illustrated example, frame assembly 3500 includes a vent 3400 and a connection port 3600 for connecting to a short tube 4180 of air circuit 4170. Frame assembly 3500 also serves as a central hub, to which liner assembly 3075 or nose pillow assembly 7075, positioning and stabilizing structure 3300, and short tube 4180 are connected, for example, in a removable or more permanent manner. Frame assembly 3500 is configured to allow sealing forces to be transferred from positioning and stabilizing structure 3300 to liner assembly 3075 or nose pillow assembly 7075.

[0264] In one form of this technology, the frame assembly 3500 and the pad assembly 3075 or the nasal pillow assembly 7075 are repeatedly and removably engaged with each other, for example to allow cleaning and / or replacement of the pad assembly 3075 or the nasal pillow assembly 7075. When the frame assembly 3500 and the pad assembly 3075 are engaged, they form an air chamber 3200. Similarly, when the frame assembly 3500 and the nasal pillow assembly 7075 are engaged, they form an air chamber 7200. The air chambers 3200 and 7200 can receive a pressurized gas flow from a short tube 4180 of the air circuit 4170, which can pass through the sealing formations 3100 and 7100 and enter the patient's airway for inhalation.

[0265] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, then the patient interface may not be suitable for respiratory pressure therapy.

[0266] Patient interfaces 3000 and 7000 of one form according to the present technology are constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0267] Patient interfaces 3000 and 7000 of one form according to the present technology are constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0268] Patient interfaces 3000 and 7000 of one form according to the present technology are constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0269] Sealing Formation Structure

[0270] In one form of this technology, the seal-forming structures 3100, 7100 provide a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structures 3100, 7100 where sealing 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 structures, and the shape of the patient's face.

[0271] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100, 7100.

[0272] In some forms of this technology, the sealing structures 3100, 7100 are made of a biocompatible material, such as silicone rubber.

[0273] The sealing structures 3100 and 7100 according to this technology can be made of soft, flexible, and elastic materials (such as silicone resin).

[0274] In some forms of this technology, a system is provided comprising more than one sealing formation structure 3100, 7100, each sealing formation structure 3100, 7100 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, 7100 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.

[0275] Sealing mechanism

[0276] 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 chambers 3200, 7200, to facilitate a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0277] 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.

[0278] 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.

[0279] 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.

[0280] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0281] 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.

[0282] bridge or ridge of the nose

[0283] 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.

[0284] 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.

[0285] upper lip area

[0286] 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.

[0287] 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.

[0288] Chin area

[0289] 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.

[0290] 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.

[0291] Forehead area

[0292] 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.

[0293] nose pillow

[0294] In one form, the sealing structure of the non-invasive patient interface includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0295] 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.

[0296] Figures 87 to 103 A sealing formation structure 7100 of a nasal pillow assembly 7075 (also referred to as a liner assembly 7075) according to an example of the present technology is shown. In the illustrated example, the sealing formation structure 7100 can be considered as a nasal pillow liner including a pair of nasal pillows 7130, which is configured to provide a pressurized gas flow to the patient's nostrils by forming a seal with the respective nostrils of the patient's nose (e.g., by forming a seal against the peripheral area of ​​the patient's nostrils).

[0297] In the illustrated example, each of the pair of nasal pillows 7130 includes a truncated cone 7140 (at least a portion of which abuts against the peripheral region of the patient's nostril to form a seal) and a handle 7145 configured to connect the truncated cone 7140 to an inflation chamber 7200. In this example, each of the nasal pillows 7130 may include an upper flexible region 7142 (on the underside of the truncated cone 7140 and connecting the truncated cone 7140 to the handle 7145) and / or a lower flexible region 7143 (adjacent to the base of the handle 7145 and connecting the handle 7145 to the inflation chamber 7200). The upper flexible region 7142 and / or the lower flexible region 7143 may work together to facilitate a universal joint structure that accommodates relative movement (displacement and angle) between the truncated cone 7140 and the inflation chamber 7200.

[0298] In the illustrated example, such as Figures 92 to 95 As best shown, each of the nasal pillows 7130 comprises a truncated cone 7140 with a double-walled structure, namely, the truncated cone 7140 includes an outer wall or sealing flange 7144 and an inner wall or support flange 7146. The sealing flange 7144 may include a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm. The support flange 7146 may be relatively thicker than the sealing flange 7144. The support flange 7146 is a spring-like element or includes a spring-like element and serves to support the sealing flange 7144 during use and prevent it from buckling. During use, the sealing flange 7144 is readily responsive to system pressure acting on its bottom surface by the inflation chamber 7200, thereby forming a tight seal with the face (e.g., the patient's nostrils).

[0299] In use, the pillow 7130 is placed at the entrance of the nostril so that it engages with the entrance of the patient's airway. When the positioning and stabilizing structure 3300 is adjusted, tension begins to pull the pillow 7130 into the nostril. Continuous insertion of the pillow 7130 into the nostril causes the handle 7145 to collapse through the trampoline base 7131 provided by the inflation chamber 7200, moving the base of the pillow 7130 toward the upper surface of the inflation chamber 7200. The handle 7145 may include a thinned or reduced-thickness portion. The thinned portion allows the pillow 7130 to easily rebound or produce a trampoline effect, and is therefore easier to adjust to fit the patient's nasal angle. The trampoline base 7131 may be angled with the bottom of the pillow 7130 or the patient's septum and / or upper lip. This improves the comfort and stability of the patient interface.

[0300] In one form of this technology, the sealing structure 7100 forms a seal at least partially on the columellar region of the patient's nose.

[0301] As described above, the nasal pillow assembly 7075 can be manufactured in a variety of sizes that are interchangeably attached to the single frame assembly 3500. For example, the nasal pillow assembly 7075 may include two or more different sizes / shapes. For example, the pad assembly may include a small size containing a small-sized sealing formation structure, a medium size containing a medium-sized sealing formation structure, and a large size containing a large-sized sealing formation structure. In examples, each size may include a varying size and / or profile of the sealing formation structure relative to the other sizes to provide alternative sealing formation surfaces for different patients. This has the advantage of allowing the patient to conform to the pillow, the size of which is designed to optimally fit the patient's specific anatomy, such as the size and orientation of the nostrils.

[0302] Further instances and details of the exemplary pillow are described in PCT Publication No. WO 2015 / 070289, which is incorporated herein by reference in its entirety.

[0303] nose pads

[0304] Figures 25 to 37 A sealing structure 3100 according to an example of the present technology is shown. In the illustrated example, the sealing structure 3100 can be considered a nasal pad and is designed to provide a pressurized airflow to the patient's nostrils by sealing against at least the lower side of the patient's nose, see, for example, [reference needed]. Figure 4 , Figure 55 and Figure 56 The exemplary sealing structure 3100 will engage the patient's face below the bridge of the nose, and in some instances, depending on the size and shape of the patient's nose, it may engage the patient's nose below the nasal protuberance. The exemplary sealing structure 3100 will engage the patient's face at least above the vermilion border of the upper lip. Thus, the exemplary sealing structure 3100 can seal against the upper part of the patient's lips during use. Furthermore, the patient's mouth can remain uncovered by the sealing structure 3100 of the depicted example, allowing the patient to breathe freely, i.e., directly into the atmosphere, without being disturbed by the sealing structure 3100.

[0305] An exemplary nasal pad may include an upper saddle-shaped area or recessed area with positive curvature on the pad. Furthermore, the nasal pad can be understood as having a single targeted seal-forming area or surface, whereas a pillow pad may have two targeted seal-forming areas (one for each nostril). The pad may also have a posterior wall that contacts the upper part of the patient's lips, and an upper central surface that contacts the lower side of the patient's nose. These two surfaces on the patient's face may form a nasolabial angle between them (see...). Figure 2E The pad can be shaped to have a nasolabial angle ranging from 90 to 120 degrees.

[0306] Furthermore, the shape and size of the exemplary sealing structure 3100 can also be designed such that no part of the sealing structure 3100 enters the patient's nostrils during use.

[0307] like Figures 33 to 37 As best shown, the exemplary seal-forming structure 3100 may include at least two regions with different thicknesses: an outer support region 3108 and an inner region 3114. In another example, a third region with another different thickness (in addition to the outer support region 3108 and the inner region 3114) may also exist: a middle outer region 3110. In yet another further example, one or more additional regions with different thicknesses (in addition to the outer support region 3108, the middle outer region 3110, and the inner region 3114) may exist. As can be seen in the depicted example, different thicknesses can be created by extending regions of different thicknesses to different distances within the interior of the seal-forming structure 3100, such that the outer surface of the seal-forming structure 3100 remains smooth. At the transition regions between regions of different thicknesses, the outer surface may not be non-uniform. Therefore, the exterior of the exemplary seal-forming structure 3100 is continuous and smooth.

[0308] In the depicted example, a nostril opening 3102 may be formed through an inner region 3114. The nostril opening 3102 is positioned to be substantially aligned with the patient's corresponding nostril to provide a pressurized gas flow to the patient's nostril for inhalation and to pass exhaled gas back into the sealing structure 3100 for exhaust to the atmosphere via the vent 3400. A bridging portion 3104 may also be present within the inner region 3114, positioned between the nostril openings 3102.

[0309] In the examples, the sealing structure 3100 in different examples can have different sizes and shapes, and therefore, each variant can provide an optimal fit for patients with noses and faces of different shapes and sizes.

[0310] In this example, the sealing structure 3100 may include two or more different sizes / shapes. For example, Figures 38 to 39 An exemplary small-size seal-forming structure 3100 is shown. Figures 40 to 41 An exemplary small-scale sealing formation structure 3100 is shown, and Figures 42 to 43 An exemplary medium-sized seal-forming structure 3100 is shown. As illustrated, the size and / or profile of the seal-forming structure can be varied to provide alternative seal-forming surfaces for different patients.

[0311] In an example, one or more thickened portions (e.g., thickened portions of silicone resin) may be provided to one or more regions of the seal-forming structure 3100 to increase support and stability for those regions, for example, to ensure gasket stability and sealing performance. In an example, the one or more thickened portions may be created by increasing the thickness of the seal-forming structure 3100 in one or more regions entering the interior of the seal-forming structure 3100, such that the outer surface of the seal-forming structure 3100 remains continuous and smooth. The one or more thickened portions may include similar or different thicknesses. In an example, the thickness of the thickened portions and / or the specific positioning of the thickened portions along the seal-forming structure 3100 may depend at least in part on the dimensions of the seal-forming structure 3100.

[0312] For example, Figures 62 to 67 An exemplary small-scale sealing structure 3100 is shown, which includes a thickened portion 3120 along the top side (closer to the bridge of the nose) and a thickened portion 3121 along the bottom side (closer to the upper lip), for example, the thickened portions 3120, 3121 of a closely spaced frame connection structure 3150 disposed along the lower side of the sealing structure 3100 in the inner region 3114 of the sealing structure 3100.

[0313] on the contrary, Figures 68 to 71 An exemplary medium-sized sealing structure 3100 is shown, which includes a thickened portion 3122 along the bottom side (closer to the upper lip) of the sealing structure 3100, for example, a thickened portion 3122 disposed along the lower side of the sealing structure 3100 near the frame connection structure 3150 in each of the outer support regions 3108 of the sealing structure 3100. In this example, no additional thickened portion is provided to the medium-sized sealing structure 3100 along the top side (closer to the bridge of the nose).

[0314] However, it should be understood that other instances of thickened portions (e.g., thickness and / or positioning) in one or more areas of the sealing forming structure 3100 are possible.

[0315] Frame connection structure

[0316] like Figures 25 to 30 As shown, the frame connection structure 3150 is designed and arranged to removably and repeatedly connect the gasket assembly 3075 to the frame assembly 3500, for example, to facilitate cleaning, replacement, and / or replacement of different gasket assemblies 3075 with different sizes of the seal forming structure 3100, as described above regarding Figures 38 to 43 As stated above.

[0317] The frame connection structure 3150 includes a sealing connection portion 3160 adapted to connect to the sealing forming structure 3100 and a frame connection portion 3170 adapted to connect to the frame assembly 3500.

[0318] The frame connection structure 3150 can be permanently (e.g., overmolded) or removably (e.g., interference fit assembly) connected to the sealing formation structure 3100.

[0319] In an example, such as Figures 92 to 93 As shown, the frame connection structure 7150 of the nose pillow assembly 7075 is similar to the frame connection structure 3150 of the pad assembly 3075. For example, the frame connection structure 7150 includes an overmolded connection with the sealing forming structure 7100. For example, as described below, Figures 92 to 93 The nose pillow assembly 7075 shown may include dual-hardness silicone components, wherein the frame connection structure 7150 includes a silicone material with higher hardness, and the sealing forming structure 7100 includes a silicone material with lower hardness than the frame connection structure overmolded into the frame connection structure 7150.

[0320] In alternative instances, such as Figures 94 to 97 As shown, the frame connection structure 7150 and the sealing formation structure 7100 can be integrally formed as a single piece from a silicone resin material of the same hardness. For example, Figures 94 to 97 The illustrated nose pillow assembly 7075 may include a silicone component of uniform hardness, wherein the frame connection structure 7150 and the sealing formation structure 7100 comprise a one-piece molded construction made of a silicone material of uniform hardness. In examples, the silicone material includes Shore A hardness greater than 30 Shore A, such as 40 Shore A, 30 to 50 Shore A, and less than 50 Shore A.

[0321] Overmolded construction

[0322] In the illustrated example, the frame connection structures 3150, 7150 and the sealing forming structures 3100, 7100 include an overmolded construction to form a single integrated component.

[0323] For example, frame connection structures 3150, 7150 include a first portion or base mold, and sealing forming structures 3100, 7100 include a second portion or overmolded part disposed (e.g., by overmolding) to the first portion.

[0324] In the examples, the frame connection structures 3150, 7150 comprise a material that is more rigid than the sealing formation structures 3100, 7100. In the examples, the frame connection structures 3150, 7150 and the sealing formation structures 3100, 7100 may comprise similar materials (e.g., thermoplastic elastomers (TPE) or silicone resins), wherein the frame connection structures 3150, 7150 have a higher hardness (e.g., a higher Shore A hardness) than the sealing formation structures 3100, 7100, thereby providing a dual-hardness component.

[0325] In this example, the padding assemblies 3075 and 7075 can be formed by a two-stage injection molding process, in which different materials are injected into the same molding machine to form the padding assemblies 3075 and 7075. For example, in a first step, the molding machine injects a first material into a closed cavity (i.e., the first injection) to shape the frame connection structures 3150 and 7150 (i.e., the first part or base mold). In a second step, the molding machine injects a second material into the remaining space of the closed cavity (i.e., the second injection) to shape the sealing structures 3100 and 7100 (i.e., the second part or overmolded part) as overmolded parts onto the frame connection structures 3150 and 7150. In the example, the frame connection structures 3150, 7150 may include an insert after the first injection, and the molding machine may move the mold core and / or the insert (i.e., the frame connection structures 3150, 7150) to create a second cavity for forming the sealing formation structures 3100, 7100 in the second injection.

[0326] In examples, the sealing structures 3100 and 7100 can be molded onto the frame connection structures 3150 and 7150 by overmolding with a material capable of chemical bonding or self-adhesion to the frame connection structures 3150 and 7150. For example, as Figure 30 As shown, the sealing connection portion 3160 of the frame connection structure 3150 can provide one or more mating surfaces 3615 (e.g., engagement areas) configured to engage with the sealing forming structure 3100. Increasing the engagement area can make this engagement more robust. In an example, the sealing connection portion 3160 can provide a chemical bond without mechanical interlocking. As a result, the connection does not include cracks, hermetic seals, or clean interfaces. It should be understood that the frame connection structure 7150 can be engaged to the sealing forming structure 7100 in a similar manner to that described above.

[0327] As a result, the entire gasket assembly 3075, 7075 may include silicone resin materials with different hardness ranges. In an example, the frame connection structure 3150, 7150 (i.e., the first injection or base mold) may include a silicone resin material with higher hardness (e.g., Shore A hardness greater than 60 Shore A, such as 65 Shore A, 60 to 70 Shore A, 60 to 90 Shore A, up to 70 Shore A, up to 90 Shore A), and the sealing forming structure 3100, 7100 (i.e., the second injection or overmolding part) may include a silicone resin material with lower hardness than the frame connection structure 3150, 7150 (e.g., Shore A hardness greater than 30 Shore A, such as 40 Shore A, 30 to 50 Shore A, less than 50 Shore A).

[0328] In this example, the frame connection structures 3150, 7150 (i.e., the first injection or base mold) may include a higher hardness LSR material, and the sealing forming structures 3100, 7100 (i.e., the second injection or overmolding) may include a lower hardness LSR material. However, it should be understood that other suitable materials may be used.

[0329] The higher-rigidity frame connection structures 3150, 7150 include a more rigid material adapted for connection to the frame assembly 3500. As illustrated, the frame connection portion 3170 of the frame connection structures 3150, 7150 forms a barbed end or undercut 3175, 7175, which acts as an interface or retainer adapted for connection to the frame assembly 3500, see, for example, [reference needed]. Figure 13 , Figure 92 , Figure 94 and Figure 97 The use of silicone materials and the overmolding process for forming the frame connection structures 3150, 7150 allows for demolding of the barbed ends or undercut portions, which allows the gasket assemblies to include smaller dimensions and profiles (e.g., smaller and easier to manufacture than overmolded seals on rigid plastic clips). The use of higher-hardness silicone materials for the frame connection structures 3150, 7150 also offers the advantages of greater strength against physical damage caused by external forces (e.g., different compression resistance compared to rigid plastic clips) and lower manufacturing costs.

[0330] In the illustrated example, frame connection structures 3150, 7150 are arranged along the inner surface or inner periphery of sealing structures 3100, 7100, such that the frame connection structures 3150, 7150 are arranged or oriented toward the interior of the gasket assembly, i.e., the frame connection structures 3150, 7150 protrude inward from the inner surface or inner periphery of sealing structures 3100, 7100 toward the cavity of sealing structures 3100, 7100, which forms at least a portion of the inflation chambers 3200, 7200. This arrangement allows the frame connection structures 3150, 7150 and their undercuts 3175, 7175 to extend over and onto the frame assembly 3500 for attachment.

[0331] In the example, the frame connection structures 3150, 7150 and their undercut portions 3175, 7175 extend around the entire periphery or the entire inner and outer periphery of the sealing forming structures 3100, 7100. In an alternative example, the frame connection structures 3150, 7150 and their undercut portions 3175, 7175 may extend along one or more selected portions of the periphery of the sealing forming structures 3100, 7100, for example, along a portion of the inner and outer periphery of the sealing forming structures 3100, 7100.

[0332] In examples, the frame connection structures 3150, 7150 may provide a profile that forms a smooth and continuous curve along the periphery of the cavities of the sealing structures 3100, 7100; for example, the frame connection structures 3150, 7150 are flush with the sealing structures 3100, 7100. In examples, the length of the frame connection structures 3150, 7150 protruding into the cavities may be the same along the entire periphery of the sealing structures 3100, 7100. It should be understood that in alternative examples, the profile of the frame connection structures 3150, 7150 may vary along one or more portions of the periphery of the sealing structures 3100, 7100. For example, the length of the frame connection structures 3150, 7150 may vary along one or more portions of the periphery of the sealing structures 3100, 7100.

[0333] The lower-hardness sealing structures 3100, 7100 include a softer, more comfortable material adapted to form a seal with the patient's face. Furthermore, sealing lips 3850, 7850 are formed together with the sealing structures 3100, 7100, having a lower-hardness material. As described below, sealing lips 3850, 7850 are arranged along the inner surface or inner periphery of the sealing structures 3100, 7100 and are adapted to form a seal with the frame assembly 3500 (e.g., when the pressure within the inflation chambers 3200, 7200 increases), for example, to prevent leakage, thereby achieving more effective treatment and patient satisfaction.

[0334] In the illustrated example, frame connection structures 3150, 7150 are disposed along the edges of the cavities of sealing structures 3100, 7100, and sealing lips 3850, 7850 are disposed within the cavities of frame connection structures 3150, 7150. The frame connection structures 3150, 7150 and the sealing lips 3850, 7850 form a space between them to accommodate a portion of the frame assembly 3500 for attaching gasket assemblies 3075, 7075 to the frame assembly 3500, as described below.

[0335] In the example, the frame connection structures 3150, 7150 (i.e., the first injection or base mold) may include colors similar to or different from those of the sealing forming structures 3100, 7100 (i.e., the second injection or overmolding), for example, the frame connection structures 3150, 7150 and the sealing forming structures 3100, 7100 may include transparent or substantially transparent colors.

[0336] In the examples, the frame connection structures 3150, 7150 (i.e., the first injection or base mold) may include a surface finish similar to or different from that of the sealing forming structures 3100, 7100 (i.e., the second injection or overmolding). For example, the frame connection structures 3150, 7150 may have a highly polished surface finish, and the sealing forming structures 3100, 7100 may have a textured surface finish.

[0337] Figure 31 and Figure 32 This is an alternative view of the gasket assembly 3075, showing a comparison between the frame connection structure 3150 and the sealing formation structure 3100 according to an example of the present technology.

[0338] Framework components

[0339] like Figures 15 to 24 and Figures 98 to 99 As shown, the frame assembly 3500 includes a body 3510 and a cover 3580 disposed on the front side of the body 3510.

[0340] In this example, the body 3510 and the cover 3580 may be made of a relatively rigid material (e.g., polypropylene, polycarbonate) (e.g., molded).

[0341] The body 3510 includes a body portion 3520, a liner connection portion 3530, and a cover connection portion 3540. Furthermore, as described in more detail below, the body 3510 and the cover 3580 cooperate to form a vent 3400 and cooperate to retain the diffuser 3450 (e.g., filter material) of the vent 3400 within the frame assembly 3500.

[0342] In the illustrated example, each of the pair of hardener arms 3302 of the positioning and stabilizing structure 3300 is connected to a respective side of the body 3510 via a corresponding one of a pair of flexible joints 3305. In this example, the flexible joints 3305 may be permanently connected to the body 3510 and may be permanently connected to the respective hardener arms 3302, for example, by overmolding or interference fit assembly. However, the hardener arms 3302 may be connected to the body 3510 in other suitable ways.

[0343] Cover 3580 includes a front wall 3585 and a tube portion 3590. Tube portion 3590 includes a connection port 3600 for connecting to a short tube 4180 of an air circuit 4170. In this example, cover 3580 may also be referred to as a tube connector.

[0344] In the illustrated example, the short tube 4180 can be directly connected to the connection port 3600 or otherwise configured to the connection port 3600 without using a bend or swivel bend. For example, the short tube 4180 can be directly connected to the front side of the tube portion 3590 of the cover 3580. The short tube 4180 can be permanently or removably connected to the connection port 3600. A permanent connection can be achieved by means of overmolding or interference fit assembly. In an alternative example, the short tube 4180 can be connected to the connection port 3600 via a bend or swivel bend. In yet another example, the air circuit 4170 can be connected (e.g., directly or via a bend) to the connection port 3600 without using the short tube 4180.

[0345] In the illustrated example, the anterior side of the anterior wall 3585 includes a contoured surface that integrates into the anterior side of the tube portion 3590. For example, for aesthetic purposes, the anterior wall and anterior side of the tube portion 3590 provide the anterior side of the patient interfaces 3000, 7000.

[0346] In the illustrated example, the rear side of the tube portion 3590 protrudes from the rear side of the front wall 3585. The cap connection portion 3540 of the body 3510 is in the form of a tube, adapted, for example, to telescopically receive the rear side of the tube portion 3590 to align and connect the cap 3580 to the body 3510. As illustrated, the tube portion 3590 and the cap connection portion 3540 include snap-fit ​​or interference fit components; for example, the rear side of the tube portion 3590 includes a peripheral groove 3595 adapted to engage peripheral beads 3545 along the interior of the cap connection portion 3540 (see, for example, [reference needed]). Figure 13 However, it should be understood that the cover 3580 can be attached to the body 3510 in other suitable ways, for example, in a removable or more permanent manner.

[0347] In the illustrated example, a stop is provided on the rear side of the front wall 3585 to prevent the tube portion 3590 from being over-inserted into the cap connection portion 3540 of the body 3510. Furthermore, in this example, the recessed area 3550 in the front side of the body 3510 includes a plurality of ribs 3560 forming a portion of the vent 3400 along its periphery, and these ribs 3560 can provide steps 3562, which are constructed and arranged to provide a stop at the outer edge of the front wall 3585. These stops maintain the spacing between the front wall 3585 and the sides and bottom of the recessed area 3550, which forms a diffusion section for the vent 3400 including a diffusion member 3450, as discussed in more detail below.

[0348] In an example, the cover 3580 and the body 3510 may each include alignment features to ensure that the cover 3580 and the body 3510 are correctly aligned or oriented for assembly. For example, as Figure 57 and Figure 58 Ideally, the cover 3580 may include a protrusion 3581 (e.g., a convex alignment feature) that is adapted to receive a corresponding recess 3511 (e.g., a concave alignment feature) in the body 3510. However, other suitable alignment features are also possible.

[0349] In this example, frame component 3500 (e.g., see the front wall of body 3510 and cap 3580) includes a curvature designed to follow the natural curvature of the patient's upper lip (e.g., when viewed from above, as...). Figure 20 and Figure 24 As shown in the diagram, this curvature also prevents contact pressure from concentrating on any specific point on the patient's upper lip, allowing the contact pressure from the headgear tension to be evenly distributed across the patient's upper lip, for example, to minimize or eliminate skin breakage caused by prolonged concentrated contact pressure. Another advantage of the curvature is that less material may be required, which reduces the overall weight of the patient interface 3000. The curvature also minimizes any protrusion of the patient interface 3000 from the patient's face in the forward direction, improving the inconspicuousness of the patient interface 3000.

[0350] In this example, the frame assembly 3500 may be made in one size, but the gasket assemblies 3075, 7075 may be made in multiple sizes, which may be attached to a single frame assembly 3500 by connection features having common dimensions. For example, the gasket sizes may include sealing formations of different sizes that have frame connection structures of common dimensions for attachment to a common frame assembly 3500.

[0351] Connection between padding assembly and frame assembly

[0352] In the illustrated example, the frame connection portions 3170, 7170 of the gasket assemblies 3075, 7075 and the gasket connection portion 3530 of the frame assembly 3500 include interference fit components.

[0353] For example, the frame connection portions 3170 and 7170 of the padding assemblies 3075 and 7075 form barbed ends or undercuts 3175 and 7175, and the padding connection portion 3530 of the frame assembly 3500 includes a channel having an undercut 3535 along the rear wall of the channel. Figure 13 and Figure 97 As shown, the barbed ends or undercuts 3175, 7175 of the frame connecting portions 3170, 7170 are designed and arranged to engage above and behind the undercut 3535 of the padding connecting portion 3530 to releasably connect the padding assemblies 3075, 7075 to the frame assembly 3500. In an example, the barbed ends of the frame connecting portions 3170, 7170 and the channels of the frame assembly 3500 form tongues and grooves to removably and repeatedly connect the padding assemblies 3075, 7075 to the frame assembly 3500.

[0354] In the example, the relatively flexible material of the padding assemblies 3075, 7075 allows the frame connection structures 3150, 7150 and their frame connection portions 3170, 7170 to extend over the padding connection portion 3530 until the barbed ends or undercuts 3175, 7175 of the frame connection portions 3170, 7170 can engage or engage with the undercut 3535 of the padding connection portion 3530 (e.g., the frame connection structures 3150, 7150), thereby forming a relatively flexible ring that can extend over the relatively rigid frame assembly 3500 for attachment.

[0355] like Figure 30 As shown, the frame connection portion 3170 of the frame connection structure 3150 may include a tapered or angled guide surface 3171 to guide and facilitate outward deflection of the frame connection portion 3170 over and rearwardly over the pad connection portion 3530 of the frame assembly 3500. For example, the tapered or angled guide surface 3171 is adapted to engage the tapered or angled guide surface on the pad connection portion 3530 of the frame assembly 3500 to facilitate assembly. It should be understood that the frame connection portion 7170 of the frame connection structure 7150 may include a similar configuration to facilitate assembly.

[0356] In the example, the higher-rigidity frame connection structures 3150, 7150 can be or act as “pad clips” designed and arranged to removably and repeatedly clamp the padding assemblies 3075, 7075 to the frame assembly 3500. For example, the increased rigidity provided by the higher-rigidity material of the frame connection structures 3150, 7150 can act as a clamp structure designed to reduce deformation of the frame connection structures 3150, 7150, thereby allowing the frame connection structures 3150, 7150 to maintain the engagement between the padding assemblies 3075, 7075 and the frame assembly 3500 and preventing the padding assemblies 3075, 7075 from being removed from the frame assembly 3500.

[0357] The padding assemblies 3075, 7075 and the frame assembly 3500 can be separated by applying sufficient force to cause the frame connection structures 3150, 7150 of the padding assemblies 3075, 7075 to extend out of the channel to detach from or pass over the undercut 3535 of the padding connection portion 3530 of the frame assembly 3500.

[0358] Sealing lip edge

[0359] As described above, sealing lips 3850 and 7850 are formed together with sealing structures 3100 and 7100 made of a material with lower hardness. For example... Figures 29 to 30 and Figures 96 to 97 As best shown, the sealing lips 3850, 7850 are in the form of flexible fins arranged along the inner surface or inner and outer periphery of the sealing structures 3100, 7100. The sealing lips 3850, 7850 protrude into the cavities of the sealing structures 3100, 7100, which form at least a portion of the inflation chambers 3200, 7200.

[0360] In an example, such as Figure 13 and Figure 97 As shown, sealing lips 3850, 7850 are designed and arranged to engage frame assembly 3500 to form a pneumatic seal with the gasket connection portion 3530 of frame assembly 3500 (e.g., the rear wall of the channel). In an example, sealing lips 3850, 7850 may be constructed and arranged to engage frame assembly 3500 when gasket assemblies 3075, 7075 are initially attached to frame assembly 3500, for example, the sealing lips 3850, 7850 are arranged as the gasket connection portion 3530 of frame assembly 3500. When the pressure within inflation chambers 3200, 7200 increases above atmospheric pressure to treat respiratory distress, the pneumatic seal is strengthened and the sealing force is increased when sealing lips 3850, 7850 are pressed against frame assembly 3500 with greater force.

[0361] In an alternative embodiment, when the gasket assemblies 3075, 7075 are initially connected to the frame assembly 3500, the sealing lips 3850, 7850 may be spaced apart from or adjacent to the frame assembly 3500, and when the pressure within the inflation chambers 3200, 7200 increases, the sealing lips 3850, 7850 form a seal with the frame assembly 3500.

[0362] The sealing lips 3850 and 7850 are long enough that during assembly, when the frame connection structures 3150 and 7150 of the gasket assemblies 3075 and 7075 extend over the gasket connection portion 3530 of the frame assembly 3500, the sealing lips 3850 and 7850 will not get stuck or trapped in the frame assembly 3500.

[0363] In the example, the lengths of the sealing lips 3850 and 7850 may be the same along the entire periphery of the sealing structures 3100 and 7100. In an alternative example, the lengths of the sealing lips 3850 and 7850 may vary along one or more portions of the periphery of the sealing structures 3100 and 7100.

[0364] For example, such as Figure 72 and Figure 73 As shown in the example, the sealing lip 3850 may be longer at both outer ends or sides of the sealing forming structure 3100 to prevent the sealing lip 3850 from being held or trapped when the gasket assembly 3075 is laterally stretched and released during its assembly onto the frame assembly 3500. This configuration in Figure 73 The best way to show, Figure 73 The portion of the sealing lip 3850 at the two outer ends or sides of the sealing structure 3100 is shown to be longer than the portion of the sealing lip 3850 at the top (upper) side and bottom (lower) side of the sealing structure 3100 (i.e., protruding further into the cavity of the sealing structure 3100). It should be understood that the sealing lip 7850 may include a similar configuration.

[0365] Furthermore, the curvature of the sealing lips 3850 and 7850 can vary along one or more portions of the periphery of the sealing structures 3100 and 7100. For example, as Figure 72As best shown, the longer sealing lips 3850 at the two outer ends or sides of the sealing forming structure 3100 may also include curvature such that the sealing lips 3850 at the two outer ends or sides of the sealing forming structure 3100 protrude or bend further away from the frame connecting structure 3150 than portions of the sealing lips 3850 at the top (upper) and bottom (lower) sides of the sealing forming structure 3100. This arrangement also facilitates the assembly of the gasket assembly 3075 onto the outer ends of the frame assembly 3500 without causing the sealing lips 3850 to be held or trapped, for example, by providing sufficient space between the frame connecting structure 3150 and the sealing lips 3850 to allow for the connection of the frame connecting structure 3150 without causing the sealing lips 3850 to be trapped in the frame assembly 3500 during assembly. It should be understood that the sealing lips 7850 may include a similar configuration.

[0366] Alignment features

[0367] In this example, patient interfaces 3000 and 7000 may include visual and / or tactile indicators to prevent or minimize orientation errors and improper assembly / disassembly. This ensures correct assembly / disassembly, avoids accidental damage to patient interfaces 3000 and 7000, and also reduces any user frustration associated with assembly / disassembly.

[0368] In the example, the padding assemblies 3075, 7075 and frame assembly 3500 may each include alignment features to ensure that the padding assemblies 3075, 7075 and frame assembly 3500 are properly aligned or oriented for assembly.

[0369] For example, such as Figures 16 to 18 , Figure 93 , Figure 95 , Figure 98 and Figure 99 As best shown, the padding connection portion 3530 of the frame assembly 3500 may include one or more protrusions 3537 (e.g., convex alignment features) within the channel, which are adapted to receive a corresponding one of one or more recesses 3177, 7177 (e.g., concave alignment features) along the frame connection portions 3170, 7170 of the padding assemblies 3075, 7075. As illustrated, the protrusions 3537 / recesses 3177, 7177 are provided only on one side (e.g., the upper side) of the frame assembly 3500 / padding assembly 3075, 7075 to ensure that the padding assemblies 3075, 7075 are correctly oriented when connected to the frame assembly 3500.

[0370] In alternative instances, such as Figures 59 to 61As shown, the padding connection portion 3530 of the frame assembly 3500 may include a single protrusion 3537 on the outer side of the frame assembly 3500, the protrusion 3537 being adapted to receive a corresponding recess 3177 along the outer side of the frame connection portion 3170 of the padding assembly 3075.

[0371] In another instance, such as Figures 72 to 75 and Figures 98 to 99 As shown, the padding connection portion 3530 of the frame assembly 3500 may include a single protrusion 3577 on the central upper side of the frame assembly 3500, the single protrusion 3577 being adapted to receive corresponding cutouts 3179, 7179 along the central upper side of the padding assemblies 3075, 7075.

[0372] exist Figures 16 to 18 , Figures 59 to 61 , Figure 93 and Figure 95 In the example, recesses 3177 and 7177 are provided on the inner side of the periphery of frame connection structures 3150 and 7150. Figures 72 to 75 and Figures 98 to 99 In the examples, cutouts 3179 and 7179 include complete cutouts on the periphery of frame connection structures 3150 and 7150, such that prominent recesses are provided on the edges of padding assemblies 3075 and 7075. Figures 16 to 18 and Figures 59 to 61 Compared to the examples, Figures 72 to 75 and Figures 98 to 99 The incision configuration and its position on the central upper side of the padding assemblies 3075, 7075 can provide clearer visual guidance to the patient, allowing them to more easily assemble the padding assemblies 3075, 7075 onto the frame assembly 3500 in the correct orientation.

[0373] It should be understood that the alignment feature may include alternative shapes and locations. For example, the alignment feature may be provided along any one or more portions of the periphery of the padding assembly and the frame assembly, and the alignment feature may include any suitable shape, such as a cut or recess on the inner or outer side of the frame connection structures 3150, 7150. Furthermore, it should be understood that any suitable number of alignment features (e.g., any suitable number of cuts and / or recesses) may be provided, and alignment feature alternatives may be combined with each other, for example, see [reference needed]. Figure 75 , Figure 93 , Figure 95 , Figure 98 and Figure 99 The frame assembly 3500 has cutouts 3179, 7179 and recesses 3177, 7177 adapted to receive cutouts 3179, 7179 and recesses 3177 on the inner sides of the frame connection structures 3150, 7150. Figure 75 and Figures 98 to 99Protrusions 3577 and 3537 (not shown). In each embodiment, the alignment features are arranged such that misalignment and incorrect assembly of the padding assemblies 3075, 7075 and the frame assembly 3500 can be reduced. In the embodiment, the alignment features can prevent assembly unless the alignment features of the padding assemblies 3075, 7075 and the frame assembly 3500 are aligned with each other.

[0374] Inflation chamber

[0375] 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 can 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.

[0376] In this example, the inflation chamber 7200 is configured to allow air to flow between the two nostrils and to supply air from the RPT device. In this example, the inflation chamber 7200 may include an elastomeric material and may be formed (e.g., molded) with the sealing formation structure 7100 as a single and integral component. In this example, the inflation chamber 7200 may provide cushioning between the sealing formation structure 7100 and the positioning and stabilizing structure 3300.

[0377] In an example, such as Figure 103As shown, the inflation chamber 7200 includes a rear wall 7220 (between the pillow and frame connection portion), and the rear wall 7220 includes a rear surface 7222. In one form of the present technology, when the patient interface is in use, the rear surface 7222 is configured and arranged to directly contact the patient's upper lip or upper lip. For example, at least a portion of the rear surface 7222 is configured and arranged to contact at least a portion of the upper lip extending between the subnasal point and the mouth. In an example, the rear surface may be configured to contact a portion of the upper lip above the vermilion border, for example, the nasal pillow assembly includes a low profile on the face and minimizes the volume suspended above the vermilion border. In an example, the rear surface may be configured to contact the upper portion, lower portion, and / or central portion of the upper lip. In an example, the rear surface may be configured to contact the central portion and / or lateral portion of the upper lip. In an example, the rear surface may contact along the entire upper lip, not just at the center. This direct contact with at least a portion of the upper lip helps distribute the padding load over the nostrils and upper lip. In this example, the support on the upper lip provided by the nasal pillow assembly 7075 allows for less support on the cheek provided by the positioning and stabilizing structures 3300 (e.g., a pair of hardening arms 3302). The support on the upper lip also improves seal stability by helping to keep the pillow 7130 in place within the nostrils and reduces the nasal pillow assembly's ability to roll off the upper lip.

[0378] In one example, the air chamber 7200 may form one or more flexural areas (e.g., flexural areas adjacent to each of the adjacent pillows) that are designed and arranged to bend and / or flex in response to forces encountered during use of the patient interface (e.g., tube resistance) or movement of the patient's head (e.g., pushing the patient interface against the pillows). In another example, the air chamber 7200 may include disengagement areas (e.g., between flexural areas adjacent to each of the adjacent pillows) configured and arranged to disengage the flexural areas such that movement in one flexural area substantially does not affect the other; for example, the nose pillow associated with one flexural area may remain in place even if another flexural area associated with another nose pillow is disrupted.

[0379] In the illustrated example, the inflation chamber 7200 is configured to receive a pressurized gas flow from the air circuit 4170, which can pass through the sealing structure 7100 and enter the patient's airway for inhalation. In this example, one or more portions of the inflation chamber 7200 may be reinforced (e.g., reinforcers or reinforced sections) to increase the stiffness or rigidity of the inflation chamber 7200, thereby enhancing its resistance to deformation or collapse during use (e.g., in response to loads applied by the sealing structure 7100). Furthermore, the reinforcement may be configured and arranged to increase the volume of the inflation chamber 7200 to improve the circulating noise performance of the airflow. That is, one or more walls of the inflation chamber 7200 may be configured to improve noise performance without compromising sealing and comfort performance.

[0380] For example, such as Figure 104 As shown, the air chamber 7200 of the nose pillow assembly 7075 can be updated (relative to...). Figure 95 The air chamber of the nose pillow assembly includes reinforcements in one or more parts of the air chamber 7200.

[0381] In an example, one or more portions of the rear wall of the air chamber 7200 (configured to face and / or contact the patient's face during use) and / or one or more portions of the front wall (configured to face away from the patient's face during use) may include thickened wall regions 7230 (e.g., up to 2 mm) to increase the rigidity around at least a portion of the periphery of the air chamber 7200. Figure 104 As shown, such a thickened wall region 7230 can be arranged along the lower part of the nasal pillow assembly, for example, along a portion of the rear / front wall extending from the frame connection structure 7150 of the inflation chamber 7200.

[0382] In this example, one or more reinforcing members 7240 (e.g., one or more ribs) may be disposed along the boundary of the thickened wall region 7230. As illustrated, the one or more ribs 7240 may be disposed along the inner surface of the rear / front wall, for example, integrally formed with the rear / front wall. The one or more ribs 7240 may extend around the entire inner periphery of the inflation chamber, and / or the one or more ribs may extend around one or more selected portions of the inner periphery of the inflation chamber.

[0383] In an example, at least a portion of the base or platform 7131 of the inflation chamber 7200 between the nasal bolsters 7130 may include a thickened wall region 7250 (e.g., up to 2 mm) to increase the rigidity of the base or platform 7131. As illustrated, the thickened wall region 7250 may be centrally located between the nasal bolsters 7130.

[0384] As described above, the thickened wall region 7230 along one or more portions of the rear and / or front wall, one or more ribs 7240 along the rear and / or front wall, and / or the thickened wall region 7250 along the base or platform 7131 can reduce deformation or collapse of the inflation chamber 7200 during use (e.g., in response to loads applied by the sealing forming structure 7100). In this example, the nose pillow 7130 can be better held in place with reinforcements to improve fit confidence, and the user's seal and comfort can be improved by avoiding over-compression of the nose pillow assembly.

[0385] In an example, at least the outermost wall 7260 of the air chamber 7200 may be thickened and / or provided with a larger radius or degree of curvature to increase the volume or depth formed by the air chamber 7200 (e.g., up to 2 mm). In an example, the increased depth D provided by the outermost wall 7260 (e.g., see...) Figure 104 The nose pillow 7130 can be repositioned further away from the frame connection structure 7150 by up to 2 mm. As mentioned above, the increased volume of the air chamber 7200 can improve the airflow circulation noise performance.

[0386] Figure 105 This is a cross-sectional view of the nose pillow assembly 7075, illustrating an example according to the present technology. Figure 104 The examples shown in the image (shown in solid lines) are similar to... Figure 95 The comparison between the examples shown (shown by dashed lines) is illustrated in the figure. Figure 104 The outer sidewall 7260 of the example shown is relative to Figure 95 The example shown has increased the volume or depth of the air chamber 7200.

[0387] In the illustrated example, such as Figures 104 to 107 As shown, the frame connection structure 7150 and the sealing formation structure 7100 are made of silicone resin material of the same hardness (e.g., similar to...). Figures 94 to 97 (As shown in the example) the integral terrain becomes a single piece. However, it should be understood that the nose pillow assembly 7075 may include dual-hardness silicone components, wherein the frame connection structure 7150 includes a silicone material with higher hardness, and the sealing forming structure 7100 includes a silicone material with lower hardness (e.g., similar to...). Figures 92 to 93 (Examples shown in the text).

[0388] Figure 106 It shows Figure 104 A cross-sectional view of the nose pillow assembly 7075 attached to the frame assembly 3500, and Figure 107 It shows Figure 104 A cross-sectional view of the nose pillow assembly 7075 attached to the MPMU frame assembly 6500 for MPMU applications (described in more detail below).

[0389] In some forms of this technology, the air chambers 3200 and 7200 do not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chambers. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve adherence to therapy.

[0390] In some forms of this technology, the air chambers 3200 and 7200 are made of a transparent material (e.g., transparent polycarbonate). Using transparent materials reduces the obtrusiveness of the patient interface and helps improve adherence to the therapy. Transparent materials also help clinicians observe how the patient interface is positioned and functions.

[0391] In some forms of this technology, the air chambers 3200 and 7200 are made of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0392] Positioning and stabilizing structure

[0393] The sealing structures 3100 and 7100 of the patient interfaces 3000 and 7000 of this technology can be kept in a sealed position during use by positioning and stabilizing structure 3300.

[0394] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chambers 3200, 7200 to lift the face away.

[0395] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interfaces 3000 and 7000.

[0396] 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 unintended interference with the patient interface) on the patient interfaces 3000 and 7000.

[0397] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with a patient wearing it while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0398] 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.

[0399] 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.

[0400] 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.

[0401] 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 one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0402] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable band, such as an elastically extendable band. For example, the band can be configured to be tensioned during use, and the guiding force causes the sealing structure to make sealing contact with a portion of the patient's face. In one instance, the band can be configured as a tie.

[0403] 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.

[0404] 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.

[0405] 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.

[0406] 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.

[0407] 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.

[0408] 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 suitable for small-sized heads but not for large-sized heads.

[0409] refer to Figures 4 to 7 and Figure 44 to Figure 56 The illustration shows a positioning and stabilizing structure 3300 according to an example of the present technology. In the illustrated example, the positioning and stabilizing structure 3300 includes a pair of hardening arms 3302 and a headband assembly 3330 disposed to the pair of hardening arms 3302. The hardening arms 3302 and the headband assembly 3330 cooperate to hold the patient interfaces 3000, 7000 of the present technology in a sealed position during use, for example, the hardening arms 3302 guide the tension vector generated by the headband assembly 3330, such that the sealing forming structures 3100, 7100 abut against the base seal of the patient's nose.

[0410] As described above, each of the pair of hardener arms 3302 is connected to a respective side of the body 3510 of the frame assembly 3500 via a corresponding one of the pair of flexible joints 3305. However, the hardener arms 3302 may be connected to the body 3510 in other suitable ways.

[0411] In the illustrated example, the headband assembly 3330 includes a pair of straps 3340, 3350 (e.g., each strap is made of elastic fabric), which are connected to each other by an adjustment mechanism (e.g., a buckle 3360) that allows for length adjustment in addition to the length adjustment provided by the elasticity of the straps 3340, 3350, as described below.

[0412] As shown in the figure, the pair of belts includes a first longer belt 3340 and a second shorter belt 3350. In the intermediate, unstretched state, the first belt 3340 is longer than the second belt 3350 in its original length.

[0413] Each band 3340, 3350 can be made of an elastic material and can have elastic properties. In other words, each band can be elastically stretched to increase its length (e.g., by a stretching force applied by the patient) and, upon release of the stretching force, returns to or contracts to its original length in an intermediate state. Each band can be made of or include any elastomeric material, such as elastic rubber, TPE, silicone, etc. The material of each band can also represent any combination of the aforementioned materials with other materials. Each band can be a single-layer band or a multi-layer band. Each band can be woven, knitted, braided, molded, extruded, or otherwise formed. Each band can include or can be made of a textile material such as a woven material. Such materials can include synthetic or natural fibers, on the one hand to provide desired and beneficial surface properties, such as tactile properties and skin comfort. On the other hand, the material of each band can include an elastomeric material for providing desired elastomeric properties. In the illustrated example, each band is stretchable. This allows for stretching of the entire length of each band, which produces a comfortable force-displacement profile.

[0414] The first strap 3340 includes a side strap portion 3342 and a back strap portion 3344. As illustrated, the back strap portion 3344 includes a dividing region that divides the back strap portion 3344 into two back strap portions 3344a and 3344b, i.e., the side strap portion 3342 branches into two back strap portions 3344a and 3344b. The second strap 3350 includes a side strap portion 3352.

[0415] In the illustrated example, one end of the side strap portion 3352 is non-adjustably connected to the buckle 3360, and the two back strap portions 3344a, 3344b of the back strap portion 3344 are wrapped around or pass through the buckle 3360 to allow adjustment relative to the buckle 3360.

[0416] The headband assembly 3330 is hardened via inserted hardener arms 3302 in a specific segment, for example, from the frame assembly 3500 up to a location near the patient's cheekbone. Each band 3340, 3350 of the headband assembly 3330 may be in the form of a hollow band configured to receive a corresponding one of the hardener arms 3302 therein. When each band slides onto and is secured to the corresponding hardener arm 3302 at one end of the corresponding hardener arm 3302 near the frame assembly 3500, each band can be considered to have traveled over the corresponding one of the hardener arms 3302.

[0417] In the illustrated example, each of the 3340 and 3350 bands has a tubular configuration, such as that from... Figure 44A The diagram in the figure indicates an oval or circle shape and is based on Figure 44BAn exemplary cross-sectional view is obtained. However, it should be understood that the positioning and stabilizing structure 3300 can take any other shape, such as a flat or sheet-like shape, a single layer, multiple layers, or a laminated construction.

[0418] Each side strap portion 3342, 3352 of each strap 3340, 3350 includes a buttonhole 3343, 3353, for example, in a slit configuration. The buttonholes 3343, 3353 may be located on the outer surface of each strap 3340, 3350 (i.e., the surface facing away from the patient when worn) and are adapted to receive a corresponding hardener arm 3302 for insertion into or removal from the tubular or sleeve-shaped strap 3340, 3350. Alternatively, the buttonholes 3343, 3353 may be located on the inner surface of each strap 3340, 3350. In an example, each side strap portion 3342, 3352 may include a pouch-shaped end adapted to receive the corresponding hardener arm 3302 near the end of the frame assembly 3500.

[0419] In the illustration, each end of the first band 3340 includes a reinforcing portion or finger-like tab 3345, 3347, and the end of the second band 3350 opposite the fastener 3360 includes a reinforcing portion or finger-like tab 3355. In an example, each reinforcing portion or finger-like tab 3345, 3347, 3355 comprises a material different from that of the bands 3340, 3350, such as TPE material. In an example, each reinforcing portion or finger-like tab 3345, 3347, 3355 may be overmolded to the respective ends of the bands 3340, 3350; however, each reinforcing portion or finger-like tab 3345, 3347, 3355 may be attached to the bands in other suitable ways.

[0420] Each reinforcing portion or finger-like protrusion 3345, 3347, 3355 provides reinforcement to the respective ends of the straps 3340, 3350, for example, to avoid or reduce the possibility of the patient tearing or ripping the straps 3340, 3350. Furthermore, the reinforcing portions or finger-like protrusions 3345, 3355 help provide the patient with visual and tactile guidance on how to slide the straps 3340, 3350 onto or remove them from the respective sclerotic arms 3302, and can aid in identifying the location of the buttonholes 3343, 3353. Additionally, after the two back strap portions 3344a, 3344b are wrapped around or passed through the buckle 3360, the reinforcing portion or finger-like protrusion 3347 is positioned (e.g., overmolded) to the ends of the two back strap portions 3344a, 3344b to prevent the strap 3340 from being removed from the buckle 3360. In addition, the reinforced portion or finger-like protrusion 3347 provides visual and tactile indications for adjusting the back strap portion 3344 relative to the buckle 3360.

[0421] like Figure 4 , Figure 55and Figure 56 As shown, the side strap portions 3342 and 3352 of each of the straps 3340 and 3350 are adapted to extend along both sides of the patient's head when worn, while the back strap portion 3344 of the strap 3340 is adapted to extend along the back of the patient's head.

[0422] To allow the headband assembly 3330 to be stretched during use, the length of the headband assembly 3330 can be smaller than the average head circumference of the patient. For example, the length of the headband assembly 3330 (e.g., as...) Figure 45 As shown, the length of the back strap portion 3340 of the headgear assembly (fully retracted relative to the buckle 3360) can be less than 600 mm in one instance and less than 500 mm in another. However, headgear strap assemblies 3330 of different lengths can be provided to patients according to their head circumference, which may be gender-specific.

[0423] In the illustrated example, straps 3340 and 3350 are connected by a buckle 3360, which allows for length adjustment in addition to the length adjustment provided by the elasticity of the straps 3340 and 3350. As illustrated, the buckle 3360 includes a body 3362 having a first end portion 3364 and a second end portion 3366. In the illustrated example, the first end portion 3364 is bent upward or angled relative to the second end portion 3366. The second end portion 3366 is connected to the end of the strap 3350, for example, by overmolding. The body 3362 includes openings for receiving back strap portions 3344a and 3344b, namely a first opening 3370 configured to receive back strap portions 3344a and 3344b and a pair of second openings 3372a and 3372b configured to receive each of the back strap portions 3344a and 3344b. The crossbar 3380 separates the first opening 3370 from the second openings 3372a and 3372b, and the crossbar 3382 separates the opening 3372b from the opening 3372a.

[0424] As illustrated, the back strap portions 3344a and 3344b extend upward through the first opening 3370, around the crossbar 3380, and downward through the respective openings in the second openings 3372a and 3372b. Each of the second openings 3372a and 3372b includes an angled edge or surface 3375 arranged to resist adjustment during use.

[0425] In this example, the hook and loop fastener 3360 comprises a relatively rigid material, such as polypropylene or polyethylene, and may include an overmolded component, such as a TPE material. For example, in Figure 51 and Figure 52In an exemplary cross-section of the snap fastener 3360, the snap fastener 3360 includes a relatively rigid base 3390, such as polypropylene or polyethylene, and a softer overmolding member 3391, such as TPE. In the illustrated example, the overmolding member 3391 is not positioned along the openings 3370, 3372a, and 3372b. In the example, one or more portions (e.g., the area surrounding the openings 3370, 3372a, and 3372b, such as...) may be... Figure 50 (As shown in the shaded area) Polishing may be used, for example, to reduce friction and facilitate sliding or sliding adjustment of the back strap portions 3344a, 3344b relative to the buckle 3360. However, other suitable materials are also possible.

[0426] Figures 53 to 56 This is an exemplary view illustrating belt adjustment of a headband assembly 3330 according to an example of the present technology. The headband assembly 3330 allows for precise tension adjustment and thus ensures a better seal for the padding assembly 3075, especially after repeated use and / or cleaning of the headband assembly 3330, which could lead to a loss of belt elasticity. For example, sufficient tension of the headband assembly 3330 may be particularly important for the nose pad type seal formation 3100 of the present technology, compared to a pillow-type seal formation where a smaller tension is required for sealing.

[0427] An adjustment mechanism (e.g., hook and loop 3360) is operable to allow the patient to adjust the (effective) length of the elastic bands 3340 and 3350 to maintain the desired tension and fit over time. For example, the elastic bands 3340 and 3350 can be adjusted via the hook and loop 3360 in a first adjusted position (e.g., as shown). Figure 45 and Figure 55 As shown, the back strap portion 3340 is substantially retracted relative to the buckle 3360) and one or more second adjusted positions (e.g., as shown). Figure 56As shown, the back strap portion 3340 is connected at a point where it overlaps to a different degree than in the first adjusted position. In each adjusted position, the headband assembly 3330 may include (1) an intermediate or unstretched state, wherein the headband assembly 3330 includes an intermediate or unstretched length (i.e., no tensile force is applied to the elastic bands 3340, 3350 to elastically stretch the bands 3340, 3350), and (2) one or more stretched or extended states, wherein the headband assembly 3330 includes one or more extended or stretched lengths (i.e., tensile force is applied to the elastic bands 3340, 3350 to elastically stretch and increase the length of the bands 3340, 3350). In each adjusted position, the material of the bands 3340, 3350 limits the extended or stretched length in the extended position to a certain extent, i.e., the maximum or effective length of the headband assembly 3330 in each adjusted position. When the elastic band 3340 is adjusted relative to the buckle 3360 (e.g., from a first adjusted position to a second adjusted position), the intermediate or unstretched length of the headband assembly 3330 changes; for example, the length shortens when adjusted from the first adjusted position to the second adjusted position. This shortened length in the intermediate or unstretched state also shortens the extended or stretched length; for example, the maximum or effective length of the headband assembly 3330 in the second adjusted position is shortened. This arrangement allows adjustment of the maximum or effective stretchable length, for example, to accommodate the loss of elasticity in the band, in order to maintain a comfortable force displacement profile. Therefore, the elasticity of the bands 3340, 3350 provides an adjustment mechanism to allow length adjustment in a given adjusted position, and the buckle 3360 provides an additional adjustment mechanism to allow length adjustment beyond the range provided by the elasticity of the bands 3340, 3350.

[0428] like Figure 53 As shown, when the buckle extends substantially parallel to the back strap portions 3344a, 3344b to resist unintentional adjustment caused by friction between the back strap portions 3344a, 3344b (each free end of the back strap portions 3344a, 3344b) and the angled edges or surfaces 3375 in the respective second openings 3372a, 3372b, the buckle 3360 is in the locked position. Figure 54As shown, the buckle 3360 can be raised or pivoted to the unlocked position, causing the buckle to extend laterally across the back strap portions 3344a, 3344b. This allows for adjustment due to reduced friction between the back strap portions 3344a, 3344b (each free end of the back strap portions 3344a, 3344b) and the angled edges or surfaces 3375 in the respective second openings 3372a, 3372b. That is, the buckle 3360 in the unlocked position can be angled to allow the back strap portions 3344a, 3344b to slide easily relative to the buckle 3360 for length adjustment. This arrangement is achieved by multiple forward and backward bends in the back strap portions 3344a, 3344b that wrap around a crossbar 3380 within the buckle 3360, for example, based on the Capstan effect principle.

[0429] This arrangement provides patients with a simple and easy-to-use buckle adjustment mechanism, especially when the patient is wearing a patient interface. In this example, such an adjustment arrangement can be performed with one hand and can include a one-step adjustment, such as simply pulling the free end of the back strap portions 3344a, 3344b relative to the buckle 3360 (e.g., via the reinforcing portion or finger-like protrusion 3347) to tighten, and simply pivoting and pulling the buckle 3360 relative to the back strap portions 3344a, 3344b to loosen.

[0430] Figure 55 This is a side view of a patient interface on a patient's head, shown as an example of the present technology, with the headband assembly in a first adjusted position (e.g., a looser position). Figure 56 This is a side view of a patient interface on a patient's head, shown as an example of the present technology, with the headband assembly in a second adjusted position (e.g., a tighter position).

[0431] Figures 83A to 86B Various views are shown illustrating the application, adjustment, and removal of a patient interface 3000 according to an example of this technology.

[0432] For example, in Figure 83A In this process, by keeping the patient interface 3000 away from the patient's nose to ensure the positioning and stabilization of the structure 3300 which is bent or oriented upwards, the patient begins to conform to the patient interface 3000. This facilitates the orientation and engagement of the sealing formation structure 3100 relative to the patient's nose, and also facilitates the orientation and engagement of the positioning and stabilization structure 3300 above the top of the patient's head.

[0433] Figure 83BThe figure shows the patient placing the padding assembly 3075 and its sealing structure 3100 below the patient's nose and ensuring it is comfortably against the patient's face. The figure also shows the patient beginning to put on the positioning and stabilizing structure 3300 by pulling the lower one of the back strap portions 3344a with one hand while holding the frame assembly 3500 / padding assembly 3075 with the other hand, to pull the headband assembly 3330 onto the patient's head. Figure 83C and Figure 83D A headband assembly 3330 is shown that extends back around the patient's head to hold the patient interface 3000 on the patient's nose, for example, wherein the higher one of the backband portions 3344b is comfortably positioned on top of the patient's head.

[0434] As shown in the figure, one of the segmented back strap portions 3344b is positioned above the patient's occipital lobe, while the other segmented back strap portion 3344a is positioned below the patient's occipital lobe, for example, to cup the back of the patient's head for support and stability. However, it should be understood that the back strap portions 3344a and 3344b can be positioned at different locations along the back of the patient's head, for example, to adjust the tension or position for the patient's preference and / or comfort. For example, as Figure 55 and Figure 56 As shown, the two back strap portions 3344a and 3344b can be positioned closer to each other toward the top of the patient's head. For example, the two back strap portions 3344a and 3344b are typically positioned above the patient's occipital lobe. Figure 84A and Figure 84B This is an exemplary view showing the adjustment of the segmented back strap portions 3344a, 3344b to achieve a comfortable fit, for example, by unfolding the back strap portions 3344a, 3344b to loosen them or pulling them closer together to tighten them.

[0435] If additional adjustments to the headband assembly 3330 are required, they can be made via the buckle 3360 as described above. For example, the headband assembly 3330 can be tightened by pulling the free ends of the back strap portions 3344a, 3344b away from the buckle 3360 (e.g., via the reinforcing portion or finger-like protrusion 3347), as... Figure 86A As shown. The strap portion can be grasped on either side of the buckle 3360 and... Figure 86B The hood strap assembly 3330 can be loosened by pulling, or by pulling the buckle 3360 relative to the strap portion.

[0436] It should be understood that the headband assembly 3330 can be assembled to the patient interface 3000 such that the buckle 3360 can be located on the right or left side of the patient's head, for example, depending on the patient's preference, to facilitate adjustment during wear. For example, the buckle 3360 is preferably located on the right side of the patient's head to facilitate adjustment of the buckle 3360 by the patient with their right hand.

[0437] The patient interface 3000 is now fitted and ready for immediate use, meaning that the short tube 4180 of the patient interface 3000 can be connected to the air circuit 4170 for delivering pressurized gas from the air circuit 4170 to the patient interface 3000.

[0438] like Figure 85 As shown, the patient interface 3000 can be removed by pulling the frame assembly 3500 / pad assembly 3075 together with the back strap portions 3344a, 3344b upward and above the patient's head.

[0439] Vent

[0440] In one embodiment, the patient interface 3000, 7000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gas (e.g., carbon dioxide).

[0441] In some configurations, the ventilation port 3400 is configured to allow continuous airflow from the interior of the inflation chambers 3200, 7200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0442] One form of vent 3400 according to the present technology includes a plurality of holes, for example, about 2 or more holes, about 5 to about 50 holes, about 10 to about 40 holes, about 10 to about 20 holes, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0443] The vent 3400 may be located in the inflation chambers 3200 and 7200. Alternatively, the vent 3400 may be located in a disengaged structure, such as a rotating shaft.

[0444] Figures 4 to 24 A ventilation port 3400 according to an example of the present technology is illustrated. In the illustrated example, the ventilation port 3400 is disposed to a frame assembly 3500, and the ventilation port 3400 includes a diffuser member 3450 (e.g., filter material) along the ventilation airflow path, the diffuser member 3450 being designed and arranged to diffuse the exhaust ventilation airflow to generate less noise. The diffused ventilation airflow also reduces or eliminates jetting of the ventilation airflow, which will not be jetted onto the bed and / or a companion adjacent to the patient interface.

[0445] As shown in the figure, the body 3510 includes an inner surface 3512 (along the rear side) and an outer surface 3514 (along the front side). The inner surface 3512 is adapted to face inward toward the pressurized volume of the inflation chamber 3200 during use, and the outer surface 3514 is adapted to face toward the atmosphere during use. A porous venting device 3515 is provided on each side of the body 3510 of the cover connection portion 3540. Each porous venting device 3515 includes a plurality of vents 3516 extending from the inner surface 3512 through the body 3510 to the outer surface 3514 to allow gas to be released into the atmosphere. The outer surface 3514 forms the bottom of a recessed area 3550 in the front side of the body 3510.

[0446] In the illustrated example, such as Figures 21 to 22 As best shown, each porous vent 3515 is arranged in an arc or U-shape, with the open end oriented toward the cap connection portion 3540. A spacer 3518 (e.g., a U-shaped protrusion) is provided to the outer surface 3514 and extends along the inner and outer peripheries of the respective porous vent 3515 to support the respective diffuser member 3450. The spacer 3518 supports the diffuser member 3450 in a relationship spaced apart from the outlet end of each of the outer surface 3514 and the vent openings 3516, see, for example, [reference needed]. Figure 9 .

[0447] Furthermore, a plurality of ribs 3560 are provided along the outer periphery of the recessed area 3550, the plurality of ribs 3560 being spaced apart along the periphery of each porous vent 3515. In the illustrated example, each of the spaced-apart ribs 3560 along the periphery of each porous vent 3515 includes a stepped configuration comprising a first lower step 3561 and a second upper step 3562.

[0448] In the illustrated example, the first lower step 3561 of each of the spaced-apart ribs 3560 is designed and arranged to support the outer edge of the corresponding diffuser member 3450. Therefore, the spacer 3518, together with the first step 3561 of the spaced-apart ribs 3560, forms a raised platform to support the diffuser member 3450 in a relationship spaced apart from the outlet end of each of the outer surface 3514 and the vents 3516, for example, to minimize noise. Moreover, this spacing or offset between the diffuser member 3450 and the outlet end of each of the vents 3516 creates an air gap, which ensures that the vents 3516 are never blocked by the diffuser member 3450.

[0449] As described above, the second upper step 3562 of each of the spaced-apart ribs 3560 is designed and arranged to provide a stop for the outer edge of the front wall 3585 when the cover 3580 is attached to the body 3510. In an alternative embodiment, the second upper step 3562 of each of the spaced-apart ribs may not be provided, see, for example, see Figure 58 , Figure 58 Ribs 3560, each consisting of only the first step 3561, are shown.

[0450] When the cover 3580 is attached to the body 3510, the front wall 3585 is supported in a relationship spaced apart from the outer surface 3514 or the bottom of the recessed area 3550, to accommodate and retain the diffuser member 3450 between the front wall 3585 and the spacer 3518 / first step 3561, i.e., the body 3510 and the cover 3580 form a shell or cylinder for the diffuser member 3450. Furthermore, as described below, the outer edge or periphery of the front wall 3585 is spaced apart from the outer edge or periphery of the recessed area 3550, and this space or gap between the front wall 3585 and the periphery of the recessed area 3550 forms the vent outlet 3420 of the vent 3400.

[0451] As illustrated, each diffusion member 3450 is arranged to cover a corresponding porous venting device 3515, such that flow exiting the venting orifice 3516 of the porous venting device 3515 flows into the diffusion member 3450. In an example, the diffusion member 3450 may be made of a porous material that allows gas to flow through it but diffuses any jet or other flow pattern exiting the venting orifice 3516, such as non-woven or woven fiber materials. In an example, the diffusion member 3450 may include a diffusion material similar to or the same as a filter material or filter medium. In an example, the diffusion member 3450 may include a thickness of about 0.1 mm to 10 mm, such as 3 mm to 8 mm, 5 mm to 7 mm, 6 mm to 8 mm, or, for example, 7 mm; however, other suitable thicknesses are also possible. In the illustrated example, the diffusion member 3450 comprises a single layer; however, it should be understood that the diffusion member 3450 may include two or more layers, such as stacked layers of similar or different diffusion materials.

[0452] In this example, the cover 3580 is removably attached to the body 3510, for example, to allow for cleaning and / or replacement of the diffuser member 3450. Alternatively, the entire frame assembly 3500 can be replaced instead of the individual diffuser member 3450.

[0453] The body 3510 and the cover 3580 cooperate to form a diffusion section including a diffusion section inlet 3410 (i.e., the outlet end of each of the vents 3516) and a diffusion section outlet 3420 (i.e., the gap between the front wall 3585 and the periphery of the recessed area 3550), the diffusion section outlet 3420 corresponding to the vent outlet of the vent 3400. As illustrated, spaced-apart ribs 3560 are provided within the diffusion section between the diffusion section inlet 3410 and the diffusion section outlet 3420 to separate the airflow around the periphery of the frame assembly 3500.

[0454] In the illustrated example, spaced-apart ribs 3560 are arranged to support the individual diffuser members 3450 and to separate the airflow. In the illustrated example, additional ribs 3565 may be provided along the upper and lower sides of the cover connection portion 3540. These ribs 3565 cooperate with ribs 3560 to separate the airflow; however, these ribs 3565 are not arranged to support the individual diffuser members 3450. In alternative examples, these ribs 3565 may not be provided.

[0455] Furthermore, in an alternative embodiment, one or more ribs may be provided to the cover 3580. For example, one or more ribs on the cover 3580 may cooperate with one or more ribs provided to the body 3510 to separate airflow. In another embodiment, one or more ribs may be provided to the cover 3580 instead of the ribs provided to the body 3510 to separate airflow.

[0456] In one example, the one or more ribs may comprise a single-piece construction integral with the body 3510 and / or the one or more ribs may comprise a single-piece construction integral with the cover 3520, such as one or more ribs molded as single pieces with the body 3510 and / or the cover 3520. In an alternative example, the one or more ribs may be formed separately from the body 3510 and assembled to the body 3510 during separation, and / or the one or more ribs may be formed separately from the cover 3520 and assembled to the cover 3520 during separation, for example, the one or more ribs may be separately molded and individually assembled to the body 3510 and / or the cover 3520. However, it should be understood that the one or more ribs may be provided to the vent in other suitable ways.

[0457] In the illustrated example (for example, see...) Figure 14The spaced-apart ribs 3560, 3565 act as diverters, establishing spaced-apart and separated airflow paths V that divide or distribute the exhaust airflow around the periphery of the frame assembly 3500 throughout the treatment pressure. Specifically, the spaced-apart ribs 3560, 3565 are positioned and oriented relative to the diffuser section inlet 3410 and diffuser section outlet 3420 to segment the turbulent kinetic energy at the diffuser section inlet 3410 (i.e., the outlet end of each of the vents 3516) to optimize the exhaust airflow and minimize noise. In an example, the spaced-apart ribs 3560, 3565 can segment the turbulent kinetic energy into substantially equal segments, allowing energy to be uniformly directed to the diffuser section outlet 3420, i.e., the vent outlet of the vent 3400. However, it should be understood that the spaced-apart ribs 3560, 3565 can segment the flow into unequal and / or equal segments.

[0458] It should be understood that the front wall 3585 forms a diffusion section outlet 3420, i.e., the vent outlet of the vent 3400, which is radially spaced outward from the vent inlet 3517 (i.e., the inlet end of each of the vents 3516) and the diffusion section inlet 3410 (i.e., the outlet end of each of the vents 3516) of the vent 3400. That is, the venting airflow cannot flow directly through the vents 3516 to the diffusion section outlet 3420, i.e., the vent outlet, and must at least partially flow radially from the vent inlet 3517 to the vent outlet 3420.

[0459] In use, the vent 3400 is disposed at the patient interface 3000 to allow gas to flow from the interior of the patient interface (e.g., the inflation chamber 3200) to the exterior of the patient interface 3000 (e.g., to the atmosphere). The vent 3400 is designed and arranged to provide a ventilation path that passes through multiple vents 3516 of each porous ventilation device 3515 into a diffusion section, through individual diffusion members 3450, and then through separate ventilation paths V provided by spaced-apart ribs 3560, 3565 to reach the ventilation outlet 3420. In an example, not all flow needs to pass through the diffusion member 3450; for example, at least some flow can bypass the diffusion member 3450 and flow directly from the vent to the branched ventilation paths provided by the spaced-apart ribs to reach the ventilation outlet 3420.

[0460] The vent 3400 is designed and arranged to improve the diffuseness of the ventilation airflow to generate lower turbulent kinetic energy and thus reduce noise, for example, to improve the patient's sleep quality. The diffuseness depends at least in part on the airflow through the vent and along the ventilation airflow path, and on the air velocity across the ventilation airflow path. High air velocity has high turbulent kinetic energy, and turbulent kinetic energy is an indicator of noise.

[0461] In the illustrated example, the vent 3400 provides several features to generate lower turbulent kinetic energy. For example, each porous vent 3515 includes a vent 3516, which is designed and arranged to prevent crossflow and allow the airflow volume to be distributed substantially uniformly into the diffuser section. Spacers 3518 and spaced-apart ribs 3560, spaced apart from the vents 3516, support the diffuser member 3450, for example, to minimize noise and prevent the diffuser member 3450 from becoming blocked. Furthermore, the spaced-apart ribs 3560, 3565 act as airflow separators to separate the exhaust flow for reducing turbulent kinetic energy.

[0462] Various aspects of the ventilation port 3400 can be adjusted or optimized to provide the desired flow-pressure curve within the therapeutic pressure range. In practice, one or more characteristics of various aspects of the ventilation port 3400 can be adjusted, for example, based on ventilation requirements, acoustic requirements, therapeutic requirements, etc.

[0463] For example, the shape, size, quantity, orientation, and spacing of ribs 3560 and 3565 can be optimized to regulate flow.

[0464] In this example, the number of ribs 3560, 3565 along the recessed area can vary, for example, with changes in the size of the venting assembly and / or the number and size of the vent orifices. In this example, the spacing between the ribs can be approximately 7 mm to 9 mm. In this example, the frame assembly 3500 can include 5 to 30 ribs; however, other suitable numbers of ribs are also possible. For example, the frame assembly 3500 can include 10 to 20 ribs, or 8 to 15 ribs. In this example, 3 to 15 ribs (e.g., 5 to 10 ribs) can be associated with each porous vent 3515.

[0465] In this example, ribs 3560 and 3565 may extend in a direction substantially orthogonal / tangential to the body 3510 of the frame assembly 3500. For example, ribs 3560 and 3565 may extend in a direction substantially orthogonal to the main surface (e.g., outer surface 3514) of the body 3510. This orientation of the ribs, for example, minimizes any dead zones in the airway compared to ribs oriented at an acute angle relative to the body 3510. This orientation of the ribs also helps the airflow exit the air outlet 3420 (i.e., the gap between the anterior wall 3585 and the periphery of the recessed area) in a direction substantially perpendicular to the overall plane of the body 3510, thereby directing the airflow away from the patient's face during use.

[0466] In the examples, each of ribs 3560 and 3565 includes a typically small thickness, such as 1 mm to 2 mm, for example, 1.2 mm. This small thickness maximizes the ventilation space for air by creating a wider airflow path, for example. However, other suitable thicknesses are also possible.

[0467] In this example, the shape, size, orientation, and number of vents 3516 for each porous vent 3515 can be adjusted. In this example, each vent is generally circular and may have a diameter in the range of about 0.7 mm to 1.2 mm (e.g., 1 mm). In this example, each vent may include a taper or draft angle; for example, the diameter of each vent may decrease from the inlet end at the inner surface to the outlet end at the outer surface. In the illustrated example, each porous vent 3515 includes 8 vents; however, other suitable numbers of vents are possible. For example, each porous vent 3515 may include 2 to 30 vents, such as 5 to 20 vents, 5 to 10 vents, or 6 to 8 vents.

[0468] In this example, the axes of the flow paths passing through each of the vents 3516 can be parallel to or at an angle to each other, thus avoiding crossflows to prevent additional noise.

[0469] In this example, the dimensions of the front wall 3585 can be adjusted to adjust the dimensions of the vent outlet 3420 (i.e., the gap between the front wall 3585 and the periphery of the recessed area).

[0470] In this example, the thickness, material, and shape of each diffuser member 3450 can be adjusted. In this example, each diffuser member 3450 is shaped to cover the vent 3516 of the corresponding porous venting device.

[0471] In this example, it should be understood that adjustments to one or more parameters can be made in conjunction with one or more other parameters of the vent 3400 to optimize diffusion and reduce turbulent kinetic energy, thereby reducing noise. For example, certain ratios between parameters can be adjusted to optimize diffusion. In this example, the size / number of ribs 3560 and 3565 can be adjusted in conjunction with the size / number of vents 3516. For example, an exemplary ratio of the number of ribs to the number of vents could be 0.5 to 1.0, such as 0.6 to 0.8; however, other suitable ratios are also possible. In another example, the size / number of ribs 3560 and 3565 can be adjusted in conjunction with the overall dimensions of patient interfaces 3000 and 7000.

[0472] Although the air vent 3400 is described in relation to a nasal pad type patient interface, it should be understood that one or more aspects of the air vent 3400 can be applied to other types of patient interfaces, such as nasal patient interfaces, full-face patient interfaces, and nasal fork type patient interfaces.

[0473] In the example, Figures 4 to 24The frame assembly 3500 and its air vent 3400 shown may include a frame / air vent arrangement for single-patient multiple-use (SPMU) applications (e.g., for home use). In this example, an alternative frame assembly may be provided for the patient interface for multi-patient multi-purpose (MPMU) applications (e.g., for sleep laboratory or hospital use).

[0474] Figures 76 to 82C A patient interface 6000 including an MPMU frame assembly 6500 according to an example of the present technology is shown. In the illustrated example, the patient interface 6000 is substantially similar to the patient interface 3000, but for MPMU applications, the frame assembly 6500 is used instead of the frame assembly 3500. As illustrated, the frame assembly 6500 also serves as a central hub, to which the liner assemblies 3075, 7075, positioning and stabilizing structure 3300, and short tube 4180 are connected, for example, in a removable or more permanent manner.

[0475] In this example, frame assembly 6500 is similar to frame assembly 3500, but includes different venting devices. As illustrated, frame assembly 6500 includes a vent 6400 that does not include the diffusion section found in vent 3400, but only includes porous venting devices 6515 disposed on each side of the connection port 3600 to the body 6510. This frame assembly 6500 provides a structure that can be better suited to MPMU applications and requirements, such as ease of cleaning / cleaning between uses, fewer parts, and greater rigidity / durability to withstand repeated use.

[0476] Each porous venting device 6515 includes a plurality of vents 6516 that extend from the inner surface 6512 (adapted to be oriented toward the interior of the inflation chambers 3200, 7200, i.e., the pressurized volume) through the body 6510 to the outer surface 6514 (adapted to be oriented toward the atmosphere in use) to allow gas to be released into the atmosphere.

[0477] In the illustrated example, the vents 6516 of each porous venting device 6515 can be arranged in a row. For example... Figure 81 , Figure 82A and Figure 82BAs illustrated, the outer surface 6514 of the body may provide spaced-apart (e.g., generally parallel) surface regions 6525 with a stepped arrangement, wherein the outlet ends of each row of vents 6516 are arranged along a corresponding one of the surface regions 6525. That is, the outer surface 6514 of the body may include ridges or ribs 6524 providing this stepped arrangement of surface regions 6525. In the illustrated example, the ridges 6524 are arranged on each side of the connection port 3600 such that the surface regions 6525 gradually decrease in height away from the connection port 3600. This arrangement aligns the axes of the flow paths through each of the vents 6516 parallel or at an angle to each other, thereby avoiding crossflow and preventing noise. In this example, these ridges or ribs 6524 may facilitate the manufacture (e.g., molding) of the frame assembly 6500 and its vents 6400.

[0478] It should be understood that each porous venting device 6515 may include any suitable number of columns, such as 2 to 10 columns, 3 to 5 columns, and each column may include any suitable number of vents, such as 1 to 20 vents, 2 to 10 vents, 2 to 5 vents. Furthermore, it should be understood that each porous venting device 6515 may include vents arranged in an alternative manner, such as radially or randomly arranged in rows.

[0479] The shape, size, orientation, and number of vents 6516 in each porous vent 6515 can be adjusted. In an example, each vent is generally circular and may have a diameter in the range of about 0.7 mm to 1.2 mm (e.g., 1 mm). In an example, each vent may include a taper or draft angle, for example, the diameter of each vent may decrease from the inlet end at the inner surface to the outlet end at the outer surface. In the illustrated example, each porous vent 6515 includes 18 vents; however, other suitable numbers of vents are also possible. For example, each porous vent 6515 may include 2 to 40 vents, such as 5 to 25 vents or 10 to 20 vents.

[0480] The short tube 4180 can be permanently or removably connected to the connection port 3600. In an example, such as... Figure 82C As shown, the short tube 4180 and the connecting portion 3600 may include snap-fit ​​or interference-fit components, such as the sleeve 4185 of the short tube 4180 including a peripheral groove 4186 adapted to engage a peripheral bead 3605 along the interior of the connecting port 3600. However, it should be understood that the short tube 4180 may be connected to the connecting port 3600 in other suitable ways, for example, in a removable or more permanent manner.

[0481] Similar to frame assembly 3500, a pair of hardener arms 3302 of positioning and stabilizing structure 3300 are connected to each side of frame assembly 6500 via a corresponding one of a pair of flexible joints 3305. As described above, headband assembly 3330 can be connected to hardener arms 3302.

[0482] In addition, the frame assembly 6500 includes a padding connection portion 6530 similar to the padding connection portion 3530 of the frame assembly 3500, which is designed and arranged to releasably connect the padding assemblies 3075, 7075 to the frame assembly 6500, as described above.

[0483] Disconnection structure

[0484] In one form, the patient interface 3000, 7000 includes at least one disconnection structure, such as a swivel or ball socket.

[0485] Connection port

[0486] Connection port 3600 allows connection to air circuit 4170.

[0487] Forehead support

[0488] In one configuration, the patient interface 3000 includes a forehead support 3700. For example, Figure 3A A non-invasive patient interface 3000 according to one aspect of the present technology is shown, the non-invasive patient interface 3000 including a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700.

[0489] Anti-suffocation valve

[0490] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0491] port

[0492] In one embodiment of this technology, the patient interfaces 3000, 7000 include one or more ports that allow access to the volume within the inflation chambers 3200, 7200. 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 chambers 3200, 7200, such as pressure.

[0493] air circuit

[0494] According to one aspect of the art, 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, 7000) during use.

[0495] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block of the RPT device 4000. The 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.

[0496] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating elements 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 the air circuit 4170. The heating elements may communicate with a controller, such as a central controller. 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.

[0497] oxygen delivery

[0498] In one form of this technology, supplemental oxygen can be delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block, to air circuit 4170 and / or to patient interfaces 3000, 7000.

[0499] Glossary

[0500] 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.

[0501] General Concepts

[0502] Air In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0503] 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.

[0504] For example, the environment relative to a humidifier humidityThis 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.

[0505] In another instance, environmental stress can be stress that is either close to the body or outside the body.

[0506] 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 can be generated by sources outside the room.

[0507] Automated Positive Airway Pressure (APAP) Therapy : Among them, CPAP therapy, in which the treatment pressure can be automatically adjusted between minimum and maximum (e.g., varying with each breath), depends on the presence of an indication of an SDB event.

[0508] Continuous positive airway pressure (CPAP) therapy In this treatment, the therapeutic 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.

[0509] flow Flow rate is the volume (or mass) of air delivered per unit time. It can refer to an instantaneous quantity. In some cases, a reference to flow rate will be a scalar quantity, i.e., a quantity that only has magnitude. In other cases, a reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be represented by symbols. Q The term "flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0510] In the context of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Total flow rate Qt This is the flow rate of air leaving the RPT unit. Ventilation flow rate. Qv This is the flow rate of air leaving the vent to allow exhaled gas to escape. Leakage flow rate. Ql This refers to flow leakage from the patient interface system or elsewhere. Respiratory flow. Qr It is the flow rate of air received from the patient's respiratory system.

[0511] humidifierThe 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.

[0512] leakage The term "leak" will be used to refer to unintended airflow. 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 the swivel bend leading to the environment.

[0513] Conducted noise (acoustic) Conducted noise, as used in this document, refers to noise transmitted to the patient through pneumatic paths, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0514] Radiated noise (acoustic) Radiated noise in this document refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0515] Ventilation noise (acoustic) Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening, such as the vent of a patient interface.

[0516] patient People, regardless of whether they have respiratory illnesses.

[0517] pressure: Force per unit area. Pressure can be expressed in a series of units, including cmH2O, gf / cm². 2 And hectopascals. 1 cmH2O equals 1 gf / cm³ 2 The pressure is approximately 0.98 hectopascals. Unless otherwise stated, pressures in this specification are given in cmH2O.

[0518] Pressure in the patient interface is represented by symbols Pm Give, and treat stress with symbols Pt The treatment pressure is given as the pressure exerted through the mask at the current moment. Pm The target value to be achieved.

[0519] Respiratory Pressure Therapy (RPT) Air supply is applied to the airway inlet under a treatment pressure that is normally positive relative to the atmosphere.

[0520] Ventilator Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0521] Material

[0522] Silicone resin or silicone elastomer A 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.

[0523] polycarbonate : A thermoplastic polymer of bisphenol A carbonate.

[0524] Mechanical properties

[0525] Resilience The ability of a material to absorb energy when it elastically deforms and release energy when it is unloaded.

[0526] elasticity During unloading, virtually all of the energy is released. This includes, for example, certain silicones and thermoplastic elastomers.

[0527] hardness The material's inherent resistance to deformation (e.g., measured by Young's modulus or indentation on standardized sample sizes). hardness (Described using a scale).

[0528] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0529] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0530] 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.

[0531] 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.

[0532] Rigid structures or componentsA structure or component that does not substantially change shape when subjected to loads typically encountered during use. An example of this use could be, for instance, establishing and maintaining a sealed relationship between a patient interface and the inlet of a patient's airway under a pressure load of approximately 20 to 30 cmH2O.

[0533] For example, an I-beam may have a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another instance, a structure or component may be flexible in the first direction and rigid in the second direction.

[0534] Respiratory circulation

[0535] Sleep apnea According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction in the airway prevents airflow even with the patient's effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0536] respiratory rate The rate of a patient's spontaneous breathing is usually measured in breaths per minute.

[0537] Duty cycle Inhalation time Ti Total breathing time Ttot The ratio.

[0538] Try to breathe. The work that a person who breathes spontaneously attempts to do while breathing.

[0539] The expiratory phase of the respiratory cycle: The time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0540] Traffic limits Flow restriction is considered a state of respiratory function in which increased effort by the patient does not result in a corresponding increase in flow. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0541] Types of flow-limited inhalation waveforms:

[0542] (i) flat It has an upward curve, followed by a relatively flat section, and then a downward curve.

[0543] (ii) M-shapedIt has two local peaks, one at the leading edge and one at the trailing edge, as well as a relatively flat area between the two peaks.

[0544] (iii) Chair-shaped It has a single local peak at the leading edge, followed by a relatively flat section.

[0545] (Iv) Reverse chair shape It has a relatively flat section, followed by a single local peak at the trailing edge.

[0546] Insufficient breathing According to some definitions, inadequate breathing is considered a reduction in flow, rather than an interruption of flow. In one form, inadequate breathing can be considered to have occurred when the flow rate drops below a threshold rate for a sustained period of time. Central inadequate breathing is considered to have occurred when inadequate breathing is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered inadequate breathing:

[0547] (i) The patient’s breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0548] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0549] hyperventilation Traffic volume increased to above normal levels.

[0550] Inspiratory phase of the respiratory cycle The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0551] Airway patency The degree or extent of airway opening. Smooth The airway is open. Airway patency can be quantified, for example, a value of one (1) indicates that the airway is open, and a value of zero (0) indicates that the airway is closed (obstructed).

[0552] Positive end-expiratory pressure (PEEP) The pressure above atmospheric pressure that exists in the lungs at the end of expiration.

[0553] Peak traffic (Qpeak) The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0554] respiratory flow, patient Airflow rate, respiratory airflow rate (Qr) These terms can be understood as referring to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0555] Tidal volume (Vt) Inspiratory volume: The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, inspiratory volume... Vi The volume of inhaled air is equal to the volume of exhaled air. Ve (The volume of exhaled air), therefore, the volume of a single tidal element. Vt It can be defined as equal to any quantity. In fact, tidal volume... Vt Estimated as inspiratory volume Vi and expiratory volume Ve A combination of, for example, the average.

[0556] (Inhalation) Time (Ti) The duration of the inspiratory portion of the respiratory flow waveform.

[0557] (Call-out) Time (Te) The duration of the expiratory portion of the respiratory flow waveform.

[0558] (Total) Time (Ttot) The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0559] Typical recent ventilation Ventilation volume at a predetermined time scale Vent The recent values ​​of ventilation volume tend to converge, which is a measure of the central tendency of recent values ​​of ventilation volume.

[0560] Upper airway obstruction (UAO) This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential across the upper airway increases (Starling resistor behavior).

[0561] ventilation ( Vent Minute ventilation is a measurement of the rate at which gases are exchanged by a patient's respiratory system. Measurements of ventilation can include one or both of inspiratory flow rate and expiratory flow rate (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0562] ventilation

[0563] Adaptive Servo Ventilator (ASV) A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined based on a certain characteristic of the patient (such as the patient's respiratory characteristics).

[0564] Backup rateThe parameters of the ventilator are set such that, if not triggered by spontaneous breathing effort, the ventilator will deliver the minimum respiratory rate (usually in breaths per minute) to the patient.

[0565] Looping Termination of the inspiratory phase of the ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, it is considered that the ventilator will periodically stop delivering breaths at the end of the inspiratory phase of the respiratory cycle.

[0566] Positive expiratory airway pressure (EPAP) The pressure of changes in breathing is added to it to generate the base pressure of the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0567] End-expiratory pressure (EEP) EEP is the desired mask pressure that the ventilator attempts to achieve at the end of the expiratory phase of breathing. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP is equal to EPAP.

[0568] Inspiratory Positive Airway Pressure (IPAP) The maximum desired mask pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.

[0569] Pressure support This indicates the pressure increase during inspiratory breathing that exceeds the pressure increase during expiratory breathing. It typically refers to the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., ...). PS = IPAP – EPAP In some cases, pressure support refers to the difference that a ventilator is designed to achieve, rather than the difference that it actually achieves.

[0570] Servo ventilator A ventilator that measures a patient’s ventilation, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0571] Autonomous / Timed (S / T) This is a mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of air.

[0572] swing : A term equivalent to stress support.

[0573] trigger When the ventilator delivers a breath of air to a patient who is breathing independently Air This is believed to be triggered by the patient's effort at the beginning of the respiratory phase of the respiratory cycle.

[0574] anatomy

[0575] Facial Anatomy

[0576] Alar (nose wing): The outer wall or "wing" of each nostril (plural: alar)

[0577] Nasal angle The angle formed between the nostrils and the nasal wings.

[0578] Nasal alar tip: nose wing The outermost point on.

[0579] Nasal alar curvature (or nasal alar ridge) point Each nostrils The last point in the curved baseline, in nostrils It can be found in the folds formed by the cheeks.

[0580] Auricle: The entire visible external portion of the ear.

[0581] (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.

[0582] (Nasal) Cartilage Framework The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0583] Nose columella: Separate the nostrils and extend the skin strip from the nasal protuberance to the upper lip.

[0584] Nasal columellar angle: The angle between the line drawn through the midpoint of the nostril cavity and the line drawn perpendicular to the Frankfurt horizontal plane and intersecting the lower nasal point.

[0585] Frankfurt Horizon The 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.

[0586] The dot between the eyebrows: Located on soft tissue, it is the most prominent point in the midsagittal plane of the forehead.

[0587] Lateral nasal cartilage The cartilaginous plate is roughly triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0588] Below the lip (midpoint of the lower lip) The lips that extend between the mouth and the point below the nose.

[0589] On the upper lip (midpoint of the upper lip) The lips that extend between the point below the nose and the mouth.

[0590] Greater nasal cartilageThe 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... nostrils Three or four small cartilages.

[0591] Nostrils The nostril is a roughly oval-shaped opening that forms the entrance to the nasal cavity. The singular form of nares is nostril (naris). The nostrils are separated by the nasal septum.

[0592] Nasolabial folds or nasolabial folds The skin folds or grooves that separate the cheeks from the upper lip, extending from each side of the nose to the corners of the mouth.

[0593] Nasolabial angle The angle between the columella and the upper lip (which intersect at the subnasal point).

[0594] base point under ear The lowest point where the auricle attaches to the facial skin.

[0595] Ear base point The highest point where the auricle attaches to the facial skin.

[0596] Nasal protrusion: The most prominent point or tip of the nose can be identified in a side view of the rest of the head.

[0597] Philtrum: The midline groove extends from the lower border of the nasal septum to the top of the upper lip.

[0598] Anterior chin point: Located on the soft tissue, at the very front midpoint of the chin.

[0599] Back (nose) The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0600] sagittal plane The sagittal plane is a vertical plane running from front (front part) to back (back part). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0601] Bridge of the nose point: Located on the soft tissue, it is the most recessed point covering the forehead-nose suture area.

[0602] Septal cartilage (nose) The nasal septum cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0603] lower edge of the nostril : 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.

[0604] Subnasal pointLocated on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0605] Above the chin 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.

[0606] Skull Anatomy

[0607] Frontal bone The frontal bone includes a large vertical portion ( Forehead scales ), which corresponds to the area called the forehead.

[0608] mandible The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0609] maxilla The maxilla forms the upper jaw and is located above the mandible and below the eye socket. frontal process of maxilla It protrudes upward from one side of the nose and forms part of its outer boundary.

[0610] Nasal bone The nasal bones are two small, rectangular bones whose size and shape vary among individuals; they are placed side by side in the middle and upper parts of the face and form the "bridge" of the nose through their intersection.

[0611] Root of the nose: The junction of the frontal bone and the two nasal bones is located directly between the eyes and in the depression above the bridge of the nose.

[0612] occipital bone The occipital bone is located in the posterior and inferior parts of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity connects to the vertebral canal. The curved plate behind the foramen magnum is... Pillow scales .

[0613] eye socket The bony cavity in the skull that houses the eyeball.

[0614] parietal bone The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0615] 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.

[0616] cheekbones The face includes two cheekbones, which are located on the upper and outer parts of the face and form the protrusions of the cheeks.

[0617] Respiratory Anatomy

[0618] Diaphragm:A sheet of muscle extending across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0619] throat The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0620] lung The lungs are the human respiratory organs. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0621] nasal cavity The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal bones. The anterior part of the nasal cavity is the nasal part, while the posterior part connects to the nasopharynx via the posterior nasal aperture.

[0622] pharynx: The pharynx is a part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is routinely divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0623] Patient Interface

[0624] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of patients rebreathing excessive CO2 by opening to the atmosphere in a safe manner.

[0625] Bending pipe: A bend is an example of a structure that guides the axis of an airflow traveling through it to change direction 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 removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0626] frame The term "frame" is 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.

[0627] headgear The term "headgear" is considered to refer to a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold a patient interface in place on the patient's face for delivery of respiratory therapy. Some straps are formed from laminated composites of soft, flexible, elastic materials such as foam and fabric.

[0628] membrane The term "membrane" is to be understood as referring to a typically thin element that is preferably substantially non-flexural but tensile.

[0629] Inflation chamber The mask inflation chamber is considered to refer to a portion of the patient interface having a wall that at least partially encloses a volume of air pressurized to above atmospheric pressure during use. A shell may form part of the wall of the mask inflation chamber.

[0630] seal : 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 to achieve "sealing" between them, without requiring a separate "seal" element itself.

[0631] shell The term "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 could 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.

[0632] reinforcement A reinforcement is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0633] pillar: The strut will be considered a structural component designed to increase the compressibility of another component in at least one direction.

[0634] Rotary axis (Noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis under low torque. In one form, the shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of an air delivery conduit, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. In use, little or no airflow leaks from the shaft.

[0635] Lace (Noun): A structure designed to resist tension.

[0636] Vent (Noun): Permission Air A structure that allows air to flow from inside the mask or through a 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.

[0637] The shape of the structure

[0638] 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.

[0639] To facilitate the description of the shape of three-dimensional structures and surfaces, we first consider points. p The cross-section passing through the surface of the structure. See also Figures 3B to 3F The diagram illustrates points on the surface. p Examples of cross-sections at the location, and the resulting planar curves. Figures 3B to 3F It also has illustrations p The outward normal vector at that location. p The outward normal vector at a point points away from the surface. In some instances, we describe the surface from the perspective of an imaginary little person standing upright on it.

[0640] One-dimensional curvature

[0641] Plane curves in p The curvature at a point can be described as having a sign (e.g., positive, negative) and magnitude (e.g., 1 / 2). p (The radius of the circle on the curve at that point).

[0642] Positive curvature: if p If the curve at a point turns towards the outward normal, then the curvature at that point will be taken as positive (if the imagined figure leaves the point). p (Then they must go uphill). See also Figure 3B (and Figure 3C Compared to a relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave curves.

[0643] Zero curvature: if p If the curve at point is a straight line, then the curvature will be zero (if the imagined figure leaves point). p Then they can walk horizontally, without going up or down. (See also...) Figure 3D .

[0644] Negative curvature: if p If the curve at a point deviates from the outward normal, then the curvature in that direction at that point will be negative (if the imagined figure moves away from the point). p (Then they must go downhill). See also Figure 3E (and Figure 3F Compared to a relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to a relatively large negative curvature). Such curves are usually called convex curves.

[0645] Curvature of a two-dimensional surface

[0646] 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. Figures 3B to 3F A planar curve in a plane can be an instance of multiple cross-sections at a specific point.

[0647] Principal curvature and principal direction: The direction of the normal plane where the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum curvature appears in Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section in the main direction. p The principal curvature at a point is the curvature along the principal direction.

[0648] Surface area: A set of connection points on a surface. Within a region, this set of points can have similar characteristics, such as curvature or sign.

[0649] Saddle-shaped area: At each point, there are regions where the principal curvature has opposite signs, one positive and the other negative (depending on the direction the imagined person is turning, they could be going uphill or downhill).

[0650] vaulted area:Regions where the principal curvature has the same sign at each point, such as both being positive ("recessed vault") or both being negative ("convex vault").

[0651] Cylindrical area: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0652] Planar area: Two of the surface regions have a principal curvature of zero (or, for example, zero within manufacturing tolerances).

[0653] Surface edge: The boundary or limit of a surface or area.

[0654] path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a path on a surface from... f (0) to f (1) A continuous spatial curve. In some forms of this technique, a “path” can be described as a route or distance, including, for example, a set of points on a surface. (An imagined path for a person is the place where they walk on the surface, and is similar to a garden path).

[0655] Path length: In some forms of this technique, "path length" will be considered to refer to the length along the surface from f (0) to f (1) The distance, that is, the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imagined person would be the distance they must walk along the path on the surface).

[0656] 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 with the same length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same length as the straight-line distance between the two points. (For the imaginary reader, straight-line distance will correspond to a distance that is "in a straight line.")

[0657] Space curves

[0658] Space curves Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, meaning they have no endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3QThe typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0659] Tangent unit vector (or unit tangent vector): For each point on the curve, the vector at that point specifies the direction and magnitude from that point. The tangential unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along the curve and falling from their aircraft at a specific point, the direction of the tangential vector is the direction they would have traveled.

[0660] Unit normal vector: As an imagined person moves along the curve, the tangent vector itself also changes. The unit vector that changes in the same direction as the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0661] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see example...). Figure 3P ) or alternatively by the left-hand rule ( Figure 3O To determine.

[0662] Close plane: A plane containing a unit tangent vector and a unit principal normal vector. See also Figure 3O and Figure 3P .

[0663] Twisting of space curves: The torsion at a point on a space curve is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in a plane has zero torsion. A space curve deviating relatively small from the osculating plane will have a relatively small amount of torsion (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of torsion (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3S The twist near the top coil of the spiral is greater than Figure 3S The size of the twist of the bottom coil of the spiral.

[0664] refer to Figure 3P According to the right-hand rule, a space curve turning in the direction of the right-hand binormal can be considered to have a right-hand positive twist (e.g., as...). Figure 3S(As shown in the right-handed spiral). A space curve that rotates away from the direction of the right-handed binormal can be considered to have right-handed negative torsion (e.g., a left-handed spiral).

[0665] Equivalently, and referring to the left-hand rule (see...) Figure 3O A space curve that turns in the direction of the left-hand secondary normal can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0666] hole

[0667] 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. Figure 3I The structure shown has a one-dimensional hole defined by a planar curve on its surface.

[0668] 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 Figure 3L padding and Figure 3M and Figure 3N 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 Figure 3K The structure shown has a two-dimensional hole defined by the surface shown.

[0669] Other notes

[0670] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly encompassed within this technique. The upper and lower limits of these intermediate ranges (which may be independently included within the intermediate range) are also encompassed within this technique, but are subject to any explicit exclusions within the range. Where the range includes one or both limitations, the range excluding any one or both of those included limitations is also included within this technique.

[0671] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used for any suitable significant number to the extent that actual technical implementation may allow or require them.

[0672] 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 technology 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.

[0673] 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 specified, any and all components described herein should be understood as being capable of being manufactured, and therefore can be manufactured together or separately.

[0674] 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.

[0675] 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. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0676] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0677] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0678] 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 that are not required for practicing the techniques described. 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 aspects may be performed simultaneously or even concurrently.

[0679] Therefore, it should be understood that numerous modifications can be made to the illustrative examples, and other arrangements can be designed, without departing from the spirit and scope of this technology.

[0680] List of reference numerals

[0681]

[0682]

[0683]

Claims

1. A patient interface for delivering a flow of air at a positive pressure with respect to ambient air pressure to an entrance of the patient’s airways including at least an entrance to the patient’s nares, to improve sleep disordered breathing, while the patient is sleeping, the patient interface comprising: a frame assembly; and a nasal pillow assembly configured to be removably and repeatably connectable to the frame assembly, characterized in that the frame assembly and the nasal pillow assembly form at least a portion of a plenum chamber pressurisable to a therapeutic pressure, the nasal pillow assembly comprises a single piece construction including a seal-forming structure and a frame connecting structure, the seal-forming structure being constructed and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s airways, the frame connecting structure being constructed and arranged to removably and repeatably connect the nasal pillow assembly to the frame assembly, the seal-forming structure includes a pair of nasal pillows configured to form a seal with respective nares of the patient’s nose, the seal-forming structure comprises a first elastomeric material and the frame connecting structure comprises a second elastomeric material, the first elastomeric material comprises a lower Shore A hardness or stiffness than the second elastomeric material, the frame connecting structure comprises an undercut portion acting as an interface or catch adapted to connect to the frame assembly, the frame connecting structure is arranged along an inner surface or inner periphery of the seal-forming structure such that the frame connecting structure and the undercut portion thereof are arranged or oriented towards an interior of the nasal pillow assembly forming at least a portion of the plenum chamber, and at least a portion of the nasal pillow assembly is configured to directly contact the patient’s upper or superior lip in use.

2. The patient interface of claim 1, wherein, the plenum chamber comprises a rear wall including a rear surface configured and arranged to directly contact the patient’s upper or superior lip.

3. The patient interface of any one of claims 1 to 2, wherein, each of the pair of nasal pillows comprises a frusto-conical body configured to form a seal against a peripheral region of the naris of the patient.

4. The patient interface of any one of claims 1 to 2, wherein, each of the pair of nasal pillows comprises a double-walled construction including an outer wall and an inner wall.

5. The patient interface of claim 4, wherein, the outer wall is relatively thinner than the inner wall.

6. The patient interface of any one of claims 1 to 2, wherein, the seal-forming structure and the frame connecting structure comprise an overmoulded construction to form a single piece integrated component.

7. The patient interface of claim 6, wherein, the frame connecting structure comprises a base mould and the seal-forming structure comprises an overmould provided to the base mould.

8. The patient interface of any one of claims 1 to 2, wherein, each of the first and second elastomeric materials comprises a TPE or silicone material.

9. The patient interface of any one of claims 1 to 2, wherein, the frame connecting structure comprises one or more docking surfaces configured to interface with the seal-forming structure.

10. The patient interface of any one of claims 1 to 2, wherein, the first elastomeric material comprises a hardness in the range 30 to 50 Shore A and the second elastomeric material comprises a hardness in the range 60 to 90 Shore A.

11. The patient interface of any one of claims 1 to 2, wherein, the patient interface further comprises a sealing lip provided to the seal-forming structure of the first elastomeric material, the sealing lip being constructed and arranged to form a seal with the frame assembly.

12. The patient interface of any one of claims 1 to 2, wherein, the frame assembly is relatively stiffer than the frame connecting structure.

13. The patient interface of any one of claims 1 to 2, wherein, The frame connection structure and the undercut thereof extend around the entire perimeter or periphery of the seal-forming structure.

14. The patient interface of any one of claims 1 to 2, wherein, The patient interface further comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

15. The patient interface of any one of claims 1 to 2, wherein, The patient interface further comprises a cushion assembly configured to be removably and repeatably connectable to the frame assembly, the cushion assembly comprising a nasal pad adapted to form a seal against at least an underside of the patient's nose, and a selected one of the cushion assembly and the nasal pillow assembly is interchangeably attachable to the frame assembly.

16. The patient interface of any one of claims 1 to 2, wherein, One or more portions of the plenum chamber formed by the nasal pillow assembly include a reinforcement configured to increase a rigidity or stiffness of the plenum chamber and / or to increase a volume of the plenum chamber.

17. The patient interface of claim 16, wherein, The reinforcement includes a thickened wall region along one or more portions of a rear wall and / or a front wall of the plenum chamber formed by the nasal pillow assembly.

18. The patient interface of claim 17, wherein, The reinforcement includes one or more ribs along a boundary of the thickened wall region.

19. The patient interface of claim 16, wherein, The reinforcement includes a thickened wall region along a portion of a base of the plenum chamber between the pair of nasal pillows.

20. A CPAP system for providing positive pressure gas to a patient for respiratory therapy, the CPAP system comprising: a patient interface according to any one of claims 1 to 19; characterized in that the CPAP system further comprises: an RPT device configured to supply a flow of gas at a therapeutic pressure; and an air delivery conduit configured to communicate the flow of gas at the therapeutic pressure from the RPT device to the patient interface.

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