Textured seal forming structure for patient interface

Abstract

A patient interface may include an inflation chamber pressurizable to a treatment pressure; a seal-forming structure constructed and arranged to seal with an area of the patient's face, the seal-forming structure formed from a silicone, a first portion of the seal-forming structure comprising a textured silicone surface, a second portion of the seal-forming structure comprising a textured silicone surface, and a third portion of the seal-forming structure comprising a textured silicone surface. A second portion of the seal-forming structure comprising a textured silicone surface configured to contact the patient's face in use and having a plurality of protrusions and recesses, the second portion of the seal-forming structure comprising a non-textured silicone surface, and the recesses being recessed below the non-textured silicone surface and the protrusions of the textured silicone surface; and a positioning and stabilizing structure configured to maintain the seal forming structure in a therapeutically effective position on the patient's head.

Description

[0001] This patent document contains a portion of copyrighted material. The copyright holder does not object to anyone copying the patent document or patent disclosure appearing in the patent office's patent archives or records by fax, but otherwise retains all copyright rights.

[0002] 1. Cross-references to related applications This application claims priority to U.S. Provisional Application No. 63 / 498,891, filed April 28, 2023, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field 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.

[0004] 2.2 Description of related technologies 2.2.1 The Human Respiratory System and Its Disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0005] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood, and carbon dioxide to move in the opposite direction. The trachea divides into the right main bronchus and the left main bronchus, which eventually further divide into the terminal bronchioles. The bronchi form the conduction airways and do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones. See John B. West's *Physiology of Respiratory Systems*, Lippincott Williams & Wilkins, 2012. Respiratory Physiology 9th edition of "The 9th Edition ...

[0006] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0007] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related malventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0008] 2.2.2 Treatment Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0009] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0010] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to the therapy if they find one or more of the following to be true: uncomfortable, difficult to use, expensive, or unsightly.

[0011] 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 their breathing work. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory distress syndromes, including conditions such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0012] Invasive ventilation (IV) provides ventilatory support to patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0013] 2.2.3 Respiratory Therapy System These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0014] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0015] 2.2.3.1 Patient Interface Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure to achieve the therapy, such as a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow-based therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0016] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not maintain adequate pressure. Mask systems designed 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 the ambient environment.

[0017] Some masks may be clinically disadvantageous for this technique, such as those that block airflow through the nose and only allow it through the mouth.

[0018] 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 for this technology, these masks may be uncomfortable or impractical.

[0019] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0020] Some masks may cause claustrophobia, anxiety, and / or a feeling of being too abrupt to some patients.

[0021] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to the other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0022] Therefore, some masks are obtrusive, unsightly, expensive, ill-fitting, difficult to use, and / or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Wearing the wrong size mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed to be 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 prolonged wear (e.g., for several hours) can be uncomfortable. This discomfort can lead to decreased patient adherence to therapy, especially when the mask is worn during sleep.

[0023] CPAP therapy is very effective in treating certain breathing disorders, provided the patient adheres to the therapy. Patients may not adhere to the therapy if the mask is uncomfortable or difficult to use. Because 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 their mask, and this can affect patient adherence.

[0024] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0025] For these reasons, a unique field has emerged for patient interfaces used to deliver CPAP during sleep.

[0026] 2.2.3.1.1 Sealing Formation Structure Patient interfaces may include sealing structures. Because the sealing 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.

[0027] 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 surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In one form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be known by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0028] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​a patient's face may not be suitable for use 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.

[0029] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be modified to form a seal.

[0030] 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 during face-to-face engagement of the seal-forming structure. The seal-forming structure may include an air- or fluid-filled gasket, or a molded or shaped surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0031] 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 on the patient's face when positive pressure is applied within 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.

[0032] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these elements uncomfortable.

[0033] Another form of sealing structure can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0034] The following patent applications disclose a series of patient interface sealing structure technologies: WO 1998 / 004310; WO2006 / 074513; WO 2010 / 135785.

[0035] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0036] ResMed Inc. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (describes SWIFT). TM Other aspects of the nose pillow cover), U.S. Patent Application 2009 / 0044808 (describes SWIFT) TM Other aspects of the LT nose pillow cover); International patent applications WO2005 / 063328 and WO 2006 / 130903 (describe MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052560 (describes SWIFT) TM Other aspects of the FX nose pillow mask).

[0037] 2.2.3.1.2 Positioning and Stabilizing Structure The seal-forming structure of a patient interface used in pneumatic therapy is subject to counter-stress from pneumatic pressure, which can disrupt the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain a tight seal with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: the effectiveness of the technique in maintaining the seal-forming structure in the desired position and sealing it with the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0038] 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.

[0039] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems, such as poor fit, bulkiness, discomfort, and inconvenience of use.

[0040] 2.2.3.1.3 Pressurized air duct In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit that is fluidly connected to the patient interface at a position anterior to the patient's face when the patient interface is positioned over the patient's face during use. The conduit can extend forward from the patient interface away from the patient's face.

[0041] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also functions as part of a headgear to position and stabilize a sealing portion of the patient interface at the appropriate location on the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tubing." Such patient interfaces allow a catheter in the air circuit that provides a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than the front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US 2007 / 0246043, the contents of which are incorporated herein by reference, wherein a catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0042] Ideally, the patient interface with a head sleeve should allow the patient to feel comfortable during prolonged wear while asleep, forming an airtight and stable seal with the patient's face, while also conforming to a certain range of the patient's head shape and size.

[0043] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device 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 airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0044] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system (such as the RPT device and the patient interface) during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for both inhalation and exhalation.

[0045] 2.2.3.4 Humidifier Delivering unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases airway comfort for the patient. Additionally, in cooler climates, warm air applied to the area inside and around the patient interface on the face is generally more comfortable than cold air.

[0046] 2.2.3.5 Ventilation port technology Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., to the surrounding environment). 3. Summary of the Invention 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.

[0048] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0049] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0050] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0051] One form of this technology includes a positioning and stabilizing structure configured to provide force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0052] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0053] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, the size and configuration of which are designed to receive an airflow at the therapeutic pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface also includes positioning and stabilizing structures to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head.

[0054] Another aspect of this technology is a series of modular elements that can be interconnected to form different types of patient interfaces.

[0055] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably to form different modular components.

[0056] One aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; a sealing structure configured and arranged to seal an area of ​​the patient's face, the sealing structure being formed of silicone resin, a first portion of the sealing structure including a textured silicone resin surface configured to contact the patient's face in use and having a plurality of protrusions or recesses, and a second portion of the sealing structure including a non-textured silicone resin surface; and a positioning and stabilizing structure configured to hold the sealing structure in a therapeutically effective position on the patient's head.

[0057] Another aspect of this technology relates to a sealing structure configured and arranged to seal an area of ​​a patient's face. The sealing structure is formed of silicone resin. A first portion of the sealing structure includes a textured silicone resin surface configured to contact the patient's face in use and having a plurality of protrusions or recesses. A second portion of the sealing structure includes a non-textured silicone resin surface.

[0058] Another aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; a sealing structure configured and arranged to seal an area of ​​the patient's face, the sealing structure being formed of silicone resin, a first portion of the sealing structure including a textured silicone resin surface configured to contact the patient's face in use and having a plurality of protrusions and recesses, a second portion of the sealing structure including a non-textured silicone resin surface, and the recesses being recessed below the non-textured silicone resin surface and the protrusions of the textured silicone resin surface; and a positioning and stabilizing structure configured to hold the sealing structure in a therapeutically effective position on the patient's head.

[0059] 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 a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use, the sealing structure being formed of silicone resin, a first portion of the sealing structure including a textured silicone resin surface configured to contact the patient's face during use and having a plurality of protrusions and recesses, the sealing... The second portion of the forming structure includes a non-textured silicone surface, and the recess is recessed below the non-textured silicone surface and the protrusions of the textured silicone surface; and a positioning and stabilizing structure configured to hold the sealing forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the supraaural base point of the patient's head; wherein the patient interface is configured such that the patient's mouth is not covered, or if the sealing forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without a pressurized airflow through the inlet port of the inflation chamber.

[0060] In examples of the aspects in the preceding four paragraphs: (a) the protrusions of the untextured silicone surface and the textured silicone surface may be at the same height relative to the recesses of the textured silicone surface; (b) the protrusions of the untextured silicone surface and the textured silicone surface may be at different heights relative to the recesses of the textured silicone surface; (c) the protrusions may include a first group of protrusions at a first height relative to the recesses and a second group of protrusions at a second height relative to the recesses that is different from the first height; (d) the protrusions may have the same height relative to the recesses; (e) each of the protrusions may be spaced evenly from adjacent protrusions, each of the protrusions being spaced a first distance from a first adjacent protrusion and spaced from a second adjacent protrusion. Unlike the first distance, the second distance, (f) the protrusions can be formed as a pattern including columns and rows, (g) each of the protrusions in the first column of the column can have a uniform first shape and a first height relative to the concave portion, (h) each of the protrusions in the second column of the column adjacent to the first column of the column can have a uniform second shape and a second height relative to the concave portion, (i) each of the protrusions in the first row of the row can have a uniform first shape and a first height relative to the concave portion, (j) each of the protrusions in the second row of the row adjacent to the first row of the row can have a uniform second shape and a second height relative to the concave portion, (k) each of the protrusions can have a uniform cross-sectional area along its height, (l) the protrusions in Each of the protrusions may have a cross-sectional area decreasing from the adjacent recess to the peak; (m) each of the protrusions may have the same cross-sectional area at its base as the adjacent protrusion; (n) each of the protrusions may have a cross-sectional area at its base that is different from the cross-sectional area of ​​at least one adjacent protrusion; (o) a textured silicone surface may be formed on the surface of the sealing structure, the surface of which is configured to contact the patient's nose in use; (p) a textured silicone surface may be formed on the surface of the sealing structure, the surface of which is configured to contact the upper lip of the patient in use; (q) a textured silicone surface may be formed on the surface of the sealing structure, the surface of which is configured to contact the upper lip of the patient in use. In use, the silicone resin surface may not be formed on the surface of the sealing structure, which is configured to contact the outer side of the patient's mouth on the patient's face during use; (s) the textured silicone resin surface may be formed on the rear side of the sealing structure to contact the patient's face during use; (t) the textured silicone resin surface may be formed on the front side of the sealing structure such that at least a portion of the textured silicone resin surface is away from and does not contact the patient's face during use; (u) the sealing structure may be a full-face arrangement configured to seal against the patient's face around the patient's nose and mouth during use; (v) the sealing structure may be a nose arrangement.The nasal arrangement is configured to seal against the patient's face around the patient's nose (including the patient's nasal protuberance) during use, while leaving the patient's mouth uncovered. (w) The sealing structure can be a nasal pad arrangement configured to seal against the lower periphery of the patient's nose during use, while leaving at least a portion of the patient's mouth and the patient's nasal protuberance uncovered. (x) The sealing structure can be an ultra-compact full-face arrangement configured to seal against the patient's face together around the patient's nose and mouth during use. The sealing structure has at least one nasal opening and one oral opening. The at least one nasal opening is configured to direct airflow under the treatment pressure to the patient's nostrils, and the oral opening is configured to direct airflow under the treatment pressure to the patient's mouth. (y) The ventilation structure can be configured to allow the patient's exhaled air to flow continuously from the interior of the inflatable chamber to the surrounding environment. The size and shape of the ventilation structure are designed to maintain the treatment pressure in the inflatable chamber during use. (z) The sealing structure can include a flange. The rim has an outer surface and an inner surface opposite to the outer surface, at least a portion of the outer surface being configured to contact the patient's face during use, the inner surface being configured not to contact the patient's face during use, and the textured silicone surface may be formed on the outer surface and not on the inner surface, (aa) the textured silicone surface may be configured to simulate textiles, (bb) the textured silicone surface may be configured to simulate textiles with a woven pattern, (cc) the textured silicone surface may be configured to simulate textiles with a knitted pattern, (dd) a portion of the non-textured silicone surface may be configured to contact the patient's face during use, (ee) the non-textured silicone surface may be configured not to contact the patient's face during use, (ff) the textured silicone surface is formed by laser etching, (gg) the silicone resin may be a two-component silicone rubber comprising a 1:1 ratio of type A silicone rubber and type B silicone rubber, (hh) the silicone resin may be a two-component silicone rubber comprising a 2:1 ratio of type A silicone rubber and type B silicone rubber, (ii) the silicone resin may have as used in ASTM Shore A and Shore B indentation hardness measured by D2240 in the range of approximately 30 to approximately 60; (jj) silicone resin can have Shore A and Shore B indentation hardness in different ranges; (kk) silicone resin can have Shore A indentation hardness in the range of approximately 30 to approximately 60 and Shore B indentation hardness in the range of approximately 35 to approximately 68, as measured using ASTM D2240; (ll) silicone resin can have Shore A and Shore B resilience in the range of approximately 40% to 80%, as measured using ASTM D1054; (mm) the seal-forming structure can be treated with vacuum ultraviolet (VUV) treatment; (nn) the textured silicone resin surface can be treated with VUV treatment.Furthermore, without VUV treatment of the untextured silicone resin surface, (oo) random cracks can be formed on the textured silicone resin surface, (pp) random cracks spanning from approximately 500 nm to approximately 1.5 µm can be formed on the textured silicone resin surface, (qq) the silicone resin on the textured silicone resin surface may have a higher surface roughness than the silicone resin on the untextured silicone resin surface, (rr) the silicone resin of the sealing structure may include one or more pigments, (ss) the sealing structure may include an organosilicon layer, (tt) the textured silicone resin surface may include an organosilicon layer, and the untextured silicone resin surface may lack an organosilicon layer, (uu) the organosilicon layer may be at least 1 μm deep, 2 to 5 μm deep, 2 to 10 μm deep, 2 to 20 μm deep, 2 to 50 μm deep, or 10 to 100 μm deep, and / or (vv) the silicone resin on the textured silicone resin surface may have a higher surface roughness than the silicone resin on the untextured silicone resin surface.

[0061] One aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure; a sealing formation structure configured and arranged to seal an area of ​​the patient's face, the sealing formation structure being formed of silicone and treated with vacuum ultraviolet (VUV) treatment; and a positioning and stabilizing structure configured to hold the sealing formation structure in a therapeutically effective position on the patient's head.

[0062] Another aspect of this technology relates to a sealing structure constructed and arranged to seal an area of ​​a patient's face, the sealing structure being formed of silicone resin and treated with vacuum ultraviolet (VUV) treatment.

[0063] 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; and a sealing structure constructed and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use, the sealing structure being formed of silicone resin and treated with vacuum ultraviolet light. The treatment involves external (VUV) processing; and a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the supraaural base point; wherein the patient interface is configured such that the patient's mouth is not covered, or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized airflow through the inlet port of the inflation chamber. Examples of aspects in the preceding three paragraphs include: (a) the seal-forming structure can be treated with vacuum ultraviolet (VUV) processing, (b) a textured silicone surface can be treated with VUV processing, and a non-textured silicone surface can be treated without VUV processing, (c) random cracks can be formed on the textured silicone surface, and (d) random cracks spanning from approximately 500 nm to approximately 1.5 nm can be formed on the textured silicone surface. (e) The silicone resin on the textured silicone resin surface may have a higher surface roughness than the silicone resin on the untextured silicone resin surface; (f) The silicone resin of the sealing structure may include one or more pigments; (g) The sealing structure may include an organosilicon layer; (h) The textured silicone resin surface may include an organosilicon layer, and the untextured silicone resin surface may lack an organosilicon layer; (i) The organosilicon layer may be at least 1 micrometer deep, 2 to 5 micrometer deep, 2 to 10 micrometer deep, 2 to 20 micrometer deep, 2 to 50 micrometer deep, or 10 to 100 micrometer deep; and / or (j) The silicone resin on the textured silicone resin surface may have a higher surface roughness than the silicone resin on the untextured silicone resin surface.

[0064] 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.

[0065] One aspect of this technology is a method for manufacturing equipment.

[0066] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0067] One aspect of certain forms of this technology is an easy-to-use medical device, for example, easy to use by a person without medical training, a person with limited dexterity and vision, or a person with limited experience in using this type of medical device.

[0068] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., a person in a household).

[0069] 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. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0070] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as processors in dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0071] Of course, parts of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of each aspect can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0072] Other features of the technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions This technology is illustrated by way of example rather than limitation in the various figures of the accompanying drawings, and similar reference numerals in the figures refer to similar elements, including: 4.1 Breathing Therapy System Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nose pillow receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0074] Figure 1BA system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, receiving 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.

[0075] Figure 1C A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a full-face mask and 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.

[0076] 4.2 Respiratory System and Facial Anatomy 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.

[0077] 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.

[0078] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corner of the mouth. It also indicates the upper, lower, radially inward, and radially outward directions.

[0079] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0080] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfort plane and the nasolabial angle. The coronal plane is also indicated.

[0081] Figure 2F A basal view of the nose with several identified 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.

[0082] Figure 2G A side view showing the surface features of the nose is shown.

[0083] 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.

[0084] Figure 2I An anatomical view of the medial side 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.

[0085] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0086] Figure 2K This diagram shows a side view of the skull, including the surface contours of the head and several muscles. 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.

[0087] Figure 2L The frontal lateral view of the nose is shown.

[0088] 4.3 Patient Interface Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0089] Figure 3A-1 It shows the effect when in use. Figure 3A The force on the patient interface.

[0090] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0091] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0092] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0093] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3FThe curvature amplitude shown has a relatively small amplitude compared to that shown.

[0094] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0095] Figure 3G A 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 dome and saddle-shaped areas are indicated.

[0096] 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-shaped area are indicated.

[0097] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0098] Figure 3J It shows the way Figure 3I The cross-section of the structure. The surface shown in the figure is... Figure 3I The structure defines a two-dimensional hole.

[0099] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0100] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0101] Figure 3M It shows the way Figure 3L The cross-section of the mask is shown, and the inner surface of the airbag is also shown. The inner surface defines two-dimensional openings in the mask.

[0102] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0103] Figure 3O The diagram illustrates the left-hand rule.

[0104] Figure 3P The right-hand rule is illustrated.

[0105] Figure 3Q The left ear is shown, including the left ear spiral.

[0106] Figure 3R The right ear is shown, including the right ear spiral.

[0107] Figure 3S A right-handed spiral is shown.

[0108] 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.

[0109] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0110] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The view is oriented perpendicular to the center 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.

[0111] Figure 3W It shows the way Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the liner in this region, the intermediate contact surface can be a tangent at the upper and lower points.

[0112] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 substantially coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane substantially 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.

[0113] Figure 3Y A patient interface with a catheter tip cap, according to this technology, is shown.

[0114] Figure 3Y-1 It shows the effect when in use. Figure 3Y The force on the patient interface.

[0115] 4.4 RPT device Figure 4AAn RPT device of one form according to the present technology is shown.

[0116] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to the blower and patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0117] 4.5 Respiratory waveform Figure 5 The diagram shows a typical breathing waveform of a person during sleep.

[0118] 4.6 Modular Figure 6A A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0119] Figure 6B A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0120] Figure 6C It shows that it can be used with Figure 6A padding or Figure 6B A perspective view of the tube used with the liner.

[0121] Figure 6D It shows that it can be used with Figure 6A padding or Figure 6B A perspective view of the hardener arm used with the padding.

[0122] Figure 6E It shows that it can be used with Figure 6A A perspective view of the headgear strap used with padding.

[0123] Figure 6F It shows that it can be used with Figure 6B A perspective view of the headgear strap used with padding.

[0124] Figure 6G It shows removable assembly to Figure 6C pipe or Figure 6D Front view of a pair of sleeves on the hardener arm.

[0125] Figure 6H It shows removable assembly to Figure 6D A front view of the complete sleeve on the hardener arm.

[0126] Figure 6IIt shows removable assembly to Figure 6D A front perspective view of another alternative form of the complete sleeve of the hardener arm.

[0127] Figure 6J It is worn connected to Figure 6C pipe, Figure 6E headgear and Figure 6G The sleeve Figure 6A A front view of the patient with the padding.

[0128] Figure 6K It is worn connected to Figure 6D rigid arm, Figure 6E headgear and Figure 6H The sleeve Figure 6A A front view of the patient with the padding.

[0129] Figure 6L It is worn connected to Figure 6C catheter head cover and Figure 6F The headgear Figure 6B A front view of the patient with the padding.

[0130] Figure 6M It is worn connected to Figure 6D hardener arm, Figure 6F headgear and Figure 6I The sleeve Figure 6B A front view of the patient with the padding.

[0131] Figure 6N yes Figure 6L A perspective view of the vent.

[0132] Figure 6O yes Figure 6M A separate perspective view of a portion of the air circuit.

[0133] Figure 6P This is a schematic diagram illustrating possible combinations of the patient interface.

[0134] 4.7 Textured Silicone Surface Figure 7A A detailed view of a portion of the technical front of the fabric is shown.

[0135] Figure 7B A detailed view of a portion of the technical back of the fabric is shown.

[0136] Figure 8A A first pattern is shown on the first side of a piece of silicone resin.

[0137] Figure 8B A second pattern is shown on the first side of a piece of silicone resin.

[0138] Figure 8CA third pattern is shown on the second side of a piece of silicone resin.

[0139] Figure 9A A detailed view of a portion of the technical front of the fabric is shown.

[0140] Figure 9B A detailed view of a portion of the technical back of the fabric is shown.

[0141] Figure 9C A detailed view of the knitted structure of the fabric is shown.

[0142] Figure 9D This is a schematic diagram depicting the brushing of fabric.

[0143] Figure 10A A first pattern is shown on the first side of a piece of silicone resin.

[0144] Figure 10B A second pattern is shown on the first side of a piece of silicone resin.

[0145] Figure 10C A third pattern is shown on the second side of a piece of silicone resin.

[0146] Figure 11A A detailed view of a portion of the technical front of the fabric is shown.

[0147] Figure 11B A detailed view of a portion of the technical back of the fabric is shown.

[0148] Figure 11C A detailed view of the knitted structure of the fabric is shown.

[0149] Figure 11D This is a schematic diagram depicting the cutting of fabric.

[0150] Figure 12A A first pattern is shown on the first side of a piece of silicone resin.

[0151] Figure 12B A second pattern is shown on the first side of a piece of silicone resin.

[0152] Figure 12C A third pattern is shown on the second side of a piece of silicone resin.

[0153] Figure 13A A detailed view of a portion of the technical front of the fabric is shown.

[0154] Figure 13B A detailed view of a portion of the technical back of the fabric is shown.

[0155] Figure 13C A detailed view of the knitted structure of the fabric is shown.

[0156] Figure 13D This is a schematic diagram depicting the brushing of fabric.

[0157] Figure 14A A first pattern is shown on the first side of a piece of silicone resin.

[0158] Figure 14B A second pattern is shown on the first side of a piece of silicone resin.

[0159] Figure 14C A third pattern is shown on the second side of a piece of silicone resin.

[0160] Figure 15A A plan view of a textured silicone surface according to an example of the present technology is shown.

[0161] Figure 15B Examples of this technology are shown. Figure 15A A front view of the textured silicone resin surface in the image.

[0162] Figure 16A A plan view of a textured silicone surface according to an example of the present technology is shown.

[0163] Figure 16B Examples of this technology are shown. Figure 16A A front view of the textured silicone resin surface in the image.

[0164] Figure 17A A front view of a textured silicone surface according to an example of the present technology is shown.

[0165] Figure 17B A front view of a textured silicone surface according to an example of the present technology is shown.

[0166] Figure 18A A front view of the untreated surface is shown.

[0167] Figure 18B A front view of a processed surface according to an example of the present technology is shown.

[0168] Figure 19A A front view of the untreated surface is shown.

[0169] Figure 19B A front view of a processed surface according to an example of the present technology is shown.

[0170] Figure 20A This is a front perspective view of a head-mounted display.

[0171] Figure 20B yes Figure 20A Rear perspective view of the head-mounted display. 5. Detailed Implementation Before describing this technology in more detail, it should be understood that the technology is not limited to the specific instances that may vary as described herein. 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.

[0173] The following description is provided for various instances that may share one or more common characteristics and / or features. 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.

[0174] 5.1 Therapy In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0175] In some instances of this technology, positive pressure air is supplied to the patient's nasal passages via one or both nostrils.

[0176] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0177] 5.2 Respiratory Therapy System In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0178] 5.3 Patient Interface According to one aspect of this technology, such as Figure 3A The non-invasive patient interface 3000 shown includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged around the patient's airway inlet to maintain positive pressure at the patient's airway inlet. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0179] like Figure 3Y As shown, the non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, and a connection for connecting to an air circuit (e.g., Figures 1A to 1CThe air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which sense it or they may be replaced by different components, such as components of different sizes.

[0180] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0181] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the ambient environment, for example, at least 2, 4, 6, 10 or 20 cmH2O relative to the ambient environment.

[0182] 5.3.1 Sealing Formation Structure In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary over time and from patient to patient within a given treatment session, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0183] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0184] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0185] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicone.

[0186] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0187] 5.3.1.1 Sealing Mechanism In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the positive system pressure acting on its underside within the inflation chamber 3200, promoting a tight, sealed engagement with the face. This pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0188] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends at least partially around the periphery. The support flange is or includes a spring-like element and serves to support the sealing flange from buckling during use.

[0189] 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.

[0190] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0191] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0192] 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.

[0193] 5.3.1.2 Nasal bridge or nasal ridge area 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.

[0194] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge of the nose or the ridge of the nose of a patient's face during use.

[0195] 5.3.1.3 Upper lip area In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0196] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0197] 5.3.1.4 Chin area In one embodiment, the non-invasive patient interface 3000 includes a sealing structure that forms a seal on the chin area of ​​the patient's face during use.

[0198] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0199] 5.3.1.5 Forehead area 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.

[0200] 5.3.1.6 Nasal pillow In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0201] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the stem. Additionally, the nasal pillow connection structure of the present invention includes a flexible region adjacent to the base of the stem. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the truncated cone can be axially displaced toward the structure to which the stem is connected.

[0202] 5.3.1.7 Nose mask only In one form, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway rather than around the patient's mouth. The sealing structure 3100 may be configured to form a seal over the patient's upper lip. The patient interface 3000 may leave the patient's mouth uncovered. This patient interface 3000 may deliver a supply of air or breathable gas to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask only.

[0203] One form of the nasal mask according to this technology is conventionally recognized as a nasal mask, having a sealing formation 3100 configured to surround the nose on the patient's face and seal above the bridge of the nose. The nasal mask is typically triangular in shape. In one form, the non-invasive patient interface 3000 includes the sealing formation 3100, which, in use, forms a seal against an upper lip region (e.g., the upper lip), against the patient's bridge of the nose or at least a portion of the nasal ridge above the nasal protuberance, and against each lateral aspect of the patient's nose on the patient's face (e.g., near the patient's nasolabial fold). Figure 1B The patient interface 3000 shown has this type of sealing structure 3100. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 through a single orifice.

[0204] Another form of nose mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 could be identified as a "nose pad" mask, while the sealing formation structure 3100 could be identified as a "nose pad liner." In one form, for example, as... Figure 3Y As shown, the sealing forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal alae. The sealing forming structure 3100 can also form a seal on the upper part of the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely follow the lower side of the patient's nose and may not contact the nasal bridge region of the patient's nose or any portion of the patient's nose beyond the nasal protuberance. In one form of nasal pad, the sealing forming structure 3100 includes a bridging portion that divides the opening into two orifices, each orifice supplying air or breathable gas to a corresponding patient's nostril during use. The bridging portion can be configured to contact or abut against the patient's columella during use for a seal. Alternatively, the sealing forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nostrils.

[0205] In some forms, the nasal mask alone may include a nasal pillow as described above.

[0206] 5.3.1.8 Nose and mouth mask In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to form a seal around the inlet of the patient's nasal airway and also around the patient's mouth. The sealing structure 3100 can be configured to form a seal on the patient's face near the chin area. The patient interface 3000 can deliver a supply of air or breathable gas to both nostrils and the mouth of the patient 1000. This type of patient interface can be identified as a nose and mouth mask.

[0207] One form of the nose and mouth mask according to the present technology is a mask conventionally referred to as a "full-face mask," having a sealing formation structure 3100 configured to seal around the nose, below the mouth, and above the bridge of the nose on the patient's face. The nose and mouth mask is typically triangular in shape. In one form, the patient interface 3000 includes the sealing formation structure 3100, which, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), over at least a portion of the patient's bridge of the nose or nasal ridge above the nasal protuberance, and over the cheek areas of the patient's face. Figure 1C The patient interface 3000 shown is of this type. This patient interface 3000 delivers a supply of air or breathable gas to the two nostrils and mouth of the patient 1000 through a single opening. This type of sealing structure 3100 can be referred to as a "nose and mouth liner".

[0208] In another form, the patient interface 3000 includes a sealing structure 3100 that, in use, forms a seal on the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), below and / or on the front surface of the nasal projection portion of the patient's nose, on the nasal alae of the patient's nose, and on each lateral side of the patient's face, for example, forming a seal near the nasolabial fold. The sealing structure 3100 may also form a seal on the upper part of the patient's lips. A patient interface 3000 having this type of sealing structure may have a single opening configured to deliver an airflow or breathable gas to the patient's two nostrils and mouth; may have an orifice configured to deliver air or breathable gas to the mouth and nostrils configured to deliver air or breathable gas to the nostrils; or may have an orifice for delivering air to the patient's mouth and two nostrils for delivering air to the corresponding nostrils. This type of patient interface 3000 may have a nasal portion and a mouth portion, with the nasal portion forming a seal on the patient's face in a position similar to a nose pad mask.

[0209] In another form of the nose and mouth mask, the patient interface 3000 may include a sealing formation 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal on the patient's face around the patient's mouth.

[0210] In some forms, the sealing structure 3100 may have a nasal portion that is separate from and distinct from the oral portion. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0211] It should be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the above examples of nasal mask only and nasal and mouth masks.

[0212] 5.3.1.9 Textured silicone surface for sealing structure Examples of the aforementioned seal-forming structure 3100 can be textured at one or more areas of the patient's face during use. The texture applied to the seal-forming structure 3100 can mimic the look and / or feel of textiles, such as textiles with knitted or woven patterns, by using basic geometric designs, textile designs, and pattern designs.

[0213] The seal-forming structure 3100 made of silicone rubber can irritate a patient's skin after several hours of continuous wear, which can be a particularly serious problem for older patients who may have sensitive and fragile skin. The tactile feedback / feel of silicone rubber can often feel like rubber to the patient, so texturing to alter the feel of the silicone rubber to make it softer and / or more breathable may be advantageous. The resilience of silicone is also enhanced, making it feel more like human tissue and therefore more comfortable during prolonged wear. A textured silicone surface can also reduce friction on the patient's skin when pressure is applied to the face, more easily repel dirt and other particles, and can have improved tactile properties that make the seal-forming structure 3100 more comfortable. A textured silicone surface can also be easier to clean and more hydrophobic. A textured silicone surface can also be smoother in appearance. Furthermore, a textured silicone surface can have a visually more appealing rough finish. Additionally, a textured silicone surface can be more flexible and stretchable than untreated molded silicone.

[0214] The molding silicone resin is treated with laser etching and V+UV (vacuum ultraviolet radiation) technology, which can modify the molding silicone resin to have the feel of velvet, napped and plush fabrics by mimicking knitted structures and producing / simulating textile textures at various depths (e.g., in the form of textile patterns) on silicone rubber at depths between 10 μm and 2500 μm.

[0215] The silicone resin used in these processes to create, for example, textured seal-forming structures 3100 can be liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). These processes can also be applied to other rubber materials, such as thermoplastic polyurethane (TPU) or thermoplastic elastomer (TPE).

[0216] Silicone rubber can be a two-component silicone rubber, such as a 1:1 mixture of type A and type B silicone rubber to enhance the soft touch and rebound effect on the surface, such as easy deformation under finger pressure. Silicone rubber can also be a two-component silicone rubber, such as a 2:1 mixture of type A and type B silicone rubber to enhance the soft touch and rebound effect on the surface, such as easy deformation under finger pressure. In examples, LSR can have Shore A (or type A) and Shore B (or type B) indentation hardness in the range of about 30 to about 60, as measured using ASTM D2240. In examples, LSR can have Shore A (or type A) and Shore B (or type B) indentation hardness in different ranges. For example, as measured using ASTM D2240, the Shore A indentation hardness can be in the range of about 30 to about 60, and the Shore B indentation hardness can be in the range of about 35 to about 68. In practice, as measured using ASTM D1054, the LSR can have Shore A (or Type A) and Shore B (or Type B) resilience in the range of approximately 40% to 80%.

[0217] Figure 7A and Figure 7B The technical front 6001 and technical back 6002 of the raised single-sided plain knit fabric 6000 are shown respectively. The loop rows 6003 and loop warps 6004 of the fabric 6000 are also identified in the details of these figures. Figures 8A to 8C Examples of textured silicone surfaces 6010 are depicted having protrusions 6011 and recesses, depressions, surfaces with positive curvature, surfaces with convex dome shapes, or recesses 6012 between protrusions 6011, the textured silicone surfaces 6010 being formed to simulate the appearance and / or feel of napped single-knit fabric 6000. Figure 8C It is also shown how the shape and size of the protrusions 6011 and the recesses 6012 can simulate the coil rows 6013 and coil warps 6014, so that the textured silicone surface 6010 simulates the appearance and / or feel of a napped single-sided plain knit fabric 6000. Figure 8A In the example, the depth of the textured silicone surface 6010 between the protrusion 6011 and the recess 6012 is... Figure 8B and Figure 8C The values ​​are 10 μm and 20 μm.

[0218] Figures 9A to 9DIt shows that it can be made by Figures 10A to 10C Another example of fabric simulated in the texturized silicone resin surface 6030. Figure 9A and Figure 9B The front and back sides of the warp-knitted napped fabric 6020 are shown respectively. Figure 9C A detailed view of the structure of warp-knitted pile fabric 6020 is shown. Ribs 6023 and loop warps 6024 of fabric 6020 are also identified in the figure. Figure 9D A brushing operation is depicted on a warp-knitted napped fabric 6020 having a roller brush 6025. Figures 10A to 10C An example of a textured silicone surface 6030 having protrusions 6031 and recesses 6032 between the protrusions 6031 is depicted, the textured silicone surface 6030 being formed to simulate the appearance and / or feel of a warp-knitted napped fabric 6020. Figure 10C It is also shown how the shape and size of the protrusions 6031 and the recesses 6032 can simulate the ribs 6033 and the loops 6034, so that the textured silicone surface 6030 simulates the appearance and / or feel of the warp-knitted napped fabric 6020. Figure 10A In the example, the depth of the textured silicone surface 6030 between the protrusion 6031 and the recess 6032 is... Figure 10B and Figure 10C The thicknesses are 40 μm and 60 μm. Figures 15A to 15B Plan view and front view of the textured silicone surface 6030 from an electron microscope are depicted, showing the height of the protrusion 6031, the depth of the recess 6032, and the shapes of the protrusion 6031 and the recess 6032. Here, the top of the protrusion 6031 is curved. The base of the protrusion 6031 is approximately circular, but in other instances, it can be square, rectangular, or triangular.

[0219] Figures 11A to 11D It shows that it can be made by Figures 12A to 12C Another example of fabric simulated in the texturized silicone resin surface 6050. Figure 11A and Figure 11B The front and back sides of the velvet fabric 6040 are shown respectively. Figure 11C A detailed view of the structure of velvet fabric 6040 is shown. Ribs 6043 and wale 6044 of fabric 6040 are also identified in the figure. Figure 11D The image depicts a cutting operation performed on velvet fabric 6040 using a cutting blade 6045 to separate the first layer 6046 from the second layer 6047. Figures 12A to 12C An example of a textured silicone surface 6050 having protrusions 6051 and recesses 6052 between the protrusions 6051 is depicted, the textured silicone surface 6050 being formed to simulate the appearance and / or feel of velvet fabric 6040. Figure 12C It is also shown how the shape and size of the protrusions 6051 and the recesses 6052 can simulate the ribs 6053 and the coil longitudinals 6054, so that the textured silicone surface 6050 simulates the appearance and / or feel of velvet fabric 6040. Figure 12A In the example, the depth of the textured silicone surface 6050 between the protrusion 6051 and the recess 6052 is 400 μm. Figure 12B The middle is 300 μm. Figure 12C The thickness is 400 μm.

[0220] Figures 13A to 13D It shows that it can be made by Figures 14A to 14C Another example of fabric simulated in the texturized silicone resin surface 6070. Figure 13A and Figure 13B The technical front 6061 and technical back 6062 of the interlocking napped suede fabric 6060 are shown respectively. Figure 13C A detailed view of the structure of the interlocking napped suede fabric 6060 is shown. The loop rows 6063 and loop warp rows 6064 of the suede fabric 6060 are also identified in the figure. Figure 13D A brushing operation is depicted on an interlocking napped suede fabric 6060 having a roller brush 6065. Figures 14A to 14C An example of a textured silicone surface 6070 having protrusions 6071 and recesses 6072 between protrusions 6071 is depicted, the textured silicone surface 6070 being formed to simulate the appearance and / or feel of an interlocking napped suede fabric 6060. Figure 14C The shape and size of the protrusions 6071 and recesses 6072 are also shown to simulate the coil rows 6073 and coil warps 6074, so that the textured silicone surface 6070 simulates the appearance and / or feel of interlocking napped suede fabric 6060. Figure 14A In the example, the depth of the textured silicone surface 6070 between the protrusion 6071 and the recess 6072 is... Figure 14B and Figure 14C The sizes are 20 μm and 40 μm. Figures 16A to 16B Plan view and front view of the textured silicone surface 6070 from an electron microscope are depicted, showing the height of the protrusion 6071, the depth of the recess 6072, and the shapes of the protrusion 6071 and the recess 6072. Here, the top of the protrusion 6071 is pointed. The base of the protrusion 6071 is approximately circular, but in other instances, it can be square, rectangular, or triangular.

[0221] from Figure 17A and Figure 17B The difference between the curved and flat surfaces of the textured silicone resin surface 6080 can be seen. Figure 17AThe protrusions 6081 and recesses 6082 on the curved surface are depicted. Figure 17B The protrusion 6081 and the recess 6082 on the flat surface are depicted. It can be seen that... Figure 17A The protrusions 6081 and recesses 6082 on the textured silicone surface 6080 of the curved surface shown are greater than those on the curved surface. Figure 17B The inconsistency is even greater on the flat surface.

[0222] exist Figures 8A to 8C , Figures 10A to 10C , Figures 12A to 12C and Figures 14A to 14C In this example, the textured silicone resin surfaces 6010, 6030, 6050, and 6070 can be formed by a mold tool during the silicone resin molding process. In other words, the protrusions 6011, 6031, 6051, and 6071 and the recesses 6012, 6032, 6052, and 6072 are formed in a negative form in the mold tool to produce the corresponding structures of the textured silicone resin surfaces 6010, 6030, 6050, and 6070. A sealing structure 3200 having the textured silicone resin surfaces 6010, 6030, 6050, and 6070 can then be cured. The height from the bottom of the recesses 6012, 6032, 6052, and 6072 to the top of the protrusions 6011, 6031, 6051, and 6071 can be at least 150 micrometers, at least 200 micrometers, at least 250 micrometers, or 250 to 300 micrometers. In other examples, the height from the bottom of the recesses 6012, 6032, 6052, and 6072 to the top of the protrusions 6011, 6031, 6051, and 6071 can be at most 0.3 mm. The protrusions 6011, 6031, 6051, and 6071 can have a base width from 0.1 mm to 0.5 mm, or approximately 0.25 mm. The peaks of the protrusions 6011, 6031, 6051, and 6071 can be spaced apart by approximately 0.24 to 0.26 mm, or from 0.1 mm to 0.4 mm.

[0223] As discussed above, vacuum ultraviolet (VUV) treatment can be applied to the entire seal-forming structure 3200, or only to portions including the textured silicone surfaces 6010, 6030, 6050, and 6070. VUV treatment can be applied to the textured silicone surfaces 6010, 6030, 6050, 6070, or any other textured silicone surface, or any silicone surface that was not textured during molding. VUV treatment can be applied to the desired silicone surface after it has cured. Portions of the seal-forming structure 3100 (e.g., portions other than the textured silicone surfaces 6010, 6030, 6050, and 6070) can be masked so that the textured silicone surfaces 6010, 6030, 6050, and 6070 are subjected to VUV treatment, while other portions are not.

[0224] VUV treatment can be performed by applying light with a wavelength less than 200 nm to a desired area of ​​the silicone resin. This VUV treatment can affect the silicone resin by creating a thin silicone layer on its surface. This silicone layer can be at least 1 micrometer deep, 2 to 5 micrometers deep, 2 to 10 micrometers deep, 2 to 20 micrometers deep, 2 to 50 micrometers deep, or 10 to 100 micrometers deep.

[0225] Figures 18A to 19B This demonstrates how VUV treatment can affect silicone resin by forming cracks 7002 on the silicone resin surface. Figures 18A to 19B Images from a scanning electron microscope are depicted. Figure 18A and Figure 19A An untreated silicone surface 7000 is shown, which lacks... Figure 18B and Figure 19B Cracks 7002 exist in the treated silicone resin surface 7001. Cracks 7002 can form randomly. The range of microcracks 7002 can be from submicron (approximately 500 nm) to approximately 1.5 µm. Furthermore, compared to… Figure 18A and Figure 18B The diagram shows that VUV treatment increases surface roughness. Compared to untreated silicone, the advantages of VUV treatment include reduced friction (static and dynamic) between the silicone surface and skin and fabrics such as clothing and bedding. VUV-treated silicone may be better at blocking dust and debris than untreated silicone. VUV-treated silicone may be smoother than untreated silicone. VUV-treated silicone may be harder than untreated silicone. VUV-treated silicone may have more comfortable tactile properties (e.g., feel) than untreated silicone.

[0226] VUV treatment can also cause silicone resin to yellow. To avoid the finished product becoming unsightly due to yellowing after VUV treatment, silicone resin can be masked with one or more pigments. The color and amount of pigment can be chosen to blur or cover up the visual effect of yellowing.

[0227] In an example of this technology, one or more of the textured silicone resin surfaces 6010, 6030, 6050, and 6070 described above can be applied to a seal-forming structure 3100 made of silicone resin. Furthermore, a first portion of the seal-forming structure 3100 may include one or more of the textured silicone resin surfaces 6010, 6030, 6050, and 6070, which are positioned to contact a patient's face during use. The textured silicone resin surfaces 6010, 6030, 6050, and 6070 may have multiple protrusions 6011, 6031, 6051, and 6071 and recesses 6012, 6032, 6052, and 6072. The seal-forming structure 3100 may also include a second portion without a textured silicone resin surface, which may or may not contact the patient's face during use. The recesses 6012, 6032, 6052, and 6072 of the textured silicone resin surfaces 6010, 6030, 6050, and 6070 can be recessed below the protrusions 6011, 6031, 6051, and 6071 of the non-textured surface and the textured silicone resin surfaces 6010, 6030, 6050, and 6070.

[0228] In some instances, the protrusions 6011, 6031, 6051, and 6071 of the non-textured silicone surfaces and the textured silicone surfaces 6010, 6030, 6050, and 6070 may be at the same height relative to the recesses 6012, 6032, 6052, and 6072 of the textured silicone surfaces 6010, 6030, 6050, and 6070. In alternative instances, the protrusions 6011, 6031, 6051, and 6071 of the non-textured silicone surfaces and the textured silicone surfaces 6010, 6030, 6050, and 6070 may be at different heights relative to the recesses 6012, 6032, 6052, and 6072 of the textured silicone surfaces 6010, 6030, 6050, and 6070.

[0229] In some instances, protrusions 6011, 6031, 6051, and 6071 may include a first group of protrusions 6011, 6031, 6051, and 6071 at a first height relative to recesses 6012, 6032, 6052, and 6072, and a second group of protrusions 6011, 6031, 6051, and 6071 at a second height relative to recesses 6012, 6032, 6052, and 6072, wherein the second height differs from the first height. In alternative instances, all protrusions 6011, 6031, 6051, and 6071 may have the same height relative to recesses 6012, 6032, 6052, and 6072.

[0230] In some instances, each of the protrusions 6011, 6031, 6051, and 6071 may be spaced apart from its adjacent protrusions 6011, 6031, 6051, and 6071 by a uniform distance. In alternative instances, each of the protrusions 6011, 6031, 6051, and 6071 may be spaced apart from its first adjacent protrusions 6011, 6031, 6051, and 6071 by a first distance, and from its second adjacent protrusions 6011, 6031, 6051, and 6071 by a second distance different from the first distance.

[0231] In another example, protrusions 6011, 6031, 6051, and 6071 can be formed in a column and row pattern. Each of the protrusions 6011, 6031, 6051, and 6071 in the first column can have a uniform first shape and a first height relative to the recesses 6012, 6032, 6052, and 6072. Each of the protrusions 6011, 6031, 6051, and 6071 in the second column adjacent to the first column can have a uniform second shape and a second height relative to the recesses 6012, 6032, 6052, and 6072. Each of the protrusions 6011, 6031, 6051, and 6071 in the first row can have a uniform first shape and a first height relative to the recesses 6012, 6032, 6052, and 6072. Each of the protrusions 6011, 6031, 6051, 6071 in the second row of the row adjacent to the first row of the row can have a uniform second shape and second height relative to the recesses 6012, 6032, 6052, 6072.

[0232] In a further example, each of the protrusions 6011, 6031, 6051, and 6071 may have a uniform cross-sectional area along its height. In an alternative example, the cross-sectional area of ​​each of the protrusions 6011, 6031, 6051, and 6071 may decrease from the adjacent recesses 6012, 6032, 6052, and 6072 to the peaks of the protrusions 6011, 6031, 6051, and 6071.

[0233] In some instances, each of the protrusions 6011, 6031, 6051, and 6071 may have the same cross-sectional area at its base as its adjacent protrusions 6011, 6031, 6051, and 6071. In alternative instances, each of the protrusions 6011, 6031, 6051, and 6071 may have a different cross-sectional area at its base than that of at least one adjacent protrusion 6011, 6031, 6051, and 6071.

[0234] In one example, textured silicone surfaces 6010, 6030, 6050, and 6070 can be formed on the surface of the sealing structure 3100, which is configured to contact the patient's nose during use. In another example, textured silicone surfaces 6010, 6030, 6050, and 6070 can be formed on the surface of the sealing structure 3100, which is configured to contact the upper part of the patient's lips during use. In a further example, textured silicone surfaces 6010, 6030, 6050, and 6070 can be formed on the surface of the sealing structure 3100, which is configured to contact the lower part of the patient's lips during use. In a further example, textured silicone surfaces 6010, 6030, 6050, and 6070 are not formed on the surface of the sealing structure 3100, the surface of which is configured to contact the patient's face on the outer side of the patient's mouth during use. Conversely, non-textured silicone surfaces may contact the patient's face on the outer side of the patient's mouth during use. In a further example, textured silicone surfaces 6010, 6030, 6050, and 6070 may be formed on the rear side of the sealing structure 3100 to contact the patient's face during use. In a further example, textured silicone surfaces 6010, 6030, 6050, and 6070 are formed on the front side of the sealing structure 3100, such that at least a portion of the textured silicone surfaces 6010, 6030, 6050, and 6070 faces away from the patient's face and does not contact the patient's face during use.

[0235] In some instances, the sealing structure 3100 may include a flange having an outer surface and an inner surface opposite the outer surface, at least a portion of the outer surface being configured to contact a patient's face in use, and the inner surface being configured not to contact a patient's face in use. Textured silicone surfaces 6010, 6030, 6050, and 6070 are formed on the outer surface but not on the inner surface.

[0236] like Figure 20A and Figure 20BAs shown, the head-mounted display interface 11000 may include a user interface structure 11100, a display unit housing 11200, and a support structure 11300. The head-mounted display interface 11000 can output computer-generated images to a user wearing the head-mounted display interface 11000.

[0237] In some forms, the user interface structure 11100 may be constructed of comfortable materials (e.g., foam, textiles, silicone, etc.) and may come into contact with the user's face. This user interface structure 11100 may help distribute the forces applied to the user's face, making the head-mounted display interface 11000 more comfortable to wear. The user interface structure 11100 may include the textured silicone surface features described in the preceding paragraphs, including protrusions and recesses. Parts of the user interface structure 11100 may have a textured silicone surface, and parts may not. The user interface structure 11100 may also be VUV treated.

[0238] The display unit housing 11200 may include electronic components for outputting computer-generated images. The display unit housing 11200 may be formed of a rigid or semi-rigid material to protect the electronic components.

[0239] The support structure 11300 can be similar to the positioning and stabilizing structures described above. For example, the support structure 11300 may include a band constructed at least partially of a textile material. This band may be stretchable to fit users of different sizes. To provide stiffness and / or stability, the band may also be hardened or include a hardener.

[0240] In some forms, the head-mounted display interface 1100 may include a battery (e.g., a rechargeable battery) within the display unit housing 11200. The head-mounted display interface may be removably connected to a charger to charge the battery.

[0241] In other forms, the head-mounted display interface 11000 may include a port (not shown) for receiving a power cord connected to a battery.

[0242] like Figure 20B As illustrated, some forms of the head-mounted display interface 11000 may include at least one opening 11104 in the user interface structure 11000. This at least one opening 11104 may be aligned with the user's nose when the user wears the head-mounted display interface 11000. For example, a single opening may be aligned with both nostrils, or each nostril may have a separate opening. The illustrated example also shows a user interface structure 11000 that supports the user's nose. Alternatively, the user interface structure 11000 may include a structure surrounding the at least one opening 11104 received within the user's nostrils.

[0243] In some forms, the display unit housing 11200 may include a blower (e.g., not shown but similar to blower 6502). The blower in the display unit housing 11200 can generate a pressurized breathable gas stream, which can be output through at least one opening 11104. The patient can inhale the pressurized gas through their nose as described in any of the examples above. Therefore, the user interface structure 11000 can be sealed around at least a portion of the user's face (e.g., to prevent leakage of pressurized air). Additionally, although not shown, the opening 11104 may extend around the user's mouth, allowing the user to also inhale the pressurized air through their mouth.

[0244] In some forms, the head-mounted display interface 11000 can combine features of AR / VR and respiratory therapy. For example, a patient can use the head-mounted display interface 11000 to receive pressurized air to alleviate breathing difficulties. Simultaneously, the user can view computer-generated image output from the display unit housing 11200. Utilizing AR / VR with therapeutic features can make both the therapy and the patient's interface more comfortable (e.g., thereby improving patient compliance). For example, computer-generated images can help patients fall asleep faster, allowing for more effective use of the therapy.

[0245] 5.3.2 Inflation Chamber The air chamber 3200 has a periphery whose shape is designed to complement the surface contour of a typical face in the area where a seal will be formed during use. During use, the boundary edges of the air chamber 3200 are positioned close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend around the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0246] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve adherence to therapy.

[0247] In some forms of this technology, the air chamber 3200 is made of a transparent material (e.g., transparent polycarbonate). Using a transparent material reduces the prominence of the patient interface and helps improve adherence to the therapy. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0248] In some forms of this technology, the air chamber 3200 is made of a translucent material. Using a translucent material can reduce the protrusion of the patient interface and help improve adherence to the therapy.

[0249] In some forms, the air chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0250] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textiles, or foam). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less, for example, a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0251] 5.3.2.1 Multiple openings like Figure 6A and Figure 6B As shown, different air chambers 3200-1, 3200-2 can be formed as part of multi-opening liners 3050-1, 3050-2. In the illustrated example, each of liners 3050-1, 3050-2 includes three openings, although alternative liners can be formed with more or fewer openings.

[0252] In some forms, different openings can serve different functions. For example, some openings may be simply inlet openings, while others may be simply outlet openings.

[0253] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, one opening can serve as both an inlet and an outlet.

[0254] These multiple openings allow for various configurations of air delivery to the inflation chambers 3200-1 and 3200-2. For example, depending on patient needs and / or patient comfort, a given liner 3050-1 or 3050-2 may be used in an “upper tube” configuration (e.g., using a catheter head cap as described below) or a “lower tube” configuration (e.g., using a single catheter in front of the patient’s face).

[0255] 5.3.2.1.1 Nose and mouth mask like Figure 6AAs shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlet ports 3254-1, which can be used to deliver gas into and / or out of the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 can be located on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0256] In some forms, the inflation chamber 3200-1 may also include at least one ventilation opening 3402-1 (see example...) Figure 6A The vent opening 3402-1 can be located at the center of the inflation chamber 3200-1. For example, the vent opening 3402-1 can be located between the inlet ports 3254-1 of the inflation chamber.

[0257] In some forms, the inflation chamber 3200-1 may include a pair of recesses 3266-1. Each recess 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each recess 3266-1 may form a partially recessed surface.

[0258] 5.3.2.1.2 Nose mask only Only the air chamber 3200-2 of the nose pad 3050-2 can be similar to the air chamber 3200-1 of the mouth and nose pad 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0259] like Figure 6B As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 can be located on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0260] In some forms, the air chamber 3200-2 may also include at least one vent opening 3402-2 (see example...) Figure 6B The vent opening 3402-2 can be located at the center of the inflation chamber 3200-2. For example, the vent opening 3402-2 can be located between the inlet ports 3254-2 of the inflation chamber.

[0261] In some forms, the inflation chamber 3200-2 may include a pair of recesses 3266-2. Each recess 3266-2 may be located near one of the inflation chamber inlet ports 3254-2. Each recess 3266-2 may form a partially recessed surface.

[0262] 5.3.3 Positioning and Stabilizing Structure The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300. Since the positioning and stabilizing structure 3300 engages with the patient's head to hold the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 can include and function as a "headgear". Figure 3A and Figure 3A-1 Examples of positioning and stabilizing structures are shown in the figure.

[0263] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away (i.e., F). 充气 ).

[0264] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0265] Continue to refer to Figure 3A-1 The 3300 provides force F for positioning and stabilizing the structure. PSS This force helps maintain the air chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSS It can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, the headgear strap can provide a strap force F on its own. 带 This is to ensure that the sealing structure 3100 is held on the patient's face. Force F 带 It can also be guided at least partially in the upward direction to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 3100 and the inflation chamber 3200, but gravity will act on the entire patient interface 3000 (i.e., in relation to the illustrated gravity F). g (in the same direction).

[0266] Gravity F g It can be related to frictional force F f Conversely, this frictional force can act in relation to gravity F. g In the opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 in the downward direction (e.g.) Figure 3A-1 (As shown), frictional force F f The force will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200g Conversely, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. g Conversely, friction can act at any point along the patient interface 3000 in contact with the patient's skin (or hair). Friction force F f Under gravity F g It extends in the opposite direction and along the patient's skin (or hair). For example, in some forms, gravity F g It can also be offset by the vertical component of the reaction force from the patient’s face acting on the sealing structure 3100, for example, in the nasal ridge and chin area of ​​the patient’s face.

[0267] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g and blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS The reaction force from the patient's head acting on the portion of the patient interface 3000 is balanced, and the sealing structure 3100 is still maintained in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some instances, the positioning and stabilizing structure 3300 can be adjustable, such that the positioning and stabilizing force F is adjusted during assembly. PSS Greater than the precise equilibrium gravity F g and blowing force F 充气 The required force is sufficient to hold the patient interface 3000 sufficiently tightly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral decubitus) will not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force F required to achieve balance. PSS .

[0268] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as those from tube resistance or accidental interference with the patient interface.

[0269] In one form of this technology, a positioning and stabilizing structure 3300 is provided, configured to conform to the manner in which a patient wears it while sleeping. In one instance, the positioning and stabilizing structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one instance, the positioning and stabilizing structure 3300 includes at least one strip with a rectangular cross-section. In one instance, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0270] 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 is on a pillow.

[0271] 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 is on a pillow.

[0272] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a disengaging portion located between the front and rear portions of the positioning and stabilizing structure 3300. The disengaging portion does not resist compression and may be, for example, flexible or soft. The disengaging portion is constructed and arranged such that when the patient rests their head on the pillow, the presence of the disengaging portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0273] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0274] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable band, such as a resiliently 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 an example, the band can be configured as a tie.

[0275] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of its lower edge passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0276] In one form of the technology applicable to nasal masks only or to full-face masks, the positioning and stabilizing structure includes a second strap, which is configured and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0277] In one form of the technology applicable to nasal masks only or to full-face masks, 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 separate from each other.

[0278] 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.

[0279] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.

[0280] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a holding force corresponding to a range of sizes and / or shapes. 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, and another form suitable for small-sized heads but not for large-sized heads.

[0281] 5.3.3.1 Catheter head cover 5.3.3.1.1 Catheter head sheath In some forms of this technology, the positioning and stabilization structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example through the inflation chamber 3200 and the sealing formation structure 3100. Figure 3YIn the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 for delivering air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth) during use. This allows the conduit of the air circuit 4170, which provides a pressurized airflow, to connect to a connection port 3600 of the patient interface, located in a position other than the front of the patient's face, such as at the top of the patient's head.

[0282] exist Figure 3Y In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use, and extending above the corresponding ear (above the back of the ear on the patient's head) through the corresponding cheek area to a curved tube 3610 at the top of the patient's head. This form of the technology may be advantageous because if the patient is sleeping with their head on their side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0283] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension during use to help maintain the sealing structure 3100 in a sealed position.

[0284] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the band can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the band, such that the sealing structure remains substantially centered.

[0285] exist Figure 3YIn the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some instances, the two tubes 3350 are formed integrally, while in other instances, the tubes 3350 are formed separately but are connected in use and can be detached, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-connector. The T-connector may have two arms / branches, each of which is fluidly connected to one of the corresponding tubes 3350. Additionally, the T-connector may have a third arm or opening that provides a connection port 3600 for fluid connection to the air circuit 4170 in use. This opening may be an inlet 3332 for receiving a pressurized airflow (see, for example, 6C).

[0286] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0287] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0288] In some configurations, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be tilted relative to each other, and the third arm can be tilted relative to the first two arms. The tilting of the first two arms can resemble the shape of the patient's head to conform to that shape.

[0289] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This allows the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0290] In some forms, at least one arm of a T-connector (or Y-connector) may be at least partially rigid. This helps maintain the shape of the connector so that bending of the connector does not block the airflow path.

[0291] Tube 3350 may be formed of a flexible material, such as an elastomer, like silicone or TPE, and / or of one or more textile and / or foam materials. Tube 3350 may have a pre-formed shape and be able to bend or move into another shape when a force is applied, but can return to the original pre-formed shape when the force is not applied. The shape of tube 3350 may be generally arched or curved, approximating the contour of a patient's head between the top of the head and the nasal or oral region.

[0292] In some instances, the one or more tubes 3350 are compression-resistant to prevent blockage if compressed during use (e.g., if compressed between a patient's head and a pillow, especially if only one tube 3350 is present). The tube 3350 may be configured to have sufficient structural stiffness to resist compression, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0293] Each tube 3350 can be configured to receive an airflow from a connection port 3600 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the entrance to the patient's airway. Figure 3Y In the example shown, each tube 3350 is positioned in use along a path extending from the inflation chamber 3200 through the patient's cheek region and above the patient's ear to reach the curved tube 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may, in use, cover the maxillary region of the patient's head. Another portion of each tube 3350 may cover an area of ​​the patient's head above the supraacular base of the patient's head. Each tube 3350 may also be positioned over one or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The curved tube 3610 may, in use, be positioned over the patient's parietal bone, over the frontal bone, and / or over the junction between them (e.g., the coronal suture).

[0294] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned across the top of the patient's head, allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. In some instances, the headgear 3350 is configured to allow the upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially disengaged from the inflation chamber 3200. Thus, the sealing structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined position range).

[0295] As described above, in some embodiments of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a nose pad, which is typically located below the nose and seals to the lower periphery of the nose (e.g., a pad below the nose). A positioning and stabilizing structure 3300, including a tube 3350, can be configured and arranged to pull the sealing-forming structure 3100 into the patient's face below the nose using a sealing force in a posterior and superior direction (e.g., posterosuperior direction). The posterosuperior sealing force allows the sealing-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face, such as on either side of the patient's nose and above the patient's lips.

[0296] The catheter, such as a headband, which forms part of the positioning and stabilizing structure 3300, can provide a force F that aids in positioning and stabilization. PSS The force. For example... Figure 3Y-1 The diagram illustrates the positioning and stabilizing force F. PSS It can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, each conduit can provide a force F pointing in the rearward direction and the corresponding lateral direction. 导管 This is so that the sealing structure 3100 remains against the patient's face (to the upper lip and below the nose) and resists the positive pressure in the air chamber 3200 to lift away from the face (i.e., F 充气 The guiding force F 导管 It can also be guided at least partially in the upward direction to overcome gravity F. g .

[0297] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force helps to grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0298] The position of the patient's head can also change the clamping force of the catheters. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface, such as a pillow) can additionally expand in order to maintain substantially the same pressurized airflow rate.

[0299] Gravity F g It can be related to frictional force F f Conversely, this frictional force can act in relation to gravity F. g In the opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 in the downward direction (e.g.) Figure 3A-1 (As shown), frictional force F fThe force will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. g Conversely, friction can act at any point along the patient interface 3000 in contact with the patient's skin (or hair). Friction force F f Under gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0300] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g and blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS The reaction force from the patient's head acting on the portion of the patient interface 3000 is balanced, and the sealing structure 3100 is still maintained in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some instances, the positioning and stabilizing structure 3300 can be adjustable, such that the positioning and stabilizing force F is adjusted during assembly. PSS Greater than the precise equilibrium gravity F g and blowing force F 充气The required force is sufficient to hold the patient interface 3000 sufficiently tightly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral decubitus) will not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force F required to achieve balance. PSS .

[0301] The textured silicone surface and VUV treatment described in Section 5.3.1.9 above may also be applied to the positioning and stabilizing structure 3300 of the tube 3350, or the entire tube 3350 may have one of the textured silicone surface and / or VUV treatment. The beneficial effects of the textured silicone surface and VUV treatment described above may similarly benefit the tube 3350 by improving patient comfort.

[0302] 5.3.3.1.2 Extendable and non-extendable pipe sections In some embodiments of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments, for example, formed by an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube having a tube wall having an extendable accordion-like structure. Figure 3Y The patient interface 3000 shown includes a tube 3350, the upper portion of which includes extendable tube sections, each tube section being in the form of an extendable accordion-like structure 3362.

[0303] In some forms, the extendable accordion structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion structure 3328 can be biased toward a constricted position and can move to an extended position when the patient wears the positioning and stabilizing structure 3300. Because portions of the tube 3350 can be substantially non-extendable (e.g., a non-extendable tube segment 3363), the accordion structure 3328 allows the positioning and stabilizing structure 3300 to stretch to fit different head sizes. This allows a single-size tube 3350 to be used with multiple head sizes. For example, as a result of the accordion structure 3328, the positioning and stabilizing structure 3300 can be “one size fits all.” Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can choose the length that best fits their head, and the accordion structure 3328 can be slightly adjusted to fit an individual patient.

[0304] In some configurations, inlet 3332 may be located in the middle of conduit 6320. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0305] The cross-sectional shape of the non-extendable tube segment 3363 of tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of the tube on the side facing and contacting other parts of the patient's face or head can be more comfortable to wear than a tube, for example, having a circular cross-section.

[0306] In some embodiments of this technology, the non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downwards along both sides of the patient's head and then bend forward and inwards to connect to the inflation chamber 3200 at the front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 may extend to the same vertical position as the connection point with the inflation chamber 3200 (or, in some embodiments, below the connection point with the inflation chamber 3200). That is, the tube 3350 may protrude at least partially upwards before connecting to the inflation chamber 3200. A portion of the tube 3350 may be located below the inflation chamber 3200 and / or the sealing forming structure 3100. The tube 3350 may contact the patient's face below the cheekbone, which may be more comfortable than contacting the patient's cheekbone and may avoid excessively obscuring the patient's peripheral vision.

[0307] 5.3.3.1.3 Catheter head connection port In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 3Y In the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., above the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 can be configured to be fluidly connected to a conduit of the air circuit 4170. The bend 3610 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially disengage the conduit from the positioning and stabilizing structure 3300. In some instances, the bend 3610 can be configured to rotate about a substantially vertical axis of rotation, and in some specific instances, by rotating about two or more axes. In some instances, the bend can include a tube 3350 or be connected to a tube 3350 via a ball-and-socket connector. In use, the connection port 3600 can be located in the sagittal plane of the patient's head.

[0308] Patient interfaces without a connection port positioned in front of the patient's face may be advantageous, as some patients may find catheters connected to a patient interface in front of the patient's face unsightly and / or obtrusive. For example, a catheter connected to a patient interface in front of the patient's face may easily interfere with bedding, especially if the catheter extends downward from the patient interface during use. Forms of this technology that include patient interfaces with a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: lateral position, supine position (e.g., on their back, typically facing upward), or prone position (e.g., on their front, typically facing downward). Furthermore, connecting the catheter to the front portion of the patient interface may exacerbate a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during movement of the patient's head or the catheter, resulting in displacement away from the face. Tube resistance may not be a problem when forces are received in a position above the patient's head rather than in front of the patient's face near the sealing structure (where tube resistance is more likely to disrupt the seal).

[0309] 5.3.3.1.4 Fluid Connection of Head Sleeve Two tubes 3350 are fluidly connected at their lower ends to an inflation chamber 3200. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured to allow the patient to easily and reliably connect the two components together. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a reassuring click or similar sound, allowing the patient to easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature configured to engage with a convex mating feature on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex mating feature configured to connect to a concave mating feature on the inflation chamber 3200. In other instances, each tube 3350 may include a convex or concave connector formed of a flexible material, such as silicone or TPE, for example, the same material forming the tube 3350.

[0310] In other instances, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, a resilient, flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be compressed to reduce its diameter, allowing it to be compressed into a port in the inflation chamber 3200, and the inherent resilience of the silicone pushes the tube 3350 outward to hermetically seal the tube 3350 in the port. Alternatively, in a hard-on-hard engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or inflation chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the inflation chamber 3200 to form or reinforce a seal between the tube 3350 and the inflation chamber 3200.

[0311] 5.3.3.2 Headgear In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 with at least one strap, which may be worn by a patient to assist in properly orienting the sealing-forming structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

[0312] As described above, some forms of the headgear 3302 may be made of textile materials that can comfortably fit against the patient's skin. The textiles may be flexible to conform to various facial contours. While the textiles may include a hardener along a selected length, this may limit the bending, flexing, and / or stretching of the headgear 3302.

[0313] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similar stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or stretchable more than the surrounding portions). This allows the hood 3302 to stretch under tension, which can help provide a sealing force for the seal-forming structure 3100.

[0314] Two types of hoods, the four-point hood 3302-1 and the two-point hood 3302-2, are discussed in more detail below as illustrative examples.

[0315] 5.3.3.2.1 Four-point connection like Figure 6EAs shown, some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be connected to four separate locations on the inflation chamber 3200, on the frame of the inflation chamber 3200, and / or on the arm of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help maintain the sealing structure 3100 in the sealed position. Figure 3A The positioning and stabilizing structure of the 3300 can also be considered as a four-point connection headgear.

[0316] In some forms, the headgear 3302-1 may include a lower band 3304-1, which may be attached to the lower portion of the padding 3050-1. The lower band 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower band 3304-1 may cover the masseter muscle on either side of the patient's face. Therefore, the lower band 3304-1 may contact the patient's head below the ear. The lower band 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or trapezius muscle.

[0317] The headgear 3302-1 may also include an upper band 3305-1, which may cover the temporal bone, parietal bone, and / or occipital bone. The upper band 3305-1 may also be connected to the tube 3350 (e.g., by abutting against the flap 3320).

[0318] The posterior strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and upper strap 3305-1 on a given side (e.g., left or right) are also connected to the adjacent posterior strap 3307-1. Therefore, the height of the posterior strap 3307-1 can be approximately the combined height of the lower strap 3304-1 and upper strap 3305-1. In use, the posterior strap 3307-1 can cover the occipital and / or parietal bones. This allows the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0319] In the illustrated example, the headband 3302-1 can be formed in a generally X shape. The lower band 3304-1 and the upper band 3305-1 can be attached to the rear band 3307-1 using stitching, ultrasonic welding, or any similar process.

[0320] In some configurations, the lower band 3304-1 is connected to the magnetic member 3306-1. For example, each lower band 3304-1 can be connected to the magnetic member 3306-1, thereby allowing adjustment of the length of each lower band 3304-1. The magnetic member 3306-1 can be removably connected to the magnet 3370-1 (described below), allowing the lower band 3304-1 to be disconnected from the inflation chamber 3200, without affecting the length of the lower band 3304-1.

[0321] In some configurations, the top band 3305-1 can be directly connected to the tab 3320 of the tube 3350. The top band 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each top band 3305-1.

[0322] In some configurations, the headgear 3302-1 can be used only with the nose and mouth pads 3050-1 (for example, because the nose pad 3050-1 alone does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0323] 5.3.3.2.2 Two-point connection like Figure 6F As shown, some forms of the headgear 3302-2 can be two-point connected headgears. This means that the headgear 3302-2 can be connected to two separate locations.

[0324] In some forms, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., sewn) together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0325] In some forms of this technology, the positioning and stabilizing structure 3300, in addition to the tube 3350, includes at least one headband for positioning and stabilizing the sealing structure 3100 at the entrance to the patient's airway. Figure 3Y As shown, the patient interface 3000 includes a strap 3307-2 forming part of a positioning and stabilizing structure 3300. For example, the strap 3307-2 may be referred to as a back strap or a hood strap. The hood strap 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other embodiments of the present technology, one or more additional straps may be provided. For example, an example of a patient interface 3000 with nose and mouth pads according to the present technology may have a second lower strap configured to abut against the patient's head near the neck and / or against the posterior surface of the patient's neck.

[0326] exist Figure 3Y In the example shown, the band 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350, which are positioned on each side of the patient's head and wrap around the back of the patient's head, for example, covering or located below the occipital bone of the patient's head during use. The band 3310 is connected to each tube above the patient's ear. Reference Figure 3YThe positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 can be attached between the tabs 3320. The strap 3310 can be flexible enough to wrap around the back of the patient's head and comfortably rest against the patient's head, even under tension during use.

[0327] like Figure 6F As shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear band 3307-2 of the headgear 3302-2 (e.g., configured to contact the back portion of the patient's head) can be wider than the surrounding portion of the headgear 3302-2. The middle section 3308-2 of the rear band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear band 3307-2 can move relative to the lower section. This can allow for greater band coverage over the back region of the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower band (e.g., 3304-1).

[0328] In some configurations, the headgear 3302-2 can be used only with the nose pad 3050-2 (e.g., because the nose and mouth pads 3050-1 do not have four connection points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0329] 5.3.3.3 Hardener Arm like Figure 6D As shown, the hardening arm 3340 may be an elongated rigid member that helps hold the pad (e.g., nose and mouth pad 3050-1 or nose pad 3050-2) in the operating position. The hardening arm 3340 may contact one side of the patient's head and provide force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0330] In some forms, the hardening arm 3340 is made of a rigid material (e.g., plastic). A rigid material may not allow the hardening arm 3340 to stretch. Additionally, the hardening arm 3340 may be inflexible and may be non-flexible. The hardening arm 3340 may be pre-molded into a desired shape to conform to the patient's head. For example, the hardening arm 3340 may be molded into a curved shape to substantially correspond to the shape of the patient's head side (e.g., covering the masseter muscle and / or temporal bone).

[0331] In some forms, the hardener arm 3340 can be molded to fit the head of a particular patient (e.g., a custom hardener arm 3340).

[0332] In some forms, the hardener arm 3340 may be flexible in at least one direction. For example, the hardener arm 3340 may be flexible about its width but inflexible along its length. In other words, the hardener arm 3340 may bend about an axis along its width, but may not bend about an axis perpendicular to its width. This allows individual patients to adjust the hardener arm 3340 for a better fit to their individual head.

[0333] In some forms, the hardening arm 3340 can remain in its new position after bending. This allows patients to adjust the shape of the hardening arm 3340 to suit their specific head shape, and then the hardening arm 3340 will maintain the desired shape during use to improve patient comfort.

[0334] In some forms, the first end 3342 of the hardening arm 3340 may be a free end, and the second end 3344 of the hardening arm 3340 (e.g., opposite the first end 3342) may be fixed. The first end 3342 may be curved to minimize sharp edges that could cause patient discomfort. In use, the first end 3342 may also cover the patient's head near the temporal bone. The second end 3344 may be fixed to the arm connection structure 3504.

[0335] In some forms, the arm connection structure 3504 may resemble the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 may have substantially the same shape. This allows the conduit connection structure 3500 or the arm connection structure 3504 to fit into a recess (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth liner 3050-1 or the nose liner 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0336] In some configurations, the arm connection 3504 can serve as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the hardener arm 3340 does not deliver pressurized air to the inflation chamber 3200. The hardener arm 3340 can be used with a “lower tube” configuration, where a hose connects to and delivers air to the inflation chamber 3200 through the vent opening 3402 (e.g., 3402-1 and / or 3402-2). In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Therefore, the arm connection 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict airflow into or out of the inflation chamber 3200.

[0337] 5.3.4 Vent In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gases (e.g., carbon dioxide).

[0338] In some configurations, the airway 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure within the inflation chamber during use.

[0339] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0340] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disengaged structure, such as a rotating shaft.

[0341] like Figure 6N As shown, the ventilation port 3450 can be used with the patient interface 3000. The ventilation port 3450 may have a shape substantially similar to that of the ventilation opening 3402-1 (e.g., a substantially circular shape).

[0342] The vent 3450 can be connected to the mouth and nose inflation chamber 3200-1 (e.g., Figure 6A (as illustrated) or only nasal inflation chamber 3200-2 (e.g., Figure 6B Used together (as shown in the illustration).

[0343] Continue to refer to Figure 6A The ventilator 3450 may include a ventilator housing 3404, which may be configured to engage with the ventilator opening 3402. The ventilator housing 3404 may be made of a rigid or semi-rigid material. For example, the ventilator housing 3404 may be made of plastic, metal, or any similar material. The ventilator housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable bending that may affect the position of the seal-forming structure 3100 on the patient's face).

[0344] The ventilation housing 3404 may include a front surface 3408, a rear surface 3412, and a recess 3416. The front surface 3408 faces away from the patient's face during use and may be positioned outside the pressurized volume of the inflation chamber 3200. The rear surface 3412 is positioned opposite the front surface 3408. During use, the rear surface 3412 may face the patient and may be arranged within the pressurized volume of the inflation chamber 3200. The recess 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the inflation chamber 3200 may be received within the recess 3416 to hold the airway 3400 in place.

[0345] In some configurations, the diffuser 3448 can be used in conjunction with the ventilation housing 3404. The diffuser 3448 can help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 can help limit the decibel level associated with air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 can limit the decibel level at any point within the patient interface.

[0346] In some forms, the diffuser 3448 can diffuse and thus slow down the exhaust gases exiting the inflation chamber 3200 and through the ventilation housing 3404. The diffuser 3448 can help avoid jetting and associated discomfort for the patient and / or bed partner (e.g., noise caused by jetting onto pillows, sheets, bedding, etc.).

[0347] In some forms, the diffuser may include a front surface 3456 that faces away from the patient during use. The outer diameter of the front surface 3456 may be smaller than the inner diameter of the vent housing 3404 adjacent to the front surface 3408. This can create a gap 3464 through which air can travel.

[0348] 5.3.5 Disconnection from the connection structure In one form, the patient interface 3000 includes at least one disconnection structure, such as a swivel or ball socket.

[0349] 5.3.6 Connection Port Connection port 3600 allows connection to air circuit 4170.

[0350] 5.3.7 Forehead Support In one embodiment, the patient interface 3000 includes a forehead support 3700.

[0351] 5.3.8 Anti-suffocation valve In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0352] 5.3.9 Modularization As mentioned above, the pads, hoods, and sleeves can come in different styles to correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). Patients or clinicians can choose certain combinations of pads, hoods, and sleeves to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed October 28, 2022, the entire contents of which are incorporated herein by reference.

[0353] In some forms, different styles of padding, caps, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be beneficial from a manufacturing perspective, as it allows for the creation of a greater variety of patient interfaces using fewer components. Additionally or alternatively, these combinations can allow patients to change the style of their patient interface without altering each individual component.

[0354] Air can be delivered to the patient in one of two main ways. In one instance, the patient can be delivered via a head cannula 3350 (see example...). Figure 3Y This receives a pressurized airflow. This can be referred to as an "upper tube" configuration, and the connection port can be positioned at the top of the patient's head. In other instances, the patient can receive a pressurized airflow through a catheter connected to the inflation chamber 3200, for example, through connection port 3600 (see example). Figure 3A This can be referred to as a "lower tube" configuration, where the airflow duct is located in front of the patient's face. Different patients are more comfortable with one style of air delivery than with another (e.g., due to the patient's sleeping posture). Therefore, it is beneficial to allow the use of a single style of patient interface in either a "higher tube" or "lower tube" configuration.

[0355] The patient interface can be part of a modular component with various interchangeable parts, which patients and / or clinicians can swap out for one or more different styles of components. The following description illustrates the various combinations that can be produced by assembling the different parts together.

[0356] 5.3.9.1 Sleeve In some configurations, to allow for modularity, the sleeve can be used with the tube 3350 and / or the hardener arm 3340. The sleeve may at least partially surround the tube 3350 and / or the hardener arm 3340. For example... Figures 6G to 6I As shown, sleeves of different shapes can be used, which can correspond to different types of positioning and stabilization structures 3300. In some forms, the sleeve configuration can be customized to fit a specific user's face. For example, the sleeve can be configured in a relatively posterior area of ​​the patient's head.

[0357] In some forms, the sleeve can be made of comfortable materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfortable materials can come into contact with the patient during use and feel soft against the patient's skin, thereby improving patient compliance.

[0358] The material can also be flexible to help put on or take off the sleeve from the tube 3350 or the hardener arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube or catheter head cap 3350 or the hardener arm 3340, which can be adapted to the shape of an individual patient's head.

[0359] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or hardener arm 3340. The elastic material can then return to its initial position, which rests against the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0360] As described in more detail below, some forms of sleeves can be specifically designed for hardening elements (e.g., tube 3350 and / or hardener arm 3340). However, sleeves can facilitate interchangeable connection of hardening elements with versions or styles of pads (e.g., mouth and nose pads 3050-1, nose pads only 3050-2, etc.).

[0361] 5.3.9.1.1 Catheter sleeve like Figure 6G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the aforementioned tube 3350.

[0362] like Figure 6G As shown, the catheter sleeve 3351 may include similar components. Figure 6C The tube 3350 shown is in a curved shape. The flexible material used to construct the catheter sleeve 3351 allows the catheter sleeve 3351 to be further bent to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0363] In some forms, the catheter sleeve 3351 may include a first opening or an upper opening 3352. The upper opening 3352 may be located at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel extending along at least a portion of the catheter sleeve 3351.

[0364] like Figure 6GAs shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite to the upper opening 3352. The catheter sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the catheter sleeve 3351 may be configured in a relatively posterior or anterior region of the patient's head.

[0365] Some forms of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the sleeve 3351). The rigid or semi-rigid member may be made of a plastic material or a similar material. Alternatively, the lower extension 3354 may be reinforced using manufacturing processes (e.g., stitching hardened threads, plain knitting, using a thicker material).

[0366] like Figure 6G As shown, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated example, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may also be positioned anywhere along the lower extension 3354.

[0367] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (see, for example, see...) Figure 6J When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0368] 5.3.9.1.2 Four-point arm sleeve like Figure 6H As shown, another example of the sleeve is the four-point arm sleeve 3380, which can be used in conjunction with the hardener arm 3340 described above.

[0369] like Figure 6H As shown, the four-point arm sleeve 3380 may include similar components. Figure 6D The curvature arm 3340 shown is curved in shape. The flexible material used to construct the four-point arm sleeve 3380 allows the four-point arm sleeve 3380 to be further bent to correspond to the shape of the curvature arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0370] like Figure 6HAs shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be positioned at one end of the four-point arm sleeve 3380.

[0371] In the illustrated example, the shape and / or structure of the lower extension 3384 is substantially the same as that of the lower extension 3354. For example, the lower extension 3384 may be more rigid than the rest of the four-point arm sleeve 3380 (e.g., due to hardening of the wire or rigid material).

[0372] like Figure 6H As shown, some forms of the lower extension 3384 may include a connecting member 3386. In the illustrated example, the connecting member 3386 may be a magnet, although in other examples, the connecting member 3386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3386 may also be positioned at one end of the lower extension 3384, although the connecting member 3386 may also be positioned anywhere along the lower extension 3384.

[0373] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (see, for example...) Figure 6K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0374] like Figure 6H As shown, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When the four-point arm sleeve 3380 is worn by a patient, the tabs 3394 may be positioned on the patient's head in a position substantially the same as that of the tabs 3320 when the patient wears the tube 3350.

[0375] 5.3.9.1.3 Two-point arm sleeve like Figure 6I As shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the hardener arm 3340 described above.

[0376] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

[0377] like Figure 6IAs shown, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening for a channel through the two-point arm sleeve 3380-1. In the illustrated example, the lower opening 3388-1 may lead to the surface of the conduit sleeve 3380-1.

[0378] like Figure 6I As shown, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tabs 3320 on the tube 3350. When the two-point arm sleeve 3380-1 is worn by a patient, the tabs 3394-1 may be positioned on the patient's head in a position substantially the same as the position of the tabs 3320 when the patient wears the tube 3350.

[0379] 5.3.9.2 Assembled Patient Interface like Figures 6J to 6M As illustrated, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different styles based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple styles of patient interfaces) simplifies manufacturing and / or allows patients to more easily switch between different styles of patient interfaces.

[0380] 5.3.9.2.1 Nose and Mouth Mask Upper Tube Configuration like Figure 6J As illustrated, a patient can wear a pad 3050-1 in an upper tube configuration with a tube 3350 and a four-point head covering 3302-1. This assembly can form the upper tube's nose and mouth patient interface 3000-1.

[0381] In some configurations, the catheter sleeve can be used with tube 3350 to allow the patient to experience an "upper tube" air delivery method with the mouth and nasal pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, connectors of other forms, or even those other than the catheter sleeve, can be used.

[0382] In the illustrated example, the conduit sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the conduit connection structure 3500) can be used to connect the tube 3350 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point sleeve 3302-1 (see example). Figure 6E Alternatively, different connection methods can be used.

[0383] like Figure 6JAs illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension for maintaining the padding 3050-1 in a sealed position on the patient's head.

[0384] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0385] 5.3.9.2.2 Nose and Mouth Mask Lower Tube Configuration like Figure 6K As illustrated, the patient can wear the pad 3050-1 in the lower tube configuration, which includes a hardening arm 3340 and a four-point headgear 3302-1. This assembly forms the lower tube's nose and mouth patient interface 3000-2.

[0386] In some configurations, the catheter sleeve can be used in conjunction with the sclerotherapy arm 3340 to allow the patient to experience a “lower tube” air delivery method with the mouth and nasal pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, connectors of other forms, or even those other than the catheter sleeve, can be used.

[0387] In the illustrated example, the conduit sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 (via conduit connection structure 3504) can be used to connect the hardener arm 3340 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point head sleeve 3302-1 (see example). Figure 6E Alternatively, different connection methods can be used.

[0388] like Figure 6K As illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension for maintaining the padding 3050-1 in a sealed position on the patient's head.

[0389] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0390] 5.3.9.2.3 Nose mask upper tube configuration like Figure 6LAs shown, the patient can wear the pad 3050-2 in the upper tube configuration, which includes the tube 3350 and the two-point head covering 3302-2. This assembly can form the upper tube, with a nasal patient interface 3000-3. The catheter sleeve can be used with the tubing 3350 and can provide additional comfort to the patient. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding an additional connection point. In the illustrated example, the tubing 3350 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0391] like Figure 6L As shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide tension for maintaining the pad 3050-2 in a sealed position on the patient's head.

[0392] 5.3.9.2.4 Nasal mask lower tube configuration like Figure 6M As illustrated, the patient can wear the pad 3050-2 in the upper tube configuration, which includes a hardening arm 3340 and a two-point headgear 3302-2. This assembly can form the lower tube nasal-only patient interface 3000-4.

[0393] The catheter sleeve can be used with the sclerosing arm 3340 and can provide additional comfort to the patient. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding additional connection points. In the illustrated example, the sclerosing arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0394] like Figure 6M As illustrated, the two-point headgear 3302-2 can be connected to the tab 3320 on the sleeve to provide tension for maintaining the pad 3050-2 in a sealed position on the patient's head.

[0395] 5.3.9.2.5 Component Modularization Figure 6P The diagram illustrates how to combine different components to form the four different patient interfaces described above. As shown, different parts can be reused for different styles of patient interfaces. This allows for easier manufacturing and assembly because large quantities of the same parts can be produced and used in various styles. The only part not used in multiple styles could be the sleeve. However, the sleeve is easier to manufacture. Figure 6O A portion of the air circuit 4170, which can interface with a patient interface, is shown. Figure 6N The diagram shows interchangeable styles based on the patient interface. Figure 6O The air vent 3404 of the air circuit shown.

[0396] 5.4 RPT device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0397] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0398] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0399] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow rate sensor 4274.

[0400] One or more of the air path objects may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by a chassis 4016, or is formed as part of it.

[0401] 5.4.1 Mechanical and pneumatic components of the RPT device The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be positioned as respective independent units.

[0402] 5.4.1.1 Air Filter One form of RPT device according to the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0403] exist Figure 4BIn one embodiment shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0404] exist Figure 4B In one embodiment shown, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0405] 5.4.1.2 Muffler One form of RPT device according to the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0406] In one form of this technology (see, for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0407] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0408] 5.4.1.3 Pressure Generator In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0409] The pressure generator 4140 can be controlled by the therapy device controller 4240.

[0410] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (such as a compressed air reservoir), or a bellows.

[0411] 5.4.1.4 Transducer The transducer can be located inside or outside the RPT device. An external transducer can be situated on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or sends data to or to the RPT device.

[0412] In one form of this technology (see example) Figure 4B One or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow velocity, pressure, or temperature at that point in the aerodynamic path.

[0413] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.

[0414] In one embodiment, the signal from transducer 4270 can be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0415] 5.4.1.5 Anti-overflow valve like Figure 4B As shown, in one form of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, towards the motor 4144.

[0416] 5.4.2 Electronic components of the RPT device 5.4.2.1 Power Supply The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0417] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0418] 5.4.2.2 Input Device In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical or software devices accessible via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0419] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0420] 5.4.2.3 Central Controller In one form of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0421] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings, and microcontrollers such as the STM32 family from STMicroelectronics. In some alternative forms of this technology, 32-bit RISC CPUs, such as the STR9 family of microcontrollers from STMicroelectronics, or 16-bit RISC CPUs, such as the MSP430 family of microcontrollers from Texas Instruments, may also be applicable.

[0422] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0423] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0424] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0425] The central controller 4230 can be configured to provide output signals to one or more of the output devices 4290, pressure generator 4140, therapy device controller 4240, data communication interface 4280 and / or humidifier 5000.

[0426] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transitory computer-readable storage medium (such as memory 4260). In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, a remote positioning device may determine the control settings of a ventilator or detect respiratory-related events by analyzing stored data from any of the sensors described herein.

[0427] 5.5 Air Circuit According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) during use.

[0428] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. This air circuit may be referred to as an air delivery tube. In some cases, separate branches of the circuit for inhalation and exhalation may be present. In other cases, a single branch is used.

[0429] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as temperature sensors. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0430] 5.6 Humidifier 5.6.1 Overview of Humidifiers In one form of this technology, a humidifier 5000 is provided to change the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to the ambient air) before it is delivered to the patient's airway.

[0431] 5.7 Respiratory waveform Figure 5 The diagram shows a typical respiratory waveform of a sleeping person. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. Although parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume. Vt 0.5 L, inhalation time Ti 1.6 seconds, peak inspiratory flow rate Q Peak 0.4 L / sec, exhalation time Te 2.4 seconds, peak expiratory flow rate Q Peak -0.5 L / s. Total duration of respiration. Ttot It takes approximately 4 seconds. Humans typically breathe at a rate of about 15 breaths per minute (BPM), and their ventilation is... Vent Approximately 7.5 L / min. Typical duty cycle. Ti and TtotThe ratio is approximately 40%.

[0432] 5.8 Glossary 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.

[0433] 5.8.1 General Rules Air In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0434] environment In some forms of this technology, the term "environment" is considered to mean (i) the outside of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0435] For example, relative to humidifier The ambient humidity can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This type of ambient humidity can differ from the humidity outside the patient's bedroom.

[0436] In another instance, environmental stress can be stress that is either close to or outside the body.

[0437] 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.

[0438] Automated Positive Airway Pressure (APAP) Therapy The therapeutic pressure is automatically adjustable between minimum and maximum for CPAP therapy, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0439] Continuous positive airway pressure (CPAP) therapy Respiratory pressure therapy, in which the therapeutic pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when signs of partial upper airway obstruction are not present.

[0440] Flow rateFlow velocity: The volume (or mass) of air delivered per unit time. Flow velocity can refer to an instantaneous quantity. In some cases, the reference to flow velocity will be a scalar quantity, i.e., a quantity that only has a magnitude. In other cases, the reference to flow velocity will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow velocity can be represented by symbols. Q The term "flow rate" is sometimes simply abbreviated as "flow rate" or "airflow".

[0441] In the case of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd This is the air velocity leaving the RPT device. Total velocity. Qt It is the flow rate of air and any supplemental gases reaching the patient interface via the air circuit. (Airflow rate) Qv This is the flow rate of air leaving the vent to allow for the flushing of exhaled air. Leakage flow rate. Ql This refers to leaking flow rate from the patient interface system or elsewhere. (Respiratory flow rate) Qr It is the airflow rate received from the patient's respiratory system.

[0442] Flow therapy Breathing therapy involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is typically positive throughout the patient’s respiratory cycle.

[0443] humidifier The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured to have a physical structure that enables it to deliver a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0444] leakage Leakage is considered an unintended airflow. In one instance, a leak might occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak might occur in a swivel bend leading to the surrounding environment.

[0445] 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.

[0446] 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 by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0447] Ventilation noise (acoustic) Ventilation noise in this document refers to noise generated by the flow of air through any ventilator, such as the ventilator opening of a patient interface.

[0448] Oxygen-rich air Oxygen-rich air is air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-rich air" is sometimes shortened to "oxygen".

[0449] Medical oxygen Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0450] patient People, regardless of whether they have respiratory illnesses.

[0451] pressure: Force per unit area. Pressure can be expressed in units, including cmH2O, gf / cm². 2 And hectopascals. 1 cmH2 equals 1 gf / cm³ 2 And approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m) 2 =1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0452] 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 transmitted through the interface at the current moment. Pm The target value obtained.

[0453] Respiratory pressure therapy Air supply is applied to the airway inlet at a treatment pressure that is typically positive relative to the atmosphere.

[0454] Ventilator Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0455] 5.8.1.1 Materials and their properties hardness Indentation hardness refers to the hardness measured by an indenter or hardness tester, which is a material property measured by indentation through an indenter (e.g., according to ASTM D2240).

[0456] • “Soft” materials may include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0457] • “Hard” materials can include polycarbonate, polypropylene, and can be, for example, not easily deformed under finger pressure.

[0458] Silicone resin or silicone elastomer Synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0459] polycarbonate : A thermoplastic polymer of bisphenol A carbonate.

[0460] 5.8.1.2 Mechanics axis: a. neutral axis A beam or slab with no longitudinal stress or strain in its cross-section.

[0461] b. Vertical axis An axis that extends along the length of a shape. This axis typically passes through the center of the shape.

[0462] c. Circular axis A vertical axis relative to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0463] Deformation The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0464] elasticity The ability of a material to recover its original geometry after deformation.

[0465] soft Structure or component: A structure or component that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support its own weight.

[0466] Resilience The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0467] elasticity During unloading, virtually all of the energy is released. This includes, for example, certain siloxanes and thermoplastic elastomers.

[0468] rigidity Structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered during use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the patient's airway inlet at a pressure of approximately 20 to 30 cmH2O.

[0469] 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.

[0470] Stiffness of structure or component (or rigidity Stiffness is 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 torque. The structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.

[0471] viscosity The ability of a material to resist flow.

[0472] viscoelasticity The ability of a material to exhibit elastic and viscous behavior during deformation.

[0473] yield This refers to the situation where a material does not return to its original geometry after deformation.

[0474] 5.8.1.3 Structural Components Compression component: A structural element that resists compressive forces.

[0475] bend A bend is an example of a structure that guides the axis of airflow through it at an angle to change direction. 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 an approximately circular cross-section. In another form, a bend can have an oval 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.

[0476] 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.

[0477] membrane The term "membrane" is to be understood as referring to a typically thin element that is preferably substantially non-flexural but tensile.

[0478] Lace (noun) A structure designed to resist tension.

[0479] Thin structure: a. beam, i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0480] b. membrane, i. Two dimensions are relatively long, and one dimension is relatively thin. It easily deforms in response to bending forces. It is resistant to tension (and possibly compression).

[0481] c. Plate shell i. They can be relatively long in two directions, with one dimension being thinner. They can have bending, tensile, and / or compressive stiffness.

[0482] Thick structure: solid seal : can be the noun form referring to structure ("sealing") or the verb form referring to effect ("sealing"). Two elements can be constructed and / or arranged to "seale" or to achieve "sealing" between them, without requiring a separate "sealing" element itself.

[0483] case The term "shell" is considered to refer to a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be an outer 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.

[0484] Reinforcing components A reinforcement is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0485] support The support will be considered a structural component designed to increase the compressibility of another component in at least one direction.

[0486] Rotation axis (noun)A sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the shaft can be configured to rotate by an angle of at least 360 degrees. In another form, the shaft can be configured to rotate by 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, there may be little or no air leakage from the shaft.

[0487] 5.8.2 Respiratory cycle 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 despite a patent airway due to reduced or absent respiratory effort. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0488] respiratory rate The rate of spontaneous breathing in a patient is usually measured in breaths per minute.

[0489] Duty cycle : The ratio of inspiratory time Ti to total respiratory time Ttot.

[0490] effort (Breathing): The work done by a person who breathes spontaneously, attempting to breathe.

[0491] respiratory cycle The expiratory phase: the time period from the start of expiratory flow to the start of inspiratory flow.

[0492] respiratory cycle The inspiratory phase: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory phase of the respiratory cycle.

[0493] Flowability (Airway): The degree to which the airway is open or the degree to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, a value (1) for patent and a value of zero (0) for closed (obstructed).

[0494] Positive end-expiratory pressure (PEEP) The pressure above atmospheric pressure present in the lungs at the end of exhalation.

[0495] Peak flow rate ( Q Peak ): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0496] Respiratory flow rate, 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.

[0497] 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), and therefore the individual tidal volume 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.

[0498] Inhalation time ( Ti ): The duration of the inspiratory portion of the respiratory flow waveform.

[0499] Call-out time ( Te ): The duration of the expiratory portion of the respiratory flow waveform.

[0500] 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.

[0501] Typical recent ventilation Vent is a measure of the central tendency of recent values ​​of ventilation over a predetermined time scale.

[0502] 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 may even decrease as the pressure differential across the upper airway increases (Starling resistance behavior).

[0503] 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 is understood as volume per minute.

[0504] 5.8.3 Anatomy 5.8.3.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar) Alar angle: The angle formed between the alae of each nostril.

[0505] Alar tip: the outermost point on the ala of the nose.

[0506] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0507] Auricle: The entire visible external part of the ear.

[0508] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0509] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0510] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0511] Columellar angle: The angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the horizontal plane of the flange that intersects the subnasal point.

[0512] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0513] The glabella: Located on the soft tissue, at the most prominent point in the sagittal plane in the middle of the forehead.

[0514] Lateral nasal cartilage: a roughly triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0515] Lower lip (lower lip margin point): The lip that extends between the lower point of the nasal septum and the mouth.

[0516] Upper lip (upper lip margin point): The lip that extends between the mouth and the supramental region.

[0517] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four small cartilages of the alar.

[0518] Nostrils (Nares / Nostrils): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal septum (naris, nostril). Nostrils are separated by the nasal septum.

[0519] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0520] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0521] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0522] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0523] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0524] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0525] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0526] Nasal ridge: The nasal ridge is the midline protrusion of the nose, extending from the bridge of the nose to the tip of the nose.

[0527] The sagittal plane is a vertical plane running from front to back. The median sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0528] The bridge of the nose point: located on the soft tissue, it is the most concave point covering the nasofrontal suture.

[0529] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0530] Posterosuperior lateral segment: 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.

[0531] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0532] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue. Skull Anatomy Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0533] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0534] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0535] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0536] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0537] Occipital bone: The occipital bone is located in the dorsal and lower parts of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0538] The eye socket is the bony cavity in the skull that houses the eyeball.

[0539] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0540] 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.

[0541] Cheekbones: The face consists of two cheekbones, located on the upper and outer parts of the face and forming the protruding part of the cheek.

[0542] 5.8.3.2 Anatomy of the Respiratory System Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0543] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0544] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0545] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0546] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0547] 5.8.4 Patient Interface Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0548] Headgear: A headgear is considered to be a form of positioning and stabilizing structure designed to secure a device (e.g., a mask) to the head.

[0549] Inflation chamber: The mask inflation chamber is considered to be part of the patient interface, having walls that at least partially enclose a volume of space within which air is pressurized to above atmospheric pressure during use. A shell may form part of the walls of the mask inflation chamber.

[0550] Sealing: can be the noun form referring to a structure ("sealing") or the verb form referring to an effect ("sealing"). Two elements can be constructed and / or arranged to "seale" or to achieve "sealing" between them without requiring a separate "sealing" element itself.

[0551] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, depending on the mask design and treatment pressure, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute.

[0552] 5.8.5 Structural Shape Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another instance, a structure may include a first surface and a second surface.

[0553] 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 viewpoint of an imaginary little person standing upright on it.

[0554] 5.8.5.1 One-dimensional curvature The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0555] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the imaginary figures leave point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0556] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary figures leave point p, they can walk horizontally without going up or down). See also Figure 3D .

[0557] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary figures left point p, they would have to go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0558] 5.8.5.2 Curvature of Two-Dimensional Surfaces A 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 through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. Different curvatures at that point may have the same sign or different signs. Each curvature at that point has an amplitude, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0559] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at P is the curvature along the principal direction.

[0560] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar properties, such as curvature or sign.

[0561] Saddle region: At each point, the principal curvature has opposite signs, that is, one is positive and the other is negative (depending on the direction the hypothetical person is turning, they can be walking uphill or downhill).

[0562] Dome region: A region where the principal curvatures at each point have the same sign, such as both being positive ("concave dome") or both being negative ("convex dome").

[0563] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0564] Planar region: A surface region where both principal curvatures are 0 (or, for example, 0 within manufacturing tolerances).

[0565] Surface edge: The boundary or limit of a surface or region.

[0566] Path: In some forms of this technique, "path" will be considered a path in the mathematical topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0567] Path length: In some forms of this technique, "path length" refers to the distance along the surface from f(0) to f(1), 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 imaginary person would be the distance they walk along the path on the surface).

[0568] 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 region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be a path with the same path length as the straight-line distance between the two points. (For a hypothetical person, straight-line distance will correspond to the distance as a "straight line".) 5.8.5.3 Space Curves Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. An imaginary person walking along a space curve could be imagined as walking along 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 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0569] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0570] Unit normal vector: This is the vector that changes as an imagined person moves along the curve. The unit vector pointing in the direction of the tangent vector's change is called the principal normal vector. It is perpendicular to the tangent vector.

[0571] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0572] Oscillating plane: A plane containing both a unit tangent vector and a unit principal normal vector. See appendix. Figure 3O and 3P .

[0573] Space curve twist: The twist of a space curve at a point is the magnitude of the rate of change of the unit vector of the two normals at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero twist. A space curve deviating relatively small from the osculating plane will have a relatively small amount of twist (e.g., a slightly inclined spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of twist (e.g., a sharply inclined spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3S The amount of twist of the bottom coil of the spiral.

[0574] refer to Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand side of the double normal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0575] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve pointing towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0576] 5.8.5.4 holes Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0577] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The two-dimensional hole in the structure shown is defined by the surface shown.

[0578] 5.9 Other Remarks 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 stated range are broadly encompassed within this technology. The upper and lower limits of these intermediate ranges may be independently included within the intermediate range and also within the scope of this technology, but are subject to any express exclusions within the stated range. Where a stated range includes one or two limitations, the range excluding one or both of those included limitations is also included within this technology.

[0579] Furthermore, where one or more values ​​stated herein are implemented as part of this technology, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used for any suitable valid digits to the extent that practical technical implementations may allow or require them.

[0580] Furthermore, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5% to 10% of the stated value.

[0581] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0582] When a particular material is identified for use in constructing a component, an obvious alternative material with similar properties may be used as a substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as capable of being manufactured and therefore can be manufactured together or separately.

[0583] 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 specifies otherwise.

[0584] 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 precedence over such publications due to prior inventions. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0585] The terms “comprises” and “comprising” should be understood as: referring to an element, component, or non-exclusive step, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0586] The 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. These headings should not be used to interpret the scope or limit of the claims.

[0587] 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 necessary for practicing the techniques. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence can be modified and / or aspects thereof can be performed simultaneously or even concurrently.

[0588] Therefore, it should be understood that various modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

[0589] 5.10 List of reference numerals

Claims

1. A patient interface, comprising: An inflation chamber capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for the patient to breathe; A sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use, the sealing structure being formed of silicone resin, a first portion of the sealing structure including a textured silicone resin surface configured to contact the patient's face during use and having a plurality of protrusions and recesses, a second portion of the sealing structure including a non-textured silicone resin surface, and the recesses being recessed below the non-textured silicone resin surface and the protrusions of the textured silicone resin surface; as well as A positioning and stabilizing structure configured to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above an auricular base point. The patient interface is configured such that the patient's mouth is not covered, or if the sealing structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized airflow through the inlet port of the inflation chamber.

2. The patient interface of claim 1, wherein the protrusions on the untextured silicone surface and the textured silicone surface are at the same height relative to the recesses on the textured silicone surface.

3. The patient interface according to claim 1, wherein the protrusions on the untextured silicone surface and the textured silicone surface are at different heights relative to the recesses on the textured silicone surface.

4. The patient interface according to any one of claims 1 to 3, wherein the protrusion comprises a first group of protrusions at a first height relative to the recess and a second group of protrusions at a second height relative to the recess that is different from the first height.

5. The patient interface according to any one of claims 1 to 3, wherein the protrusion has the same height as the recess.

6. The patient interface according to any one of claims 1 to 5, wherein each of the protrusions is spaced evenly from the adjacent protrusions.

7. The patient interface according to any one of claims 1 to 5, wherein each of the protrusions is spaced apart from a first adjacent protrusion by a first distance and from a second adjacent protrusion by a second distance different from the first distance.

8. The patient interface according to any one of claims 1 to 7, wherein the protrusion is formed as a pattern comprising columns and rows.

9. The patient interface of claim 8, wherein each of the protrusions in the first column of the columns has a uniform first shape and a first height relative to the recess.

10. The patient interface of claim 9, wherein each of the protrusions in the second column of the column adjacent to the first column of the column has a uniform second shape and a second height relative to the recess.

11. The patient interface according to any one of claims 8 to 10, wherein each of the protrusions in the first row of said rows has a uniform first shape and a first height relative to said recess.

12. The patient interface according to any one of claims 8 to 11, wherein each of the protrusions in the second row of the rows adjacent to the first row of the rows has a uniform second shape and a second height relative to the recess.

13. The patient interface according to any one of claims 1 to 12, wherein each of the protrusions has a uniform cross-sectional area along its height.

14. The patient interface according to any one of claims 1 to 12, wherein the cross-sectional area of ​​each of the protrusions decreases from the adjacent recess to the peak.

15. The patient interface according to any one of claims 1 to 14, wherein each of the protrusions has the same cross-sectional area at its base as the adjacent protrusion.

16. The patient interface according to any one of claims 1 to 14, wherein each of the protrusions has a cross-sectional area at its base that is different from the cross-sectional area of ​​at least one adjacent protrusion.

17. The patient interface according to any one of claims 1 to 16, wherein the textured silicone surface is formed on the surface of the sealing structure, the surface of the sealing structure being configured to contact the patient's nose in use.

18. The patient interface according to any one of claims 1 to 17, wherein the textured silicone surface is formed on the surface of the sealing structure, the surface of the sealing structure being configured to contact the upper lip of the patient in use.

19. The patient interface according to any one of claims 1 to 18, wherein the textured silicone surface is formed on the surface of the sealing structure, the surface of the sealing structure being configured to contact the lower lip of the patient in use.

20. The patient interface according to any one of claims 1 to 19, wherein the textured silicone surface is not formed on the surface of the sealing structure, the surface of the sealing structure being configured to contact the patient's face on the outer side of the patient's mouth during use.

21. The patient interface according to any one of claims 1 to 20, wherein the textured silicone surface is formed on the rear side of the sealing structure to contact the patient's face in use.

22. The patient interface according to any one of claims 1 to 21, wherein the textured silicone surface is formed on the front side of the sealing structure such that at least a portion of the textured silicone surface is away from the patient's face and does not contact the patient's face during use.

23. The patient interface according to any one of claims 1 to 22, wherein the sealing formation is a full-face arrangement configured to seal against the patient's face together around the patient's nose and mouth during use.

24. The patient interface according to any one of claims 1 to 23, wherein the sealing formation is a nasal arrangement configured to seal against the patient's face around the patient's nose, including the patient's nasal protrusion, in use while leaving the patient's mouth uncovered.

25. The patient interface according to any one of claims 1 to 24, wherein the sealing structure is a nose pad arrangement configured to seal against the lower periphery of the patient's nose in use, while leaving at least a portion of the patient's mouth and the patient's nasal protrusion uncovered.

26. The patient interface according to any one of claims 1 to 22, wherein the sealing formation is an ultra-compact full-face arrangement configured to seal against the patient's face together around the patient's nose and mouth during use, the sealing formation having at least one nasal opening and one oral opening, the at least one nasal opening being configured to direct the airflow under the treatment pressure to the patient's nostrils, and the oral opening being configured to direct the airflow under the treatment pressure to the patient's mouth.

27. The patient interface according to any one of claims 1 to 26, further comprising a ventilation structure configured to allow gas exhaled by the patient to flow continuously from the interior of the air chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain the therapeutic pressure in the air chamber during use.

28. The patient interface according to any one of claims 1 to 27, wherein the sealing structure includes a flange having an outer surface and an inner surface opposite to the outer surface, at least a portion of the outer surface being configured to contact the patient's face in use, and the inner surface being configured not to contact the patient's face in use. The textured silicone resin surface is formed on the outer surface but not on the inner surface.

29. The patient interface according to any one of claims 1 to 28, wherein the textured silicone surface is configured to mimic textiles.

30. The patient interface according to any one of claims 1 to 29, wherein the textured silicone surface is configured to mimic a textile with a woven pattern.

31. The patient interface according to any one of claims 1 to 30, wherein the textured silicone surface is configured to mimic a textile with a knitted pattern.

32. The patient interface according to any one of claims 1 to 32, wherein a portion of the untextured silicone surface is configured to contact the patient's face in use.

33. The patient interface according to any one of claims 1 to 32, wherein the untextured silicone surface is configured not to contact the patient's face during use.

34. The patient interface according to any one of claims 1 to 33, wherein the textured silicone surface is formed by laser etching.

35. The patient interface according to any one of claims 1 to 34, wherein the silicone resin is a two-component silicone rubber comprising type A silicone rubber and type B silicone rubber in a 1:1 ratio.

36. The patient interface according to any one of claims 1 to 35, wherein the silicone resin is a two-component silicone rubber comprising type A silicone rubber and type B silicone rubber in a 2:1 ratio.

37. The patient interface according to any one of claims 1 to 36, wherein the silicone resin has a Shore A and Shore B indentation hardness in the range of about 30 to about 60 as measured using ASTM D2240.

38. The patient interface according to any one of claims 1 to 37, wherein the silicone resin has Shore A and Shore B indentation hardness in different ranges.

39. The patient interface according to any one of claims 1 to 38, wherein the silicone resin has a Shore A indentation hardness in the range of about 30 to about 60 and a Shore B indentation hardness in the range of about 35 to about 68, as measured using ASTM D2240.

40. The patient interface according to any one of claims 1 to 39, wherein the silicone resin has Shore A and Shore B resilience in the range of about 40% to 80% as measured using ASTM D1054.

41. The patient interface according to any one of claims 1 to 40, wherein the sealing structure is treated with vacuum ultraviolet (VUV) treatment.

42. The patient interface according to any one of claims 1 to 41, wherein the textured silicone surface is treated with the VUV treatment, and the untextured silicone surface is not treated with the VUV treatment.

43. The patient interface according to any one of claims 1 to 42, wherein cracks are randomly formed on the textured silicone surface.

44. The patient interface according to any one of claims 1 to 43, wherein cracks spanning from about 500 nm to about 1.5 µm are randomly formed on the textured silicone surface.

45. The patient interface according to any one of claims 1 to 44, wherein the silicone resin on the textured silicone resin surface has a higher surface roughness than the silicone resin on the untextured silicone resin surface.

46. ​​The patient interface according to any one of claims 1 to 45, wherein the silicone resin on the textured silicone resin surface has a higher surface friction than the silicone resin on the untextured silicone resin surface.

47. The patient interface according to any one of claims 1 to 46, wherein the silicone resin of the sealing structure comprises one or more pigments.

48. The patient interface according to any one of claims 1 to 47, wherein the sealing structure comprises a silicone layer.

49. The patient interface according to any one of claims 1 to 48, wherein the textured silicone resin surface comprises an organosilicon layer, and the non-textured silicone resin surface lacks an organosilicon layer.

50. The patient interface according to any one of claims 1 to 49, wherein the silicone layer is at least 1 micrometer deep, 2 to 5 micrometer deep, 2 to 10 micrometer deep, 2 to 20 micrometer deep, 2 to 50 micrometer deep, or 10 to 100 micrometer deep.

51. A patient interface, comprising: An inflation chamber capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for the patient to breathe; A sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that the airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use, the sealing structure being formed of silicone resin and treated with vacuum ultraviolet (VUV) treatment; as well as A positioning and stabilizing structure configured to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above an auricular base point. The patient interface is configured such that the patient's mouth is not covered, or if the sealing structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized airflow through the inlet port of the inflation chamber.

52. The patient interface of claim 51, wherein the textured silicone surface is treated with the VUV treatment, and the untextured silicone surface is not treated with the VUV treatment.

53. The patient interface according to claim 51 or 52, wherein cracks are randomly formed on the textured silicone surface.

54. The patient interface according to any one of claims 51 to 53, wherein cracks spanning from about 500 nm to about 1.5 µm are randomly formed on the textured silicone surface.

55. The patient interface according to any one of claims 51 to 54, wherein the silicone resin on the textured silicone resin surface has a higher surface roughness than the silicone resin on the untextured silicone resin surface.

56. The patient interface according to any one of claims 51 to 55, wherein the silicone resin on the textured silicone resin surface has a higher surface roughness than the silicone resin on the untextured silicone resin surface.

57. The patient interface according to any one of claims 51 to 56, wherein the silicone resin of the sealing structure comprises one or more pigments.

58. The patient interface according to any one of claims 51 to 57, wherein the sealing structure comprises a silicone layer.

59. The patient interface according to any one of claims 51 to 58, wherein the textured silicone surface comprises a silicone layer, and the non-textured silicone surface lacks a silicone layer.

60. The patient interface according to any one of claims 51 to 59, wherein the silicone layer is at least 1 micrometer deep, 2 to 5 micrometer deep, 2 to 10 micrometer deep, 2 to 20 micrometer deep, 2 to 50 micrometer deep, or 10 to 100 micrometer deep.

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