Patient interface and the positioning and stabilization structure for the patient interface

Abstract

This utility model relates to a patient interface and a positioning and stabilizing structure for the patient interface. A positioning and stabilizing structure for a patient interface has a pair of side straps, a top strap, and a rear strap. The positioning and stabilizing structure further includes at least one strap with a chin engagement portion configured to bias the patient's chin toward a closed mouth position, thereby reducing or eliminating mouth leakage, and / or a mouth closure member or portion is configured to abut against the patient's mouth for engagement and sealing, thereby reducing or eliminating mouth leakage.

Description

[0001] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0002] 1. Cross-references to related applications

[0003] This application claims the benefit of Australian Provisional Application No. 2023903551, filed on 6 November 2023, which is incorporated herein by reference in its entirety. Technical Field

[0004] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Technology

[0005] 2.2 Description of relevant technologies

[0006] 2.2.1 The Human Respiratory System and Its Disorders

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

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

[0009] There are a range of breathing disorders. Some conditions can be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0011] 2.2.2 Treatment

[0012] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0013] 2.2.2.1 Respiratory pressure therapy

[0014] 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).

[0015] 2.2.3 Respiratory Therapy System

[0016] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0017] 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.

[0018] 2.2.3.1 Patient Interface

[0019] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be administered, the patient interface can form a seal with, for example, an area of ​​the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure) to achieve the therapy. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply 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.

[0020] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0021] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0022] If patients need to insert part of the mask structure into their mouths to create and maintain a seal via their lips, some masks may be uncomfortable or impractical for this technique.

[0023] Some face masks may not be very practical to use while sleeping, for example, when the head is resting on a pillow and the person is sleeping on their side in bed.

[0024] Some masks may cause claustrophobia, anxiety and / or may feel too abrupt to some patients.

[0025] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head comprises bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy sessions.

[0026] Therefore, some masks have disadvantages such as being obtrusive, unsightly, expensive, poorly fitted, difficult to use, and / or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized 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 are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the mask is worn during sleep.

[0027] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to therapy if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, which could affect patient adherence.

[0028] While masks designed for other applications (e.g., pilots) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.

[0029] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0030] 2.2.3.1.1 Sealing Formation Structure

[0031] Patient interfaces may include sealing structures. Since 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.

[0032] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover, the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both the nostril and mouth regions 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.

[0033] A sealing structure that may be effective in one area of ​​a patient's face may be unsuitable in another, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0034] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0035] 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. This seal-forming structure may include an air- or fluid-filled liner, or a molded or formed 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.

[0036] Another type of seal-forming structure incorporates a valve seal made of a 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, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0037] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0038] 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.

[0039] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0040] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to Puritan Bennett.

[0041] ResMed Inc. has manufactured the following products that incorporate a nose pillow: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO2004 / 073778 (which describes SWIFT). TM (Regarding the nose pillow mask), US Patent Application 2009 / 0044808 (which describes SWIFT) TM (Regarding the LT nasal pillow mask); International patent applications WO2005 / 063328 and WO2006 / 130903 (which describe MIRAGE LIBERTY) TM All aspects of a full-face mask); International patent application WO2009 / 052560 (which describes SWIFT) TM (All aspects of the FX nose pillow mask).

[0042] 2.2.3.1.2 Positioning and stabilizing structure

[0043] The seal-forming structure of a patient interface used in positive pressure therapy is subject to the corresponding force of pneumatic pressure that can disrupt the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealed relationship with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: the effectiveness of the technique in maintaining the seal-forming structure in the desired position and sealing it against the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0044] One technique involves using adhesives, for example, see U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0045] 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.

[0046] 2.2.3.1.3 pressurized air duct

[0047] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit. When the patient interface is positioned over the patient's face during use, the air circuit is fluidly connected to the patient interface at a location in front of the patient's face. The conduit can extend forward from the patient interface away from the patient's face.

[0048] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing sealing structures

[0049] Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also serves as part of a headband to position and stabilize a sealed portion of the patient interface in the appropriate part of the patient's face. This type of patient interface may be referred to as having a "catheter headband" or "headband tubing." Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, wherein the catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0050] Ideally, when the patient is asleep, the patient interface with a headband tube should be comfortable for the patient to wear for an extended period of time, forming an airtight and stable seal with the patient's face, while also being adaptable to a range of patient head shapes and sizes.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0052] 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, an RPT device can also function as a flow-based therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0053] Device designers may face an infinite number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute, subtle changes in one or more parameters.

[0054] 2.2.3.3 Air Circuit

[0055] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for both inhalation and exhalation.

[0056] 2.2.3.4 Humidifier

[0057] Delivering an airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface to produce humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air applied to the area within and around the patient interface on the face is generally more comfortable than cold air.

[0058] 2.2.3.5 Data Management

[0059] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has been "adherent," such as the patient having used their RPT device according to one or more "adherence rules." One example of an adherence rule for CPAP therapy is that, in order to be considered adherent, a patient is required to use the RPT device for at least 4 hours per night for at least 21 days out of a 30-day period. To determine patient adherence, the RPT device provider (such as a healthcare provider) may manually obtain data describing the patient's therapy using the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can notify a third party that the patient is adherent.

[0060] Patient therapy may exist in other ways that benefit from the communication of therapy data with third parties or external systems.

[0061] Existing processes for communicating and managing such data can be expensive, time-consuming, and error-prone.

[0062] 2.2.3.6 Vent technology

[0063] Some forms of therapeutic systems may include vents to allow the flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., a pneumatic chamber) to the external space of the patient interface, such as to the surrounding environment.

[0064] 2.2.4 Screening, Diagnosis and Monitoring Systems

[0065] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and its application typically involves a clinical specialist. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has involved two nights of observation in the clinic: one night for pure diagnosis and a second night for the clinician to determine treatment parameters. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0066] Screening and diagnosis typically describe identifying a condition from its signs and symptoms. Screening usually yields a true / false result, indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0067] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may be unavailable or unable to afford them. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Utility Model Content

[0068] 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.

[0069] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0070] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0071] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0072] One form of this technology includes a positioning and stabilizing structure configured to provide forces that 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.

[0073] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0074] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, the inlet port being sized and configured to receive an airflow at the treatment pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to 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 an airflow at the treatment pressure is delivered to at least an inlet of the patient's nostril. The sealing structure is configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle in use. The patient interface also includes positioning and stabilizing structures to provide force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0075] Another aspect of this technology is a series of modular elements that can be interconnected to form different types of patient interfaces.

[0076] In one form, each modular element has at least two versions or types. These styles or types can be used interchangeably to form different modular components.

[0077] One form of this technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including a pair of side straps, a top strap and a rear strap, the positioning and stabilizing structure also including a lower strap, wherein the lower strap includes a mouth-blocking member or portion configured to abut against the patient's mouth for engagement and sealing, thereby reducing or eliminating mouth leakage.

[0078] The positioning and stabilizing structure may include one or more of the following: wherein the rear portion is configured to engage the rear of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or is located near the junction between the occipital bone and the parietal bone; wherein the top portion is configured to engage the upper part of the patient's head in use and is configured to cover the parietal bone of the patient's head in use; wherein the mouth closure member or portion includes a mouth engagement portion made of silicone; wherein the patient-facing surface of the silicone is "adhesive" to help ensure that the lips do not move apart; wherein the mouth closure element or portion includes a mouth engagement portion made of a biocompatible and substantially nonporous material; wherein the mouth engagement portion includes a fabric with a substantially nonporous coating; wherein the mouth engagement portion is integrally formed with the lower band; wherein the mouth engagement portion is inserted into the lower band, or may be attached to the patient-facing surface of the lower band or portion; and / or wherein the lower band is configured to extend below the patient's ear and attach to the rear band at the rear of the patient's head.

[0079] Another form of this technology includes a positioning and stabilizing structure for a patient interface, comprising a pair of side straps, a top strap, and a rear strap, and further comprising a chin strap including a chin engagement portion, the chin strap being configured to bias the patient's chin toward a closed mouth position, thereby reducing or eliminating mouth leakage.

[0080] In the example, the positioning and stabilizing structure may include one or more of the following: wherein the rear portion is configured to engage the rear of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or is located near the junction between the occipital and parietal bones; wherein the top portion is configured to engage the upper portion of the patient's head in use and is configured to cover the parietal bone of the patient's head in use; wherein the chin strap is connected to the side strap and is configured to be positioned substantially horizontal to the patient's ear and in front of the patient's ear; wherein the chin engagement portion is wider than the rest of the chin strap; wherein the chin engagement portion is shaped to have a substantially concave portion to conform to the patient's chin; wherein in use, the chin strap is configured to apply a force to the patient's chin, the force biasing the patient's chin toward a position where the patient's mouth is closed; and / or wherein the chin strap is length-adjustable and / or elastic.

[0081] According to another aspect of the present technology, a positioning and stabilizing structure for a patient interface is provided, the positioning and stabilizing structure including a pair of side straps, a top strap and a rear strap, the positioning and stabilizing structure further including at least one strap including a chin engagement portion configured to bias the patient's chin toward a closed mouth position, thereby reducing or eliminating mouth leakage, and / or a mouth closure member or portion is configured to engage and seal the patient's mouth, thereby reducing or eliminating mouth leakage.

[0082] In the example, the positioning and stabilizing structure may include one or more of the following features: wherein the posterior portion is configured to engage the posterior portion of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or is located near the junction between the occipital and parietal bones, and the top portion is configured to engage the upper portion of the patient's head in use and is configured to cover the parietal bone of the patient's head in use; wherein the band is configured to move between a mouth-sealing position and a chin-supporting position; wherein, whether in a mouth-sealing mode or a chin-banding mode, the band remains attached to the side band or the posterior band at the same connection point; wherein the band is configured to both seal the mouth and serve as a chin support; wherein the band is attached to the side band, the posterior band, or both the side band and the posterior band simultaneously.

[0083] In the example, a patient interface for treating a patient with respiratory distress may be provided, the patient interface comprising: a sealing forming portion configured to form a seal with the patient's nasal airway, the seal being configured to form a seal with at least the patient's upper lip, nasal ala, and anterior nasal portion during use; and a positioning and stabilizing structure as described above to support the sealing forming portion.

[0084] 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.

[0085] One aspect of this technology is a method for manufacturing equipment.

[0086] 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.

[0087] 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.

[0088] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in a person's home).

[0089] 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 tank that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0090] 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.

[0091] Of course, parts of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0092] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0093] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:

[0094] 4.1 Respiratory Therapy System

[0095] Figure 1AA system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow and 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 partner 1100 is also shown. The patient is sleeping in a supine position.

[0096] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0097] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0098] 4.2 Respiratory System and Facial Anatomy

[0099] 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.

[0100] 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.

[0101] Figure 2C It is a frontal view of a face with many recognizable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the directions of up, down, radially inward, and radially outward.

[0102] Figure 2D It is a side view of the head with many recognizable 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.

[0103] Figure 2EThis is another side view of the head. It indicates the approximate location of the Frankfort plane and the nasolabial angle. The coronal plane is also indicated.

[0104] Figure 2F A bottom view of the nose with many recognizable 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.

[0105] Figure 2G A side view showing the surface features of the nose.

[0106] 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.

[0107] Figure 2I An anatomical view of the medial part of the nose is shown, approximately a few millimeters from the midsagittal plane, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0108] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0109] 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.

[0110] Figure 2L The frontal lateral view of the nose is shown.

[0111] 4.3 Patient Interface

[0112] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0113] Figure 3A-1 It shows the effect when in use. Figure 3A The force on the patient interface.

[0114] 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 compared with... Figure 3C The curvature shown has a relatively large magnitude compared to the previous value.

[0115] Figure 3CA schematic diagram of a cross-section through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when compared with... Figure 3B The curvature shown has a relatively small size compared to the previous value.

[0116] Figure 3D A schematic diagram of a cross-section through the structure at a single point is shown. The outward normal direction at that point is indicated. The curvature at that point has a zero value.

[0117] Figure 3E A schematic diagram of a cross-section through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when compared with... Figure 3F The curvature shown has a relatively small size compared to the previous value.

[0118] Figure 3F A schematic diagram of a cross-section through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when compared with... Figure 3E The curvature shown has a relatively large magnitude compared to the previous value.

[0119] Figure 3G A padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The dome-shaped area and the saddle-shaped area are indicated.

[0120] 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 points A and B is indicated. Two saddle-shaped areas and a dome-shaped area are indicated.

[0121] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0122] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown in the figure is... Figure 3I The structure defines a two-dimensional hole.

[0123] 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.

[0124] Figure 3L A face mask with an inflatable air bladder as padding is shown.

[0125] Figure 3M It shows crossing Figure 3LThe image shows a cross-section of the mask, and the inner surface of the bladder is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0126] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0127] Figure 3O The diagram illustrates the left-hand rule.

[0128] Figure 3P The right-hand rule is illustrated.

[0129] Figure 3Q The left ear is shown, including the left ear spiral.

[0130] Figure 3R The right ear is shown, including the right ear spiral.

[0131] Figure 3S A right-handed spiral is shown.

[0132] 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.

[0133] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0134] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0135] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V A section is shown at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies in the sagittal plane and contacts the gasket of the inflation chamber only at two points (upper point 3220 and lower point 3230) in the sagittal plane. Depending on the geometry of the gasket in this region, the intermediate contact plane can be a section at the upper and lower points.

[0136] Figure 3X The location shown is for use on the face. Figure 3UThe air chamber 3200. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 substantially coincides with the central sagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane generally corresponds to the "plane of the face". 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.

[0137] Figure 3Y A patient interface in the form of a nasal cannula according to the present technology is shown.

[0138] Figure 3Z A patient interface with a catheter headband in one form according to the present technology is shown.

[0139] Figure 3Z-1 It shows the effect when in use. Figure 3Z The force on the patient interface.

[0140] 4.4 RPT device

[0141] Figure 4 shows one form of RPT device according to the present technology.

[0142] 4.5 Humidifier

[0143] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0144] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0145] 4.6 Respiratory waveform

[0146] Figure 6 shows a typical breathing waveform of a person while sleeping.

[0147] 4.7 Modularization

[0148] Figure 7A 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.

[0149] Figure 7B 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.

[0150] Figure 7C It shows that it can be used with Figure 7A padding or Figure 7B A perspective view of the tube used with the liner.

[0151] Figure 7D It shows that it can be used with Figure 7A padding or Figure 7B A perspective view of the hardener arm used with the padding.

[0152] Figure 7E It shows that it can be used with Figure 7A A perspective view of the headband strap used with the padding.

[0153] Figure 7F It shows that it can be used with Figure 7B A perspective view of the headband strap used with the padding.

[0154] Figure 7G It shows removable assembly to Figure 7C pipe or Figure 7D Front view of a pair of sleeves on the hardener arm.

[0155] Figure 7H It shows removable assembly to Figure 7D Front view of the complete sleeve of the hardener arm.

[0156] Figure 7I It shows removable assembly to Figure 7D A front perspective view of another alternative form of the complete sleeve of the hardener arm.

[0157] Figure 7J It is worn connected to Figure 7C pipe, Figure 7E headband and Figure 7G The sleeve Figure 7A A front view of the patient with the padding.

[0158] Figure 7K It is worn connected to Figure 7D hardener arm, Figure 7E headband and Figure 7H The sleeve Figure 7A A front view of the patient with the padding.

[0159] Figure 7L It is worn connected to Figure 7C catheter headband and Figure 7F headband Figure 7B A front view of the patient with the padding.

[0160] Figure 7M It is worn connected to Figure 7D hardener arm, Figure 7F headband and Figure 7I The sleeve Figure 7B A front view of the patient with the padding.

[0161] Figure 7N yes Figure 7L A perspective view of the vent.

[0162] Figure 7O yes Figure 7M A separate perspective view of a portion of the air circuit.

[0163] Figure 7P This is a schematic diagram illustrating possible combinations of the patient interface.

[0164] 4.8 Patient interface including the positioning and stabilization structure of this technology

[0165] Figure 8 This is a perspective view of a patient interface with a positioning and stabilizing structure according to this technology.

[0166] Figure 9 This is a perspective view of a patient interface with a positioning and stabilizing structure, according to another form of this technology.

[0167] Figure 10 This is a perspective view of a patient interface with a positioning and stabilizing structure according to this technology.

[0168] Figure 11 This is a perspective view of a patient interface with a positioning and stabilizing structure according to this technology. Detailed Implementation

[0169] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0170] The following descriptions are provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features may constitute another example.

[0171] 5.1 Treatment

[0172] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0173] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0174] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0175] 5.2 Respiratory Therapy System

[0176] 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.

[0177] 5.3 Patient Interface

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

[0179] like Figure 3Z 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, a pneumatic chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a connection for connecting to an air circuit (e.g., Figure 1A-1C The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which sense it or they may be replaced by different components, for example, components of different sizes.

[0180] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal cannulas 3810a, 3810b that can deliver air to the corresponding nostril of a patient 1000 via corresponding orifices in their tips. Such nasal cannulas typically do not form a seal with the inner or outer skin surface of the nostril. This type of interface results in one or more gaps that are intentionally present by design during use, but are generally not fixed in size, making them susceptible to unpredictable changes due to movement during use. Unlike other types of mask-based respiratory therapy systems, this allows for complex pneumatic variables in the respiratory therapy system when pneumatic control and / or evaluation are implemented. Air to the nasal tip can be delivered through one or more air supply lumens 3820a, 3820b coupled to the unsealed patient interface 3800. Lumens 3820a, 3820b extend from the unsealed patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. The "vent" or gap at the unsealed patient interface 3800 is a passage between the tips 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, allowing excess airflow to escape into the surrounding environment via the patient's nostril.

[0181] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, then the patient interface may not be suitable for respiratory pressure therapy.

[0182] 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.

[0183] 5.3.1 Sealing Formation Structure

[0184] 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 area where a seal actually occurs (the actual sealing surface) can vary over time and from patient to patient within a given treatment course, 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.

[0185] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0186] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0187] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicone resin.

[0188] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0189] 5.3.1.1 Sealing Mechanism

[0190] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0191] 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 boundary edges of the sealing flange and the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from buckling during use.

[0192] 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.

[0193] In one form, the seal-forming structure includes a tension section. In use, the tension section maintains tension, for example, through adjacent areas of the sealing flange.

[0194] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0195] 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 tension portion, and a portion having an adhesive or bonding surface.

[0196] 5.3.1.2 Nasal middle or nasal ridge region

[0197] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the nasal midline or nasal ridge region of the patient's face during use.

[0198] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the nasal midline or nasal ridge region of the patient's face during use.

[0199] 5.3.1.3 Upper lip area

[0200] 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.

[0201] 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.

[0202] 5.3.1.4 Chin area

[0203] 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.

[0204] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​the patient's face during use.

[0205] 5.3.1.5 Forehead area

[0206] 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.

[0207] 5.3.1.6 Nasal pillow

[0208] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0209] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the structure to which the nasal pillow of the present invention is connected includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that is adaptable to relative movement of the truncated cone and the structure to which the nasal pillow is connected, both in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the structure to which the handle is connected.

[0210] 5.3.1.7 Nose mask only

[0211] In one embodiment, 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 seal over the patient's lips. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver an air or breathable gas supply 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.

[0212] One form of the nasal mask according to this technology is conventionally recognized as a nasal mask, having a sealing forming structure 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 forming structure 3100, which, in use, forms a seal against the upper lip region (e.g., supralipal), against at least a portion of the nasal ridge above the nasal protuberance or nasal tip, and against the patient's face on each side of the nose, for example, near the 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.

[0213] Another form of the pure nasal mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad". In one form, for example, as... Figure 3ZAs shown, the sealing forming structure 3100 is configured to form a seal with the lower nasal surface 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 to the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing to the patient's nasal ala. The sealing forming structure 3100 can seal to the upper part of the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely fit the lower side of the patient's nose and may not contact the bridge area of ​​the patient's nose or any portion of the patient's nose above 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 nostril during use. The bridging portion can be configured to contact or abut against the patient's columella during use. Alternatively, the sealing forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nostrils.

[0214] In some forms, a simple nasal mask may include a nasal pillow as described above.

[0215] 5.3.1.8 Nose and mouth mask

[0216] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around an inlet to the patient's nasal airway and around the patient's mouth. The sealing structure 3100 may be configured to seal against the patient's face near the chin area. The patient interface 3000 can deliver air or breathable gas to the nostrils and mouth of the patient 1000. This type of patient interface can be identified as a nasal mask and mouth mask.

[0217] One form of the nose and mouth mask according to the present technology is conventionally recognized as a full-face mask, having a sealing forming structure 3100 configured to seal around the nose, below the mouth, and above the bridge of the nose on the patient's face. The nose and mouth mask is typically triangular in shape. In one form, the patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal on the patient's chin area (which may include the area below and / or directly below the lip), the patient's bridge of the nose or at least a portion of the nasal ridge above the nasal protuberance, and the cheek area of ​​the patient's face. Figure 1C The patient interface 3000 shown belongs to this type. This patient interface 3000 delivers air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of sealing structure 3100 can be referred to as a nasal / mouth liner.

[0218] In another form, the patient interface 3000 includes a sealing formation structure 3100 that, in use, forms a seal on the lower and / or anterior surface of the nasal projection portion of the patient's nose, the nasal alae of the patient's nose, and the patient's face on each lateral side of the patient's nose (e.g., near the nasolabial fold) in the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip). The sealing formation structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 having this type of sealing formation 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 can have a nose portion and a mouth portion, with the nose portion sealing to the patient's face in a position similar to a nose pad.

[0219] In another form of the nasal 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 around the patient's mouth against the patient's face.

[0220] In some forms, the sealing structure 3100 may have a nasal portion that is separate from and distinct from the mouth portion. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0221] 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 a pure nasal mask and a naso-oral mask.

[0222] 5.3.2 Inflation Chamber

[0223] In the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend around the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0224] 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 protruding and / or more comfortable for the wearer, which can improve adherence to therapy.

[0225] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve adherence to the therapy. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0226] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0227] 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.

[0228] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in 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, such as a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0229] 5.3.2.1 Multiple openings

[0230] like Figure 7A and Figure 7B 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, liners 3050-1, 3050-2 each include three openings, although alternative liners can be formed with more or fewer openings.

[0231] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0232] 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.

[0233] These multiple openings allow for various configurations of air delivery into the inflation chambers 3200-1 and 3200-2. For example, depending on the patient's needs and / or comfort, the patient can use a given pad 3050-1 or 3050-2 in a "tube-up" configuration (e.g., using a catheter headband described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0234] 5.3.2.1.1 Nose and mouth mask

[0235] like Figure 7A As 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).

[0236] In some forms, the air chamber 3200-1 may also include at least one vent opening 3402-1 (see, for example, Figure 7A 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 arranged between the inlet ports 3254-1 of the inflation chamber.

[0237] 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.

[0238] 5.3.2.1.2 Nose mask only

[0239] Only the air chamber 3200-2 of the nasal 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.

[0240] like Figure 7B 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).

[0241] In some forms, the air chamber 3200-2 may also include at least one ventilation opening 3402-2 (see, for example, Figure 7BVentilation opening 3402-2 can be located at the center of inflation chamber 3200-2. For example, ventilation opening 3402-2 can be arranged between inflation chamber inlet ports 3254-2.

[0242] 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.

[0243] 5.3.3 Positioning and Stabilizing Structure

[0244] 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 "headband". Figure 3A and Figure 3A-1 An example of a positioning and stabilizing structure is shown in the figure.

[0245] 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 ).

[0246] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0247] 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 headband can provide a force F individually. 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).

[0248] 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 3200 g Conversely, but 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 Relatively speaking, friction can act at any point along the patient interface 3000 where it contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair). In some forms, gravity F g It can also be offset by the vertical component of the reaction force from the patient’s face, which acts on the sealing structure 3100, for example, in the bridge of the nose and chin area of ​​the patient’s face.

[0249] 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 It can exceed gravity F g And blowing force F 充气 The sum of all (including any additional positioning and stabilizing forces F) PSS The reaction force acting on the patient interface 3000 from the patient's head balances the reaction force and still keeps the sealing structure 3100 in the proper sealing position, but may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSSWhen the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when installed, the positioning and stabilizing force F... PSS Greater than the precise equilibrium gravity F g And explosive force F 充气 The required force is to hold the patient interface 3000 sufficiently close against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the air chamber 3200 during side sleeping) 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 .

[0250] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of disturbance forces on the patient interface 3000, such as those from tube resistance or unintended interference with the patient interface.

[0251] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0252] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0253] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a side-lying sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0254] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0255] 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 for engagement with a hook material portion.

[0256] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap can be configured to be under tension during use, and a guiding force pulls the sealing structure into a sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0257] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraauricular point of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0258] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0259] In one form of the technology applicable to nose-only masks or 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.

[0260] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt that is flexible and, for example, non-rigid. An advantage of this is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0261] 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.

[0262] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0263] 5.3.3.1 Catheter headband

[0264] 5.3.3.1.1 catheter headband

[0265] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more headband tubes 3350, which, for example, deliver pressurized air received from a conduit forming part of an air circuit 4170 from the RPT device to the patient's airway via an inflation chamber 3200 and a sealing formation structure 3100. Figure 3Z In 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, in use, position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face (e.g., on the top of the patient's head).

[0266] exist Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 positioned on a different side of the patient's head during use, and extending above the corresponding ear (above an auricular base point above the patient's head) across the corresponding cheek region to a curved tube 3610 on the top of the patient's head. This form of the technology may be advantageous because if the patient sleeps with their head turned to the side, and one tube 3350 is compressed to block or partially block the gas flow along that tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, for example, one tube, or two or more tubes.

[0267] 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.

[0268] 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.

[0269] exist Figure 3Z In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but connected in use and can be disconnected, 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 a corresponding tube 3350. Additionally, the T-connector may have a third arm or opening that provides a connection port 3600 for fluid connection to an air circuit 4170 in use. This opening may be an inlet 3332 for receiving a pressurized airflow (see, for example, 7C).

[0270] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0271] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0272] 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 angle formed by the first two arms can resemble the shape of the patient's head in order to conform to that shape.

[0273] 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.

[0274] In some forms, at least one arm of a T-connector (or Y-connector) can be at least partially rigidified. This helps maintain the shape of the connector so that bending of the connector does not block the airflow path.

[0275] Tube 3350 may be formed of a flexible material, such as an elastomer, for example, silicone or TPE, and / or of one or more fabrics and / or foam materials. Tube 3350 may have a pre-shaped form and be able to bend or move into another shape when a force is applied, but return to the original pre-shaped form when the force is not applied. Tube 3350 may typically be arcuate or curved, its shape approximating the head contour between the top of the patient's head and the nasal or oral region.

[0276] In some examples, the one or more tubes 3350 are compression-resistant to prevent blockage if compressed during use, for example, if compressed between the patient's head and the pillow, especially if there is only one tube 3350. The tube 3350 can be formed with sufficient structural stiffness to resist crushing, or can be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0277] 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 3Z In the example shown, each tube 3350 is positioned in use along a path extending from the inflation chamber 3200 across the patient's cheek area and above the patient's ear to the curved tube 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraauricular point. Each tube 3350 may also be positioned on 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 be positioned on the patient's parietal bone, frontal bone, and / or the junction between them (e.g., the coronal suture) in use.

[0278] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range spanning the top of the patient's head, thus allowing the patient interface 3000 to be positioned for the comfort or fit of an individual patient. In some examples, the headband tube 3350 is configured to allow movement of the upper portion of the patient interface 3000 (e.g., the connection port 3600) 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 separated 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 range).

[0279] As described above, in some examples of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a pad, which is generally located below the nose and seals to the lower periphery of the nose (e.g., a subnasal pad). A positioning and stabilizing structure 3300 (including a tube 3350) can be configured and arranged to pull the sealing-forming structure 3100 under the patient's nose using sealing forces in a posterior and superior direction (e.g., a 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, for example, on either side of the patient's nose and above the patient's lips.

[0280] Catheters forming part of the positioning and stabilizing structure 3300, such as headbands, can provide forces that aid in positioning and stabilizing the FPSS. For example... Figure 3Z-1 As shown, the positioning and stabilizing force F PSS The force can be the resultant force of various forces from different elements of the positioning and stabilizing structure 3300. For example, each catheter can provide a force F catheter guided posteriorly and in the corresponding lateral direction to keep the sealing forming structure 3100 against the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the inflation chamber 3200 to lift away from the face (i.e., F inflation). The guiding force F catheter can also be guided at least partially superiorly to overcome gravity Fg.

[0281] 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 clamp the patient's head. This force can be caused by the inflation 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.

[0282] The position of the patient's head can also change the clamping force of the catheter. For example, if the patient is lying on their side, the weight of the patient's head may compress one catheter, and another catheter (e.g., the outer part not between the patient's head and the sleeping surface, such as a pillow) may additionally expand in order to maintain substantially the same pressurized airflow.

[0283] 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 3200 g Conversely, but 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 Relatively speaking, friction can act at any point along the patient interface 3000 where it contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0284] In some forms, the sum of the various forces can equal zero, causing the patient interface 3000 to be in equilibrium (e.g., not moving along the patient's face during use). Specifically, gravity Fg and the inflation force F tend to move the seal-forming structure 3100 away from the desired sealing position. Positioning and stabilizing forces F are applied. PSS In order to counteract the gravity Fg and the blowing force F of inflation (as well as any frictional force Ff) and maintain the proper positioning of the seal-forming structure 3100. Despite the positioning and stabilizing force F... PSS It can exceed the sum of gravity Fg and inflation force F (where any additional positioning and stabilizing force FPSS is balanced by the reaction force from the patient's head acting on the portion of the patient interface 3000) and still hold the seal-forming structure 3100 in the proper sealing position, but 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 examples, the positioning and stabilizing structure 3300 can be adjustable, such that when installed, the positioning and stabilizing force F... PSS The precise balance required for inflation, balancing gravity Fg and bursting force F, ensures that the patient interface 3000 is held 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 side sleeping) do 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 FPSS required to achieve balance.

[0285] 5.3.3.1.2 Extendable and non-extendable tube sections

[0286] In some examples 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 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 3Z The patient interface 3000 shown includes a tube 3350, the upper part of which includes extendable tube sections, each of which is in the form of an extendable accordion structure 3362.

[0287] 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 retracted position and can be moved to an extended position when the patient is prone and the positioning and stabilizing structure 3300 is in place. 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 be stretched to accommodate 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.

[0288] 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.

[0289] The cross-sectional shape of the non-extendable 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 flat surface on the side of the tube facing and contacting other parts of the patient's face or head can be more comfortable to wear than, for example, a tube with a circular cross-section.

[0290] In some examples of this technology, a non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headband tube 3350 may extend downwards to the side of the patient's head, then bend forward and inwards to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 extends to a position at the same vertical position as (or, in some examples, below) the connection to 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.

[0291] 5.3.3.1.3 catheter headband connection port

[0292] 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 3Z In the illustrated form of the present technology, the connection port 3600 is located on top of the patient's head (e.g., in a position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 may be configured for fluid connection with a conduit of the air circuit 4170. The bend 3610 may 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 examples, the bend 3610 may be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the bend may include a tube 3350 or be connected to the tube 3350 via a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient's head during use.

[0293] Patient interfaces with a connection port not located in front of the patient's face may be advantageous because some patients may find catheters connected to patient interfaces in front of the patient's face unsightly and / or not prominent. For example, a catheter connected to a patient interface in front of the patient's face may easily disturb bedding or sheets, 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: a side-lying position, a supine position (e.g., on their back, generally up), or a prone position (e.g., on their front, generally down). Furthermore, connecting the catheter to the front of the patient interface exacerbates a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during head movement or catheter movement, resulting in displacement away from the face. Tube resistance is likely to be a less problematic issue when the forces applied at the position above the patient's head are greater than those applied in front of the patient's face, closer to the sealing structure (where tube resistance may be more likely to disrupt the seal).

[0294] 5.3.3.1.4 Headband tubing fluid connection

[0295] 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 a 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 "re-secure 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 onto a rigid connector, for example, made of 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 examples, each tube 3350 may include a convex or concave connector formed of a flexible material (e.g., silicone or TPE), for example, the tubes 3350 may be formed of the same material.

[0296] In other examples, 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 elasticity 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 pressed against the engagement between the tube and the circumferential surface around the port or connector of the inflation chamber 3200 to form or reinforce the seal between the tube 3350 and the inflation chamber 3200.

[0297] 5.3.3.2 Headband

[0298] In some forms, the positioning and stabilizing structure 3300 may include a headband 3302 having at least one strap that can be worn by a patient to help the sealing forming structure 3100 be properly oriented against the patient's face (e.g., to limit or prevent leakage).

[0299] As described above, some forms of the headband 3302 can be made of fabric material that can comfortably fit against the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric may include a stiffener along a selected length, it can limit the bending, flexing, and / or stretching of the headband 3302.

[0300] In some forms, the headband 3302 may be at least partially stretchable. For example, the headband 3302 may comprise an elastic or similar stretchable material. For example, the entire headband 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the headband 3302 to stretch under tension, which may help provide a sealing force for the seal-forming structure 3100.

[0301] The two types of headbands, the four-point headband 3302-1 and the two-point headband 3302-2, are discussed in more detail below as illustrative examples.

[0302] 5.3.3.2.1 Four points connected

[0303] like Figure 7EAs shown, some forms of the headband 3302-1 can be a four-point connection headband. This means that the headband 3302-1 can be connected to four separate locations on the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to the arm of the inflation chamber 3200. The headband 3302-1 may include four different straps that provide tension to help maintain the sealing formation 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 headband.

[0304] In some forms, the headband 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. Thus, 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 the trapezius muscle.

[0305] The headband 3302-1 may also include a superior band 3305-1, which may cover the temporal bone, parietal bone, and / or occipital bone. The superior band 3305-1 may also be connected to the tube 3350 (e.g., by connection to the lamina 3320).

[0306] The posterior band 3307-1 can extend between the upper band 3305-1 and the lower band 3304-1. The lower band 3304-1 and upper band 3305-1 on a given side (e.g., left or right) can also be connected adjacent to each other to the posterior band 3307-1. Therefore, the height of the posterior band 3307-1 can be approximated as the combined height of the lower band 3304-1 and upper band 3305-1. In use, the posterior band 3307-1 can cover the occipital and / or parietal bones. This allows the posterior band 3307-1 to help anchor the headband 3302-1 to the patient's head.

[0307] In the example shown, the headband 3302-1 may be formed in a generally X shape. The lower band 3304-1 and the upper band 3305-1 may be attached to the rear band 3307-1 by stitching, ultrasonic welding or any similar process.

[0308] In some configurations, the lower band 3304-1 is connected to the magnetic member 3306-1. For example, each lower band 3304-1 may pass through the magnetic member 3306-1, thereby allowing adjustment of the length of each lower band 3304-1. The magnetic member 3306-1 may be removably connected to the magnet 3370-1 (described below), such that the lower band 3304-1 can be disconnected from the inflation chamber 3200, but the length of the lower band 3304-1 may remain unaffected.

[0309] 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.

[0310] In some configurations, the headband 3302-1 may be used only with the nose pad 3050-1 (e.g., because the nose pad 3050-1 alone does not have four connection points). However, the headband 3302-1 may be used interchangeably with the tube 3350 and the hardener arm 3340.

[0311] 5.3.3.2.2 Two points connected

[0312] like Figure 7F As shown, some forms of headband 3302-2 can be two-point connected headbands. This means that headband 3302-2 can be connected to two separate locations.

[0313] In some forms, the headband 3302-2 may be formed from a continuous sheet of material. In other words, the headband 3302-2 may not be formed from multiple bands 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 bands. In other forms, the headband 3302-2 may be formed from multiple bands (e.g., two upper bands, a back band, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0314] 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 3Z As shown, the patient interface 3000 includes a band 3307-2 forming part of a positioning and stabilization structure 3300. For example, the band 3307-2 may be referred to as a back band or a posterior head band. The posterior band 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other examples of the present technology, one or more additional bands may be provided. For example, an example of a patient interface 3000 with a nose and mouth pad according to the present technology may have a second lower band configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0315] exist Figure 3Z 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, to cover the occipital bone of the patient's head or to be 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 3ZThe positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 can be attached between the tabs 3320. Even under tension during use, the strap 3310 has sufficient flexibility to wrap around the back of the patient's head and comfortably rest against the patient's head.

[0316] like Figure 7F As shown, some forms of the headband 3302-2 may be at least partially bifurcated. For example, the rear band 3307-2 of the headband 3302-2 (e.g., configured to contact the back of the patient's head) may be wider than the surrounding portion of the headband 3302-2. The middle portion 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 may be movable 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 headband 3302-2 to the patient's head since there is no lower band (e.g., 3304-1).

[0317] In some configurations, headband 3302-2 may be used only with nose pad 3050-2 (e.g., because nose and mouth pad 3050-1 does not have four connection points). However, headband 3302-2 may be used interchangeably with tube 3350 and hardener arm 3340.

[0318] 5.3.3.3 Hardener Arm

[0319] like Figure 7D As shown, the hardening arm 3340 may be an elongated rigid member that helps hold the pad (e.g., nasal and mouth pad 3050-1 or nasal 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.

[0320] 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 substantially inflexible and may not be able to bend. The hardening arm 3340 can be pre-molded into a desired shape to conform to the patient's head. For example, the hardening arm 3340 can be molded into a curved shape to roughly correspond to the shape of one side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0321] In some forms, the hardener arm 3340 can be molded to fit a specific patient's head (e.g., a custom hardener arm 3340).

[0322] In some forms, the hardening arm 3340 may be flexible in at least one direction. For example, the hardening arm 3340 may be flexible in its width but inflexible in its length. In other words, the hardening arm 3340 may bend about an axis along its width, but not about an axis perpendicular to its length. This allows individual patients to adjust the hardening arm 3340 to better fit their individual head.

[0323] 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.

[0324] In some forms, the first end 3342 of the hardening arm 3340 may be a free end, while 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 adjacent to the temporal bone. The second end 3344 may be fixed to the arm connection structure 3504.

[0325] 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 pad 3050-1 or nose pad 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0326] In some forms, the arm connection structure 3504 can be used 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 in a "tube-down" configuration, where the hose is connected to the vent opening 3402 (e.g., 3402-1 and / or 3402-2) and air is delivered to the inflation chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Therefore, the arm connection structure 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict airflow into or out of the inflation chamber 3200.

[0327] 5.3.4 Other examples of two-point connection headbands

[0328] Next reference Figures 8 to 10 In one form of technology particularly applicable to nasal masks only, the positioning and stabilizing structure 3300 includes a side portion or strap 3312, a top portion or strap 3314, and a rear portion or strap 3316. The top portion 3314 can be configured to engage the upper part of the patient's head in use, and can, for example, be configured to cover the parietal bone of the patient's head in use. The rear portion 3316 can be configured to engage the rear part of the patient's head in use, and can, for example, be configured to cover the occipital bone of the patient's head in use, or be located near the junction between the occipital and parietal bones.

[0329] In the example, a liner module 3270, including a sealing forming structure 3100, is connected to a frame or frame portion 3272, and a side or strip 3112 is connected to the frame 3270 via a suitable connector (e.g., a ring 3274). Each side portion 3312 may extend from the frame or frame portion of the patient interface 3000 and the junction of the top portion 3314 and the rear portion 3316. Each side portion 3312 may be located on a path extending between the corresponding eye and ear of the patient.

[0330] In the example, one or more of the strips or sections may include textiles. In the example, the strip or section includes foam covered by fabric.

[0331] exist Figures 8 to 10 In each of the examples shown, the sealing forming structure 3100 can form a seal around the patient's nasal airway, and can be configured, for example, to form a seal at least on the patient's upper lip, nasal alae, and the anterior nasal portion of the patient's nose during use.

[0332] In the example, the side strap or portion 3312 may include a reinforcing arm. The reinforcing arm may be an elongated member that provides an increased level of rigidity to the corresponding side portion 3312 compared to some other portions of the positioning and stabilizing structure 3300. In some forms, the reinforcing arm is configured to be rigid or semi-rigid in at least one direction. For example, the reinforcing arm may be made of a relatively rigid material. Additionally, the reinforcing arm may be configured to a shape that makes deformation of the reinforcing arm difficult in one or more directions, but the reinforcing arm may be flexible in at least one direction. The reinforcing arm may be pre-molded into a desired shape to fit the patient's head. In some forms, the patient may be able to further deform the reinforcing arm into a desired shape. In the example, the side strap or portion 3312 may include a sleeve. The reinforcing arm may be positioned inside the sleeve. In the example, the reinforcing arm may be attached to the sleeve, for example, using an adhesive and / or a heat-activated material.

[0333] Examples of techniques for incorporating reinforcements into headbands are disclosed in Australian Patent Application No. 2023902766, the contents of which are incorporated herein by reference.

[0334] 5.3.5 Headband with a mouth-closing section

[0335] Next reference Figure 9 In one form of this technology, the positioning and stabilizing structure 3300 also includes a lower band or portion 3318, which includes a mouth closure member or portion 6000. In an example, the mouth closure member 6000 includes a mouth engagement portion 6010. In one example, the mouth engagement portion 6010 may be made of silicone. In an example, the patient-facing surface of the silicone may be slightly "sticky," which can help ensure that the lips do not move apart. In other examples, the mouth engagement portion 6010 may be made of an alternative biocompatible, substantially non-porous material. In one example, the mouth engagement portion 6010 may include a fabric with a suitable substantially non-porous coating. In an example, the mouth engagement portion 6010 may be integrally formed with the lower band or portion 3318. Alternatively, the mouth engagement portion 6010 may be embedded in the lower band or portion 3318, or may be attached to the patient-facing surface of the lower band or portion 3318.

[0336] In the example, the lower band or section 3318 extends below the patient's ear and connects to the back or band 3316 at the back of the patient's head.

[0337] During use, the mouth engagement portion 6010 can form a seal with the patient's lips, thereby reducing or eliminating mouth leakage.

[0338] The lower band or portion 3318 may include an adjustment device (not shown) for adjusting its length, thereby adjusting the force with which the mouth engagement portion 6010 engages with the patient's lips. Alternatively or additionally, the lower band or portion 3318 may be elastic.

[0339] 5.3.6 Headband with chin strap

[0340] Next reference Figure 10 In another form of this technology, the positioning and stabilizing structure 3300 may include a chin strap or chin support portion 6100. The chin strap 6100 may be attached to a side strap or portion 3312, for example, substantially flush with the patient's ear and in front of the patient's ear.

[0341] The chin band 6100 may include a chin engagement portion 6110, which, in an example, may be wider than the rest of the chin band 6100. In an example, the chin engagement portion 6110 may be shaped to have a substantially concave portion to conform to the patient's chin.

[0342] In use, the chin strap 6100 can apply force to the patient's chin, which biases the patient's chin toward a closed position of the patient's mouth. By keeping the patient's mouth closed, the chance of the patient experiencing oral leakage is reduced. The chin strap 6100 may include an adjustment device (not shown) for adjusting the length of the chin strap 6100 and thereby adjusting the biasing force on the patient's chin. Alternatively or additionally, the chin strap 6100 may be elastic.

[0343] In another form of this technology, such as Figure 11 As shown, straps 3318 or 6100 can be used as chin straps or mouth seals. This can be achieved by allowing the same strap to be used in... Figure 9 and Figure 10 The positions shown are moved or alternated, while adjustments are made (e.g., longitudinally via hook and loop fasteners and / or one or more buckles, belts 3312, 3316 including tabs with slots, the belts being adjustably connected to the tabs through the slots, etc.) to ensure a good fit.

[0344] One or more straps can be made in a modular form, allowing the chin cup or nose attachment to be swapped out depending on whether the user wants to cover the mouth or support the chin.

[0345] In one configuration, whether in the mouth-sealed mode or the chin strap mode, the strap can remain attached to the positioning and stabilizing structure at the same connection point.

[0346] However, in order to achieve a more ideal force vector suitable for mouth seals or chin straps, the ends of the strap can be at different points (e.g., Figures 9 to 10 The strap connects to the rest of the positioning and stabilizing structure at the exemplary point shown in the diagram. Furthermore, the strap can be detached from the positioning and stabilizing structure as needed by the patient.

[0347] In another form, such as Figure 11 As shown, the strap can both seal the mouth and serve as a chin support. In this example, the strap can be attached to strap 3312 (e.g., its rigid portion), strap 3316, or both straps 3312 and 3316 simultaneously (e.g., in...). Figure 9 and Figure 10 (as shown in the image). Optionally, the two straps 3318 and 6110 can be used simultaneously, or they can be integrated with the ability to be separated from each other (e.g., where they intersect) if the user only wishes to use one of them. The two straps can be adjustablely connected to each other.

[0348] 5.3.7 Vent

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

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

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

[0352] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disconnected structure (e.g., a rotating shaft).

[0353] like Figure 7N 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 generally circular shape).

[0354] The vent 3450 can be connected to the mouth and nose inflation chamber 3200-1 (e.g., Figure 7A (as illustrated) or a pure nasal inflatable chamber 3200-2 (e.g., Figure 7B Used together (as shown in the illustration).

[0355] Continue to refer to Figure 7A The vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402. The vent housing 3404 may be made of a rigid or semi-rigid material. For example, the vent housing 3404 may be made of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable bending that could affect the position of the seal-forming structure 3100 on the patient's face).

[0356] 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 located outside the pressurized volume of the inflation chamber 3200. The rear surface 3412 is arranged 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.

[0357] 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.

[0358] In some configurations, the diffuser 3448 can diffuse and thus slow the exhaust from the inflation chamber 3200 and through the vent housing 3404. The diffuser 3448 can help avoid jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting pillows, sheets, bedding, etc.).

[0359] 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 creates a gap 3464 through which air can pass.

[0360] 5.3.8 Decoupling Structure

[0361] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and a socket.

[0362] 5.3.9 Connection Port

[0363] Connection port 3600 allows connection to air circuit 4170.

[0364] 5.3.10 Forehead Support

[0365] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0366] 5.3.11 Anti-suffocation valve

[0367] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0368] 5.3.12 port

[0369] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0370] 5.3.13 Modularization

[0371] As mentioned above, the padding, headband, and sleeve can be of different types, which can correspond to different uses (e.g., mouth breathing, nose breathing, etc.). Patients or clinicians can choose certain combinations of padding, headband, and sleeve 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 on 28 October 2022, the entire contents of which are incorporated herein by reference.

[0372] In some forms, different types of padding, headbands, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as it allows for the creation of a greater variety of patient interfaces using fewer components. Additionally or optionally, these combinations can allow patients to change the type of patient interface without altering each component.

[0373] Air can be delivered to the patient in one of two main ways. In one example, the patient can be delivered via a headband tube 3350 (see, for example, Figure 3Z This receives a pressurized airflow. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, the patient can receive the airflow through a catheter connected to the inflation chamber 3200 (e.g., through connection port 3600 (see example, ...). Figure 3A This receives a pressurized airflow. This can be referred to as a "tube-down" configuration, where the airflow duct is positioned in front of the patient's face. Different patients are more comfortable with one type of air delivery than another (e.g., due to the patient's sleep type). Therefore, it may be beneficial to allow the use of a single type of patient interface in either a "tube-up" or "tube-down" configuration.

[0374] 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 components of different types. The following description illustrates the various combinations that can be produced by assembling the different parts together.

[0375] 5.3.13.1 Sleeve

[0376] In some configurations, to allow for modularity, the sleeve can be used with tube 3350 and / or hardener arm 3340. The sleeve can at least partially surround tube 3350 and / or hardener arm 3340. For example... Figures 7G to 7I As shown, sleeves of different shapes can be used, corresponding to different types of positioning and stabilization structures 3300. In some forms, the sleeve configuration can be customized to fit the face of a particular user. For example, the sleeve can be configured in a relatively posterior area of ​​the patient's head.

[0377] In some forms, the sleeve can be made of comfort materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfort materials can come into contact with the patient during use and feel soft against the patient's skin, thereby improving patient compliance.

[0378] The material can also be flexible to facilitate the donning or removal of 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 headband 3350 or the hardener arm 3340, which can be adapted to the shape of an individual patient's head.

[0379] 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 is in close contact with the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0380] As described in more detail below, some forms of the sleeve can be specifically designed for hardening elements (e.g., tube 3350 and / or hardener arm 3340). However, the sleeve can facilitate interchangeable connection of the hardening element with versions or types of pads (e.g., mouth and nose pad 3050-1, nose pad only 3050-2, etc.).

[0381] 5.3.13.1.1 catheter sleeve

[0382] like Figure 7G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the tube 3350 described above.

[0383] like Figure 7G As shown, the catheter sleeve 3351 may include similar components. Figure 7C 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).

[0384] In some forms, the catheter sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be disposed 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.

[0385] like Figure 7G As 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 a particular user's face. For example, the lower extension 3354 of the catheter sleeve 3351 may be configured in a relatively posterior or relatively anterior region of the patient's head.

[0386] 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).

[0387] like Figure 7G 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.

[0388] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headband 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (e.g., see...). Figure 7J When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0389] 5.3.13.1.2 Four-point arm sleeve

[0390] like Figure 7H 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.

[0391] like Figure 7H As shown, the four-point arm sleeve 3380 may include similar components. Figure 7DThe curvature shape of the curative arm 3340 is shown. 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 curative arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0392] like Figure 7H As 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.

[0393] In the example shown, 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).

[0394] like Figure 7H 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.

[0395] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headband 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (e.g., see...). Figure 7K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0396] like Figure 7H 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 substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0397] 5.3.13.1.3 Two-point arm sleeve

[0398] like Figure 7I 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.

[0399] 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.

[0400] like Figure 7I As 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 example shown, the lower opening 3388-1 may lead to the surface of the conduit sleeve 3380-1.

[0401] like Figure 7I 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 location substantially the same as the location of the tabs 3320 when the patient wears the tube 3350.

[0402] 5.3.13.2 Assembled Patient Interface

[0403] like Figures 7J to 7M As illustrated, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between multiple types of patient interfaces.

[0404] 5.3.13.2.1 upper tube configuration of nose and mouth mask

[0405] like Figure 7J As illustrated, a patient can wear a pad 3050-1 with a tube 3350 and a four-point headband 3302-1 in an upper tube configuration. This assembly can form the upper tube nose and mouth patient interface 3000-1.

[0406] In some configurations, the catheter sleeve can be used with tube 3350 to allow the patient to experience a "tube-up" air delivery type with mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headband 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0407] In the example shown, 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 headband 3302-1 (see example, Figure 7E Alternatively, different connection methods can be used.

[0408] like Figure 7J As illustrated, the four-point headband 3302-1 can be connected at four separate locations to provide tension for maintaining the pad 3050-1 in a sealed position on the patient's head.

[0409] 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.

[0410] 5.3.13.2.2 Nose and mouth mask lower tube configuration

[0411] like Figure 7K As illustrated, the patient can wear a pad 3050-1 with a hardener arm 3340 and a four-point headband 3302-1 in the lower tube configuration. This assembly can form the lower tube's nasal and mouth patient interfaces 3000-2.

[0412] In some configurations, the catheter sleeve can be used in conjunction with the sclerotherapy arm 3340 to allow patients to experience a “tube-down” air delivery type with the mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headband 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0413] In the example shown, 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 pad 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point headband 3302-1 (see example, Figure 7E Alternatively, different connection methods can be used.

[0414] like Figure 7K As illustrated, the four-point headband 3302-1 can be connected at four separate locations to provide tension for maintaining the pad 3050-1 in a sealed position on the patient's head.

[0415] 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.

[0416] 5.3.13.2.3 Nose mask tubes are configured upwards

[0417] like Figure 7L As illustrated, the patient can wear a pad 3050-2 with a tube 3350 and two headbands 3302-2 in an upper tube configuration. This assembly can form an upper tube, nasal patient interface 3000-3 only.

[0418] 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.

[0419] like Figure 7L As shown, the two-point headband 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.

[0420] 5.3.13.2.4 Nasal mask tubes configured downwards

[0421] like Figure 7M As illustrated, the patient can wear a pad 3050-2 with a hardener arm 3340 and two-point headband 3302-2 in the upper tube configuration. This assembly can form the lower tube nasal-only patient interface 3000-4.

[0422] The catheter sleeve can be used with the sclerosing arm 3340 and can provide additional patient comfort. 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 sclerosing arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0423] like Figure 7M As illustrated, the two-point headband 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.

[0424] 5.3.13.2.5 Modular components

[0425] Figure 7P illustrates how different components can be combined to form the four different patient interfaces described above. As shown, different components can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because a large number of the same components can be produced and used in multiple types. The only component not used in multiple types could be a sleeve. However, sleeves are easier to manufacture. Figure 7O A portion of the air circuit 4170 that can interface with the patient is shown, while Figure 7N This demonstrates interchangeable replacements based on the type of patient interface. Figure 7O The air vent 3404 of the air circuit shown.

[0426] 5.4 RPT device

[0427] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0428] 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.

[0429] 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.

[0430] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an intake filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0431] 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 or formed as part of chassis 4016.

[0432] The RPT device 4000 may include a power supply 4210 and a pressure generator 4140. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0433] 5.5 Humidifier

[0434] 5.5.1 Humidifier Overview

[0435] In one form of this technology, a humidifier 5000 is provided (e.g., as...). Figure 5A As shown), it changes the absolute humidity of the air or gas 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.

[0436] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to accommodate the humidifier reservoir 5110 and includes a heating element 5240.

[0437] 5.6 Respiratory waveform

[0438] Figure 6 shows a typical respiratory waveform of a sleeping person. The horizontal axis represents time, and the vertical axis represents respiratory flow. Parameter values ​​can vary, and typical breathing can have the following approximations: tidal volume... Vt 0.5 L, inhalation time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, peak expiratory flow rate Qpeak -0.5 L / s. Total duration of respiration. T General It takes approximately 4 seconds. Humans typically breathe at a rate of about 15 breaths per minute (BPM), with a ventilation volume of approximately 7.5 L / min. A typical work cycle (the ratio of Ti to Ttot) is approximately 40%.

[0439] 5.7 Glossary

[0440] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0441] 5.7.1 General

[0442] 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.

[0443] environment In some forms of this technology, the term "environment" will be considered to mean (i) the outside of the treatment system or the patient, and (ii) the area directly surrounding the treatment system or the patient.

[0444] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity in the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0445] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0446] 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, for example, noise generated by the RPT device or emitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0447] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0448] Continuous positive airway pressure (CPAP) therapy This refers to respiratory pressure therapy, where the treatment pressure remains largely constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when such an indication is not present.

[0449] flowFlow rate is the volume (or mass) of air delivered per unit time. It can refer to an instantaneous quantity. In some cases, a reference to flow rate will be a scalar quantity, i.e., a quantity that only has magnitude. In other cases, a reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be assigned the symbol Q. Sometimes 'flow rate' is simply shortened to 'flow' or 'airflow'.

[0450] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the airflow exiting the RPT device. Total flow rate Qt It is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv This is the flow rate of air leaving the vent to allow for flushing of exhaled air. Leakage flow rate. Ql This is leaked flow from the patient interface system or elsewhere. (Respiratory flow) Qr It is the flow rate of air received from the patient's respiratory system.

[0451] 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.

[0452] Humidifier The term "humidifier" will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient's medical respiratory symptoms.

[0453] leakage Leakage is considered an unintended airflow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel bend leading to the surrounding environment.

[0454] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered 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.

[0455] Noise, radiated (acoustic): In this document, radiated noise refers to noise transmitted to the patient through the surrounding air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0456] Vent noise (acoustic)Ventilation noise in this document refers to noise generated by the airflow through any ventilation port (such as the ventilation port of a patient interface).

[0457] 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 abbreviated as "oxygen".

[0458] Medical oxygen Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0459] patient People, regardless of whether they have respiratory illnesses.

[0460] pressure: Force per unit area. Pressure can be measured within a unit area, including cmH2O and gf / cm². 2 And hectopascals. 1 cmH2O equals 1 gf / cm2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 =1 mbar - 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0461] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0462] Respiratory pressure therapy Air supply is applied to the airway inlet under a therapeutic pressure that is normally positive relative to the atmosphere.

[0463] Ventilator Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0464] 5.7.1.1 Materials and their properties

[0465] Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., measured according to ASTM D2240).

[0466] "Soft" materials can include silicone or thermoplastic elastomers (TPEs) and can, for example, be easily deformed under finger pressure.

[0467] "Hard" materials can include polycarbonate and polypropylene, and are not easily deformed, for example, under finger pressure.

[0468] Silicone resin or silicone elastomer Synthetic rubber. In this specification, references to silicone resin refer 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.

[0469] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0470] 5.7.1.2 Mechanics

[0471] axis:

[0472] a. Neutral axis: The axis in the cross-section of a beam or slab where there is no longitudinal stress or strain.

[0473] b. Longitudinal axis: An axis that extends along the length of the shape. This axis typically passes through the center of the shape.

[0474] c. Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0475] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in a direction relative to an axis). This can include stretching or compression, bending, and twisting.

[0476] elasticity The ability of a material to recover its original geometry after deformation.

[0477] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0478] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0479] elasticity During unloading, virtually all of the energy is released. This includes, for example, certain siloxanes and thermoplastic elastomers.

[0480] Rigid structures or components: Structures or components that do not change shape substantially when subjected to loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure load of approximately 20 to 30 cmH2O.

[0481] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0482] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0483] viscosity The ability of a material to resist flow.

[0484] viscoelasticity The ability of a material to exhibit elastic and viscous behavior during deformation.

[0485] yield This refers to the situation where a material does not return to its original geometry after deformation.

[0486] 5.7.1.3 Structural Components

[0487] Compression component: A structural element that resists compressive forces.

[0488] Bend: A bend is an example of a structure that directs the axis of airflow through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an oval or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, about 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0489] Frame: The frame is understood to refer to the mask structure that bears the tensile load between two or more connection points with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0490] Membrane: A membrane will be understood to mean a typically thin element that preferably has little to no bending resistance but has tensile resistance.

[0491] Lacing (noun): A structure designed to resist tension.

[0492] Thin structure:

[0493] a. beam,

[0494] 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.

[0495] b. membrane,

[0496] i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to stretching (and possibly compression).

[0497] c. Plates and shells

[0498] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0499] Thick structure: solid

[0500] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("to seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0501] Shell: Shell will be understood to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a mask can be an outer shell. In some forms, the outer shell can be multifaceted. In some forms, the outer shell can be airtight. In some forms, the outer shell may not be airtight.

[0502] Reinforcing member: A reinforcing member will be understood as a structural component designed to improve the bending resistance of another component in at least one direction.

[0503] Support: A support will be understood as a structural component designed to improve the compressibility of another component in at least one direction.

[0504] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there can be little or no airflow leakage from the rotary shaft.

[0505] 5.7.2 Respiratory cycle

[0506] Apnea: According to some definitions, apnea is considered to occur when airflow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when, despite the patient's efforts, some form of airway obstruction prevents airflow. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0507] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0508] Duty cycle: The ratio of inhalation time Ti to total respiratory time Ttotal.

[0509] Effort (breathing): The work done by a person who breathes voluntarily, attempting to breathe.

[0510] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0511] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0512] Types of flow-limited inhalation waveforms:

[0513] (i) Flattened: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0514] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0515] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat part.

[0516] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0517] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate decreases below a threshold rate for a sustained period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0518] (i) The patient’s breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0519] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0520] Hyperventilation: Increased airflow to above normal levels.

[0521] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0522] Airway patency : The degree to which the airway is open or the degree to which the airway is open. A patent airway is open. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0523] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0524] Peak flow (Q peak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0525] Respiratory flow rate, patient air flow rate, respiratory air flow rate （ Qr These synonymous terms can be understood as referring to RPT. The device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory rate," is based on the patient's actual respiratory rate. Actual respiratory flow is usually expressed in liters per minute.

[0526] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, for example, the average.

[0527] Inhalation time （ Ti ): The duration of the inspiratory portion of the respiratory flow waveform.

[0528] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0529] Total time (Ttotal): 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.

[0530] Typical short-term ventilation: Recent values ​​of ventilation (Vent) within a predetermined time range tend to cluster around its peak value. The ventilation value is a measure of the central tendency of recent ventilation values.

[0531] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure gradient across the upper airway increases (Starling resistance behavior).

[0532] ventilation (Vent): A measurement of the rate at which gases are exchanged by a patient's respiratory system. Measurements of ventilation can include one or both of inspiratory flow rate and expiratory flow rate (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0533] 5.7.3 Ventilation

[0534] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined based on a certain characteristic of the patient (e.g., the patient's respiratory characteristics).

[0535] Standby rate: A parameter of the ventilator that sets the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0536] Cycled: The termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, it is considered that the ventilator periodically stops delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0537] Positive expiratory airway pressure (EPAP): The base pressure to which the pressure changes within the respiratory tract to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0538] End-expiratory pressure (EEP): The desired interface pressure that the ventilator will attempt to achieve at the end of the expiratory phase. If the pressure waveform template (Φ) is zero at the end of expiration, i.e., when Φ=1, Π(Φ)=0, then EEP equals EPAP.

[0539] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.

[0540] Pressure support: This refers to the pressure increase during inspiratory breathing that exceeds the pressure during expiratory breathing, and typically means the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0541] Servo ventilator: A ventilator that measures a patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0542] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0543] Oscillation: A term equivalent to pressure support.

[0544] Triggering: A patient is considered to be triggered when a ventilator or other respiratory therapy device (such as an RPT device or a portable oxygen concentrator) delivers a volume of breathable gas to a spontaneously breathing patient. Triggering typically occurs at or near the start of a respiratory portion of the patient's effortful respiratory cycle.

[0545] 5.7.4 Anatomy

[0546] 5.7.4.1 Facial Anatomy

[0547] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0548] Alar angle: The angle formed between the alae of each nostril.

[0549] Alar tip: the outermost point on the ala of the nose.

[0550] 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.

[0551] Auricle: The entire visible external part of the ear.

[0552] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0553] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0554] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0555] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal plane that intersects the lower point of the nasal septum.

[0556] 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.

[0557] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0558] 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.

[0559] Lower lip (lower lip margin point): The lip extending between the lower point of the nasal septum and the mouth.

[0560] Upper lip (upper lip border point): The lip that extends between the mouth and the mentagrophytes.

[0561] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves forward around the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane, which contains three or four small cartilages of the alar.

[0562] Nostrils (Nares / Nostrils): Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris) (nostril). Nostrils are separated from the nasal septum.

[0563] Nasolabial folds or nasolabial grooves: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0564] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0565] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0566] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0567] 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.

[0568] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0569] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0570] The nasal ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0571] Sagittal plane: A vertical plane running from front to back. The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0572] The bridge of the nose point is located on the soft tissue and is the most concave point in the area covering the nasolabial fold.

[0573] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0574] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0575] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0576] Supramental point: The point with the greatest concavity located on the midline of the lower lip, between the midpoint of the lower lip and the premental point of the soft tissue.

[0577] Skull Anatomy

[0578] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0579] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0580] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla protrudes upward from one side of the nose and forms part of the lateral border.

[0581] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their intersection.

[0582] Nasal root: The indentation between the frontal bone and the two nasal bones, located directly between the eyes and above the bridge of the nose.

[0583] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes the foramen magnum (or occipital cavity), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0584] The eye socket is the bony cavity in the skull that houses the eyeball.

[0585] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0586] 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.

[0587] Cheekbones: The face consists of two cheekbones, which are located on the upper and outer parts of the face and form the prominent parts of the cheeks.

[0588] 5.7.4.2 Anatomy of the Respiratory System

[0589] Diaphragm: A muscular sheet 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.

[0590] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0591] Lungs: The human respiratory organ. The conduction zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0592] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face, above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal bones. The anterior part of the nasal cavity is the nasal part, while the posterior part connects to the nasopharynx via the posterior nasal aperture.

[0593] 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).

[0594] 5.7.5 Patient Interface

[0595] 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.

[0596] Headband: A headband is a form of positioning and stabilizing structure designed to hold a device (e.g., a mask) on the head.

[0597] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having a wall that at least partially surrounds a volume of space, which, in use, is inflated to a pressure exceeding atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0598] Sealing: can be the noun form referring to a structure (sealant) or the verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0599] Ventilation port (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0600] 5.7.6 Shape of the structure

[0601] Products according to this technology may include one or more three-dimensional mechanical structures, such as a mask liner or impeller. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe associated surface orientation, location, function, or some other characteristic. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contact (e.g., external) surface and separate non-face-contact (e.g., underside or internal) surfaces. In another example, the structure may include a first surface and a second surface.

[0602] To aid in describing the shape of three-dimensional structures and surfaces, first consider the cross-section of the surface passing through the structure at point p. See also Figures 3B to 3F These examples show a cross-section at point p on the surface and the resulting planar curve. The resulting plane is curved on the surface. Figures 3B to 3F The diagram also illustrates the outward normal vector at point p, the outward normal vector at point p far from the surface, and the outward normal vector at point p far from the surface. In some examples, we describe the surface from the perspective of an imaginary little person standing upright on it.

[0603] 5.7.6.1 One-dimensional curvature

[0604] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle that just touches the curve at p).

[0605] Positive curvature: If the curve at point p turns outwards towards the normal, then the curvature at that point is considered positive (if you imagine a little person leaving 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 usually called concave curves.

[0606] Zero curvature: If the curve at point p is a straight line, then the curvature is considered zero (if you imagine a tiny person leaving point p, they could walk horizontally without going up or down). See also Figure 3D .

[0607] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point is considered negative (if you imagine a small person leaving point p, they must be going 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 usually called convex curves.

[0608] 5.7.6.2 Curvature of a Two-Dimensional Plane

[0609] The description of the shape at a given point on a two-dimensional surface according to this technique may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outwardly normal direction (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0610] 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 point p is the curvature along the principal direction.

[0611] 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.

[0612] Saddle-shaped region: The region where the principal curvature has opposite signs at each point, i.e., one is positive and the other is negative (depending on the direction the imagined person is turning, they can be going uphill or downhill).

[0613] Dome region: A region where the principal curvature has the same sign at every point, for example, both are positive ("concave dome") or both are negative ("convex dome").

[0614] 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.

[0615] Planar region: A region of surface in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0616] Surface edge: The boundary or limit of a surface or region.

[0617] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0618] Path length: In some forms of this technique, "path length" will be considered to mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0619] 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 length as the straight-line distance between the two points. On a non-planar surface, there may not be any paths with the same length as the straight-line distance between the two points. (For an imaginary person, straight-line distance is equivalent to the distance a crow flies.)

[0620] 5.7.6.3 Space Curves

[0621] Space curves: Unlike planar curves, space curves do not necessarily lie in any specific plane. Space curves can be closed, meaning they have no endpoints. A space curve can be considered a one-dimensional segment of three-dimensional space. An imaginary human walking along a DNA helix walks along a space curve. The typical human left ear contains a helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0622] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangential unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along the curve and falling from their aircraft at a specific point, the direction of the tangential vector is the direction they would have traveled.

[0623] Unit normal vector: When an imagined person moves along a curve, this tangential vector itself also changes. The unit vector that changes in the same direction as the tangential vector is called the unit principal normal vector. It is perpendicular to the tangential vector.

[0624] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see example, Figure 3P) or alternatively by the left-hand rule ( Figure 3O To determine.

[0625] Occult plane: A plane containing both the unit tangential vector and the unit principal normal vector. See also Figure 3O and Figure 3P .

[0626] Torque of a space curve: Torque at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree to which the curve deviates from its osculating plane. A space curve lying in a plane has zero torque. A space curve deviating relatively small from its osculating plane will have a relatively small torque (e.g., a gently sloping spiral path). A space curve deviating relatively large from its osculating plane will have a relatively large torque (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3S The twist near the top coil of the spiral is greater than Figure 3S The size of the twist of the bottom coil of the spiral.

[0627] refer to Figure 3P According to the right-hand rule, a space curve turning toward the right-hand secondary normal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown). A spatial curve that turns away from the right-handed secondary normal direction can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0628] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve that turns toward the left-hand secondary 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 .

[0629] 5.7.6.4 Hole

[0630] Surfaces can have one-dimensional pores, for example, 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, Figure 3I The structure shown has a one-dimensional hole in a surface defined by a planar curve.

[0631] The structure can have two-dimensional pores, for example, 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, Figure 3L padding and Figure 3M and Figure 3NAn example cross-section through the liner is shown, indicating the inner surface defining the two-dimensional orifice. In yet another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Through Figure 3K The structure shown has a two-dimensional hole defined by the surface shown.

[0632] 5.8 Other Remarks

[0633] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0634] Unless the context explicitly states otherwise and where a range of values ​​is provided, it should be understood that each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range, as well as any other value or intermediate value within the range, is broadly encompassed within this technique. The upper and lower limits of these intermediate ranges (which may be independently included within the intermediate range) are also encompassed within this technique, but are subject to any explicit exclusions within the range. Where the range includes one or both limitations, the range excluding any one or both of those included limitations is also included within this technique.

[0635] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation allows or requires them.

[0636] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5-10% of the stated value.

[0637] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0638] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as being capable of being manufactured, and therefore can be manufactured together or separately.

[0639] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0640] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0641] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0642] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0643] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques described. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0644] 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.

Claims

1. A positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a pair of side straps, a top strap and a rear strap, the positioning and stabilizing structure further comprising a lower strap, wherein the lower strap includes a mouth closure member or portion configured to engage and seal the patient's mouth, thereby reducing or eliminating mouth leakage.

2. The positioning and stabilizing structure for a patient interface according to claim 1, wherein the posterior band is configured to engage the posterior portion of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or be located near the junction between the occipital and parietal bones.

3. The positioning and stabilizing structure for a patient interface according to claim 2, wherein the top band is configured to engage the upper part of the patient's head in use and is configured to cover the parietal bone of the patient's head in use.

4. The positioning and stabilizing structure for a patient interface according to claim 1, wherein the mouth closure member or portion comprises a mouth engagement portion made of silicone resin.

5. The positioning and stabilizing structure for a patient interface according to claim 4, wherein the patient-facing surface of the silicone is "adhesive" to help ensure that the patient's lips do not move apart.

6. The positioning and stabilizing structure for a patient interface according to claim 1, wherein the mouth closure member or portion comprises a mouth engagement portion made of a biocompatible and substantially nonporous material.

7. The positioning and stabilizing structure for a patient interface according to claim 6, wherein the mouth engagement portion comprises a fabric with a substantially non-porous coating.

8. The positioning and stabilizing structure for a patient interface according to claim 6, wherein the mouth engagement portion is integrally formed with the lower band.

9. The positioning and stabilizing structure for a patient interface according to claim 6, wherein the mouth engagement portion is embedded in the lower band, or may be connected to the lower band or a portion of the patient-facing surface.

10. The positioning and stabilization structure for a patient interface according to claim 1, wherein the lower band is configured to extend below the patient's ear and connect to the rear band at the back of the patient's head.

11. A patient interface for treating a patient with respiratory distress, comprising: A sealing forming portion, the sealing forming portion being configured to form a seal with the patient's nasal airway, the seal being configured to form a seal with at least the patient's upper lip, nasal alae and the anterior portion of the patient's nose during use; and The positioning and stabilizing structure according to claim 1.

12. A positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a pair of side straps, a top strap and a rear strap, the positioning and stabilizing structure further comprising a chin strap including a chin engagement portion, the chin strap being configured to bias the patient's chin toward a closed mouth position, thereby reducing or eliminating mouth leakage.

13. The positioning and stabilizing structure for a patient interface according to claim 12, wherein the rear band is configured to engage the rear of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or be located near the junction between the occipital and parietal bones.

14. The positioning and stabilizing structure for a patient interface according to claim 13, wherein the top band is configured to engage the upper part of the patient's head in use and is configured to cover the parietal bone of the patient's head in use.

15. The positioning and stabilizing structure for a patient interface according to claim 12, wherein the chin strap is connected to the side strap and configured to be positioned substantially horizontally to the patient's ear and in front of the patient's ear.

16. The positioning and stabilizing structure for a patient interface according to claim 12, wherein the chin engagement portion is wider than the remainder of the chin band.

17. The positioning and stabilizing structure for a patient interface according to claim 12, wherein the chin engagement portion is shaped to have a generally recessed portion to conform to the patient's chin.

18. The positioning and stabilizing structure for a patient interface according to claim 12, wherein in use, the chin strap is configured to apply a force to the patient's chin, the force biasing the patient's chin toward a position where the patient's mouth is closed.

19. The positioning and stabilizing structure for a patient interface according to claim 12, wherein the chin strap is length-adjustable and / or elastic.

20. A patient interface for treating a patient with respiratory distress, comprising: A sealing forming portion, the sealing forming portion being configured to form a seal with the patient's nasal airway, the seal being configured to form a seal with at least the patient's upper lip, nasal alae and the anterior portion of the patient's nose during use; and The positioning and stabilizing structure according to claim 12.

21. A positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a pair of side straps, a top strap, and a rear strap, the positioning and stabilizing structure further comprising at least one strap including a chin engagement portion configured to bias a patient's chin toward a closed mouth position to reduce or eliminate mouth leakage, and / or a mouth closure member or portion configured to engage and seal the patient's mouth to reduce or eliminate mouth leakage.

22. The positioning and stabilizing structure for a patient interface according to claim 21, wherein the rear band is configured to engage the rear of the patient's head in use and is configured to cover the occipital bone of the patient's head in use, or be located near the junction between the occipital and parietal bones, and the top band is configured to engage the upper part of the patient's head in use and is configured to cover the parietal bone of the patient's head in use.

23. The positioning and stabilizing structure for a patient interface according to claim 21, wherein the band is configured to move between a mouth-sealing position and a chin-supporting position.

24. The positioning and stabilizing structure for a patient interface according to claim 21, wherein, whether in a mouth-sealing mode or a chin strap mode, the strap remains attached to the side strap or the rear strap at the same connection point.

25. The positioning and stabilizing structure for a patient interface according to claim 21, wherein the band is configured to both seal the mouth and serve as a chin support.

26. The positioning and stabilizing structure for a patient interface according to claim 21, wherein the strap is attached to the side strap, the rear strap, or both the side strap and the rear strap.

27. A patient interface for treating a patient with respiratory distress, comprising: A sealing forming portion, the sealing forming portion being configured to form a seal with the patient's nasal airway, the seal being configured to form a seal with at least the patient's upper lip, nasal alae and the anterior portion of the patient's nose during use; and The positioning and stabilizing structure according to claim 21.

Images