Positioning and stabilizing structure for patient interface

Abstract

The invention relates to a positioning and stabilizing structure for a patient interface. A positioning and stabilizing structure for a full face mask for a patient interface includes an upper strap portion, a lower strap portion, and two front strap portions. Each front belt portion has a substantially triangular surface having a first width and a second width, the second width being less than the first width and disposed more forward in use, the upper and lower belt portions are each connected to or integrally formed with each front belt portion at respective corners of the generally triangular surface, each front belt portion being connected or connectable to a connection portion that engages with the plenum chamber. The connection portion is releasably engageable with the plenum chamber. The upper strap portion and the lower strap portion connect the front strap portion in front of the patient's ear in use.

Description

[0001] This application is a divisional application of the patent application with application number 202080047014.2 (PCT / IB2020 / 055965), filed on December 27, 2021, with an international application date of June 24, 2020, and the invention name being “Positioning and stabilizing structure for a patient interface”.

[0002] 1 Cross-reference to related applications

[0003] This application claims the benefit of Australian Provisional Patent Application No. 2019902272 filed on 28 June 2019, the entire contents of which are incorporated herein by reference. Background Art 2.1 Technical Field

[0005] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Description of related technologies

[0007] 2.2.1 Human respiratory system and its disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0009] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to pass from the inhaled air into the venous blood and expel carbon dioxide in the opposite direction. The trachea is divided into the left and right main bronchi, which ultimately divide into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. See Respiratory Physiology, 9th edition, published by John B. West, Lippincott Williams & Wilkins, 2012.

[0010] There is a range of breathing disorders. Some conditions can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0011] 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.

[0012] A range of treatments have been used to treat or ameliorate such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0013] 2.2.2 Treatment

[0014] Various therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV) have been used to treat one or more of the above-mentioned breathing disorders.

[0015] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0016] 2.2.3 Treatment system

[0017] These treatments can be provided by a treatment system or device.Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0018] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0019] 2.2.3.1 Patient interface

[0020] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway.

[0021] Certain other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the environment inside.

[0022] Certain masks may be clinically disadvantageous to the present technology, for example where they block airflow through the nose and only allow it through the mouth.

[0023] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, this may be uncomfortable or impractical with the present technology.

[0024] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0025] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0026] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0027] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0028] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0029] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0030] 2.2.3.1.1 Sealing structure

[0031] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0032] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. This single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0033] A seal-forming structure that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0034] Certain seal-forming structures may be designed for mass manufacturing so that one design is appropriate, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0035] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, there will be a gap 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 sheet seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal-forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0037] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0038] Another form of seal-forming structure may use an adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove adhesive from their face.

[0039] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0040] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0041] ResMed Inc. has manufactured the following products incorporating nasal pillows: SWIFT™ Nasal Pillows Mask, SWIFT™ II Nasal Pillows Mask, SWIFT™ LT Nasal Pillows Mask, SWIFT™ FX Nasal Pillows Mask, and MIRAGE LIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Inc.: International Patent Application WO 2004 / 073,778 (which describes other aspects of ResMed Inc.'s SWIFT™ Nasal Pillows); U.S. Patent Application 2009 / 0044808 (which describes other aspects of ResMed Inc.'s SWIFT™ LT Nasal Pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe other aspects of ResMed Inc.'s MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of ResMed Inc.'s SWIFT™ FX Nasal Pillows).

[0042] 2.2.3.1.2 Positioning and stabilization

[0043] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0044] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0045] Another technique is to use one or more straps and / or stabilizing harnesses.Many such harnesses suffer from one or more of poor fit, bulk, discomfort, and awkward use.

[0046] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0047] A respiratory pressure therapy (RPT) device may be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow may be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0048] 2.2.3.3 Humidifier

[0049] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0050] 2.2.3.4 Data Management

[0051] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the use over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0052] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0053] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0054] 2.2.3.5 Mandibular reduction

[0055] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduces vibration of the palate.

[0056] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0057] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0058] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs, such as the ResMed NarvalCC™ MRD, are designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0059] 2.2.3.6 Ventilation technology

[0060] Some forms of therapy systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space of the patient interface (eg, a plenum) to a space outside the patient interface, such as to the environment.

[0061] 2.2.4 Screening, diagnosis and surveillance systems

[0062] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves professional clinical staff to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep-disordered breathing involves observing the patient in the clinic for two nights, one night for pure diagnosis and the second night for the clinician to titrate the treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0063] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis can yield clinically actionable information. Screening and diagnosis tend to be one-time processes, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only for screening / diagnosis, while some can also be used for monitoring.

[0064] A clinical expert may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Summary of the invention

[0065] The present technology is intended to provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0066] One aspect of the present technology relates to devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0067] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0068] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0069] One form of the present technology includes a positioning and stabilizing structure for a full-face mask for a patient interface, the positioning and stabilizing structure comprising:

[0070] Upper belt part;

[0071] The lower belt portion; and

[0072] two front strap portions, each front strap portion connected to or integrally formed with the upper strap portion and the lower strap portion, each front strap portion connected or connectable to a connecting portion that engages with an interface portion of a patient interface; and

[0073] wherein the upper and lower strap portions connect to the front strap portion in front of the patient's ears during use;

[0074] Another form of the present technology includes a patient interface comprising

[0075] a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0076] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and

[0077] A positioning and stabilizing structure for the entire face, comprising:

[0078] Upper belt part;

[0079] The lower belt portion; and

[0080] front strap portions, each having a generally triangular surface having a first width and a second width, the second width being less than the first width and being disposed more forwardly in use, the upper strap portion and the lower strap portion each being connected to or integrally formed with each front strap portion at a respective corner of the generally triangular surface, the front strap portions being connected or connectable to a connection portion that engages with the inflatable chamber, the connection portion being capable of releasably engaging the inflatable chamber; and

[0081] wherein the upper and lower strap portions connect the front strap portion in front of the patient's ears in use; and

[0082] The front strap portion forms a loop when connected with the connecting portion, and the loop is adjustable to adjust the direction and size of the head strap vector.

[0083] In examples: a) the upper strap portion is configured to cover the parietal bone of the patient's skull; and / or b) the lower strap portion is configured to cover or be located below the occipital bone of the patient's skull.

[0084] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0085] Upper belt part;

[0086] Lower belt part;

[0087] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0088] the front strap portion comprising a strap receiving portion and a strap attachment portion, the strap attachment portion being releasably connectable to the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages a connecting portion that engages an interface portion of a patient interface;

[0089] Wherein the strap receiving portion is configured to engage the strap attachment portion in a selected one of a plurality of possible positions, wherein the plurality of possible positions includes a plurality of possible angular positions of the strap attachment portion relative to the strap receiving portion.

[0090] Another form of the present technology is a patient interface comprising

[0091] a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0092] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and

[0093] A positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0094] Upper belt part;

[0095] Lower belt part;

[0096] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0097] the front strap portion comprising a strap receiving portion and a strap attachment portion, the strap attachment portion being releasably connectable to the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages the connecting portion which engages the inflatable chamber;

[0098] wherein the strap receiving portion is configured to engage the strap attachment portion at a selected one of a plurality of possible positions, wherein the plurality of possible positions includes a plurality of possible angular positions of the strap attachment portion relative to the strap receiving portion, and wherein at any one of the plurality of possible positions the strap attachment portion is completely connected within the boundaries of the strap receiving portion, and wherein the angle between the strap attachment portion and the strap receiving portion when they are connected is configured to cause pivotable movement of the inflatable chamber and / or the seal-forming structure.

[0099] In an instance: a) the upper strap portion and the lower strap portion connect the front strap portion in front of the patient's ears during use; b) the connecting portion is capable of releasably engaging the interface portion; c) the upper strap portion is configured to cover the parietal bone of the patient's skull; and / or d) the lower strap portion is configured to cover the occipital bone of the patient's skull or to be located below the occipital bone of the patient's skull.

[0100] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0101] Upper belt part;

[0102] Lower belt part;

[0103] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0104] the front strap portion comprising a strap receiving portion and a strap attachment portion, the strap attachment portion being releasably connectable to the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages a connecting portion that engages an interface portion of a patient interface;

[0105] Wherein the strap receiving portion is configured to engage the strap attachment portion in a selected one of a plurality of possible positions to adjust the direction and magnitude of the head strap vector.

[0106] Another form of the present technology is a patient interface comprising

[0107] a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0108] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and

[0109] A positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0110] Upper belt part;

[0111] Lower belt part;

[0112] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0113] the front strap portion comprising a strap receiving portion and a strap attachment portion, the strap attachment portion being releasably engageable with the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages the connecting portion which engages the inflatable chamber;

[0114] wherein the band receiving portion is configured to engage the band attachment portion at a selected one of a plurality of possible positions to adjust the direction and magnitude of a headband vector, and wherein the headband vector is configured to cause pivotable movement of the inflatable chamber and / or seal-forming structure.

[0115] In an example: a) the upper strap portion and the lower strap portion connect the front strap portion in front of the patient's ears during use; b) the upper strap portion is configured to cover the parietal bone of the patient's skull; c) the lower strap portion is configured to cover the occipital bone of the patient's skull or be located below the occipital bone of the patient's skull; d) the width of the strap receiving portion decreases from its rear end to the front end, and wherein the width of the strap receiving portion is not narrower than the strap attachment portion between the rear end and the front end; e) the strap attachment portion includes a hook material; f) the strap receiving portion includes a patient-facing surface and an opposite non-patient-facing surface, wherein the non-patient-facing surface is provided with a continuous loop material to engage the hook material of the strap attachment portion; g) the connecting portion is capable of releasably connecting to the interface portion; h) the front strap portion passes through a slot in the connecting portion; i) the connecting portion is attached to a frame that is connected to a cushion module of the inflatable chamber; j) the connecting portion is attached to the cushion module; k) at least a portion of the front strap portion is configured to cover the cheek area of ​​the patient's face; l) the upper strap portion, the lower strap portion and the front strap portion are integrally formed from a single piece of material; m) the upper strap portion The invention relates to a cushioning module comprising: a cushioning module forked into a first strap portion covering the upper surface of the patient's parietal bone and a second strap portion covering the rear surface of the patient's parietal bone; n) the upper strap portion is connected to the lower strap portion by a rear connecting strap portion; and / or o) the upper strap portion and the rear connecting strap portion form a substantially annular shape; p) the maximum width of the strap receiving portion is approximately two to approximately four times wider than the maximum width of the strap attachment portion; q) the angle between the strap attachment portion and the strap receiving portion when they are connected is configured to cause movement of a cushioning module connected to the connecting portion; r) the upper portion of the cushioning module is configured to move in a rearward direction when the strap attachment portion is substantially parallel to the lower strap portion; s) the upper portion of the cushioning module is configured to move in a forward direction when the strap attachment portion is aligned with the upper strap portion; and / or t) the front strap portion has a generally triangular surface having a first width and a second width, the second width being smaller than the first width and being arranged to be more forward than the first width in use, and each of the upper strap portion and the lower strap portion is connected to the front strap portion or formed integrally with the front strap portion at corresponding corners of the generally triangular surface.

[0116] Another form of the present technology includes a connecting member for a patient interface, the connecting member being configured to removably connect one side of a positioning and stabilizing structure to a side of an interface portion of a patient interface, wherein the connecting member is configured to engage at least two strap portions of the stabilizing structure.

[0117] Another form of the present technology is a patient interface comprising

[0118] a plenum chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0119] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle;

[0120] a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a first strap portion and a second strap portion; and

[0121] an interfacing portion having a first component configured to removably engage an interfacing portion of a patient interface;

[0122] a first strap connection portion configured to engage with the first strap portion; and

[0123] a second strap connection portion configured to engage with the second strap portion;

[0124] wherein the interface connection portion is configured to engage the interface portion via a magnetic coupling, and

[0125] Wherein, the first belt connecting portion and the second belt connecting portion are movable relative to the interface connecting portion.

[0126] In the examples: a) the first strap connection portion is an upper strap connection portion for connecting to the upper strap portion of the positioning and stabilizing structure in use; b) the second strap connection portion is a lower strap connection portion for connecting to the lower strap portion of the positioning and stabilizing structure in use; c) the connecting member includes a single upper strap connection portion and a single lower strap connection portion; d) the upper strap connection portion includes a first hook portion, the first hook portion is configured to receive an end of the upper strap portion; e) the lower strap connection portion includes a second hook portion, the second hook portion is configured to receive an end of the lower strap portion; f) the upper strap connection portion includes a first loop portion, the first loop portion is configured to receive g) the lower strap includes a second loop portion configured to receive the end of the lower strap portion; h) the interface connection portion and the interface portion are configured to prevent or limit rotation of the interface connection portion relative to the interface portion when the patient interface is in use; i) the interface connection portion includes a first bearing structure configured to engage a second bearing structure of the interface portion; j) the interface connection portion and the interface portion are configured to prevent or limit rotation of the interface connection portion relative to the interface portion about a horizontal axis when the patient interface is in use; k) the interface connection portion is configured to connect to the inflatable chamber; l) the interface connection portion is configured to be connected to a frame of the patient interface; m) a single magnetic latch connects the interface connection portion and the interface portion, wherein the first component is a first component of the magnetic latch and the second component of the magnetic latch is a part of the interface portion; n) the first component is a protrusion that is configured to be received in a groove of the interface portion; o) the second component is bonded to the inflatable chamber; p) the second component is overmolded to the inflatable chamber; q) the interface connection portion includes a curved edge that is suitable for being grasped by a user when disconnecting the interface connection portion from the interface portion; r) the curved edge is disposed at the interface portion a front side of the mouth connection portion; s) the connection member is formed using an additive manufacturing process to produce a customized design for the patient's anthropometric data; t) the connection member is formed of metal; u) the metal retains the new shape after being heated and deformed into the new shape; v) the upper band connection portion is connected to the interface connection portion by a ball and socket mechanism; w) the lower band connection portion is connected to the interface connection portion by a ball and socket mechanism; x) the upper band connection portion is capable of moving independently of the lower band connection portion by means of a first ball and socket mechanism; and / or y) the lower band connection portion is capable of moving independently of the upper band connection portion by means of a second ball and socket mechanism.

[0127] Another form of the present technology includes a patient interface assembly comprising:

[0128] Interface part;

[0129] a positioning and stabilizing structure comprising an upper belt portion and a lower belt portion; and

[0130] Two connecting members, each connecting member is configured to receive a respective end of the upper strap portion and a respective end of the lower strap portion, wherein each connecting member is configured to be removably attachable to a respective left-hand side or right-hand side of the interface portion.

[0131] In an instance: a) the connecting member is connected to the interface portion in a fixed orientation; b) the connecting member is connected to the shell in a fixed orientation; c) increasing tension in the upper strap connecting portion causes the upper portion of the pad to move in a rearward direction; and / or d) increasing tension in the lower strap connecting portion causes the lower portion of the inflatable chamber to move in a rearward direction.

[0132] Another form of the present technology includes a patient interface system comprising:

[0133] Interface part;

[0134] a first headband configured to be removably connected to the interface portion; and

[0135] a second headband configured to be removably connected to the interface portion;

[0136] wherein at least one band portion of the second headband is located or exists differently than the band portion of the first headband;

[0137] Wherein only one of the first headband or the second headband is connected to the interface portion at any one time.

[0138] Another form of the present technology includes a patient interface system comprising:

[0139] Interface part;

[0140] a first connection member configured to be removably coupled to the interface portion;

[0141] a second connection member configured to be removably coupled to the interface portion;

[0142] a first headband configured to be removably connected to the interface portion via a first connection member; and

[0143] a second headband configured to be removably connected to the interface portion via a second connection member;

[0144] wherein the strap of the first headband is different from the strap of the second headband;

[0145] wherein the first connection member and the second connection member are each configured to engage the interface portion at a connection point, and at least one band portion of the first headband and at least one band portion of the second headband are configured to extend generally toward the connection point; and

[0146] Wherein only one of the first headband or the second headband is connected to the interface portion at any one time.

[0147] In the example: a) the first headband includes a two-point connection; b) the second headband includes a four-point connection; c) the second headband includes a two-point connection; d) the first headband includes the positioning and stabilizing structure described in paragraphs

[0053] to

[0055] above; e) the first headband includes the positioning and stabilizing structure described in paragraphs

[0056] to

[0058] above; f) the first headband includes the positioning and stabilizing structure described in paragraphs

[0059] to

[0060] above; g) the connecting portion connected to the first headband and the connecting member connected to the second headband are configured to be removably connected to the interface portion at the same location; h) a single magnetic A latch connects the connecting portion and the connecting member to the interface portion, wherein a first portion of the magnetic latch is part of the connecting portion or the connecting member and a second portion of the magnetic latch is part of the interface portion; i) the first connecting member and the second connecting member are each configured to magnetically couple to the interface portion; j) a headband vector provided by the first headband or the second headband is configured to cause pivotable movement of the interface structure; k) the interface structure is configured to pivot about a connection point; and / or l) the first connecting member includes a loop configured to receive a strap of the first headband and the second connecting member includes two loops each configured to receive a strap of the second headband.

[0148] Another form of the present technology includes a patient interface comprising

[0149] a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient;

[0150] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and

[0151] Used for full face positioning and stabilization of the structure.

[0152] Another form of the present technology includes a positioning and stabilizing structure for a full-face mask, the positioning and stabilizing structure comprising:

[0153] Upper belt part;

[0154] The lower belt portion; and

[0155] a front strap portion, each front strap portion being connected to or integrally formed with an upper strap portion and a lower strap portion, the front strap portion being connected or connectable to a connecting portion that engages with an inflatable chamber, the connecting portion being capable of releasably engaging the inflatable chamber; and

[0156] wherein the upper and lower strap portions connect the front strap portion in front of the patient's ears in use; and

[0157] The front strap portion forms a loop when connected with the connecting portion, and the loop is adjustable to adjust the direction and size of the head strap vector.

[0158] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0159] Upper belt part;

[0160] Lower belt part;

[0161] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0162] The front band part includes:

[0163] with a receiving portion; and

[0164] a strap attachment portion releasably connectable to the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages the connecting portion which engages the inflatable chamber;

[0165] wherein the strap receiving portion is configured to engage the strap attachment portion in a selected one of a plurality of possible positions,

[0166] wherein the plurality of possible positions comprises a plurality of possible angular positions of the belt attachment portion relative to the belt receiving portion, and

[0167] Wherein, the angle between the belt attachment portion and the belt receiving portion when they are connected is configured to cause pivotable movement of the inflation chamber and / or the seal-forming structure.

[0168] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0169] Upper belt part;

[0170] Lower belt part;

[0171] at least one front strap portion connected to or integrally formed with the upper and lower strap portions;

[0172] The front band part includes:

[0173] with a receiving portion; and

[0174] a strap attachment portion releasably connectable to the strap receiving portion such that the front strap portion forms a loop, wherein in use the loop engages the connecting portion which engages the inflatable chamber;

[0175] wherein the strap receiving portion is configured to engage the strap attachment portion in a selected one of a plurality of possible positions to adjust the direction and magnitude of the head strap vector, and

[0176] Therein, the headband vectors are configured to cause pivotable movement of the inflatable chamber and / or the seal-forming structure.

[0177] Another form of the present technology includes a connection member for connecting a positioning and stabilizing structure to a plenum chamber, the connection member comprising:

[0178] an interfacing portion having a first component configured to removably engage an interfacing portion of a patient interface;

[0179] a first strap connection portion configured to engage with the first strap portion; and

[0180] a second strap connection portion configured to engage with the second strap portion;

[0181] wherein the interface connection portion is configured to engage the interface portion via a magnetic coupling, and

[0182] Wherein, the first belt connecting portion and the second belt connecting portion are each movably connected to the interface connecting portion.

[0183] One aspect of one form of the present technology is a method of making a device.

[0184] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using medical devices of this type.

[0185] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0186] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier canister that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment.

[0187] The described methods, systems, devices and apparatus can be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, a respiratory monitor and / or a respiratory therapy device. In addition, the described methods, systems, devices and apparatus can provide improvements in the art of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0188] Of course, a part of these aspects may form a sub-aspect of the present technology. Each aspect and / or each of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0189] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0190] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0191] 4.1 Treatment system

[0192] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air at a positive pressure from a RPT device 4000. 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 sleeps in a supine sleeping position.

[0193] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0194] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0195] 4.2 Respiratory system and facial anatomy

[0196] Figure 2A A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0197] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0198] Figure 2C is a front view of the face with several surface anatomical features labeled, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The superior, inferior, radially inward, and radially outward directions are also labeled.

[0199] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal ridge, nasal apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0200] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0201] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0202] Figure 2G A side view of the nasal surface features is shown.

[0203] 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.

[0204] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0205] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0206] Figure 2KA side view of the skull is shown with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0207] Figure 2L An anterolateral view of the nose is shown.

[0208] 4.3 Patient Interface

[0209] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0210] Figure 3B A schematic diagram of a cross section through 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 is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0211] Figure 3C A schematic diagram of a cross section through 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 is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0212] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0213] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0214] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0215] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0216] Figure 3HA cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and one dome region are indicated.

[0217] Fig. 3I A surface having a structure with a one-dimensional hole on the surface is shown. The plane curves shown form the boundaries of the one-dimensional hole.

[0218] Figure 3J Shown through Fig. 3I The surface shown is in Fig. 3I A two-dimensional hole is defined in the structure.

[0219] Figure 3K Shows Fig. 3I A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig. 3I The surface of the two-dimensional holes is defined in the structure.

[0220] Figure 3L A mask with an inflatable bladder as cushion is shown.

[0221] Figure 3M Shown through Figure 3L FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0222] Figure 3N Shown by Figure 3L Another cross section of a mask of FIG. The inner surface is also indicated.

[0223] Fig.3O The left hand rule is shown.

[0224] Figure 3P The right hand rule is shown.

[0225] Figure 3Q The left ear is shown, including the left ear helix.

[0226] Figure 3R The right ear is shown, including the right ear helix.

[0227] Figure 3S A right-hand helix is ​​shown.

[0228] Figure 3T Views of a mask are shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0229] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0230] Figure 3V Shows Figure 3U A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the air chamber into left and right sides.

[0231] Figure 3W Shown through Figure 3V The cross section of the air-filled chamber is Figure 3V 32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and contacts the liner of the plenum at just two points on the sagittal plane, the upper point 3220 and the lower point 3230. Depending on the geometry of the liner in this area, the middle contact plane can be a tangent at the upper point and the lower point.

[0232] Figure 3X Shows Figure 3U The inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 is roughly coincident with the central sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'plane of the face'. Figure 3X In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is approximately located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0233] 4.4 RPT device

[0234] Figure 4A One form of RPT device according to the present technology is shown.

[0235] Figure 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0236] 4.5 Humidifier

[0237] Figure 5A is an isometric view of a humidifier according to one form of the present technology.

[0238] Figure 5B An isometric view of a humidifier in accordance with one form of the present technology is shown showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0239] 4.6 Respiration Waveform

[0240] Figure 6 A model typical breathing waveform of a person during sleep is shown.

[0241] 4.7 Specific Examples of This Technology

[0242] Figure 7 A front perspective view of a patient interface according to an example of the present technology is shown.

[0243] Figure 7-1 Shows the Figure 7 Front perspective view of the patient interface.

[0244] Figure 8 Shows Figure 7 Rear perspective view of the patient interface.

[0245] Fig. 9 Shows Figure 7 Rear view of the patient interface.

[0246] Fig.10 Shows Figure 7 Front view of the patient interface.

[0247] Fig.11 Shows Figure 7 Left side view of the patient interface.

[0248] Fig.12 Shows Figure 7 Right side view of the patient interface.

[0249] Fig.13 Shows Figure 7 Top view of the patient interface.

[0250] Fig.14 Shows Figure 7 Bottom view of the patient interface.

[0251] Fig.15 A front perspective view of a connection member according to an example of the present technology is shown.

[0252] Fig.16 Shows Fig.15 A rear perspective view of a connecting member.

[0253] Fig.17 Shows Fig.15 Front view of the connecting member.

[0254] Fig.18 Shows Fig.15 Rear view of the connecting member.

[0255] Fig.19 Shows Fig.15 Left side view of the connecting member.

[0256] Fig. 20 Shows Fig.15 Right side view of the connecting member.

[0257] Fig.21 Shows Fig.15 Top view of the connecting member.

[0258] Fig. 22 Shows Fig.15 Bottom view of the connecting member.

[0259] Fig.23 Shown attached to the right side of the full face mask Fig.15 A front perspective view of a connecting member.

[0260] Figure 23-1 Shown wearing Fig.23 Front perspective view of a patient with a full face mask.

[0261] Figure 23-2 Shown is the observation along line 23-2--23-2 Fig.23 0014] A cross-sectional view of a full-face mask is shown, and the connection between the connecting member and the full-face mask is illustrated.

[0262] Fig.24 Shows the connection to Fig.23 The right side of the full face mask Fig.15 A rear perspective view of a connecting member.

[0263] Fig.25 Shows the connection to Fig.23 The right side of the full face mask Fig.15 Right side view of the connecting member.

[0264] Fig.26 Shows Fig.23 Left side view of the full face mask.

[0265] Fig. 27 Shows Fig.23 Front view of a full-face mask, wherein Fig.15 The connecting member is connected to the right side of the mask.

[0266] Fig.28 Shows Fig.23 top view of full face mask.

[0267] Fig.29 Shows Fig.23 Bottom view of a full face mask.

[0268] Fig.30 Shows Fig. 27 Exploded view of the mask and connecting components. DETAILED DESCRIPTION

[0269] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0270] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. 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. In addition, in any one of the examples, any single feature or combination of features may constitute another example.

[0271] 5.1 Treatment

[0272] In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0273] In certain examples of the present technology, a supply of air under positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0274] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0275] 5.2 Treatment system

[0276] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 .

[0277] 5.3 Patient Interface

[0278] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of 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, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0279] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0280] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to ambient.

[0281] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 10 cmH20 relative to ambient.

[0282] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 20 cmH20 relative to ambient.

[0283] 5.3.1 Sealing structure

[0284] In one form of the present 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 sealing is likely to occur. The area where sealing actually occurs - the actual sealing surface - can vary from day to day and from patient to patient within a given course of treatment, depending on a range of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0285] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0286] In some forms of the present technology, the seal-forming structure 3100 is comprised of a biocompatible material such as silicone rubber.

[0287] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible and resilient material such as silicone.

[0288] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not small-sized heads, and another form that is suitable for small-sized heads but not large-sized heads.

[0289] 5.3.1.1 Sealing mechanism

[0290] In one form, the seal forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure inside the inflatable chamber 3200 acting on its bottom surface, so that it forms a tight sealing engagement with the face. The pressure assist mechanism can work together with the elastic tension in the positioning and stabilizing structure.

[0291] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, such as about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use.

[0292] In one form, the seal-forming 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 to be in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0293] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example, by an adjacent region of the sealing flange.

[0294] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0295] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0296] 5.3.1.2 Nose bridge or nasal ridge area

[0297] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge or nasal ridge region of the patient's face.

[0298] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0299] 5.3.1.3 Upper lip area

[0300] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0301] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0302] 5.3.1.4 Chin area

[0303] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0304] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin area of ​​a patient's face.

[0305] 5.3.1.5 Forehead area

[0306] In one form, the seal-forming 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.

[0307] 5.3.1.6 Nasal pillows

[0308] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0309] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0310] 5.3.2 Inflatable chamber

[0311] In the area where a seal is formed when in use, the plenum chamber 3200 has a perimeter that is shaped to complement the surface contour of an average person's face. A pressurized air stream can flow into the plenum chamber 3200 to pressurize it to a treatment pressure (e.g., 6 cmH2O above ambient air pressure). When in use, the boundary edge of the plenum chamber 3200 is positioned very close to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend along the entire perimeter of the plenum chamber 3200 when in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed by a single homogeneous piece of material. The seal-forming structure 3100 can form a seal with the patient's face to maintain the treatment pressure within the plenum chamber 3200 and limit the leakage of pressurized air to the surrounding environment.

[0312] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable to the wearer, which can improve compliance with treatment.

[0313] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0314] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0315] In some forms of the present technology, the plenum chamber 3200 includes a cushion module. The cushion module includes a housing. In some examples of the present technology, the cushion module can be directly connected to a headband connection member or connection portion as described herein. The headband connection member or connection portion can include a magnetic latch component. The headband connection member or connection portion can be directly connected to the housing of the cushion module by a magnetic latch mechanism. The magnetic latch mechanism includes a first component and a second component, the first component being a part of the connection portion or connection member, as discussed herein, and the second component being a part of the cushion module. The first component and the second component include magnets, and / or one of these components includes a magnetically attractive material, such as steel. In some examples, the second component is integrated into a rigid or flexible housing of the cushion module. The magnet or magnetically attractive material can be molded into the housing. Alternatively, the magnet or magnetically attractive material can be bonded to the housing. The magnetic latch can also include other mechanical features to enhance the engagement and supplement the magnetic attraction. The advantage of integrating the headband connection directly into the cushion module is that there are fewer parts because a separate frame component is no longer required to connect the headband to the plenum chamber. This may make the patient interface easier to use, easier to clean, and / or less expensive to manufacture.

[0316] 5.3.3 Positioning and stabilizing the structure

[0317] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state during use by the positioning and stabilizing structure 3300 .

[0318] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the positive pressure in the plenum 3200 to lift off the face.

[0319] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0320] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0321] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a smaller side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strip that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0322] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0323] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0324] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion located between the front of the positioning and stabilising structure 3300 and the back of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on the pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0325] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt 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 belt. In one form, the fabric outer layer includes a loop material for engaging with the hook material portion. The material used to construct the positioning and stabilizing structure 3300 may have the ability to stretch to adjust to different patient head sizes. This is described in AU2019902270, the entire contents of which are incorporated herein by reference.

[0326] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in tension when in use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0327] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is flexible and, for example, non-rigid. An advantage of this aspect is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0328] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is configured to be breathable to allow moisture to be transmitted through the belt.

[0329] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is 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.

[0330] 5.3.3.1 Two-point headband

[0331] In one example of the present technology, the positioning and stabilising structure 3300 comprises a headband formed from a plurality of headband strap portions. Figures 7 to 14 A headband according to an example of the present technology is shown. The headband includes an upper strap portion 3301. The upper strap portion 3301 can be configured to cover the parietal bone of the patient's skull. The headband also includes a lower strap portion 3302. The lower strap portion 3302 can be configured to cover the occipital bone of the patient's skull. The upper strap portion 3301 and the lower strap portion 3302 are connected to at least one front strap portion 3303. The upper strap portion 3301 and the lower strap portion 3302 connect the front strap portion 3303 in front of the patient's ears during use. In the illustrated embodiment, the headband includes two front strap portions 3303, one on the left and right sides of the patient's skull. The two front strap portions 3303 can each be integrally formed with one end of the upper strap portion 3301 and one end of the lower strap portion 3302.

[0332] Each front strap portion 3303 is connected or connectable to a connection portion 3306 that engages with an interface portion 3500 of a patient interface 3000. Figures 7 to 14 In the illustrated embodiment, the interface portion 3500 includes an ultra-compact full-face mask that is configured to seal with the patient's mouth and nose. The ultra-compact full-face mask seals to the patient's nostrils below the nose. In other embodiments, the interface portion 3500 may include a full-face mask or other mask that is configured to form a seal with the patient's airway and provide air flow. The seal-forming structure of the full-face mask forms a seal with the bridge of the patient's nose.

[0333] In the illustrated embodiment, the front strap portion 3303 includes a strap receiving portion 3304 and a strap attachment portion 3305 (as in Fig.14). The strap attachment portion 3305 is capable of releasably connecting to the strap receiving portion 3304 so that the front strap portion 3303 forms a loop. The loop engages a connecting portion 3306 that engages with the interface portion 3500. In some forms of the present technology, the connecting portion 3306 forms a portion of the interface portion 3500. The strap receiving portion 3304 is configured to engage the strap attachment portion 3305 in a selected one of a plurality of possible positions. Each of the plurality of possible positions is completely located on the strap receiving portion. In other words, the strap attachment portion 3305 is completely located within the boundaries of the strap receiving portion 3304 when engaged to the strap attachment portion 3305. The strap attachment portion 3305 is wide enough to allow a wide range of adjustment, and also limits contact between the strap attachment portion 3305 and the patient's skin (e.g., the patient's cheek). The belt attachment portion 3305 can have a rough and / or frictional surface, and the width of the belt receiving portion can allow multiple adjustment positions without the belt attachment portion 3305 extending beyond the boundaries of the belt receiving portion 3304. The multiple possible positions include multiple possible angular positions of the belt attachment portion 3305 relative to the belt receiving portion 3304. The belt attachment portion 3305 is engaged at one of the multiple angular positions so that an angle is formed between the first and second portions of the bottom edge of the front belt portion loop. For example, the bottom edge of the belt attachment portion 3305 can be displaced from the bottom edge of the belt receiving portion 3304 so that the two bottom edges are not colinear. At any of the multiple angular positions, the bottom edge of the belt attachment portion 3305 remains higher than the bottom edge of the belt receiving portion 3304. The possible positions can differ from each other in the up-down and front-back directions.

[0334] By changing which of a plurality of possible positions on the strap receiving portion 3304 engages with the strap attachment portion 3305, the patient can adjust the direction and / or magnitude of the headband vector. The phrase "headband vector" is used herein to refer to the magnitude and direction of the force applied by the headband to the interface portion 3500. Figures 7 to 14 In the illustrated embodiment, the headband vector is applied by the front band portion loop to the connection portion 3306. Generally, adjusting the position of the band attachment portion 3305 in the up-down direction will adjust the direction of the headband vector. Adjusting the position of the band attachment portion 3305 in the front-back direction will adjust the magnitude of the headband vector by increasing or decreasing the size of the front band portion loop. Increasing the size of the front band portion loop increases the magnitude of the force applied by the headband. Similarly, decreasing the size of the front band portion loop decreases the magnitude of the force applied by the headband.

[0335] The width W of the belt receiving portion 3304 (see Fig.11The widest portion of the band receiving portion 3304 is substantially wider (e.g., two, three, or four times wider) than the width of the band attachment portion 3305. The upper band portion 3301 and the lower band portion 3302 connect the band receiving portion 3304 adjacent to the wider rear end of the band receiving portion 3304. In other words, the upper band portion 3301 and the lower band portion 3302 connect the band receiving portion 3304 behind the widest width W. The width of the upper band portion 3301 and the lower band portion 3302 may continue to increase to further back than the widest width W (e.g., the widest width W of the band receiving portion 3304 may not be the widest portion of the positioning and stabilizing structure 3300). Figures 7 to 14 In the illustrated embodiment, the rear end of the belt receiving portion 3304 has a generally triangular surface. One side of the triangular surface is the widest width W, and the triangular surface narrows in the forward direction toward the belt attachment portion 3305. The upper belt portion 3301 and the lower belt portion 3302 are connected to the upper and lower corners of the triangular rear end of the belt receiving portion 3304, respectively. The front end of the belt receiving portion 3304 has a generally rectangular surface, adjacent to the remaining corners of the triangular rear end of the belt receiving portion 3304. The front end of the belt receiving portion 3304 can have a width that is approximately equal to the width of the belt attachment portion 3305. In some instances, the width of the front end can be equal to the width of the belt attachment portion 3305. In other instances, the width of the front end can be greater than the width of the belt attachment portion 3305. This can allow the belt attachment portion 3305 to be adjusted to more angular positions while remaining within the boundaries of the belt receiving portion 3305.

[0336] The strap attachment portion 3305 can engage the rear end of the strap receiving portion 3304 when positioned in one or more possible positions of the strap receiving portion 3304. The rear end of the strap receiving portion 3304 can cover the cheek of the patient's face, and preferably covers the upper cheek area. The rear end of the strap receiving portion 3304 is preferably relatively large, approximately 20 cm in some examples. 2 , to provide a large number of possible positions for engaging the strap attachment portion 3305, and thus achieve a greater range of possible headband vectors. In other words, the area of ​​the rear end of the strap receiving portion 3304 is larger than the area of ​​the strap attachment portion 3305, and can accommodate the strap attachment portion 3305 in multiple positions.

[0337] In the illustrated embodiment, the strap attachment portion 3305 comprises a hook material. The strap receiving portion 3304 has a patient-facing surface and an opposing non-patient-facing surface. The non-patient-facing surface is provided with a continuous loop material to engage the hook material of the strap attachment portion 3305. In other embodiments, the strap attachment portion 3305 may comprise a continuous loop material engaging the non-patient-facing surface, and the non-patient-facing surface of the strap receiving portion 3304 comprises a hook material.

[0338] In the illustrated embodiment, the connecting portion 3306 includes a loop through which the front strap portion 3303 is passed. In other embodiments (not shown), the connecting portion 3306 may include a hook structure that the front strap portion loop can engage. In this way, the front strap portion 3303 can be removed from the connecting portion 3306 without removing the strap attachment portion 3305 from the strap receiving portion 3304. This can enable the strap attachment portion 3305 to maintain substantially the same position relative to the strap receiving portion 3304. Therefore, the front strap portion 3303 can be removed from the connecting portion 3306 and reattached to the connecting portion 3306 without substantially changing the headband force vector provided by the front strap portion 3303.

[0339] In some embodiments (not shown), the connecting portion 3306 is attached to a frame connected to the cushion module. In other embodiments, the connecting portion 3306 is directly connected to the cushion module of the interface portion 3500. Preferably, the connecting portion 3306 is connected by a removable connection. In some instances, this may include a magnetic latch. In other instances, the connection may be attached by a clip. The front strap portion 3303 may be removed from the interface portion 3500 without removing the strap attachment portion 3305 from the strap receiving portion 3304. In other embodiments, the connecting portion 3306 is fixedly engaged to the frame or cushion module.

[0340] The ability to change the direction and / or magnitude of the headband vector enables the patient to better form a seal between the seal-forming structure and the patient's face. Figure 8 and 9 As shown, the ultra-compact full face mask can include separate sealing portions for the patient's nose and mouth. In other words, a portion of the plenum chamber 3200 seals under the patient's nose and around the patient's mouth. In some instances, the portion of the seal-forming structure that seals under the patient's nose can be separate from the portion of the seal-forming structure that seals around the patient's mouth. In other words, the portion of the seal-forming structure that seals under the patient's nose can have a perimeter that is separate from the portion of the seal-forming structure that seals around the patient's mouth. In other instances, a single seal can seal under the patient's nose and around the patient's mouth, thereby requiring only a single sealing portion. This can achieve a shorter overall length required to seal the patient's face.

[0341] Typically, the upper seal-forming structure 3100 seals around the perimeter of the patient's nose. Specifically, this may include contacting the patient's lower nasal septum, the nose wing near the alar rim (e.g., around the opening to each nostril), and / or the nasolabial groove. Figure 7-1As shown, the sealing force F1 associated with the upper seal-forming structure 3100 is directed in both an upward and rearward direction. In other words, the sealing force is directed in both an upward direction (i.e., upward into the columella) and a rearward direction (i.e., downward into the upper lip and nasolabial groove) and into the patient's head.

[0342] Typically, the lower seal-forming structure 3100 seals around the perimeter of the patient's mouth. Specifically, this may include contacting the patient's upper and / or lower lips around an area that is wider than the width of the patient's mouth. In other words, the lower seal-forming structure 3100 seals radially outward of the corners of the patient's mouth or mouth area. Figure 7-1 As shown, the sealing force F2 associated with the lower seal-forming structure is directed only in the rearward direction. In other words, the sealing force associated with the patient's mouth is ideally directed directly toward their head and will not deviate downward / upward.

[0343] The front band portion 3303 determines the resultant force F that will act on the seal-forming structure 3100 as a whole. R . Change the resultant force F exerted by the headband R 3304) can provide different amounts of force to the two portions (i.e., under the patient's nose and around the patient's mouth). This can allow the patient to selectively adjust the sealing force in these two areas. In other words, the patient may be able to increase the sealing force around their mouth without substantially increasing the sealing force around their nose in order to improve the seal without reducing comfort. For example, the resultant force F R The angle will be angled relative to a generally horizontal axis (e.g., the Frankfurt horizontal plane). When the belt attachment portion 3305 is coupled to the belt receiving portion 3304 adjacent the lower edge of the front belt portion 3303, the angle relative to this axis is smaller (see, e.g., Fig.11 ). When the strap attachment portion 3305 is coupled to the strap receiving portion 3304 closer to the upper edge of the front strap portion, the angle increases (see e.g. Fig.11 ).

[0344] The belt attachment portion 3305 is adjusted by the patient so that it is ideally neither completely horizontal (i.e., only in the rearward direction) nor completely vertical (i.e., only in the upward direction). Thus, the resultant force F R The components of the force F will be directed in both the rearward and upward directions, so that the seal-forming structure 3100 will have components of force in two directions (e.g., to help seal the nose and mouth). In some examples, the headband can be positioned so that the strap attachment portion 3305 extends below the horizontal plane when coupled to the strap receiving portion 3304, so that the resultant force F R The component points in the downward direction rather than the upward direction.

[0345] The connecting portion 3306 can be rotationally fixed relative to the interface portion 3500 (when the two are coupled together). Therefore, when the position of the belt attachment portion 3305 changes, the cushion module (i.e., the seal-forming structure 3100 and / or the inflatable chamber 3200) and the connecting portion 3306 can move together. If the belt attachment portion 3305 is substantially parallel to the lower belt portion 3302 or is coupled at a relatively small angle relative to the lower belt portion 3302, the cushion module will pivot so that the upper portion of the cushion module moves in a rearward direction. For example, this may occur if the bottom edge of the belt attachment portion 3305 is collinear with or deviates within approximately 5° of the bottom edge of the lower belt portion 3302 and / or the bottom edge of the belt receiving portion 3304. This can allow the patient to apply a greater sealing force in the rearward direction. In other words, as the belt attachment portion 3305 becomes more collinear with the bottom edge of the lower belt portion 3302, the rearward component of the force increases, which in turn reduces the upward component. For the same magnitude, the resultant force F R A greater proportion of the nasolabial folds are directed in the posterior direction. Thus, the patient will experience greater forces applied to his or her upper lip, lower lip, and / or nasolabial folds than to the patient's inferior septum point and / or columella.

[0346] If the belt attachment portion 3305 is attached at a greater angle, such as aligned with the upper belt portion 3301, this causes the cushion module to pivot so that the upper portion of the cushion module moves in a forward direction. For example, this may occur if the top edge of the belt attachment portion 3305 is collinear with or offset to within approximately 5° of the top edge of the upper belt portion 3301 and / or the top edge of the belt receiving portion 3304. This can allow the patient to apply a greater sealing force in an upward direction. In other words, as the belt attachment portion 3305 becomes less collinear with the bottom edge of the lower belt portion 3302, the upward component of the force increases, which in turn reduces the rearward component. For the same magnitude, the resultant force F R A greater proportion of the force is directed in the upward direction. Therefore, the patient will feel a greater force applied to the lower point of his nasal septum and / or columella than to his upper lip, lower lip and / or nasolabial folds.

[0347] By adjusting the position of the belt attachment portion 3305, the patient can achieve a personalized sealing force optimized for sealing, stability and comfort. Some patients may be able to withstand greater forces on their lower nasal septum point and / or columella, and thus can achieve a better seal around their nostrils, although it may be at the expense of the seal around their mouth. On the contrary, some patients may be able to withstand less force on their lower nasal septum point and / or columella, and thus can achieve a better seal around their mouth, although it may be at the expense of the seal around their nostrils. In either case, the force around the smaller one of the orifices (i.e., nose or mouth) will not reduce the sealing force enough to leak the air in the plenum 3200 to the surrounding environment. However, increasing the sealing force at one position can increase, decrease or keep the sealing force at another position constant. For example, if only the angle changes and the size remains the same, increasing the force in one position (e.g., mouth) will reduce the seal at another position (e.g., nose). However, if both the size and the angle are adjusted, the sealing force can increase, decrease or remain the same at each corresponding position (i.e., adjacent nose and mouth).

[0348] The upper strap portion 3301 and the lower strap portion 3302 may be adjustable, such as by means of buckles (not shown) configured to vary the length of the respective portions, or by having portions formed of an elastic material.

[0349] In another embodiment (not shown), the upper strap portion 3301 is bifurcated into a first strap portion that covers the upper surface of the patient's parietal bone and a second strap portion that covers the rear surface of the patient's parietal bone. The first strap portion and the second strap portion can be reconnected on opposite sides of the patient's head to form a single strap portion. In some embodiments, the first strap portion and the second strap portion have a smaller width than the upper strap portion 3301. Bifurcating the upper strap portion 3301 into the first strap portion and the second strap portion can help the headgear achieve stability of the patient interface 3000.

[0350] exist Figures 7 to 14 In the illustrated embodiment, the upper strap portion 3301 is connected to the lower strap portion 3302 by the rear strap portion 3310. In one example, the upper strap portion 3301 and the rear strap portion 3310 form a substantially annular shape. In other embodiments, the top portion of the upper strap portion 3301 may be connected to the rear strap portion 3310 to form a substantially annular shape, while the lateral portion of the upper strap portion 3301 that abuts against the lateral surface of the patient's head remains connected to the front strap portion 3303. In some examples, portions of the lower strap portion 3302 also form portions of a substantially annular shape.

[0351] In some embodiments (not shown), the headband may include more than two front strap portions 3303. In alternative embodiments, the front strap portion 3303 may be connected to only one of the upper strap portion 3301 or the lower strap portion 3302. The front strap may be connected to one or more alternative straps that form part of the headband. Thus, the two-point headband improves modularity. There may be many different headband styles. There are multiple different headband designs that may include a front strap portion 3303 with a strap receiving portion 3304 and a strap attachment portion 3305 and multiple possible positions. In addition, as long as the interface portion 3500 includes a suitable connection portion 3306, the patient can select the most comfortable or stable headband from different headband styles.

[0352] In some embodiments, the entire headband may be formed from a single piece of material, rather than from separate pieces that are stitched or otherwise connected together.

[0353] The benefit of having a two-point headband connection while maintaining control over both the size and direction of the headband vector is that the patient may only need to adjust the two front strap portions 3303, rather than four connection points as required in many examples of headbands in the prior art. It is also easier to change the direction of the headband vector because it only requires adjusting the position of the strap attachment portion 3305 (e.g., changing the strap attachment portion 3305 between multiple angular positions). Many examples of headbands in the prior art require adjusting the upper / upper strap and the lower / lower strap at the same time. Therefore, the headband of the present invention can be more easily adjusted. In addition, if a connection portion that can be releasably engaged with the interface portion 3500 is used, only an initial setup may be required. Once adjusted, the headband can be removed from the mask so that the patient can easily put on and take off the patient interface 3000 without having to readjust the strap portion of the headband.

[0354] In some embodiments, the front band portion 3303 can be made of a different fabric than the rest of the headband, for example with a different pattern or texture to improve the aesthetics of the headband. The front band portion 3303 provides an increased fabric area for implementing decorative features. These can be customizable for the patient. Improving the aesthetics of the headband can lead to improved compliance with treatment.

[0355] The two-point headband is simpler than many examples of prior art headbands and requires only two pieces of hook material and two connecting portions. This can improve manufacturability and can make the manufacture of the headband easier, faster and / or cheaper. The two-point headband connection with the interface portion 3500 can also improve the manufacture of the interface portion 3500, because the interface portion 3500 will only need to be able to attach to the two connecting portions 3306. This will reduce design complexity and can make the manufacture of the headband easier, faster and / or cheaper.

[0356] 5.3.4 Connecting components

[0357] Figures 15 to 30 Yet another embodiment of the present technology is shown and includes a connection member 3800 for a patient interface 3000 . Figures 15 to 22 A connecting member 3800 is shown. Figures 23 to 30 A connection member 3800 is shown connected to the right side of the full face mask of the patient interface 3000. The left side of the full face mask is also configured to receive a second connection member 3800 (not shown). The connection member 3800 is configured to removably connect one side of the positioning and stabilizing structure 3300 to one side of the interface portion 3500 of the patient interface 3000. The connection member 3800 is configured to engage at least two strap portions of the positioning and stabilizing structure 3300, which includes a plurality of straps of the headgear.

[0358] The connecting member 3800 includes a strap connection portion for connecting to two strap portions of the headband in use. The connecting member 3800 may include an upper strap connection portion 3801 for connecting to the upper strap portion 3301 of the headband in use. The connecting member 3800 may also include a lower strap connection portion 3802 for connecting to the lower strap portion 3302 of the positioning and stabilizing structure in use. In the illustrated embodiment, the connecting member 3800 includes a single upper strap connection portion 3801 and a single lower strap connection portion 3802. The upper strap connection portion 3801 is located above the lower strap connection portion 3802.

[0359] exist Figures 15 to 30 In the illustrated embodiment, the upper strap connection portion 3801 includes a first loop portion 3803, which is configured to receive the end of the upper strap portion 3301. The first loop portion 3803 is substantially rectangular. In use, the front end of the upper strap portion 3301 passes through the hole formed by the first loop portion 3803 and is then removably attached to (e.g., by hook and loop attachment) the rear end of the upper strap portion 3301 to form an upper strap portion loop. Similarly, the lower strap connection portion 3802 includes a second loop portion 3804, which is configured to receive the end of the lower strap portion. The second loop portion 3804 is also substantially rectangular. The front end of the lower strap portion 3302 passes through the hole formed by the second loop portion 3804 and is then removably attached to the rear end of the lower strap portion 3302 to form a lower strap portion loop.

[0360] In an alternative embodiment (not shown), the upper strap connection portion 3801 may include a first hook configured to receive an end of the upper strap portion 3301. The front end of the upper strap portion 3301 may pass around the first hook and then be removably attached to the rear end of the upper strap portion 3301 to form an upper strap portion 3301 loop. The upper strap portion 3301 loop may be capable of engaging and disengaging the first hook without separating the front end from the rear end of the upper strap portion 3301. The lower strap connection portion 3802 may include a second hook configured to receive an end of the lower strap portion 3302. As described above for the upper strap portion 3301, the front end of the lower strap portion 3302 may pass around the second hook and be removably attached to the rear end of the lower strap portion 3302 to form a lower strap portion loop. The lower strap portion loop may be capable of engaging and disengaging the second hook without separating the front end from the rear end of the lower strap portion.

[0361] The connection member 3800 also includes an interface connection portion 3805 that is configured to be removably connected to the interface portion 3500. The interface connection portion 3805 can be located below the upper belt connection portion 3801. The interface connection portion 3805 can also be located above the lower belt connection portion 3802. The interface connection portion 3805 can be movably coupled to the remainder of the connection member 3800 (e.g., the upper belt connection portion 3801 and the lower belt connection portion 3802).

[0362] The interface connection portion 3805 and the interface portion 3500 can be configured to prevent or limit rotation of the interface connection portion 3805 relative to the interface portion 3500 when the patient interface 3000 is in use. In other words, the connecting member 3800 may not be able to rotate as a single piece when connected to the interface portion 3500. For example, one or more mechanical features may be provided to mechanically engage the connecting member 3800 to the interface portion 3500. The interface connection portion 3805 or the interface portion 3500 may include one or more lugs that fit into corresponding recesses on the other portion. The mechanical features may lock the connecting member 3800 in a predetermined orientation relative to the interface portion 3500 when the two portions are engaged. Fixing the position of the connecting member 3800 relative to the interface portion 3500 can better transfer forces from the band portion of the headgear to the interface portion 3500, thereby improving stability and sealing. Figures 23 to 30 In the illustrated embodiment, the interface connection member 3800 includes a bearing structure 3806. The bearing structure 3806 is configured to engage a complementary bearing structure 3560 of the interface portion 3500. The engagement between the first bearing structure 3806 and the second bearing structure 3560, when in use, restricts the connection member 3800 from rotating relative to the interface portion 3500 about a substantially horizontal axis of rotation. Similar bearing arrangements may be used with Figures 7 to 14In other examples, the engagement between the first bearing structure 3806 and the second bearing structure 3560 can limit the connection member 3800 from rotating relative to the interface portion 3500 about a substantially vertical axis of rotation during use.

[0363] The connection member 3800 can be connected to the interface portion 3500 by a variety of different connection means (e.g., a clip or a magnetic latch). Figures 15 to 30 In the embodiment shown, the magnetic latch connects the interface connection portion 3805 and the interface portion 3500. The first part 3807 of the magnetic latch is part of the interface connection portion 3805, and the second part 3550 of the magnetic latch (in Figures 26 to 30 3500). The second part 3550 of the magnetic latch may be overmolded or bonded to the interface part 3500. The first part 3807 of the magnetic latch may include a protrusion 3808 that fits into a groove 3551 of the second part 3550 of the magnetic latch (see Fig.16 ). The protrusion 3808 can be integrally formed with the interface connection portion 3805. In the illustrated embodiment, the protrusion 3808 is cylindrical and protrudes from the surface of the interface connection portion 3805. The groove 3551 is generally rectangular, but can have rounded ends. The protrusion 3808 can help ensure that the two parts of the magnetic latch are properly aligned when the latch is in use. In some instances, the protrusion 3808 can be a non-uniform shape so that it cannot be inserted into the groove 3551 in all orientations. The non-uniform shape of the protrusion 3808 can further help limit the rotation of the connection portion 3800 relative to the interface portion 3500. The non-uniform shape can also help the patient properly position the connection portion 3800 (e.g., so that the upper belt connection portion 3801 and the lower belt connection portion 3802 extend in a rearward direction).

[0364] The magnetic latch may include one or more magnets as one of the first component 3807 or the second component 3550 and include another magnet or a magnetically attractive material (e.g., steel) as the other component. Thus, the first component 3807 and the second component 3550 of the magnetic latch are removably attached to each other by attraction of the magnets. Preferably, the magnets have a suitable strength to allow the user to easily disengage the latch while also preventing inadvertent disengagement during the patient's sleep. In the illustrated embodiment, the magnets and / or magnetically attractive material are not shown in the figure. The first recess 3809 in the first component 3808 and the second recess 3552 in the second component 3550 ( Fig.30 ) is configured to receive a magnet and / or magnetically attractive material.

[0365] In other examples (not shown), the magnet is cylindrical and protrudes from the surface of the interface connection portion 3805. The magnet engages with a corresponding recess on the surface of the interface portion 3500. The recess contains or is adjacent to a magnetically attractive material or another magnet to engage the first magnet. In this case, an additional protrusion of the magnetic latch may not be required.

[0366] In other examples, the magnets can be embedded in lugs protruding from the surface of the interface connection portion 3805 or the interface portion 3500 and can be configured to engage with corresponding recesses in the other portion. In other examples, the magnets or lugs can have different shapes, such as cubes. These shapes can limit the rotation of the connection member 3800 relative to the interface portion 3500.

[0367] The magnetic latch may include other mechanical features that also lock the connection member 3800 to the interface portion 3500. In these embodiments, the first component 3807 and the second component 3550 may be embedded in the connection member 3800 and the interface portion 3500 and may only make contact on a single surface. In some examples, a plurality of corresponding recesses may be provided to receive lugs or magnets. This may allow the position of the connection member 3800 relative to the interface portion 3500 to be variable and, therefore, allow for a more customized fit to the patient.

[0368] In such Figures 23 to 30 In the illustrated embodiment, the interfacing portion 3805 is configured to connect to the frame 3580, which is configured to connect to the cushion module of the plenum chamber 3200. In some embodiments, the interfacing portion 3805 is configured to connect to the housing of the cushion module of the patient interface 3000.

[0369] When the orientation of the connection member 3800 is restricted relative to the interface portion 3500, the band portion of the headband is adjusted so that the interface portion 3500, in particular the cushion module, can pivot. For example, the connection member 3800 as a whole may not be able to pivot relative to the interface portion 3500. Therefore, the tension in the upper band portion 3801 and the lower band portion 3802 causes the connection member 3800, the interface portion 3500, and the cushion module to rotate as a single body. This enables personalized matching of the patient 1000. The relationship between the two different forces applied to the connection member 3800 by the upper band portion 3301 and the lower band portion 3302 of the headband can enable the cushion module to pivot. In one example, tensioning the upper band portion 3301, thereby increasing the force applied to the interface portion 3500 by the upper band portion 3301, without adjusting the lower band portion 3302, will cause the cushion to pivot, so that the upper portion of the cushion (and the upper portion of the connection member 3800 and the upper portion of the interface portion 3500) moves in the rearward direction. Similarly, tensioning the lower strap portion 3302, thereby increasing the force applied by the lower strap portion 3302 to the interface portion 3500, without adjusting the upper strap portion 3301, will cause the cushion to pivot, causing the lower portion of the cushion (and the lower portion of the connecting member 3800 and the lower portion of the interface portion 3500) to move in a rearward direction. Thus, by increasing the ability to customize the sealing force vector, the patient may be better able to achieve a personalized fit.

[0370] With e.g. Figure 8 Unlike the ultra-compact full-face mask shown, Figures 23 to 30 The cushion of the full-face mask does not include separate sealing portions for the patient's nose and mouth. In other words, a single seal is formed around the patient's nose and mouth (which may also be the case in some examples of ultra-compact full-face masks). The seal-forming structure 3100 can contact the ridge of the patient's nose, the area outside the nasolabial grooves, and the lower lip so that the patient's nasal prominence and mouth are located within the plenum chamber 3200. Pivoting the cushion will not produce a better sealing force around only one of the nose or mouth because the sealing force is applied to both orifices (i.e., increasing the strength of the seal near the patient's nose also increases the seal around the patient's mouth). The pivoting of the full-face mask can be particularly applied to comfort. For example, the patient can pivot the upper portion of the cushion in a forward direction (e.g., by tensioning only the lower strap) to relieve pressure on the patient's nose (e.g., pressure on the ridge of the patient's nose). This can increase the force near the patient's mouth (e.g., force on the patient's lower lip), where the patient can tolerate greater force. In another example, the patient can pivot the upper portion of the cushion in a rearward direction (e.g., by tensioning only the upper strap) to apply pressure to the patient's nose (e.g., force applied to the ridge of the patient's nose). This can increase the force against the patient's nose.

[0371] In some forms, the pivoting of the full-face mask caused by adjusting the front strap portions 3303 may not significantly reduce the sealing force along any portion of the perimeter of the seal-forming structure 3100. Instead, the patient can adjust the length of any number (i.e., one, two, three, or four) of the front strap portions 3303 without affecting the position of any other front strap portions 3303. In other words, adjusting only one front strap 3303 on each side will increase the sealing force near the corresponding area (e.g., near the mouth) without necessarily reducing the sealing force in another area (e.g., near the nose) because the position of the unadjusted front strap portion 3303 may not change. Adjusting only one set of the front strap portions (e.g., the top strap or the bottom strap) may still increase the overall sealing force of the entire full-face mask. This is similar to Figure 7-1 The difference shown is that the angle adjustment of the front band portion 3303 can increase the sealing force around the nose, possibly at the expense of the sealing force around the mouth.

[0372] Patients can adjust Figures 23 to 30 The patient may also be able to make finer adjustments (e.g., with the front strap portion 3303) to maximize their comfort without having to reduce the sealing force of the seal-forming structure 3100. Figure 7-14 compared to the example shown).

[0373] The force applied to the interface portion 3500 by the upper strap portion 3301 and the lower strap portion 3302 can be adjusted by changing the size of the upper strap portion loop and the lower strap portion loop, for example, by adjusting the position where the front connecting end of the strap portion connects to the rear receiving end of the strap portion. Increasing the size of the upper strap portion loop will increase the amount of force applied to the interface portion 3500 by the upper strap portion 3301. Similarly, decreasing the size of the upper strap portion loop will decrease the amount of force applied by the upper strap portion 3301. The same applies to the lower strap portion 3302.

[0374] In the illustrated embodiment, the interfacing portion 3805 includes an outwardly curved edge 3810 adapted to be grasped by a user when disconnecting the interfacing portion 3805 from the interface portion 3500. The curved edge 3810 is disposed on the front side of the interfacing portion 3805. The curved edge 3810 helps the patient more easily peel off the connection member 3800 and disconnect it from the interface portion 3500.

[0375] The connection member 3800 can be used on different styles of interface portions having different cushion modules, including full face masks, compact full face masks, and ultra-compact full face masks. The size of the connection member 3800 can vary depending on the type of mask it is configured to be used with. The distance between the upper strap connection portion 3801 and the lower strap connection portion 3802 can also vary depending on the type and size of mask it is configured to be used with. The connection member 3800 can also be configured for use with existing four-point connection head straps.

[0376] The patient interface assembly may include an interface portion 3500, a positioning and stabilizing structure 3300 including an upper strap portion 3301 and a lower strap portion 3302, and two connecting members 3800. Each connecting member 3800 may be configured to receive a respective end of the upper strap portion 3301 and a respective end of the lower strap portion 3302. Each connecting member 3800 may also be configured to be removably attached to a respective left-hand side or right-hand side of the interface portion 3500.

[0377] The connection member 3800 as described above provides several advantages. Since the headband can be removed without disconnecting the headband from the interface portion 3500, the straps of the headband may only need to be adjusted once during the initial fit of the patient. This makes the patient interface 3000 easier and quicker for the patient to use. Once properly fitted, they can also achieve the best seal and stability. It is easier and quicker to put on / take off the headband, especially without having to tighten / relax the strap portions each time the mask is put on / taken off. The frame or cushion module can also be easier and / or cheaper to manufacture, given that only two connection points are required instead of the typical four-point connection. The connection member 3800 can also achieve a two-point headband connection while maintaining the advantages of a four-point headband, such as increased stability, better fit and increased adjustment range.

[0378] 5.3.4.1 Modularity of connecting components and connecting parts

[0379] The interface portion 3500 can be configured to connect to a variety of different connection members 3800 and / or connection portions 3306 as described herein. For example, compatible magnetic latches can be present on different headband connection members 3800 and / or connection portions 3306 (e.g., by having the same first part 3807 of the magnetic latch), so that different headband connection members 3800 and / or connection portions 3306 can be connected to the same frame or cushion of the interface portion 3500 (i.e., the second part 3550 of the magnetic latch). Therefore, different types of headbands, such as two-point headbands and four-point headbands, can be used with the same mask. In other words, the mask can provide the same type of seal to the patient's face (e.g., nose seal, mouth seal, nose-mouth seal, etc.) regardless of whether the connection member 3800 or the connection portion 3306 is used. Changing the connection member 3800 and / or the connection portion 3306 may only change the headband vectors of different types of headbands (e.g., the headband associated with the connection member 3800 and / or the connection portion 3306), but may not change the location from which the vectors originate. In other words, the same mask receives the connection member 3800 or the connection portion 3306 at the same location, so the force vectors applied by the different styles of headbands generally originate from the same or substantially the same location (e.g., from the connection point).

[0380] Embodiments of the present technology include a patient interface system that includes an interface portion 3500, a first headband configured to be removably connected to the interface portion 3500, and a second headband configured to be connected to the interface portion 3500. The first headband and the second headband can be two-point or four-point connection headbands. The first headband and / or the second headband can be in the form of one of the headbands described above. In some examples, the patient interface system includes at least one connection member 3800 connected to one side of the first headband and / or the second headband. Preferably, there are two connection members 3800, one connected to each side of the first headband and / or the second headband. The patient interface system may also include a connection portion 3306, which is configured to connect the first headband and / or the second headband to the interface portion 3500. The connection portion 3306 and the connection member 3800 are configured to be removably connected to the interface portion 3500 at the same location (e.g., connection point). A single magnetic latch connects the connection portion 3306 and the connection member 3800 to the interface portion 3500, wherein a first part 3807 of the magnetic latch is part of the connection portion 3306 or the connection member 3800, and a second part 3550 of the magnetic latch is part of the interface portion 3500. The second part 3550 may be part of a frame of the interface portion 3500, or it may be part of a cushion (e.g., a housing) of the interface portion 3500. The first part 3807 of the connection portion 3306 and the first part 3807 of the connection member 3800 are substantially the same size (e.g., same length, same diameter, etc.) so that either may be coupled to the second part 3550 with substantially the same fit.

[0381] In some instances, the first headband and the second headband extend toward approximately the same position. For example, the first headband and the second headband each extend approximately toward the connection point. Therefore, the patient feels the first headband and the second headband band at approximately the same position, regardless of which headband is connected to the interface portion 3500. In other words, the first headband and the second headband band can cover the cheek area of ​​the patient and extend toward the nasolabial groove of the patient, although the end points of the bands may not be the same. For example, in a two-point connection system, a single band on each side of the patient's head can extend toward one position of the interface portion 3500, while in a four-point connection system, a pair of bands on each side of the patient's head can extend toward two separate points that are radially outside of the position in the two-point connection system. Although the exact positions in the two-point and four-point connections are different, the bands at each position extend approximately toward the second component 3550, so that the origin of the headband vector is substantially the same.

[0382] There are many benefits to having an interface portion 3500 configured to connect to different headbands. These include improved modularity, which increases flexibility and diversity, so that different headband devices can be connected to the same cushion module. Another advantage can be improved usability. By allowing patients to change to different headbands while keeping the same mask, patients can try different headband options with the same mask to find the mask that provides the best comfort, stability and seal. When switching between different styles of headbands, patients will be able to maintain the desired length adjustment (e.g., to deliver the desired sealing force) while the corresponding headband is disconnected from the interface portion 3500. This allows patients to easily reconnect any style of headband to the interface portion 3500 without having to readjust the length of the corresponding band. In other words, the headband vector can be pre-set and maintained so that the direction and magnitude of the force provided by the headband are the same after the headband is reattached to the interface portion 3500. The ability to connect to different headbands can also allow for reduced facial marks or pain. Headbands sometimes cause facial marks, especially when the same headband is repeatedly used in contact with the patient's face in the same position. In one example, the bands of different styles of headbands can extend toward the same position on the patient's face, but may not completely cover the same surface of the patient's cheek. The ability to replace the headband without replacing the entire mask enables the patient to use different headbands that contact the face at different positions, thereby avoiding facial marks at the same position on the face. The patient can repeatedly change (e.g., every other day, every other week, every other month, etc.) the style of the headband to reduce facial indentations. The headbands of the patient interface system can be significantly different (e.g., one is a two-point connection headband and the other is a four-point connection headband), or they can be less significantly different, such as by having a substantially identical structure but the difference is that one of the headbands contacts an area of ​​the patient's face, while the other does not contact the area. For example, the area of ​​the band can be different between one headband and another headband. In one form, the position or presence of at least one band portion of the second headband is different from the band portion of the first headband.

[0383] Another benefit may be the use of a single style of headband (e.g., a two-point headband, a four-point headband, etc.) with different styles of masks. This may allow the patient to try different styles of masks while continuing to use a headband style that the patient is comfortable with. For example, when starting treatment, the patient may be given a mask that seals only around the patient's nostrils and a mask that seals around the patient's nose and mouth. The patient may try the fit and comfort of each style of mask while continuing to use the same style of headband. In some instances, the patient may be able to switch the headband from a first style of mask to a second style of mask without having to adjust the headband vector on the headband (e.g., repositioning the band attachment portion 3305 relative to the band receiving portion 3304). The patient may be able to easily switch the preferred headband between different masks while maintaining the same headband vector (e.g., sealing force). In other instances, different styles of masks require different headband vectors. This is because different styles of masks seal at different locations on the patient's face. Different vectors are needed to provide adequate sealing force for different sealing areas associated with different styles of masks.Interchangeable headgear still allows the patient to use a preferred style of headgear while using different types of masks.

[0384] 5.3.4.2 Customized connection components

[0385] In some embodiments, the connection member 3800 can be customized for the patient's specific anthropometric data. The connection member 3800 has multiple directional variables that affect the fit and forces on the mask. These include size, relative spacing, and orientation. For example: vertical position relative to the interface portion 3500; outside-in position relative to the interface portion 3500; front-to-back position relative to the interface portion 3500; rotational orientation about the vertical axis; rotational orientation about the outside-in axis; rotational orientation about the front-to-back axis; and overall rotational orientation about the connection between the interface connection portion 3805 and the interface portion 3500, such as rotation around a magnetic latch.

[0386] In some embodiments, the angle of the upper strap connection portion 3801 relative to the interface connection portion 3805 can be adjustable. Additionally, or alternatively, the angle of the lower strap connection portion 3802 relative to the interface connection portion 3805 can be adjustable.

[0387] The connection member 3800 can be customizable for an individual patient so that one or more of the variables are specific to the patient's anthropometric data. This allows the connection member 3800 to be adapted to achieve an optimal fit for comfort, stability, and sealing. In some instances, the connection member 3800 is formed using additive manufacturing techniques (e.g., 3D printing) to produce a customized design for the patient's anthropometric data. This can involve measuring the patient, creating a model of the patient, and running an analysis to optimize the optimal shape and size of the connection member 3800.

[0388] In other examples, the connecting member 3800 is formed of a material that can maintain the new shape after being heated and deformed into the new shape. In these embodiments, the connecting member 3800 is heated and bent to adjust the properties to provide the best position for the patient. This can be done by a sleep technician when fitting the mask to the patient.

[0389] In other examples, a series of different connection members 3800 are provided, including predefined options configured for different patient head shapes and sizes. The connection members 3800 can differ in size and shape and can each be configured to fit a different set of anthropometric data.

[0390] In other examples, the connection member 3800 may include one or more ball and socket connections, such as Figures 15 to 303805. The upper belt connection portion 3801 can be connected to the interface connection portion 3805 by a first ball-and-socket mechanism 3811. Similarly, the lower belt connection portion 3802 can be connected to the interface connection portion 3805 by a second ball-and-socket mechanism 3812. The upper belt connection portion 3801 and the lower belt connection portion 3802 are therefore able to rotate relative to the interface portion 3500. For example, the ball-and-socket mechanisms 3811, 3812 can allow the upper connection portion 3801 and the lower connection portion 3802 to move (e.g., pivot) respectively when the connecting member 3800 is coupled to the interface portion 3500. The ball-and-socket mechanisms 3811, 3812 allow rotation even when the first bearing structure 3806 and the second bearing structure 3560 limit the movement between the interface connection portion 3805 and the interface portion. Each ball-and-socket mechanism 3811, 3812 is also independent of another ball-and-socket mechanism 3812, 3811, thereby allowing the ball-and-socket mechanisms 3811, 3812 to have independent angular positions. In some instances, the ball-and-socket mechanisms 3811, 3812 may be sufficiently tight that they do not move during use, but rather may be manually adjusted by a patient or clinician / technician. In other words, the ball-and-socket mechanisms 3811, 3812 may not rotate freely, but rather may be held in a particular position unless manually actuated by a patient or clinician / technician. For example, moving the strap attachment portion 3305 relative to the strap receiving portion 3304 may cause at least one of the ball-and-socket mechanisms 3811, 3812 to rotate. In other words, changing the angular position of the strap attachment portion 3305 relative to the strap receiving portion 3304 may change the magnitude and direction of the headband vector. The corresponding ball-and-socket mechanisms 3811, 3812 rotate as the headband vector changes, such that the corresponding ball-and-socket mechanisms 3811, 3812 are aligned with the headband vector (e.g., the surfaces of the corresponding connection portions 3801, 3803 are orthogonal relative to the headband vector). In other examples, the patient or clinician / technician can adjust the rotational position of the ball and socket mechanisms 3811, 3812 before the strap attachment portion 3305 is coupled to the strap receiving portion 3304. In other words, the position of the ball and socket mechanisms 3811, 3812 can be adjusted to determine the direction of the final headband vector. The strap attachment portion 3305 can be coupled to the strap receiving portion 3304 at a desired position to set the magnitude of the headband vector.

[0391] Because the ball-and-socket mechanisms 3811, 3812 are independent of one another, the patient or clinician / technician can actuate only one or the other depending on the patient's specific needs. In other examples, the ball-and-socket mechanisms 3811, 3812 can be rotatably coupled via the first bearing structure 3806 (e.g., the ball-and-socket mechanisms 3811, 3812 and the first bearing structure 3806 are rotatable together). When the first bearing structure 3806 and the second bearing mechanism 3560 are engaged, the ball-and-socket mechanisms 3806, 3560 cannot rotate, thereby limiting the adjustment of the upper connection portion 3801 and the lower connection portion 3802 when the connecting member 3800 is coupled to the interface portion 3500 (e.g., no adjustment occurs when the patient is asleep).

[0392] 5.3.5 Ventilation

[0393] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0394] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured so that the vent flow has a sufficient amplitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber during use.

[0395] One form of a 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.

[0396] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure such as a swivel.

[0397] 5.3.6 Decoupled Structure

[0398] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0399] 5.3.7 Connection Port

[0400] The connection port 3600 allows connection to the air circuit 4170 .

[0401] 5.3.8 Forehead support

[0402] In one form, the patient interface 3000 includes a forehead support 3700 .

[0403] 5.3.9 Anti-asphyxia valve

[0404] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0405] 5.3.10 Ports

[0406] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0407] 5.4 RPT device

[0408] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0409] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0410] The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can 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 can include a handle 4018.

[0411] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0412] One or more air path items may be disposed within a removable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0413] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0414] 5.4.1 Mechanical and pneumatic components of the RPT device

[0415] The RPT device may include one or more of the following components in an integral unit, including the pneumatic component 4100. In an alternative form, one or more of the following components may be provided as separate units.

[0416] 5.4.1.1 Air filter

[0417] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0418] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0419] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0420] 5.4.1.2 Silencer

[0421] An RPT device according to one form of the present technology may include a silencer 4120 , or a plurality of silencers 4120 .

[0422] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140 .

[0423] In one form of the present technology, an outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0424] 5.4.1.3 Pressure generator

[0425] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver air supply, for example, at a rate of up to about 120 liters per minute and at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0426] 5.4.1.4 Anti-overflow valve

[0427] In one form of the present technology, an anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0428] 5.4.2 RPT device algorithm

[0429] As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium such as memory 4260. The algorithms 4300 are generally grouped into groups called modules.

[0430] 5.5 Air circuit

[0431] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000 .

[0432] 5.5.1 Oxygen delivery

[0433] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0434] 5.6 Humidifier

[0435] 5.6.1 Humidifier Overview

[0436] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0437] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. 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 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0438] 5.7 Respiration Waveform

[0439] Figure 6 The following figure shows a typical breathing waveform of a model of a person during sleep. The horizontal axis is time and the vertical axis is respiratory flow. While the parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, expiratory time Te 2.4 s, peak expiratory flow Qpeak -0.5 L / s. The total duration of the breath Ttot is about 4 s. A person usually breathes at a rate of about 15 breaths per minute (BPM) and a ventilation rate of Vent of about 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0440] 5.8 Glossary

[0441] For purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0442] 5.8.1 General

[0443] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0444] Environment: In certain forms of the present technology, the term environment can have the following meanings: (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0445] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0446] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0447] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0448] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0449] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0450] Flow: The volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, reference to flow will be to a scalar quantity, i.e. a quantity having only magnitude. In other cases, reference to flow will be to a vector quantity, i.e. a quantity having both magnitude and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0451] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The total flow, Qt, is the air flow leaving the RPT device. The ventilation flow, Qv, is the air flow leaving the vent to allow for washout of exhaled gases. The leakage flow, Ql, is the leakage flow from the patient interface system or elsewhere. The respiratory flow, Qr, is the air flow received into the patient's breathing system.

[0452] Humidifier: The term humidifier shall be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0453] Leakage: The word leakage is to be considered as undesired air flow. 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 the return bend to the surrounding environment.

[0454] Patient: A person, whether or not they have a respiratory condition.

[0455] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 , hectopascal. 1 cmH2O is equal to 1 gf / cm 2 And about 0.98 hectopascal. In this specification, unless otherwise specified, the pressure is given in cmH2O.

[0456] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0457] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0458] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0459] 5.8.1.1 Materials

[0460] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, 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.

[0461] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0462] 5.8.1.2 Mechanical properties

[0463] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0464] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, some silicones and thermoplastic elastomers.

[0465] Hardness: The ability of a material to resist deformation (e.g. as described by Young's modulus or the indentation hardness scale measured on a standardized sample size).

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

[0467] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0468] 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 a moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions.

[0469] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, such as within 1 second.

[0470] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with the entrance to a patient's airway, for example at a pressure of about 20 to 30 cmH2O.

[0471] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0472] 5.8.2 Anatomy

[0473] 5.8.2.1 Facial anatomy

[0474] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0475] Soft skeleton of the nose: The soft skeleton of the nose includes the septal, lateral, major and minor cartilages.

[0476] Nare: The roughly oval-shaped hole that forms the entrance to the nasal cavity. The singular form of nare is naris (naris). The nostrils are separated by the nasal septum.

[0477] 5.8.2.2 Anatomy of the skull

[0478] Frontal Bone: The frontal bone includes a large vertical portion (squama frontalis) which corresponds to the area called the forehead.

[0479] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0480] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0481] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0482] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0483] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0484] Orbit: The bony cavity in the skull that holds the eyeball.

[0485] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0486] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0487] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0488] 5.8.3 Patient interface

[0489] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0490] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In some forms, the elbow may be rotatable relative to a mating component, such as approximately 360 degrees. In some forms, the elbow may be removable from a mating component, such as via a snap connection. In some forms, the elbow may be assembled to a mating component via a one-time snap during manufacturing, but may not be removed by the patient.

[0491] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0492] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcements configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0493] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0494] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0495] Seal: can be a noun form referring to a structure (seal) or a verb form referring to that effect (seal). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without the need for a separate 'seal' element itself.

[0496] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0497] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0498] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0499] Swivel (noun): A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the component preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0500] Tie (noun): A structure used to resist tension.

[0501] Vent (noun): A structure that allows air flow from the interior of a mask or duct to ambient air, e.g., for effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0502] 5.8.4 Structure shape

[0503] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other characteristics. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0504] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure, cf. FIG. 3B to FIG. 3F , which show a cross section at a point p on the surface and an example of the resulting plane curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0505] 5.8.4.1 Curvature in one dimension

[0506] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0507] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point is positive (if the imaginary person were to leave that point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared to the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0508] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0509] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). See Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0510] 5.8.4.2 Curvature of a two-dimensional surface

[0511] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, such as a relatively small magnitude. FIG. 3B to FIG. 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0512] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example of Figure 3B and the minimum value appears at Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0513] Region of a surface: A connected set of points on a surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0514] Saddle region: A region where at each point the principal curvatures have opposite signs, i.e. one sign is positive and the other is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0515] Dome area: The area where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0516] Cylindrical region: A region where one of the principal curvatures is zero (or is zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0517] Planar Region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0518] Edge of a surface: The boundary or limit of a surface or area.

[0519] Path: In some forms of the present technology, a 'path' will be taken to mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0520] Path length: In some forms of the present technology, 'path length' will be taken to be the distance along the surface from f(0) to f(1), i.e. the distance along a path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0521] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there can exist a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there can exist no path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.

[0522] 5.8.4.3 Space curve

[0523] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and twist 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 a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0524] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her craft at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0525] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector pointing in the direction of the change in the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0526] 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 for example Figure 3P ) or optionally by the left-hand rule ( Fig.3O ) to determine.

[0527] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0528] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0529] Reference Figure 3P According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0530] Likewise, referring to the left-hand rule (see Fig.3O ), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0531] 5.8.4.4 Holes

[0532] A surface can have one-dimensional pores, for example pores bounded by a plane curve or by a space curve. A thin structure (e.g., a membrane) with pores can be described as having one-dimensional pores. See, for example, Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0533] A structure can have a two-dimensional hole, such as a hole defined by a surface. For example, a pneumatic tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional hole. For example, see Figure 3L The padding and the Figure 3M and Figure 3N , showing an inner surface defining a two-dimensional hole. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Figure 3K A two-dimensional hole in the shown structure bounded by the shown surface.

[0534] 5.9 Other notes

[0535] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0536] Unless the context clearly indicates and provides a numerical range, it should be understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other such value or intervening value in the range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the range. In the case where the range includes one or both of the limits, the present technology also includes ranges excluding either or both of those included limits.

[0537] Furthermore, where a value or values ​​are used herein as part of implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0538] 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 the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of representative methods and materials are described herein.

[0539] When a specific material is identified for use in a component of construction, obvious alternative materials with similar properties are used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0540] It must be noted that as used herein and the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0541] All publications mentioned herein are incorporated herein in their entirety by reference, to disclose and describe methods and / or materials as the subject of those publications. Providing the publications discussed herein is only for the disclosures before the filing date of the present application. Anything herein should not be construed as admitting that the present technology is not entitled to the priority of these publications due to previous inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed separately.

[0542] The terms “comprises” and “comprising” should be understood to refer to elements, components or steps in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0543] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the disclosure or claims as a whole. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0544] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order may be modified, and / or aspects of the order may be performed simultaneously or even synchronously.

[0545] It is therefore to be understood that numerous modifications may be made to the exemplary embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0546] 5.10 Reference Symbols List

[0547] 1000 patients

[0548] 1100 Bed Partner

[0549] 3000 Patient Interface

[0550] 3100 Seal forming structure

[0551] 3200 Inflatable Chamber

[0552] 3210 strings

[0553] 3220 points

[0554] 3230 lower point

[0555] 3300 Positioning and stabilizing structures

[0556] 3301 Upper belt part

[0557] 3302 Lower belt part

[0558] 3303 Front band

[0559] 3304 with receiving part

[0560] 3305 with attachment part

[0561] 3306 Connection part

[0562] 3310 rear connecting belt part

[0563] 3400 Vent

[0564] 3500 Interface Section

[0565] 3550 Second part of magnetic latch

[0566] 3551 Slot

[0567] 3552 Second Depression

[0568] 3560 Second bearing structure

[0569] 3580 Framework

[0570] 3600 port

[0571] 3700 Forehead Support

[0572] 3800 Connecting components

[0573] 3801 Upper belt connection part

[0574] 3802 Lower belt connection part

[0575] 3803 The first ring portion of the upper belt connection part

[0576] 3804 The second ring portion of the lower belt connection part

[0577] 3805 Interface connection part

[0578] 3806 First bearing structure

[0579] 3807 Magnetic Latch First Part

[0580] 3808 Protrusion

[0581] 3809 The First Depression

[0582] 3810 Curved Edge

[0583] 3811 The first ball and socket mechanism

[0584] 3812 Second ball and socket mechanism

[0585] 4000 RPT device

[0586] 4010 External housing

[0587] 4012 upper part

[0588] 4014 lower part

[0589] 4015 Panel

[0590] 4016 Chassis

[0591] 4018 Handle

[0592] 4020 Pneumatic Block

[0593] 4100 Pneumatic parts

[0594] 4110 Air Filter

[0595] 4112 Inlet Air Filter

[0596] 4114 Outlet air filter

[0597] 4120 Silencer

[0598] 4122 Inlet silencer

[0599] 4124 Exit Muffler

[0600] 4140 Pressure Generator

[0601] 4142 Blower

[0602] 4144 Brushless DC Motor

[0603] 4160 Anti-spillback valve

[0604] 4170 Air Circuit

[0605] 4180 Supplemental Oxygen

[0606] 4200 Electrical components

[0607] 4202 Printed Circuit Board Assembly (PCBA)

[0608] 4210 Power Supply

[0609] 4220 Input Device

[0610] 4270 Converter

[0611] 5000 Humidifier

[0612] 5002 Humidifier inlet

[0613] 5004 Humidifier outlet

[0614] 5006 Humidifier Base

[0615] 5110 Storage

[0616] 5120 Conductive part

[0617] 5130 Humidifier Reservoir Base

[0618] 5135 Locking lever

[0619] 5150 Water Level Indicator

[0620] 5240 Heating element

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealingly delivering, in use, a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a breathing cycle of the patient, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to a nares of the patient, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a first strap portion and a second strap portion; A connecting member for connecting the positioning and stabilizing structure to the inflatable chamber, the connecting member comprising: an interfacing portion having a first component configured to removably engage an interfacing portion of the patient interface; a first strap connection portion configured to engage with the first strap portion; and a second strap connection portion configured to engage with the second strap portion; wherein the interface connection portion is configured to engage the interface portion via a magnetic coupling, and Wherein, the first belt connection part and the second belt connection part are each movably connected to the interface connection part.

2. A patient interface according to claim 1, wherein: The first strap connection portion is an upper strap connection portion for connection to the first strap portion of the positioning and stabilising structure in use.

3. A patient interface according to any one of claims 1 or 2, wherein: The second strap connection portion is a lower strap connection portion for connection to the second strap portion of the positioning and stabilising structure in use.

4. A patient interface according to claim 3, when dependent on claim 2, wherein: The connecting member includes a single upper belt connecting portion and a single lower belt connecting portion.

5. A patient interface according to any one of claims 3 to 4, when dependent on claim 2, wherein: The upper strap connection portion includes a first hook portion configured to receive an end of the first strap portion.

6. A patient interface according to any one of claims 3 to 4, when dependent on claim 2, wherein: The upper strap connection portion includes a first loop portion configured to receive an end of the first strap portion.

7. A patient interface according to any one of claims 4 to 6, when dependent on claim 3, wherein: The lower strap connection portion includes a second hook portion configured to receive an end of the second strap portion.

8. A patient interface according to any one of claims 4 to 6, when dependent on claim 3, wherein: The lower strap includes a second loop portion configured to receive an end of the second strap portion.

9. The patient interface of claim 1, wherein: The interfacing portion and the interface portion are configured to prevent or limit rotation of the interfacing portion relative to the interface portion when the patient interface is in use.

10. A patient interface according to claim 9, wherein: The interface connection portion includes a first bearing structure configured to engage a second bearing structure of the interface portion.

11. A patient interface according to any one of claims 9 or 10, wherein: The interfacing portion and the interface portion are configured to prevent or limit rotation of the interfacing portion relative to the interface portion about a horizontal axis when the patient interface is in use.

12. A patient interface according to any one of claims 1 or 11, wherein: The interfacing portion is configured to connect to the plenum chamber.

13. A patient interface according to any one of claims 1 or 11, wherein: The interface connection portion is configured to connect to a frame of the patient interface.

14. A patient interface according to any one of claims 1 or 9 to 13, wherein: A single magnetic latch connects the interface connection portion and the interface portion, and wherein the first component is a first component of the magnetic latch and a second component of the magnetic latch is part of the interface portion, and the first component and the second component are configured to be removably connected.

15. A patient interface according to any one of claims 1 or 9 to 14, wherein: The first component is a protrusion configured to be received in a slot of the interface portion.

16. A patient interface according to claim 15, when dependent on claim 14, wherein: The second component is bonded to the plenum.

17. A patient interface according to claim 15, when dependent on claim 14, wherein: The second component is overmolded to the plenum.

18. A patient interface according to any one of claims 9 to 17, wherein: The interfacing portion includes a curved edge adapted to be grasped when disconnecting the interfacing portion from the interface portion.

19. A patient interface according to claim 18, wherein: The curved edge is disposed at a front side of the interface connection portion.

20. A patient interface according to any one of claims 1 to 19, wherein: The connection member is formed using an additive manufacturing process to produce a customized design specific to the patient's anthropometric data.

21. A patient interface according to any one of claims 1 to 20, wherein: The connecting member is formed of metal.

22. A patient interface according to claim 21, wherein: The metal retains the new shape after being heated and deformed into the new shape.

23. A patient interface according to claims 1 to 22, wherein: The upper strap connection portion is connected to the interface connection portion via a first ball and socket mechanism.

24. A patient interface according to any one of claims 1 to 23, wherein: The lower strap connection portion is connected to the interface connection portion via a second ball and socket mechanism.

25. A patient interface according to any one of claims 23 or 24, wherein: The upper strap connection portion is movable independently of the lower strap connection portion by means of the first ball and socket mechanism.

26. A patient interface according to any one of claims 23 to 24, wherein: The lower belt connection portion is movable independently of the upper belt connection portion by means of the second ball and socket mechanism.

27. A patient interface assembly, the patient interface assembly comprising: Interface part; a positioning and stabilizing structure, the positioning and stabilizing structure comprising an upper belt portion and a lower belt portion; as well as Two connecting members according to any one of claims 1 to 26, each of the connecting members is configured to receive a respective end of the upper strap portion and a respective end of the lower strap portion, wherein each of the connecting members is configured to be removably attachable to a respective left-hand side or right-hand side of the interface portion.

28. A patient interface assembly according to claim 27, wherein: The connecting member is connected to the interface portion in a fixed orientation.

29. A patient interface assembly according to any one of claims 27 or 28, when dependent on claim 12, wherein: The connecting member is connected to the plenum in a fixed orientation.

30. A patient interface assembly according to any one of claims 27 to 29, when dependent on claim 12, wherein: Increasing the tension on the upper strap connection portion moves the upper portion of the interface portion in a rearward direction.

31. A patient interface assembly according to any one of claims 27 to 30, when dependent on claim 12, wherein: Increasing the tension in the lower belt connection portion moves the lower portion of the plenum chamber in a rearward direction.

32. A patient interface system, the patient interface system comprising: Interface part; a first connection member configured to be removably coupled to the interface portion; a second connection member configured to be removably coupled to the interface portion; a first headband configured to be removably connected to the interface portion via the first connection member; as well as a second headband configured to be removably connected to the interface portion via the second connection member; wherein the strap of the first headband is different from the strap of the second headband; wherein the first connecting member and the second connecting member are each configured to engage the interface portion at a connection point, and at least one band portion of the first headband and at least one band portion of the second headband are configured to extend generally toward the connection point; Wherein only one of the first headband or the second headband is connected to the interface portion at any one time.

33. A patient interface system according to claim 32, wherein: The first headband includes a two-point connection.

34. A patient interface system according to claim 33, wherein: The first headband comprises a positioning and stabilising structure according to any one of claims 1 to 23.

35. A patient interface system according to any one of claims 32 to 34, wherein: The second headband includes a four-point connection.

36. A patient interface system according to claim 35, wherein: The patient interface system comprises two connection members according to any one of claims 1 to 26, connecting the second headgear to the interface portion.

37. A patient interface system according to claim 36, wherein: The connection portion connected to the first headband and the connection member connected to the second headband are configured to be removably connected to the interface portion at the same position.

38. A patient interface system according to claim 37, when dependent on claim 14, wherein: A second magnetic latch connects the connecting portion to the interface portion.

39. A patient interface system according to any one of claims 32 to 38, wherein: The first connection member and the second connection member are each configured to magnetically couple to the interface portion.

40. A patient interface system according to any one of claims 32 to 39, wherein: A headband vector provided by the first headband or the second headband is configured to cause pivotable movement of the interface portion.

41. A patient interface system according to claim 40, wherein: The interface portion is configured to pivot about the connection point.

42. A patient interface system according to any one of claims 32 to 41, wherein: The first connecting member includes one loop configured to receive a strap of the first headband, and the second connecting member includes two loops each configured to receive a strap of the second headband.

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