Patient interface and pad therefor

Abstract

A patient interface, the patient interface comprising: a plenum chamber; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway; and a vent allowing continuous flow of gas exhaled by the patient from the interior of the plenum chamber into the environment. The seal-forming structure may include a gasket that is deformable and resilient and is at least partially formed of a grid structure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Australian patent application No. 2022901964 filed on 14 July 2022, the entire contents of which are hereby incorporated by reference. Background Art 2.1 Technical Field

[0004] 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.

[0005] 2.2 Description of related technologies

[0006] 2.2.1 Human respiratory system and its disorders

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

[0008] The airway includes a series of branch tubes, and when the branch tubes penetrate deeper into the lungs, the branch tubes become narrower, shorter and more numerous. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air to the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to respiratory bronchioles and eventually to alveoli. The alveolar region of the lungs is the location where gas exchange occurs and is referred to as the respiratory zone. See John B. West, published by Lippincott Williams & Wilkins in 2012, Respiratory Physiology, 9th edition.

[0009] There is a range of breathing disorders. Some disorders may be characterised by specific events such as apnea, hypopnea and hyperpnea.

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

[0011] Obstructive sleep apnea (OSA), a form of sleep disordered breathing (SDB), is characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall areas during sleep. The condition causes the affected patient to stop breathing, typically for a period of 30 to 120 seconds, sometimes 200 to 300 times per night. The condition often results in excessive daytime sleepiness and may lead to cardiovascular disease and brain damage. The syndrome is a common disorder, particularly common in middle-aged overweight men, but the affected person may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory control center, in which there is a rhythmic alternating cycle of rising and falling breathing strength, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated lack of oxygen, CSR may be harmful. In some patients, CSR is associated with repeated micro-awakenings from sleep, which cause severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

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

[0015] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common features. These features include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term that covers many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents; (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of therapies have been used to treat or ameliorate such conditions. In addition, such therapies can be used to prevent breathing disorders in otherwise healthy individuals. However, these therapies have a number of disadvantages.

[0020] 2.2.2 Therapy

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

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the application of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as canister or tube ventilators).

[0024] 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 by CPAP therapy can be voluntary, so if the patient finds the device used to provide such therapy to be one or more of the following: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the therapy.

[0025] 2.2.3 Respiratory therapy system

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

[0027] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0028] Another form of therapy system is a mandibular repositioning device.

[0029] 2.2.3.1 Patient interface

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

[0031] Certain other mask systems may not be functionally suitable for use in this field. For example, a purely decorative mask may not be able to maintain the appropriate pressure. Mask systems used for underwater swimming or diving may be configured to prevent the entry of water from a higher pressure outside, but will not maintain the internal air at a pressure higher than the ambient pressure.

[0032] Certain masks may be clinically undesirable for the present technology, for example if they block airflow through the nose and only allow it through the mouth.

[0033] Certain masks may be uncomfortable or impractical with the present technology if the patient is required to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips.

[0034] Certain masks may not be practical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0035] The design of a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head is composed of bones, 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 over the course of a respiratory therapy session.

[0036] Due to these challenges, some masks have one or more of the following disadvantages: obtrusive, unsightly, expensive, poorly fitted, difficult to use and / or uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. The wrong size mask may lead to reduced compliance, reduced comfort and poor patient results. Masks designed only for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks for the administration of anesthetics are tolerable for their original applications, but despite this, such masks may be undesirably uncomfortable when worn for long periods of time (e.g., several hours). This discomfort may lead to reduced compliance of the patient to therapy. This is even more true if the mask is worn during sleep.

[0037] 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. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, and this may affect patient compliance.

[0038] While a mask used for other applications (such as a navigator) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for use in other applications.

[0039] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0040] 2.2.3.1.1 Sealing structure

[0041] The patient interface may include a seal-forming structure. Since the seal-forming structure 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.

[0042] The patient interface may be characterized in part based on the design intent of the seal-forming structure to engage with the face during use. In one form of the 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 the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a 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 the patient interface, the seal-forming structure may include an element that surrounds the mouth area during use, for example by forming a seal on the lower lip area of ​​the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds the nostrils and mouth area during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0043] A seal-forming structure that is effective in one area of ​​a patient's face may be inadequate in another area, for example due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0044] Certain seal-forming structures may be designed for mass manufacturing so that one design can fit and be 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 be adjusted to form a seal.

[0045] 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, with the seal-forming structure in face-to-face 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 in order to achieve a seal.

[0046] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery 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 seal-forming portion of the previous style, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, causing leaks.

[0047] Another type of seal-forming structure may include friction-fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0048] Another form of seal forming structure can use adhesive to achieve the seal. Some patients may find it inconvenient to frequently apply and remove adhesive on their face.

[0049] 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.

[0050] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett, U.S.A. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0051] ResMed, Inc. has manufactured the following products incorporating nasal pillows: SWIFT™ nasal pillows, SWIFT™ II nasal pillows, SWIFT™ LT nasal pillows, SWIFT™ FX nasal pillows, and MIRAGE LIBERTY™ full face mask. The following patent applications assigned to ResMed, Inc. describe examples of nasal pillows: International Patent Application WO 2004 / 073,778 (describing, inter alia, aspects of ResMed, Inc.'s SWIFT™ nasal pillows), U.S. Patent Application 2009 / 0044808 (describing, inter alia, aspects of ResMed, Inc.'s SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing, inter alia, aspects of ResMed, Inc.'s MIRAGE LIBERTY™ full face mask); International Patent Application WO 2009 / 052,560 (describing, inter alia, aspects of ResMed, Inc.'s SWIFT™ FX nasal pillows).

[0052] 2.2.3.1.2 Positioning and stabilization

[0053] A seal-forming structure of a patient interface for positive air pressure therapy is subject to a corresponding force of air pressure that would break the seal. Therefore, a variety of techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate portion of the face.

[0054] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0055] Another technique is to use one or more straps and / or stabilizing straps.Many of these straps suffer from one or more of poor fit, bulk, discomfort, and inconvenience in use.

[0056] 2.2.3.1.3 Pressurized air duct

[0057] In one type of therapy system, a flow of pressurized air is provided to a patient interface through a conduit in an air circuit that is fluidly connected to the patient interface such that when the patient interface is positioned on the patient's face during use, the conduit extends forwardly from the patient's face out of the patient interface. This may sometimes be referred to as a "tube down" configuration.

[0058] Some patients find such interfaces unsightly or claustrophobic and therefore resist wearing them, reducing patient compliance. Additionally, the tubing connected to the interface in front of the patient's face can sometimes be easily entangled in bedding.

[0059] 2.2.3.1.4 Pressurized air ducts for positioning / stabilizing seal-forming structures

[0060] An alternative type of treatment system that seeks to address these problems includes a patient interface in which the tube that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize the seal-forming portion of the patient interface to the appropriate portion of the patient's face. This type of patient interface may be referred to as having a "conduit headgear" or "headgear conduit." Such a patient interface allows the conduit in the air circuit that provides the pressurized air flow from the respiratory pressure therapy device to be connected to the patient interface at a position other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to the tube in the patient interface through a port that is positioned on the top of the patient's head during use.

[0061] A patient interface incorporating headgear tubing may provide some advantages, such as avoiding tubing connected to the patient interface in front of the patient's face, which may be unsightly and obtrusive. Ideally, however, a patient interface incorporating headgear tubing is comfortable for the patient to wear for extended periods of time while the patient is asleep, forms an airtight and stable seal with the patient's face, and is also capable of conforming to a range of patient head shapes and sizes.

[0062] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

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

[0064] The designer of a device may be faced with making an infinite number of choices. Design criteria often conflict, meaning that some design choices are out of the ordinary or unavoidable. Furthermore, some aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

[0065] 2.2.3.3 Air circuit

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

[0067] 2.2.3.4 Humidifier

[0068] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases airway comfort for the patient. 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.

[0069] 2.2.3.5 Data Management

[0070] There may be a clinical reason for obtaining data to determine whether a patient receiving respiratory therapy has been "compliant," e.g., the patient has used their RPT device in accordance with one or more "compliance rules." An 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 therapy for a patient using the RPT device, calculate usage 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 notify a third party that the patient is compliant.

[0071] There may be other aspects of a patient's therapy that would benefit from communicating therapy data to a third party or external system.

[0072] Existing processes for communicating and managing this data can be one or more of the following: costly, time-consuming, and error-prone.

[0073] 2.2.3.6 Ventilation techniques

[0074] 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 (eg, a plenum) of the patient interface to a space outside the patient interface, such as to the environment.

[0075] 2.2.4 Screening, diagnosis and surveillance systems

[0076] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts 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 the treatment of sleep apnea involves two nights of observation of the patient in the clinic, one night for pure diagnosis, and the second night for titration of treatment parameters by the clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosis / monitoring sleep apnea at home.

[0077] Screening and diagnosis generally describe the identification of a condition based on its signs and symptoms. Screening generally gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis yields clinically actionable information. Screening and diagnosis tend to be a one-time process, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0078] A clinical specialist may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical specialist may not be available or the patient may not be able to afford the clinical specialist. Different clinical specialists may disagree on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. Summary of the invention

[0079] The present technology is intended to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0080] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0081] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0082] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0083]

[0013] Another aspect of one form of the present technology is a patient interface molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0084] 3.1 Pads with grid structure

[0085] Another aspect of the present technology includes a patient interface comprising:

[0086] a plenum chamber capable of being pressurized to a therapeutic pressure of at least 4 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;

[0087] 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, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapy pressure in the plenum throughout the patient's breathing cycle;

[0088] a vent that allows gas exhaled by the patient to flow continuously from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; and

[0089] wherein the seal-forming structure comprises a cushion which is deformable and resilient and is at least partially formed of a lattice structure;

[0090] Wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the inflation chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

[0091] In the example:

[0092] The seal-forming structure includes a face-engaging membrane configured to contact the patient's face, the face-engaging membrane being flexible and resilient and at least partially covering the cushion in use;

[0093] the patient interface comprising a chassis portion at least partially forming the plenum, the seal-forming structure being attached to and supported by the chassis portion, the chassis portion being stiffer than the seal-forming structure;

[0094] The face engaging membrane extends from the chassis portion;

[0095] The facial engaging membrane is formed of an elastomeric material;

[0096] The cushion is positioned outside the plenum;

[0097] The patient interface includes a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0098] the chassis portion and the seal-forming structure together form a cushioning module removably attached to the positioning and stabilising structure;

[0099] The patient interface comprises a frame configured to connect the positioning and stabilising structure to the cushion module;

[0100] The cushion module is removably attached to the frame;

[0101] the positioning and stabilizing structure comprising a pair of gas delivery tubes configured to provide the flow of air at a therapeutic pressure to the plenum chamber and configured to provide a force to maintain the seal-forming structure in a sealed position;

[0102] The cushion is formed flat and is bent into a three-dimensional shape during assembly with the face-engaging membrane; and / or

[0103] The pad is formed into a three-dimensional shape.

[0104] In another example:

[0105] The lattice structure is 3D printed;

[0106] The mesh structure is 3D printed in a shape that corresponds to the unique patient’s face;

[0107] The grid structure is injection molded;

[0108] The mesh structure is formed by TPU;

[0109] The grid structure is formed of silicone;

[0110] The mesh structure is formed of a material having a durometer hardness in the range of 20 Shore A to 80 Shore A;

[0111] The grid structure includes a two-dimensional structure;

[0112] The grid structure includes a three-dimensional structure;

[0113] The grid structure includes one of the following structures: a fluorite structure, a truncated cube structure, an IsoTruss structure, a hexagonal honeycomb structure, a gyroid structure, and a Schwarz structure;

[0114] the pad is formed from a foam having holes therein forming the grid structure; and / or

[0115] • The size, shape and / or spacing of the holes varies along the length of the pad and / or between a first side of the pad and a second side of the pad.

[0116] In another example:

[0117] the cushion includes one or more features that vary between different positions at which the seal-forming structure engages the patient's face;

[0118] The one or more characteristics of the cushion include the stiffness of the cushion;

[0119] The one or more features of the pad include one or more features of the grid structure;

[0120] The one or more characteristics of the grid structure include the shape, thickness, density, spacing, relative orientation and / or material of the cells forming the grid structure;

[0121] the seal-forming structure being configured to seal to the patient's face at the upper portion of the patient's lips, outside the patient's nose, and at the patient's nasal ridge;

[0122] The cushion includes an upper lip portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the upper lip of the patient, the cushion includes a nasal portion side disposed within a corresponding portion of the seal-forming structure, the corresponding portion of the seal-forming structure being configured to seal to the patient's face at each side of the patient's nose, and the cushion is stiffer at the nasal portion side than at the upper lip portion.

[0123] the cushion includes a nasal ridge portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the patient's nasal ridge, and the cushion is stiffer on the nasal portion side than at the nasal ridge portion;

[0124] the seal-forming structure is configured to seal to the patient's face at the lower portion of the patient's lips, at the patient's cheeks, outside the patient's nose, and at the patient's nasal ridge;

[0125] the cushion includes a lower lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at the patient's lower lip, the cushion includes a pair of cheek portions disposed within respective portions of the seal-forming structure configured to seal to the patient's face at the patient's cheeks, and the cushion is stiffer in the cheek portions than in the lower lip portion;

[0126] The cushion includes a nasal portion side, which is disposed within a corresponding portion of the seal-forming structure, the corresponding portion of the seal-forming structure being configured to seal to the patient's face at the outside of the patient's nose, the cushion includes a nasal ridge area, which is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the patient's nasal ridge, and the cushion is stiffer at the nasal portion side than at the nasal ridge portion.

[0127] the seal-forming structure is configured to seal to the patient's face at the lower portion of the patient's lips, at the patient's cheeks, at the upper portion of the patient's lips, and at a lower periphery of the patient's nose, the lower periphery of the patient's nose including the nasal wings and the nasal prominence area of ​​the patient's nose;

[0128] the cushion includes a lower lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at the patient's lower lip, the cushion includes a cheek portion disposed within a corresponding portion of the seal-forming structure configured to seal to the patient's face at the patient's cheek, the cushion being stiffer in the cheek portion than in the lower lip portion;

[0129] The cushion includes an upper lip portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the upper lip of the patient, the cushion includes a lower nasal peripheral portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the lower periphery of the patient's nose, and the cushion is stiffer in the upper lip portion than in the lower nasal peripheral portion.

[0130] the seal-forming structure is configured to seal to the patient's face at the upper portion of the patient's lips, between the nose wing and the nasolabial groove, and at a lower periphery of the patient's nose, the lower periphery of the patient's nose including the nose wing and the nasal prominence area of ​​the patient's nose;

[0131] the cushion comprises an upper lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at the upper lip of the patient, the cushion comprises a pair of rear corner portions disposed within a portion of the seal-forming structure configured to seal to the patient's face between the nasal wing and the nasolabial groove, and the cushion is stiffer in the rear corner portions than in the upper lip portion; and / or

[0132] The cushion includes a lower nasal peripheral portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the lower periphery of the patient's nose, and the cushion is stiffer in the rear corner portion than in the lower nasal peripheral portion.

[0133] In another example:

[0134] the lattice structure includes one or more features that vary between a patient-facing side of the cushion and a non-patient-facing side of the cushion, the patient-facing side of the cushion corresponding to a side of the seal-forming structure configured to contact the patient's face in use, and the non-patient-facing side of the cushion corresponding to a side of the seal-forming structure configured to face away from the patient's face in use;

[0135] The grid structure on the patient-facing side of the pad is configured to avoid leaving red marks on the patient's face;

[0136] The lattice structure of the non-patient-facing side of the cushion is configured to easily adapt to the shape of the patient's face;

[0137] The grid structure comprises cells that are smaller on the patient-facing side than on the non-patient-facing side;

[0138] the variation in the one or more characteristics of the lattice structure causing the cushion to be less stiff on the patient-facing side of the cushion than on the non-patient-facing side of the cushion;

[0139] The material forming the cells of the lattice structure is thinner on the patient-facing side of the pad than on the non-patient-facing side of the pad;

[0140] The material forming the cells of the grid structure has a thickness on the patient-facing side of the pad in the range of 0.3 mm to 0.5 mm;

[0141] The material forming the cells of the grid structure has a thickness on the non-patient-facing side of the pad in the range of 0.8 mm to 1.2 mm, such as 1 mm;

[0142] the lattice structure comprises one or more characteristics that vary along the length of the cushion, wherein in use, the cushion receives a distributed load applied to a non-patient-facing side of the cushion along the length of the cushion, and wherein due to the variation in the one or more characteristics, the cushion applies a different distributed load to the patient's face along the length of the cushion;

[0143] the grid structure includes one or more features that vary at and / or near locations corresponding to sensitive facial features on the patient's face;

[0144] the change in the one or more characteristics causes the cushion to apply less pressure on the sensitive facial feature in use than would be applied in the absence of the change in the one or more characteristics;

[0145] the change in the one or more characteristics causing the cushion to apply less pressure on the sensitive facial feature than the cushion applies to the patient's face around the sensitive facial feature in use;

[0146] the variation in the one or more characteristics of the mesh structure results in lower stiffness in the cushion at and / or near the location corresponding to the sensitive facial feature;

[0147] The cushion comprises a recess configured to align with a sensitive facial feature on the patient's face in use, the recess being shaped to receive the sensitive facial feature;

[0148] The shape of the recess is designed to provide a gap between the cushion and the sensitive facial feature in the undeformed state;

[0149] the cushion comprises one or more force redistribution features configured to, in use, at least partially redirect forces received on a non-patient-facing side of the cushion in a region of the cushion aligned with a sensitive facial feature to one or more regions of the cushion juxtaposed with or spaced apart from the sensitive facial feature;

[0150] the one or more force redistribution features comprising a beam structure within the cushion, the beam structure being positioned to span, in use, from a first region of the cushion located on a first side of the sensitive facial feature, to a second region of the cushion covering the sensitive facial feature, and into a third region of the cushion located on a second side of the sensitive facial feature;

[0151] at least one of the one or more force redistribution features comprises a reinforced region within the cushion, the reinforced region being stiffer than one or more adjacent regions within the cushion, the reinforced region being positioned to span, in use, from a first region of the cushion located on a first side of the sensitive facial feature, to a second region of the cushion overlying the sensitive facial feature, and into a third region of the cushion located on a second side of the sensitive facial feature, the reinforced region being reinforced by a change in one or more characteristics of the grid structure at the reinforced region;

[0152] The change in the one or more characteristics of the grid structure includes a change in the shape, thickness, density, spacing, relative orientation and / or material of the cells forming the grid structure;

[0153] The cushion is stiffer near the patient's face in the first and third regions than in the second region;

[0154] The sensitive facial feature is the patient's nasal ridge;

[0155] The patient-facing side of the cushion is defined by cells of the grid structure that are exposed to contact the facial engaging membrane;

[0156] the cushion comprises a uniform surface on the patient-facing side of the cushion covering the cells of the grid structure; and / or

[0157] • The uniform surface is formed integrally with the cells of the grid structure.

[0158] In another example:

[0159] The cushion is removable from the patient interface;

[0160] at least some of the air flow through the plenum flows through the lattice structure forming the cushion;

[0161] The pad forms a heat and moisture exchanger (HMX);

[0162] The liner covers the plenum inlet port; and / or

[0163] The cushion fills most of the space of the plenum.

[0164] In another aspect of the disclosed technology, a patient interface for delivering an air flow to a patient to treat sleep-disordered breathing includes: a plenum chamber and a seal-forming structure. The plenum chamber is capable of being pressurized to a treatment pressure that is at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port, the size and structure of the plenum chamber inlet port being designed to receive an air flow at the treatment pressure for the patient to breathe. The seal-forming structure is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, the seal-forming structure having a hole therein so that the air flow at the treatment pressure is delivered to at least one entrance of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's breathing cycle in use.

[0165] In an example, the seal-forming structure includes a cushion configured to be disposed between the inflatable chamber and the patient's face in use, the cushion including a plurality of interconnected struts forming a plurality of voids.

[0166] In further examples, in use, when the seal-forming structure is engaged with the patient's face, the struts are configured to flex, thereby changing the size, shape and / or orientation of the void to allow the cushion to conform to the patient's face.

[0167] In other examples: (a) the struts are resilient; (b) a characteristic of the cushion varies across the cushion such that the characteristic is different in a first portion of the cushion than in a second portion of the cushion, the first portion of the cushion having a different degree of flexibility than the second portion of the cushion; (c) the characteristic of the cushion is: 1) the thickness of the struts, 2) the density of the struts, 3) the orientation of the struts, 4) the spacing of the struts, 5) the size of the voids, 6) the orientation of the voids, and / or 7) the density of the voids; (d) the thickness of the struts in the first portion of the cushion is different than the density of the voids. The thickness is different from the thickness of the support in the second portion of the cushion; (e) the size of the void in the first portion of the cushion is different from the size of the void in the second portion of the cushion; (f) the first portion of the cushion corresponds to a sensitive facial feature of the patient and the second portion of the cushion does not correspond to a sensitive facial feature; (g) the sensitive facial feature is the nasal ridge of the patient; (h) the first portion of the cushion has greater flexibility than the second portion of the cushion; and / or (i) the support and the void form a grid structure.

[0168] In additional examples: (a) the cushion is not formed of a foam material, and (b) the cushion is constructed of a foam material and has a plurality of macropores formed therein to form the void.

[0169] In another aspect of the disclosed technology, a patient interface includes a seal-forming structure having a cushion similar to bubble wrap.

[0170] In another aspect of the disclosed technology, a patient interface includes a seal-forming structure having a cushion including a plurality of bladders (eg, inflatable bladders).

[0171] In other examples, a plurality of hinge portions are interspersed between the bladders such that each bladder is movable relative to an adjacent bladder via the hinge portions.

[0172] In other examples, the hinge portions are thinned regions (eg, living hinges).

[0173] In other examples, the stiffness or flexibility of the plurality of bladders may vary between bladders. In other examples, the stiffness or the flexibility may be varied by adjusting the amount of fluid in each bladder.

[0174] In another aspect of the disclosed technology, a patient interface includes a seal-forming structure having a cushion including a plurality of relatively flexible, relatively thin hinge portions interspersed between relatively rigid portions. In further examples, the hinge portions and the relatively rigid portions form a grid.

[0175] 3.2 Automatically determine size

[0176] One form of the present technology includes automatically determining the dimensions of components of a patient interface (also referred to hereinafter as a "facial interface") that interfaces with the patient's face without the assistance of trained individuals or others.

[0177] Another aspect of one form of the present technology is to automatically measure facial features of a subject (eg, a patient / user) based on data collected from the user.

[0178] Another aspect of one form of the present technology is automatically recommending a facial interface size based on a comparison between data collected from a user and a corresponding data record.

[0179] Another aspect of one form of the present technology is to automatically recommend a customized facial interface size based on data collected from a user. Based on the facial geometry of a given user, the customized facial interface can be unique to the given user.

[0180] Another aspect of one form of the present technology is a mobile application that conveniently determines the appropriate facial interface size for a particular user based on a two-dimensional image.

[0181] Another aspect of one form of the present technology is a mobile application that conveniently determines the appropriate facial interface size for a particular user based on a three-dimensional image.

[0182] Some versions of the present technology include an automated method for selecting a facial interface based on a facial interface size. The method may operate in one or more processors. The method may include receiving image data captured by an image sensor. The captured image data may contain one or more facial features of an intended user of the facial interface, the one or more facial features associated with a predetermined reference feature having a known size. The method may include detecting one or more facial features of the user in the captured image data. The method may include detecting the predetermined reference feature in the captured image data. The method may include processing image pixel data of the image to measure aspects of the one or more facial features detected in the image based on the predetermined reference feature. The method may include selecting a facial interface size from a set of standard facial interface sizes based on a comparison between the measured aspects of the one or more facial features and dimensional information associated with a data record of a set of standard facial interface sizes and the measured aspects of the one or more facial features.

[0183] In some versions, the aspect of the one or more facial features may include a distance between a nose bridge point and a suprachinal point of the user. The method may include calculating a value of the measured aspect based on a scaling factor derived from the reference feature. The method may include adjusting the value of the measured aspect using an anthropometric correction factor. The anthropometric correction factor may be calculated based on facial interface return data. The method may include calculating the scaling factor based on the known dimensions of the predetermined reference feature and a detected pixel count for the detected reference feature. The predetermined reference feature may be a coin. Detecting the reference feature may include applying a cascade classifier to the captured image data. The method may include calculating a value of the measured aspect based on a scaling factor derived from the coin. The method may include calculating the scaling factor based on the known dimensions of the coin in the captured image data and a detected pixel count of the coin detected. The detected pixel count of the coin detected may be the width of an ellipse fitted to the coin. The predetermined reference feature may be a cornea or an iris of the user.

[0184] In some versions, the method may include, for image capture, displaying the reference feature on a display interface of a display device coupled to the image sensor. The display interface may include a positioning guide and a real-time action preview of content detected by the image sensor. The content may include the reference feature displayed on the display interface. The method may include controlling the capture of the image data to satisfy at least one alignment condition. The at least one alignment condition may include detecting the position of the reference feature of the real-time action preview within the frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within approximately + / -10 degrees of an up-down extension axis. The at least one alignment condition may include detecting a tilt condition within approximately + / -5 degrees of an up-down extension axis. Detection of the tilt condition may be performed by reading an inertial measurement unit (IMU).

[0185] In some versions, the predetermined reference feature can be a QR code. Optionally, processing the image pixel data can include performing a pixel count. The method can include generating an automated electronic quote for purchase and / or automated shipping instructions for the facial interface based on the selected facial interface size. The method can include calculating an average of the measured aspects of the facial features based on multiple captured images of the one or more facial features. Optionally, the method can include automatically recommending a custom facial interface size based on data collected from the user, and the custom facial interface can be unique to the given user based on the facial geometry of the given user.

[0186] Some versions of the present technology include a system for automatically recommending a facial interface size that is complementary to facial features of a particular user. The system may include one or more servers. The one or more servers may be configured to communicate with a computing device over a network. The one or more servers may be configured to receive image data captured by an image sensor, wherein the captured image data may contain one or more facial features of an intended user of the facial interface, the one or more facial features being associated with a predetermined reference feature having a known size. The one or more servers may be configured to detect the one or more facial features of the user in the captured image data. The one or more servers may be configured to detect the predetermined reference feature in the captured image data. The one or more servers may be configured to process image pixel data of the image to measure aspects of the one or more facial features detected in the image based on the predetermined reference feature. The one or more servers may be configured to select a facial interface size from a set of standard facial interface sizes based on a comparison between the measured aspects of the one or more facial features and size information associated with a data record of a set of standard facial interface sizes and the measured aspects of the one or more facial features.

[0187] In some versions, the aspect of the one or more facial features may include a distance between a nose bridge point and a chin point of the user. The one or more servers may be configured to calculate the value of the measured aspect based on a scaling factor derived from the reference feature. The one or more servers may be configured to adjust the value of the measured aspect using an anthropometric correction factor. The anthropometric correction factor may be calculated based on facial interface return data. The one or more servers may be configured to calculate the scaling factor based on the known size of the predetermined reference feature and a detected pixel count for the detected reference feature. The predetermined reference feature may include a coin. The one or more servers may be configured to detect the reference feature by applying a cascade classifier to the captured image data. The one or more servers may be further configured to calculate the value of the measured aspect based on a scaling factor derived from the coin. The one or more servers may be configured to calculate the scaling factor based on the known size of the coin in the captured image data and a detected pixel count of the coin detected. The detected pixel count of the coin detected may be the width of an ellipse fitted to the coin. The predetermined reference feature may be a cornea of ​​the user.

[0188] In some versions, the system may include the computing device. The computing device may be configured to generate a display of the reference feature on a display interface of a display device that can be coupled to the image sensor for image capture. The display interface may include a positioning guide and a real-time action preview of the content detected by the image sensor. The content may include the reference feature displayed on the display interface. The computing device may be further configured to control the capture of the image data to meet at least one alignment condition. The at least one alignment condition may include detecting the position of the reference feature of the real-time action preview within the frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within approximately + / -10 degrees of the upper-lower extension axis. The at least one alignment condition may include detecting a tilt condition within approximately + / -5 degrees of the upper-lower extension axis. The detection of the tilt condition may be performed by reading an inertial measurement unit (IMU).

[0189] In some versions, the predetermined reference feature may include a QR code. In some cases, to process the image pixel data, the one or more servers may be configured to perform pixel counting. The one or more servers may be configured to generate an automated electronic quote for purchase and / or automated shipping instructions for the facial interface based on the selected facial interface size. The one or more servers may be configured to calculate an average of the measured aspects of the facial feature based on multiple captured images of the facial feature. The one or more servers may be configured to communicate the selected facial interface size to the computing device via the network. Optionally, the server may be configured to automatically recommend a custom facial interface size based on data collected from the user, and based on the facial geometry of the given user, the customized facial interface may be unique to the given user.

[0190] Some versions of the present technology include a system for automatically recommending a facial interface size that is complementary to a particular user's facial features. The system may include a mobile computing device. The mobile computing device may be configured to communicate with one or more servers over a network. The mobile computing device may be configured to receive captured image data of an image. The captured image data may include one or more facial features of a user, the one or more facial features associated with a predetermined reference feature having a known size. The image data may be captured using an image sensor. The mobile computing device may be configured to detect the one or more facial features of the user in the captured image data. The mobile computing device may be configured to detect the predetermined reference feature in the captured image data. The mobile computing device may be configured to process image pixel data of the image to measure aspects of the one or more facial features detected in the image based on the predetermined reference feature. The mobile computing device may be configured to select a facial interface size from a set of standard facial interface sizes based on a comparison between the measured aspects of the one or more facial features and size information associated with a data record of a set of standard facial interface sizes and the measured aspects of the one or more facial features.

[0191] In some versions, the aspect of the one or more facial features may include a distance between a nose bridge point and a chin point of the user. The mobile computing device may be configured to calculate the value of the measured aspect based on a scaling factor derived from the reference feature. The mobile computing device may be further configured to adjust the value of the measured aspect using an anthropometric correction factor. The anthropometric correction factor may be calculated based on facial interface return data. The mobile computing device may be configured to calculate the scaling factor based on the known size of the predetermined reference feature and a detected pixel count for the detected reference feature. The predetermined reference feature may be a coin. The mobile computing device may be configured to detect the reference feature by applying a cascade classifier to the captured image data. The mobile computing device may be configured to calculate the value of the measured aspect based on a scaling factor derived from the coin. The mobile computing device may be configured to calculate the scaling factor based on the known size of the coin in the captured image data and a detected pixel count of the coin detected. The detected pixel count of the coin detected may be the width of an ellipse fitting the coin. In some versions, the predetermined reference feature may be the user's cornea or iris.

[0192] The mobile computing device may be configured to generate a display of the reference feature on a display interface of a display device that may be coupled to the image sensor for image capture. The display interface may include a positioning guide and a real-time action preview of the content detected by the image sensor. The content may include the reference feature displayed on the display interface. The mobile computing device may be configured to control the capture of the image data to meet at least one alignment condition. The at least one alignment condition may include detecting the position of the reference feature of the real-time action preview within the frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within approximately + / -10 degrees of the upper-lower extension axis. The at least one alignment condition may include detecting a tilt condition within approximately + / -5 degrees of the upper-lower extension axis. The detection of the tilt condition may be performed by reading an inertial measurement unit (IMU).

[0193] In some versions, the predetermined reference feature may be a QR code. In some cases, to process the image pixel data, the mobile computing device may be configured to perform pixel counting. The mobile computing device may be configured to request an automated electronic quote for purchase and / or automated shipping instructions for the facial interface based on the selected facial interface size. The mobile computing device may be configured to calculate an average of the measured aspects of the facial feature based on multiple captured images of the facial feature. The mobile computing device may be configured to communicate the selected facial interface size to the server via the network. Optionally, the mobile phone may be configured to automatically recommend a customized facial interface size based on data collected from the user, wherein the customized facial interface may be unique to the given user based on the facial geometry of the given user.

[0194] Some versions of the present technology include an apparatus for automatically recommending a facial interface size that is complementary to facial features of a particular user. The apparatus may include components for receiving image data captured by an image sensor. The captured image data may contain one or more facial features of an intended user of the facial interface, the one or more facial features being associated with a predetermined reference feature having a known size. The apparatus may include components for detecting the one or more facial features of the user in the captured image data. The apparatus may include components for detecting the predetermined reference feature in the captured image data. The apparatus may include components for processing image pixel data of the image to measure aspects of the one or more facial features detected in the image based on the predetermined reference feature. The apparatus may include components for selecting a facial interface size from a set of standard facial interface sizes based on a comparison between the measured aspects of the one or more facial features and size information associated with a data record of a set of standard facial interface sizes and the measured aspects of the one or more facial features.

[0195] 3.3 Personalization

[0196] An aspect of one form of the present technology is a processor-implemented method for producing a mesh structure of a customized patient interface assembly, the method comprising:

[0197] Using the communication circuitry to receive data representing one or more key point features of a person's head;

[0198] identifying, using at least one processor, one or more keypoint feature locations of the keypoint feature based on the data;

[0199] determining, using the at least one processor, a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0200] One or more manufacturing machines are controlled based on the set of manufacturing specifications to produce the lattice structure of the patient interface assembly.

[0201] An aspect of one form of the present technology is a processor-implemented method for producing a mesh structure of a customized patient interface assembly, the method comprising:

[0202] Using the communication circuitry to receive data representing one or more key point features of a person's head;

[0203] identifying, using at least one processor, one or more keypoint feature locations of the keypoint feature based on the data;

[0204] determining, using the at least one processor, a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0205] One or more manufacturing machines are caused to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0206] In an example: (a) the data represents one or more key point features of a head of an intended user of the patient interface; (b) the data includes image data; (c) at least a portion of the image data is captured by an image sensor; (d) the method includes the step of capturing at least a portion of the image data using an image sensor; (e) the data includes two-dimensional image data; and / or (f) the data includes three-dimensional image data.

[0207] In an example, causing one or more manufacturing machines to produce the lattice structure of the patient interface component includes controlling the one or more manufacturing machines to produce the lattice structure of the patient interface component based on the set of manufacturing specifications.

[0208] In an example, the method is performed by a manufacturing system including the at least one processor and the communication circuit.

[0209] In an example, the method includes: (a) a step of capturing at least a portion of the data using an image sensor; and / or (b) a step of identifying at least one relationship between two or more of the key point feature locations, wherein the manufacturing specification set is determined at least in part based on the at least one relationship between the two or more of the key point feature locations.

[0210] In an example, identifying the at least one relationship between the two or more of the key point feature locations includes determining the distance between two or more of: a subnasal point, a nasal bridge point, a tragus point, a posteriormost point of the head, a superiormost point of the head, a lateralmost point of the right orbital rim, a lateralmost point of the left orbital rim, a inferiormost point of the orbital rim, a Frankfurt horizontal plane, and a coronal plane aligned with the tragus point.

[0211] In an example, identifying the at least one relationship between the two or more key point feature positions in the key point feature position comprises: (a) determining the distance between the subnasal point and the tragus point in the sagittal plane; (b) determining the vertical distance between the subnasal point and the bridge of the nose point in the sagittal plane; (c) determining the distance between the subnasal point and the coronal plane aligned with the tragus point, the distance being perpendicular to the coronal plane; (d) determining the distance between the outermost point of the left orbital margin or the outermost point of the right orbital margin and the bridge of the nose point aligned with the tragus point; (e) determining the vertical distance between the subnasal point and the uppermost point of the head; (f) determining the vertical distance between the uppermost point of the head and the Frankfort horizontal plane; (g) determining the distance between the rearmost point of the head and the coronal plane aligned with the tragus point, the distance being perpendicular to the coronal plane; and / or (h) determining the distance between the lateralmost point of the left orbital rim and the lateralmost point of the right orbital rim.

[0212] In an example: (a) the method includes the step of determining at least one performance requirement of the grid structure of the patient interface component based on the one or more key point feature locations; (b) the at least one performance requirement includes one or more of the following: stiffness, contact pressure, compliance, force applied by or to the component, elasticity, size, and positioning on the head; (c) the grid structure of the patient interface component includes multiple regions, and at least one performance requirement is determined for each region; (d) the at least one performance requirement is determined at least in part based on a property of another component of the patient interface, the other component being intended for use with the customized patient interface component; and / or (e) the manufacturing specification set is determined at least in part based on the at least one performance requirement.

[0213] In some examples, the step of determining the at least one performance requirement includes receiving and analyzing facial motion data representing changes in shape and / or size of the patient's face during facial motions.

[0214] In an example, the set of manufacturing specifications includes: (a) at least one material specification; (b) at least one construction technique specification; and / or (c) at least one size specification.

[0215] In an example, determining the manufacturing specification set includes: (a) selecting the manufacturing specification set from multiple existing manufacturing specification sets; (b) selecting the existing manufacturing specification set based on a comparison between the one or more key point feature positions determined for the person and one or more key point feature positions associated with the existing manufacturing specification set; and / or (c) selecting multiple manufacturing specifications from multiple existing manufacturing specifications to form the manufacturing specification set.

[0216] In an example, the method includes generating manufacturing machine programming instructions for producing the lattice structure of the patient interface assembly based on the manufacturing specification set. In an example, producing the lattice structure of the patient interface assembly includes programming at least one manufacturing machine using the manufacturing machine programming instructions, and operating the at least one manufacturing machine according to the manufacturing machine programming instructions.

[0217] In an example: (a) generating the manufacturing machine programming instructions includes generating a diagram representing the manufacturing specification set, and generating the manufacturing machine programming instructions based on the diagram; and / or (b) generating the manufacturing machine programming instructions includes generating a model of the mesh structure of the patient interface component based on the manufacturing specification set, and generating the manufacturing machine programming instructions based on the model.

[0218] In an example, producing the mesh structure of the patient interface assembly includes: (a) additive manufacturing the mesh structure; (b) 3D printing the mesh structure; (c) laser cutting the mesh structure; (d) knitting the mesh structure; (e) weaving the mesh structure; and / or (f) generating instructions for one or more manufacturing devices, the one or more manufacturing devices being configured to produce the mesh structure, the instructions controlling the one or more manufacturing devices to produce the mesh structure based on the generated instructions.

[0219] In an example, the patient interface assembly includes a cushion of a seal-forming structure of the patient interface.

[0220] One aspect of one form of the present technology is a system for producing a lattice structure of a customized patient interface assembly, the system comprising:

[0221] One or more processors configured to receive data representing one or more key point features of a person;

[0222] The one or more processors are further configured to identify one or more keypoint feature locations of the keypoint feature based on the data;

[0223] The one or more processors are further configured to determine a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0224] At least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0225] An aspect of one form of the present technology is a processor-implemented method performed by a processing system including at least one processor and communication circuitry for producing a mesh structure of a patient interface assembly, the method comprising:

[0226] using the communication circuitry to receive data representative of one or more key point features of a person's head;

[0227] identifying, using the processing system, one or more keypoint feature locations of the keypoint feature based on the data;

[0228] using the processing system, determining a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0229] Using the communication circuitry, the manufacturing specification set is communicated to a manufacturing system including at least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the manufacturing specification set.

[0230] One aspect of one form of the present technology is a system for producing a lattice structure of a customized patient interface assembly, the system comprising:

[0231] One or more processors configured to receive data representing one or more key point features of a person's head;

[0232] The one or more processors are further configured to identify one or more keypoint feature locations of the keypoint feature based on the data;

[0233] The one or more processors are further configured to determine a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0234] The one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0235] An aspect of one form of the present technology is a processor-implemented method performed by a processing system including at least one processor and communication circuitry for producing a mesh structure of a patient interface assembly, the method comprising:

[0236] using the communication circuitry to receive data representing one or more key point feature locations of key point features of a person's head;

[0237] using the processing system, determining a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0238] Using the communication circuitry, the manufacturing specification set is communicated to a manufacturing system including at least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the manufacturing specification set.

[0239] One aspect of one form of the present technology is a system for producing a lattice structure of a customized patient interface assembly, the system comprising:

[0240] one or more processors for receiving one or more key point feature locations of key point features of a person's head, the one or more key point feature locations being identified from data representing the one or more key point features of the head;

[0241] The one or more processors are further configured to determine a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0242] The one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0243] An aspect of one form of the present technology is a processor-implemented method for producing a mesh structure of a patient interface assembly, the method comprising:

[0244] receiving, using communication circuitry, a set of manufacturing specifications for producing the mesh structure of the patient interface assembly, wherein the set of manufacturing specifications is determined based on one or more keypoint feature locations identified from data representing one or more keypoint features of a person's head; and

[0245] One or more manufacturing machines are controlled based on the set of manufacturing specifications to produce the lattice structure of the patient interface assembly.

[0246] An aspect of one form of the present technology is a processor-implemented method for producing a mesh structure of a patient interface assembly, the method comprising:

[0247] receiving, using communication circuitry, a set of manufacturing specifications for producing the mesh structure of the patient interface assembly, wherein the set of manufacturing specifications is determined based on one or more keypoint feature locations identified from data representing one or more keypoint features of a person's head; and

[0248] One or more manufacturing machines are caused to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0249] In an example, causing one or more manufacturing machines to produce the lattice structure of the patient interface component includes controlling the one or more manufacturing machines to produce the lattice structure of the patient interface component.

[0250] One aspect of one form of the present technology is a system for producing a lattice structure of a customized patient interface assembly, the system comprising:

[0251] one or more processors for receiving a set of manufacturing specifications for producing the mesh structure of the patient interface assembly, wherein the set of manufacturing specifications is determined based on one or more key point feature locations identified from data representing one or more key point features of a person's head; and

[0252] At least one manufacturing machine configured to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0253] An aspect of one form of the present technology is a processor-implemented method for producing a mesh structure of a patient interface assembly, the method comprising:

[0254] obtaining information representing one or more key feature locations of a person's head based on data received from the device using the communication circuit;

[0255] using at least one processor, determining a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0256] One or more manufacturing machines are caused to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0257] One aspect of one form of the present technology is a system for producing a lattice structure of a patient interface assembly, the system comprising:

[0258] One or more processors, the one or more processors are used to obtain information representing one or more key point feature positions of a person's head;

[0259] The one or more processors are further configured to determine a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0260] The one or more processors are further configured to produce the lattice structure of the patient interface assembly based on the set of manufacturing specifications.

[0261] One aspect of one form of the present technology is an apparatus for producing a lattice structure of a patient interface assembly, the apparatus comprising:

[0262] A component for obtaining information representing the location of one or more key point features of a person's head;

[0263] means for determining a set of manufacturing specifications for producing the mesh structure of the patient interface assembly based on the one or more keypoint feature locations; and

[0264] Components of the lattice structure for producing the patient interface assembly based on the set of manufacturing specifications.

[0265] In an example, the patient interface assembly includes: (a) a cushion of a seal-forming structure for the patient interface.

[0266] Another form of the present technology includes a cushion for a patient interface produced by any of the above-described methods and / or systems.

[0267] Another form of the present technology includes a cushion for a patient interface, the cushion comprising a mesh structure formed by 3D printing based on instructions generated based on identification of facial landmarks and / or distances between said landmarks.

[0268] The described methods, systems, devices, and apparatus may be implemented to improve the comfort, cost, efficacy, ease of use, and manufacturability of customized patient interfaces and / or components thereof.

[0269] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor (such as a processor of a special purpose computer) for: identifying key point features and / or their locations; identifying relationships between the key point features; determining functional requirements (e.g., for a patient interface and / or one or more of its components); determining manufacturing specifications; and / or producing or generating manufacturing machine programmable instructions. In addition, the described methods, systems, devices, and apparatus may provide improvements in the technical field of automatically generating machine programming instructions for producing customized patient interfaces and / or components thereof. In addition, the described methods, systems, devices, and apparatus provide increased flexibility in producing customized patient interfaces and / or components thereof that will properly fit the user and provide the most comfortable and / or faster production of customized patient interfaces and / or components thereof. Examples of the present technology provide customized patient interfaces and / or components thereof more quickly (e.g., from the time they are requested) and / or with a level of accuracy that conventional methods are unable to provide at least because it is impossible for patients, clinicians, and / or manufacturers to accurately consider and implement all of the factors to be considered in providing customized patient interfaces and / or components thereof with accuracy, improved comfort, and / or without expending significant cost and / or time.

[0270] 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 and vision, or by a person with limited experience in using medical devices of this type.

[0271] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., within the person's home).

[0272] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment.

[0273] The described methods, systems, devices, and apparatus may 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 may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0274] Of course, parts of these aspects may form sub-aspects of the present technology. In addition, each sub-aspect and / or aspect in the sub-aspect and / or aspect may be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.

[0275] Other features of the present technology will become apparent by considering the information contained in the following Detailed Description, Abstract, Drawings, and Claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0276] 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 similar elements, including:

[0277] 4.1 Respiratory therapy system

[0278] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. Also shown is a bed partner 1100. The patient is sleeping in a supine sleeping position.

[0279] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000.

[0280] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying sleeping position.

[0281] 4.2 Respiratory system and facial anatomy

[0282] 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.

[0283] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, lateral 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.

[0284] Figure 2C is a front view of a face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial groove, and lip corner point. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0285] Figure 2D is a side view of the head with several surface anatomical features identified, including the glabella, nasal bridge, nasal prominence, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge point, supraauricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also indicated.

[0286] 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.

[0287] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermilion of the upper lip, nostrils, subnasal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0288] Figure 2G A side view showing the surface features of the nose.

[0289] 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.

[0290] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, particularly showing the medial crus of the septal cartilage and the greater alar cartilage.

[0291] Figure 2J A frontal view of the skull including the frontal, nasal and zygomatic bones is shown. The nasal turbinates are also indicated, as well as the maxilla and mandible.

[0292] Figure 2K A lateral view of the skull is shown with the outline of the surface of the head and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0293] Figure 2L An anterolateral view of the nose is shown.

[0294] 4.3 Patient Interface

[0295] Figure 3A A patient interface in the form of a nasal mask in accordance with one form of the present technology is shown.

[0296] 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 when Figure 3C The curvature magnitude shown has a relatively large magnitude in comparison.

[0297] 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 when Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0298] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0299] 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 of relatively small magnitude in comparison.

[0300] 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 has a relatively large magnitude in comparison.

[0301] 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.

[0302] Figure 3H A cushion for a 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 A and B is indicated. Two saddle regions and one dome region are indicated.

[0303] Fig. 3I A surface is shown having a structure with a one-dimensional hole in the surface. The illustrated plane curve forms the boundary of the one-dimensional hole.

[0304] Figure 3J Shown through Fig. 3I The illustrated surface defines Fig. 3I Two-dimensional holes in the structure.

[0305] Figure 3K Shows Fig. 3I A perspective view of a structure including two-dimensional holes and one-dimensional holes is also shown. Fig. 3I The surface of the two-dimensional holes in the structure.

[0306] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0307] 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 bladder. The inner surface defines a two-dimensional hole in the mask.

[0308] Figure 3N Shown through Figure 3L Another cross section of a mask. The inner surface is also indicated.

[0309] Fig.3O Exemplifies the left-hand rule.

[0310] Figure 3P The right-hand rule is illustrated.

[0311] Figure 3Q The left ear is shown, including the left ear helix.

[0312] Figure 3R The right ear is shown, including the right ear helix.

[0313] Figure 3S A right-hand helix is ​​shown.

[0314] 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.

[0315] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0316] Figure 3V Shows Figure 3U A view of the rear portion of the plenum chamber. The view is oriented normal to the median contact plane. Figure 3V The sagittal plane in the middle bisects the chamber into left-hand and right-hand sides.

[0317] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3201, which lies in the sagittal plane and contacts the liner of the plenum chamber at only two points on the sagittal plane, the upper point 3221 and the lower point 3230. Depending on the geometry of the liner in this area, the middle contact plane can be a section at the upper point and the lower point.

[0318] Figure 3X Shown in position for use on the face Figure 3U The inflatable chamber 3200. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the median 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 the figure, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3221 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0319] Figure 3Y A patient interface in the form of a nasal cannula is shown in accordance with one form of the present technology.

[0320] Figure 3Z A patient interface having a catheter tip cover in accordance with one form of the present technology is shown.

[0321] 4.4RPT device

[0322] Figure 4A One form of RPT device according to the present technology is shown.

[0323] 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.

[0324] 4.5 Humidifier

[0325] Figure 5A An isometric view of a humidifier according to one form of the present technology is shown.

[0326] Figure 5B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0327] 4.6 Respiratory waveform

[0328] Figure 6A shows a typical breathing waveform model of a person while sleeping.

[0329] 4.7 Patient Interfaces According to Additional Examples of the Present Technology

[0330] Figure 7 is a cross-sectional view of a cushion module of an example patient interface according to the present technology, the cushion module being in an in-use position.

[0331] Figure 7-1 is a detailed view of a portion of a cushion for a patient interface according to an example of the present technology.

[0332] Figure 7-2 yes Figure 7-1 Detail of a portion of a cushion when in use.

[0333] Fig. 8A is a cross-sectional view of a cushion module of a patient interface according to another example of the present technology.

[0334] Figure 8B yes Fig. 8A Detail of a portion of a patient interface.

[0335] Figure 8C is a cross-sectional view of a portion of a patient interface according to another example of the present technology.

[0336] Fig. 9 is a detailed view of a portion of a patient interface according to another example of the present technology.

[0337] Fig.10 is a cross-sectional view of a cushion module of a patient interface according to another example of the present technology, the cushion module being in an in-use position.

[0338] Fig.11 is a perspective view of a patient interface according to another example of the present technology.

[0339] Fig.12 is a cross-sectional view of a cushion module of a patient interface according to another example of the present technology.

[0340] Fig.13A is a rear view of a cushion module of a patient interface according to another example of the present technology.

[0341] Fig. 13B yes Fig.13A A rear lower perspective view of a pad module.

[0342] Fig.14A is a rear upper perspective view of a cushion module of a patient interface according to another example of the present technology.

[0343] Fig. 14B yes Fig.14AFront view of the gasket module.

[0344] Fig. 14C yes Fig.14A The pad module is Fig. 14B Cross-sectional view at identified segment 14C-14C.

[0345] Fig.15A is a detailed view of a portion of a cushion for a patient interface according to another example of the present technology.

[0346] Fig. 15B is a schematic diagram of a portion of a cushion for a patient interface according to another example of the present technology.

[0347] Fig.16 is a detailed view of a portion of a cushion for a patient interface according to another example of the present technology.

[0348] Fig.17 is a detailed view of a portion of a cushion for a patient interface according to another example of the present technology.

[0349] Fig.18 is a schematic diagram of a cushion for a patient interface according to another example of the present technology.

[0350] Fig.19A is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0351] Fig.19B The pad according to the example of the present technology is subjected to Fig.19A The load shown is a graph of force / contact pressure applied on the user's face.

[0352] Fig.19C is a schematic diagram of a portion of a cushion for a patient interface according to another example of the present technology.

[0353] Fig. 20A is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0354] Fig. 20B The pad according to the example of the present technology is subjected to Fig. 20A The load shown is a graph of force / contact pressure applied on the user's face.

[0355] Fig.21A is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0356] Fig.21B The pad according to the example of the present technology is subjected to Fig.21AThe load shown is a graph of force / contact pressure applied on the user's face.

[0357] Fig.22A is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0358] Fig. 22B yes Fig.22A The pad should be subjected to Fig.22A The load shown is a graph of force / contact pressure applied on the user's face.

[0359] Fig. 22C is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0360] Fig.22D is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0361] Fig.22E is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0362] Fig.22F is a schematic diagram of a cushion of a patient interface according to another example of the present technology, which cushion contacts the user's face and bears a load.

[0363] Figure 22G is a schematic diagram of a pad according to another example of the present technology, the pad having a pad body including a grid structure.

[0364] Fig.22H is a schematic diagram of a pad according to another example of the present technology, the pad having a pad body including a grid structure.

[0365] Fig.22I is a schematic diagram of a pad according to another example of the present technology, the pad having a pad body including a grid structure.

[0366] Fig.22J is a schematic diagram of a pad according to another example of the present technology, the pad having a pad body including a grid structure.

[0367] FIG. 23A to FIG. 23F is a detailed view of a pad according to an example of the present technology.

[0368] 4.8 Automatic size determination

[0369] Fig.24 is an illustration of an example system for automatically determining a facial interface size, the system including a computing device.

[0370] Fig.25 is used for Fig.24 A block diagram of an example architecture of a computing device of a system including example components suitable for implementing methods of the present technology.

[0371] Fig.26A is a flow chart of a pre-capture phase method of an example version of the present technology.

[0372] Fig.26B is a flow chart of the capture phase method of some versions of the present technology.

[0373] Fig.26C is a flow chart of the post-capture image processing stage methods of some versions of the present technology.

[0374] Fig.26D is a flow chart of the comparison and output phase methods of some versions of exemplary method embodiments of the present technology.

[0375] Fig. 27 A schematic diagram of a system 100 according to another example of the present technology is shown.

[0376] FIG. 28A to FIG. 28F A flowchart of a method 7000 and aspects thereof according to another example of the present technology is shown.

[0377] Fig.29 A side view of a user's head is shown with multiple distances associated with method 7000 identified.

[0378] Fig. 30A and Fig. 30B Depicted are patient facial expressions that may be captured as part of method 7000. DETAILED DESCRIPTION

[0379] 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 vary. 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.

[0380] 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 of the examples, any single feature or combination of features may constitute another example.

[0381] 5.1 Therapy

[0382] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an entrance to the airway of a patient 1000 .

[0383] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

[0384] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0385] 5.2 Respiratory therapy system

[0386] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800 .

[0387] 5.3 Patient Interface

[0388] According to one aspect of the present technology, such as Figure 3A The non-invasive patient interface 3000 shown 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. 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 so as to maintain a positive pressure at the entrance of the patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for implementing positive pressure therapy.

[0389] like Figure 3Z As shown, a non-invasive patient interface 3000 according to another 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, and a connector for connecting to an air circuit (such as Figures 1A to 1C The air circuit 4170 shown in FIG. 4 is a form of connection port 3600. The plenum 3200 may be formed from one or more modular components, in the sense that it or they may be replaced with different components (e.g., components of different sizes).

[0390] 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.

[0391] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0392] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0393] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH20 relative to ambient.

[0394] 5.3.1 Sealing structure

[0395] The patient interface 3000 may include a seal-forming structure 3100. The seal-forming structure 3100 may be constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. In addition, the seal-forming structure 3100 may have holes therein so that, in use, a flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nares. The seal-forming structure 3100 may be constructed and arranged to, in use, maintain a therapeutic pressure in the plenum 3200 throughout the patient's breathing cycle.

[0396] 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 a seal may occur. The area where a seal actually occurs (the actual sealing surface) may vary over time and from patient to patient within a given course of treatment, depending on a number 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.

[0397] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0398] In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material (e.g., silicone rubber). In other forms, the seal-forming structure 3100 includes a foam base pad 3110 and a textile membrane portion 3220, as further described below.

[0399] A seal-forming structure 3100 in accordance with the present technology may be comprised of a soft, flexible, elastic material such as silicone.

[0400] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 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 for small-sized heads, and another form of the seal-forming structure that is suitable for small-sized heads but not for large-sized heads. However, examples of the present technology may be suitable for a wide range of heads, and therefore may be used by patients with relatively large heads and relatively small heads.

[0401] 5.3.1.1 Sealing mechanism

[0402] In one form, the seal forming structure comprises a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on the underside of the sealing flange within the interior of the plenum 3200 to urge it into tight sealing engagement with the face. The pressure assist mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0403] 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 less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that 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 over at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange in use to prevent it from bending.

[0404] 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 due to elastic tension in the positioning and stabilizing structure.

[0405] In one form, the seal-forming structure comprises a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent region of the sealing flange.

[0406] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0407] 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.

[0408] 5.3.1.2 Nose bridge or nasal ridge area

[0409] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over a nasal bridge region or nasal ridge region of the patient's face.

[0410] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of a patient's face in use.

[0411] 5.3.1.3 Upper lip area

[0412] 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.

[0413] 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.

[0414] 5.3.1.4 Chin area

[0415] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin region of the patient's face.

[0416] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal over a chin region of a patient's face in use.

[0417] 5.3.1.5 Forehead area

[0418] 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.

[0419] 5.3.1.6 Nasal pillows

[0420] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each nasal puff or pillow constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0421] 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 underside of a patient's nose; a stem; and a flexible region located on the underside 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 base of the stem. These flexible regions can work together to facilitate a universal joint structure that accommodates displacement and angular relative movement of the frustoconical body and the structure to which the nasal pillows are connected. For example, the frustoconical body can be axially displaced toward the structure to which the stem is connected.

[0422] In one example of a nasal pillow, at least a portion of the frustoconical body of each nasal pillow can be shaped and sized to enter a corresponding nostril of the patient. In another example of a nasal pillow, the frustoconical body of each nasal pillow can be shaped and sized not to enter a corresponding nostril of the patient. Each nasal pillow can be configured to seal against a portion of the patient's nose that defines a corresponding nostril, including the patient's columella and a corresponding ala.

[0423] In some examples of nasal pillows, each nasal pillow can be stemless. The frustoconical body of each nasal pillow can be directly attached to a portion of the patient interface 3000 that defines the plenum chamber 3200.

[0424] 5.3.1.7 Nasal mask

[0425] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal against the upper lip region (e.g., the upper lip), against at least a portion of the patient's nose bridge or nasal ridge above the pronasal point, and against the patient's face on each outer side of the patient's nose (e.g., near the patient's nasolabial grooves). Figure 1B The patient interface 3000 shown has this type of seal-forming structure 3100. This patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be referred to as a "nasal cushion", and a patient interface 3000 having such a seal-forming structure 3100 may be identified as a "nasal mask".

[0426] 5.3.1.8 Full face mask

[0427] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), on the patient's bridge of the nose or on at least a portion of the nasal ridge at the nasal protuberance, and on the cheek area of ​​the patient's face. Figure 1C The patient interface 3000 shown is of this type. The patient interface 3000 can deliver a supply of air or breathable gas through a single orifice to the nostrils and mouth of the patient 1000. This type of seal-forming structure 3100 can be referred to as a "full face cushion" and the patient interface 3000 can be referred to as a "full face mask."

[0428] 5.3.1.9 Ultra-compact full-face mask

[0429] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal on the patient's face over the patient's chin region (which may include the patient's lower lip and / or the area just below the lower lip), over the lower and / or front surfaces of the patient's nasal prominence, and over each outer side of the patient's nose (e.g., near the nasolabial groove). The seal-forming structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nostrils and the patient's mouth, may have an oral aperture configured to provide air or breathable gas to the mouth and nasal apertures configured to provide air or breathable gas to the nostrils, or may have an oral aperture for delivering air to the patient's mouth and two nasal apertures for delivering air to the respective nostrils. This type of patient interface 3000 may be referred to as an ultra-compact full-face mask and may include an ultra-compact full-face cushion.

[0430] 5.3.1.10 Nose support mask

[0431] In one form, for example Figure 3Z As shown, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose around the nostrils in use. The seal-forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including the lower surface and / or the front surface to the patient's nasal prominence and to the patient's nasal wings. The seal-forming structure 3100 can form a seal against the patient's upper lips. This type of seal-forming structure 3100 may be referred to as, for example, a "cradle cushion", "nose cushion", or "nose floor cushion".

[0432] The shape of the seal-forming structure 3100 may be configured to match or fit closely to the underside of the patient's nose and may not contact the bridge area of ​​the patient's nose or any portion of the patient's nose above the nasal prominence. In one form of the nasal pad, the seal-forming structure 3100 includes a bridge portion that divides the opening into two orifices, each of which supplies air or breathable gas to a corresponding one of the patient's nostrils in use. The bridge portion may be configured to contact or seal the patient's columella in use. Alternatively, the seal-forming structure 3100 may include a single opening to provide air flow or breathable gas to both nostrils of the patient.

[0433] 5.3.2 Inflatable chamber

[0434] The plenum chamber 3200 may be formed by a portion of the patient interface 3000 having a perimeter shaped to complement the surface contour of an average human face in the area where a seal will be formed in use. In use, the edge of the portion of the patient interface 3000 forming the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the portion of the patient interface 3000 forming the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0435] 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 for the wearer, which can improve compliance with therapy.

[0436] In some forms of the present technology, the plenum chamber 3200 is formed of one or more components of a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0437] In some forms of the present technology, the plenum chamber 3200 is formed from one or more components of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0438] 5.3.3 Positioning and stabilizing the structure

[0439] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position in use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may comprise and function as a "headgear" in that it engages the patient's head to maintain the patient interface 3000 in a sealed position.

[0440] In one form, the positioning and stabilising structure 3300 provides a retaining force at least sufficient to overcome the effect of the positive pressure in the plenum 3200 to lift off the face.

[0441] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0442] 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.

[0443] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with the manner in which it is worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0444] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed 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.

[0445] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be not too large and bulky to prevent a patient from being in a side sleeping position with the side region of the patient's head lying on a pillow.

[0446] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or floppy band. The decoupling portion is constructed and arranged such that when the patient rests their head on the pillow, the presence of the decoupling portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0447] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt comprised of a laminate of a fabric patient contacting 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 comprises a loop material to engage with a hook material portion.

[0448] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be in tension during use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.

[0449] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that in use at least a portion of a lower edge of the first strap passes above the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0450] In one form of the present technology suitable for use with a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that in use at least a portion of an upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0451] In one form of the present technology suitable for use with a nasal-only mask or a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to move away from each other.

[0452] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a bendable and, for example, non-rigid belt. An advantage of this aspect is that the belt is more comfortable for the patient lying on it when the patient is sleeping.

[0453] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a band configured to be breathable to allow moisture to transfer through the band.

[0454] 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 being 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, and another form of the positioning and stabilizing structure that is suitable for small-sized heads but not for large-sized heads.

[0455] 5.3.3.1 Catheter head cover

[0456] 5.3.3.1.1 Catheter head sleeve

[0457] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head cuffs 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the plenum chamber 3200 and the seal-forming structure 3100. Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface at a location other than the front of the patient's face, such as at the top of the patient's head.

[0458] Because air can be contained and passed through the head cuff to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It will be appreciated that an inflatable positioning and stabilizing structure 3300 does not require that all components of the positioning and stabilizing structure 3300 be inflatable. For example, in Figure 3Z In the example shown, the positioning and stabilizing structure 3300 includes an inflatable tube 3350 and a non-inflatable belt portion 3310 .

[0459] exist Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 is positioned on a different side of the patient's head in use, and extends across a corresponding cheek area above the corresponding ear (above the supra-auricular base on the patient's head) to a curved tube 3612 on the top of the patient's head 1000. This form of technology may be advantageous because if the patient sleeps with their head on their side and one of the tubes is compressed to block or partially block the flow of gas along the tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the present technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek area), and the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another area) to help secure the patient interface 3000 on the patient's head.

[0460] exist Figure 3Z In the form of the present technology shown, two tubes 3350 are fluidly connected to each other and to a connection port 3600 at the upper end. In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but connected in use and can be disconnected, such as for cleaning or storage. In the case of using separate tubes, they can be connected together indirectly, for example, each can be connected to a T-shaped connector having two arms / branches and a third arm or opening, each arm / branch being fluidly connected to a corresponding one of the tubes 3350, the third arm or opening providing a connection port 3600 for fluid connection to the air circuit 4170 in use.

[0461] The tube 3350 may be formed of a flexible material, such as an elastomer, for example, silicone or TPE, or one or more textile and / or foam materials. The tube 3350 may have a preformed shape and be able to bend or move into another shape when a force is applied, but may return to the original preformed shape when the force is absent. The shape of the tube 3350 may be generally arcuate or curved, with a shape that approximates the contour of the patient's head between the top of the head and the nose or mouth area.

[0462] As described in U.S. Pat. No. 6,044,844, which is incorporated herein, the tubes 3350 can be crush resistant to avoid obstruction of the flow of breathable gas through the tubes if either tube is crushed during use, such as if it is squeezed between the patient's head and nasal pillows. In all cases, crush resistant tubes may not be necessary, as the pressurized gas in the tubes can act as a splint to prevent or at least limit the crushing of the tubes 3350 during use. Compression resistant tubes may be advantageous in situations where only a single tube 3350 is present, as if the single tube becomes blocked during use, the flow of gas will be restricted and the efficacy of the therapy will cease or be reduced. In some examples, the dimensions of the tubes 3350 can be designed so that in the event that one of the tubes 3350 is blocked, each tube 3350 is able to provide sufficient gas flow to the plenum chamber 3200 on its own.

[0463] Each tube 3350 can be configured to receive air flow from a connection port 3600 located on the top of the patient's head and deliver the air flow to a seal-forming structure 3100 located at the entrance of the patient's airway. Figure 3Z In the example shown, each tube 3350 is located on a path extending from the plenum chamber 3200 across the cheek area of ​​the patient and reaching the curved tube 3612 above the patient's ear during use. For example, the portion of each tube 3350 near the plenum chamber 3200 can cover the maxillary area of ​​the patient's head during use. Another portion of each tube 3350 can cover an area of ​​the patient's head that is higher than the supra-auricular base point of the patient's head. Each tube 3350 can also be located on the patient's sphenoid and / or temporal bones and one or both of the patient's frontal and parietal bones. The curved tube 3612 can be located on the patient's parietal bone, on the frontal bone, and / or on the junction between them (e.g., the coronal suture) during use.

[0464] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient's head, such that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some examples, the headcuff 3350 is configured to allow an upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to a lower portion of the patient interface 3000 (e.g., the plenum 3200). That is, the connection port 3600 can be at least partially decoupled from the plenum 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0465] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is generally positioned under the nose and seals to a lower periphery of the nose (e.g., a nasal floor cushion). The positioning and stabilizing structure 3300, including the tube 3350, can be constructed and arranged to draw the seal-forming structure 3100 into the patient's face under the nose with a sealing force vector in a posterior and superior direction (e.g., a posterior-superior direction). The sealing force vector having a posterior-superior lateral direction can promote the seal-forming structure 3100 to form a good seal against both the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face on either side of the patient's nose and above the patient's lips.

[0466] 5.3.3.1.2 Extendable and non-extendable pipe sections

[0467] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments, such as formed from an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall having an extendable accordion-like structure. Figure 3Z The illustrated patient interface 3000 comprises a tube 3350 , an upper portion of which comprises extendable tube segments, each of which is in the form of an extendable accordion-like structure 3362 .

[0468] The cross-sectional shape of the non-extensible tube segment 3363 of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example as described in U.S. Patent No. 6,044,844. A cross-sectional shape presenting a flat surface of the tube on the side facing and contacting other parts of the patient's face or head can be more comfortable to wear than, for example, a tube having a circular cross-section.

[0469] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 from a low angle. The headcuff tube 3350 may extend downward along the side of the patient's head and then bend forward and medially to connect to the plenum chamber 3200 in front of the patient's face. Before connecting to the plenum chamber 3200, the tube 3350 may extend to the same vertical position as the connection with the plenum chamber 3200, or in some examples, at a position below it. That is, the tube 3350 may protrude in an at least partially upward direction before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the cushion module 3150 and / or the seal-forming structure 3100. The tube 3350 is located at a low position in front of the patient's face, promoting contact with the patient's face below the patient's cheekbones, which may be more comfortable than contacting the patient's cheekbones and may avoid excessive blurring of the patient's peripheral vision.

[0470] 5.3.3.1.3 Catheter head cover connection port

[0471] In some forms of the present technology, the patient interface 3000 may include a connection port 3600 located near an upper portion, an outer portion, or a rear portion of the patient's head. Figure 3Z In the illustrated form of the present technology, the connection port 3600 is located on the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3612 that forms the connection port 3600. The elbow 3612 can be configured to be fluidly connected to the conduit of the air circuit 4170. The elbow 3612 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially decouple the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3612 can be configured to rotate by rotating around a substantially vertical axis, and in some specific examples, by rotating around two or more axes. In some examples, the elbow may include a tube 3350 or be connected to the tube by a ball joint. The connection port 3600 can be located in the sagittal plane of the patient's head during use.

[0472] A patient interface having a connection port that is not positioned in front of the patient's face may be advantageous because some patients may find the conduit connected to the patient interface in front of their face unsightly and / or unobtrusive. For example, a conduit connected to the patient interface in front of the patient's face may be prone to interfering with bedding or sheets, particularly if the conduit extends downward from the patient interface during use. A form of the present technology including a patient interface having a connection port positioned above the patient's head during use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side sleeping position, a supine position (e.g., on its back, with the overall face facing upward) or in a prone position (e.g., on its front, with the overall face facing downward). In addition, connecting the conduit to the front of the patient interface may exacerbate a problem known as tube resistance, in which the conduit applies an undesirable force on the patient interface during movement of the patient's head or conduit, resulting in displacement away from the face. Tube resistance may be a smaller problem when the force received at the upper position of the patient's head is greater than the force received in front of the patient's face close to the seal-forming structure (wherein tube resistance may be more likely to destroy the seal).

[0473] 5.3.3.1.4 Head-sleeve fluid connection

[0474] The two tubes 3350 are fluidly connected to the inflatable chamber 3200 at their lower ends. In some forms of the present technology, the connection between the tubes 3350 and the inflatable chamber 3200 is achieved by the connection of two rigid connectors. The tubes 3350 and the inflatable chamber 3200 can be configured so that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the inflatable chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a "secure click" or similar sound, which is easy to use for the patient because the patient can know that each tube 3350 has been correctly connected to the inflatable chamber 3200. In one form, the tubes 3350 are formed of silicone or a textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature that is configured to connect to a convex mating feature on the inflatable chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum 3200. In other examples, the tubes 3350 may each include a male or female connector formed from a flexible material such as silicone or TPE, e.g., the tubes 3350 are formed from the same material.

[0475] In other examples, a compression seal is used to connect each tube 3350 to the plenum 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard joint between the tube 3350 and the plenum 3200, each tube 3350 and / or the plenum 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may be pushed against the junction between the tube and the circumferential surface around the port or connector of the plenum 3200 to form or enhance the seal between the tube 3350 and the plenum 3200.

[0476] 5.3.3.1.5 Catheter headband

[0477] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap in addition to the tube 3350, the at least one headgear strap being used to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. Figure 3Z As shown, the patient interface 3000 includes a strap portion 3310 that forms part of the positioning and stabilizing structure 3300. For example, the strap portion 3310 may be referred to as a back strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 with full face padding according to examples of the present technology may have a second lower strap that is configured to rest against the patient's head proximal to the patient's neck and / or against the rear surface of the patient's neck.

[0478] exist Figure 3Z In the example shown, the strap portion 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350 that are positioned on each side of the patient's head and around the back of the patient's head, such as covering the occipital bone of the patient's head or located below the occipital bone of the patient's head in use. The strap portion 3310 is connected to each tube above the patient's ears. Figure 3Z , the positioning and stabilizing structure 3300 includes a pair of tabs 3355. In use, the strap portion 3310 can be connected between the tabs 3355. Even when in a tensioned state in use, the strap portion 3310 can be flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head.

[0479] 5.3.4 Ventilation

[0480] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases (eg, carbon dioxide).

[0481] In some forms, the vent 3400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to the environment. The vent 3400 is configured so that the vent flow is of a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0482] 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.

[0483] 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.

[0484] In some forms, the patient interface 3000 may include a vent 3400 to allow gases exhaled by the patient to flow continuously from the interior of the plenum 3200 to the environment throughout the patient's breathing cycle, for example, and the vent 3400 is sized and shaped to maintain a therapeutic pressure in the plenum during use.

[0485] 5.3.5 Decoupling Structure

[0486] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0487] 5.3.6 Connection Port

[0488] The connection port 3600 allows connection to the air circuit 4170 .

[0489] 5.3.7 Forehead support

[0490] In one form, the patient interface 3000 includes a forehead support. In some examples, the forehead support may be part of the frame 3700 or connected to the frame.

[0491] 5.3.8 Anti-suffocation valve

[0492] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0493] In some examples, the AAV is disposed at the connection port 3600 of the patient interface 3000 or at the connection between the plenum chamber 3200 and the short tube 3610 , such as an inlet port connector.

[0494] 5.3.9 Ports

[0495] 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.

[0496] 5.3.10 Pad module and its parts

[0497] In some examples of the present technology, the patient interface 3000 includes a cushion module 3150. The cushion module 3150 can be formed from components that form the plenum chamber 3200, the seal-forming structure 3100, and, in some examples, additional components or portions.

[0498] Figure 7 A cushion module 3150 is shown in contact with the patient's face. In this example, the cushion module 3150 includes a chassis portion 3210 that partially forms a plenum chamber 3200. In this example, the seal-forming structure 3100 also partially forms the plenum chamber 3200. The chassis portion 3210 and the seal-forming structure 3100 together form the plenum chamber 3200 by enclosing a volumetric space (e.g., a breathing cavity) that can be filled with air at a therapeutic pressure (such as at least 4 cmH2O or at least 6 cmH2O above ambient air pressure).

[0499] The cushion module 3150 may be formed with other components such as a frame and a positioning and stabilizing structure 3300. Figure 3A Patient interface 3000 is shown. Figure 7 The cushion module 3150 in the embodiment of the present invention can be separated from the other components of the patient interface 3000. More generally, in some examples of the present technology, the patient interface 3000 includes a removable cushion module 3150.

[0500] In some examples, the cushion module 3150 may be replaced in the patient interface 3000 with another cushion module 3150, such as a cushion module having a different size (or at least having a seal-forming structure 3100 having a different size or shape).

[0501] In other examples, the cushion module 3150 may not be separate from other components or portions of the patient interface 3000, such as the positioning and stabilizing structure 3300. In some examples, the cushion module 3150 may include a chassis portion 3210, at least a portion of which is integrally formed with one or both of the head cuffs 3350, or with a portion of the positioning and stabilizing structure. Unless the context clearly requires otherwise, the features of the patient interface 3000 disclosed herein should be understood to apply regardless of whether the patient interface has a chassis portion 3210 that is part of a removable cushion module 3150.

[0502] Plenum chamber 3200 may include one or more plenum chamber inlet ports 3240 sized and configured to receive a flow of air at a therapeutic pressure for patient breathing.

[0503] exist Figure 7 In the example shown, the plenum chamber 3200 includes a plenum chamber inlet port 3240. In particular, the bottom plate portion 3210 defines an opening configured to connect to a fluid connector (e.g., such as Figure 3A The air circuit 4170 can be connected to the fluid connector by means of an elbow or the like as shown. The opening forms the plenum inlet port 3240.

[0504] As will be described in detail, a cushion module 3150 of a patient interface 3000 according to examples of the present technology may also include a cushion 3130. It should be understood that while in some examples of the present technology, a cushion 3130 may only form a small portion of an assembly, the assembly may still be identified as a cushion module 3150.

[0505] FIG. 8A to FIG. 8B , Fig.10 , Fig.12 , FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C An additional cushion module 3150 of a patient interface 3000 in accordance with the present technology is shown. Figures 7 to 10 and Fig.12 The cushion modules 3150 shown are pure nasal cushion modules 3150, leaving the patient's mouth uncovered. These cushion modules may include a single hole and may include a seal-forming structure 3100 that is configured to seal to the patient's nasal ridge and sides of the nose, the patient's cheeks, and the patient's upper lip. Fig.11 , FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14CThe cushion module 3150 shown is configured to seal around both the patient's nose and mouth. The cushion module 3150 that seals to the patient's nose and mouth may include an oral aperture 3271 through which a pressurized air flow may be provided to the patient's mouth and one or more nasal apertures 3272 through which a pressurized air flow may be provided to the patient's nasal airways. The cushion module 3150 may include a single nasal aperture 3272 (e.g., FIG. 13A to FIG. 13B ), or may include two nasal apertures 3272 configured to provide air flow to the corresponding nostrils at a positive pressure (e.g. FIG. 14A to FIG. 14C 31). The seal-forming structure 3100 may include a nose portion 3110 and a mouth portion 3120. The nose portion 3110 may be configured to seal around the nasal airway of a patient during use. The mouth portion 3120 may be configured to seal around the mouth of a patient during use.

[0506] 5.3.11 Connection to positioning and stabilizing structures

[0507] The patient interface 3000 may include a positioning and stabilizing structure 3300 to provide a force to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head. The positioning and stabilizing structure 3300 may include one or more straps configured to attach to respective sides of the plenum 3200 and wrap around the back of the patient's head.

[0508] As described above, in some examples, the chassis portion 3210 and the seal-forming structure 3100 may form a gasket module 3150 . Figures 7 to 10 and Fig.12 The liner modules 3150 are shown. These liner modules 3150 can be configured to be connected to the Figure 3A The positioning and stabilizing structure 3300 is shown. Figure 3A In the examples shown, the patient interface includes a frame 3700. The frame 3700 is configured to connect the positioning and stabilizing structure 3300 to the cushion module 3150. In these examples, the cushion module 3150 is removably attached to the frame 3700, but in other examples, the frame 3700 may be permanently attached to the cushion module 3150.

[0509] It should be understood that in some examples, the patient interface 3000 does not include a forehead support. For example, Figure 3A The forehead support of the frame 3700 shown may be replaced by a pair of upper arms 3311 (eg FIG. 13A to FIG. 13B As shown), each upper arm 3311 extends at least upwardly and laterally, so that the upper belt 3313 (similar to Fig.11 The upper strap 3313 shown can be connected to the upper arm 3311.

[0510] In some examples, the patient interface 3000 does not include the frame 3700 as a detachable component, and instead the cushion module 3150 may include a pair of upper arms 3311 (eg, FIG. 13A to FIG. 13B ). The upper arm 3311 may be connected to the upper strap 3313 (similar to Fig.11 The upper straps 3313 may be positioned above the supra-auricular base points of the patient's head during use and may each be passed between the corresponding eyes and ears of the patient's head.

[0511] like Fig.11 As shown, the positioning and stabilizing structure 3300 may also include a pair of lower straps 3317 configured to be connected to the frame of either the outer side of the cushion module 3150 or the patient interface 3000. The lower straps 3317 may be located below the subauricular base of the patient's head during use.

[0512] In other examples, the patient interface may include a positioning and stabilizing structure 3300, which includes a pair of gas delivery tubes 3350, which are configured to provide air flow to the inflatable chamber 3200 at a therapeutic pressure and are configured to provide a force to maintain the seal-forming structure 3100 in a sealed position. Figure 3Z An example of such a positioning and stabilizing structure 3300 is shown.

[0513] It should be understood that the cushion module 3150 and its components and portions may be implemented in a patient interface 3000 having any type of positioning and stabilizing structure 3300 .

[0514] 5.3.12 Sealing structure with gasket

[0515] Some forms of the present technology include a patient interface 3000 comprising a seal-forming structure 3000 including a cushion 3130. The cushion 3130 may be deformable and resilient, for example, to provide a cushioning function when engaged with the patient's face.

[0516] The pad 3130 may be at least partially formed from a mesh structure. Figures 7 to 14C The patient interface 3000 or cushion module 3150 shown has a cushion 3130 formed from a lattice structure.

[0517] In some forms of the present technology, the cushion 3130 is airtight and forms a seal directly against the surface of the patient's face. Fig. 9 Such an example is shown.

[0518] In other forms of the present technology, the cushion 3130 is at least partially covered by another portion of the seal-forming structure 3100 that seals to the patient's facial surface, while the cushion 3130 provides a cushioning function. Figure 7 , FIG. 8A to FIG. 8C and Figures 10 to 14C An example of such a patient interface 3000 is shown. In these examples, the seal-forming structure can include a face engaging membrane 3118. The face engaging membrane 3118 can be configured to contact the face and can be flexible and resilient.

[0519] In use, the facial engaging membrane 3118 may at least partially cover the cushion 3130. In some examples (such as Fig.12 and FIG. 14A to FIG. 14C In the example shown in FIG. 31 , when the seal-forming structure 3100 is not engaged with the patient's face, the facial engaging membrane 3118 may cover the cushion 3130 and be in contact with or very close to the cushion 3130. Figures 8A to 8C As shown, for example, in some embodiments, when the seal-forming structure 3100 is not engaged with the patient's face, at least a portion of the facial engaging membrane 3118 may be separated from the cushion 3130, but when the seal-forming structure is engaged with the patient's face, the facial engaging membrane may contact and at least partially cover the cushion 3130 during use, such as Figure 7 and Fig.10 shown.

[0520] In some examples (such as Figures 7 to 14C In the example shown in FIG. 3 , the patient interface includes a chassis portion 3210 that at least partially forms an inflatable chamber 3200. A seal-forming structure 3100 may be attached to and supported by the chassis portion 3210, and the chassis portion may be stiffer than the seal-forming structure 3100. For example, Figure 7 , FIG. 8A to FIG. 8C , Fig. 9 , Fig.10 and Fig.12 As shown in the cross-section in FIG, the chassis portion 3210 is significantly thicker than the facial engaging membrane 3118. Fig. 9 In some examples, the cushion 3130 is more flexible than the chassis portion 3210, so that in use, when the cushion 3130 is deformed in engagement with the patient's face, the chassis portion 3210 supports the cushion 3130. In these examples, the seal-forming structure 3100 (e.g., the face-engaging membrane 3118 and / or the cushion 3130, as the case may be) is attached to the periphery of the chassis portion 3210, and the chassis portion 3210 defines most of the volume of the inflatable chamber 3200.

[0521] like Figure 7 , FIG. 8A to FIG. 8C , Fig. 9 , Fig.10 and Fig.12As shown, by way of example, the face engaging membrane 3118 may extend from the chassis portion 3210. The face engaging membrane 3118 may be formed of an elastomeric material (e.g., such as silicone or TPE). In some examples, the chassis portion 3210 is also formed of an elastomeric material (such as silicone or TPE), and may be formed of the same elastomeric material as the face engaging membrane 3118. In some examples, the chassis portion 3210 and the face engaging membrane 3118 may be integrally formed, such as molded together in a single molding step / round by injection molding. In other examples, the face engaging membrane 3118 may be overmolded onto the face engaging membrane 3118. In other examples, the chassis portion 3210 may be formed of a material that is substantially rigid during normal use (such as polycarbonate or a similar material), and may have a thinner wall than the elastomeric chassis portion 3210, so that it may be identified as a shell. In further examples, the facial engaging membrane 3118 may be formed from a textile material (e.g., a textile material backed with an air-impermeable layer, which may be formed from silicone or TPU, for example).

[0522] In some examples, chassis portion 3210 may be formed of an elastomeric material and have a thickness of 2 mm or more, such as 3 mm, 3.5 mm, or 4 mm or more. In some examples, face engaging membrane 3118 may be formed of an elastomeric material and may have a thickness of 1.5 mm or less, such as 1 mm, 0.75 mm, 0.5 mm, or 0.3 mm or less. In some examples, face engaging membrane 3118 may have a thickness of 0.25 mm or 0.2 mm.

[0523] exist Figure 7 , FIG. 8A to FIG. 8C , Fig. 9 , Fig.10 and FIG. 13A to FIG. 13B as well as FIG. 14A to FIG. 14C In the example shown, the cushion 3130 is positioned inside the inflatable chamber 3200. The inflatable chamber 3200 located adjacent to the cushion 3130 is defined by the chassis portion 3210 and / or the face engaging membrane 3118. Advantageously, this means that the cushion 3130 does not need to be made airtight and can be formed from a mesh structure with open cells, which can provide different stiffness characteristics than a sealed mesh structure.

[0524] In another example, if Fig. 9As shown, the cushion 3130 is not completely positioned inside the inflatable chamber 3200, but partially defines the inflatable chamber 3200. In this example, there is no facial engagement membrane 3118. The cushion 3130 is connected to the chassis portion 3210 around the periphery of the inflatable chamber 3200. The cushion 3130 provides a cushioning function and also forms a seal to the patient's face. In this example, at least at the surface that defines the inflatable chamber 3200 and forms a seal to the patient's face, the cushion 3130 is airtight. The cushion 3130 can be formed by a grid structure, but can have an airtight outer layer. The airtight outer layer can be applied to the grid structure, for example, as a coating, or can be formed integrally with the grid structure, the coating being formed, for example, of an elastomeric material (such as silicone or TPE). Advantageously, the integrally formed airtight layer can be formed during the same process (such as 3D printing or injection molding) that forms the grid structure of the cushion 3130.

[0525] In another form, such as Fig.11 and Fig.12 In the example shown, the cushion 3130 is positioned outside of the plenum chamber 3200. That is, the cushion 3130 is located outside of the air flow path through the plenum chamber 3200. Advantageously, this arrangement can make the surfaces defining the plenum chamber 3200 easier to clean because the plenum chamber 3200 can be defined by uniform surfaces (such as the uniform surfaces of the chassis portion 3210 and the facial engaging membrane 3118). These uniform surfaces are also unobstructed by the cushion 3130. In addition, because the cushion 3130 is not in contact with the patient's exhaled breath and the associated moisture and any other fluids, the cushion can be less prone to becoming dirty. Fig.11 and Fig.12 In the example shown, the cushion 3130 is connected to the chassis portion 3210 and the face engaging membrane 3118 but is attached to their outer surfaces. Fig.12 As shown, for example, the face engaging membrane 3118 covers the patient-facing side, which in this example is the side of the cushion 3130 that faces the plenum 3200. In this example, the face engaging membrane 3118 is wrapped around the cushion 3130 to partially cover the cushion 3130 from the inside (e.g., from the plenum 3200 side). In these examples, the cushion 3130 can be positioned so that in use, the cushion can deform against the chassis portion 3210. Advantageously, the chassis portion 3210 is rigid and holds the cushion 3130 in place and provides a less deformable structure for the cushion 3130 to deform against.

[0526] In some examples, the pad 3130 includes one or more clips by which the pad is attached to the chassis portion. In other examples, the pad 3130 is bonded or welded to the chassis portion and / or the face engaging membrane 3118, or is attached in another suitable manner.

[0527] 5.3.12.1 Forming a gasket for a heat and moisture exchanger

[0528] As described above, in some examples, at least a portion of cushion 3130 is disposed within plenum 3200. Additionally, in some examples, at least some of the airflow flowing through plenum 3200 flows through the lattice structure forming cushion 3130. Figure 8C A cushion module 3150 is shown including a cushion 3130 in which an air flow delivered to a patient flows through the cushion 3130. Similar to other cushions 3130 disclosed herein, the cushion 3130 can be formed of a mesh structure. The mesh structure can be uncovered or include uncovered portions and is air permeable, thereby allowing air to flow from one side to the other.

[0529] In some examples, cushion 3130 may function primarily as cushion 3130, but depending on the nature of the shape and / or size of plenum 3200 and cushion 3130, cushion 3130 may be positioned within plenum 3200 such that air flows through the cushion within plenum 3200. Figure 8C In the example shown), the cushion 3130 also forms a heat and moisture exchanger (HMX). The HMX can be used to increase the temperature and / or humidity of the air flow before it is delivered to the patient. The cushion 3130 can absorb some of the heat and moisture from the gas exhaled by the patient into the plenum 3200. The cushion 3130 can then transfer the heat and moisture to the air flow before the patient inhales the air flow delivered to the plenum 3200. In some examples, the cushion 3130 can function as an HMX, can be formed of a mesh structure, and can also function as a cushion 3130 for a seal-forming structure 3100.

[0530] exist Figure 8C In the example shown, the liner 3130 at least partially covers the plenum inlet port 3240. This requires or at least facilitates the flow of incoming air through the liner 3130. Figure 8C The cushion module 3150 shown is intended for use with a patient interface 3000 (such as Figure 3A3240), but the vent 3400 of the patient interface 3000 may be disposed upstream of the plenum inlet port 3240, such as in a connector defining the connection port 3600. Thus, the patient's exhaled air must return through the plenum inlet port 3240 before reaching the vent 3400, transferring heat and moisture to the lattice structure forming the cushion 3130 on the way. In other examples, the vent 3400 may be formed by or disposed on one or more walls forming the plenum 3200, downstream of the plenum inlet port 3240 but upstream of the cushion 3130. That is, the vent 3400 may be disposed between the plenum inlet port 3240 and the cushion 3130. In such examples, some or all of the exhaled air may flow through the cushion 3130, but be discharged through the vent 3400 before being able to return through the plenum inlet port 3240.

[0531] exist Figure 8C In the example shown, the cushion 3130 fills a majority of the space in the plenum chamber 3200. The cushion 3130 can be configured to fill at least a majority of the dead space that exists once portions of the patient's nose are received within the interior of the cushion module 3150 in use. It should be understood that reference to the cushion 3130 filling the space within the plenum chamber 3200 refers to the overall size of the cushion, which is the overall volume defined by the peripheral surface of the cushion 3150, e.g., the volume of material actually occupied by the lattice structure plus the volume of the voids defined by the lattice structure.

[0532] In examples where the cushion 3130 fills at least a majority of the space of the plenum chamber 3200 and / or at least partially covers the plenum chamber inlet port 3240 (including examples where the cushion 3130 forms a HMX), the cushion 3130 may be provided with one or more holes, peripheral passages, or other open channels configured to allow free flow of air into and out of the patient's airway in the event that the lattice structure forming the cushion 3130 becomes inadvertently blocked (e.g., blocked by excess fluid, moisture, etc. due to unintended operating conditions, misuse, or any other reason). Despite such openings or passages, during normal operating conditions, the cushion 3130 may still function as a HMX to at least improve the temperature and / or humidity of air delivered to the patient's airway.

[0533] Although Figure 8C The cushion module 3150 shown is a nose cushion, but the cushion 3130 formed of a mesh structure and forming HMX can be provided in any suitable type of cushion module 3150, such as for a full face mask (e.g., Fig.11 The type of patient interface 3000 shown), ultra-compact full-face masks (e.g., FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14CThe type of patient interface 3000 shown), a nasal mask (e.g., Figure 3Z The patient interface 3000 may be configured as a patient interface 3000 of the type shown in the drawings, or any other suitable patient interface 3000 in which the cushion 3130 may be disposed, including a patient interface 3000 having nasal pillows.

[0534] The pad 3130 that also forms HMX may include a grid structure formed of a material and / or formed with a specific structure that promotes the absorption of heat and / or moisture from exhaled breath and the release of the heat and / or moisture into the air flow delivered to the patient's airway. In some examples, the grid structure is formed of a material that can absorb moisture. For example, the grid structure may be formed of a fiber material, paper, or a suitable foam, etc. In one form, the grid structure may be formed by injection molding or 3D printing pulp. In other examples, the physical structure of the grid structure (e.g., the shape and size of the cell, or the general shape and size of each part that forms an opportunistic / random grid) may promote moisture condensation onto the surface of the grid structure material and then evaporate from the surface. In some examples, the grid structure may be used as an HMX by absorbing moisture into the material that forms HMX and also by facilitating moisture condensation on the surface of the grid structure. In examples where the structure of the grid structure promotes condensation and evaporation to provide HMX functionality, the grid structure may be formed by any suitable material disclosed herein by any suitable process. In further examples, the mesh structure forming the liner 3130 may be impregnated with a hygroscopic material to form HMX.

[0535] The cushion 3130 may be removed from the patient interface 3000, for example, for cleaning or replacement. This is particularly useful for a cushion 3130 that also forms an HMX, as the cushion may need to be regularly cleaned or replaced more often than the cushion module 3150 or the patient interface 3000 needs to be replaced. It should also be understood that the cushion 3130 described herein that does not also form an HMX may be removable.

[0536] exist Figure 8C In some examples, the liner 3130 is formed of a mesh structure and also forms an HMX; in some examples, the mesh structure disclosed herein can be used to form an HMX that is not the liner 3130 but is used only or primarily as an HMX. For example, such a component may not engage the user's face during use.

[0537] 5.3.13 Grid structure

[0538] As stated above, the pad 3130 may be formed from a grid structure.

[0539] For example, Figure 8B , Figure 8C , Fig. 9 Figure 15 to Fig.18 and FIG. 23A to FIG. 23B As indicated, the pad 3130 may include a pad body 3131 formed of a grid structure. That is, the material forming the pad 3130 is constructed and arranged to form a grid. The grid structure may include a plurality of cells. When describing features or properties of the pad 3130, it should be understood that, unless the context requires otherwise, these features or properties may be features or properties of the pad body 3131, rather than features or properties of other portions of the pad 3130 (such as any pad clips or added layers). For example, even though the pad 3130 has a pad clip or outer layer that is not formed of a grid structure, if the pad body 3131 has a grid structure, the pad 3130 may be described as being formed of a grid structure.

[0540] In some examples, such as Figure 7-1 As shown, the grid structure can be formed by a plurality of interconnected struts 3166 forming a plurality of voids 3168. The structure of the struts 3166 can be repeated in two or three dimensions to form a plurality of cells forming a grid. In an example, each void can be considered to be an empty space defined by each cell. Such a grid structure may be advantageous in providing a relatively light, flexible and breathable structure. In an example, the pad 3130 may include 20 or more voids.

[0541] In use, such as Figure 7-2 As shown, the grid structure can provide flexibility to conform to facial features and / or accommodate anthropometric changes. When the patient interface is engaged with the patient's face, the struts 3166 can flex, thereby changing the size, shape and / or orientation of the voids to allow the cushion 3130 to conform to the patient's face. Additionally, as described later in this disclosure, the characteristics of the grid structure can vary in different portions of the grid to adjust the stiffness or flexibility of the cushion for different areas of the patient's face. For example, stiffness and flexibility can be adjusted by changing or varying the material of the struts, the thickness of the struts, the density of the struts, the orientation of the struts, the spacing of the struts, the size of the voids, the orientation of the voids, the density of the voids, the arrangement of the cells, and / or the density of the cells.

[0542] This lattice structure is different from foam materials, which usually use a blowing agent to form a cell / pore structure at a microscopic level. This lattice structure has a repeating macroscopic cellular structure built up by the material forming the struts.

[0543] In some examples of the present technology, the mesh structure can be 3D printed. In some specific examples, the mesh structure can be 3D printed in a shape corresponding to a unique patient's face, such as using any of the personalized or automatically determined sizing techniques described herein. In other examples, the mesh structure can be formed by another additive manufacturing technology or another manufacturing technology capable of producing a mesh structure, or can be formed by injection molding. In some examples, the mesh structure can be formed by knitting in a form similar to a spacer fabric. In some examples, the mesh structure can be woven. In an alternative example, the padding can resemble bubble wrap rather than a mesh structure.

[0544] In some examples, the mesh structure is formed of an elastomeric material. The mesh structure is formed of silicone or of TPE. In some examples, the mesh structure is formed of TPU. In an example, the mesh structure is formed of a material having a durometer hardness in the range of 20 Shore A to 80 Shore A. In other examples, depending on the geometry, the hardness may be in the range of 15 Shore A to 100 Shore A. For example, other ranges contemplated are 15 Shore A to 50 Shore A, 30 Shore A to 80 Shore A, 30 Shore A to 60 Shore A, 20 Shore A to 50 Shore A, and 20 Shore A to 40 Shore A. In one form, the hardness is 30 Shore A.

[0545] Various possible grid structures are contemplated. In some examples, the grid structure includes a two-dimensional structure (e.g., a honeycomb). In other examples, the grid structure includes a three-dimensional structure. In an example, the grid structure may include: a fluorite structure (in Fig.23A ), truncated cubic structure (in Fig. 23B ), composite bundle tube (IsoTruss) structure (in Fig.23C ), hexagonal honeycomb structure (in Fig.23D ), a gyroid structure (shown in Fig.23E ) or the Schwarz structure (shown in Fig.23F ). In some examples, the pad 3130 may be formed of another mesh structure. In some examples, the pad 3130 may be formed of multiple mesh structures.

[0546] In some examples of the present technology, the cushion 3130 is formed flat and is bent into a three-dimensional shape during assembly with the facial engaging membrane 3118. For example, in some forms, the cushion 3130 may be 3D printed in a flat configuration. The cushion 3130 may be flexible and capable of assuming a three-dimensional shape corresponding to a curvature along the length of the facial engaging membrane 3118. In other examples, the cushion 3130 may be formed in a three-dimensional shape. In some examples, the cushion 3130 may be 3D printed in a three-dimensional curved shape. As will be described, the cushion 3D printed in a three-dimensional curved shape may be customized.

[0547] In some other examples, the mesh structure can be knitted. In other examples, the mesh structure can be formed from a foam having holes formed therein to form the mesh structure. For example, the holes can be formed by laser cutting.

[0548] Fig.18 A foam cushion 3130 is schematically illustrated having a cushion body 3131 with a plurality of holes 3136 formed in the cushion body 3131. Forming the holes 3136 removes material from the cushion body 3131 to effectively form the cushion body into a grid structure (although in some examples, the cushion body 3131 may be formed (e.g., molded) with pre-existing holes, meaning that no material removal is required) or at least formed into a shape such that the cushion body 3131 behaves like a grid structure. In some examples, the size, shape, and / or spacing of the holes 3136 varies along the length of the cushion 3130 and / or between a first side of the cushion 3130 and a second side of the cushion 3130. In some examples, the size, shape, and / or spacing of the holes 3136 may be selected, for example, based on facial data representing one or more features of the user's face to provide a cushion 3130 with one or more attributes tailored to a particular user.

[0549] The cushion 3130 formed by the grid structure may advantageously be able to be designed and produced with fine control over certain properties, at least compared to the uniform mass of foam in some examples. In examples of the present technology, the grid structure forming the cushion 3130 may be designed and produced with greater softness or compliance in specific areas of contact with the face where compliance is required more than other areas. The properties of the cushion 3130 formed by, for example, a uniform mass of foam may be more dependent on the overall cross-sectional shape and overall stiffness, making it more difficult to achieve fine control of the properties of a specific location, while in examples of the present technology, the properties of the grid structure may be changed at specific locations within the cushion 3130. In some examples, the grid structure may be configured to optimize contact pressure based on tissue elasticity and expected dynamic action. In some examples, the cushion 3130 may apply pressure for a static seal while the facial engagement membrane 3118 provides an inflatable dynamic seal.

[0550] Due to perceived cleanability issues, some patients may not like the idea of ​​using foam cushions in their patient interface 3000. In examples of the present technology, cushions 3130 formed from a mesh structure may be at least as comfortable as foam cushions, but may be more attractive to patients who do not like foam. In some examples, the mesh structure has open cells and is formed from a machine washable material. In some examples, the entire cushion module 3150 may be formed from a machine washable or sterilizable material (e.g., the facial engaging membrane 3118 is formed from silicone, the mesh structure is formed from TPU or silicone, the chassis portion 3210 is formed from silicone or polycarbonate, etc.), which means that the cushion module 3150 can be disconnected from the rest of the patient interface 3000 and easily cleaned or sterilized.

[0551] 5.3.13.1 Various attributes

[0552] In some forms of the present technology, the cushion 3130 may include one or more characteristics that vary between different locations where the seal-forming structure 3100 engages the patient's face. As an example, the one or more characteristics that vary may include the stiffness of the cushion 3130. That is, the cushion 3130 may be stiffer in a portion corresponding to one location on the patient's face than in a portion corresponding to another location on the patient's face. The one or more characteristics that vary may include characteristics of the lattice structure, such as any one or more of the shape, thickness, density, spacing, relative orientation, and / or material of the cells forming the lattice structure.

[0553] It should be understood that the manner in which the grid structure can be configured to provide a region with higher stiffness in one location compared to another location will depend on the specific grid structure. In some examples, the grid structure may include a beam grid structure, for example, a grid structure formed by a network of components that behave as beams or struts. In one such example, the pad 3130 may include a first region and a second region, the first region being stiffer due to the increased thickness and / or density of the struts. In another example, the pad 3130 may include a grid structure formed by bendable beams. There may be a large number of easily bendable beams in the first region, while there may be a small number of relatively inflexible beams in the second region, making the first region more compliant or less stiff than the second region. It should be understood that multiple parameters can be modified throughout the grid structure to provide different behaviors in different regions of the pad 3130. In some examples, more voids may be provided in regions of the grid structure with lower stiffness than in regions with higher stiffness.

[0554] Generally, where a pad 3130 is described herein as being more compliant or less stiff in one area than in another, or more stiff in one area than in another, the specific parameters / features of the lattice structure of the pad 3130 may be altered as desired to provide the desired difference in behavior between the areas.

[0555] In some examples, a grid structure may be provided having features that result in more complex behavior than just stiffness or flexibility. For example, in some forms of the present technology, the grid structure may be formed by struts, but some or all of the struts may be curved (C-shaped or other shapes). The curved struts may bend in a controlled manner. In other examples, some or all of the struts may be straight and may be configured to flex during use. For example, a strut may be used to resist loads directed along its length until the point at which the strut can flex. When flexed, the stiffness of the strut may be reduced, and the strut may allow further compression without excessive stiffness. Such an arrangement may provide a long "travel" (e.g., high fit) without applying excessive force between the user's face and the cushion 3130.

[0556] In some examples, the lattice structure can be configured to define voids that close (or move toward a more closed position) during compression of the cushion 3130. When substantially all of the voids in a region are closed, the cushion 3130 can be significantly reinforced because it may have no more capacity for compression. In some examples, the number, size, and shape of available voids can be selected to produce such reinforcement in certain areas where a greater amount of support may be desired.

[0557] 5.3.13.1.1 Changes of pure nasal mask

[0558] In some examples, the patient interface 3000 may include a seal-forming structure 3100 configured to seal to the patient's face at the top of the patient's lips, outside the patient's nose, and at the patient's nasal ridge. This type of patient interface 3000 may be referred to as a nasal mask, into which the tip of the patient's nose is inserted. Figures 7 to 10 and Fig.12 Examples of cushion modules 3150 suitable for use with nasal masks are shown. In these examples, the cushion 3130 is positioned around the entire periphery of the patient's nose in use, but in other examples, the cushion 3130 may be positioned only within a specific portion of the seal-forming structure 3100.

[0559] The cushion 3130 may include an upper lip portion disposed within a portion of the seal-forming structure 3100 that is configured to seal to the patient's face at the upper lip of the patient. In some examples, the cushion 3130 may include a nasal portion side disposed within a corresponding portion of the seal-forming structure 3100 that is configured to seal to the patient's face at each side of the patient's nose. In some examples, the cushion 3130 may have a higher stiffness at the nasal portion side than at the upper lip portion. In some additional examples, the cushion 3130 may include a nasal ridge portion disposed within a portion of the seal-forming structure 3100 that is configured to seal to the patient's face at the nasal ridge of the patient. In some examples, the cushion 3130 may have a higher stiffness at the nasal portion side than at the nasal ridge portion. The cushion 3130 may advantageously be less stiff at the nasal ridge than elsewhere, as the nasal ridge can be a sensitive area and is also a surface with a high curvature where a high level of compliance is required to avoid leaks.

[0560] In another form, the seal-forming structure 3100 is configured to seal to the patient's face at the upper portion of the patient's lips, between the nose wing and the nasolabial groove, and at the lower periphery of the patient's nose, the lower periphery of the patient's nose including the nose wing and the nasal protuberance area of ​​the patient's nose. This type of patient interface 3000 may be referred to as a nose support mask or a below-the-nose mask, etc. The seal-forming structure 3100 may be configured not to engage the patient's nasal ridge. In such a patient interface 3000, the seal-forming structure 3100 may include one or two nasal apertures 3272.

[0561] The seal-forming structure 3100 may include an upper lip portion disposed within a portion of the seal-forming structure 3100, the portion of which is configured to seal to the patient's face at the upper lip of the patient. The cushion 3130 may also include a pair of rear corner portions disposed within a portion of the seal-forming structure 3100, the portion of which is configured to seal to the patient's face between the nose wing and the nasolabial groove. The cushion 3130 may have a higher stiffness in the rear corner portions than in the upper lip portion. In some examples, the cushion 3130 may include a lower nasal peripheral portion disposed within a portion of the seal-forming structure, the portion of which is configured to seal to the patient's face at the lower periphery of the patient's nose. In some specific examples, the cushion 3130 has a higher stiffness in the rear corner portions than in the lower nasal peripheral portion.

[0562] 5.3.13.1.2 Changes in oronasal masks

[0563] In some examples, the patient interface 3000 may include a seal-forming structure 3100 configured to seal to the patient's face at the lower portion of the patient's lips, at the patient's cheeks, outside the patient's nose, and at the patient's nasal ridge. This type of patient interface 3000 may be referred to as a full face mask that seals around both the nose and mouth, into which the tip of the patient's nose is inserted. Fig.11 Such a patient interface 3000 is shown. The seal-forming structure 3100 in this example includes a single hole that is configured to provide air flow to both the patient's nose and mouth. In this example, the cushion 3130 is positioned around the entire periphery of the patient's nose and mouth in use, but in other examples, the cushion 3130 may be positioned only within a specific portion of the seal-forming structure 3100.

[0564] The cushion 3130 may include a lower lip portion disposed within a portion of the seal-forming structure 3100, the portion of which is configured to seal to the patient's face at the lower lip of the patient. In some forms, the cushion 3130 may include a pair of cheek portions disposed within a corresponding portion of the seal-forming structure 3100, the corresponding portion of which is configured to seal to the patient's face at the patient's cheeks. In some examples, the cushion 3130 may be stiffer in the cheek portions than in the lower lip portion. The cushion 3130 may include a nose portion side disposed within a corresponding portion of the seal-forming structure 3100, the corresponding portion of which is configured to seal to the patient's face outside the patient's nose. In some examples, the cushion 3130 includes a nasal ridge area disposed within a portion of the seal-forming structure 3100, the portion of which is configured to seal to the patient's face at the patient's nasal ridge. In some examples, the cushion 3130 may be stiffer on the side of the nose portion than on the nose ridge portion. The cushion 3130 may advantageously be less stiff at the nose ridge than at other portions because the nose ridge can be a sensitive area and is also a surface with a high curvature where a high level of compliance is needed to avoid leaks.

[0565] In some examples (such as FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C, the seal-forming structure 3100 is configured to seal to the patient's face at the lower portion of the patient's lips, at the patient's cheeks, at the upper portion of the patient's lips, and at the lower periphery of the patient's nose, the lower periphery of the patient's nose including the nasal wings and the nasal prominence area of ​​the patient's nose. This type of patient interface 3000 may be referred to as a compact full face mask, an ultra-compact full face mask, a minimal contact full face mask, or an under-the-nose full face mask, among others. The patient interface 3000 may be configured not to engage the nasal ridge. The seal-forming structure 3100 may include a pair of nasal apertures 3272, each of the pair of nasal apertures being configured to provide air flow to a corresponding one of the patient's nostrils (e.g., FIG. 14A to FIG. 14C ), or may include a single nasal aperture 3272 configured to provide air flow to both nostrils (e.g. FIG. 13A to FIG. 13B The seal-forming structure 3100 may also include a mouth hole to provide air flow to the patient's mouth, such as FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C In another example, the seal-forming structure 3100 may include a single hole to provide air flow to both the patient's nose and mouth. The cushion 3130 may be positioned around the entire periphery of the patient's nose and mouth, or may be positioned only in specific portions of the seal-forming structure 3100.

[0566] The cushion 3130 may include a lower lip portion disposed within a portion of the seal-forming structure 3100 that is configured to seal to the patient's face at the lower lip of the patient, such as FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C The cushion 3130 may include a cheek portion disposed within a corresponding portion of the seal-forming structure 3100 that is configured to seal to the patient's face at the patient's cheek, such as FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C In some specific examples, the cushion 3130 is stiffer in the cheek portion than in the lower lip portion. FIG. 14A to FIG. 14C As shown, the pad 3130 is only disposed within the lower lip portion and cheek portion of the seal forming structure 3100.

[0567] The cushion 3130 may also include an upper lip portion disposed within a portion of the seal-forming structure 3100, the portion of the seal-forming structure being configured to seal to the patient's face at the upper lip of the patient. In some examples, the cushion 3130 includes a lower nasal peripheral portion disposed within a portion of the seal-forming structure 3100, the portion of the seal-forming structure being configured to seal to the patient's face at the lower periphery of the patient's nose. In some examples, the cushion 3130 may also include a pair of rear corner portions disposed within a portion of the seal-forming structure 3100, the portion of the seal-forming structure being configured to seal to the patient's face between the nose wing and the nasolabial groove. The cushion 3130 may be stiffer in the upper lip portion and / or the rear corner portion than in the lower nasal peripheral portion. Advantageously, the cushion 3130 may have a lower stiffness at the lower nose periphery and / or under the lip than other areas because the lower nose periphery and / or under the lip may be sensitive areas and / or may have complex surface geometries requiring a high level of compliance. Fig.13A As shown, the cushion 3130 is disposed within the lower lip portion and cheek portion of the seal-forming structure 3100 and also extends into the upper lip portion of the seal-forming structure 3100 but intersects the sagittal plane during use.

[0568] 5.3.13.1.3 Changes between the patient-facing side and the non-patient-facing side

[0569] In addition or alternatively to varying between positions on the patient's face, in some examples, the grid structure includes one or more features that vary between a patient-facing side (also identified as a user-facing side) of the cushion 3130 and a non-patient-facing side (also identified as a non-user-facing side) of the cushion 3130, wherein the patient-facing side of the cushion corresponds to a side of the seal-forming structure 3100 that is configured to contact the patient's face during use, and the non-patient-facing side of the cushion corresponds to a side of the seal-forming structure 3100 that is configured to face away from the patient's face during use. FIG. 15A to FIG. 15B and Figures 16 to 18 A pad 3130 having this variation in the grid structure is schematically shown.

[0570] In some forms, the mesh structure of the patient-facing side of the cushion is constructed to be highly compliant, comfortable, and / or constructed and arranged to avoid leaving red marks on the patient's face. The mesh structure of the non-patient-facing side of the cushion can be constructed to easily adapt to the overall size and shape of the patient's face. Fig.15AAs shown by way of example, the grid structure includes gaps 3168 that are smaller on the patient-facing side than on the non-patient-facing side. Small gaps can result in a lower risk of leaving facial marks on the patient-facing side, while large gaps on the non-patient-facing side can allow the grid structure of the seal-forming structure 3100 to be easily adapted to different facial shapes and sizes (e.g., by having increased flexibility due to relatively large gaps). Facial marks may be considered unsightly and / or embarrassing, and may also be associated with discomfort during use. In some examples, the grid structure includes cells that are smaller on the patient-facing side than on the non-patient-facing side.

[0571] Fig. 15B Another example is schematically shown, in which a cushion 3130 includes a cushion body 3131 formed by a grid structure defining voids 3168. In this example, the voids 3168 are smaller on the patient-facing side than on the non-patient-facing side. The grid structure includes voids that gradually decrease in a direction from the non-patient-facing side to the patient-facing side. In this example, the density of the cushion 3130 gradually increases toward the patient-facing side, ultimately forming a uniform surface 3133 on the patient-facing side to provide a smooth and comfortable interface.

[0572] Variations in one or more features of the lattice structure can make the cushion 3130 more compliant or less stiff on the patient-facing side of the cushion than on the non-patient-facing side of the cushion. Such an arrangement can advantageously allow the patient-facing side to easily conform to complex geometries on the surface of the patient's face (e.g., to form a good seal), while on the non-patient-facing side, the cushion is able to resist compressive forces and adjust more to fit the overall shape and size of the patient's face.

[0573] like Fig.16 and Fig.17 By way of example, the material forming the cells of the lattice structure (e.g., struts 3166) may be thinner on the patient-facing side of the pad 3130 than on the non-patient-facing side of the pad 3130. In some examples, the material forming the cells of the lattice structure has a thickness in the range of 0.3 mm to 0.5 mm on the patient-facing side of the pad 3130. In a particular example, the material forming the cells of the lattice structure has a thickness in the range of 0.8 mm to 1.2 mm, such as approximately 1 mm on the non-patient-facing side of the pad 3130.

[0574] In some examples, such as Fig.16In the illustrated cushion 3130, the patient-facing side of the cushion 3130 (e.g., the cushion body 3131 of the cushion) is defined by the cells of the grid structure. The cells may be exposed to contact the facial engaging membrane 3118. The cushion 3130 in this example, or at least the patient-facing side thereof, may advantageously have a high degree of compliance. In this example, the cushion 3130 may include a uniform surface 3132 defining the non-patient-facing side of the cushion 3130. In other examples, the cushion 3130 may not include the uniform surface 3132 of the non-patient-facing side, but may instead expose the cells.

[0575] In other examples, such as Fig.17 In the illustrated cushion 3130, on the patient-facing side of the cushion 3130, the cushion 3130 includes a uniform surface 3133. The uniform surface may cover the cells of the grid structure. This may advantageously result in a lower risk of facial marking during use.

[0576] In some examples, the uniform surface 3132 and / or 3133 of the patient-facing side and / or the non-patient-facing side, as the case may be, may be integrally formed with the cells of the lattice structure. For example, the uniform surface 3132 and / or 3133 may be 3D printed together with the lattice structure and connected to the lattice structure.

[0577] In other examples, the uniform surface 3132 and / or 3133 may be formed separately and attached to the grid structure, as appropriate. In some examples, the non-patient-facing uniform surface 3133 may be provided only in one or more predetermined locations, such as where the cushion 3130 abuts against another portion of the cushion module 3150 (e.g., the chassis portion 3210).

[0578] As described above, in some examples, the grid structure may be formed of a foam having a plurality of pores formed therein (e.g., pores in the macroscopic structure of the pad 3130 as distinct from the microscopic pores / air cells of the foam material). The pores may be formed, for example, by laser cutting, or the pad 3130 may be formed (e.g., molded) with pores. The size, shape, and / or spacing of the pores may be varied within the pad 3130 to vary one or more properties (e.g., stiffness, compliance). Fig.18 Schematically illustrates a foam cushion 3130 having a cushion body 3131 with a plurality of holes 3136 formed in the cushion body 3131. The holes 3136 in this example are on a first side ( Fig.18 on the left side of the pad) than on the second side of the pad ( Fig.18The holes 3136 may be smaller on the right side of the liner 3130 so that the first side of the liner 3130 has a different stiffness than the second side 3130. Alternatively or additionally, the holes 3136 may vary in size, shape, and / or spacing along the length of the liner 3130. Fig.18 In the example shown, the holes are circular, but in other examples, the holes may have shapes other than circular.

[0579] 5.3.13.1.4 Changes near sensitive facial features

[0580] In some examples of the present technology, the cushion 3130 may include a grid structure that includes one or more features that vary at and / or near locations corresponding to sensitive facial features on the user's face. The variation in features may be, for example, a variation in any one or more of the shape, thickness, density, spacing, relative orientation, and / or material of the cells forming the grid structure.

[0581] Fig.19A The cushion 3130 is schematically shown in contact with the patient's face in the area of ​​a sensitive facial feature and on either side of the sensitive facial feature. The sensitive facial feature may be a prominent / convex facial feature such as the bridge of the nose, the nasal prominence, or the cheekbone. The cushion 3130 receives a uniformly distributed load on the non-patient-facing side of the cushion 3130, which may be, for example, a load transferred to the cushion 3130 from tension in the headgear straps of the positioning and stabilizing structure 3300 transferred through the components of the patient interface 3000. Fig.19B Shows Fig.19A A graph of the force or contact pressure on the patient's face in the area shown.

[0582] Fig.19B Two curves are plotted. The solid curve represents the force or pressure applied to the user's face by a cushion 3130 having a uniform grid structure (which may be identified as a "non-optimized" cushion 3130). Fig.19B As shown, the force / pressure applied to the face by the non-optimized cushion 3130 at and near the sensitive facial feature is increased due to the additional compression of the mesh structure caused by the protruding / convex facial feature. The dashed line represents the force or pressure applied to the user's face by a cushion 3130 having one or more characteristics that vary at or near the sensitive facial feature. This cushion 3130 may be considered an "optimized" cushion 3130. The term "optimized" should be understood to mean "better" in the context of certain outcomes (such as comfort, stability, etc.). As Fig.19BAs shown, due to the changing characteristics of the grid structure, the force / pressure applied to the user's face at the sensitive facial feature is not increased. In one example, the grid structure can be configured to have a lower stiffness in the area configured to contact the sensitive facial feature than in the areas on either side of the sensitive facial feature. The lower stiffness in this illustrated example then results in the force between the sensitive facial feature and the cushion 3130 being no greater than the force between other areas and the cushion 3130.

[0583] More generally, the change in the one or more characteristics of the mesh structure can cause the cushion 3130 to apply less pressure on the sensitive facial feature during use than it would have applied in the absence of the change. Fig.19B , this is illustrated by the optimized cushion 3130 applying less force on the face at the sensitive facial feature than the non-optimized cushion 3130. The optimized cushion 3130 applies a more even load across the surface of the user's face because some of the load that would otherwise be applied to the sensitive facial feature is instead applied to either side of the sensitive facial feature of the user's face (on which side of the face sensitivity is lower). Thus, although the cushion 3130 as a whole is subject to the same load, less load is applied to the sensitive facial feature than the non-optimized cushion 3130. This can advantageously adequately support the patient interface 3000 on the user's face while maintaining a good seal and without creating pain points at the sensitive facial feature.

[0584] In another example, the change in the one or more characteristics may result in the cushion 3130 applying less pressure on the sensitive facial feature than the cushion 3130 applies to the user's face around the sensitive facial feature during use. The change in the one or more characteristics of the mesh structure may result in greater compliance of the cushion 3130 at and / or near the location corresponding to the sensitive facial feature. Fig. 20A The cushion 3130 is schematically shown in contact with the user's face in the area of ​​a sensitive facial feature and on either side of the sensitive facial feature. The cushion 3130 receives an evenly distributed load on the non-user-facing side of the cushion 3130. Fig. 20B Shows Fig. 20A A graph of the force or contact pressure on the user's face in the area shown.

[0585] Fig. 20B The solid curve in Fig.19B The solid line curve in is essentially the same and represents the force / pressure applied across the user's face by the non-optimized pad 3130, showing the increase in force at this sensitive facial feature. Fig. 20BThe dashed curve in represents the force / pressure applied across the user's face by an optimized cushion 3130 according to another example of the present technology. In this example, despite the presence of a raised sensitive facial feature, the change in the grid structure results in less force being applied to the user's face at the sensitive facial feature than on either side of the sensitive facial feature. Advantageously, this can provide a particularly comfortable seal-forming structure 3100 because substantially all of the load is applied to the less sensitive area surrounding the sensitive facial feature. In this example and in reference to Fig.19B In the example of the optimized cushion 3130 described, the optimized cushion 3130 applies a greater load on either side of the sensitive facial feature than the non-optimized cushion 3130, i.e., the optimization of the grid structure increases the force on either side of the sensitive facial feature, which may be desirable because these areas may be able to support the load more comfortably than the area of ​​the sensitive facial feature. The load at the sensitive facial feature may be limited to the force required to prevent leakage at the sensitive facial feature, or approximate that force with a safety factor.

[0586] Fig.19C An example of a cushion 3130 having a grid structure having characteristics that vary along the length of the cushion 3130 is shown. In this example, the cushion 3130 includes uniform surfaces 3132 and 3133 on the non-patient-facing side and the patient-facing side of the cushion 3130, respectively. The cushion 3130 also includes a recess 3134 that is configured to engage a sensitive facial feature, such as the bridge of the nose or the cheekbone. The grid-like pattern depicting the cushion body 3131 schematically represents the grid structure. In this example, the orientation of the cells forming the grid structure varies near the recess 3134 to provide different behaviors at and near the recess 3134. For example, this variation in the orientation of the grid structure at and near the recess 3134 can result in a lower stiffness at the recess 3134, which in turn can provide a comfortable engagement between the cushion 3130 and the sensitive facial feature.

[0587] Fig. 22C Another example of a cushion 3130 is shown that includes a variation of a lattice structure feature configured to provide user comfort. As schematically illustrated, the cushion 3130 includes a reinforced area 3139 within the cushion that is stiffer than one or more adjacent areas within the cushion (e.g., left and right areas of the cushion 3130, and areas between the reinforced area 3139 and the recess 3134). In this example, the reinforced area 3139 is positioned from a first side located on the sensitive facial feature (e.g., Fig. 22C The first area of ​​the pad 3130 covering the sensitive facial feature (eg, the left side in FIG. 1 ) spans to a second area of ​​the pad 3130 covering the sensitive facial feature, and enters a second side of the sensitive facial feature (eg, Fig. 22CThe reinforcement area 3139 may be reinforced by changing one or more characteristics of the grid structure at the reinforcement area 3139. Fig. 22C As illustrated, the mesh structure is denser in the reinforced area 3139 than in the surrounding compliant area 3138. For example, the increased density may be formed by more material, smaller voids, additional struts, and / or smaller and more numerous cells. The actual parameters that may be varied to increase stiffness will depend on the specific mesh structure used in various examples.

[0588] Fig.22D Yet another example of a cushion 3130 is shown that includes a grid structure having changes in characteristics that result in a lower stiffness of the cushion 3130 at and around a location corresponding to a sensitive facial feature than in other areas. In this example, the cushion 3130 includes a reinforced region 3139 and a compliant region 3138 (i.e., a compliant region having higher flexibility / lower stiffness than the reinforced region), each of which is formed by a change in characteristics of the grid structure (such as a change in one or more of the shape, thickness, density, spacing, relative orientation, and / or material of the cells forming the grid structure). Further, in this example, the reinforced region 3139 spans from a first region of the cushion 3130 on a first side of the sensitive facial feature (e.g., on the left side in FIG. 22 ), to a second region of the cushion 3130 covering the sensitive facial feature, and into a third region of the cushion 3130 located on the second side of the sensitive facial feature (e.g., on the left side in FIG. 22 ). Fig.22D ). In this example, the cushion 3130 is stiffer near the patient's face in the first and third regions than in the second region. That is, the reinforcement region 3139 is provided all the way to the side of the cushion 3130 that engages the patient's face in the region on either side of the sensitive facial feature during use. Additionally, the cushion 3130 includes a compliant region 3138 surrounding the sensitive facial feature that is configured to provide a less stiff region at the sensitive facial feature for comfort, while the reinforcement region 3139 is stiffer to transfer a majority of the total force on the cushion 3130 to the less sensitive regions of the patient's face on either side of the sensitive facial feature.

[0589] FIG. 22G to FIG. 22J Schematically illustrated are four different ways by which a lattice structure formed by a network of struts around voids may be configured to provide different stiffnesses and conformability.Each figure shows a cushion 3130 comprising a cushion body 3131 comprising a lattice structure.

[0590] exist Figure 22GIn the embodiment of the present invention, the lattice structure is formed by relatively thick struts 3166 that are relatively far apart (with relatively high pitch) from each other, thereby forming relatively large gaps 3168. This structure can provide a pad 3130 with medium stiffness and high fitting distance.

[0591] exist Fig.22H , the grid structure is formed by relatively thin struts 3166 that are relatively far apart (at a relatively high pitch) from each other, thereby forming relatively large gaps 3168. This structure can provide a pad 3130 with low stiffness and a high fit distance.

[0592] exist Fig.22I , the lattice structure is formed by relatively thick struts 3166 that are relatively close to each other (with relatively low pitches) to form relatively small gaps 3168. This structure can provide a pad 3130 with high stiffness and a lower fitting distance.

[0593] exist Fig.22J In the embodiment of the present invention, the grid structure is formed by relatively thin struts 3166 that are relatively close to each other (with relatively low spacing) to form relatively small gaps 3168. This structure can provide a pad 3130 with medium stiffness and medium fitting distance. Fig.22J As shown, the patient-facing side of the pad 3130 may include a uniform surface 3133 that may be thicker than the struts to provide a comfortable surface during use. In some examples, the uniform surface 3133 may be 1.5 to 3 times thicker than the thinnest portion of some or all of the struts, such as between 1.7 to 2.5 times thicker, such as twice as thick.

[0594] As described elsewhere herein, the liner 3130 may include a lattice structure having one or more characteristics that vary to provide different properties at different locations within the liner 3130. Fig. 22C and Fig.22D Described in more detail above, including reinforced regions 3139 and compliant regions 3138, these regions are formed by variations in characteristics of the lattice structure (such as strut thickness).

[0595] Fig.22E Another example of a cushion 3130 is shown that includes a cushion body 3131 that includes a lattice structure. The cushion is schematically shown against a patient's face. The patient's face has a protrusion that represents a sensitive facial feature, such as a bridge of the nose or other sensitive features. In this example, the cushion 3130 includes a reinforcement area 3139 on each outer side of the sensitive facial feature, which is connected to each other near the non-patient-facing side of the cushion 3130. The reinforcement area 3139 can be, for example, Fig.22IThe structure shown is formed because the structure provides high stiffness. Near the sensitive facial feature, the cushion 3130 includes a compliant area 3138, which can be less stiff than the reinforced area 3139. The compliant area 3138 can be made of Fig.22H The structure shown is formed because it provides low stiffness and high adaptability / compliance. Along the patient-facing side of the cushion 3130, the cushion body 3131 can be composed of Fig.22J The lattice structure shown is formed with medium stiffness and medium fitting distance. Smaller gaps and thinner struts can provide a comfortable feel against the patient's face. The cushion 3130 can include a uniform layer of material along the patient-facing side to provide a smooth surface.

[0596] Fig.22F Shows something like Fig.22E Another example of a pad 3130 is shown. In this example, the Fig.22H The structure shown forms a compliant zone 3138 that extends all the way to the patient-facing surface of the cushion 3130 at sensitive facial features. Fig.22E The structure of the pad 3130 shown is arranged on the patient-facing side (i.e. Fig.22J The structure of Fig.22F The sensitive facial features are not directly above the sensitive facial features, but are set on either side of the sensitive facial features. Fig.22H The compliant region 3138 formed by the illustrated structure extends substantially all the way to the surface of the cushion 3130, allowing the patient-facing side of the cushion 3130 to be oriented parallel to the surface at the sensitive facial features (as determined by the Fig.22F The structure with smaller gaps (such as indicated by the arrow in FIG. 31 ) provided along the patient-facing surface of the pad 3130 is highly stretchable. Fig.22J as shown) may allow for less stretch in the surface.

[0597] While certain variations in the lattice structure forming the cushion 3130 are described above (and elsewhere) in the context of reducing loads on sensitive facial features, it should be understood that these variations may be applied in any cushion 3130 having one or more regions that are stiffer than one or more other regions, even in situations where no particular facial feature is considered to be a sensitive facial feature.

[0598] Fig.21AAnother example of a cushion 3130 is schematically shown, which includes a grid structure that contacts the user's face near a raised / protruding sensitive facial feature (such as the bridge of the nose, the nasal prominence, or the cheekbone, etc.). In this example, the load on the non-user-facing side of the cushion 3130 is a non-uniform distributed load. As illustrated, the distributed load on the left side is greater than the distributed load on the right side. There is also a recess 3134 in the cushion 3130, which will be described in more detail below.

[0599] Fig.21B A graph of force / pressure across a user's face near sensitive facial features is shown. The solid line curve shows the force applied on the face by the non-optimized pad 3130, which receives Fig.21A The non-uniform distributed load is shown in Figure 2. Fig.21B As shown, the force transmitted to the face is greater on the left side of the sensitive facial feature and less on the right side of the sensitive facial feature, corresponding to the non-uniform distributed load applied to the cushion 3130. However, Fig.21B The dashed curve in shows the force transmitted to the face by the optimized cushion 3130. As illustrated, despite the non-uniform distributed load applied to the non-user-facing side of the cushion 3130, the force applied to the face on either side of the sensitive facial feature is substantially the same due to the variations in the lattice structure forming the cushion 3130.

[0600] In reference 19A to 22D As will be apparent from the described examples, in some examples where the lattice structure includes one or more features that vary along the length of the cushion 3130, the cushion 3130 may receive a distributed load applied to the non-user-facing side of the cushion 3130, while due to the variation in the lattice structure, the cushion 3130 may apply a different distributed load to the user's face along the length of the cushion 3130. In some specific examples, the cushion 3130 may receive a non-uniform distributed load applied to the non-user-facing side of the cushion 3130 along the length of the cushion 3130, while due to the variation in the one or more features, the cushion 3130 applies a uniform load to the user's face along the length of the cushion. Advantageously, the cushion 3130 may be optimized to receive the non-uniform distributed load, but apply a smoothed, more even (e.g., more nearly uniform) load to the user's face, the user's face having a maximum force that is less than the maximum force of the distributed load on the user's face. This may make the patient interface 3000 particularly comfortable to wear, while still being able to form a good seal during use.

[0601] 5.3.13.2 Features near sensitive facial features

[0602] Fig.21AThe cushion 3130 is schematically shown in an undeformed state when in contact with the user's face at and on either side of a sensitive facial feature, which may be the bridge of the nose, the nasal prominence, the cheekbone, or other raised or sensitive feature. The cushion 3130 in this example includes a recess 3134 that is configured to align with the sensitive facial feature during use. The shape of the recess 3134 may be designed to accommodate the sensitive facial feature, such as Fig.21A shown.

[0603] In some examples, the shape of the recess 3134 is designed to provide a gap between the cushion 3130 and the sensitive facial feature in the undeformed state, such as Fig.21A That is, in the undeformed state, the recess may be larger than the sensitive facial feature such that the cushion 3130 does not contact the sensitive facial feature. However, in use, when the cushion 3130 is pulled into contact with the user's face, the cushion 3130 may compress and conform to the user's face such that there is no longer a gap at the recess 3134 and a good seal is formed against the sensitive facial feature. However, the presence of the recess 3134 and its gap in the undeformed state may result in particularly low forces being applied to the sensitive facial feature in use because there may be very little compression of the cushion in the area of ​​the recess 3134, or at least less compression than would be the case without the recess 3134.

[0604] In other examples, the recess 3134 may not be so large that a gap exists around the sensitive facial feature even in the undeformed state. The recess 3134 may substantially match the shape of the sensitive facial feature, for example, or may even be smaller than the sensitive facial feature. However, the presence of even a small recess 3134 may reduce the force applied to the sensitive facial feature to some extent, because the recess 3134 may act as a buffer, reducing the specific amount of compression of the cushion 3130 required at the sensitive facial feature. Advantageously, the recess 3134 may provide a particularly comfortable patient interface 3000.

[0605] Fig.21B Two force / pressure curves are shown across the user's face near sensitive facial features. The solid curve shows the force applied to the user's face by an unoptimized cushion 3130 without the recess 3134, and the dashed curve shows the force applied to the user's face by an optimized cushion 3130 that also has a recess 3134. Fig.21A Recess 3134 shown. like Fig.21BAs shown, the force transmitted to the sensitive facial feature by the cushion 3130 with the recess 3134 is less than the force transmitted to the sensitive facial feature by the cushion 3130 without the recess 3134. In addition, at least in part due to the recess 3134, the force applied to the sensitive facial feature by the cushion 3130 with the recess 3134 is less than the force applied to the user's face on either side of the sensitive facial feature.

[0606] In some examples of the present technology, the cushion 3130 may include one or more force redistribution features configured to redirect, in use, forces received on the non-user-facing side of the cushion 3130 in an area of ​​the cushion 3130 aligned with a sensitive facial feature to one or more areas of the cushion 3130 that are juxtaposed with or spaced apart from the sensitive facial feature. The force redistribution features may be variations of characteristics of the mesh structure, or may be additional or alternative features to the properties of the mesh structure.

[0607] Fig.22A A cushion 3130 is schematically shown in accordance with another example of the present technology, which contacts the user's face near sensitive facial features and receives a distributed load on its non-user-facing side. Fig. 22B A graph is shown of the force or pressure applied by the cushion 3130 to the user's face during use. Fig.22A The illustrated cushion 3130 includes a force redistribution feature in the form of a beam structure 3137 within the cushion 3130 (e.g., within the cushion body 3131 of the cushion 3130). The beam structure 3137 is positioned to span, in use, from a first region A of the cushion 3130 located on a first side of the sensitive facial feature, to a second region B of the cushion 3130 covering the sensitive facial feature, and into a third region C of the cushion 3130 located on a second side of the sensitive facial feature.

[0608] The beam structure 3137 is configured to redirect forces received at region B aligned with the sensitive facial feature to regions A and C juxtaposed with and spaced apart from the sensitive facial feature. Fig. 22B As shown, because the beam structure 3137 redirects the force to the regions A and C where the user can better tolerate the force, the force delivered to the user's face in region B at the location of the sensitive facial feature is less than the force delivered to the user's face in regions A and C. In this example, the cushion 3130 also includes Fig.21A and Fig.21B The example shown has a similar recess 3134, which also has the effect of reducing the force applied to the sensitive facial feature. Fig. 22B As shown, the reduction in force throughout region B can be much greater than the reduction in force resulting from the presence of recess 3134 alone, and can affect a wider area (eg, substantially all of region B).

[0609] In some examples, the pad 3130 includes a void adjacent to the beam structure 3137 in region B but not in regions A and C on the user-facing side of the beam structure 3137, which may cause the beam structure 3137 to transmit forces received at region B to the pad 3130 at regions A and C. Additionally or alternatively, the pad 3130 may have a lower stiffness in region B (e.g., due to a change in the grid structure), which may also cause forces to be more easily transmitted to regions A and C of the pad 3130 rather than region B.

[0610] This has been discussed above in the context of grid structures with regions of different stiffness. Fig. 22C , which shows another example of a pad 3130 having a force redistribution feature. In this example, the force redistribution feature includes a reinforced area 3139 within the pad 3130 that is stiffer than one or more adjacent areas within the pad 3130. In this example, the reinforced area 3139 is reinforced by a change in one or more characteristics of the mesh structure at the reinforced area 3139. As schematically illustrated, the reinforced area 3139 is positioned from a first side (e.g., Fig. 22C The first area of ​​the pad 3130 covering the sensitive facial feature (eg, the left side in FIG. 1 ) spans to a second area of ​​the pad 3130 covering the sensitive facial feature, and enters a second side of the sensitive facial feature (eg, Fig. 22C The third area of ​​the pad 3130 is on the right side of the figure. Fig. 22C As illustrated, the density of the grid structure in the reinforcement area 3139 is greater than that of the surrounding compliant area 3138. For example, the increased density can be formed by more material, smaller gaps, additional struts and / or smaller and more cells. The actual parameters that can be changed to increase stiffness will depend on the specific grid structure used in various examples. The reinforcement area 3139 in this example provides an effect similar to the beam structure 3137 described above, and can act like a beam to protect the sensitive facial features. The reinforcement area 3139 can form a force redistribution feature to transfer the load on the pad 3130 at least partially away from the sensitive facial features and into the adjacent area of ​​the area with lower engagement sensitivity. The reinforcement area 3139 can be formed by a more slender or denser grid structure, and the surrounding compliant area 3138 can be formed by a rougher, less dense grid structure to provide lower stiffness and reduce weight. In this example, the surface layer of the pad 3130 can be formed by the same material as the grid structure, or it can be a different material, such as textiles, foams, silicones, etc.

[0611] This has been discussed above in the context of grid structures with regions of different stiffness. Fig.22D, which shows another example of a pad 3130 having a force redistribution feature. In this example, the pad 3130 includes a reinforced area 3139 and a compliant area 3138, each of which is formed by a change in the characteristics of the grid structure (such as a change in one or more of the shape, thickness, density, spacing, relative orientation and / or material of the cells forming the grid structure). The reinforced area 3139 in this example forms a force redistribution feature. In addition, in this example, the reinforced area 3139 spans from a first area of ​​the pad 3130 on a first side of the sensitive facial feature (e.g., on the left side in FIG. 22 ), to a second area of ​​the pad 3130 covering the sensitive facial feature, and into a third area of ​​the pad 3130 on a second side of the sensitive facial feature (e.g., on the left side in FIG. 22 ). Fig.22D ). In this example, the cushion 3130 is stiffer near the patient's face in the first and third regions than in the second region. That is, the reinforcement region 3139 is provided all the way to the side of the cushion 3130 that engages the patient's face in the regions on either side of the sensitive facial feature during use. Additionally, the cushion 3130 includes a compliant region 3138 surrounding the sensitive facial feature that is configured to provide a region of lower stiffness at the sensitive facial feature for comfort. In this example, the reinforcement region 3139 is stiffer to form a force redistribution feature that transfers a majority of the total force on the cushion 3130 to less sensitive regions of the patient's face on either side of the sensitive facial feature. The portion of the reinforcement region 3139 that spans between the two side regions can be used as a bridge to connect portions of the reinforcement region 3139 on the sides. The center portion, bridge portion, or beam-like portion may transfer loads to either side of the sensitive facial feature, while the side portions may form the primary load path to transfer forces to less sensitive areas on either side of the sensitive facial feature. In some examples, the center portion of the reinforced region 3139, which is similar to the bridge, may be stiffer than the side portions of the reinforced region 3139. It should be understood that in some examples, there are three or more regions of different stiffness within the cushion 3130.

[0612] 5.3.13.3 Personalization

[0613] In some examples, the mesh structure of the cushion 3130 is 3D printed in a size or shape corresponding to a unique user's face. For example, known methods or methods described herein (e.g., reference Fig.24 , Fig.25 and FIG. 26A to FIG. 26D ) to obtain facial data, which may represent a partial or complete three-dimensional shape of the user's face or one or more features of the user's face. The mesh structure may then be 3D printed in a shape corresponding to the user's face based on the facial data.

[0614] In some examples, the mesh structure can be formed with a specific thickness (e.g., the overall thickness of the cushion body 3131) based on the facial data of the intended user. For example, the relative thickness of the cushion 3130 in various areas corresponding to different areas of the patient's face can be determined based on the facial data.

[0615] Advantageously, 3D printing of mesh structures may be particularly suitable for implementing personalization based on unique facial data, as such production of cushions with custom shapes may be cost-effective, at least compared to other techniques such as injection molding. Fig.18 As described, forming the cushion 3130 from foam may also be suitable for personalization because the size, shape, spacing, location and / or number of holes can be easily changed based on facial data during laser cutting or other computer controlled cutting operations to produce optimal or tailored size and performance characteristics.

[0616] In some examples, the grid structure of the pad 3130 is configured to optimize contact pressure for a unique individual. The grid structure can be configured based on facial data corresponding to the unique individual so that the pad 3130 provides a contact pressure in one or more areas that is less than the contact pressure provided when the facial data is not used. The grid structure can be adjusted to optimize the contact pressure for a specific user during use.

[0617] In some examples, the cushion 3130 includes one or more personalized features and is formed in a three-dimensional curved shape based on the facial data. In other examples, the cushion 3130 includes one or more personalized features based on the facial data and is formed in a flat shape. It should be understood that in some examples, the cushion 3130 may not be personalized and may be formed in a three-dimensional curved shape or a flat shape.

[0618] A cushion 3130 formed (e.g., 3D printed) into a three-dimensional personalized shape may produce better comfort and / or performance than a cushion 3130 produced as a flat shape and without personalization, but a cushion 3130 produced as a flat shape may be considered useful for some applications because it can be provided at a lower cost.

[0619] In some examples, the pad 3130 may be formed in a flat configuration but may have one or more features or characteristics that are personalized, such as the overall thickness of the pad 3130 or one or more properties of the grid structure, such as the thickness, spacing, density, shape, size, orientation, etc. of the cells forming the grid structure. A pad 3130 formed in a three-dimensional curved shape may additionally or alternatively implement personalization in the three-dimensional curved profile of the pad 3130 (e.g., a spatial curve along the length of the pad 3130).

[0620] Either or both of the overall (eg, macroscopic) shape of the cushion 3130 and the characteristics of the mesh structure forming the cushion 3130 may be personalized based on facial data. 19A to 22D An example of an "optimized" cushion 3130 is shown, which has features configured to avoid applying excessive force to sensitive facial features. In some examples of the present technology, facial data for a unique user's face may include details identifying the shape and / or location of sensitive facial features (e.g., the bridge of the nose, cheekbones, or other sensitive areas). This facial data can then be used to personalize the cushion 3130 so that its behavior conforms to the reference 19A to 22D For example, the facial data may be used to form a grid structure having varying characteristics in the construction of the cells such that the grid structure has lower stiffness in the correct area corresponding to the vicinity of the sensitive facial feature than in other areas. Alternatively or additionally, the facial data may be used to form a recess that is located in the correct position and / or has the correct / sufficient size to correspond to the sensitive facial feature of the particular user from whom the facial data was obtained.

[0621] 5.4 Automatic size determination

[0622] Examples according to the present technology may be provided in a range of sizes (e.g., Figures 7 to 22D The seal-forming structure 3100 (also referred to as a "facial interface," "interface," "user interface," etc.) of the patient interface 3000 is provided so that when a patient purchases or a clinician prescribes the patient interface 3000, an optimal size can be selected from the range of sizes. Systems and methods for assisting a user in determining the correct or optimal size of the seal-forming structure 3100 are described below. It should be understood that in some examples, the systems and methods may be used to select subcomponents of the seal-forming structure 3100, such as a cushion 3130 (e.g., formed by a mesh structure) or other components of the patient interface 3000, such as a positioning and stabilizing structure 3300. It should also be understood that, in practice, the seal-forming structure 3100 may form part of a removable cushion module 3150, meaning that size selection or customization of the seal-forming structure 3100 may require selection or customization of a cushion module 3150 having the seal-forming structure 3100. Furthermore, references to dimensioning an interface should be understood as alternative references to dimensioning a gasket 3130 formed by the lattice structure for the seal-forming structure, or a gasket module 3150 including such a gasket 3130 .

[0623] In a beneficial embodiment, the present technology may employ an application that may be downloaded from a manufacturer or a third-party server to a smartphone or tablet with an integrated camera. When launched, the application may provide visual and / or audio instructions. When prompted or otherwise instructed, the user may use an image sensor (such as a camera function) to activate a process of scanning or capturing one or more images of the user's face, and the facial interface size may be recommended based on analysis of the captured images or videos by a processor of the phone or cloud. In an alternative embodiment, instead of capturing an image of the object in real time, the user may be prompted to select and / or upload an existing image of the user's face for image processing and analysis to determine the size. In one example, the image is a 2D image of the user's face. In another example, the image is a 3D image of the face (i.e., containing depth information about the selected portion). This may allow the correct or optimal size of the facial interface to be quickly and conveniently identified for the user, which improves user fit and comfort.

[0624] As further described below, the present technology allows a user to capture an image or series of images of their facial structure. Instructions provided by an application stored on a computer-readable medium, such as when executed by a processor, detect various facial landmarks within the image, measure and scale the distances between such landmarks, compare these distances to the data record, and recommend an appropriate facial interface size. Thus, a consumer's automated device may allow accurate facial interface selection, such as at home, to allow the customer to determine size or fit without the assistance of trained personnel.

[0625] 5.4.1 System

[0626] Fig.24 An example system 200 is depicted, which can be implemented for automatically measuring facial features and determining facial interface size. System 200 can generally include one or more of server 210, communication network 220, and computing device 230. Server 210 and computing device 230 can communicate via communication network 220, which can be a wired network 222, a wireless network 224, or a wired network with a wireless link 226. In some versions, server 210 can communicate unidirectionally with computing device 230 by conveying information to computing device 230, and vice versa. In other embodiments, server 210 and computing device 230 can share information and / or process tasks. The system can be implemented, for example, to allow automatic purchase of a user interface, where the process can include the process of automatically determining size described in more detail herein. For example, a customer can order a facial interface online after performing a facial interface selection process that automatically identifies a suitable facial interface size by performing image analysis of the customer's facial features.

[0627] 5.4.1.1 Computing device

[0628] Computing device 230 may be a desktop or laptop computer 232 or a mobile device such as a smartphone 234 or tablet computer 236 . Fig.25 A general architecture 300 of a computing device 230 is depicted. The device 230 may include one or more processors 310. The device 230 may also include a display interface 320, a user control / input interface 331, a sensor 340 and / or a sensor interface for one or more sensors, an inertial measurement unit (IMU) 342, and a non-volatile memory / data storage device 350.

[0629] Sensor 340 may be one or more cameras (e.g., CCD charge coupled devices or active pixel sensors) integrated into computing device 230, such as those provided in smartphones or laptop computers. Alternatively, where computing device 230 is a desktop computer, device 230 may include a computer for communicating with an external camera (e.g., a CCD charge coupled device or an active pixel sensor). Fig.24 The sensor 340 may be coupled to a webcam 233 as depicted. Other exemplary sensors that may be integrated with the computing device or located external to the computing device and may be used to assist in performing the methods described herein include light detectors for stereo cameras that capture three-dimensional images, or capable of detecting reflected light from lasers or strobed / structured light sources. In one embodiment, the sensor 340 includes the 3D TrueDepth Camera of the Apple iPhone or similar sensors employed in other mobile devices capable of 3D facial scanning.

[0630] The user control / input interface 331 allows the user to provide commands or respond to prompts or instructions provided to the user. This may be, for example, a touch panel, keyboard, mouse, microphone and / or speaker.

[0631] Display interface 320 may include a display or LCD panel or the like to display prompts, output information (such as facial measurements or interface size recommendations), and other information, such as a capture display, as described in further detail below.

[0632] The memory / data storage device 350 may be an internal memory of the computing device, such as RAM, flash memory, or ROM. In some embodiments, the memory / data storage device 350 may also be an external memory associated with the computing device 230, such as, for example, an SD card, a server, a USB flash drive, or an optical disk. In other embodiments, the memory / data storage device 350 may be a combination of external memory and internal memory. The memory / data storage device 350 includes stored data 354 and processor control instructions 352 that direct the processor 310 to perform certain tasks. The stored data 354 may include data received by the sensor 340, such as captured images, and other data provided as part of the application. The processor control instructions 352 may also be provided as part of the application.

[0633] 5.4.1.2 Applications for facial feature measurement and facial interface dimension determination

[0634] One such application is an application 360 for facial feature measurement and / or facial interface size determination, which may be an application downloadable to a mobile device such as a smartphone 234 and / or tablet 236. The application 360 may be stored on a computer-readable medium such as a memory / data storage device 350, the application including programming instructions for use by the processor 310 to perform certain tasks related to facial feature measurement and / or facial interface size determination. The application also includes data that may be processed by the algorithm of the automated method. Such data may include data records, reference features, and correction factors, as explained in more detail below.

[0635] 5.4.2 Methods for automatic measurement and sizing

[0636] like FIG. 26A to FIG. 26D As illustrated in the flowchart of , one aspect of the present technology is a method for controlling a processor (such as processor 310) to measure facial features of a user using a two-dimensional or three-dimensional image, and to recommend or select an appropriate facial interface size based on the obtained measurement results, such as from a set of standard sizes. The method can generally be characterized as including three or four different stages: a pre-capture stage 400, a capture stage 500, a post-capture image processing stage 600, and a comparison and output stage 700.

[0637] In some cases, the application for facial feature measurement and facial interface size determination may control the processor 310 to output a visual display including a reference feature on the display interface 320. The user may position the feature adjacent to their facial features, such as by moving the camera. Then, when certain conditions (such as alignment conditions) are met, the processor may capture and store one or more images of the facial features associated with the reference feature. This may be done with the help of a mirror 330. The mirror 330 reflects the displayed reference feature and the user's face onto the camera. The application then controls the processor 310 to identify certain facial features within these images and measure the distances between them. Then, through image analysis processing, the facial feature measurements (which may be pixel counts) may be converted to standard facial interface measurements using scaling factors based on the reference features. Such values ​​may be, for example, standardized units of measurement, such as meters or inches, and values ​​expressed in such units suitable for interface size determination. Additional correction factors may be applied to these measurements. The facial feature measurements may be compared to a data record that includes measurement ranges corresponding to different interface sizes for a particular interface form. A recommended size may then be selected based on the comparison and output to the user as a recommendation. Such a process can be conveniently accomplished within the comfort of the user's own home (if the user so chooses). The application can perform the method in a few seconds. In one example, the application performs the method in real time. The manufacturer or supplier can arrange for automatic shipment of a facial interface of the recommended size to a user-specified address.

[0638] 5.5 Methods and Systems for Producing Customized Patient Interfaces

[0639] Described below are systems and methods for producing a grid structure of a patient interface or components thereof in accordance with additional examples of the present technology. The following systems and methods may be used with the automatic sizing and personalization examples above, or as an alternative. References to patient interfaces that are customized, tailored, personalized, optimized, and the like should be understood to refer to a patient interface having at least one customized component (e.g., a pad 3130 formed by a customized grid structure), even if some or all of the other components of the patient interface are not customized.

[0640] 5.5.1 System Architecture

[0641] Examples of the systems outlined herein may include one or more computing devices having one or more processors programmed or configured to perform the various functions described herein. While examples may describe certain information being stored and / or processing tasks being performed by a particular device, it should be understood that alternative embodiments that share such information and / or processing tasks are contemplated.

[0642] Fig. 27 A schematic diagram of an exemplary system 100 is shown, which can be used to perform various aspects of the present technology as described herein. It should be understood that the system 100 can receive data from an external system and send data to the external system, and can control the operation of components outside the system 100. The system 100 can generally include a customization server 102, which manages the collection and processing of data related to the design and production of customized components for patient interface 3000. The customization server 102 has a processing facility, which is represented by one or more processors 104, a memory 106, and other components that are typically present in such a computing device. It should be understood that the server 102, the processor 104, and the memory 106 can take any suitable form known in the art, such as a "cloud-based" distributed server architecture or a dedicated server architecture. In the illustrated exemplary embodiment, the memory 106 stores information that can be accessed by the processor 104, including instructions 108 that can be executed by the processor 104 and data 110 that can be retrieved, manipulated, or stored by the processor 104. The memory 106 may be any suitable component known in the art that can store information in a manner accessible by the processor 104 , including computer-readable media or other media that stores data readable by electronic means.

[0643] The processor 104 may be any suitable device known to those skilled in the art. Although the processor 104 and the memory 106 are illustrated as being located in a single unit, it should be understood that this is not intended to be limiting, and the functionality of each as described herein may be performed by multiple processors and memories, which may or may not be remote from each other and other components of the system 100. The instructions 108 may include any set of instructions suitable for execution by the processor 104. For example, the instructions 108 may be stored as computer code on a computer-readable medium. The instructions may be stored in any suitable computer language or format. The data 110 may be retrieved, stored or modified by the processor 104 according to the instructions 110. The data 110 may also be formatted in any suitable computer-readable format. The data 110 may also include a record 112 of a control routine or algorithm for implementing various aspects of the system 100.

[0644] Although in Fig. 27In the embodiment, server 102 is shown as including only memory 106, but server 102 may also be able to access other external memories, data stores, or databases (not shown). For example, information processed at server 102 may be sent to an external data store (or database) for storage, or may be accessed by server 102 from an external data store (or database) for further processing. Additionally, system 100 may include multiple such data stores and / or databases. In some cases, the data store or database may be able to be accessed separately, such as each being able to be accessed by a different server. In other cases, the data stores or databases described herein are not necessarily separated, but may be stored together, but as a part of a separate file, folder, column of a table in a common file, etc.

[0645] The server 102 may communicate with the operator workstation 114 to provide the operator with access to various functions and information. Such communications may be performed via a network 120. The network 120 may include a variety of configurations and protocols, including the Internet, an intranet, a virtual private network, a wide area network, a local network, a private network (whether wired or wireless) using a proprietary communication protocol of one or more companies, or a combination thereof.

[0646] Server 102 performing one or more operations may include using artificial intelligence and / or machine learning algorithms. Server 102 may be configured to generate a training data set and / or use a trained data set (by server 102 or external to server 102) to make certain decisions.

[0647] The exemplary system 100 includes one or more user devices 130 that are equipped to obtain data related to the shape and / or size of a user's face, head, or features thereof, as will be further described below. By way of example, the user device 130 may include a mobile computing device (such as a smartphone 130A or a tablet computer 130B) or a personal computing device (such as a laptop or desktop computer 130C), each of which is equipped with an image sensor (such as a camera). Although the present technology will be described herein as utilizing image data obtained using a camera, alternative embodiments are contemplated in which other sensors are used to obtain data related to the shape and / or size of a user's head or features thereof. For example, such sensors may include a stereo camera for capturing three-dimensional images, or a light detector capable of detecting reflected light from a laser or strobed / structured light source.

[0648] The exemplary system 100 may include one or more manufacturing systems 140 configured to manufacture a customized patient interface or components thereof. The manufacturing system 140 may include one or more manufacturing devices 142 configured to physically produce components of the patient interface 3000. In some examples, the manufacturing device 142 is a 3D printer, a knitting machine, a braiding machine, a laser cutter, or other additive manufacturing equipment. In an example, the manufacturing system 140 may include multiple types of manufacturing devices 142 for manufacturing different components of the patient interface 3000. The manufacturing device 142 may include one or more controllers 144 for controlling operating hardware 146 (e.g., knitting hardware or 3D printing hardware) and a dedicated user interface for operator input / monitoring of the manufacturing device 142. The manufacturing device 142 may also communicate with other components of the manufacturing system, for example, a manufacturing server 150 that manages the production of a customized patient interface or components thereof communicates with the customization server 102 and / or a manufacturing operator workstation 152.

[0649] In some examples, one or more of the manufacturing devices 142 is a laser cutter configured to cut one or more components of the patient interface and / or modify one or more components produced (e.g., components produced by another manufacturing device 142). The laser cutter can provide flexibility to provide complex shapes with a certain accuracy, repeatability, speed, and / or automation. The laser cutter can also allow for customization of a large number of components produced at a certain speed by modifying the length and / or shape of the component based on the patient's analysis results.

[0650] In some examples, one or more manufacturing devices may be provided at a manufacturing plant, a clinician's office, and / or a patient's home. In some examples, a component may be produced at one location by one or more of the manufacturing devices and then further modified at another location by one or more of the manufacturing devices. In some examples, one or more manufacturing devices disposed at different locations may receive instructions from the same manufacturing server 150, the same customization server 102, and / or the same manufacturing operator workstation 152. In some examples, one or more manufacturing devices disposed at different locations may report the results of producing and / or modifying the component to the manufacturing server 150, the customization server 102, and / or the manufacturing operator workstation 152.

[0651] In some examples, one or more devices in example system 100 may include communication circuitry configured to communicate with one or more other devices in system 100 directly and / or via network 120 .

[0652] 5.5.2 Methods for custom manufacturing of grid structures

[0653] like FIG. 28A to FIG. 28EAs illustrated in the flowchart of FIG. 7000 , one aspect of the present technology is a method 7000 of producing at least one customized component of a patient interface 3000 for treating sleep disordered breathing. The customized component can be, for example, a component of a seal-forming structure 3100 formed of a mesh structure (such as a cushion 3130). The customized component can be customized for an individual patient in one or more ways, such as in shape, size, or another attribute (e.g., the attributes described above with respect to personalization and / or optimization of the mesh structure).

[0654] refer to Fig.28A An example of method 7000 may generally be characterized as including three phases: a user data capture phase 7100 , a specification determination phase 7200 , and a production phase 7300 .

[0655] 5.5.2.1 User data capture phase

[0656] In order to produce a patient interface that provides effective treatment and is comfortable for the user to wear, the patient interface, or at least its components, need to be customized to conform to the size and / or shape of the user's head (and more specifically, to conform to the facial features). In order to provide such customization, it is usually necessary to collect information about the size and / or shape of the user's head (including the user's facial features in many cases).

[0657] In an example of the present technology, the user data capture phase 7100 includes obtaining information representing the location of one or more key point features of the user's head. As used herein, the term "key point" shall refer to a specific point, area, or feature on a person's head that is associated with an element of the head (including facial features). The location of a key point may be defined, for example, relative to other key points or fixed reference points. Examples of head key points may include, but are not limited to: the subnasal point, the nasal bridge point, the tragus point, the rearmost point of the patient's head, the uppermost point of the patient's head, the lateralmost point of the orbital rim, the lowermost point of the orbital rim, the Frankfurt horizontal plane, the sagittal plane, and the coronal plane aligned with the tragus point. Other examples of key points may be FIG. 2B to FIG. 2F Those features illustrated in any of the Figures.

[0658] 5.5.2.1.1 Image Data Capture

[0659] In an example, obtaining relevant information in the user capture phase 7100 may include: Fig.28B Image data of at least a portion of the user's head is captured at 7102, and key point feature locations are identified based on the image data at 7104. By way of example, the image data may be captured using a camera of a smartphone 130A, a tablet computer 130B, or a computer 130C.

[0660] U.S. Patent Publication No. 2018 / 0117272, U.S. Patent Publication No. 2019 / 0167934, U.S. Patent No. 7,827,038, U.S. Patent No. 8,254,637, and U.S. Patent No. 10,157,477 describe exemplary methods and systems for capturing data (e.g., image data) of at least a portion of a user's head, determining patient characteristics, and / or fitting mask characteristics to a patient, each of which is incorporated herein by reference in its entirety. Other exemplary software tools for generating a three-dimensional model of a user's head or a portion thereof may include: a "Capture" application available from Standard Cyborg; a "Scandy Pro" application available from Scandy, LLC; "Fiber 3D" available from Guangzhou Zhimei Technology Co., Ltd.; "Unre 3D FaceApp" available from UNRE AI LIMITED; and "Bellus3D FaceApp" available from Bellus3D, Inc. Furthermore, any of the techniques related to automatic sizing described elsewhere herein may be used with or as an alternative to the facial data acquisition techniques described in this section.

[0661] In an alternative example, the relevant information may be obtained by the user or clinician performing a series of measurements on the user's head, and a record of these measurements created and input into the system 100, ie, obviating the requirement to capture image data.

[0662] 5.5.2.1.2 Key point feature identification

[0663] In the example, the key point features of the user identified at 7104 may be based on two-dimensional image data. U.S. Patent Publication No. 2018 / 0117272 describes an exemplary method and system for determining key point features of a user and their locations based on two-dimensional image data.

[0664] In an example, identifying key point features based on the image data at 7104 may include (at Fig.28C A three-dimensional model of the user's face and / or head is generated at 7110 of the present invention. The three-dimensional model can be analyzed to identify key point features of the user and determine their locations at 7112. U.S. Patent Publication No. 2019 / 0167934 describes an exemplary method and system for identifying key point features and their locations from a three-dimensional model. As an example, a three-dimensional model can be generated based on data received from a 3D scanner, a stereo camera, and / or multiple images of a user's face and / or head captured from different positions and / or orientations of a capture device and / or a patient.

[0665] In an example, a local processing facility at the point where the image data is captured (e.g., smartphone 130A, tablet 130B, or computer 130C) can be used to identify key point features (including generating a three-dimensional model in the example). In an alternative example, the image data can be communicated to a remote processing facility (e.g., custom server 102) for further processing.

[0666] 5.5.2.1.3 Relationships between key point features

[0667] In some forms of the present technology, method 7000 may include identifying relationships between key point features. Such relationships may provide information about the user's anthropometric measurements, thereby providing a reference for customizing the patient interface or its components for the user. By way of example, the relationships between key point features may include distances (i.e., spacing between features) and relative angles.

[0668] In an example, identifying relationships between key point features may include determining distances between two or more of: a subnasal point, a nasal bridge point, a tragus point, a posterior-most point of the patient's head, a superior-most point of the patient's head, a lateral-most point of the right orbital rim, a lateral-most point of the left orbital rim, a inferior-most point of the orbital rim, a Frankfurt horizontal plane, and a coronal plane aligned with the tragus point.

[0669] It will be appreciated that the keypoint features to be identified (and their associated relationships) may be affected by the design or configuration of the patient interface to be manufactured or its components: that is, some keypoint features will be relevant to certain designs or components but not to others. In an example, only selected keypoint features and their relationships may be evaluated. In an alternative example, an entire set of keypoint features from a list of possible keypoint features that can be identified may be evaluated to allow the data set to be used across a range of patient interfaces or their components.

[0670] Fig.29 A side view of a patient's head is shown with a plurality of key point feature spacings described below identified. Each feature spacing is located between a pair of key point feature locations. Each of these spacings may be useful in determining the size and shape of the patient's head and the locations of its features for use in customizing the pad 3130 for the patient.

[0671] In an example, a distance D1 between the subnasal point and a coronal plane aligned with the tragus point may be determined, the distance D1 being perpendicular to the coronal plane. This keypoint feature spacing may enable the spacing on the anterior-posterior axis between the upper portion of the patient's lip and the patient's ear to be considered in the design of custom components of the patient interface 3000.

[0672] In an example, a distance D2 between the subnasal point and the tragus point in the sagittal plane may be determined. The distance D2 may be a direct distance in the sagittal plane that includes both a vertical component and a horizontal component (e.g., a diagonal distance between the subnasal point and the vertical upper tragus point in the sagittal plane). Together with the horizontal distance D1 between the subnasal point and the tragus point, the distance D2 may enable the height of the ear relative to the lower periphery of the patient's nose to be considered in the design of a custom component for the patient interface 3000.

[0673] In an example, a vertical distance D3 between the subnasal point and the nasal bridge point in the sagittal plane may be determined. This distance D3 may enable the height of the patient's nose and / or the spacing between the lower periphery of the patient's nose and the patient's eyes to be considered in the design of a custom component for the patient interface 3000. In particular, this spacing may be particularly useful in determining the shape and / or size of, for example, a custom cushion 3130 of the seal-forming structure 3100.

[0674] In an example, a distance D4 between the outermost point of the orbital rim and a coronal plane aligned with the tragus point can be determined, the distance D4 being perpendicular to the coronal plane. This spacing can allow the distance between the patient's ear and the patient's eye to be considered in the design of custom components for the patient interface 3000.

[0675] In an example, a vertical distance D5 between the lower nose point and the uppermost point of the patient's head may be determined. This characteristic spacing may allow the height of the patient's head and the spacing between the lower periphery of the patient's nose and the top of the patient's head to be considered in the design of a custom component for the patient interface 3000. This characteristic spacing may be particularly useful in determining the shape and / or size of, for example, a custom cushion 3130.

[0676] In an example, a vertical distance D6 between the uppermost point of the patient's head and the Frankfurt horizontal plane may be determined. This characteristic spacing may enable consideration of the distance between the top of the patient's head and the patient's ear or lower orbital rim in the design of a custom component for the patient interface 3000. This distance may be particularly useful in determining the shape and / or size of, for example, a custom cushion 3130.

[0677] In an example, a distance D7 between the posteriormost point of the head and a coronal plane aligned with the tragus point may be determined, the distance D7 being perpendicular to the coronal plane. This characteristic spacing may allow the size of the patient's head and / or the distance between the patient's ear and the back of the patient's head to be considered in the design of custom components for the patient interface 3000.

[0678] The aforementioned relationship is given by way of example only, and is not intended to limit all forms of the present technology.

[0679] 5.5.2.2 Specification determination stage

[0680] In the specification determination phase 7200, the example of method 7000 includes determining a set of manufacturing specifications for producing a patient interface or one or more components thereof (such as a cushion 3130 or its mesh structure formed by a mesh structure) based on one or more key point feature locations and / or relationships between them.

[0681] In an example, such specifications are determined based on one or more performance requirements of the component. Examples of such performance requirements may include one or more of the following: stiffness, contact pressure, compliance, force applied by or to the component, elasticity, size (including the size and relative angle of the features of the component), touch, breathability, heat dissipation and / or positioning on the user's head. Such performance criteria may be affected by one or more of the following: efficacy of providing treatment (e.g., sealing of the patient interface and / or reduction in the possibility of occlusion during use), user comfort (e.g., the touch feel of the component and the relative positioning to avoid more sensitive areas of the user's head) and manufacturing considerations (e.g., material cost and / or manufacturing complexity). It should be understood that the performance requirements for the component will be affected by one or more key point feature positions and / or the relationship between them, and examples of the one or more key point feature positions and / or the relationship between them are further described below. In an example, the custom component specifications may be determined in part based on non-performance characteristics (such as color).

[0682] In an example, performance requirements may be based on functional requirements that are not derived from keypoint feature locations and / or relationships therebetween as described above.

[0683] In some examples, the step of determining the at least one performance requirement includes receiving and analyzing facial motion data that indicates changes in the shape and / or size of the patient's face during facial motions. In one form of the present technology, the patient may be prompted to record himself making different facial expressions as part of obtaining the facial motion data, which may be used to optimize the response of the mesh structure of the cushion 3130 to the facial motions. For example, the cushion 3130 may be adjusted to respond to the way a unique user's face tends to move.

[0684] Fig. 30A and Fig. 30B Two facial expressions are shown. In one example, a patient may record or otherwise capture, via image or video, themselves making the following facial expressions: Fig. 30A The closed mouth emoji shown then changes to Fig. 30B The change in facial size and / or shape between these two expressions may be analyzed and used to optimize the response of the grid structure 3130, for example enabling the cushion 3130 to maintain a sufficient and preferably high comfort level of contact pressure at the sealing surface during facial motion.

[0685] In some examples, the patient may be prompted to record FIG. 30A to FIG. 30B Facial expressions in addition or alternative to those shown, such as clenched jaw, relaxed jaw, partially open mouth, pursed lips, smile, frown, bared teeth, puffed cheeks, and / or postures (such as looking up, looking down, looking to the side, lying on the back on a pillow, lying on the side on a pillow, etc.). In some examples, facial movement data can be acquired while the patient is speaking.

[0686] In some examples, changes in the positions and / or relative spacing of keypoint features on the patient's face during facial motions may be analyzed, and manufacturing specifications may be generated based at least in part on the changes.

[0687] The performance requirements and resulting manufacturing specifications will depend on the particular type or style of custom component to be produced.

[0688] In an example, a custom component may include a cushion 3130 or a grid structure thereof as described herein. Reference to the production of a custom cushion 3130 should be understood as at least a reference to its grid structure, whether or not the grid structure forms the entire, complete cushion 3130. The cushion 3130 may be customized for a specific patient by forming it in a specific shape and / or size based on key point feature locations and / or their relationships, thereby achieving a comfortable and stable fit for the specific patient. Figures 7 to 23F An exemplary pad 3130 is described.

[0689] In an example, the performance requirements of one component of the patient interface may be affected by the properties or characteristics of another component. By way of example, for a custom cushion 3130, certain performance requirements may be determined in part by the size and / or configuration of the chassis portion 3210 or the plenum chamber 3200 to which the cushion 3130 is to be attached.

[0690] In an example, the manufacturing specifications may include material specifications. A specific material or material mixture may be selected based on performance requirements such as stiffness, hardness, flexibility, compliance, or tactile feel. In some examples, a material may be selected based on the preferences of the patient for whom the custom component is being produced.

[0691] In an example, the manufacturing specifications may include construction specifications. For example, in a pad 3130 including a mesh structure, a specific type / pattern of the mesh structure may be selected based on performance requirements for the component (e.g., FIG. 23A to FIG. 23F In the case where the mesh structure is formed by knitting, knitting stitches may be specified.

[0692] In an example, determining the set of manufacturing specifications may include selecting the set of manufacturing specifications from a plurality of existing sets of manufacturing specifications. In an example, determining the set of manufacturing specifications may include selecting a plurality of manufacturing specifications from a plurality of existing manufacturing specifications to form the set of manufacturing specifications. The selection of the existing manufacturing specifications may be based on a similarity between one or more key point feature locations and / or their relationships determined for the user and those key point feature locations and / or their relationships associated with the existing manufacturing specifications.

[0693] Identifying key point features and / or their locations (e.g., at 7104 and / or at 7112), identifying relationships between key point features, determining functional requirements (e.g., for a patient interface and / or one or more components thereof) (e.g., at 7202), and / or determining manufacturing specifications (e.g., at 7204) may include using artificial intelligence and / or machine learning algorithms. For example, a trained data set may be used to identify key point features and / or their locations. In some examples, captured image data and / or a three-dimensional model used to identify key point features may be used in the training data set. In another example, a trained data set may be used to identify manufacturing specifications based on key point features, their locations, and / or functional requirements.

[0694] 5.5.2.3 Production of custom components

[0695] In an example, producing a patient interface or a component thereof (e.g., cushion 3130) based on a set of manufacturing specifications at 7300 includes: generating, at 7302, manufacturing machine programming instructions for producing the patient interface or a component thereof based on the set of manufacturing specifications (see Fig.28E ). The manufacturing machine 142 is programmed at 7304 using the manufacturing machine programming instructions, and the manufacturing machine is operated at 7306 according to the manufacturing machine programming instructions to produce the patient interface or components thereof.

[0696] In some examples, producing the customized component at 7300 includes additive manufacturing (e.g., 3D printing) of the customized component. Manufacturing machine 142 may include a 3D printer to print the customized component (e.g., cushion 3130 or its lattice structure). Manufacturing machine 142 may include a laser cutter to cut and / or modify the customized component (e.g., cushion 3130 formed of foam and having laser cut holes) to form it into a lattice structure.

[0697] 5.5.2.3.1 Generate Manufacturing Machine Programming Instructions

[0698] In an example, manufacturing machine programming instructions for producing a patient interface or a component thereof (e.g., cushion 3130) may be automatically generated based on a set of manufacturing specifications. In an example, the manufacturing machine programming instructions may be generated from a model of the patient interface or component embodying the set of manufacturing specifications. Software tools are known for generating manufacturing machine programming instructions from two-dimensional and three-dimensional models. Some aspects of the programming instructions may be automatically determined.

[0699] In an example, generating manufacturing machine programming instructions for producing a patient interface or a component thereof based on a set of manufacturing specifications at 7302 includes generating a graphical representation of one or more manufacturing specifications at 7310 (see Fig.28F ). In such examples, generating manufacturing machine programming instructions at 7302 includes generating instructions based on a diagram representing manufacturing specifications at 7312.

[0700] In an example, the illustration may include a two-dimensional model of the patient interface or components thereof, such as one or more two-dimensional images. In an example, details of the manufacturing specifications may be provided by visually encoding the model, i.e., certain manufacturing specifications may be obtained by visually identifying features of the illustration. In an example, the illustration may include a three-dimensional model of the patient interface or components thereof. In such an example, details of the manufacturing specifications may be encoded into the three-dimensional model.

[0701] In an example, the diagram may be generated at a first processing facility (eg, customization server 102) and communicated to an appropriate manufacturer system 140 for use in generating manufacturing machine programming instructions.

[0702] In other examples, the generation of the diagram and the manufacturing machine programming instructions may be performed at a single processing facility, such as by using a first software application to generate the diagram and a second software application to generate the manufacturing machine programming instructions.

[0703] In an example, the diagram may be converted into a model from which the manufacturing machine programming instructions may be generated. In an alternative example, the manufacturing specifications may be embodied in a diagram that is configured to be directly converted into the manufacturing machine programming instructions. In an example, the set of manufacturing specifications may be converted into the manufacturing machine programming instructions without generating an intermediate model or diagram.

[0704] In an example, a set of manufacturing specifications may be used to modify an existing template from which manufacturing machine programming instructions are generated. Such templates may have associated with them predefined baseline rules, such as those related to manufacturing constraints or general performance requirements for a particular component design. In an exemplary embodiment, such templates may include predefined regions of a component design, wherein the manufacturing specifications are used to modify parameters of each predefined region.

[0705] 5.5.2.4 Delivery of Customized Components

[0706] In an example, after the custom patient interface or its components are produced, an automated distribution system can be used to manage delivery to the user. In an example, the custom patient interface or its components (e.g., cushion 3130) can be delivered directly to the user from the facility of the manufacturing system 140, or delivered to a designated collection point or address.

[0707] In examples where multiple components are to be produced or at least supplied with at least one customized component, an assembly phase may be performed. In examples, the assembly may be performed by a supplier of the patient interface. In the case where the manufacturer of the customized component is a third party, the customized component may be delivered to a supplier facility to be assembled with other components prior to delivery to the user.

[0708] 5.5.2.5 Matching users with existing products

[0709] According to one aspect of the present technology, user-specific data (e.g., measurements obtained from a user or user profile information) can be used to select a patient interface component from a set of existing component configurations having associated manufacturing specifications and programming instructions. For example, the selection can be based on a comparison between a data record related to the user-specific data and information associated with the existing component configurations.

[0710] In an example, existing component configurations may be developed based on one or more datasets representing key point features of heads representative of a user population. For example, a dataset may include a model of a human head having features associated with various profile categories, such as gender, age, or physique. Such models may be trained, for example, using artificial intelligence and / or machine learning algorithms. Manufacturing specifications may be developed based on analysis of such representative models and programming instructions generated therefrom.

[0711] 5.5.2.6 Use feedback to modify specifications and / or update models

[0712] According to one aspect of the present technology, feedback from a user, clinician, and / or manufacturing operator may be used to update parameters and / or models used to perform one or more of the operations discussed above (e.g., identifying key point features and / or their locations, identifying relationships between key point features, determining functional requirements, and / or determining manufacturing specifications). The feedback may be received via a user interface displayed on the RPT device, the user device 130, the operator workstation 114, and / or the manufacturing operator workstation 152.

[0713] The user may provide feedback after receiving the customized patient interface. After a predetermined period of time (e.g., after receiving or beginning to use the patient interface) and / or after a predetermined amount of use, the user may input information indicating the fit of the patient interface when the patient interface is used for the first time. The user may be asked predefined questions about different aspects of the patient interface and / or asked to evaluate different features of the mask. The clinician may input feedback received from the user and / or feedback based on observations of the user using the patient interface. The manufacturing operator may provide feedback based on the production of the customized patient interface by the manufacturing equipment 142. For example, the manufacturing operator may inspect the manufactured patient interface and input defects in the patient interface caused by the manufacturing process.

[0714] Feedback from users, clinicians, and / or manufacturing operators may be used (e.g., via artificial intelligence and / or machine learning algorithms) to modify manufacturing specifications and / or update models used to identify key point features and / or their locations, identify relationships between key point features, and / or identify manufacturing specifications.

[0715] 5.6RPT device

[0716] 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, 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.

[0717] 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.

[0718] The RPT device can have an outer housing 4010 formed of two parts: an upper part 4012 and a lower part 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.

[0719] 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 and a flow sensor.

[0720] One or more air path items may be located within a removable unitary structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0721] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. 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.

[0722] 5.6.1 Mechanical and pneumatic components of RPT device

[0723] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.

[0724] 5.6.1.1 Air filter

[0725] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0726] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0727] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0728] 5.6.1.2 Silencer

[0729] An RPT device according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120 .

[0730] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .

[0731] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0732] 5.6.1.3 Pressure generator

[0733] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may be capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, 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.

[0734] The pressure generator 4140 may be under the control of a therapy device controller.

[0735] In other forms, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0736] 5.6.1.4 Anti-overflow valve

[0737] In one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0738] 5.6.2RPT device algorithm

[0739] As described above, in some forms of the present technology, the central controller of the RPT device 4000 may be configured to implement one or more algorithms represented as computer programs stored in a non-transitory computer-readable storage medium such as a memory. Algorithms are typically grouped into groups called modules.

[0740] In other forms of the present technology, some or all of the algorithm may be implemented by a controller of an external device, such as a local external device or a remote external device. In this form, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm executed at the external device may be communicated to the external device via a local external communication network or a remote external communication network. In such forms, the portion of the algorithm to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute a portion of the algorithm.

[0741] In this form, therapy parameters generated by the external device via the therapy engine module (if so forming part of the algorithm executed by the external device) may be communicated to the central controller for transfer to the therapy control module.

[0742] 5.7 Air circuit

[0743] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to travel between two components (such as the RPT device 4000 and the patient interface 3000) in use.

[0744] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate branches of the circuit for inhalation and exhalation. In other cases, a single branch is used.

[0745] 5.8 Humidifier

[0746] 5.8.1 Humidifier Overview

[0747] 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.

[0748] 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.

[0749] 5.8.2 Humidifier components

[0750] 5.8.2.1 Water storage tank

[0751] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid to be evaporated (e.g., water) to humidify the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification at least for the duration of a respiratory therapy session, such as a night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0752] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0753] According to one form, the reservoir 5110 may be arranged, for example, along a Figure 5A and Figure 5B The sideways orientation is shown removed from the humidifier 5000.

[0754] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or among its subassemblies, such as when the reservoir 5110 is displaced and / or rotated from its normal operating orientation. Since the air flow to be humidified by the humidifier 5000 is generally pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure through leakage and / or flow resistance.

[0755] 5.8.2.2 Conductive part

[0756] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are also suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (e.g., having a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved with a material of appropriate geometry that has a lower conductivity.

[0757] 5.8.2.3 Humidifier reservoir base

[0758] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 5B), the humidifier reservoir base is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking feature, such as a locking rod 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0759] 5.8.2.4 Water level indicator

[0760] The humidifier reservoir 5110 may include FIG. 5A to FIG. 5B Water level indicator 5150 is shown. In some forms, water level indicator 5150 may provide a user (such as patient 1000 or a caregiver) with one or more indications regarding the amount of volume of water in humidifier reservoir 5110. The one or more indications provided by water level indicator 5150 may include an indication of a maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200 ml, 300 ml, or 400 ml.

[0761] 5.8.2.5 Heating elements

[0762] In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 may include a heat generating component, such as a resistive heating track. One suitable example of a heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0763] In some forms, the heating element 5240 may be disposed in the humidifier base 5006, wherein heat may be provided to the humidifier reservoir 5110 primarily by conduction, such as Figure 5B shown.

[0764] 5.9 Respiratory Waveform

[0765] Figure 6 A shows a typical breathing waveform model of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow. Although the parameter values ​​may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time Ti 1.6 s, peak inspiratory flow Qpeak 0.4L / s, exhalation time Te 2.4s, peak expiratory flow Qpeak -0.5L / s. The total duration of breathing Ttotal is about 4s. People usually breathe at a rate of about 15 breaths per minute (BPM), and the ventilation volume Vent is about 7.5L / minute. The typical duty cycle (the ratio of Ti to Ttot) is about 40%.

[0766] 5.10 Glossary

[0767] For the 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.

[0768] 5.10.1 General Concepts

[0769] Air: in some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.

[0770] Environment: In certain forms of the present technology, the term environment will be taken to mean both (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0771] For example, relative to the environment of the humidifier humidity This may be the humidity of the air directly surrounding the humidifier, such as the humidity in the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0772] In another example, ambient pressure may be the pressure immediately adjacent to or external to the body.

[0773] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, rather than, for example, noise generated by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0774] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the treatment pressure is automatically adjusted (eg, breath-by-breath) between a minimum and a maximum limit, depending on whether there is an indication of a SDB event.

[0775] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapy pressure may be substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the entrance to the airway is slightly higher during exhalation and slightly lower during inhalation. 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.

[0776] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate will be references to a scalar quantity, i.e., a quantity having only magnitude. In other cases, references to flow rate will be references to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate may be given by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow" or "airflow".

[0777] 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 device flow Qd is the flow of air leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas that reaches the patient interface via the air circuit. The ventilation flow Qv is the flow of air leaving the vent to allow washout of exhaled gases. The leakage flow Ql is the flow that leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0778] Flow Therapy: Respiratory therapy that involves delivering air flow to the airway entrance at a controlled flow rate, called the therapy flow, which is usually positive throughout the patient's respiratory cycle.

[0779] Humidifier: The term humidifier shall be deemed to mean a humidifying device constructed and arranged or physically configured to provide a therapeutically beneficial amount of water (H2O) vapor to an air flow to relieve a patient's medical respiratory condition.

[0780] Leak: The term leak is to be considered as unintended air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow leading to the environment.

[0781] Conducted noise (acoustics): Conducted noise in this document refers to the noise transmitted to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0782] Radiated noise (acoustics): Radiated noise in this document refers to the noise transmitted to the patient by the ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0783] Vent Noise (Acoustics): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent hole of a patient interface.

[0784] Oxygen-enriched air: air having an oxygen concentration greater than that of atmospheric air (21%), such as at least about 50% oxygen,...

Claims

1. A patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 4 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 ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapy pressure in the plenum chamber throughout a breathing cycle of the patient; a vent that allows gases exhaled by the patient to flow continuously from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; and wherein the seal-forming structure comprises a cushion, the cushion being deformable and resilient and being at least partially formed of a lattice structure; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered during use.

2. A patient interface according to claim 1, wherein the seal-forming structure includes a facial engaging membrane, which is configured to contact the patient's face, the facial engaging membrane is flexible and elastic, and at least partially covers the cushion during use.

3. A patient interface according to claim 2, wherein the patient interface includes a chassis portion that at least partially forms the inflatable chamber, the seal-forming structure is attached to and supported by the chassis portion, and the chassis portion is more rigid than the seal-forming structure.

4. A patient interface according to claim 3, wherein the face engaging membrane extends from the chassis portion.

5. A patient interface according to claim 3 or claim 4, wherein the facial engaging membrane is formed from an elastomeric material.

6. A patient interface according to any one of claims 3 to 5, wherein the cushion is positioned outside of the plenum chamber.

7. A patient interface according to any one of claims 3 to 6, wherein the patient interface includes a positioning and stabilizing structure, which is configured to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head when in use.

8. A patient interface according to claim 7, wherein the chassis portion and the seal-forming structure together form a cushion module that is removably attached to the positioning and stabilising structure.

9. A patient interface according to claim 8, wherein the patient interface includes a frame configured to connect the positioning and stabilizing structure to the cushion module.

10. A patient interface according to claim 9, wherein the cushion module is removably attached to the frame.

11. A patient interface according to claim 7 or claim 8, wherein the positioning and stabilizing structure includes a pair of gas delivery tubes, which are configured to provide the air flow to the inflatable chamber under therapeutic pressure and are configured to provide force to maintain the seal-forming structure in a sealing position during use.

12. A patient interface according to any one of claims 2 to 11, wherein the cushion is formed flat and is bent into a three-dimensional shape during assembly with the facial engaging membrane.

13. A patient interface according to any one of claims 1 to 11, wherein the cushion is formed into a three-dimensional shape.

14. A patient interface according to any one of claims 1 to 13, wherein the lattice structure is 3D printed.

15. A patient interface according to claim 14, wherein the mesh structure is 3D printed in a shape corresponding to a unique patient's face.

16. A patient interface according to any one of claims 1 to 13, wherein the lattice structure is injection moulded.

17. A patient interface according to any one of claims 1 to 13, wherein the lattice structure is formed from TPU.

18. A patient interface according to any one of claims 1 to 13, wherein the lattice structure is formed from silicone.

19. A patient interface according to any one of claims 1 to 18, wherein the lattice structure is formed from a material having a durometer hardness in the range of 20 Shore A to 80 Shore A.

20. A patient interface according to any one of claims 1 to 19, wherein the lattice structure comprises a two-dimensional structure.

21. A patient interface according to any one of claims 1 to 19, wherein the lattice structure comprises a three-dimensional structure.

22. A patient interface according to any one of claims 1 to 19, wherein the grid structure comprises one of the following structures: a fluorite structure, a truncated cube structure, an IsoTruss structure, a hexagonal honeycomb structure, a gyroid structure and a Schwarz structure.

23. A patient interface according to any one of claims 1 to 13 wherein the cushion is formed from a foam having holes therein forming the lattice structure.

24. A patient interface according to claim 23, wherein the size, shape and / or spacing of the apertures varies along the length of the cushion and / or between a first side of the cushion and a second side of the cushion.

25. A patient interface according to any one of claims 1 to 24, wherein the cushion includes one or more features that vary between different positions where the seal-forming structure engages the patient's face.

26. A patient interface according to claim 25, wherein the one or more characteristics of the cushion include the stiffness of the cushion.

27. A patient interface according to claim 25 or claim 26, wherein the one or more features of the cushion include one or more features of the lattice structure.

28. A patient interface according to any one of claims 25 to 27, wherein the one or more characteristics of the grid structure include the shape, thickness, density, spacing, relative orientation and / or material of the cells forming the grid structure.

29. A patient interface according to any one of claims 1 to 28, wherein the seal-forming structure is configured to seal to the patient's face at the top of the patient's lips, outside the patient's nose, and at the patient's nasal ridge.

30. A patient interface according to claim 29, wherein the cushion includes an upper lip portion, the upper lip portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the upper lip of the patient, the cushion includes a nasal portion side, the nasal portion side is disposed within a corresponding portion of the seal-forming structure, the corresponding portion of the seal-forming structure is configured to seal to the patient's face at each side of the patient's nose, and the cushion is stiffer at the nasal portion side than at the upper lip portion.

31. A patient interface according to claim 30, wherein the cushion includes a nasal ridge portion, the nasal ridge portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the patient's nasal ridge, and the cushion is stiffer on the nasal portion side than at the nasal ridge portion.

32. A patient interface according to any one of claims 1 to 28, wherein the seal-forming structure is configured to seal to the patient's face at the bottom of the patient's lips, at the patient's cheeks, at the outside of the patient's nose, and at the patient's nasal ridge.

33. A patient interface according to claim 32, wherein the cushion includes a lower lip portion, the lower lip portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the patient's lower lip, the cushion includes a pair of cheek portions, the pair of cheek portions are disposed within corresponding portions of the seal-forming structure, the corresponding portions of the seal-forming structure are configured to seal to the patient's face at the patient's cheeks, and the cushion is stiffer in the cheek portions than in the lower lip portion.

34. A patient interface according to claim 32 or claim 33, wherein the cushion includes a nasal portion side, the nasal portion side is disposed within a corresponding portion of the seal-forming structure, the corresponding portion of the seal-forming structure is configured to seal to the patient's face on the outside of the patient's nose, the cushion includes a nasal ridge area, the nasal ridge area is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the patient's nasal ridge, and the cushion is stiffer on the nasal portion side than on the nasal ridge portion.

35. A patient interface according to any one of claims 1 to 28, wherein the sealing forming structure is configured to seal to the patient's face at the lower portion of the patient's lips, at the patient's cheeks, at the upper portion of the patient's lips, and at the lower periphery of the patient's nose, the lower periphery of the patient's nose including the nostrils and the nasal protuberance area of ​​the patient's nose.

36. A patient interface according to claim 35, wherein the cushion includes a lower lip portion, the lower lip portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the patient's lower lip, the cushion includes a cheek portion, the cheek portion is disposed within a corresponding portion of the seal-forming structure, the corresponding portion of the seal-forming structure is configured to seal to the patient's face at the patient's cheek, and the cushion is stiffer in the cheek portion than in the lower lip portion.

37. A patient interface according to claim 35 or claim 36, wherein the cushion includes an upper lip portion, the upper lip portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the upper lip of the patient, the cushion includes a lower nasal peripheral portion, the lower nasal peripheral portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure being configured to seal to the patient's face at the lower periphery of the patient's nose, and the cushion is stiffer in the upper lip portion than in the lower nasal peripheral portion.

38. A patient interface according to any one of claims 1 to 28, wherein the sealing forming structure is configured to seal to the patient's face at the upper portion of the patient's lips, between the nasal wings and the nasolabial grooves, and at the lower periphery of the patient's nose, the lower periphery of the patient's nose including the nasal wings and the nasal protuberance area of ​​the patient's nose.

39. A patient interface according to claim 38, wherein the cushion includes an upper lip portion, the upper lip portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the upper lip of the patient, the cushion includes a pair of rear corner portions, the pair of rear corner portions are disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face between the nose wing and the nasolabial groove, and the cushion is stiffer in the rear corner portions than in the upper lip portion.

40. A patient interface according to claim 39, wherein the cushion includes a lower nasal peripheral portion, the lower nasal peripheral portion is disposed within a portion of the seal-forming structure, the portion of the seal-forming structure is configured to seal to the patient's face at the lower periphery of the patient's nose, and the cushion is stiffer in the rear corner portion than in the lower nasal peripheral portion.

41. A patient interface according to any one of claims 1 to 40, wherein the grid structure includes a plurality of cells, the grid structure including one or more features, the one or more features varying between a patient-facing side of the cushion and a non-patient-facing side of the cushion, the patient-facing side of the cushion corresponding to a side of the sealing forming structure configured to contact the patient's face during use, and the non-patient-facing side of the cushion corresponding to a side of the sealing forming structure configured to face away from the patient's face during use.

42. A patient interface according to claim 41, wherein the grid structure on the patient-facing side of the cushion is configured to avoid leaving red marks on the patient's face.

43. A patient interface according to claim 41 or claim 42, wherein the grid structure of the non-patient-facing side of the cushion is configured to easily adapt to the shape of the patient's face.

44. A patient interface according to any one of claims 41 to 43, wherein the cells of the patient-facing side are smaller than the cells of the non-patient-facing side.

45. A patient interface according to any one of claims 41 to 44, wherein the variation in the one or more characteristics of the lattice structure causes the pad to be less stiff on the patient-facing side of the pad than on the non-patient-facing side of the pad.

46. ​​A patient interface according to any one of claims 41 to 45, wherein the material of the cells forming the grid structure is thinner on the patient-facing side of the pad than on the non-patient-facing side of the pad.

47. A patient interface according to any one of claims 41 to 46, wherein the material forming the cells of the grid structure has a thickness in the range of 0.3mm to 0.5mm on the patient-facing side of the pad.

48. A patient interface according to any one of claims 41 to 47, wherein the material forming the cells of the grid structure has a thickness in the range of 0.8 mm to 1.2 mm on the non-patient facing side of the pad.

49. A patient interface according to any one of claims 1 to 40, wherein the lattice structure includes one or more features that vary along the length of the cushion, wherein in use, the cushion receives a distributed load applied to a non-patient-facing side of the cushion along the length of the cushion, and wherein due to the variation in the one or more features, the cushion applies different distributed loads to the patient's face along the length of the cushion.

50. A patient interface according to claim 49, wherein the grid structure includes one or more features that vary at and / or near locations corresponding to sensitive facial features on the patient's face.

51. A patient interface according to claim 50, wherein said change in said one or more characteristics causes said cushion to apply less pressure on said sensitive facial feature during use than would be applied in the absence of said change in said one or more characteristics.

52. A patient interface according to claim 50 or claim 51, wherein the change in one or more characteristics causes the pressure applied by the cushion on the sensitive facial feature during use to be less than the pressure applied by the cushion to the patient's face around the sensitive facial feature.

53. A patient interface according to any one of claims 50 to 52, wherein said variation in said one or more characteristics of said lattice structure results in lower stiffness in said cushion at and / or near said location corresponding to said sensitive facial feature.

54. A patient interface according to any one of claims 1 to 40, wherein the cushion includes a recess configured to align with a sensitive facial feature on the patient's face during use, the recess being shaped to accommodate the sensitive facial feature.

55. A patient interface according to claim 54, wherein the recess is shaped to provide a gap between the cushion and the sensitive facial feature in an undeformed state.

56. A patient interface according to any one of claims 1 to 40, wherein the cushion includes one or more force redistribution features, which are configured to redirect, during use, forces received on a non-patient-facing side of the cushion in an area of ​​the cushion aligned with a sensitive facial feature to at least partially one or more areas of the cushion that are adjacent to or spaced apart from the sensitive facial feature.

57. A patient interface according to claim 56, wherein the one or more force redistribution features include a beam structure located within the pad, the beam structure being positioned to span, during use, from a first area of ​​the pad located on a first side of the sensitive facial feature, to a second area of ​​the pad covering the sensitive facial feature, and into a third area of ​​the pad located on a second side of the sensitive facial feature.

58. A patient interface according to claim 56, wherein at least one of the one or more force redistribution features comprises a reinforced area within the pad, the reinforced area being stiffer than one or more adjacent areas within the pad, the reinforced area being positioned to span, during use, from a first area of ​​the pad located on a first side of the sensitive facial feature, to a second area of ​​the pad covering the sensitive facial feature, and into a third area of ​​the pad located on a second side of the sensitive facial feature, the reinforced area being reinforced by changes in one or more characteristics of the grid structure at the reinforced area.

59. A patient interface according to claim 58, wherein the changes in one or more characteristics of the grid structure include changes in the shape, thickness, density, spacing, relative orientation and / or material of the cells forming the grid structure.

60. A patient interface according to claim 58 or claim 59 wherein the cushion is stiffer near the patient's face in the first and third regions than in the second region.

61. A patient interface according to any one of claims 56 to 60, wherein the sensitive facial feature is a nasal ridge of the patient.

62. A patient interface according to any one of claims 2 to 40 when dependent on claim 2, wherein the patient-facing side of the cushion is defined by cells of the grid structure that are exposed to contact the facial engaging membrane.

63. A patient interface according to any one of claims 2 to 40 when dependent on claim 2, wherein the cushion comprises a uniform surface on the patient-facing side of the cushion covering the cells of the grid structure.

64. A patient interface according to claim 63, wherein the uniform surface is formed integrally with the cells of the grid structure.

65. A patient interface according to any one of claims 1 to 64, wherein the cushion is configured to be removable from the patient interface.

66. A patient interface according to any one of claims 1 to 65, wherein at least some of the air flow through the plenum flows through the lattice structure forming the cushion.

67. A patient interface according to claim 66, wherein the cushion forms a heat and moisture exchanger.

68. A patient interface according to claim 66 or 67, wherein the cushion covers the plenum chamber inlet port.

69. A patient interface according to any one of claims 66 to 68, wherein the cushion fills a majority of the space in the plenum chamber.

70. A patient interface for delivering a flow of air to a patient to treat sleep disordered breathing, the patient interface comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 4 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 ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to a nares of the patient, the seal-forming structure constructed and arranged, in use, to maintain the therapy pressure in the plenum chamber throughout a breathing cycle of the patient; and wherein the seal-forming structure comprises a gasket having a plurality of interconnected struts forming a plurality of voids, Wherein, in use, when the seal-forming structure is engaged with the patient's face, the struts are configured to flex, thereby changing the size, shape and / or orientation of the voids to allow the cushion to conform to the patient's face.

71. A patient interface according to claim 70, wherein the struts are resilient.

72. A patient interface according to any one of claims 70 and 71, wherein characteristics of the pad vary across the pad such that the characteristics are different in a first portion of the pad than in a second portion of the pad, the first portion of the pad having a different degree of flexibility than the second portion of the pad.

73. A patient interface according to claim 72, wherein the characteristics of the cushion are: 1) the thickness of the struts; 2) the density of the struts; 3) the orientation of the struts; 4) the spacing of the struts; 5) the size of the voids; 6) the orientation of the voids; and / or 7) the density of the voids.

74. A patient interface according to claim 73, wherein the thickness of the struts in the first portion of the cushion is different from the thickness of the struts in the second portion of the cushion.

75. A patient interface according to claim 73 wherein the dimensions of the voids in the first portion of the cushion are different than the dimensions of the voids in the second portion of the cushion.

76. A patient interface according to any one of claims 72 to 75, wherein the first portion of the cushion corresponds to a sensitive facial feature of the patient and the second portion of the cushion does not correspond to a sensitive facial feature.

77. A patient interface according to claim 76, wherein the sensitive facial feature is a nasal ridge of the patient.

78. A patient interface according to any one of claims 72 to 76, wherein the first portion of the cushion has greater flexibility than the second portion of the cushion.

79. A patient interface according to any one of claims 70 to 78, wherein the struts and the voids form a lattice structure.

80. A patient interface according to any one of claims 70 to 79 wherein the cushion is not formed from a foam material.

81. A patient interface according to any one of claims 70 to 79 wherein said cushion is constructed of a foam material and has a plurality of macropores formed therein to form said voids.

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