CN119894559A

CN119894559A - Patient interface and cushion therefor

Info

Publication number: CN119894559A
Application number: CN202380064034.4A
Authority: CN
Inventors: A·J·贝特; V·格雷; M·C·霍格; S·J·瓦格纳; J·袁; A·S·戴维森; I·A·劳
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2022-07-14
Filing date: 2023-07-14
Publication date: 2025-04-25
Also published as: EP4554643A1; WO2024011290A1

Abstract

A patient interface, the patient interface comprising: an inflatable chamber; a seal-forming structure constructed and arranged to form a seal with an area of a patient's face surrounding an entrance to the patient's airway; a vent that allows gas exhaled by the patient to flow continuously from the interior of the inflatable chamber to the environment. The seal-forming structure may include a cushion that is deformable and resilient and is at least partially formed of a mesh structure.

Description

Patient interface and cushion therefor

Cross Reference to Related Applications

The application claims the benefit of australian patent application 2022901964 filed on 7.14 of 2022, the entire contents of which are incorporated herein by reference.

Background

2.1 Technical field

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

2.2 Description of related Art

2.2.1 Human respiratory system and disorders thereof

The respiratory system of the human body promotes gas exchange. The nose and mouth form the entrance to the airway of the patient.

The airway includes a series of branches that become narrower, shorter, and more as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to move in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is the location where gas exchange occurs and is referred to as the respiratory region. See 9 th edition of respiratory physiology (Respiratory Physiology) by John b.west published by the liberty, williams and Wilkins groups (Lippincott Williams & Wilkins) 2012.

There are a range of respiratory disorders. Certain diseases may be characterized by specific events such as apneas, hypopneas, and hyperbreaths.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), tidal breathing (CSR), respiratory insufficiency, obese Hyperventilation Syndrome (OHS), chronic Obstructive Pulmonary Disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by events that include the occlusion or blockage of the upper air passage during sleep. It results from the combination of abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall areas during sleep. The condition stops the breathing of the affected patient, typically for a period of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This condition often results in excessive daytime sleepiness, and may lead to cardiovascular disease and brain damage. This syndrome is a common disorder, particularly in overweight men in middle age, but the affected person may not be aware of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Tidal breathing (CSR) is another form of sleep disordered breathing. CSR is an obstacle to the respiratory control center of a patient, where there is a rhythmic alternating period of fluctuation in respiratory intensity known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR may be detrimental due to insufficient repetitive oxygen. In some patients, CSR is associated with repeated arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is a covered term for respiratory disorders in which the lungs cannot inhale enough oxygen or exhale enough CO2 to meet the needs of the patient. Respiratory failure may encompass some or all of the following disorders.

Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath while exercising.

Obesity Hyperventilation Syndrome (OHS) is defined as a combination of severe obesity when there are no other known causes of hypoventilation and chronic hypercapnia when awake. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have some common features. These characteristics include increased airflow resistance, prolonged expiratory phases of respiration, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (major risk factor), occupational exposure, air pollution and genetic factors. Symptoms include effort dyspnea, chronic cough, and sputum production.

Neuromuscular disease (NMD) is a broad term that encompasses many diseases and afflictions that impair muscle function either directly by intrinsic muscle pathology or indirectly by neuropathology. Some NMD patients are characterized by progressive muscle damage that results in loss of walking ability, wheelchairs, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as fast-progressive and slow-progressive (i) disorders characterized by muscle damage worsening over months and leading to death within years (e.g., amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD) in teenagers; ii) variable or slow-progressive disorders characterized by muscle damage worsening over years and only slightly shortening the life expectancy (e.g., limb banding, facial shoulder humerus, and tonic muscular dystrophy).

Chest wall disorders are a group of thoracic deformities that result in an inefficient coupling between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercarbonated respiratory failure. Scoliosis and/or kyphosis may lead to severe respiratory failure. Symptoms of respiratory failure include dyspnea during exercise, peripheral edema, sitting breathing, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

A range of therapies have been used to treat or ameliorate such conditions. In addition, other healthy individuals may utilize such therapies to prevent the occurrence of respiratory disorders. However, these therapies have a number of drawbacks.

2.2.2 Therapy

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 respiratory disorders described above.

2.2.2.1 Respiratory pressure therapy

Respiratory pressure therapy is the application of air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as tank ventilators or ducted ventilators).

Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is to act as a pneumatic splint for continuous positive airway pressure and may 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 may be voluntary, so if the patient finds the device for providing such therapy to be one or more of uncomfortable, difficult to use, expensive, and unsightly, the patient may choose to not follow the therapy.

2.2.3 Respiratory therapy System

These respiratory therapies may be provided by a respiratory therapy system or apparatus. Such systems and devices may also be used to screen, diagnose, or monitor conditions without treatment thereof.

The 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.

Another form of therapy system is a mandibular reduction device.

2.2.3.1 Patient interface

The patient interface may be used to couple the breathing apparatus to its wearer, for example by providing an air flow to the inlet of the airway. The air flow may 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 airway via an aero-cut tube. Depending on the therapy to be applied, the patient interface may form a seal with an area, such as the patient's face, to facilitate delivering the gas at a pressure that is sufficiently different from ambient pressure (e.g., a positive pressure of about 10cmH ₂ O relative to ambient pressure) to achieve the therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10cmH ₂ O. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nostrils, but explicitly avoid a complete seal. One example of such a patient interface is a nasal cannula.

Some other mask systems may not be functionally suitable for use in the art. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving may be configured to prevent ingress of water at higher pressure from the outside, but not to maintain the internal air at a pressure above ambient pressure.

Certain masks may be clinically disadvantageous to the present technique, for example if they block the flow of air through the nose and only allow it to pass through the mouth.

If a patient is required to insert a portion of the mask structure in their mouth to create and maintain a seal with their lips, some masks may be uncomfortable or impractical for the present technique.

Some masks may be impractical to use while sleeping, such as when lying on the side in a bed and the head sleeping on a pillow.

The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may be moved relative to the other bones of the skull. The entire head may move during the course of the respiratory therapy session.

Because of these challenges, some masks suffer from one or more of the disadvantages of being obtrusive, unsightly, expensive, poorly fitting, difficult to use, and/or uncomfortable, particularly when worn for a long period of time or when the patient is unfamiliar with the system. Wrong sized masks may result in 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 administration of anesthetics are tolerable for their original application, but nonetheless such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may lead to reduced patient compliance with the therapy. This is especially true if the mask is worn during sleep.

CPAP therapy is very effective in treating certain respiratory disorders, provided that the patient is compliant with the therapy. If the mask is uncomfortable or difficult to use, the patient may not be in compliance with the therapy. Because patients are often advised to regularly clean their masks, if the masks are difficult to clean (e.g., difficult to assemble or disassemble), the patients may not be able to clean their masks, and this may affect patient compliance.

While masks for other applications (e.g., navigator) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

For these reasons, patient interfaces for delivering CPAP during sleep form a different field.

2.2.3.1.1 Seal forming structure

The patient interface may include a seal-forming structure. Because 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.

The patient interface may be characterized in part by the design intent of the seal-forming structure to engage the face in 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 naris and a second sub-portion that forms a seal around the right naris. In one form of the patient interface, the seal-forming structure may comprise a single element which in use surrounds both nostrils. Such a single element may be designed to cover, for example, the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming structure may comprise an element that in use surrounds the mouth region, for example by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may comprise a single element that in use surrounds the nostrils and mouth regions. These different types of patient interfaces may be variously named by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral-nasal masks.

Effective seal-forming structures in one region of a patient's face may be inadequate in another region, for example due to different shapes, structures, variability and sensitivity regions of the patient's face. For example, a seal on swimming goggles covering the forehead of a patient may not be suitable for use on the nose of a patient.

Certain seal-forming structures may be designed for mass production so that one design can conform to 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 the mass-produced patient interface, one or both must be adjusted to form the seal.

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 comprise an air or fluid filled gasket, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is 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 the seal.

Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the mask to provide self-sealing against the patient's face when positive pressure is applied within the mask. Similar to the seal-forming portions of the previous versions, if the fit between the face and mask is not good, additional force may be required to achieve the seal, otherwise the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may buckle or flex during use, thereby causing leakage.

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

Another form of seal-forming structure may use an adhesive to effect the seal. Some patients may find it inconvenient to apply and remove adhesive to their face often.

A series of patient interface seal forming construction techniques are disclosed in the following patent applications assigned to Raschmez Inc. (RESMED LIMITED), WO 1998/004,310, WO 2006/074,513, WO 2010/135,785.

One form of nasal pillow is found in Adam Circuit (Adam Circuit) manufactured by Tascow corporation (Puritan Bennett). Another nasal pillow or nasal spray is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Tascow corporation (Puritan-Bennett Corporation).

The rui mex company has manufactured products that incorporate nasal pillows, SWIFTTM nasal pillow masks, SWIFTTMII nasal pillow masks, SWIFTTM LT nasal pillow masks, SWIFTTM FX nasal pillow masks, and MIRAGE LIBERTYTM full face masks. Examples of nasal pillows are described in International patent application WO2004/073,778 (which describes in particular aspects of the nasal pillow of Ramez Inc. SWIFTTM), U.S. patent application 2009/0044808 (which describes in particular aspects of the nasal pillow of Ramez Inc. SWIFTTM LT), international patent applications WO 2005/063,328 and WO 2006/130,903 (which describes in particular aspects of the face mask of Ramez Inc. MIRAGE LIBERTYTM), and International patent application WO 2009/052,560 (which describes in particular aspects of the nasal pillow of Ramez Inc. SWIFTTM FX).

2.2.3.1.2 Positioning and stabilization

A seal-forming structure for a patient interface for positive air pressure therapy is subjected to counter stress by air pressure to break the seal. Thus, various techniques have been used to position the seal-forming structure and maintain it in sealing relation with the appropriate portion of the face.

One technique is to use an adhesive. See, for example, U.S. patent application publication No. US2010/0000534. However, the use of adhesives may be uncomfortable for some people.

Another technique is to use one or more straps and/or stabilizing straps. Many such belts suffer from one or more of poor fit, bulkiness, discomfort, and inconvenience in use.

2.2.3.1.3 Pressurized air conduit

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 the conduit extends forward from the patient's face when the patient interface is positioned on the patient's face during use. This may sometimes be referred to as a "tube down" configuration.

Some patients find such interfaces unsightly or create claustrophobia sensations and thus prevent wearing them, reducing patient compliance. Additionally, catheters connected to the anterior interface of the patient's face may sometimes become easily entangled with bedding.

2.2.3.1.4 Pressurized air conduit for locating/stabilizing seal forming structure

An alternative type of treatment system that seeks to address these problems includes a patient interface in which a 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 "catheter headgear" or "headgear tubing. Such a patient interface allows a conduit in an air circuit providing a flow of pressurized air from the respiratory pressure therapy device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. patent publication No. US2007/0246043, the contents of which are incorporated herein by reference, wherein a catheter is connected to a tube in a patient interface through a port that is positioned on top of the patient's head in use.

Patient interfaces incorporating headgear tubing may provide advantages, such as avoiding a catheter connected to the patient interface in front of the patient's face, which may be unsightly and obtrusive. However, it is desirable that a patient interface incorporating headgear tubing be able to be comfortable for a patient to wear for extended periods of time while forming an airtight and stable seal with the patient's face while also being able to conform to a range of patient head shapes and sizes.

2.2.3.2 Respiratory Pressure Therapy (RPT) device

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the above-described therapies, such as by operating the device to generate an air stream for delivery to an interface of an airway. The air flow may be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, the RPT device may also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

The designer of the device may be faced with an unlimited number of choices. Design criteria often conflict, meaning that some design choices go beyond routine or unavoidable. Furthermore, certain aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

2.2.3.3 Air Loop

An air circuit is a conduit or tube 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 inhalation and exhalation. In other cases, a single branched air circuit is used for both inhalation and exhalation.

2.2.3.4 Humidifier

Delivering the air flow without humidification may result in airway dryness. A humidifier with an RPT device and patient interface is used to generate humidified gases that minimize drying of nasal mucosa and increase patient airway comfort. In addition, in colder climates, warm air, which is typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

2.2.3.5 Data management

There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy has "complied with," e.g., the patient has used his RPT device according to one or more "compliance rules. An example of a compliance rule for CPAP therapy is to require the patient to use the RPT device for at least four hours per night for at least 21 or 30 consecutive days in order to consider the patient to be compliance. To determine patient compliance, a provider of the RPT device (such as a healthcare provider) may manually obtain data describing the therapy of the patient using the RPT device, calculate usage over a predetermined period of time, and compare to compliance rules. Once the healthcare provider has determined that the patient has used his RPT device according to compliance rules, the healthcare provider may notify third parties of the patient's compliance.

Patient therapy may have other aspects that benefit from communicating therapy data to a third party or external system.

Existing processes of communicating and managing such data may present one or more of the problems of high cost, long time consumption, and error-prone.

2.2.3.6 Ventilation technique

Some forms of treatment systems may include vents to allow for flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (e.g., plenum) of the patient interface to an exterior space of the patient interface, such as into the environment.

2.2.4 Screening, diagnostic and monitoring System

Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disease and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalograms (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for the treatment of sleep disordered breathing involves two-night observations of the patient at the clinic, one night with a pure diagnosis and the second night with a titration of therapeutic parameters by the clinician. Thus, PSG is both expensive and inconvenient. In particular, it is not suitable for in-home screening/diagnosis/monitoring of sleep disordered breathing.

Screening and diagnosis generally describes the identification of a disorder based on its signs and symptoms. Screening typically gives true/false results indicating whether the patient's SDB is so severe that further investigation is required, and diagnosis may yield clinically actionable information. Screening and diagnosis are often disposable procedures, while monitoring the progress of a condition may continue indefinitely. Some screening/diagnostic systems are only suitable for screening/diagnosis, while some may also be used for monitoring.

Clinical professionals may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or where the patient may not be charged with the cost of the clinical expert. Different clinical professionals may not agree on the condition of the patient. Furthermore, a given clinical expert may apply different criteria at different times.

Disclosure of Invention

The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating, or preventing a respiratory disorder.

An aspect of certain forms of the present technology is to provide methods and/or devices that improve patient compliance with respiratory therapy.

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

3.1 Gasket with grid Structure

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

A plenum capable of being pressurized to a therapeutic pressure of at least 4cmH ₂ O above ambient air pressure, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

A seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an inlet of the patient's airway, the seal-forming structure having an aperture therein such that the air flow at the therapeutic pressure is delivered to at least one inlet of the patient's nostrils, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

A vent allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the environment, said vent being sized and shaped to maintain the therapeutic pressure in the plenum in use, and

Wherein the seal-forming structure comprises a cushion that is deformable and resilient and is at least partially formed from a lattice structure;

wherein the patient interface is configured to allow the patient to breathe from the environment through the mouth thereof in the absence of a flow of pressurized air through the plenum inlet port, or the patient interface is configured such that the patient's mouth is uncovered in use.

In the example:

The seal-forming structure comprising 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;

The patient interface comprising a chassis portion at least partially forming the plenum chamber, the seal-forming structure being attached to and supported by the chassis portion, the chassis portion being more rigid than the seal-forming structure;

The face-engaging film extending from the chassis portion;

the face-engaging film is formed of an elastomeric material;

The liner is positioned outside the plenum;

The patient interface comprising a positioning and stabilizing structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head;

The chassis portion and the seal-forming structure together form a cushion module removably attached to the positioning and stabilizing structure;

the patient interface comprising a frame configured to connect the positioning and stabilizing structure to the cushion module;

The cushion module is removably attached to the frame;

The positioning and stabilizing structure includes a pair of gas delivery tubes configured to provide the air flow to the plenum at a therapeutic pressure and configured to provide a force to hold the seal-forming structure in a sealed position;

the cushion is formed flat and is bent into a three-dimensional shape during assembly with the face-engaging film, and/or

The pad is formed in a three-dimensional shape.

In further examples:

The grid structure is 3D printed;

the mesh structure is 3D printed in a shape corresponding to the unique patient face;

the mesh structure is injection molded;

The mesh structure is formed of TPU;

the lattice structure is formed of silicone;

The mesh structure is formed of a material having a durometer hardness in the range 20 shore a to 80 shore a;

the grid structure comprises a two-dimensional structure;

the grid structure comprises a three-dimensional structure;

The lattice structure includes one of a fluorite structure, a truncated cube structure, a composite bundle tube (isotrus) structure, a hexagonal honeycomb structure, a spiral icosahedron (gyroid) structure, and a Schwarz (Schwarz) structure;

The cushion is formed of foam having cells therein forming the lattice structure, and/or

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

In further examples:

The cushion comprising one or more features that vary between different positions at which the seal-forming structure engages the patient's face;

The one or more characteristics of the cushion include the stiffness of the cushion;

The one or more characteristics of the pad include one or more characteristics of the mesh structure;

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

The seal-forming structure is configured to seal to the patient's face at the upper lip of the patient, outside the patient's nose, and at the patient's nasal ridge;

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 an upper lip of the patient, the cushion comprising a nose portion side disposed within a corresponding portion of the seal-forming structure configured to seal to the patient's face at each side of the patient's nose, and the cushion being stiffer at the nose portion side than at the upper lip portion.

The cushion comprising a nose ridge portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at the patient's nose ridge, and the cushion being stiffer on the nose portion side than at the nose ridge portion;

The seal-forming structure is configured to seal to the patient's face at the patient's lower lip, at the patient's cheek, outside the patient's nose, and at the patient's nasal ridge;

The cushion comprising a lower lip portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure configured to seal to the patient's face at the lower lip of the patient, the cushion comprising a pair of cheek portions disposed within respective portions of the seal-forming structure, the respective portions of the seal-forming structure configured to seal to the patient's face at the cheek of the patient, and the cushion being stiffer in the cheek portions than in the lower lip portion;

The cushion comprises a nose portion side disposed within a respective portion of the seal-forming structure configured to seal to the patient's face outside the patient's nose, the cushion comprising a nose ridge region disposed within a portion of the seal-forming structure configured to seal to the patient's face at the patient's nose ridge, and the cushion is more rigid at the nose portion side than at the nose ridge portion.

The seal-forming structure is configured to seal to the patient's face at the patient's lower lip, at the patient's cheek, at the patient's upper lip, and at the patient's lower periphery of the patient's nose, the lower periphery of the patient's nose including the nasal wings and the nasal projection region of the patient's nose;

The cushion comprising a lower lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at a lower lip portion of the patient, the cushion comprising 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 more rigid in the cheek portion than in the lower lip portion;

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 an upper lip of the patient, the cushion comprises a lower nasal peripheral portion disposed within a portion of the seal-forming structure 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.

The seal-forming structure is configured to seal to the patient's face at the patient's upper lip, between the alar and the nasolabial fold, and at the patient's lower periphery of the patient's nose, the lower periphery of the patient's nose including the alar and the nose cone region of the patient's nose;

The cushion including an upper lip portion disposed within a portion of the seal-forming structure, the portion of the seal-forming structure configured to seal to the patient's face at the upper lip of the patient, the cushion including a pair of rear corner portions disposed within a portion of the seal-forming structure, the portion of the seal-forming structure configured to seal to the patient's face between the nose wing and the nose-lip groove, and the cushion being stiffer in the rear corner portions than in the upper lip portion, and/or

The cushion includes a lower nasal peripheral portion disposed within a portion of the seal-forming structure 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.

In further examples:

The mesh structure comprising one or more features that vary between a 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 a 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;

The grid structure on the patient facing side of the cushion is configured to avoid leaving a red imprint on the patient's face;

the mesh structure of the non-patient-facing side of the cushion is configured to easily adapt to the shape of the patient's face;

the grid structure comprising cells that are smaller on the patient-facing side than on the non-patient-facing side;

The change in the one or more characteristics of the mesh structure results in the cushion being less stiff on the patient-facing side of the cushion than on the non-patient-facing side of the cushion;

The material forming the cells of the grid structure is thinner at the patient-facing side of the cushion than at the non-patient-facing side of the cushion;

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 cushion;

The material forming the cells of the grid structure has a thickness in the range of 0.8mm to 1.2mm (such as 1 mm) on the non-patient facing side of the cushion;

the mesh structure comprising one or more features that vary along a length of the cushion, wherein in use the cushion receives a distributed load applied to a non-patient-facing side of the cushion along said length of the cushion, and wherein the cushion applies a different distributed load to the patient's face along said length of the cushion due to the variation of the one or more features;

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;

the change in the one or more characteristics results in the cushion exerting less pressure on the sensitive facial feature in use than would be exerted without the change in the one or more features;

The change in the one or more characteristics results in the cushion exerting less pressure on the sensitive facial feature in use than the cushion exerting about the sensitive facial feature to the patient's face;

The change in the one or more characteristics of the mesh structure results in a lower stiffness in the cushion at and/or near the location corresponding to the sensitive facial feature;

the cushion comprising a recess configured to align, in use, with a sensitive facial feature on the patient's face, the recess being shaped to receive the sensitive facial feature;

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

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

The one or more force redistribution features comprise a beam structure located 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;

At least one of the one or more force redistribution features comprises a stiffening region within the cushion that is stiffer than one or more adjacent regions within the cushion, the stiffening 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 that covers the sensitive facial feature, and into a third region of the cushion located on a second side of the sensitive facial feature, the stiffening region being stiffened by a change in one or more characteristics of the lattice structure at the stiffening region;

the variation of the one or more features of the lattice structure includes variations in shape, thickness, density, spacing, relative orientation, and/or material of the cells forming the lattice structure;

the cushion being stiffer in the first and third regions near the patient's face than in the second region;

the sensitive facial feature is the patient's nasal ridge;

The patient facing side of the cushion is defined by the cells of the mesh structure that are exposed to contact the face-engaging film;

the cushion comprises a uniform surface on the patient facing side of the cushion covering the cells of the grid structure, and/or

The uniform surface is integrally formed with the cells of the grid structure.

In further examples:

The cushion is removable from the patient interface;

At least some of the air flow through the plenum flows through the mesh structure forming the liner;

The gasket forms a heat-moisture exchanger (HMX);

The gasket covering the plenum inlet port, and/or

The liner fills most of the space of the plenum.

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 is capable of being pressurized to a therapeutic pressure of at least 4cmH2O above ambient air pressure, the plenum including a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration. The seal-forming structure is 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 air flow at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.

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

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

In further examples, (a) the strut is resilient, (b) the 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 that 1) the thickness of the strut, 2) the density of the strut, 3) the orientation of the strut, 4) the spacing of the struts, 5) the size of the void, 6) the orientation of the void, and/or 7) the density of the void, (d) the thickness of the strut in the first portion of the cushion is different than the thickness of the strut in the second portion of the cushion, (e) the size of the void in the first portion of the cushion is different than 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 of the patient, (g) the orientation of the void is the void, 6) the thickness of the strut in the first portion of the cushion is different than the thickness of the strut in the second portion of the cushion, and/or (i) the second portion of the cushion has a more flexible mesh than the second portion of the void.

In further 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.

In another aspect of the disclosed technology, a patient interface includes a seal-forming structure having a cushion that resembles a blister pack.

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

In further 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.

In further examples, the hinge portions are thinned regions (e.g., living hinges).

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

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.

3.2 Automatic sizing

One form of the present technique includes automatically sizing components of a patient interface (also referred to hereinafter as a "face interface") that interfaces with a patient's face without the assistance of a trained individual or other person.

Another aspect of one form of the present technology is to automatically measure facial features of an object (e.g., patient/user) based on data collected from the user.

Another aspect of one form of the present technology is to automatically recommend facial interface dimensions based on a comparison between data collected from a user and corresponding data records.

Another aspect of one form of the present technology is to automatically recommend custom facial interface dimensions based on data collected from a user. Based on the facial geometry of a given user, the customized facial interface may be unique to the given user.

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

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

Some versions of the technology include automated methods for selecting a face interface based on face interface dimensions. 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 include one or more facial features of an intended user of the facial interface that are associated with predetermined reference features of known dimensions. 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 an aspect of the one or more facial features detected in the image based on the predetermined reference feature. The method may include selecting a face interface size from a set of standard face interface sizes based on a comparison between the measured aspects of the one or more face features and data record related size information for the set of standard face interface sizes and the measured aspects of the one or more face features.

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 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 a value of the measured aspect using the anthropometric correction factor. The anthropometric correction factor may be calculated based on the face interface return data. The method may include calculating 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. 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 size of the coin in the captured image data and a detected pixel count of the detected coin. The detected pixel count of the detected coin may be adapted to the width of the ellipse of the coin. The predetermined reference feature may be the cornea or iris of the user.

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 live action preview of the content detected by the image sensor. The content may include the reference feature displayed on the display interface. The method may include controlling the capturing of the image data to meet at least one alignment condition. The at least one alignment condition may include detecting a position of the reference feature of the live action preview within a frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within about +/-10 degrees of the up-down extension axis. The at least one alignment condition may include detecting a tilt condition within about +/-5 degrees of the up-down extension axis. Detection of the tilt condition may be performed by reading an Inertial Measurement Unit (IMU).

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

Some versions of the present technology include a system for automatically recommending face interface dimensions that are 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 the computing device over a network. The one or more servers may be configured to receive image data captured by the image sensor, wherein the captured image data may include one or more facial features of an intended user of the facial interface, the one or more facial features being associated with predetermined reference features having known dimensions. The one or more servers may be configured to detect 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 features. The one or more servers may be configured to select a face interface size from a set of standard face interface sizes based on a comparison between the measured aspects of the one or more facial features and data record related size information for the set of standard face interface sizes and the measured aspects of the one or more facial features.

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 values of the measured aspects based on scaling factors derived from the reference features. The one or more servers may be configured to adjust the value of the measured aspect using the anthropometric correction factor. The anthropometric correction factor may be calculated based on the face 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 comprise 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 a 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 the detected pixel count of the detected coin. The detected pixel count of the detected coin may be adapted to the width of the ellipse of the coin. The predetermined reference feature may be the cornea of the user.

In some versions, the system may include the computing device. The computing device may be configured to generate, for image capture, a display of the reference feature on a display interface of a display device couplable to the image sensor. The display interface may include a positioning guide and a live 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 capture of the image data to satisfy at least one alignment condition. The at least one alignment condition may include detecting a position of the reference feature of the live action preview within a frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within about +/-10 degrees of the up-down extension axis. The at least one alignment condition may include detecting a tilt condition within about +/-5 degrees of the up-down extension axis. Detection of the tilt condition may be performed by reading an Inertial Measurement Unit (IMU).

In some versions, the predetermined reference feature may include a QR code. In some cases, to process image pixel data, the one or more servers may be configured to perform pixel counts. The one or more servers may be configured to generate automated electronic offers 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 from the plurality of captured images of the facial feature. The one or more servers may be configured to communicate the selected face interface size to the computing device over the network. Optionally, the server may be configured to automatically recommend custom face interface dimensions based on data collected from the user, and the custom face interface may be unique to a given user based on the face geometry of the given user.

Some versions of the present technology include a system for automatically recommending face interface dimensions that are complementary to facial features of a particular user. 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 the user that are associated with predetermined reference features of known dimensions. The image data may be captured using an image sensor. The mobile computing device may be configured to detect 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 an aspect 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 face interface size from a set of standard face interface sizes based on a comparison between the measured aspects of the one or more facial features and data record related size information for the set of standard face interface sizes and the measured aspects of the one or more facial features.

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 a 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 the human measurement correction factor. The anthropometric correction factor may be calculated based on the face 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 a 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 from the known size of the coin in the captured image data and a detected pixel count of the detected coin. The detected pixel count of the detected coin may be adapted to the width of the ellipse of the coin. In some versions, the predetermined reference feature may be the cornea or iris of the user.

The mobile computing device may be configured to generate, for image capture, a display of the reference feature on a display interface of a display device coupleable with the image sensor. The display interface may include a positioning guide and a live 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 capture of the image data to satisfy at least one alignment condition. The at least one alignment condition may include detecting a position of the reference feature of the live action preview within a frame of the positioning guide. The at least one alignment condition may include detecting a tilt condition within about +/-10 degrees of the up-down extension axis. The at least one alignment condition may include detecting a tilt condition within about +/-5 degrees of the up-down extension axis. Detection of the tilt condition may be performed by reading an Inertial Measurement Unit (IMU).

In some versions, the predetermined reference feature may be a QR code. In some cases, to process 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 an automated shipping description 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 from the plurality of captured images of the facial feature. The mobile computing device may be configured to communicate the selected face interface size to a server over the network. Optionally, the mobile phone may be configured to automatically recommend custom face interface dimensions based on data collected from the user, wherein the custom face interface may be unique to a given user based on the face geometry of the given user.

Some versions of the technology include a device for automatically recommending face interface dimensions that are complementary to facial features of a particular user. The apparatus may include means for receiving image data captured by an image sensor. The captured image data may include one or more facial features of an intended user of the facial interface that are associated with predetermined reference features of known dimensions. The apparatus may include means for detecting one or more facial features of the user in the captured image data. The apparatus may include means for detecting the predetermined reference feature in the captured image data. The apparatus may include means for processing image pixel data of the image to measure an aspect of the one or more facial features detected in the image based on the predetermined reference feature. The apparatus may include means for selecting a face interface size from a set of standard face interface sizes based on a comparison between the measured aspects of the one or more face features and data record related size information for the set of standard face interface sizes and the measured aspects of the one or more face features.

3.3 Personalization

One aspect of one form of the present technology is a processor-implemented method for producing a grid structure for a custom patient interface assembly, the method comprising:

Using the communication circuit to receive data representative of one or more key point features of the person's head;

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

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

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

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

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 comprises image data, (c) at least a portion of the image data is captured by an image sensor, (d) the method comprises the step of capturing at least a portion of the image data using the image sensor, (e) the data comprises two-dimensional image data, and/or (f) the data comprises three-dimensional image data.

In an example, causing one or more manufacturing machines to produce the grid structure of the patient interface assembly includes controlling the one or more manufacturing machines to produce the grid structure of the patient interface assembly based on the set of manufacturing specifications.

In an example, the method is performed by a manufacturing system that includes the at least one processor and the communication circuit.

In an example, the method includes (a) capturing at least a portion of the data using an image sensor, and/or (b) identifying at least one relationship between two or more of the keypoint feature positions, wherein the set of manufacturing specifications is determined based at least in part on the at least one relationship between the two or more of the keypoint feature positions.

In an example, identifying the at least one relationship between the two or more of the keypoint feature locations includes determining a distance between two or more of a subnasal point, a nasal bridge point, a tragus point, a final point of the head, an uppermost point of the head, a right orbital rim outermost point, a left orbital rim outermost point, an orbital rim lowermost point, a frankfurt horizontal plane, and a coronal plane aligned with the tragus point.

In an example, identifying the at least one relationship between the two or more keypoint feature locations includes (a) determining a distance between the subnasal point and the tragus point in a sagittal plane, (b) determining a vertical distance between the subnasal point and the nasal bridge point in a sagittal plane, (c) determining a distance between the subnasal point and the coronal plane aligned with the tragus point, the distance being perpendicular to the coronal plane, (d) determining a distance between the left or right orbital rim outermost point and the coronal plane aligned with the tragus point, the distance being perpendicular to the coronal plane, (e) determining a vertical distance between the subnasal point and the uppermost point of the head, (f) determining a vertical distance between the uppermost point of the head and a frankfurt horizontal plane, (g) determining a 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 (h) determining a distance between the left or right orbital rim outermost point and the orbital rim.

In an example, (a) the method includes the steps of determining at least one performance requirement of the mesh structure of the patient interface assembly based on the one or more keypoint feature locations, (b) the at least one performance requirement includes one or more of stiffness, contact pressure, compliance, force exerted by or to the assembly, elasticity, size, and positioning on the head, (c) the mesh structure of the patient interface assembly includes a plurality of regions, and at least one performance requirement is determined for each region, (d) the at least one performance requirement is determined based at least in part on a property of another assembly of the patient interface that is intended for use with the custom patient interface assembly, and/or (e) the set of manufacturing specifications is determined based at least in part on the at least one performance requirement.

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 motion.

In an example, the set of manufacturing specifications includes (a) at least one material specification, (b) at least one construction specification, and/or (c) at least one dimensional specification.

In an example, determining the set of manufacturing specifications includes (a) selecting the set of manufacturing specifications from a plurality of existing sets of manufacturing specifications, (b) selecting the existing set of manufacturing specifications based on a comparison between the one or more keypoint feature locations determined for the person and one or more keypoint feature locations associated with the existing set of manufacturing specifications, and/or (c) selecting a plurality of manufacturing specifications from a plurality of existing manufacturing specifications to form the set of manufacturing specifications.

In an example, the method includes generating manufacturing machine programming instructions for producing the grid structure of the patient interface assembly based on the set of manufacturing specifications. In an example, producing the grid structure of the patient interface assembly includes programming at least one manufacturing machine with the manufacturing machine programming instructions, and operating the at least one manufacturing machine in accordance with the manufacturing machine programming instructions.

In an example, (a) generating the manufacturing machine programming instructions includes generating a graph representing the set of manufacturing specifications, and generating the manufacturing machine programming instructions based on the graph, and/or (b) generating the manufacturing machine programming instructions includes generating a model of the grid structure of the patient interface assembly based on the set of manufacturing specifications, and generating the manufacturing machine programming instructions based on the model.

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) braiding the mesh structure, and/or (f) generating instructions for one or more manufacturing devices 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.

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

One aspect of one form of the present technology is a system for producing a grid structure for a custom patient interface assembly, the system comprising:

One or more processors to receive data representative of one or more keypoint features of a person;

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

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

At least one manufacturing machine configured to produce the grid structure of the patient interface assembly based on the set of manufacturing specifications.

One 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 grid structure of patient interface assemblies, the method comprising:

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

Identifying, using the processing system, one or more keypoint feature locations of the keypoint feature based on the data;

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

Using the communication circuit, the set of manufacturing specifications is communicated to a manufacturing system that includes at least one manufacturing machine configured to produce the grid structure of the patient interface assembly based on the set of manufacturing specifications.

One or more processors for receiving data representative of one or more key point features of a person's head;

The one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system that includes at least one manufacturing machine configured to produce the grid structure of the patient interface assembly based on the set of manufacturing specifications.

using the communication circuit to receive data representative of one or more keypoint feature positions of a keypoint feature of a human head;

One or more processors to receive one or more keypoint feature locations of a keypoint feature of a head of a person, the one or more keypoint feature locations identified from data representative of the one or more keypoint features of the head;

One aspect of one form of the present technology is a processor-implemented method for producing a grid structure of a patient interface assembly, the method comprising:

using communication circuitry to receive a set of manufacturing specifications for producing the grid 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 representative of one or more keypoint features of a human head, and

In an example, causing one or more manufacturing machines to produce the grid structure of the patient interface assembly includes controlling the one or more manufacturing machines to produce the grid structure of the patient interface assembly.

One or more processors to receive a set of manufacturing specifications for producing the grid 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 representative of one or more keypoint features of a human head, and

obtaining information representative of one or more keypoint feature positions of the human head based on data received from the apparatus using the communication circuit;

Determining, using at least one processor, a set of manufacturing specifications for producing the grid structure of the patient interface assembly based on the one or more keypoint feature locations, and

One aspect of one form of the present technique is a system for producing a grid structure of a patient interface assembly, the system comprising:

one or more processors for obtaining information representative of one or more keypoint feature positions of a human head;

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

One aspect of one form of the present technique is an apparatus for producing a mesh structure of a patient interface assembly, the apparatus comprising:

Means for obtaining information representative of the location of one or more keypoint features of the human head;

Means for determining a set of manufacturing specifications for producing the grid structure of the patient interface assembly based on the one or more keypoint feature locations, and

Means for producing the grid structure of the patient interface assembly based on the set of manufacturing specifications.

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

Another form of the present technique includes a cushion for a patient interface produced by any of the methods and/or systems described above.

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

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

The described methods, systems, apparatus and devices may be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, for identifying keypoint features and/or locations thereof, identifying relationships between the keypoint features, determining functional requirements (e.g., for a patient interface and/or one or more components thereof), determining manufacturing specifications, and/or generating manufacturing machine programmable instructions. Furthermore, the described methods, systems, apparatuses, and devices may provide improvements in the art of automatically generating machine programming instructions for producing custom patient interfaces and/or components thereof. Furthermore, the described methods, systems, apparatuses, and devices provide increased flexibility in producing custom patient interfaces and/or components thereof that will properly fit users and provide for the most comfortable and/or faster production of custom patient interfaces and/or components thereof. Examples of the present technology provide custom patient interfaces and/or components thereof faster (e.g., from the time requested) and/or with accuracy than conventional methods, which may not provide for such accuracy at least because patients, clinicians, and/or manufacturers may not accurately consider and implement all of the factors to consider in providing custom patient interfaces and/or components thereof with accuracy, improved comfort, and/or without significant cost and/or time.

One aspect of certain forms of the present technology is an easy-to-use medical device, for example, easy-to-use by persons who are not medically trained, by persons with limited dexterity and vision, or by persons with limited experience in using this type of medical device.

One aspect of one form of the present technology is a portable RPT device that may be carried by a person (e.g., in a person's home).

One aspect of one form of the present technique is a patient interface that can be cleaned in a 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 tub that may be cleaned in a patient's home, such as in soapy water, without the need for specialized cleaning equipment.

The described methods, systems, apparatuses, and devices 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. Furthermore, 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).

Of course, portions of these aspects may form sub-aspects of the present technique. Furthermore, various sub-aspects and/or aspects of the sub-aspects and/or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

Other features of the present technology will become apparent from consideration of the following detailed description, abstract, drawings, and claims.

Drawings

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

4.1 respiratory therapy System

Fig. 1A shows a system comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow that receives a supply of positive pressure air 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. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

Fig. 1B shows a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a supply of positive pressure air 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.

Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a supply of air at positive pressure 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.

4.2 Respiratory System and facial anatomy

Figure 2A shows a schematic diagram of the human respiratory system including nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveoli, heart and diaphragm.

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, lateral nasal cartilage, alar cartilage, nostrils, upper labia, lower labia, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

Fig. 2C is a front view of a face with several identified surface anatomical features including an upper lip, an upper lip red, a lower lip, a mouth width, a medial canthus, a nasal wing, a nasolabial sulcus, and a labial corner. Also indicated are up, down, radially inward and radially outward directions.

Fig. 2D is a side view of a head having several surface anatomical features identified, including inter-eyebrow points, nose bridge points, nose points, subnasal points, upper lip, lower lip, upper chin points, nasal ridges, nasal alar ridge points, upper ear base points, and lower ear base points. The up-down direction and the front-back direction are also indicated.

Fig. 2E is another side view of the head. The approximate location of frankfurt level and nose lip angle is indicated. Coronal plane is also indicated.

Figure 2F shows a bottom view of the nose with several features identified including the nasolabial sulcus, the lower lip, the upper lip red, the nostrils, the subnasal points, the small nasal posts, the protruding nasal points, the long axis of the nostrils, and the mid-sagittal plane.

Fig. 2G shows a side view of the skin feature of the nose.

Fig. 2H shows subcutaneous structures of the nose, including lateral cartilage, septal cartilage, alar cartilage, seedlike cartilage, nasal bone, epidermis, adipose tissue, frontal processes of the maxilla, and fibrous adipose tissue.

Fig. 2I shows a medial anatomic view of the nose approximately a few millimeters from the median sagittal plane, particularly showing the medial foot of the septal cartilage and the alar cartilage.

Fig. 2J shows a front view of the skull including frontal, nasal and zygomatic bones. Turbinates, as well as maxilla and mandible, are also indicated.

Fig. 2K shows a profile of the surface of the head and an outside view of the skull with several muscles. Bones such as frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone are shown. The chin protuberance is indicated. The following muscles are shown, the two abdominal muscles, the masticatory muscles, the sternocleidomastoid and the trapezius.

Fig. 2L shows a front-to-outside view of the nose.

4.3 Patient interface

Fig. 3A illustrates a patient interface in the form of a nasal mask in accordance with one form of the present technique.

Fig. 3B shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively large amplitude when compared to the amplitude of curvature shown in fig. 3C.

Fig. 3C shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively small amplitude when compared to the amplitude of curvature shown in fig. 3B.

Fig. 3D shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a zero value.

Fig. 3E shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and has a relatively small amplitude when compared to the curvature amplitude shown in fig. 3F.

Fig. 3F shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and a relatively large amplitude when compared to the curvature amplitude shown in fig. 3E.

Fig. 3G shows a cushion for a mask comprising two pillows. The outer surface of the pad is indicated. Indicating the edges of the surface. The dome area and saddle area are indicated.

Fig. 3H shows a cushion for a mask. The outer surface of the pad is indicated. Indicating the edges of the surface. The path on the surface between points a and B is indicated. The straight line distance between a and B is indicated. Two saddle regions and one dome region are indicated.

Fig. 3I shows a surface with a one-dimensional pore structure in the surface. The illustrated planar curves form the boundaries of a one-dimensional hole.

Fig. 3J shows a cross section through the structure of fig. 3I. The illustrated surfaces define two-dimensional apertures in the structure of fig. 3I.

Fig. 3K shows a perspective view of the structure of fig. 3I, including two-dimensional holes and one-dimensional holes. The surface defining the two-dimensional aperture in the structure of fig. 3I is also shown.

Figure 3L shows a mask with an inflatable bladder as a cushion.

Fig. 3M shows a cross section through the mask of fig. 3L and shows the inner surface of the bladder. The inner surface defines a two-dimensional aperture in the mask.

Fig. 3N shows an additional cross section through the mask of fig. 3L. The inner surface is also indicated.

Fig. 3O illustrates the left hand rule.

Fig. 3P illustrates the right hand rule.

Fig. 3Q shows the left ear, including the left ear spiral.

Fig. 3R shows the right ear, including the right ear spiral.

Fig. 3S shows a right-hand spiral.

Fig. 3T shows a view of the mask including a sign of torsion of the spatial curve defined by the edges of the sealing film in different regions of the mask.

Fig. 3U shows a view of the plenum chamber 3200, showing the sagittal and intermediate contact planes.

Fig. 3V shows a view of the rear of the plenum of fig. 3U. The direction of this view is orthogonal to the intermediate contact plane. The sagittal plane in fig. 3V bisects the plenum into left-hand and right-hand sides.

Fig. 3W shows a cross-section through the plenum of fig. 3V, the cross-section being taken at the sagittal plane shown in fig. 3V. The "middle contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3201, which lies in the sagittal plane and contacts the cushion of the plenum at only two points on the sagittal plane (upper point 3221 and lower point 3230). Depending on the geometry of the pad in this region, the intermediate contact plane may be a tangential plane at the upper and lower points.

Fig. 3X shows the plenum chamber 3200 of fig. 3U in a position for use on a face. The sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in the in-use position. The intermediate contact plane generally corresponds to the "plane of the face" when the plenum is in the use position. In fig. 3X, the plenum chamber 3200 is the plenum chamber of the mask and the upper point 3221 is located approximately on the nose bridge point and the lower point 3230 is located on the upper lip.

Fig. 3Y illustrates a patient interface in the form of a nasal cannula in accordance with one form of the present technique.

Fig. 3Z illustrates a patient interface with a catheter hub in accordance with one form of the present technique.

4.4RPT device

Fig. 4A illustrates an RPT device in one form in accordance with the present technique.

Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in one form in accordance with the present technique. The upstream and downstream directions are indicated with reference to the blower and patient interface. The blower is defined upstream of the patient interface and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any particular moment. An article located in the pneumatic path between the blower and the patient interface is downstream of the blower and upstream of the patient interface.

4.5 Humidifier

Figure 5A illustrates an isometric view of a humidifier in one form in accordance with the present technique.

Fig. 5B illustrates an isometric view of a humidifier in one form in accordance with the present technique, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

4.6 Respiratory waveform

Fig. 6A shows a typical breathing waveform model of a person while sleeping.

4.7 Patient interface according to further examples of the present technology

Fig. 7 is a cross-sectional view of a cushion module of a patient interface in accordance with an example of the present technique, the cushion module being in a use position.

Fig. 7-1 is a detailed view of a portion of a cushion of a patient interface in accordance with an example of the present technique.

Fig. 7-2 is a detail view of a portion of the pad of fig. 7-1 in use.

Fig. 8A is a cross-sectional view of a cushion module of a patient interface in accordance with another example of the present technique.

Fig. 8B is a detailed view of a portion of the patient interface of fig. 8A.

Fig. 8C is a cross-sectional view of a portion of a patient interface in accordance with another example of the present technique.

Fig. 9 is a detailed view of a portion of a patient interface in accordance with another example of the present technique.

Fig. 10 is a cross-sectional view of a cushion module of a patient interface in accordance with another example of the present technique, the cushion module being in a use position.

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

Fig. 12 is a cross-sectional view of a cushion module of a patient interface in accordance with another example of the present technique.

Fig. 13A is a rear view of a cushion module of a patient interface in accordance with another example of the present technique.

Fig. 13B is a rear lower perspective view of the cushion module of fig. 13A.

Fig. 14A is a rear, upper perspective view of a cushion module of a patient interface in accordance with another example of the present technique.

Fig. 14B is a front view of the cushion module of fig. 14A.

FIG. 14C is a cross-sectional view of the cushion module of FIG. 14A at the segment 14C-14C identified in FIG. 14B.

Fig. 15A is a detailed view of a portion of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 15B is a schematic view of a portion of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 16 is a detailed view of a portion of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 17 is a detailed view of a portion of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 18 is a schematic view of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 19A is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 19B is a graph of force/contact pressure exerted on a user's face when subjected to a load as shown in fig. 19A by a cushion in accordance with an example of the present technique.

Fig. 19C is a schematic view of a portion of a cushion of a patient interface in accordance with another example of the present technique.

Fig. 20A is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 20B is a graph of force/contact pressure exerted on a user's face when subjected to a load as shown in fig. 20A by a cushion in accordance with an example of the present technique.

Fig. 21A is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 21B is a graph of force/contact pressure exerted on a user's face when subjected to a load as shown in fig. 21A by a cushion in accordance with an example of the present technique.

Fig. 22A is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 22B is a graph of the force/contact pressure exerted on the user's face by the cushion of fig. 22A when subjected to the load shown in fig. 22A.

Fig. 22C is a schematic view of a cushion of a patient interface in contact with a user's face and bearing a load in accordance with another example of the present technique.

Fig. 22D is a schematic view of a cushion of a patient interface in contact with a user's face and bearing a load in accordance with another example of the present technique.

Fig. 22E is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 22F is a schematic view of a cushion of a patient interface in contact with a user's face and under load in accordance with another example of the present technique.

Fig. 22G is a schematic view of a cushion having a cushion body including a lattice structure in accordance with another example of the present technology.

Fig. 22H is a schematic view of a cushion having a cushion body including a lattice structure in accordance with another example of the present technology.

Fig. 22I is a schematic view of a cushion having a cushion body including a lattice structure in accordance with another example of the present technology.

Fig. 22J is a schematic view of a cushion having a cushion body including a lattice structure in accordance with another example of the present technology.

Fig. 23A to 23F are detailed views of a pad according to an example of the present technology.

4.8 Automatic sizing

FIG. 24 is an illustration of an example system for automatically determining face interface dimensions that includes a computing device.

FIG. 25 is a block diagram of an example architecture of a computing device for the system of FIG. 24, including example components suitable for implementing the methods of the present technology.

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

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

Fig. 26C is a flow chart of a post-capture image processing stage method of some versions of the present technique.

Fig. 26D is a flow chart of a compare and output stage method of some versions of an exemplary method embodiment of the present technology.

Fig. 27 shows a schematic diagram of a system 100 in accordance with another example of the present technology.

Fig. 28A-28F illustrate a method 7000, and flow diagrams of aspects thereof, in accordance with another example of the present technique.

Fig. 29 shows a side view of a user's head that has identified a plurality of distances associated with method 7000.

Fig. 30A and 30B depict a patient's facial expression that may be captured as part of method 7000.

Detailed Description

Before the present technology is described in further detail, it is to be understood that this technology is not limited to particular examples described herein, as such may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing particular examples described herein only and is not intended to be limiting.

The following description is provided in connection with 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 further examples.

5.1 Therapy

In one form, the present technique includes a method for treating a respiratory disorder that includes applying positive pressure to an entrance to an airway of a patient 1000.

In some examples of the present technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

In certain examples of the present technology, oral breathing is restricted, constrained, or prevented.

5.2 Respiratory therapy System

In one form, the present technique 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 the patient 1000 via the air circuit 4170 and the patient interface 3000 or 3800.

5.3 Patient interface

In accordance with one aspect of the present technique, a non-invasive patient interface 3000, such as shown in fig. 3A, includes functional aspects of a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an 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 an entrance to the airway of a patient in order to maintain a positive pressure at the entrance to the airway of the patient 1000. Thus, the sealed patient interface 3000 is suitable for achieving positive pressure therapy.

As shown in fig. 3Z, a non-invasive patient interface 3000 in accordance with another aspect of the present technique includes functional aspects of a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit, such as the air circuit 4170 shown in fig. 1A-1C. The plenum chamber 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).

If the patient interface is not able to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of providing a supply of air at a positive pressure of at least 6cmH2O relative to the environment.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of providing a supply of air at a positive pressure of at least 10cmH2O relative to the environment.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of providing a supply of air at a positive pressure of at least 20cmH2O relative to the environment.

5.3.1 Seal formation Structure

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. Further, the seal-forming structure 3100 may have apertures therein such that, in use, an air flow at the therapeutic pressure is delivered to at least one inlet of a nostril of the patient. The seal-forming structure 3100 may be constructed and arranged to maintain a therapeutic pressure in the plenum chamber 3200 throughout a patient's respiratory cycle in use.

In one form of the present technique, the seal forming structure 3100 provides a target seal forming region and may additionally provide a cushioning function. The target seal forming area is an area on the seal forming structure 3100 where a seal may occur. The area where the seal actually occurs (the actual sealing surface) may vary over time and from patient to patient within a given treatment session, depending on a number of factors including, for example, the location of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

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

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

The seal forming structure 3100 according to the present technology may be constructed of a soft, flexible, resilient material, such as silicone.

In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure configured to correspond to a different size and/or shape range. For example, the system may include one form of seal forming structure 3100 suitable for large size heads but not for small size heads, and another such seal forming structure suitable for small size heads but not for large size heads. However, examples of the present technology may be applicable to a wide range of heads, and thus may be used by patients having relatively large heads and relatively small heads.

5.3.1.1 Sealing mechanism

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

In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1mm (e.g., about 0.25mm to about 0.45 mm) that extends around the perimeter of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and an edge of the plenum chamber 3200 and extends over at least a portion of the path around the perimeter. The support flange is or comprises a spring-like element and acts to support the sealing flange against bending in use.

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 compression, for example due to elastic tension in the positioning and stabilising structure.

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

In one form, the seal-forming structure includes a region having an adhesive or cohesive surface.

In some forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having an adhesive or cohesive surface.

5.3.1.2 Nasal bridge or nasal ridge regions

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

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

5.3.1.3 Upper lip region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over an upper lip region (i.e., an upper lip portion) of the patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over an upper lip region of a patient's face in use.

5.3.1.4 Chin region

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

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

5.3.1.5 Forehead area

In one form, the seal-forming structure forms a seal over a forehead region of a patient's face in use. In this form, the plenum chamber may cover the eye in use.

5.3.1.6 Nasal pillows

In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

A nasal pillow in accordance with one aspect of the present technique includes a frustoconical body, at least a portion of which forms a seal on an underside of a patient's nose, a handle, and a flexible region located on the underside of the frustoconical body and connecting the frustoconical body to the handle. Furthermore, the structure to which the nasal pillows of the present technology are attached includes a flexible region adjacent the base of the handle. These flexible regions may cooperate to facilitate a universal joint structure that accommodates displacement and angular relative movement of the structure to which the frustoconical and nasal pillow are connected. For example, the frustoconical body may be axially displaced toward the structure to which the stem is connected.

In one example of nasal pillows, at least a portion of the truncated cone of each nasal pillow may be shaped and sized to enter a corresponding nostril of a patient. In another example of nasal pillows, the frustoconical shape and size of each nasal pillow may be designed not to enter the corresponding nostril of the patient. Each nasal pillow may be configured to seal against a portion of the patient's nose defining a respective nostril, including the patient's columella and respective wings.

In some examples of nasal pillows, each nasal pillow may be sessile. The truncated cone of each nasal pillow may be directly attached to a portion of the patient interface 3000 defining the plenum chamber 3200.

5.3.1.7 Nose mask

In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that forms, in use, a seal to an upper lip region (e.g., upper lip), to at least a portion of the bridge of the nose of the patient or the nasal ridge above the point of the nasal projection, and to the patient's face on each lateral side of the patient's nose (e.g., at a location proximate to the patient's nasolabial sulcus). The patient interface 3000 shown in fig. 1B has a seal-forming structure 3100 of this type. The patient interface 3000 may 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 "nose pad" and the patient interface 3000 with such seal-forming structure 3100 may be identified as a "nose mask".

5.3.1.8 Full face mask

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

5.3.1.9 Ultra-compact full face mask

In one form, the patient interface 3000 includes a seal-forming structure 3100 that forms, in use, a seal on the patient's face over the chin area of the patient (which may include the patient's lower lip and/or the area directly below the lower lip), on the lower and/or anterior surfaces of the patient's nasal projection, and on each lateral side of the patient's nose (e.g., near the nasolabial sulcus). The seal forming structure 3100 may also form a seal against the upper lip of the patient. A patient interface 3000 with this type of seal-forming structure may have a single opening configured to deliver an air flow or breathable gas to both nostrils and mouth of a patient, may have a mouth aperture configured to provide air or breathable gas to the mouth and a nose aperture configured to provide air or breathable gas to the nostrils, or may have a mouth aperture for delivering air to the mouth of a patient and two nose 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.

5.3.1.10 Nose mask

In one form, as shown for example in fig. 3Z, the seal-forming structure 3100 is configured to form a seal with a lower surface of the nose around the nostrils in use. The seal-forming structure 3100 may be configured to seal around the nostrils of the patient at the lower periphery of the patient's nose, including to the lower and/or anterior surfaces of the patient's nasal protrusions and to the patient's wings. The seal forming structure 3100 may form a seal against an upper lip of a patient. This type of seal forming structure 3100 may be referred to as, for example, a "cradle cushion," nose pad, "or" nose pad.

The seal forming structure 3100 may be shaped to match or closely conform to the underside of the patient's nose and may not contact the nasal bridge region of the patient's nose or any portion of the patient's nose above the nasal projection. In one form of nasal cushion, the seal forming structure 3100 includes a bridge portion that divides the opening into two apertures, each of which, in use, supplies air or breathable gas to a respective one of the patient's nostrils. The bridge portion may be configured to contact or seal the patient's columella during use. Alternatively, the seal-forming structure 3100 may include a single opening to provide an air flow or breathable gas to both nostrils of the patient.

5.3.2 Plenum

The plenum chamber 3200 may be formed by a portion of the patient interface 3000 having a perimeter shaped to complement the surface contours in the region of an average person's face 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 against the adjacent surface of the face. The 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 a portion of the patient interface 3000 forming the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and seal forming structure 3100 are formed from a single sheet of homogeneous material.

In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and/or more comfortable for the wearer, which may improve compliance with the therapy.

In some forms of the present technology, the plenum chamber 3200 is formed from one or more components of a transparent material (e.g., transparent polycarbonate). The use of transparent materials may reduce the obtrusive feel of the patient interface and help improve compliance with therapy. The use of transparent materials may help a clinician to see how the patient interface is positioned and functioning.

In some forms of the present technology, the plenum chamber 3200 is formed from one or more components of translucent material. The use of translucent materials may reduce the obtrusive feel of the patient interface and help to improve compliance with therapy.

5.3.3 Positioning and stabilization Structure

The seal-forming structure 3100 of the 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 include and function as a "headgear" in that it engages the patient's head to hold the patient interface 3000 in a sealed position.

In one form, the positioning and stabilizing structure 3300 provides a retention force at least sufficient to overcome the positive pressure effect in the plenum chamber 3200 to lift off the face.

In one form, the positioning and stabilizing structure 3300 provides a retention force to overcome the effects of gravity on the patient interface 3000.

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

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with the manner in which the patient is wearing the structure 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 volume 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.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent the patient from lying down in a supine sleep position, with the back area of the patient's head on a pillow.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying on the pillow in a side sleep position with a lateral region of the patient's head.

In one form of the present technique, the positioning and stabilizing structure 3300 is provided with a decoupling portion 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 is not resistant to compression and may be, for example, a flexible or floppy tape. The decoupling portion is constructed and arranged such that when a 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 breaking the seal.

In one form of the present technique, the positioning and stabilizing structure 3300 includes a strap composed 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 outer layer of fabric includes loop material to partially engage with the hook material.

In certain forms of the present technology, the positioning and stabilizing structure 3300 comprises an extensible (e.g., elastically extensible) strap. For example, the strap may be configured to be under tension in use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap may be configured as a lace.

In one form of the present technique, the positioning and stabilizing structure includes a first strap constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes over an above-the-ear base of the patient's head and covers a portion of the parietal bone and not the occipital bone.

In one form of the present technology applicable to a pure nasal mask or full face mask, the positioning and stabilizing structure includes a second strap constructed and arranged such that, in use, at least a portion of an upper edge of the second strap passes under an inframarginal base of the patient's head and covers or is located under the occiput of the patient's head.

In one form of the present technology applicable to a pure nasal mask or 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 one another.

In some forms of the present technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. This aspect has the advantage that the belt is more comfortable for the patient lying thereon when sleeping.

In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture to pass through the strap.

In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a retention force 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 such positioning and stabilizing structure that is suitable for small-sized heads but not for large-sized heads.

5.3.3.1 Catheter headgear

5.3.3.1.1 Catheter head sleeve

In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the plenum chamber 3200 and seal forming structure 3100. In the form of the present technique illustrated in fig. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tube 3350 is configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 over an appropriate portion (e.g., nose and/or mouth) of the patient's face. 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 in a position other than the front of the patient's face, such as at the top of the patient's head.

Because air may be contained and passed through the headgear tube to deliver pressurized air from the air circuit 4170 to the airway of the patient, the positioning and stabilizing structure 3300 may be described as inflatable. It is appreciated that the inflatable positioning and stabilizing structure 3300 need not all of the components of the positioning and stabilizing structure 3300 be inflatable. For example, in the example shown in fig. 3Z, the positioning and stabilizing structure 3300 includes an inflatable tube 3350 and a non-inflatable strap portion 3310.

In the form of the present technique illustrated in fig. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head in use and extending across a respective cheek region above a respective ear (above an on-the-ear base on the patient's head) to an elbow 3612 on top of the patient's 1000 head. This form of technique may be advantageous because if the patient sleeps sideways on his head and one of the tubes is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the present technology, patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one example where the patient interface has one tube 3350, a single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek region), and the strap 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 region) to help secure the patient interface 3000 to the patient's head.

In the form of the present technique shown in fig. 3Z, two tubes 3350 are fluidly connected to each other at an upper end and to a connection port 3600. In some examples, two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately but connected in use, and may be disconnected, e.g., for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example, each may be connected to a T-connector having two arms/branches, each fluidly connected to a respective one of the tubes 3350, and a third arm or opening that in use provides a connection port 3600 for fluid connection to the air circuit 4170.

The tube 3350 may be formed of a flexible material, such as an elastomer, e.g., silicone or TPE, or one or more textiles and/or foam materials. The tube 3350 may have a preformed shape and be able to bend or move to another shape when a force is applied, but may return to the original preformed shape in the absence of the force. The tube 3350 may be generally arcuate or curved in shape that approximates the contour of the patient's head between the top of the head and the nose or mouth region.

As described in U.S. patent No. 6,044,844, incorporated herein, the tube 3350 may be pressure resistant to avoid the flow of breathable gas through the tube from being blocked if either tube is crushed during use, for example if it is compressed between the patient's head and nasal pillow. In all cases, crush resistant tubing may not be necessary as the pressurized gas in the tubing may act as a splint to prevent, or at least limit, crushing of the tubing 3350 during use. The pressure resistant tubing may be advantageous in the presence of only a single tube 3350, as if the single tube became plugged during use, the flow of gas would be restricted and the efficacy of the therapy would cease or decrease. In some examples, the tubes 3350 may be sized such that each tube 3350 is capable of providing sufficient gas flow to the plenum chamber 3200 on its own in the event that one of the tubes 3350 is occluded.

Each tube 3350 may be configured to receive an air flow from a connection port 3600 located on top of the patient's head and deliver the air flow to a seal-forming structure 3100 located at the entrance to the patient's airway. In the example shown in fig. 3Z, each tube 3350 is located in use on a path extending from the plenum chamber 3200 across the cheek region of the patient and over the ear of the patient to the elbow 3612. For example, a portion of each tube 3350 proximate to the plenum chamber 3200 may cover a maxillary region of a patient's head in use. Another portion of each tube 3350 may cover an area of the patient's head above the on-ear base point of the patient's head. Each tube 3350 may also be located on one or both of the patient's sphenoid and/or temporal bones and the patient's frontal and parietal bones. Elbow 3612 may be located, in use, on the patient's parietal bone, frontal bone, and/or at junctions therebetween (e.g., coronal sutures).

In some forms of the present technology, patient interface 3000 is configured such that connection port 3600 may be positioned in a range of positions across the top of the patient's head, such that patient interface 3000 may be positioned to suit the comfort or fit of an individual patient. In some examples, headgear tube 3350 is configured to allow an upper portion of patient interface 3000 (e.g., connection port 3600) to move relative to a lower portion of patient interface 3000 (e.g., plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. As such, 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).

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 carrier cushion that generally underlies and seals to the lower periphery of the nose (e.g., a nose-bottom cushion). The positioning and stabilizing structure 3300, including tube 3350, may be constructed and arranged to pull the seal-forming structure 3100 under the nose into the patient's face with a sealing force vector in a posterior and superior direction (e.g., posterior-superior direction). Having a sealing force vector in the posterior superior lateral direction may facilitate the seal forming structure 3100 forming a good seal to both the lower periphery of the patient's nose and the anterior facing surfaces of the patient's face on either side of the patient's nose and the upper part of the patient's lips.

5.3.3.1.2 Extendable and inextensible tube portions

In some examples of the present technology, one or both of the tubes 3350 are inextensible in length. However, in some forms, the tube 3350 may include one or more extendable tube segments, such as formed from an extendable accordion structure. In some forms, patient interface 3000 may include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube that includes a tube wall having an extendable accordion structure. The patient interface 3000 shown in fig. 3Z includes a tube 3350 having an upper portion that includes extendable tube segments, each in the form of an extendable accordion 3362.

The cross-sectional shape of the non-extendable tube section 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rounded rectangular, for example, as described in U.S. patent No. 6,044,844. The cross-sectional shape of the flat surface of the tube is presented on the side facing and contacting the patient's face or other part of the head more comfortably to wear than, for example, a tube having a circular cross-section.

In some examples of the present technology, non-extendable pipe section 3363 connects to plenum chamber 3200 from a low angle. Headgear tubes 3350 may extend down the sides of the patient's head and then curve forward and inward to connect to the plenum chamber 3200 in front of the patient's face. Prior to connection to the plenum chamber 3200, the tube 3350 may extend to the same vertical position as the connection to the plenum chamber 3200, or in some examples, in a lower portion thereof. That is, the tube 3350 may protrude in an at least partially upward direction prior to connection with the plenum chamber 3200. A portion of the tube 3350 may be located below the gasket module 3150 and/or the seal forming structure 3100. The tube 3350 is positioned lower forward of the patient's face, facilitating 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.

5.3.3.1.3 Catheter headgear connection port

In some forms of the present technique, patient interface 3000 may include a connection port 3600 located near an upper, lateral, or posterior portion of a patient's head. For example, in the form of the present technique illustrated in fig. 3Z, the connection port 3600 is located on top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, patient interface 3000 includes an elbow 3612 that forms connection port 3600. The elbow 3612 may be configured to fluidly connect with a conduit of the air circuit 4170. Elbow 3612 may be configured to rotate relative to positioning and stabilizing structure 3300 to at least partially decouple the catheter from positioning and stabilizing structure 3300. In some examples, elbow 3612 may be configured to rotate by rotation about a substantially vertical axis, and in some particular examples, by rotation about 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 may lie in use in the sagittal plane of the patient's head.

A patient interface having a connection port that is not positioned in front of a patient's face may be advantageous because some patients may find the catheter connected to the patient interface in front of their face unsightly and/or unobtrusive. For example, a conduit connected to a patient interface in front of a patient's face may be prone to interference with bedding or sheets, particularly if the conduit extends downwardly from the patient interface in use. The form of the present technology including a patient interface having a connection port positioned above the patient's head in use may enable the patient to more easily or comfortably lie or sleep in one or more of a side sleep position, a supine position (e.g., on the back thereof, generally upwardly facing), or a prone position (e.g., on the front thereof, generally downwardly facing). Furthermore, connecting the catheter to the front of the patient interface may exacerbate a problem known as tube drag, wherein the catheter exerts undesirable forces on the patient interface during patient head or catheter movement, resulting in displacement away from the face. Tube resistance may be a minor issue when the force experienced at a location above the patient's head is stronger than the force experienced in front of the patient's face proximate the seal-forming structure (where tube resistance may be more likely to break the seal).

5.3.3.1.4 Headgear fluid connection

Two tubes 3350 are fluidly connected at their lower ends to a plenum chamber 3200. In some forms of the present technology, the connection between the tube 3350 and the plenum chamber 3200 is achieved by a connection of two rigid connectors. The tube 3350 and the plenum chamber 3200 may be configured so that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and/or audible feedback in the form of a "click-through" or similar sound, which is easy for the patient to use because the patient may know that each tube 3350 has been properly connected to the plenum 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 over-molded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connector on each tube 3350 may include a female mating feature configured to connect with a male mating feature on the plenum 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 chamber 3200. In other examples, the tubes 3350 may each include a male or female connector formed of a flexible material (such as silicone or TPE), e.g., the tubes 3350 are formed of the same material.

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

5.3.3.1.5 Catheter headgear strap

In some forms of the present technology, the positioning and stabilizing structure 3300 includes, in addition to the tube 3350, at least one headgear strap for positioning and stabilizing the seal-forming structure 3100 at the entrance to the patient's airway. As shown in fig. 3Z, patient interface 3000 includes a strap portion 3310 that forms part of positioning and stabilizing structure 3300. For example, 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 bands may be provided. For example, a patient interface 3000 with a full cushion in accordance with examples of the present technology may have a second lower band configured to rest against the patient's head proximal to the patient's neck and/or against the back surface of the patient's neck.

In the example shown in fig. 3Z, 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 to cover or underlie the occiput of the patient's head in use. The strap portion 3310 is connected to each tube over the patient's ear. Referring to fig. 3Z, the positioning and stabilizing structure 3300 includes a pair of tabs 3355. In use, the strap portion 3310 may be connected between the tabs 3355. The strap portion 3310 may be flexible enough to wrap around the back of the patient's head and comfortably rest against the patient's head, even when under tension during use.

5.3.4 Vents

In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for flushing of exhaled gases (e.g., carbon dioxide).

In some forms, the vent 3400 is configured to allow a continuous flow of vent gas 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 such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure in the plenum in use.

One form of vent 3400 in accordance with 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.

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.

In some forms, the patient interface 3000 may include a vent 3400 to allow, for example, continuous flow of patient-exhaled gas from the interior of the plenum chamber 3200 into the environment throughout the patient's respiratory cycle, the vent 3400 being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use.

5.3.5 Decoupling structure

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

5.3.6 Connection port

Connection port 3600 allows connection to air circuit 4170.

5.3.7 Forehead support

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

5.3.8 Anti-asphyxia valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

In some examples, the AAV is disposed at a connection port 3600 of the patient interface 3000 or at a connection (such as an inlet port connector) between the plenum chamber 3200 and the spool 3610.

5.3.9 Ports

In one form of the present technique, 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 for direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

5.3.10 Cushion module and portions thereof

In some examples of the present technology, patient interface 3000 includes cushion module 3150. The cushion module 3150 may be formed from components forming the plenum chamber 3200, the seal-forming structure 3100, and (in some examples, also) additional components or portions.

Fig. 7 shows cushion module 3150 in contact with a patient's face. In this example, the cushion module 3150 includes a chassis portion 3210 that partially forms the plenum chamber 3200. In this example, the seal-forming structure 3100 also forms, in part, a plenum chamber 3200. The chassis portion 3210 and the seal forming structure 3100 together form a plenum chamber 3200 by enclosing a volume of space (e.g., a breathing cavity) that may be filled with air at a therapeutic pressure (such as at least 4cmH ₂ O or at least 6cmH ₂ O above ambient air pressure).

The cushion module 3150 may form a patient interface 3000 as shown in fig. 3A with other components, such as a frame and positioning and stabilizing structure 3300. The cushion module 3150 of fig. 7 may be separate from other components of the patient interface 3000. More generally, in some examples of the present technology, patient interface 3000 includes a removable cushion module 3150.

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).

In other examples, cushion module 3150 may not be separate from other components or portions of patient interface 3000 (such as 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 cannulas 3350, or with portions 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 as part of the removable cushion module 3150.

The plenum chamber 3200 may include one or more plenum chamber inlet ports 3240 that are sized and configured to receive an air flow at a therapeutic pressure for patient respiration.

In the example shown in fig. 7, the plenum chamber 3200 includes one plenum chamber inlet port 3240. In particular, the chassis portion 3210 defines an opening configured to connect to a fluid connector (e.g., an elbow, as shown in fig. 3A, or the like) to which the air circuit 4170 may connect. The opening forms a plenum inlet port 3240.

As will be described in detail, the cushion module 3150 of the patient interface 3000 in accordance with examples of the present technique may also include a cushion 3130. It should be appreciated that while in some examples of the present technology, the gasket 3130 may form only a small portion of the assembly, the assembly may still be identified as a gasket module 3150.

Fig. 8A-8B, 10, 12, 13A-13B, and 14A-14C illustrate other cushion modules 3150 of a patient interface 3000 in accordance with the present technique. The cushion module 3150 shown in fig. 7-10 and 12 is a pure nasal cushion module 3150 leaving the mouth of the patient uncovered. These cushion modules may include a single aperture and may include seal forming structure 3100 configured to seal to the patient's nasal ridge and sides of the nose, the patient's cheeks, and the patient's upper lip. The cushion module 3150 shown in fig. 11, 13A-13B, and 14A-14C is configured to seal around both the nose and mouth of a patient. The cushion module 3150 sealed to the patient's nose and mouth may include a mouth aperture 3271 through which a flow of pressurized air may be provided to the patient's mouth and one or more nose apertures 3272 through which a flow of pressurized air may be provided to the patient's nasal airway. The cushion module 3150 may include a single nasal aperture 3272 (as shown in fig. 13A-13B), or may include two nasal apertures 3272 configured to provide air flow to respective nostrils at positive pressure (as shown in fig. 14A-14C). The seal forming structure 3100 can include a nose portion 3110 and a mouth portion 3120. The nose portion 3110 may be configured to seal around the nasal airways of a patient in use. The mouth portion 3120 may be configured to seal around the mouth of a patient in use.

5.3.11 Connection to positioning and stabilizing structure

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 chamber 3200 and wrap around the back of the patient's head.

As described above, in some examples, the chassis portion 3210 and the seal forming structure 3100 may form a cushion module 3150. Fig. 7 to 10 and 12 each show a pad module 3150. These cushion modules 3150 may be configured to connect to a positioning and stabilizing structure 3300 as shown in fig. 3A. In the example shown in fig. 3A, 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, cushion module 3150 is removably attached to frame 3700, but in other examples, frame 3700 may permanently attach cushion module 3150.

It should be appreciated that in some examples, patient interface 3000 does not include forehead support. For example, the forehead support of the frame 3700 shown in fig. 3A may be replaced with a pair of upper arms 3311 (as shown in fig. 13A-13B), each of the upper arms 3311 extending at least upwardly and laterally such that an upper strap 3313 of the positioning and stabilizing structure 3300 (similar to the upper strap 3313 shown in fig. 11) may be connected to the upper arms 3311.

In some examples, patient interface 3000 does not include frame 3700 as a separable component, and alternatively cushion module 3150 may include a pair of upper arms 3311 (shown in fig. 13A-13B). The upper arm 3311 may be connected to an upper strap 3313 (similar to the upper strap shown in fig. 11). The upper straps 3313 may be located above an above-the-ear base point of the patient's head in use and may each pass between the respective eyes and ears of the patient's head.

As shown in fig. 11, the positioning and stabilizing structure 3300 may also include a pair of lower straps 3317 configured to connect to the cushion module 3150 or to the frame of either side of the patient interface 3000. The lower strap 3317 may be located below a sub-aural base of the patient's head in use.

In other examples, the patient interface may include a positioning and stabilizing structure 3300 that includes a pair of gas delivery tubes 3350 configured to provide air flow to the plenum chamber 3200 at therapeutic pressure and configured to provide a force to hold the seal-forming structure 3100 in a sealed position. Fig. 3Z illustrates an example of such a positioning and stabilizing structure 3300.

It should be appreciated that cushion module 3150 and its components and portions may be employed in a patient interface 3000 having any type of positioning and stabilizing structure 3300.

5.3.12 Seal forming structure with gasket

Some forms of the present technique include a patient interface 3000 that includes a seal-forming structure 3000 that includes a cushion 3130. The cushion 3130 may be deformable and resilient, for example, and may provide cushioning when engaged with a patient's face.

The liner 3130 may be formed at least in part from a lattice structure. The patient interface 3000 or cushion module 3150 shown in fig. 7-14C has a cushion 3130 formed from a mesh structure.

In some forms of the present technique, the cushion 3130 is airtight and forms a seal directly against the surface of the patient's face. Fig. 9 shows such an example.

In other forms of the present technique, the cushion 3130 is at least partially covered by another portion of the seal forming structure 3100 that seals to the surface of the patient's face, while the cushion 3130 provides a cushioning function. Fig. 7, 8A-8C, and 10-14C illustrate examples of such patient interfaces 3000. In these examples, the seal forming structure may include a face engaging film 3118. The face-engaging film 3118 may be configured to contact the face, and may be flexible and elastic.

In use, the face-engaging film 3118 may at least partially cover the cushion 3130. In some examples (such as the examples shown in fig. 12 and 14A-14C), when the seal forming structure 3100 is not engaged with the patient's face, the face-engaging film 3118 may cover the cushion 3130 and be in contact with or in close proximity to the cushion 3130. As shown in fig. 8A-8C, for example, in some forms, at least a portion of the face-engaging film 3118 may be separable from the cushion 3130 when the seal-forming structure 3100 is not engaged with the patient's face, but may contact and at least partially cover the cushion 3130 in use when the seal-forming structure is engaged with the patient's face, for example as shown in fig. 7 and 10.

In some examples (such as the examples shown in fig. 7-14C), the patient interface includes a chassis portion 3210 that at least partially forms the plenum chamber 3200. The seal forming structure 3100 may be attached to and supported by a chassis portion 3210, which may be more rigid than the seal forming structure 3100. For example, as shown in cross-section in fig. 7, 8A-8C, 9,10, and 12, the chassis portion 3210 is significantly thicker than the face-engaging film 3118. In the example of fig. 9, the cushion 3130 is more flexible than the chassis portion 3210 such that, in use, the chassis portion 3210 supports the cushion 3130 when the cushion 3130 is deformed while engaging the patient's face. In these examples, the seal forming structure 3100 (e.g., the face engaging film 3118 and/or the cushion 3130, as the case may be) is attached to the perimeter of the chassis portion 3210, and the chassis portion 3210 defines a majority of the volume of the plenum chamber 3200.

As shown in fig. 7, 8A-8C, 9, 10, and 12, by way of example, a face-engaging film 3118 may extend from the chassis portion 3210. The face-engaging film 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 film 3118. In some examples, the chassis portion 3210 and the face engagement film 3118 may be integrally formed, e.g., molded together in a single molding step/round by injection molding. In other examples, the face-engaging film 3118 may be over-molded onto the face-engaging film 3118. In further examples, the chassis portion 3210 may be formed of a material that is substantially rigid during normal use (such as polycarbonate or 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 face engaging film 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).

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

In the examples shown in fig. 7, 8A-8C, 9, 10 and 13A-13B and 14A-14C, the liner 3130 is positioned inside the plenum chamber 3200. A plenum chamber 3200 located adjacent to the cushion 3130 is defined by the chassis portion 3210 and/or the face-engaging film 3118. Advantageously, this means that the gasket 3130 need not be made airtight and may be formed from a lattice structure with open cells, which may provide a different stiffness characteristic than a sealed lattice structure.

In another example, as shown in fig. 9, the liner 3130 is not positioned entirely inside the plenum chamber 3200, but rather partially defines the plenum chamber 3200. In this example, there is no face-engaging film 3118. A liner 3130 is connected to the chassis portion 3210 around the perimeter of the plenum chamber 3200. The cushion 3130 provides cushioning and also forms a seal against the patient's face. In this example, the cushion 3130 is airtight at least at the surface defining the plenum chamber 3200 and forming a seal against the patient's face. The liner 3130 may be formed of a mesh structure, but may have an airtight outer layer. The airtight outer layer may be applied to the lattice structure, for example, as a coating formed of an elastomeric material (such as silicone or TPE), or may be integrally formed with the lattice structure. Advantageously, the integrally formed air barrier may be formed during the same process (such as 3D printing or injection molding) that forms the lattice structure of liner 3130.

In another form, such as the example shown in fig. 11 and 12, the liner 3130 is positioned outside of the plenum chamber 3200. That is, the liner 3130 is located outside of the air flow path through the plenum chamber 3200. Advantageously, this arrangement may make the surfaces defining the plenum chamber 3200 easier to clean, as the plenum chamber 3200 may be defined by uniform surfaces (such as uniform surfaces of the chassis portion 3210 and the face-engaging film 3118). These uniform surfaces are also unobstructed by the pad 3130. Furthermore, since the cushion 3130 is not in contact with the patient's exhalation and associated humidity and any other fluids, the cushion may be less prone to become dirty. In the example shown in fig. 11 and 12, a liner 3130 is connected to but attached to the outer surfaces of chassis portion 3210 and face-engaging film 3118. As shown in fig. 12, for example, the face-engaging film 3118 covers the patient-facing side, which in this example is the side of the cushion 3130 that faces the plenum chamber 3200. In this example, the face-engaging film 3118 is wrapped around the cushion 3130 to partially cover the cushion 3130 from the inside (e.g., from the side of the plenum chamber 3200). In these examples, the pad 3130 may be positioned such that, in use, the pad is capable of deforming against the chassis portion 3210. Advantageously, the chassis portion 3210 is rigid and holds the pad 3130 in place and provides a less deformable structure against which the pad 3130 deforms.

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 cushion 3130 is glued or welded to the chassis portion and/or face-engaging film 3118, or attached in another suitable manner.

5.3.12.1 Gasket for forming a heat-moisture exchanger

As described above, in some examples, at least a portion of the liner 3130 is disposed within the plenum chamber 3200. Additionally, in some examples, at least some of the air flow through the plenum chamber 3200 flows through a grid structure forming a cushion 3130. Fig. 8C shows a cushion module 3150 that includes a cushion 3130 in which an air flow delivered to a patient flows through the cushion 3130. Similar to the other pads 3130 disclosed herein, the pads 3130 may be formed from a mesh structure. The mesh structure may be uncovered or include uncovered portions and is air permeable, thus allowing air to flow from one side to the other.

In some examples, the liner 3130 may serve primarily as only the liner 3130, but depending on the shape and/or size properties of the plenum chamber 3200 and the liner 3130, the liner 3130 may be positioned within the plenum chamber 3200 such that air flows through the liner within the plenum chamber 3200. In other examples, such as the example shown in fig. 8C, the gasket 3130 also forms a heat-moisture exchanger (HMX). The HMX may be used to increase the temperature and/or humidity of the air stream prior to delivering the air stream to the patient. The cushion 3130 may absorb some heat and moisture from the gases exhaled by the patient into the plenum chamber 3200. The cushion 3130 may then transfer heat and moisture to the air flow delivered to the plenum chamber 3200 prior to the patient inhaling the air flow. In some examples, the gasket 3130 may function as an HMX, may be formed from a mesh structure, and may also function as a gasket 3130 for the seal forming structure 3100.

In the example shown in fig. 8C, the liner 3130 at least partially covers the plenum inlet port 3240. This requires, or at least promotes, the flow of incoming air through the liner 3130. The cushion module 3150 shown in fig. 8C may be contemplated for use with a patient interface 3000 (such as the patient interface shown in fig. 3A), 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 exhalation must return through the plenum inlet port 3240 before reaching the vent 3400, passing heat and moisture to the mesh structure forming the cushion 3130. In other examples, the vent 3400 may be formed by or disposed on one or more walls forming the plenum chamber 3200, downstream of the plenum inlet port 3240 but upstream of the gasket 3130. That is, the vent 3400 may be disposed between the plenum inlet port 3240 and the gasket 3130. In such examples, some or all of the expired air may flow through the cushion 3130 but be exhausted through the vent 3400 before being able to return through the plenum inlet port 3240.

In the example shown in fig. 8C, the liner 3130 fills most of the space of the plenum chamber 3200. The cushion 3130 may be configured to fill at least a substantial portion of the dead space that would exist once portions of the patient's nose were received inside the cushion module 3150 in use. It should be understood that reference to the liner 3130 filling the space within the plenum chamber 3200 refers to the overall size of the liner, which is the overall volume defined by the peripheral surface of the liner 3150, e.g., the volume of material actually occupied by the grid structure plus the volume of voids defined by the grid structure.

In examples where the liner 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 liner 3130 forms a HMX), the liner 3130 may be provided with one or more holes, peripheral passageways, or other open channels configured to allow free flow of air into and out of the patient airway when the mesh structure forming the liner 3130 becomes inadvertently blocked (e.g., blocked by excess fluid, moisture, etc., due to unexpected operating conditions, misuse, or any other reason). Despite such openings or passageways, during normal operating conditions, cushion 3130 may still function as HMX to at least improve the temperature and/or humidity of air delivered to the patient's airway.

Although the cushion module 3150 shown in fig. 8C is a nasal cushion, the cushion 3130 formed from a mesh structure and forming an HMX may be disposed within any suitable type of cushion module 3150, such as for a full face mask (e.g., of the type of patient interface 3000 shown in fig. 11), an ultra-compact full face mask (e.g., of the type of patient interface 3000 shown in fig. 13A-13B and 14A-14C), a nasal mask (e.g., of the type shown in fig. 3Z), or any other suitable patient interface 3000 in which a cushion 3130 may be disposed, including a patient interface 3000 with a nasal pillow.

The cushion 3130, which also forms HMX, may include a mesh structure formed of a material and/or formed with a specific structure that facilitates the absorption of heat and/or moisture from the exhaled breath and the release of that heat and/or moisture into the air stream delivered to the patient's airway. In some examples, the lattice structure is formed of a material capable of absorbing moisture. For example, the lattice structure may be formed of fibrous material, paper, or a suitable foam, or the like. In one form, the mesh structure may be formed by injection molding or 3D printing pulp. In other examples, the physical structure of the lattice structure (e.g., the shape and size of the cells, or the general shape and size of the portions forming the opportunistic/random lattice) may promote condensation of moisture onto and subsequent evaporation from the surface of the lattice structure material. In some examples, the mesh structure may be used as HMX by absorbing moisture into the material forming the HMX and also by facilitating condensation of the moisture on the surface of the mesh structure. In examples where condensation and evaporation are facilitated by the structure of the mesh structure to provide HMX functionality, the mesh structure may be formed from any suitable material disclosed herein by any suitable process. In further examples, the lattice structure forming the liner 3130 may be impregnated with a hygroscopic material to form HMX.

The cushion 3130 may be removable 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 require periodic cleaning or replacement more often than is required to replace the cushion module 3150 or patient interface 3000. It should also be appreciated that the liner 3130 described herein that does not also form HMX may be removable.

In the example of fig. 8C, the pad 3130 is formed from a mesh structure and also forms HMX, in some examples, the mesh structures disclosed herein may be used to form HMX that is not the pad 3130, but rather is used only or primarily as HMX. For example, such components may not engage the face of the user in use.

5.3.13 Grid structure

As stated above, the liner 3130 may be formed from a mesh structure.

For example, as labeled in fig. 8B, 8C, 9, 15-18, and 23A-23B, the liner 3130 may include a liner body 3131 formed of a mesh structure. That is, the material forming the liner 3130 is constructed and arranged to form a grid. The grid structure may include a plurality of cells. In describing the features or attributes of the gasket 3130, it should be understood that these features or attributes may be features or attributes of the gasket body 3131, but not features or attributes of other portions of the gasket 3130 (such as any gasket clips or added layers), unless the context requires otherwise. For example, although the pad 3130 has a pad clip or outer layer that is not formed of a mesh structure, if the pad body 3131 has a mesh structure, the pad 3130 may be described as being formed of a mesh structure.

In some examples, as shown in fig. 7-1, the lattice structure may be formed from a plurality of interconnect pillars 3166 forming a plurality of voids 3168. The structure of the pillars 3166 may be repeated in two or three dimensions to form a plurality of cells that make up a grid. In an example, each void may be considered as an empty space defined by each cell. Such a mesh structure may be advantageous in providing a relatively lightweight, flexible, and breathable structure. In an example, the liner 3130 may include 20 or more voids.

In use, as shown in fig. 7-2, the mesh structure may provide flexibility to conform to facial features and/or to accommodate anthropometric changes. When the patient interface is engaged with the patient's face, the struts 3166 may flex, thereby changing the size, shape, and/or orientation of the void to allow the cushion 3130 to conform to the patient's face. Additionally, as described later in this disclosure, the characteristics of the mesh structure may be varied in different portions of the mesh to adjust the stiffness or flexibility of the cushion for different regions of the patient's face. For example, stiffness and flexibility may be adjusted by altering or changing 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 cells, and/or the density of the cells.

The cell structure is different from the foam material, which generally forms a cell/pore structure at a microscopic level with a foaming agent. The lattice structure has a repeating macroscopic honeycomb structure constructed from the material forming the struts.

In some examples of the present technology, the grid structure may be 3D printed. In some particular examples, the mesh structure may be 3D printed with a shape corresponding to a unique patient face, for example, using any of the personalized or automatic sizing techniques described herein. In other examples, the mesh structure may be formed by another additive manufacturing technique or another manufacturing technique capable of producing a mesh structure, or may be formed by injection molding. In some examples, the lattice structure may be formed by knitting in a form similar to a spacer fabric. In some examples, the mesh structure may be woven. In alternative examples, the liner may resemble a blister pack, rather than a grid structure.

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

Various possible lattice structures are envisioned. In some examples, the lattice structure includes a two-dimensional structure (e.g., a honeycomb). In further examples, the mesh structure comprises a three-dimensional structure. In examples, the lattice structure may include a fluorite structure (shown in FIG. 23A), a truncated cube structure (shown in FIG. 23B), a composite bundle tube (IsoTruss) structure (shown in FIG. 23C), a hexagonal honeycomb structure (shown in FIG. 23D), a spiral icosahedron (gyroid) structure (shown in FIG. 23E), or a Schwarz (Schwarz) structure (shown in FIG. 23F). In some examples, the pad 3130 may be formed from another mesh structure. In some examples, the liner 3130 may be formed from a plurality of mesh structures.

In some examples of the present technology, cushion 3130 is formed flat and is bent into a three-dimensional shape during assembly with face-engaging film 3118. For example, in some forms, the liner 3130 may be 3D printed in a flat configuration. The cushion 3130 may have flexibility and be capable of assuming a three-dimensional shape corresponding to curvature along the length of the face-engaging film 3118. In other examples, the liner 3130 may be formed in a three-dimensional shape. In some examples, the pad 3130 may be 3D printed in a three-dimensional curved shape. As will be described, the pad 3D printed in a three-dimensional curved shape can be customized.

In some other examples, the mesh structure may be knitted. In further examples, the lattice structure may be formed from a foam having cells formed therein to form the lattice structure. The holes may be formed, for example, by laser cutting.

Fig. 18 schematically illustrates a foam cushion 3130 having a cushion body 3131 with a plurality of apertures 3136 formed in the cushion body 3131. Forming the holes 3136 removes material from the pad body 3131 to effectively form the pad body into a grid structure (although in some examples, the pad body 3131 may be formed (e.g., molded) with existing holes, meaning that no material removal is required) or at least into a shape such that the pad body 3131 behaves like a grid structure. In some examples, the size, shape, and/or spacing of the apertures 3136 varies along the length of the liner 3130 and/or between the first side of the liner 3130 and the second side of the liner 3130. In some examples, the size, shape, and/or spacing of the apertures 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 having one or more properties tailored to a particular user.

The cushion 3130 formed from the lattice structure may advantageously be capable of being designed and produced with fine control over certain properties, at least as compared to foam of uniform quality in some examples. In examples of the present technology, the lattice structure forming cushion 3130 may be designed and produced to have greater softness or compliance in certain areas of the face contact that require compliance than other areas. The properties of the liner 3130 formed from, 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 particular location, while in examples of the present technology, the properties of the lattice structure may be changed at a particular location within the liner 3130. In some examples, the mesh structure may be configured to optimize contact pressure based on tissue elasticity and expected dynamic behavior. In some examples, cushion 3130 may apply pressure for static sealing while face-engaging membrane 3118 provides an inflatable dynamic seal.

Some patients may dislike the idea of using a foam cushion in their patient interface 3000 due to perceived cleanability issues. In examples of the present technology, the cushion 3130 formed of a mesh structure may be at least as comfortable as a foam cushion, but may be more attractive to patients dislike foam. In some examples, the lattice structure has open cells and is formed of a machine washable material. In some examples, the entire cushion module 3150 may be formed of a machine washable or sterilizable material (e.g., the face-engaging membrane 3118 is formed of silicone, the mesh structure is formed of TPU or silicone, the chassis portion 3210 is formed of silicone or polycarbonate, etc.), meaning that the cushion module 3150 may be disconnected from the rest of the patient interface 3000 and easily cleaned or sterilized.

5.3.13.1 Various attributes

In some forms of the present technology, the cushion 3130 may include one or more features that vary between different locations where the seal-forming structure 3100 engages the patient's face. As an example, the one or more varying characteristics may include the stiffness of the liner 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 varying features may include features of the grid structure, such as any one or more of shape, thickness, density, spacing, relative orientation, and/or material of the cells forming the grid structure.

It should be appreciated that the manner in which the lattice structure may be configured to provide a region of higher stiffness at one location as compared to another location will depend on the particular lattice structure. In some examples, the lattice structure may include a beam lattice structure, e.g., a lattice structure formed from a network of members that appear as beams or struts. In one such example, the pad 3130 may include a first region that is stiffer due to the increased thickness and/or density of the struts and a second region. In another example, the pad 3130 may include a lattice structure formed from bendable beams. There may be a large number of easily bendable beams in the first region and a small number of relatively inflexible beams in the second region, such that the first region is more compliant or less rigid than the second region. It should be appreciated that multiple parameters may be modified throughout the grid structure to provide different behavior in different areas of the pad 3130. In some examples, more voids may be provided in areas of the grid structure having lower stiffness than areas having higher stiffness.

In general, the pads 3130 are described herein as being more compliant or less rigid in one region than in another region, or in the case of being more rigid in one region than in another region, the particular parameters/characteristics of the mesh structure that constructs the pads 3130 may be varied as needed to provide the desired differences in behavior between the regions.

In some examples, a mesh structure may be provided with features that result in more complex behavior than just stiffness or flexibility. For example, in some forms of the present technology, the lattice structure may be formed of struts, but some or all of the struts may be curved (C-shaped or otherwise). The curved struts may be curved in a controlled manner. In other examples, some or all of the struts may be straight and may be configured to flex in use. For example, the struts may be used to resist loads directed along their length up to the point where the struts may flex. Upon buckling, the stiffness of the struts may decrease and the struts may allow further compression without excessive stiffness. Such an arrangement may provide a long "stroke" (e.g., high fit) without requiring excessive force to be applied between the user's face and the cushion 3130.

In some examples, the lattice structure may be configured to define voids that close (or move toward a more closed position) during compression of the liner 3130. When substantially all of the voids in the region are closed, the gasket 3130 may be significantly reinforced because it may not have more compression capacity. In some examples, the number, size, shape of available voids may be selected to create such reinforcement in certain areas that may require substantial support.

5.3.13.1.1 Variation of a pure nasal mask

In some examples, the patient interface 3000 may include a seal-forming structure 3100 configured to seal to the patient's face at the upper lip of the patient, outside of 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 patient's nasal tip is inserted. Fig. 7-10 and 12 illustrate examples of cushion modules 3150 suitable for use with nasal masks. 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 within only a particular portion of the seal forming structure 3100.

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 nose portion side disposed within a respective 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 liner 3130 is stiffer at the nose portion side than at the upper lip portion. In some further 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 be stiffer on the nose portion side than at the nose ridge portion. The pad 3130 may advantageously be less stiff at the nasal ridge than at other portions, as the nasal ridge may be a sensitive area and also a surface with high curvature where a high level of compliance is required to avoid leakage.

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 wings and the nasolabial folds, and at the lower periphery of the patient's nose, including the wings and the nose cone region of the patient's nose. This type of patient interface 3000 may be referred to as a nose pad mask, a sub-nasal mask, or the like. The seal forming structure 3100 may be configured not to engage the nasal ridge of the patient. In such a patient interface 3000, the seal forming structure 3100 may include one or two nasal apertures 3272.

The seal forming structure 3100 can 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. The cushion 3130 may also include a pair of rear corner portions disposed within a portion of the seal forming structure 3100 that is configured to seal to the patient's face between the nasal wings and the nasolabial folds. The liner 3130 may be stiffer in the rear corner portion 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 configured to seal to the patient's face at the lower periphery of the patient's nose. In some particular examples, the cushion 3130 is stiffer in the rear corner portion than in the lower nose peripheral portion.

5.3.13.1.2 Changes to the oronasal mask

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 lip of the patient, at the cheek of the patient, outside the nose of the patient, and at the nasal ridge of the patient. 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 patient's nose tip is inserted. Fig. 11 shows such a patient interface 3000. The seal forming structure 3100 in this example includes a single aperture configured to provide air flow to both the nose and mouth of the patient. 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 within only a particular portion of the seal forming structure 3100.

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. In some forms, the cushion 3130 may include a pair of cheek portions disposed within respective portions of the seal-forming structure 3100 that are configured to seal to the patient's face at the patient's cheek. In some examples, cushion 3130 may be stiffer in the cheek portion 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 configured to seal to the patient's face outside of the patient's nose. In some examples, the cushion 3130 includes a nasal ridge region 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 be stiffer on the nose portion side than on the nose ridge portion. The pad 3130 may advantageously be less stiff at the nasal ridge than at other portions, as the nasal ridge may be a sensitive area and also a surface with high curvature where a high level of compliance is required to avoid leakage.

In some examples (such as the examples shown in fig. 13A-13B and 14A-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, which includes the nasal wings and the nasal protuberance region of the patient's nose. This type of patient interface 3000 may be referred to as a compact full face mask, ultra-compact full face mask, minimal contact full face mask, or sub-nasal full face mask, among others. 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 which is configured to provide an air flow to a respective one of the patient's nostrils (as shown in fig. 14A-14C), or may include a single nasal aperture 3272 configured to provide an air flow to both nostrils (as shown in fig. 13A-13B). The seal forming structure 3100 may also include an oral aperture to provide an air flow to the patient's mouth, as shown in fig. 13A-13B and 14A-14C. In further examples, the seal forming structure 3100 may include a single aperture to provide air flow to both the nose and mouth of the patient. The cushion 3130 may be positioned around the entire periphery of the patient's nose and mouth, or may be positioned only in certain portions of the seal forming structure 3100.

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, for example, as shown in fig. 13A-13B and 14A-14C. The cushion 3130 may include cheek portions disposed within respective portions of the seal-forming structure 3100 that are configured to seal to the patient's face at the patient's cheeks, as shown, for example, in fig. 13A-13B and 14A-14C. In some particular examples, cushion 3130 is stiffer in the cheek portion than in the lower lip portion. As shown in fig. 14A to 14C, the gasket 3130 is provided only in the lip lower portion and the cheek portion of the seal forming structure 3100.

The cushion 3130 may also 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 includes a lower nasal peripheral portion disposed within a portion of the seal forming structure 3100 that is 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 that is configured to seal to the patient's face between the wings and the nasolabial folds. The liner 3130 may be stiffer in the upper lip portion and/or the rear corner portion than in the lower nose peripheral portion. Advantageously, the cushion 3130 may have a lower stiffness at the lower nasal periphery and/or lower lip than other regions, as the lower nasal periphery and/or lower lip may be sensitive regions and/or may have complex surface geometries, requiring a high level of compliance. As shown in fig. 13A, a cushion 3130 is disposed within the lower labial and cheek portions of the seal-forming structure 3100 and also extends into the upper labial portion of the seal-forming structure 3100 but intersects the sagittal plane in use.

5.3.13.1.3 Changes between patient-facing and non-patient-facing sides

Additionally or alternatively to varying between locations on the patient's face, in some examples, the mesh structure includes one or more features that vary between a patient-facing side (also identified as a user-facing side) of the cushion 3130, which corresponds to a side of the seal-forming structure 3100 configured to contact the patient's face in use, and a non-patient-facing side (also identified as a non-user-facing side) of the cushion 3130, which corresponds to a side of the seal-forming structure 3100 configured to face away from the patient's face in use. Fig. 15A to 15B and fig. 16 to 18 schematically show a pad 3130 having such a variation in the lattice structure.

In some forms, the mesh structure of the patient-facing side of the cushion is configured to be highly compliant, comfortable, and/or constructed and arranged to avoid leaving a red imprint on the patient's face. The mesh structure of the non-patient-facing side of the cushion may be configured to easily adapt to the overall size and shape of the patient's face. As shown by way of example in fig. 15A, the lattice structure includes voids 3168 that may be smaller on the patient-facing side than on the non-patient-facing side. The small void may make the risk of leaving a facial imprint on the patient-facing side low, while the large void on the non-patient-facing side may allow the mesh 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 the relatively large void). The facial imprint may be considered unsightly and/or embarrassing and may also be associated with discomfort during use. In some examples, the grid structure may include cells that are smaller on the patient-facing side than on the non-patient-facing side.

Fig. 15B schematically illustrates another example, in which a gasket 3130 includes a gasket body 3131 formed from a mesh structure defining voids 3168. In this example, void 3168 is smaller on the patient-facing side than on the non-patient-facing side. The lattice structure includes voids that taper in a direction from the non-patient facing side to the patient facing side. In this example, the density of the pad 3130 increases gradually toward the patient facing side, eventually forming a uniform surface 3133 on the patient facing side to provide a smooth and comfortable interface.

Variations in one or more characteristics of the lattice structure may cause the cushion 3130 to be more compliant or less rigid on the patient-facing side of the cushion than on the non-patient-facing side of the cushion. Such an arrangement may advantageously allow the patient-facing side to readily 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 make greater adjustments to fit the overall shape and size of the patient's face.

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

In some examples, such as in the cushion 3130 shown in fig. 16, the patient-facing side of the cushion 3130 (e.g., the cushion body 3131 of the cushion) is defined by cells of the grid structure. The cells may be exposed to contact the face-engaging film 3118. The cushion 3130, or at least the patient facing side thereof, in this example may advantageously be highly compliant. 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.

In other examples, such as in the cushion 3130 shown in fig. 17, the cushion 3130 includes a uniform surface 3133 on the patient-facing side of the cushion 3130. The uniform surface may cover cells of the grid structure. This may advantageously result in a lower risk of leaving a facial imprint during use.

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

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

As described above, in some examples, the lattice structure may be formed from a foam having a plurality of pores formed therein (e.g., pores in the macrostructure of the liner 3130 that are distinct from the microscopic cells/pores of the foam material). These holes may be formed by, for example, laser cutting, or the gasket 3130 may be formed (e.g., molded) with holes. The size, shape, and/or spacing of these holes may be varied within the pad 3130 in order 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 apertures 3136 formed in the cushion body 3131. The aperture 3136 in this example is smaller on a first side (left side in fig. 18) of the pad 3130 than on a second side (right side in fig. 18) of the pad so that the first side of the pad 3130 has a different stiffness than the second side 3130. Alternatively or additionally, the apertures 3136 may vary in size, shape, and/or spacing along the length of the liner 3130. In the example shown in fig. 18, the holes are circular, but in other examples, the holes may have shapes other than circular.

5.3.13.1.4 Changes in proximity to sensitive facial features

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

Fig. 19A schematically illustrates a cushion 3130 in contact with the patient's face in the region of and on either side of a sensitive facial feature. The sensitive facial feature may be a protruding/raised facial feature such as the bridge of the nose, nose points or cheekbones. The cushion 3130 receives a uniformly distributed load on the non-patient-facing side of the cushion 3130, which may be, for example, the load transferred to the cushion 3130 from tension in headgear straps of the positioning and stabilizing structure 3300 transferred through components of the patient interface 3000. Fig. 19B shows a graph of force or contact pressure on the patient's face in the area shown in fig. 19A.

Fig. 19B plots two curves. The solid line curve represents the force or pressure applied to the user's face by the cushion 3130 having a uniform mesh structure (which may be identified as an "un-optimized" cushion 3130). As shown in fig. 19B, the force/pressure applied to the face by the non-optimized cushion 3130 increases at and near the sensitive facial features due to the additional compression of the mesh structure caused by the protruding/raised facial features. The dashed line represents the force or pressure applied to the user's face by cushion 3130 having one or more characteristics that vary at or near the sensitive facial feature. The liner 3130 may be considered to be an "optimized" liner 3130. The term "optimized" should be understood as "better" in the context of certain results (such as comfort, stability, etc.). As shown in fig. 19B, the force/pressure applied to the user's face at the sensitive facial feature is not increased due to the changing nature of the mesh structure. In one example, the mesh structure may be configured to have a lower stiffness in regions configured to contact the sensitive facial feature than in regions on either side of the sensitive facial feature. The lower stiffness in this illustrated example then results in a force between the sensitive facial feature and the cushion 3130 that is no greater than the force between the other regions and the cushion 3130.

More generally, the change in the one or more characteristics of the lattice structure may result in the cushion 3130 exerting less pressure on the sensitive facial feature in use than would be exerted without the change. In fig. 19B, this is illustrated by the optimized cushion 3130 exerting less force on the face at the sensitive facial feature than the un-optimized cushion 3130. The cushion 3130 has been optimized to apply a more uniform load on 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 (where the sensitivity is lower). Thus, although the cushion 3130 as a whole is subjected to the same load, the load applied to the sensitive facial feature is less than that applied by the non-optimized cushion 3130. This may advantageously adequately support patient interface 3000 on the user's face while maintaining a good seal and without creating a pain spot at the sensitive facial features.

In further examples, the change in the one or more characteristics may result in the cushion 3130 exerting less pressure on the sensitive facial feature in use than the cushion 3130 exerting pressure on the user's face around the sensitive facial feature. The change in the one or more characteristics of the lattice structure may result in greater compliance of the pad 3130 at and/or near the location corresponding to the sensitive facial feature. Fig. 20A schematically shows a cushion 3130 in contact with the user's face in the region of and on either side of the sensitive facial feature. The pad 3130 receives a uniformly distributed load on the non-user-facing side of the pad 3130. Fig. 20B shows a graph of force or contact pressure on the user's face in the area shown in fig. 20A.

The solid line curve in fig. 20B is substantially the same as the solid line curve in fig. 19B and represents the force/pressure applied across the user's face by the non-optimized cushion 3130, showing the increase in force at the sensitive facial feature. The dashed curve in fig. 20B represents the force/pressure applied across the user's face by an optimized cushion 3130 in accordance with another example of the present technique. In this example, despite the presence of a raised sensitive facial feature, the change in the mesh 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 may provide a particularly comfortable seal-forming structure 3100 because almost all of the load is applied to the less sensitive areas around the sensitive facial features. In this example, and in the example of the optimized cushion 3130 described with reference to fig. 19B, 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 mesh structure increases the force on either side of the sensitive facial feature, which may be desirable because these regions may be able to support the load more comfortably than the regions 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 approximated by a safety factor.

Fig. 19C shows an example of a pad 3130 having a lattice structure with features that vary along the length of the pad 3130. In this example, the cushion 3130 includes uniform surfaces 3132 and 3133 on the non-patient-facing side and patient-facing side of the cushion 3130, respectively. The cushion 3130 also includes a recess 3134 configured to engage sensitive facial features, such as the bridge of the nose or cheekbones. The mesh-like pattern depicting the pad body 3131 schematically represents the mesh structure. In this example, the orientation of the cells forming the lattice structure varies near the recess 3134 to provide different behavior at and near the recess 3134. For example, the change in the orientation of the lattice structure at and near the recess 3134 may result in a lower stiffness at the recess 3134, which in turn may provide a comfortable engagement between the cushion 3130 and the sensitive facial feature.

Fig. 22C illustrates another example of a pad 3130 that includes variations in grid structure characteristics configured to provide user comfort. As schematically illustrated, the gasket 3130 includes a reinforced region 3139 within the gasket that is stiffer than one or more adjacent regions within the gasket (e.g., left and right regions of the gasket 3130, and regions between the reinforced region 3139 and the recess 3134). In this example, the stiffening region 3139 is positioned to span from a first region of the cushion 3130 located on a first side of the sensitive facial feature (e.g., the left side in fig. 22C), to a second region of the cushion 3130 covering the sensitive facial feature, and into a third region of the cushion 3130 located on a second side of the sensitive facial feature (e.g., the right side in fig. 22C). The reinforced region 3139 may be reinforced by a change in one or more characteristics of the lattice structure at the reinforced region 3139. As illustrated in fig. 22C, the mesh structure has a greater density in the reinforced region 3139 than the surrounding compliant region 3138. For example, increased density may be formed by more material, smaller voids, additional struts, and/or smaller and more cells. The actual parameters that may be changed to increase stiffness will depend on the particular mesh structure used in the various examples.

Fig. 22D shows yet another example of a cushion 3130 that includes a grid structure whose variation in characteristics results in a lower stiffness of the cushion 3130 than other areas at locations corresponding to sensitive facial features and around. In this example, the pad 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 formed by a change in a characteristic of the grid structure (such as a change in one or more of shape, thickness, density, spacing, relative orientation, and/or material of the cells forming the grid structure). Further, in this example, the stiffening region 3139 spans from a first region of the cushion 3130 on a first side of the sensitive facial feature (e.g., 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., the right side in fig. 22D). In this example, the cushion 3130 is stiffer near the patient's face in the first region and the third region than in the second region. That is, the stiffening region 3139 is disposed all the way to the cushion 3130 side that engages the patient's face in regions on either side of the sensitive facial feature in 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, while the stiffening region 3139 is stiffer to transmit a majority of the total force on the cushion 3130 to regions of lower sensitivity of the patient's face on either side of the sensitive facial feature.

Fig. 22G-22J schematically illustrate four different ways by which a lattice structure formed by a network of struts around a void may be constructed to provide different stiffness and fit. Each figure shows a pad 3130 comprising a pad body 3131 comprising a grid structure.

In fig. 22G, the lattice structure is formed of relatively thick struts 3166 that are spaced relatively far apart (at relatively high pitch) from each other, thereby forming relatively large voids 3168. This structure can provide the gasket 3130 with moderate stiffness and high fitting distance.

In fig. 22H, the lattice structure is formed of relatively thin struts 3166 that are spaced relatively far apart (at relatively high pitch) from each other, thereby forming relatively large voids 3168. This structure may provide the gasket 3130 with low rigidity and high fitting distance.

In fig. 22I, the lattice structure is formed of relatively thick struts 3166 that are spaced relatively close to each other (at relatively low pitch) to form relatively small voids 3168. This structure may provide the gasket 3130 with high rigidity and a lower fitting distance.

In fig. 22J, the lattice structure is formed of relatively thin struts 3166 that are spaced relatively close to each other (at relatively low pitch) to form relatively small voids 3168. This structure may provide a cushion 3130 having a medium stiffness and a medium mating distance. As shown in fig. 22J, the patient-facing side of the cushion 3130 may include a uniform surface 3133 that may be thicker than the struts to provide a comfortable surface in use. In some examples, the thickness of the uniform surface 3133 may be 1.5 to 3 times, such as between 1.7 to 2.5 times, such as twice as thick, the thinnest portion of some or all of the struts.

As described elsewhere herein, the liner 3130 may include a grid structure having one or more features that may be varied to provide different properties at different locations within the liner 3130. FIGS. 22C and 22D are described in more detail above, including reinforcing regions 3139 and compliant regions 3138, which are formed by variations in the characteristics of the lattice structure, such as strut thickness.

Fig. 22E shows a further example of a pad 3130 comprising a pad body 3131 comprising a grid structure. The cushion is schematically shown against the patient's face. The patient's face has a protrusion that represents a sensitive facial feature, such as the bridge of the nose or other sensitive feature. In this example, the cushion 3130 includes a stiffening region 3139 on each outer side of the sensitive facial feature that connects to each other near the non-patient facing side of the cushion 3130. The reinforced region 3139 may be formed, for example, by the structure shown in fig. 22I, because the structure provides high rigidity. In the vicinity of the sensitive facial feature, the cushion 3130 includes a compliant region 3138, which may be less rigid than the stiffening region 3139. Compliant region 3138 may be formed from the structure shown in fig. 22H because the structure provides low stiffness and high fit/compliance distance. Along the patient-facing side of the cushion 3130, the cushion body 3131 may be formed from a mesh structure as shown in fig. 22J, with moderate stiffness and moderate mating distance. Smaller voids and thinner struts may provide a comfortable feel against the patient's face. The cushion 3130 may include a uniform layer of material along the patient-facing side to provide a smooth surface.

Fig. 22F shows a further example of a liner 3130 similar to that shown in fig. 22E. In this example, the compliant region 3138 formed by the structure shown in fig. 22H extends at the sensitive facial features all the way to the surface of the patient-facing side of the cushion 3130. The structure disposed along the patient-facing side of the cushion 3130 shown in fig. 22E (i.e., the structure of fig. 22J) is not disposed directly over the sensitive facial feature in fig. 22F, but is disposed on either outside of the sensitive facial feature. The compliant region 3138 formed by the structure shown in fig. 22H extends substantially all the way to the surface of the cushion 3130, allowing the patient-facing side of the cushion 3130 to have high extensibility in a direction parallel to the surface at the sensitive facial feature (indicated by the arrow in fig. 22F). Structures with smaller voids (as shown in fig. 22J) disposed along the patient-facing surface of the pad 3130 may allow for less stretch in the surface.

While certain variations in the grid structure forming the cushion 3130 are described above (and elsewhere) in the context of reducing the load on the sensitive facial features, it should be appreciated that these variations may be applied to any cushion 3130 having one or more regions that are stiffer than one or more other regions, even in the event that no particular facial feature is deemed to be a sensitive facial feature.

Fig. 21A schematically illustrates another example of a cushion 3130 that includes a lattice structure that contacts the user's face near raised/protruding sensitive facial features (such as the bridge of the nose, nose points, or cheekbones, etc.). In this example, the load on the non-user-facing side of the pad 3130 is a non-uniformly distributed load. As illustrated in the figure, 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 liner 3130, which will be described in more detail below.

Fig. 21B shows a graph of force/pressure across a user's face in the vicinity of sensitive facial features. The solid line curve shows the force applied on the face by the non-optimized cushion 3130, which receives the non-uniformly distributed load shown in fig. 21A. As shown in fig. 21B, the force transferred to the face is larger on the left side of the sensitive facial feature and smaller on the right side of the sensitive facial feature, corresponding to the unevenly distributed load applied to the cushion 3130. However, the dashed curve in fig. 21B shows the force transferred to the face by the optimized cushion 3130. As illustrated, the forces applied to the face on either side of the sensitive facial feature are substantially the same due to the variation in the lattice structure forming the cushion 3130, despite the non-uniformly distributed load applied to the non-user facing side of the cushion 3130.

As is apparent in the examples described with reference to fig. 19A-22D, in some examples in which 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 particular examples, the cushion 3130 may receive a non-uniformly distributed load applied to the non-user-facing side of the cushion 3130 along the length of the cushion 3130, while the cushion 3130 applies a uniform load to the user's face along the length of the cushion due to the variation in the one or more characteristics. Advantageously, the cushion 3130 may be optimized to receive non-uniformly distributed loads, but to apply a smoothed, more even (e.g., more nearly uniform) load to the user's face, which has a maximum force that is less than the maximum force of the distributed load on the user's face. This may make patient interface 3000 particularly comfortable to wear while still being able to form a good seal in use.

5.3.13.2 Features near sensitive facial features

Fig. 21A schematically illustrates the cushion 3130 in an undeformed state when it is in contact with a user's face at and on either side of a sensitive facial feature, which may be the bridge of the nose, a nose point, cheekbones, or other raised or sensitive features. The cushion 3130 in this example includes a recess 3134 configured to align with a sensitive facial feature in use. The recess 3134 may be shaped to receive the sensitive facial feature, as shown in fig. 21A.

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 an undeformed state, as shown in 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 no gaps exist at the recess 3134 and a good seal against sensitive facial features is formed. However, the presence of the recess 3134 and its gap in the undeformed state may result in a particularly small force being exerted on the sensitive facial feature in use, as there may be little compression of the cushion in the region of the recess 3134, or at least less compression than without the recess 3134.

In other examples, the recess 3134 may not be so large that gaps exist 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, even the presence of small recesses 3134 may reduce the force applied to sensitive facial features to some extent, as the recesses 3134 may act as a slow release, reducing the specific amount of compression required of the cushion 3130 at the sensitive facial features. Advantageously, recess 3134 may provide a particularly comfortable patient interface 3000.

Fig. 21B shows two force/pressure curves across the user's face in the vicinity of sensitive facial features. The solid line curve shows the force applied to the user's face by the non-optimized cushion 3130 without the recess 3134, and the dashed line curve shows the force applied to the user's face by the optimized cushion 3130, which also has the recess 3134 as shown in fig. 21A. As shown in fig. 21B, the force transmitted to the sensitive facial feature by the cushion 3130 having the recess 3134 is smaller than the force transmitted to the sensitive facial feature by the cushion 3130 without the recess 3134. Further, due at least in part to the recess 3134, the force applied to the sensitive facial feature by the cushion 3130 having the recess 3134 is less than the force applied to the user's face on either side of the sensitive facial feature.

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 at the non-user-facing side of the cushion 3130 in an area of the cushion 3130 aligned with the sensitive facial feature into one or more areas of the cushion 3130 that are side-by-side or spaced apart from the sensitive facial feature. The force redistribution feature may be a change in a characteristic of the mesh structure, or may be an additional or alternative feature of a property of the mesh structure.

Fig. 22A schematically illustrates a cushion 3130 in contact with a user's face near sensitive facial features and receiving distributed loads on its non-user facing side in accordance with further examples of the present technology. Fig. 22B shows a graph of the force or pressure applied by the cushion 3130 to the face of a user in use. The pad 3130 shown in fig. 22A includes a force redistribution feature in the form of a beam structure 3137 within the pad 3130 (e.g., inside the pad body 3131 of the pad 3130). The beam structure 3137 is positioned to span, in use, from a first region a of the cushion 3130 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 on a second side of the sensitive facial feature.

The beam structure 3137 is configured to redirect forces received at region B aligned with the sensitive facial feature into regions a and C that are side-by-side and spaced apart from the sensitive facial feature. As shown in fig. 22B, because beam structure 3137 redirects forces to areas a and C where the user is better able to tolerate the forces, the forces transferred to the user's face at the location of the sensitive facial feature in area B are less than the forces transferred to the user's face in areas a and C. In this example, the cushion 3130 also includes a recess 3134 similar to the example shown in fig. 21A and 21B, which also has the effect of reducing the force applied to the sensitive facial feature. However, as shown in fig. 22B, the magnitude of the force reduction in the entire region B may be much greater than that caused by the presence of the recess 3134 alone, and may affect a wider region (e.g., substantially the entire region B).

In some examples, the pad 3130 includes a void in the user-facing side of the beam structure 3137 in region B and not adjacent to the beam structure 3137 in regions a and C, which may cause the beam structure 3137 to transmit forces received at region B into the pad 3130 at regions a and C. Additionally or alternatively, the pad 3130 has a lower stiffness in region B (e.g., due to the change in the lattice structure), which may also make it easier for forces to be transferred to regions a and C of the pad 3130 instead of region B.

Fig. 22C, which illustrates another example of a pad 3130 with force redistribution features, has been discussed above in the context of a grid structure with regions of different stiffness. In this example, the force redistribution feature includes a reinforced region 3139 within the pad 3130 that is stiffer than one or more adjacent regions within the pad 3130. In this example, the reinforced region 3139 is reinforced by a change in one or more characteristics of the lattice structure at the reinforced region 3139. As illustrated schematically, the stiffening region 3139 is positioned to span from a first region of the cushion 3130 on a first side of the sensitive facial feature (e.g., the left side in fig. 22C), to a second region of the cushion 3130 covering the sensitive facial feature, and into a third region of the cushion 3130 on a second side of the sensitive facial feature (e.g., the right side in fig. 22C). As illustrated in fig. 22C, the mesh structure has a greater density in the reinforced region 3139 than the surrounding compliant region 3138. For example, increased density may be formed by more material, smaller voids, additional struts, and/or smaller and more cells. The actual parameters that may be changed to increase stiffness will depend on the particular mesh structure used in the various examples. The reinforced regions 3139 in this example provide similar effects to the beam structure 3137 described above and may function as a beam to protect the sensitive facial features. The reinforced region 3139 may form a force redistribution feature to at least partially transfer the load on the cushion 3130 away from the sensitive facial feature and into an adjacent region of the region of lower joint sensitivity. The reinforced regions 3139 may be formed of finer or denser grid structures and the surrounding compliant regions 3138 may be formed of coarser, less dense grid structures to provide lower stiffness and weight savings. In this example, the surface layer of the pad 3130 may be formed of the same material as the mesh structure, or may be a different material, such as a textile, foam, silicone, or the like.

Fig. 22D, which illustrates another example of a pad 3130 with force redistribution features, has been discussed above in the context of a grid structure with regions of different stiffness. In this example, the pad 3130 includes reinforced regions 3139 and compliant regions 3138, each formed by a change in a characteristic 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 regions 3139 in this example form a force redistribution feature. Further, in this example, the stiffening region 3139 spans from a first region of the cushion 3130 on a first side of the sensitive facial feature (e.g., 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 on the second side of the sensitive facial feature (e.g., the right side in fig. 22D). In this example, the cushion 3130 is stiffer near the patient's face in the first region and the third region than in the second region. That is, the stiffening region 3139 is disposed all the way to the cushion 3130 side that engages the patient's face in regions on either side of the sensitive facial feature in use. Additionally, the cushion 3130 includes a compliant region 3138 surrounding the sensitive facial feature, the compliant region configured to provide a region of lower stiffness at the sensitive facial feature to achieve comfort. In this example, the stiffening region 3139 is stiffer to form a force redistribution feature that transmits 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 reinforcing region 3139 that spans between the two side regions may serve as a bridge connecting the portions of the reinforcing region 3139 of the side. The central portion, bridge portion, or beam-like portion may transmit load to either side of the sensitive facial feature, while the side portions may form a primary load path to transmit force to less sensitive areas on either side of the sensitive facial feature. In some examples, a central portion of the reinforced region 3139, similar to a bridge, may be stiffer than side portions of the reinforced region 3139. It should be appreciated that in some examples, there are three or more regions of different stiffness within the liner 3130.

5.3.13.3 Personalization

In some examples, the mesh structure of the cushion 3130 is 3D printed in a size or shape corresponding to a unique user face. For example, the face data, which may represent a three-dimensional shape of part or all of the user's face or one or more features of the user's face, may be obtained using known methods or methods described herein (e.g., with reference to fig. 24, 25, and 26A-26D). The mesh structure may then be 3D printed in a shape corresponding to the user's face based on the face data.

In some examples, the mesh structure may be formed at a particular thickness (e.g., an overall thickness of the cushion body 3131) based on facial data of an intended user. For example, the relative thickness of the cushion 3130 in various regions corresponding to different regions of the patient's face may be determined based on the facial data.

Advantageously, 3D printing of the mesh structure may be particularly suitable for implementing personalization based on unique facial data, as it may be cost effective to produce a cushion having a customized shape at least as compared to other techniques, such as injection molding. For example, as described with reference to fig. 18, forming the cushion 3130 from foam may also be suitable for implementing personalization, as the size, shape, spacing, location, and/or number of holes may be easily changed based on facial data during laser cutting or other computer controlled cutting operations to produce optimal or custom-made size and performance characteristics.

In some examples, this grid structure of pads 3130 is configured to optimize contact pressure for a unique individual. The mesh structure may be configured based on facial data corresponding to a unique individual such that the cushion 3130 provides less contact pressure in one or more regions than would be provided without the facial data. The mesh structure may be tuned to optimise the contact pressure for a particular user in use.

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

The cushion 3130 formed (e.g., 3D printed) into a three-dimensional personalized shape may produce better comfort and/or performance than a cushion 3130 that is produced into a flat shape and is not personalized, but a cushion 3130 produced into a flat shape may be considered useful for some applications because it may be provided at a lower cost.

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

Either or both of the overall (e.g., macroscopic) shape of the cushion 3130 and the characteristics of the mesh structure forming the cushion 3130 may be personalized based on the facial data. Fig. 19A-22D illustrate examples of "optimized" pads 3130 having features configured to avoid applying excessive forces to sensitive facial features. In some examples of the present technology, the facial data of the unique user's face may include details identifying the shape and/or location of sensitive facial features (e.g., nose bridge, cheekbones, or other sensitive areas). This facial data may then be used to personalize the cushion 3130 so that its behavior conforms to the manner described with reference to any of fig. 19A-22D. For example, the facial data may be used to form a grid structure with varying characteristics in the construction of the cells such that the grid structure has lower stiffness in the correct region corresponding to the vicinity of the sensitive facial feature than in other regions. Alternatively or additionally, the facial data may be used to form a recess that is in the correct location and/or has the correct/sufficient size to correspond to the sensitive facial features of the particular user to whom the facial data was acquired.

5.4 Automatic sizing

The seal-forming structure 3100 (which may also be referred to as a "face interface," "interface," and "user interface," etc.) according to examples of the present technology (e.g., the examples shown in fig. 7-22D, or any other examples disclosed herein) may be provided in a range of sizes such that an optimal size may be selected from the range of sizes when a patient purchases or a clinician prescribes the patient interface 3000. The following describes systems and methods for helping a user determine the correct or optimal size of the seal forming structure 3100. It should be appreciated that in some examples, the systems and methods may be used to select sub-components of the seal-forming structure 3100, such as the cushion 3130 (e.g., formed from a mesh structure) or other components of the patient interface 3000, such as the positioning and stabilizing structure 3300. It should also be appreciated that in practice, the seal-forming structure 3100 may form part of the removable liner module 3150, meaning that the size selection or customization of the seal-forming structure 3100 may require the selection or customization of the liner module 3150 with the seal-forming structure 3100. Furthermore, references to determining the dimensions of an interface should be understood to alternatively reference to determining the dimensions of a gasket 3130 formed from the mesh structure for the seal forming structure or a gasket module 3150 comprising such a gasket 3130.

In an advantageous embodiment, the present technology may employ an application that may be downloaded from a manufacturer or third party server to a smart phone 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 face interface size may be recommended based on analysis of the captured images or video by a processor of the handset or cloud. In alternative embodiments, 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 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 a face (i.e., containing depth information about the selected portion). This may allow for quick and convenient identification of the correct or optimal dimensions of the facial interface for the user, which improves user fit and comfort.

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

5.4.1 System

Fig. 24 depicts an example system 200 that may be implemented for automatically measuring facial features and determining facial interface dimensions. The system 200 may generally include one or more of a server 210, a communication network 220, and a computing device 230. The server 210 and the computing device 230 may communicate via a communication network 220, which may be a wired network 222, a wireless network 224, or a wired network with a wireless link 226. In some versions, server 210 may communicate unidirectionally with computing device 230 by communicating information to computing device 230, and vice versa. In other embodiments, the server 210 and computing device 230 may share information and/or process tasks. The system may be implemented, for example, to allow for automatic purchase of a user interface, where the process may include an automatic sizing process described in more detail herein. For example, a customer may subscribe to a face interface online after performing a face interface selection process that automatically identifies the appropriate face interface size by image analysis of the customer's facial features.

5.4.1.1 Computing device

The computing device 230 may be a desktop or laptop computer 232 or a mobile device, such as a smartphone 234 or tablet 236. Fig. 25 depicts a general architecture 300 of a computing device 230. 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, sensors 340 and/or sensor interfaces for one or more sensors, an Inertial Measurement Unit (IMU) 342, and a non-volatile memory/data storage device 350.

The sensor 340 may be one or more cameras (e.g., CCD charge coupled devices or active pixel sensors) integrated into the 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 sensor interface for coupling with an external camera (such as webcam 233 depicted in fig. 24). Other exemplary sensors that may be integral to or external to the computing device that may be used to help perform the methods described herein include a light detector for a stereo camera that captures three-dimensional images, or that is capable of detecting reflected light from a laser or a strobe/structured light source. In one embodiment, the sensor 340 comprises an Apple iPhone three-dimensional raw depth camera (3D TrueDepth Camera) or similar sensor employed in other mobile devices capable of 3D facial scanning.

The user control/input interface 331 allows a 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.

The 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.

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

5.4.1.2 Application for facial feature measurement and facial interface sizing

One such application is application 360 for facial feature measurement and/or facial interface sizing, which may be an application that is downloadable to a mobile device, such as smart phone 234 and/or tablet 236. The application 360 may be stored on a computer readable medium, such as the memory/data storage 350, that includes programming instructions for the processor 310 to perform certain tasks related to facial feature measurement and/or facial interface sizing. The application also includes data that can 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.

5.4.2 Method for automatic measurement and sizing

As illustrated by the flow charts of fig. 26A-26D, 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 two-dimensional or three-dimensional images, and to recommend or select an appropriate facial interface size, such as from a set of standard sizes, based on the resulting measurements. The method can generally be characterized as including three or four distinct phases, a pre-capture phase 400, a capture phase 500, a post-capture image processing phase 600, and a comparison and output phase 700.

In some cases, an application for facial feature measurement and facial interface sizing may control the processor 310 to output a visual display including reference features on the display interface 320. The user may position the feature adjacent to his facial features, such as by moving the camera. The processor may then capture and store one or more images of facial features associated with the reference feature when certain conditions (such as alignment conditions) are met. This can be done with the aid of a mirror 330. Mirror 330 reflects the displayed reference features and the user's face onto the camera. The application then controls the processor 310 to identify certain facial features within the images and measure the distance 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 a scaling factor 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 as are appropriate for interface sizing. 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. The size of the recommendation may then be selected based on the comparison and output to the user as a recommendation. Such a process may be conveniently implemented within the comfort of the user's own home (if the user chooses to do so). The application may perform the method within a few seconds. In one example, the application executes the method in real time. The manufacturer or vendor may arrange for the face interface of the recommended size to be automatically shipped to the user-specified address.

5.5 Methods and systems for producing custom patient interfaces

The following describes 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 above examples of automatic sizing and personalization, or alternatively. References to a custom, custom-made, personalized, optimized, etc. patient interface should be understood to refer to a patient interface having at least one custom component (e.g., a cushion 3130 formed by a custom mesh structure), even if some or all of the other components of the patient interface are not custom-made.

5.5.1 System architecture

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 the storage of certain information and/or the execution of processing tasks by particular devices, it should be understood that alternative embodiments are contemplated that share such information and/or processing tasks.

Fig. 27 shows a schematic diagram of an exemplary system 100 that may be used to perform various aspects of the present technology as described herein. It should be appreciated that the system 100 may receive data from and transmit data to external systems and may control the operation of components external to the system 100. The system 100 may generally include a customization server 102 that manages the collection and processing of data related to the design and production of customization components for the patient interface 3000. The customization server 102 has processing facilities represented by one or more processors 104, memory 106, and other components typically found in such computing devices. It should be appreciated that the server 102, processor 104, and memory 106 may 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 accessible by the processor 104, including instructions 108 executable by the processor 104 and data 110 retrievable, manipulable, or storable by the processor 104. Memory 106 may be any suitable means known in the art capable of storing information in a manner accessible by processor 104, including a computer readable medium or other medium that stores data readable by an electronic device.

The processor 104 may be any suitable device known to those skilled in the art. Although the processor 104 and memory 106 are illustrated as being located within a single unit, it should be understood that this is not intended to be limiting and that the functionality of each as described herein may be performed by multiple processors and memories that 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 control routines or algorithms for implementing aspects of the system 100.

Although server 102 is shown in fig. 27 as including only memory 106, server 102 may also be capable of accessing other external memory, data storage, or databases (not shown). For example, information processed at the server 102 may be sent to an external data store (or database) for storage or may be accessed by the server 102 from the external data store (or database) for further processing. Additionally, the system 100 may include a plurality of such data stores and/or databases. In some cases, the data store or the 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 store or database described herein need not be separate, but may be stored together, but as part of separate files, folders, columns of tables in a common file, etc.

The server 102 may communicate with an operator workstation 114 to provide operators with access to various functions and information. Such communication may be performed via network 120. Network 120 may include a variety of configurations and protocols including the internet, intranets, virtual private networks, wide area networks, local networks, private networks (whether wired or wireless) using one or more public proprietary communication protocols, or combinations thereof.

The server 102 performing one or more operations may include using artificial intelligence and/or machine learning algorithms. Server 102 may be configured to generate training data sets and/or employ the trained data sets (either by server 102 or external to server 102) to make certain decisions.

The exemplary system 100 includes one or more user devices 130 that are configured to obtain data related to the shape and/or size of a user's face, head, or features thereof, as will be described further below. By way of example, the user device 130 may include a mobile computing device (such as a smartphone 130A or tablet 130B) or a personal computing device (such as a laptop or desktop computer 130C) that is each 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 a stroboscopic/structured light source.

Exemplary system 100 may include one or more manufacturing systems 140 configured to manufacture custom patient interfaces or components thereof. Manufacturing system 140 may include one or more manufacturing devices 142 configured to physically produce components of patient interface 3000. In some examples, manufacturing device 142 is a 3D printer, knitting machine, braiding machine, laser cutter, or other additive manufacturing device. In an example, manufacturing system 140 may include multiple types of manufacturing equipment 142 for manufacturing different components of patient interface 3000. The manufacturing equipment 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 equipment 142. Manufacturing facility 142 may also communicate with other components of the manufacturing system, for example, manufacturing server 150, which manages the production of custom patient interfaces or components thereof, communicates with custom server 102 and/or manufacturing operator workstation 152.

In some examples, one or more of the manufacturing devices 142 are laser cutters 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 may provide flexibility to provide complex shapes with particular precision, repeatability, speed, and/or automation. The laser cutter may also allow for tailoring of a mass-produced component at a specific rate by modifying the length and/or shape of the component based on the patient's analysis results.

In some examples, one or more manufacturing devices may be provided at a manufacturing factory, at a clinician's office, and/or at a patient's home. In some examples, components may be produced by one or more of the manufacturing equipment at one location and then further modified by one or more of the manufacturing equipment at another location. 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.

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

5.5.2 Method for custom manufacturing grid structures

As illustrated by the flow charts of fig. 28A-28E, one aspect of the present technology is a method 7000 of producing at least one custom component of a patient interface 3000 for treating sleep disordered breathing. The custom component may be, for example, a component of a seal forming structure 3100 (such as a gasket 3130) formed from a mesh structure. The customization component can customize for an individual patient in one or more ways, such as in terms of shape, size, or another attribute (e.g., the attribute described above with respect to personalization and/or optimization of the grid structure).

Referring to fig. 28A, an example of a 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.

5.5.2.1 User data Capture phase

In order to produce a patient interface that provides effective treatment and is comfortable to wear by the user, 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 particularly to the facial features). To provide such customization, it is often necessary to gather information about the size and/or shape of the user's head (including facial features of the user in many cases).

In an example of the present technology, the user data capture stage 7100 includes obtaining information representative of one or more keypoint feature locations of a user's head. As used herein, the term "keypoints" shall refer to particular points, regions, or features on a human head that are associated with elements of the head, including facial features. The location of the keypoints may be defined, for example, with respect to other keypoints or fixed reference points. Examples of head keypoints may include, but are not limited to, a subnasal point, a nasal bridge point, a tragus point, a patient's head last point, a patient's head uppermost point, an orbital rim outermost point, an orbital rim lowermost point, a frankfurt horizontal plane, a sagittal plane, and a coronal plane aligned with the tragus point. Other examples of keypoints may be those features illustrated by any of figures 2B-2F.

5.5.2.1.1 Image data capture

In an example, obtaining relevant information in user capture stage 7100 can include capturing image data of at least a portion of a user's head at 7102 of fig. 28B, and identifying keypoint feature locations based on the image data at 7104. By way of example, image data may be captured using a camera of smartphone 130A, tablet 130B, or computer 130C.

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 adapting mask characteristics for a patient are described in U.S. patent publication No. 2018/017272, 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, 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 portion thereof may include a "Capture" application available from Standard Cyborg, a "Scandy Pro" application available from Scandy, LLC, a "fiber 3D" available from Guangzhou Zhimei technologies, inc., a "Unre 3D FaceApp" available from UNRE AI LIMITED, and a "Bacillus 3D FaceApp" available from Bacillus 3D, inc. Furthermore, any of the techniques described elsewhere herein in connection with automatically sizing may be used with or as an alternative to the facial data acquisition techniques described in this section.

In alternative examples, 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 is created and entered into the system 100, i.e., obviating the need to capture image data.

5.5.2.1.2 Key feature identification

In an example, identifying the keypoint feature of the user at 7104 may be based on two-dimensional image data. U.S. patent publication No. 2018/017272 describes an exemplary method and system for determining key point features of a user and their location based on two-dimensional image data.

In an example, identifying keypoint features based on image data at 7104 may include generating (at 7110 of fig. 28C) a three-dimensional model of the user's face and/or head. The three-dimensional model may be analyzed to identify key-point features of the user and determine their location at 7112. U.S. patent publication No. 2019/0167934 describes an exemplary method and system for identifying keypoint features and their locations from a three-dimensional model. As an example, a three-dimensional model may be generated based on data received from a 3D scanner, a stereo camera, and/or from multiple images of a user's face and/or head captured from different locations and/or orientations of the capture device and/or patient.

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

5.5.2.1.3 Relationships between key point features

In some forms of the present technique, method 7000 may include identifying relationships between the keypoint features. Such relationships may provide information about the user's anthropometric measures, providing a reference for customizing the patient interface or components thereof for the user. By way of example, the relationship between the keypoint features may include distance (i.e., spacing between features) and relative angle.

In an example, identifying the relationship between the keypoint features may include determining a distance between two or more of a subnasal point, a nasal bridge point, a tragus point, a last point of the patient's head, an uppermost point of the patient's head, a right orbital rim outermost point, a left orbital rim outermost point, an orbital rim lowermost point, a frankfurt level, and a coronal plane aligned with the tragus point.

It should be appreciated that the key point features to be identified (and their associated relationships) may be affected by the design or configuration of the patient interface or component thereof to be manufactured, i.e., some key point features will be associated with certain designs or components, but not others. In an example, only selected keypoint features and their relationships may be evaluated. In an alternative example, the entire set of keypoint features from a list of possible keypoint features that can be identified may be evaluated in order to allow the use of a data set across a range of patient interfaces or components thereof.

Fig. 29 shows a side view of a patient's head identifying a plurality of keypoint feature pitches described below. Each feature pitch is located between a pair of keypoint feature locations. Each of these pitches may be useful in determining the size and shape of the patient's head and the location of its features for customizing the pad 3130 for the patient.

In an example, a distance D1 between the sub-nasal 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 consideration of the spacing on the anterior-posterior axis between the upper lip of the patient and the ear of the patient in the design of the custom assembly of patient interface 3000.

In an example, a distance D2 between a subnasal point and a 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 a subnasal point and a vertical superior tragus point in the sagittal plane). Together with the horizontal distance D1 between the subnasal and tragus points, this 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 the custom assembly for the patient interface 3000.

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 the custom assembly for patient interface 3000. In particular, this spacing may be particularly useful in determining, for example, the shape and/or size of the custom pad 3130 of the seal forming structure 3100.

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

In an example, a vertical distance D5 between the subnasal point and the uppermost point of the patient's head may be determined. This feature spacing may enable 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 the custom assembly for patient interface 3000. This feature spacing may be particularly useful in determining, for example, the shape and/or size of the custom pad 3130.

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 feature spacing may enable the distance between the top of the patient's head and the patient's ear or lower orbital rim to be considered in the design of the custom assembly for patient interface 3000. This distance may be particularly useful in determining, for example, the shape and/or size of custom pad 3130.

In an example, a distance D7 between the head's final point and a coronal plane aligned with the tragus point may be determined, the distance D7 being perpendicular to the coronal plane. This feature spacing may enable 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 the custom assembly for patient interface 3000.

The foregoing relationships are given by way of example only and are not intended to limit all forms of the present technology.

5.5.2.2 Specification determination stage

In the specification determination phase 7200, an example of the method 7000 includes determining a set of manufacturing specifications for producing the patient interface or one or more components thereof (such as the cushion 3130 formed from the mesh structure or the mesh structure thereof) based on the one or more keypoint feature locations and/or the relationship therebetween.

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 stiffness, contact pressure, compliance, force applied by or to the component, elasticity, dimensions (including dimensions and relative angles of features of the component), tactile sensation, breathability, thermal dissipation, and/or positioning on the user's head. Such performance criteria may be affected by one or more of efficacy of providing therapy (e.g., sealing of the patient interface and/or reduced likelihood of occlusion during use), user comfort (e.g., touch feel of the assembly and 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 appreciated that performance requirements for the component will be affected by one or more keypoint feature locations and/or relationships therebetween, examples of which are further described below. In an example, custom component specifications may be determined based in part on non-performance characteristics (such as color).

In an example, the performance requirements may be based on functional requirements that are not derived from the keypoint feature location and/or the relationship therebetween as described above.

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 motion. In one form of the present technique, the patient may be prompted to record himself as making a different facial expression as part of acquiring facial motion data that may be used to optimize the response of the mesh structure of the cushion 3130 to facial motion. For example, the cushion 3130 may be adjusted to respond to the manner in which the unique user's face tends to move.

Fig. 30A and 30B show two facial expressions. In one example, the patient may record or otherwise make himself with a closed mouth expression as shown in fig. 30A by image or video capturing, and then become a open mouth expression of 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 lattice structure 3130, for example, to enable the cushion 3130 to maintain a sufficient and preferably high-comfort level of contact pressure at the sealing surface during facial movements.

In some examples, the patient may be prompted to record additional or alternative facial expressions to those shown in fig. 30A-30B, such as expressions to tighten the lower jaw, relax the lower jaw, partially open the mouth, stick up the lips, smile, frown, pyridine, bulge the cheeks, and/or various poses (such as look up, top down, side view, lie on the back on the pillow, lie on the side on the pillow, etc.). In some examples, facial motion data may be acquired while the patient is speaking.

In some examples, changes in the location and/or relative spacing of key point features on a patient's face during facial motion may be analyzed, and manufacturing specifications may be generated based at least in part on the changes.

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

In an example, the customization component may include a liner 3130 or a grid structure thereof as described herein. Reference to the production of a custom pad 3130 should be understood to refer at least to its lattice structure, whether or not the lattice structure forms the entire complete pad 3130. A comfortable and stable fit for a particular patient may be achieved by forming the pad 3130 in a particular shape and/or size based on the keypoint feature location and/or its relationship, thereby customizing the pad for that particular patient. An exemplary gasket 3130 is described above with reference to fig. 7-23F.

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

In an example, the manufacturing specifications may include material specifications. The particular material or mixture of materials may be selected based on performance requirements such as stiffness, hardness, flexibility, compliance, or feel. In some examples, the material may be selected based on the preferences of the patient for whom the custom component is being produced.

In an example, the manufacturing specifications may include construction specifications. For example, in a pad 3130 that includes a mesh structure, the particular type/pattern of mesh structure may be selected based on performance requirements for the component (e.g., one of the example structures in fig. 23A-23F). In the case where the mesh structure is formed by knitting, the needle steps may be designated.

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 specification may be based on similarity between one or more keypoint feature locations and/or relationships thereof determined for the user and those keypoint feature locations and/or relationships thereof associated with the existing manufacturing specification.

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

5.5.2.3 Production custom assembly

In an example, producing the patient interface or component thereof (e.g., cushion 3130) based on the set of manufacturing specifications at 7300 includes producing manufacturing machine programming instructions for producing the patient interface or component thereof based on the set of manufacturing specifications at 7302 (see fig. 28E). Manufacturing machine 142 is programmed with manufacturing machine programming instructions at 7304 and the manufacturing machine is operated to produce the patient interface or components thereof according to the manufacturing machine programming instructions at 7306.

In some examples, producing the customized component at 7300 includes additive manufacturing (e.g., 3D printing) of the customized component. The manufacturing machine 142 may include a 3D printer to print the customized component (e.g., the pad 3130 or grid structure thereof). The manufacturing machine 142 may include a laser cutter to cut and/or modify a custom component (e.g., a liner 3130 formed of foam and having laser cut holes) to form it into a grid structure.

5.5.2.3.1 To generate manufacturing machine programming instructions

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

In an example, generating manufacturing machine programming instructions for producing the patient interface or components thereof based on the set of manufacturing specifications at 7302 includes generating a graphical representation representing 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 the graphical representation representing the manufacturing specification at 7312.

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 the illustrated features. In an example, the illustration may include a three-dimensional model of the patient interface or components thereof. In such examples, details of the manufacturing specifications may be encoded into the three-dimensional model.

In an example, the illustration may be generated at a first processing facility (e.g., customization server 102) and communicated to an appropriate manufacturer system 140 for generating manufacturing machine programming instructions.

In other examples, the generating of the illustration 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 illustration and a second software application to generate the manufacturing machine programming instructions.

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

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 predefined baseline rules associated with them, e.g., related to manufacturing constraints, or generic performance requirements for a particular component design. In an exemplary embodiment, such templates may include predefined areas of the component design, with manufacturing specifications used to modify parameters of each predefined area.

5.5.2.4 Custom component delivery

In an example, after the customized patient interface or components thereof are produced, an automated delivery system may be used to manage delivery to the user. In an example, the custom patient interface or component thereof (e.g., liner 3130) may be delivered directly to the user from the facility of the manufacturing system 140, or to a designated collection point or address.

In examples where multiple components are to be produced or at least supplied with at least one custom component, an assembly phase may be performed. In an example, the assembly may be performed by a vendor 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 vendor facility for assembly with other components prior to delivery to the user.

5.5.2.5 User matching to existing products

In accordance with an aspect of the present technique, user-specific data (e.g., measurements obtained from a user or user profile information) may 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 may be based on a comparison between user-specific data and data records related to information associated with existing component configurations.

In an example, an existing component configuration may be developed based on one or more data sets representing key point features representing the heads of a user group. For example, the data set may include a model of a human head having characteristics associated with each profile category (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 thereby.

5.5.2.6 Use feedback to modify specifications and/or update models

In accordance with an aspect of the present technique, feedback from a user, clinician, and/or manufacturing operator may be used to update parameters and/or models for performing one or more of the operations discussed above (e.g., identifying keypoint features and/or locations thereof, identifying relationships between keypoint features, determining functional requirements, and/or determining manufacturing specifications). 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.

The user may provide feedback after receiving the custom patient interface. After a predetermined period of time (e.g., after receiving or beginning use of the patient interface) and/or after a predetermined amount of use, the user may enter information indicating the patient interface fit when the patient interface was first used. The user may be asked predefined questions regarding 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 custom patient interface by manufacturing equipment 142. For example, a manufacturing operator may inspect a manufactured patient interface and enter defects in the patient interface caused by the manufacturing process.

Feedback from the user, clinician, and/or manufacturing operator may be used (e.g., via artificial intelligence and/or machine learning algorithms) to modify the manufacturing specifications and/or update the model used to identify keypoint features and/or locations thereof, to identify relationships between keypoint features, and/or to identify the manufacturing specifications.

5.6RPT device

An RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electrical components and is configured to perform one or more algorithms, such as any of all or part of the methods described herein. The RPT device 4000 may be configured to generate an air flow for delivery to an airway of a patient, such as for treating one or more respiratory disorders described elsewhere in this document.

In one form, RPT device 4000 is constructed and arranged to be capable of delivering an air flow in the range of-20L/min to +150L/min while maintaining a positive pressure of at least 6cmH2O, or at least 10cmH2O, or at least 20cmH 2O.

The RPT device may have an outer housing 4010 formed in two parts, an upper part 4012 and a lower part 4014. Further, 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 may include a handle 4018.

The pneumatic path of 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 positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as pressure sensors and flow sensors.

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 an external housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical component 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In alternative forms, RPT device 4000 may include more than one PCBA 4202.

5.6.1RPT mechanical and pneumatic assembly

The RPT device may include one or more of the following components in an overall unit. In alternative forms, one or more of the following components may be located as respective individual units.

5.6.1.1 Air filter

An RPT device in accordance with one form of the present technique may include an air filter 4110 or a plurality of air filters 4110.

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

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.

5.6.1.2 Muffler

An RPT device in accordance with one form of the present technique may include one muffler 4120 or a plurality of silencers 4120.

In one form of the present technique, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

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

5.6.1.3 Pressure generator

In one form of the present technique, 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. The 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/minute, at a positive pressure ranging from about 4cmH2O to about 20cmH2O, or in other forms of up to about 30cmH2O when delivering respiratory pressure therapies. The blower may be as described in any one 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.

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

In other forms, 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.

5.6.1.4 Anti-overflow return valve

In one form of the present technique, the spill valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The spill-resistant valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144.

5.6.2RPT device algorithm

As described above, in some forms of the present technology, the central controller of 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 memory). Algorithms are typically grouped into groups called modules.

In other forms of the present technology, some or all of the algorithms 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 the input signal and/or intermediate algorithm output required by the algorithm portion executing 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, portions 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 a controller of the external device. Such programs configure the controller of the external device as part of the execution algorithm.

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

5.7 Air Circuit

The air circuit 4170 in accordance with an aspect of the present technique is a tube or pipe 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.

In particular, the air circuit 4170 may be fluidly connected with an outlet of the pneumatic block 4020 and the patient interface. This 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.

5.8 Humidifier

5.8.1 Humidifier overview

In one form of the present technology, a humidifier 5000 (e.g., as shown in fig. 5A) is provided to vary the absolute humidity of the air or gas for delivery to the patient relative to ambient air. In general, humidifier 5000 is used to increase the absolute humidity of the air stream and increase the temperature of the air stream (relative to ambient air) prior to delivery to the airway of the patient.

The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air stream, and a humidifier outlet 5004 for delivering a humidified air stream. In some forms, as shown in fig. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006 that may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

5.8.2 Humidifier Assembly

5.8.2.1 Water reservoir

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

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 can be configured to facilitate the air flow to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

According to one form, the reservoir 5110 can be removed from the humidifier 5000, for example, in a lateral direction as shown in fig. 5A and 5B.

The reservoir 5110 can also be configured to prevent liquid from flowing therefrom, such as through any of the apertures and/or intermediate the subassemblies thereof, 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 typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure by leakage and/or flow impedance.

5.8.2.2 Conductive portion

According to one arrangement, the reservoir 5110 includes a conductive portion 5120 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 can be arranged as a plate, although other shapes are equally applicable. All or a portion of the conductive portion 5120 can be made of a thermally conductive material such as aluminum (e.g., approximately 2mm thick, such as 1mm, 1.5mm, 2.5mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity may be achieved with a material of a suitable geometry that is less conductive.

5.8.2.3 Humidifier reservoir base

In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (shown in fig. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking feature, such as a locking bar 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

5.8.2.4 Water level indicator

The humidifier reservoir 5110 may include a water level indicator 5150 as shown in fig. 5A to 5B. In some forms, the water level indicator 5150 can provide a user (such as the patient 1000 or caregiver) with one or more indications as to the amount of water volume in the humidifier reservoir 5110. The one or more indications provided by the 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 200ml, 300ml, or 400 ml.

5.8.2.5 Heating element

In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide a heat input to one or more volumes of water in the humidifier reservoir 5110 and/or to the air flow. The heating element 5240 can comprise 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 described in PCT patent application publication No. WO 2012/171072, which is incorporated herein by reference in its entirety.

In some forms, the heating element 5240 can be disposed in the humidifier base 5006, wherein heat can be provided primarily by conduction to the humidifier reservoir 5110, as shown in fig. 5B.

5.9 Respiratory waveform

Fig. 6A 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 an approximation of tidal volume Vt 0.5L, inhalation time Ti1.6 s, peak inhalation flow Qpeak 0.4L/s, exhalation time Te 2.4s, peak exhalation flow Qpeak-0.5L/s. The total duration tstotal of respiration is about 4s. The person typically breathes at a rate of about 15 Breaths Per Minute (BPM) with a ventilation Vent of about 7.5L/min. A typical duty cycle (ratio of Ti to Ttot) is about 40%.

5.10 Glossary of terms

For purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

5.10.1 General concept

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

Environment in some forms of the present technology, the term environment will be considered to mean external to (i) the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity in a room in which the patient is sleeping. This ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

In another example, the ambient pressure may be pressure immediately adjacent to the body or outside the body.

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

Automatic Positive Airway Pressure (APAP) therapy-CPAP therapy in which the treatment pressure is automatically adjustable (e.g., different per breath) between a minimum and maximum limit, depending on whether an indication of an SDB event is present.

Continuous Positive Airway Pressure (CPAP) therapy, which may be a respiratory pressure therapy in which the therapeutic pressure may be substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the inlet of the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increase in response to detecting an indication of partial upper airway obstruction, and decrease in the absence of an indication of partial upper airway obstruction.

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

In an example of patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle and thus 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 to the patient interface via the air circuit. The ventilation flow Qv is the flow of air exiting the vent to allow flushing of the exhaled air. Leakage flow rate Ql is the flow rate that leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the respiratory system of the patient.

Flow therapy-respiratory therapy that involves delivering an air flow to the entrance of an airway at a controlled flow rate called the therapeutic flow rate, which is generally positive throughout the respiratory cycle of the patient.

Humidifier the term humidifier will be taken to mean a humidification device constructed and arranged or configured with physical structure to be able to provide a therapeutically beneficial amount of water (H ₂ O) vapor to an air stream to alleviate a patient's medical respiratory condition.

Leakage the term leakage will be considered as unintended air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow that leads to the environment.

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

Radiated noise (acoustic) the radiated noise in this document refers to noise transmitted by ambient air to a patient. In one form, the radiated noise may be quantified by measuring the acoustic power/pressure level of the subject in question in accordance with ISO 3744.

Vent noise (acoustic) vent noise in this document refers to noise generated by air flow through any vent, such as a vent hole of a patient interface.

Oxygen enriched air is air having an oxygen concentration greater than the oxygen concentration of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "oxygen-enriched air" is sometimes abbreviated "oxygen".

Medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

Patients, humans, whether or not they have respiratory disorders.

Pressure, force per unit area. The pressure may be expressed in unit ranges including cmH ₂O、g-f/cm² and hPa. 1cmH ₂ O is equal to 1g-f/cm ² and is approximately 0.98 hPa (1 hPa=100 Pa=100N/m ² =1 mbar to 0.001 atm). In this specification, unless otherwise indicated, pressures are given in cmH ₂ O.

The pressure in the patient interface is given by the symbol Pm and the therapeutic pressure, which represents the target value obtained by the interface pressure Pm at the current moment, is given by the symbol Pt.

Respiratory pressure therapy, the application of an air supply to the inlet of the airway at a therapeutic pressure that is generally positive relative to the atmosphere.

Ventilator-a mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

5.10.1.1 Material

Silicone or silicone elastomer, a synthetic rubber. In the present specification, reference to silicone is to Liquid Silicone Rubber (LSR) or Compression Molded Silicone Rubber (CMSR). One form of commercially available LSR is SILASTIC (which includes a range of products sold under this trademark) manufactured by Dow Corning corporation (Dow Corning). Another manufacturer of LSR is the Wacker group (Wacker). Unless specified to the contrary, exemplary forms of LSR have a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate-thermoplastic polymers of bisphenol A carbonate.

5.10.1.2 Mechanical Properties

Rebound resilience is the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Elasticity-essentially all energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Hardness-the ability of the material itself to resist deformation (described, for example, by Young's modulus or indentation hardness scale measured on a standardized sample size).

"Soft" materials may include silicone or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

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

Stiffness (or rigidity) of a structure or component, the ability of the structure or component to resist deformation in response to an applied load. The load may be a force or moment, such as compression, tension, bending or torsion. The structure or assembly may provide different resistances in different directions. The anti-sense of stiffness is flexibility.

A flexible structure or assembly that will change shape (e.g., bend) when allowed to support its own weight for a relatively short period of time, such as 1 second.

Rigid structure or assembly-a structure or assembly that will not substantially change shape when subjected to loads typically encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient airway, for example, under a load of approximately 20 to 30cmH2O of pressure.

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

5.10.2 Respiratory cycle

Apneas an apnea is considered to have occurred by some definition when the flow drops below a predetermined threshold for a period of time (e.g., 10 seconds). Obstructive apneas are considered to occur when some obstruction of the airway does not allow air flow despite efforts by the patient. Central apneas are considered to occur when an apnea is detected due to reduced or absent respiratory effort despite the patency of the airway. Mixed apneas are considered to occur when a reduction in respiratory effort or the absence of an airway obstruction occurs simultaneously.

The expiratory portion of the respiratory cycle is the period of time from the start of expiratory flow to the start of inspiratory flow.

Hypopnea-by some definitions, hypopnea is considered a decrease in flow, not an interruption in flow. In one form, a hypopnea may be considered to occur when the flow rate falls below a threshold rate for a period of time. Central hypopneas will be considered to occur when hypopneas are detected due to reduced respiratory effort. In one form of adult, any of the following may be considered to be hypopneas:

(3272) The patient's respiration is reduced by 30% for at least 10 seconds plus the associated 4% desaturation, or

(Ii) The patient's respiration decreases (but less than 50%) for at least 10 seconds with at least 3% associated desaturation or arousal.

Hyperbreathing-flow increases to a level above normal.

The inspiratory portion of the respiratory cycle, the period of time from the start of inspiratory flow to the start of expiratory flow, will be considered the inspiratory portion of the respiratory cycle.

5.10.3 Anatomy of

5.10.3.1 Facial anatomy

The alar wings (Ala) are the outer walls or "wings" of each nostril (plural: alar wings (alar)).

Nose wing end, the outermost point on the nose wing.

The point of curvature (or nasal alar crest) of the nasal alar, the last point in the curved baseline of each nasal alar, is found in the fold formed by the connection of the nasal alar to the cheek.

Auricle-the entire externally visible portion of the ear.

Nasal bone frame-nasal bone frame includes nasal bone, frontal process of maxilla and nasal portion of frontal bone.

Cartilage frame of the nose the cartilage frame of the nose includes septal cartilage, lateral cartilage, large cartilage and small cartilage.

The columella nasi is the skin strip that separates the nostrils and extends from the point of the nasal process to the upper lip.

Nose columella angle-the angle between a line drawn through the midpoint of the nostril lumen and a line drawn perpendicular to the frankfurt horizontal plane and intersecting the subnasal point.

Frankfurt horizontal plane: a line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the recess above the tragus of the auricle.

The point between the eyebrows is the most prominent point in the median sagittal plane of the forehead, which is located on the soft tissue.

Lateral nasal cartilage, a generally triangular cartilage plate. The upper edge of which is attached to the nasal bone and the frontal process of the maxilla, and the lower edge of which is connected to the alar cartilage of the nose.

The great cartilage of nasal wing is the cartilage plate below the lateral nasal cartilage. It curves around the anterior portion of the nostril. The posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the nasal wings.

Nostril-a generally oval lumen forming the entrance to the nasal cavity. The singular form of a nostril (nares) is a nostril (naris) (nostril). The nostrils are separated by the nasal septum.

Nasolabial folds or nasal labial folds-skin folds or furrows extending from each side of the nose to the corners of the mouth, which separate the cheek from the upper lip.

Nose lip angle-the angle between the columella and the upper lip (while intersecting at the point under the nose).

Subaural base point-the lowest point where the pinna attaches to the facial skin.

The base point on the ear, the highest point where the pinna attaches to the facial skin.

Nose point-the most protruding point or tip of the nose, which may be identified in the lateral view of the rest of the head.

In humans, a midline groove extends from the lower boundary of the nasal septum to the top of the lip in the upper lip region.

The anterior chin point is the most anterior midpoint of the chin, which is located on the soft tissue.

Ridge (nose) the nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protrusion point.

Sagittal plane-a vertical plane from anterior (anterior) to posterior (posterior). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

Nose bridge point is the most concave point on soft tissue covering frontal nasal suture area.

Septal cartilage (nose) the septal cartilage forms part of the septum and separates the anterior parts of the nasal cavity.

The lower edge of the nose wing is the point at the lower edge of the base of the nose wing where the base of the nose wing joins the skin of the upper (upper) lip.

Subnasal point is the point where the small nasal post meets the upper lip in the median sagittal plane, located on the soft tissue.

The suprachin point is the point with the greatest concavity located between the midpoint of the lower lip and the anterior chin point of the soft tissue in the midline of the lower lip.

5.10.3.2 Skull anatomy

Frontal bone comprises a large vertical portion (frontal scale), corresponding to the area called forehead.

Mandible-mandible forms the mandible. The geniog is the bone bulge of the jaw that forms the chin.

Maxillary bone-the maxilla forms the upper jaw and is located above the mandible and below the orbit. The maxillary frontal process protrudes upward from the lateral side of the nose and forms part of the lateral border.

Nasal bone-nasal bone is two small oval bones that vary in size and form among individuals, are positioned side by side in the middle and upper portions of the face, and form a nasal "bridge" through their junction.

The nasal root is the intersection of the frontal bone and two nasal bones, and is directly positioned between eyes and is positioned in a concave area at the upper part of the nose bridge.

Occiput, occiput is located in the dorsal and inferior parts of the cranium. It includes oval cavity, i.e. occipital macropore, through which cranial cavity communicates with vertebral canal. The curved plate behind the occipital macropores is occipital scale.

Orbit-a bone cavity in the skull that accommodates the eyeball.

Parietal bone-parietal bone is a bone that when joined together forms the top cap and both sides of the cranium.

Temporal bone is located on the base and sides of the skull and supports that portion of the face called the temple.

Cheekbones-the face includes two cheekbones that are located in the upper and lateral portions of the face and form the protrusion of the cheeks.

5.10.3.3 Anatomy of respiratory system

Diaphragm, muscle piece extending across the bottom of the rib cage. The diaphragm separates the chest cavity, which contains the heart, lungs and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

The larynx, the larynx or larynx, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung, respiratory organ of human. The conducting areas of the lung contain the trachea, bronchi, bronchioles and terminal bronchioles. The respiratory region contains respiratory bronchioles, alveolar ducts, and alveoli.

Nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by vertical fins called nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called turbinates (nasal conchae) (singular "turbinates") or turbinates (turbinate). The front of the nasal cavity is the nose, while the back is incorporated into the nasopharynx via the posterior nasal orifice.

Pharynx is a portion of the throat immediately below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections, nasopharynx (upper pharynx) (nasal part of pharynx), oropharynx (middle pharynx) (oral part of pharynx), and hypopharynx (hypopharynx).

5.10.4 Patient interface

An anti-asphyxia valve (AAV) is a component or sub-component of a mask system that reduces the risk of a patient re-breathing excessive CO2 by opening to the atmosphere in a safe manner.

Bend pipe is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating assembly, for example about 360 degrees. In some forms, the elbow may be removable from the mating assembly, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating assembly via a disposable snap during manufacture, but cannot be removed by the patient.

Frame-the frame will be considered to mean the structure of the mask that is subject to tension loads between two or more connection points with the headgear. The mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frames may also be airtight.

Headgear-headgear will be considered to mean a form of positioning and stabilising structure designed for use on the head. For example, the headgear may include a collection of one or more supports, straps, and stiffeners configured to position and retain the patient interface in position on the patient's face for delivering respiratory therapy. Some laces are formed from a laminate composite of soft, flexible, resilient material, such as foam and fabric.

Film-film will be considered to mean a typically thin element, which preferably has substantially no resistance to bending but resistance to stretching.

Plenum chamber the mask plenum chamber will be considered to mean that portion of the patient interface having a wall at least partially enclosing a volume of space having air pressurized therein to above atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

Sealing may refer to a noun form of the structure ("seal") or to a verb form of the effect ("seal"). The two elements may be constructed and/or arranged to "seal" or to achieve a "seal" therebetween without the need for a separate "sealing" element itself.

Shell the shell will be understood to mean a curved, relatively thin structure with bending, stretching and compression stiffness. For example, the curved structural wall of the mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

Reinforcement-reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

Struts-struts will be considered structural components designed to increase the compression resistance of another component in at least one direction.

The swivel (term) is a subassembly of components that are configured to rotate, preferably independently, about a common axis, preferably at low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the assembly preferably includes a pair of mating cylindrical conduits. In use, there may be little or no air flow leakage from the swivel.

The laces (nouns) are designed to resist tension.

Vents (noun) are structures that allow air to flow from the interior of the mask or conduit into the ambient air for clinically effective flushing of exhaled air. For example, depending on mask design and therapeutic pressure, clinically effective irrigation may involve a flow rate of about 10 liters per minute to about 100 liters per minute.

5.10.5 Shape of structure

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

To facilitate the description of the three-dimensional structure and the shape of the surface, we first consider a cross-section through the surface of the structure at point p. Referring to fig. 3B to 3F, these figures illustrate examples of cross sections at point p on the surface, and the resulting planar curves. Fig. 3B to 3F also illustrate the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the perspective of an imaginary small person standing upright on the surface.

5.10.5.1 One-dimensional curvature

The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and an amplitude (e.g., 1/radius of a circle just touching the curve at p).

Positive curvature if the curve at p turns to the outer normal, the curvature of this point will be taken as positive (if the imagined small person leaves the point p, they have to walk up a slope). See fig. 3B (relatively large positive curvature compared to fig. 3C) and fig. 3C (relatively small positive curvature compared to fig. 3B). Such curves are commonly referred to as concave curves.

Zero curvature-if the curve at p is a straight line, the curvature will take zero (if an imaginary small person leaves the point p, they can walk horizontally without going up or down). See fig. 3D.

Negative curvature if the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken negative (if an imagined small person leaves point p, they must walk down a hill). See fig. 3E (relatively small negative curvature compared to fig. 3F) and fig. 3F (relatively large negative curvature compared to fig. 3E). Such curves are commonly referred to as convex curves.

5.10.5.2 Curvature of two-dimensional surface

The description of the shape at a given point on a two-dimensional surface according to the present technique may include a plurality of normal cross-sections. The plurality of cross-sections may cut the surface in a plane comprising an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at this point has, for example, a relatively small amplitude. The planar curves in fig. 3B-3F may be examples of such multiple cross-sections at particular points.

Principal curvature and principal direction the direction of the normal plane in which the curvature of the curve takes its maximum and minimum values is called the principal direction. In the examples of fig. 3B to 3F, the maximum curvature occurs in fig. 3B and the minimum curvature occurs in fig. 3F, so fig. 3B and 3F are cross-sections in the main direction. The principal curvature at p is the principal direction curvature.

Surface area-collection of connection points on a surface. The set of points in the region may have similar characteristics, such as curvature or sign.

Saddle-shaped regions-regions where the principal curvatures have opposite signs at each point, i.e. one is positive and the other is negative (depending on the direction in which the imagined person turns, they can walk up or down a slope).

Dome area-areas where the principal curvature has the same sign at each point, e.g., both positive ("concave dome") or both negative ("convex dome").

A cylindrical region where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

Planar area-a surface area in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

Edge of a surface-the boundary or boundary of a surface or region.

Path in some forms of the present technology, a "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous space curve from f (0) to f (1) on a surface. In some forms of the present technology, a "path" may be described as a route or course, including, for example, a set of points on a surface. (imagined paths of people are where they walk on a surface and are similar to garden paths).

Path length in some forms of the present technology, "path length" will be considered to mean the distance along the surface from f (0) to f (1), i.e., the distance along the path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (the imaginary path length of a person would be the distance they must travel along the path over the surface).

Linear distance-linear distance is the distance between two points on a surface, but is independent of the surface. On a planar area, there will be a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path with the same path length as the straight-line distance between the two points. (for an imagined person, the straight line distance will correspond to the distance "in line")

5.10.5.3 Space curve

Space curve-unlike a plane curve, the space curve does not have to lie in any particular plane. The space curve may be closed, i.e. without end points. The space curve may be considered as a one-dimensional segment of three-dimensional space. An imaginary person walking on one strand of the DNA helix walks along the space curve. A typical human left ear includes a helix, which is a left-handed helix, see fig. 3Q. A typical human right ear includes a spiral, which is a right-hand spiral, see fig. 3R. Fig. 3S shows a right-hand spiral. The edges of the structure, e.g. the edges of the membrane or impeller, may follow a spatial curve. In general, a spatial curve can be described by curvature and torsion at each point on the spatial curve. Torque is a measure of how the curve rotates out of plane. The torque has a sign and magnitude. The twist at a point on the spatial curve may be characterized with reference to tangential vectors, normal vectors, and secondary normal vectors at that point.

Tangential unit vector (or unit tangential vector) for each point on the curve, the vector at that point specifies the direction from that point and the size. The tangential unit vector is a unit vector pointing in the same direction as the curve at that point. If an imagined person flies along a curve and falls off his aircraft at a certain point, the direction of the tangential vector is the direction she will travel.

Unit normal vector-the tangent vector itself will change as an imagined person moves along the curve. The unit vector in the same direction as the tangential vector change direction is referred to as a unit principal normal vector. It is perpendicular to the tangential vector.

Auxiliary normal unit vector-auxiliary normal unit vector is perpendicular to both tangential and principal normal vectors. Its direction may be determined by the right hand rule (see e.g. fig. 3P) or alternatively by the left hand rule (fig. 3O).

And the dense tangent plane is a plane containing the unit tangential vector and the unit principal normal vector. See fig. 3O and 3P.

Torsion of the space curve torsion at a point of the space curve is the magnitude of the rate of change of the unit vector of the sub-normal at that point. It measures the extent to which the curve deviates from the chamfer. The space curve lying in the plane has zero torsion. A space curve that deviates from the close-cut plane by a relatively small amount will have a relatively small magnitude of twist (e.g., a gently sloping helical path). A space curve that deviates from the close-cut plane by a relatively large amount will have a relatively large twist size (e.g., a steeply inclined helical path). Referring to fig. 3S, since T2> T1, the magnitude of twist near the top coil of the spiral of fig. 3S is greater than the magnitude of twist of the bottom coil of the spiral of fig. 3S.

Referring to the right hand rule of fig. 3P, a space curve that turns toward the right hand secondary normal direction may be considered to have a right hand positive twist (e.g., the right hand spiral shown in fig. 3S). The space curve turning away from the right hand secondary normal direction may be considered to have a right hand negative twist (e.g., left hand spiral).

Likewise, referring to the left hand rule (see fig. 3O), a space curve that turns toward the left hand secondary normal direction may be considered to have a left hand positive twist (e.g., a left hand spiral). The left hand is therefore positive and equivalent to the right hand negative. See fig. 3T.

5.10.5.4 Holes

The surface may have one-dimensional holes, such as holes defined by a planar curve or by a spatial curve. A thin structure (e.g., a film) with holes can be described as having one-dimensional holes. See, for example, the one-dimensional holes defined by planar curves in the structured surface shown in fig. 3I.

The structure may have two-dimensional apertures, such as apertures defined by surfaces. For example, a pneumatic tire has a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional aperture. See, for example, the liner of fig. 3L and example cross-sections through the liner in fig. 3M and 3N, where the interior surfaces defining the two-dimensional holes are indicated. In yet another example, the conduit may include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by an inner surface of the conduit. See also the two-dimensional holes defined by the illustrated surfaces through the structure shown in fig. 3K.

5.11 Other remarks

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

Unless the context clearly dictates otherwise and where a range of values is provided, it is to be understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the technology. The upper and lower limits of these intermediate ranges, which may independently be included in the intermediate ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

Further, where a value or values stated herein are implemented as part of the technology, it is to be understood that such values may be approximate, unless otherwise stated, and that such values may be used for any suitable significant number to the extent that an actual technical implementation may permit or require it.

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

Obvious alternatives with similar properties may be used as alternatives when a particular material is identified for constructing a component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

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

All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject matter of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such disclosure by virtue of prior application. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "comprises" and "comprising" are to be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

The subject matter used in the detailed description is included solely for the purpose of facilitating the reader's reference and is not intended to limit the subject matter found throughout the disclosure or claims. The subject matter headings are not to be used to interpret the scope of the claims or the claims limitations.

Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, terminology and symbols may imply specific details that are not required to practice the present technology. For example, although the terms "first" and "second" may be used, they are not intended to represent any order, unless otherwise indicated, but rather may be used to distinguish between different elements. Furthermore, while process steps in a method may be described or illustrated in a sequential order, such order is not required. Those skilled in the art will recognize that such sequences may be modified and/or aspects thereof may be performed simultaneously or even synchronously.

Accordingly, it should be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

Claims

1. A patient interface, the patient interface comprising:

a plenum chamber capable of being pressurized to a therapeutic pressure of at least 4cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

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 air flow at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

a vent allowing gas exhaled by the patient to continuously flow from the interior of the plenum to the environment, the vent being sized and shaped to maintain the therapeutic pressure in the plenum in use, and

wherein the patient interface is configured to allow the patient to breathe from the environment through the mouth thereof in the absence of a flow of pressurized air through the plenum inlet port, or is configured to leave the patient's mouth uncovered in use.

2. A patient interface according to claim 1, wherein the seal forming structure comprises 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.

3. The patient interface of claim 2, wherein the patient interface includes a chassis portion at least partially forming the plenum chamber, the seal-forming structure being attached to and supported by the chassis portion, the chassis portion being 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 face-engaging membrane is formed of an elastomeric material.

6. The 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 3-6, wherein the patient interface comprises a positioning and stabilizing structure configured to provide a force to retain 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 removably attached to the positioning and stabilizing structure.

9. The patient interface of claim 8, wherein the patient interface comprises 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 stabilising structure comprises a pair of gas delivery tubes configured to provide the air flow to the plenum chamber at a therapeutic pressure and configured to provide a force to retain the seal-forming structure in a sealed position in use.

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

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

14. A patient interface according to any one of claims 1-13, wherein the grid 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 face.

16. A patient interface according to any one of claims 1-13, wherein the mesh structure is injection molded.

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

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

19. A patient interface according to any one of claims 1-18, wherein the mesh 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 1-19, wherein the grid structure comprises a two-dimensional structure.

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

22. The patient interface according to any one of claims 1 to 19, wherein the mesh structure comprises one of a fluorite structure, a truncated cube structure, a composite bundle tube (isotrus) structure, a hexagonal honeycomb structure, a spiral icosahedron (gyroid) structure, and a Schwarz (Schwarz) structure.

23. A patient interface according to any one of claims 1-13, wherein the cushion is formed of foam having cells 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 1-24, wherein the cushion comprises one or more features that vary between different positions at which 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 a stiffness of the cushion.

27. A patient interface according to claim 25 or claim 26, wherein the one or more characteristics of the cushion comprise one or more characteristics of the mesh structure.

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

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

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

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

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

33. A patient interface according to claim 32, wherein the cushion comprises a lower lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at a lower lip of the patient, the cushion comprising a pair of cheek portions disposed within respective portions of the seal-forming structure configured to seal to the patient's face at cheeks of the patient, and the cushion being 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 comprises a nose portion side disposed within a respective portion of the seal-forming structure configured to seal to the patient's face outside the patient's nose, the cushion comprising a nose ridge region disposed within a portion of the seal-forming structure configured to seal to the patient's face at the patient's nose ridge, and the cushion being more rigid at the nose portion side than at the nose ridge portion.

35. A patient interface according to any one of claims 1-28, wherein the seal-forming structure is configured to seal to the patient's face at the patient's lower lip, at the patient's cheek, at the patient's upper lip, and at a lower periphery of the patient's nose, the lower periphery of the patient's nose including nasal wings and a nasal protuberance region of the patient's nose.

36. A patient interface according to claim 35, wherein the cushion comprises a lower lip portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at a lower lip of the patient, the cushion comprising a cheek portion disposed within a respective 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.

37. A patient interface according to claim 35 or claim 36, wherein 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 an upper lip of the patient, the cushion comprises a lower nasal peripheral portion disposed within a portion of the seal-forming structure configured to seal to the patient's face at the lower peripheral portion 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 1-28, wherein the seal-forming structure is configured to seal to the patient's face at an upper portion of the patient's lips, between the nosewings and the nasolabial folds, and at a lower periphery of the patient's nose, the lower periphery of the patient's nose including the nosewings and a nose lobe region of the patient's nose.

39. A patient interface according to claim 38, wherein 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 an upper lip of the patient, the cushion comprising 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 nose wings and the nose-lip groove, and the cushion being 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 disposed within a portion of the seal-forming structure 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 1-40, wherein the grid structure comprises a plurality of cells, the grid structure comprising one or more features that vary between a 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 a 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.

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 a red imprint on the patient's face.

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

44. A patient interface according to any one of claims 41-43, 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 41-44, wherein the change in the one or more characteristics of the mesh structure results in the cushion being less stiff on the patient-facing side of the cushion than on the non-patient-facing side of the cushion.

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

47. A patient interface according to any one of claims 41-46, 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 cushion.

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

49. A patient interface according to any one of claims 1-40, wherein the grid structure comprises one or more features that vary along a 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 the cushion applies a different distributed load to the patient's face along the length of the cushion as a result of the variation of the one or more features.

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 the change in the one or more characteristics results in the cushion exerting less pressure on the sensitive facial feature in use than would be exerted without the change in the one or more characteristics.

52. A patient interface according to claim 50 or claim 51, wherein the change in the one or more characteristics results in the cushion exerting less pressure on the sensitive facial feature in use than the cushion exerting about the sensitive facial feature to the patient's face.

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

54. A patient interface according to any one of claims 1-40, wherein the cushion comprises a recess configured to align, in use, with a sensitive facial feature on the patient's face, the recess being shaped to receive 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 1-40, wherein the cushion comprises one or more force-redistribution features configured to redirect, in use, forces received in a region of the cushion aligned with a sensitive facial feature on a non-patient-facing side of the cushion at least partially into one or more regions of the cushion that are side-by-side or spaced apart from the sensitive facial feature.

57. A patient interface according to claim 56, wherein the one or more force redistribution features comprise a beam structure located 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 overlying the sensitive facial feature, and into a third region of the cushion 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 stiffening region within the cushion that is stiffer than one or more adjacent regions within the cushion, the stiffening region being positioned to span, in use, from a first region of the cushion that is on a first side of the sensitive facial feature, to a second region of the cushion that covers the sensitive facial feature, and into a third region of the cushion that is on a second side of the sensitive facial feature, the stiffening region being stiffened by a change in one or more characteristics of the mesh structure at the stiffening region.

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

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

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

62. A patient interface according to any one of claims 2-40 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 face-engaging membrane.

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

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

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

66. The 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 mesh structure forming the cushion.

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

68. The patient interface of claim 66 or 67, wherein the cushion covers the plenum chamber inlet port.

69. The patient interface of any one of claims 66 to 68, wherein the cushion fills a majority of the space of 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 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 air flow at the therapeutic pressure is delivered to at least one entrance to the patient's nostrils, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and

Wherein the seal-forming structure includes a liner having a plurality of interconnecting 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 bend, thereby altering the size, shape and/or orientation of the void 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 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.

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

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

75. A patient interface according to claim 73, wherein the size of the void in the first portion of the cushion is different than the size of the void in the second portion of the cushion.

76. A patient interface according to any one of claims 72-75, 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 72-76, wherein the first portion of the cushion is more flexible than the second portion of the cushion.

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

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

81. A patient interface according to any one of claims 70-79, wherein the cushion is constructed of a foam material and has a plurality of large holes formed therein to form the voids.