Positioning and stabilizing structure for patient interface

Abstract

The present disclosure relates to a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a knitted spacer fabric having a first section continuously joined to a second section configured, in use, to surround an ear region of a wearer's head, wherein the first section is configured to be thicker than the second section.

Description

TECHNICAL FIELD

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatuses, and their use. BACKGROUND

[0002] 1.2 Description of Related Art

[0003] 1.2.1 The Human Respiratory System and Its Disorders

[0004] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0005] The airways include a sequence of branching tubes when the branching airways penetrate deeper into the lung, they become narrower, shorter, and more numerous. The main function of the lung is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide from venous blood to exhaled air. The trachea divides into the left and right main bronchus, which eventually subdivide into terminal bronchioles. The bronchi make up the conducting airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and ultimately the alveolar sacs. The alveolar region of the lung is where gas exchange occurs and is known as the respiratory zone. See West, John B. Respiratory Physiology - The Essentials. 9th ed. Lippincott Williams & Wilkins, 2012.

[0006] There is a range of respiratory diseases. Certain diseases can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest Wall Disorders.

[0008] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) that involves partial or complete obstruction of the upper airways. A person with OSA can experience OSA episodes throughout the night, which typically last between 30 seconds and 120 seconds. These episodes can occur up to several hundred times per night, and can be associated with severe daytime sleepiness, morning headaches, and decreased intellectual function. See, for example, Sullivan, U.S. Patent No. 4,994,350.

[0009] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive, rhythmic cycles of increasing and decreasing ventilation, repeated de-oxygenation and re-oxygenation of the arterial blood, and arousal from sleep. CSR can be harmful due to the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which leads to severe sleep disruption, increased sympathetic activity, and increased afterload. See, e.g., U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is an encompassing term for respiratory diseases in which the lungs cannot take in enough oxygen or remove enough CO2 to sustain the patient's needs. Respiratory failure can encompass some or all of the following diseases.

[0011] Patients with respiratory insufficiency, a form of respiratory failure, can experience abnormal shortness of breath on exercise.

[0012] Obstructive Sleep Apnea (OSA) is a condition arising from repeated lair obstruction during sleep. Symptoms include snoring, excessive daytime sleepiness, and waking with a choking or gasping sensation. OSA is associated with cardiovascular morbidity and mortality.

[0013] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, an extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the primary risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include: labored breathing, cough, and sputum production.

[0014] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly, such as with muscular dystrophy, or indirectly, such as with ALS. Some NMD patients are characterised by progressive muscular impairment, which can lead to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness, and eventually death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle weakness that worsens over months and leads to death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle weakness that worsens over years, and only mildly shortens life expectancy (e.g. Limb girdle, Facioscapulohumeral, and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, breathing difficulties when exercising and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0015] Pectus deformities are a group of thoracic wall deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. These conditions are often characterised by a restrictive defect and have the potential for long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals can utilise such therapies to prevent the development of respiratory disorders. However, these have a number of shortcomings.

[0017] 1.2.2 Treatment

[0018] A variety of respiratory therapies have been used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV) and high flow therapy (HFT).

[0019] 1.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy is the application of air supply to the entrance of the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapies such as the tank respirator or cuirass).

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnoea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and thus patients can elect not to comply with therapy if they find the device used to provide such therapy to be any one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0022] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways. The ventilatory support assists the patient in breathing and / or maintains adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, as in the forms of OHS, COPD, NMD, and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0023] Invasive ventilation (IV) provides ventilatory support to a patient who is unable to breathe effectively on their own, and can be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0024] 1.2.3 Respiratory therapy systems

[0025] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0026] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0027] 1.2.3.1 Patient interface

[0028] A patient interface can be used to interface a respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air can be provided via a mask to the nose and / or mouth of a patient, via a tube to the mouth, or via a tracheostomy tube to the trachea of a patient. Depending on the treatment to be applied, the patient interface can form a seal with the area around, for example, the patient’s face, to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., positive pressure of about 10 cmH20 relative to ambient) to effect treatment. For other forms of treatment, such as the delivery of oxygen, the patient interface can not include a seal sufficient to facilitate delivery to the airways of a supply of gas at positive pressure of about 10 cmH20. For flow therapies such as nasal HFT, the patient interface is configured to blow gas into the nares, but specifically to avoid a full seal. One example of such a patient interface is a nasal hood.

[0029] Certain mask systems can not be functionally suitable for the art. For example, purely decorative masks can not be able to maintain an appropriate pressure. Mask systems used for underwater swimming or diving can be configured to prevent water from the outside higher pressure from entering, but will not maintain the internal air at a pressure higher than ambient pressure.

[0030] Certain masks can be clinically disadvantageous for the art, for example if they obstruct airflow through the nose and only allow it through the mouth.

[0031] Certain masks can be uncomfortable or impractical for the art if the patient is required to insert a part of the mask structure in their mouth to create and maintain a seal through their lips.

[0032] Certain masks can be impractical to use while sleeping, for example while lying on their side in bed with their head on a pillow.

[0033] Certain masks can cause some patients to feel claustrophobia, discomfort, and / or can feel excessively annoying.

[0034] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The whole head can move during respiratory treatment.

[0035] Accordingly, some masks have the disadvantages of being protruding, aesthetically undesirable, expensive, ill-fitting, difficult to use, and / or uncomfortable, especially when worn for long periods or when the patient is not familiar with the system. Masks that are the wrong size can result in reduced compliance, reduced comfort, and poorer patient outcomes. Masks designed only for pilots, masks designed as part of personal protection equipment (e.g. filtering masks), SCUBA masks, or masks for administration of anaesthetics can be tolerable for their original application, but nonetheless such masks can be undesirably uncomfortable when worn for long periods (e.g. several hours). This discomfort can result in reduced patient compliance with therapy, particularly if the mask is worn during sleep.

[0036] CPAP therapy is highly effective for treating certain respiratory disorders, provided a patient complies with the therapy. If a mask is uncomfortable or difficult to use, patients can not comply with therapy. Since it is typically recommended that patients clean their masks on a regular basis, if a mask is difficult to clean (e.g. difficult to assemble or disassemble), a patient can not clean their mask, and this can impact patient compliance.

[0037] While masks for other applications (e.g. navigators) can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0038] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0039] 1.2.3.1.1 Seal-forming structure

[0040] A patient interface can include a seal-forming structure. Since the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0041] A patient interface can be characterized in part by the intended design of the seal-forming structure to interface with the face in use. In one form of patient interface, the seal-forming structure can include a first sub-portion that forms a seal around the left nare and a second sub-portion that forms a seal around the right nare. In one form of patient interface, the seal-forming structure can include a single element that encircles both nare in use. Such a single element can be designed to cover, for example, the supra-lip region and the bridge of the nose region of the face. In one form of patient interface, the seal-forming structure can include an element that encircles the mouth region in use, for example by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that encircles both the nare and the mouth region in use. These different types of patient interfaces can be known by various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nose masks.

[0042] A seal-forming structure that is effective in one region of a patient's face can be inappropriate in another region, for example due to different shape, structure, variability and sensitivity regions of a patient's face. For example, a seal on a swimming goggle that covers a patient's forehead can not be suitable for use on a patient's nose.

[0043] Certain seal-forming structures can be designed for mass production, such that one design can fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface, one or the other must be modified to form a seal.

[0044] One type of seal-forming structure extends around the periphery of a patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in face-to-face engagement with the patient's face. This seal-forming structure can include an air or fluid-filled cushion, or a molded or formed surface of an elastomeric (e.g., rubbery) sealing element. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0045] Another type of seal-forming structure incorporates a flap seal of thin material around the periphery of the face mask, so as to provide a self-seal against the patient's face when positive pressure is applied within the face mask. Similar to the previous type of seal-forming structure, if the fit between the face and the face mask is not good, additional force can be required to achieve a seal, or the face mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can wrinkle or buckle in use, causing a leak.

[0046] Another type of seal-forming structure can include a friction fit element, for example for insertion into a nare, however some patients find these uncomfortable.

[0047] Another form of seal-forming structure can use an adhesive to achieve a seal. Some patients can find it inconvenient to apply and remove adhesive from their face on a regular basis.

[0048] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0049] 1.2.3.1.2 Positioning and stabilising structures

[0050] Seal-forming structures of patient interfaces for positive air pressure therapy are subject to corresponding forces of air pressure to disrupt the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in sealing engagement with a suitable portion of the face. Several factors can be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is in maintaining the seal-forming structure in the desired position and in sealing engagement with the face during use of the patient interface by a patient; how comfortable the interface is for the patient; whether the patient feels intrusive and / or claustrophobic when wearing the patient interface; and aesthetic appeal.

[0051] One technique is the use of an adhesive, see for example US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesive can be uncomfortable for some people.

[0052] Another technique is the use of one or more straps and / or stabilising straps. Many such straps suffer from one or more of the problems of being unsightly, cumbersome, uncomfortable and inconvenient to use.

[0053] It is desirable that a patient interface is comfortable for a patient to wear for extended periods of time when the patient is sleeping, forms a leak-tight and stable seal with the patient's face, while also being able to accommodate a range of patient head shapes and sizes when the patient is sleeping.

[0054] 1.2.3.2 Ventilation techniques

[0055] Some forms of therapy system can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow flow of gas from an interior space of the patient interface, for example a plenum chamber, to an exterior of the patient interface, for example the ambient environment.

[0056] The vent can include an orifice and the gas can flow through the orifice in use of the mask. Many such vents are noisy. Others can become obstructed in use and thus provide inadequate venting. Some vents can disrupt the sleep of a bed partner 1100 of the patient 1000, for example through noise or focussed airflow.

[0057] ResMed Inc. has developed a number of improved mask venting technologies, see for example International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0058] Noise table for existing masks (ISO 17510-2:2007, 10 cmH20 pressure 1 m)

[0059]

[0060] (* only one sample, measured at 10 cmH20 in CPAP mode using test method specified in ISO 3744) Utility Content

[0061] The present technology is directed towards providing a medical device for use in screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0062] A first aspect of the present technology relates to apparatus for use in screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0063] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0064] One aspect of certain forms of the present technology is to provide methods and / or apparatus to improve patient compliance with respiratory therapy.

[0065] One form of the present technology comprises a positioning and stabilising structure for a patient interface, characterised in that the positioning and stabilising structure comprises a knitted spacer fabric having a first section continuously joined to a second section, the second section being configured to surround a binauric region of a wearer's head in use, wherein the first section is configured to be thicker than the second section.

[0066] The positioning and stabilising structure allows the wearer to be in a supine sleeping position or a side sleeping position, thereby providing the wearer with more comfortable, effective breathing and sleep therapy. The positioning and stabilising structure has high air permeability, is soft but has good elasticity, and can provide good cushioning effect.

[0067] One form of the present technology comprises a positioning and stabilising structure for a patient interface, characterised in that the positioning and stabilising structure comprises a knitted spacer fabric having a first section continuously joined to a second section, the second section being configured to surround the occipital region of the head of a wearer in use, wherein the first section is configured to be thicker than the second section, and a second single fabric adhered or laminated to the knitted spacer fabric.

[0068] In one form, the first section is configured to cover the occiput and parietal bone of the head of a wearer in use.

[0069] In one form, the positioning and stabilising structure is constructed as a single knitted spacer fabric having a perimeter shape such that, when formed into a 3D shape, the perimeter shape is complementary to the head of a wearer.

[0070] In one form, the first section comprises a first spacer layer sandwiched between a first top layer and a first bottom layer, wherein the first spacer layer comprises crimped filaments and / or multifilaments in a cross structure.

[0071] In one form, the first section is characterised by a thickness of about 2 mm to about 10 mm.

[0072] In one form, the second section comprises a second spacer layer sandwiched between a second top layer and a second bottom layer, wherein the second spacer layer comprises crimped filaments and / or multifilaments in a cross structure.

[0073] In one form, the second section is characterised by a thickness of about 1 mm to about 6 mm.

[0074] In one form, the filaments and / or multifilaments are characterised by a diameter of about 0.1 mm to about 0.5 mm.

[0075] In one form, the filaments and / or multifilaments are characterised by a linking distance of about 3 to about 10 needles.

[0076] In one form, the filaments and / or multifilaments are formed of a material selected from polyester, nylon, regenerated yarn, cotton, viscose, rayon, acrylic fibre, elastane, or a combination thereof.

[0077] In one form, the first top layer and / or the first bottom layer is a fabric having a knit structure independently selected from single jersey, circular knit jacquard, flat knit, weft knit, and wrap knit.

[0078] In one form, the second top layer and / or the second bottom layer is a fabric having a knit structure independently selected from single jersey, circular knit jacquard, flat knit, weft knit, and wrap knit.

[0079] In one form, the second top layer and the second bottom layer comprise a mesh.

[0080] In one form, the second section includes an edge formed by sealing and / or welding the second top layer to the second bottom layer.

[0081] In one form, the edge is free of the second spacer layer.

[0082] In one form, the edge has a width of about 1 mm to about 10 mm.

[0083] In one form, the first section includes two arms, wherein the arms are configured to couple to one another to form a strap that covers the parietal bone of a wearer’s head when in use.

[0084] In one form, the knit spacer fabric further includes a third section continuously joined to the first section.

[0085] In one form, the third section includes a third top layer adjacent to a third bottom layer.

[0086] In one form, the third top layer is welded and / or sealed to the third bottom layer.

[0087] In one form, the third section is configured to couple with a seal-forming structure and / or an inflatable chamber.

[0088] In one form, the positioning and stabilizing structure further includes a second single fabric adhered or laminated to the knit spacer fabric.

[0089] In one form, the second single fabric is another knit spacer fabric.

[0090] In one form, the positioning and stabilizing structure further includes a foam material sandwiched between the knit spacer fabric and the second single fabric.

[0091] In one form, the foam material is adhered or laminated to the knit spacer fabric and the second single fabric.

[0092] One form of the technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0093] One aspect of certain forms of the technology is a medical device that is easy to use, for example by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0094] One aspect of one form of the technology is a portable RPT device that can be carried by a person, for example in a person’s home.

[0095] One aspect of one form of the technology is a patient interface that can be washed in soapy water at a patient’s home, for example, without the need for specialised cleaning equipment. One aspect of one form of the technology is a humidifier tank that can be washed in soapy water at a patient’s home, for example, without the need for specialised cleaning equipment.

[0096] The described methods, systems, devices, and apparatuses can be implemented to improve the functioning of processors, such as processors of special purpose computers, respiratory monitors, and / or respiratory treatment devices. Moreover, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0097] Of course, some of these aspects can form sub-aspects of the technology. Furthermore, various aspects of the sub-aspects and / or aspects can be combined in various ways, and also form further aspects or sub-aspects of the technology.

[0098] Other features of the technology will be apparent from consideration of the following detailed description, from the abstract, from the drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0099] The technology is illustrated in the drawings in example and non-limiting ways, in which like reference numerals denote similar elements, including:

[0100] 3.1 Respiratory therapy system

[0101] Figure 1A A system is shown, including a patient 1000 wearing a patient interface 3000 in the manner of a nasal pillow, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes 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.

[0102] Figure 1BA system is shown comprising a patient 1000 wearing a patient interface 3000 as a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passes along an air circuit 4170 to the patient 1000.

[0103] Figure 1C A system is shown comprising a patient 1000 wearing a patient interface 3000 as a full face mask receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying sleep position.

[0104] 3.2 Respiratory system and facial anatomy

[0105] Figure 2A A diagrammatic view of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, oesophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

[0106] Figure 2B A view of the upper airways of a human is shown, including the nasal cavity, nasal bones, nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0107] Figure 2C is a front view of a face with several surface anatomical features identified, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alar base, nasolabial sulcus and cheilion. Also indicated are superior, inferior, radially inward and radially outward directions.

[0108] Figure 2D is a side view of a head with several surface anatomical features identified, including the glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasal ridge, alar crest, otobasion superior and otobasion inferior. Also indicated are superior-inferior and anterior-posterior directions.

[0109] Figure 2E is another side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. Also indicated is the coronal plane.

[0110] Figure 2F is a bottom view of a nose with several features identified, including the nasolabial sulcus, lower lip, upper vermilion, nostril, subnasale, columella, pronasale, long axis of the nostril and central sagittal plane.

[0111] Figure 2G is a side view of nasal surface features.

[0112] Figure 2HSubcutaneous structures of the nose are shown, including lateral cartilages, septal cartilage, alar cartilages, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrofatty tissue.

[0113] Figure 2I Medial dissection of the nose is shown, about a few millimeters medial to the central sagittal plane, showing, among other things, the septal cartilage and the medial crura of the alar cartilages.

[0114] Figure 2J An anterior view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. Also indicated are the turbinate bones, as well as the maxilla and mandible.

[0115] Figure 2K A lateral view of the skull is shown, with the surface contours of the head, as well as several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0116] Figure 2L An anterolateral view of the nose is shown.

[0117] 3.3 Patient interface

[0118] Figure 3A A patient interface in the form of a nasal mask according to an form of the present technology is shown.

[0119] Figure 3B A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively large magnitude when compared to the curvature magnitude shown. Figure 3C

[0120] A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively small magnitude when compared to the curvature magnitude shown. Figure 3C Figure 3B A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a zero value.

[0121] Figure 3D A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the curvature magnitude shown.

[0122] Figure 3E Figure 3F A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the curvature magnitude shown.

[0123] Figure 3F ​​A schematic view of a cross section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a negative sign and has a relatively large magnitude when compared to the curvature magnitude shown. Figure 3E

[0124] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. A dome and a saddle region are indicated.

[0125] Figure 3H A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. A 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 a dome region are indicated.

[0126] Figure 3I A surface of a structure with a one-dimensional hole on the surface is shown. The planar curve shown forms the boundary of the one-dimensional hole.

[0127] Figure 3J A cross section through a structure is shown. The surface shown bounds a two-dimensional hole in the structure. Figure 3I Figure 3I

[0128] Figure 3K A perspective view of a structure is shown, including a two-dimensional hole and a one-dimensional hole. The surface bounding the two-dimensional hole in the structure is also shown. Figure 3I Figure 3I

[0129] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0130] Figure 3M A cross section through a mask is shown, and the inner surface of the bladder is shown. The inner surface bounds a two-dimensional hole in the mask. Figure 3L

[0131] Another cross section through a mask is shown. The inner surface is also indicated. Figure 3N Figure 3L

[0132] Figure 3O The left-hand rule is shown.

[0133] Figure 3P The right-hand rule is shown.

[0134] Figure 3Q The left ear, including the left ear screw, is shown.

[0135] Figure 3R The right ear, including the right ear screw, is shown. ​​​​​​​

[0136] Figure 3S A right hand helix is shown.

[0137] Figure 3T A view of the mask is shown, including the notation of the twist of the space curve defined by the edge of the sealing membrane in different regions of the mask.

[0138] Figure 3U A view of the plenum 3200 is shown, showing the sagittal plane and the mid-contact plane.

[0139] Figure 3V A view of the back of the plenum of Figure 3U is shown. The orientation of this view is perpendicular to the mid-contact plane. Figure 3V The sagittal plane in bisects the plenum into a left hand side and a right hand side.

[0140] Figure 3W A cross section through the plenum of Figure 3V is shown, the cross section being taken at the sagittal plane shown in Figure 3V . The "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and just touches the cushion of the plenum at two points on the sagittal plane, an upper point 3220 and a lower point 3230. Depending on the geometry of the cushion in this region, the mid-contact plane can be a tangent at the upper and lower points.

[0141] Figure 3X A view of the plenum 3200 of Figure 3U in use on a face. When the plenum is in the use position, the sagittal plane of the plenum 3200 is substantially coincident with the central sagittal plane of the face. When the plenum is in the use position, the mid-contact plane substantially corresponds to the "plane of the face". In Figure 3X , the plenum 3200 is a nasal plenum, and the upper point 3220 is located approximately at the sellion, while the lower point 3230 is located at the sublabiale.

[0142] 3.4 Knitted spacer fabric

[0143] Figure 4A A perspective view of a patient interface including a positioning and stabilising structure according to one form of the present technology is shown.

[0144] Figure 4B A perspective view of a positioning and stabilising structure according to one form of the present technology is shown.

[0145] Figure 4C A perspective view of a knitted spacer fabric in a positioning and stabilising structure is shown.

[0146] Figure 4D An exploded view of one form of positioning and stabilizing structure according to the present technology is shown. Detailed Implementation

[0147] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0148] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0149] 4.1 Treatment

[0150] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0151] In some examples of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0152] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0153] 4.2 Respiratory Therapy System

[0154] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0155] 4.3 Patient Interface

[0156] According to one aspect of this technology, such as Figure 3A The illustrated noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0157] If the patient interface does not comfortably deliver the minimum level of positive pressure to the airways, the patient interface can not be suitable for respiratory pressure therapy.

[0158] The patient interface 3000 according to an form of the present technology is structured and arranged to be capable of providing a supply of air at a positive pressure above ambient, for example at least 2, 4, 6, 10 or 20 cmH20 relative to ambient.

[0159] 4.3.1 Seal-forming structure

[0160] In an form of the present technology, the seal-forming structure 3100 provides a target seal-forming region, and can additionally provide a cushioning function. The target seal-forming region is the region of the seal-forming structure 3100 where a seal is intended to occur. The region where a seal actually occurs - the actual sealing surface - can vary from day to day and from patient to patient, depending on a range of factors including, for example, the position of the patient interface on the face, the tension in the positioning and stabilising structure, and the shape of the patient's face.

[0161] In an form, the target seal-forming region is located on an outer surface of the seal-forming structure 3100.

[0162] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, for example silicone rubber.

[0163] The seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible, resilient material, for example silicone.

[0164] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure 3100 that is suitable for large sized heads, but not small sized heads, and another that is suitable for small sized heads, but not large sized heads.

[0165] 4.3.1.1 Sealing mechanism

[0166] In an form, the seal-forming structure includes a sealing flange that utilises a pressure-assisted sealing mechanism. In use, the sealing flange is able to readily respond to the system positive pressure acting on its underside from within the plenum chamber 3200, thereby causing it to form a tight sealing engagement with the face. This pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilising structure.

[0167] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness of less than about 1 mm, such as from about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum chamber 3200. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the edge of the plenum chamber 3200 and extends at least part of the way around the periphery. The support flange is or includes a spring-like element and acts to support the seal flange in use to prevent it from buckling.

[0168] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is configured and arranged to be in compression, for example as a result of the elastic tension in the positioning and stabilising structure.

[0169] In one form, the seal-forming structure includes a tensioned portion. In use, the tensioned portion is held in tension, for example by adjacent regions of the seal flange.

[0170] In one form, the seal-forming structure includes a region having a tacky or adhesive surface.

[0171] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioned portion, and a portion having a tacky or adhesive surface.

[0172] 4.3.1.2 Mid-nose or nasal ridge region

[0173] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the mid-nose region or the nasal ridge region of the patient’s face in use.

[0174] In one form, the seal-forming structure includes a saddle region configured to form a seal when used on the mid-nose region or the nasal ridge region of the patient’s face.

[0175] 4.3.1.3 Upper lip region

[0176] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e. above the lip) of the patient’s face in use.

[0177] In one form, the seal-forming structure includes a saddle region configured to form a seal on the upper lip region of the patient’s face in use.

[0178] 4.3.1.4 Chin region

[0179] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which forms a seal on the chin region of the patient's face in use.

[0180] In one form, the seal-forming structure includes a chin region configured to form a seal when in use on the chin region of the patient's face.

[0181] 4.3.1.5 Forehead region

[0182] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face in use. In this form, the plenum chamber can cover the eyes in use.

[0183] 4.3.1.6 Nasal pillows

[0184] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or pillows, each nasal puff or pillow being constructed and arranged to form a seal with a respective naris of the patient's nose.

[0185] A nasal pillow according to an aspect of the present technology includes a frusto-cone that forms a seal on an underside of a patient's nose, a stem, and a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stem. Further, the connected structure of the nasal pillow of the present technology includes a flexible region proximate the bottom of the stem. The flexible regions can act in concert to facilitate a universal joint structure that can accommodate relative movement of both displacement and angular movement between the frusto-cone and the connected structure of the nasal pillow. For example, the position of the frusto-cone can be moved axially towards the connected structure of the stem.

[0186] 4.3.1.7 Nasal and oral mask

[0187] In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance of the patient's nares and also around the patient's mouth. The seal-forming structure 3100 can be configured to seal to the patient's face proximate the chin region. This patient interface 3000 can deliver air or a breathable gas to the patient's 1000 nares and mouth. This type of patient interface can be identified as a nasal and oral mask.

[0188] One form of nasal mask according to the present technology is a form that is traditionally identified as a full face mask, having a seal-forming structure 3100 configured to seal around the nose, below the mouth and over the nasal bridge on the patient’s face. The shape of the nasal mask is generally triangular. In one form, the patient interface 3000 comprises a seal-forming structure 3100 which in use forms a seal to the patient’s chin region (which can include the region below the patient’s lip and / or directly below the lip), at least a portion of the patient’s nasal bridge or nasal ridge above the sellion, and to the patient’s cheek regions of the face. Figure 1C The illustrated patient interface 3000 is of this type. This patient interface 3000 can deliver air or breathable gas to the patient’s 1000 nares and mouth through a single orifice. The seal-forming structure 3100 of this type can be referred to as a nasal-or mouth-pieces.

[0189] In another form, the patient interface 3000 comprises a seal-forming structure 3100 which in use forms a seal on the patient’s chin region (which can include the region below the patient’s lip and / or directly below the lip), on the inferior and / or anterior surface of the patient’s nose at the sellion portion of the patient’s nose, on each lateral side of the patient’s nose, for example near the nasolabial sulcus, on the patient’s ala of the nose and on the patient’s face. The seal-forming structure 3100 can also form a seal against the patient’s lip. The patient interface 3000 having a seal-forming structure of this type can have a single opening configured to deliver a flow of air or breathable gas to both of the patient’s nares and mouth, can have a mouthpiece configured to provide air or breathable gas to the mouth and a naris configured to provide air or breathable gas to a naris, or can have a mouthpiece for delivering air to the patient’s mouth and two nares for delivering air to respective nares. The patient interface 3000 of this type can have a nasal portion that seals to the patient’s face at a location similar to a nasal cradle and a mouth portion.

[0190] In another form of nasal and mouth mask, the patient interface 3000 can comprise a seal-forming structure 3100 having a nasal portion comprising a nasal pillow and a mouth portion configured to form a seal to the patient’s face around the patient’s mouth.

[0191] In some forms, the seal-forming structure 3100 can have a nasal portion that is separate and distinct from a mouth portion. In other forms, the seal-forming structure 3100 can form a continuous seal around the patient’s nose and mouth.

[0192] It will be appreciated that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, the patient interface 3000 can comprise a combination of different features of the above-described examples of only nasal masks and nasal and mouth masks.

[0193] 4.3.2 Plenum chamber

[0194] In use, the plenum chamber 3200 has a perimeter shaped to complement the surface contours of an average human face. In use, the bounding edges of the plenum chamber 3200 are positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single sheet of homogenous material.

[0195] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, these eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0196] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, for example, transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. The use of a transparent material can assist a clinician to observe how the patient interface is positioned and functioning.

[0197] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0198] In some forms, the plenum chamber 3200 is constructed from a rigid material, such as polycarbonate. The rigid material can provide support to the seal-forming structure.

[0199] In some forms, the plenum chamber 3200 is constructed from a flexible material (for example, from a soft, flexible, elastomeric material such as silicone, fabric, foam, or the like). For example, in an example, it can be formed from a material having a Young’s modulus of 0.4 GPa or less, for example, a foam. In some forms of the technology, the plenum chamber 3200 can be made from a material having a Young’s modulus of 0.1 GPa or less, for example, a rubber. In other forms of the technology, the plenum chamber 3200 can be made from a material having a Young’s modulus of 0.7 Mpa or less, for example, between 0.7 Mpa and 0.3 MPa. One example of such a material is silicone.

[0200] 4.3.3 Positioning and stabilising structure

[0201] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300. Since the positioning and stabilizing structure 3300 engages with the patient's head to hold the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 can include and function as a "headgear". Figure 3A An example of a positioning and stabilizing structure is shown in the figure.

[0202] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face (i.e., F). 充气 ).

[0203] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0204] Gravity F g It can be related to frictional force F f Conversely, frictional force F f It can act on gravity F g In the opposite direction. When gravity pulls the sealing structure 3100 and the air chamber 3200 downwards, the frictional force F... f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, the component of the total frictional force will also be opposite to the gravitational force Fg associated with any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. Friction can act at any point along the patient interface 3000 that contacts the patient's skin (or hair). Frictional force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair). In some forms, gravity F g It can also be counteracted by the vertical component of the reaction force from the patient's face acting on the sealing structure 3100, for example, in the nasal ridge and chin area of ​​the patient's face.

[0205] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g And blowing force F 充气 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g And blowing force F 充气 The sum of any additional positioning and stabilizing forces F PSS The reaction force from the patient's head acting on the portion of the patient interface 3000 is balanced, and the sealing structure 3100 is still held in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when assembled, the positioning and stabilizing force F... PSS Greater than the precise balancing force F g And blowing force F 充气 The required force is sufficient to hold the patient interface 3000 sufficiently tightly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force F required to achieve balance. PSS .

[0206] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0207] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0208] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0209] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying in a side sleeping position with a side region of the patient's head on a pillow.

[0210] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion between the front of the positioning and stabilising structure 3300 and the rear of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or soft strap. The decoupling portion is constructed and arranged so that when a patient lies with their head on a pillow, the presence of the decoupling portion prevents forces acting on the rear from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0211] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed and arranged from a laminate of a fabric patient contact layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to enable moisture (e.g. sweat) to pass through the strap. In one form, the fabric outer layer comprises loop material for partial engagement with hook material.

[0212] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is extendable, for example elastically extendable. For example, the strap can be configured to be in tension when in use and to direct forces to pull the seal forming structure into sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0213] In one form of the present technology, the positioning and stabilising structure comprises a first tie configured and arranged so that, in use, at least a portion of a lower edge of the first tie passes over an otobasion superior of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0214] In one form of the present technology suitable for use with a nasal only mask or with a full face mask, the positioning and stabilising structure comprises a second tie configured and arranged so that, in use, at least a portion of an upper edge of the second tie passes under an otobasion inferior of the patient's head and covers or is located under the occipital bone of the patient's head.

[0215] In one form of the present technology suitable for use with a nasal only mask or with a full face mask, the positioning and stabilising structure comprises a third tie configured and arranged to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to separate from each other.

[0216] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie on while sleeping.

[0217] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap configured to be breathable to allow moisture to be transported through the strap.

[0218] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 3300, each configured to provide a retention force to correspond to a different size and / or shape range. For example, the system can comprise one form of positioning and stabilising structure 3300 suitable for a large size head, but not suitable for a small size head, and another form of positioning and stabilising structure suitable for a small size head, but not suitable for a large size head.

[0219] It has been found that with some positioning and stabilising structures, maceration of the wearer's skin can be observed. In particular, when the wearer rolls and turns during sleep, the positioning and stabilising structure can rub against the skin, causing discomfort. While foam can be used, they can be heat retaining and are not ideal for air circulation. There is therefore a need for a positioning and stabilising structure that can provide a more comfortable and effective breathing and sleep therapy for the wearer. There is a need for a positioning and stabilising structure that has high breathability, is soft but has good elasticity, and can provide a good cushioning effect.

[0220] In one form of the present technology, a positioning and stabilising structure 4300 Figure 4A ) for a patient interface 3000 is provided. The positioning and stabilising structure 4300 comprises a knitted spacer fabric. The knitted spacer fabric has a first section 4001 continuously joined to a second section 4003. The second section 4003 can be configured to surround a pinna region of a wearer's head when in use. The first section 4001 can be configured to be thicker than the second section 4003.

[0221] The first section 4001 is linked to the second section 4003 without any interruption or connector. In this regard, the knitted spacer fabric is formed as a single piece with the first section 4001 seamlessly transitioning to the second section 4003. No stitching, sewing or any form of adhesive is used.

[0222] The pinna region of a wearer's head includes a point superior and a point inferior. In certain forms of the present technology, the second section 4003 surrounds the wearer's ear. As Figure 4A shown, the second section 4003 can form a perimeter around the wearer's ear. In certain forms of the present technology, the second section 4003 can be hollowed out so that the wearer's ear protrudes.

[0223] In certain forms of the present technology, the first section 4001 is continuously joined to two second sections 4003, each of the second sections 4003 configured to surround each pinna region of a wearer's head when in use.

[0224] In certain forms of the present technology, the first section 4001 is configured to cover the occipital and parietal bones of the head of a wearer, in use.

[0225] In certain forms of the present technology, the positioning and stabilising structure 4300 is constructed as a single knit spacer fabric having a perimeter shape such that, when formed into a 3D shape, it is complementary to the head of a wearer. Figure 4A A positioning and stabilising structure 4300 is shown in its 3D configuration. The positioning and stabilising structure 4300 can be coupled to the seal-forming structure 4100 and / or the plenum chamber 4200 to form the patient interface 3000. Figure 4B A positioning and stabilising structure 4300 is shown in its 2D configuration. The end portions 4007a and 4007b can be joined together to form a strap that, in use, covers the parietal bones of the head of a wearer. The end portions 4005a and 4005b can be coupled to respective end portions of the seal-forming structure 4100 and / or the plenum chamber 4200. Together with the connector 4009, which, in use, covers the occipital bone of the head of a wearer, the positioning and stabilising structure 4300 fits over the head of a wearer to achieve the advantages described herein.

[0226] In certain forms of the present technology, the positioning and stabilising structure 4300 further comprises a second single fabric adjacent to the single knit spacer fabric, the second single fabric having a perimeter shape such that, when formed into a 3D shape with the single knit spacer fabric, it is complementary to the head of a wearer. For example, the second single fabric can be a second knit spacer fabric that is adhered or laminated to the (first) single knit spacer fabric. The positioning and stabilising structure 4300 can further comprise a foam material. The foam material can be sandwiched between the first and second knit spacer fabrics.

[0227] Figure 4D Another positioning and stabilising structure 4300 is shown in its flat configuration. The positioning and stabilising structure 4300 comprises a first knit spacer fabric 4027 and a second single fabric adjacent to the first knit spacer fabric 4027. The second single fabric can be a knit spacer fabric 4029. The positioning and stabilising structure 4300 can further comprise a foam material 4031. The foam material 4031 can be sandwiched between the first knit spacer fabric 4027 and the second knit spacer fabric 4029. The positioning and stabilising structure 4300 can further comprise a first adhesive layer 4033. The first adhesive layer 4033 can be sandwiched between the first knit spacer fabric 4027 and the foam material 4031. The positioning and stabilising structure 4300 can further comprise a second adhesive layer 4035. The second adhesive layer 4035 can be sandwiched between the second knit spacer fabric 4029 and the foam material 4031. This positioning and stabilising structure 4300 can provide greater comfort to a user due to the greater amount of padding.

[0228] 4.3.4 Knitted spacer fabric

[0229] In one form of the technology, the first section 4001 includes a first spacer layer 4011 sandwiched between a first top layer 4013 and a first bottom layer 4015. Figure 4C ) The first spacer layer 4011 can include crimped filaments and / or multifilaments in a cross structure (lateral configuration) 4400. Other possible configurations include X-structures, S-structures, and Z-structures. The filaments and / or multifilaments can also be in a columnar structure. Alternatively, the first spacer layer 4011 can include crimped filaments and / or multifilaments in a longitudinal configuration.

[0230] Spacer fabrics contain a combination of two separate pieces of fabric interconnected with spacer yarns (forming a spacer layer) such that the fabric has a 3D appearance. Knitted spacer fabrics refer to two separate pieces of knitted fabric separated by spacer yarns. A defined distance can be established between the pieces of fabric due to the spacer yarns. The construction of the spacer layer can influence the functionality of the spacer fabric in terms of temperature regulation, breathability, pressure stability, and pressure elasticity. Additionally, the outer fabric pieces can be similarly or differently constructed to achieve other functionalities. For example, the material type and surface properties of the outer layers can influence the elasticity and comfort properties of the positioning and stabilizing structure, and additionally influence moisture transport and air circulation between the pieces, providing thermal control and avoiding maceration of the skin.

[0231] In one form of the technology, the first section 4001 is characterized by a thickness of about 2 mm to about 10 mm. Preferably, the thickness is about 2 mm to about 6 mm, or about 5 mm to about 6 mm.

[0232] In one form of the technology, the second section 4003 includes a second spacer layer 4017 sandwiched between a second top layer 4019 and a second bottom layer 4021. The second spacer layer 4017 can include crimped filaments and / or multifilaments in a cross structure (lateral configuration). The filaments and / or multifilaments can also be in a columnar structure. Alternatively, the second spacer layer 4017 can include crimped filaments and / or multifilaments in a longitudinal configuration.

[0233] In one form of the technology, the second section 4003 is characterized by a thickness of about 1 mm to about 6 mm. Preferably, the thickness is about 1 mm to about 4 mm, or about 1 mm to about 2 mm.

[0234] The thickness of the first section 4001 and the second section 4003 can be varied by varying the thickness of the first and second spacer layers 4011 and 4017. For example, the thickness of the first section 4001 can be 6 mm, and the thickness of the second section 4003 can be 1 mm. In this way, the first section 4001 is configured to be thicker than the second section 4003. Preferably, the thickness of the first section 4001 is relatively thicker than the second section 4003.

[0235] In one form of the technology, the thickness ratio of the first section 4001 to the second section 4003 is about 2: 1 to about 8: 1, about 2: 1 to about 7: 1, about 2: 1 to about 6: 1, about 2: 1 to about 5: 1, or about 2: 1 to about 4: 1. In one form of the technology, the thickness ratio is about 2: 1 to about 6: 1.

[0236] The first and second spacer layers 4011 and 4017 can include monofilaments and / or multifilaments. Monofilaments refer to a single solid filament. Multifilaments refer to a yarn having a plurality of filament fibers twisted together. While spacer fabrics having monofilaments can be stiffer and can resist high pressures and can allow for directional transport of fluids and heat, spacer fabrics having multifilaments allow for more movement and flexibility. Thus, a combination of monofilaments and multifilaments can be used to form the positioning and stabilizing structure 4300. For example, the first spacer layer 4011 can include monofilaments, while the second spacer layer 4017 can include multifilaments.

[0237] In one form of the technology, the monofilaments and / or multifilaments are characterized by a diameter of about 0.1 mm to about 0.5 mm. Preferably, the diameter can be about 0.1 mm to about 0.2 mm. The diameter can affect the stiffness of the spacer fabric.

[0238] In one form of the technology, the monofilaments and / or multifilaments are characterized by a connection distance of about 3 to about 10 needle pitches. Preferably, the connection distance can be about 4 to about 8 needle pitches. The connection distance refers to the inclination of the spacer yarn; that is, the angle of the filaments in the spacer layer between the two outer fabric layers. The connection distance can affect the compressibility of the spacer fabric.

[0239] In one form of the technology, the monofilaments and / or multifilaments are formed from a material selected from polyurethane, polyester, nylon, and / or regenerated yarn. Other materials include, but are not limited to, cotton, viscose, rayon, acrylic, elastane (Lycra, Spandex, Coolmax), blended yarns including different proportions or combinations of polyester and cotton / viscose, cotton / acrylic, polyacrylic fibers.

[0240] In one form of the technology, the first top layer 4013 and / or the first bottom layer 4015 are fabrics each independently having a knit structure. The knit structure can be a warp knit or a weft knit, or a single jersey, a circular knit jacquard, a flat knit, a double jersey, or a double rib knit. Warp knitting includes Tricot, Milanese knit, Raschel knit, stitch bonding, and extended stitch bonding.

[0241] In one form of the present technology, the second top layer 4019 and / or the second bottom layer 4021 is a fabric that has a knit structure independently of each other. The knit structure can be a warp knit or a weft knit, or a single jersey, a circular knit jacquard, a flat knit, a double knit, or a double pique.

[0242] In one form of the present technology, the second top layer 4019 and the second bottom layer 4021 each independently comprise a mesh. The mesh can be an eyelet mesh and / or a dot mesh. The mesh can have a square structure, such as a bi-axial four-thread square, a bi-axial six-thread square, a four-axial six-thread square, a diamond mesh, or a thickened diamond. The mesh can have other structures of holes, such as a triangle, an octagon, a dodecagon, a regular hexagon, an irregular hexagon, and a circle. The mesh improves heat circulation and airflow.

[0243] In one form of the present technology, the mesh is characterized by a hole size or different sizes of hole sizes. For example, the hole size can be about 0.4 mm to about 0.5 mm x about 0.5 mm to about 0.6 mm. The hole size can be about 0.6 mm to about 0.9 mm x about 0.7 mm to about 1.0 mm. The hole size can be about 1.0 mm to about 1.90 mm x about 2.0 mm to about 2.5 mm.

[0244] In one form of the present technology, the first spacer layer 4011 is continuously joined to the second spacer layer 4017. In this regard, the first spacer layer 4011 is linked to the second spacer layer 4017 without any interruption or connector. In other words, there is no seam between the first spacer layer and the second spacer layer. For example, the first section 4001 can be transferred to the second section 4003 by adjusting the length of the filament. The type of filament can also be changed between a monofilament and a multifilament as desired.

[0245] In one form of the present technology, the first top layer 4013 is continuously joined to the second top layer 4019. In this regard, the first top layer 4013 is linked to the second top layer 4019 without any interruption or connector. The first section 4001 can be transferred to the second section 4003 (e.g., a mesh) by adjusting the knit pattern or method.

[0246] In one form of the present technology, the first bottom layer 4015 is continuously joined to the second bottom layer 4021. In this regard, the first top layer 4015 is linked to the second top layer 4021 without any interruption or connector. The first section 4001 can be transferred to the second section 4003 (e.g., a mesh) by adjusting the knit pattern or method.

[0247] The compressive strength of the first section 4001 and the second section 4003 can be in the range of about 5 kPa to about 25 kPa.

[0248] In one form of the technology, the first section 4001 is characterized by a compressive strength of about 5 kPa to about 20 kPa, about 5 kPa to about 15 kPa, or about 5 kPa to about 10 kPa.

[0249] In one form of the technology, the second section 4003 is characterized by a compressive strength of about 5 kPa to about 20 kPa, about 10 kPa to about 20 kPa, or about 15 kPa to about 20 kPa.

[0250] The elongation of the first section 4001 and the second section 4003 can be in the range of about 0.1% to about 20% when a force of 2 N to 10 N is applied.

[0251] In one form of the technology, the first section 4001 is characterized by an elongation of about 1% to about 20%, about 2% to about 20%, about 4% to about 20%, about 6% to about 20%, about 8% to about 20%, about 10% to about 20%, about 12% to about 20%, about 14% to about 20%, or about 16% to about 20%.

[0252] In one form of the technology, the second section 4003 is characterized by an elongation of about 0.1% to about 20%, about 0.1% to about 18%, about 0.1% to about 16%, about 0.1% to about 14%, about 0.1% to about 12%, about 0.1% to about 10%, about 0.1% to about 8%, about 0.1% to about 6%, or about 0.1% to about 5%.

[0253] In one form of the technology, the second section includes an edge 4023 formed by sealing and / or welding the second top layer 4019 to the second bottom layer 4021. For example, the edge can be sealed using ultrasonic welding, RF welding, or hot die cutting.

[0254] In one form of the technology, the edge 4023 is free of the second spacer layer 4017. In this regard, the edge 4023 is comprised of the second top layer 4019 and the second bottom layer 4021, and is free of monofilaments and / or multifilaments. This can facilitate sealing and / or welding of the edge, and enhance the soft seal, while preventing filament protrusion through the seal.

[0255] In one form of the technology, the edge 4023 can be a rounded edge 4025. This further reduces the likelihood of wearer chafing and discomfort.

[0256] In one form of the present technology, the edge 4023 is characterized by a width of about 1 mm to about 10 mm, about 1 mm to about 9 mm, about 1 mm to about 8 mm, about 1 mm to about 7 mm, about 1 mm to about 6 mm, about 1 mm to about 5 mm, or about 1 mm to about 4 mm. Preferably, the width can be about 2 mm to about 5 mm, or about 2 mm to about 3 mm. This prevents wear and tear and provides a close fit of the positioning and stabilizing structure to the wearer's head.

[0257] In one form of the present technology, the edge is characterized by a thickness of about 0.1 mm to about 1 mm, about 0.1 mm to about 0.9 mm, about 0.1 mm to about 0.8 mm, about 0.1 mm to about 0.7 mm, about 0.1 mm to about 0.6 mm, or about 0.1 mm to about 0.5 mm. Preferably, the thickness is about 0.3 mm to about 0.5 mm.

[0258] In one form of the present technology, the first section 4001 includes two arms 4007a and 4007b. The arms 4007a and 4007b can be configured to be coupled to each other to form a band. In use, the band can cover the parietal bone of the wearer's head. The arms 4007a and 4007b can be coupled by sealing and / or welding. A sealing or welding process compatible with the material can be used, such as heat, ultrasonic, high frequency / RF, and hot die cutting. Other methods of coupling the arms 4007a and 4007b can be conventional stitching (sewing), or using a seam tape made of TPU heat bonding, co-polyester bonding tape. The seam tape can further incorporate different kinds of surface finishes to enhance aesthetics / functionality. The seam tape can be shaped in a way that provides a combination of rigidity and stretchiness in specific areas.

[0259] In one form of the present technology, the knitted spacer fabric further includes third sections 4005a and 4005b continuously joined to the first section 4001. In this regard, the third sections 4005a and 4005b link to the first section 4001 without any interruption or connector.

[0260] In one form of the present technology, the third sections 4005a and 4005b include a third top layer adjacent to a third bottom layer. A third spacer layer can be sandwiched between these outer layers. The third top layer can be sealed and / or welded to the third bottom layer. Alternatively, the third sections 4005a and 4005b can consist of a third top layer adjacent to a third bottom layer; i.e., there is no third spacer layer. The third sections 4005a and 4005b can be configured to be coupled with the seal-forming structure and / or the plenum chamber. For example, the third sections 4005a and 4005b can be coupled by forming loops with the hinge pins at respective ends of the seal-forming structure and / or the plenum chamber. For example, refer to Figure 4AIn one form of the present technology, the third segments 4005a and 4005b are configured to be more flexible than the first segment 4001. This allows the third segments 4005a and 4005b to couple with the seal-forming structure and / or the plenum chamber. In one form of the present technology, the third segments 4005a and 4005b are configured to be more flexible than the second segment 4002. This allows the third segments 4005a and 4005b to couple with the seal-forming structure and / or the plenum chamber.

[0261] In one form of the present technology, the third segments 4005a and 4005b are characterized by a thickness of about 2 mm to about 5 mm. Preferably, the thickness is about 3 mm to about 4 mm. In other forms of the present technology, the third segments 4005a and 4005b are configured to be thinner relative to the first segment 4001. This allows the third segments 4005a and 4005b to be more flexible so that it can couple with the seal-forming structure and / or the plenum chamber.

[0262] In one form of the present technology, the first segment 4001 is formed using an elastic fabric. This allows the positioning and stabilising structure to stretch to fit the wearer's head. This also allows the positioning and stabilising structure to stretch to fit different head sizes. The first segment can be characterised by a stretchability of about 120% to about 800% relative to its original size. In other forms, the stretchability is about 120% to about 750%, about 120% to about 700%, about 120% to about 650%, about 120% to about 600%, about 120% to about 550%, about 120% to about 500%, about 120% to about 450%, about 120% to about 400%, about 120% to about 350%, about 120% to about 300%, about 120% to about 250%, about 120% to about 200%, or about 120% to about 150%.

[0263] In one form of the present technology, the third segments 4005a and 4005b are formed using an elastic fabric. This allows the positioning and stabilising structure to stretch to fit the wearer's head. This also allows the user to fasten the coupling with the seal-forming structure and / or the plenum chamber. The third segments 4005a and 4005b can be characterised by a stretchability of about 120% to about 800% relative to their original size. In other forms, the stretchability is about 120% to about 750%, about 120% to about 700%, about 120% to about 650%, about 120% to about 600%, about 120% to about 550%, about 120% to about 500%, about 120% to about 450%, about 120% to about 400%, about 120% to about 350%, about 120% to about 300%, about 120% to about 250%, about 120% to about 200%, or about 120% to about 150%.

[0264] Examples of elastic fabrics can be, but are not limited to, elastic nonwoven fabrics, elastic woven fabrics, knitted fabrics such as jersey knits, polyesters, cotton, spandex, or nylon.

[0265] In one form of the technology, the second section 4003 is formed using a non-elastic or low-elastic fabric. This allows the positioning and stabilising structure to be controlled into position and prevents the problem of bunching / kinking. The second section 4003 can be characterised by a stretchability of about 100% to about 120% relative to its original size.

[0266] The knitted spacer fabric can additionally be surface coated. The surface coating can be on the top fabric layer and / or the bottom fabric layer. For example, if the bottom fabric layer is in contact with the wearer's skin, it can be a hydrophilic coating. The hydrophilic coating can wick away moisture, which can also provide a cool or cool feeling. The coating can also be hygroscopic. For example, if the top fabric layer is not in contact with the wearer's skin, it can be a hydrophobic coating.

[0267] Accordingly, a single piece of knitted spacer fabric is able to be assembled into a 3D positioning and stabilising structure. In use, the thicker first section 4001 provides compressibility, thus making the wearer comfortable. As the first section 4001 has a greater tensile strength than the second section 4003, in use, the positioning and stabilising structure is able to maintain its 3D shape and minimise displacement. Accordingly, a hardener is not necessary. The thinner second section 4003 provides breathability.

[0268] In one form of the technology, the positioning and stabilising structure further comprises a second single fabric adjacent to the first knitted spacer fabric 4027. The second single fabric can be a second knitted spacer fabric 4029. The second single fabric can also be an elastic fabric. In use, the elastic fabric can be in contact with the user's head, thus providing better comfort. The second single fabric can be adhered to or laminated to the first knitted spacer fabric 4027.

[0269] The second knitted spacer fabric 4029 can have different properties to the first knitted spacer fabric 4027. For example, the thickness of the first, second and / or third sections, the type of filament in the spacer fabric, the material used for the top and bottom layers can be varied to provide a positioning and stabilising structure that is soft and comfortable for the user to use. By having two layers of knitted spacer fabric, a greater range of compression and stretchability can be achieved.

[0270] The first knitted spacer fabric 4027 can be adhered or laminated to the second single fabric. Various methods can be used, such as hot melt, adhesive tape and / or fabric glue. For example, a TPU film can be used to combine the first knitted spacer fabric 4027 with the second single fabric.

[0271] The first knitted spacer fabric 4027 and the second single fabric are substantially similar in size such that when adhered or laminated to each other, there is substantially no excess around the edges. For example, thermoforming or hot die cutting can be used to shape the first knitted spacer fabric 4027 and the second single fabric. The same mold can be used for the first knitted spacer fabric 4027 and the second single fabric.

[0272] In one form of the present technology, the positioning and stabilising structure 4300 further comprises a foam material 4031. The foam material 4031 can be sandwiched between the first knitted spacer fabric 4027 and the second single fabric. The foam is porous to allow moisture (e.g. sweat) to pass through the positioning and stabilising structure 4300. Alternatively or additionally, the positioning and stabilising structure 4300 can comprise a fibrous filler (e.g. a polyester fibrous filler), a non-woven filler, a foam filler, a high density interior decoration foam, a compressed polyester, a medium density polyurethane antimicrobial foam, a high density polyurethane foam, a dry fast open cell foam, a breathable foam, or a combination thereof.

[0273] In one form of the present technology, the foam material is characterised by a thickness of about 0.1 cm to about 10 cm. The thickness can be about 0.1 cm to about 9 cm, about 0.1 cm to about 8 cm, about 0.1 cm to about 7 cm, about 0.1 cm to about 6 cm, about 0.1 cm to about 5 cm, about 0.1 cm to about 4 cm, about 0.1 cm to about 3 cm, about 0.1 cm to about 2 cm, about 0.1 cm to about 1 cm, about 0.1 cm to about 0.9 cm, about 0.1 cm to about 0.8 cm, about 0.1 cm to about 0.7 cm, or about 0.1 cm to about 0.6 cm. In one form of the present technology, the foam material is characterised by a thickness of about 0.2 cm to about 0.5 cm.

[0274] The foam material 4031 can be adhered or laminated to the first knitted spacer fabric 4027 and the second single fabric. To this end, a first adhesive layer 4033 and a second adhesive layer 4035 can be incorporated. The first adhesive layer 4033 and the second adhesive layer 4035 can be TPU films. The first adhesive layer 4033 adheres the first knitted spacer fabric 4027 with the foam material 4031. The second adhesive layer 4035 adheres the second single fabric with the foam material 4031.

[0275] In one form of the present technology, a method of manufacturing a positioning and stabilising structure for a patient interface is provided. The method comprises weaving a spacer fabric, wherein the spacer fabric comprises a first section 4001 continuously joined to a second section 4003. The second section 4003 can be configured to surround a binaural region of a wearer’s head, in use. The first section 4001 can be configured to be thicker than the second section 4003.

[0276] In one form of the present technology, the method further comprises adhering or laminating the second single fabric to the knitted spacer fabric.

[0277] In one form of the present technology, the method further comprises sandwiching the foam material between the knitted spacer fabric and the second single fabric. In one form of the present technology, the method further comprises adhering or laminating the foam material to the knitted spacer fabric and the second single fabric.

[0278] 4.3.5 Vent

[0279] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0280] In certain forms, the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient, while the pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured so that the vent flow has a magnitude sufficient to reduce rebreathing of exhaled C02 by the patient, while maintaining a therapeutic pressure in the plenum chamber in use.

[0281] One form of a vent 3400 according to the present technology comprises 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.

[0282] The vent 3400 can be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure (e.g. swivel).

[0283] 4.3.6 Decoupling structure

[0284] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0285] 4.3.7 Connection port

[0286] The connection port 3600 allows connection to the air circuit 4170.

[0287] 4.3.8 Forehead support

[0288] In one form, the patient interface 3000 includes a forehead support 3700.

[0289] 4.3.9 Anti-asphyxia valve

[0290] In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0291] 4.3.10 Port

[0292] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of a property of the gas within the plenum chamber 3200, such as pressure.

[0293] 4.4 Glossary

[0294] To achieve the purposes of the present technology disclosure, one or more of the following definitions can be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions can be applied.

[0295] 4.4.1 General

[0296] Air: In certain forms of the present technology, air can be taken to mean atmospheric air, and in other forms of the present technology, air can be taken to mean some other combination of breathable gas, for example, oxygen enriched air.

[0297] Ambient: In certain forms of the present technology, the term ambient can have the following meanings (i) the exterior of the therapy system or patient, and (ii) the immediate surroundings of the therapy system or patient.

[0298] For example, the ambient humidity with respect to a humidifier can be the humidity of the air immediately surrounding the humidifier, for example, the humidity in the room in which the patient is sleeping. This ambient humidity can be different from the humidity outside the room in which the patient is sleeping.

[0299] In another example, the ambient pressure can be the pressure immediately surrounding or outside the body.

[0300] In certain forms, ambient (e.g., acoustic) noise can be taken to mean the background noise level in the room in which the patient is located, other than noise emitted from, for example, the RPT device or mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0301] Automatic positive airway pressure (APAP) therapy: CPAP therapy in which the therapy pressure is automatically adjusted between a minimum and a maximum, for example, with each breath, depending on whether or not there are indications of SBD events.

[0302] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapy pressure is approximately constant throughout the respiratory cycle of the patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, increasing in response to detecting indications of partial airway obstruction, and decreasing in the absence of indications of partial airway obstruction.

[0303] Flow rate: The volume (or mass) of air delivered per unit of time. Flow can refer to the instantaneous quantity. In some cases, reference to flow will be reference to a scalar quantity, i.e. a quantity with only a magnitude. In other cases, reference to flow will be reference to a vector quantity, i.e. a quantity with both a magnitude and a direction. Flow can be given the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0304] In the example of a patient breathing, flow can 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. Device flow Qd is the flow of air leaving the RPT device. Total flow Qt is the flow of air and any supplementary gases to the patient interface via the air circuit. Ventilation flow Qv is the flow of air leaving the vent to allow flushing of exhaled gases. Leak flow Ql is the flow of leaks from the patient interface system or elsewhere. Respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0305] Flow therapy: Respiratory therapy includes the delivery of a flow of air to the entrance of the airways at a controlled flow rate known as the therapy flow rate, which is generally positive throughout the patient's breathing cycle.

[0306] Humidifier: The term humidifier will be taken to mean a humidification apparatus constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H20) vapour to a flow of air to improve a patient's medical respiratory condition.

[0307] Leak: The word leak will be taken to mean an unwanted flow of air. In one example, a leak can occur due to an imperfect seal between a mask and a patient's face. In another example, a leak can occur in a swivel elbow to ambient.

[0308] Noise, conducted (acoustics): Conducted noise in this document refers to noise brought to the patient through the pneumatic path, such as the air circuit and patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0309] Noise, radiated (acoustics): Radiated noise in this document refers to noise brought to the patient through the ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0310] Noise, vent (acoustics): Vent noise in this document refers to noise produced by the flow of air through any vent, such as a vent of a patient interface.

[0311] Oxygen enriched air: Air with an oxygen concentration greater than atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.

[0312] Medical oxygen: Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or more.

[0313] Patient: A human, whether or not they have a respiratory condition.

[0314] Pressure: Force per unit area. Pressure can be expressed in units ranging from cmH20, g-f / cm 2 , to hundred Pascals. 1 cmH20 is equivalent to 1 g-f / cm 2 and is approximately 0.98 hundred Pascals (1 hundred Pascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atmosphere). In this specification, pressure is given in units of cmH20 unless otherwise stated.

[0315] Pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents the target value achieved by the interface pressure Pm at the current moment in time, is given the symbol Pt.

[0316] Respiratory pressure therapy: Application of a supply of air at a therapeutic pressure that is typically positive relative to atmosphere to the entrance of the airways.

[0317] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0318] 4.4.1.1 Materials and their properties

[0319] Hardness: Refers to either a durometer or an indentation hardness, which is a material property measured by an indentation made by an indenter (e.g. measured according to ASTM D2240).

[0320] • “Soft” materials can include silicones or thermoplastic elastomers (TPEs) and can deform easily, for example under finger pressure.

[0321] • “Hard” materials can include polycarbonates, polypropylenes and can not deform easily, for example under finger pressure.

[0322] Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone means liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0323] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0324] 4.4.1.2 Mechanical axis:

[0325] a. Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0326] b. Longitudinal axis: An axis that extends along the length of a shape. This axis typically passes through the center of the shape.

[0327] c. Circumferential axis: An axis that is oriented perpendicular to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders or similar shapes that have a circular and / or elliptical cross-section.

[0328] Deformation: The process by which the original geometry of a member changes when subjected to a force, e.g. a force in the direction of an axis. This method can include stretching or compression, bending and twisting.

[0329] Elasticity: The ability of a material to recover its original geometry after being deformed.

[0330] Soft structure or component: A structure or component that will change shape, e.g. bend, when left to support its own weight for a relatively short time, e.g. 1 second.

[0331] Resilience: The ability of a material to absorb energy when elastically deformed and to release energy when unloaded.

[0332] Elastic: Will release substantially all of the energy when unloaded. Includes, for example, certain siloxanes and thermoplastic elastomers.

[0333] Rigid structure or component: A structure or component that will not substantially change shape when subjected to loads typically encountered in use. An example of such use can be the setting and maintaining of a patient interface in a sealed relation to an entrance to a patient’s airways under a load of, for example, a pressure of about 20 to 30 cmH20.

[0334] As an example, an I-beam can include different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, a structure or component can be soft in the first direction and rigid in the second direction.

[0335] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, e.g. compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The inverse of stiffness is flexibility.

[0336] Viscosity: the ability of a material to resist flow.

[0337] Viscoelasticity: the ability of a material to exhibit both elastic and viscous behavior in deformation.

[0338] Yield: the condition when a material no longer returns to its original geometry after deformation.

[0339] 4.4.1.3 Structural elements

[0340] Compression member: a structural element that resists compressive forces.

[0341] Elbow: an elbow is an example of a structure that changes the direction of the axis of the air flow traveling through it by an angle. In one form, the angle can be about 90 degrees. In another form, the angle can be greater or less than 90 degrees. An elbow can have a cross-section that is approximately circular. In another form, an elbow can have an elliptical or rectangular cross-section. In certain forms, an elbow can be rotatable relative to a mating component, e.g. about 360 degrees. In certain forms, an elbow can be removable from a mating component, e.g. via a snap connection. In certain forms, an elbow can be assembled to a mating component via a one-time snap during manufacturing, but not removable by a patient.

[0342] Frame: a frame will be taken to mean a mask structure that carries the tensile load between two or more connection points with a positioning and stabilizing structure. A mask frame can be a non-airtight load carrying structure in a mask. However, some forms of mask frames can also be airtight.

[0343] Membrane: a membrane will be taken to mean a typically thin element that preferably has substantially no resistance to bending, but has resistance to stretching.

[0344] Tie (noun): a structure used to resist tension.

[0345] Thin structure:

[0346] a. Beam,

[0347] i. Beams can be relatively long in one dimension compared to the other two, making the smaller dimensions relatively thin compared to the long dimension.

[0348] b. Membranes,

[0349] i. Be relatively long in two dimensions and relatively thin in one dimension. Be easily deformable in response to bending forces. Be resistant to stretching (and possibly compression).

[0350] c. Plates and shells

[0351] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0352] Thick structures: solids

[0353] Seal: can refer to the noun form of the structure (“seal”) or the verb form of the effect (“sealing”). Two elements can be constructed and / or arranged to be ‘sealed’ or to achieve ‘sealing’ therebetween without a separate ‘seal’ element itself.

[0354] Shell: a shell will be considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, a curved structural wall of a face shield can be a shell. In some forms, a shell can be multi-faceted. In some forms, a shell can be air-tight. In some forms, a shell can not be air-tight.

[0355] Stiffener: a stiffener will be considered to mean a structural component designed to increase the resistance to bending of another component in at least one direction.

[0356] Strut: a support rod will be considered to be a structural component designed to increase the resistance to compression of another component in at least one direction.

[0357] Swivel (noun): a sub-assembly of components configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, a swivel can be configured to rotate through an angle of at least 360 degrees. In another form, a swivel can be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a pair of mating cylindrical conduits. There can be little or no air flow leakage from the swivel when in use.

[0358] 4.4.2 Anatomy

[0359] 4.4.2.1 Facial anatomy

[0360] Alae (Plural: Alae): the outer, external walls or “wings” of each nostril (singular: ala)

[0361] Nasal alar angle: The angle formed between the alae of each nostril.

[0362] Nasal alar tip: The most lateral point on the ala.

[0363] Nasal alar crease (or alar crest) point: The point at the last part of the curved base of each ala, which is found in the fold formed by the junction of the ala with the cheek.

[0364] Pinna: The entire externally visible part of the ear.

[0365] (Nasal) skeletal framework: The skeletal framework of the nose includes the nasal bones, frontal process of the maxilla, and the nasal part of the frontal bone.

[0366] (Nasal) cartilaginous framework: The cartilaginous framework of the nose includes the septum, lateral, greater, and lesser cartilages.

[0367] Columella: The skin strip that separates the nostrils and extends from the tip of the nose to the upper lip.

[0368] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal (both lines intersect at the subnasal point).

[0369] Frankfort horizontal: A line extending from the lowest point of the orbital margin to the left ear canal. The canal is the deepest point in the notch superior to the tragus of the pinna.

[0370] Glabella: The most prominent point in the median sagittal plane of the forehead, located on the soft tissue.

[0371] Lateral nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its superior border is attached to the nasal bone and frontal process of the maxilla, and its inferior border is connected to the alar cartilage.

[0372] Lip, lower (sublabial point): The lip that extends between the subnasal point and the mouth.

[0373] Lip, upper (supralabial point): The lip that extends between the mouth and the supramental point.

[0374] Alar cartilage, greater: A cartilaginous plate located inferior to the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four small cartilages that make up the ala.

[0375] Nares (Nostrils): The approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of the nostrils is naris (nostril). The nostrils are separated by the nasal septum.

[0376] Nasolabial groove or fold: The skin fold or groove that extends from each side of the nose to the corner of the mouth, which separates the cheek from the upper lip.

[0377] nasolabial angle: the angle between the columella and the upper lip (both intersecting at the subnasale point).

[0378] subaurale: the lowest point at which the auricle attaches to the skin of the face.

[0379] superaurale: the highest point at which the auricle attaches to the skin of the face.

[0380] nasion: the most prominent point or tip of the nose that can be identified in a lateral view of the rest of the head.

[0381] philtrum: the midline groove extending from the lower border of the nasal septum to the top of the lip in the region of the upper lip.

[0382] menton: the midpoint of the most forward part of the chin, on soft tissue.

[0383] ridge (nose): the midline ridge of the nose that extends from the sellion to the pronasale.

[0384] sagittal plane: a vertical plane from anterior (front) to posterior (back). The central sagittal plane is the sagittal plane that divides the body into right and left halves.

[0385] sellion: the most concave point, on soft tissue, overlying the region of the frontonasal suture.

[0386] septal cartilage (nose): the nasal septal cartilage forms part of the septum and separates the anterior parts of the nasal cavities.

[0387] superior lateral crus: the point at the lower margin of the alar base where the alar base meets the skin of the upper (superior) lip.

[0388] subnasale: the point, on soft tissue, where the columella meets the upper lip in the central sagittal plane.

[0389] supramenton: the point on the midline of the lower lip between the midpoint of the lower lip and the soft tissue menton point of maximum concavity

[0390] skull anatomy

[0391] frontal bone: the frontal bone includes a large vertical part (frontal squama) that corresponds to the region known as the forehead.

[0392] mandible: the mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0393] maxilla: the maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral boundary.

[0394] Nasal bone: The nasal bones are two small, oval-shaped bones that vary in size and shape among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0395] Nasion: The junction of the frontal bone and the two nasal bones, directly between the eyes and in the depressed area of the upper part of the bridge of the nose.

[0396] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped hole (foramen magnum) through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0397] Orbital: The bony cavity in the skull that houses the eyeball.

[0398] Parietal bone: The parietal bones are the bones that, when joined together, form the roof and the sides of the skull.

[0399] Temporal bone: The temporal bones are located at the bottom and on the sides of the skull and support the part of the face known as the temple.

[0400] Zygomatic bone: The face includes two zygomatic bones, which are located on the upper and lateral parts of the face and form the prominence of the cheeks.

[0401] 4.4.2.2 Respiratory system anatomy

[0402] Diaphragm: A muscle sheet that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0403] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0404] Lung: The respiratory organ of humans. The conducting region of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes respiratory bronchioles, alveolar ducts, and alveoli.

[0405] Nasal cavity: The nasal cavity (or nasal fossa) is the large, air-filled space in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches, which are called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nares.

[0406] Pharynx: The part of the pharynx that lies immediately below (inferior to) the nasal cavity and above the larynx and esophagus. The pharynx is conventionally divided into three segments: the nasopharynx (superior pharynx) (nasal part of the pharynx), the oropharynx (middle pharynx) (oral part of the pharynx), and the laryngopharynx (inferior pharynx).

[0407] 4.4.3 Patient interface

[0408] Anti-asphyxia valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive C02 rebreathing by the patient by venting to atmosphere in a fail-safe manner.

[0409] Headgear: Headgear refers to a form of positioning and stabilising structure that is designed to hold a device, such as a mask, in place on the head.

[0410] Plenum chamber: A mask plenum chamber will be taken to mean the part of the patient interface that has walls that at least partially enclose a volume of space that in use has air pressurised within it to above atmospheric pressure. An outer shell can form part of the walls of the mask plenum chamber.

[0411] Seal: Can refer to the noun form of the structure (“seal”) and also to the verb form of the effect (“sealing”). Two elements can be structured and / or arranged to ‘seal’ or achieve ‘sealing’ therebetween, without the need for a separate ‘seal’ element as such.

[0412] Vent: (Noun): A structure that allows air flow from inside the mask or conduit to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow of about 10 litres per minute to about 100 litres per minute, depending on the mask design and therapy pressure.

[0413] 4.4.4 Shape of a structure

[0414] A product according to the present technology can comprise one or more three-dimensional mechanical structures, such as a mask cushion or a prong. Three-dimensional structures can be joined by two-dimensional surfaces. These surfaces can be distinguished using labels to describe the relevant surface orientation, location, function, or some other characteristic. For example, a structure can comprise one or more of an anterior surface, a posterior surface, an inner surface, and an outer surface. In another example, a seal-forming structure can comprise a (e.g. external) surface that contacts the face and a separate (e.g. underside or internal) surface that does not contact the face. In another example, a structure can comprise a first surface and a second surface.

[0415] To assist in describing the shape of three-dimensional structures and surfaces, first consider a cross-section through a point p of a surface of a structure. See Figures 3B to 3F , which show examples of cross-sections at a point p on a surface and the resulting planar curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, we describe a surface from the viewpoint of an imaginary little person standing on the surface.

[0416] 4.4.4.1 One-dimensional curvature

[0417] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0418] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0419] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0420] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if the figures in the image were to leave point p, they would have to go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0421] 4.4.4.2 Curvature of Two-Dimensional Surfaces

[0422] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0423] Principal curvature and direction: The direction of the normal plane to which the curvature of a curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0424] Surface region: A set of connected points on a surface. The set of points in a region can have similar properties, such as curvature or sign.

[0425] Saddle region: A region where the principal curvatures have opposite signs at each point, i.e. one is positive and the other is negative (depending on the direction the imaginary person turns, they can walk uphill or downhill).

[0426] Dome region: A region where the principal curvatures have the same sign at each point, e.g. both are positive (“concave dome”) or both are negative (“convex dome”).

[0427] Cylindrical region: A region where one principal curvature is zero (or e.g. within manufacturing tolerances) and the other principal curvature is not zero.

[0428] Planar region: A surface region where both principal curvatures are zero (or e.g. within manufacturing tolerances).

[0429] Surface edge: The boundary or limit of a surface or region.

[0430] Path: In certain forms of the technology, a “path” will be considered to be a path in the mathematical topological sense, e.g. a continuous space curve on a surface from f(0) to f(1). In certain forms of the technology, a “path” can be described as a route or road, including e.g. a set of points on a surface. (The path of an imaginary person is where they walk on the surface, and is analogous to a garden path).

[0431] Path length: In certain forms of the technology, “path length” refers to the distance along a surface from f(0) to f(1), i.e. the distance along a path on a surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of an imaginary person would be the distance they have to walk along a path on a surface).

[0432] Straight line distance: The straight line distance is the distance between two points on a surface, but independent of the surface. On a planar region, there will be a path on the surface with the same path length as the straight line distance between two points on the surface. On a non-planar surface, there can not be a path with the same path length as the straight line distance between two points. (For an imaginary person, the straight line distance would correspond to the distance “as the crow flies”)

[0433] 4.4.4.3 Space curve

[0434] Space curve: Unlike a planar curve, a space curve does not have to lie in any particular plane. A space curve can be closed, i.e., have no endpoints. A space curve can be thought of as a one-dimensional piece of three-dimensional space. An imaginary person walking along one strand of a DNA helix walks along a space curve. A typical human left ear contains a helix, which is a left-handed helix, see Figure 3Q . A typical human right ear contains a helix, which is a right-handed helix, see Figure 3R . Figure 3S A right-handed helix is shown. The edge of a structure, e.g., the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by a curvature and a torsion at each point on the space curve. Torsion is a measure of how much a curve twists out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to a tangent vector, a normal vector, and a binormal vector at that point.

[0435] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction from that point as well as a magnitude. The tangent unit vector is the unit vector pointing in the same direction as the curve at that point. If an imaginary person is flying along a curve and falls from her vehicle at a particular point, the direction of the tangent vector is the direction in which she will travel.

[0436] Unit normal vector: As the imaginary person moves along the curve, the tangent vector itself changes. The unit vector pointing in the direction of the tangent vector's change of direction is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0437] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, e.g., Figure 3P ) or, optionally, by the left-hand rule ( Figure 3O ).

[0438] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figure 3O and 3P .

[0439] Space curve torsion: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies in a plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a slightly tilted helical path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply tilted helical path). See Figure 3S , since T2> T1, the amount of torsion near the top coil of the helix of Figure 3S is greater than the amount of torsion of the bottom coil of the helix of Figure 3S .

[0440] Referring to the right-hand rule, a spatial curve oriented in the direction of the right-hand double normal can be considered to have right-handed positive twist (e.g., a right-handed helix as shown in Figure 3P Figure 3S Turning away from the right-hand double normal direction, a spatial curve can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0441] Likewise, referring to the left-hand rule (see Figure 3O ), a spatial curve oriented in the direction of the left-hand double normal can be considered to have left-handed positive twist (e.g., a left-handed helix). Left-handed positive is thus equivalent to right-handed negative. See Figure 3T .

[0442] 4.4.4.4 Holes

[0443] A surface can have one-dimensional holes, such as holes bounded by planar curves or by spatial curves. Thin structures (e.g., membranes) having holes can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the surfaces of the structures shown in Figure 3I

[0444] A structure can have two-dimensional holes, such as holes bounded by surfaces. For example, a pneumatic tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion of Figure 3L Figure 3M and Figure 3N , which show exemplary cross-sections through which show inner surfaces bounding two-dimensional holes. In yet another example, a catheter can include one-dimensional holes (e.g., at its inlet or at its outlet) and two-dimensional holes bounded by the inner surface of the catheter. See also the two-dimensional holes bounded by the shown surfaces in the structures shown in Figure 3K

[0445] 4.5 Other Notes

[0446] A portion of the disclosure of this patent document contains material that 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 and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0447] ​​​​Unless otherwise indicated, and unless the context clearly indicates otherwise, it is within the scope of the technology that each numerical range includes each value within the range and that the upper and lower limits of the range are inclusive. It is further within the scope of the technology that any numerical range recited is inclusive of the recited range and end points.

[0448] Further, where one or more values are stated in this document as implemented as part of the technology, it is understood that such values can be approximate unless otherwise stated, and such values can be used to any suitable number of significant figures to the extent that practical technology implementations can permit or require.

[0449] Further, as used herein, “approximately,” “substantially,” “about,” or any like term means + / - 5-10% of the stated value.

[0450] 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 be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0451] When a particular material is set forth as being used in the construction of a component, it is contemplated that any and all substitutions therefor are fully encompassed by the technology. Further, any and all components described herein are to be understood as capable of being manufactured, and thus, can be manufactured, together or separately.

[0452] It must be noted that as used herein and in the appended claims, singular articles such as “a,” “an,” and “the” include their plural adjectival equivalents, unless the context clearly indicates otherwise.

[0453] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials in connection with which the publications are cited. 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 technology is not entitled to antedate such publication by virtue of prior application. Further, the dates of publication provided can be different from the actual publication dates, which can require independent confirmation.

[0454] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, referring to the possibility that there are other elements, components, or steps not listed.

[0455] The subject matter headings used in the detailed description are for the convenience of the reader and are not intended to limit the scope of the disclosure or the claims. The subject matter headings are not intended to limit the scope of the claims or the meaning of the description.

[0456] While the technology herein has been described with reference to particular examples, it is to be understood that the examples are illustrative of the principles and application of the technology. In some instances, terminology and notation can imply specific details that are not required to practice the described technology. For example, although the terms "first" and "second" can be used, unless otherwise specified, they are not intended to connote any order, but can be used to distinguish different elements. Also, although process steps in a method can be described or illustrated in sequence, such ordering is not required. Those skilled in the art will recognize that such ordering can be modified and / or aspects can be performed at the same time or even synchronously.

[0457] It will thus be appreciated that numerous modifications can be made to the exemplary embodiments, and that many alternatives can have been designed without departing from the spirit and scope of the technology.

[0458] 4.6 List of Reference Signs

[0459] Patient 1000 Bed partner 1100 Patient interface 3000 Seal-forming structure 3100 Plenum chamber 3200 Chord 3210 Upper point 3220 Lower point 3230 Positioning and stabilising structure 3300 Connection port 3600 Forehead support 3700 RPT device 4000 First section 4001 Second section 4003 Third section 4005a Third section 4005b First end 4007a Second end 4007b Connect 4009 First spacer layer 4011 First top layer 4013 First bottom layer 4015 Second spacer layer 4017 Second top layer 4019 Second bottom layer 4021 Edge 4023 Edge 4025 First knitted spacer fabric 4027 Second knitted spacer fabric 4029 Foam material 4031 First adhesive layer 4033 Second adhesive layer 4035 Seal-forming structure 4100 Air circuit 4170 Plenum chamber 4200 Positioning and stabilising structure 4300 Cross-over structure 4400 Humidifier 5000

Claims

1. A positioning and stabilising structure for a patient interface, characterised in that, Comprising: a knitted spacer fabric having a first section continuously joined to a second section, the second section configured to surround a pinna region of a wearer's head when in use; wherein the first section is configured to be thicker than the second section.

2. The positioning and stabilizing structure of claim 1, wherein, the first section is continuously joined to two second sections, each of the second sections configured to surround each pinna region of a wearer's head when in use.

3. The positioning and stabilizing structure of claim 1 or 2, wherein, the first section is configured to cover an occipital and parietal bone of a wearer's head when in use.

4. The positioning and stabilizing structure of any one of claims 1 to 3, wherein, the positioning and stabilizing structure is configured as a single knitted spacer fabric having a perimeter shape such that, when formed into a 3D shape, the perimeter shape is complementary to a wearer's head.

5. The positioning and stabilizing structure of any one of claims 1 to 4, wherein, the first section comprises a first spacer layer sandwiched between a first top layer and a first bottom layer, wherein the first spacer layer comprises crimped filaments and / or multifilaments in a cross structure.

6. The positioning and stabilizing structure of any one of claims 1 to 5, wherein, the first section is characterized by a thickness of about 2 mm to about 10 mm.

7. The positioning and stabilizing structure of any one of claims 1 to 6, wherein, the second section comprises a second spacer layer sandwiched between a second top layer and a second bottom layer, wherein the second spacer layer comprises crimped filaments and / or multifilaments in a cross structure.

8. The positioning and stabilizing structure of any one of claims 1 to 7, wherein, the second section is characterized by a thickness of about 1 mm to about 6 mm.

9. The positioning and stabilizing structure according to claim 5, characterized in that the filaments and / or multifilaments are characterized by a diameter of about 0.1 mm to about 0.5 mm.

10. The positioning and stabilizing structure of any one of claims 5, 7, 9, wherein, the filaments and / or multifilaments are characterized by a linking distance of about 3 to about 10 needles.

11. The positioning and stabilizing structure of any one of claims 5, 9, 10, wherein, the filaments and / or multifilaments are formed of a material selected from polyester, nylon, regenerated yarn, cotton, viscose, rayon, acrylic fiber, elastane, or a combination thereof.

12. The positioning and stabilizing structure according to claim 5, characterized in that the first top layer and / or the first bottom layer is a fabric having a knit structure independently selected from single jersey, circular knit jacquard, flat knit, weft knit, and wrap knit.

13. The positioning and stabilizing structure according to claim 7, characterized in that the second top layer and / or the second bottom layer is a fabric having a knit structure independently selected from single jersey, circular knit jacquard, flat knit, weft knit, and wrap knit.

14. The positioning and stabilizing structure of claim 7 or 13, wherein, the second top layer and the second bottom layer comprise a mesh.

15. The positioning and stabilizing structure of any one of claims 7, 13, 14, wherein, the second section comprises an edge formed by sealing and / or welding the second top layer to the second bottom layer.

16. The positioning and stabilizing structure of claim 15, wherein, the edge is devoid of the second spacer layer.

17. The positioning and stabilizing structure of claim 15 or 16, wherein, the edge has a width of about 1 mm to about 10 mm.

18. The positioning and stabilizing structure of any one of claims 1 to 17, wherein, the first section comprises two arms, wherein the arms are configured to couple to each other to form a band covering a parietal bone of a wearer's head when in use.

19. The positioning and stabilizing structure of any one of claims 1 to 18, wherein, the knitted spacer fabric further comprises a third section continuously joined to the first section.

20. The positioning and stabilizing structure of claim 19, wherein, the third section comprises a third top layer adjacent to a third bottom layer.

21. The positioning and stabilizing structure of claim 20, wherein, the third top layer is welded and / or sealed to the third bottom layer.

22. The positioning and stabilising structure of any one of claims 19 to 21, wherein, the third section is configured to couple with a seal-forming structure and / or an inflatable chamber.

23. The positioning and stabilizing structure of any one of claims 1 to 22, wherein, the positioning and stabilizing structure further comprises a second single fabric adhered or laminated to the knitted spacer fabric.

24. The positioning and stabilizing structure of claim 23, wherein, the second single fabric is another knitted spacer fabric.

25. The positioning and stabilizing structure of claim 23 or 24, wherein, the positioning and stabilizing structure further comprises a foam material sandwiched between the knitted spacer fabric and the second single fabric.

26. The positioning and stabilising structure of claim 25, wherein, the foam material is adhered or laminated to the knitted spacer fabric and the second single fabric.

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