Positioning and stabilizing structure for patient interface

Abstract

A patient interface includes a positioning and stabilizing structure having a headgear including an annulus portion having an upper portion configured to cover a parietal bone of a patient's head in use and a lower portion configured to cover or underlie an occipital bone of the patient's head in use. The girdle portion defines a loop having a pair of upper strap portions configured to be connected between the girdle portion and the cushion assembly on each side of the patient's head above the root of the nose in use. The headband may include a rigidified portion. The headband may be integrally formed by plain stitch knitting, and the band portion may include a blind guide to provide a tactile indication of the position of the fastening portion.

Description

[0001] This application is a divisional application of patent application number 202080027626.5, filed on February 14, 2020, and entitled “Positioning and Stabilizing Structure for Patient Interface.” Patent application number 202080027626.5 is a Chinese national phase application of PCT application number PCT / IB2020 / 051268.

[0002] 1 Cross-reference to related applications

[0003] This application claims priority to Australian Provisional Application No. 2019900507 filed on February 18, 2019, the entire contents of which are incorporated herein by reference. Background Art 2.1 Technical Field

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

[0006] 2.2 Description of Related Technologies

[0007] 2.2.1 Human respiratory system and its disorders

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

[0009] The airway comprises a series of branch tubes, which become narrower, shorter and more numerous as the branch trachea penetrate deeper into the lungs. The main function of the lungs is gas exchange, thereby allowing oxygen to enter the venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are ultimately divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

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

[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0012] A range of treatments have been used to treat or ameliorate these conditions. Furthermore, such treatments can be used to prevent respiratory distress in otherwise healthy individuals. However, these treatments have a number of drawbacks.

[0013] 2.2.2 Treatment

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

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

[0016] 2.2.3 Treatment system

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

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

[0019] Another form of treatment system is a mandibular repositioning device.

[0020] 2.2.3.1 Patient interface

[0021] The patient interface can be used to couple the respiratory apparatus to its wearer, for example by providing a flow of air to the entrance of the airway. The flow of air can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0022] Certain other mask systems may not be functionally suitable for this application. For example, a purely decorative mask may not be able to maintain adequate pressure. A mask system used for underwater swimming or diving may be configured to prevent the ingress of water from a higher external pressure, but not to maintain the internal air at a higher pressure than the ambient pressure.

[0023] Certain masks may be clinically unsuitable for this technology, for example if they block airflow through the nose and only allow it through the mouth.

[0024] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, this may be uncomfortable or impractical with the present technology.

[0025] Certain masks may not be practical for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0026] Designing a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly between individuals. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. And the entire head can move during a period of respiratory therapy.

[0027] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0028] CPAP therapy is very effective in treating certain breathing disorders, assuming patient compliance. If the mask is uncomfortable or difficult to use, patients may not comply with treatment. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean their mask, which may affect patient compliance.

[0029] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0030] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0031] 2.2.3.1.1 Sealing structure

[0032] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0033] The patient interface may be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed to, for example, cover the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region when in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region when in use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0034] A seal-forming structure that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0035] Certain seal-forming structures can be designed for mass manufacturing so that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0036] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer, such as rubber. With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0037] Another type of seal-forming structure incorporates a thin sheet of material around the perimeter of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal-forming structures, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may crease or deform during use, causing leaks.

[0038] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0039] Another form of seal-forming structure can use adhesive to achieve the seal.Some patients may find it inconvenient to frequently apply and remove adhesive from their face.

[0040] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; and WO 2010 / 135,785.

[0041] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0042] ResMed Ltd. already manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and 0043MIRAGE LIBERTY TM Full face mask. The following patent application assigned to ResMed describes an example of a nasal pillow mask: International patent application WO 2004 / 073,778 (which describes ResMed's SWIFT TM Other aspects of the nasal pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed's SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY TMAspects of full face masks); International patent application WO 2009 / 052,560 (which describes ResMed's SWIFT TM Other aspects of the FX Nasal Pillows).

[0043] 2.2.3.1.2 Positioning and stabilization

[0044] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various technologies have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0045] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0046] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses are ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0047] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0048] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the various therapies described above, for example by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0049] 2.2.3.3 Humidifier

[0050] Delivering an air stream without humidification can cause airway drying. Using a humidifier with an RPT device and patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0051] 2.2.3.4 Data Management

[0052] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as that the patient has used their RPT device according to one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider may inform the patient of the third component of compliance.

[0053] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0054] Existing methods of communicating and managing such data can be one or more of the following: expensive, time-consuming, and error-prone.

[0055] 2.2.3.5 Mandibular reduction

[0056] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite impression portion that is designed to allow for a fit over the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, puts tension on the pharyngeal walls to reduce collapse of the airway and reduces palatal vibrations.

[0057] In certain embodiments, the mandibular advancement device may include an upper plate for engaging or cooperating with teeth on the maxilla or maxilla, and a lower plate for engaging or cooperating with teeth on the maxilla or mandible. The upper and lower plates are laterally connected by a pair of connecting rods. The pair of connecting rods are symmetrically secured to the upper and lower plates.

[0058] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible is held in an advanced position. The length of the connecting rod can be adjusted to change the protrusion level of the mandible. The dentist can determine the protrusion level of the mandible, which will determine the length of the connecting rod.

[0059] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs, such as the resmed NarvalCC™ MRD, are designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0060] 2.2.3.6 Vent Technology

[0061] Some forms of therapy systems may include a vent to allow clearance of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space external to the patient interface, such as to the environment.

[0062] 2.2.4 Screening, diagnosis and surveillance systems

[0063] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep-disordered breathing involves observing the patient for two nights in the clinic, one night for pure diagnosis and the second night for clinician titration of treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0064] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically produces a true / false result, indicating whether the patient's SDB is severe enough to warrant further investigation, while diagnosis yields clinically actionable information. Screening and diagnosis are often one-time procedures, while monitoring the condition's progress can continue indefinitely. Some screening / diagnostic systems are suitable for screening / diagnosis only, while others can also be used for monitoring.

[0065] A clinical specialist may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical specialist may not be available or may be unaffordable. Different clinical specialists may disagree on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. Summary of the Invention

[0066] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0067] A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0068] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0069] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0070] One form of the present technology includes a positioning and stabilizing structure for a patient interface comprising an integrally formed strap formed by plain knitting. The strap may be connected to a frame or plenum of the patient interface at four connection points.

[0071] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising an integrally formed knitted strap including a plurality of knit structures, each knit structure including different mechanical properties. The strap may be formed by flat knitting.

[0072] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising an integrally formed knitted strap comprising at least a first portion and a second portion, the first portion having a different elasticity than the second portion. The first portion may include a hoop portion configured to rest against a rear surface and an upper surface of a patient's head. The second portion may include an upper strap portion configured to be positioned adjacent to the patient's face during use and connected between the hoop portion and an inflatable chamber of the patient interface. The strap may be formed by plain knitting.

[0073] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising an integrally formed knitted band having a plurality of vent portions that form areas of increased breathability. The vent portions may comprise a first knit structure, and the remainder of the band may comprise a second knit structure different from the first knit structure. The vent portions may be formed as a point and mesh knit structure, while the remainder of the band may be formed as a single jersey or double jersey knit structure. The band may be formed by plain knitting.

[0074] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a strap, the strap including an annular strap portion configured to rest against a posterior and superior surface of a patient's head and defining a loop having an inner periphery, the annular strap portion including a rigidizing portion located at or near the inner periphery of the loop. The rigidizing portion may include a first knit structure, and the remainder of the annular strap portion may include a second knit structure. The rigidizing portion may include a pique knit structure, and the remainder of the strap may include a single jersey or double jersey knit structure. The strap may be formed by plain knitting.

[0075] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising a strap, the strap including a fastening portion configured to loop back and secure to itself to secure the strap to a frame or plenum of the patient interface, the strap including a blind guide configured to provide a tactile indication of the position of the fastening portion of the strap. The strap may be integrally formed with a louver guide. The strap may be formed by plain knitting.

[0076] Another form of the present technology includes a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, in use, to improve sleep-disordered breathing. The patient interface comprises: 1) an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber, the size and structure of the inlet port of the inflatable chamber being determined to receive an air flow at the therapeutic pressure for the patient to breathe; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having holes therein so that the air flow at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; 3) a positioning and stabilizing structure that and stabilizing structure to provide a force to maintain the sealing forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap, the strap being constructed and arranged so that, in use, at least a portion of the strap covers an area of ​​the patient's head above the root of the nose of the patient's head; and 4) a ventilation structure that allows gas exhaled by the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured so that the patient's mouth is uncovered.

[0077] In embodiments: a) the positioning and stabilising structure may comprise: 1) a cuff portion having an upper portion configured to cover the parietal bone of the patient's head in use and a lower portion configured to cover the occipital bone of the patient's head in use, the cuff portion defining a loop; and 2) a pair of upper strap portions, each upper strap portion being configured for connection between the cuff portion and the cushion assembly on a corresponding side of the patient's head above the nasion in use; b) the cuff portion comprising a rigidising portion arranged along the length of the loop defined by the cuff portion.

[0078] In other examples: a) the rigidized portion is disposed substantially along the entire length of the loop defined by the annulus portion; b) the rigidized portion is disposed to the annulus portion proximate the inner periphery of the annulus portion; c) the rigidized portion defines at least a portion of the inner periphery of the annulus portion; d) the rigidized portion forms substantially the entire inner periphery of the annulus portion; e) the rigidized portion is disposed approximately centrally between the inner periphery of the annulus portion and the outer periphery of the annulus portion; f) the upper band portion is stretchable; g) the rigidized portion is substantially non-stretchable; h) the annulus portion includes rounded edges; i) the rigidized portion is The invention further provides for the present invention to provide a plurality of embodiments of the present invention comprising: a) a personalized portion comprising an increased material thickness relative to an adjacent portion of the cuff portion; j) a patient contacting side of the cuff portion is substantially flat, and an increased material thickness is provided to a non-patient contacting side of the cuff portion; k) the cuff portion comprises a thickness of 4 mm in the rigidized portion; l) the cuff portion comprises a thickness of 2.5 mm in areas of the cuff portion other than the rigidized portion; m) the rigidized portion is larger in an area of ​​the cuff portion proximate the upper band portion than in other areas of the cuff portion; and / or n) the rigidized portion is wider proximate the upper band portion than in other areas of the cuff portion.

[0079] In other examples: a) the loop portion includes at least one vent portion, the at least one vent portion being constructed and / or arranged to provide increased breathability through the loop portion at the vent portion; b) the vent portion includes a knitted fabric having a dotted mesh knit structure; c) the vent portion is less stretchable than other portions of the loop portion; d) the rigidized portion surrounds the vent portion; e) the loop portion includes a pair of upper vent portions, each upper vent portion being disposed adjacent a respective upper band portion; f) the rigidized portion surrounds each g) the rigidizing portion comprises a greater material thickness on a rear side of each of the upper vent portions than on a front side of each of the upper vent portions; h) the positioning and stabilizing structure comprises a pair of lower strap portions, each lower strap portion being configured to be connected between the annular band portion and the cushion assembly on a respective side of the patient's head above and below the nasal root during use; i) the annular band portion comprises a lower vent portion disposed between the pair of lower strap portions; j) the lower vent portion comprises a lower edge of the annular band portion; k) the lower edge of the lower vent portion includes a greater curvature than the lower edge of the cuff portion to produce a maximum spacing between the lower edge of the lower vent portion and the lower edge of the cuff portion at or near the sagittal plane of the patient's head during use; l) the lower band portion is stretchable; m) the cuff portion includes a knitted fabric structure; n) the annular band portion is formed by plain knitting; o) the cuff portion includes a single-sided knitted structure; p) the cuff portion includes a double-sided knitted loop-forming knitted structure; q) the rigidizing portion includes a point knit structure; r) the upper portion of the loop strap portion includes a pair of top strap portions adjustably connected to each other near the sagittal plane of the patient's head; the top strap portion is adjustably connected to the buckle; t) the top strap portion includes hook and loop fastening material to allow each top strap portion to pass through a portion of the buckle and secure back to itself; u) the positioning and stabilizing structure includes a frame coupled to the inflatable chamber, the upper strap portion being configured to be connected to the frame; and / or v) the positioning and stabilizing structure also includes a lower strap portion configured to be connected to the frame.

[0080] Another form of the present technology includes a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, in use, to improve sleep-disordered breathing. The patient interface comprises: 1) an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber, the size and structure of the inlet port of the inflatable chamber being determined to receive an air flow at the therapeutic pressure for the patient to breathe; a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having holes therein so that the air flow at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; and 3) a positioning and stabilizing structure that is configured to position and stabilize the inlet port. a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap constructed and arranged so that, in use, at least a portion of the strap covers an area of ​​the patient's head above the nasal root of the patient's head; and 4) a ventilation structure allowing gas exhaled by the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured so that the patient's mouth is uncovered.

[0081] In an embodiment: a) the positioning and stabilising structure comprises at least one strap configured to be connected to the pad assembly, the strap being formed of a knitted fabric and including a fastening portion adjacent an end of the strap, the fastening portion being constructed and / or arranged to allow the strap to be looped back and fastened to itself for connection to the pad assembly; b) the strap comprises at least one blind guide formed of a knitted fabric, the blind guide being constructed to provide a tactile indication of the position of the fastening portion on the strap.

[0082] In other examples: a) the strap is formed by plain knitting; b) the strap includes a non-patient contacting surface, and the at least one shutter guide includes a raised portion that is raised relative to the non-patient contacting surface and / or a recessed portion that is recessed relative to the non-patient contacting surface; c) the raised portion and / or the recessed portion surround at least a portion of the fastening portion of the strap; d) the raised portion includes an elongated raised profile on the non-patient contacting surface of the strap; e) the elongated raised profile is provided at one or more edges of the fastening portion; f) the elongated raised profile is provided at an edge of the fastening portion, The edges are, in use, an upper edge, a rear edge and a lower edge; g) the elongated raised profile comprises a rounded raised surface; h) the raised portion is formed by an increased thickness of the band compared to adjacent areas of the band, and the recessed portion is formed by a reduced thickness of the band compared to adjacent areas of the band; i) the fastening portion of the band comprises hook and loop fastening material; j) the fastening portion comprises an end portion and a middle portion, the end portion comprising one of a hook material and a loop material provided to the non-patient contact surface, the middle portion comprising the other of a hook material and a loop material provided to the non-patient contact surface; k) the middle portion is longer than the end portion. The middle portion may be several times longer than the end portion; l) the belt and louver guide are formed in a single knitting process; m) the louver guide comprises a point knit structure; n) the belt comprises a single knit structure; o) the belt comprises a double knit loop structure; p) the belt is connected to the cushion assembly via the frame of the patient interface; q) the belt comprises: a hoop portion having an upper portion and a lower portion, the upper portion being configured to rest against the patient's head above the parietal bone of the patient's head in use, the lower portion being configured to in use resting against the patient's head above or below the occipital bone of the patient's head; and a pair of upper strap portions, each upper strap portion being configured for connection between the annular strap portion and the cushion assembly on a corresponding side of the patient's head above the nasion in use; r) the strap comprises a pair of lower strap portions, each lower strap portion being configured for connection between the annular strap portion and the cushion assembly on a corresponding side of the patient's head above and below the nasion in use; and / or the strap(s) and shutter guides are integrally formed.

[0083] Another aspect of the present technology relates to a patient interface for sealingly delivering a flow of air to an entrance of a patient's airway at a continuous positive pressure relative to ambient air pressure, the patient's airway including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle while the patient is asleep to improve sleep-disordered breathing; the patient interface comprising: 1) an inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including a inlet port sized and configured to receive the flow of air at the therapeutic pressure for breathing by the patient; 2) a seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding the entrance of the patient's airway below a nasal bridge region of the patient's face, The fabric membrane has holes formed therein so that a flow of air at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle when in use; and 3) a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being constructed and arranged so that, in use, at least a portion of the positioning and stabilizing structure covers an area of ​​the patient's head above the root of the nose of the patient's head.

[0084] In an embodiment: a) the positioning and stabilizing structure comprises a single piece of knitted headband of a single piece of material; b) the knitted headband comprises at least one first region having a first knit structure; c) the knitted headband comprises at least one second region having a second mesh knit structure, the second mesh knit structure forming at least one ventilation region having increased flexibility compared to the first region; and d) the knitted headband comprises at least one third region having a rigidized knit structure directly adjacent to the at least one ventilation region, the rigidized knit structure having increased rigidity compared to the first knit structure and the second mesh knit structure.

[0085] In other examples: a) the rigidized knit structure surrounds the at least one ventilation area; b) the rigidized knit structure is a dotted knit structure; c) the dotted structure is a dotted pattern strip structure; d) the second mesh knit structure is a dotted mesh knit structure; e) the ventilation area has increased air permeability compared to the at least one first area and the at least one third area.

[0086] In other examples: a) the knitted headband includes a loop portion having an upper portion configured to cover the parietal bone of the patient's head when in use and a lower portion configured to cover the occipital bone of the patient's head when in use, and the loop portion defines a loop; b) the loop portion has an inner edge and an outer edge, and the rigidized knitted structure extends along the inner edge of the loop portion; c) the rigidized knitted structure forms a loop extending along the entire inner edge of the loop portion; d) the loop portion includes the at least one ventilation area; e) the knitted headband also includes a neckband portion configured to cover the occipital bone of the patient's head and / or lie on the patient's neck when in use, and the neckband portion includes the at least one ventilation area; the first knitted structure is a plain knit fabric structure.

[0087] Another aspect of the present technology relates to a patient interface for sealingly delivering a flow of air to an entrance of a patient's airway at a continuous positive pressure relative to ambient air pressure, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle while the patient is asleep to improve sleep-disordered breathing; the patient interface comprising: 1) an inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including a inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by the patient; 2) a seal-forming structure, having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the fabric membrane having holes formed therein such that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the cavity throughout the patient's breathing cycle in use; and 3) a positioning and stabilizing structure providing a force to maintain said seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being constructed and arranged such that in use at least a portion of said positioning and stabilizing structure covers an area of ​​the patient's head above the root of the nose of the patient's head.

[0088] In an embodiment: a) the positioning and stabilizing structure comprises a single piece of knitted headband of a single piece of material; b) the knitted headband comprises a first region having a first knit structure; c) the knitted headband comprises a second region having a second pique knit having increased stiffness compared to the first knit; d) the second pique knit extends along a first edge of the knitted headband and is directly adjacent to the first knit.

[0089] In other examples: a) the first knit structure extends along a second edge of the knitted headband; b) the knitted headband includes a loop portion having an upper portion configured to cover the parietal bone of the patient's head during use and a lower portion configured to cover the occipital bone of the patient's head during use, the loop portion defining a loop; c) the loop portion has an inner edge and an outer edge, and the first edge of the knitted headband forms the inner edge of the loop portion; d) the first knit structure extends along the second edge of the knitted headband, and the second edge of the knitted headband forms the outer edge of the loop portion.

[0090] In other examples: a) the first knit structure has increased stretchability compared to the second point knit structure; b) the knitted headband also includes a third area having a third mesh knit structure, and the third mesh knit structure is less rigid than the first knit structure and the second point knit structure; c) the third mesh knit structure is a point knit structure; d) the second point knit structure extends directly adjacent to the third mesh knit structure; e) the third mesh knit structure forms a ventilation area with increased breathability compared to the first area and the second area, and the second point knit structure surrounds the ventilation area; the first knit structure is a plain knit structure.

[0091] Another aspect of the present technology relates to a method of forming a positioning and stabilizing structure for a patient interface, wherein the positioning and stabilizing structure is configured to provide a force to maintain a seal-forming structure in a therapeutically effective position on the patient's head for treating sleep-disordered breathing, the method comprising: knitting a single-piece headband directly into its final shape as a single piece of material.

[0092] In other examples: a) the step of knitting a one-piece headband includes knitting at least one first area of ​​the headband having a first knit structure; b) the step of knitting a one-piece headband includes knitting at least one second area of ​​the headband having a second mesh knit structure, wherein the second mesh knit structure forms at least one ventilation area of ​​the headband having increased flexibility compared to the first area; c) the step of knitting the one-piece headband includes knitting at least one third area of ​​the headband, wherein the at least one third area has a rigidized knit structure directly adjacent to the at least one ventilation area, wherein the rigidized knit structure has increased rigidity compared to the first knit structure and the second mesh knit structure; d) the headband includes a plurality of strap portions, wherein the plurality of strap portions are configured to be connected to a cushion assembly to maintain the seal-forming structure in a therapeutically effective position on the patient's head during use.

[0093] In other examples: a) the step of knitting a one-piece headband includes a single plain knitting process; b) the rigidized knit structure surrounds the at least one ventilation area; c) the rigidized knit structure is a dotted knit structure; d) the second mesh knit structure is a dotted mesh knit structure; e) the ventilation area has increased breathability compared to the at least one first area and the at least one third area; f) the knitted headband includes a loop portion, the loop portion having an upper portion configured to cover the parietal bone of the patient's head when in use and a lower portion configured to cover the occipital bone or located below the occipital bone of the patient's head when in use, the loop portion defining a loop; g) the loop portion has an inner edge and an outer edge, and the rigidized knit structure extends along the inner edge of the loop portion; h) the rigidized knit structure forms a loop extending along the entire inner edge of the loop portion; i) the first knit structure is a plain knit fabric structure.

[0094] Another form of the present technology comprises a patient interface comprising: 1) a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and 3) positioning and stabilization. structure, the positioning and stabilizing structure provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap, the strap being constructed and arranged so that, in use, at least a portion of the strap covers an area of ​​the patient's head above the root of the nose of the patient's head; and 4) a ventilation structure that allows gas exhaled by the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the inflatable chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the inlet port of the inflatable chamber, or the patient interface is configured so that the patient's mouth is uncovered.

[0095] In an embodiment: a) the positioning and stabilizing structure includes: 1) a pair of headband conduits for receiving an air flow from a connection port on the top of the patient's head and for delivering the air flow to the entrance of the patient's airway via the seal-forming structure, each headband conduit being constructed and arranged to contact at least one area of ​​the patient's head on a respective side of the patient's head during use, the at least one area being higher above the patient's head than above the patient's head; and 2) a strap integrally formed by plain knitting.

[0096] In other examples: a) the headband includes: 1) a neckband portion configured to cover the occipital bone of the patient's head and / or lie against the patient's neck during use; a pair of upper band portions, each upper band portion being configured to connect between the neckband portion and a corresponding headband conduit on a corresponding side of the patient's head; and 3) a pair of lower band portions, each lower band portion being configured to connect between the neckband portion and a corresponding headband conduit.

[0097] In other examples: a) the single plain knitting process forms the strap; b) the strap includes a rigidized portion; c) the rigidized portion includes a point knit structure; d) the neckband portion includes the rigidized portion; e) the neckband portion includes one or more stretchable portions; f) the neckband portion includes a stretchable upper portion and a stretchable lower portion; g) the upper stretchable portion is provided along an upper edge of the neckband portion; h) the lower stretchable portion is provided along a lower edge of the neckband portion; i) the strap includes a vent portion, which is constructed and / or arranged to provide increased breathability through the strap at the vent portion; j) the vent portion is located in the neckband portion; k) the vent portion includes a knitted fabric having a point mesh knit structure; l) the vent portion is less stretchable than other portions of the loop portion; and / or m) the rigidized portion surrounds the vent portion.

[0098] In other instances: a) the strap includes a fastening portion adjacent an end of the strap, the fastening portion being constructed and / or arranged to allow the strap to be looped back and fastened to itself for connection to the plenum, the strap includes at least one blind guide formed from a knitted fabric forming the integrally formed strap and configured to provide a tactile indication of the position of the fastening portion on the strap; b) the strap includes a non-patient contacting surface, and the at least one blind guide includes a raised portion that is raised relative to the non-patient contacting surface; c) the raised portion includes an elongated raised profile on the non-patient contacting surface of the strap; d) the fastening portion of the strap includes hook and loop fastening material; and / or e) each of the upper strap portion and the lower strap portion includes a respective blind guide.

[0099] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0100] One aspect of one form of the present technology is a method of making a device.

[0101] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, a person with limited dexterity, vision, or a person with limited experience in using medical devices of this type.

[0102] One aspect of one form of the present technology is a portable RPT device that can be carried by a person, such as for use in the person's home.

[0103] One aspect of one form of the present technology is a patient interface that can be washed at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be washed at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0104] Another aspect of the present technology relates to a treatment system for treating sleep-disordered breathing, comprising: 1) a patient interface according to any of the above aspects; 2) a respiratory pressure therapy (RPT) device for providing positive pressure breathing gas; and 3) an air delivery tube for delivering breathable gas from the RPT device to the patient interface.

[0105] The described methods, systems, devices, and apparatus can be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Furthermore, the described methods, systems, devices, and apparatus can provide improvements in the art of automatically managing, monitoring, and / or treating respiratory conditions, including, for example, sleep-disordered breathing.

[0106] Of course, parts of these aspects may form sub-aspects of the present technology. In addition, various aspects and / or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0107] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0108] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0109] 4.1 Treatment System

[0110] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0111] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0112] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask, receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying position.

[0113] 4.2 Respiratory system and facial anatomy

[0114] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral chambers, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0115] Figure 2B Shown is a view of the human upper airway including the nasal chamber, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0116] Figure 2C A front view of the face with several surface anatomical features labeled, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, medial canthus, nasal ala, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated.

[0117] Figure 2D A side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subseptal point, upper lip, lower lip, supramental point, nasal ridge, alar apex, and superior and inferior auricular bases. The superior-inferior and anterior-posterior directions are also labeled.

[0118] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0119] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0120] Figure 2G A side view of the nasal surface features is shown.

[0121] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0122] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0123] Figure 2J Shown is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible, are also labeled.

[0124] Figure 2K A side view of the skull is shown, showing the outline of the head surface and several muscles. The following bones are shown: the frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also labeled. The following muscles are shown: the digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0125] Figure 2L An anterolateral view of the nose is shown.

[0126] 4.3 Patient Interface

[0127] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0128] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3C The curvature magnitude shown is relatively large in comparison.

[0129] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0130] Figure 3DA schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0131] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0132] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3E The curvature magnitude shown is relatively large in comparison.

[0133] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of this surface are shown. The dome and saddle areas are shown.

[0134] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of this surface is shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. The two saddle areas and the dome area are indicated.

[0135] Figure 3I A surface having a structure with one-dimensional holes on the surface is shown. The plane curves shown form the boundaries of the one-dimensional holes.

[0136] Figure 3J Shown through Figure 3I The surface shown is in the cross section of the structure. Figure 3I A two-dimensional hole is defined in the structure.

[0137] Figure 3K Shown Figure 3I A perspective view of the structure of , including two-dimensional holes and one-dimensional holes. Also shown is the Figure 3I The surface defining the two-dimensional pores in the structure.

[0138] Figure 3L A mask is shown with an inflatable bladder as a cushion.

[0139] Figure 3M Shown through Figure 3L FIG. 1 is a cross-section of a face mask showing the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0140] Figure 3N Shown by Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0141] Figure 3O The left-hand rule is shown.

[0142] Figure 3P The right-hand rule is shown.

[0143] Figure 3Q The left ear is shown, including the left ear helix.

[0144] Figure 3R The right ear is shown, including the right ear helix.

[0145] Figure 3S A right-hand helix is ​​shown.

[0146] Figure 3T A view of a mask is shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0147] Figure 3U A view of the plenum chamber 3200 is shown, illustrating the sagittal plane and the medial contact plane.

[0148] Figure 3V Shown Figure 3U A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the air chamber into left and right sides.

[0149] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V 32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3210, which lies in the sagittal plane and contacts the plenum cushion at exactly two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the cushion in this area, the middle contact plane may be a tangent at the upper and lower points.

[0150] Figure 3X Shown Figure 3U The inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 is approximately coincident with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'facial plane'. Figure 3X In FIG, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is located approximately on the root of the nose, while the lower point 3230 is located on the upper lip.

[0151] 4.4RPT device

[0152] Figure 4AOne form of RPT device according to the present technology is shown.

[0153] Figure 4B Schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and patient interface. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Components within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0154] 4.5 Humidifier

[0155] Figure 5A Shown is an isometric view of a humidifier according to one form of the present technology.

[0156] Figure 5B An isometric view of a humidifier in accordance with one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130 .

[0157] 4.6 Respiratory Waveform

[0158] Figure 6 A typical breathing waveform model of a person during sleep is shown.

[0159] 4.7 Specific Examples of This Technology

[0160] Figure 7 A perspective view of a positioning and stabilising structure 3300 as worn by a patient 1000 is shown in accordance with an example of the present technology.

[0161] Figure 8 Shown Figure 7 A non-patient contacting side view of the belt portion of the positioning and stabilizing structure 3300 in a flattened state.

[0162] Figure 9 Shown Figure 7 Patient contacting side view of the belt portion of the positioning and stabilizing structure 3300 in a flattened state.

[0163] Figure 10 Shown Figure 7 100 is a non-patient contacting side view of a portion of a positioning and stabilising structure 3300 in a flattened state and having a cross-section as shown.

[0164] Figure 11 Shown Figure 7 Exploded view of the fastening portion of the belt of the positioning and stabilizing structure 3300.

[0165] Figure 12 Shown Figure 733. A patient contacting side view of a portion of a positioning and stabilising structure 3300 shown in a flattened state with a cross section shown.

[0166] Figure 13 A portion of a positioning and stabilizing portion 3300 is shown while being worn by a patient 1000 in accordance with another example of the present technology.

[0167] Figure 14 Shown when patient 1000 wears Figure 13 The upper ventilation part of the positioning and stabilization structure.

[0168] Figure 15 Shown when patient 1000 wears Figure 13 The lower ventilation part of the positioning and stabilization structure.

[0169] Figure 16 A non-contact patient side view of a headband 3301 is shown showing a positioning and stabilizing structure according to another example of the present technology.

[0170] Figure 17 Shown is a perspective view of a positioning and stabilizing structure 3300 according to another example of the present technology. DETAILED DESCRIPTION

[0171] Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0172] The following description is provided about various examples that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features can constitute another example.

[0173] 5.1 Treatment

[0174] In one form, the present technology comprises a method for treating a breathing disorder comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0175] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0176] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0177] 5.2 Treatment System

[0178] In one form, the present technology includes a device or apparatus for treating a respiratory disorder. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 .

[0179] 5.3 Patient Interface

[0180] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent structure 3400, a form of 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, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway to facilitate the supply of positive pressure air to the airway.

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

[0182] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 6 cmH20 relative to ambient.

[0183] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 10 cm H20 relative to ambient.

[0184] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 20 cm H20 relative to ambient.

[0185] 5.3.1 Sealing structure

[0186] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given course of treatment, depending on a number of factors, including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0187] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0188] In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material such as silicone.

[0189] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, and resilient material such as silicone.

[0190] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large heads but not small heads, and another form of seal-forming structure that is suitable for small heads but not large heads.

[0191] 5.3.1.1 Sealing mechanism

[0192] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the positive system pressure acting on its bottom surface within the plenum 3200, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0193] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, that extends around the perimeter of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the perimeter. The support flange is or comprises a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0194] In one form, the seal-forming structure may comprise a compression seal or a gasket seal which, in use, is configured and arranged to be in compression, for example as a result of elastic tension in the positioning and stabilising structure.

[0195] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent area of ​​the sealing flange.

[0196] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0197] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having a tacky or adhesive surface.

[0198] 5.3.1.2 Nose bridge or nasal ridge area

[0199] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge or nasal ridge region of the patient's face.

[0200] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0201] 5.3.1.3 Upper lip area

[0202] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0203] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0204] 5.3.1.4 Chin area

[0205] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0206] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin region of a patient's face.

[0207] 5.3.1.5 Forehead area

[0208] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face during use.In this form, the inflatable chamber can cover the eyes during use.

[0209] 5.3.1.6 Nasal pillows

[0210] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each configured and arranged to form a seal with a corresponding nostril of the patient's nose.

[0211] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal against the bottom surface of a patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. Furthermore, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can cooperate to facilitate a universal joint structure that can adapt to relative movement of both the displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0212] 5.3.2 Inflatable chamber

[0213] In the area where the seal is formed during use, the plenum 3200 has a perimeter shaped to complement the surface contours of an average person's face. In use, the boundary edges of the plenum 3200 are positioned in close proximity to adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 during use. In some embodiments, the plenum 3200 and the seal-forming structure 3100 are formed from a single, uniform piece of material.

[0214] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with treatment.

[0215] In some forms of the present technology, the plenum chamber 3200 can be constructed of a transparent material, such as clear polycarbonate. Using a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. Using a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0216] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment.

[0217] 5.3.3. Positioning and stabilizing the structure

[0218] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position during use by a positioning and stabilising structure 3300 .

[0219] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to act upon the positive pressure in the plenum 3200 to lift off the face.

[0220] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0221] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0222] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0223] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0224] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0225] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front portion of the positioning and stabilizing structure 3300 and the back portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on the pillow, the presence of the decoupling portion prevents forces acting on the back portion from being transferred along the positioning and stabilizing structure 3300 and disrupting the seal.

[0226] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the belt. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0227] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0228] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that, in use, at least a portion of a lower edge of the first strap passes over the superior auricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0229] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that, in use, at least a portion of an upper edge of the second strap passes beneath the inferior ear base of the patient's head and overlies or lies beneath the occipital bone of the patient's head.

[0230] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0231] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is flexible and, for example, non-rigid. An advantage of this aspect is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0232] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt that is configured to be breathable to allow moisture to be transferred through the belt.

[0233] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide a retention force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large heads but not for small heads, while another form of positioning and stabilizing structure is suitable for small heads but not for large heads.

[0234] Figure 7 A patient 1000 is shown wearing a patient interface 3000 according to an example of the present technology. The patient interface 3000 includes a cushion assembly 3580 and a positioning and stabilizing structure 3300. The cushion assembly may include a frame 3500, a plenum 3200 connected to the frame, and a seal-forming structure 3100 provided to the plenum. The cavity formed by at least the plenum 3200 and the seal-forming structure 3100 may be pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum includes a plenum inlet port that is sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient 1000. The patient interface 3000 in this example includes a connection port 3600 that is connected to an air supply conduit that supplies air to the plenum 3200.

[0235] The patient interface 3000 also includes a seal-forming structure 3100 that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure 3100 has holes therein so that the flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares. In this example, the patient interface 3000 includes a seal-forming structure 3100 that seals around the nose and mouth. This type of patient interface is commonly referred to as a full-face mask. In other examples, the seal-forming structure 3100 may seal around the patient's nares and leave the patient's mouth uncovered. The seal-forming structure 3100 is constructed and arranged to, in use, maintain the treatment pressure in the plenum 3200 throughout the patient's breathing cycle.

[0236] The patient interface 3000 also includes a vent structure 3400. The vent structure 3400 allows gas exhaled by the patient to continue to flow from the interior of the plenum 3200 to the surrounding environment. The vent structure 3400 is sized and shaped to maintain a therapeutic pressure in the plenum when in use.

[0237] The patient interface 3000 also includes a positioning and stabilizing structure 3300 to provide a force to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a strap that is constructed and arranged so that, in use, at least a portion covers an area of ​​the patient's head above the nasal root of the patient's head. In one example of the present technology, the positioning and stabilizing structure 3300 includes a frame 3500 to which the inflatable chamber 3200 is connected. The frame 3500 is held in place by a plurality of strap portions of the positioning and stabilizing structure 3300.

[0238] 5.3.3.1 One-piece knitted headband

[0239] In one example of the present technology, Figure 7 When worn by the patient shown in Figure 8 and 9 , the positioning and stabilizing structure 3300 includes an integrally formed headband 3301. The headband 3301 includes a unitary structure. The headband 3301 is formed as a single, one-piece knitted strap, as opposed to a combination of multiple strap pieces that are separately formed and connected together or a single piece of strap cut from a sheet. Forming the strap portions separately and connecting them together may be slower and / or more expensive to manufacture. Cutting the headband may result in significant waste of material. However, in some examples of the present technology, the positioning and stabilizing structure 3300 may include multiple headband portions that are separately formed and connected together, while including other features of the present technology described herein.

[0240] The headband 3301 can be knitted directly into a single piece of material using a jersey knit to form its final shape, without the need to cut the headband from a single piece of material or require additional thread to sew the individual headgear pieces together. By jersey knitting the headband band 3301, the entire headband band 3301 can be knitted in a single jersey knitting process. In some examples of the present technology, the headband 3301 does not include seams or joints. In some cases, seams and joints can create uncomfortable pressure on the skin of some users.

[0241] One advantage of plain knitting is that the headband 3301 can be knitted directly into its final shape from fibers in the form of thread, yarn, etc., rather than being cut from a sheet. Cutting multiple complex shapes from a sheet can leave large offcuts that become waste. Additionally, when cutting a headband from a laminated sheet, there may be less flexibility to cost-effectively customize the headband fabric or color. New sheets may need to be laminated to create new fabric and / or color options.

[0242] Another advantage of the knitted headband 3301 is that it can be knitted to conform very closely to the shape of the patient's head, thereby enhancing comfort and stability. In some examples of the present technology, the headband 3301 can be knitted to conform to the shape of the patient's head based on a three-dimensional model of the patient's head created by imaging or scanning the patient's head.

[0243] Some existing headgear has been produced by double needle crochet knitting. Due to the complex shape of the four-point connected headgear, headgear produced by this method may be limited to a single strap profile rather than a complete headgear for a nasal mask or full face mask (e.g., a patient interface with a four-point headgear connection).

[0244] In some examples of the present technology, the headband 3301 is formed using complex knitting techniques to form a knitted structure with very good breathability, elasticity and / or aesthetics. This knitted structure can be similar to the knitted structure found in sports jerseys.

[0245] In some examples of the present technology, the headband 3301 includes multiple different colors and / or patterns. A plain knit can be used to mix colors and patterns to provide a wide range of design variations without additional cosmetic costs.

[0246] In some examples of the present technology, the headband 3301 includes one or more locally rigid and / or elastic regions. The locally rigid and / or elastic regions can be formed in the headband 3301 by a flat knitting process performed during the knitting process of the entire headband 3301. The elastic properties can be customized to meet the different requirements of each region of the headband 3301.

[0247] In some examples of the present technology, the headband 3301 is formed by plain knitting, but includes a non-planar shape even before being donned by the patient. The non-planar shape can be created by knitting the headband 3301 with different knit densities in different areas. Different properties can be provided to different areas of the headband 3301 to meet predetermined specifications. In some examples, providing such properties to the headband 3301 during plain knitting can result in the headband 3301 including a non-planar shape. In some forms of the present technology, the non-planar shape can provide the headband 3301 with predetermined properties, such as predetermined elasticity in a specific location and / or direction, or a specific force vector applied by the headband 3301 to the inflatable chamber 3200 and / or seal-forming structure 3100 during use.

[0248] In some examples of the present technology, headband 3301 is custom-made and tailored to a specific patient's anatomy and / or preferences. Plain knitting advantageously provides manufacturers with the flexibility to use a range of yarns, apply different design patterns, and apply different colors and surface geometries. In some examples, headband 3301 is knitted using a programmable knitting machine. Headbands formed using plain knitting can also be very comfortable. Using a high-gauge and fine-textured yarn, the surface finish of the band can be smooth, with a low risk of causing facial markings.

[0249] In some examples, the headband 3301 may include one or more text, graphics, trademarks, logos, etc. knitted into the headband 3301 during a single knitting operation that forms the headband 3301.

[0250] In alternative embodiments, the positioning and stabilizing structure 3300 may include one or more headbands. In some optional examples, one or more headband portions are formed by a circular knitting process.

[0251] In some examples, the headband 3301 can withstand a maximum force between 10N and 100N, more preferably between 15N and 80N, 20N and 60N, or 25N and 40N without damage. In some examples, the headband 3301 can include one or more portions having a point knit structure formed from 100% nylon and can be configured to withstand a maximum wale load of 5N to 8N (in some examples, between 6N and 7N) and a maximum course load of 2.5N to 5.5N (in some examples, between 3.5N and 4.5N). In some examples, the headband 3301 can include one or more portions having a point knit structure formed from a combination of nylon and spandex and can be configured to withstand a maximum wale load of 3N to 6N (in some examples, between 4N and 5N) and a course load of 2N to 4N (in some examples, between 2.5N and 3.5N). In some examples, the headband 3301 may include one or more portions having a single jersey knit structure formed from a combination of nylon and spandex and may be configured to withstand a maximum load of between 2.5-5N (in some examples, between 3-4N) in the wale and between 1-3N (in some examples, between 1.5-2.5N) in the course.

[0252] In some examples, the headband 3301 is configured to dry only a short time after being washed or after becoming wet from body moisture. The headband 3301 can be highly breathable and can keep the patient's skin relatively dry. The headband 3301 can be configured to be substantially non-marking on the face. The headband 3301 can be machine washable and hand washable.

[0253] Figure 8 The illustrated headband 3301 is configured to form a four-point connection with the frame 3500 or plenum 3200 of the patient interface 3000. In other examples of this technology, the headband 3301 can be configured to form a two-point connection with the frame 3500 or plenum 3200, for example when incorporated into a nasal pillow or nose pad type patient interface 3000. The headband 3301 can be connected at one or two points to the frame 3500 or plenum 3200 of a patient interface 3000 in a full-face configuration (e.g., a configuration in which the seal-forming structure 3100 seals around the lower periphery of the patient's nose and leaves most or all of the bridge of the patient's nose uncovered). In some examples, the headband 3301 can be configured as a back strap for the positioning and stabilizing structure 3300 of a catheter headband system. In such examples, the headband 3301 can cover or be positioned below the patient's occipital bone and connect between a pair of headband conduits that rest against the sides of the patient's head.

[0254] 5.3.3.2 Headband

[0255] like Figure 7As shown in FIG-9 , the positioning and stabilizing structure 3300 may include multiple strap portions. Multiple strap portions may be provided in a single headgear strap 3301, for example, Figure 7 -9 positioning and stabilizing structure 3300. In this example of the present technology, the positioning and stabilizing structure 3300 includes an annular band portion 3340. The annular band portion 3340 surrounds the back of the patient's head and provides a secure anchor for the other band portions connected to the plenum chamber 3200. The annular band portion 3340 may also be referred to as a coronary portion, a coronary band, a posterior / posterior portion, or a halo.

[0256] In this example of the present technology, the annular band portion 3340 of the positioning and stabilizing structure 3300 includes an upper portion 3302 and a lower portion 3304. The upper portion 3302 rests on the parietal bone of the patient's head during use. The lower portion 3304 is configured to rest on the patient's head above or below the occipital bone of the patient's head during use. As shown, the annular band portion 3340 defines a loop.

[0257] The positioning and stabilizing structure 3300 includes a pair of upper strap portions 3310. Each of the upper strap portions 3310 is configured to connect between the annular strap portion 3340 and the plenum chamber 3200. In use, each of the upper strap portions 3310 is positioned beside the patient's head, on a respective side, and above the patient's head.

[0258] exist Figure 7 In the example shown in Figure 9, the positioning and stabilizing structure 3300 further includes a pair of lower strap portions 3320. Each lower strap portion 3320 is configured to be connected between the annular strap portion 3340 and the inflatable chamber 3200. In use, each of the lower strap portions 3320 is positioned beside the patient's head, on a corresponding side, below the edge above the patient's head.

[0259] Each of the upper and lower strap portions 3310, 3320 may be connected to the plenum chamber 3200, either directly or via the frame 3500 of the cushion assembly 3580. Figure 7 In the example shown, the upper belt portion 3310 and the lower belt portion 3320 are connected to the inflatable chamber 3200 via the frame 3350, and the inflatable chamber 3200 is connected to the frame 3350.

[0260] One or more of the headband portions of the positioning and stabilizing structure 3330 (e.g., the upper strap portion 3310, the lower strap portion 3320, and the top strap portion 3330 described below) can include a fastening portion 3360. The fastening portion 3360 can be configured and / or arranged to allow the strap to be looped back and fastened to itself. In one example, the fastening portion 3360 can include hook and loop material. In another example, the fastening portion 3360 can include magnets that are configured to attract each other when the strap is looped back onto itself.

[0261] In some examples of the present technology, the positioning and stabilizing structure 3300 may include an upper strap portion 3310 but may not include a lower strap portion 3320. In some examples of the present technology, a patient interface 3000 may include a positioning and stabilizing structure 3300 including an upper strap portion 3310 connecting a rear portion (e.g., an annular strap portion 3340) of the positioning and stabilizing structure 3300 to an inflatable chamber 3200 including a nasal pillow or cradle cushion seal-forming structure 3100.

[0262] In this example, the annulus portion 3340 includes a rigidized portion 3345. The rigidized portion 3345 has a higher rigidity than the other portions of the annulus portion 3340. The rigidized portion 3345 may not be completely rigid, but may be "rigidized" in the sense that it is more rigid than some or all other portions of the annulus portion 3340. The rigidized portion 3345 and the other portions of the annulus portion 3340 may both be flexible to some extent, but the rigidized portion 3345 may be stiffer. The rigidized portion 3345 may be less susceptible to stretching and / or bending than the other portions of the annulus portion 3340. In this example, the rigidized portion 3345 is disposed along the length of the loop defined by the annulus portion 3345. The rigidized portion 3345 of the annulus portion 3340 may reinforce the annulus portion 3340. The reinforced cuff portion 3340 can improve the stability of the patient interface 3000 during use, as the purpose of the cuff portion 3340 is to provide an anchor for other strap portions connected to the plenum 3200 while simultaneously pulling the plenum 3200 into the patient's face under tension. The rigidized portion 3345 can be substantially non-stretchable, yet still bendable to conform to the curvature of the patient's head. The non-stretchability of the rigidized portion 3345 provides reinforcement to the cuff portion 3340, providing a more robust anchor and resulting in more stable positioning and stabilizing the structure 3300. The upper strap portion 3310 can be stretchable. In some examples of the present technology, the rigidized portion 3345 can be stretchable, but not as much as other portions of the cuff portion 3340. In some examples, the cuff portion 3340 can include a first portion disposed along the length of the loop defined by the cuff portion 3340 and a second portion disposed along the length of the loop. The second portion can include the rigidized portion 3345 and can extend along an edge of the cuff portion 3340 directly adjacent to (e.g., abutting) the first portion. The second portion may comprise a greater stiffness than the first portion. The second portion may be less flexible than the first portion. The second portion may be less stretchable than the first portion.

[0263] In an example of the technology, a rigidizing portion 3345 is provided substantially along the entire length of the loop defined by the annulus portion 3340. As shown, the annulus portion 3340 includes an inner perimeter (or inner edge) 3341 and an outer perimeter (or outer edge) 3342. In some examples, the annulus portion 3340 is stiffer at or near the inner perimeter 3341 than at or near the outer perimeter 3342. In one example, the rigidizing portion 3345 is provided to the annulus portion 3340 proximate the inner perimeter 3341 of the annulus portion 3340 (e.g., along the inner edge). The rigidizing portion 3345 can define the inner perimeter 3341 (or inner edge) of the annulus portion 3340, or alternatively, can be positioned proximate to the edge of the annulus portion 3340 that defines the inner perimeter 3341. The rigidizing portion 3345 can substantially form the entire inner perimeter 3341 of the annulus portion 3340. In other examples, the rigidified portion 3345 can be provided generally centrally between the inner perimeter 3341 of the annulus portion 3340 and the outer perimeter 3342 of the annulus portion 3340 .

[0264] Reinforcing the inner periphery 3341 around the cuff portion 3340 can be advantageous because the outer periphery 3342 (the more forward side) of the cuff portion 3340 can then be formed continuously with any other strap portions that connect the cuff portion 3340 to the plenum 3200 of the patient interface 3000. Positioning the rigidizing portion 3345 centrally between the inner periphery 3341 and the outer periphery 3342 can have the advantage of evenly distributing the pressure load on the patient's skin. The inner periphery 3341 of the cuff portion 3340 also may not need to deform as much as the outer periphery 3342, since it is the outer periphery 3342 from which the additional strap portions extend to connect to the plenum 3200 at the front of the patient's face.

[0265] The annular band portion 3340 and / or any other band portion of the positioning and stabilizing structure 3300 may include rounded edges. Rounded edges are less likely to cause skin markings and are more comfortable on the patient's skin.

[0266] In some examples of the present technology, the band portion of the positioning and stabilizing structure 3300 may be formed by knitting. That is, one or more of the upper band portion 3310, the lower band portion 3320, and the loop band portion 3340 may comprise a knitted fabric structure. In some examples, one or more of these band portions of the positioning and stabilizing structure 3300 may be formed by plain knitting. For example, the loop band portion 3340, the upper band portion 3310, and / or the lower band portion 3320 may comprise a single jersey knit fabric structure and may be formed from a combination of nylon and spandex. A single jersey knit fabric structure advantageously provides the necessary flexibility and elasticity to the band portion without excessive thickness. Alternatively, the loop band portion 3340 may comprise a double jersey knit loop structure. The rigidizing portion 3345 of the loop band portion 3340 may comprise a point knit structure (e.g., a point rib structure) and may be formed from nylon or a combination of nylon and spandex. Using a point knit structure to form the rigidizing portion 3345 may be advantageous because this type of structure is well suited to producing ridges with a sufficiently high level of rigidity while also having rounded edges. That is, the first portion of the loop portion 3340 and the second portion of the loop portion (e.g., the rigidized portion 3345) can include the same type of yarn (e.g., yarn having the same stiffness), while the second portion can have increased stiffness compared to the first portion due to the different knit structures. In one example, a point knit structure can provide increased stiffness compared to the knit structure of the first portion of the loop portion (e.g., a single jersey or double jersey knit).

[0267] The headband of the positioning and stabilizing structure 3300 can be stretchable. Advantageously, the upper strap portion 3310, lower strap portion 3320, and loop portion 3340 are stretchable. The stretchability of the loop portion 3340 of the positioning and stabilizing structure 3300 allows it to conform and tightly fit against the posterior, lateral, and upper surfaces of the patient's head during use. The stretchability in the upper and lower strap portions 3310, 3320 allows these strap portions to extend slightly in length to provide some relief when the plenum chamber 3200 is pressurized. When the plenum chamber 3200 is under pressure during use, the volume of pressurized air within the plenum chamber 3200 pushes the plenum chamber 3200 and frame 3500 forward, away from the patient's face. To maintain sealing contact between the plenum chamber 3200 and the seal-forming structure 3100 and the patient's face, the force resulting from this pressure must be counteracted by tension in the headband. The ability of the upper and lower strap portions 3310, 3320 to extend in length by at least a small amount may make wearing the patient interface 3000 more comfortable when this occurs.

[0268] Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the loop strap portion 3340 are all breathable due to the knitted structure from which they are formed. Breathability is advantageous because it can keep the headgear and the patient's skin dry while keeping the temperature of the patient's skin beneath the headgear manageable.

[0269] The rigidized portion 3345 can be a circular thickened portion of the headband material. The rigidized portion 3345 can include an increased thickness of material relative to adjacent portions of the cuff portion 3340. In some examples of the present technology, the patient contacting side of the cuff portion 3340 is generally flat, and the increased material thickness is provided to the non-patient contacting side of the cuff portion 3340. Advantageously, the additional thickness achieved by providing additional material forming the rigidized portion 3345 on the non-patient contacting side of the cuff portion 3340 allows the patient contacting side of the cuff portion 3340 to remain substantially flat. A flat surface can advantageously be more comfortable against the patient's skin than a non-flat surface. Due to the Figure 7 In the example shown, the rigidifying portion 3345 is provided on the inner periphery 3341 of the cuff portion 3340, so that the inner periphery 3341 is thicker than the outer periphery 3342. In use, the rear edge of the cuff portion 3340 is thicker than the front edge of the cuff portion 3340. The thicker inner periphery 3341 compared to the outer periphery 3342 results in a stiffer inner edge of the cuff portion 3340, thereby providing reinforcement to the cuff portion 3340.

[0270] The reinforcement of the reinforced portion 3345 is not discernible on the patient contacting side of the cuff portion 3340. In use, the patient may not be able to see and / or feel any features of the reinforced portion 3345. Figure 10 , cross-sections of the cuff portion 3340 at two locations are shown. As shown, the additional thickness at the rigidizing portion 3345 is provided only on one side of the cuff portion 3340 (the non-patient contacting side). The other side of the cuff portion 3340 is generally flat. In addition, the rigidizing portion 3345 is rounded, as are the inner edge (at the inner periphery 3341) and the outer edge (at the outer periphery 3342) of the cuff portion 3340. The smooth / rounded edges can apply only slight pressure on the wearer's side, which is particularly useful for maintaining comfort even if the patient overtightens the headgear straps.

[0271] In some examples of the present technology, the annular band portion 3340 includes a thickness in the range of 3-5 mm, such as in the range of 3.5-4.5 mm, in the rigidized portion 3345. In some examples, the rigidized portion 3345 can include a thickness of 4 mm. The thickness of the annular band portion 3340 at areas of the annular band portion 3340 other than the rigidized portion 3345 can be in the range of 1.5-3.5 mm, such as in the range of 2-3 mm, for example, 2 mm. The upper band portion 3310 and the lower band portion 3320 can also include a thickness in the range of 1.5-3.5 mm, such as in the range of 2-3 mm, for example, 2 mm.

[0272] In some examples, the rigidity of the rigidized portion 3345 may not be uniform along the length of the annulus portion 3340. The rigidized portion 3345 may be less stretchable and / or flexible at some locations than at other locations around the annulus portion 3340. In some examples, the rigidized portion 3345 may be larger at certain locations (compared to other locations) such that it has increased stiffness and / or rigidity at those specific locations. Figure 7 8, the rigidized portion 3345 is larger near the junction of the upper band portion 3310 and the loop portion 3340. In this example, the rigidized portion 3345 is wider near the upper band portion 3310 than at other locations along the loop portion 3340. In other examples of the present technology, the rigidized portion 3345 can be more rigid at specific locations due to increased material thickness and / or use of a different knit structure (in examples where the loop portion 3340 is formed by knitting).

[0273] The width and / or material thickness can vary along the length of the cuff portion 3340 to provide stiffness where stiffness / stability is desired and flexibility and / or comfort where stiffness is not desired. Additional stiffness can be particularly advantageous near the junction of the upper strap portion 3310 and the cuff portion 3340 because, in use, the upper strap portion 3310 is under tension and there is a relatively large area of ​​strap material at the junction. Strengthening this connection can help provide a high level of stability to the patient interface 3000.

[0274] The upper portion 3302 of the annular band portion 3340 may include one or more top band portions 3330. Figure 8 、 9As shown in Figures 13 and 13, in one example, the loop strap portion 3340 includes a pair of top strap portions 3330. The top strap portions 3330 can be configured to adjustably connect to each other. In one example, the top strap portions 3330 are configured to adjustably connect to each other near the sagittal plane of the patient's head. The adjustable connection between the two top strap portions 3330 can advantageously enable the positioning and stabilizing structure 3300 to fit a range of patient head shapes and sizes. In other examples of the present technology, the positioning and stabilizing structure 3330 can include a single top strap portion 3330. If only a single top strap portion 3330 is provided, it can be elastically extended in length to fit a range of patient head sizes.

[0275] The two top strap portions 3330 can be adjustably connected together via a buckle 3335. The buckle 3335 can include a pair of slots, eyelets, or other openings through which the top strap portions 3330 can be passed, thereby allowing each top strap portion 3330 to be passed through a portion of the buckle 3335 and secured back to itself. The top strap portions 3330 can each include hook-and-loop fastening material that allows the ends of each top strap portion 3330 to be fastened to the middle portion of the corresponding top strap portion 3330. In other examples of the present technology, each overhead strap portion 3330 can be fastened back to itself using a clip, elastic band, magnet, or other suitable fastening device. In an alternative example, during the manufacturing process of the positioning and stabilizing structure 3300, the two top strap portions are formed separately and then welded or sewn together to complete the loop formed by the annular strap portion 3340.

[0276] Figure 16 A headband 3301 is shown of a positioning and stabilizing structure 3300 according to another example of the present technology. The headband 3301 may be integrally formed by knitting and may be formed as a single piece of material in a single jersey knitting process. Figure 16 The headband 3301 may include reference Figure 7 - Any features and / or characteristics of the headband 3301 described in 15.

[0277] Figure 16The illustrated headband 3301 includes a pair of upper headband portions 3310, each configured to connect to the plenum chamber 3200 of the patient interface 3000 during use. In this example, each upper headband portion 3310 is configured to connect to a corresponding headband conduit of a positioning and stabilizing structure 3330, which is located on a corresponding lateral side of the patient's head during use. The headband conduits can each be configured to extend laterally across the upper portion of the patient's head from a central position on the upper portion of the patient's head, downward at the lateral sides of the patient's head, and then connect to the plenum chamber 3200 at the front and center, near the entrance to the patient's airway. Thus, the upper headband portions 3310 are configured to connect to the plenum chamber 3200 via the headband conduits. The headband 3301 also includes a pair of lower headband portions 3320, each configured to connect to the plenum chamber 3200. The lower headband portion 3320 may be connected directly to the plenum 3200 or the frame 3500 of the cushion assembly 3580 .

[0278] Figure 17 A patient interface 3000 according to another example of the present technology is shown including a cushion assembly 3590 and a positioning and stabilizing structure 3300. The cushion assembly 3590 includes an inflatable chamber 3200 and a seal-forming structure 3100. The positioning and stabilizing structure 3300 includes a headgear 3301 configured for use with a catheter headgear of a patient interface. Figure 17 The headband 3301 is shown with Figure 16 The headband is connected to the headband conduits 3900 in the same manner as the headband shown. As shown, the headband conduits are connected to the upper part of the patient's head at the connector 3903. The connection port 3600 supplies a pressurized flow of breathable gas to the headband conduits 3900. Each headband conduit 3900 includes a side portion 3901 next to the patient's head, which is connected to the plenum 3200 via a connector 3800. The plenum 3200 is located at the entrance of the patient's airway during use. More generally, each headband conduit 3900 can receive an air flow from the connection port 3600 on the top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure 3100. Each headband conduit 3900 is constructed and arranged to contact at least one area of ​​the patient's head that is higher than approximately the top of the patient's head on the corresponding side of the patient's head during use.

[0279] like Figure 17 As shown, the positioning and stabilizing structure 3300 includes a pair of upper strap portions 3310 connected between a neck strap portion 3334 and a corresponding headband conduit 3900. The neck strap portion 3334 may also be referred to as a rear portion. In this example, the upper strap portion is connected to an eyelet on a tab 3902 of the helmet conduit 3900. A lower strap portion 3320 is connected between the neck strap portion 3334 and the plenum chamber 3200, in this example via a headband clip 3322.

[0280] exist Figure 16 and 17 In the example shown, the headband 3301 does not include a loop or crown portion because the headgear conduits provide for positioning and stabilizing structure 3300 configured in the headband 3301. Figure 7 However, some examples of the present technology include a positioning and stabilizing structure 3300 that includes a headband conduit and a headband 3301 that includes a loop portion 3340 and / or a top strap portion 3330.

[0281] Figure 16 and 17 The illustrated headband 3301 includes a neckband portion 3334. The neckband portion 3334 connects each of the upper headband 3310 and the lower headband 3320. The neckband portion 3334 is configured to rest against the back surface of the patient's neck and / or against the surface of the patient's head covering the occipital bone of the patient's skull during use. The neckband portion 3334 can be configured to cover the occipital bone of the patient's head and / or lie against the patient's neck during use.

[0282] The neckband portion 3334, the upper headband portion 3310 and the lower headband portion 3320 may be integrally formed. The headband 3301 and its upper headband portion 3310, the lower headband portion 3320 and the neckband portion 3334 may be formed by a single plain knitting process.

[0283] Figure 16 The headband 3301 shown includes a rigidized portion 3345. In this example, the rigidized portion 3345 is provided on the neckband portion 3334. The rigidized portion 3345 may be provided in the same manner as described above with respect to Figure 7 15 , such as with an increased thickness and / or a more rigid knitted structure. In this example, the rigidized portion 3345 may be substantially inextensible.

[0284] The rigidized portion 3345 can reinforce the neck strap portion 3334. Since the purpose of the neck strap portion 3334 is to provide an anchor for the other strap portions connected to the plenum chamber 3200 while pulling the plenum chamber 3200 toward the patient's face under tension, this reinforcement can provide a high level of stability to the patient interface 3000 during use. The rigidized portion 3345 can be substantially non-stretchable, or at least less stretchable than the other strap portions, but can still be bendable to conform to the curvature of the patient's head. The non-stretchable or low-stretch nature of the rigidized portion 3345 provides reinforcement to the neck strap portion 3334, providing a more robust anchor and resulting in more stable positioning and stabilizing the structure 3300. The upper strap portion 3310 and the lower strap portion 3320 can be stretchable.

[0285] In addition to the rigidified portion 3345, the neckband portion 3334 may include a stretchable portion. Figure 16 In the illustrated example, the neckband portion 3334 includes stretchable portions above and below the rigidized portion 3345. In the example, the neckband portion 3334 includes an upper stretchable portion 3346 and a lower stretchable portion 3347. The stretchable portions may be provided at the upper and / or lower edges of the neckband portion 3334. In this example, the upper stretchable portion 3346 is provided along the upper edge of the neckband portion 3334, while the lower stretchable portion 3347 is provided along the lower edge of the neckband portion 3334. Providing stretchable portions at both the upper and lower edges of the neckband portion 3334 may improve patient comfort. If the upper and lower edges of the neckband portion 3334 are made substantially rigid, this configuration can concentrate the force from the headgear tension on the patient's skin. Providing stretchable portions at both the upper and lower edges can provide some relief, improving patient comfort. The stretchable portions also allow the neckband portion 3334 to conform to the curvature of the patient's neck.

[0286] 5.3.3.3 Headband ventilation

[0287] In some forms of the present technology, the positioning and stabilizing structure includes a headband having one or more ventilation portions configured and / or arranged to provide increased breathability through the headband. Figure 7 As shown in FIG-10 , the positioning and stabilizing structure 3300 includes three vent portions 3350. In this example, each vent portion 3350 is disposed within the cuff portion 3340 and provides an area of ​​increased breathability through the cuff portion 3340. The cuff portion 3340 includes a vent portion 3350 proximate each upper strap portion 3310 (e.g., at each junction between the upper strap portion 3310 and the cuff portion 3340). Additionally, the cuff portion 3340 includes a single vent portion 3350 proximate the junction between each lower strap portion 3320 and the cuff portion 3340.

[0288] In this example, the lower strap portions 3320 each extend from the cuff portion 3340 at similar locations. In examples of technology where the lower strap portions 3320 extend from more distinct locations around the cuff portion 3340, two separate vent portions 3350 can be provided, one at each junction between the lower strap portion 3320 and the cuff portion 3340. The vent portions 3350 can be positioned at locations where the headgear comprises a relatively large area / coverage on the patient's head. These areas are most susceptible to increased skin temperature and / or moisture accumulation. The junctions between the cuff portion 3340 and the upper and lower strap portions 3310 and 3320 can cover a relatively large surface area on the patient's skin, meaning that additional breathability may be required in these locations to provide a high level of patient comfort. The vent portions 3350 can advantageously prevent moisture from accumulating in the headgear material and / or on the patient's skin. The vent portions 3350 are areas with localized breathability. The knitted structures of the other headband portions of the positioning and stabilizing structure 3300 may also be highly breathable, but the vent portion 3350 may be particularly breathable due to the mesh knitted structure used to form the vent portion 3350. The vent portion 3350 also advantageously keeps the patient's skin cool by promoting fresh air exchange, at least beneath the vent portion 3350, through the material forming the headband 3301.

[0289] The ventilation portion 3350 may include a knitted fabric structure. The knitted fabric structure may be formed during the same knitting process as the loop portion 3340, the rigidized portion 3345, the upper band portion 3310, and / or the lower band portion 3320. In one example, the ventilation portion 3350 includes a point knit structure. The ventilation portion 3350 may be stretchable. However, in some examples, the ventilation portion 3350 may be less stretchable than other headband portions. The relatively low elasticity in the ventilation portion 3350 may prevent the mesh structure from being stretched to the point where the openings forming the mesh structure are blocked by the fabric, which would reduce breathability. For example, the ventilation portion 3350 may be formed from nylon or a combination of nylon and spandex.

[0290] In some examples, such as Figure 7 、 810, the rigidized portion 3345 of the cuff portion 3340 can surround the vent portion 3350. Advantageously, this can provide additional stiffness at areas of the headband portion having a large surface area that may otherwise be overly flexible. That is, due to the knitted structure, the vent portion 3350 can provide an area of ​​the cuff portion 3340 that has reduced stiffness and / or increased flexibility compared to other areas of the cuff portion (e.g., the first portion and / or second portion of the cuff portion (e.g., the rigidized portion 3345). The rigidized portion 3345 can be provided adjacent to (e.g., directly adjacent to, e.g., bordering) the vent portion 3350 to provide increased stiffness adjacent to or surrounding the vent area. Not every vent portion 3350 is surrounded by a rigidized portion 3345. In Figure 7 、 8 In the example shown in Figures 10 and 11 , the vent portion 3350 near the patient's neck is not surrounded by the rigidized portion 3345. However, the vent portion 3350 is near the upper strap portion 3310, which is surrounded by the rigidized portion 3345.

[0291] The annular band portion 3340 includes a pair of upper vent portions 3350, each of which is disposed adjacent to a corresponding upper band portion 3310. As described above, a rigidized portion 3345 surrounds each of the upper vent portions 3350. In this example, the rigidized portion 3345 includes a greater material thickness on the rear side of each upper vent portion 3350 than on the front side of each upper vent portion 3350. As described above, the rigidized portion 3345 can be formed to be stiffer near the inner periphery 3341 of the annular band portion 3340.

[0292] The annular belt portion 3340 further includes a lower ventilation portion 3350 disposed between the pair of lower belt portions 3320. Figure 8 and 9 As shown, the lower vent portion 3350 includes a lower edge 3351 that is spaced apart from the lower edge 3343 of the annulus portion 3340. The lower edge 3351 of the lower vent portion 3350 and the lower edge 3343 of the annulus portion 3340 are both arcuate in this example of the technology.

[0293] The curvature of the lower edge 3351 of the vent portion 3350 is greater than the curvature of the lower edge 3343 of the cuff portion 3340. The greater curvature of the lower edge 3351 of the vent portion 3350 provides a maximum spacing between the lower edge 3351 of the vent portion 3350 and the lower edge 3343 of the cuff portion 3340 at or near the sagittal plane of the patient's head during use. The vent portion 3350 and / or the cuff portion 3340 adjacent to the vent portion 3350 can contact or be in close proximity to the patient's neck. In addition, the mesh construction of the vent portion 3350 can be rougher than the non-mesh surface of the cuff portion 3340. Therefore, providing a spacing between the lower edge 3351 and the lower edge 3343 of the vent portion 3350 can reduce the amount of mesh fabric that comes into contact with the patient's skin. This may be particularly advantageous when contact between the cuff portion 3340 and the patient's skin occurs while the cuff portion 3340 is under tension and for an extended period of time, such as occurs during use of the patient interface 3000.

[0294] Figure 16 The headband 3301 of the illustrated positioning and stabilizing structure 3300 also includes a vent portion 3350. In this example, the vent portion 3350 is disposed within the neckband portion 3334. The vent portion 3350 may be of the same type as described above with respect to the neckband portion 3334. Figure 7 The positioning and stabilising structure 3300 and the vent portion 3350 of the headband 3301 shown in FIG-15 are of the same form and include the same features as described. In this example, the rigidising portion 3345 surrounds the vent portion 3350.

[0295] It should be noted that plain knitted fabric knitting structure (e.g. single jersey knitted fabric, double jersey knitted fabric), point knitted structure and point mesh knitted structure refer to textiles or textile parts formed by plain knitted fabric, point knitted fabric and point mesh knitted fabric knitting techniques, respectively. As those skilled in the art will understand, these textiles or textile parts form different knitted structures due to the different ways in which their yarns are interwoven.

[0296] 5.3.3.4 Guide pieces

[0297] As described above, some or all of the headband portions of the positioning and stabilizing structure 3300 may include fastening portions 3360. Figure 7 、 8 As shown in Figures 16 and 17, the upper and lower strap portions 3310, 3320 each include a fastening portion 3360 near the end of the respective strap portion. Each fastening portion 3360 is configured and / or arranged to allow the respective strap portion to be looped back and fastened to itself.

[0298] In an example, the fastening portion 3360 may include hook and loop material and / or magnets. This allows each of the upper strap portion 3310 and the lower strap portion 3320 to be connected to other components of the patient interface 3000, such as the frame 3500, or in other examples, directly to the plenum chamber 3200. The upper strap portion 3310 and the lower strap portion 3320 may be connected directly to the frame 3500 through slots or other openings, or may be connected to a headband clip, which is then connected to the frame 3500. In one example, as Figure 7 and 8 As shown, the upper strap portions 3310 are each connected to an upper strap connection point 3510 on the frame 3500. Each upper strap connection point 3510 includes a slot through which the fastening portion 3360 of the upper strap portion 3310 can be passed so that the end of the upper strap portion 3310 can be secured back to the middle / center portion of the upper strap portion 3310. In this example, the lower strap portion 3320 is connected to the headband clip 3322. Each lower strap portion 3320 is passed through a slot formed in the headband clip 3322 and then looped back and secured to itself. The headband clip 3322 is then connected to the frame 3500. In this example, the headband clip 3322 and the frame 3500 each include a magnet that enables the headband clip 3322 to be secured to a predetermined portion of the frame 3500 under magnetic attraction (and also to be quickly released from a predetermined portion of the frame 3500). Figure 16 In the example shown, the fastening portion 3360 of the upper headband portion 3310 can be looped through the eyelets on the headband conduit of the positioning and stabilizing structure 3300. The fastening portion 3360 of the lower headband 3320 can be formed in a manner similar to that of the headband 3310. Figure 7 A similar approach is shown around the slot on the plenum 3200 of the patient interface 3000 , or around the headgear clip connected to the plenum 3200 .

[0299] One or more strap portions of the positioning and stabilizing structure 3300 may include at least one blind guide 3370. In examples of the present technology in which the headband portion comprises knitted fabric, the blind guide 3370 may also be formed from knitted fabric. In some examples, the headband is formed by jersey knitting, and the blind guide 3370 is also formed by jersey knitting in the same process. The blind guide 3370 may provide a tactile indication of the position of the fastening portion 3360 on the strap. The blind guide 3370 may be a feature that the patient can feel on the surface of the headband, configured to assist the user in manipulating the headband (e.g., fitting and adjusting the strap), particularly when the mask is already being worn by the patient and the patient cannot see the headband. The blind guide 3370 may be a raised bump, raised contour, or other tactile feature to guide the user in securing the strap after looping it through slots or eyelets provided on the mask frame or headband clip. In other examples of the present technology, the blind guide 3370 may include a recessed portion.

[0300] like Figure 7 、 8 16 , each of the upper and lower strap portions 3310, 3320 includes a blind guide 3370 in the fastening portion 3360 of the corresponding strap. Each blind guide 3370 provides a tactile indication of the location of the fastening portion 3360 on a corresponding one of the upper and lower strap portions 3310, 3320. In some examples, the blind guide 3370 may also be provided to the top strap portion of the positioning and stabilizing structure 3300.

[0301] Figure 11 An exploded view of the fastening portion 3360 of the strap of the positioning and stabilizing structure 3300 is shown. In the example shown, the strap is the upper strap portion 3310 of the positioning and stabilizing structure 3300, but the features of the fastening portion 3360 and the blind guide 3370 can be applied to the lower strap portion 3320 or other strap / strap portions of the positioning and stabilizing structure 3300 in accordance with examples of the present technology. The upper strap portion 3310 includes a non-patient contacting surface on which the blind guide 3370 is provided. The blind guide 3370 may include a raised portion relative to the non-patient contacting surface of the upper strap portion 3310. The raised portion may surround at least a portion of the fastening portion 3360. As shown Figure 10 and 11 As shown, the raised portion comprises an elongated raised profile on the non-patient contacting surface of the belt. In this example, the elongated raised profile of the blind guide 3370 is provided at one or more edges of the fastening portion 3360. The elongated raised profile may be provided at the edges of the fastening portion 3360, which in use are the upper edge, the rear edge, and the lower edge. The blind guide 3370 may be provided around the periphery of the fastening portion 3360, for example, on one, two, or more sides thereof.

[0302] In other examples of the present technology, the strap of the positioning and stabilizing structure 3300 may include a concave profile that is recessed relative to the non-patient contact surface. The concave portion may surround at least a portion of the fastening portion 3360 on the strap. Any suitable features of the shape and position of the raised blind guides described herein may be applied to the recessed blind guides of other examples of the present technology. Similarly, in other examples of the present technology, any of the illustrated examples of the positioning and stabilizing structure of the present technology may include recessed blind guides rather than raised blind guides. For example, the recessed blind guides may be formed by an elongated recessed profile that surrounds the other three sides of the fastening portion 3360. The recessed profile may be formed by a reduced thickness of the strap. The present technology also includes blind guides formed by other features, such as regions of higher stiffness or portions of the headband having a different surface finish / texture than adjacent regions of the strap. The knit pattern, knit density, and / or yarn material / thickness may be varied to provide the user with a tactile indication of the location of the fastening portion on the strap.

[0303] In some examples of the present technology, the elongated raised profile of the blind guide 3370 is rounded. This can make the blind guide 3370 more comfortable to reach for the patient, more aesthetically pleasing, and can make the positioning and stabilizing structure 3300 more durable because the transition between the raised portion and the non-patient contact surface it provides is smoother.

[0304] The raised portion of the blind guide 3370 may be formed by increasing the thickness of the belt compared to adjacent areas of the belt. The additional material forming the increased thickness may be provided to the non-patient contact surface.

[0305] The fastening portion 3360 of the strap may include a hook and loop fastening material (e.g., Velcro™). The fastening portion 3360 may include an end portion 3361 including one of a hook material and a loop material disposed to the non-patient contact surface and a middle portion 3363 including the other of a hook material and a loop material disposed to the non-patient contact surface. The middle portion 3363 may be disposed adjacent to the end portion 3361 of the strap. Figure 11 In the example shown, the fastening portion 3360 includes a hook portion 3362 and a loop portion 3364. The hook portion 3362 is provided on the end portion 3361 of the upper strap portion 3310. The loop portion 3364 is provided on the middle portion 3363 of the upper strap portion 3310. In other examples, the hook portion 3362 may be provided to the middle portion 3363 of the strap, and the loop portion 3364 may be provided to the end portion 3361 of the strap. The hook portion 3362 is capable of being releasably attached to the loop portion 3364. This means that once the upper strap portion 3310 passes through an opening in another component (e.g., a slot formed in the frame 3500), the end portion 3361 can be looped back toward the middle portion 3363 and the hook portion 3362 can be releasably attached to the loop portion 3364. The blind guide 3370 may surround only one of the end portion 3361 and the middle portion 3363. In Figure 11 In the example shown, the blind guide 3370 is disposed only around the middle portion 3363 and the ring portion 3364. As shown, the blind guide 3370 is disposed around three sides of the ring portion 3364.

[0306] The middle portion 3363 can be longer than the end portions 3361. This can enable the end portions 3361 to be fastened to a range of positions along the middle portion 3363, thereby increasing the amount of length adjustability of the strap. In some examples, the middle portion 3363 is several times longer than the end portions 3361.

[0307] The belt portion comprising the blind guide 3370 (e.g., the upper belt portion 3310, the lower belt portion 3320, or any other belt portion in other examples of the present technology) and the blind guide 3370 itself can be formed together in a single knitting process. The blind guide 3370 can include a point knit structure. The belt can include a single jersey knit structure. In an alternative example of the present technology, the belt can include a double jersey knit loop structure. The belt and blind guide 3370 can be integrally formed.

[0308] The hook portion 3362 and loop portion 3364 can be formed separately and then assembled with the corresponding strap portion. They can be adhered or sewn into the strap portion of the positioning and stabilizing structure 3300. Alternatively, one or both of the hook portion 3362 and loop portion 3364 can be ultrasonically welded to the headband. In other examples of this technology, one or both of the hook portion 3362 and loop portion 3364 are knitted. The hook portion 3362 and / or loop portion 3364 can be formed in the same knitting process used to form the strap portion to which they are attached. The knitting process can include plain knitting. The hook portion 3362 and loop portion 3364 can be formed from nylon. This can reduce skin irritation due to its excellent breathability and provide a soft loop that avoids abrasion on the patient's skin. The hook portion 3362 and loop portion 3364 can be die-cut.

[0309] The upper strap portion 3310 and / or other strap portions may include visual guides 3366 indicating the ends of the strap, such as Figure 11 As shown. Visual guide 3366 can surround hook portion 3362. Visual guide 3366 can be no higher than the surface of the belt portion and can be a visual guide in the form of a colored fabric. Visual guide 3366 can also or alternatively facilitate assembly of hook portion 3362 onto the belt portion to which they are secured during the manufacturing process.

[0310] like Figure 8 and 16 As shown, each of the upper strap portion 3310 and the lower strap portion 3320 includes a fastening portion 3360. Each fastening portion 3360 includes a hook portion 3362 disposed on an end 3361 of the corresponding strap portion and a loop portion 3364 disposed on a middle portion 3363 of the corresponding strap portion. In other examples of this technology, only the upper strap portion 3310, only the lower strap portion 3320, or neither strap portion has this structure. In some examples, the knitting process used to form the headband portion is configured to precisely provide the strap portion with a predetermined level of stiffness, eliminating the need for adjustability and blind guides. In some examples, this predetermined level of stiffness can be determined based on the specific shape and size of the patient's head as determined by a scan.

[0311] In some examples, the positioning and stabilizing structure 3300 may not have a lower strap portion 3320 and may have only an upper strap portion 3310. This arrangement may be suitable for an "under the nose" type of patient interface 3000 (e.g., a seal-forming structure 3100 in the form of nasal pillows or nose pads). In such an example, the upper strap portion 3310 may have the aforementioned fastening portion 3360 and shutter guide 3370. A positioning and stabilizing structure 3300 having an upper strap portion 3310 but not a lower strap portion 3320 may have an annular strap portion 3340 having an upper portion 3302 and a lower portion 3304. One or both of the upper portion 3302 and the lower portion 3304 may be adjustable by the patient. In such an example, the upper portion 3302 and / or the lower portion 3304 may be divided into two strap portions connected by a buckle (or a similar component having an opening through which the strap can be fed). Each of the two strap portions forming the upper portion 3302 and / or lower portion 3304 may include features of a fastening portion 3360 and / or a shutter guide 3370, as described above with reference to FIG. Figure 11 described.

[0312] In some examples of the technology, the blind guide 3370 may be stretchable and in other examples, non-stretchable. The belt portion provided with the blind guide 3370 may be stretchable as a whole to provide some ductility under tension, although in some examples, only selected areas of the belt portion may be extended in length. If the area of ​​the belt portion provided with the blind guide 3370 is stretchable, the blind guide 3370 may also be formed to be stretchable (e.g., by using a knitting process that enables the blind guide to elastically extend along with the belt on which it is formed). In some examples, the blind guide 3370 may be provided to a non-stretchable portion of the belt (e.g., if the belt has a stretchable portion elsewhere along its length). In such examples, the blind guide 3370 may not be stretchable.

[0313] like Figure 12 As shown, an end guide 3371 can be provided on the patient contacting side of the headband 3301 to provide a tactile indication of the end 3361 of the strap portion. In use, once the strap portion has been fed through the slot in the frame 3500, the surface on which the guide 3371 is formed will be looped on the patient contacting side of the headband 3301.

[0314] 5.3.4 Ventilation holes

[0315] In one form, the patient interface 3000 includes a vent structure 3400 that is constructed and arranged to allow for the purging of exhaled gases, such as carbon dioxide.

[0316] In certain forms, the vent structure 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent structure 3400 is configured to provide a ventilation flow rate of a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0317] A vent structure 3400 in accordance with one form of the present technology includes a plurality of pores, for example, from about 20 to about 80 pores, or from about 40 to about 60 pores, or from about 45 to about 55 pores.

[0318] The vent structure 3400 may be located within the plenum chamber 3200. Alternatively, the vent structure 3400 is located within a separate structure, such as a swivel joint.

[0319] 5.3.5 Decoupling Structure

[0320] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel joint or a ball and socket.

[0321] 5.3.6 Connection Port

[0322] The connection port 3600 allows connection to the air circuit 4170 .

[0323] 5.3.7 Forehead support

[0324] In one form, the patient interface 3000 includes a forehead support 3700 .

[0325] 5.3.8 Anti-suffocation valve

[0326] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0327] 5.3.9 Port

[0328] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0329] 5.4RPT device

[0330] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as all or part of any of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0331] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cm H2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0332] The RPT device 4000 can have an outer housing 4010 comprised of two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 can include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0333] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0334] One or more air path items may be disposed within a removable, separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0335] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 420, a converter 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0336] 5.4.1 RPT Mechanical and Pneumatic Components

[0337] The RPT device may include one or more of the following components in an integral unit. In the alternative, one or more of the following components may be located as respective separate units.

[0338] 5.4.1.1 Air filter

[0339] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0340] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0341] In one form, an outlet filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0342] 5.4.1.2 Muffler

[0343] An RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120 .

[0344] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .

[0345] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0346] 5.4.1.3 Pressure generator

[0347] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or supply air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0348] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0349] In other forms, the pressure generator 4140 may be a piston driven pump, a pressure regulator or a bellows connected to a high pressure source (eg, a compressed air reservoir).

[0350] 5.4.1.4 Sensors

[0351] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located on or form part of an air circuit (e.g., a patient interface), for example. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0352] In one form of the present technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of an airflow characteristic, such as airflow velocity, air pressure, or temperature at that point in the pneumatic path.

[0353] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 .

[0354] In one form, the signal from the transducer 4270 may be filtered, such as by low pass, high pass or band pass filtering.

[0355] 5.4.1.4.1 Flow rate sensor

[0356] A flow rate sensor 4274 according to the present technology may be based on a differential pressure sensor, such as the SDP600 series differential pressure sensor from SENSIRION.

[0357] In one form, a signal representing flow rate from flow rate sensor 4274 is received by central controller 4230.

[0358] 5.4.1.4.2 Pressure sensor

[0359] A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a sensor from the ASDX series from HONEYWELL. Another suitable pressure sensor is a sensor from the NPA series from GENERALELECTRIC.

[0360] In one form, signals from pressure sensor 4272 are received by central controller 4230 .

[0361] 5.4.1.4.3 Motor Speed ​​Sensor

[0362] In one form of the present technology, a motor speed sensor 4276 is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed converter 4276 may be provided to the treatment device controller 4240. The motor speed converter 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0363] 5.4.1.5 Anti-overflow valve

[0364] In one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is configured and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0365] 5.4.2 RPT device electrical components

[0366] 5.4.2.1 Power supply

[0367] The power supply 4210 may be located inside or outside the housing 4010 of the RPT device 4000 .

[0368] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0369] 5.4.2.2 Input device

[0370] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may be physically connected to the housing 4010 in one form or may communicate wirelessly with a receiver electrically connected to a central controller 4230 in another form.

[0371] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0372] 5.4.3RPT device algorithm

[0373] As described above, in some forms of the present technology, central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium such as memory 4260. Algorithms 4300 are generally grouped into groups called modules.

[0374] 5.5 Air circuit

[0375] The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000, in use.

[0376] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0377] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0378] 5.5.1 Oxygen delivery

[0379] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , to the air circuit 4170 , and / or to the patient interface 3000 .

[0380] 5.6 Humidifier

[0381] 5.6.1 Humidifier Overview

[0382] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ), to change the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0383] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be respectively a humidifier inlet 5002 and a humidifier outlet 5004. The humidifier 5000 can further include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0384] 5.6.2 Humidifier components

[0385] 5.6.2.1 Reservoir

[0386] According to one arrangement, the humidifier 5000 can include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) to be evaporated in order to humidify the air flow. The water reservoir 5110 can be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, such as 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other embodiments, the humidifier 5000 can be configured to receive a water supply from an external water source (e.g., a building's water supply).

[0387] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow as it passes therethrough from the RPT device 4000. In one form, the water reservoir 5110 may be configured to cause the air flow to travel through the reservoir 5110 in a tortuous path upon contact with the volume of water therein.

[0388] According to one form, the reservoir 5110 may be, for example, Figure 5A and Figure 5B Shown removed from humidifier 5000 in a lateral orientation.

[0389] The reservoir 5110 can also be configured to prevent liquid from flowing out thereof, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation, such as through any orifices and / or between its subcomponents. As the air flow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 can also be configured to prevent loss of pneumatic pressure through leaks and / or flow resistance.

[0390] 5.6.2.2 Conducting part

[0391] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive portion 5120 can be configured as a plate, although other shapes may also be suitable. All or a portion of the conductive portion 5120 can be made of a thermally conductive material, such as aluminum (e.g., approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using a less conductive material with a suitable geometry.

[0392] 5.6.2.3 Humidifier water tank dock

[0393] In one form, the humidifier 5000 may include a humidifier reservoir docking piece 5130 (e.g., Figure 5B), the humidifier reservoir dock is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 can include a locking feature, such as a locking lever 5135, configured to retain the reservoir 5110 in the humidifier reservoir dock 5130.

[0394] 5.6.2.4 Water level indicator

[0395] The humidifier reservoir 5110 may include Figure 5A 5B . In some forms, the water level indicator 5150 can provide one or more indications to a user (e.g., patient 1000 or a caregiver) regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 can include an indication of a maximum predetermined volume of water, any fraction of the water, such as 25%, 50%, or 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0396] 5.6.2.5 Heating elements

[0397] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component such as a resistive heating track. One suitable example of a heating element 5240 is a layered heating element, such as that described in PCT Patent Application Publication WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0398] In some forms, the heating element 5240 may be provided in the humidifier base 5006, where heat may be provided to the humidifier reservoir 5110 primarily by conduction, e.g. Figure 5B shown.

[0399] 5.7 Respiratory Waveform

[0400] Figure 6 The following figure shows a typical respiratory waveform model for a sleeping person. The horizontal axis is time, and the vertical axis is respiratory flow. Although parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate Qpeak -0.5 L / s. The total duration of the breath, Ttot, is approximately 4 seconds. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), with a ventilation volume, Vent, of approximately 7.5 L / min. The typical ratio of duty cycle Ti to Ttot is approximately 40%.

[0401] 5.8 Glossary

[0402] For purposes of this technical disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0403] 5.8.1 General

[0404] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0405] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0406] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity in the room where the patient is sleeping. This ambient humidity can be different from the humidity outside the room where the patient is sleeping.

[0407] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0408] In some forms, ambient (e.g., acoustic) noise can be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0409] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjusted between a minimum and a maximum limit, eg, varying with each breath, depending on whether there is an indication of an SBD event.

[0410] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0411] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0412] In the example of a patient breathing, the flow rate 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. The total flow rate, Qt, is the flow rate of air leaving the RPT device. The ventilation flow rate, Qv, is the flow rate of air leaving the vent to allow for clearance of exhaled gases. The leakage flow rate, Ql, is the flow rate of air leaking from the patient interface system or elsewhere. The respiratory flow rate, Qr, is the flow rate of air received into the patient's respiratory system.

[0413] Humidifier: The term humidifier shall be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0414] Leakage: The word leakage is to be considered as undesirable air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return bend to the surrounding environment.

[0415] Noise, Conducted (Acoustic): Conducted noise in this document refers to the 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.

[0416] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding 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.

[0417] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any vent, such as the vent of a patient interface.

[0418] Patient: A person, whether or not they have a respiratory condition.

[0419] Pressure: force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 , hectopascal. 1cmH2O equals 1g-f / cm 2And is about 0.98 hectopascal.In this specification, unless otherwise specified, pressure is given in cmH2O.

[0420] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0421] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0422] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0423] 5.8.1.1 Materials

[0424] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0425] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0426] 5.8.1.2 Mechanical properties

[0427] Resilience: The ability of a material to absorb energy during elastic deformation and release that energy when unloaded.

[0428] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0429] Hardness: The ability of a material to resist deformation (as described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0430] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0431] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0432] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions.

[0433] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, eg, within 1 second.

[0434] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such use may be placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway, for example, at a pressure of approximately 20 to 30 cmH2O.

[0435] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction.In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0436] 5.8.2 Anatomy

[0437] 5.8.2.1 Facial anatomy

[0438] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0439] Nose angle:

[0440] Alar tip: The outermost point on the wing of the nose.

[0441] Alar bend (or alar apex) point: The most posterior point in the base of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0442] Pinna: The entire external, visible part of the ear.

[0443] (Nose) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0444] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0445] Columella: The strip of skin that separates the nostrils and extends from the protruding point of the nose to the upper lip.

[0446] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (where both lines intersect at the lower point of the nasal septum).

[0447] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea, which is the deepest point in the notch above the tragus of the auricle.

[0448] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0449] External nasal cartilage: A roughly triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla, and its lower edge connected to the greater alar cartilage.

[0450] Lip, lower (midpoint of lower lip):

[0451] Lip, upper (midpoint of upper lip):

[0452] The greater alar cartilage is a cartilaginous plate located beneath the external nasal cartilage. It curves around the front 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 smaller cartilages of the alar.

[0453] Nostril: The roughly oval-shaped opening that forms the entrance to the nasal cavity. The singular form of "nare" is "naris." The nostrils are separated by the nasal septum.

[0454] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0455] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0456] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0457] Auricular base: The highest point where the auricle attaches to the facial skin.

[0458] Nasal protuberance: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0459] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0460] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0461] The nasal ridge is the midline protrusion of the nose extending from the nasal bridge to the nasal protuberance.

[0462] Sagittal plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0463] Nasal bridge point: The most concave point on the soft tissue covering the forehead and nasal suture area.

[0464] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0465] Subalar: The point at the lower edge of the ala base where the ala base joins the skin of the upper (superior) lip.

[0466] Subnasal point: The point on the soft tissue where the columella and upper lip meet in the midsagittal plane.

[0467] Mandibular alveolar seat: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0468] 5.8.2.2 Anatomy of the skull

[0469] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to the area called the forehead.

[0470] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0471] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0472] Nasal bones: The nasal bones are two small, oval bones that vary in size and form among different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0473] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0474] Occipital bone: The occipital bone is located at the back and bottom of the skull. It contains an oval hole (the foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0475] Orbit: The bony cavity in the skull that houses the eyeball.

[0476] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0477] Temporal bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0478] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0479] 5.8.2.3 Anatomy of the respiratory system

[0480] Diaphragm: A sheet of muscle that extends across the base 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.

[0481] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0482] Lung: The respiratory organ of humans. The conducting zone of the lungs consists of the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone consists of the respiratory bronchioles, alveolar ducts, and alveoli.

[0483] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0484] Pharynx: The part of the throat located just below (underneath) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal portion of the pharynx), the oropharynx (mesopharynx) (the oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0485] 5.8.3 Patient interface

[0486] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0487] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow may be assembled to the mating component via a one-time snap-fit ​​during manufacturing but may not be removed by the patient.

[0488] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame can be a non-airtight load-bearing structure in a mask. However, some forms of mask frames can also be airtight.

[0489] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed to be placed on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcements configured to position and maintain a patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as a laminated composite of foam and fabric.

[0490] Membrane: A membrane will be understood to mean a typically thin element which is preferably substantially non-resistant to bending but resistant to stretching.

[0491] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of a wall of the mask plenum.

[0492] Seal: can be a noun form referring to a structure (seal) or a verb form referring to that effect (seal). Two elements can be configured and / or arranged to 'seal' or achieve a 'seal' between them without requiring a separate 'seal' element itself.

[0493] Shell: Shell will be understood to mean a curved, relatively thin structure that possesses bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a mask may be the shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0494] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0495] Support: A support will be considered a structural component designed to increase the compression resistance of another component in at least one direction.

[0496] Swivel: (noun) A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the 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 subassembly of the component preferably comprises a pair of matching cylindrical conduits. There can be little or no air flow leakage from the swivel during use.

[0497] Lacera (noun: a structure used to resist tension.

[0498] Vent: (noun): A structure that allows air flow from the interior of a mask or conduit to the ambient air, e.g., for effective clearance of exhaled gases. For example, clinically effective clearance may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0499] 5.8.4 Shape of the structure

[0500] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0501] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure, cf. Figures 3B to 3F , which show a cross section at a point p on the surface and an example of the resulting plane curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0502] 5.8.4.1 One-dimensional curvature

[0503] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0504] Positive curvature: If the curve at point p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person leaves point p, they must be walking uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0505] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally, without going up or down). Figure 3D .

[0506] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person leaves point p, they must be walking downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0507] 5.8.4.2 Two-dimensional surface curvature

[0508] A description of the shape at a given point on a two-dimensional surface according to the present technology can include multiple normal cross-sections. The multiple cross-sections can cut the surface in a plane including the outward normal ("normal plane"), and each cross-section can be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. The different curvatures at the point can have the same sign or different signs. Each curvature at the point has a magnitude, for example, a relatively small magnitude. Figures 3B to 3F The plane curve in may be an example of such multiple sections at specific points.

[0509] Principal curvatures and principal directions: The directions of the normal planes where the curvature of a curve takes its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example, the maximum curvature occurs at Figure 3B The minimum curvature occurs in Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0510] Region of a surface: A connected set of points on a surface. Points in a region can have similar characteristics, such as curvature or sign.

[0511] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0512] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0513] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0514] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0515] Edge of a surface: The boundary or limit of a surface or area.

[0516] Path: In some forms of this technology, 'path' will be taken to mean a path in the mathematical-topological sense, e.g., a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technology, a 'path' may be described as a route or journey, comprising, for example, a set of points on a surface. (A hypothetical person's path is where they walk on a surface, and is analogous to a garden path).

[0517] Path Length: In some forms of this technology, 'path length' will be considered to be the distance along the surface from f(0) to f(1), i.e. the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imaginary person would be the distance they would have to walk along the surface to follow a path.

[0518] Straight-line distance: Straight-line distance is the distance between two points on a surface, regardless of the surface. On a flat surface, there will be a path on the surface with the same path length as the straight-line distance between the two points on the surface. On a non-flat surface, there may not be a path with the same path length as the straight-line distance between the two points. (For an imaginary person, straight-line distance would correspond to the distance as a 'straight line'.)

[0519] 5.8.4.3 Space curve

[0520] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be considered as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear consists of a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and binormal vector at that point.

[0521] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point and the magnitude. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and dropped from their aircraft at a specific point, the direction of the tangent vector would be the direction they would be traveling.

[0522] Unit normal vector: As the imaginary person moves along the curve, this tangent vector itself changes. The unit vector pointing in the direction of the tangent vector's change is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0523] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see for example Figure 3P ) or optionally by the left-hand rule ( Figure 3O ) to confirm.

[0524] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Figure 3O and 3P .

[0525] Torsion of a space curve: The torsion of a space curve at a point is the rate of change of the binormal unit vector at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently tilted spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply tilted spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0526] Reference Figure 3P According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g. Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0527] Likewise, referring to the left-hand rule (see Figure 3O ), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus, a left-handed positive is equivalent to a right-handed negative. See Figure 3T .

[0528] 5.8.4.4 Holes

[0529] A surface may have one-dimensional pores, for example pores defined by a plane curve or by a space curve. A thin structure (such as a membrane) having pores may be described as having one-dimensional pores. See, for example, Figure 3I A one-dimensional hole in the surface of the structure shown is bounded by a planar curve.

[0530] A structure can have a two-dimensional hole, such as a hole defined by a surface. For example, a pneumatic tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, Figure 3L The padding and the Figure 3M and Figure 3N , showing an exemplary cross-section of an inner surface defining a two-dimensional aperture. In yet another example, a conduit can include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by the inner surface of the conduit. See also Figure 3K A two-dimensional hole in the shown structure is bounded by the shown surface.

[0531] 5.9 Other Notes

[0532] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0533] Unless the context clearly indicates otherwise and a numerical range is provided, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated or intervening value in that stated range, is broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges and are also encompassed within the present technology, subject to any specifically excluded limit in the stated range. Where the range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the present technology.

[0534] Furthermore, where a value or values ​​are described herein for implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated, and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0535] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0536] When a particular material is identified as being used to construct a component, obvious alternative materials having similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0537] It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0538] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosures prior to the filing date of the present application. This paper should not be construed as admitting that the present technology is not entitled to disclose earlier than this type of disclosure due to prior invention. In addition, the publication date provided may be different from the actual publication date, which may require independent confirmation.

[0539] The terms "comprises" and "comprising" should be understood to refer to elements, components or steps in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0540] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0541] Although the technology herein has been described with reference to specific examples, it should be understood that these examples only illustrate the principles and applications of the technology. In some cases, terms and symbols may imply specific details that are not required for practical use of the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to represent any order, but can be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even synchronously.

[0542] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0543] 5.7 Reference Symbols

[0544]

[0545]

[0546]

[0547]

Claims

1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to a patient's airway entrance while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient, a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap constructed and arranged such that, in use, at least a portion of the strap overlies an area of ​​the patient's head above the nasion on the patient's head; as well as a vent structure that allows continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the ambient environment through the patient's mouth without a flow of pressurized air through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered; Wherein said positioning and stabilizing structure comprises: a cuff portion having an upper portion configured to cover the parietal bone of a patient's head in use and a lower portion configured to cover the occipital bone of a patient's head in use, the cuff portion defining a loop; and a pair of upper strap portions, each upper strap portion being configured to connect, in use, between the annular strap portion and the cushion assembly on a corresponding side of the patient's head above the nasion; wherein the annulus portion includes a rigidifying portion disposed along a length of the loop defined by the annulus portion.

2. A patient interface as claimed in claim 1, wherein: The rigidifying portion is disposed along substantially the entire length of the loop defined by the annular band portion.

3. A patient interface according to claim 1 or 2, wherein: The rigidifying portion is disposed on the annular band portion near an inner periphery of the annular band portion.

4. A patient interface as claimed in claim 3, wherein: The rigidified portion defines at least a portion of the inner periphery of the annulus portion.

5. A patient interface according to claim 3 or 4, wherein: The rigidified portion forms substantially the entire inner periphery of the annular band portion.

6. A patient interface as claimed in claim 1 or 2, wherein: The rigidifying portion is generally centrally disposed between an inner periphery of the annulus portion and an outer periphery of the annulus portion.

7. A patient interface as claimed in any preceding claim wherein the upper strap portion is stretchable.

8. A patient interface as claimed in any preceding claim, wherein: The rigidified portion is substantially non-stretchable.

9. A patient interface as claimed in any preceding claim, wherein: The annulus portion includes a rounded edge.

10. A patient interface as claimed in any preceding claim, wherein: The rigidified portion includes an increased material thickness relative to adjacent portions of the annulus portion.

11. A patient interface according to claim 10, wherein: The patient contacting side of the cuff portion is generally flat, and the increased material thickness is provided to the non-patient contacting side of the cuff portion.

12. A patient interface according to claim 10 or 11, wherein: The annular band portion comprises a thickness of 4 mm in the rigidified portion.

13. A patient interface as claimed in any one of claims 10 to 12, wherein: The annular band portion comprises a thickness of 2.5 mm in an area of ​​the annular band portion excluding the rigidified portion.

14. A patient interface as claimed in any preceding claim, wherein: The rigidified portion is larger in an area of ​​the annular band portion proximate the upper band portion than in other areas of the annular band portion.

15. A patient interface according to claim 14, wherein: The rigidified portion is wider proximate the upper band portion than in other areas of the annular band portion.

16. A patient interface as claimed in any preceding claim, wherein: The cuff portion includes at least one vent portion constructed and / or arranged to provide increased breathability through the cuff portion at the vent portion.

17. A patient interface according to claim 16, wherein: The ventilation portion includes a knitted fabric having a point-and-point mesh knit structure.

18. A patient interface according to claim 16 or 17, wherein: The vent portion is less stretchable than other portions of the cuff portion.

19. A patient interface as claimed in any one of claims 16 to 18, wherein: The rigidified portion surrounds the vent portion.

20. A patient interface as claimed in any one of claims 16 to 19, wherein The annular belt portion includes a pair of upper ventilation portions, each of which is disposed adjacent to a corresponding upper belt portion.

21. A patient interface according to claim 20, wherein The rigidified portion surrounds each of the upper vent portions.

22. A patient interface according to claim 21, wherein The rigidified portion comprises a higher material thickness on a rear side of each of the upper vent portions than on a front side of each of the upper vent portions.

23. A patient interface as claimed in any preceding claim, wherein: The positioning and stabilising structure comprises a pair of lower strap portions, each lower strap portion being configured, in use, to be connected between the annular strap portion and the cushion assembly on a respective side of the patient's head above and below the nasion.

24. A patient interface as claimed in claim 23, wherein: The annular belt portion includes a lower ventilation portion disposed between the pair of lower belt portions.

25. A patient interface as claimed in claim 24, wherein: The lower vent portion includes a lower edge spaced apart from a lower edge of the annulus portion.

26. A patient interface as claimed in claim 25, wherein: The lower edge of the lower vent portion includes a greater curvature than the lower edge of the cuff portion to produce a maximum separation between the lower edge of the lower vent portion and the lower edge of the cuff portion at or near the sagittal plane of the patient's head in use.

27. A patient interface as claimed in any one of claims 23 to 26, wherein: The lower belt portion is stretchable.

28. A patient interface as claimed in any preceding claim, wherein: The loop portion includes a knitted fabric structure.

29. A patient interface as claimed in claim 28, wherein The loop portion is formed by plain knitting.

30. A patient interface as claimed in claim 28 or 29, wherein The loop portion comprises a single jersey knit construction.

31. A patient interface as claimed in claim 28 or 29, wherein The loop portion includes a double knit loop-forming knit structure.

32. A patient interface as claimed in any one of claims 28 to 31, wherein The rigidified portion includes a point knit structure.

33. A patient interface as claimed in any preceding claim, wherein: The upper portion of the annular strap portion includes a pair of top strap portions that are adjustably connected to each other near a sagittal plane of the patient's head.

34. A patient interface as claimed in claim 33, wherein: The top strap portion is adjustably connected by a buckle.

35. A patient interface as claimed in claim 33 or 34, wherein: The top strap portions include hook and loop fastening material to allow each of the top strap portions to be passed through a portion of the buckle and secured back onto itself.

36. A patient interface as claimed in any preceding claim, wherein: The positioning and stabilizing structure includes a frame connected to the plenum chamber, and the upper belt portion is configured to be connected to the frame.

37. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured, in use, to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during the patient's breathing cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber comprising a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap constructed and arranged such that, in use, at least a portion of the strap overlies an area of ​​the patient's head above the nasion of the patient's head; as well as a vent structure that permits continuous flow of gas exhaled by a patient from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to allow the patient to breathe from the ambient environment through the patient's mouth without a flow of pressurized air through the plenum inlet port, or the patient interface is configured to leave the patient's mouth uncovered; wherein the positioning and stabilizing structure comprises at least one strap configured to be connected to the cushion assembly, the strap being formed of a knitted fabric and including a fastening portion adjacent one end of the strap, the fastening portion being constructed and / or arranged to allow the strap to be looped back and fastened to itself for connection to the cushion assembly; as well as The strap includes at least one blind guide formed from the knitted fabric and configured to provide a tactile indication of the position of the fastening portion on the strap.

38. A patient interface as claimed in claim 37, wherein: The belt is formed from a plain knit.

39. A patient interface as claimed in claim 37 or 38, wherein The belt includes a non-patient contacting surface, and the at least one blind guide includes a raised portion that is raised relative to the non-patient contacting surface and / or a recessed portion that is recessed relative to the non-patient contacting surface.

40. A patient interface as claimed in claim 39, wherein: The raised portion and / or the recessed portion surround at least a portion of the fastening portion of the strap.

41. A patient interface as claimed in claim 39 or 40, wherein: The raised portion comprises an elongated raised profile on a non-patient contacting surface of the strap.

42. A patient interface as claimed in claim 41, wherein The elongated raised profile is provided at one or more edges of the fastening portion.

43. A patient interface as claimed in claim 42, wherein: The elongate raised profiles are provided at edges of the fastening portion, which in use are the upper edge, the rear edge and the lower edge.

44. A patient interface as claimed in any one of claims 39 to 43, wherein The elongated convex profile includes a rounded convex surface.

45. A patient interface as claimed in any one of claims 39 to 44, wherein The raised portions are formed by an increased thickness of the strip compared to adjacent areas of the strip, and the recessed portions are formed by a reduced thickness of the strip compared to adjacent areas of the strip.

46. ​​A patient interface as claimed in any one of claims 37 to 45, wherein The fastening portion of the strap includes hook and loop fastening material.

47. A patient interface as described in claim 46, wherein the fastening portion includes an end portion and a middle portion, the end portion includes one of a hook material and a loop material provided to the non-patient contact surface, and the middle portion includes the other of a hook material and a loop material provided to the non-patient contact surface.

48. A patient interface as claimed in claim 47, wherein The middle portion is longer than the end portions.

49. A patient interface as claimed in any one of claims 37 to 48, said strap and said blind guide being integrally formed.

50. A patient interface as claimed in any one of claims 37 to 49, wherein The belt and the blind guide are formed in a single knitting process.

51. A patient interface as claimed in any one of claims 37 to 50, wherein The guide piece comprises a dotted knitted structure.

52. A patient interface as claimed in any one of claims 37 to 51 wherein the strap comprises a single jersey knit construction.

53. A patient interface as claimed in any one of claims 37 to 52, wherein: The strap is connected to the cushion assembly via the frame of the patient interface.

54. A patient interface as claimed in any one of claims 37 to 53, wherein the strap comprises: a cuff portion having an upper portion configured to rest against the patient's head above the parietal bone in use and a lower portion configured to rest against the patient's head above or below the occipital bone in use; as well as A pair of upper strap portions are each configured to be connected between the hoop strap portion and the cushion assembly on a respective side of the patient's head above the nasion in use.

55. A patient interface as claimed in claim 54, wherein The strap includes a pair of lower strap portions, each lower strap portion being configured, in use, to be connected between the hoop strap portion and the cushion assembly on a respective side of the patient's head above and below the nasion.

56. A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the fabric membrane having apertures formed therein such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the cavity throughout a breathing cycle of the patient; a positioning and stabilising structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure being constructed and arranged such that, in use, at least a portion of the positioning and stabilising structure overlies an area of ​​the patient's head above the nasion of the patient's head, wherein the positioning and stabilizing structure comprises a one-piece knitted headband formed from a single piece of material, the knitted headband comprising: at least one first region having a first knit structure; at least one second region having a second mesh knit structure, the second mesh knit structure forming at least one ventilation region having increased flexibility compared to the first region; and At least one third region has a rigidified knit structure directly adjacent to the at least one ventilation region, the rigidified knit structure having increased rigidity compared to the first knit structure and the second mesh knit structure.

57. A patient interface as claimed in claim 56, wherein The rigidified knit structure surrounds at least the ventilation area.

58. A patient interface as claimed in any one of claims 56 and 57, wherein The rigidified knitted structure is a point knitted structure.

59. A patient interface as claimed in claim 58, wherein The dot pattern structure is a dot pattern rib structure.

60. A patient interface as claimed in any one of claims 56 to 58, wherein The second mesh knitted structure is a point knitted structure.

61. A patient interface as claimed in any one of claims 56 to 60, wherein The ventilation area has increased air permeability compared to the at least first area and the at least third area.

62. A patient interface as claimed in any one of claims 56 to 61, wherein The knitted headband includes a loop portion having an upper portion configured to cover the parietal bone of the patient's head in use, and having a lower portion configured to cover the occipital bone or located below the occipital bone of the patient's head in use, the loop portion defining a loop.

63. A patient interface as claimed in claim 62, wherein The loop portion has an inner edge and an outer edge, and the rigidified knit structure extends along the inner edge of the loop portion.

64. A patient interface as claimed in claim 63, wherein the rigidified knitted structure forms a loop extending along the entire inner edge of the loop portion.

65. A patient interface as claimed in any one of claims 62 to 64, wherein The annulus portion includes the at least one ventilation area.

66. A patient interface as claimed in any one of claims 56 to 65, wherein The knitted headband further comprises a neckband portion configured to cover the occiput of the patient's head and / or lie against the patient's neck in use, and the neckband portion comprises the at least one ventilation area.

67. A patient interface as claimed in any one of claims 56 to 66, wherein The first knitting structure is a plain knitting structure.

68. A treatment system for treating sleep-disordered breathing, comprising: A patient interface as claimed in any one of claims 56 to 67; Respiratory pressure therapy (RPT) devices for supplying breathable gas at a positive pressure; and An air delivery tube communicates the breathable gas from the RPT device to the patient interface.

69. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to a patient's airway entrance while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cm H2O to about 30 cm H2O above ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the fabric membrane having apertures formed therein such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the cavity throughout a breathing cycle of the patient; a positioning and stabilising structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure being constructed and arranged such that, in use, at least a portion of the positioning and stabilising structure overlies an area of ​​the patient's head above the nasion of the patient's head, wherein the positioning and stabilizing structure comprises a one-piece knitted headband formed from a single piece of material, the knitted headband comprising: a first region having a first knit structure; and a second area having a second point knit structure, the second point knit structure having increased stiffness compared to the first knit structure, The second point knit structure extends along a first edge of the knitted headband and is directly adjacent to the first knit structure.

70. A patient interface as claimed in claim 69, wherein The first knit structure extends along a second edge of the knitted headband.

71. A patient interface as claimed in any one of claims 69 and 70, wherein The knitted headband includes a loop portion having an upper portion configured to cover the parietal bone of the patient's head in use, and having a lower portion configured to cover the occipital bone or located below the occipital bone of the patient's head in use, the loop portion defining a loop.

72. A patient interface as claimed in claim 71, wherein The loop portion has an inner edge and an outer edge, and the first edge of the knitted headband forms the inner edge of the loop portion.

73. A patient interface as claimed in claim 72, wherein The first knit structure extends along a second edge of the knitted headband, and the second edge of the knitted headband forms an outer edge of the loop portion.

74. A patient interface as claimed in any one of claims 69 to 73, wherein The first knit structure has increased stretchability compared to the second point knit structure.

75. A patient interface as claimed in any one of claims 69 to 74, wherein The knitted headband also includes a third region having a third mesh knit structure that is less rigid than the first knit structure and the second pique knit structure.

76. A patient interface as claimed in claim 75, wherein The third mesh knitting structure is a point knitting structure.

77. A patient interface as claimed in any one of claims 75 and 76, wherein The second point knit structure extends directly adjacent to the third mesh knit structure.

78. A patient interface as claimed in any one of claims 75 to 77, wherein The third mesh knit structure forms a ventilation area having increased air permeability compared to the first area and the second area, and the second point knit structure surrounds the ventilation area.

79. A patient interface as claimed in any one of claims 69 to 78, wherein The first knitted structure is a plain knitted structure.

80. A treatment system for treating sleep-disordered breathing, comprising: A patient interface as claimed in any one of claims 69 to 79; Respiratory pressure therapy (RPT) devices for supplying breathable gas at a positive pressure; and An air delivery tube communicates the breathable gas from the RPT device to the patient interface.

81. A method of forming a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure configured to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for treating sleep-disordered breathing, the method comprising: The single-piece headband is knitted directly into its final shape as a single piece of material, consisting of: knitting at least a first region of the headband having a first knit structure; knitting at least a second region of the headband having a second mesh knit structure, the second mesh knit structure forming at least one ventilation region of the headband having increased flexibility compared to the first region; and knitting at least one third region of the headband, the at least one third region having a rigidized knit structure directly adjacent to the at least one ventilation region, the rigidized knit structure having increased rigidity compared to the first knit structure and the second mesh knit structure, Wherein, the headgear includes a plurality of strap portions configured to be connected to a cushion assembly to maintain the seal-forming structure in a therapeutically effective position on the patient's head during use.

82. The method of claim 81, wherein The step of knitting the one-piece headband includes a single flat knitting process.

83. The method of any one of claims 81 and 82, wherein The rigidified knit structure surrounds the at least one ventilation zone.

84. The method of any one of claims 81 to 83, wherein The rigidified knitted structure is a point knitted structure.

85. The method of any one of claims 81 to 84, wherein The second mesh knitted structure is a point knitted structure.

86. The method of any one of claims 81 to 85, wherein The ventilation area has increased air permeability compared to the at least one first area and the at least one third area.

87. The method of any one of claims 81 to 86, wherein The knitted headband includes a loop portion having an upper portion configured to cover the parietal bone of the patient's head in use and a lower portion configured to cover or be located below the occipital bone of the patient's head in use, the loop portion defining a loop.

88. The method of claim 87, wherein the loop portion has an inner edge and an outer edge, and the rigidized knit structure extends along the inner edge of the loop portion.

89. The method of claim 88, wherein The rigidified knit structure forms a loop extending along the entire inner edge of the loop portion.

90. The method of any one of claims 81 to 89, wherein The first knitting structure is a plain knitting structure.

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