Positioning and stabilization structure for a patient interface

Abstract

A patient interface includes a positioning and stabilization structure having a headband, the headband including an annular portion having an upper part configured to cover an upper portion of the parietal bone of a patient's head in use and a lower part configured to cover or be located below the occipital bone of the patient's head in use. The annular portion defines a loop having paired upper strap portions configured to connect between the annular portion and a cushion assembly on respective sides of the patient's head above the bridge of the nose in use. The headband may include a stiffening portion. The headband may be integrally formed by flat knitting, and the strap portion may include a guide to provide a tactile indication of the position of a fastening portion.

Description

[0001] Cross - reference to related applications

[0002] This application claims the priority of Australian Provisional Application No. 2019900507, filed on February 18, 2019, the entire content of which is incorporated herein by reference. 2 Background Art 2.1 Technical Field

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

[0006] 2.2 Description of Related Art

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the airway entrance of the patient.

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

[0010] There is a series of respiratory disorders. Some conditions can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

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

[0012] A series of treatments have been used to treat or improve such conditions. In addition, other healthy individuals can utilize such treatments to prevent the occurrence of respiratory disorders. However, these treatments have many drawbacks.

[0013] 2.2.2 Treatments

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

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

[0016] 2.2.3 Treatment systems

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

[0018] A treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a 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 connect a respiratory device to its wearer, such as by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with, for example, an area of the patient's face, thus facilitating the delivery of gas at a pressure with a sufficient difference 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 about 10 cm H2O to the airway.

[0022] Some other mask systems may not be functionally applicable in the art. For example, a purely decorative mask may not be able to maintain an appropriate pressure. A mask system for underwater swimming or diving can be configured to prevent water from a higher external pressure from entering, but does not maintain the internal air at a pressure higher than the ambient pressure.

[0023] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block the air flow through the nose and only allow it to pass through the mouth.

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

[0025] Certain face masks may not be feasible for use during sleep, such as when sleeping in a lateral position in bed with the head on a pillow.

[0026] The design of the patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among different individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible or jawbone can move relative to the other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0027] Due to these challenges, some face masks face one or more of the following problems: obtrusive, unaesthetic, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long period of time or when the patient is not familiar with the system. A face mask of the wrong size may result in reduced compliance, reduced comfort, and poor patient outcomes. Face masks designed only for pilots, face masks designed to be part of personal protective equipment (such as filter masks), SCUBA masks, or face masks designed to administer anesthetic agents are acceptable for their original applications, but are not as comfortable as desired for long-term (e.g., several hours) wear. This discomfort may lead to reduced patient compliance with the treatment. This is especially true if the face mask is worn during sleep.

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

[0029] While face masks for other applications (such as pilots) may not be suitable for treating sleep apnea, face masks designed for treating sleep apnea may be suitable for other applications.

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

[0031] 2.2.3.1.1 Seal-forming structure

[0032] The patient interface may include a seal-forming structure. Due to its direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

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

[0034] A seal-forming structure that is effective in one area of the patient's face may not be suitable in another area, for example because of differences in the shape, structure, variability, and sensitive areas of the patient's face. For example, a seal on a swimming goggle 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 production such that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be adapted to form a seal.

[0036] One type of seal-forming structure extends around the perimeter 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 face-to-face engagement with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or formed surface of a resilient seal element made of an elastomer such as rubber. For this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

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

[0038] Another type of seal-forming structure may include friction fit elements, for example for insertion into the nostrils, however some patients find these uncomfortable.

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

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

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

[0042] ResMed Limited has manufactured the following products incorporating nasal pillows: SWIFT TM Nasal Pillow Mask, SWIFT TM II Nasal Pillow Mask, SWIFT TM LT Nasal Pillow Mask, SWIFT TM FX Nasal Pillow Mask and 0043MIRAGE LIBERTY TM Full Face Mask. The following patent applications assigned to ResMed describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (which describes other aspects of ResMed's SWIFT TM Nasal Pillow), U.S. Patent Application 2009 / 0044808 (which describes other aspects of ResMed's SWIFT TM LT Nasal Pillow); International Patent Applications WO2005 / 063,328 and WO 2006 / 130,903 (which describe aspects of ResMed's MIRAGE LIBERTY TM Full Face Mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of ResMed's SWIFT TM FX Nasal Pillow).

[0043] 2.2.3.1.2 Positioning and stabilization

[0044] The seal-forming structure of a patient interface for positive pressure therapy is subject to a corresponding force of the air pressure that is to break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain its sealing relationship with the appropriate portion of the face.

[0045] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

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

[0047] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

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

[0049] 2.2.3.3 Humidifier

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

[0051] 2.2.3.4 Data Management

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

[0053] There are other aspects of patient treatment that can benefit from communication of treatment data with a third party or an external system.

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

[0055] 2.2.3.5 Mandibular Repositioning

[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 dentists or other suppliers that holds the mandible (lower jawbone) in a forward position during sleep. The MRD is a removable device that patients insert into their mouths before going to sleep and remove after waking up. Thus, the MRD is not designed to be worn continuously. The MRD can be custom-made or produced in a standard form and includes an impression part designed to fit the patient's teeth. This mechanical protrusion of the mandible enlarges the space behind the tongue, applying tension to the pharyngeal wall to reduce airway collapse and reduce palatal vibration.

[0057] In some embodiments, the mandibular advancement device may include an upper splint configured to engage or mate with teeth on the maxilla or upper jawbone and a lower splint configured to engage or mate with teeth on the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of linkages are symmetrically fixed to the upper and lower splints.

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

[0059] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs, such as the Resmed Narval CCTM 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). Thus, it is configured to minimize or prevent any movement of one or more teeth.

[0060] 2.2.3.6 Vent Port Technology

[0061] Some forms of treatment systems may include a vent port to allow the removal of exhaled carbon dioxide. The vent port may allow gas to flow from the internal space of the patient interface (such as an inflation chamber) to the external space of the patient interface, such as to the environment.

[0062] 2.2.4 Screening, Diagnostic, and Monitoring Systems

[0063] A polysomnogram (PSG) is a conventional system used for diagnosing and monitoring cardiorespiratory diseases, and typically involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on a patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. The 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 the clinician to titrate 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 are generally described as identifying a disorder from its signs and symptoms. Screening usually gives a true / false result, indicating whether the patient's SDB is severe enough to warrant further study, while diagnosis can yield clinically actionable information. Screening and diagnosis are often one-time processes, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0065] Clinical experts may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinical experts may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply different criteria at different times. 3 Summary of the Invention

[0067] The present technology relates to providing a medical device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, having one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0068] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0069] Another aspect of the present technology relates to a method for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0070] One aspect of certain forms of the present technology is a method and / or device for providing improved patient compliance with respiratory therapy.

[0071] One form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including an integrally formed band formed by flat knitting. The band can be connected to the frame or inflatable chamber of the patient interface through four connection points.

[0072] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including an integrally formed knitted band that includes a plurality of knitted structures, each knitted structure including different mechanical properties. The band may be formed by plain knitting.

[0073] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including an integrally formed knitted band that includes at least a first portion and a second portion, the first portion having a different elasticity from the second portion. The first portion may include a circumferential band portion configured to abut a posterior surface and a superior surface of a patient's head. The second portion may include a superior band portion configured to be positioned beside a patient's face in use and connected between the circumferential band portion and an inflatable chamber of the patient interface. The band may be formed by plain knitting.

[0074] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including an integrally formed knitted band having a plurality of vent portions that form regions of increased breathability. The vent portions may include a first knitted structure and other portions of the band may include a second knitted structure different from the first knitted structure. The vent portions may be formed as a dotted mesh knitted structure while other portions of the band may be formed as a single jersey or double jersey knitted structure. The band may be formed by plain knitting.

[0075] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including a band that includes a circumferential band portion configured to rest on a posterior surface and a superior surface of a patient's head and defining a loop having an inner perimeter, the circumferential band portion including a stiffening portion located at or near the inner perimeter of the loop. The stiffening portion may include a first knitted structure and other portions of the circumferential band portion may include a second knitted structure. The stiffening portion may include a dotted knitted structure while other portions of the band may include a single jersey or double jersey knitted structure. The band may be formed by plain knitting.

[0076] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including a band that includes a fastening portion configured to loop back and secure to itself to secure the band to a frame or an inflatable chamber of the patient interface, the band including a blind guide configured to provide a tactile indication of the position of the fastening portion of the band. The band may be integrally formed with a louvre guide. The band may be formed by plain knitting.

[0077] Another form of the present technology includes a patient interface for sealingly delivering an airflow to an inlet of a patient airway at a continuous positive pressure relative to the ambient air pressure, the patient airway including at least an inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure throughout the patient's respiratory cycle during patient sleep to improve sleep disordered breathing. The patient interface includes: 1) an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow for patient breathing at the therapeutic pressure; a seal-forming structure configured and arranged to form a seal with an area of the patient's face surrounding the inlet of the patient airway, the seal-forming structure having apertures such that the airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; 3) a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that in use, at least a portion of the strap covers an area of the patient's head above the bridge of the nose of the patient's head; and 4) a ventilation structure that allows exhaled gas from the patient to continuously flow from the interior of the inflatable chamber to the surrounding environment, the ventilation structure sized and shaped to maintain the 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 without a pressurized airflow passing through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0078] In an embodiment: a) the positioning and stabilizing structure may include: 1) an annular band 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 or a lower portion located below the occipital bone in use, the annular band portion defining a loop; and 2) a pair of upper strap portions, each upper strap portion configured to connect between the annular band portion and the cushion assembly on a corresponding side of the patient's head above the bridge of the nose in use; b) the annular band portion includes a stiffening portion disposed along the length of the loop defined by the annular band portion.

[0079] In other instances: a) the stiffening portion is provided substantially along the entire length of the loop defined by the annulus portion; b) the stiffening portion is provided to the annulus portion near the inner perimeter of the annulus portion; c) the stiffening portion defines at least a portion of the inner perimeter of the annulus portion; d) the stiffening portion substantially forms the entire inner perimeter of the annulus portion; e) the stiffening portion is disposed substantially centrally between the inner perimeter and the outer perimeter of the annulus portion; f) the upper band portion is stretchable; g) the stiffening portion is substantially non-stretchable; h) the annulus portion includes a rounded edge; i) the stiffening portion includes an increased material thickness relative to adjacent portions of the annulus portion; j) the patient contact side of the annulus portion is substantially flat, and the increased material thickness is provided to the non-patient contact side of the annulus portion; k) the annulus portion includes a thickness of 4 mm in the stiffening portion; l) the annulus portion includes a thickness of 2.5 mm in regions of the annulus portion other than the stiffening portion; m) the stiffening portion is greater in the region of the annulus portion near the upper band portion than in other regions of the annulus portion; and / or n) the stiffening portion is wider near the upper band portion than in other regions of the annular band portion.

[0080] In other examples: a) the annulus portion includes at least one ventilation portion configured and / or arranged to provide increased breathability through the annulus portion at the ventilation portion; b) the ventilation portion includes a knitted fabric having a dimpled mesh knitted structure; c) the ventilation portion is less stretchable than other portions of the annulus portion; d) the stiffening portion surrounds the ventilation portion; e) the annular band portion includes a pair of upper ventilation portions, each upper ventilation portion being disposed near a corresponding upper band portion; f) the stiffening portion surrounds each of the upper ventilation portions; g) the stiffening portion includes a greater material thickness on the rear side of each upper ventilation portion than on the front side of each upper ventilation portion; h) the positioning and stabilizing structure includes a pair of lower band portions, each lower band portion being configured to connect between the annulus portion and the cushion assembly on a respective side of the patient's head above and below the bridge of the nose in use; i) the annular band portion includes a lower ventilation portion disposed between the pair of lower band portions; j) the lower ventilation portion includes a lower edge spaced from the lower edge of the annulus portion; k) the lower edge of the lower ventilation portion includes a greater curvature than the lower edge of the annulus portion to create a maximum spacing between the lower edge of the lower ventilation portion and the lower edge of the annulus portion at or near the sagittal plane of the patient's head in use; l) the lower band portions are stretchable; m) the annulus portion includes a knitted fabric structure; n) the annular band portion is formed by plain knitting; o) the annulus portion includes a single-sided knitted structure; P) the annulus portion includes a double-sided knitted loop-forming knitted structure; q) the stiffening portion includes a dimpled knitted structure; r) the upper portion of the annulus portion includes a pair of top band portions adjustably connected to each other near the sagittal plane of the patient's head; the top band portions are adjustably connected to a buckle; t) the top band portions include hook-and-loop fastening material to allow each top band 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 band portion being configured to connect to the frame; and / or v) the positioning and stabilizing structure further includes a lower band portion configured to connect to the frame.

[0081] Another form of the present technology includes a patient interface for sealingly delivering an air stream at a continuous positive pressure relative to the ambient air pressure to an inlet of a patient airway, the patient airway including at least an inlet of a patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure during the patient's entire respiratory cycle while the patient is sleeping in use to improve sleep disordered breathing. The patient interface includes: 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 inflatable chamber inlet port sized and configured to receive an air stream for the patient's breathing at the therapeutic pressure; a seal-forming structure configured and arranged to form a seal with an area of the patient's face surrounding the inlet of the patient airway, the seal-forming structure having an aperture such that the air stream at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the inflatable chamber during the patient's entire respiratory cycle in use; 3) a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that at least a portion of the strap covers an area of the patient's head above the bridge of the patient's nose in use; and 4) a ventilation structure that allows exhaled gas from the patient to continuously flow from the interior of the inflatable chamber to the surrounding environment, the ventilation structure sized and shaped to maintain the therapeutic pressure in the inflatable chamber in use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized air stream passing through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0082] In an embodiment: a) the positioning and stabilizing structure includes at least one strap configured to be attached to the gasket assembly, the strap formed of a knitted fabric and including a fastening portion adjacent an end of the strap, the fastening portion configured and / or arranged to allow the strap to be looped back and fastened to itself for attachment to the gasket assembly; b) the strap includes at least one guide formed of a knitted fabric configured to provide a tactile indication of the position of the fastening portion on the strap.

[0083] In other instances: a) the strap is formed by plain knitting; b) the strap includes a non-patient contact surface, and the at least one louver guide includes a raised portion raised relative to the non-patient contact surface and / or a recessed portion recessed relative to the non-patient contact surface; c) the raised portion and / or the recessed portion surrounds at least a portion of the fastening portion of the strap; d) the raised portion includes an elongated raised profile on the non-patient contact 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 that is an upper edge, a rear edge, and a lower edge in use; g) the elongated raised profile includes a rounded raised surface; h) the raised portion is formed by an increased thickness of the strap compared to an adjacent region of the strap, and the recessed portion is formed by a decreased thickness of the strap compared to an adjacent region of the strap; i) the fastening portion of the strap includes hook-and-loop fastening material; j) the fastening portion includes an end and a middle portion, the end portion includes one of hook material and loop material provided to the non-patient contact surface, and the middle portion includes the other of hook material and loop material provided to the non-patient contact surface; k) the middle portion is longer than the end portion. The middle portion can be several times longer than the end portion; l) the strap and the louver guide are formed in a single knitting process; m) the louver guide includes a dotted knitting structure; n) the strap includes a single-sided knitting structure; o) the strap includes a double-sided knitting coil structure; p) the strap is connected to the cushion assembly via a frame of the patient interface; q) the strap includes: an annular strap portion having an upper portion and a lower portion, the upper portion being configured to abut against the patient's head above the parietal bone of the patient's head in use, and the lower portion being configured to abut against the patient's head above or below the occipital bone of the patient's head in use; and a pair of upper strap portions, each upper strap portion being configured to connect 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 includes a pair of lower strap portions, each lower strap portion being configured to connect between the annular strap portion and the cushion assembly on a corresponding side of the patient's head below the nasion in use; and / or the strap(s) and the louver guide(s) are integrally formed.

[0084] Another aspect of the present technology relates to a patient interface for sealingly delivering an air stream to an inlet of a patient's airway at a continuous positive pressure relative to ambient air pressure, the patient's airway including at least an inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of from about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during patient sleep to improve sleep disordered breathing; the patient interface comprising: 1) an inflatable chamber that at least partially forms a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air stream at the therapeutic pressure for patient breathing; 2) a seal-forming structure having a fabric membrane configured and arranged to form a pressure-assisted seal with a region of the patient's face surrounding the inlet of the patient's airway below the bridge of the patient's nose, the fabric membrane having holes formed therein such that an air stream at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle during use; and 3) a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure configured and arranged such that in use at least a portion of the positioning and stabilizing structure covers a region of the patient's head above the root of the patient's nose.

[0085] In an embodiment: a) the positioning and stabilizing structure includes a one-piece knitted headband of one-piece material; b) the knitted headband includes at least one first region having a first knitted structure; c) the knitted headband includes at least one second region having a second reticulated knitted structure that forms at least one ventilation region having increased flexibility compared to the first region; and d) the knitted headband includes at least one third region having a rigidified knitted structure directly adjacent the at least one ventilation region, the rigidified knitted structure having increased rigidity compared to the first knitted structure and the second reticulated knitted structure.

[0086] In other examples: a) the rigidified knitted structure surrounds the at least one ventilation region; b) the rigidified knitted structure is a piqué knitted structure; c) the piqué structure is a piqué stripe structure; d) the second reticulated knitted structure is a piqué reticulated knitted structure; e) the ventilation region has increased breathability compared to the at least one first region and the at least one third region.

[0087] In other examples: a) the knitted headband includes an annular band 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 the patient's head or be located below the occipital bone in use, the annular band portion defining a loop; b) the annular band portion has an inner edge and an outer edge, and the rigidified knitted structure extends along the inner edge of the annular band portion; c) the rigidified knitted structure forms a loop extending along the entire inner edge of the annular band portion; d) the annular band portion includes the at least one ventilation area; e) the knitted headband further includes a neckband portion configured to cover the occipital bone of the patient's head and / or rest on the patient's neck in use, and the neckband portion includes the at least one ventilation area; the first knitted structure is a plain knitted fabric structure.

[0088] Another aspect of the present technology relates to a patient interface for delivering a stream of air in a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the patient's airway including at least an inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout a patient's respiratory cycle while the patient is sleeping in use to improve sleep disordered breathing; the patient interface includes: 1) an inflatable chamber that at least partially forms a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive a stream of air at the therapeutic pressure for the patient to breathe; 2) a seal-forming structure having a fabric membrane configured and arranged to form a pressure-assisted seal with an area of the patient's face surrounding the inlet of the patient's airway below the nasal bridge area of the patient's face, the fabric membrane having holes formed therein such that a stream of air at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle in use; and 3) a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure configured and arranged such that at least a portion of the positioning and stabilizing structure covers an area of the patient's head above the nasion of the patient's head in use.

[0089] In an embodiment: a) the positioning and stabilizing structure includes a one-piece knitted headband of one-piece material; b) the knitted headband includes a first region having a first knitted structure; c) the knitted headband includes a second region having a second point-knit that has increased rigidity compared to the first knit; d) the second point-knit extends along a first edge of the knitted headband and is directly adjacent to the first knit.

[0090] In other examples: a) The first knitted structure extends along a second edge of the knitted headband; b) The knitted headband includes an annular band 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 or be located below the occipital bone of the patient's head in use, the annular band portion defining a loop; c) The annular band portion has an inner edge and an outer edge, and the first edge of the knitted headband forms the inner edge of the annular band portion; d) The first knitted structure extends along the second edge of the knitted headband, and the second edge of the knitted headband forms the outer edge of the annular band portion.

[0091] In other examples: a) The first knitted structure has increased stretchability compared to a second ribbed knitted structure; b) The knitted headband further includes a third region having a third reticulated knitted structure that is less rigid than the first knitted structure and the second ribbed knitted structure; c) The third reticulated knitted structure is a ribbed reticulated knitted structure; d) The second ribbed knitted structure extends directly adjacent to the third grid knitted structure; e) The third reticulated knitted structure forms a ventilation area having increased breathability compared to the first area and the second area, and the second ribbed knitted structure surrounds the ventilation area; The first knitted structure is a plain knitted fabric structure.

[0092] Another aspect of the present technology relates to a method of forming a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure being configured to provide a force to hold a seal-forming structure in a therapeutically effective position on a 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.

[0093] In other examples: a) The step of knitting the single-piece headband includes knitting at least one first region of the headband having a first knitted structure; b) The step of knitting the single-piece headband includes knitting at least one second region of the headband having a second reticulated knitted structure that forms at least one ventilation area of the headband having increased flexibility compared to the first region; c) The step of knitting the single-piece headband includes knitting at least one third region of the headband having a rigidified knitted structure directly adjacent to the at least one ventilation area, the rigidified knitted structure having increased rigidity compared to the first knitted structure and the second reticulated knitted structure; d) The cap headband includes a plurality of band portions configured to be connected to a cushion assembly to hold the seal-forming structure in a therapeutically effective position on a patient's head in use.

[0094] In other instances: a) the steps of knitting a single-piece headband include a single plain knitting process; b) the rigidified knitted structure surrounds the at least one ventilation area; c) the rigidified knitted structure is a dotted knitted structure; d) the second reticulated knitted structure is a dotted reticulated knitted 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 an annular band 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 the patient's head or a portion below the occipital bone in use, the annular band portion defining a loop; g) the annular band portion has an inner edge and an outer edge, and the rigidified knitted structure extends along the inner edge of the annular band portion; h) the rigidified knitted structure forms a loop extending along the entire inner edge of the annular band portion; i) the first knitted structure is a plain knitted fabric structure.

[0095] Another form of the present technology includes a patient interface that includes: 1) an inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an air flow at the treatment pressure for a patient to breathe; a seal-forming structure configured and arranged to form a seal with an area of the patient's face surrounding the inlet of the patient's airway, the seal-forming structure having holes such that the air flow at the treatment pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle in use; 3) a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie configured and arranged such that in use, at least a portion of the tie covers an area on the patient's head above the nasion of the patient's head; and 4) a ventilation structure that allows the patient's exhaled gas to continuously flow from the interior of the inflatable chamber to the surrounding environment, the ventilation structure sized and shaped to maintain the treatment pressure in the inflatable chamber in use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized air flow passing through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0096] 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 top of a patient's head and for delivering the air flow to an inlet 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, the at least one area being above the top of the patient's head; and 2) A band integrally formed by flat knitting.

[0097] In other examples: a) The headband includes: 1) A neckband portion configured to cover the occipital bone of the patient's head and / or rest on the patient's neck in 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.

[0098] In other examples: a) The single flat knitting process forms the band; b) The band includes a rigidified portion; c) The rigidified portion includes a pique knitting structure; d) The neckband portion includes a rigidified 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 band includes a ventilation portion configured and / or arranged to provide increased breathability through the band at the ventilation portion; j) The ventilation portion is located in the neckband portion; k) The ventilation portion includes a knitted fabric having a pique mesh knitting structure; l) The ventilation portion is less stretchable than other portions of the band; and / or m) The rigidified portion surrounds the ventilation portion.

[0099] In other examples: a) The band includes a fastening portion adjacent an end of the band, the fastening portion being configured and / or arranged to allow the band to be looped back and fastened to itself for connection to the inflatable chamber, the band including at least one blind guide formed from the knitted fabric forming the integrally formed band and configured to provide a tactile indication of the position of the fastening portion on the band; b) The band includes a non-patient contact surface, and the at least one louver guide includes a raised portion that is raised relative to the non-patient contact surface; c) The raised portion includes an elongated raised profile on the non-patient contact surface of the band; d) The fastening portion of the band includes hook-and-loop fastening material; and / or e) Each of the upper band portion and the lower band portion includes a respective blind guide.

[0100] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape complementary to the peripheral shape of an intended wearer.

[0101] One aspect of one form of the present technology is a method of manufacturing a device.

[0102] One aspect of certain forms of the present technology is an easy-to-use medical device, for example, used by a person without medical training, a person with limited dexterity, vision, or limited experience in using this type of medical device.

[0103] One aspect of one form of the present technology is a portable RPT device that can be carried by a person, for example, used in the person's home.

[0104] One aspect of one form of the present technology is a patient interface that can be washed in a patient's home, for example, washed 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 in a patient's home, for example, washed in soapy water, without the need for specialized cleaning equipment.

[0105] Another aspect of the present technology relates to a treatment system for treating sleep apnea, comprising: 1) a patient interface according to any one 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.

[0106] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Additionally, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of automatically managing, monitoring, and / or treating respiratory conditions, including, for example, sleep disordered breathing.

[0107] Of course, portions of these aspects can form sub-aspects of the present technology. Additionally, various ones of the sub-aspects and / or aspects can be combined in various ways and also form additional aspects or sub-aspects of the present technology.

[0108] Other features of the present technology will be apparent in view of the information contained in the following detailed description, the abstract, the drawings, and the claims. 4 BRIEF DESCRIPTION OF THE DRAWINGS

[0110] 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 and include:

[0111] 4.1 Treatment System

[0112] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 in the manner of a nasal pillow receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0113] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000.

[0114] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in the manner of a full face mask receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000. The patient sleeps in a lateral sleeping position.

[0115] 4.2 Respiratory System and Facial Anatomy

[0116] Figure 2A A schematic diagram of the human respiratory system including the nasal cavity and the oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0117] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, major alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0118] Figure 2C A front view of a face with several identified surface anatomical features including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial groove, and oral commissure. The upper, lower, radially inward, and radially outward directions are also marked.

[0119] Figure 2D A side view of a head with several identified surface anatomical features including the glabella, nasion, nasal prominence, subnasale, upper lip, lower lip, supramental point, nasal ridge, alar apex, upper auricular basal point, and lower auricular basal point. The up-down and front-back directions are also marked.

[0120] Figure 2E A side view of the other side of the head. The approximate positions of the Frankfurt horizontal plane and the nasolabial angle are marked. The coronal plane is also marked.

[0121] Figure 2F A bottom view of a nose showing several features with identifiers, including the nasolabial fold, lower lip, vermilion of the upper lip, nostril, subnasal point, columella, nasion, long axis of the nostril, and the central sagittal plane.

[0122] Figure 2G A side view showing the surface features of the nose.

[0123] Figure 2H A view showing the subcutaneous structures of the nose, including the lateral cartilage, septal cartilage, major alar cartilage, minor alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0124] Figure 2I A medial anatomical view of the nose about several millimeters from the central sagittal plane, showing, among other things, the medial crura of the septal cartilage and the major alar cartilage.

[0125] Figure 2J A front view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal concha, as well as the maxilla and mandible, are also labeled.

[0126] Figure 2K A side view of the skull showing the surface contour of the head and several muscles. The following bony parts are shown: 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: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0127] Figure 2L A anterolateral view of the nose.

[0128] 4.3 Patient Interface

[0129] Figure 3A A patient interface in the form of a nasal mask according to one form of the present technology is shown.

[0130] Figure 3B A schematic view 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 positive sign and has a relatively large magnitude when compared to Figure 3C the magnitude of the curvature shown.

[0131] Figure 3C A schematic view 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 positive sign and has a relatively small magnitude when compared to Figure 3B the magnitude of the curvature shown.

[0132] 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 zero value.

[0133] Figure 3E A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and has a relatively small magnitude when compared with Figure 3F the magnitude of the curvature shown.

[0134] Figure 3F A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and has a relatively large magnitude when compared with Figure 3E the magnitude of the curvature shown.

[0135] Figure 3G A pad for a face mask including two pillows is shown. The outer surface of the pad is indicated. The edge of the surface is shown. The vault and saddle regions are shown.

[0136] Figure 3H A pad for a face mask is shown. The outer surface of the pad is indicated. The edge of the surface is shown. A path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and a vault region are indicated.

[0137] Figure 3I The surface of a structure having a one-dimensional hole on the surface is shown. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0138] Figure 3J A cross-section through a Figure 3I structure is shown. The surface shown defines a two-dimensional hole in the Figure 3I structure.

[0139] Figure 3K A perspective view of a Figure 3I structure including a two-dimensional hole and a one-dimensional hole is shown. Also shown is the surface that bounds the two-dimensional hole in the Figure 3I structure.

[0140] Figure 3L A face mask having an inflatable airbag as a pad is shown.

[0141] Figure 3M A cross-section through a Figure 3L face mask is shown and the inner surface of the airbag is shown. The inner surface defines the two-dimensional hole in the mask.

[0142] Figure 3N A cross-section through a Figure 3L face mask is shown. The inner surface is also marked.

[0143] Figure 3O Shows the left - hand rule.

[0144] Figure 3P Shows the right - hand rule.

[0145] Figure 3Q Shows the left ear, including the left ear helix.

[0146] Figure 3R Shows the right ear, including the right ear helix.

[0147] Figure 3S Shows the right - hand helix.

[0148] Figure 3T Shows a view of the face mask, including the sign of the twist of the space curve defined by the edge of the sealing film in different regions of the face mask.

[0149] Figure 3U Shows a view of the inflatable chamber 3200, showing the sagittal plane and the intermediate contact plane.

[0150] Figure 3V Shows Figure 3U a view of the rear part of the inflatable chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in bisects the inflatable chamber into a left side and a right side.

[0151] Figure 3W Shows a cross - section through the Figure 3V inflatable chamber, the cross - section being taken at the sagittal plane shown in Figure 3V The "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and touches the gasket of the inflatable chamber at exactly two points (upper point 3220 and lower point 3230) on the sagittal plane. Depending on the geometry of the gasket in this region, the intermediate contact plane can be the tangent at the upper and lower points.

[0152] Figure 3X Shows Figure 3U the position of the inflatable chamber 3200 of when used on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the median sagittal plane of the face. When the inflatable chamber is in the use position, the intermediate contact plane generally corresponds to the 'face plane'. In Figure 3X the inflatable chamber 3200 is the inflatable chamber of a nasal mask, and the upper point 3220 is located approximately on the root of the nose, and the lower point 3230 is located on the upper lip.

[0153] 4.4 RPT device

[0154] Figure 4AShows an RPT device according to one form of the present technology.

[0155] Figure 4B Is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined upstream of the patient interface, and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any given moment. Components within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0156] 4.5 Humidifier

[0157] Figure 5A Shows an isometric view of a humidifier according to one form of the present technology.

[0158] Figure 5B Shows an isometric view of a humidifier according to one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.

[0159] 4.6 Respiratory waveform

[0160] Figure 6 Shows a typical respiratory waveform model of a person during sleep.

[0161] 4.7 Specific examples of the present technology

[0162] Figure 7 Shows a perspective view of the positioning and stabilization structure 3300 according to an example of the present technology when worn by a patient 1000.

[0163] Figure 8 Shows Figure 7 A non-patient contact side view of the strap portion of the positioning and stabilization structure 3300 in a flat state.

[0164] Figure 9 Shows Figure 7 A patient contact side view of the strap portion of the positioning and stabilization structure 3300 in a flat state.

[0165] Figure 10 Shows Figure 7 A non-patient contact side view of a portion of the positioning and stabilization structure 3300, which is in a flat state and has the shown cross-section.

[0166] Figure 11 Shows Figure 7 An exploded view of the fastening portion of the strap of the positioning and stabilization structure 3300.

[0167] Figure 12 Shows Figure 7Patient contact side view of a part of the positioning and stabilizing structure 3300, the patient contact side view being in a flat state and having a cross-section shown.

[0168] Figure 13 A part of the positioning and stabilizing portion 3300 according to another example of the present technology is shown while being worn by the patient 1000.

[0169] Figure 14 Shown when the patient 1000 is wearing Figure 13 The upper ventilation portion of the positioning and stabilizing structure.

[0170] Figure 15 Shown when the patient 1000 is wearing Figure 13 The lower ventilation portion of the positioning and stabilizing structure.

[0171] Figure 16 A non-contact patient side view of the headband 3301 of the positioning and stabilizing structure according to another example of the present technology is shown.

[0172] Figure 17 A perspective view of the positioning and stabilizing structure 3300 according to another example of the present technology is shown. 5 DETAILED DESCRIPTION

[0174] 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 terms used in this disclosure are for the purpose of describing the specific examples described herein only and are not intended to be limiting.

[0175] The following description is provided with respect to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, in any of the examples, any single feature or combination of features may constitute another example.

[0176] 5.1 Treatment

[0177] In one form, the present technology includes a method for treating a respiratory disorder, the method including the step of applying positive pressure to the airway inlet of the patient 1000.

[0178] In certain examples of the present technology, an air supply under positive pressure is provided to the nasal passages of the patient via one or both nostrils.

[0179] In certain examples of the present technology, mouth breathing is restricted, constrained, or prevented.

[0180] 5.2 Treatment System

[0181] In one form, the present technology includes a device or apparatus for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0182] 5.3 Patient Interface

[0183] The non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilization structure 3300, a vent structure 3400, a connection port 3600 in one form for connection to the air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single entity component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0184] If the 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.

[0185] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0186] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0187] The patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 20 cm H2O relative to the environment.

[0188] 5.3.1 Seal-Forming Structure

[0189] 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 may occur. The area where actual sealing occurs - the actual sealing surface - can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including for example the position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face.

[0190] In one form, the target seal-forming area is located on the outer surface of the seal-forming structure 3100.

[0191] In certain forms of the present technology, the seal-forming structure 3100 is made of a biocompatible material such as silicone.

[0192] The seal-forming structure 3100 according to the present technology can be constructed of a soft, flexible, and resilient material such as silicone resin.

[0193] In some 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 the seal-forming structure 3100 that is suitable for a large-sized head but not for a small-sized head, and another that is suitable for a small-sized head but not for a large-sized head.

[0194] 5.3.1.1 Sealing mechanism

[0195] 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 system positive pressure acting on its bottom surface inside the inflatable chamber 3200, thereby forming a tight sealing engagement with the face. This pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0196] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness less than about 1 mm, such as about 0.25 mm to about 0.45 mm, that extends around the perimeter of the inflatable chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflatable chamber 3200 and extends around at least a portion of the perimeter path. The support flange is or includes a spring-like element and acts to support the sealing flange against bending in use.

[0197] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is configured and arranged to be in a compressed state, for example as a result of the elastic tension in the positioning and stabilizing structure.

[0198] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example, by adjacent regions of the sealing flange.

[0199] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0200] In some 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 sticky or adhesive surface.

[0201] 5.3.1.2 Bridge of the nose or nasal crest region

[0202] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge or nasal crest region of the patient's face during use.

[0203] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the nasal bridge region or nasal crest region of the patient's face.

[0204] 5.3.1.3 Upper lip region

[0205] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0206] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the upper lip region of the patient's face during use.

[0207] 5.3.1.4 Chin region

[0208] 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 during use.

[0209] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the chin region of the patient's face during use.

[0210] 5.3.1.5 Forehead region

[0211] In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during use. In this form, the inflation chamber can cover the eyes during use.

[0212] 5.3.1.6 Nasal pillows

[0213] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal jets or nasal pillows, each nasal jet or nasal pillow being configured and arranged to form a seal with a respective nostril of the patient's nose.

[0214] A nasal pillow according to one aspect of the present technology includes: a frustum of a cone that forms a seal over at least a portion of the bottom surface of the patient's nose; a stem; a flexible region on the bottom surface of the frustum of the cone that connects the frustum of the cone to the stem. Additionally, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can act together to facilitate a universal engagement structure that can accommodate relative movement in both displacement and angle between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the position of the frustum of the cone can be axially moved towards the structure to which the stem is connected.

[0215] 5.3.2 Inflatable Chamber

[0216] In the region that forms a seal during use, the inflatable chamber 3200 has a periphery shaped to complement the surface profile of an average human face. In use, the boundary edge of the inflatable chamber 3200 is positioned in close proximity to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire periphery of the inflatable chamber 3200 during use. In some forms, the inflatable chamber 3200 and the seal-forming structure 3100 are formed from a single uniform sheet of material.

[0217] In certain forms of the present technology, the inflatable chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the inflatable chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with the treatment.

[0218] In certain forms of the present technology, the inflatable chamber 3200 may be constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with the treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functions.

[0219] In certain forms of the present technology, the inflatable 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 the treatment.

[0220] 5.3.3. Positioning and Stabilizing Structure

[0221] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a positioning and stabilizing structure 3300 during use.

[0222] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to counteract the effect of the positive pressure in the inflatable chamber 3200 to lift away from the face.

[0223] In one form, the positioning and stabilizing structure 3300 provides a holding force to counteract the effect of gravity on the patient interface 3000.

[0224] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to counteract the potential impact of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0225] In one form of the present technology, a positioning and stabilizing structure 3300 is provided, which is configured in a manner consistent with being 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 sensed or actual volume of the instrument. 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.

[0226] In one form of the present technology, a positioning and stabilizing structure is provided, and the positioning and stabilizing structure 3300 is configured to not be so large and bulky as to prevent the patient from lying in a supine sleeping position, where the back region of the patient's head is on the pillow.

[0227] In one form of the present technology, a positioning and stabilizing structure is provided, and the positioning and stabilizing structure 3300 is configured to not be so large and bulky as to prevent the patient from lying in a lateral sleeping position, where the side region of the patient's head is on the pillow.

[0228] 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 rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible strap or a soft strap. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, the presence of the decoupling portion prevents the force acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0229] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (such as sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material for engaging with a hook material portion.

[0230] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct forces to cause a seal-forming structure to make sealing contact with a portion of the patient's face. In one example, the strap can be configured as a lacing.

[0231] In one form of the present technology, the positioning and stabilizing structure includes a first lacing, which is constructed and arranged such that at least a portion of the lower edge of the first lacing passes over the upper ear base of the patient's head and covers a portion of the parietal bone without covering the occipital bone during use.

[0232] In one form of the present technique applicable to a nasal mask only or a full face mask, the positioning and stabilizing structure includes a second strap configured and arranged such that in use at least a portion of the upper edge of the second strap passes under the lower ear base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0233] In one form of the present technique applicable to a nasal mask only or a full face mask, the positioning and stabilizing structure includes a third strap configured 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.

[0234] In certain forms of the present technique, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. The advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0235] In certain forms of the present technique, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture to be transmitted through the strap.

[0236] In certain forms of the present technique, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide a holding force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for a large-sized head but not for a small-sized head, while another form of positioning and stabilizing structure is suitable for a small-sized head but not for a large-sized head.

[0237] Figure 7 A patient 1000 wearing a patient interface 3000 according to an example of the present technique is shown. The patient interface 3000 includes a cushion assembly 3580 and a positioning and stabilizing structure 3300. The cushion assembly may include a frame 3500, an inflatable chamber 3200 connected to the frame, and a seal-forming structure 3100 disposed in the inflatable chamber. The cavity formed at least by the inflatable chamber 3200 and the seal-forming structure 3100 can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The inflatable chamber includes an inflatable chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient 1000 to breathe. The patient interface 3000 in this example includes a connection port 3600 connected to an air supply conduit that supplies air to the inflatable chamber 3200.

[0238] 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 patient airway inlet. The seal-forming structure 3100 has apertures such that an airflow at the treatment pressure is delivered at least to the inlets of the patient's nostrils. 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 nostrils and leave the patient's mouth uncovered. The seal-forming structure 3100 is constructed and arranged to maintain the treatment pressure in the inflation chamber 3200 during the entire respiratory cycle of the patient in use.

[0239] The patient interface 3000 also includes a venting structure 3400. The venting structure 3400 allows the gas exhaled by the patient to flow continuously from the interior of the inflation chamber 3200 to the surrounding environment. The size and shape of the venting structure 3400 are determined to maintain the treatment pressure in the inflation chamber during use.

[0240] The patient interface 3000 also includes a positioning and stabilizing structure 3300 to provide a force for holding 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 such that in use at least a portion covers an area on the patient's head above the bridge of the nose that is above the patient's head. In one example of the present technology, the positioning and stabilizing structure 3300 includes a frame 3500 to which the inflation chamber 3200 is connected. The frame 3500 is held in place by a plurality of strap portions of the positioning and stabilizing structure 3300.

[0241] 5.3.3.1 One-piece knitted headband

[0242] In one example of the present technology, when the patient is wearing the one shown in Figure 7 and as shown separately in Figure 8 and 9 the positioning and stabilizing structure 3300 includes an integrally formed headband 3301. The headband 3301 includes a monolithic structure. The headband 3301 is formed as a single one-piece knitted band, as opposed to a combination of multiple separately formed and connected strap pieces or a one-piece strap cut from a sheet. Separately forming the strap portions and connecting them together may be slower and / or more costly to manufacture. Cutting the headband may result in significant material waste. However, in some examples of the present technology, the positioning and stabilizing structure 3300 may include a plurality of separately formed and connected headband portions while including other features of the present technology described herein.

[0243] The headband 3301 can be knitted directly into a single-piece material using plain knitting to form its final shape, without the need to cut the headband from a sheet of material or additional threads for stitching together individual headgear pieces. By plain knitting the headband 3301, the entire headband 3301 can be knitted in a single plain knitting process. In some examples of the present technology, the headband 3301 does not include seams or joints. In some cases, seams and joints may create uncomfortable pressure on the skin of some users.

[0244] One advantage of plain knitting is that the headband 3301 can be knitted directly from fibers in the form of threads, yarns, etc. into its final shape, rather than being cut from sheets. Cutting multiple complex shapes from sheets may leave large scraps, which become waste. Additionally, when cutting the headband from laminated sheets, there may be less flexibility to cost-effectively customize the headband fabric or color. New laminated sheets may need to be produced to create new fabric and / or color options.

[0245] Another advantage of the knitted headband 3301 is that the headband can be knitted to very closely conform 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 a specific patient's head based on a three-dimensional model of the specific patient's head created by imaging or scanning the head of the specific patient.

[0246] Some existing headbands have been produced by double-needle crochet knitting. Due to the complex shape of the four-point connection headband, the headbands produced by this method may be limited to a single strap-like profile, rather than a complete headband for a nasal mask or full face mask (e.g., a patient interface with a four-point headband connection).

[0247] In some examples of the present technology, complex knitting techniques are used to form the headband 3301 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 sweatshirts.

[0248] In some examples of the present technology, the headband 3301 includes a variety of different colors and / or patterns. Plain knitting can be used to blend colors and patterns to provide a wide range of design variations without additional cosmetic costs.

[0249] 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 through a plain knitting process performed during the knitting of the entire headband 3301. The elastic properties can be customized to meet the different requirements of each region of the headband 3301.

[0250] In some examples of the present technology, the headband 3301 is formed by plain knitting but includes a non-planar shape even before being worn by a patient. The non-planar shape can be created by knitting the headband 3301 with different knitting densities in different regions. Different properties can be provided to different regions of the headband 3301 to meet predetermined specifications. In some examples, providing such properties to the headband 3301 during flat knitting can result in the headband 3301 including a non-flat shape. In some forms of the present technology, the non-planar shape can provide predetermined properties to the headband 3301, such as a predetermined elasticity at a specific location and / or orientation, or a specific force vector applied by the headband 3301 to the inflatable chamber 3200 and / or the seal-forming structure 3100 during use.

[0251] In some examples of the present technology, the headband 3301 is customized and tailored to the anatomical structure and / or preferences of a specific patient. Plain knitting advantageously provides the manufacturer with the flexibility to use a range of yarns, apply different design patterns, apply different colors, and surface geometric features. In some examples, the headband 3301 is knitted by a programmable knitting machine. The headband formed by plain knitting can also be very comfortable. If high-specification and fine yarn textures are used, the surface finish of the band can be smooth, and there is a low risk of causing facial imprints.

[0252] In some examples, the headband 3301 can include one or more texts, graphics, trademarks, logos, etc. knitted into the headband 3301 during a single knitting operation of forming the headband 3301.

[0253] In an alternative embodiment, the positioning and stabilizing structure 3300 can include one or more headbands. In some alternative examples, one or more headband portions are formed by a circular knitting process.

[0254] In some examples, the headband 3301 can withstand a maximum force between 10 N and 100 N, more preferably between 15 - 80 N, 20 - 60 N, or 25 - 40 N without damage. In some examples, the headband 3301 can include one or more portions having a point-knit structure formed of 100% nylon and can be configured to withstand a maximum wale load of 5 - 8 N (between 6 - 7 N in some examples) and a maximum course load of 2.5 - 5.5 N (between 3.5 N - 4.5 N in some examples). In some examples, the headband 3301 can include one or more portions having a point-knit structure formed of a combination of nylon and spandex and can be configured to withstand a maximum load between 3 - 6 N (between 4 - 5 N in some examples) at the wales and between 2 - 4 N (between 2.5 - 3.5 N in some examples) at the courses. In some examples, the headband 3301 can include one or more portions having a single-sided knitted fabric structure formed of a combination of nylon and spandex and can be configured to withstand a maximum load between 2.5 - 5 N (between 3 - 4 N in some examples) when in the wales and between 1 - 3 N (between 1.5 - 2.5 N in some examples) when in the courses.

[0255] In some examples, the headband 3301 is configured to dry only within a short time after being washed or 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 generally not produce facial marks. The headband 3301 can be machine washable and hand washable.

[0256] Figure 8 The illustrated headband 3301 is configured to form a four-point connection with the frame 3500 or the inflatable chamber 3200 of the patient interface 3000. In other examples of the technology, the headgear band 3301 can be configured to make a two-point connection with the frame 3500 or the inflatable chamber 3200, for example when incorporated into a nasal pillow or nasal prong type of patient interface 3000. The headband 3301 can be connected to the frame 3500 or the inflatable chamber 3200 of the patient interface 3000 having a full-face configuration (such as a configuration where the seal-forming structure 3100 seals around the lower perimeter of the patient's nose and leaves most or all of the bridge of the patient's nose uncovered) at one or two points. In some examples, the headgear band 3301 can be configured as a harness for the positioning and stabilization structure 3300 of a catheter headgear system. In such an example, the headband 3301 can cover or be located below the occiput of the patient and be connected between a pair of headband catheters that rest against the sides of the patient's head.

[0257] 5.3.3.2 Headband portion

[0258] As Figure 7As shown in FIGS. -9, the positioning and stabilization structure 3300 may include a plurality of strap portions. The plurality of strap portions may be provided in a single headgear strap 3301, such as in the positioning and stabilization structure 3300 of FIGS. -9. In this example of the present technology, the positioning and stabilization structure 3300 includes an annular strap portion 3340. The annular strap portion 3340 surrounds the posterior side of the patient's head and provides a firm anchor for other strap portions connected to the inflation chamber 3200. The annular strap portion 3340 may also be referred to as a crown portion, a crown strap, a posterior / rear portion, or a halo. Figure 7 In this example of the present technology, the annular strap portion 3340 of the positioning and stabilization structure 3300 includes an upper portion 3302 and a lower portion 3304. The upper portion 3302 abuts against the parietal bone of the patient's head in use. The lower portion 3304 is configured to abut against the patient's head above or below the occipital bone of the patient's head in use. As shown, the annular strap portion 3340 defines a loop.

[0259] The positioning and stabilization structure 3300 includes a pair of upper strap portions 3310. Each of the upper strap portions 3310 is configured to be connected between the annular strap portion 3340 and the inflation chamber 3200. In use, each of the upper strap portions 3310 is located beside the patient's head, on the respective side, above the patient's head.

[0260] In the example shown in FIGS. -9, the positioning and stabilization 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 inflation chamber 3200. In use, each of the lower strap portions 3320 is located beside the patient's head, on the respective side, below the edge above the patient's head.

[0261] In Figure 7 In the example shown in FIGS. -9, the positioning and stabilization 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 inflation chamber 3200. In use, each of the lower strap portions 3320 is located beside the patient's head, on the respective side, below the edge above the patient's head.

[0262] Each of the upper strap portions 3310 and the lower strap portions 3320 may be connected directly or via the frame 3500 of the cushion assembly 3580 to the inflation chamber 3200. In Figure 7 In the example shown, the upper strap portions 3310 and the lower strap portions 3320 are connected to the inflation chamber 3200 via the frame 3350, and the inflation chamber 3200 is connected to the frame 3350.

[0263] One or more of the headband portions of the positioning and stabilization structure 3330 (such as the upper strap portions 3310, the lower strap portions 3320, and the top strap portion 3330 described below) may include a fastening portion 3360. The fastening portion 3360 may be configured and / or arranged to allow the strap to loop back and fasten to itself. In one example, the fastening portion 3360 may include hook-and-loop material. In another example, the fastening portion 3360 may include magnets configured to attract each other when the strap loops back to itself.

[0264] In some examples of the technology, the positioning and stabilization structure 3300 can include an upper strap portion 3310, but may not include a lower strap portion 3320. In some examples of the technology, the patient interface 3000 can include a positioning and stabilization structure 3300 that includes an upper strap portion 3310 that connects a rear portion (such as the circumferential strap portion 3340) of the positioning and stabilization structure 3300 to an inflation chamber 3200 that includes a nasal pillow or cradle cushion sealing formation structure 3100.

[0265] In this example, the circumferential strap portion 3340 includes a stiffened portion 3345. The stiffened portion 3345 has a higher rigidity compared to other portions of the circumferential strap portion 3340. The stiffened portion 3345 may not be completely rigid, but may be “stiffened” in the sense that it is more rigid than some or all other portions of the circumferential strap portion 3340. Both the stiffened portion 3345 and other portions of the circumferential strap portion 3340 can be flexible to some extent, but the stiffened portion 3345 can be harder. The stiffened portion 3345 may be less stretchable and / or bendable than other portions of the circumferential strap portion 3340. In this example, the stiffened portion 3345 is disposed along the length of the loop defined by the circumferential strap portion 3345. The stiffened portion 3345 of the circumferential strap portion 3340 can strengthen the circumferential strap portion 3340. Strengthening the circumferential strap portion 3340 can improve the stability of the patient interface 3000 in use because the purpose of the circumferential strap portion 3340 is to provide an anchor for other strap portions connected to the inflation chamber 3200 while pulling the inflation chamber 3200 into the patient's face under tension. The stiffened portion 3345 can be substantially non-stretchable, but can still be bendable to conform to the curvature of the patient's head. The non-stretchable property of the stiffened portion 3345 provides an enhancement to the circumferential strap portion 3340, providing a more robust anchor and resulting in a more stable positioning and stabilization structure 3300. The upper strap portion 3310 can be stretchable. In some examples of the technology, the stiffened portion 3345 can be stretchable, but less so than other portions of the circumferential strap portion 3340. In some examples, the circumferential strap portion 3340 can include a first portion disposed along the length of the loop defined by the circumferential strap portion 3340 and a second portion disposed along the length of the loop. The second portion can include the stiffened portion 3345 and can extend along an edge of the circumferential strap portion 3340 that is directly adjacent (such as adjacent) to the first portion. The second portion can include a greater stiffness than the first portion. The second portion can be less bendable than the first portion. The stretchability of the second portion is lower than that of the first portion.

[0266] In an example of the technique, the stiffening portion 3345 is disposed generally 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 stiffening portion 3345 is provided to the annulus portion 3340 adjacent to the inner perimeter 3341 of the annulus portion 3340 (e.g., along the inner edge). The stiffening portion 3345 may define the inner perimeter 3341 (or inner edge) of the annulus portion 3340, or alternatively, may be positioned adjacent to the edge of the annulus portion 3340 that defines the inner perimeter 3341. The stiffening portion 3345 may generally form the entire inner perimeter 3341 of the annulus portion 3340. In other examples, the stiffening portion 3345 may be provided generally centrally between the inner perimeter 3341 of the annulus portion 3340 and the outer perimeter 3342 of the annulus portion 3340.

[0267] Stiffening around the inner perimeter 3341 of the annulus portion 3340 can be advantageous because the outer perimeter 3342 (more forward side) of the annulus portion 3340 can then be formed continuously with any other strap portion that connects the annulus portion 3340 to the inflatable chamber 3200 of the patient interface 3000. Positioning the stiffening portion 3345 centrally between the inner perimeter 3341 and the outer perimeter 3342 can have the advantage of evenly distributing the pressure load on the patient's skin. The inner perimeter 3341 of the annulus portion 3340 may also not need to deform as much as the outer perimeter 3342 because it is the outer perimeter 3342 from which additional strap portions extend to connect to the inflatable chamber 3200 in front of the patient's face.

[0268] The annular strap portion 3340 of the positioning and stabilizing structure 3300 and / or any other strap portion may include a rounded edge. A rounded edge is less likely to cause skin marks and is more comfortable on the patient's skin.

[0269] In some examples of the present technology, the strap portions of the positioning and stabilization structure 3300 can be formed by knitting. That is, one or more of the upper strap portion 3310, the lower strap portion 3320, and the circumferential strap portion 3340 can include a knitted fabric structure. In some examples, one or more of these strap portions of the positioning and stabilization structure 3300 can be formed by plain knitting. For example, the circumferential strap portion 3340, the upper strap portion 3310, and / or the lower strap portion 3320 can include a single jersey knitted fabric structure and can be formed from a combination of nylon and spandex. The single jersey knitted fabric structure advantageously provides the necessary flexibility and elasticity to the strap portion without excessive thickness. Alternatively, the circumferential strap portion 3340 can include a double-knit loop structure. The stiffening portion 3345 of the circumferential strap portion 3340 can include a piqué knitted structure (e.g., a piqué rib structure) and can be formed from nylon or a combination of nylon and spandex. Using a piqué knitted structure to form the stiffening portion 3345 can be advantageous because this type of structure is well-suited for producing a ridge with a sufficiently high level of rigidity while also having a rounded edge. That is, the first portion of the circumferential strap portion 3340 and the second portion of the circumferential strap portion (e.g., the stiffening portion 3345) can include the same type of yarn (e.g., yarns with the same stiffness), while the second portion can have increased stiffness compared to the first portion due to the different knitted structures. In one example, the piqué knitted structure can provide increased stiffness compared to the knitted structure (e.g., single or double knitting) of the first portion of the circumferential strap portion.

[0270] The headband of the positioning and stabilization structure 3300 can be stretchable. Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the circumferential strap portion 3340 are stretchable. The stretchable property of the circumferential strap portion 3340 of the positioning and stabilization structure 3300 enables the circumferential strap portion 3340 to conform to and fit closely against the posterior, lateral, and upper surfaces of the patient's head during use. The stretchability in the upper strap portion 3310 and the lower strap portion 3320 allows these strap portions to extend slightly in length to provide some relief when the inflation chamber 3200 is pressurized. When the inflation chamber 3200 is under pressure during use, the volume of pressurized air within the inflation chamber 3200 pushes the inflation chamber 3200 and the frame 3500 in a forward direction away from the patient's face. To maintain the inflation chamber 3200 and the seal-forming structure 3100 in sealed contact with the patient's face, the force from this pressure must be counteracted by the tension in the headband. The ability of the upper strap portion 3310 and the lower strap portion 3320 to extend at least a small amount in length can make wearing the patient interface 3000 more comfortable when this occurs.

[0271] Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the circumferential strap portion 3340 are all breathable due to the knitting structure forming them. Breathability is advantageous because it can keep the headband and the patient's skin dry while keeping the temperature of the patient's skin under the headband controllable.

[0272] The stiffening portion 3345 can be a circular thickened portion of the headband material. The stiffening portion 3345 can include an increased material thickness relative to adjacent portions of the circumferential strap portion 3340. In some examples of the present technology, the patient contact side of the circumferential strap portion 3340 is substantially flat, and the increased material thickness is provided to the non-patient contact side of the circumferential strap portion 3340. Advantageously, the additional thickness to form the stiffening portion 3345 by providing additional material on the non-patient contact side of the circumferential strap portion 3340 keeps the patient contact side of the circumferential strap portion 3340 substantially flat. A flat surface can advantageously be more comfortable for the patient's skin than a non-flat surface. Since in Figure 7 the example shown, the stiffening portion 3345 is provided on the inner perimeter 3341 of the circumferential strap portion 3340, the inner perimeter 3341 is thicker than the outer perimeter 3342. In use, the rear edge of the circumferential strap portion 3340 is thicker than the front edge of the circumferential strap portion 3340. The inner perimeter 3341 being thicker compared to the outer perimeter 3342 results in a harder inner edge of the circumferential strap portion 3340, thereby providing reinforcement to the circumferential strap portion 3340.

[0273] The reinforcement of the reinforcing portion 3345 is not discernible on the patient contact side of the circumferential strap portion 3340. In use, the patient may not be able to see and / or feel any features of the reinforcing portion 3345. In Figure 10 it, cross-sections at two positions of the circumferential strap portion 3340 are shown. As shown, the additional thickness at the location where the stiffening portion 3345 is provided is only on one side (non-patient contact side) of the circumferential strap portion 3340. The other side of the circumferential strap portion 3340 is substantially flat. Additionally, the stiffening portion 3345 is circular, and the inner edge (at the inner perimeter 3341) and the outer edge (at the outer perimeter 3342) of the circumferential strap portion 3340 are also circular. The smooth / circular edges can apply only slight pressure on the use surface, which is particularly useful for maintaining comfort even when the patient overtightens the headgear strap.

[0274] In some examples of the present technology, the annulus portion 3340 includes a thickness within the range of 3 - 5 mm, for example within the range of 3.5 - 4.5 mm, in the rigidifying portion 3345. In some examples, the rigidifying portion 3345 may include a thickness of 4 mm. The thickness of the annulus portion 3340 at regions other than the rigidifying portion 3345 of the annulus portion 3340 may be within the range of 1.5 - 3.5 mm, for example within the range of 2 - 3 mm, for example 2 mm. The upper band portion 3310 and the lower band portion 3320 may also include a thickness within the range of 1.5 - 3.5 mm, for example within the range of 2 - 3 mm, for example 2 mm.

[0275] In some examples, the rigidity of the rigidifying portion 3345 may not be uniform along the length of the annulus portion 3340. The rigidifying portion 3345 may be less stretchable and / or flexible at some positions compared to other positions around the annulus portion 3340. In some examples, the rigidifying portion 3345 may be larger at specific positions (compared to other positions) such that it has increased stiffness and / or rigidity at these specific positions. As Figure 7 shown in - 8, the rigidifying portion 3345 is larger near the junction of the upper band portion 3310 and the annulus portion 3340. In this example, the rigidifying portion 3345 is wider near the upper band portion 3310 than at other positions along the annulus portion 3340. In other examples of the present technology, due to the increased material thickness and / or the use of a different knitting structure (in examples where the annulus portion 3340 is formed by knitting), the rigidifying portion 3345 may be more rigid at specific positions.

[0276] The width and / or material thickness may vary along the length of the annulus portion 3340 to provide stiffness at positions where stiffness / stability is required and flexibility and / or comfort at positions where stiffness is not required. Near the junction of the upper band portion 3310 and the annulus portion 3340, additional stiffness may be particularly advantageous because, in use, the upper band portion 3310 is under tension and there is a relatively large area of band material at the junction. Strengthening this connection can help provide a high level of stability for the patient interface 3000.

[0277] The upper portion 3302 of the annulus portion 3340 may include one or more top band portions 3330. As Figure 8 、 9As shown in FIGS. 12 and 13, in one example, the annular band portion 3340 includes a pair of top band portions 3330. The top band portions 3330 can be configured to adjust their connection to each other. In one example, the top band portions 3330 are configured to be adjustably connected to each other near the sagittal plane of the patient's head. The adjustable connection between the two top band portions 3330 can advantageously enable the positioning and stabilization structure 3300 to fit a range of patient head shapes and sizes. In other examples of the present technology, the positioning and stabilization structure 3330 can include a single top band portion 3330. If only a single top band portion 3330 is provided, it can elastically extend in length to fit a range of patient head sizes.

[0278] The two top band portions 3330 can be adjustably connected together by a buckle 3335. The buckle 3335 can include a pair of slots, eyelets, or other openings through which the top band portions 3330 can pass, such that each top band portion 3330 can pass through a portion of the buckle 3335 and be fastened back onto itself. The top band portions 3330 can each include hook-and-loop fastening material that enables the end of each top band portion 3330 to be fastened to the middle of the corresponding top band portion 3330. In other examples of the present technology, each overhead band portion 3330 can be fastened back onto itself with a clip, elastic band, magnet, or other suitable fastening means. In an alternative example, during the manufacture of the positioning and stabilization structure 3300, the two top band portions are formed separately and then welded or stitched together to complete the loop formed by the annular band portion 3340.

[0279] Figure 16 FIG. 16 shows a headband 3301 of the positioning and stabilization structure 3300 according to another example of the present technology. The headband 3301 can be integrally formed by knitting and can be formed as a single piece of material in a single flat knitting process. Figure 16 The headband 3301 can include any features and / or characteristics of the headband 3301 described with reference to FIGS. Figure 7 11 - 15.

[0280] Figure 16The headband 3301 shown includes a pair of upper headband portions 3310, each upper headband portion configured to be connected to the inflatable chamber 3200 of the patient interface 3000 in use. In this example, each upper headgear band portion 3310 is configured to be connected to a respective headgear conduit of the positioning and stabilization structure 3330, which is located on a respective lateral side of the patient's head in use. The headband conduits may each be configured to extend laterally across the upper portion of the patient's head from an intermediate 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 inflatable chamber 3200 at the front and intermediate, near the entrance to the patient's airway. Thus, the upper headband portions 3310 are configured to be connected to the inflatable chamber 3200 via the headband conduits. The headband 3301 also includes a pair of lower headband portions 3320, each lower headband portion 3320 configured to be connected to the inflatable chamber 3200. The lower headband portions 3320 may be directly connected to the inflatable chamber 3200 or to the frame 3500 of the cushion assembly 3580.

[0281] Figure 17 A patient interface 3000 including a cushion assembly 3590 and a positioning and stabilization structure 3300 is shown in another example according to the present technology. The cushion assembly 3590 includes an inflatable chamber 3200 and a seal-forming structure 3100. The positioning and stabilization structure 3300 includes a headband 3301 configured to be used with the catheter headband of the patient interface. Figure 17 The headband 3301 shown is connected to the headband conduit 3900 in the same manner as Figure 16 the headband shown. As shown, the headband conduits are joined at the upper portion of the patient's head at the joint 3903. The connection port 3600 supplies pressurized breathable air flow to the helmet conduit 3900. Each headband conduit 3900 includes a side portion 3901 beside the patient's head, which is connected to the inflatable chamber 3200 via a connector 3800, which is located at the entrance to the patient's airway in use. More generally, each headband conduit 3900 may 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 being constructed and arranged to contact at least one area of the patient's head in use, which is above the approximate top of the patient's head on the respective side of the patient's head.

[0282] As Figure 17 shown, the positioning and stabilization structure 3300 includes a pair of upper band portions 3310 that are connected between the neckband portion 3334 and the respective headband conduit 3900. The neckband portion 3334 may also be referred to as the rear / rear portion. In this example, the upper band portion is connected to an eyelet on a flap 3902 of the helmet conduit 3900. The lower band portion 3320 is connected between the neckband portion 3334 and the inflatable chamber 3200, in this example via a headband clip 3322.

[0283] exist Figure 16 and 17 In the example shown, the headband 3301 does not include a loop portion or a crown portion because the headgear conduits provide a 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.

[0284] 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 a posterior surface of a patient's neck and / or a surface of a patient's head covering an occipital bone of a patient's skull during use. The neckband portion 3334 may be configured to cover an occipital bone of a patient's head and / or lie on a patient's neck during use.

[0285] 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.

[0286] Figure 16 The headband 3301 shown includes a rigidized portion 3345. In this example, the rigidized portion 3345 is disposed on the neckband portion 3334. The rigidized portion 3345 may be configured similarly to the configuration described above with respect to Figure 7 -15 is formed in the same manner as the rigidized portion 3345 of the positioning and stabilizing structure 3300, for example with an increased thickness and / or a more rigid knitted structure. In this example, the rigidized portion 3345 may be substantially non-stretchable.

[0287] 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 towards the patient's face under tension, the 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 a more stable positioning and stabilizing structure 3300. The upper strap portion 3310 and the lower strap portion 3320 can be stretchable.

[0288] In addition to the rigidified portion 3345, the neckband portion 3334 can include stretchable portions. In Figure 16 the example shown, the neckband portion 3334 includes stretchable portions above and below the rigidified portion 3345. In the example, the neckband portion 3334 includes an upper stretchable portion 3346 and a lower stretchable portion 3347. The stretchable portions can be provided to the upper and / or lower edges of the neckband portion 3334. In this example, the stretchable upper portion 3346 is disposed along the upper edge of the neckband portion 3334, while the stretchable lower portion 3347 is disposed along the lower edge of the neckband portion 3334. Providing stretchable portions at the upper and lower edges of the neckband portion 3334 can be beneficial for patient comfort. If the upper and lower edges of the neckband portion 3334 are made substantially rigid, the forces from the headband tension can be concentrated on the patient's skin in such a configuration. Providing stretchable portions at the upper and lower edges can provide some relief and improve patient comfort. The stretchable portions can also conform the neckband portion 3334 to the curvature of the patient's neck.

[0289] 5.3.3.3 Headband Ventilation

[0290] 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. As Figure 7 shown in FIG. -10, the positioning and stabilizing structure 3300 includes three ventilation portions 3350. In this example, each ventilation portion 3350 is disposed in the loop portion 3340, and each ventilation portion provides an area of increased breathability through the loop portion 3340. The loop portion 3340 includes ventilation portions 3350 near each upper band portion 3310 (e.g., at each junction between the upper band portion 3310 and the loop portion 3340). Additionally, the loop portion 3340 includes a single ventilation portion 3350 near the junction between each lower band portion 3320 and the loop portion 3340.

[0291] In this example, the lower band portions 3320 all extend from the toroidal portion 3340 at similar locations. In examples of techniques where the lower band portions 3320 extend from more diverse locations around the toroidal portion 3340, two separate ventilation portions 3350 may be provided, one at each junction between the lower band portion 3320 and the toroidal portion 3340. The ventilation portions 3350 may be provided at locations on the headband where it includes a relatively large area / coverage on the patient's head. These areas are most prone to increased skin temperature and / or moisture accumulation. The junctions between the toroidal portion 3340 and the upper band portion 3310 and the lower band portion 3320 may cover a relatively large surface area on the patient's skin, which means that additional breathability may be required at these locations to provide a high level of patient comfort. The ventilation portions 3350 may advantageously prevent moisture from accumulating in the headband material and / or on the patient's skin. The ventilation portions 3350 are regions with local breathability. The knitting structure of the other headband portions of the positioning and stabilization structure 3300 may also be highly breathable, but the ventilation portions 3350 may be particularly breathable due to the mesh knitting structure used to form them. The ventilation portions 3350 also advantageously keep the patient's skin cool, at least under the ventilation portions 3350, by facilitating fresh air exchange through the material forming the headband 3301.

[0292] The ventilation portions 3350 may include a knitted fabric structure. The knitted fabric structure may be formed in the same knitting process as that forming the toroidal portion 3340, the stiffening portion 3345, the upper band portion 3310, and / or the lower band portion 3320. In one example, the ventilation portions 3350 include a dotted knit structure. The ventilation portions 3350 may be stretchable. However, in some examples, the ventilation portions 3350 may be less stretchable than other headband portions. The relatively low elasticity in the ventilation portions 3350 may prevent the mesh structure from being stretched to such an extent that the openings forming the mesh structure are blocked by the fabric, which would reduce breathability. For example, the ventilation portions 3350 may be formed of nylon or a combination of nylon and elastane.

[0293] In some examples, such as Figure 7 , 8As shown in FIGS. 9 and 10, the stiffening portion 3345 of the headband portion 3340 can surround the ventilation portion 3350. Advantageously, this can provide additional stiffness at the region of the headband portion having a large surface area, which otherwise could be overly flexible. That is, due to the knitted structure, the ventilation portion 3350 can provide a region of the headband portion 3340 having reduced stiffness and / or increased flexibility compared to other regions of the headband portion (such as the first portion and / or the second portion of the headband portion (such as the stiffening portion 3345)). The stiffening portion 3345 can be provided adjacent (such as directly adjacent, such as in contact) to the ventilation portion 3350 to provide increased stiffness adjacent to or surrounding the ventilation area. Not every ventilation portion 3350 is surrounded by the stiffening portion 3345. In Figure 7 , 8 the example shown in FIGS. 9 and 10, the ventilation portion 3350 near the patient's neck is not surrounded by the stiffening portion 3345. However, the ventilation portion 3350 is close to the upper band portion 3310 surrounded by the stiffening portion 3345.

[0294] The headband portion 3340 includes a pair of upper ventilation portions 3350, each upper ventilation portion being disposed close to a corresponding upper band portion 3310. As described above, the stiffening portion 3345 surrounds each upper ventilation portion 3350. In this example, the stiffening portion 3345 includes a higher material thickness on the rear side of each upper ventilation portion 3350 than on the front side of each upper ventilation portion 3350. As described above, the stiffening portion 3345 can be formed to be stiffer near the inner perimeter 3341 of the headband portion 3340.

[0295] The headband portion 3340 further includes a lower ventilation portion 3350 disposed between the pair of lower band portions 3320. As Figure 8 and 9 shown, the lower ventilation portion 3350 includes a lower edge 3351 spaced apart from the lower edge 3343 of the headband portion 3340. The lower edge 3351 of the lower ventilation portion 3350 and the lower edge 3343 of the headband portion 3340 are both arcuate in the present technical example.

[0296] The curvature of the lower edge 3351 of the ventilation portion 3350 is greater than the curvature of the lower edge 3343 of the annulus portion 3340. The greater curvature of the lower edge 3351 of the ventilation portion 3350 provides a maximum spacing between the lower edge 3351 of the ventilation portion 3350 and the lower edge 3343 of the annulus portion 3340 at or near the sagittal plane of the patient's head during use. The ventilation portion 3350 and / or the annulus portion 3340 near the ventilation portion 3350 may contact or be in close proximity to the patient's neck. Additionally, the mesh structure of the ventilation portion 3350 may be rougher than the non-mesh surface of the annulus portion 3340. Thus, providing a spacing between the lower edge 3351 of the ventilation portion 3350 and the lower edge 3343 can reduce the amount of contact between the mesh fabric and the patient's skin. This can be particularly advantageous when contact between the annulus portion 3340 and the patient's skin occurs while the annulus portion 3340 is under tension and for an extended period of time (such as occurs during use of the patient interface 3000).

[0297] Figure 16 The headband 3301 of the positioning and stabilizing structure 3300 shown also includes a ventilation portion 3350. In this example, the ventilation portion 3350 is disposed in the neckband portion 3334. The ventilation portion 3350 may take the same form and include the same characteristics as described above regarding the ventilation portion 3350 of the positioning and stabilizing structure 3300 and the headband 3301 shown in Figure 7 -15. In this example, a stiffening portion 3345 surrounds the ventilation portion 3350.

[0298] It should be noted that plain knit structures (such as single jersey, double jersey), rib knit structures, and rib mesh knit structures refer to textiles or textile portions formed by plain knit, rib, and rib mesh knitting techniques respectively, and as will be understood by those skilled in the art, these textiles or textile portions form different knit structures due to the different ways their interlacing yarns are formed.

[0299] 5.3.3.4 Blind guiding member

[0300] As described above, some or all of the headband portions of the positioning and stabilizing structure 3300 may include fastening portions 3360. As shown in Figure 7 、 8 and 16, the upper band portion 3310 and the lower band portion 3320 each include a fastening portion 3360 near the end of the respective band portion. Each fastening portion 3360 is configured and / or arranged to allow the respective band portion to be looped back and fastened to itself.

[0301] In an example, the fastening portion 3360 can 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 instances directly to the inflation chamber 3200. The upper strap portion 3310 and the lower strap portion 3320 can be directly connected to the frame 3500 through slots or other openings, or can be connected to a headband clip, which is then connected to the frame 3500. In one example, as Figure 7 and 8 shown, each of the upper strap portions 3310 is 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 pass, such that the end of the upper strap portion 3310 can be fixed back onto the middle / center of the upper strap portion 3310. In this example, the lower strap portion 3320 is connected to a headband clip 3322. Each lower strap portion 3320 passes through a slot formed in the headband clip 3322 and is then looped back and fixed 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 fixed to a predetermined portion of the frame 3500 under magnetic attraction (and also to be quickly released from the predetermined portion of the frame 3500). In Figure 16 the example shown, the fastening portion 3360 of the upper headband portion 3310 can form a loop through an eyelet on the headband conduit of the positioning and stabilization structure 3300. The fastening portion 3360 of the lower headband 3320 can surround a slot on the inflation chamber 3200 of the patient interface 3000 or a headband clip connected to the inflation chamber 3200 in a manner similar to that Figure 7 shown.

[0302] One or more strap portions of the positioning and stabilization structure 3300 can include at least one blind guide 3370. In examples of the present technology where the headband portion includes knitted fabric, the blind guide 3370 can also be formed of knitted fabric. In some examples, the headband is formed by plain knitting, and the blind guide is also formed by plain knitting in the same process. The louver guide 3370 can provide a tactile indication of the position of the fastening portion 3360 on the strap. The blind guide 3370 can be a feature that a patient can feel on the surface of the headband, configured to assist a user in manipulating the headband (such as assembling and adjusting the strap), especially when the face mask has been worn by the patient and the patient cannot see the headband. The louver guide 3370 can be a raised bump, a raised profile, or other tactile features to guide the user to fix the strap back onto itself after looping the strap through a slot or eyelet provided on the face mask frame or the headband clip. In other examples of the present technology, the blind guide 3370 can include a recessed portion.

[0303] AsFigure 7 , 8 As shown in FIGS. 15 and 16, each of the upper belt portion 3310 and the lower belt portion 3320 includes a blind guide 3370 in the fastening portion 3360 of the respective belt. Each blind guide 3370 provides a tactile indication of the position of the fastening portion 3360 on the respective one of the upper belt portion 3310 and the lower belt portion 3320. In some examples, the blind guide 3370 may also be provided to the top belt portion of the positioning and stabilizing structure 3300.

[0304] Figure 11 FIG. 17 shows an exploded view of the fastening portion 3360 of the belt of the positioning and stabilizing structure 3300. In the example shown, the belt is the upper belt portion 3310 of the positioning and stabilizing structure 3300, but according to examples of the present technology, the features of the fastening portion 3360 and the louver guide 3370 may be applied to the lower belt portion 3320 of the positioning and stabilizing structure 3300 or other belts / belt portions. The upper belt portion 3310 includes a non-patient contact surface on which the blind guide 3370 is provided. The louver guide 3370 may include a raised portion relative to the non-patient contact surface of the upper belt portion 3310. The raised portion may surround at least a portion of the fastening portion 3360. As Figure 10 and 11 shown, the raised portion includes an elongated raised profile on the non-patient contact 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 that are the upper edge, the rear edge, and the lower edge in use. The louver guide 3370 may be provided around the perimeter of the fastening portion 3360, for example, on one, two, or more of its sides.

[0305] In other examples of the present technology, the belt of the positioning and stabilizing structure 3300 may include a recessed profile that is recessed relative to the non-patient contact surface. The recessed portion may surround at least a portion of the fastening portion 3360 on the belt. Any suitable features of the shape and position of the raised louver guide described herein may be applied to the recessed louver guide according to other instances of the present technology. Similarly, in other examples of the present technology, any of the illustrated examples of the positioning and stabilizing structure according to the present technology may include a recessed blind guide instead of a raised blind guide. For example, the recessed louver guide may be formed by an elongated recessed profile and may surround the other three sides of the fastening portion 3360. The recessed profile may be formed by a reduced thickness of the belt. The present technology also includes blind guides formed by other features, such as regions having a higher stiffness, portions of the headband having a different surface finish / texture from adjacent regions of the belt. The knitting pattern, knitting density, and / or yarn material / thickness may vary in order to provide a tactile indication to the user of the position of the fastening portion on the belt.

[0306] In some examples of the present technology, the elongate raised profile of the blind guide 3370 is circular. This can make the 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.

[0307] The raised portion of the guide 3370 can be formed by increasing the thickness of the strap compared to the adjacent regions of the strap. The additional material forming the increased thickness can be provided to the non-patient contact surface.

[0308] The fastening portion 3360 of the strap can include hook-and-loop fastening material (e.g., VelcroTM). The fastening portion 3360 can include an end 3361 and a middle 3363. The end 3361 includes one of hook material and loop material disposed on the non-patient contact surface, and the middle 3363 includes the other of hook material and loop material disposed on the non-patient contact surface. The middle 3363 can be disposed adjacent to the end 3361 of the strap. In Figure 11 the example shown, the fastening portion 3360 includes a hook portion 3362 and a loop portion 3364. The hook portion 3362 is disposed on the end 3361 of the upper strap portion 3310. The loop portion 3364 is disposed on the middle 3363 of the upper strap portion 3310. In other examples, the hook portion 3362 can be provided to the middle 3363 of the strap, and the loop portion 3364 can be provided to the end 3361 of the strap. The hook portion 3362 is capable of releasably attaching to the loop portion 3364. This means that once the upper strap portion 3310 passes through an opening (e.g., a slot formed in the frame 3500) in another component, the end 3361 can loop back towards the middle 3363 and the hook portion 3362 can releasably attach to the loop portion 3364. The blind guide 3370 can be disposed around only one of the end 3361 and the middle 3363. In Figure 11 the example shown, the guide 3370 is disposed only around the middle 3363 and the loop portion 3364. As shown, the guide 3370 is disposed around three sides of the loop portion 3364.

[0309] The middle 3363 can be longer than the end 3361. This can enable the end 3361 to be fastened to a series of positions along the middle 3363, thereby increasing the amount of length adjustability of the strap. In some examples, the middle 3363 is several times longer than the end 3361.

[0310] The belt portion including the louver 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 louver guide 3370 itself can be formed together in a single knitting process. The louver guide 3370 can include a dotted knit structure. The belt can include a single-sided knitted fabric structure. In alternative examples of the technology, the belt can include a double-sided knitted loop structure. The belt and the blind guide 3370 can be integrally formed.

[0311] The hook portion 3362 and the loop portion 3364 can be formed separately and then assembled with the corresponding belt portion. They can be adhered to or sewn into the belt portion of the positioning and stabilizing structure 3300. Alternatively, one or both of the hook portion 3362 and the loop portion 3364 can be ultrasonically welded to the headband. In other examples of the technology, one or both of the hook portion 3362 and the loop portion 3364 are knitted. The hook portion 3362 and / or the loop portion 3364 can be formed in the same knitting process used to form the belt portion they are provided on. The knitting process can include plain knitting. The hook portion 3362 and the loop portion 3364 can be formed of nylon. This can reduce skin irritation through excellent breathability and can provide soft loops that avoid abrasion to the patient's skin. The hook portion 3362 and the loop portion 3364 can be die-cut.

[0312] The upper belt portion 3310 and / or other belt portions can include a visual guide 3366 indicating the end of the belt, as Figure 11 shown. The visual guide 3366 can surround the hook portion 3362. The 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. The visual guide 3366 can also or alternatively facilitate the assembly of the hook portion 3362 to the belt portion to which they are fixed during the manufacturing process.

[0313] As Figure 8 and 16 shown, each of the upper belt portion 3310 and the lower belt portion 3320 includes a fastening portion 3360. Each fastening portion 3360 includes a hook portion 3362 provided at the end 3361 of the corresponding belt portion and a loop portion 3364 provided at the middle 3363 of the corresponding belt portion. In other examples of the technology, only the upper belt portion 3310, only the lower belt portion 3320, or no belt portion has this structure. In some examples, the knitting process for forming the headband portion is configured to precisely provide a predetermined level of stiffness to the belt portion such that adjustability and blind guides are not required. In some examples, the predetermined hardness level can be determined based on the specific shape and size of the patient's head determined by scanning.

[0314] In some examples, the positioning and stabilization structure 3300 may not have a lower strap portion 3320 and may only have an upper strap portion 3310. Such an arrangement may be suitable for a “below the nose” type of patient interface 3000 (e.g., having a seal-forming structure 3100 in the form of nasal pillows or nasal cushions). In such examples, the upper strap portion 3310 may have the fastening portion 3360 and the louver guide 3370 as described above. The positioning and stabilization structure 3300 having the upper strap portion 3310 instead of the lower strap portion 3320 may have an annular strap portion 3340 that has an upper part 3302 and a lower part 3304. One or both of the upper part 3302 and the lower part 3304 may be adjustable by the patient. In such examples, the upper part 3302 and / or the lower part 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 part 3302 and / or the lower part 3304 may include features of the fastening portion 3360 and / or the louver guide 3370 as described above with reference to Figure 11 as described.

[0315] The louver guide 3370 may be stretchable in some examples of the technology and non-stretchable in other examples. The strap portion provided with the louver guide 3370 may be stretchable as a whole to provide some extensibility under tension, although in some examples, only a selected area of the strap portion may extend in length. If the area of the strap portion provided with the louver guide 3370 is stretchable, the louver guide 3370 may also be formed to be stretchable (e.g., by using a knitting process that enables the louver guide to elastically extend together with the strap on which it is formed). In some examples, the louver guide 3370 may be provided to a non-stretchable portion of the strap (e.g., if the strap has stretchable portions elsewhere along its length). In such examples, the louver guide 3370 may not be stretchable.

[0316] As Figure 12 shown, an end louver guide 3371 may be provided on the patient contact side of the head strap 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 louver guide 3371 is formed will loop around on the patient contact side of the head strap 3301.

[0317] 5.3.4 Ventilation holes

[0318] In one form, the patient interface 3000 includes a ventilation structure 3400 that is constructed and arranged to allow the cleaning of exhaled gas, such as carbon dioxide.

[0319] In some forms, the venting structure 3400 is configured to allow continuous venting flow from the interior of the plenum 3200 to the ambient environment while the pressure within the plenum is positive relative to the ambient environment. The venting structure 3400 is configured such that the venting flow rate has a magnitude sufficient to reduce patient rebreathing of exhaled CO2 while maintaining the therapeutic pressure within the plenum during use.

[0320] The venting structure 3400 according to one form of the present technology includes a plurality of holes, such as from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0321] The venting structure 3400 may be located within the plenum 3200. Alternatively, the venting structure 3400 is located within a decoupling structure, such as a rotary joint.

[0322] 5.3.5 Decoupling Structure

[0323] In one form, the patient interface 3000 includes at least one decoupling structure, such as a rotary joint or a ball and socket.

[0324] 5.3.6 Connection Port

[0325] The connection port 3600 allows connection to the air circuit 4170.

[0326] 5.3.7 Forehead Bracket

[0327] In one form, the patient interface 3000 includes a forehead support 3700.

[0328] 5.3.8 Anti - Asphyxiation Valve

[0329] In one form, the patient interface 3000 includes an anti - asphyxiation valve.

[0330] 5.3.9 Port

[0331] 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 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 3200, such as pressure.

[0332] 5.4 RPT Device

[0333] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described in whole or in part herein. The RPT device 4000 may be configured to generate an air flow for delivery to a patient airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0334] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering an air stream 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.

[0335] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. In addition, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016, which supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0336] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (such as a blower 4142) capable of supplying air under positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0337] One or more air path components may be provided in a detachable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be provided within the outer housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or forms part of it.

[0338] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 420, transducers 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.

[0339] 5.4.1 RPT Instrument Mechanical and Pneumatic Components

[0340] The RPT device may include one or more of the following components in an integrated unit. In alternative forms, one or more of the following components may be located as corresponding separate units.

[0341] 5.4.1.1 Air Filter

[0342] The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0343] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0344] In one form, the outlet filter 4114, such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0345] 5.4.1.2 Muffler

[0346] The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0347] In one form of the present technology, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0348] In one form of the present technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0349] 5.4.1.3 Pressure Generator

[0350] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or supplying air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impeller 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 at up to about 30 cmH2O. The blower may be as described in any one 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.

[0351] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0352] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (such as a compressed air reservoir), or a bellows.

[0353] 5.4.1.4 Sensors

[0354] The transducer may be inside the RPT device or outside the RPT device. The external transducer may be located, for example, on an air circuit (such as a patient interface) or form part of an air circuit. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor that sends or transmits data to the RPT device.

[0355] In one form of the present technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. One or more sensors 4270 can 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.

[0356] In one form of the present technology, one or more transducers 4270 can be located near the patient interface 3000.

[0357] In one form, the signal from the transducer 4270 can be filtered, for example, by low-pass, high-pass, or band-pass filtering.

[0358] 5.4.1.4.1 Flow Velocity Sensor

[0359] The flow velocity sensor 4274 according to the present technology can be based on a differential pressure sensor, such as the SDP600 series differential pressure sensors from SENSIRION.

[0360] In one form, the signal representative of the flow velocity from the flow velocity sensor 4274 is received by the central controller 4230.

[0361] 5.4.1.4.2 Pressure Sensor

[0362] The pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. Examples of suitable pressure sensors are sensors from the HONEYWELL ASDX series. Another suitable pressure sensor is a sensor from the NPA series of GENERAL ELECTRIC.

[0363] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0364] 5.4.1.4.3 Motor Speed Sensor

[0365] 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 the blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to the treatment device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0366] 5.4.1.5 Anti-backflow Valve

[0367] In one form of the present technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is configured and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0368] 5.4.2 Electrical Components of the RPT Device

[0369] 5.4.2.1 Power Supply

[0370] The power supply 4210 can be located inside or outside the housing 4010 of the RPT device 4000.

[0371] In one form of the present technology, the power supply 4210 only supplies power to the RPT device 4000. In another form of the present technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000.

[0372] 5.4.2.2 Input Device

[0373] 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 can be physical devices or software devices accessible through a touch screen. The buttons, switches or dials can be physically connected to the housing 4010 in one form, or can wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0374] In one form, the input device 4220 can be constructed and arranged to allow a person to select values and / or menu options.

[0375] 5.4.3 RPT Device Algorithms

[0376] As described above, in some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium such as the memory 4260. The algorithms 4300 are generally grouped into groups called modules.

[0377] 5.5 Air Circuit

[0378] The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged to allow an air flow to travel between two components such as the RPT device 4000 and the patient interface 3000 in use.

[0379] 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 for the inhalation and exhalation circuits. In other cases, a single limb is used.

[0380] 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 raise the temperature of the air. The heating elements 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 elements may communicate with a controller such as the 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.

[0381] 5.5.1 Oxygen Delivery

[0382] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170 and / or to the patient interface 3000.

[0383] 5.6 Humidifier

[0384] 5.6.1 Humidifier Overview

[0385] In one form of the present technology, a humidifier 5000 (such as as Figure 5A shown) is provided to change the absolute humidity of the air or gas delivered to the patient relative to the surrounding air. Generally, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the air stream (relative to the ambient air) before delivery to the patient's airway.

[0386] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving the air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, as Figure 5A and Figure 5B shown, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0387] 5.6.2 Humidifier Components

[0388] 5.6.2.1 Reservoir

[0389] According to an arrangement, the humidifier 5000 can include a water reservoir 5110 configured to hold or retain a volume of liquid (such as water) to be evaporated for humidifying an air stream. The water reservoir 5110 can be configured to hold a predetermined maximum volume of water to provide sufficient humidification at least for the duration of a respiratory therapy session (such as one 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 forms, the humidifier 5000 can be configured to receive a water supply from an external water source (such as a building's water supply system).

[0390] According to one aspect, the water reservoir 5110 is configured to add humidity to an air stream as the air stream from the RPT device 4000 passes through it. In one form, the water reservoir 5110 can be configured to cause the air stream to travel through the reservoir 5110 in a tortuous path when in contact with a volume of water therein.

[0391] According to one form, the reservoir 5110 can be removed from the humidifier 5000, for example, in a lateral direction as shown in Figure 5A and Figure 5B shown.

[0392] The reservoir 5110 can also be configured to prevent liquid from flowing out of it, 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 sub-components. When the air stream to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 can also be configured to prevent loss of pneumatic pressure through leakage and / or flow impedance.

[0393] 5.6.2.2 Conduction portion

[0394] According to an arrangement, the reservoir 5110 includes a conduction portion 5120 configured to allow effective heat transfer from a heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conduction portion 5120 can be arranged as a plate, although other shapes can also be suitable. All or part of the conduction portion 5120 can be made of a thermally conductive material, such as aluminum (such as 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, a material with lower conductivity can be used to achieve suitable thermal conductivity with a suitable geometry.

[0395] 5.6.2.3 Humidifier water tank dock

[0396] In one form, the humidifier 5000 can include a humidifier reservoir docking member 5130 (as shown in Figure 5BAs shown, the humidifier reservoir docking member is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir docking member 5130 may include a locking feature, such as a locking lever 5135, that is configured to hold the reservoir 5110 in the humidifier reservoir docking member 5130.

[0397] 5.6.2.4 Water level indicator

[0398] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figure 5A -5B. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as the 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 may include an indication of the maximum predetermined volume of water, any portion of the water, such as 25%, 50%, or 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0399] 5.6.2.5 Heating element

[0400] In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to an air stream. The heating element 5240 may include a heat generating component such as a resistive heating track. A suitable example of the heating element 5240 is a laminated heating element, such as the laminated heating element described in PCT patent application publication text WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0401] 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, as shown in Figure 5B shown.

[0402] 5.7 Respiratory waveform

[0403] Figure 6 A typical respiratory waveform model of a person during sleep is shown. The horizontal axis is time and the vertical axis is respiratory flow. Although the parameter values may vary, a typical respiration may 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, peak expiratory flow rate Qpeak -0.5 L / s. The total duration of respiration Ttot is approximately 4 s. A person typically breathes at a rate of about 15 breaths per minute (BPM), and the ventilation volume Vent is about 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0404] 5.8 Glossary

[0405] For purposes of implementing the objectives of the present disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

[0406] 5.8.1 General Principles

[0407] Air: In certain 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 refer to some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0408] Environment: In certain forms of the present technology, the term environment may have the following meanings (i) external to the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0409] For example, the ambient humidity relative to a humidifier may 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 may be different from the humidity outside the room where the patient is sleeping.

[0410] In another example, the ambient pressure may be the pressure directly surrounding the body or outside the body.

[0411] In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where the patient is located, in addition to noise generated, for example, by an RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0412] Auto Positive Airway Pressure (APAP) Therapy: A CPAP therapy in which the treatment pressure is automatically adjustable between a minimum and a maximum, for example, varying with each breath, depending on whether there is an indication of an SBD event.

[0413] Continuous Positive Airway Pressure (CPAP) Therapy: A breathing pressure therapy in which the treatment pressure may be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, increasing in response to detecting an indication of a partial upper airway obstruction and decreasing in the absence of an indication of a partial upper airway obstruction.

[0414] Flow: The volume (or mass) of air delivered per unit time. Flow can refer to an instantaneous quantity. In some cases, reference to flow will be reference to a scalar, i.e., a quantity having only magnitude. In other cases, reference to flow will be reference to a vector, i.e., a quantity having both magnitude and direction. Flow can be given the symbol Q. 'Flow' is sometimes simply abbreviated to 'flux' or 'airflow'.

[0415] In an example of patient breathing, flow can nominally be 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 Qt is the flow of air leaving the RPT device. The ventilation flow Qv is the flow of air leaving the vent to allow clearance of exhaled gas. The leak flow Ql is the flow of air leaking from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0416] Humidifier: The term humidifier will be taken to mean a humidifying device constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical breathing condition.

[0417] Leak: The word leak will be taken to mean an undesired air flow. In one example, a leak can occur due to an imperfect seal between a face mask and a patient's face. In another example, a leak can occur in a return elbow to the surrounding environment.

[0418] Noise, conducted (acoustic): Conducted noise in this document refers to noise brought to the patient through a pneumatic path such as an air circuit and a 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.

[0419] Noise, radiated (acoustic): Radiated noise in this document refers to noise 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.

[0420] Noise, ventilated (acoustic): Ventilated noise in this document refers to noise generated by the air flow through any vent such as the vent of a patient interface.

[0421] Patient: A person, whether or not they have a respiratory condition.

[0422] Pressure: Force per unit area. Pressure can be expressed in units including cmH2O, g-f / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2And is approximately 0.98 Pascals. In this specification, unless otherwise stated, pressures are given in cmH2O.

[0423] The pressure in the patient interface is given by the symbol Pm, while the therapy pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the mask pressure Pm.

[0424] Respiratory Pressure Therapy (RPT): Air supply is applied to the airway inlet at a typically positive therapy pressure relative to the atmosphere.

[0425] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0426] 5.8.1.1 Materials

[0427] 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 (including the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is the Wacker Group. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) durometer hardness in the range of approximately 35 to approximately 45 as measured using ASTM D2240.

[0428] Polycarbonate: A transparent thermoplastic polymer that is a bisphenol A carbonate.

[0429] 5.8.1.2 Mechanical Properties

[0430] Resilience: The ability of a material to absorb energy during elastic deformation and release the energy upon unloading.

[0431] Elasticity: Substantially all of the energy will be released upon unloading. Includes, for example, certain siloxanes and thermoplastic elastomers.

[0432] Hardness: The ability of a material to resist deformation by itself (described, for example, by Young's modulus or a durometer hardness scale measured on a standardized sample size).

[0433] "Soft" materials can include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure.

[0434] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum and are not easily deformed, for example, under finger pressure.

[0435] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistances in different directions.

[0436] Flexible structure or component: A structure or component that will change shape (e.g., bend) when made to support its own weight over a relatively short time, such as within 1 second.

[0437] Rigid structure or component: A structure or component that will generally not change shape when subjected to the loads normally encountered in use. An example of such use can be, for example, setting and maintaining a patient interface in a sealed relationship with the entrance of a patient airway under a pressure of approximately 20 to 30 cmH2O.

[0438] As an example, an I-beam can include a different bending stiffness (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component can be flexible in a first direction and rigid in a second direction.

[0439] 5.8.2 Anatomy

[0440] 5.8.2.1 Anatomical structure of the face

[0441] Ala: The outer lateral wall or "wing" of each nostril (plural: alae)

[0442] Ala angle:

[0443] Ala tip: The outermost point on the ala.

[0444] Ala bend (or ala apex) point: The most posterior point in the bending baseline of each ala, which is found in the fold formed by the junction of the ala and the cheek.

[0445] Auricle: The entire outer visible part of the ear.

[0446] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0447] (Nasal) soft skeleton: The nasal soft skeleton includes the septum, the lateral, the major, and the minor cartilages.

[0448] Columella: A strip of skin that separates the nostrils and extends from the nasal tip to the upper lip.

[0449] Columella angle: The included angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (while the two lines intersect at the inferior point of the nasal septum).

[0450] Frankfurt horizontal plane: A line extending from the lowest point on the edge of the eye socket to the left cochlea. The cochlea is the deepest point in the notch of the upper tragus of the auricle.

[0451] Glabella: Located on the soft tissue, the most prominent point in the mid-sagittal plane of the forehead.

[0452] External nasal cartilage: A cartilaginous plate that is roughly triangular. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the major alar cartilage.

[0453] Lip, lower (midpoint of lower lip):

[0454] Lip, upper (midpoint of upper lip):

[0455] Major alar cartilage: A cartilaginous plate located below 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 includes three or four small cartilages of the ala.

[0456] Nostril (nasal aperture): An approximately oval-shaped opening that forms the entrance to the nasal cavity. The singular form of nostril (nare) is naris (nasal aperture). The nostrils are separated by the nasal septum.

[0457] Nasolabial groove or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0458] Nasolabial angle: The angle between the columella and the upper lip (meeting at the inferior nasal septal point).

[0459] Inferior auricular basal point: The lowest point where the auricle is attached to the facial skin.

[0460] Superior auricular basal point: The highest point where the auricle is attached to the facial skin.

[0461] Nasal tip point: The most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0462] Philtrum: A midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip region.

[0463] Menton: Located on the soft tissue, the midpoint of the most anterior part of the chin.

[0464] Ridge (nose): The nasal ridge is a midline protrusion on the nose that extends from the nasion to the nasal tip point.

[0465] Sagittal plane: A vertical plane that runs from front (anterior) to back (posterior). The mid-sagittal plane is the sagittal plane that divides the body into a right and a left half.

[0466] Nasion: Located on the soft tissue, the most concave point covering the fronto-nasal suture area.

[0467] Septal cartilage (nose): The septal cartilage forms part of the septum and separates the anterior part of the nasal cavity chambers.

[0468] Subnasale: The point at the lower edge of the base of the ala, where the base of the ala joins the skin of the upper (superior) lip.

[0469] Gnathion: The point on the soft tissue at the intersection of the columella and the upper lip in the median sagittal plane.

[0470] Gnathion: The point on the midline of the lower lip at the greatest concavity between the midpoint of the lower lip and the soft tissue pogonion.

[0471] 5.8.2.2 Anatomical structures of the skull

[0472] Frontal bone: The frontal bone includes a large vertical part (frontal squama), which corresponds to the area known as the forehead.

[0473] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony prominence of the mandible that forms the chin.

[0474] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.

[0475] Nasal bones: The nasal bones are two small oval bones, which vary in size and form in different individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose at their point of junction.

[0476] Nasion: The intersection of the frontal bone and the two nasal bones, directly between the eyes and in the depressed area above the bridge of the nose.

[0477] Occipital bone: The occipital bone is located at the posterior and lower part of the skull. It includes an oval opening (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squama.

[0478] Orbit: The bony cavity in the skull that houses the eyeball.

[0479] Parietal bone: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0480] Temporal bone: The temporal bones are located at the base and sides of the skull and support the part of the face called the temple.

[0481] Zygomatic bone: The face includes two zygomatic bones, which are located in the upper and lateral parts of the face and form the prominence of the cheek.

[0482] 5.8.2.3 Anatomical structures of the respiratory system

[0483] Diaphragm: A muscular sheet that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0484] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0485] Lungs: The organs of respiration in humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0486] Nasal cavity: The nasal cavity (or nasal fossa) is the 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 fin called the nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, and the back joins the nasopharynx via the internal nares.

[0487] Pharynx: The part of the throat located immediately below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (lower pharynx).

[0488] 5.8.3 Patient Interface

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

[0490] Elbow: An elbow is an example of a structure that redirects the axis of the air flow passing through it by a certain angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have an approximately circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to a mating component, for example, about 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap connection. In some forms, the elbow can be snap-assembled to the mating component during manufacturing but cannot be removed by the patient.

[0491] Frame: The frame will be considered to mean a mask structure that bears the tension load between two or more connection points to the headband. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames can also be airtight.

[0492] Headgear: Headgear will be considered to mean a form of structure designed for positioning and stabilization on the head. For example, headgear may include a collection of one or more support rods, straps, and reinforcements configured to position and hold a patient interface on a patient's face in a position for delivering respiratory therapy. Some straps are formed from soft, flexible, elastic materials such as laminated composites of foam and fabric.

[0493] Membrane: A membrane will be considered to refer to a typically thin element that preferably has substantially no resistance to bending but has resistance to stretching..

[0494] Inflatable chamber: A mask inflatable chamber will be considered to mean a part of a patient interface having a wall that at least partially encloses a volume of space that, in use, has air pressurized therein to a pressure above atmospheric pressure. A housing may form part of the wall of the mask inflatable chamber.

[0495] Seal: Can refer to the noun form of the structure (seal) or the verb form of the effect (seal). Two elements may be configured and / or arranged to'seal' or achieve a'seal' therebetween without the need for a separate'seal' element itself.

[0496] Housing: A housing will be considered to mean a curved and relatively thin structure having bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a mask can be a housing. In some forms, the housing can be polyhedral. In some forms, the housing can be airtight. In some forms, the housing may not be airtight.

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

[0498] Support: A support will be considered to be a structural component designed to increase the compressive resistance of another component in at least one direction.

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

[0500] Strap (noun): A structure for resisting tension.

[0501] Vent port: (noun): A structure that allows air flow from inside the mask or catheter to ambient air, e.g., for effective clearance of exhaled gas. For example, clinically effective clearance can involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

[0502] 5.8.4 Shape of the structure

[0503] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask gasket or a pusher. The three-dimensional structure may be joined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relevant surface orientation, position, function, or some other feature. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the sealing-forming structure may include a surface (e.g., an outer surface) that contacts the face and a separate surface (e.g., a lower side or an inner surface) that does not contact the face. In another example, the structure may include a first surface and a second surface.

[0504] To assist in describing the shape of the three-dimensional structure and the surface, first consider a cross-section through a point p on the surface of the structure. See Figures 3B to 3F , which show cross-sections at point p on the surface and examples of the resulting planar curves. Figures 3B to 3F Also shown is the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the viewpoint of an imaginary little person standing upright on the surface.

[0505] 5.8.4.1 One-dimensional curvature

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

[0507] Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken as positive (if the imaginary little person leaves point p, they must walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C ) and Figure 3C (relatively small positive curvature compared to Figure 3B ). Such curves are typically referred to as concave.

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

[0509] Negative curvature: If the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken as negative (if imaginary little people leave point p, they must go downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F and Figure 3F (relatively large negative curvature compared to Figure 3E ). Such curves are commonly referred to as convex.

[0510] 5.8.4.2 Curvature of a Two-Dimensional Surface

[0511] The description of the shape at a given point on a two-dimensional surface according to the present technology can include a plurality of normal cross-sections. The plurality of 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 plane curve with a corresponding curvature. The different curvatures at that point can have the same sign or different signs. Each curvature at that point has a magnitude, for example a relatively small magnitude. Figures 3B to 3F The plane curves in

[0512] can be examples of such a plurality of cross-sections at a specific point. Figures 3B to 3F In the example of Figure 3B the maximum curvature occurs in Figure 3F and the minimum curvature occurs in Figure 3B and Figure 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

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

[0514] Saddle region: A region where the principal curvatures have opposite signs at each point, i.e., one sign is positive and the other sign is negative (depending on the direction in which imaginary individuals turn, they can go up or down).

[0515] Vault region: A region where the principal curvatures have the same sign at each point, such as two positive (“concave vault”) or two negative (“convex vault”).

[0516] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is not zero.

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

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

[0519] Path: In certain forms of the present technology, a 'path' will be considered to mean a path in the mathematical-topological sense, such as a continuous space curve on a surface from f(0) to f(1). In certain forms of the present technology, a 'path' can be described as a route or course, including, for example, a set of points on a surface. (The path of a hypothetical person is where they walk on the surface and is analogous to a garden path).

[0520] Path length: In certain forms of the present technology, 'path length' will be considered to be the distance along a surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a hypothetical person will be the distance they must walk along the path on the surface.

[0521] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without considering the surface. On a planar region, there will be a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For an imaginary individual, the straight-line distance will correspond to the distance as a'straight line').

[0522] 5.8.4.3 Space curve

[0523] Space curve: Different from a planar curve, a space curve does not have to lie in any specific plane. A space curve can be closed, i.e., have no endpoints. A space curve can be considered as a one-dimensional segment of three-dimensional space. A hypothetical person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q .. A typical human right ear includes a helix, which is a right-handed helix, see Figure 3R .. Figure 3S A right-handed helix is shown. The edge of a structure, such as the edge of a membrane or an impeller, can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0524] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction as well as the magnitude starting from the said point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person is flying along a curve and drops from their aircraft at a particular point, the direction of the tangent vector is the direction in which she will travel.

[0525] Unit normal vector: When a hypothetical person moves along the curve, this tangent vector itself changes. The unit vector pointing in the direction of the change of the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0526] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Figure 3P ) or alternatively by the left-hand rule ( Figure 3O ).

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

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

[0529] Referring to Figure 3P the right-hand rule of Figure 3S , a space curve oriented towards the right-hand side binormal direction can be considered to have a right-handed positive torsion (e.g., the right-handed helix shown in

[0530] ). A space curve that turns away from the right-hand binormal direction can be considered to have a right-handed negative torsion (e.g., a left-handed helix). Figure 3O ) and similarly, referring to the left-hand rule (see Figure 3T ), a space curve oriented towards the left-hand binormal direction can be considered to have a left-handed positive torsion (e.g., a left-handed helix). Thus, left-handed positive is equivalent to right-handed negative. See

[0531] 5.8.4.4 Holes

[0532] A surface can have one-dimensional holes, e.g., holes bounded by a plane curve or by a space curve. A thin structure (e.g., a membrane) with holes can be described as having one-dimensional holes. For example, see the one-dimensional hole in the surface bounded by a plane curve of the structure shown in Figure 3I .

[0533] The structure can have two-dimensional pores, such as pores defined by a surface. For example, a pneumatic tire has a two-dimensional pore defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example Figure 3L the gasket and through Figure 3M and Figure 3N the exemplary cross-sections in, which show the inner surface defining the two-dimensional pore. In yet another example, a conduit can include a one-dimensional pore (e.g., at its inlet or at its outlet) and a two-dimensional pore defined by the inner surface of the conduit. Also see Figure 3K the two-dimensional pore defined by the shown surface in the shown structure.

[0534] 5.9 Other Remarks

[0535] Part of the disclosure of this patent document contains copyrighted material. The copyright owner does not object to anyone reproducing these patent documents or patent disclosures in the form in which they appear in the patent office files or records, but reserves any and all copyright rights otherwise.

[0536] Unless explicitly stated in the context and where a numerical range is provided, it should be understood that each intermediate value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated value or intermediate value within the said range are broadly included in the present technology. The upper and lower limits of these intermediate ranges can be independently included in the intermediate range and also in the scope of the present technology, subject to any explicit exclusionary bounds within the said range. In the case where the range includes one or both of the limiting values, ranges excluding any one or both of the included limiting values are also included in the present technology.

[0537] Furthermore, in the case where one or more values described herein are implemented as part of the present technology, it should be understood that such values can be approximate unless otherwise stated, and such values can be used to any appropriate significant digits to the extent that the practical technology implementation permits or requires them.

[0538] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this 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.

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

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

[0541] All publications mentioned herein are hereby incorporated by reference in their entirety to disclose and describe the methods and / or materials as the subject matter of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. This application should not be construed as an admission that the present technology is not entitled to antedate such disclosure by virtue of a prior invention. Further, the provided publication dates may be different from the actual publication dates, which may require independent verification.

[0542] The terms "comprises" and "comprising" are to be understood as: referring to each element, each component, or each step in a non-exclusive manner, indicating that the marked elements, components, or steps may be present or utilized, or a combination with other elements, components, or steps that are not marked.

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

[0544] Although the techniques herein have been described with reference to specific examples, it should be understood that these examples merely illustrate the principles and applications of the techniques. In some cases, the terms and symbols may imply specific details that are not required for the practice of the techniques. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to denote any order, but may be used to distinguish different elements. Further, although the process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence can be modified and / or aspects thereof can be performed simultaneously or even synchronously.

[0545] Accordingly, it should be understood that many modifications can be made to the illustrative examples without departing from the spirit and scope of the present technology, and other arrangements can be designed.

[0546] 5.7 List of Reference Signs

[0547]

[0548]

[0549]

[0550]

Claims

1. A patient interface for delivering a sealed airflow at a continuous positive pressure relative to the ambient air pressure to the patient airway inlet to improve sleep disordered breathing while the patient is sleeping, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of 4 cmH2O to 30 cmH2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface comprising: An inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; A seal-forming structure configured to form a seal with an area of the patient's face surrounding the inlet of the patient airway, the seal-forming structure having an aperture therein such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the seal-forming structure configured to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle in use; A positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure configured such that in use at least a portion covers an area on the patient's head above the nasion on the patient's head; And A ventilation structure allowing continuous flow of gas exhaled by the patient from the interior of the inflatable chamber to the surrounding environment, the ventilation structure sized and shaped to maintain the therapeutic pressure in the inflatable chamber in use; Wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized airflow passing through the inflatable chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered; Wherein the positioning and stabilizing structure includes: A knitted band 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 or a lower portion located below the occipital bone in use, the band portion defining a loop and having an inner perimeter and an outer perimeter; and Paired upper band portions, each upper band portion configured to connect between the band portion and a cushion assembly on a corresponding side of the patient's head above the nasion in use; Wherein the band portion includes a first knitted structure forming a first portion extending along at least a portion of the outer perimeter of the band portion, Wherein the band portion includes a second stiffened knitted structure forming a second stiffened portion disposed near the inner perimeter of the band portion, and Wherein the first knitted structure and the second stiffened knitted structure are integrally formed as a single piece, the first knitted structure is a different knitted structure from the second stiffened knitted structure, and the first portion has increased stretchability compared to the second stiffened portion.

2. The patient interface according to claim 1, wherein, The second stiffening portion is disposed generally along the entire length of the loop defined by the annulus portion.

3. The patient interface according to claim 1, wherein, The first portion extends along the entire outer perimeter of the annulus portion.

4. The patient interface according to claim 3, wherein, The second stiffening portion defines at least a portion of the inner perimeter of the annulus portion.

5. The patient interface according to claim 3, wherein, The second stiffening portion forms generally the entire inner perimeter of the annulus portion.

6. The patient interface according to claim 1, wherein, The first portion is directly adjacent to the second stiffening portion.

7. The patient interface of claim 1, wherein the upper strap portion is stretchable.

8. The patient interface according to claim 1, wherein, The second stiffening portion is generally non-stretchable.

9. The patient interface according to claim 1, wherein, The annulus portion includes a circular edge.

10. The patient interface according to any one of claims 1 to 9, wherein, The second stiffening portion includes an increased material thickness relative to an adjacent portion of the annulus portion.

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

12. The patient interface according to claim 10, wherein, The annulus portion includes a thickness of 4 mm in the second stiffening portion.

13. The patient interface according to claim 10, wherein, The positioning and stabilizing structure includes a one-piece knitted headband of a single piece of material, the one-piece knitted headband including the knitted annulus portion.

14. The patient interface according to any one of claims 1 to 9, wherein, The second stiffening portion is greater in the region of the annulus portion near the upper strap portion than in other regions of the annulus portion.

15. The patient interface according to claim 14, wherein, The second stiffening portion is wider near the upper strap portion than in other regions of the annulus portion.

16. The patient interface according to any one of claims 1 to 9, wherein, The annulus portion includes at least one vent portion configured to provide increased breathability through the annulus portion at the vent portion.

17. The patient interface according to claim 16, wherein, The vent portion includes a knitted fabric having a dimpled mesh knitted structure.

18. The patient interface according to claim 16, wherein, The vent portion is less stretchable than other portions of the annulus portion.

19. The patient interface according to claim 16, wherein, The second stiffening portion surrounds the vent portion.

20. The patient interface according to claim 16, wherein, The annulus portion includes a pair of upper vent portions, each upper vent portion being disposed near a respective upper strap portion.

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

22. The patient interface according to claim 21, wherein, The second stiffening portion includes 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.

23. The patient interface according to any one of claims 1 to 9, wherein, The positioning and stabilizing structure includes a pair of lower strap portions, each lower strap portion configured to connect between the annulus portion and the cushion assembly on a respective side of the patient's head above and below the bridge of the nose in use.

24. The patient interface according to claim 23, wherein, The annulus portion includes a lower vent portion disposed between the pair of lower strap portions.

25. The patient interface according to claim 24, wherein, The lower vent portion includes a lower edge spaced from the lower edge of the annulus portion.

26. The patient interface according to claim 25, wherein, The lower edge of the lower vent portion includes a greater curvature than the lower edge of the annulus portion to create a maximum spacing between the lower edge of the lower vent portion and the lower edge of the annulus portion at or near the sagittal plane of the patient's head in use.

27. The patient interface according to claim 23, wherein, The lower strap portion is stretchable.

28. The patient interface according to any one of claims 1 to 9, wherein The entire annulus portion includes a knitted fabric structure.

29. The patient interface according to claim 28, wherein, The annulus portion is formed by plain knitting.

30. The patient interface according to claim 28, wherein, The annulus portion includes a single-sided knitted structure.

31. The patient interface according to claim 28, wherein, The annulus portion includes a double-sided knitted loop formed knitted structure.

32. The patient interface according to claim 28, wherein, The second stiffening portion includes a dimpled knitted structure.

33. The patient interface according to any one of claims 1 to 9, wherein, The upper portion of the annulus portion includes a pair of top band portions that are adjustably connected to each other near the sagittal plane of the patient's head.

34. The patient interface according to claim 33, wherein, The top band portions are adjustably connected by a buckle.

35. The patient interface according to claim 34, wherein, The top band portions include hook-and-loop fastening material to allow each of the top band portions to pass through a portion of the buckle and secure back to itself.

36. The patient interface according to any one of claims 1 to 9, wherein, The positioning and stabilization structure includes a frame connected to the inflatable chamber, and the upper band portion is configured to be connected to the frame.

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