Positioning and stabilization structure for a patient interface

Abstract

To provide medical equipment for screening, diagnosis, monitoring, improvement, treatment or prevention of a respiratory disease, in which comfortability, cost, effectiveness, usability, or manufacturability has been improved.SOLUTION: A patient interface includes a positioning and stabilization structure including a headgear. The headgear includes a ring strap part together with an upper part placed on the parietal bone of the head of a patient when in use and a lower part placed on the occipital bone of the head of the patient or disposed on the lower side of the occipital bone of the head of the patient when in use. The ring strap part defines a loop having a pair of upper strap parts configured to connect between the ring strap part and a cushion assembly in use on a respective side of the patient's head above an otobasion superius. The headgear can include a rigidity-enhanced part. The headgear can be integrally formed by weft knitting, and the strap part can include a blind guide that provides tactile notification on a place of a fastening part.SELECTED DRAWING: Figure 7

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Application No. 2019900507, filed on 18 February 2019. The entire content of each of these documents is incorporated herein by reference in its entirety.

[0002] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory - related diseases. This technology also relates to medical devices or apparatus and their use.

Background Art

[0003] 2.2 Description of related technologies 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0004] These airways include a series of branching tubes that become narrower, shorter and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, taking oxygen from the air into venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, and this region is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific manifestations (e.g., apnea, hypopnea and hyperventilation).

[0006] Examples of respiratory diseases 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 disease.

[0007] To treat or improve such conditions, a range of treatments are used. Furthermore, in other respects, healthy individuals can also advantageously utilize preventive treatment for respiratory diseases. However, in these, there are multiple drawbacks.

[0008] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are used for the treatment of one or more of the above respiratory diseases.

[0009] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, continuous positive pressure respiratory therapy functions as an air sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment provision, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0010] 2.2.3 Treatment system These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating the disease.

[0011] The treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0012] As another form of treatment system, there is a mandibular repositioning device.

[0013] 2.2.3.1 Patient Interface The patient interface can be used, for example, to provide an interface to the breathing apparatus to the wearer by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other forms of treatment such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0014] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of a purely decorative mask, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the ambient.

[0015] Certain masks may be clinically unfavorable in this technology (e.g., when the mask blocks the air flow through the nose and only allows air flow through the mouth).

[0016] In certain masks, it may be uncomfortable or impractical in this technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state through the lips.

[0017] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on the pillow).

[0018] In the design of patient interfaces, there are multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment.

[0019] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there is one or more of the reasons such as being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask can withstand their original uses, but in the case of such masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with the treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0020] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0021] In the case of masks for other uses (e.g., pilots), they may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0022] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0023] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0024] The patient interface may be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0025] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0026] A particular seal-forming structure can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it is necessary to conform one or both to some extent to account for the mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface.

[0027] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure can include an air or fluid-filled cushion or can include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0028] Another type of seal-forming structure uses a thin flap seal located 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 previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal, or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the shape of the patient, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0029] Another type of seal-forming structure can include friction fit elements inserted into the nostrils, for example, although there are patients who find these seal-forming portions uncomfortable.

[0030] Another form of seal-forming structure can use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0031] Techniques for forming a patient interface seal structure within a certain range are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0032] One form of nasal pillows can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Corporation.

[0033] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describes the appearance of ResMed Limited's SWIFT® Nasal Pillow), U.S. Patent Application No. 2009 / 0044808 (in particular, describes the appearance of ResMed Limited's SWIFT® LT Nasal Pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describe the appearance of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (in particular, describes the appearance of ResMed Limited's SWIFT® FX Nasal Pillow).

[0034] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of the patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0035] In one technique, an adhesive part is used. For example, refer to Patent Document 1: US Patent Application Publication No. US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0036] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a large number of such harnesses, one or more of the following points apply: poor fit, bulky, uncomfortable, and difficult to handle.

[0037] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above-mentioned treatments, or as part of a system, for example, by operating the device to generate an air delivery flow to the interface to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0038] 2.2.3.3 Humidifier If the delivery of the air flow is carried out without humidification, it may lead to drying of the airway. When a humidifier is used together with an RPT device and a patient interface, a humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient's airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort more than in the case of cold air.

[0039] 2.2.3.4 Data Management For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate the usage rate over a given period, and compare this to the compliance rule. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0040] In a patient's treatment, there may be other ways to benefit from communicating treatment data to a third party or an external system.

[0041] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur.

[0042] 2.2.3.5 Mandibular Repositioning 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 providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before the patient goes to sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall to reduce airway collapse and reduce palatal vibration.

[0043] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit with the teeth on the maxilla or maxilla bone and a lower splint intended to engage or fit with the teeth on the maxilla or mandible. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0044] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0045] Some MRDs are configured to push the mandible forward relative to the maxilla bone, and some are designed to hold the mandible in a forward position, like other MADs such as the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temple and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth.

[0046] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a ventilation section for pushing out the exhaled carbon dioxide. This ventilation section can enable the gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0047] 2.2.4 Screening, diagnostic system and monitoring system A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases, and typically requires specialized clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For the PSG of sleep disordered breathing, it was necessary to observe the patient in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for the titration of treatment parameters by a clinician. Therefore, the PSG is costly and has low convenience. The screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0048] Generally, screening and diagnosis are to identify a disease by its signs and symptoms. Usually, screening gives a true / false result indicating whether the patient's SDB requires further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can be continued indefinitely. Some screening / diagnostic systems are only compatible with screening / diagnosis, while some can also be used for monitoring.

[0049] Clinical experts can appropriately perform patient screening, diagnosis, or monitoring based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may vary regarding a patient's condition. Furthermore, certain clinical experts may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

[0050]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0051] Brief Description of the Technology This technology is related to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0052] The first aspect of this technology is related to a device used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases.

[0053] Another aspect of this technology is related to a method used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory disorders.

[0054] One aspect of a specific form of this technology is to provide a method and / or device for improving patient compliance regarding respiratory treatment.

[0055] One form of the present technology includes a positioning and stabilization structure for a patient interface, and the positioning and stabilization structure includes an integrally formed strap formed by warp knitting. The strap can be connected to the frame of the patient interface or the plenum chamber via four connection points.

[0056] Another form of the present technology includes a positioning and stabilization structure for a patient interface, and the positioning and stabilization structure includes an integrally formed knitted strap including a plurality of knitted structures, each knitted structure including different mechanical properties. The strap can be formed by warp knitting.

[0057] Another form of the present technology includes a positioning and stabilization structure for a patient interface. The positioning and stabilization structure includes an integrally formed knitted strap including at least a first portion and a second portion, the first portion having a different elasticity from the second portion. The first portion can include a ring strap portion configured to be disposed opposite the rear and upper surfaces of the patient's head. The second portion can include an upper strap portion. The upper strap portion is disposed along the patient's face during use and is configured to connect between the ring strap portion and the plenum chamber of the patient interface. The strap can be formed by warp knitting.

[0058] Another form of the present technology includes a positioning and stabilization structure for a patient interface. The positioning and stabilization structure includes an integrally formed knitted strap having a plurality of ventilation portions forming a region with higher air permeability. The ventilation portions can include a first knitted structure, and other portions of the strap can include a second knitted structure different from the first knitted structure. The ventilation portions can be formed together with a pique mesh knitted structure, while other portions of the strap can be formed together with a single jersey or double jersey knitted structure. The strap can be formed by warp knitting.

[0059] Another form of the technology includes a positioning and stabilization structure for a patient interface. The positioning and stabilization structure includes a strap that includes a ring strap portion. This ring strap portion is disposed opposite the rear and upper surfaces of the patient's head and is configured to define a loop having an inner circumference. The ring strap portion includes a stiffening portion at or near the inner circumference of the loop. The stiffening portion may include a first knitted structure, and other portions of the ring strap portion may include a second knitted structure. The stiffening portion may include a picot knitted structure, while other portions of the strap may include a single jersey or double jersey knitted structure. The strap may be formed by transverse knitting.

[0060] Another form of the technology includes a positioning and stabilization structure for a patient interface. The positioning and stabilization structure includes a strap that includes a fastening portion. The fastening portion is looped back on itself and secured to itself to secure the strap to the frame of the patient interface or the plenum chamber. The strap includes a blind guide configured to provide a tactile notification of the location of the fastening portion of the strap. The strap may be integrally formed with the blind guide. The strap may be formed by transverse knitting.

[0061] Another form of the present technology includes a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a continuous positive pressure with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep, so that sleep disordered breathing is improved. The patient interface includes: 1) a plenum chamber that can be pressurized to at least a therapeutic pressure of 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing; 2) a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding the inlet to the patient's airway, the seal-forming structure having holes therein such that the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; 3) a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged to be placed at least in part over an area of the patient's head above the upper ear tragus during use; and 4) a ventilation structure that allows the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber during use; and the patient interface is configured such that the patient can breathe from the surroundings through his or her mouth in the absence of a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0062] In an embodiment, a) the positioning and stabilizing structure has an upper part configured to be placed on the parietal bone of the patient's head during use and a lower part configured to be placed on the occipital bone of the patient's head or disposed below the occipital bone of the patient's head during use, the lower part being a ring strap part having a loop defined by the ring strap part, and b) the ring strap part includes a stiffening part provided along the length of the loop defined by the ring strap part.

[0063] In a further embodiment, a) the stiffening part is provided substantially along the entire length of the loop defined by the ring strap part; b) the stiffening part is provided to the ring strap part in the vicinity of the inner circumference of the ring strap part; c) the stiffening part defines at least a part of the inner circumference of the ring strap part; d) the stiffening part substantially forms the entire inner circumference of the ring strap part; e) the stiffening part is provided substantially centrally between the inner circumference of the ring strap part and the outer circumference of the ring strap part; f) the upper strap part is stretchable; g) the stiffening part is substantially non-stretchable; h) the ring strap part includes a circular edge; i) the material thickness of the stiffening part is greater than that of the adjacent part of the ring strap part; j) the patient contact side of the ring strap part is substantially flat, and a greater material thickness is imparted to the non-patient contact side of the ring strap part; k) the thickness of the ring strap part is 4 mm at the stiffening part; l) the thickness of the ring strap part is 2.5 mm in the region of the ring strap part other than the stiffening part; m) the stiffening part is greater in the region of the ring strap part adjacent to the upper strap part than in other regions of the ring strap part; and / or, n) the stiffening part is wider in the upper strap part than in other regions of the ring strap part.

[0064] In a further embodiment, a) the ring strap portion includes at least one vent portion structured and / or arranged to provide higher breathability through the ring strap portion at the vent portion; b) the vent portion includes a knitted fabric having a pique mesh structure; c) the vent portion is less stretchable than other parts of the ring strap portion; d) the stiffening portion surrounds the vent portion; e) the ring strap portion includes a pair of upper vent portions, each upper vent portion being provided adjacent to each upper strap portion; f) the stiffening portion surrounds each of the upper vent portions; g) the material thickness of the stiffening portion is greater at the rear side of each upper vent portion than at the front side of each upper vent portion; h) the positioning and stabilizing structure includes a pair of lower strap portions, each lower strap portion being configured to connect between the ring strap portion and the cushion assembly at each side of the patient's head below the upper ear base in use; i) the ring strap portion includes a lower vent portion provided between the pair of lower strap portions; j) the lower vent portion includes a lower edge spaced from the lower edge of the ring strap portion; k) the curvature of the lower edge of the lower vent portion is higher than that of the lower edge of the ring strap portion, so that a maximum spacing is obtained between the lower edge of the lower vent portion and the lower edge of the ring strap portion in the sagittal plane of the patient's head or in the vicinity thereof in use; l) the lower strap portion is stretchable; m) the ring strap portion includes a knitted fabric structure; n) the ring strap portion is formed by transverse knitting; o) the ring strap portion includes a single jersey knitted fabric structure; p) the ring strap portion includes a double jersey loop-forming knitted fabric structure; q) the stiffening portion includes a pique knitted fabric structure; r) the upper part of the ring strap portion includes a pair of supra-head strap portions adjustably interconnected in the vicinity of the sagittal plane of the patient's head; s) the supra-head strap portions are adjustably connected to a buckle; t) the supra-head strap portions include a hook-and-loop fastener material, by which each of the supra-head strap portions can be sent through a part of the buckle and fixed on itself; u) the positioning and stabilizing structure includes a frame connected to the plenum chamber, and the upper strap portion is configured to connect to the frame;And / or, v) the positioning and stabilizing structure further includes a lower strap portion configured to connect to the frame.;

[0065] Another form of the present technology includes a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a continuously positive pressure relative to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so that sleep disordered breathing is improved. The patient interface includes: 1) a plenum chamber that can be pressurized to at least a therapeutic pressure of 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for the patient's breathing; 2) a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding the inlet to the patient's airway, the seal-forming structure having a hole therein, whereby the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use; 3) a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged to be placed at least partially over an area of the patient's head above the upper ear tragus during use; and 4) a ventilation structure that moves a continuous gas flow exhaled by the patient from the interior of the plenum chamber to the atmosphere, the ventilation structure being sized and shaped such that it can maintain the therapeutic pressure within the plenum chamber during use, and the patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0066] In an embodiment, a) the positioning and stabilization structure includes at least one strap configured to connect to a cushion assembly, the strap being formed from a braided fabric and including a fastening portion near an end of the strap, the fastening portion being structured and / or arranged to loop the strap back onto itself and fasten itself to connect to the cushion assembly; b) the strap includes at least one blind guide, the at least one blind guide being formed by the braided fabric and configured to provide a tactile notification of the location of the fastening portion on the strap.

[0067] In a further embodiment, a) the strap is formed by transverse knitting; b) the strap includes a non-patient contact surface, and at least one blind guide includes a raised portion raised with respect to the non-patient contact surface and / or a recessed portion recessed with respect to the non-patient contact surface; c) the raised portion and / or the recessed portion surround at least a part of the fastening portion of the strap; d) the raised portion includes an elongated raised outer shape on the non-patient contact surface of the strap; e) the elongated raised outer shape is provided at one or more edges of the fastening portion; f) the elongated raised outer shape is provided at the edges of the fastening portion that are the upper edge, the rear edge, and the lower edge during use; g) the elongated raised outer shape includes a circular raised surface; h) the raised portion is formed by a thicker strap compared to the adjacent region of the strap, and the recessed portion is formed by a thinner strap compared to the adjacent region of the strap; i) the fastening portion of the strap includes a surface fastener material; j) the fastening portion includes an end portion with one of the hook material and the loop material provided on the non-patient contact surface, and an intermediate portion with the other of the hook material and the loop material provided on the non-patient contact surface; k) the intermediate portion is longer than the end portion. The intermediate portion is several times longer than the end portion; l) the strap and the blind guide are formed during a single knitting process; m) the blind guide includes a picot knitted structure; n) the strap includes a single jersey knitted structure; o) the strap includes double jersey loop formation; p) the strap is connected to the cushion assembly via the frame of the patient interface; q) the strap has an upper portion configured to be placed on the patient's head on the parietal bone of the patient's head during use, and a ring strap portion having a lower portion configured to be placed on the patient's head on the occipital bone of the patient's head during use or to be disposed below the occipital bone of the patient's head, and a pair of upper strap portions each configured to connect between the ring strap portion and the cushion assembly at each side portion of the patient's head above the upper ear base point during use; r) the strap includes a pair of lower strap portions, and each lower strap portion is configured to connect between the ring strap portion and the cushion assembly at each side portion of the patient's head below the upper ear base during use; and / or, s) the strap and the blind guide are integrally formed.

[0068] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet of a patient's airway, including at least the patient's nostril inlet, at a continuous positive pressure relative to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O, which is higher than the ambient air pressure during use throughout the patient's respiratory cycle during sleep, so as to improve sleep disordered breathing. The patient interface includes: 1) a plenum chamber that at least partially forms a cavity that can be pressurized up to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing; 2) a seal-forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face that surrounds an inlet to the patient's airway below the nasal bridge region of the patient's face, the fabric membrane having holes formed therein such that the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use; and 3) a positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure being constructed and arranged such that at least a part thereof is placed on an area of the patient's head above the upper ear base point of the patient's head during use.

[0069] In an embodiment, a) the positioning and stabilization structure includes a one-piece knitted headgear strap of a single material piece; b) the knitted headgear strap includes at least one first region having a first knitting structure; c) the knitted headgear strap includes at least one second region, and the at least one second region has a second mesh knitting structure forming at least one ventilation region that is more flexible than the first region; d) the knitted headgear strap includes at least one third region where a stiffening knitting structure is directly adjacent to at least one ventilation region, and the stiffening knitting structure has a higher rigidity compared to the first knitting structure and the second mesh knitting structure.

[0070] In a further embodiment, a) the stiffening knitting structure surrounds at least one ventilation region; b) the stiffening knitting structure is a picot knitting structure; c) the picot knitting structure is a picot rib structure; d) the second mesh knitting structure is a picot mesh knitting structure; e) the ventilation region has a higher breathability compared to at least one first region and at least one third region.

[0071] In a further embodiment, a) the knitted headgear strap includes a ring strap portion. This ring strap portion has an upper part configured to be placed on the parietal bone of the patient's head during use and a lower part configured to be placed on the occipital bone of the patient's head or disposed under the occipital bone of the patient's head during use, and a loop is defined by the ring strap portion; b) the ring strap portion has an inner edge and an outer edge, and the stiffening knitting structure extends along the inner edge of the ring strap portion; c) the stiffening knitting structure forms a loop extending along the entire inner edge of the ring strap portion; d) the ring strap portion includes at least one ventilation region; e) the knitted headgear strap further includes a neck strap portion configured to be placed on the occipital bone of the patient's head and / or disposed relative to the patient's neck during use, and the neck strap portion includes at least one ventilation region; the first knitting structure is a jersey knitting structure.

[0072] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlet, at a positive pressure continuously with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so as to improve sleep disordered breathing. The patient interface includes: 1) a plenum chamber at least partially forming a cavity pressurizable to at least a therapeutic pressure of 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for the patient's breathing; 2) a seal-forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge region of the patient's face, the fabric membrane having holes formed therein such that the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use; and 3) a positioning and stabilization structure providing a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure being constructed and arranged to be placed at least partially over an area of the patient's head above the upper ear base points of the patient's head during use.

[0073] In an embodiment, a) the positioning and stabilization structure includes a one-piece knitted headgear strap of a single piece of material; b) the knitted headgear strap includes a first region having a first knitting structure; c) the knitted headgear strap includes a second region having a second picot knitting structure, the second picot knitting structure having a higher stiffness than the first knitting structure; d) the second picot knitting structure extends along a first edge of the knitted headgear strap and is directly adjacent to the first knitting structure.

[0074] In a further embodiment, a) the first knitting structure extends along a second edge of the knitting headgear strap; b) the knitting headgear strap includes a ring strap portion. This ring strap portion has an upper part configured to be placed on the parietal bone of the patient's head during use and a lower part configured to be placed on the occipital bone of the patient's head or disposed below the occipital bone of the patient's head during use, and a loop is defined by the ring strap portion; c) the ring strap portion has an inner edge and an outer edge, and the inner edge of the ring strap portion is formed by the first edge of the knitting headgear strap; d) the first knitting structure extends along the second edge of the knitting headgear strap, and the outer edge of the ring strap portion is formed by the second edge of the knitting headgear strap.

[0075] In a further embodiment, a) the first knitting structure has a higher stretchability compared to the second picot knitting structure; b) the knitting headgear strap further includes a third region having a third mesh knitting structure, and the third mesh knitting structure has a lower rigidity than the first knitting structure and the second picot knitting structure; c) the third mesh knitting structure is a picot mesh knitting structure; d) the second picot knitting structure is directly adjacent to the third mesh knitting structure; e) the third mesh knitting structure forms a ventilation region having higher air permeability than the first region and the second region, the second picot knitting structure surrounds the ventilation region; the first knitting structure is a jersey knitting structure.

[0076] Another aspect of the present technology relates to a method of forming a positioning and stabilization structure for a patient interface. The positioning and stabilization structure is configured to provide a force for holding a seal-forming structure in a therapeutically effective position on the patient's head for the treatment of sleep apnea. The method includes knitting a one-piece headgear strap directly into a final shape as a single piece of material.

[0077] In a further embodiment, a) the step of knitting the one-piece headgear strap includes knitting at least one first region of the headgear strap having a first knitting structure; b) the step of knitting the one-piece headgear strap includes knitting at least one second region of the headgear strap having a second mesh knitting structure, and by the second mesh knit, at least one ventilation region of the headgear strap having a higher flexibility than the first region is formed; c) the step of knitting the one-piece headgear strap includes knitting at least one third region of the headgear strap having a stiffening knitting structure in the immediate vicinity of at least one ventilation region, the stiffening knitting structure having a higher stiffness compared to the first knitting structure and the second mesh knitting structure; d) the headgear strap includes a plurality of strap portions. These plurality of strap portions are configured to be connected to a cushion assembly so as to be held in a therapeutically effective position on a patient's head during use.

[0078] In a further embodiment, a) the step of knitting the one-piece headgear strap includes a single weft knitting process; b) the stiffening knitting structure surrounds at least one ventilation region; c) the stiffening knitting structure is a picot knitting structure; d) the second mesh knitting structure is a picot mesh knitting structure; e) the ventilation region has a higher breathability compared to at least one first region and at least one third region; f) the knitted headgear strap includes a ring strap portion. This ring strap portion has an upper portion configured to be placed on the parietal bone of a patient's head during use and a lower portion configured to be placed on the occipital bone of a patient's head or disposed below the occipital bone of a patient's head during use, and a loop is defined by the ring strap portion; g) the ring strap portion has an inner edge and an outer edge, and the stiffening knitting structure extends along the inner edge of the ring strap portion; h) the stiffening knitting structure forms a loop extending along the entire inner edge of the ring strap portion; i) the first knitting structure is a jersey knitting structure.

[0079] Another form of the present technology includes a patient interface. The patient interface is: 1) a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing; 2) a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having a hole therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; 3) a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a tie, the tie being constructed and arranged to be placed at least in part over an area of the patient's head above the upper ear base points of the patient's head during use; and 4) a ventilation structure that moves a continuous gas flow exhaled by the patient from inside the plenum chamber to the atmosphere, the ventilation structure being sized and shaped such that it can maintain the treatment pressure within the plenum chamber during use, and the patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0080] In an embodiment, a) the positioning and stabilization structure includes: 1) a pair of headgear conduits for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, each headgear conduit being constructed and arranged to contact at least one area of the patient's head above the upper ear base points of the patient's head on each side of the patient's head during use; and 2) a strap integrally formed by cross-weaving.

[0081] In a further embodiment, a) the headgear strap includes: 1) a neck strap portion configured to be placed on the occipital bone of the patient's head and / or disposed opposite the patient's neck during use; 2) a pair of upper strap portions, each of the pair of upper strap portions being configured to connect between the neck strap portion and each headgear conduit on each side of the patient's head; and 3) a pair of lower strap portions, each of the pair of lower strap portions being configured to connect between the neck strap portion and each headgear conduit.

[0082] In a further embodiment, a) the strap is formed by a single weft knitting process; b) the strap includes a stiffening portion; c) the stiffening portion includes a picot knitted structure; d) the neck strap portion includes a stiffening portion; e) the neck strap portion includes one or more stretchable portions; f) the neck strap portion includes an upper stretchable portion and a lower stretchable portion; g) the upper stretchable portion is provided along the upper edge of the neck strap portion; h) the lower stretchable portion is provided along the lower edge of the neck strap portion; i) the strap includes a ventilation portion having a structure and / or arrangement that provides higher breathability through the strap at the ventilation portion; j) the ventilation portion is disposed within the neck strap portion; k) the ventilation portion includes a knitted fabric having a picot mesh knitted structure; l) the ventilation portion is less stretchable than other portions of the ring strap portion; and / or m) the stiffening portion surrounds the ventilation portion.

[0083] In a further embodiment, a) the strap includes a fastening portion near the end of the strap, the fastening portion being structured and / or arranged to connect to the plenum chamber by looping the strap around itself and fastening it to itself, the strap includes at least one blind guide, the at least one blind guide being formed by a braided fabric forming an integrally formed strap, and the at least one blind guide is configured to provide a tactile notification of the location of the fastening portion on the strap; b) the strap includes a non-patient contact surface, the at least one blind guide includes a raised portion, the raised portion being raised relative to the non-patient contact surface; c) the raised portion includes an elongate raised profile on the non-patient contact surface of the strap; d) the fastening portion of the strap includes hook-and-loop material; and / or e) the upper strap portion and the lower strap portion each include each blind guide.

[0084] Another aspect of one form of the technology is a patient interface shaped or otherwise constructed with a peripheral shape that is complementary to the intended wearer's shape.

[0085] One aspect of one form of the technology is a method of manufacturing the device.

[0086] One aspect of a particular form of the technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are less dexterous or lack insight, or people with limited experience using this type of medical device.

[0087] One aspect of one form of the technology is a portable RPT device that is portable by a human (e.g., around the home).

[0088] One aspect of one form of the technology is a patient interface that can be cleaned, for example, with soap and water in the patient's home, without the need for special cleaning equipment. One aspect of one form of the technology is a patient interface that can be cleaned, for example, with soap and water in the patient's home, without the need for special cleaning equipment.

[0089] Another aspect of the present technology relates to a treatment system for use in the treatment of sleep disordered breathing. The system includes: 1) a patient interface according to any of the above aspects; 2) a respiratory pressure therapy (RPT) device for supplying breathable gas at positive pressure; and 3) an air delivery tube for passing breathable gas from the RPT device to the patient interface.

[0090] The methods, systems, devices, and apparatuses described can be embodied to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the methods, systems, devices, and apparatuses described enable improvements in the technical field of the automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0091] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of various ones of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0092] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0093] 4 Brief Description of the Drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include the following like elements:

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0095] 5 Detailed Description of Embodiments of the Present Technology Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0096] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment can be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0097] 5.1 Treatment Method In one form, the present technology includes a method for treating a respiratory disease. The method includes the step of applying positive pressure to the entrance of the airway of the patient 1000.

[0098] In a specific embodiment of the present technology, the air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0099] In certain embodiments of the present technology, mouth breathing is restricted, limited, or prevented.

[0100] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device can include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0101] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation structure 3400, one form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities can be provided by one or more physical components. In some forms, one physical component can provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0102] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0103] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the ambient.

[0104] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the ambient.

[0105] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the ambient.

[0106] 5.3.1 Seal formation structure In one form of the present technology, the seal formation structure 3100 may provide a target seal formation area and may further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement location of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0107] In one form, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0108] In a particular form of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0109] The seal formation structure 3100 according to the present technology may be composed of a soft, flexible and elastic material (e.g., silicone).

[0110] In a particular form of the present technology, a system including more than one seal formation structure 3100 is provided. Each seal formation structure 3100 is configured to correspond to different sizes and / or shape ranges. For example, the system may include one form of the seal formation structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0111] 5.3.1.1 Sealing mechanism In one form, the seal formation structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilization structure.

[0112] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral portion of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0113] 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 constructed and arranged to be in a compressed state, for example, due to elastic tension in a positioning and stabilizing structure.

[0114] In one form, the seal forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0115] In one form, the seal forming structure includes a region having an adhesive surface or an adherent surface.

[0116] In certain forms of the technology, the seal forming structure may include one or more of a pressure assist sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or an adherent surface.

[0117] 5.3.1.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0118] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0119] 5.3.1.3 Upper Lip Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0120] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face during use.

[0121] 5.3.1.4 Jaw Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0122] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use.

[0123] 5.3.1.5 Forehead Region In one form, the seal-forming structure forms a seal over the forehead region of the patient's face when the seal is in use. In such a form, the plenum chamber may cover the eyes during use.

[0124] 5.3.1.6 Nasal Pillows In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose.

[0125] The nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a part of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, and connects the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially toward the structure to which the stem is connected.

[0126] 5.3.2 Plenum Chamber The plenum chamber 3200 has a perimeter of a shape that is complementary to the surface profile of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close 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 can extend around the entire edge of the plenum chamber 3200 during use. In some forms, the plenum chamber 3200 and the seal forming structure 3100 are formed from a single homogeneous piece of material.

[0127] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because the pressure is often reduced and / or the comfort of the wearer is increased.

[0128] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the harshness of the pressure of the patient interface and can assist in improving compliance with treatment. The use of a transparent material can assist the clinician in verifying the placement and function of the patient interface.

[0129] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the pressing tightness of the patient interface can be reduced, and compliance with treatment can be assisted in improving.

[0130] 5.3.3 Positioning and Stabilization Structure The seal formation structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0131] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure in the plenum chamber 3200 for lifting off the face.

[0132] In one form, the positioning and stabilization structure 3300 provides holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0133] In one form, the positioning and stabilization structure 3300 provides holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tubing drag or accidental interference with the patient interface).

[0134] In one form of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure 3300 has a non - obtrusive outer shape or cross - sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0135] In one embodiment of the present technology, there is provided a positioning and stabilization structure 3300 configured such that it does not have an overly large or bulging size that would interfere with a patient sleeping in a supine sleep position with the patient's head resting on the pillow in the rear region of the patient's head.

[0136] In one embodiment of the present technology, there is provided a positioning and stabilization structure 3300 configured such that it does not have an overly large or bulging size that would interfere with a patient sleeping in a lateral sleep position with the patient's head resting on the pillow in the lateral region of the patient's head.

[0137] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a decoupling site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This decoupling site is not resistant to compression and can be, for example, a flexible or flimsy strap. The decoupling portion is constructed and arranged so as to avoid a situation where, when the patient lies with their head on the pillow, the presence of the decoupling portion causes a force to the rear to be transmitted along the positioning and stabilization structure 3300 and interfere with the seal.

[0138] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one embodiment, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0139] In a particular embodiment of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut when in use and direct a force to bring a seal-forming structure into close contact with a part of the patient's face. In one example, the strap can be configured as a tie.

[0140] In one form of the present technology, the positioning and stabilization structure includes a first tie, which is constructed and arranged such that at least a part of its lower edge moves upward to the upper auricular point of the patient's head during use and covers a part of the parietal bone without covering the occipital bone.

[0141] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a part of its upper edge passes below the lower auricular point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head during use.

[0142] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in a divergent direction.

[0143] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and for example non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0144] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable such that water vapor can pass through it.

[0145] In a particular form of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system may include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0146] Figure 7 shows patient 1000 wearing patient interface 3000 according to an example of the present technology. Patient interface 3000 includes cushion assembly 3580 and positioning and stabilization structure 3300. The cushion assembly can include frame 3500, plenum chamber 3200 connected to the frame, and seal-forming structure 3100 provided to the plenum chamber. The cavity formed by at least the plenum chamber 3200 and the seal-forming structure 3100 can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber includes a plenum chamber inlet port sized and configured to receive an airflow at a treatment pressure for breathing by patient 1000. Patient interface 3000 in this example includes connection port 3600 connected to an air supply conduit. Air is supplied from the air supply conduit to plenum chamber 3200.

[0147] Patient interface 3000 can also include seal-forming structure 3100 constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's airway. Seal-forming structure 3100 has holes therein such that an airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils. In this example, patient interface 3000 includes seal-forming structure 3100 that seals around both the nose and the mouth. This type of patient interface is generally known as a full-face mask. In other examples, seal-forming structure 3100 can seal around the patient's nostrils and the patient's mouth can be exposed. Seal-forming structure 3100 is constructed and arranged to maintain a treatment pressure within plenum chamber 3200 throughout the patient's breathing cycle during use.

[0148] Patient interface 3000 further includes ventilation structure 3400. Ventilation structure 3400 enables the gas exhaled by the patient to flow continuously from inside plenum chamber 3200 to the surroundings. Ventilation structure 3400 is sized and shaped to maintain the treatment pressure within the plenum chamber during use.

[0149] The patient interface 3000 also includes a positioning and stabilization structure 3300 that provides a force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's head. The positioning and stabilization structure, including a tie, is constructed and arranged such that at least a portion thereof covers a region of the patient's head above the upper ear base point of the patient's head during use. In one example of the present technology, the positioning and stabilization structure 3300 includes a frame 3500 to which the plenum chamber 3200 is connected. The frame 3500 is held in place by a plurality of strap portions of the positioning and stabilization structure 3300.

[0150] 5.3.3.1 One-piece knitted headgear strap In one example of the present technology, although shown being worn by the patient in FIG. 7 and separated in FIGS. 8 and 9, the positioning and stabilization structure 3300 includes a one-piece headgear strap 3301. The headgear strap 3301 includes a unitary structure. The headgear strap 3301 is formed as a single one-piece knitted strap, which is in contrast to forming a combination of a plurality of strap pieces separately and connecting them together or cutting a one-piece strap from a sheet of material. Separately forming and attaching the strap portions to each other can lead to a decrease in speed and / or an increase in cost in manufacturing. Cutting the headgear strap can lead to a significant waste of material. However, in some examples of the present technology, the plurality of headgear strap portions that may be included in the positioning and stabilization structure 3300 are formed separately and connected together while including other features of the present technology described herein.

[0151] Since the headgear strap 3301 can be knitted directly into its final shape as a single piece of material using flat knitting, there is no need to cut the headgear strap from a material sheet, nor is there a need to stitch together individual headgear pieces using additional thread. By flat knitting the headgear strap 3301, it becomes possible to sew the entire headgear strap 3301 in a single flat knitting process. In some examples of the present technology, the headgear strap 3301 does not include seams or joints. If there are seams and joints, in some situations, they may cause some users to feel uncomfortable pressure on the skin.

[0152] One advantage of flat knitting is that it is possible to knit the headgear strap 3301 directly from fibers in the form of thread, yarn, etc. (rather than cutting the headgear strap 3301 directly from the sheet) to obtain the final shape directly. When cutting multiple complex shapes from the sheet, large cut edges may remain, resulting in waste. Furthermore, when cutting the headgear strap from a laminated sheet, the flexibility for cost - effectively customizing the fabric or color of the headgear may also be reduced. To obtain new fabric and / or color options, new sheet laminations may be required.

[0153] Another advantage of the knitted headgear strap 3301 is that it can be knitted to fit extremely well to the shape of the patient's head, leading to improved comfort and stability. In some examples of the present technology, the headgear strap 3301 can be knitted to fit the shape of a particular patient's head based on a three - dimensional model of that particular patient's head generated using imaging or scanning of the patient's head.

[0154] Some existing head gears are produced by double - needle crochet. The head gear strap produced by this method can be limited to a single - strap - like outer shape and cannot be applied to a complete head gear (e.g., a patient interface with a four - point head gear connection) for a nose mask or a full - face mask due to the complex shape of the four - point connection head gear strap.

[0155] In some examples of the present technology, the head gear strap 3301 is formed using advanced knitting techniques to form a knitted structure with extremely good breathability, elasticity, and / or aesthetic appeal. Such a knitted structure may be similar to that found in sports jerseys.

[0156] In some examples of the present technology, the head gear strap 3301 may include a plurality of different colors and / or patterns. By using cross - knitting to mix colors and patterns, it is possible to obtain a wider variety of designs without incurring additional aesthetic costs.

[0157] In some examples of the present technology, the head gear strap 3301 includes one or more regions where rigidity and / or elasticity are localized. These regions where rigidity and / or elasticity are localized can be formed in the head gear strap 3301 by a cross - knitting process performed when knitting the entire head gear strap 3301. It is possible to individually adjust the elastic properties to meet the different requirements of each region of the head gear strap 3301.

[0158] In some examples of the present technology, the headgear strap 3301 is formed by warp knitting and includes a non-planar shape even before being worn by a patient. The non-planar shape can be generated by knitting the headgear strap 3301 with different knitting densities in different regions. Different properties can be imparted to different regions of the headgear strap 3301 to meet predetermined specifications. In some examples, by providing such properties to the headgear strap 3301 during warp knitting, a headgear strap 3301 including a non-planar shape can be obtained. In some forms of the present technology, the non-planar shape can impart a predetermined property (e.g., a predetermined elasticity at a specific location and / or direction) to the headgear strap 3301 or a specific force vector added from the headgear strap 3301 to the plenum chamber 3200 and / or the seal-forming structure 3100 during use.

[0159] In some examples of the present technology, the headgear strap 3301 is customized and individually adjusted according to the anatomical structure and / or preferences of a specific patient. Using warp knitting is advantageous because the manufacturer can obtain flexibility in the use of a range of yarns, the application of different design patterns, and the application of different colors and surface geometry features. In some examples, the headgear strap 3301 is knitted by a programmable knitting machine. A headgear strap formed by warp knitting can also be extremely comfortable. When a high-gauge and fine-yarn fabric is used, the surface finish of the strap can be smoothed, and the risk of leaving marks on the face can be reduced.

[0160] In some examples, in the headgear strap 3301, one or more texts, graphics, trademarks, logos, etc. can be knitted into the headgear strap 3301 during a single knitting operation for the formation of the headgear strap 3301.

[0161] In another example, the positioning and stabilization structure 3300 may include one or more headgear straps. In some other examples, one or more headgear strap portions are formed by a circular knitting process.

[0162] In some examples, the maximum force that the headgear strap 3301 can withstand without damage is 10 N to 100 N, more preferably 15 N to 80 N, 20 N to 60 N, or 25 N to 40 N. In some examples, the headgear strap 3301 may include one or more portions having a pique knitting structure formed of 100% nylon and may be configured to withstand a maximum load of 5 N to 8 N (6 N to 7 N in some examples) in the wale and a maximum load of 2.5 N to 5.5 N (3.5 N to 4.5 N in some examples) in the course. In some examples, the headgear strap 3301 may include one or more portions having a pique knitting structure formed with a combination of nylon and spandex and may be configured to withstand a maximum load of 3 N to 6 N (4 N to 5 N in some examples) in the wale and a maximum load of 2 N to 4 N (2.5 N to 3.5 N in some examples) in the course. In some examples, the headgear strap 3301 may include one or more portions having a single jersey knitting structure formed with a combination of nylon and spandex and may be configured to withstand a maximum load of 2.5 N to 5 N (3 N to 4 N in some examples) in the wale and a maximum load of 1 N to 3 N (1.5 N to 2.5 N in some examples) in the course.

[0163] In some examples, the headgear strap 3301 is structured to dry in a short time after washing or after being wet by body moisture. The headgear strap 3301 may be able to have high breathability and keep the patient's skin in a relatively dry state. The headgear strap 3301 may be configured such that substantially no facial marks are generated. The headgear strap 3301 may be machine washable and hand washable.

[0164] The headgear strap 3301 shown in FIG. 8 is configured to create a four-point connection to the frame 3500 or the plenum chamber 3200 of the patient interface 3000. In other examples of the present technology, the headgear strap 3301 can be configured to form a two-point connection to the frame 3500 or the plenum chamber 3200 (e.g., when incorporated within a nasal pillow type or nasal cradle retention type patient interface 3000). The headgear strap 3301 can connect at one or two points to the frame 3500 or the plenum chamber 3200 of a patient interface 3000 having a full face configuration (e.g., a configuration in which the seal forming structure 3100 seals around the perimeter of the lower side of the patient's nose and most or all of the patient's nasal bridge nose is exposed). In some examples, the headgear strap 3301 can be configured as a backstrap for the positioning and stabilization structure 3300 of a conduit headgear system. In such an example, the headgear strap 3301 can be placed or disposed under the back of the patient's skull and connect between a pair of headgear conduits disposed on the lateral sides of the patient's head.

[0165] 5.3.3.2 Headgear Strap Portion As shown in FIGS. 7-9, the positioning and stabilization structure 3300 can include a plurality of strap portions. The plurality of strap portions can be provided within a single headgear strap 3301, such as in the positioning and stabilization structure 3300 of FIGS. 7-9. In this example of the present technology, the positioning and stabilization structure 3300 includes a ring strap portion 3340. By surrounding the posterior side of the patient's head with the ring strap portion 3340, a strong anchor is obtained for other strap portions that connect to the plenum chamber 3200. The ring strap portion 3340 can also be known as a crown, head crown strap, rear / rear portion, or halo.

[0166] In this example of the present technology, the ring strap portion 3340 of the positioning and stabilization structure 3300 includes an upper portion 3302 and a lower portion 3304. In use, the upper portion 3302 is disposed opposite the patient's head across the vertex of the patient's head. The lower portion 3304 is configured to be disposed relative to the patient's head across the occipital bone of the patient's head or below the occipital bone of the patient's head in use. As shown, a loop is defined by the ring strap portion 3340.

[0167] The positioning and stabilization structure 3300 includes a pair of upper strap portions 3310. Each of the upper strap portions 3310 is configured to connect between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the upper strap portions 3310 is disposed on each side along the patient's head from above the patient's head to the upper ear base.

[0168] In the example shown in FIGS. 7-9, the positioning and stabilization structure 3300 also includes a pair of lower strap portions 3320. Each of the lower strap portions 3320 is configured to connect between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the lower strap portions 3320 is disposed on each side along the patient's head from below the patient's head to the upper ear base.

[0169] The connection of each of the upper strap portion 3310 and the lower strap portion 3320 to the plenum chamber 3200 may be made directly or via the frame 3500 of the cushion assembly 3580. In the example shown in FIG. 7, the upper strap portion 3310 and the lower strap portion 3320 are connected to the plenum chamber 3200 (via the frame 3350 to which the plenum chamber 3200 is connected).

[0170] In one or more of the headgear strap portions of the positioning and stabilization structure 3330 (for example, the upper strap portion 3310, the lower strap portion 3320, and the supra-head strap portion 3330 described below), a fastening portion 3360 may be included. The fastening portion 3360 may be configured and / or arranged such that it allows the strap to loop back onto itself 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 be attached to each other when the strap is looped back onto itself.

[0171] In some examples of the present technology, the positioning and stabilization structure 3300 may include the upper strap portion 3310, but may not include the lower strap portion 3320. In some examples of the present technology, the patient interface 3000 may include the positioning and stabilization structure 3300 that includes the upper strap portion 3310. The upper strap portion 3310 connects the rear portion of the positioning and stabilization structure 3300 (for example, the ring strap portion 3340) to the plenum chamber 3200 that includes the nasal pillow or the cradle-retaining cushion seal forming structure 3100.

[0172] In this example, the ring strap portion 3340 includes a stiffening portion 3345. The stiffening portion 3345 has a higher rigidity than other parts of the ring strap portion 3340. Although the stiffening portion 3345 may not be rigid as a whole, it can be "stiffened" in that it has a higher rigidity than some or all of the other parts of the ring strap portion 3340. The stiffening portion 3345 and the other parts of the ring strap portion 3340 can all be flexible to a certain extent, but the stiffening portion 3345 can be more rigid. The stiffening portion 3345 can be made less stretchable and / or less bendable than other parts of the ring strap portion 3340. In this example, the stiffening portion 3345 is provided along the length of the loop defined by the ring strap portion 3345. The stiffening portion 3345 of the ring strap portion 3340 can reinforce the ring strap portion 3340. By reinforcing the ring strap portion 3340, the stability of the patient interface 3000 during use can be improved. This is because the purpose of the ring strap portion 3340 is to anchor the other strap portions connected to the plenum chamber 3200 (under the tension for pulling the plenum chamber 3200 into the patient's face). The stiffening portion 3345 may be substantially non-stretchable, but in that case, it can still be bendable to conform to the curvature of the patient's head. Since the stiffening portion 3345 is non-stretchable, the ring strap portion 3340 can be reinforced, the anchor of the positioning and stabilization structure 3300 becomes stronger, and the stability increases. The upper strap portion 3310 can be stretchable. In some examples of this technology, the stiffening portion 3345 can be stretchable, but has less stretchability than other parts of the ring strap portion 3340. In some examples, the ring strap portion 3340 can include a first portion provided along the length of the loop defined by the ring strap portion 3340 and a second portion provided along the length of the loop. The second portion can include the stiffening portion 3345 and can extend along the edge of the ring strap portion 3340 that is directly adjacent to the first portion (for example, having a boundary with the first portion). The second portion can be more rigid than the first portion.The second portion may be less flexible than the first portion. The second portion may be less stretchable than the first portion.

[0173] In this example of the technology, the stiffening portion 3345 is provided along substantially the entire length of the loop defined by the ring strap portion 3340. As shown, the ring strap portion 3340 includes an inner circumference (or inner edge) 3341 and an outer circumference (or outer edge) 3342. In some examples, the ring strap portion 3340 is more rigid in the vicinity of the inner circumference 3341 than in the vicinity of the outer circumference 3342. In one example, the stiffening portion 3345 is provided on the ring strap portion 3340 in the vicinity of the inner circumference 3341 of the ring strap portion 3340 (e.g., along the inner edge). The stiffening portion 3345 may define the inner circumference 3341 of the ring strap portion 3340 or may be disposed adjacent to the edge of the ring strap portion 3340 that defines the inner circumference 3341. The stiffening portion 3345 may form substantially the entire inner circumference 3341 of the ring strap portion 3340. In other examples, the stiffening portion 3345 may be provided substantially centrally between the inner circumference 3341 of the ring strap portion 3340 and the outer circumference 3342 of the ring strap portion 3340.

[0174] Reinforcing the inner circumference 3341 around the ring strap portion 3340 can be advantageous in that it may be possible to form the outer circumference 3342 (more anteriorly) of the ring strap portion 3340 in proximity to any other strap portion that connects the ring strap portion 3340 to the plenum chamber 3200 of the patient interface 3000. Disposing the stiffening portion 3345 centrally between the inner circumference 3341 and the outer circumference 3342 can be advantageous in that the distribution of the pressure load on the patient's skin becomes uniform. The inner circumference 3341 of the ring strap portion 3340 may also not need to be deformed as much as the outer circumference 3342. This is because a further strap portion extends from the outer circumference 3342 and connects to the plenum chamber 3200 in front of the patient's face.

[0175] The ring strap portion 3340 and / or any other optional strap portion of the positioning and stabilization structure 3300 may include a circular edge. In the case of a circular edge, it is less likely to cause skin marks and may be comfortable for the patient's skin.

[0176] In some examples of the present technology, the strap portions of the positioning and stabilization structure 3300 may be formed by knitting. That is, one or more of the upper strap portion 3310, the lower strap portion 3320, and the ring strap portion 3340 may include a knitted fabric structure. In some examples, one or more of these strap portions of the positioning and stabilization structure 3300 may be formed by weft knitting. For example, the ring strap portion 3340, the upper strap portion 3310, and / or the lower strap portion 3320 may include a single jersey knit structure and may be formed from a combination of nylon and spandex. The single jersey knit structure makes it possible to obtain the flexibility and elasticity required for the strap portion without an extra thickness, which is advantageous. Alternatively, the ring strap portion 3340 may include double jersey loop formation. The stiffening portion 3345 of the ring strap portion 3340 may include a piqué fabric structure (e.g., a piqué rib structure) and may be formed from nylon or a combination of nylon and spandex. Using a piqué fabric structure in the formation of the stiffening portion 3345 may be advantageous because this type of structure is very suitable for generating ridges having a sufficiently high level of rigidity (while having a circular edge). That is, the first portion of the ring strap portion 3340 and the second portion of the ring strap portion (i.e., the stiffening portion 3345) may include the same type of yarn (e.g., yarns having the same rigidity), and the second portion may have a higher rigidity than the first portion due to a different knitting structure. In the example, the piqué knitting structure may include a higher rigidity compared to the knitting structure of the first portion of the ring strap portion (e.g., a single knit or double jersey knit).

[0177] The headgear strap of the positioning and stabilization structure 3300 can be stretchable. Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the ring strap portion 3340 are stretchable. The ring strap portion 3340 of the positioning and stabilization structure 3300 being stretchable enables the ring strap portion 3340 to fit and conform precisely to the back, sides, and top of the patient's head during use. Since the upper strap portion 3310 and the lower strap portion 3320 are stretchable, a slight elongation of their lengths is possible, allowing for a certain degree of relaxation when the plenum chamber 3200 is pressurized. When the plenum chamber 3200 is under pressure during use, due to the amount of pressurized air in the plenum chamber 3200, the plenum chamber 3200 and the frame 3500 are pushed forward in a direction away from the patient's face. To maintain contact in a sealed state between the plenum chamber 3200 and the seal-forming structure 3100 and the patient's face, the tension within the headgear strap needs to counteract the force from this pressure. The ability of the lengths of the upper strap portion 3310 and the lower strap portion 3320 to elongate by at least a small amount improves the comfort of wearing the patient interface 3000 when this occurs.

[0178] Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the ring strap portion 3340 all have breathability due to the braided structure which is the material forming them. The reason breathability is advantageous is that it can keep the headgear strap and the patient's skin dry while being able to manage the temperature of the patient's skin under the headgear strap.

[0179] The stiffening portion 3345 can be a rounded and thick portion of the headgear strap material. The stiffening portion 3345 can include a greater material thickness compared to an adjacent portion of the ring strap portion 3340. In some examples of the present technology, the patient contact side of the ring strap portion 3340 is substantially flat, and a greater material thickness is provided to the non-patient contact side of the ring strap portion 3340. Advantageously, by achieving an extra thickness by providing an extra material forming the stiffening portion 3345 on the non-patient contact side of the ring strap portion 3340, the patient contact side of the ring strap portion 3340 is held substantially flat. In the case of a flat surface, it can be more comfortable for the patient's skin than in the case of a non-flat surface, which can be advantageous. In the example shown in FIG. 7, since the stiffening portion 3345 is provided on the inner circumference 3341 of the ring strap portion 3340, the inner circumference 3341 can be made thicker than the outer circumference 3342. In use, the trailing edge portion of the ring strap portion 3340 is thicker than the leading edge portion of the ring strap portion 3340. Making the inner circumference 3341 thicker than the outer circumference 3342 increases the rigidity of the inner edge portion of the ring strap portion 3340 and enables reinforcement of the ring strap portion 3340.

[0180] Reinforcement of the reinforcement portion 3345 can be made unrecognizable on the patient contact side of the ring strap portion 3340. In use, it can be made impossible for the patient to visually recognize and / or feel any features of the reinforcement portion 3345. In FIG. 10, cross-sections at two locations of the ring strap portion 3340 are illustrated. As shown, the extra thickness in the stiffening portion 3345 is provided only on one side (non-patient contact side) of the ring strap portion 3340. The other side of the ring strap portion 3340 is substantially flat. Further, the stiffening portion 3345 is circular, similar to the inner edge portion of the ring strap portion 3340 (at the inner circumference 3341) and the outer edge portion of the ring strap portion 3340 (at the outer circumference 3342). It can be particularly useful in that comfort is maintained even when the headgear strap is tightened too much, since only a slight pressure is applied to the user's face from the smooth / circular edge.

[0181] In some examples of the present technology, the ring strap portion 3340 includes the stiffening portion 3345 within a thickness range of 3 to 5 mm (for example, within a range of 3.5 to 4.5 mm). In some examples, the thickness of the stiffening portion 3345 can be 4 mm. The thickness of the ring strap portion 3340 can be within a range of 1.5 to 3.5 mm (for example, within a range of 2 to 3 mm) (for example, 2 mm) in the region of the ring strap portion 3340 other than the stiffening portion 3345. The thicknesses of the upper strap portion 3310 and the lower strap portion 3320 can also be within a range of 1.5 to 3.5 mm (for example, within a range of 2 to 3 mm) (for example, 2 mm).

[0182] In some examples, the stiffness of the stiffening portion 3345 can be non-uniform along the length of the ring strap portion 3340. The stiffening portion 3345 can be less stretchable and / or more flexible at some locations compared to other locations around the ring strap portion 3340. In some examples, the stiffening portion 3345 can be larger at certain locations (compared to other locations), thereby increasing the stiffness and / or hardness at these specific locations. As shown in FIGS. 7-8, the stiffening portion 3345 becomes larger in the vicinity of the junction of the upper strap portion 3310 and the ring strap portion 3340. In this example, the stiffening portion 3345 becomes wider in the vicinity of the upper strap portion 3310 (other than other locations along the ring strap portion 3340). In other examples of the present technology, the stiffening portion 3345 can be more rigid at specific locations due to the use of a larger material thickness and / or a different knitting structure (in an example where the ring strap portion 3340 is formed by knitting).

[0183] By varying the width and / or material thickness along the length of the ring strap portion 3340, rigidity can be obtained where rigidity / stability is required, and flexibility and / or comfort can be obtained where rigidity is not so necessary. It can be particularly advantageous to provide extra rigidity in the vicinity of the junction of the upper strap portion 3310 and the ring strap portion 3340, because in use the upper strap portion 3310 is under tension and there is a relatively large area of strap material at the junction. By strengthening this junction, a high level of stability of the patient interface 3000 can be supported.

[0184] The upper part 3302 of the ring strap portion 3340 may include one or more overhead strap portions 3330. As shown in FIGS. 8, 9 and 13, in one example the ring strap portion 3340 includes a pair of overhead strap portions 3330. The overhead strap portions 3330 may be configured to adjust their connection to each other. In one example, the overhead strap portions 3330 are configured to be adjustably connected to each other in the vicinity of the sagittal plane of the patient's head. The adjustable connection between the two overhead strap portions 3330 can make it possible to adapt the positioning and stabilization structure 3300 to patients with a range of head shapes and sizes, which can be advantageous. In other examples of the technology, the positioning and stabilization structure 3330 may include a single overhead strap portion 3330. If only a single overhead strap portion 3330 is provided, it may be possible to elastically extend its length, so that it can fit patients with a range of head sizes.

[0185] The two overhead strap portions 3330 can be adjustably connected together with a buckle 3335. The buckle 3335 can include a pair of slots, eyelets, or other openings. Through these slots, eyelets, or other openings, the overhead strap portions 3330 can pass therethrough, whereby each overhead strap portion 3330 can be fed through a part 3335 of the buckle and secured to itself. Each overhead strap portion 3330 can include a hook-and-loop material that enables fastening the end of each overhead strap portion 3330 to the middle portion of each overhead strap portion 3330. In other examples of the present technology, clips, elastic bands, magnets, or other suitable fastening means can be used to fasten each overhead strap portion to itself. In another example, after the two overhead strap portions are separately formed during the manufacture of the positioning and stabilizing structure 3300, they are welded or sewn together to complete a loop formed by the ring strap portion 3340.

[0186] FIG. 16 shows a headgear strap 3301 of a positioning and stabilizing structure 3300 according to another example of the present technology. This headgear strap 3301 can be integrally formed by knitting and can be formed as a single piece of material in a single weft knitting process. The headgear strap 3301 of FIG. 16 can include any of the headgear strap 3301 features and / or characteristics described with reference to FIGS. 7-15.

[0187] The headgear strap 3301 shown in FIG. 16 includes a pair of upper headgear strap portions 3310. Each of the upper headgear strap portions 3310 is configured to be connected to the plenum chamber 3200 of the patient interface 3000 during use. In this example, each of the upper headgear strap portions 3310 is configured to be connected to each headgear conduit of the positioning and stabilization structure 3330 (positioned on each lateral side of the patient's head during use). Each headgear conduit extends laterally from an intermediate location above the upper portion of the patient's head across the lower side of the lateral side of the patient's head to the upper portion of the patient's head and then extends forwardly and medially and may be configured to connect to the plenum chamber 3200 in the vicinity of the entrance to the patient's airway. Thus, the upper headgear strap portions 3310 are configured to be connected to the plenum chamber 3200 via the headgear conduits. The headgear strap 3301 also includes a pair of lower headgear strap portions 3320. Each of these lower headgear strap portions 3320 is configured to be connected to the plenum chamber 3200. The lower headgear strap portions 3320 may be directly connected to the plenum chamber 3200 or the frame 3500 of the cushion assembly 3580.

[0188] FIG. 17 shows a patient interface 3000 including a cushion assembly 3590 and a positioning and stabilization structure 3300 according to another example of the present technology. The cushion assembly 3590 includes a plenum chamber 3200 and a seal forming structure 3100. The positioning and stabilization structure 3300 includes a headgear strap 3301. The headgear strap 3301 is configured to be used with the conduit headgear of the patient interface. The headgear strap 3301 shown in FIG. 17 connects to the headgear conduit 3900 in the same manner as the headgear strap shown in FIG. 16. As shown, the headgear conduit is joined at a junction 3903 at the upper portion of the patient's head. From a connection port 3600, a pressurized flow of breathable gas is supplied to the headgear conduit 3900. Each headgear conduit 3900 includes a lateral portion 3901 along the patient's head. The lateral portion 3901 connects via a connector 3800 to a plenum chamber 3200 disposed at the entrance to the patient's airway during use. More generally, each headgear conduit 3900 may receive an air flow from a connection port 3600 on the patient's head and deliver the air flow to the entrance of the patient's airway via a seal forming structure 3100, and each headgear conduit 3900 is constructed and arranged to contact at least one region of the patient's head above the upper ear base point on each side of the patient's head during use.

[0189] As shown in FIG. 17, the positioning and stabilization structure 3300 includes a pair of upper strap portions 3310. These upper strap portions 3310 connect between a neck strap portion 3334 and each headgear conduit 3900. The neck strap portion 3334 may also be referred to as the rear / rear portion. In this example, the upper strap portion connects to an eyelet on a tab 3902 of the headgear conduit 3900. In this example, the lower strap portion 3320 connects between the neck strap portion 3334 and the plenum chamber 3200 via a headgear clip 3322.

[0190] In the examples shown in FIGS. 16 and 17, the reason that the headgear strap 3301 does not include a ring strap portion or an overhead strap portion is that in the positioning and stabilization structure 3300 as a counterpart of the headgear strap 3301, the functions of the ring strap portion and the overhead strap portion in the examples shown in FIGS. 7 to 15 are obtained from the headgear conduit. However, in some examples of the present technology, a positioning and stabilization structure 3300 including a headgear conduit and a headgear strap 3301 including a ring strap portion 3340 and / or an overhead strap portion 3330 is provided.

[0191] The headgear strap 3301 shown in FIGS. 16 and 17 includes a neck strap portion 3334. The neck strap portion 3334 is connected to the upper headgear strap 3310 and the lower headgear strap 3320 respectively. The neck strap portion 3334 is configured to be disposed with respect to the surface of the patient's head placed on the back of the patient's neck and / or on the occipital bone of the patient's skull during use. The neck strap portion 3334 can be configured to be placed on the occipital bone of the patient's head and / or disposed with respect to the patient's neck during use of the patient's neck.

[0192] The neck strap portion 3334, the upper headgear strap portion 3310, and the lower headgear strap portion 3320 can be integrally formed. The headgear strap 3301 and its upper headgear strap portion 3310, lower headgear strap portion 3320, and neck strap portion 3334 can be formed by a single flat knitting process.

[0193] The headgear strap 3301 shown in FIG. 16 includes a stiffening portion 3345. In this example, the stiffening portion 3345 is provided on the neck strap portion 3334. The stiffening portion 3345 can be formed in any of the same manners as described above, for example, using a greater thickness and / or a higher stiffness knitted structure, in relation to the stiffening portion 3345 of the positioning and stabilizing structure 3300 shown in FIGS. 7-15. In this example, the stiffening portion 3345 can be substantially non-stretchable.

[0194] The stiffening portion 3345 can reinforce the neck strap portion 3334. This reinforcement can provide a high level of stability to the patient interface 3000 during use. This is because 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 stiffening portion 3345 can be substantially non-stretchable or may be at least less stretchable than the other strap portions, but in that case, it can still be bendable to conform to the curvature of the patient's head. Making the stiffening portion 3345 non-stretchable or having low stretchability enables the reinforcement of the neck strap portion 3334, resulting in a more robust anchor and leading to a more stable positioning and stabilizing structure 3300. The upper strap portion 3310 and the lower strap portion 3320 can be stretchable.

[0195] The neck strap portion 3334 may include a stretchable portion in addition to the stiffening portion 3345. In the example shown in FIG. 16, the neck strap portion 3334 includes stretchable portions above and below the stiffening portion 3345. In this example, the neck strap portion 3334 includes an upper stretchable portion 3346 and a lower stretchable portion 3347. The stretchable portion may be provided at the upper edge and / or the lower edge of the neck strap portion 3334. In this example, the upper stretchable portion 3346 is provided along the upper edge of the neck strap portion 3334, and the lower stretchable portion 3347 is provided along the lower edge of the neck strap portion 3334. Providing the stretchable portion at the upper and lower edges of the neck strap portion 3334 may be advantageous for patient comfort. Substantially stiffening the upper and lower edges of the neck strap portion 3334 allows the forces from the headgear tension to be concentrated on the patient's skin in this configuration. Providing the stretchable portion at the upper and lower edges may allow for a certain degree of relaxation, leading to improved patient comfort. The stretchable portion may also enable the neck strap portion 3334 to conform to the curvature of the patient's neck.

[0196] 5.3.3.3 Ventilation of the Headgear In some forms of the present technology, the positioning and stabilization structure includes a headgear strap having one or more ventilation portions. These one or more ventilation portions are structured and / or arranged to allow for greater breathability through the headgear strap. As shown in FIGS. 7-10, the positioning and stabilization structure 3300 includes three ventilation portions 3350. In this example, the ventilation portions 3350 are each provided within the ring strap portion 3340, providing a region of greater breathability through the ring strap portion 3340. In the ring strap portion 3340, the ventilation portions 3350 are provided in the vicinity of each of the upper strap portions 3310 (for example, at each junction between the upper strap portion 3310 and the ring strap portion 3340). Further, in the ring strap portion 3340, a single ventilation portion 3350 is provided in the vicinity of the junction between each of the lower strap portions 3320 and the ring strap portion 3340.

[0197] In this example, both of the lower strap portions 3320 extend from the ring strap portion 3340 at similar locations. In an example of this technique where the lower strap portion 3320 extends from a more individualized location around the ring strap portion 3340, two separate ventilation portions 3350 can be provided, one at each of the junctions between the lower strap portion 3320 and the ring strap portion 3340. These ventilation portions 3350 can be provided where the headgear strap includes a relatively large area / footprint on the patient's head. In the case of these areas, they may be most susceptible to the effects of skin temperature rise and / or moisture accumulation. Due to the junctions between the ring strap portion 3340 and the upper strap portion 3310 and the lower strap portion 3320, a relatively large surface area on the patient's skin can be covered, so additional breathability may be desired at these locations for providing a high level of patient comfort. These ventilation portions 3350 can advantageously avoid the accumulation of moisture in the headgear material and / or on the patient's skin. These ventilation portions 3350 are areas where the breathability is localized. The knitting structure of the other headgear strap portions of the positioning and stabilization structure 3300 can also increase breathability, but due to the mesh-like knitted structure used for forming the ventilation portions 3350, the ventilation portions 3350 can be made to have particularly high breathability. These ventilation portions 3350 facilitate the exchange of fresh air through the material forming the headgear strap 3301, so that at least under the ventilation portions 3350, the patient's skin is also kept cool.

[0198] These ventilation portions 3350 may include a knitted structure. The formation of the knitted structure can be performed during the same knitting process as the knitting process for forming the ring strap portion 3340, the stiffening portion 3345, the upper strap portion 3310, and / or the lower strap portion 3320. In one example, the ventilation portion 3350 includes a picot mesh knitted structure. The ventilation portion 3350 can be stretchable. However, in some examples, the ventilation portion 3350 can be made less stretchable than other headgear strap portions. Making the ventilation portion 3350 relatively less elastic can avoid a situation where the openings forming the mesh structure are blocked by the fabric and the mesh structure is stretched to a range that can cause a reduction in breathability. These ventilation portions 3350 can be formed from, for example, nylon or a combination of nylon and spandex.

[0199] In some examples, as shown in FIGS. 7, 8, and 10, the stiffening portion 3345 of the ring strap portion 3340 can surround the ventilation portion 3350. Thereby, advantageously, additional rigidity can be obtained in the region of the headgear strap portion that has a large surface area and can be overly stretched in other cases. That is, due to the knitted structure, the ventilation portion 3350 provides lower rigidity and / or higher flexibility in the region of the ring strap portion 3340 compared to other regions of the ring strap portion (e.g., the first site and / or the second site of the ring strap portion (e.g., the stiffening portion 3345)). Since these stiffening portions 3345 can be provided adjacent to the ventilation portion 3350 (e.g., directly adjacent (e.g., in contact at the boundary)), higher rigidity can be obtained adjacent to or surrounding the ventilation region. Each ventilation portion 3350 does not necessarily have to be surrounded by the stiffening portion 3345. In the examples shown in FIGS. 7, 8, and 10, the ventilation portion 3350 near the patient's neck is not surrounded by the stiffening portion 3345. However, the ventilation portion 3350 near the upper strap portion 3310 is surrounded by the stiffening portion 3345.

[0200] The ring strap portion 3340 includes a pair of upper ventilation portions 3350, and each upper ventilation portion 3350 is provided adjacent to each upper strap portion 3310. As described above, the stiffening portion 3345 surrounds each upper ventilation portion 3350. In this example, the material thickness of the stiffening portion 3345 is greater at the rear side of each upper ventilation portion 3350 than at the front side of each upper ventilation portion 3350. As described above, the stiffening portion 3345 can be formed to have higher rigidity in the vicinity of the inner circumference 3341 of the ring strap portion 3340.

[0201] The ring strap portion 3340 also includes a lower ventilation portion 3350 provided between a pair of lower strap portions 3320. As shown in FIGS. 8 and 9, the lower ventilation portion 3350 includes a lower edge portion 3351 spaced apart from the lower edge portion 3343 of the ring strap portion 3340. The lower edge portion 3351 of the lower ventilation portion 3350 and the lower edge portion 3343 of the ring strap portion 3340 are both arcuate in this example of the present technology.

[0202] The curvature of the lower edge portion 3351 of the ventilation portion 3350 is greater than the curvature of the lower edge portion 3343 of the ring strap portion 3340. By making the curvature of the lower edge portion 3351 of the ventilation portion 3350 larger in this way, a maximum interval can be obtained between the lower edge portion 3351 of the ventilation portion 3350 and the lower edge portion 3343 of the ring strap portion 3340 provided in the sagittal plane of the patient's head or in the vicinity thereof during use. The ventilation portion 3350 and / or the ring strap portion 3340 in the vicinity of the ventilation portion 3350 can contact the patient's neck or can be provided extremely close to the patient's neck. Further, the mesh structure of the ventilation portion 3350 can be coarser than the non-mesh surface of the ring strap portion 3340. Therefore, providing an interval between the lower edge portion 3351 and the lower edge portion 3343 of the ventilation portion 3350 can lead to a reduction in the contact amount between the mesh fabric and the patient's skin. This can be particularly advantageous when contact occurs between the ring strap portion 3340 and the patient's skin in a state where the ring strap portion 3340 is under tension for a long time (as in the case of using the patient interface 3000).

[0203] The headgear strap 3301 of the positioning and stabilization structure 3300 shown in FIG. 16 also includes a ventilation portion 3350. In this example, the ventilation portion 3350 is provided in the neck strap portion 3334. The ventilation portion 3350 can have the same form and characteristics as those described above in relation to the ventilation portion 3350 and the headgear strap 3301 of the positioning and stabilization structure 3300 shown in FIGS. 7 to 15. In this example, the stiffening portion 3345 surrounds the ventilation portion 3350.

[0204] As will be understood by those skilled in the art, the terms jersey knitting structure (e.g., single jersey knit, double jersey knit), pique knitting structure, and pique mesh knitting structure refer to textiles or textile parts formed by jersey and pique respectively, and it should be noted that they refer to the pique mesh knitting technique that forms different knitting structures due to different entanglement patterns of yarns.

[0205] 5.3.3.4 Blind Guide As described above, a fastening portion 3360 can be provided in part or all of the headgear strap portion of the positioning and stabilization structure 3300. As shown in FIGS. 7, 8, and 16, the upper strap portion 3310 and the lower strap portion 3320 each include a fastening portion 3360 in the vicinity of the end of each strap portion. These fastening portions 3360 are each arranged in a structure and / or arrangement that enables each strap portion to loop back on itself and fasten to itself.

[0206] In an example, the fastening portion 3360 may include hook and loop material and / or magnets. This enables connecting the upper strap portion 3310 and the lower strap portion 3320 respectively to other components of the patient interface 3000 (e.g., the frame 3500) or in other examples directly to the plenum chamber 3200. The upper strap portion 3310 and the lower strap portion 3320 may be directly connected to the frame 3500 through slots or other openings, or alternatively, after connecting to a headgear clip, the headgear clip may be connected to the frame 3500. In one example, as shown in FIGS. 7 and 8, each upper strap portion 3310 is connected to an upper strap connection point 3510 on the frame 3500. Through the slots included in each upper strap connection point 3510, it is possible to pass the fastening portion 3360 of the upper strap portion 3310, so that the end of the upper strap portion 3310 can be fixed onto the middle / central portion of the upper strap portion 3310. In this example, the lower strap portion 3320 is connected to a headgear clip 3322. Each lower strap portion 3320 loops back onto itself and is fixed to itself after passing through a slot formed in the headgear clip 3322. Thereafter, the headgear clip 3322 is connected to the frame 3500. In this example, the magnets included in the headgear clip 3322 and the frame 3500 respectively enable fixing the headgear clip 3322 to a predetermined portion of the frame 3500 (and quickly releasing it from the predetermined portion of the frame 3500) by magnetic force. In the example shown in FIG. 16, the fastening portion 3360 of the upper headgear strap portion 3310 may be looped through an eyelet on the headgear conduit of the positioning and stabilization structure 3300. The fastening portion 3360 of the lower headgear strap 3320 may be looped through a slot on the plenum chamber 3200 of the patient interface 3000, or alternatively, may be looped through a headgear clip connected to the plenum chamber 3200 in the same manner as shown in FIG. 7.

[0207] One or more of the strap portions of the positioning and stabilization structure 3300 may include at least one blind guide 3370. In an example of the present technology where a knitted fabric is included in the headgear strap portion, the blind guide 3370 may also be formed by the knitted fabric. In some examples, the headgear strap is formed by horizontal knitting, and the blind guide is also formed by horizontal knitting during the same process. The blind guide 3370 may provide a tactile notification about the location of the fastening portion 3360 on the strap. The blind guide 3370 may be a feature that can be felt by a patient on the surface of the headgear strap and is configured to assist a user in operating the headgear strap (e.g., fitting and adjusting the strap), especially when the patient is wearing a mask and cannot visually see the headgear strap. The blind guide 3370 may be a raised bump, a raised outer shape, or other tactile features that guide a user in looping the strap through a slot or eyelet provided in the mask frame or headgear clip and then securing the strap to themselves. In other examples of the present technology, the blind guide 3370 may include a recess.

[0208] As shown in FIGS. 7, 8, and 16, the upper strap portion 3310 and the lower strap portion 3320 each include a blind guide 3370 in the fastening portion 3360 of each strap. Each blind guide 3370 provides a tactile notification about the location of the fastening portion 3360 on each of the upper strap portion 3310 and the lower strap portion 3320. In some examples, the blind guide 3370 may also be provided in the overhead strap portion of the positioning and stabilization structure 3300.

[0209] FIG. 11 shows an exploded view of the fastening portion 3360 of the strap of the positioning and stabilization structure 3300. In the illustrated example, the strap is the upper strap portion 3310 of the positioning and stabilization structure 3300, but the features of the fastening portion 3360 and the blind guide 3370 may be applied to the lower strap portion 3320 of the positioning and stabilization structure 3300 or other strap / strap portions according to an example of the present technology. In the upper strap portion 3310, a non-patient contact surface is included where the blind guide 3370 is provided. The blind guide 3370 may include a raised portion with respect to the non-patient contact surface of the upper strap portion 3310. This raised portion may surround at least a part of the fastening portion 3360. As shown in FIGS. 10 and 11, the raised portion includes an elongated raised profile on the non-patient contact surface of the strap. 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 3360 of the fastening portion (which are the upper edge, the rear edge, and the lower edge during use). The blind guide 3370 may be provided around the fastening portion 3360 (e.g., one side, two sides, or more sides).

[0210] In other examples of the present technology, the strap of the positioning and stabilization structure 3300 may include a concave outer shape that is concave with respect to the non-patient contact surface. This recess may surround at least a portion of the fastening portions 3360 on the strap. Any suitable features of the shape and location of the raised blind guide described herein may be applied to the concave blind guide according to other examples of the present technology. Similarly, in other examples of the present technology, in any of the illustrated examples of the positioning and stabilization structure according to the present technology, a concave blind guide may be provided instead of the raised blind guide. For example, the concave blind guide may be formed by an elongated concave outer shape and may surround three or more sides of the fastening portion 3360. The concave outer shape may be formed by a thinner strap. The present technology includes blind guides formed by other features, such regions being more rigid and having a different surface finish / weave than the adjacent regions of the strap at the site of the headgear strap. By changing the knitting pattern, knitting density and / or yarn material / thickness, it is possible to provide a tactile notification to the user about the location of the fastening portion on the strap.

[0211] In some examples of the present technology, the elongated raised outer shape of the blind guide 3370 is circular. This may make the blind guide 3370 more comfortable for the patient to touch, more aesthetically pleasing, and the smooth transition between the raised portions and the non-patient contact surface on which the raised portions are provided may also increase the durability of the positioning and stabilization structure 3300.

[0212] The raised portions of the blind guide 3370 may be formed by a strap that is thicker than the adjacent regions of the strap. Extra material to form the thicker thickness may be provided to the non-patient contact surface.

[0213] The fastening portion 3360 of the strap may include a surface fastener material (e.g., Velcro (registered trademark)). The fastening portion 3360 may include an end portion 3361 including one of a hook material and a loop material provided on the non-patient contact surface, and an intermediate portion 3363 including the other of the hook material and the loop material provided on the non-patient contact surface. The intermediate portion 3363 may be provided adjacent to the end portion 3361 of the strap. In the example shown in FIG. 11, the fastening portion 3360 includes a hook portion 3362 and a loop portion 3364. The hook portion 3362 is provided at the end portion 3361 of the upper strap portion 3310. The loop portion 3364 is provided at the intermediate portion 3363 of the upper strap portion 3310. In other examples, the hook portion 3362 may be provided at the intermediate portion 3363 of the strap, and the loop portion 3364 may be provided at the end portion 3361 of the strap. The hook portion 3362 can be detachably attached to the loop portion 3364. That is, after the upper strap portion 3310 is sewn through an opening in another component (e.g., a slot formed in the frame 3500), the end portion 3361 can be looped back to the intermediate portion 3363, and the hook portion 3362 can be detachably attached to the loop portion 3364. The blind guide 3370 may surround only one of the end portion 3361 and the intermediate portion 3363. In the example shown in FIG. 11, the blind guide 3370 is provided only around the intermediate portion 3363 and the loop portion 3364. As shown, the blind guide 3370 is provided around three sides of the loop portion 3364.

[0214] The intermediate portion 3363 may be longer than the end portion 3361. This may enable the end portion 3361 to be fastened to a location within a certain range along the intermediate portion 3363, increasing the length adjustability of the strap. In some examples, the intermediate portion 3363 is several times longer than the end portion 3361.

[0215] A strap portion including a blind guide 3370 (e.g., in other examples of the present technology, the upper strap portion 3310, the lower strap portion 3320, or any other arbitrary strap portion) and the blind guide 3370 itself can be formed together in a single knitting process. The blind guide 3370 can include a picot knitted structure. The strap can include a single jersey knitted structure. In another example of the present technology, the strap can include double jersey loop formation. The strap and the blind guide 3370 can be integrally formed.

[0216] The hook portion 3362 and the loop portion 3364 can be assembled with each strap portion after being separately formed. They can be adhered or sewn to the strap portion of the positioning and stabilizing structure 3300. Alternatively, one or both of the hook portion 3362 and the loop portion 3364 may be ultrasonically welded to the headgear strap. In other examples of the present 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 process as the knitting process used for forming the strap portion where the hook portion 3362 and / or the loop portion 3364 are provided. The knitting process can include flat knitting. The hook portion 3362 and the loop portion 3364 can be formed from nylon. Thereby, skin inflammation can be reduced through excellent breathability, and since a soft loop is obtained, abrasion of the patient's skin is avoided. The hook portion 3362 and the loop portion 3364 can be die-cut.

[0217] The upper strap portion 3310 and / or other strap portions can include a visual guide 3366 indicating the end of the strap as shown in FIG. 11. The visual guide 3366 can surround the hook portion 3362. The visual guide 3366 may not be raised above the surface of the strap portion and can be a visual guide in the form of a colored fabric. Alternatively, the visual guide 3366 can also facilitate the assembly of the hook portion 3362 and the strap portion which is the fixing destination of the hook portion 3362 during manufacturing.

[0218] As shown in FIGS. 8 and 16, the upper strap portion 3310 and the lower strap portion 3320 each include a fastening portion 3360. The fastening portion 3360 includes a hook portion 3362 provided at an end portion 3361 of each strap portion and a loop portion 3364 provided at an intermediate portion 3363 of each strap portion. In other examples of the present technology, this configuration may be provided only on the upper strap portion 3310, only on the lower strap portion 3320, or not provided on any of these strap portions. In some examples, the knitting process used to form the headgear strap portion is configured to provide a predetermined level of rigidity to the strap portion with high precision, thereby eliminating the need for adjustability and blind guides. In some examples, this predetermined level of rigidity may be determined based on the specific shape and size of the patient's head (as determined by scanning).

[0219] In some examples, the positioning and stabilization structure 3300 may include only the upper strap portion 3310 and not the lower strap portion 3320. Such an arrangement may be suitable for a "below the nose" type of patient interface 3000 (e.g., one having a seal-forming structure 3100 in the form of a nasal pillow or nasal cradle holder). In such an example, the upper strap portion 3310 may have the fastening portion 3360 and the blind guide 3370 described above. When the positioning and stabilization structure 3300 has the upper strap portion 3310 but does not have the lower strap portion 3320, the positioning and stabilization structure 3300 may have a ring strap portion 3340 having an upper portion 3302 and a lower portion 3304. One or both of the upper portion 3302 and the lower portion 3304 may be adjustable by the patient. In such an example, the upper portion 3302 and / or the lower portion 3304 may be divided into two strap portions connected by a buckle (or a similar component having an opening through which the strap can be passed internally). Each of these two strap portions forming the upper portion 3302 and / or the lower portion 3304 may include the features of the fastening portion 3360 and / or the blind guide 3370 as described above with reference to FIG. 11.

[0220] The blind guide 3370 can be stretchable in some examples of the present technology and non-stretchable in other examples. The strap portion provided with the blind guide 3370 may be made stretchable as a whole so as to obtain a certain extensibility under tension. However, in some examples, only the length of the selected area of the strap portion may be extended. The area of the strap portion provided with the blind guide 3370 is stretchable, and the blind guide 3370 may be formed to be stretchable (for example, by using a knitting process that enables the blind guide to elastically extend together with the strap on which the blind guide is placed). In some examples, the blind guide 3370 can be provided on a non-stretchable part of the strap (for example, when the strap has stretchable portions at any location along its length). In such examples, the blind guide 3370 can be non-stretchable.

[0221] As shown in FIG. 12, the end blind guide 3371 can be provided on the patient contact side of the headgear strap 3301 so as to provide a tactile notification for the end 3361 of the strap portion. During use, when the strap portion is fed through the slot in the frame 3500, the surface formed with the blind guide 3371 is looped across the patient contact side of the headgear strap 3301.

[0222] 5.3.4 Ventilation portion In one form, the patient interface 3000 includes a ventilation structure 3400 configured and arranged to allow the extrusion of exhaled gas (e.g., carbon dioxide).

[0223] In certain embodiments, the ventilation structure 3400 is configured to allow a continuous ventilation flow from the interior of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive relative to the atmosphere. The ventilation structure 3400 is configured such that, during use, while maintaining the therapeutic pressure within the plenum chamber, the magnitude of the ventilation flow rate is large enough to reduce rebreathing of exhaled CO2 by the patient.

[0224] One form of the ventilation structure 3400 according to the present technology includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

[0225] The ventilation structure 3400 can be disposed within the plenum chamber 3200. Alternatively, the ventilation structure 3400 is disposed within a disconnect structure (e.g., a swivel).

[0226] 5.3.5 Disconnect Structure(s) In one embodiment, the patient interface 3000 includes at least one disconnect structure (e.g., a swivel or ball and socket).

[0227] 5.3.6 Connection Port The connection port 3600 enables connection to the air circuit 4170.

[0228] 5.3.7 Forehead Support In one embodiment, the patient interface 3000 includes a forehead support 3700.

[0229] 5.3.8 Anti - asphyxiation Valve In one embodiment, the patient interface 3000 includes an anti - asphyxiation valve.

[0230] 5.3.9 Port In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the properties (e.g., pressure) of the gas within the plenum chamber 3200.

[0231] 5.4 RPT Device 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 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an air flow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described in any one of the paragraphs herein, for example.

[0232] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O.

[0233] The RPT device can have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0234] The pneumatic path of the pneumatic RPT device 4000 can include one or more pneumatic circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0235] One or more of the air path items may be disposed within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be disposed within an external housing 4010. In one form, the pneumatic block 4020 is supported by a chassis 4016 or formed as part of the chassis 4016.

[0236] The RPT device 4000 can include 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 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 can include more than one PCBA 4202.

[0237] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device can include one or more of the following components within an integrated unit. In an alternative form, one or more of the following components can be disposed as separate units.

[0238] 5.4.1.1 Air Filter(s) An RPT device according to one form of the technology can include an air filter 4110 or air filters 4110.

[0239] In one form, an inlet air filter 4112 is disposed at the beginning of the upstream air path of the pressure generator 4140.

[0240] In one form, an outlet air filter 4114 (e.g., an antibacterial factor) is disposed between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0241] 5.4.1.2 Muffler(s) The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0242] In one form of the present technology, the inlet muffler 4122 is disposed above the pressure generator 4140 within the pneumatic path.

[0243] In one form of the present technology, the outlet muffler 4124 is disposed between the pressure generator 4140 and the patient interface 3000 within the pneumatic path.

[0244] 5.4.1.3 Pressure Generator In one form of the present technology, the pressure generator 4140 that generates the flow or supply of air at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impeller may be disposed within a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated 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 WO2013 / 020167.

[0245] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0246] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0247] 5.4.1.4 Converter(s) The transducer may be provided inside the RPT device or, alternatively, outside the RPT device. An external transducer may be arranged, for example, on an air circuit or may form part of an air circuit (e.g., a patient interface). The external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that sends or moves a data RPT device).

[0248] In one form of the technology, one or more transducers 4270 may be arranged upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of the characteristics of the air flow (e.g., flow rate, pressure or temperature at that point in the air pressure path).

[0249] In one form of the technology, one or more transducers 4270 may be arranged in the vicinity of the patient interface 3000.

[0250] In one form, the signal from the transducer 4270 may be filtered (e.g., by low-pass, high-pass or band-pass filtering).

[0251] 5.4.1.4.1 Flow rate sensor The flow rate sensor 4274 according to the technology may be based on a differential pressure transducer (e.g., an SDP600 series differential pressure transducer from SENSIRION).

[0252] In one form, a signal indicative of the flow rate from the flow rate sensor 4274 is received by the central controller 4230.

[0253] 5.4.1.4.2 Pressure sensor The pressure sensor 4272 according to the technology may be arranged in fluid communication with the air pressure path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0254] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0255] 5.4.1.4.3 Motor speed converter In one form of the present technology, a motor speed converter 4276 can be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor (e.g., a Hall effect sensor).

[0256] 5.4.1.5 Anti-spillback valve In one form of the present technology, an anti-spillback valve 4160 can be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the motor 4144 of the blower).

[0257] 5.4.2 RPT device electrical components 5.4.2.1 Power supply The power supply 4210 can be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0258] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0259] 5.4.2.2 Input device In one aspect of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one aspect, or may wirelessly communicate with a receiver electrically connected to the central controller 4230 in another aspect.

[0260] In one aspect, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options.

[0261] 5.4.3 RPT Device Algorithm As described above, in some aspects of the present technology, the central control device 4230 can be configured to embody one or more algorithms 4300 represented as a computer program recorded in a non-transitory computer-readable recording medium (e.g., memory 4260). These algorithms 4300 are generally grouped into groups called modules.

[0262] 5.5 Air Circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000) during use.

[0263] 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 may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0264] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., a temperature sensor). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., the central controller 4230). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349. The entire disclosure of this document is incorporated herein by reference for all purposes.

[0265] 5.5.1 Oxygen Supply In one form of the technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0266] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and the temperature of the air stream before delivery to the patient airway.

[0267] The humidifier 5000 can 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, such as those shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 can further include a humidifier base 5006. The humidifier base 5006 can be adapted to receive the humidifier reservoir 5110 and can include a heating element 5240.

[0268] 5.6.2 Humidifier Component 5.6.2.1 Water Reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least the respiratory therapy session (e.g., overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0269] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate the movement of the air flow along a serpentine path within the reservoir 5110 while the air flow contacts a certain amount of water within the reservoir 5110.

[0270] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction as shown, for example, in FIGS. 5A and 5B.

[0271] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent air pressure loss through leakage and / or flow impedance.

[0272] 5.6.2.2 Conductive Site According to one arrangement, the reservoir 5110 includes a conductive site 5120 configured to enable efficient heat transfer from the heating element 5240 to a certain amount of liquid in the reservoir 5110. In one form, the conductive site 5120 can be arranged as a plate, although other shapes may also be suitable. All or part of the conductive site 5120 can be composed of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, appropriate thermal conductivity can be achieved with a lower conductivity material of appropriate geometry.

[0273] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 can include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in FIG. 5B). In some arrangements, the humidifier reservoir dock 5130 can include a locking function (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0274] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 can include a water level indicator 5150 as shown in FIGS. 5A - 5B. In some forms, the water level indicator 5150 can provide one or more indications to a user such as the patient 1000 or caregiver regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 can include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0275] 5.6.2.5 Heating Element In some cases, the heating element 5240 can be provided to the humidifier 5000 that provides heat input to one or more of the water amount in the humidifier reservoir 5110 and / or the water amount to the air flow. The heating element 5240 can include a heat generating component such as an electric resistance heating track. As one suitable example of the heating element 5240, there is a layered heating element described in, for example, PCT Patent Application Publication No. WO2012 / 171072. In this specification, the whole of this document is incorporated by reference for reference purposes.

[0276] In some forms, the heating element 5240 can be provided into the humidifier base 5006. In the humidifier base 5006, heat can be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B.

[0277] 5.7 Respiratory waveform FIG. 6 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Since the parameter values can vary, a typical respiration can have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 seconds, peak inspiratory flow rate, Qpeak, 0.4 L / second, expiratory time, Te, 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / second. The total duration Ttot of respiration is about 4 seconds. A human typically breathes about 15 times per minute (BPM) and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%.

[0278] 5.8 Glossary For the purpose of disclosing the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0279] 5.8.1 General Air: In certain forms of the present technology, air can mean the atmosphere, and in other forms of the present technology, air can mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0280] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0281] For example, the atmospheric humidity for a humidifier can be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such atmospheric humidity may be different from the humidity outside the room where the patient is sleeping.

[0282] In another example, the atmospheric pressure can be the pressure directly around or outside the body.

[0283] In certain forms, the atmospheric (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, other than the noise generated, for example, from the RPT device or from the mask or patient interface. The atmospheric noise can be generated from sources outside the room.

[0284] Automatic Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB during respiration.

[0285] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient (e.g., increases in response to detection of signs of partial upper airway obstruction and decreases in the absence of notification of partial upper airway obstruction).

[0286] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. The flow rate can refer to the instantaneous amount. In some cases, when referring to the flow rate, it may refer to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it may refer to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate may be assigned the symbol Q. The "flow rate" may be abbreviated as "flow" in some cases.

[0287] In an example of a patient's breathing, the flow rate can be nominally positive pressure for the inhalation portion of the patient's breathing cycle and thus negative for the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0288] Humidifier: The word "humidifier" is interpreted to mean a humidifying device constructed, 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.

[0289] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the ambient elbow.

[0290] Noise conduction (acoustic): In this document, conductive noise refers to noise conveyed to the patient by an air pressure path (e.g., an air circuit and the patient interface and the air within). In one form, conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0291] Noise emission (acoustic): In this document, emitted noise refers to noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0292] Noise ventilation (acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in a patient interface).

[0293] Patient: A person who has or does not have a respiratory disease.

[0294] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0295] The pressure in the patient interface is given the symbol Pm, and the treatment pressure representing the target value to be achieved by the mask pressure Pm at the present time is given the symbol Pt.

[0296] Respiratory pressure therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0297] Ventilator: A mechanical device that provides pressure assistance when a patient performs part or all of the breathing motion.

[0298] 5.8.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molding silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

[0299] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0300] 5.8.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0301] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0302] Hardness: The ability of a material to resist deformation of itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). · "Soft" materials may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. · "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0303] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). A structure or component may provide different resistances in different directions.

[0304] Flopy structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supported by its own weight.

[0305] Rigid structure or component: A structure or component that substantially does not change its shape when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient airway inlet under a pressure load of, for example, approximately 20 to 30 cmH2O.

[0306] As an example, an I-beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0307] 5.8.2 Anatomical structure 5.8.2.1 Facial anatomical structure Ala: The outer wall or "wing" of each nasal cavity (plural: alar)

[0308] Alar angle:

[0309] Alare: The outermost point on the alar

[0310] Alar curvature (or alar apex) point: The rearmost point on the curvilinear reference line of each alar, seen at the fold formed by the junction of the alar and the cheek.

[0311] Auricle: The entire visible part of the ear

[0312] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0313] (Nasal) cartilage skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0314] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0315] Columella angle: The angle between a line drawn through the midpoint of the nasal aperture and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasale point.

[0316] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the porion. The porion is the deepest point from the upper notch to the tragus of the auricle.

[0317] Glabella: A point located in the soft tissue and most prominent on the mid-sagittal plane of the forehead.

[0318] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0319] Lip, lower (Labrale inferius):

[0320] Lip, upper (Labrale superius):

[0321] Major alar cartilage: A plate of cartilage located below the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0322] Nostril (Naris): Generally an elliptical wing-shaped aperture that forms the entrance to the nasal cavity. The singular form of nares is naris (nasal aperture). These nares are separated by the nasal septum.

[0323] Nasolabial groove or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth and separates the cheek from the upper lip.

[0324] Nasolabial angle: The angle between the columella and the upper lip, intersecting the subnasale point.

[0325] Lower auricular attachment point: The lowest point of attachment of the auricle to the facial skin.

[0326] Upper auricular attachment point: The highest point of attachment of the auricle to the facial skin.

[0327] Nasion: The most prominent point or tip of the nose, which can be identified in a lateral view of the remaining part of the head portion.

[0328] Philtrum: A midline groove that extends from the lower border of the nasal septum to the upper lip in the upper lip region.

[0329] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0330] (Nasal) Ridge: The nasal ridge is a midline elevation of the nose that extends from the nasion to the nasion tip.

[0331] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into right and left halves.

[0332] Nasion: The most concave point on the area of the fronto-nasal suture, located on the soft tissue.

[0333] Septal cartilage (nose): The septal cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0334] Lowest alar point: The point at the lower periphery of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0335] Subnasale: Located on the soft tissue, the point where the columella joins the upper lip in the median sagittal plane.

[0336] Stomion: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0337] 5.8.2.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the area known as the forehead.

[0338] Mandible: The mandible forms the lower jaw. The mental eminence is a bony prominence of the jaw and forms the jaw.

[0339] Maxilla: The maxilla forms the upper jaw and is located below the lower jaw and below the eye socket. The frontal process of the maxilla projects upward by the side of the nose and forms the outer boundary portion thereof.

[0340] Nasal bone: The nasal bones are two small rectangular bones, and their sizes and shapes vary from person to person. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0341] Nasion: The intersection of the frontal bone and the two nasal bones, and it is a concave area directly provided between the upper part of the eye and the bridge of the nose.

[0342] Occipital bone: The occipital bone is located at the back and lower part of the skull. The occipital bone contains the foramen magnum, which is an elliptical hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved panel on the posterior side of the foramen magnum is the occipital squama.

[0343] Orbit: A bony cavity in the skull that contains the eyeball.

[0344] Parietal bone: The parietal bones are bones that form the top and sides of the skull when joined together.

[0345] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0346] Zygomatic bone: The two zygomatic bones contained in the face are located in the upper and outer parts of the face and form the zygomatic eminence.

[0347] 5.8.2.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet-like muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0348] Larynx: The larynx, or voice box, which houses the vocal folds, connects the lower part of the pharynx (hypopharynx) to the trachea.

[0349] Lungs: The respiratory organs in humans. The conductive zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0350] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinate bones. In front of the nasal cavity is the nose, and behind it leads into the nasopharynx through the posterior nares.

[0351] Pharynx: The part of the throat located directly below the nasal cavity (downward) and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0352] 5.8.3 Patient Interface Anti-asphyxia valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening into the atmosphere in a fail-safe manner.

[0353] Elbow: An elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an 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 a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to the mating component. In a particular form, the elbow can be removable from the mating component, for example, via a snap connection. In a particular form, the elbow can be assembled to the mating component via a one-time snap during manufacture while being non-removable by the patient.

[0354] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame may be airtight.

[0355] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a set of one or more struts, ties, and supplementary stiffeners configured to position and hold the patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and a fabric).

[0356] Membrane: The membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contracting.

[0357] Pleated Chamber: The mask pleated chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleated chamber.

[0358] Seal: When used as a noun (the "seal"), it can refer to the structure, and when used as a verb (to "seal"), it can refer to the effect. The two elements can be constructed and / or arranged such that they "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0359] Shell: The shell is taken to mean a relatively thin-walled, curved structure having bending, tensile, and compressive rigidity. For example, the curved structure wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0360] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0361] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0362] Swiivel (noun): A sub-assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate at an angle of at least 360 degrees. In another form, the swivel can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of air flow from the swivel.

[0363] Tie (noun): A structure designed to resist tension.

[0364] Ventilation: (noun): A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and the treatment pressure.

[0365] 5.8.4 Shape of the Structure The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by a two-dimensional surface. These surfaces may be distinguished using labels to describe the direction, position, function, or some other property of the associated surface. 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 embodiment, the seal-forming structure may include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0366] To facilitate the description of the shape of the three-dimensional structure and the surface, first consider the cross-section at a point p through the surface of the structure. See FIGS. 3B - 3F. FIGS. 3B - 3F show an example of a cross-section at a point p on the surface and an example of the resulting planar curve. FIGS. 3B - 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0367] 5.8.4.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0368] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, they need to walk uphill). See FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often called concave.

[0369] Zero curvature: When the curve at p is a straight line, the curvature is taken to be zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither uphill nor downhill). See FIG. 3D.

[0370] Negative curvature: When the curve at p bends in a direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person walks away from point p, they need to walk downhill). See FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often called convex.

[0371] 5.8.4.2 Curvature of a two - dimensional surface The description of the shape at a given point on a two - dimensional surface according to the present technology can include a plurality of vertical cross - sections. The plurality of cross - sections can cut the surface in a plane including the outward normal (the "normal plane"), and each cross - section can be taken in a different direction. As a result of each cross - section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point can have the same sign or different signs. Each curvature at that point has a magnitude (for example, relatively small). The planar curves in FIGS. 3B - 3F can be examples of such a plurality of cross - sections at a particular point.

[0372] Principal curvature and direction: The directions of the normal planes at which the curvature of a curve takes its maximum and minimum values are called the principal directions. In the examples of FIGS. 3B to 3F, since the maximum curvature occurs in FIG. 3B and the minimum in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0373] Region of a surface: A set of connected points on a surface. This set of points within the region can have similar properties (e.g., curvature or sign).

[0374] Saddle region: A region where the principal curvatures have opposite signs (i.e., one has a positive sign and the other has a negative sign) at each point (depending on the direction in which an imaginary person walking on the uphill or downhill could face).

[0375] Dome region: A region where the principal curvatures have the same sign (both positive for a "concave dome" or both negative for a "convex dome") at each point.

[0376] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0377] Plane region: A region of a surface where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0378] Edge of a surface: The boundary or limit of a surface or region.

[0379] Path: In a particular form of the present technology, "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In a particular form of the present technology, "path" can be described, for example, as a route or course that includes a set of points on a surface. (The path of an imaginary person is where one walks on the surface and is similar to a garden path).

[0380] Path length: In a particular form of the present technology, the "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance walked along the path on the surface).

[0381] Straight-line distance: The straight-line distance is the distance between two points on the surface, without considering the surface. On a planar region, there is a distance along the edge of 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 a hypothetical person, the straight-line distance corresponds to the "distance a crow flies").

[0382] 5.8.4.3 Space curve Space curve: Different from a planar curve, a space curve does not necessarily exist in any particular plane. A space curve can be closed. That is, it has no end points. A space curve can be regarded as a one-dimensional piece of three-dimensional space. A hypothetical person walking along the strand of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., 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 the manner in which a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point.

[0383] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls from their vehicle at a specific point, the direction of the tangent vector is the direction in which the person should be moving.

[0384] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0385] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0386] Contact plane: The plane that contains the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0387] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the contact plane of the curve. The torsion of a space curve that lies in a plane is zero. When the deviation from the contact plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (e.g., a gently sloping helical path). When the deviation from the contact plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (e.g., a steeply sloping helical path). Referring to Figure 3S, since T2 > T1, the magnitude of the torsion near the top coil of the helix in Figure 3S is greater than the magnitude of the torsion of the bottom coil of the helix in Figure 3S.

[0388] Referring to the right-hand rule of FIG. 3P, a space curve that bends in the direction of the right-hand normal can be regarded as having a positive twist in the right-hand direction (e.g., a right-hand helix as shown in FIG. 3S). A space curve that faces away from the right-hand normal direction can be regarded as having a negative twist of the right hand (e.g., a left-hand helix).

[0389] Similarly, referring to the left-hand rule (see FIG. 3O), a space curve that faces the left-hand normal direction can be regarded as having a positive twist of the left hand (e.g., a left-hand helix). Therefore, the positive direction of the left hand corresponds to the negative direction of the right hand. See FIG. 3T.

[0390] 5.8.4.4 Holes The surface can have one-dimensional holes (e.g., holes bounded by a planar curve or a space curve). In the case of a thin structure (e.g., a membrane) that includes a hole, this structure can be described as having a one-dimensional hole. For example, refer to the state where the one-dimensional hole in the surface of the structure shown in FIG. 3I is bounded by a planar curve.

[0391] The structure can have two-dimensional holes (e.g., holes bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. For example, refer to the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. Also refer to the two-dimensional hole passing through the structure shown in FIG. 3K and bounded by the surface as illustrated.

[0392] 5.9 Other Considerations Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if someone reproduces this patent document or this patent disclosure by fax, as long as it is as described in the patent file or record of the Patent Office and for the intended purpose, but retains all copyrights for other purposes.

[0393] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range of the technology is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the recited range, they are encompassed by the technology. If the recited range includes one or both of these limitations, ranges exceeding either or both of these recited limitations are also encompassed by the technology.

[0394] Furthermore, when values (singular or plural) are embodied as part of the technology herein, unless otherwise specified, it is understood that such values can be approximated and used to any appropriate significant digits up to the extent permitted or required by practical technical implementation.

[0395] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Any methods and materials similar or equivalent to those described in this specification can be used in the practice or testing of this technology, but a limited number of exemplary methods and materials are described herein.

[0396] Although a particular material is described as being preferably used for the construction of a component, obvious alternative materials with similar properties can be used as substitutes. Furthermore, unless stated to the contrary, any and all components described in this specification are understood to be manufacturable and can be manufactured either collectively or individually.

[0397] As used in this specification and the appended claims, the singular forms "a", "an" and "the" are to be noted as including their plural equivalents unless the context clearly indicates otherwise.

[0398] All of the publications described in this specification are hereby incorporated by reference for the disclosure and description of the methods and / or materials for which they are the subject. The publications described in this specification are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification is to be construed as an admission that the present technology does not antedate such publications by virtue of prior invention. Further, the dates of publication of the described publications may be different from the actual publication dates and may need to be individually verified.

[0399] The terms "comprises" and "comprising" are to be construed as referring to elements, components or steps in a non-exclusive sense, indicating that the recited elements, components or steps may be present, utilized or combined with other elements, components or steps not expressly recited.

[0400] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0401] Although the techniques in this specification have been described with reference to specific embodiments, it should be understood that these embodiments merely illustrate the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, although the description or illustration of process steps in this method may be presented in an ordered manner, such an order is not necessary. A person skilled in the art will recognize that such an order can be changed and / or that the aspects can be performed simultaneously or even more synchronously.

[0402] Therefore, it should be understood that numerous variations are possible in exemplary embodiments and that other arrangements can be devised without departing from the spirit and scope of the technology.

Description of Reference Numerals

[0403] Patient 1000 Bedding partner 1100 Patient interface 3000 Seal formation structure 3100 Pleural cavity 3200 Tendon 3210 Upper point 3220 Lower point 3230 Positioning and stabilization structure 3300 Headgear strap 3301 Upper part of the ring strap portion 3302 Lower part of the ring strap portion 3304 Upper strap portion 3310 Lower strap portion 3320 Headgear clip 3322 Suprahead strap portion 3330 Lateral connection strap portion 3332 Neck strap portion 3334 Ring strap part 3340 Inner circumference of the ring strap part 3341 Outer circumference of the ring strap part 3342 Lower edge part of the ring strap part 3343 Rigidifying part 3345 Upper stretchable part 3346 Lower stretchable part 3347 Ventilation part 3350 Lower edge part of the ventilation part 3351 Fastening part 3360 End part 3361 Hook part 3362 Middle part 3363 Loop part 3364 Blind guide 3370 End blind guide 3371 Ventilation structure 3400 Frame 3500 Upper strap connection point 3510 Cushion assembly 3580 Cushion assembly 3590 Connection port 3600 Forehead support part 3700 Headgear conduit 3900 Side part 3901 Joint part 3903 RPT device 4000 External housing 4010 Upper part 4012 Lower part 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic block 4020 Air filter 4110 Inlet air filter 4112 Outlet air filter 4114 Muffler 4120 Inlet muffler 4122 Outlet muffler 4124 Pressure generator 4140 Blower 4142 Motor 4144 Anti-spillback valve 4160 Air circuit 4170 Supplementary oxygen 4180 Electrical components 4200 Printed circuit board assembly (PCBA) 4202 Electrical power supply 4210 Input device 4220 Converter 4270 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier base 5006 Humidifier reservoir 5110 Conductive part 5120 Humidifier reservoir dock 5130 Lock lever 5135 Water level indicator 5150 Heating element 5240

Claims

1. 1. A patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nares, comprising: The patient interface provides approximately 4 cmH above ambient air pressure in use throughout the patient's breathing cycle while the patient is sleeping. ２ O ~ approx. 30cmH ２ and configured to maintain a therapeutic pressure in the range of O to improve sleep disordered breathing; The patient interface comprises: At least 6 cmH above ambient air pressure ２ a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes formed therein such that an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the cavity, in use, throughout the patient's respiratory cycle; a positioning and stabilising structure for providing a force to hold said seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilising structure constructed and arranged such that, in use, at least a portion of said positioning and stabilising structure rests on a region of the patient's head above an upper ear base point of the patient's head; Including, The positioning and stabilizing structure includes a one-piece knitted headgear strap of a single piece of material, the knitted headgear strap comprising: at least one first region having a first knit structure; at least one second region having a second mesh knit structure forming at least one ventilation region that is more flexible than the first region; at least one third region having a pique knit construction; Including, the pique knit structure is immediately adjacent to and borders at least one of the ventilation areas; and A patient interface, wherein the pique knitted structure has a higher stiffness compared to the first knitted structure and the second mesh knitted structure.

2. The patient interface of claim 1 , wherein the pique knit structure forms a rib bordering the ventilation area.

3. 3. The patient interface of claim 1 or 2, wherein the pique knit structure surrounds at least one of the ventilation areas.

4. 4. A patient interface according to any one of claims 1 to 3, wherein the ventilation region has a higher breathability compared to the at least one first region and the at least one third region.

5. the knitted headgear strap includes a ring strap portion; The ring strap portion is a top portion adapted to rest on the parietal bone of the patient's head in use; a lower portion configured to be placed on or below the occipital bone of the patient's head in use; A patient interface according to claim 1 , wherein the ring strap portion defines a loop.

6. 6. A patient interface according to claim 5, wherein the ring strap portion has an inner edge and an outer edge, the pique knit structure extending along the inner edge of the ring strap portion.

7. 7. A patient interface according to claim 5 or 6, wherein the pique knit structure forms a loop that extends along an entire inner edge of the ring strap portion.

8. A patient interface according to any one of claims 5 to 7, wherein the ring strap portion includes at least one vent area.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the knitted headgear strap further comprises a neck strap portion configured to rest on the occipital bone of the patient's head and / or be positioned against the patient's neck in use, the neck strap portion including at least one ventilation area.

10. 10. The patient interface of claim 1, wherein the first knit structure is a jersey knit structure.

11. 1. A therapeutic system for treating sleep disordered breathing, comprising: A patient interface according to any one of claims 1 to 10; A respiratory pressure therapy (RPT) device that delivers breathable gas at positive pressure; and A treatment system including an air delivery tube for passing breathable gas from the RPT device to the patient interface.

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