Connector for positioning and stabilization structure

Abstract

To provide a connector for a positioning and stabilization structure of a patient interface.SOLUTION: A patient interface includes: a plenum chamber that can be pressurized up to a therapeutic pressure; a seal forming structure constructed and arranged so as to maintain the therapeutic pressure in the plenum chamber; and a positioning and stabilization structure for providing the force to hold the seal forming structure at a therapeutically effective position on the head of a patient. The positioning and stabilization structure includes an arm and a strap removably received around the arm. The strap includes: a first connection part having a mechanical connector, which is engaged with the arm and is configured to restrict the movement of the arm inside and outside a cavity; a second connection part arranged with an interval from the external surface of the first connection part; and a sleeve folded on the second connection part and positioned between the first connection part and the second connection part.SELECTED DRAWING: Figure 6C

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Application No. 2020900227 (filing date: January 29, 2020). The entire content of this document is incorporated herein by reference for all purposes. 2 Background of the technology 2.1 Technical field

[0002] This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0003] 2.2 Description of related technologies 2.2.1 The human respiratory system and its disorders

[0004] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0005] These airways include a series of bronchial 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 in oxygen from the inhaled air into the 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 form the conducting airways and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See Non - Patent Document 1 below.

[0006] A range of respiratory disorders exist. Certain disorders can be characterized by specific manifestations (e.g., apnea, hypopnea, and hyperventilation).

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of upper airway closure or obstruction during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, as well as the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a disease, the apnea of affected patients typically lasts for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disorder, especially common in middle-aged overweight men, but patients have no awareness of the symptoms. See Patent Document 1 (Sullivan).

[0009] Respiratory insufficiency is a general term for respiratory disorders, referring to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the needs of the patient. Respiratory insufficiency may include some or all of the following disorders.

[0010] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0011] To treat or improve such diseases, a certain range of treatments are being used. Furthermore, in other aspects, healthy people can also advantageously utilize the preventive treatment of respiratory disorders. However, there are multiple defects in these. 2.2.2 Treatment

[0012] A variety of respiratory treatments (e.g., continuous positive airway pressure (CPAP) treatment, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow treatment (HFT)) are being used for the treatment of one or more of the above respiratory disorders. 2.2.2.1 Respiratory pressure treatment

[0013] Respiratory pressure therapy is the application of supplying air to the entrance of the airway at a controlled target pressure that is normally positive pressure with respect to the atmosphere over the entire respiratory cycle of the patient (different from negative pressure therapy such as, for example, tank ventilators and cuirass ventilators).

[0014] 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 to move forward or backward against the posterior oropharyngeal wall, the continuous positive airway pressure functions as an air pressure 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 about the device used to provide the treatment, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal. 2.2.2.2 Flow therapy

[0015] In all respiratory therapies, the delivery of a defined therapeutic pressure is not necessarily intended. In some respiratory therapies, the delivery of a defined tidal volume is intended by delivering an inspiratory flow profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy by the flow of conditioned or high-concentration gas can only be used as an adjunct to the patient's spontaneous breathing. In one example, high-flow therapy (HFT) is the provision of a continuous, heated, humidified airflow at a "therapy flow" that is maintained approximately constant throughout the respiratory cycle through an unsealed or open patient interface. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory disorders. As one mechanism of action, providing high-flow air to the airway inlet improves ventilation efficiency because it allows the flushing or washing out of CO2 exhaled from the patient's anatomic dead space. For this reason, HFT is sometimes referred to as dead space therapy (DST). Other benefits include improved warmth and humidification (possibly due to the benefits of secretion control) and the possibility of a gentle increase in airway pressure. As an alternative to a constant flow, the therapy flow can follow a profile that varies over the respiratory cycle.

[0016] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe that a continuous flow of oxygen-enriched air be delivered to the patient's airway at a specified oxygen concentration (oxygen fraction in ambient air from 21% to 100%) and at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM). 2.2.2.3 Supplemental Oxygen

[0017] For a particular patient, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is referred to as HFT with supplemental oxygen. 2.2.3 Respiratory therapy system

[0018] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating a disease.

[0019] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 2.2.3.1 Patient interface

[0020] A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example 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 tracheostomy tube to the patient's trachea. Depending on the treatment applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with the ambient pressure for treatment execution (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver an air blast to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0021] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of masks for purely decorative purposes, it may not be possible to maintain appropriate pressure. Mask systems used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and to not maintain internal air at a higher pressure than the surroundings.

[0022] Certain masks may be clinically unfavorable in the present technology (for example, when the mask blocks the airflow through the nose and only allows airflow through the mouth).

[0023] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0024] Certain masks may be impractical for use during sleep (for example, when sleeping on the side in bed with the head on a pillow).

[0025] There are multiple challenges in the design of patient interfaces. 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 therapy period.

[0026] Due to these problems, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: too 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 administration mask can withstand their original uses, but in such cases, they can be unacceptably uncomfortable for long-term (e.g., several hours) wear. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0027] CPAP treatment is extremely effective in the treatment of certain respiratory disorders 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 can affect the patient's compliance.

[0028] Masks designed for other uses (e.g., pilots) 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.

[0029] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field. 2.2.3.1.1 Seal-forming structure

[0030] The patient interface may include a seal-forming structure. Since the patient interface makes 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.

[0031] The patient interface can 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 can 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 can 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 can include an element that surrounds the mouth 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 can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0032] 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, variability, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on a patient's forehead may be inappropriate for use on the patient's nose.

[0033] A particular seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of the mismatch between them.

[0034] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure may include an air or fluid filled cushion or may include a shaped or formed surface of an elastomeric seal element such as rubber. With this type of seal-forming structure, when 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.

[0035] Another type of seal-forming structure uses a thin flap seal disposed 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, when the alignment between the face and the mask is poor, 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 during use, causing leakage.

[0036] Another type of seal-forming structure may include a friction fit element inserted into the nostrils for example, although there are patients who find this uncomfortable.

[0037] Another form of seal-forming structure may use an adhesive to achieve a seal. There are patients who always find it inconvenient to attach or remove the adhesive to their face.

[0038] Disclosures of a range of patient interface seal-forming structure techniques are available in (the following patent applications assigned to ResMed Limited: Patent Document 2; Patent Document 3; Patent Document 4).

[0039] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 5 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0040] 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 examples of nasal pillow masks: Patent Document 6 (in particular, describes the appearance of ResMed Limited's SWIFT® nasal pillow); Patent Document 7 (in particular, describes the appearance of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 8 and 9 (in particular, describe the appearance of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); Patent Document 10 (in particular, describes the appearance of ResMed Limited's SWIFT® FX nasal pillow). 2.2.3.1.2 Positioning and Stabilization

[0041] The seal-forming structure of a patient interface used for positive pressure air therapy is subject to the corresponding forces of air pressure that impede sealing. Therefore, various techniques are used to position the seal-forming structure and maintain a seal against the appropriate part of the face.

[0042] In one technique, an adhesive part is used. See, for example, Patent Document 11. However, when an adhesive part is used, there may be discomfort.

[0043] In another technique, one or more straps and / or stabilization harnesses are used. In the case of many such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable and difficult to handle. 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0044] The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above-mentioned therapies or as part of a system, for example, by operating the device to generate an air delivery flow to the interface to the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0045] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0046] An example of a special requirement for a specific RPT device is acoustic noise.

[0047] Table of noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample).

[0048] [Table 1]

[0049] As one known RPT device used for the treatment of sleep disordered breathing, there is the S9 sleep therapy system (manufacturer: ResMed Limited). As another example of an RPT device, there is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent ventilation for patients for a certain range for the treatment of multiple diseases (non-limiting examples include NMD, OHS, and COPD).

[0050] The ResMed Elisee™ 150 ventilator and the ResMed VSIII™ ventilator can provide assistance for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of multiple diseases. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0051] The device designers can be presented with countless options. Since the design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters. 2.2.3.3 Air Circuit

[0052] The air circuit is a conduit or tube constructed and arranged such that during use, an air flow moves between two components of the respiratory therapy system (e.g., the RPT device and the patient interface). In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation. 2.2.3.4 Humidifier

[0053] When the delivery of the air flow is performed without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, humidified gas is generated, thus minimizing drying of the nasal mucosa and increasing the comfort of the patient airway. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air.

[0054] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0055] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed next to the pillow may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient, and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, safety constraints may be more stringent than those of industrial humidifiers.

[0056] Although many medical humidifiers are known, such medical humidifiers can suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use. 2.2.3.5 Data Management

[0057] There may be a case where data is obtained 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) can obtain data describing the patient's treatment with the RPT device manually, 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.

[0058] In a patient's treatment, there may be other ways to benefit from communication of treatment data to a third party or an external system.

[0059] 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. 2.2.3.6 Mandibular Repositioning

[0060] 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 jawbone) 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 portion 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, reducing airway collapse and reducing palatal vibration.

[0061] In certain examples, the mandibular advancement device may include an upper splint intended to engage or fit with the teeth on the maxilla or maxillary bone, and a lower splint intended to engage or fit with the teeth on the maxilla or mandibular bone. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. The pair of connecting rods are symmetrically fixed on the upper splint and the lower splint.

[0062] 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 change the protrusion level of the mandible. The dentist can determine the protrusion level according to the mandible, and as a result, the length of the connecting rod is determined.

[0063] There are also MRDs configured to push the mandible forward relative to the maxilla, and there are those designed to hold the mandible in a forward position, like other MADs such as the ResMed Narval CC (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, it is configured to minimize or prevent any movement of one or more of the teeth. 2.2.3.7 Ventilation technology

[0064] Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section may enable 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).

[0065] This ventilation section may include an orifice, and when using a mask, gas can flow through the orifice. In the case of a number of such ventilation sections, it is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation sections, for example, due to noise or airflow concentration, it may interfere with the sleep of patient 1000 and co - sleeper 1100.

[0066] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: Patent Document 12; Patent Document 13; Patent Document 14; Patent Document 15; Patent Document 16.

[0067] Table of noises of conventional masks (ISO17510 - 2:2007, at 1 m under 10 cmH2O pressure)

[0068] [Table 2]

[0069] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0070] List the sound pressure values of various subjects as follows:

[0071] [Table 3]

[0072] 2.2.4 Screening, diagnostic systems and monitoring systems

[0073] A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders and typically requires expert 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), electromyogram (EMG)). For PSG of sleep disordered breathing, patients needed to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0074] 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 warrants 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 / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0075] A clinical expert can appropriately perform screening, diagnosis, or monitoring of a patient 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 disease. Furthermore, a certain clinical expert may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

[0076]

Patent Document 1

Patent Document 2

[0077] [Non-Patent Document 1] "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012. [Summary of the Invention]

[0078] 3 Brief Description of the Technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0079] A first aspect of the present technology relates to an apparatus for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0080] Another aspect of the present technology relates to a method for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0081] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respect to respiratory therapy.

[0082] One form of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilization structure. The patient interface may further include a ventilation structure. The patient interface may be further configured to keep the patient's mouth exposed, or, when the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the surroundings through their mouth when there is no pressurized air flow through the plenum chamber inlet port.

[0083] Another aspect of the present technology relates to a face-mounted interface. This face-mounted interface may include a face interface and a positioning and stabilization structure. The face interface may be configured to contact the user's (e.g., patient's) face. The positioning and stabilization structure is structured to hold the face interface in an effective position relative to the user's face.

[0084] In some embodiments, the face-mounted interface is a patient interface and is used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders. However, the face-mounted interface can be any device worn on the user's face. The user can be a patient, an operator, an observer, or any other person.

[0085] Another aspect of one form of the technology relates to a positioning and stabilization structure. This positioning and stabilization structure is configured to connect to a face interface (e.g., the plenum chamber of a patient interface) and to provide a force to hold the face interface in an effective position on the user's head.

[0086] Another aspect of one form of the technology relates to a patient interface that includes: a plenum chamber that can be pressurized to a treatment pressure; a seal-forming structure constructed and arranged to form a seal with an area of the patient's face around an inlet to the patient's airway to deliver air flow in a sealed manner at the treatment pressure, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; and 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 includes at least one rigid arm configured to be positioned adjacent to the patient's cheek during use and a strap removably received around the rigid arm and configured to contact a posterior region of the patient's head during use.

[0087] Another aspect of one form of the present technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes at least one rigid arm configured to be positioned adjacent to a user's cheek during use, and a strap removably received around the rigid arm and configured to contact a rear region of the user's head during use.

[0088] Another aspect of one form of the present technology is a patient interface including: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face around an inlet to the patient's airway for hermetically delivering an air flow at the therapeutic pressure, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; and a positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure includes: at least one arm, and a strap removably received around the arm, the strap including a first rigid connection having a mechanical connection that engages the rigid arm and restricts movement of the rigid arm inside and outside the cavity of the strap.

[0089] Another aspect of one form of the present technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes: at least one arm, and a strap removably received around the arm, the strap including a first rigid connection having a mechanical connection that engages the rigid arm and restricts movement of the rigid arm inside and outside the cavity of the strap.

[0090] Another aspect of one form of the present technology relates to a patient interface including: a plenum chamber that can be pressurized up to a therapeutic pressure; a seal-forming structure constructed and arranged to form a seal with an area of the patient's face around an inlet to the patient's airway to deliver air flow in a sealed manner at the therapeutic pressure, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; and 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 includes a strap configured to contact a posterior region of the patient's head during use. The strap includes a first rigid connection portion and a second rigid connection portion spaced apart from an outer surface of the first rigid connection portion, and a sleeve is folded over the second rigid connection portion and positioned between the first rigid connection portion and the second rigid connection portion.

[0091] Another aspect of one form of the present technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes a strap configured to contact a posterior region of a user's head during use, the strap including a first rigid connection portion and a second rigid connection portion spaced apart from an outer surface of the first rigid connection portion, and a sleeve is folded over the second rigid connection portion and positioned between the first rigid connection portion and the second rigid connection portion.

[0092] Another aspect of one form of the technology relates to a patient interface including: a plenum chamber that can be pressurized up to a therapeutic pressure; a seal forming structure constructed and arranged to form a seal with a region of the patient's face around an inlet to the patient's airway to deliver air flow in a sealed manner at the therapeutic pressure; and 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 includes a first rigid connection and a sleeve constructed from a flexible material. The sleeve is folded onto the first rigid connection.

[0093] Another aspect of one form of the technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes a first rigid connection and a sleeve constructed from a flexible material. The sleeve is folded onto the first rigid connection.

[0094] Another aspect of one form of the technology is a patient interface including: a plenum chamber that can be pressurized up to a therapeutic pressure; a seal forming structure constructed and arranged to form a seal with a region of the patient's face around an inlet to the patient's airway to deliver air flow in a sealed manner at the therapeutic pressure, the seal forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; and 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 includes at least one arm and a strap removably received around the rigid arm. The strap includes a first connection portion having a mechanical connector configured to engage the arm, a second connection portion spaced apart from an outer surface of the first connection portion, and a sleeve constructed from a flexible material.

[0095] Another aspect of one form of the present technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes at least one arm and a strap removably received around the rigid arm. The strap includes a first coupling having a mechanical connector configured to engage the arm, a second coupling spaced apart from the outer surface of the first coupling, and a sleeve constructed from a flexible material.

[0096] Another aspect of one form of the present technology is a patient interface including: a plenum chamber pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow for breathing by a patient at the treatment pressure; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face around an inlet to the patient's airway, the seal-forming structure having holes therein such that air flow is delivered at least to an inlet to the patient's nostrils at the treatment pressure, the seal-forming structure constructed and arranged to maintain the treatment pressure within the plenum chamber throughout a patient breathing cycle during use; and a positioning and stabilization structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure includes: at least one rigid arm configured to be positioned adjacent to a patient's cheek during use; a strap removably received around the rigid arm, the strap configured to contact a posterior region of the patient's head during use, the strap including a first rigid connection portion forming an opening to a cavity, the rigid arm positionable into the cavity through the opening, the first rigid connection portion having a mechanical connector configured to engage the rigid arm and limit movement of the rigid arm inside and outside the cavity; a second rigid connection portion spaced apart from an outer surface of the first rigid connection portion; and a sleeve constructed of a flexible material, the sleeve folded onto the second rigid connection portion and positioned between the first rigid connection portion and the second rigid connection portion.

[0097] In certain forms, the sleeve includes an outer surface including an outermost surface of the strap and an inner surface including a boundary of the cavity.

[0098] In certain forms, the mechanical connector of the first rigid connection part includes a protrusion, and the rigid arm includes a recess configured to receive the protrusion.

[0099] In certain forms, the protrusion extends at an angle of 40° - 60° from the inner surface of the first rigid connection part.

[0100] In certain forms, the mechanical connector includes a snap - fit connection.

[0101] In certain forms, the flexible material is a textile.

[0102] In certain forms, the flexible material is elastic and / or elastomeric.

[0103] In certain forms, the first rigid connection part and the second rigid connection part generally have a circular shape, and the rigid arm further includes an extension having at least a part of the generally circular shape.

[0104] In certain forms, the rigid arm is configured not to extend in a rearward direction beyond the patient's ear.

[0105] In certain forms, the strap includes a first piece and a second piece connected together using a length adjuster, and the length adjuster is configured to vary the usable length of the strap.

[0106] In certain forms, the strap is bifurcated.

[0107] In certain forms, at least one rigid arm includes a first rigid arm configured to be positioned on the left side of the patient's head during use and a second rigid arm. The second rigid arm is coupled to a positioning and stabilization structure and is configured to be positioned adjacent to the patient's right cheek during use. The strap is removably received around the second rigid arm and includes: a third rigid coupling defining a second opening for the cavity, wherein the second rigid arm is positioned into the cavity through the second opening and a mechanical connector of the third rigid coupling engages the second rigid arm to limit movement of the second rigid arm inside and outside the second opening of the cavity; and a fourth rigid coupling spaced from the outer surface of the first rigid coupling. The sleeve is folded over the fourth rigid coupling and positioned between the third rigid coupling and the fourth rigid coupling.

[0108] In certain forms, the plenum chamber inlet port is a first plenum chamber inlet port and the plenum chamber further includes a second plenum chamber inlet port. The first plenum chamber inlet port is configured to receive an air flow at a treatment pressure and the second plenum chamber inlet port is configured to receive a plug configured to prevent a situation where the air flow escapes at the treatment pressure.

[0109] In certain forms, the rigid arm includes a plug.

[0110] In certain forms, the plug is removable from the second opening to allow a flow of pressurized air through the second opening.

[0111] In certain forms, the rigid arm is at least partially flexible, thereby adjusting the outer shape to substantially conform to the patient's cheek.

[0112] In certain forms, a nasal pillow or cradle is defined by a seal-forming structure.

[0113] In certain forms, the first rigid connection portion, the second rigid connection portion, and the sleeve are all connected together using an adhesive.

[0114] In certain forms, the width of the cavity is smaller than the width of the rigid arm, and the sleeve is configured to stretch when receiving the rigid arm.

[0115] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with an edge shape that is complementary to the intended wearer's shape.

[0116] One aspect of one form of the present technology is a method of manufacturing a patient interface.

[0117] In certain forms, the method includes the step of forming a strap, which is performed as follows: providing a flexible material; inserting a second connection portion into a cavity of the flexible material; folding an end of the flexible material into the cavity to enclose the second connection portion; and inserting a first connection portion into the cavity.

[0118] In certain forms, the method includes the step of connecting a positioning and stabilization structure to a seal-forming structure. The step is performed as follows: providing a connection opening in the plenum chamber; and inserting a plug of the rigid arm into the connection opening.

[0119] In certain forms, the method includes adding an adhesive around the connection opening to fix the plug within the opening.

[0120] In certain forms, the method includes removing the plug from the connection opening.

[0121] One form of another aspect of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilization structure. The seal-forming structure may include an inlet port, and the plenum chamber may include at least one connection port.

[0122] In certain forms, the inlet port is configured to receive pressurized air, and the at least one connection port is configured to receive a plug that restricts fluid flow through the connection port.

[0123] In certain forms, the inlet port is configured to receive a cover, and the at least one connection port is configured to receive pressurized air.

[0124] In certain forms, the positioning and stabilization structure is connected at the connection port. The positioning and stabilization structure may also be a conduit headgear that conveys fluid from above the patient's head of the plenum chamber. Alternatively, the positioning and stabilization structure may be a plug connected to a rigid arm.

[0125] Another aspect of one form of the present technology relates to a positioning and stabilization structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilization structure includes: at least one rigid arm configured to be positioned adjacent to the user's cheek in use; and a strap removably received around the rigid arm and configured to contact a rear region of the user's head in use, the strap including a first rigid connection portion that forms an opening to a cavity, the rigid arm being positionable within the cavity through the opening, and the mechanical connector of the first rigid connection portion being configured to engage the rigid arm and limit movement of the rigid arm within and outside the cavity, a second rigid connection portion spaced apart from the outer surface of the first rigid connection portion, and a sleeve constructed of a flexible material, the sleeve being folded over the second rigid connection portion and positioned between the first rigid connection portion and the second rigid connection portion.

[0126] One aspect of one form of the present technology is a method of manufacturing a positioning and stabilization structure.

[0127] In certain forms, the method of manufacturing the positioning and stabilization structure includes providing a flexible material; inserting a second connection portion into a cavity of the flexible material; folding an end of the flexible material into the cavity to enclose the second connection portion; and inserting a first connection portion into the cavity to form the strap.

[0128] Another aspect of one form of the present technology is a patient interface comprising: a plenum chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than the 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 breathing by the patient and a connection inlet port sized and structured to receive an air flow for breathing by the patient at the treatment pressure; a seal-forming structure constructed and arranged to form a seal with an area of the patient's face around the entrance to the patient's airway, the seal-forming structure having holes therein so that the air flow is delivered at least to the entrance to the patient's nostrils at the treatment pressure, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; the connection inlet port being configured to removably receive a positioning and stabilization structure so that a force is provided to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure includes at least one of: a rigid arm configured to restrict fluid flow through the connection inlet port, the arm being configured to be positioned along the patient's cheek during use; and a conduit headgear configured to convey air flow through the connection inlet port to the patient.

[0129] In certain forms, the rigid arm is coupled to the connection inlet port. The rigid arm includes: a plug removably received within the connection inlet port, the plug being configured to restrict air flow through the connection inlet port; and a rigid arm portion configured to be positioned adjacent to the patient's cheek.

[0130] In certain forms, the plenum chamber inlet port is configured to receive an air flow during use.

[0131] In certain forms, the conduit headgear is connected to the connection inlet port, and the conduit headgear has an inlet configured to receive an air flow, the inlet being positioned above the upper portion of the patient's head during use, and an inlet; and a hollow tube configured to convey the air flow to the plenum chamber.

[0132] In certain forms, the cover is removably received within the plenum chamber inlet port with the conduit headgear connected to the connection inlet port, and the cover restricts fluid flow through the plenum chamber inlet port.

[0133] In certain forms, the rigid arm and the conduit headgear are interchangeably connectable to the connection inlet port.

[0134] One aspect of the present technology is a method of using a patient interface.

[0135] In certain forms, the method includes: providing a seal-forming structure; selecting a positioning and stabilizing structure from among one of the rigid arm and the conduit headgear; connecting the positioning and stabilizing structure to the connection inlet port; connecting one of the air circuit and the cover to the plenum chamber inlet port; and providing an air flow through one of the positioning and stabilizing structure and the air circuit and restricting the air flow using one of the cover and the positioning and stabilizing structure.

[0136] Another aspect of the present technology relates to a positioning and stabilizing structure configured to support a face interface (e.g., the plenum chamber of a patient interface). The positioning and stabilizing structure includes at least one of: a rigid arm configured to restrict fluid flow through the connection inlet port, the arm being configured to be positioned along the user's cheek during use; and a conduit headgear configured to convey an air flow through the connection inlet port to the user.

[0137] One aspect of one form of the present technology is a method of using a positioning and stabilization structure.

[0138] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0139] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0140] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap water in the patient's home, and no special cleaning equipment is required. One aspect of one form of the present technology is a humidifier tank that can be cleaned, for example, with soap water in the patient's home, and no special cleaning equipment is required.

[0141] The methods, systems, devices, and apparatuses described can be embodied to improve the functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy 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 diseases (e.g., sleep apnea).

[0142] 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.

[0143] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0144] 4 Brief Description of the Drawings This technology is illustrated by way of non - limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements. 4.1 Respiratory Therapy System

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Mode for Carrying Out the Invention

[0145] 5 Detailed Description of Examples of the Technology Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0146] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples can constitute a further example. 5.1 Treatment

[0147] In one form, the technology includes a method for treating a respiratory disorder. The method includes applying a positive pressure to the entrance of the airway of patient 1000.

[0148] In a specific example of the technology, an air supply at positive pressure is provided to the nasal passage of the patient through one or both of the nostrils.

[0149] In a specific example of the technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy System

[0150] In one form, the technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 that supplies an air flow to patient 1000 through an air circuit 4170 and a patient interface 3000.

[0151] In one form, the present technology includes a face contact system for interaction with a user's face. The system can include a face interface that engages or contacts the user's face. This face interface can include the patient interface 3000 or any other system that interacts with the user's face. 5.3 Patient Interface

[0152] The face contact system can include a face interface configured to be positioned opposite or in the vicinity of the user's face. This face interface is positioned and arranged to interact with anatomical features on the user's face. An example of a face interface is the non-invasive patient interface 3000.

[0153] The 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 section 3400, a form of connection port 3600 for connection to the 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(s) to the patient 1000's airway so as to maintain a positive pressure at the entrance to the patient's airway. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0154] 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.

[0155] The 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.

[0156] The patient interface 3000 according to one aspect 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 surroundings.

[0157] The patient interface 3000 according to one aspect 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 surroundings. 5.3.1 Seal formation structure

[0158] In one aspect of the present technology, the seal formation structure 3100 may provide a target seal formation area and may further provide a cushioning function. The seal formation structure 3100 may also be referred to as a cushion. In other examples of a face contact system, the cushion may contact the user's face but may not seal the user's face. The target seal formation area is an area where a seal may occur in the seal formation structure 3100. The area where the seal actually occurs (i.e., the actual sealing surface) may vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0159] In one aspect, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0160] In a particular aspect of the present technology, the seal formation structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0161] The seal formation structure 3100 according to the present technology may be constructed from a soft, flexible, and elastic material (e.g., silicone).

[0162] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of a seal-forming 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. 5.3.1.1 Sealing mechanism

[0163] In one form, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can act on its underside in easy response to the positive system pressure within the plenum chamber 3200 to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0164] 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 edge length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0165] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilizing structure.

[0166] 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.

[0167] In one form, the seal-forming structure includes a region having an adhesive surface or an adherent surface.

[0168] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted seal flange, a compression seal, a gasket seal, a tension portion, and a portion having an adhesive surface or an adherent surface. 5.3.1.2 Nasal bridge or nasal sill region

[0169] 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.

[0170] 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. 5.3.1.3 Upper lip region

[0171] 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.

[0172] 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. 5.3.1.4 Jaw region

[0173] 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.

[0174] 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. 5.3.1.5 Forehead region

[0175] 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 can cover the eyes during use. 5.3.1.6 Nasal pillows

[0176] In one form (see, e.g., FIG. 3G), 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.

[0177] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion 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, connecting the frustum of the cone to the stem. Additionally, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a self-aligning structure. The self-aligning structure accommodates relative movement between both the displacement and angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem is connected. 5.3.1.7 Sub-nasal mask

[0178] As shown in FIGS. 6A-6C, the seal-forming structure 3100 of the patient interface 3000 includes a sub-nasal mask. The sub-nasal mask may be similar to a nasal pillow in that it is formed adjacent to the patient's nasal cavities and the patient's mouth is exposed to the surroundings. The seal-forming structure 3100 takes the form of a sub-nasal mask seal around the outer surface of the patient's nose.

[0179] In the illustrated form, the seal-forming structure 3100 may seal around the outside of the nose and may include a single opening for each nasal cavity. In other forms, the seal-forming structure 3100 may include a single opening that receives both nasal cavities. 5.3.2 Plenum chamber

[0180] The plenum chamber 3200 has an edge of a shape that is complementary to the surface profile of an average person's face in the area 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 perimeter of the 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.

[0181] 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.

[0182] In a particular form 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.

[0183] In a particular form of the present technology, the plenum chamber 3200 is constructed from a translucent material. By using a translucent material, the harshness of the pressure of the patient interface can be reduced and compliance with treatment can be assisted.

[0184] As shown in FIGS. 6A and 6B, the plenum chamber 3200 includes an opening or connection port 3600. When exposed, the connection port 3600 provides fluid communication between the surrounding area and the nasal cavity (even when the seal forming structure 3100 is sealed against the patient's face). In the illustrated form, the connection port 3600 defines an elliptical shape and is disposed at the center of the plenum chamber 3200. In other forms, the connection port 3600 may have different sizes or may define different shapes.

[0185] The connection port 3600 defines an opening for receiving the flow of pressurized fluid. Specifically, since the air circuit 4170 can be connected to the connection port 3600, a fluid path from the RPT device 4000 to the patient's airway is obtained. In the illustrated form, the protrusion 3212 is connected to the plenum chamber 3200 and extends into the connection port 3600 (see, for example, FIG. 6A). The protrusion 3212 can be connected to the air circuit 4170 and can hold the air circuit 4170 against the plenum chamber 3200. For example, the air circuit may include a ring 4171 formed of a rigid or semi-rigid material (e.g., plastic). When the air circuit 4170 is fully connected to the plenum chamber 3200 (see, for example, FIG. 6B), the protrusion 3212 engages with the ring 4171 in a snap-fit arrangement (e.g., engagement of the protrusion 3212 creates a substantially airtight seal. This substantially airtight seal can be released by providing a tensile force).

[0186] As shown in FIG. 6B, when the air circuit 4170 is connected to the plenum chamber 3200, it is substantially impossible for air to escape through the interface between the plenum chamber 3200 and the ring 4171. Air can be directly supplied from the air circuit 4170 into the plenum chamber 3200, thereby enabling the patient to inhale pressurized air through his / her nose (or mouth if a different mask is used). 5.3.3 Positioning and Stabilization Structure

[0187] The positioning and stabilization structure 3300 can generally be referred to as a structure that maintains the position of the face interface at a desired position on the user's face.

[0188] In some forms, a single positioning and stabilization structure 3300 may be usable with multiple types of face interfaces. Other forms of positioning and stabilization structures may be usable with a single type of face interface.

[0189] The seal forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by the positioning and stabilization structure 3300 during use.

[0190] 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.

[0191] In one form, the positioning and stabilization structure 3300 provides holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0192] In one form, the positioning and stabilization structure 3300 provides holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (e.g., due to tubing drag or accidental interference with the patient interface).

[0193] 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 example, the positioning and stabilization structure 3300 has a low-profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0194] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be overly large or bulging in size so as to interfere when a patient lies in a supine sleep position with the patient's head resting on the pillow in the rear region of the patient's head.

[0195] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be overly large or bulging in size so as to interfere when a patient lies in a lateral sleep position with the patient's head resting on the pillow in the side region of the patient's head.

[0196] In one form of the present technology, the positioning and stabilization structure 3300 includes a release portion disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release portion is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged so as to prevent a situation where, when a patient lies with the head resting on the pillow, the force to the rear portion is transmitted along the positioning and stabilization structure 3300 due to the presence of the release portion and the seal is obstructed.

[0197] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0198] In a particular form 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 during use and direct a force to bring the seal forming structure 3100 into close contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0199] The straps of the positioning and stabilization structure 3300 can be at least partially constructed from a compliant material (e.g., a moisture-active material, a heat-active material, a growth-stimulating material, and / or a combination of different materials) as described in PCT / SG2020 / 050792. The entire content of this reference is incorporated herein by reference. Since the straps can expand, the comfort for patients under various usage conditions is increased.

[0200] In one form of the technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a part of its lower edge moves upward and passes over the upper ear base point of the patient's head and covers a part of the parietal bone without covering the occipital bone when in use.

[0201] In one form of the 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 under the lower ear base 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 when in use.

[0202] In one form of the technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie 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.

[0203] In a particular form of the technology, the positioning and stabilization structure 3300 includes straps that are bendable and for example non-rigid. An advantage of this aspect is that the straps are more comfortable when the patient lies on their side during sleep.

[0204] In a particular form of the technology, the positioning and stabilization structure 3300 includes straps constructed to be breathable such that water vapor can pass through the interior.

[0205] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. The 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 can include one form of the positioning and stabilization structure 3300 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.

[0206] As shown in FIGS. 6A-6Q, the positioning and stabilization structure 3300 can include a headgear assembly 3302. The headgear assembly 3302 includes a sleeve 3304 and a pair of arms 3306 (e.g., a left arm and a right arm). Each of the arms 3306 can be a rigid arm 3306. The sleeve 3304 and the arms 3306 are both connected to the seal-forming structure 3100 and the plenum chamber 3200 to hold the seal-forming structure 3100 and the plenum chamber 3200 in a therapeutically effective position relative to the patient's face (e.g., where there is substantially no pressurized air leakage between the patient's face and the seal-forming structure 3100).

[0207] In the illustrated form, the sleeve 3304 is constructed of a flexible material. This enables the sleeve 3304 to bend and flex, allowing it to conform to the heads of patients with different outer shapes.

[0208] In certain embodiments, sleeve 3304 may be constructed of an elastic material or may have elastic properties. In other words, sleeve 3304 may be stretchable when a tensile force is applied and may return to its original position (when the tensile force is released). Sleeve 3304 may be constructed of a textile that includes one or more elastomeric properties or an elastomeric material may be provided within sleeve 3304 along with the textile. For example, sleeve 3304 may be at least partially constructed of spandex, thermoplastic elastomer (TPE), silicone, or similar materials. Sleeve 3304 may be knitted, nitted, braided, molded, extrusion molded, or formed by other methods. Sleeve 3304 may generally include a flat rectangular shape and may be formed with cavity 3308. Cavity 3308 may extend through sleeve 3304 and may be capable of receiving another object.

[0209] The textile may provide user comfort (e.g., abrasion resistance) when sleeve 3304 is resting against the user's face. The elastomeric material may enable sleeve 3304 to stretch and better fit around the patient's head (e.g., without being too tight). A portion of sleeve 3304 may be bifurcated such that two separate sites are included in a portion of sleeve 3304. For example, sleeve 3304 may include a first rear section 3310a and a second rear section 3310b. When sleeve 3304 is worn by a patient, first rear section 3310a and second rear section 3310b contact the rear portion of the patient's head. First rear section 3310a may be disposed at least partially spaced from second rear section 3310b and may assist in distributing the force applied onto the patient's head from sleeve 3304.

[0210] In certain forms, the sleeve 3304 can be formed as a plurality of pieces (e.g., a first portion 3304a and a second portion 3304b) and can be connected together by a fastener 3312 (e.g., a buckle). For adjusting the fit of the sleeve 3304 to the patient's head, the fastener 3312 changes the usable length of the sleeve 3304 (e.g., the length of the sleeve 3304 exposed to the patient's head). The sum of the usable length of the sleeve 3304 and the length of the seal-forming structure 3100 is approximately equal to the circumference of the patient's head. The patient can increase or decrease the usable length (e.g., by moving the portion(s) 3304a and 3304b relative to each other through the fastener 3312) to place the sleeve 3304 snugly (without being too tight) against the head. In other forms, the sleeve 3304 can be formed as a single body and the patient cannot adjust the usable length of the sleeve 3304. Instead, the patient can select from different sizes of sleeves 3304 (e.g., sleeves 3304 having different preselected usable lengths).

[0211] The sleeve 3304 can be at least partially rigidized (e.g., using a stiffening screw or other rigid or semi-rigid material). The rigid or semi-rigid material in the sleeve 3304 can control where the sleeve 3304 can stretch (e.g., provided on at least one side of an elastic or elastomeric material to allow stretching in a single direction). This can prevent the sleeve 3304 from stretching too far and collapsing (e.g., due to breakage of an elastic or elastomeric material). The rigid or semi-rigid material can also control the flexure of the sleeve 3304 and assist in maintaining the shape of the sleeve 3304. For example, the rigid or semi-rigid material can assist in maintaining the generally rectangular shape of the sleeve 3304. The rigid or semi-rigid material can also impart supplementary rigidity to the sleeve 3304, providing resistance to bending.

[0212] In other forms, the sleeve 3304 can be at least partially stiffened by a stiffening portion. This stiffening portion can be moldable for improved comfort or can be formed into a shape that provides a better fit to the patient's face. For example, the material of the stiffening portion can include a thermoplastic or a thermosoftening plastic whose material properties depend on an activator (e.g., the material properties such as stiffness change when the temperature is within a predetermined range). In other forms, the stiffness of the stiffening portion changes upon being processed. The material properties (e.g., stiffness) of the stiffening portion can change when it is subjected to other activators (excluding temperature). Non-limiting examples of activators include electric current, chemicals, pressure, and / or force. An example of the stiffening portion is described in PCT / SG2020 / 050792. The entire document is incorporated herein by reference for all purposes.

[0213] As shown in FIG. 6C, at each end of the sleeve 3304, an opening 3315 is provided for the cavity 3308. If the sleeve 3304 includes two separate parts 3304a and 3304b, the sleeve 3304 includes two separate cavities 3308 as well as two separate openings 3315 (e.g., the cavity 3308 within the first part 3304a is not connected to the cavity 3308 within the second part 3304b). Conversely, if the sleeve 3304 is formed as a single body, it can include a single cavity 3308.

[0214] The shape of the opening 3315 for the cavity 3308 is generally circular (e.g., circular, elliptical), in contrast to the remaining part of the sleeve 3304 being generally rectangular. The opening 3315 for the cavity 3308 can also be wider than the remaining part of the cavity 3308 (e.g., the inner diameter of the opening is wider than the remaining part of the sleeve). As a result, the wider opening 3315 makes it easier to insert an object, so the reception of the object into the cavity 3308 can be assisted. In the illustrated example, the circular shape maintains the rigidity of the opening 3315, so access to the cavity is always possible (e.g., the situation where the cavity 3308 is closed due to self-destruction of the sleeve 3304 is eliminated).

[0215] As shown in FIG. 6C, the rigid arms 3306 extend from either side of the seal formation structure 3100. In the illustrated example, both rigid arms 3306 are substantially identical to each other (e.g., having the same length), and the following description of the features will be made for a single rigid arm 3306, but these features are provided on both.

[0216] As shown in FIGS. 6E and 6F, the rigid arm 3306 includes a plug 3316 provided at one end. The plug 3316 is formed of a rigid or semi-rigid material and is positioned adjacent to the seal formation structure 3100. In some forms, the plug 3316 and the seal formation structure 3100 can be formed as an integral piece. In other forms, the connection of the plug 3316 to the seal formation structure 3100 can be made (e.g., using one or more of fasteners, adhesives, magnets, press-fitting, snap-fitting, etc.).

[0217] In certain forms, the plenum chamber 3200 includes an orifice 3202 on the outer surface (see, e.g., FIG. 6S). Since the orifice 3202 can extend towards the center of the plenum chamber 3200, the orifice 3202 can provide fluid communication between the inside and / or outside of the plenum chamber 3200. When the plug 3316 is inserted into the orifice 3202, the entry and exit of fluid (e.g., pressurized gas) through the orifice 3202 is restricted. Since the fixing of the plug 3316 can be performed using press fitting, the frictional engagement between the orifice 3202 and the plug 3316 restricts all entry and exit of fluid to the orifice 3202. In addition to press fitting, an adhesive (e.g., a bonding adhesive) can be used to hold the plug 3316 within the orifice 3202. Since the plug 3316 can be permanently connected within the orifice 3202 (e.g., during the assembly of the patient interface 3000), the flow of fluid through the orifice 3202 is restricted after the completion of the assembly.

[0218] The clamping body 3320 is connected to the plug 3316 and positioned outside the orifice 3202, while the plug 3316 is received within the orifice 3202. The clamping body 3320 is formed of a rigid material (e.g., hard plastic) and is configured to maintain its shape. In the illustrated example, the clamping body 3320 at least partially forms a circular shape (e.g., circular, elliptical, etc.). The shape of the clamping body 3320 can form a shape substantially identical to the opening to the cavity 3308. Thereby, the clamping body 3320 can be received within the cavity 3308.

[0219] In one form, the clamping body 3320 includes a first clamping body portion 3320a and a second clamping body portion 3320b. The clamping body portions 3320a and 3320b can have shapes that are inverted with respect to each other and can each define a part of a partially circular shape. Since at least one discontinuity (e.g., a gap) exists between the clamping body portion 3320a and the clamping body portion 3320b, these clamping bodies do not form the whole of a partially circular shape. In the illustrated example, since a pair of discontinuities exist between the clamping body portion 3320a and the clamping body portion 3320b, the clamping body portions 3320a and 3320b are independent of each other. In other examples, the clamping body 3320 can include more or fewer clamping body portions depending on the number of discontinuities.

[0220] In one form, the clamping body 3320 includes an aperture 3324 positioned through the surface of the clamping body 3320. The shape of the aperture 3324 can be rectangular or can have other suitable shapes (e.g., circular, triangular, pentagonal). In the illustrated form, the clamping body portions 3320a and 3320b each include an aperture 3324. These apertures 3324 are positioned separated by approximately 180° (e.g., a straight line passes through the centers of both apertures 3324; see FIGS. 6E and 6S). In other words, the apertures 3324 of the clamping body 3320 are provided on opposite sides of the clamping body 3320.

[0221] In one form, the clamping body 3320 is rigidly connected to the plug 3316 and is not rotatable relative to the plug 3316. The arrangement direction of the apertures 3324 relative to each other and the arrangement direction relative to the plug 3316 are kept constant. The clamping body 3320 can be bendable (i.e., flexible) relative to the plug 3316. The amount of flexibility of the clamping body 3320 can be limited so that it does not collapse (e.g., break with a snap).

[0222] Each rigid arm 3306 may include an arm portion 3328. The arm portion 3328 includes a fixed end 3329 connected to the plug 3316 and a free end 3330 distal from the plug 3316. Since the fixed end 3329 can be permanently connected to the plug 3316, separation of the arm portion 3328 and the plug 3316 is impossible. Since the arm portion 3328 extends between the clamping body portions 3320a and 3320b, the clamping body portions 3320a and 3320b are curved around the arm portion 3328. Since the arm portion 3328 also has a relatively flat and elongated configuration, the arm portion 3328 is spaced apart from the clamping body portions 3320a and 3320b. The arm portion 3328 also includes a curved edge (e.g., in the vicinity of the free end 3330) and substantially does not include sharp edges or corners. The arm portion 3328 also includes a substantially smooth surface.

[0223] As shown in FIGS. 6E and 6F, the arm portion 3328 may be constructed of a semi-rigid material that can be somewhat movable. In other words, the patient may be able to bend the arm portion 3328 to a suitable position, and the arm portion 3328 can maintain its position (after the patient releases the bending force). Specifically, the patient may be able to impart a curvature to the arm portion 3328 (e.g., concave with respect to the patient's head, convex with respect to the patient's head, or both). The patient may be able to repeatedly adjust the arm portion 3328 until the position preferred by the patient is achieved.

[0224] As shown in FIG. 6E, the arm portion 3328 is substantially linear (e.g., parallel to the sagittal plane of the patient) and has little curvature relative to the patient. The patient can grasp and bend the arm portion 3328. In the illustrated example, the patient is grasping the arm portion 3328 near the free end 3330, but the patient can grasp the arm portion 3328 at any location. If a single bend is provided near the center of the arm portion 3328 and near either end 3329 or 3330, the longer arm portion 3328 can be curved (i.e., concave and / or convex). The patient can grasp the arm portion 3328 at multiple locations and create multiple bends along the length of the arm portion 3328. Each bend can have the same or a different radius of curvature relative to any other bend along the length of the arm portion 3328.

[0225] As shown in FIG. 6F, the free end 3330 of the arm portion 3328 is bent relative to the seal forming structure 3100 and takes a concave orientation. In this example, the remainder of the arm portion 3328 remains relatively linear (e.g., neither concave nor convex). The patient can further bend the arm portion 3328 along the remaining length or keep a section of the arm portion 3328 linear. When the patient completes the bending of the arm portion 3328, the curvature of the arm portion 3328 is maintained (until the patient attempts to re-bend the arm portion 3328). In other words, the added curvature is maintained by the arm portion 3328 of rigid or semi-rigid material and the arm portion 3328 does not return to a neutral (e.g., straight) position when the bending force is released.

[0226] As shown in FIGS. 6F and 6G, after the curvature of the arm portion 3328 is set (e.g., to a desired position of the patient), the sleeve 3304 can be slid along the length of the arm portion 3328 to at least partially cover the arm portion 3328. Since the sleeve 3304 is made of a flexible material, the sleeve 3304 can be adapted to any curvature that the arm portion 3328 has. For example, since the sleeve 3304 is bendable in all directions, the sleeve 3304 can substantially conform to the shape of the arm portion 3328. Since the arm portion 3328 has a rigid or semi-rigid structure, the sleeve 3304 is held in that shape. In other examples, after the sleeve 3304 is at least partially slid over the arm portion 3328, the arm portion 3328 can be bent.

[0227] As shown in FIG. 6G, the arm portion 3328 can be inserted into the cavity 3308 of the sleeve 3304. In another aspect, the sleeve 3304 can be slipped over the arm portion 3328 through the cavity 3308. First, the free end 3330 of the arm portion 3328 is inserted into the sleeve 3304 through the cavity 3308. The arm portion 3328 is further pressed inside the sleeve 3304 (i.e., further into the cavity 3308) until substantially all of the arm portion 3328 is provided within the sleeve 3304. The curved edge and the side portion of the arm portion 3328 assist in limiting or preventing tearing or breaking of the sleeve 3304 during insertion of the arm portion 3328. In other words, the arm portion 3328 does not include sharp edges that could dig into and create holes in the holes in the sleeve 3304. The smooth surface of the arm portion 3328 also assists in limiting tearing or breaking of the sleeve 3304 during insertion of the arm portion 3328 (i.e., it is limited that a rough surface catches on the sleeve 3304).

[0228] In other forms, the rigid arm 3306 may or may not include a substantially small arm portion 3328. Nevertheless, the sleeve 3304 can be connected to the clamping body 3320 as described. In some forms, the sleeve 3304 may include higher supplementary rigidity to compensate for the reduction in the length of the arm portion 3328.

[0229] As shown in FIG. 6G, the sleeve 3304 can be moved (or translated) in a direction approaching the plug 3316. As a result, the range for slipping the sleeve 3304 on the arm portion 3328 is enlarged. As shown in FIG. 6H, the arm portion 3328 is fully inserted into the cavity 3308 of the sleeve 3304. In other words, the opening 3315 of the cavity 3308 is positioned adjacent to the fixed end 3329 of the arm portion 3328. The cavity 3308 can extend beyond the length of the arm portion 3328 (for example, the length of the cavity 3308 can be made longer than the length of the arm portion 3328), but since further translation of the sleeve 3304 is restricted by the plug 3316, the arm portion cannot extend further into the cavity 3308. Since the plug 3316 is wider than the opening 3315, further entry of the arm portion 3328 into the cavity 3308 is prevented. The sleeve 3304 receives the clamping body portions 3320a and 3320b into the cavity 3308 and engages with the clamping body portions 3320a and 3320b to mechanically connect the sleeve 3304 to the rigid arm 3306. The engagement between the sleeve 3304 and the rigid arm 3306 facilitates the release of the mechanical connection, thus promoting the easy removal of the sleeve 3304 from the arm portion 3328 (see, for example, FIG. 6I). To remove the sleeve 3304, the reverse of the operation of positioning the sleeve 3304 on the arm portion 3328 is performed. As shown in FIG. 6I, the sleeve 3304 can be moved in a direction away from the plug 3316. As a result, the range in which the sleeve 3304 slips on the arm portion 3328 is reduced.

[0230] As shown in FIG. 6J, while the first portion 3304a and the second portion 3304b of the sleeve 3304 can be slipped onto the arm portion 3328 substantially simultaneously, the plenum chamber 3200 and the seal forming structure 3100 are positioned with respect to the patient's oronasal region (e.g., the patient's nose and / or mouth). Since each of the portions 3304a and 3304b can be slipped onto each arm portion 3328 as described above, the opening 3315 of the common cavity 3308 (or the individual cavities 3308) is positioned adjacent to each plug 3316. When the portions 3304a and 3304b are slipped, the positioning and stabilizing structure 3300 comes into closer contact with the patient's head. In other words, when the portions 3304a and 3304b are pulled toward the front of the patient's head, the sleeve 3304 faces the rear of the patient's head (e.g., the sleeve 3304 is taut).

[0231] As shown in FIG. 6K, after the sleeve portions 3304a and 3304b are connected to each plug 3316, the patient can adjust the usable length of the sleeve 3304. The patient can increase or decrease the usable length of the sleeve 3304 using the fastener 3312 so that the sleeve 3304 is comfortable for the patient's head. In other words, the patient can adjust the usable length so that the seal forming structure 3100 fits snugly against the patient's face and is not too tight (e.g., does not protrude into the patient's face, does not leave red marks on the patient's skin). Before adjusting the length of the sleeve 3304, the patient can position the sleeve 3304 along the back of his or her head. For example, the patient can move the sleeve 3304 in an upward or downward direction to provide an appropriate force to the seal forming structure 3100 and / or to maximize the patient's comfort. If the sleeve 3304 is bifurcated, the patient can also change the relative positions of the respective bifurcated sections to adjust the force and / or comfort. The patient can also adjust the usable length before wearing the positioning and stabilizing structure 3300 (e.g., if the usable length is too small for wearing).

[0232] The patient can hold the seal forming structure 3100 and / or the plenum chamber 3200 at a predetermined position adjacent to his or her mouth and nose region while adjusting the usable length of the sleeve 3304. This helps to ensure an appropriate seal (e.g., appropriate position, substantially no leakage) between the seal forming structure 3100 and the patient's skin. By holding the seal forming structure 3100 in the desired position, the sleeve 3304 can be tightened to an appropriate usable length. For example, the usable length varies depending on the position where the patient positions the sleeve 3304. When the sleeve 3304 is positioned higher on the patient's head, the usable length required to achieve the same sealing force is longer (e.g., because the position of the seal forming structure 3100 is always positioned adjacent to the patient's nose and / or mouth).

[0233] As shown in FIGS. 6L - 6Q, the assembly of the sleeve 3304 is performed by positioning the first (or inner) connecting portion 3334 and the second (or outer) connecting portion 3338 at both ends (or within the cavity 3308) of the cavity 3308. The connecting portions 3334 and 3338 are positioned adjacent to the ends of the sleeve 3304 and can form an opening 3315 within the sleeve 3304. In other words, the outer connecting portion 3338 includes a generally circular shape. The inner connecting portion 3334 may also include the same generally circular shape.

[0234] As shown in FIG. 6L, when initially assembling the sleeve 3304, neither the connecting portion 3334 nor the connecting portion 3338 is present within the cavity 3308. The sleeve 3304 is generally flat, and the opening 3315 and the cavity 3308 are generally closed. In other words, the sides of the sleeve 3304 are adjacent to each other, so the internal volume of the cavity 3308 is low. The sleeve 3304 may generally have a rectangular shape, but is flexible and may be capable of a shape change (e.g., to a circular cross - section). The outer connecting portion 3338 is selected and moved to a position adjacent to the sleeve 3304. The outer connecting portion 3338 has a generally circular cross - section with a hollow central portion. In the illustrated example, the outer connecting portion 3338 has a diameter larger than that of the sleeve 3304.

[0235] As shown in FIG. 6M, the outer connecting portion 3338 is positioned within the cavity 3308 of the sleeve 3304. The flexible material of the sleeve 3304 can expand to receive the outer connecting portion 3338. In other words, the outer connecting portion 3338 causes the sleeve 3304 to expand when the sleeve 3304 is inserted into the cavity 3308, so that the end portion on the sleeve 3304 is wider than the center of the sleeve 3304. The opening 3315 of the cavity 3308 may have a different shape from the rest of the cavity 3308. The outer connecting portion 3338 holds the sleeve 3304 in a generally wider and circular position, while the remaining portion of the sleeve 3304 (and thus the remaining portion of the cavity 3308) remains in a generally flat rectangular orientation. The outer connecting portion 3338 can be composed of a rigid or semi-rigid material (e.g., hard plastic) and thus retains its shape under pressure. In other words, even if there is a biasing force or elastic force that attempts to return the sleeve 3304 to its original position, the outer connecting portion 3338 cannot change its shape.

[0236] As shown in Figure 6M, the outer connecting portion 3338 is slid into the cavity 3308 and is disposed at a distance from the initial opening 3315 of the sleeve 3304. In other words, the edge of the sleeve 3304 (e.g., the free end 3342) is not aligned with the edge of the outer connecting portion 3338. A part of the sleeve 3304 extends beyond the outer connecting portion 3338 on either side (e.g., the left side and the right side as shown in Figure 6M). The outer connecting portion 3338 can be fastened to the sleeve 3304 at an appropriate position within the cavity 3308. For example, the fixing of the outer connecting portion 3338 can be performed by using an adhesive (e.g., a bonding adhesive), using mechanical fasteners, using magnetic fasteners, sewing, or any other similar means. After the outer connecting portion 3338 is positioned at the desired location, the free ends 3342 of the sleeve 3304 are folded inwardly together. In other words, the free ends 3342 of the sleeve 3304 are folded so as to be positioned within the cavity 3308. The free ends 3342 are folded so as to rest on the surface of the outer connecting portion 3338. Therefore, the outer connecting portion 3338 is at least partially sandwiched between the folds of the sleeve 3304. The greater the separation distance at which the outer connecting portion 3338 is disposed away from the free ends 3342, the greater the length of the sleeve 3304 that can be folded over the outer connecting portion 3338. This flow may cover only a portion of the outer connecting portion 3338, or may cover the outer connecting portion 3338 entirely (so as to be entirely enclosed by the sleeve 3304). After the free ends 3342 are folded, the outer end of the outer connecting portion 3338 (e.g., the left end as shown in Figure 6N) is substantially aligned with the opening 3315 of the cavity 3308. Thus, after the folding of the free ends 3342, due to the shape of the outer connecting portion 3338, the shape of the opening 3315 is formed with respect to the cavity 3308.

[0237] After the free end 3342 of the sleeve 3304 is folded onto the outer connection portion 3338, the free end 3342 can be fixed to the outer connection portion 3338 and / or the sleeve 3304. For example, the fixing of the outer connection portion 3338 can be performed by using an adhesive (e.g., a bonding adhesive), a mechanical fastener, a magnetic fastener, sewing, or any other similar means. The free end 3342 is fixed so as not to move away and move in a direction away from the outer connection portion 3338. In some forms, the same means are used in both the connection of the outer connection portion 3338 into the cavity 3308 and the connection of the free end 3342 to the outer connection portion 3338 and / or the sleeve 3304 (e.g., only a single means is used). In some forms, the outer connection portion 3338 may not be directly connected to the sleeve 3304. In that case, the free end 3342 can be folded entirely onto the outer connection portion 3338 and connected to the sleeve 3304, thereby forming a pocket around the outer connection portion 3338. The outer connection portion 3338 can be movable (e.g., when not fixed to the sleeve 3304 itself), and in that case, the movable range is only within the boundary of the pocket.

[0238] As shown in FIG. 6O, the inner connection portion 3334 is selected and moved to a position adjacent to the sleeve 3304. The inner connection portion 3334 generally has a circular cross-section with a hollow central portion. The outer diameter of the inner connection portion 3334 is less than the inner diameter of the outer connection portion 3338. Since the inner connection portion 3334 is positioned at the opening 3315 of the cavity 3308 (i.e., the edge of the outer connection portion 3338) and is narrower than the opening 3315, it can slide into the opening 3315.

[0239] The inner connecting portion 3334 includes at least one protrusion 3346 extending towards the center of the inner connecting portion 3334. In the illustrated example, the inner connecting portion 3334 includes a pair of protrusions 3346. These protrusions 3346 can extend at an angle θ in a direction away from the surface of the inner connecting portion 3334 (see, for example, FIG. 6Q). The angle θ can be an angle measured from an axis 3348 parallel to the radial axis of the inner connecting portion 3334. In some forms, the angle θ is between 10° and 90°. In some forms, the angle θ is between 20° and 80°. In some forms, the angle θ is between 30° and 70°. In some forms, the angle θ is between 35° and 65°. In some forms, the angle θ is between 40° and 60°. In some forms, the angle θ is approximately 55°. In some forms, both protrusions 3346 extend at the same angle (e.g., in a mutually inverted form).

[0240] The protrusion 3346 may extend to a point or may be curved. Since these protrusions 3346 are spaced apart from each other, they do not contact the other protrusion 3346. The protrusion 3346 also does not extend from the inner connecting portion 3334. In other words, the protrusion 3346 is entirely maintained within the volume of the inner connecting portion 3334.

[0241] As shown in FIG. 6P, the inner connecting portion 3334 is slid into the cavity 3308. The inner connecting portion 3334 is rested on the free end 3342 of the sleeve 3304 within the cavity 3308. As can be seen from the cross-section, the sleeve 3304 includes different material layers within the cavity 3308. For example, starting from the outside, the sleeve 3304 forms the outermost surface of the positioning and stabilizing structure 3300, the outer connecting portion 3338 is positioned directly inside the sleeve 3304, the free end 3342 of the sleeve 3304 is folded over the outer connecting portion 3338, and the inner connecting portion 3334 is positioned directly inside the free end 3342. Thus, four layers are provided and adjacent (or neighboring) layers are not the same (e.g., the positioning and stabilizing structure 3300 is provided alternately as flexible and rigid / semi-rigid).

[0242] After the inner connecting portion 3334 is positioned at the desired position, the inner connecting portion 3334 can be fixed within the cavity. For example, the fixing of the inner connecting portion 3334 can be performed by using an adhesive (e.g., a bonding adhesive), using mechanical fasteners, using magnetic fasteners, sewing, or any other similar means. This position can be substantially aligned with the outer connecting portion 3338. For example, the inner connecting portion 3334 and the outer connecting portion 3338 can be concentric, and the edges of the inner connecting portion 3334 and the outer connecting portion 3338 can be aligned. In other words, both the inner connecting portion 3334 and the outer connecting portion 3338 can be positioned at the opening 3315. The space between the protrusions 3346 provides a space that extends into the cavity 3308 through the opening 3315.

[0243] Returning to FIGS. 6G - 6I, the arm portion 3328 is narrower than the width between the protrusions 3346. Since the sleeve 3304 slides along the arm portion 3328, these protrusions 3346 do not generate resistance. In other words, when the protrusions 3346 can contact the arm portion 3328, the protrusions 3346 do not make the sliding of the sleeve 3304 along the arm portion 3328 more difficult. The wider opening due to the outer connecting portion 3338 increases the target area when the patient inserts the arm portion 3328. The shape of the sleeve 3304 (e.g., generally rectangular) does not generally change when the arm portion 3328 is inserted.

[0244] As shown in FIG. 6H, the opening 3315 of the sleeve 3304 is slid to the plug 3316. When the arm portion 3328 is received within the cavity 3308, the clamping body portions 3320a and 3320b are received entirely within the inner connecting portion 3334. When the patient aligns the protrusion 3346 of the inner connecting portion 3334 with the clamping body portions 3320a and 3320b, the protrusion 3346 can be received within the clamping body portions 3320a and 3320b. The angle θ of the protrusion 3346 aids in maintaining engagement between each protrusion 3346 and the clamping body 3320. After the protrusion 3346 enters each clamping body portion 3320a and 3320b, the sleeve 3304 is held relative to the plug 3316 (e.g., it becomes non - movable in a direction away from the plug 3316).

[0245] When the sleeve 3304 is fixed in place, the positioning and stabilization structure 3300 is fixed to the patient's head. As shown in FIGS. 6J and 6K, the arm portion 3328 extends along the patient's cheek in a direction away from the oral - nasal region and extends to the rear of the patient's head. The arm portion 3328 also extends in an upward direction along the patient's head (e.g., see FIG. 6K). In some forms, the arm portion 3328 does not extend beyond each ear of the patient. In other words, the free end 3330 of the arm portion 3328 does not extend behind the patient's ear. The arm portion 3328 extends so as not to contact the patient's ear. For example, the arm portion 3328 extends along a line that protrudes above the patient's ear so that the arm portion 3328 does not cross the ear (e.g., does not cause discomfort to the patient). The sleeve 3304 extends from the oral - nasal region to the rear of the patient's head and back to the oral - nasal region. Since the sleeve 3304 follows the same line as the arm portion 3328, the sleeve 3304 also does not cross the patient's ear.

[0246] In other forms (not shown), the free end 3330 of each arm portion 3328 can extend to a point in front of each ear and can contact the patient's face below the upper ear base point and above the lower ear base point. The sleeve 3304 can bifurcate and extend around the patient's ear to minimize contact with the patient's ear.

[0247] Returning to FIG. 6I, the patient can disengage the protrusion 3346 from the clamping body portions 3320a and 3320b and slide and release the sleeve 3304 from the arm portion 3328. In some forms, when removing the sleeve 3304, the patient can apply an appropriate force directed in a direction away from the plug 3316. By applying this force, the protrusion can exit from each of the clamping body portions 3320a and 3320b, whereby the sleeve 3304 becomes movable freely again with respect to the plug 3316. In other forms, when removing the protrusion 3346 from the clamping body portions 3320a and 3320b, the force alone may be insufficient (without breaking the protrusion 3346 (and thereby preventing further connection)). In that case, the patient may need to apply a compressive force to the connecting portions 3334 and 3338 and then apply a force to the sleeve 3304 to move it away from the plug. In other words, the patient squeezes the outer connecting portion 3338 so as to compress the inner connecting portion 3334 and withdraw the protrusion 3346 from the clamping body portions 3320a and 3320b. At this point, the inner connecting portion 3334 is no longer mechanically engaged with the plug 3316 and can move relative to the plug 3316. Since the connecting portions 3334 and 3338 are made of a rigid or semi-rigid material, only a small amount of deflection may be required to move the protrusion 3346 in and out of the clamping body portions 3320a and 3320b.

[0248] As shown in FIG. 6R, when the air circuit 4170 is removed from the plenum chamber 3200, the connection port 3600 may be exposed. Similarly, the plug 3316 may also be removed from the plenum chamber 3200. The plug 3316, the clamping body 3320, and the arm portion 3328 are formed as a single piece (for example, since they are interconnected, they cannot be separated), and each of them is removed from the plenum chamber 3200 together. At this location, the orifice 3202 remains. Similar to the connection port 3600, the orifice 3202 provides fluid communication into the plenum chamber 3200. While these plugs 3316 are positioned within the orifice 3202, the entry and exit of fluid (such as air) are substantially prevented, but when the plug 3316 is removed, free entry and exit of air become possible. The connection of the plug 3316 can be made by press-fitting, snap-fitting, or similar connections such that repeated insertion and removal of the plug 3316 (as shown in FIGS. 6R and 6S, for example) are possible and fluid flow through each orifice 3202 during insertion of each plug 3316 is restricted. This can assist in cleaning the interior of the plenum chamber 3200 by the patient (for example, after use every night).

[0249] Alternatively, the plug 3316 may be integrally formed with the plenum chamber 3200 (or more broadly, the face interface) as a one-piece structure. This can lead to simplification of the manufacture of the patient interface 3000 (or generally, a face-mounted interface) (for example, through molding). Even only the plug 3316 can prevent the entry or exit of air flow, but due to the integral formation, there may be cases where an air flow path does not exist.

[0250] As shown in FIGS. 6T - 6W, the cover 3354 can be positioned on the connection port 3600 so as to substantially prevent the entry and exit of fluid into the plenum chamber 3200. The connection of the cover 3354 to the plenum chamber 3200 within the connection port 3600 can be made by friction fitting, press fitting, snap fitting, magnetic engagement or similar connections such that the cover 3354 is removable and (upon connection) also restricts fluid flow through the connection port 3600. The fluid conduit 3358 (e.g., conduit headgear) can be connected to the seal forming structure 3100 at the orifice 3202. The fluid conduit 3358 is a hollow tube and includes an inlet 3362 at the center of the hollow tube. When worn by the patient, the fluid conduit 3358 can extend along a path similar to the arm portion 3328 (e.g., along the cheek) to the upper part of the patient's head. The air circuit 4170 can be connected to the fluid conduit 3358 at the inlet 3362 (i.e., in the region above the patient's head) and can provide pressurized air through the fluid conduit 3358 to the plenum chamber 3200. In other words, the air flow moves from the inlet 3362 through the hollow tube of the fluid conduit 3358 to the plenum chamber 3200. In this configuration (i.e., with the fluid conduit 3358 connected), the fluid conduit 3358 can function as a positioning and stabilization structure 3300 and can consistently assist in holding the seal forming structure 3100 against the patient's face in a therapeutically effective position. Further, the rear strap 3366 can be connected to the tab 3370 of the fluid conduit 3358. The rear strap 3366 can extend around the rear of the patient's head (e.g., across the patient's head in the vicinity of the occipital bone). Thereafter, the patient can select a modality of using the patient interface 3000 to deliver pressurized air to their airway. A major factor in determining this can be the patient's comfort (e.g., where to extend the air circuit 4170 from the patient interface).

[0251] The fluid conduit 3358 can convey pressurized air to the seal-forming structure 3100. The fluid conduit 3358 can be constructed and / or lined with an impermeable material (e.g., silicon, thermoformed and / or laminated structure). The connection of the fluid conduit 3358 to the plenum chamber 3200 is made in a seamless transition or substantially seamless transition manner (e.g., within the orifice 3202) so as to prevent or substantially prevent the situation where pressurized air escapes to the surroundings. In one example, the fluid conduit 3358 is a dual lumen tube. 5.3.4 Ventilation section

[0252] In one form, the patient interface 3000 includes a ventilation section 3400 constructed and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0253] In certain forms, the ventilation section 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the surroundings when the pressure in the plenum chamber is positive relative to the surroundings. The ventilation section 3400 is configured such that, while maintaining the treatment pressure in the plenum chamber during use, the magnitude of the ventilation flow rate is large enough to reduce the rebreathing of exhaled CO2 by the patient.

[0254] One form of the ventilation section 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0255] The ventilation section 3400 can be disposed within the plenum chamber 3200. Alternatively, the ventilation section 3400 is disposed within a disconnect structure (e.g., a swivel). 5.3.5 Disconnect structure(s)

[0256] In one form, the patient interface 3000 includes at least one disconnect structure (e.g., a swivel or ball and socket). 5.3.6 Connection port

[0257] The connection port 3600 enables connection to the air circuit 4170. 5.3.7 Frontal support

[0258] In one form, the patient interface 3000 includes a frontal support 3700. 5.3.8 Anti-asphyxia valve

[0259] In one form, the patient interface 3000 includes an anti-asphyxia valve. 5.3.9 Ports

[0260] In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the amount 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 characteristics (e.g., pressure) of the gas within the plenum chamber 3200. 5.4 RPT device

[0261] 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 4300 (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 to be delivered to a patient's airway for the treatment of one or more of the respiratory diseases described anywhere in this document, for example.

[0262] 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.

[0263] The RPT device may 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 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0264] The pneumatic path of the pneumatic RPT device 4000 may include one or more air path 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., pressure sensors and flow sensors).

[0265] One or more of the air path items may be arranged within a removable integral structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0266] The RPT device 4000 can have an electrical power supply 4210, one or more input devices 4220, a pressure generator 4140, and a transducer 4270. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202. 5.4.1 RPT Device Mechanical and Pneumatic Components

[0267] The RPT device may include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components may be arranged as separate individual units. 5.4.1.1 Air Filter(s)

[0268] The RPT device according to one embodiment of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0269] In one embodiment, the inlet air filter 4112 is disposed at the beginning of the upstream of the air pressure path of the pressure generator 4140.

[0270] In one embodiment, the outlet air filter 4114 (e.g., antibacterial factor) is disposed between the outlet of the air pressure block 4020 and the patient interface 3000. 5.4.1.2 Muffler(s)

[0271] The RPT device according to one embodiment of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0272] In one embodiment of the present technology, the inlet muffler 4122 is disposed upstream of the pressure generator 4140 in the air pressure path.

[0273] In one embodiment of the present technology, the outlet muffler 4124 is disposed between the pressure generator 4140 and the patient interface 3000 in the air pressure path. 5.4.1.3 Pressure Generator

[0274] In one aspect of the technology, the pressure generator 4140 that generates an air flow or supply 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(s) may be disposed within a volute. The blower can deliver an air supply at a rate 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 aspects up to about 30 cmH2O, when performing respiratory pressure therapy. 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 International Publication No. 2013 / 020167.

[0275] The pressure generator 4140 may be under the control of a therapy device controller 4240.

[0276] In other aspects, 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. 5.4.1.4 Transducer(s)

[0277] The transducer may be provided inside the RPT device or outside the RPT device. An external transducer may be disposed, for example, on the air circuit or may form part of the air circuit (e.g., the 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 data to the RPT device).

[0278] In one aspect of the technology, one or more transducers 4270 may be disposed 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 a characteristic of the air flow (e.g., flow rate, pressure, or temperature at that point in the air pressure path).

[0279] In one form of the present technology, one or more converters 4270 may be disposed in the vicinity of the patient interface 3000.

[0280] In one form, the signals from the converter 4270 may be filtered (e.g., by low-pass, high-pass, or band-pass filtering). 5.4.1.5 Anti-spillback valve

[0281] In one form of the present technology, an anti-spillback valve 4160 may 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). 5.4.2 RPT device electrical components 5.4.2.1 Power supply

[0282] The power supply 4210 may be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0283] 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. 5.4.2.2 Input device

[0284] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials may be physical devices or software devices that are accessible via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may wirelessly communicate with a receiver that is electrically connected to a central controller in another form.

[0285] In one form, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options. 5.5 Air Circuit

[0286] An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that during use, an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0287] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0288] 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., a central controller). 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. 5.5.1 Supplemental Gas Delivery

[0289] In one form of the present technology, a supplemental gas, e.g., 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. 5.6 Humidifier

[0290] In one aspect of the present technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., as shown in FIG. 4B). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of an air flow before it is delivered to the patient's airway. 5.7 Respiratory waveform

[0291] FIG. 5 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 breath can have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, T i , 1.6 s, peak inspiratory flow rate, Qpeak, 0.4 L / s, expiratory time, T e , 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / s. The total duration of a breath, T tot is about 4 s. A human typically takes about 15 breaths per minute (BPM) and the ventilation, Vent, is about 7.5 L / min. A typical duty cycle, T i and T tot ratio is about 40%. 5.8 Glossary

[0292] For the purposes of the disclosure of the present technology, in certain aspects of the present technology, one or more of the following definitions may apply. In other aspects of the present technology, other definitions may apply. 5.8.1 General

[0293] Air: In certain aspects of the present technology, air may mean atmosphere, and in other aspects of the present technology, air may mean a combination of other breathable gases (e.g., oxygen-enriched air).

[0294] Ambient: In certain aspects of the present technology, the term "ambient" should be taken to mean (i) outside of the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0295] For example, the ambient humidity with respect to a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0296] In another example, the ambient pressure can be the pressure directly surrounding or outside the body.

[0297] In certain forms, ambient (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 from, for example, an RPT device or from a mask or patient interface. Ambient noise can be generated from sources outside the room.

[0298] Automatic Positive Airway Pressure (APAP) therapy: A CPAP therapy that can automatically adjust the therapy pressure, for example, between a minimum limit and a maximum limit during the breathing cycle, depending on the presence or absence of signs of SDB onset.

[0299] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet slightly increases during exhalation and slightly decreases during inhalation. In some forms, the pressure varies between different breathing 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).

[0300] 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 refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate can be assigned the symbol Q. The "flow rate" may be briefly referred to as "flow" or "airflow".

[0301] In an example of a patient's breathing, the flow can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The device flow Qd is the flow of air exiting the RPT device. The total flow Qt is the flow of air and any supplemental gas reaching the patient interface via the air circuit. The ventilation flow Qv is the flow of air exiting the ventilation section to allow for the outflow of the exhaled gas. The leak flow Ql is the flow of leakage from the patient interface system or other locations. The breathing flow Qr is the flow of air received into the patient's respiratory system.

[0302] Flow therapy: A respiratory therapy that includes delivering an air flow to the airway inlet at a controlled flow rate, referred to as a therapy flow rate, which is typically positive pressure throughout the patient's breathing cycle.

[0303] Humidifier: The term "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 respiratory condition.

[0304] 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 a swivel elbow to the surroundings.

[0305] Noise conduction (acoustic): In this document, conductive noise refers to noise conveyed to the patient by an air pressure path (e.g., the air circuit and the patient interface and the air within it). In one form, conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0306] Noise emission (acoustic): In this document, emitted noise refers to noise conveyed to the patient by the ambient air. In one form, emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0307] Noise, ventilation (acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., the ventilation holes of a patient interface).

[0308] Oxygen-enriched air: Oxygen having an oxygen concentration higher than the oxygen concentration of the atmosphere (21%) (e.g., at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99%). "Oxygen-enriched air" may be abbreviated as "oxygen" in some cases.

[0309] Medical oxygen: Medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

[0310] Patient: A person with or without a respiratory disease.

[0311] 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 (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0312] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure representing the target value to be achieved by the interface pressure Pm at the current time is given the symbol Pt.

[0313] Respiratory pressure therapy: Addition of air supply to the airway inlet at a therapeutic pressure that is typically positive pressure with respect to the atmosphere.

[0314] Ventilator: A mechanical device that provides pressure assistance when a patient performs some or all of the breathing movements. 5.8.1.1 Materials

[0315] Silicone or silicone elastomer: A synthetic rubber. As used herein, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression molded 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 stated, 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.

[0316] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate. 5.8.1.2 Mechanical properties

[0317] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0318] Elastic: Releases substantially all energy during unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0319] 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 can include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. ● "Hard" materials can include polycarbonate, polypropylene, steel or aluminum and cannot be easily deformed, for example, under finger pressure.

[0320] 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, extension, bending, or torsion). A structure or component can provide different resistance in different directions. The antonym of stiffness is flexibility.

[0321] Flabby structure or component: A structure or component that changes its shape (e.g., bends) relatively quickly (e.g., within 1 second) when supported under its own weight.

[0322] Rigid structure or component: A structure or component that does not substantially change its shape when subjected to 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's airway inlet at a pressure load of, for example, approximately 20 - 30 cmH2O.

[0323] As an example, an I - beam can include different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component can be flabby in a first direction and rigid in a second direction. 5.8.2 Respiratory cycle

[0324] Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not allowed due to some airway obstruction. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0325] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0326] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0327] Work (breathing): The breathing effort is said to refer to the movement performed by the spontaneous breathing of the person attempting to breathe.

[0328] Expiratory part of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0329] Flow limitation: Flow limitation is interpreted as a situation in a patient's breathing where an increase in the patient's work does not cause a corresponding increase in the flow. When flow limitation occurs in the inspiratory part of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs in the expiratory part of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0330] Types of waveforms of inspiratory flow limitation: (i) Flattening: After an ascent, a relatively flat part follows, and then a descent occurs. (ii) M-shaped: Having one local peak in the rising part and one local peak in the falling part, with a relatively flat part between these two peaks. (iii) Chair-shaped: Having a single local peak, which occurs in the rising part and is followed by a relatively flat part. (iv) Inverse chair-shaped: A single local peak follows a relatively flat part, and this peak occurs in the falling part.

[0331] Respiratory depression: According to some definitions, respiratory depression means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a period, it is said that respiratory depression has occurred. When respiratory depression is detected due to a decrease in breathing effort, it is said that central respiratory depression has occurred. In one form in adults, any of the following may occur and be regarded as respiratory depression: (i) A decrease of 30% in the patient's respiration is associated with at least a 4% desaturation for at least 10 seconds, or (ii) A decrease (less than 50%) in the patient's respiration continues for at least 10 seconds and is associated with at least a 3% desaturation or an arousal occurs.

[0332] Hyperventilation: An increase in flow to a level higher than the normal flow rate.

[0333] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0334] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0335] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of expiration.

[0336] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0337] Respiratory flow, air flow, patient air flow, respiratory gas flow (Qr): These terms can be understood to refer to the estimation of the respiratory air flow of the RPT device and are the actual respiratory flow of the patient, usually expressed in liters per minute, as opposed to the "true respiratory flow" or "true respiratory flow".

[0338] Tidal volume (Vt): The amount of air inhaled or exhaled during a normal inspiration without extra effort. In principle, since the inspiratory volume Vi (the amount of air inhaled) is equal to the expiratory volume Ve (the amount of air exhaled), a single tidal volume Vt can be defined as equal to either amount. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inspiratory volume Vi and the expiratory volume Ve).

[0339] (Inspiratory) time (Ti ): Duration of the inspiratory part of the respiratory flow waveform.

[0340] (Expiration) time (T e ): Duration of the expiratory part of the respiratory flow waveform.

[0341] (Total) time (T tot ): Total duration between the start of one inspiratory part of the respiratory flow waveform and the start of the next inspiratory part of the respiratory flow waveform.

[0342] Typical recent ventilation: Ventilation value (i.e., degree of tendency of the center of the most recent ventilation values) where the most recent values of ventilation Vent over a given time scale tend to cluster.

[0343] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. May be associated with a state of flow limitation where flow may increase slightly or decrease along with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0344] Ventilation (Vent): Measurement of the gas exchange rate performed by the patient's respiratory system. The measurement of ventilation may include one or both of the inspiratory flow and the expiratory flow per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as volume and is understood as volume per minute. 5.8.3 Anatomical structure 5.8.3.1 Facial anatomical structure

[0345] Ala: The outer outer wall or "wing" of each nasal cavity (plural: alar)

[0346] Alare: The outermost point on the alar nose.

[0347] 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.

[0348] Auricle: The entire visible part of the ear.

[0349] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0350] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0351] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0352] Columella Angle: The angle between a line drawn through the midpoint of the nasal aperture and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0353] Frankfurt Horizontal Plane: A line extending from the lowest point of the orbital margin to the auricular point. The auricular point is the deepest point from the upper notch to the earlobe of the auricle.

[0354] Glabella: Located in the soft tissue, the most prominent point in the mid-sagittal plane of the forehead.

[0355] Lateral Nasal Cartilage: Generally a 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.

[0356] Major Alar Cartilage: A plate of cartilage located below the lateral nasal cartilage. It curves around the front part of the nasal aperture. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0357] Nasal Aperture (Nares): Generally an oval alar aperture that forms the entrance to the nasal cavity. The singular form of nares is naris (nasal aperture). These nasal apertures are separated by the nasal septum.

[0358] Nasolabial Groove or Nasolabial Fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0359] Nasolabial angle: The angle between the nasal column and the upper lip, which intersects the subnasale point.

[0360] Subaurale: The lowest point of attachment of the auricle to the facial skin.

[0361] Supraaurale: The highest point of attachment of the auricle to the facial skin.

[0362] Nasion: The most prominent point or tip of the nose, which can be identified in the lateral view of the remaining part of the head portion.

[0363] Philtrum: The midline groove extending from the lower border of the nasal septum to the upper part of the lip in the upper lip region.

[0364] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0365] (Nasal) sill: The nasal sill is the midline ridge of the nose, extending from the sellion to the nasion.

[0366] Sagittal plane: A vertical plane extending from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into the right and left halves.

[0367] Sellion: The most concave point on the soft tissue, located on the region of the fronto-nasal suture.

[0368] Septal cartilage (nasal): The septal cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0369] Alar lowest point: The point at the lower periphery of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0370] Subnasale: Located on the soft tissue, the point where the nasal column joins the upper lip in the median sagittal plane.

[0371] Spragion: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion. 5.8.3.2 Anatomical Structure of the Skull

[0372] Frontal bone: The frontal bone includes the frontal squama, which is a large vertical portion corresponding to the area known as the forehead region.

[0373] Mandible: The mandible forms the lower jaw. The mental eminence is a bony prominence of the jaw and forms the jaw.

[0374] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0375] Nasal bones: The nasal bones are two small rectangular bones, which vary in size and shape among individuals. 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.

[0376] Nasion: The intersection of the frontal bone and the two nasal bones, which is a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0377] Occipital bone: The occipital bone is located on the back and lower part of the skull. It includes the foramen magnum, which is an elliptical hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved panel behind the foramen magnum is the occipital squama.

[0378] Orbit: A bony cavity in the skull that contains the eyeball.

[0379] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0380] 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.

[0381] Zygomatic bone: The two zygomatic bones included in the face are located in the upper and outer parts of the face and form the zygomatic prominences. 5.8.3.3 Anatomical Structure of the Respiratory System

[0382] Diaphragm: A sheet of muscle that extends over the bottom of the rib cage. 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.

[0383] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0384] Lungs: The respiratory organs in humans. The conducting zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0385] 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. There is a nose at the front of the nasal cavity, and it connects to the nasopharynx at the back via the posterior nares.

[0386] 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 sections: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (midpharyngeal part) (the oral part of the pharynx), and the laryngopharynx (hypopharynx). 5.8.4 Patient Interface

[0387] Anti-asphyxia valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathed excessive CO2 by opening to the atmosphere in a fail-safe manner.

[0388] 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 relative 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 manufacturing while being non-removable by the patient.

[0389] 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.

[0390] 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 collection of one or more struts, ties, and supplementary rigid materials configured to position and hold a face interface (e.g., a 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 foam and fabric).

[0391] Membrane: The membrane is typically taken to mean a thin element and preferably substantially resists bending and resists stretching.

[0392] Pleural chamber: The mask pleural 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 may form part of the wall of the mask pleural chamber.

[0393] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal (off)"), it can refer to its effect. Two elements can be constructed and / or arranged so as to "seal" or obtain a "sealing" effect between them without requiring a separate "seal" element itself.

[0394] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structural 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.

[0395] Reinforcing member: A reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0396] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0397] Swivel (noun): A sub-assembly of components configured to rotate preferably independently and preferably with low torque about a common axis. In one form, the swivel can be constructed to rotate at an angle of at least 360 degrees. In another form, the swivel can be constructed 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. During use, there is little leakage of the air flow from the swivel.

[0398] Tai (noun): A structure designed to resist tension.

[0399] Ventilation part: (noun) A structure that enables air flow to the ambient air inside the mask or conduit and enables clinically effective flushing of the exhaled gas. For example, in clinically effective flushing, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure. 5.8.5 Shape of the structure

[0400] The product according to this technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure can be bounded by a two-dimensional surface. These surfaces can be distinguished using labels to describe the direction, position, function, or some other characteristic 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 example, 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 example, the structure may include a first surface and a second surface.

[0401] 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 to 3F. FIGS. 3B to 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 to 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 examples, this surface is described from the perspective of a fictional small person standing upright on the surface. 5.8.5.1 Curvature in one dimension

[0402] 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).

[0403] 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 referred to as concave.

[0404] 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.

[0405] 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 referred to as convex. 5.8.5.2 Curvature of a two-dimensional surface

[0406] The description of the shape at a given point on a two-dimensional surface according to this 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 ("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 (e.g., relatively small). The planar curves in FIGS. 3B to 3F can be examples of such a plurality of cross-sections at a specific point.

[0407] Principal curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values is called the principal direction. 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.

[0408] Region of the surface: A set of connected points on the surface. This set of points within the region can have similar characteristics (e.g., curvature or sign).

[0409] Saddle region: A region where the principal curvatures have opposite signs (i.e., one positive and the other negative) at each point (depending on the direction in which an imaginary person walking uphill or downhill would face).

[0410] 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.

[0411] 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.

[0412] Plane region: A region of the surface where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0413] Edge of the surface: The boundary or limit of the surface or region.

[0414] Path: In a particular form of the present technology, a "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, a "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path of an imaginary person is where they walk on the surface and is similar to a garden path).

[0415] Path length: In certain embodiments of the present technology, "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).

[0416] 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"). 5.8.5.3 Space curve

[0417] Space curve: Unlike a planar curve, a space curve does not necessarily exist within any particular plane. A space curve can be closed. That is, it has no end points. A space curve can be considered 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 edges 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 way 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.

[0418] 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.

[0419] 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.

[0420] 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 alternatively the left-hand rule (Figure 3O).

[0421] Contact plane: The plane that contains the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0422] 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.

[0423] Referring to the right-hand rule of FIG. 3P, a space curve that bends in the direction of the right-hand sub-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 sub-normal direction can be regarded as having a negative twist of the right hand (e.g., a left-hand helix).

[0424] Similarly, referring to the left-hand rule (see FIG. 3O), a space curve that faces the left-hand sub-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. 5.8.5.4 Holes

[0425] A surface can have a one-dimensional hole (e.g., a hole bounded by a planar curve or a space curve). In the case of a thin structure (e.g., a membrane) containing 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.

[0426] A structure can have a two-dimensional hole (e.g., a hole 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. 5.9 Other Considerations

[0427] Part of the disclosure of this patent document contains content that is protected by copyright. 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.

[0428] Unless otherwise clearly apparent from the context and unless a range of values is provided, each intervening value between the lower limit of 1 / 10 of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value in the stated range of the description is understood to be included in this technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the stated range, they are included in this technology. If the stated range includes one or both of these limits, ranges exceeding either or both of these stated limits are also included in this technology.

[0429] Furthermore, when a value (singular or plural) is embodied as part of this technology in this specification, unless otherwise specified, it is understood that such a value can be approximated and used to any appropriate significant digits up to the range permitted or required by practical technical implementation.

[0430] Furthermore, "about", "substantially", "approximately" or any similar term used in this specification means + / -5 to + / -10% of the stated value.

[0431] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as commonly understood by those skilled in the art to which this technology belongs. Any methods and materials similar to or equivalent to those described in this specification can be used in the practice or testing of this technology, but only a limited number of exemplary methods and materials are described in this specification.

[0432] Although a specific material is described as being preferably used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and thus may be manufactured either collectively or individually.

[0433] As used in this specification and the appended claims, note that the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0434] All publications mentioned 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 herein are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such publications by virtue of prior invention. Further, the dates of the publications may be different from the actual dates of publication and may need to be individually verified.

[0435] The terms "comprises" and "comprising" are to be construed as having a non-exclusive meaning, indicating that the recited elements, components, or steps may be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0436] 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 entire scope of the claims. These headings should not be used in the interpretation of the scope of the claims or limitations of the scope of the claims.

[0437] Although the techniques in this specification have been described with reference to specific examples, it should be understood that these examples 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, the terms "first" and "second" are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Furthermore, the description or illustration of process steps in this method may be presented in an ordered manner, but 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.

[0438] Therefore, it should be understood that numerous variations are possible in exemplary examples without departing from the spirit and scope of the technology, and other arrangements can be devised.

Description of Reference Signs

[0439] 5.10 List of Reference Signs 1000 Patient 1100 Bedmate 3000 Patient Interface 3100 Seal Forming Structure 3200 Plenum Chamber 3202 Orifice 3210 Tendon 3212 Protrusion 3220 Upper Point 3230 Lower Point 3300 Structure 3302 Headgear Assembly 3304 Sleeve 3304a First Portion 3304b Second Portion 3306 Single Rigid Arm 3306 Rigid Arm 3308 Cavity 3310a First Rear Section 3310b Second Rear Section 3312 Fastener 3315 Opening 3316 Plug 3320 Body 3320a First body part 3320b Second body part 3324 Aperture 3328 Arm part 3329 End part 3330 Free end 3334 Inner connecting part 3338 Outer connecting part 3342 Free end 3346 Protrusion 3348 Shaft 3354 Cover 3358 Fluid conduit 3362 Inlet 3366 Rear strap 3370 Tab 3400 Ventilation part 3600 Connection port 3700 Forehead support part 3744 ISO 4000 RPT device 4010 External housing 4012 Upper part 4014 Portion 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic block 4110 Air filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Anti - spillback valve 4170 Air circuit 4171 Ring 4180 Supplementary gas 4200 Electrical components 4202 Single printed circuit board assembly PCBA 4210 Power supply 4220 Input device 4270 Converter 5000 Humidifier

Claims

Claim 1 A patient interface, comprising At least 6 cmH higher than the ambient air pressure ２ A plenum chamber capable of being pressurized to a treatment pressure at least 6 cmH higher than the ambient air pressure, said plenum chamber including a plenum chamber inlet port, said plenum chamber inlet port being sized and configured to receive an air flow at said treatment pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face around an entrance to the patient's airway, the seal-forming structure having a hole therein such that the air flow is delivered at the treatment pressure to at least an entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; and a positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, wherein the positioning and stabilization structure comprises at least one rigid arm configured to be positioned adjacent to the patient's cheek during use; and a strap removably received around the rigid arm and configured to contact a rear region of the patient's head during use, wherein the strap comprises a first rigid connection portion forming an opening for a cavity, the rigid arm being positionable into the cavity through the opening, the first rigid connection portion having a mechanical connector, the mechanical connector being configured to engage the rigid arm and limit movement of the rigid arm inside and outside of the cavity; a second rigid connection portion spaced apart from an outer surface of the first rigid connection portion; and a sleeve constructed from a flexible material, the sleeve being folded over the second rigid connection portion and positioned between the first rigid connection portion and the second rigid connection portion, the patient interface comprising. Claim 2 The patient interface according to claim 1, wherein the sleeve comprises an outer surface including an outermost surface of the strap and an inner surface including a boundary of the cavity. Claim 3 The patient interface according to claim 1 or 2, wherein the mechanical connector of the first rigid connection portion comprises a protrusion, and the rigid arm comprises a recess configured to receive the protrusion. Claim 4 The patient interface according to claim 3, wherein the protrusion extends at an angle of 40° to 60° from an inner surface of the first rigid connection portion, the angle being measured with respect to an axis parallel to a radial axis of the first rigid connection portion. Claim 5 The mechanical connector is the patient interface according to any one of claims 1 to 4, including snap-fit connection.

6. The flexible material is a textile, and the patient interface according to any one of claims 1 to 5.

7. The flexible material is elastic and / or elastomeric, and the patient interface according to any one of claims 1 to 6.

8. The first rigid connecting portion and the second rigid connecting portion have a generally circular shape, and the rigid arm further includes an extension having at least a part of the generally circular shape, and the patient interface according to any one of claims 1 to 7.

9. The rigid arm is configured not to extend further rearward than the patient's ear, and the patient interface according to any one of claims 1 to 8.

10. The strap includes a first piece and a second piece connected together using a length adjuster, and the length adjuster is configured to change the usable length of the strap, and the patient interface according to any one of claims 1 to 9.

11. The strap is of a branched type, and the patient interface according to any one of claims 1 to 10.

12. The at least one rigid arm includes a first rigid arm configured to be positioned on the left side of the patient's head during use, A second rigid arm connected to the positioning and stabilization structure, wherein the second rigid arm is configured to be positioned adjacent to the right cheek of the patient during use, and the second rigid arm. The strap is removably received around the second rigid arm, and the strap is A third rigid connecting portion that defines a second opening for the cavity, wherein the second rigid arm can be positioned into the cavity through the second opening, and the third rigid connecting portion has a mechanical connector, and the mechanical connector engages with the second rigid arm and limits the movement of the second rigid arm inside and outside the second opening of the cavity. A fourth rigid connecting portion spaced apart from the outer surface of the first rigid connecting portion. Including. The sleeve is folded over the fourth rigid connection part and positioned between the third rigid connection part and the fourth rigid connection part, the patient interface according to any one of claims 1 to 11.

13. The plenum chamber inlet port is a first plenum chamber inlet port, the plenum chamber further includes a second plenum chamber inlet port, the first plenum chamber inlet port is configured to receive the air flow at the treatment pressure, and the second plenum chamber inlet port is configured to receive a plug configured to prevent a situation where the air flow escapes at the treatment pressure, the patient interface according to any one of claims 1 to 12.

14. The rigid arm includes the plug, the patient interface according to claim 13.

15. The plug is removable from the second opening so as to allow a flow of pressurized air through the second opening, the patient interface according to claim 13 or 14.

16. The rigid arm is at least partially flexible to adjust the outer shape so as to substantially correspond to the cheek of the patient, the patient interface according to any one of claims 1 to 15.

17. A nasal pillow or a cradle is defined by the seal forming structure, the patient interface according to any one of claims 1 to 16.

18. The first rigid connection part, the second rigid connection part and the sleeve are connected together using an adhesive, the patient interface according to any one of claims 1 to 17.

19. The width of the cavity is less than the width of the rigid arm, and the sleeve is configured to stretch when receiving the rigid arm, the patient interface according to any one of claims 1 to 18.

20. A method for manufacturing the patient interface according to any one of claims 1 to 19, the manufacturing method comprising: providing the flexible material; inserting a second connection part into the cavity of the flexible material; folding an end of the flexible material into the cavity to enclose the second connection part; and inserting a first connection part into the cavity, thereby forming the strap.

21. The manufacturing method further includes a step of connecting the positioning and stabilizing structure to the seal forming structure, and the connecting step includes: providing a connection opening in the plenum chamber; and inserting the plug of the rigid arm into the connection opening, the manufacturing method according to claim 20. **Claim 22** The manufacturing method according to claim 21, further including adding an adhesive around the connection opening to fix the plug within the opening. **Claim 23** The manufacturing method according to claim 21, further including removing the plug from the connection opening. **Claim 24** A patient interface, comprising: At least 6 cmH higher than the ambient air pressure ２ A plenum chamber capable of being pressurized to a treatment pressure at least 6 cmH higher than the ambient air pressure, the plenum chamber including a plenum chamber inlet port and a connection inlet port, the plenum chamber inlet port being sized and structured to receive an air flow at the treatment pressure for breathing by a patient, and the connection inlet port being sized and structured to receive an air flow at the treatment pressure for breathing by the patient; a seal forming structure constructed and arranged to form a seal with a region of the patient's face around an entrance to the patient's airway, the seal forming structure having a hole therein such that the air flow is delivered at least to an entrance to the patient's nostrils at the treatment pressure, the seal forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; and the connection inlet port is configured to removably receive a positioning and stabilizing structure that provides a force for holding the seal forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including: a rigid arm configured to restrict fluid flow through the connection inlet port, the rigid arm being configured to be positioned along the patient's cheek during use; and a conduit headgear configured to convey the air flow to the patient through the connection inlet port, the patient interface including at least one of these. **Claim 25** The rigid arm is connected to the connection inlet port, and the rigid arm includes: a plug removably received within the connection inlet port, the plug including: a plug configured to restrict the air flow through the connection inlet port; and an arm portion configured to be positioned adjacent to the patient's cheek, the patient interface according to claim 24. **Claim 26** The patient interface according to claim 25, wherein the plenum chamber inlet port is configured to receive the air flow during use. **Claim 27** The conduit headgear is connected to the connection inlet port, and the conduit headgear is an inlet configured to receive the air flow, the inlet being disposed above the head of the patient during use; and a hollow tube configured to convey the air flow to the plenum chamber, The patient interface according to claim 24, comprising.

28. Further comprising a cover, the cover being removably received within the plenum chamber inlet port while the conduit headgear is connected to the connection inlet port, the cover restricting fluid flow through the plenum chamber inlet port. The patient interface according to claim 27.

29. The patient interface according to any one of claims 24 to 28, wherein the rigid arm and the conduit headgear are interchangeably connectable to the connection inlet port.

30. A method of using the patient interface according to any one of claims 24 to 29, the method comprising: providing the seal-forming structure; selecting the positioning and stabilizing structure from one of the rigid arm and the conduit headgear; connecting the positioning and stabilizing structure to the connection inlet port; connecting one of the air circuit and the cover to the plenum chamber inlet port; and providing an air flow through one of the positioning and stabilizing structure and the air circuit, and restricting the air flow using one of the cover and the positioning and stabilizing structure, A method of use, comprising.

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